Order zithromax online uk

Start Preamble https://blog.printpapa.com/can-you-buy-zithromax-online Centers for Medicare & order zithromax online uk. Medicaid Services (CMS), HHS. Proposed rule order zithromax online uk.

This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This proposed rule would also establish a permanent mitigation policy to smooth the impact order zithromax online uk of year-to-year changes in IPF payments related to decreases in the IPF wage index. In addition, this proposed rule includes a request for comment on the results of the data analysis of the IPF Prospective Payment System adjustments.

The proposed changes in this rule would be effective for IPF discharges occurring during the order zithromax online uk Fiscal Year (FY) beginning October 1, 2022 through September 30, 2023 (FY 2023). Lastly, this proposed rule requests information on Measuring Equity and Healthcare Quality Disparities Across CMS Quality Programs. To be assured consideration, comments must be received at one of the addresses provided below by May 31, 2022.

In commenting, please refer to order zithromax online uk file code CMS-1769-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed). 1 order zithromax online uk.

Electronically. You may submit electronic comments on this order zithromax online uk regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2 order zithromax online uk. By regular mail. You may mail written comments to the following address ONLY.

Centers for Medicare & order zithromax online uk. Medicaid Services, Department of Health and Human Services, Attention. CMS-1769-P, P.O order zithromax online uk.

Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments order zithromax online uk to be received before the close of the comment period. 3.

By express or overnight mail. You may send written comments to order zithromax online uk the following address ONLY. Centers for Medicare &.

Medicaid Services, order zithromax online uk Department of Health and Human Services, Attention. CMS-1769-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information order zithromax online uk on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

Start Further Info The IPF Payment Policy mailbox at IPFPaymentPolicy@cms.hhs.gov for general information. Mollie Knight order zithromax online uk (410) 786-7948 or Eric Laib (410) 786-9759, for information regarding the market basket update or the labor-related share. Nick Brock (410) 786-5148 or Theresa Bean (410) 786-2287, for information regarding the regulatory impact analysis.

Lauren Lowenstein, (410) 786-4507, for information regarding the inpatient psychiatric facilities quality reporting program. End Further Info End Preamble order zithromax online uk Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment.

We post all comments received before the close of the comment period on the following website as soon as possible after they have been received order zithromax online uk. Http://www.regulations.gov. Follow the search order zithromax online uk instructions on that website to view public comments.

CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will order zithromax online uk post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Availability of Certain Tables Exclusively Through the Internet on the CMS Website Addendum A to this proposed rule summarizes the FY 2023 IPF PPS payment rates, outlier threshold, cost of living adjustment factors (COLA) for Alaska and Hawaii, national and upper limit cost-to-charge ratios, and adjustment factors. In addition, the B Addenda to this proposed rule shows Start Printed Page 19416 the complete listing order zithromax online uk of ICD-10 Clinical Modification (CM) and Procedure Coding System (PCS) codes, the FY 2023 IPF PPS comorbidity adjustment, and electroconvulsive therapy (ECT) procedure codes. The A and B Addenda are available online at.

Https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. Tables setting forth the FY 2023 Wage Index for Urban Areas Based on Core-Based Statistical Area (CBSA) Labor Market Areas and the FY 2023 Wage Index Based on CBSA Labor Market Areas for Rural Areas are available exclusively through the internet, on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​IPFPPS/​WageIndex.html. I.

Executive Summary A. Purpose This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs) for discharges occurring during Fiscal Year (FY) 2023 beginning October 1, 2022 through September 30, 2023. This proposed rule would also establish a permanent mitigation policy to smooth the impact of year-to-year changes in IPF payments related to changes in the IPF wage index.

In addition, this proposed rule includes a request for comment on the results of the data analysis of the IPF Prospective Payment System (PPS) adjustments. Lastly, this proposed rule requests information on Measuring Equity and Healthcare Quality Disparities Across CMS Quality Programs. B.

Summary of the Major Provisions 1. Inpatient Psychiatric Facilities Prospective Payment System For the IPF PPS, we are proposing to— Establish a permanent mitigation policy in order to smooth the impact of year-to-year changes in IPF payments related to decreases to the IPF wage index. • Solicit comments on the results of the data analysis of the IPF PPS adjustments, which have been summarized in a technical report posted to the Centers for Medicare &.

Medicaid Services (CMS) website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS. Update the IPF PPS base rate by the 2016-based IPF market basket update (3.1 percent) adjusted for economy-wide productivity (0.4 percentage point) as required by section 1886(s)(2)(A)(i) of the Social Security Act (the Act), resulting in a proposed IPF payment rate update of 2.7 percent for FY 2023. Make technical rate setting updates.

The IPF PPS payment rates would be adjusted annually for inflation, as well as statutory and other policy factors. This rule proposes to update. ++ The IPF PPS Federal per diem base rate from $832.94 to $856.80.

++ The IPF PPS Federal per diem base rate for providers who failed to report quality data to $840.11. ++ The ECT payment per treatment from $358.60 to $368.87. ++ The ECT payment per treatment for providers who failed to report quality data to $361.69.

++ The labor-related share from 77.2 percent to 77.4 percent. ++ The wage index budget-neutrality factor to 1.0016. ++ The fixed dollar loss threshold amount from $16,040 to $24,270 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF PPS payments.

2. Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program We are not proposing any changes to the IPFQR Program. However, we are including a request for information (RFI) on the Overarching Principles for Measuring Healthcare Quality Disparities Across CMS Quality Programs.

Feedback provided will inform future efforts in all CMS Quality programs and, as applicable, may be introduced in the IPFQR as future RFIs or proposals. C. Summary of Impacts Provision descriptionTotal transfers &.

Cost reductionsFY 2023 IPF PPS payment updateThe overall economic impact of this proposed rule is an estimated $50 million in increased payments to IPFs during FY 2023. II. Background A.

Overview of the Legislative Requirements of the IPF PPS Section 124 of the Medicare, Medicaid, and State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) required the establishment and implementation of an IPF PPS.

Specifically, section 124 of the BBRA mandated that the Secretary of the Department of Health and Human Services (the Secretary) develop a per diem PPS for inpatient hospital services furnished in psychiatric hospitals and excluded psychiatric units including an adequate patient classification system that reflects the differences in patient resource use and costs among psychiatric hospitals and excluded psychiatric units. €œExcluded psychiatric unit” means a psychiatric unit of an acute care hospital or of a Critical Access Hospital (CAH), which is excluded from payment under the Inpatient Prospective Payment System (IPPS) or CAH payment system, respectively. These excluded psychiatric units will be paid under the IPF PPS.

Section 405(g)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) extended the IPF PPS to psychiatric distinct part units of CAHs.

Sections 3401(f) and 10322 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by section 10319(e) of that Act and by section 1105(d) of the Health Care and Education Reconciliation Act of 2010 (Pub.

L. 111-152) (hereafter referred to jointly as “the Affordable Care Act”) added subsection (s) to section 1886 of the Act. Section 1886(s)(1) of the Act titled “Reference to Establishment and Implementation of System,” refers to section 124 of the BBRA, which relates to the establishment of the IPF PPS.

Section 1886(s)(2)(A)(i) of the Act requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the IPF PPS for the rate year (RY) beginning in 2012 (that is, a RY that coincides with a FY) and each subsequent RY. Section 1886(s)(2)(A)(ii) of the Act required the application of an “other adjustment” that reduced any update to an IPF PPS base rate by a percentage point amount specified in section 1886(s)(3) of the Act for the RY beginning in 2010 through the RY beginning in 2019. As noted in the FY 2020 IPF PPS final rule, for the RY beginning in 2019, section 1886(s)(3)(E) of the Act required that the other adjustment reduction be equal to 0.75 percentage point.

This was the final year Start Printed Page 19417 the statute required the application of this adjustment. Because FY 2021 was a RY beginning in 2020, FY 2021 was the first-year section 1886(s)(2)(A)(ii) did not apply since its enactment. Sections 1886(s)(4)(A) through (D) of the Act require that for RY 2014 and each subsequent RY, IPFs that fail to report required quality data with respect to such a RY will have their annual update to a standard Federal rate for discharges reduced by 2.0 percentage points.

This may result in an annual update being less than 0.0 for a RY, and may result in payment rates for the upcoming RY being less than such payment rates for the preceding RY. Any reduction for failure to report required quality data will apply only to the RY involved, and the Secretary will not consider such reduction in computing the payment amount for a subsequent RY. Additional information about the specifics of the current Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program is available in the FY 2020 IPF PPS and Quality Reporting Updates for FY Beginning October 1, 2019 final rule (84 FR 38459 through 38468).

To implement and periodically update these provisions, we have published various proposed and final rules and notices in the Federal Register. For more information regarding these documents, see the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​index.html?. €‹redirect=​/​InpatientPsychFacilPPS/​.

B. Overview of the IPF PPS On November 15, 2004, we published the IPF PPS final rule in the Federal Register (69 FR 66922). The November 2004 IPF PPS final rule established the IPF PPS, as required by section 124 of the BBRA and codified at 42 CFR part 412, subpart N.

The November 2004 IPF PPS final rule set forth the Federal per diem base rate for the implementation year (the 18-month period from January 1, 2005 through June 30, 2006), and provided payment for the inpatient operating and capital costs to IPFs for covered psychiatric services they furnish (that is, routine, ancillary, and capital costs, but not costs of approved educational activities, bad debts, and other services or items that are outside the scope of the IPF PPS). Covered psychiatric services include services for which benefits are provided under the fee-for-service Part A (Hospital Insurance Program) of the Medicare program. The IPF PPS established the Federal per diem base rate for each patient day in an IPF derived from the national average daily routine operating, ancillary, and capital costs in IPFs in FY 2002.

The average per diem cost was updated to the midpoint of the first year under the IPF PPS, standardized to account for the overall positive effects of the IPF PPS payment adjustments, and adjusted for budget-neutrality. The Federal per diem payment under the IPF PPS is comprised of the Federal per diem base rate described previously and certain patient- and facility-level payment adjustments for characteristics that were found in the regression analysis to be associated with statistically significant per diem cost differences. With statistical significance defined as p less than 0.05.

A complete discussion of the regression analysis that established the IPF PPS adjustment factors can be found in the November 2004 IPF PPS final rule (69 FR 66933 through 66936). The patient-level adjustments include age, Diagnosis-Related Group (DRG) assignment, and comorbidities, as well as adjustments to reflect higher per diem costs at the beginning of a patient's IPF stay and lower costs for later days of the stay. Facility-level adjustments include adjustments for the IPF's wage index, rural location, teaching status, a cost-of-living adjustment for IPFs located in Alaska and Hawaii, and an adjustment for the presence of a qualifying emergency department (ED).

The IPF PPS provides additional payment policies for outlier cases, interrupted stays, and a per treatment payment for patients who undergo electroconvulsive therapy (ECT). During the IPF PPS mandatory 3-year transition period, stop-loss payments were also provided. However, since the transition ended as of January 1, 2008, these payments are no longer available.

C. Annual Requirements for Updating the IPF PPS Section 124 of the BBRA did not specify an annual rate update strategy for the IPF PPS and was broadly written to give the Secretary discretion in establishing an update methodology. Therefore, in the November 2004 IPF PPS final rule, we implemented the IPF PPS using the following update strategy.

Calculate the final Federal per diem base rate to be budget-neutral for the 18-month period of January 1, 2005 through June 30, 2006. Use a July 1 through June 30 annual update cycle. Allow the IPF PPS first update to be effective for discharges on or after July 1, 2006 through June 30, 2007.

The November 2004 final rule (69 FR 66922) implemented the IPF PPS. In developing the IPF PPS, and to ensure that the IPF PPS can account adequately for each IPF's case-mix, we performed an extensive regression analysis of the relationship between the per diem costs and certain patient and facility characteristics to determine those characteristics associated with statistically significant cost differences on a per diem basis. That regression analysis is described in detail in our November 28, 2003 IPF proposed rule (68 FR 66923.

66928 through 66933) and our November 15, 2004 IPF final rule (69 FR 66933 through 66960). For characteristics with statistically significant cost differences, we used the regression coefficients of those variables to determine the size of the corresponding payment adjustments. In the November 2004 IPF final rule, we explained the reasons for delaying an update to the adjustment factors, derived from the regression analysis, including waiting until we have IPF PPS data that yields as much information as possible regarding the patient-level characteristics of the population that each IPF serves.

We indicated that we did not intend to update the regression analysis and the patient-level and facility-level adjustments until we complete that analysis. Until that analysis is complete, we stated our intention to publish a notice in the Federal Register each spring to update the IPF PPS (69 FR 66966). On May 6, 2011, we published a final rule in the Federal Register titled, “Inpatient Psychiatric Facilities Prospective Payment System—Update for Rate Year Beginning July 1, 2011 (RY 2012)” (76 FR 26432), which changed the payment rate update period to a RY that coincides with a FY update.

Therefore, final rules are now published in the Federal Register in the summer to be effective on October 1st. When proposing changes in IPF payment policy, a proposed rule is issued in the spring, and the final rule in the summer to be effective on October 1st. For a detailed list of updates to the IPF PPS, we refer readers to our regulations at 42 CFR 412.428.

The most recent IPF PPS annual update was published in a final rule on August 4, 2021 in the Federal Register titled, “Medicare Program. FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)” (86 FR 42608), which updated the IPF PPS payment rates for FY 2022. That final rule updated the IPF PPS Federal per diem base rates that were Start Printed Page 19418 published in the FY 2021 IPF PPS Rate Update final rule (85 FR 47042) in accordance with our established policies.

III. Provisions of the FY 2023 IPF PPS Proposed Rule A. Proposed FY 2023 Market Basket Update and Productivity Adjustment for the IPF PPS 1.

Background Originally, the input price index that was used to develop the IPF PPS was the “Excluded Hospital with Capital” market basket. This market basket was based on 1997 Medicare cost reports for Medicare participating inpatient rehabilitation facilities (IRFs), IPFs, long-term care hospitals (LTCHs), cancer hospitals, and children's hospitals. Although “market basket” technically describes the mix of goods and services used in providing health care at a given point in time, this term is also commonly used to denote the input price index (that is, cost category weights and price proxies) derived from that market basket.

Accordingly, the term market basket as used in this document, refers to an input price index. Since the IPF PPS inception, the market basket used to update IPF PPS payments has been rebased and revised to reflect more recent data on IPF cost structures. We last rebased and revised the IPF market basket in the FY 2020 IPF PPS rule, where we adopted a 2016-based IPF market basket, using Medicare cost report data for both Medicare participating freestanding psychiatric hospitals and psychiatric units.

We refer readers to the FY 2020 IPF PPS final rule for a detailed discussion of the 2016-based IPF PPS market basket and its development (84 FR 38426 through 38447). References to the historical market baskets used to update IPF PPS payments are listed in the FY 2016 IPF PPS final rule (80 FR 46656). 2.

Proposed FY 2023 IPF Market Basket Update For FY 2023 (beginning October 1, 2022 and ending September 30, 2023), we are proposing to update the IPF PPS payments by a market basket increase factor with a productivity adjustment as required by section 1886(s)(2)(A)(i) of the Act. Consistent with historical practice, we are proposing to estimate the market basket update for the IPF PPS based on the most recent forecast available at the time of rulemaking from IHS Global Inc. (IGI).

IGI is a nationally recognized economic and financial forecasting firm with which CMS contracts to forecast the components of the market baskets and productivity adjustment. For the proposed rule, based on IGI's fourth quarter 2021 forecast with historical data through the third quarter of 2021, the 2016-based IPF market basket increase factor for FY 2023 is 3.1 percent. Section 1886(s)(2)(A)(i) of the Act requires that, after establishing the increase factor for a FY, the Secretary shall reduce such increase factor for FY 2012 and each subsequent FY, by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.

Section 1886(b)(3)(B)(xi)(II) of the Act sets forth the definition of this productivity adjustment. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost reporting period, or other annual period) (the “productivity adjustment”). The United States Department of Labor's Bureau of Labor Statistics (BLS) publishes the official measures of productivity for the United States economy.

We note that previously the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act was published by BLS as private nonfarm business MFP. Beginning with the November 18, 2021 release of productivity data, BLS replaced the term “multifactor productivity” with “total factor productivity” (TFP). BLS noted that this is a change in terminology only and will not affect the data or methodology.

As a result of the BLS name change, the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as private nonfarm business total factor productivity. However, as mentioned previously, the data and methods are unchanged. We refer readers to www.bls.gov for the BLS historical published TFP data.

A complete description of IGI's TFP projection methodology is available on the CMS website at https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Statistics-Trends-and-Reports/​MedicareProgramRatesStats/​MarketBasketResearch. In addition, in the FY 2022 IPF final rule (86 FR 42611), we noted that effective with FY 2022 and forward, CMS changed the name of this adjustment to refer to it as the productivity adjustment rather than the MFP adjustment. Section 1886(s)(2)(A)(i) of the Act requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the IPF PPS for the RY beginning in 2012 (a RY that coincides with a FY) and each subsequent RY.

For this FY 2023 IPF PPS proposed rule, based on IGI's fourth quarter 2021 forecast, the proposed productivity adjustment for FY 2023 (the 10-year moving average of TFP for the period ending FY 2023) is projected to be 0.4 percent. Accordingly, we are proposing to reduce the 3.1 percent IPF market basket update by this 0.4 percentage point productivity adjustment, as mandated by the Act. This results in a proposed FY 2023 IPF PPS payment rate update of 2.7 percent (3.1−0.4 = 2.7).

We are also proposing that if more recent data become available, we would use such data, if appropriate, to determine the FY 2023 IPF market basket update and productivity adjustment for the final rule. 3. Proposed FY 2023 IPF Labor-Related Share Due to variations in geographic wage levels and other labor-related costs, we believe that payment rates under the IPF PPS should continue to be adjusted by a geographic wage index, which would apply to the labor-related portion of the Federal per diem base rate (hereafter referred to as the labor-related share).

The labor-related share is determined by identifying the national average proportion of total costs that are related to, influenced by, or vary with the local labor market. We are proposing to continue to classify a cost category as labor-related if the costs are labor-intensive and vary with the local labor market. Based on our definition of the labor-related share and the cost categories in the 2016-based IPF market basket, we are proposing to continue to include in the labor-related share the sum of the relative importance of Wages and Salaries.

Employee Benefits. Professional Fees. Labor-related.

Administrative and Facilities Support Services. Installation, Maintenance, and Repair Services. All Other.

Labor-related Services. And a portion of the Capital-Related relative importance from the 2016-based IPF market basket. For more details regarding the methodology for determining specific cost categories for inclusion in the 2016-based IPF labor-related share, see the FY 2020 IPF PPS final rule (84 FR 38445 through 38447).

The relative importance reflects the different rates of price change for these cost categories between the base year (FY 2016) and FY 2023. Based on IGI's fourth quarter 2021 forecast of the 2016-based IPF market basket, the sum of the FY 2023 relative importance moving average of Wages and Salaries. Employee Benefits.

Professional Fees. Start Printed Page 19419 Labor-related. Administrative and Facilities Support Services.

Installation, Maintenance, and Repair Services. All Other. Labor-related Services is 74.4 percent.

We also propose, consistent with prior rulemaking, that the portion of Capital-Related costs that are influenced by the local labor market is 46 percent. Since the relative importance for Capital-Related costs are 6.6 percent of the 2016-based IPF market basket for FY 2023, we propose to take 46 percent of 6.6 percent to determine a labor-related share of Capital-Related costs for FY 2023 of 3.0 percent. Therefore, we propose a total labor-related share for FY 2023 of 77.4 percent (the sum of 74.4 percent for the labor-related share of operating costs and 3.0 percent for the labor-related share of Capital-Related costs).

We are also proposing that if more recent data become available, we would use such data, if appropriate, to determine the FY 2023 labor-related share for the final rule. For more information on the labor-related share and its calculation, we refer readers to the FY 2020 IPF PPS final rule (84 FR 38445 through 38447). Table 1 shows the proposed FY 2023 labor-related share and the final FY 2022 labor-related share using the 2016-based IPF market basket relative importance.

Table 1—FY 2023 Proposed IPF Labor-Related Share and FY 2022 IPF Labor-Related Share Relative importance, proposed labor-related share FY 2023 1Relative importance, labor-related share FY 2022 2Wages and Salaries53.352.8Employee Benefits13.413.6Professional Fees. Labor-related4.34.3Administrative and Facilities Support Services0.60.6Installation, Maintenance and Repair1.31.3All Other Labor-related Services1.51.5Subtotal74.474.1Labor-related portion of Capital-Related (.46)3.03.1Total Labor-Related Share77.477.21  Based on the 4th quarter 2021 IHS Global Inc. Forecast of the 2016-based IPF market basket.2  Based on the 2nd quarter 2021 IHS Global Inc.

Forecast of the 2016-based IPF market basket. We invite public comments on the proposed labor-related share for FY 2023. B.

Proposed Updates to the IPF PPS Rates for FY Beginning October 1, 2022 The IPF PPS is based on a standardized Federal per diem base rate calculated from the IPF average per diem costs and adjusted for budget-neutrality in the implementation year. The Federal per diem base rate is used as the standard payment per day under the IPF PPS and is adjusted by the patient-level and facility-level adjustments that are applicable to the IPF stay. A detailed explanation of how we calculated the average per diem cost appears in the November 2004 IPF PPS final rule (69 FR 66926).

1. Determining the Standardized Budget-Neutral Federal Per Diem Base Rate Section 124(a)(1) of the BBRA required that we implement the IPF PPS in a budget-neutral manner. In other words, the amount of total payments under the IPF PPS, including any payment adjustments, must be projected to be equal to the amount of total payments that would have been made if the IPF PPS were not implemented.

Therefore, we calculated the budget-neutrality factor by setting the total estimated IPF PPS payments to be equal to the total estimated payments that would have been made under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) methodology had the IPF PPS not been implemented.

A step-by-step description of the methodology used to estimate payments under the TEFRA payment system appears in the November 2004 IPF PPS final rule (69 FR 66926). Under the IPF PPS methodology, we calculated the final Federal per diem base rate to be budget-neutral during the IPF PPS implementation period (that is, the 18-month period from January 1, 2005 through June 30, 2006) using a July 1 update cycle. We updated the average cost per day to the midpoint of the IPF PPS implementation period (October 1, 2005), and this amount was used in the payment model to establish the budget-neutrality adjustment.

Next, we standardized the IPF PPS Federal per diem base rate to account for the overall positive effects of the IPF PPS payment adjustment factors by dividing total estimated payments under the TEFRA payment system by estimated payments under the IPF PPS. The information concerning this standardization can be found in the November 2004 IPF PPS final rule (69 FR 66932) and the RY 2006 IPF PPS final rule (71 FR 27045). We then reduced the standardized Federal per diem base rate to account for the outlier policy, the stop loss provision, and anticipated behavioral changes.

A complete discussion of how we calculated each component of the budget-neutrality adjustment appears in the November 2004 IPF PPS final rule (69 FR 66932 through 66933) and in the RY 2007 IPF PPS final rule (71 FR 27044 through 27046). The final standardized budget-neutral Federal per diem base rate established for cost reporting periods beginning on or after January 1, 2005 was calculated to be $575.95. The Federal per diem base rate has been updated in accordance with applicable statutory requirements and § 412.428 through publication of annual notices or proposed and final rules.

A detailed discussion on the standardized budget-neutral Federal per diem base rate and the electroconvulsive therapy (ECT) payment per treatment appears in the FY 2014 IPF PPS update notice (78 FR 46738 through 46740). These documents are available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​index.html. IPFs must include a valid procedure code for ECT services provided to IPF beneficiaries in order to bill for ECT Start Printed Page 19420 services, as described in our Medicare Claims Processing Manual, Chapter 3, Section 190.7.3 (available at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c03.pdf.

) There were no changes to the ECT procedure codes used on IPF claims as a result of the final update to the ICD-10-PCS code set for FY 2023. Addendum B to this proposed rule shows the ECT procedure codes for FY 2023 and is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. 2.

Proposed Update of the Federal per Diem Base Rate and Electroconvulsive Therapy Payment per Treatment The current (FY 2022) Federal per diem base rate is $832.94 and the ECT payment per treatment is $358.60. For the proposed FY 2023 Federal per diem base rate, we applied the payment rate update of 2.7 percent—that is, the proposed 2016-based IPF market basket increase for FY 2023 of 3.1 percent less the proposed productivity adjustment of 0.4 percentage point—and the proposed wage index budget-neutrality factor of 1.0016 (as discussed in section III.D.1 of this proposed rule) to the FY 2022 Federal per diem base rate of $832.94, yielding a proposed Federal per diem base rate of $856.80 for FY 2023. Similarly, we applied the proposed 2.7 percent payment rate update and the proposed 1.0016 wage index budget-neutrality factor to the FY 2022 ECT payment per treatment of $358.60, yielding a proposed ECT payment per treatment of $368.87 for FY 2023.

Section 1886(s)(4)(A)(i) of the Act requires that for RY 2014 and each subsequent RY, in the case of an IPF that fails to report required quality data with respect to such RY, the Secretary will reduce any annual update to a standard Federal rate for discharges during the RY by 2.0 percentage points. Therefore, we are applying a 2.0 percentage point reduction to the Federal per diem base rate and the ECT payment per treatment as follows. For IPFs that fail to report required data under the IPFQR Program, we applied a 0.7 percent payment rate update—that is, the proposed IPF market basket increase for FY 2023 of 3.1 percent less the proposed productivity adjustment of 0.4 percentage point for an update of 2.7 percent, and further reduced by 2.0 percentage points in accordance with section 1886(s)(4)(A)(i) of the Act—and the proposed wage index budget-neutrality factor of 1.0016 to the FY 2022 Federal per diem base rate of $832.94, yielding a proposed Federal per diem base rate of $840.11 for FY 2023.

For IPFs that fail to report required data under the IPFQR Program, we applied the proposed 0.7 percent annual payment rate update and the proposed 1.0016 wage index budget-neutrality factor to the FY 2022 ECT payment per treatment of $358.60, yielding a proposed ECT payment per treatment of $361.69 for FY 2023. Lastly, we are also proposing that if more recent data become available, we would use such data, if appropriate, to determine the FY 2023 Federal per diem base rate and ECT payment per treatment for the final rule. C.

Proposed Updates to the IPF PPS Patient-Level Adjustment Factors 1. Overview of the IPF PPS Adjustment Factors The IPF PPS payment adjustments were derived from a regression analysis of 100 percent of the FY 2002 Medicare Provider and Analysis Review (MedPAR) data file, which contained 483,038 cases. For a more detailed description of the data file used for the regression analysis, see the November 2004 IPF PPS final rule (69 FR 66935 through 66936).

We are proposing to continue to use the existing regression-derived adjustment factors established in 2005 for FY 2023. However, we have used more recent claims data to simulate payments to finalize the outlier fixed dollar loss threshold amount and to assess the impact of the IPF PPS updates. 2.

IPF PPS Patient-Level Adjustments The IPF PPS includes payment adjustments for the following patient-level characteristics. Medicare Severity Diagnosis Related Groups (MS-DRGs) assignment of the patient's principal diagnosis, selected comorbidities, patient age, and the variable per diem adjustments. A.

Proposed Update to MS-DRG Assignment We believe it is important to maintain for IPFs the same diagnostic coding and Diagnosis Related Group (DRG) classification used under the IPPS for providing psychiatric care. For this reason, when the IPF PPS was implemented for cost reporting periods beginning on or after January 1, 2005, we adopted the same diagnostic code set (ICD-9-CM) and DRG patient classification system (MS-DRGs) that were utilized at the time under the IPPS. In the RY 2009 IPF PPS notice (73 FR 25709), we discussed CMS' effort to better recognize resource use and the severity of illness among patients.

CMS adopted the new MS-DRGs for the IPPS in the FY 2008 IPPS final rule with comment period (72 FR 47130). In the RY 2009 IPF PPS notice (73 FR 25716), we provided a crosswalk to reflect changes that were made under the IPF PPS to adopt the new MS-DRGs. For a detailed description of the mapping changes from the original DRG adjustment categories to the current MS-DRG adjustment categories, we refer readers to the RY 2009 IPF PPS notice (73 FR 25714).

The IPF PPS includes payment adjustments for designated psychiatric DRGs assigned to the claim based on the patient's principal diagnosis. The DRG adjustment factors were expressed relative to the most frequently reported psychiatric DRG in FY 2002, that is, DRG 430 (psychoses). The coefficient values and adjustment factors were derived from the regression analysis discussed in detail in the November 28, 2003 IPF proposed rule (68 FR 66923.

66928 through 66933) and the November 15, 2004 IPF final rule (69 FR 66933 through 66960). Mapping the DRGs to the MS-DRGs resulted in the current 17 IPF MS-DRGs, instead of the original 15 DRGs, for which the IPF PPS provides an adjustment. For FY 2023, we are not proposing any changes to the IPF MS-DRG adjustment factors.

Therefore, we are retaining the existing IPF MS-DRG adjustment factors. In the FY 2015 IPF PPS final rule published August 6, 2014 in the Federal Register titled, “Inpatient Psychiatric Facilities Prospective Payment System—Update for FY Beginning October 1, 2014 (FY 2015)” (79 FR 45945 through 45947), we finalized conversions of the ICD-9-CM-based MS-DRGs to ICD-10-CM/PCS-based MS-DRGs, which were implemented on October 1, 2015. Further information on the ICD-10-CM/PCS MS-DRG conversion project can be found on the CMS ICD-10-CM website at https://www.cms.gov/​Medicare/​Coding/​ICD10/​ICD-10-MS-DRG-Conversion-Project.html.

For FY 2023, we are proposing to continue to make the existing payment adjustment for psychiatric diagnoses that group to one of the existing 17 IPF MS-DRGs listed in Addendum A. Addendum A is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. Psychiatric principal diagnoses that do not group to one of the 17 designated MS-DRGs will still receive the Federal per diem base rate and all other applicable adjustments.

Start Printed Page 19421 however, the payment will not include an MS-DRG adjustment. The diagnoses for each IPF MS-DRG will be updated as of October 1, 2022, using the final IPPS FY 2023 ICD-10-CM/PCS code sets. The FY 2023 IPPS/LTCH PPS final rule includes tables of the changes to the ICD-10-CM/PCS code sets, which underlie the FY 2023 IPF MS-DRGs.

Both the FY 2023 IPPS final rule and the tables of final changes to the ICD-10-CM/PCS code sets, which underlie the FY 2023 MS-DRGs, are available on the CMS IPPS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​AcuteInpatientPPS/​index.html. Code First As discussed in the ICD-10-CM Official Guidelines for Coding and Reporting, certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology. For such conditions, ICD-10-CM has a coding convention that requires the underlying condition be sequenced first followed by the manifestation.

Wherever such a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes (etiology followed by manifestation). In accordance with the ICD-10-CM Official Guidelines for Coding and Reporting, when a primary (psychiatric) diagnosis code has a “code first” note, the provider will follow the instructions in the ICD-10-CM Tabular List.

The submitted claim goes through the CMS processing system, which will identify the principal diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign a DRG code for adjustment. The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. For more information on the code first policy, we refer readers to the November 2004 IPF PPS final rule (69 FR 66945) and see sections I.A.13 and I.B.7 of the FY 2020 ICD-10-CM Coding Guidelines, available at https://www.cdc.gov/​nchs/​data/​icd/​10cmguidelines-FY2020_​final.pdf.

In the FY 2015 IPF PPS final rule, we provided a code first table for reference that highlights the same or similar manifestation codes where the code first instructions apply in ICD-10-CM that were present in ICD-9-CM (79 FR 46009). In FY 2022 there were 18 codes finalized for deletion from the ICD-10-CM codes in the IPF Code First table. For FY 2023, we are proposing to delete 2 ICD-10-PCS codes and proposing to add 48 ICD-10-PCS codes to the IPF Code First table.

The proposed FY 2023 Code First table is shown in Addendum B on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. b. Proposed Payment for Comorbid Conditions The intent of the comorbidity adjustments is to recognize the increased costs associated with comorbid conditions by providing additional payments for certain existing medical or psychiatric conditions that are expensive to treat.

In our RY 2012 IPF PPS final rule (76 FR 26451 through 26452), we explained that the IPF PPS includes 17 comorbidity categories and identified the new, revised, and deleted ICD-9-CM diagnosis codes that generate a comorbid condition payment adjustment under the IPF PPS for RY 2012 (76 FR 26451). Comorbidities are specific patient conditions that are secondary to the patient's principal diagnosis and that require treatment during the stay. Diagnoses that relate to an earlier episode of care and have no bearing on the current hospital stay are excluded and must not be reported on IPF claims.

Comorbid conditions must exist at the time of admission or develop subsequently, and affect the treatment received, length of stay (LOS), or both treatment and LOS. For each claim, an IPF may receive only one comorbidity adjustment within a comorbidity category, but it may receive an adjustment for more than one comorbidity category. Current billing instructions for discharge claims, on or after October 1, 2015, require IPFs to enter the complete ICD-10-CM codes for up to 24 additional diagnoses if they co-exist at the time of admission, or develop subsequently and impact the treatment provided.

The comorbidity adjustments were determined based on the regression analysis using the diagnoses reported by IPFs in FY 2002. The principal diagnoses were used to establish the DRG adjustments and were not accounted for in establishing the comorbidity category adjustments, except where ICD-9-CM code first instructions applied. In a code first situation, the submitted claim goes through the CMS processing system, which will identify the principal diagnosis code as non-psychiatric and search the secondary codes for a psychiatric code to assign an MS-DRG code for adjustment.

The system will continue to search the secondary codes for those that are appropriate for comorbidity adjustment. As noted previously, it is our policy to maintain the same diagnostic coding set for IPFs that is used under the IPPS for providing the same psychiatric care. The 17 comorbidity categories formerly defined using ICD-9-CM codes were converted to ICD-10-CM/PCS in our FY 2015 IPF PPS final rule (79 FR 45947 through 45955).

The goal for converting the comorbidity categories is referred to as replication, meaning that the payment adjustment for a given patient encounter is the same after ICD-10-CM implementation as it will be if the same record had been coded in ICD-9-CM and submitted prior to ICD-10-CM/PCS implementation on October 1, 2015. All conversion efforts were made with the intent of achieving this goal. For FY 2023, we are proposing to continue to use the same comorbidity adjustment factors in effect in FY 2022.

The proposed FY 2023 comorbidity adjustment factors are found in Addendum A, available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. For FY 2023, we are proposing to add 10 ICD-10-CM/PCS codes and remove 1 ICD-10-CM/PCS code from the Coagulation Factor category. Proposing to add 3 ICD-10-CM/PCS codes and remove 11 ICD-10-CM/PCS codes from the Oncology Treatment comorbidity category.

And proposing to add 4 ICD-10-CM/PCS codes to the Poisoning comorbidity category. The proposed FY 2023 comorbidity codes are shown in Addenda B, available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. In accordance with the policy established in the FY 2015 IPF PPS final rule (79 FR 45949 through 45952), we reviewed all new FY 2023 ICD-10-CM codes to remove codes that were site “unspecified” in terms of laterality from the FY 2023 ICD-10-CM/PCS codes in instances where more specific codes are available.

As we stated in the FY 2015 IPF PPS final rule, we believe that specific diagnosis codes that narrowly identify anatomical sites where disease, injury, or a condition exists should be used when coding patients' diagnoses whenever these codes are available. We finalized in the FY 2015 IPF PPS rule, that we would remove site “unspecified” codes from the IPF PPS ICD-10-CM/PCS codes in instances when laterality codes (site specified codes) are available, as the clinician should be able to identify a more Start Printed Page 19422 specific diagnosis based on clinical assessment at the medical encounter. There were no proposed changes to the FY 2023 ICD-10-CM/PCS codes, therefore, we are not proposing to remove any of the new codes.

c. Proposed Patient Age Adjustments As explained in the November 2004 IPF PPS final rule (69 FR 66922), we analyzed the impact of age on per diem cost by examining the age variable (range of ages) for payment adjustments. In general, we found that the cost per day increases with age.

The older age groups are costlier than the under 45 age group, the differences in per diem cost increase for each successive age group, and the differences are statistically significant. For FY 2023, we are proposing to continue to use the patient age adjustments currently in effect in FY 2022, as shown in Addendum A of this rule (see https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html ). d.

Proposed Variable Per Diem Adjustments We explained in the November 2004 IPF PPS final rule (69 FR 66946) that the regression analysis indicated that per diem cost declines as the length of stay (LOS) increases. The variable per diem adjustments to the Federal per diem base rate account for ancillary and administrative costs that occur disproportionately in the first days after admission to an IPF. As discussed in the November 2004 IPF PPS final rule, we used a regression analysis to estimate the average differences in per diem cost among stays of different lengths (69 FR 66947 through 66950).

As a result of this analysis, we established variable per diem adjustments that begin on day 1 and decline gradually until day 21 of a patient's stay. For day 22 and thereafter, the variable per diem adjustment remains the same each day for the remainder of the stay. However, the adjustment applied to day 1 depends upon whether the IPF has a qualifying ED.

If an IPF has a qualifying ED, it receives a 1.31 adjustment factor for day 1 of each stay. If an IPF does not have a qualifying ED, it receives a 1.19 adjustment factor for day 1 of the stay. The ED adjustment is explained in more detail in section III.D.4 of this propose rule.

For FY 2023, we are proposing to continue to use the variable per diem adjustment factors currently in effect, as shown in Addendum A to this rule, which is available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. A complete discussion of the variable per diem adjustments appears in the November 2004 IPF PPS final rule (69 FR 66946). D.

Proposed Updates to the IPF PPS Facility-Level Adjustments The IPF PPS includes facility-level adjustments for the wage index, IPFs located in rural areas, teaching IPFs, cost of living adjustments for IPFs located in Alaska and Hawaii, and IPFs with a qualifying ED. 1. Wage Index Adjustment a.

Background As discussed in the RY 2007 IPF PPS final rule (71 FR 27061), RY 2009 IPF PPS (73 FR 25719) and the RY 2010 IPF PPS notices (74 FR 20373), in order to provide an adjustment for geographic wage levels, the labor-related portion of an IPF's payment is adjusted using an appropriate wage index. Currently, an IPF's geographic wage index value is determined based on the actual location of the IPF in an urban or rural area, as defined in § 412.64(b)(1)(ii)(A) and (C). Due to the variation in costs and because of the differences in geographic wage levels, in the November 2004 IPF PPS final rule, we required that payment rates under the IPF PPS be adjusted by a geographic wage index.

We proposed and finalized a policy to use the unadjusted, pre-floor, pre-reclassified IPPS hospital wage index to account for geographic differences in IPF labor costs. We implemented use of the pre-floor, pre-reclassified IPPS hospital wage data to compute the IPF wage index since there was not an IPF-specific wage index available. We believe that IPFs generally compete in the same labor market as IPPS hospitals so the pre-floor, pre-reclassified IPPS hospital wage data should be reflective of labor costs of IPFs.

We believe this pre-floor, pre-reclassified IPPS hospital wage index to be the best available data to use as proxy for an IPF specific wage index. As discussed in the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), under the IPF PPS, the wage index is calculated using the IPPS wage index for the labor market area in which the IPF is located, without considering geographic reclassifications, floors, and other adjustments made to the wage index under the IPPS. For a complete description of these IPPS wage index adjustments, we refer readers to the FY 2019 IPPS/LTCH PPS final rule (83 FR 41362 through 41390).

Our wage index policy at § 412.424(a)(2), requires us to use the best Medicare data available to estimate costs per day, including an appropriate wage index to adjust for wage differences. When the IPF PPS was implemented in the November 2004 IPF PPS final rule, with an effective date of January 1, 2005, the pre-floor, pre-reclassified IPPS hospital wage index that was available at the time was the FY 2005 pre-floor, pre-reclassified IPPS hospital wage index. Historically, the IPF wage index for a given RY has used the pre-floor, pre-reclassified IPPS hospital wage index from the prior FY as its basis.

This has been due in part to the pre-floor, pre-reclassified IPPS hospital wage index data that were available during the IPF rulemaking cycle, where an annual IPF notice or IPF final rule was usually published in early May. This publication timeframe was relatively early compared to other Medicare payment rules because the IPF PPS follows a RY, which was defined in the implementation of the IPF PPS as the 12-month period from July 1 to June 30 (69 FR 66927). Therefore, the best available data at the time the IPF PPS was implemented was the pre-floor, pre-reclassified IPPS hospital wage index from the prior FY (for example, the RY 2006 IPF wage index was based on the FY 2005 pre-floor, pre-reclassified IPPS hospital wage index).

In the RY 2012 IPF PPS final rule, we changed the reporting year timeframe for IPFs from a RY to the FY, which begins October 1 and ends September 30 (76 FR 26434 through 26435). In that FY 2012 IPF PPS final rule, we continued our established policy of using the pre-floor, pre-reclassified IPPS hospital wage index from the prior year (that is, from FY 2011) as the basis for the FY 2012 IPF wage index. This policy of basing a wage index on the prior year's pre-floor, pre-reclassified IPPS hospital wage index has been followed by other Medicare payment systems, such as hospice and inpatient rehabilitation facilities.

By continuing with our established policy, we remained consistent with other Medicare payment systems. In FY 2020, we finalized the IPF wage index methodology to align the IPF PPS wage index with the same wage data timeframe used by the IPPS for FY 2020 and subsequent years. Specifically, we finalized to use the pre-floor, pre-reclassified IPPS hospital wage index from the FY concurrent with the IPF FY as the basis for the IPF wage index.

For example, the FY 2020 IPF wage index was based on the FY 2020 pre-floor, pre-reclassified IPPS hospital wage index rather than on the FY 2019 pre-floor, pre-reclassified IPPS hospital wage index. Start Printed Page 19423 We explained in the FY 2020 proposed rule (84 FR 16973), that using the concurrent pre-floor, pre-reclassified IPPS hospital wage index will result in the most up-to-date wage data being the basis for the IPF wage index. We noted that it would also result in more consistency and parity in the wage index methodology used by other Medicare payment systems.

We indicated that the Medicare SNF PPS already used the concurrent IPPS hospital wage index data as the basis for the SNF PPS wage index. CMS proposed and finalized similar policies to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index data in other Medicare payment systems, such as hospice and inpatient rehabilitation facilities. Thus, the wage adjusted Medicare payments of various provider types are based upon wage index data from the same timeframe.

For FY 2023, we propose to continue to use the concurrent pre-floor, pre-reclassified IPPS hospital wage index as the basis for the IPF wage index. B. Office of Management and Budget (OMB) Bulletins 1.

Background The wage index used for the IPF PPS is calculated using the unadjusted, pre-reclassified and pre-floor IPPS wage index data and is assigned to the IPF on the basis of the labor market area in which the IPF is geographically located. IPF labor market areas are delineated based on the Core-Based Statistical Area (CBSAs) established by the OMB. Generally, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census.

However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses through OMB Bulletins. These bulletins contain information regarding CBSA changes, including changes to CBSA numbers and titles. OMB bulletins may be accessed online at https://www.whitehouse.gov/​omb/​information-for-agencies/​bulletins/​.

In accordance with our established methodology, the IPF PPS has historically adopted any CBSA changes that are published in the OMB bulletin that corresponds with the IPPS hospital wage index used to determine the IPF wage index and, when necessary and appropriate, has proposed and finalized transition policies for these changes. In the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), we adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for MSAs, and the creation of Micropolitan Statistical Areas and Combined Statistical Areas.

In adopting the OMB CBSA geographic designations in RY 2007, we did not provide a separate transition for the CBSA-based wage index since the IPF PPS was already in a transition period from TEFRA payments to PPS payments. In the RY 2009 IPF PPS notice, we incorporated the CBSA nomenclature changes published in the most recent OMB bulletin that applied to the IPPS hospital wage index used to determine the current IPF wage index and stated that we expected to continue to do the same for all the OMB CBSA nomenclature changes in future IPF PPS rules and notices, as necessary (73 FR 25721). Subsequently, CMS adopted the changes that were published in past OMB bulletins in the FY 2016 IPF PPS final rule (80 FR 46682 through 46689), the FY 2018 IPF PPS rate update (82 FR 36778 through 36779), the FY 2020 IPF PPS final rule (84 FR 38453 through 38454), and the FY 2021 IPF PPS final rule (85 FR 47051 through 47059).

We direct readers to each of these rules for more information about the changes that were adopted and any associated transition policies. In part due to the scope of changes involved in adopting the CBSA delineations for FY 2021, we finalized a 2-year transition policy in the FY 2021 IPF PPS final rule consistent with our past practice of using transition policies to help mitigate negative impacts on hospitals of certain wage index policy changes. We applied a 5-percent cap on wage index decreases to all IPF providers that had any decrease in their wage indexes, regardless of the circumstance causing the decline, so that an IPF's final wage index for FY 2021 would not be less than 95 percent of its final wage index for FY 2020, regardless of whether the IPF was part of an updated CBSA.

We refer readers to the FY 2021 IPF PPS final rule (85 FR 47058 through 47059) for a more detailed discussion about the wage index transition policy for FY 2021. On March 6, 2020, OMB issued OMB Bulletin 20-01 (available on the web at https://www.whitehouse.gov/​wp-content/​uploads/​2020/​03/​Bulletin-20-01.pdf ). In considering whether to adopt this bulletin, we analyzed whether the changes in this bulletin would have a material impact on the IPF PPS wage index.

This bulletin creates only one Micropolitan statistical area. As discussed in further detail in section III.D.1.b.ii of this proposed rule since Micropolitan areas are considered rural for the IPF PPS wage index, this bulletin has no material impact on the IPF PPS wage index. That is, the constituent county of the new Micropolitan area was considered rural effective as of FY 2021 and would continue to be considered rural if we adopted OMB Bulletin 20-01.

Therefore, we did not propose to adopt OMB Bulletin 20-01 in the FY 2022 IPF PPS proposed rule. 2. Micropolitan Statistical Areas OMB defines a “Micropolitan Statistical Area” as a CBSA associated with at least one urban cluster that has a population of at least 10,000, but less than 50,000 (75 FR 37252).

We refer to these as Micropolitan Areas. After extensive impact analysis, consistent with the treatment of these areas under the IPPS as discussed in the FY 2005 IPPS final rule (69 FR 49029 through 49032), we determined the best course of action would be to treat Micropolitan Areas as “rural” and include them in the calculation of each state's IPF PPS rural wage index. We refer readers to the FY 2007 IPF PPS final rule (71 FR 27064 through 27065) for a complete discussion regarding treating Micropolitan Areas as rural.

C. Proposed Permanent Cap on Wage Index Decreases As discussed in section III.D.1.b.(1) of this proposed rule, we have proposed and finalized temporary transition policies in the past to mitigate significant changes to payments due to changes to the IPF PPS wage index. Specifically, for FY 2016 (80 FR 46652), we implemented a 50/50 blend for all geographic areas consisting of the wage index values computed using the then-current OMB area delineations and the wage index values computed using new area delineations based on OMB Bulletin No.

13-01. In FY 2021 (85 FR 47059), we implemented a 2-year transition to mitigate any negative effects of wage index changes by applying a 5-percent cap on any decrease in an IPF's wage index from the IPF's final wage index from FY 2020. We explained that we believed the 5-percent cap would provide greater transparency and would be administratively less complex than the prior methodology of applying a 50/50 blended wage index.

We indicated that no cap would be applied to the reduction in the wage index for the second year, that is, FY 2022, and that this transition approach struck an appropriate balance by providing a transition period to mitigate the resulting short-term instability and negative impacts on providers and time for them to adjust to their new labor Start Printed Page 19424 market area delineations and wage index values. In FY 2022 (86 FR 42616 through 42617), a couple of commenters recommended CMS extend the transition period adopted in the FY 2021 IPF PPS final rule. Because we did not propose to modify the transition policy that was finalized in the FY 2021 IPF PPS final rule, we did not extend the transition period for FY 2022.

In the FY 2022 IPF PPS final rule, we stated that we continued to believe that applying the 5-percent cap transition policy in year one provided an adequate safeguard against any significant payment reductions associated with the adoption of the revised CBSA delineations in FY 2021, allowed for sufficient time to make operational changes for future FYs, and provided a reasonable balance between mitigating some short-term instability in IPF payments and improving the accuracy of the payment adjustment for differences in area wage levels. However, we acknowledged that certain changes to wage index policy may significantly affect Medicare payments. In addition, we reiterated that our policy principles with regard to the wage index include generally using the most current data and information available and providing that data and information, as well as any approaches to addressing any significant effects on Medicare payments resulting from these potential scenarios, in notice and comment rulemaking.

With these policy principles in mind, we considered for this FY 2023 proposed rule how best to address the potential scenarios about which commenters raised concerns. That is, scenarios in which changes to wage index policy may significantly affect Medicare payments. In the past, we have established transition policies of limited duration to phase in significant changes to labor market areas.

In taking this approach in the past, we sought to mitigate short-term instability and fluctuations that can negatively impact providers due to wage index changes. In accordance with the requirements of the IPF PPS wage index regulations at § 412.424(a)(2), we use an appropriate wage index based on the best available data, including the best available labor market area delineations, to adjust IPF PPS payments for wage differences. We have previously stated that, because the wage index is a relative measure of the value of labor in prescribed labor market areas, we believe it is important to implement new labor market area delineations with as minimal a transition as is reasonably possible.

However, we recognize that changes to the wage index have the potential to create instability and significant negative impacts on certain providers even when labor market areas do not change. In addition, year-to-year fluctuations in an area's wage index can occur due to external factors beyond a provider's control, such as the buy antibiotics PHE, and for an individual provider, these fluctuations can be difficult to predict. We also recognize that predictability in Medicare payments is important to enable providers to budget and plan their operations.

In light of these considerations, we are proposing a permanent approach to smooth year-to-year changes in providers' wage indexes. We are proposing a policy that we believe increases the predictability of IPF PPS payments for providers and mitigates instability and significant negative impacts to providers resulting from changes to the wage index. As previously discussed, we believed applying a 5-percent cap on wage index decreases for FY 2021 provided greater transparency and was administratively less complex than prior transition methodologies.

In addition, we believed this methodology mitigated short-term instability and fluctuations that can negatively impact providers due to wage index changes. Lastly, we believed the 5-percent cap applied to all wage index decreases for FY 2021 provided an adequate safeguard against significant payment reductions related to the adoption of the revised CBSAs. However, as discussed earlier in this section of the proposed rule, we recognize there are circumstances that a 1-year mitigation policy, like the one adopted for FY 2021, would not effectively address future years in which providers continue to be negatively affected by significant wage index decreases.

Typical year-to-year variation in the IPF PPS wage index has historically been within 5 percent, and we expect this will continue to be the case in future years. Because providers are usually experienced with this level of wage index fluctuation, we believe applying a 5-percent cap on all wage index decreases each year, regardless of the reason for the decrease, would effectively mitigate instability in IPF PPS payments due to any significant wage index decreases that may affect providers in a year. Therefore, we believe this approach would address concerns about instability that commenters raised in the FY 2022 IPF PPS rule.

In addition, we believe that applying a 5-percent cap on all wage index decreases would support increased predictability about IPF PPS payments for providers, enabling them to more effectively budget and plan their operations. Lastly, because applying a 5-percent cap on all wage index decreases would represent a small overall impact on the labor market area wage index system, we believe it would ensure the wage index is a relative measure of the value of labor in prescribed labor market areas. As discussed in further detail in section III.D.1.e of this proposed rule, we estimate that applying a 5-percent cap on all wage index decreases will have a very small effect on the wage index budget neutrality factor for FY 2023.

Because the wage index is a measure of the value of labor (wage and wage-related costs) in a prescribed labor market area relative to the national average, we anticipate that in the absence of proposed policy changes most providers will not experience year-to-year wage index declines greater than 5 percent in any given year. Therefore, we anticipate that the impact to the wage index budget neutrality factor in future years would continue to be minimal. We also believe that when the 5-percent cap would be applied under this proposal, it is likely that it would be applied similarly to all IPFs in the same labor market area, as the hospital average hourly wage data in the CBSA (and any relative decreases compared to the national average hourly wage) would be similar.

While this policy may result in IPFs in a CBSA receiving a higher wage index than others in the same area (such as situations when delineations change), we believe the impact would be temporary. The Secretary has broad authority to establish appropriate payment adjustments under the IPF PPS, including the wage index adjustment. As discussed earlier in this section, the IPF PPS regulations require us to use an appropriate wage index based on the best available data.

For the reasons discussed in this section, we believe a 5-percent cap on wage index decreases would be appropriate for the IPF PPS. Therefore, for FY 2023 and subsequent years, we are proposing to apply a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, regardless of the circumstances causing the decline. That is, we are proposing that an IPF's wage index for FY 2023 would not be less than 95 percent of its final wage index for FY 2022, regardless of whether the IPF is part of an updated CBSA, and that for subsequent years, a provider's wage index would not be less than 95 percent of its wage index calculated in the prior FY.

This also means that if an IPF's Start Printed Page 19425 prior FY wage index is calculated with the application of the 5-percent cap, the following year's wage index would not be less than 95 percent of the IPF's capped wage index in the prior FY. For example, if an IPF's wage index for FY 2023 is calculated with the application of the 5-percent cap, then its wage index for FY 2024 would not be less than 95 percent of its capped wage index in FY 2023. Lastly, we propose that a new IPF would be paid the wage index for the area in which it is geographically located for its first full or partial FY with no cap applied, because a new IPF would not have a wage index in the prior FY.

We would reflect the proposed permanent cap on wage index decreases at § 412.424(d)(1)(i). As previously discussed, we believe this proposed methodology would maintain the IPF PPS wage index as a relative measure of the value of labor in prescribed labor market areas, increase predictability of IPF PPS payments for providers, and mitigate instability and significant negative impacts to providers resulting from significant changes to the wage index. In section VIII.C.2 of this proposed rule, we estimate the impact to payments for providers in FY 2023 based on this proposed policy.

We also note that we would examine the effects of this policy on an ongoing basis in the future in order to assess its appropriateness. D. Proposed Adjustment for Rural Location In the November 2004 IPF PPS final rule, (69 FR 66954) we provided a 17 percent payment adjustment for IPFs located in a rural area.

This adjustment was based on the regression analysis, which indicated that the per diem cost of rural facilities was 17 percent higher than that of urban facilities after accounting for the influence of the other variables included in the regression. This 17 percent adjustment has been part of the IPF PPS each year since the inception of the IPF PPS. For FY 2023, we propose to continue to apply a 17 percent payment adjustment for IPFs located in a rural area as defined at § 412.64(b)(1)(ii)(C) (see 69 FR 66954 for a complete discussion of the adjustment for rural locations).

E. Proposed Budget Neutrality Adjustment Changes to the wage index are made in a budget-neutral manner so that updates do not increase expenditures. Therefore, for FY 2023, we are proposing to continue to apply a budget-neutrality adjustment in accordance with our existing budget-neutrality policy.

This policy requires us to update the wage index in such a way that total estimated payments to IPFs for FY 2023 are the same with or without the changes (that is, in a budget-neutral manner) by applying a budget neutrality factor to the IPF PPS rates. We use the following steps to ensure that the rates reflect the FY 2023 update to the wage indexes (based on the FY 2019 hospital cost report data) and the labor-related share in a budget-neutral manner. Step 1.

Simulate estimated IPF PPS payments, using the FY 2022 IPF wage index values (available on the CMS website) and labor-related share (as published in the FY 2022 IPF PPS final rule (86 FR 42608). Step 2. Simulate estimated IPF PPS payments using the proposed FY 2023 IPF wage index values (available on the CMS website), the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and the proposed FY 2023 labor-related share (based on the latest available data as discussed previously).

Step 3. Divide the amount calculated in step 1 by the amount calculated in step 2. The resulting quotient is the proposed FY 2023 budget-neutral wage adjustment factor of 1.0016.

Step 4. Apply the FY 2023 budget-neutral wage adjustment factor from step 3 to the FY 2022 IPF PPS Federal per diem base rate after the application of the market basket update described in section III.A of this proposed rule, to determine the FY 2023 IPF PPS Federal per diem base rate. For this proposed rule, we also followed these steps to separately calculate the budget neutrality factor associated with the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year.

First, we calculated the budget neutrality factor associated with the proposed FY 2023 IPF wage index and proposed FY 2023 labor-related share. We divided the amount of simulated payments using the FY 2022 IPF wage index and labor-related share by the amount of simulated payments using the proposed FY 2023 wage index and proposed FY 2023 labor-related share. The resulting quotient is 1.0017.

Next, we calculated the budget neutrality factor associated with the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year. We divided the amount of simulated payments using the proposed FY 2023 wage index and proposed FY 2023 labor-related share by the amount of simulated payments using the proposed FY 2023 wage index, the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and the proposed FY 2023 labor-related share. The resulting quotient is 0.9999.

The combined budget neutrality factor, which is the proposed FY 2023 budget-neutral wage adjustment factor as discussed earlier in this section, is 1.0016. 2. Proposed Teaching Adjustment In the November 2004 IPF PPS final rule, we implemented regulations at § 412.424(d)(1)(iii) to establish a facility-level adjustment for IPFs that are, or are part of, teaching hospitals.

The teaching adjustment accounts for the higher indirect operating costs experienced by hospitals that participate in graduate medical education (GME) programs. The payment adjustments are made based on the ratio of the number of full-time equivalent (FTE) interns and residents training in the IPF and the IPF's average daily census (ADC). Under the Inpatient Prospective Payment System (IPPS), Medicare makes direct GME payments (for direct costs such as resident and teaching physician salaries, and other direct teaching costs) to all teaching hospitals including those paid under a PPS, and those paid under the TEFRA rate-of-increase limits.

These direct GME payments are made separately from payments for hospital operating costs and are not part of the IPF PPS. In addition, direct GME payments do not address the estimated higher indirect operating costs teaching hospitals may face. The results of the regression analysis of FY 2002 IPF data established the basis for the payment adjustments included in the November 2004 IPF PPS final rule.

The results showed that the indirect teaching cost variable is significant in explaining the higher costs of IPFs that have teaching programs. We calculated the teaching adjustment based on the IPF's “teaching variable,” which is (1 + (the number of FTE residents training in the IPF/the IPF's ADC)). The teaching variable is then raised to the 0.5150 power to result in the teaching adjustment.

This formula is subject to the limitations on the number of FTE residents, which are described in this section of the proposed rule. We established the teaching adjustment in a manner that limited the incentives for IPFs to add FTE residents for the purpose of increasing their teaching adjustment. We imposed a cap on the number of FTE residents that may be counted for purposes of calculating the teaching adjustment.

The cap limits the number of FTE residents that teaching IPFs may count for the purpose of calculating the IPF PPS Start Printed Page 19426 teaching adjustment, not the number of residents teaching institutions can hire or train. We calculated the number of FTE residents that trained in the IPF during a “base year” and used that FTE resident number as the cap. An IPF's FTE resident cap is ultimately determined based on the final settlement of the IPF's most recent cost report filed before November 15, 2004 (publication date of the IPF PPS final rule).

A complete discussion of the temporary adjustment to the FTE cap to reflect residents due to hospital closure or residency program closure appears in the RY 2012 IPF PPS proposed rule (76 FR 5018 through 5020) and the RY 2012 IPF PPS final rule (76 FR 26453 through 26456). In the regression analysis, the logarithm of the teaching variable had a coefficient value of 0.5150. We converted this cost effect to a teaching payment adjustment by treating the regression coefficient as an exponent and raising the teaching variable to a power equal to the coefficient value.

We note that the coefficient value of 0.5150 was based on the regression analysis holding all other components of the payment system constant. A complete discussion of how the teaching adjustment was calculated appears in the November 2004 IPF PPS final rule (69 FR 66954 through 66957) and the RY 2009 IPF PPS notice (73 FR 25721). As with other adjustment factors derived through the regression analysis, we do not plan to rerun the teaching adjustment factors in the regression analysis until we more fully analyze IPF PPS data.

Therefore, in this FY 2023 proposed rule, we are proposing to continue to retain the coefficient value of 0.5150 for the teaching adjustment to the Federal per diem base rate. 3. Proposed Cost of Living Adjustment for IPFs Located in Alaska and Hawaii The IPF PPS includes a payment adjustment for IPFs located in Alaska and Hawaii based upon the area in which the IPF is located.

As we explained in the November 2004 IPF PPS final rule, the FY 2002 data demonstrated that IPFs in Alaska and Hawaii had per diem costs that were disproportionately higher than other IPFs. Other Medicare prospective payment systems (for example, the IPPS and LTCH PPS) adopted a COLA to account for the cost differential of care furnished in Alaska and Hawaii. We analyzed the effect of applying a COLA to payments for IPFs located in Alaska and Hawaii.

The results of our analysis demonstrated that a COLA for IPFs located in Alaska and Hawaii will improve payment equity for these facilities. As a result of this analysis, we provided a COLA in the November 2004 IPF PPS final rule. A COLA for IPFs located in Alaska and Hawaii is made by multiplying the non-labor-related portion of the Federal per diem base rate by the applicable COLA factor based on the COLA area in which the IPF is located.

The COLA factors through 2009 were published by the Office of Personnel Management (OPM), and the OPM memo showing the 2009 COLA factors is available at https://www.chcoc.gov/​content/​nonforeign-area-retirement-equity-assurance-act. We note that the COLA areas for Alaska are not defined by county as are the COLA areas for Hawaii. In 5 CFR 591.207, the OPM established the following COLA areas.

City of Anchorage, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse. City of Fairbanks, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse. City of Juneau, and 80-kilometer (50-mile) radius by road, as measured from the Federal courthouse.

Rest of the state of Alaska. As stated in the November 2004 IPF PPS final rule, we update the COLA factors according to updates established by the OPM. However, sections 1911 through 1919 of the Non-foreign Area Retirement Equity Assurance Act, as contained in subtitle B of title XIX of the National Defense Authorization Act (NDAA) for FY 2010 (Pub.

L. 111-84, October 28, 2009), transitions the Alaska and Hawaii COLAs to locality pay. Under section 1914 of NDAA, locality pay was phased in over a 3-year period beginning in January 2010, with COLA rates frozen as of the date of enactment, October 28, 2009, and then proportionately reduced to reflect the phase-in of locality pay.

When we published the proposed COLA factors in the RY 2012 IPF PPS proposed rule (76 FR 4998), we inadvertently selected the FY 2010 COLA rates, which had been reduced to account for the phase-in of locality pay. We did not intend to propose the reduced COLA rates because that would have understated the adjustment. Since the 2009 COLA rates did not reflect the phase-in of locality pay, we finalized the FY 2009 COLA rates for RY 2010 through RY 2014.

In the FY 2013 IPPS/LTCH final rule (77 FR 53700 through 53701), we established a new methodology to update the COLA factors for Alaska and Hawaii, and adopted this methodology for the IPF PPS in the FY 2015 IPF final rule (79 FR 45958 through 45960). We adopted this new COLA methodology for the IPF PPS because IPFs are hospitals with a similar mix of commodities and services. We believe it is appropriate to have a consistent policy approach with that of other hospitals in Alaska and Hawaii.

Therefore, the IPF COLAs for FY 2015 through FY 2017 were the same as those applied under the IPPS in those years. As finalized in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53700 and 53701), the COLA updates are determined every 4 years, when the IPPS market basket labor-related share is updated. Because the labor-related share of the IPPS market basket was most recently updated for FY 2022, the COLA factors were updated in FY 2022 IPPS/LTCH rulemaking (86 FR 45547).

As such, we also updated the IPF PPS COLA factors for FY 2022 (86 FR 42621 through 42622) to reflect the updated COLA factors finalized in the FY 2022 IPPS/LTCH rulemaking. Table 2 shows the proposed IPF PPS COLA factors effective for FY 2022 through FY 2025. Table 2—IPF PPS Cost-of-Living Adjustment Factors.

IPFs Located in Alaska and HawaiiAreaFY 2022 through FY 2025Alaska:City of Anchorage and 80-kilometer (50-mile) radius by road1.22City of Fairbanks and 80-kilometer (50-mile) radius by road1.22City of Juneau and 80-kilometer (50-mile) radius by road1.22Rest of Alaska1.24Hawaii:City and County of Honolulu1.25Start Printed Page 19427County of Hawaii1.22County of Kauai1.25County of Maui and County of Kalawao1.25 The proposed IPF PPS COLA factors for FY 2023 are also shown in Addendum A to this proposed rule, and is available on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​InpatientPsychFacilPPS/​tools.html. 4. Proposed Adjustment for IPFs With a Qualifying Emergency Department (ED) The IPF PPS includes a facility-level adjustment for IPFs with qualifying EDs.

We provide an adjustment to the Federal per diem base rate to account for the costs associated with maintaining a full-service ED. The adjustment is intended to account for ED costs incurred by a psychiatric hospital with a qualifying ED or an excluded psychiatric unit of an IPPS hospital or a CAH, for preadmission services otherwise payable under the Medicare Hospital Outpatient Prospective Payment System (OPPS), furnished to a beneficiary on the date of the beneficiary's admission to the hospital and during the day immediately preceding the date of admission to the IPF (see § 413.40(c)(2)), and the overhead cost of maintaining the ED. This payment is a facility-level adjustment that applies to all IPF admissions (with one exception which we described), regardless of whether a particular patient receives preadmission services in the hospital's ED.

The ED adjustment is incorporated into the variable per diem adjustment for the first day of each stay for IPFs with a qualifying ED. Those IPFs with a qualifying ED receive an adjustment factor of 1.31 as the variable per diem adjustment for day 1 of each patient stay. If an IPF does not have a qualifying ED, it receives an adjustment factor of 1.19 as the variable per diem adjustment for day 1 of each patient stay.

The ED adjustment is made on every qualifying claim except as described in this section of the proposed rule. As specified in § 412.424(d)(1)(v)(B), the ED adjustment is not made when a patient is discharged from an IPPS hospital or CAH and admitted to the same IPPS hospital's or CAH's excluded psychiatric unit. We clarified in the November 2004 IPF PPS final rule (69 FR 66960) that an ED adjustment is not made in this case because the costs associated with ED services are reflected in the DRG payment to the IPPS hospital or through the reasonable cost payment made to the CAH.

Therefore, when patients are discharged from an IPPS hospital or CAH and admitted to the same hospital's or CAH's excluded psychiatric unit, the IPF receives the 1.19 adjustment factor as the variable per diem adjustment for the first day of the patient's stay in the IPF. For FY 2023, we are proposing to continue to retain the 1.31 adjustment factor for IPFs with qualifying EDs. A complete discussion of the steps involved in the calculation of the ED adjustment factors are in the November 2004 IPF PPS final rule (69 FR 66959 through 66960) and the RY 2007 IPF PPS final rule (71 FR 27070 through 27072).

E. Other Final Payment Adjustments and Policies 1. Outlier Payment Overview The IPF PPS includes an outlier adjustment to promote access to IPF care for those patients who require expensive care and to limit the financial risk of IPFs treating unusually costly patients.

In the November 2004 IPF PPS final rule, we implemented regulations at § 412.424(d)(3)(i) to provide a per-case payment for IPF stays that are extraordinarily costly. Providing additional payments to IPFs for extremely costly cases strongly improves the accuracy of the IPF PPS in determining resource costs at the patient and facility level. These additional payments reduce the financial losses that would otherwise be incurred in treating patients who require costlier care, and therefore, reduce the incentives for IPFs to under-serve these patients.

We make outlier payments for discharges in which an IPF's estimated total cost for a case exceeds a fixed dollar loss threshold amount (multiplied by the IPF's facility-level adjustments) plus the Federal per diem payment amount for the case. In instances when the case qualifies for an outlier payment, we pay 80 percent of the difference between the estimated cost for the case and the adjusted threshold amount for days 1 through 9 of the stay (consistent with the median LOS for IPFs in FY 2002), and 60 percent of the difference for day 10 and thereafter. The adjusted threshold amount is equal to the outlier threshold amount adjusted for wage area, teaching status, rural area, and the COLA adjustment (if applicable), plus the amount of the Medicare IPF payment for the case.

We established the 80 percent and 60 percent loss sharing ratios because we were concerned that a single ratio established at 80 percent (like other Medicare PPSs) might provide an incentive under the IPF per diem payment system to increase LOS in order to receive additional payments. After establishing the loss sharing ratios, we determined the current fixed dollar loss threshold amount through payment simulations designed to compute a dollar loss beyond which payments are estimated to meet the 2 percent outlier spending target. Each year when we update the IPF PPS, we simulate payments using the latest available data to compute the fixed dollar loss threshold so that outlier payments represent 2 percent of total estimated IPF PPS payments.

2. Proposed Update to the Outlier Fixed Dollar Loss Threshold Amount In accordance with the update methodology described in § 412.428(d), we are proposing to update the fixed dollar loss threshold amount used under the IPF PPS outlier policy. Based on the regression analysis and payment simulations used to develop the IPF PPS, we established a 2 percent outlier policy, which strikes an appropriate balance between protecting IPFs from extraordinarily costly cases while ensuring the adequacy of the Federal per diem base rate for all other cases that are not outlier cases.

Our longstanding methodology for updating the outlier fixed dollar loss threshold involves using the best available data, which is typically the most recent available data. Last year for the FY 2022 IPF PPS final rule, we finalized the use of FY 2019 claims rather than the more recent FY 2020 claims for updating the outlier fixed dollar loss threshold (86 FR 42623). We Start Printed Page 19428 noted that our use of the FY 2019 claims to set the final outlier fixed dollar loss threshold for FY 2022 deviated from our longstanding practice of using the most recent available year of claims, but remained otherwise consistent with the established outlier update methodology.

We explained that we finalized our proposal to deviate from our longstanding practice of using the most recent available year of claims only because, and to the extent that, the “antibiotics disease 2019” (abbreviated “buy antibiotics”) Public Health Emergency (PHE) appeared to have significantly impacted the FY 2020 IPF claims. We further stated that we intended to continue to analyze further data in order to better understand both the short-term and long-term effects of the buy antibiotics PHE on IPFs (86 FR 42624). For this FY 2023 IPF PPS proposed rulemaking, consistent with our longstanding practice, we analyzed the most recent available data for simulating IPF PPS payments in FY 2023.

We observed a continuation of two main trends that we noted in our analysis of FY 2020 claims for FY 2022—that is, an overall increase in average cost per day and an overall decrease in the number of covered days. However, we also identified that some providers had significant increases in their charges, resulting in higher than normal estimated cost per day that would skew our estimate of outlier payments for FY 2022 and FY 2023. Historically, we have applied statistical trims under the IPF PPS in order to improve the statistical validity of the data used for ratesetting.

In the November 2004 final rule, we explained that we applied a 3 standard deviation trim on cost per day prior to calculating the average per diem cost used to calculate the IPF PPS Federal per diem base rate (69 FR 66927). Furthermore, as discussed in section III.E.3 of this proposed rule, our longstanding policy applies a ceiling on a provider's cost-to-charge ratio when it exceeds 3 standard deviations from the mean cost-to-charge ratio for urban or rural providers. We are proposing a similar approach in order to address the skew in estimated cost per day that we observed in the FY 2021 claims.

Specifically, we are proposing for FY 2023 to exclude providers from our simulation of IPF PPS payments for FY 2022 and FY 2023 if their change in estimated average cost per day is outside 3 standard deviations from the mean. Based on an analysis of the December 2021 update of FY 2021 IPF claims and the FY 2022 rate increases, we believe it is necessary to update the fixed dollar loss threshold amount to maintain an outlier percentage that equals 2 percent of total estimated IPF PPS payments. We are proposing to update the IPF outlier threshold amount for FY 2023 using FY 2021 claims data and the same methodology that we used to set the initial outlier threshold amount in the RY 2007 IPF PPS final rule (71 FR 27072 and 27073), which is also the same methodology that we used to update the outlier threshold amounts for years 2008 through 2022.

However, as discussed earlier in this section, we also propose for FY 2023 to exclude providers from our impact simulations whose change in simulated cost per day is outside 3 standard deviations from the mean. Based on an analysis of these updated data, we estimate that IPF outlier payments as a percentage of total estimated payments are approximately 3.2 percent in FY 2022. Therefore, we are proposing to update the outlier threshold amount to $24,270 to maintain estimated outlier payments at 2 percent of total estimated aggregate IPF payments for FY 2023.

This proposed update is an increase from the FY 2022 threshold of $16,040. 3. Proposed Update to IPF Cost-to-Charge Ratio Ceilings Under the IPF PPS, an outlier payment is made if an IPF's cost for a stay exceeds a fixed dollar loss threshold amount plus the IPF PPS amount.

In order to establish an IPF's cost for a particular case, we multiply the IPF's reported charges on the discharge bill by its overall cost-to-charge ratio (CCR). This approach to determining an IPF's cost is consistent with the approach used under the IPPS and other PPSs. In the FY 2004 IPPS final rule (68 FR 34494), we implemented changes to the IPPS policy used to determine CCRs for IPPS hospitals, because we became aware that payment vulnerabilities resulted in inappropriate outlier payments.

Under the IPPS, we established a statistical measure of accuracy for CCRs to ensure that aberrant CCR data did not result in inappropriate outlier payments. As we indicated in the November 2004 IPF PPS final rule (69 FR 66961), we believe that the IPF outlier policy is susceptible to the same payment vulnerabilities as the IPPS. Therefore, we adopted a method to ensure the statistical accuracy of CCRs under the IPF PPS.

Specifically, we adopted the following procedure in the November 2004 IPF PPS final rule. Calculated two national ceilings, one for IPFs located in rural areas and one for IPFs located in urban areas. Computed the ceilings by first calculating the national average and the standard deviation of the CCR for both urban and rural IPFs using the most recent CCRs entered in the most recent Provider Specific File (PSF) available.

For FY 2023, we propose to continue to follow this methodology. To determine the rural and urban ceilings, we multiplied each of the standard deviations by 3 and added the result to the appropriate national CCR average (either rural or urban). The upper threshold CCR for IPFs in FY 2023 is 2.0472 for rural IPFs, and 1.7279 for urban IPFs, based on CBSA-based geographic designations.

If an IPF's CCR is above the applicable ceiling, the ratio is considered statistically inaccurate, and we assign the appropriate national (either rural or urban) median CCR to the IPF. We apply the national median CCRs to the following situations. New IPFs that have not yet submitted their first Medicare cost report.

We continue to use these national median CCRs until the facility's actual CCR can be computed using the first tentatively or final settled cost report. IPFs whose overall CCR is in excess of three standard deviations above the corresponding national geometric mean (that is, above the ceiling). Other IPFs for which the MAC obtains inaccurate or incomplete data with which to calculate a CCR.

We are proposing to continue to update the FY 2023 national median and ceiling CCRs for urban and rural IPFs based on the CCRs entered in the latest available IPF PPS PSF. Specifically, for FY 2023, to be used in each of the three situations listed previously, using the most recent CCRs entered in the CY 2022 PSF, we provide an estimated national median CCR of 0.5720 for rural IPFs and a national median CCR of 0.4200 for urban IPFs. These calculations are based on the IPF's location (either urban or rural) using the CBSA-based geographic designations.

A complete discussion regarding the national median CCRs appears in the November 2004 IPF PPS final rule (69 FR 66961 through 66964). IV. Comment Solicitation on Analysis of IPF PPS Adjustments A.

Background As discussed in section III.C.1 of this proposed rule, we are proposing to continue to use the existing regression-derived adjustment factors for FY 2023. In the November 15, 2004 final rule, we indicated that we did not intend to update the regression analysis and the patient-level and facility-level adjustments until we complete further Start Printed Page 19429 analysis of IPF costs using IPF PPS data that yields as much information as possible regarding the patient-level characteristics of the population that each IPF serves. Since that time, we undertook analysis to better understand IPF industry practices so that we may refine the IPF PPS in the future, as appropriate.

For RY 2012, we identified several areas of concern for future refinement, and we invited comments on these issues in the RY 2012 IPF PPS proposed and final rules. For further discussion of these issues and to review the public comments, we refer readers to the RY 2012 IPF PPS proposed rule (76 FR 4998) and final rule (76 FR 26432). Our preliminary analysis, which we previously discussed in the FY 2016 IPF PPS final rule (80 FR 46693 through 46694), also revealed variation in cost and claim data, particularly related to labor costs, drugs costs, and laboratory services.

We found that some providers have very low labor costs, or very low or missing drug or laboratory costs or charges, relative to other providers. As we noted in the FY 2016 IPF PPS final rule, our preliminary analysis of 2012 to 2013 IPF data found that over 20 percent of IPF stays reported no ancillary costs, such as laboratory and drug costs, in their cost reports, or laboratory or drug charges on their claims. In the past, we stated that we expect that most patients requiring hospitalization for active psychiatric treatment would need drugs and laboratory services, and we reminded providers that the IPF PPS Federal per diem base rate includes the cost of all ancillary services, including drugs and laboratory services.

On November 17, 2017, we issued Transmittal 12, which made changes to the hospital cost report form CMS- 2552-10 (OMB No. 0938-0050), and included the requirement that cost reports from psychiatric hospitals include certain ancillary costs, or the cost report will be rejected. On January 30, 2018, we issued Transmittal 13, which changed the implementation date for Transmittal 12 to be for cost reporting periods ending on or after September 30, 2017.

For details, we refer readers to see these Transmittals, which are available on the CMS website at https://www.cms.gov/​Regulationsand-Guidance/​Guidance/​Transmittals/​index.html. CMS suspended the requirement that cost reports from psychiatric hospitals include certain ancillary costs effective April 27, 2018, in order to consider excluding all-inclusive rate providers from this requirement. CMS issued Transmittal 15 on October 19, 2018, reinstating the requirement that cost reports from psychiatric hospitals, except all-inclusive rate providers, include certain ancillary costs.

B. Update and Comment Solicitation on Analysis of IPF PPS Adjustments Working in collaboration with a contractor, we have undertaken further analysis of more recent IPF cost and claim information. We have posted a report on the CMS website, which summarizes the results of the latest analysis.

For public awareness, this report is available online at https://www.cms.gov/​medicare/​medicare-fee-for-service-payment/​inpatientpsychfacilpps. This updated analysis finds that the existing IPF PPS model continues to be generally appropriate in terms of effectively aligning IPF PPS payments with the cost of providing IPF services, but suggests that certain updates to the codes, categories, adjustment factors, and ECT payment amount per treatment could improve payment accuracy. We are requesting comments on the results of our latest analysis as summarized in the report.

In particular, we are interested in comments about the following topics, which are discussed in detail in the report. The report summarizes results of the analysis regarding patient-level characteristics, about which we are requesting comments. ++ The updated regression analysis suggests that certain technical changes to the DRG and comorbidity adjustment factors, consolidation of the age categories for the patient age adjustment, and changes to the adjustment factors for age and length of stay could be appropriate.

++ The analysis of ancillary costs for IPF stays with ECT suggests that a higher ECT payment amount per treatment could better align IPF PPS payments with the costs of furnishing ECT. ++ The analysis of the outlier percentage suggests that fewer IPF cases qualify for outliers under the current 2 percent outlier target than were estimated when the IPF PPS was established. We estimate that increasing the outlier percentage would increase the number of IPF cases that qualify for outliers, but would have distributional effects due to budget neutrality.

The report summarizes the results of analysis regarding facility-level characteristics, about which we are requesting comments. ++ The updated regression analysis suggests that updating the adjustment factors for teaching facilities, rural facilities, and facilities with an ED could improve payment accuracy. However, we estimate such changes could have positive and negative effects on payments for different types of IPFs.

++ The analysis of occupancy-related control variables included in the regression model indicates that these control variables are correlated with the rural adjustment factor, and that removal of these control variables from the model could result in an increase to the rural adjustment factor in the regression model. The report summarizes certain areas where we believe additional research is needed. We are requesting comments about the results summarized in the report.

We are also requesting comments about additional analyses that we should undertake to better understand how these issues affect the cost of providing IPF services, and how the IPF PPS could better account for these costs. ++ We analyzed the costs associated with social determinants of health, but found that our analysis was confounded by a low frequency of IPF claims reporting the applicable ICD-10 diagnosis codes. We are soliciting public comments about the results of this analysis, and whether there are additional patient characteristics that affect the cost of providing IPF services that may not be consistently reported on claims.

Additionally, we are soliciting public comments about how we could better identify such patient characteristics and their effects on costs. ++ We analyzed the costs associated with the percentage of low-income patients that IPFs treat, based on a construction of the Disproportionate Share Hospitals (DSH) percentage that is used in other payment systems using the data currently available for IPFs. We are soliciting public comments about the results of this analysis, which suggest that the addition of an adjustment factor for disproportionate share intensity could improve the accuracy of IPF PPS payments.

V. Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program A. Overarching Principles for Measuring Equity and Healthcare Quality Disparities Across CMS Quality Programs—Request for Information Significant and persistent disparities in healthcare outcomes exist in the United States.

Belonging to an underserved community is often associated with worse health Start Printed Page 19430 outcomes.[] With this in mind, CMS aims to advance health equity, by which we mean the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes. CMS is working to advance health equity by designing, implementing, and operationalizing policies and programs that support health for all the people served by our programs, eliminating avoidable differences in health outcomes experienced by people who are disadvantaged or underserved, and providing the care and support that our beneficiaries need to thrive.[] We are committed to achieving equity in healthcare outcomes for our enrollees by supporting healthcare providers' quality improvement activities to reduce health disparities, enabling them to make more informed decisions, and promoting healthcare provider accountability for healthcare disparities.[] Measuring healthcare disparities in quality measures is a cornerstone of our approach to advancing healthcare equity. Hospital performance results that illustrate differences in outcomes between patient populations have been reported to hospitals confidentially since 2018.

This RFI consists of three sections. The first section discusses a general framework that could be utilized across CMS quality programs to assess disparities in healthcare quality. The next section outlines approaches that could be used in the IPFQR Program to assess drivers of healthcare quality disparities in the IPFQR Program.

Additionally, this section discusses measures of health equity that could be adapted for use in the IPFQR Program. Finally, the third section solicits public comment on the principles and approaches listed in the first two sections as well as seeking other thoughts about disparity measurement guidelines for the IPFQR Program. 1.

Cross-Setting Framework To Assess Healthcare Quality Disparities CMS has identified five key considerations that we could apply consistently across CMS programs when advancing the use of measurement and stratification as tools to address health care disparities and advance health equity. The remainder of this section describes each of these considerations. A.

Identification of Goals and Approaches for Measuring Healthcare Disparities and Using Measures Stratification Across CMS Quality Programs By quantifying healthcare disparities through measure stratification (that is, measuring performance differences among subgroups of beneficiaries), we aim to provide useful tools for healthcare providers to drive improvement based on data. We hope that these results support healthcare providers efforts in examining the underlying drivers of disparities in their patients' care and to develop their own innovative and targeted quality improvement interventions. Quantification of health disparities can also support communities in prioritizing and engaging with healthcare providers to execute such interventions, as well as providing additional tools for accountability and decision-making.

There are several different conceptual approaches to reporting health disparities in the acute care setting, including two complementary approaches that are already used to confidentially provide disparity information to hospitals for a subset of existing measures. The first approach, referred to as the “within-hospital disparity method,” compares measure performance results for a single measure between subgroups of patients with and without a given factor. This type of comparison directly estimates disparities in outcomes between subgroups and can be helpful to identify potential disparities in care.

This type of approach can be used with most measures that include patient-level data. The second approach, referred to as the “between-hospital disparity methodology,” provides performance on measures for only the subgroup of patients with a particular social risk factor. These approaches can be used by a healthcare provider to compare their own measure performance on a particular subgroup of patients against subgroup-specific state and national benchmarks.

Alone, each approach may provide an incomplete picture of disparities in care for a particular measure, but when reported together with overall quality performance, these approaches may provide detailed information about where differences in care may exist or where additional scrutiny may be appropriate. For example, the between-provider disparity method may indicate that an IPF underperformed (when compared to other facilities on average) for patients with a given social risk factor, which would signal the need to improve care for this population. However, if the IPF also underperformed for patients without that social risk factor, the measured difference, or disparity in care, (the “within-hospital” disparity, as described above) could be negligible even though performance for the group that has been historically marginalized remains poor.

We refer readers to the technical report describing the CMS Disparity Methods in detail as well as the FY 2018 IPPS/LTCH PPS final rule (82 FR 38405 through 38407) and the posted Disparity methods Updates and Specifications Report posted on the QualityNet website.[] Start Printed Page 19431 CMS is interested in whether similar approaches to the two discussed in the previous paragraph could be used to produce confidential stratified measure results for selected IPF QRP measures, as appropriate and feasible. However, final decisions regarding disparity reporting will be made at the program-level, as CMS intends to tailor the approach used in each setting to achieve the greatest benefit and avoid unintentional consequences or biases in measurement that may exacerbate disparities in care. B.

Guiding Principles for Selecting and Prioritizing Measures for Disparity Reporting We intend to expand our efforts to provide stratified reporting for additional clinical quality measures, provided they offer meaningful, actionable, and valid feedback to healthcare providers on their care for populations that may face social disadvantage or other forms of discrimination or bias. We are mindful, however, that it may not be possible to calculate stratified results for all quality measures, and that there may be situations where stratified reporting is not desired. To help inform prioritization of the next generation of candidate measures for stratified reporting, we aim to receive feedback on several systematic principles under consideration that we believe will help us prioritize measures for disparity reporting across programs.

(1) Programs may consider stratification among existing clinical quality measures for further disparity reporting, prioritizing recognized measures which have met industry standards for measure reliability and validity. (2) Programs may consider measures for prioritization that show evidence that a treatment or outcome being measured is affected by underlying healthcare disparities for a specific social or demographic factor. Literature related to the measure or outcome should be reviewed to identify disparities related to the treatment or outcome, and should carefully consider both social risk factors and patient demographics.

In addition, analysis of Medicare-specific data should be done in order to demonstrate evidence of disparity in care for some or most healthcare providers that treat Medicare patients. (3) Programs may consider establishing statistical reliability and representation standards (for example, the percent of patients with a social risk factor included in reporting facilities) prior to reporting results. They may also consider prioritizing measures that reflect performance on greater numbers of patients to ensure that the reported results of the disparity calculation are reliable and representative.

(4) After completing stratification, programs may consider prioritizing the reporting of measures that show differences in measure performance between subgroups across healthcare providers. c. Principles for Social Risk Factor and Demographic Data Selection and Use Social risk factors are the wide array of non-clinical drivers of health known to negatively impact patient outcomes.

These include factors such as socioeconomic status, housing availability, and nutrition (among others), often inequitably affecting historically marginalized communities on the basis of race and ethnicity, rurality, sexual orientation and gender identity, religion, and disability.[] Identifying and prioritizing social risk or demographic variables to consider for disparity reporting can be challenging. This is due to the high number of variables that have been identified in the literature as risk factors for poorer health outcomes and the limited availability of many self-reported social risk factors and demographic factors across the healthcare sector. Several proxy data sources, such as area-based indicators of social risk and imputation methods, may be used if individual patient-level data is not available.

Each source of data has advantages and disadvantages for disparity reporting. • Patient-reported data are considered to be the gold standard for evaluating quality of care for patients with social risk factors.[] While data sources for many social risk factors and demographic variables are still developing among several CMS settings, the IPFQR Program will begin collecting mandatory patient-level data for certain chart-abstracted measures the FY 2024 payment determination and subsequent years (86 FR 42608). • CMS Administrative Claims data have long been used for quality measurement due to their availability and will continue to be evaluated for usability in measure development and or stratification.

Using these existing data allows for high impact analyses with negligible healthcare provider burden. For example, dual eligibility for Medicare and Medicaid has been found to be an effective indicator of social risk in beneficiary populations.[] There are, however, limitations in these data's usability for stratification analysis. • Area-based indicators of social risk create approximations of patient risk based on the neighborhood or context that a patient resides in.

Several indexes, such as Agency for Healthcare Research and Quality (AHRQ) Socioeconomic Status (SES) Index, [] Start Printed Page 19432 Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (CDC/ATSDR) Social Vulnerability Index (SVI),[] and Health Resources and Services Administration (HRSA) Area Deprivation Index (ADI),[] provide multifaceted contextual information about an area and may be considered as an efficient way to stratify measures that include many social risk factors. • Imputed data sources use statistical techniques to estimate patient-reported factors, including race and ethnicity. One such tool is the Medicare Bayesian Improved Surname Geocoding (MBISG) method (currently in version 2.1), which combines information from administrative data, surname, and residential location to estimate patient race and ethnicity.[] d.

Identifying Meaningful Performance Differences While we aim to use standardized approaches where possible, identifying differences in performance on stratified results will be made at the program level due to contextual variations across programs and settings. We look forward to feedback on the benefits and limitations of the possible reporting approaches described below. • Statistical approaches could be used to reliably group results, such as using confidence intervals, creating cut points based on standard deviations, or using a clustering algorithm.

Programs could use a ranked ordering and percentile approach, ordering healthcare providers in a ranked system based on their performance on disparity measures to quickly allow them to compare their performance to other similar healthcare providers. Healthcare providers could be categorized into groups based on their performance using defined thresholds, such as fixed intervals of results of disparity measures, indicating different levels of performance. • Benchmarking, or comparing individual results to state or national average, is another potential reporting strategy.

• Finally, a ranking system may not be appropriate for all programs and care settings, and some programs may only report disparity results. e. Guiding Principles for Reporting Disparity Measures Reporting of the results discussed above can be employed in several ways to drive improvements in quality.

Confidential reporting, or reporting results privately to healthcare providers, is generally used for new programs or new measures recently adopted for programs through notice and comment rulemaking to give healthcare providers an opportunity to become more familiar with calculation methods and to improve before other forms of reporting are used. In addition, many results are reported publicly, in accordance with the statute. This method provides all stakeholders with important information on healthcare provider quality, and in turn, relies on market forces to incentivize healthcare providers to improve and become more competitive in their markets without directly influencing payment from CMS.

One important consideration is to assess differential impact on IPFs, such as those located in rural, or critical access areas, to ensure that reporting does not disadvantage already resource-limited settings. The type of reporting chosen by programs will depend on the program context. Regardless of the methods used to report results, it is important to report stratified measure data alongside overall measure results.

Review of both measures results along with stratified results can illuminate greater levels of detail about quality of care for subgroups of patients, providing important information to drive quality improvement. Unstratified quality measure results address general differences in quality of care between healthcare providers and promote improvement for all patients, but unless stratified results are available, it is unclear if there are subgroups of patients that benefit most from initiatives. Notably, even if overall quality measure scores improve, without identifying and measuring differences in outcomes between groups of patients, it is impossible to track progress in reducing disparity for patients with heightened risk of poor outcomes.

2. Approaches to Assessing Drivers of Healthcare Quality Disparities and Developing Measures of Healthcare Equity in the IPFQR Program This section presents information on two approaches for the IPFQR Program. The first section presents information about a method that could be used to assist IPFs in identifying potential drivers of healthcare quality disparities.

The second section describes measures of healthcare equity that might be appropriate for inclusion in the IPFQR Program. A. Performance Disparity Decomposition In response to the FY 2022 IPF PPS proposed rule's RFI (86 FR 19494 through 19500), “Closing the Health Equity Gap in CMS Quality Programs”, some stakeholders noted that identifying which factors are contributing to the performance gaps may not always be straightforward, especially if the IPF has limited information or resources to determine the extent to which a patient's social determinants of health (SDOH) or other mediating factors (for example.

Health histories) explain a given disparity. An additional complicating factor is the reality that there are likely multiple SDOH and other mediating factors responsible for a given disparity, and it may not be obvious to the IPF which of these factors are the primary drivers. Consequently, CMS may consider methods to use the data already available in enrollment, claims, and assessment data to estimate the extent to which various SDOH (for example, transportation, health literacy) and other mediating factors drive disparities in an effort to provide more actionable information.

Researchers have utilized decomposition techniques to examine inequality in health care and, specifically, as a way to understand and explain the underlying causes of inequality.[] At a high level, regression decomposition is a method that allows one to estimate the extent to which disparities (that is, differences) in measure performance between subgroups of patient populations are due to specific factors. These factors can be either non-clinical (for example, SDOH) or clinical. Similarly, CMS may utilize regression decomposition to Start Printed Page 19433 identify and calculate the specific contribution of SDOHs and other mediating factors to observed disparities.

This approach may better inform our understanding of the extent to which providers and policy-makers may be able to narrow the gap in healthcare outcomes. Additionally, provider-specific decomposition results could be shared through confidential results so that IPFs can see the disparities within their facility with more granularity, allowing them to set priority targets in some performance areas while knowing which areas of their care are already relatively equitable. Importantly, these results could help IPFs identify reasons for disparities that might not be obvious without having access to additional data sources (for example.

The ability to link data across providers). To more explicitly demonstrate the types of information that could be provided through decomposition of a measure disparity, consider the following example for a given IPF. Figures 1 through 3 depict an example (using hypothetical data) of how a disparity in a measure of Medicare Spending Per Beneficiary (MSPB) between dual eligible beneficiaries (that is, those enrolled in Medicare and Medicaid) and non-dual eligible beneficiaries (that is, those with Medicare only) could be decomposed among two mediating factors, one SDOH and one clinical factor.

(1) Low health literacy and (2) high volume of emergency department (ED) use. These examples were selected because they are factors the healthcare provider could mitigate the effects of, if they were shown to be drivers of disparity in their IPF. Additionally, high volume ED use is used as a potential mediating factor that could be difficult for IPFs to determine on their own, as it would require having longitudinal data for patients across multiple facilities.

In Figure 1, the overall Medicare spending disparity is $1,000. Spending, on average, is $5,000 per non-dual beneficiary and $6,000 per dual beneficiary. We can also see from Figure 2 that in this IPF, the dual population has twice the prevalence of beneficiaries with low health literacy and high ED use compared to the non-dual population.

Using regression techniques, the difference in overall spending between non-dual and dual beneficiaries can be divided into three causes. (1) A difference in the prevalence of mediating factors (for example. Low health literacy and high ED use) between the two groups, (2) a difference in how much spending is observed for beneficiaries with these mediating factors between the two groups, and (3) differences in baseline spending that are not due to either (1) or (2).

In Figure 3, the `Non-Dual Beneficiaries' column breaks down the overall spending per non-dual beneficiary, $5,000, into a baseline spending of $4,600 plus the effects of the higher spending for the 10 percent of non-dual beneficiaries with low health literacy ($300) and the 5 percent with high ED use ($100). The `Dual Beneficiaries' column similarly decomposes the overall spending per dual beneficiary ($6,000) into a baseline spending of $5,000, plus the amounts due to dual beneficiaries' 20 percent prevalence of low health literacy ($600, twice as large as the figure for non-dual beneficiaries because the prevalence is twice as high), and dual beneficiaries' 10 percent prevalence of high-volume ED use ($200, similarly twice as high as for non-duals beneficiaries due to higher prevalence). This column also includes an additional $100 per risk factor because dual beneficiaries experience a higher cost than non-dual beneficiaries within the low health literacy risk factor, and similarly within the high ED use risk factor.

Based on this information, an IPF can determine that the overall $1,000 disparity can be divided into differences simply due to risk factor prevalence ($300 + $100 = $400 or 40 percent of the total disparity), disparities in costs for beneficiaries with risk factors ($100 + $100 = $200 or 20 percent) and disparities that remain unexplained (differences in baseline costs. $400 or 40 percent). In particular, the IPF can see that simply having more patients with low health literacy and high ED use accounts for a disparity of $400.

In addition, there is still a $200 disparity stemming from differences in costs between non-dual and dual patients for a given risk factor, and another $400 that is not explained by either low health literacy or high ED use. These differences may instead be explained by other SDOH that have not yet been included in this breakdown, or by the distinctive pattern of care decisions made by providers for dual and non-dual beneficiaries. These cost estimates would provide additional information that facilities could use when determining where to devote resources aimed at achieving equitable health outcomes (for example, facilities may choose to focus efforts on the largest drivers of a disparity).

Start Printed Page 19434 Start Printed Page 19435 b. Measures Related to Health Equity Beyond identifying disparities in individual health outcomes and by individual risk factors, there is interest in developing more comprehensive measures of health equity that reflect organizational performance. When determining which equity measures could be prioritized for development for the IPFQRP Program, CMS may consider the following.

Measures should be actionable in terms of quality improvement. Measures should help beneficiaries and their caregivers make informed healthcare decisions. Measures should not create incentives to lower the quality of care.

And Measures should adhere to high scientific acceptability standards. CMS has developed measures assessing health equity, or designed to promote health equity, in other settings outside of the IPF. As a result, there may be measures that could be adapted for use in the IPFQR Program.

The remainder of this section discusses two such measures, beginning with the Health Equity Summary Score (HESS), and then a structural measure assessing the degree of hospital leadership engagement in health equity performance data. Start Printed Page 19436 (1) Health Equity Summary Score The HESS measure was developed by the CMS OMH []  [] to identify and to reward healthcare providers (that is, Medicare Advantage [MA] plans) that perform relatively well on measures of care provided to beneficiaries with social risk factors (SRFs), as well as to discourage the non-treatment of patients who are potentially high-risk, in the context of value-based purchasing. Additionally, a version of the HESS is under consideration for the Hospital Inpatient Quality Reporting (HIQR) program.[] The HESS composite measure provides a summary of equity of care delivery by combining performance and improvement across multiple measures and multiple at-risk groups.

The HESS was developed with the following goals. Allow for “multiple grouping variables, not all of which will be measurable for all plans,” allow for “disaggregation by grouping variable for nuanced insights,” and allow for the future usage of additional and different SRFs for grouping.[] The HESS computes across-provider disparity in performance, as well as within-provider and across-provider disparity improvement in performance. Calculation starts with a cross-sectional score and an overall improvement score for each SRF of race/ethnicity and dual eligibility, for each plan.

The overall improvement score is based on two separate improvement metrics. Within-plan improvement and nationally benchmarked improvement. Within-plan improvement is defined as how that plan improves the care of patients with SRFs relative to higher-performing patients between the baseline period and performance period, and is targeted at eliminating within-plan disparities.

Nationally benchmarked improvement is improvement of care for beneficiaries with SRFs served by that MA plan, relative to the improvement of care for similar beneficiaries across all MA plans, and is targeted at improving the overall care of populations with SRFs. Within-plan improvement and nationally benchmarked improvement are then combined into an overall improvement score. Meanwhile, the cross-sectional score measures overall measure performance among beneficiaries with SRFs during the performance period, regardless of improvement.

To calculate a provider's overall score, the HESS uses a composite of five clinical quality measures based on HEDIS data and seven MA Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient experience measures. A provider's overall HESS score is calculated once using only CAHPS-based measures and once using only HEDIS-based measures, due to incompatibility between the two data sources. The HESS uses a composite of these measures to form a cross-sectional score, a nationally benchmarked improvement score, and a within-plan improvement score, one for each SRF.

These scores are combined to produce an SRF-specific blended score, which is then combined with the blended score for another SRF to produce the overall HESS. (2) Degree of Hospital Leadership Engagement in Health Equity Performance Data CMS has developed a structural measure for use in acute care hospitals assessing the degree to which hospital leadership is engaged in the collection of health equity performance data, with the motivation that that organizational leadership and culture can play an essential role in advancing equity goals. This structural measure, entitled the Hospital Commitment to Health Equity measure (MUC2021-106) was included on the 2021 CMS List of Measures Under Consideration (MUC List) [] and assesses hospital commitment to health equity using a suite of equity-focused organizational competencies aimed at achieving health equity for racial and ethnic minorities, people with disabilities, sexual and gender minorities, individuals with limited English proficiency, rural populations, religious minorities, and people facing socioeconomic challenges.

The measure will include five attestation-based questions, each representing a separate domain of commitment. A hospital will receive a point for each domain where they attest to the corresponding statement (for a total of 5 points). At a high level, the five domains cover the following areas.

(1) Strategic plan to reduce health disparities. (2) approach to collecting valid and reliable demographic and SDOH data. (3) analyses performed to assess disparities.

(4) engagement in quality improvement activities; [] and (5) leadership involvement in activities designed to reduce disparities. The specific questions asked within each domain, as well as the detailed measure specification are found in the CMS List of MUC for December 2021 at https://www.cms.gov/​files/​document/​measures-under-consideration-list-2021-report.pdf. An IPF could receive a point for each domain where data are submitted through a CMS portal to reflect actions taken by the IPF for each corresponding domain (for a point total).

CMS believes this type of organizational commitment structural measure may complement the health disparities approach described in previous sections, and support IPFs in quality improvement, efficient, effective use of resources, and leveraging available data. As defined by AHRQ, structural measures aim to “give consumers a sense of a healthcare provider's capacity, systems, and processes to provide high-quality care.” [] We acknowledge that collection of this structural measure may impose administrative and/or reporting requirements for IPFs. We are interested in obtaining feedback from stakeholders on conceptual and measurement priorities for the IPFQR Program to better illuminate organizational commitment to health equity.

Start Printed Page 19437 3. Solicitation of Public Comment The goal of this request for information is to describe key principles and approaches that we will consider when advancing the use of quality measure development and stratification to address healthcare disparities and advance health equity across our programs. We invite general comments on the principles and approaches described previously in this section of the rule, as well as additional thoughts about disparity measurement or stratification guidelines suitable for overarching consideration across CMS' QRP programs.

Specifically, we invite comment on. €¢ Identification of Goals and Approaches for Measuring Healthcare Disparities and Using Measure Stratification Across CMS Quality Reporting Programs ++ The use of the within- and between-provider disparity methods in IPFs to present stratified measure results ++ The use of decomposition approaches to explain possible causes of measure performance disparities ++ Alternative methods to identify disparities and the drivers of disparities Guiding Principles for Selecting and Prioritizing Measures for Disparity Reporting ++ Principles to consider for prioritization of health equity measures and measures for disparity reporting, including prioritizing stratification for validated clinical quality measures, those measures with established disparities in care, measures that have adequate sample size and representation among healthcare providers and outcomes, and measures of appropriate access and care. Principles for Social Risk Factor and Demographic Data Selection and Use ++ Principles to be considered for the selection of social risk factors and demographic data for use in collecting disparity data including the importance of expanding variables used in measure stratification to consider a wide range of social risk factors, demographic variables and other markers of historic disadvantage.

In the absence of patient-reported data we will consider use of administrative data, area-based indicators and imputed variables as appropriate Identification of Meaningful Performance Differences ++ Ways that meaningful difference in disparity results should be considered. Guiding Principles for Reporting Disparity Measures ++ Guiding principles for the use and application of the results of disparity measurement. Measures Related to Health Equity ++ The usefulness of a HESS score for IPFs, both in terms of provider actionability to improve health equity, and in terms of whether this information would support Care Compare website users in making informed healthcare decisions.

++ The potential for a structural measure assessing an IPF's commitment to health equity, the specific domains that should be captured, and options for reporting this data in a manner that would minimize burden. ++ Options to collect facility-level information that could be used to support the calculation of a structural measure of health equity. ++ Other options for measures that address health equity.

While we will not be responding to specific comments submitted in response to this RFI in the FY 2023 IPF PPS final rule, we will actively consider all input as we develop future regulatory proposals or future subregulatory policy guidance. Any updates to specific program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice-and-comment rulemaking, as necessary. VI.

Collection of Information Requirements This rule proposes updates to the prospective payment rates, outlier threshold, and wage index for Medicare inpatient hospital services provided by IPFs. It also proposes to establish a default mitigation policy for providers negatively affected by changes to the IPF PPS wage index. While discussed in section IV (Comment Solicitation on Analysis of IPF PPS Adjustments) of this preamble, the active requirements and burden associated with our hospital cost report form CMS-2552-10 (OMB control number 0938-0050) are unaffected by this rule.

Overall, this rule's proposed changes would not impose any new or revised “collection of information” requirements or burden as defined under 5 CFR 1320.3(c).). Consequently, this rule is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.

). VII. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually.

We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VIII. Regulatory Impact Analysis A.

Statement of Need This rule proposes updates to the prospective payment rates for Medicare inpatient hospital services provided by IPFs for discharges occurring during FY 2023 (October 1, 2022 through September 30, 2023). We are proposing to apply the 2016-based IPF market basket increase of 3.1 percent, less the productivity adjustment of 0.4 percentage point as required by 1886(s)(2)(A)(i) of the Act for a proposed total FY 2023 payment rate update of 2.7 percent. In this proposed rule, we are proposing to update the outlier fixed dollar loss threshold amount, update the IPF labor-related share, and update the IPF wage index to reflect the FY 2023 hospital inpatient wage index.

Lastly, for FY 2023 and subsequent years, we are proposing to apply a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, regardless of the circumstances causing the decline. B. Overall Impact We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.

L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub.

L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)) Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to Start Printed Page 19438 result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”). (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency.

(3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or with economically significant effects ($100 million or more in any 1 year). We estimate that the total impact of these changes for FY 2023 payments compared to FY 2022 payments will be a net increase of approximately $50 million. This reflects a $90 million increase from the update to the payment rates (+$105 million from the 4th quarter 2021 IGI forecast of the 2016-based IPF market basket of 3.1 percent, and -$15 million for the productivity adjustment of 0.4 percentage point), as well as a $40 million decrease as a result of the update to the outlier threshold amount.

Outlier payments are estimated to change from 3.2 percent in FY 2022 to 2.0 percent of total estimated IPF payments in FY 2023. Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is “economically significant” as measured by the $100 million threshold. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.

Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined that this rulemaking is “significant”. Therefore, OMB has reviewed these proposed regulations, and the Departments have provided the following assessment of their impact. C.

Detailed Economic Analysis In this section, we discuss the historical background of the IPF PPS and the impact of this proposed rule on the Federal Medicare budget and on IPFs. 1. Budgetary Impact As discussed in the November 2004 and RY 2007 IPF PPS final rules, we applied a budget neutrality factor to the Federal per diem base rate and ECT payment per treatment to ensure that total estimated payments under the IPF PPS in the implementation period would equal the amount that would have been paid if the IPF PPS had not been implemented.

This Budget neutrality factor included the following components. Outlier adjustment, stop-loss adjustment, and the behavioral offset. As discussed in the RY 2009 IPF PPS notice (73 FR 25711), the stop-loss adjustment is no longer applicable under the IPF PPS.

As discussed in section III.D.1 of this proposed rule, we are proposing to update the wage index and labor-related share, as well as apply the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, in a budget neutral manner by applying a wage index budget neutrality factor to the Federal per diem base rate and ECT payment per treatment. Therefore, the budgetary impact to the Medicare program of this proposed rule will be due to the market basket update for FY 2023 of 3.1 percent (see section III.A.2 of this proposed rule) less the productivity adjustment of 0.4 percentage point required by section 1886(s)(2)(A)(i) of the Act and the update to the outlier fixed dollar loss threshold amount. We estimate that the FY 2023 impact will be a net increase of $50 million in payments to IPF providers.

This reflects an estimated $90 million increase from the update to the payment rates and a $40 million decrease due to the update to the outlier threshold amount to set total estimated outlier payments at 2.0 percent of total estimated payments in FY 2023. This estimate does not include the implementation of the required 2.0 percentage point reduction of the productivity-adjusted market basket update factor for any IPF that fails to meet the IPF quality reporting requirements (as discussed in section III.B.2. Of this proposed rule).

2. Impact on Providers To show the impact on providers of the changes to the IPF PPS discussed in this proposed rule, we compare estimated payments under the proposed IPF PPS rates and factors for FY 2023 versus those under FY 2022. We determined the percent change in the estimated FY 2023 IPF PPS payments compared to the estimated FY 2022 IPF PPS payments for each category of IPFs.

In addition, for each category of IPFs, we have included the estimated percent change in payments resulting from the proposed update to the outlier fixed dollar loss threshold amount. The updated wage index data including the proposed labor-related share and the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year. And the proposed market basket update for FY 2023, as reduced by the proposed productivity adjustment according to section 1886(s)(2)(A)(i) of the Act.

To illustrate the impacts of the proposed FY 2023 changes in this proposed rule, our analysis begins with FY 2021 IPF PPS claims (based on the 2021 MedPAR claims, December 2021 update). As discussed in section III.E.2 of this proposed rule, we also proposed to exclude providers from our impact simulations whose change in estimated cost per day is outside 3 standard deviations from the mean. We estimate FY 2022 IPF PPS payments using these 2021 claims, the finalized FY 2022 IPF PPS Federal per diem base rates, and the finalized FY 2022 IPF PPS patient and facility level adjustment factors (as published in the FY 2022 IPF PPS final rule (86 FR 42608)).

We then estimate the FY 2022 outlier payments based on these simulated FY 2022 IPF PPS payments using the same methodology as finalized in the FY 2022 IPF PPS final rule (86 FR 42623 through 42624) where total outlier payments are maintained at 2 percent of total estimated FY 2022 IPF PPS payments. Each of the following changes is added incrementally to this baseline model in order for us to isolate the effects of each change. The proposed update to the outlier fixed dollar loss threshold amount.

The proposed FY 2023 IPF wage index, the proposed 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and the proposed FY 2023 labor-related share. The proposed market basket update for FY 2023 of 3.1 percent less the proposed productivity adjustment of 0.4 percentage point in accordance with section 1886(s)(2)(A)(i) of the Act for a payment rate update of 2.7 percent. Our proposed column comparison in Table 3 illustrates the percent change in payments from FY 2022 (that is, October 1, 2022, to September 30, 2022) to FY 2023 (that is, October 1, 2022, to September 30, 2023) including all the proposed payment policy changes.

Start Printed Page 19439 Table 3—FY 2023 IPF PPS Proposed Payment ImpactsFacility by typeNumber of facilitiesOutlierFY 2023 wage index (with cap) and LRSTotal percent change 1(1)(2)(3)(4)(5)All Facilities1,418−1.20.01.5Total Urban1,148−1.30.01.4Urban unit677−1.90.00.7Urban hospital471−0.40.12.4Total Rural270−0.8−0.21.7Rural unit213−0.9−0.21.6Rural hospital57−0.4−0.32.0By Type of Ownership:Freestanding IPFs:Urban Psychiatric Hospitals:Government119−1.80.10.9Non-Profit88−0.70.32.3For-Profit264−0.10.02.7Rural Psychiatric Hospitals:Government30−0.7−0.31.7Non-Profit12−1.5−0.11.1For-Profit15−0.1−0.32.3IPF Units:Urban:Government92−2.40.00.3Non-Profit450−2.2−0.10.4For-Profit135−1.00.11.8Rural:Government48−0.80.01.9Non-Profit123−0.9−0.21.5For-Profit42−1.0−0.21.4By Teaching Status:Non-teaching1,234−0.90.11.8Less than 10% interns and residents to beds99−1.6−0.20.810% to 30% interns and residents to beds61−2.9−0.4−0.7More than 30% interns and residents to beds24−3.70.2−0.9By Region:New England102−1.8−0.50.4Mid-Atlantic181−1.6−0.11.0South Atlantic219−0.7−0.11.9East North Central233−1.0−0.21.4East South Central143−1.0−0.31.4West North Central102−1.7−0.30.7West South Central211−0.50.32.5Mountain99−0.70.12.0Pacific128−1.70.91.8By Bed Size:Psychiatric Hospitals:Beds. 0-2482−0.50.22.4Beds. 25-4973−0.10.12.7Beds.

50-7578−0.1−0.12.5Beds. 76 +295−0.50.12.2Psychiatric Units:Beds. 0-24486−1.50.01.2Beds.

25-49240−1.7−0.10.9Beds. 50-75100−2.2−0.10.3Beds. 76 +64−2.1−0.10.51  This column includes the impact of the updates in columns (3) through (5) above, and of the proposed IPF market basket update factor for FY 2023 (3.1 percent), reduced by 0.4 percentage point for the proposed productivity adjustment as required by section 1886(s)(2)(A)(i) of the Act.

3. Impact Results Table 3 displays the results of our analysis. The table groups IPFs into the categories listed here based on characteristics provided in the Provider of Services file, the IPF PSF, and cost report data from the Healthcare Cost Report Information System.

Facility Type. Location. Teaching Status Adjustment.

Census Region. Size. The top row of the table shows the overall impact on the 1,418 IPFs included in the analysis.

In column 2, we present the number of facilities of each type that had information available in the PSF, had claims in the MedPAR dataset for FY 2021, and were not excluded due to the proposed trim on providers whose change in estimated cost per day is outside 3 standard deviations from the mean. Start Printed Page 19440 In column 3, we present the effects of the update to the outlier fixed dollar loss threshold amount. We estimate that IPF outlier payments as a percentage of total IPF payments are 3.2 percent in FY 2022.

Therefore, we propose to adjust the outlier threshold amount to set total estimated outlier payments equal to 2.0 percent of total payments in FY 2023. The estimated change in total IPF payments for FY 2023, therefore, includes an approximate 1.2 percent decrease in payments because we would expect the outlier portion of total payments to decrease from approximately 3.2 percent to 2.0 percent. The overall impact of the estimated decrease to payments due to updating the outlier fixed dollar loss threshold (as shown in column 3 of Table 3), across all hospital groups, is a 1.2 percent decrease.

The largest decrease in payments due to this change is estimated to be 3.7 percent for teaching IPFs with more than 30 percent interns and residents to beds. In column 4, we present the effects of the proposed budget-neutral update to the IPF wage index, the proposed Labor-Related Share (LRS), and the 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year discussed in section III.D.2 of this proposed rule. This represents the effect of using the concurrent hospital wage data as discussed in section III.D.1.a of this proposed rule.

That is, the impact represented in this column reflects the proposed update from the FY 2022 IPF wage index to the proposed FY 2023 IPF wage index, which includes basing the FY 2023 IPF wage index on the FY 2023 pre-floor, pre-reclassified IPPS hospital wage index data, applying a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year, and updating the LRS from 77.2 percent in FY 2022 to 77.4 percent in FY 2023. We note that there is no projected change in aggregate payments to IPFs, as indicated in the first row of column 4. However, there would be distributional effects among different categories of IPFs.

For example, we estimate the largest increase in payments to be 0.9 percent for Pacific IPFs, and the largest decrease in payments to be 0.5 percent for New England IPFs. IPF payments are therefore estimated to increase by 1.4 percent in urban areas and 1.7 percent in rural areas. Overall, IPFs are estimated to experience a net increase in payments as a result of the updates in this proposed rule.

The largest payment increases are estimated at 2.7 percent for freestanding urban for-profit IPFs and IPF hospitals with 25-49 beds. 4. Effect on Beneficiaries Under the FY 2023 IPF PPS, IPFs will continue to receive payment based on the average resources consumed by patients for each day.

Our longstanding payment methodology reflects the differences in patient resource use and costs among IPFs, as required under section 124 of the BBRA. We expect that updating IPF PPS rates in this proposed rule will improve or maintain beneficiary access to high quality care by ensuring that payment rates reflect the best available data on the resources involved in inpatient psychiatric care and the costs of these resources. We continue to expect that paying prospectively for IPF services under the FY 2023 IPF PPS will enhance the efficiency of the Medicare program.

5. Regulatory Review Costs If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will be directly impacted and will review this proposed rule, we assume that the total number of unique commenters on the most recent IPF proposed rule will be the number of reviewers of this proposed rule.

For this FY 2023 IPF PPS proposed rule, the most recent IPF proposed rule was the FY 2022 IPF PPS proposed rule, and we received 898 unique comments on this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed rule. It is possible that not all commenters reviewed the FY 2022 IPF proposed rule in detail, and it is also possible that some reviewers chose not to comment on that proposed rule.

For these reasons, we thought that the number of commenters would be a fair estimate of the number of reviewers who are directly impacted by this proposed rule. We are soliciting comments on this assumption. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule.

Therefore, for the purposes of our estimate, we assume that each reviewer reads approximately 50 percent of this proposed rule. Using the May, 2020 mean (average) wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this proposed rule is $114.24 per hour, including overhead and fringe benefits https://www.bls.gov/​oes/​current/​oes119111.htm. Assuming an average reading speed of 250 words per minute, we estimate that it would take approximately 50 minutes (0.833 hours) for the staff to review half of this proposed rule, which contains a total of approximately 25,000 words.

For each IPF that reviews the proposed rule, the estimated cost is (0.833 × $114.24) or $95.16. Therefore, we estimate that the total cost of reviewing this proposed rule is $85,453.68 ($95.16 × 898 reviewers). D.

Alternatives Considered The statute does not specify an update strategy for the IPF PPS and is broadly written to give the Secretary discretion in establishing an update methodology. We continue to believe it is appropriate to routinely update the IPF PPS so that it reflects the best available data about differences in patient resource use and costs among IPFs as required by the statute. Therefore, we are proposing to.

Update the IPF PPS using the methodology published in the November 2004 IPF PPS final rule. Apply the proposed 2016-based IPF PPS market basket update for FY 2023 of 3.1 percent, reduced by the statutorily required proposed productivity adjustment of 0.4 percentage point along with the proposed wage index budget neutrality adjustment to update the payment rates. And use a FY 2023 IPF wage index which uses the FY 2023 pre-floor, pre-reclassified IPPS hospital wage index as its basis.

Additionally, we are proposing to apply a 5-percent cap on any decrease to a provider's wage index from its wage index in the prior year. Lastly, we are proposing for FY 2023 to exclude providers from our simulation of IPF PPS payments for FY 2022 and FY 2023 if their change in estimated cost per day is outside 3 standard deviations from the mean. E.

Accounting Statement As required by OMB Circular A-4 (available at www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​circulars/​A4/​a-4.pdf ), in Table 4, we have prepared an accounting statement showing the classification of the expenditures associated with the updates to the IPF wage index and payment rates in this proposed rule. Table 4 provides our best estimate of the increase in Medicare payments under the IPF PPS as a result of the changes presented in this proposed rule and based on the data for 1,418 IPFs with data available in the PSF, with claims in our FY 2021 MedPAR claims dataset, and which were not excluded due to the proposed trim on providers whose change in Start Printed Page 19441 estimated cost per day is outside 3 standard deviations from the mean. Lastly, Table 4 also includes our best estimate of the costs of reviewing and understanding this proposed rule.

Table 4—Accounting Statement. Classification of Estimated Costs, Savings, and TransfersCategoryPrimary estimate ($million/year)Low estimateHigh estimateUnitsYear dollarsDiscount ratePeriod coveredRegulatory Review Costs0.072020FY 2023Annualized Monetized Transfers from Federal Government to IPF Medicare Providers50FY 2023FY 2023 F. Regulatory Flexibility Act The RFA requires agencies to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities.

For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most IPFs and most other providers and suppliers are small entities, either by nonprofit status or having revenues of $8 million to $41.5 million or less in any 1 year. Individuals and states are not included in the definition of a small entity.

Because we lack data on individual hospital receipts, we cannot determine the number of small proprietary IPFs or the proportion of IPFs' revenue derived from Medicare payments. Therefore, we assume that all IPFs are considered small entities. The Department of Health and Human Services generally uses a revenue impact of 3 to 5 percent as a significance threshold under the RFA.

As shown in Table 3, we estimate that the overall revenue impact of this proposed rule on all IPFs is to increase estimated Medicare payments by approximately 1.5 percent. As a result, since the estimated impact of this proposed rule is a net increase in revenue across almost all categories of IPFs, the Secretary has determined that this proposed rule will have a positive revenue impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals.

This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. As discussed in section VIII.C.2 of this proposed rule, the rates and policies set forth in this proposed rule will not have an adverse impact on the rural hospitals based on the data of the 213 rural excluded psychiatric units and 57 rural psychiatric hospitals in our database of 1,418 IPFs for which data were available.

Therefore, the Secretary has determined that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals. G. Unfunded Mandate Reform Act (UMRA) Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation.

In 2022, that threshold is approximately $165 million. This proposed rule does not mandate any requirements for state, local, or tribal governments, or for the private sector. This proposed rule would not impose a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of more than $165 million in any 1 year.

H. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This proposed rule does not impose substantial direct costs on state or local governments or preempt state law.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &. Medicaid Services, approved this document on March 24, 2022. Start List of Subjects Administrative practice and procedureHealth facilitiesMedicarePuerto RicoReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &.

Medicaid Services proposes to amend 42 CFR part 412 as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 412 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part2.

Section 412.424 is amended by revising paragraph (d)(1)(i) to read as follows. End Amendment Part Methodology for calculating the Federal per diem payment amount. * * * * * (d) * * * (1) * * * (i) Adjustment for wages.

CMS adjusts the labor portion of the Federal per diem base rate to account for geographic differences in the area wage levels using an appropriate wage index. (A) The application of the wage index is made on the basis of the location of the inpatient psychiatric facility in an urban or rural area as defined in § 412.402. (B) Beginning October 1, 2022, CMS applies a cap on decreases to the wage index, such that the wage index applied to an inpatient psychiatric facility is not less than 95 percent of the wage index applied to that inpatient psychiatric facility in the prior fiscal year.

* * * * * Start Signature Dated. March 29, 2022. Xavier Becerra, Secretary, Department of Health and Human Services.

End Signature End Supplemental Information BILLING CODE 4120-01-PBILLING CODE 4120-01-C[FR Doc. 2022-06906 Filed 3-31-22. 4:15 pm]BILLING CODE 4120-01-PStart Preamble Start Printed Page 19442 Centers for Medicare &.

Medicaid Services (CMS), HHS. Proposed rule. This proposed rule proposes to establish a permanent mitigation policy to smooth the impact of year-to-year changes in hospice payments related to changes in the hospice wage index.

This rule also proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2023. In addition, this rule proposes updates to the Hospice Quality Reporting Program (HQRP) including the Hospice Outcomes and Patient Evaluation tool. An update on Quality Measures (QMs) that will be in effect in FY 2023 for the HQRP and future QMs.

Updates on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment, discusses a request for information (RFI) on health equity. To be assured consideration, comments must be received at one of the addresses provided below, by May 31, 2022. In commenting, please refer to file code CMS-1773-P.

Comments, including mass comment submissions, must be submitted in one of the following three ways (choose only one of the ways listed). 1. Electronically.

You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions. 2.

By regular mail. You may mail written comments to the following address ONLY. Centers for Medicare &.

Medicaid Services, Department of Health and Human Services, Attention. CMS-1773-P, P.O. Box 8010, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail.

You may send written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-1773-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info For general questions about hospice payment policy, send your inquiry via email to.

Hospicepolicy@cms.hhs.gov. For questions regarding the CAHPS® Hospice Survey, contact Lori Teichman at (410) 786-6684 and Lauren Fuentes at (410) 786-2290. For questions regarding the hospice quality reporting program, contact Cindy Massuda at (410) 786-0652.

End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received.

Http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual.

CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. Wage index addenda will be available only through the internet on our website at.

Https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Wage-Index.html. I. Executive Summary This proposed rule proposes to establish a permanent mitigation policy to smooth the impact of year-to-year changes in the hospice payments related to changes in the hospice wage index.

This rule also proposes updates to the hospice wage index as well as updates to the hospice payment rates, and cap amount for FY 2023 as required under section 1814(i) of the Social Security Act (the Act). In addition, in this proposed rule CMS discusses updates to HQRP that include the Hospice Outcomes and Patient Evaluation (HOPE) tool with national beta testing. The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey with Star Ratings.

Developing a web-based survey. Public Reporting. A request for information that builds from last year's discussion on health equity, and update on advancing a health information exchange.

Lastly, the overall economic impact of this proposed rule is estimated to be $580 million in increased payments to hospices for FY 2023. II. Background A.

Hospice Care Hospice care is a comprehensive, holistic approach to treatment that recognizes the impending death of a terminally ill individual and warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. Medicare regulations define “palliative care” as patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice (42 CFR 418.3).

Palliative care is at the core of hospice philosophy and care practices, and is a critical component of the Medicare hospice benefit. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through a collaboration of professionals and other caregivers, with the goal of making the beneficiary as physically and emotionally comfortable as possible.

Hospice provides compassionate beneficiary and family/caregiver-centered care for those who are terminally ill. As referenced in our regulations at § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3. That is, the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course.

The regulations at § 418.22(b)(2) require that clinical information and other documentation that support the medical prognosis accompany the certification and be filed in the medical record with it. Additionally, the regulations at § 418.22(b)(3) require that the Start Printed Page 19443 certification and recertification forms include a brief narrative explanation of the clinical findings that support a life expectancy of 6 months or less. Under the Medicare hospice benefit, once a terminally ill patient elects to receive hospice care, a hospice interdisciplinary group (IDG) is essential in ensuring the provision of primarily home-based services, keeping the choices of the patient and family first and foremost.

The hospice IDG works with the beneficiary, family, and caregiver(s) to develop a coordinated, comprehensive care plan. Reduce unnecessary diagnostics or ineffective therapies. And maintain ongoing communication with individuals and their families about changes in their condition and care.

The beneficiary's care plan will shift over time to meet the changing needs of the individual, family, and caregiver(s) as the individual approaches the end of life. If, in the judgment of the hospice IDG, which includes the hospice physician, the patient's symptoms cannot be effectively managed at home, then the patient is eligible for general inpatient care (GIP), a more medically intense level of care. GIP must be provided in a Medicare-certified hospice freestanding facility, skilled nursing facility, or hospital.

GIP is provided to ensure that any new or worsening symptoms are intensively addressed so that the beneficiary can return to their home and continue to receive routine home care (RHC). Limited, short-term, intermittent, inpatient respite care (IRC) is also available to provide relief for the family or other caregivers, or when the family or other caregivers are absent. Additionally, an individual can receive continuous home care (CHC) during a period of crisis, in which an individual requires continuous care to achieve palliation or management of acute medical symptoms so that the individual can remain at home.

CHC may be covered for as much as 24 hours a day, and these periods must be predominantly nursing care, in accordance with the regulations at § 418.204. A minimum of 8 hours of nursing care, or nursing and aide care, must be furnished on a particular day to qualify for the CHC rate (§ 418.302(e)(4)). Hospices must comply with applicable civil rights laws,[] including section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, under which covered entities must take appropriate steps to ensure effective communication with patients and patient care representatives with disabilities, including the provisions of auxiliary aids and services.

In addition, they must take reasonable steps to ensure meaningful access for individuals with limited English proficiency, consistent with Title VI of the Civil Rights Act of 1964. Further information about these requirements may be found at. Http://www.hhs.gov/​ocr/​civilrights.

B. Services Covered by the Medicare Hospice Benefit Coverage under the Medicare hospice benefit requires that hospice services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a Medicare-certified hospice program.

These covered services include. Nursing care. Physical therapy.

Occupational therapy. Speech-language pathology therapy. Medical social services.

Home health aide services (called hospice aide services). Physician services. Homemaker services.

Medical supplies (including drugs and biologicals). Medical appliances. Counseling services (including dietary counseling).

Short-term inpatient care in a hospital, nursing facility, or hospice inpatient facility (including both respite care and procedures necessary for pain control and acute or chronic symptom management). Continuous home care during periods of crisis, and only as necessary to maintain the terminally ill individual at home. And any other item or service, which is specified in the plan of care and for which payment may otherwise be made under Medicare in accordance with Title XVIII of the Act.

Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, the hospice program. And that the written plan be periodically reviewed by the beneficiary's attending physician (if any), the hospice medical director, and an interdisciplinary group (section 1861(dd)(2)(B) of the Act). The services offered under the Medicare hospice benefit must be available to beneficiaries as needed, 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act).

Upon the implementation of the hospice benefit, the Congress also expected hospices to continue to use volunteer services, though Medicare does not pay for these volunteer services (section 1861(dd)(2)(E) of the Act). As stated in the FY 1983 Hospice Wage Index and Rate Update proposed rule (48 FR 38149), the hospice must have an interdisciplinary group composed of paid hospice employees as well as hospice volunteers, and that “the hospice benefit and the resulting Medicare reimbursement is not intended to diminish the voluntary spirit of hospices.” This expectation supports the hospice philosophy of community based, holistic, comprehensive, and compassionate end of life care. C.

Medicare Payment and Quality for Hospice Care Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Act, and the regulations in 42 CFR part 418, establish eligibility requirements, payment standards and procedures. Define covered services. And delineate the conditions a hospice must meet to be approved for participation in the Medicare program.

Part 418, subpart G, provides for a per diem payment based on one of four prospectively-determined rate categories of hospice care (RHC, CHC, IRC, and GIP), based on each day a qualified Medicare beneficiary is under hospice care (once the individual has elected). This per diem payment is meant to cover all of the hospice services and items needed to manage the beneficiary's care, as required by section 1861(dd)(1) of the Act. While recent news reports [] have brought to light the potential role hospices could play in medical aid in dying (MAID) where such practices have been legalized in certain states, we wish to remind hospices that the Assisted Suicide Funding Restriction Act of 1997 (Pub.

L. 105-12) prohibits the use of Federal funds to provide or pay for any health care item or service or health benefit coverage for the purpose of causing, or assisting to cause, the death of any individual including mercy killing, euthanasia, or assisted suicide. This means that while payments made to hospices are to cover all items, services, and drugs for the palliation and management of the terminal illness and related conditions, Federal funds cannot be used for the prohibited activities, even in the context of a per diem payment.

However, the prohibition does not pertain to the provision of an item or service for the purpose of alleviating pain or discomfort, even if such use may Start Printed Page 19444 increase the risk of death, so long as the item or service is not furnished for the specific purpose of causing or accelerating death. 1. Omnibus Budget Reconciliation Act of 1989 Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub.

L. 101-239) amended section 1814(i)(1)(C) of the Act and provided changes in the methodology concerning updating the daily payment rates based on the hospital market basket percentage increase applied to the payment rates in effect during the previous Federal fiscal year. 2.

Balanced Budget Act of 1997 Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) established that updates to the hospice payment rates beginning FY 2002 and in subsequent FYs are to be the hospital market basket percentage increase for the current FY.

Section 4442 of the BBA amended section 1814(i)(2) of the Act, effective for services furnished on or after October 1, 1997, to require that hospices submit claims for payment for hospice care furnished in an individual's home only on the basis of the geographic location at which the service is furnished. Previously, local wage index values were applied based on the geographic location of the hospice provider, regardless of where the hospice care was furnished. Section 4443 of the BBA amended sections 1812(a)(4) and 1812(d)(1) of the Act to provide for hospice benefit periods of two 90-day periods, followed by an unlimited number of 60-day periods.

3. FY 1998 Hospice Wage Index Final Rule The FY 1998 Hospice Wage Index final rule (62 FR 42860) implemented a new methodology for calculating the hospice wage index and instituted an annual Budget Neutrality Adjustment Factor (BNAF) so aggregate Medicare payments to hospices would remain budget neutral to payments calculated using the 1983 wage index. 4.

FY 2010 Hospice Wage Index Final Rule The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR 39384) instituted an incremental 7-year phase-out of the BNAF beginning in FY 2010 through FY 2016. The BNAF phase-out reduced the amount of the BNAF increase applied to the hospice wage index value, but was not a reduction in the hospice wage index value itself or in the hospice payment rates. 5.

The Affordable Care Act Starting with FY 2013 (and in subsequent FYs), the market basket percentage update under the hospice payment system referenced in sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act are subject to annual reductions related to changes in economy-wide productivity, as specified in section 1814(i)(1)(C)(iv) of the Act. In addition, sections 1814(i)(5)(A) through (C) of the Act, as added by section 3132(a) of the Patient Protection and Affordable Care Act (PPACA) (Pub. L.

111-148), required hospices to begin submitting quality data, based on measures specified by the Secretary of the Department of Health and Human Services (the Secretary) for FY 2014 and subsequent FYs. Since FY 2014, hospices that fail to report quality data have their market basket percentage increase reduced by 2 percentage points. Note that with the passage of the Consolidated Appropriations Act, 2021 (hereafter referred to as CAA 2021) (Pub.

L. 116-260), the reduction changes to 4 percentage points beginning in FY 2024. Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) of the PPACA, required, effective January 1, 2011, that a hospice physician or nurse practitioner have a face-to-face encounter with the beneficiary to determine continued eligibility of the beneficiary's hospice care prior to the 180th day recertification and each subsequent recertification, and to attest that such visit took place.

When implementing this provision, the Centers for Medicare &. Medicaid Services (CMS) finalized in the FY 2011 Hospice Wage Index final rule (75 FR 70435) that the 180th day recertification and subsequent recertifications would correspond to the beneficiary's third or subsequent benefit periods. Further, section 1814(i)(6) of the Act, as added by section 3132(a)(1)(B) of the PPACA, authorized the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and other purposes.

The types of data and information suggested in the PPACA could capture accurate resource utilization, which could be collected on claims, cost reports, and possibly other mechanisms, as the Secretary determined to be appropriate. The data collected could be used to revise the methodology for determining the payment rates for RHC and other services included in hospice care, no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. In addition, CMS was required to consult with hospice programs and the Medicare Payment Advisory Commission (MedPAC) regarding additional data collection and payment revision options.

6. FY 2012 Hospice Wage Index Final Rule In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through 47314) it was announced that beginning in 2012, the hospice aggregate cap would be calculated using the patient-by-patient proportional methodology, within certain limits. Existing hospices had the option of having their cap calculated through the original streamlined methodology, also within certain limits.

As of FY 2012, new hospices have their cap determinations calculated using the patient-by-patient proportional methodology. If a hospice's total Medicare payments for the cap year exceed the hospice aggregate cap, then the hospice must repay the excess back to Medicare. 7.

IMPACT Act of 2014 The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185) became law on October 6, 2014.

Section 3(a) of the IMPACT Act mandated that all Medicare certified hospices be surveyed every 3 years beginning April 6, 2015 and ending September 30, 2025. In addition, section 3(c) of the IMPACT Act requires medical review of hospice cases involving beneficiaries receiving more than 180 days of care in select hospices that show a preponderance of such patients. Section 3(d) of the IMPACT Act contains a new provision mandating that the cap amount for accounting years that end after September 30, 2016, and before October 1, 2025 be updated by the hospice payment percentage update rather than using the consumer price index for urban consumers (CPI-U) for medical care expenditures.

8. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50452) finalized a requirement that the Notice of Election (NOE) be filed within 5 calendar days after the effective date of hospice election. If the NOE is filed beyond this 5-day period, hospice providers are liable for the services furnished during the days from the effective date of hospice election to the date of NOE filing (79 FR 50474).

As with the NOE, the claims processing system must be notified of a beneficiary's discharge from hospice or hospice benefit revocation within 5 Start Printed Page 19445 calendar days after the effective date of the discharge/revocation (unless the hospice has already filed a final claim) through the submission of a final claim or a Notice of Termination or Revocation (NOTR). The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50479) also finalized a requirement that the election form include the beneficiary's choice of attending physician and that the beneficiary provide the hospice with a signed document when he or she chooses to change attending physicians. In addition, the FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50496) provided background, described eligibility criteria, identified survey respondents, and otherwise implemented the Hospice Experience of Care Survey for informal caregivers.

Hospice providers were required to begin using this survey for hospice patients as of 2015. Finally, the FY 2015 Hospice Wage Index and Rate Update final rule required providers to complete their aggregate cap determination not sooner than 3 months after the end of the cap year, and not later than 5 months after, and remit any overpayments. Those hospices that fail to submit their aggregate cap determinations on a timely basis will have their payments suspended until the determination is completed and received by the Medicare contractor (79 FR 50503).

9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), CMS finalized two different payment rates for RHC. A higher per diem base payment rate for the first 60 days of hospice care and a reduced per diem base payment rate for subsequent days of hospice care.

CMS also finalized a service intensity add-on (SIA) payment payable for certain services during the last 7 days of the beneficiary's life. A service intensity add-on payment will be made for the social worker (SW) visits and nursing visits provided by a registered nurse (RN), when provided during routine home care in the last 7 days of life. The SIA payment is in addition to the routine home care rate.

The SIA payment is provided for visits of a minimum of 15 minutes and a maximum of 4 hours per day (80 FR 47172). In addition to the hospice payment reform changes discussed, the FY 2016 Hospice Wage Index and Rate Update final rule implemented changes mandated by the IMPACT Act, in which the cap amount for accounting years that end after September 30, 2016 and before October 1, 2025 would be updated by the hospice payment update percentage rather than using the CPI-U (80 FR 47186). In addition, we finalized a provision to align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the FY for FY 2017 and thereafter.

Finally, the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47144) clarified that hospices would have to report all diagnoses on the hospice claim as a part of the ongoing data collection efforts for possible future hospice payment refinements. 10. FY 2017 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52160), CMS finalized several new policies and requirements related to the HQRP.

First, CMS codified the policy that if the National Quality Forum (NQF) made non-substantive changes to specifications for HQRP measures as part of the NQF's re-endorsement process, CMS would continue to utilize the measure in its new endorsed status, without going through new notice-and-comment rulemaking. CMS would continue to use rulemaking to adopt substantive updates made by the NQF to the endorsed measures adopted for the HQRP. Determinations about what constitutes a substantive versus non-substantive change would be made on a measure-by-measure basis.

Second, we finalized two new quality measures for the HQRP for the FY 2019 payment determination and subsequent years. (1) Hospice Visits when Death is Imminent Measure Pair. And (2) Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission (81 FR 52173).

The data collection mechanism for both of these measures is the Hospice Item Set (HIS), and the measures were effective April 1, 2017. Regarding the CAHPS® Hospice Survey, CMS finalized a policy that hospices that receive their CMS Certification Number (CCN) after January 1, 2017 for the FY 2019 Annual Payment Update (APU) and January 1, 2018 for the FY 2020 APU will be exempted from the Hospice CAHPS® requirements due to newness (81 FR 52182). The exemption is determined by CMS and is only for 1 year.

11. FY 2020 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38484), we finalized rebased payment rates for CHC and GIP and set those rates equal to their average estimated FY 2019 costs per day. We also rebased IRC per diem rates equal to the estimated FY 2019 average costs per day, with a reduction of 5 percent to the FY 2019 average cost per day to account for coinsurance.

We finalized the FY 2020 proposal to reduce the RHC payment rates by 2.72 percent to offset the increases to CHC, IRC, and GIP payment rates to implement this policy in a budget-neutral manner in accordance with section 1814(i)(6) of the Act (84 FR 38496). In addition, we finalized a policy to use the current year's pre-floor, pre-reclassified hospital inpatient wage index as the wage adjustment to the labor portion of the hospice rates. Finally, in the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38505), we finalized modifications to the hospice election statement content requirements at § 418.24(b), and added a requirement for hospices, upon request, to furnish an election statement addendum effective beginning in FY 2021.

The addendum must list items, services, and drugs the hospice has determined to be unrelated to the terminal illness and related conditions, to increase coverage transparency for beneficiaries under a hospice election. 12. Consolidated Appropriations Act, 2021 Division CC, section 404 of the CAA 2021 amended section 1814(i)(2)(B) of the Act and extended the provision that currently mandates the hospice cap be updated by the hospice payment update percentage (hospital market basket update reduced by the productivity adjustment) rather than the CPI-U for accounting years that end after September 30, 2016 and before October 1, 2030.

Prior to enactment of this provision, the hospice cap update was set to revert to the original methodology of updating the annual cap amount by the CPI-U beginning on October 1, 2025. Division CC, section 407(b) of CAA 2021 revised section 1814(i)(5)(A)(i) to increase the payment reduction for hospices who fail to meet hospice quality measure reporting requirements from 2 percentage points to 4 percentage points beginning with FY 2024. 13.

FY 2022 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2022 Hospice Wage Index and Rate Update final rule (86 FR 42532 through 42539), we finalized a policy to rebase and revise the labor shares for CHC, RHC, IRC and GIP using Medicare cost report (MCR) data for freestanding hospices (collected via CMS Form 1984-14, OMB NO. 0938-0758) for Start Printed Page 19446 2018. We established separate labor shares for CHC, RHC, IRC, and GIP based on the calculated compensation cost weights for each level of care from the 2018 MCR data.

The revised labor shares were implemented in a budget neutral manner through the use of labor share standardization factors. In the FY 2022 final rule, we removed the seven original Hospice Item Set (HIS) measures from the program because a more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available and already publicly reported. The Hospice Comprehensive Assessment Measure, NQF #3235, is one measure that is calculated and rolled up by completion of the seven individual measures.

This measure helps to ensure all hospice patients receive a holistic comprehensive assessment. Also, in or after May 2022, we will start publicly reporting the two new claims-based measures. Specifically, this includes the.

(1) Hospice Visits in the Last Days of Life (HVLDL) (which replaces the HIS Hospice Visits when Death is Imminent measure pair). And (2) Hospice Care Index (HCI) that includes 10 indicators that collectively represent different aspects of hospice care and aim to convey a comprehensive characterization of the quality of care furnished by a hospice throughout the hospice stay. Related to these changes, we finalized reporting eight quarters of claims data in order to display small providers.

We finalized the public reporting of Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey Star ratings on Care Compare to begin no sooner than FY 2022. III. Provisions of the Proposed Rule A.

Proposed FY 2023 Hospice Wage Index and Rate Update 1. Proposed FY 2023 Hospice Wage Index The hospice wage index is used to adjust payment rates for hospices under the Medicare program to reflect local differences in area wage levels, based on the location where services are furnished. The hospice wage index utilizes the wage adjustment factors used by the Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital wage adjustments.

Our regulations at § 418.306(c) require each labor market to be established using the most current hospital wage data available, including any changes made by the Office of Management and Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions. In general, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses.

On March 6, 2020, OMB issued Bulletin No. 20-01, which provided updates to and superseded OMB Bulletin No. 18-04 that was issued on September 14, 2018.

The attachments to OMB Bulletin No. 20-01 provided detailed information on the update to statistical areas since September 14, 2018, and were based on the application of the 2010 Standards for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2017 and July 1, 2018. (For a copy of this bulletin, we refer readers to the following website.

Https://www.whitehouse.gov/​wp-content/​uploads/​2020/​03/​Bulletin-20-01.pdf. ) In OMB Bulletin No. 20-01, OMB announced one new Micropolitan Statistical Area, one new component of an existing Combined Statistical Area (CSA), and changes to New England City and Town Area (NECTA) delineations.

In the FY 2021 Hospice Wage Index final rule (85 FR 47070) we stated that if appropriate, we would propose any updates from OMB Bulletin No. 20-01 in future rulemaking. After reviewing OMB Bulletin No.

20-01, we determined that the changes in Bulletin 20-01 encompassed delineation changes that would not affect the Medicare wage index for FY 2022. Specifically, the updates consisted of changes to NECTA delineations and the redesignation of a single rural county into a newly created Micropolitan Statistical Area. The Medicare wage index does not utilize NECTA definitions, and, as most recently discussed in the FY 2021 Hospice Wage Index final rule (85 FR 47070), we include hospitals located in Micropolitan Statistical areas in each state's rural wage index.

Therefore, in the FY 2022 Hospice Wage Index final rule (86 FR 42528) we adopted the updates set forth in OMB Bulletin No. 20-01 consistent with our longstanding policy of adopting OMB delineation updates. In the FY 2020 Hospice Wage Index final rule (84 FR 38484), we finalized the proposal to use the current FY's hospital wage index data to calculate the hospice wage index values.

In the FY 2021 Hospice Wage Index final rule (85 FR 47070), we adopted the revised OMB delineations with a 5-percent cap on wage index decreases, where the estimated reduction in a geographic area's wage index would be capped at 5-percent in FY 2021 and no cap would be applied to wage index decreases for the second year (FY 2022). For FY 2023, the proposed hospice wage index would be based on the FY 2023 hospital pre-floor, pre-reclassified wage index for hospital cost reporting periods beginning on or after October 1, 2018 and before October 1, 2019 (FY 2019 cost report data). The proposed FY 2023 hospice wage index would not take into account any geographic reclassification of hospitals, including those in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act.

The proposed FY 2023 hospice wage index would include a 5-percent cap on wage index decreases as discussed later in this section. The appropriate wage index value would be applied to the labor portion of the hospice payment rate based on the geographic area in which the beneficiary resides when receiving RHC or CHC. The appropriate wage index value is applied to the labor portion of the payment rate based on the geographic location of the facility for beneficiaries receiving GIP or IRC.

In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we adopted the policy that, for urban labor markets without a hospital from which hospital wage index data could be derived, all of the CBSAs within the state would be used to calculate a statewide urban average pre-floor, pre-reclassified hospital wage index value to use as a reasonable proxy for these areas. For FY 2023, the only CBSA without a hospital from which hospital wage data can be derived is 25980, Hinesville-Fort Stewart, Georgia. The FY 2023 wage index value for Hinesville-Fort Stewart, Georgia is 0.8620.

There exist some geographic areas where there were no hospitals, and thus, no hospital wage data on which to base the calculation of the hospice wage index. In the FY 2008 Hospice Wage Index final rule (72 FR 50217 through 50218), we implemented a methodology to update the hospice wage index for rural areas without hospital wage data. In cases where there was a rural area without rural hospital wage data, we use the average pre-floor, pre-reclassified hospital wage index data from all contiguous CBSAs, to represent a reasonable proxy for the rural area.

The term “contiguous” means sharing a border (72 FR 50217). Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, for rural Puerto Rico, we would not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity of almost all of Puerto Rico's various Start Printed Page 19447 urban areas to non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas).

Instead, we would continue to use the most recent wage index previously available for that area. For FY 2023, we propose to continue using the most recent pre-floor, pre-reclassified hospital wage index value available for Puerto Rico, which is 0.4047, subsequently adjusted by the hospice floor. As described in the August 8, 1997 Hospice Wage Index final rule (62 FR 42860), the pre-floor and pre-reclassified hospital wage index is used as the raw wage index for the hospice benefit.

These raw wage index values are subject to application of the hospice floor to compute the hospice wage index used to determine payments to hospices. As previously discussed, the pre-floor, pre-reclassified hospital wage index values below 0.8 will be further adjusted by a 15 percent increase subject to a maximum wage index value of 0.8. For example, if County A has a pre-floor, pre-reclassified hospital wage index value of 0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593.

Since 0.4593 is not greater than 0.8, then County A's hospice wage index would be 0.4593. In another example, if County B has a pre-floor, pre-reclassified hospital wage index value of 0.7440, we would multiply 0.7440 by 1.15, which equals 0.8556. Because 0.8556 is greater than 0.8, County B's hospice wage index would be 0.8.

The proposed hospice wage index applicable for FY 2023 (October 1, 2022 through September 30, 2023) is available on the CMS website at. https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Wage-Index.html. 2.

Proposed Permanent Cap on Wage Index Decreases As discussed in section III.A.1, we have proposed and finalized temporary transition policies in the past to mitigate significant changes to payments due to changes to the hospice wage index. Specifically, in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142) we implemented a 50/50 blend for all geographic areas consisting of the wage index values using the then-current OMB area delineations and the wage index values using OMB's new area delineations based on OMB Bulletin No. 13-01.

In the FY 2021 Hospice Wage Index final rule (85 FR 47070), we adopted the revised OMB delineations with a 5-percent cap on wage index decreases, where the estimated reduction in a geographic area's wage index would be capped at 5-percent in FY 2021 and no cap would be applied to wage index decreases for the second year (FY 2022). As explained, we believed the 5-percent cap would provide greater transparency and be administratively less complex than the prior methodology of applying a 50/50 blended wage index. We noted that this transition approach struck an appropriate balance by providing a transition period to mitigate the resulting -short-term instability and negative impacts on providers and time for them to adjust to their new labor market area delineations and wage index values.

In the FY 2022 Hospice Wage Index and Payment Rate Update final rule (86 FR 42541), a few commenters stated that providers should be protected against substantial payment reductions due to dramatic reductions in wage index values from one year to the next. Because we did not propose to modify the transition policy that was finalized in the FY 2021 Hospice final rule, we did not extend the transition period for FY 2022. In the FY 2022 Hospice final rule, we stated that we continued to believe that applying the 5-percent cap transition policy in year one provided an adequate safeguard against any significant payment reductions associated with the adoption of the revised CBSA delineations in FY 2021, allowed for sufficient time to make operational changes for future FYs, and provided a reasonable balance between mitigating some short-term instability in hospice payments and improving the accuracy of the payment adjustment for differences in area wage levels.

However, we acknowledged that certain changes to wage index policy may significantly affect Medicare payments. In addition, we reiterated that our policy principles with regard to the wage index include generally using the most current data and information available and providing that data and information, as well as any approaches to addressing any significant effects on Medicare payments resulting from these potential scenarios, in notice and comment rulemaking. With these policy principles in mind, we considered for this FY 2023 Hospice proposed rule how best to address the potential scenarios, which commenters raised concerns.

That is, scenarios in which changes to wage index policy may significantly affect Medicare payments. In the past, we have established transition policies of limited duration to phase in significant changes to labor market areas. In taking this approach in the past, we sought to mitigate short term instability and fluctuations that can negatively impact providers due to wage index changes.

In accordance with the requirement of our regulations at § 418.306(c) each labor market is established using the most current hospital wage data available, including any changes made by the OMB to the Metropolitan Statistical Areas (MSAs) definitions. We have previously stated that, because the wage index is a relative measure of the value of labor in prescribed labor market areas, we believe it is important to implement new labor market area delineations with as minimal a transition as is reasonably possible. However, we recognize that changes to the wage index have the potential to create instability and significant negative impacts on certain providers even when labor market areas do not change.

In addition, year-to-year fluctuations in an area's wage index can occur due to external factors beyond a provider's control, such as the buy antibiotics PHE, and for an individual provider, these fluctuations can be difficult to predict. We also recognize that predictability in Medicare payments is important to enable providers to budget and plan their operations. In light of these considerations, we are proposing a permanent approach to smooth year-to-year changes in providers' wage indexes.

We are proposing a policy that increases the predictability of hospice payments for providers, and mitigates instability and significant negative impacts to providers resulting from changes to the wage index. As previously discussed, we believed that applying a 5-percent cap on wage index decreases for FY 2021 provided greater transparency and was administratively less complex than prior transition methodologies. In addition, we believed this methodology mitigated short term instability and fluctuations that can negatively impact providers due to wage index changes.

Lastly, we believed the 5-percent cap applied to all wage index decreases for FY 2021 provided an adequate safeguard against significant payment reductions related to the adoption of the revised CBSAs. However, as discussed earlier in this section of the proposed rule, we recognize there are circumstances that a one-year mitigation policy, like the one adopted for FY 2021, would not effectively address future years in which providers continue to be negatively affected by significant wage index decreases. Typical year-to-year variation in the hospice wage index has historically been within 5-percent, and we expect Start Printed Page 19448 this will continue to be the case in future years.

Therefore, we believe that applying a 5-percent cap on all wage index decreases in future years, regardless of the reason for the decrease, would effectively mitigate instability in hospice payments due to any significant wage index decreases that may affect providers in any year that commenters raised in the FY 2022 Hospice final rule. In addition, we believe that applying a 5-percent cap on all wage index decreases would increase the predictability of hospice payments for providers, enabling them to more effectively budget and plan their operations. Lastly, we believe that applying a 5-percent cap on all wage index decreases, from the prior year, would have a small overall impact on the labor market area wage index system.

As discussed in further detail in section III.A.4. Of this proposed rule, we estimate that applying a 5-percent cap on all wage index decreases, from the prior year, will have a very small effect on the wage index budget standardization factors for FY 2023. Because the wage index is a measure of the value of labor (wage and wage-related costs) in a prescribed labor market area relative to the national average, we anticipate that most providers will not experience year-to-year wage index declines greater than 5-percent in any given year.

We believe that applying a 5-percent cap on all wage index decreases, from the prior year, would continue to maintain the accuracy of the overall labor market area wage index system. Therefore, for FY 2023 and subsequent years, we are proposing to apply a permanent 5-percent cap on any decrease to a geographic area's wage index from its wage index in the prior year, regardless of the circumstances causing the decline. That is, we are proposing that a geographic area's wage index for FY 2023 would not be less than 95 percent of its final wage index for FY 2022, regardless of whether the geographic area is part of an updated CBSA, and that for subsequent years, a geographic area's wage index would not be less than 95 percent of its wage index calculated in the prior FY.

We further propose that if a geographic area's prior FY wage index is calculated based on the 5-percent cap, then the following year's wage index would not be less than 95 percent of the geographic area's capped wage index in the prior FY. For example, if a geographic area's wage index for FY 2023 is calculated with the application of the 5-percent cap, then its wage index for FY 2024 would not be less than 95 percent of its capped wage index in FY 2023. Likewise, we are proposing to make the corresponding regulations text changes at § 418.306(c) as follows.

Starting on October 1, 2022, CMS applies a cap on decreases to the hospice wage index such that the wage index applied to a geographic area is not less than 95 percent of the wage index applied to that geographic area in the prior FY. This 5-percent cap on negative wage index changes would be implemented in a budget neutral manner through the use of wage index standardization factors. Furthermore, the 5-percent cap would be applied after the application of the hospice wage index floor.

Therefore, pre-floor, pre-reclassified hospital wage index values below 0.8 would be adjusted by the 15 percent increase, subject to a maximum wage index value of 0.8. If there is a 5 percent decrease from the previous FY's wage index value after the application of the hospice wage index floor, then the 5-percent cap on wage index decreases would also be applied. In section III.A.4 of this proposed rule, we estimate the impact to payments for providers in FY 2023 based on this proposed policy.

We also note that we would examine the effects of this policy on an ongoing basis in the future in order to assess its appropriateness. 3. Proposed FY 2023 Hospice Payment Update Percentage Section 4441(a) of the BBA (Pub.

L. 105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the inpatient hospital market basket percentage increase set out under section 1886(b)(3)(B)(iii) of the Act, minus 1 percentage point.

Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the inpatient market basket percentage increase for that FY. In the FY 2022 IPPS final rule CMS finalized the proposal to rebase and revise the IPPS market baskets to reflect a 2018 base year. We refer readers to the FY 2022 IPPS final rule for further information (86 FR 45194 through 45208).

Section 3401(g) of the Affordable Care Act mandated that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage would be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP) as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost reporting period, or other annual period) (the “productivity adjustment”). The United States Department of Labor's Bureau of Labor Statistics (BLS) publishes the official measures of productivity for the United States economy.

We note that previously the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) was published by BLS as private nonfarm business multifactor productivity. Beginning with the November 18, 2021 release of productivity data, BLS replaced the term “multifactor productivity” with “total factor productivity” (TFP). BLS noted that this is a change in terminology only and will not affect the data or methodology.

As a result of the BLS name change, the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as “private nonfarm business total factor productivity”. However, as mentioned, the data and methods are unchanged. We refer readers to http://www.bls.gov for the BLS historical published TFP data.

A complete description of IGI's TFP projection methodology is available on the CMS website at https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Statistics-Trends-and-Reports/​MedicareProgramRatesStats/​MarketBasketResearch. In addition, in the FY 2022 IPPS final rule (86 FR 45214), we noted that beginning with FY 2022, CMS changed the name of this adjustment to refer to it as the “productivity adjustment” rather than the “MFP adjustment”. The proposed hospice payment update percentage for FY 2023 is based on the proposed inpatient hospital market basket update of 3.1 percent (based on IHS Global Inc.'s fourth quarter 2021 forecast with historical data through the third quarter 2021).

Due to the requirements at sections 1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the proposed inpatient hospital market basket update for FY 2023 of 3.1 percent must be reduced by a productivity adjustment as mandated by the Affordable Care Act (currently estimated to be 0.4 percentage point for FY 2023). In effect, the proposed hospice payment update percentage for FY 2023 would be 2.7 percent. We also propose that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for Start Printed Page 19449 example, more recent estimates of the inpatient hospital market basket update and productivity adjustment), we would use such data, if appropriate, to determine the hospice payment update percentage for FY 2023 in the final rule.

We continue to believe it is appropriate to routinely update the hospice payment system so that it reflects the best available data about differences in patient resource use and costs among hospices as required by the statute. Therefore, we are proposing to. (1) Update hospice payments using the methodology outlined and apply the 2018-based IPPS market basket update for FY 2023 of 3.1 percent, reduced by the statutorily required productivity adjustment of 0.4 percentage point along with the wage index budget neutrality adjustment to update the payment rates.

And (2) use the FY 2023 hospice wage index which uses the FY 2023 pre-floor, pre-reclassified IPPS hospital wage index as its basis. In the FY 2022 Hospice Wage Index final rule (86 FR 42532 through 42539), we rebased and revised the labor shares for RHC, CHC, GIP and IRC using MCR data for freestanding hospices (CMS Form 1984-14, OMB Control Number 0938-0758) from 2018. The current labor portion of the payment rates are.

For RHC, 66.0 percent. For CHC, 75.2 percent. For GIP, 63.5 percent.

And for IRC, 61.0 percent. The non-labor portion is equal to 100 percent minus the labor portion for each level of care. The non-labor portion of the payment rates are as follows.

For RHC, 34.0 percent. For CHC, 24.8 percent. For GIP, 36.5 percent.

And for IRC, 39.0 percent. 4. Proposed FY 2023 Hospice Payment Rates There are four payment categories that are distinguished by the location and intensity of the hospice services provided.

The base payments are adjusted for geographic differences in wages by multiplying the labor share, which varies by category, of each base rate by the applicable hospice wage index. A hospice is paid the RHC rate for each day the beneficiary is enrolled in hospice, unless the hospice provides CHC, IRC, or GIP. CHC is provided during a period of patient crisis to maintain the patient at home.

IRC is short-term care to allow the usual caregiver to rest and be relieved from caregiving. And GIP is to treat symptoms that cannot be managed in another setting. As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47172), we implemented two different RHC payment rates, one RHC rate for the first 60 days and a second RHC rate for days 61 and beyond.

In addition, in that final rule, we implemented an SIA payment for RHC when direct patient care is provided by an RN or social worker during the last 7 days of the beneficiary's life. The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided (up to 4 hours total) that occurred on the day of service, if certain criteria are met. In order to maintain budget neutrality, as required under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted by a service intensity add-on budget neutrality factor (SBNF).

The SBNF is used to reduce the overall RHC rate in order to ensure that SIA payments are budget-neutral. At the beginning of every FY, SIA utilization is compared to the prior year in order calculate a budget neutrality adjustment. In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52156), we initiated a policy of applying a wage index standardization factor to hospice payments in order to eliminate the aggregate effect of annual variations in hospital wage data.

Typically, the wage index standardization factor is calculated using the most recent, complete hospice claims data available. However, due to the buy antibiotics PHE, in the FY 2022 Hospice Wage Index and Payment Rate Update proposed rule we looked at using hospice claims data before the declaration of the buy antibiotics PHE (FY 2019) to determine if there were significant differences between utilizing 2019 and 2020 claims data. The difference between using FY 2019 and FY 2020 hospice claims data was minimal.

Therefore, in the FY 2022 Hospice Wage Index and Payment Rate Update final rule (86 FR 42543), we stated that we would continue our practice of using the most recent, complete hospice claims data available. For FY 2023 hospice rate setting, we saw minimal differences in using the updated data. Therefore, we are continuing our longstanding policy of using the most recent data available.

Specifically, we are using FY 2021 claims data with the FY 2023 payment rate updates. In order to calculate the wage index standardization factor, we simulate total payments using FY 2021 hospice utilization claims data with the FY 2022 wage index (pre-floor, pre-reclassified hospital wage index with the hospice floor, without the 5-percent cap on wage index decreases) and FY 2022 payment rates and compare it to our simulation of total payments using the FY 2023 hospice wage index (pre-floor, pre-reclassified hospital wage index with hospice floor, with the 5-percent cap on wage index decreases) and FY 2022 payment rates. By dividing payments for each level of care (RHC days 1 through 60, RHC days 61+, CHC, IRC, and GIP) using the FY 2022 wage index and payment rates for each level of care by the FY 2023 wage index and FY 2022 payment rates, we obtain a wage index standardization factor for each level of care.

The wage index standardization factors for each level of care are shown in the Tables 1 and 2. The proposed FY 2023 RHC rates are shown in Table 1. The proposed FY 2023 payment rates for CHC, IRC, and GIP are shown in Table 2.

Table 1—Proposed FY 2023 Hospice RHC Payment RatesCodeDescriptionFY 2022 payment ratesSIA budget neutrality factorWage index standardization factorProposed FY 2023 hospice payment updateProposed FY 2023 payment rates651Routine Home Care (days 1-60)$203.401.00041.00081.027$209.14651Routine Home Care (days 61+)160.741.00031.00071.027165.25 Start Printed Page 19450 Table 2—Proposed FY 2023 Hospice CHC, IRC, and GIP Payment RatesCodeDescriptionFY 2022 payment ratesWage index standardization factorProposed FY 2023 hospice payment updateProposed FY 2023 payment rates652Continuous Home Care Full Rate = 24 hours of care$1,462.52 ($60.94 per hour)1.00241.027$1,505.61655Inpatient Respite Care473.751.00071.027486.88656General Inpatient Care1,068.281.00161.0271,098.88 Sections 1814(i)(5)(A) through (C) of the Act require that hospices submit quality data, based on measures to be specified by the Secretary. In the FY 2012 Hospice Wage Index and Rate Update final rule (76 FR 47320 through 47324), we implemented a HQRP as required by those sections. Hospices were required to begin collecting quality data in October 2012 and submit those quality data in 2013.

Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY. The proposed FY 2023 rates for hospices that do not submit the required quality data would be updated by the proposed FY 2023 hospice payment update percentage of 2.7 percent minus 2 percentage points. These rates are shown in Tables 3 and 4.

Table 3—Proposed FY 2023 Hospice RHC Payment Rates for Hospices That DO NOT Submit the Required Quality DataCodeDescriptionFY 2022 payment ratesSIA budget neutrality factorWage index standardization factorProposed FY 2023 hospice payment update of 2.7% minus 2 percentage points = +0.7%Proposed FY 2023 payment rates651Routine Home Care (days 1-60)$203.401.00041.00081.007$205.07651Routine Home Care (days 61+)160.741.00031.00071.007162.03 Table 4—Proposed FY 2023 Hospice CHC, IRC, and GIP Payment Rates for Hospices That DO NOT Submit the Required Quality DataCodeDescriptionFY 2022 payment ratesWage index standardization factorProposed FY 2023 hospice payment update of 2.7% minus 2 percentage points = +0.7%Proposed FY 2023 payment rates652Continuous Home Care Full Rate= 24 hours of care$1,462.52 ($60.94 per hour)1.00241.007$1,476.29655Inpatient Respite Care$473.751.00071.007$477.40656General Inpatient Care1,068.281.00161.0071,077.48 5. Proposed Hospice Cap Amount for FY 2023 As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47183), we implemented changes mandated by the IMPACT Act of 2014 (Pub. L.

113-185). Specifically, we stated that for accounting years that end after September 30, 2016 and before October 1, 2025, the hospice cap is updated by the hospice payment update percentage rather than using the CPI-U. Division CC, section 404 of the CAA 2021 extended the accounting years impacted by the adjustment made to the hospice cap calculation until 2030.

In the FY 2022 Hospice Wage Index final rule (86 FR 42539), we finalized conforming regulations text changes at § 418.309 to reflect the provisions of the CAA 2021. Therefore, for accounting years that end after September 30, 2016 and before October 1, 2030, the hospice cap amount is updated by the hospice payment update percentage rather than using the CPI-U. The proposed hospice cap amount for the FY 2023 cap year is $32,142.65, which is equal to the FY 2022 cap amount ($31,297.61) updated by the proposed FY 2023 hospice payment update percentage of 2.7 percent.

B. Proposed Updates to the Hospice Quality Reporting Program 1. Background and Statutory Authority The Hospice Quality Reporting Program (HQRP) specifies reporting requirements for the Hospice Item Set (HIS), administrative data, and Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey.

Section 1814(i)(5) of the Act requires the Secretary to establish and maintain a quality Start Printed Page 19451 reporting program for hospices. Section 1814(i)(5)(A)(i) of the Act was amended by section 407(b) of Division CC, Title IV of the CAA 2021 (Pub. L.

116-260) to change the payment reduction for failing to meet hospice quality reporting requirements from 2 to 4 percentage points. This policy will apply beginning with FY 2024 annual payment update (APU) that is based on CY 2022 quality data. Specifically, the Act requires that, beginning with FY 2014 through FY 2023, the Secretary shall reduce the market basket update by 2 percentage points and beginning with the FY 2024 APU and for each subsequent year, the Secretary shall reduce the market basket update by 4 percentage points for any hospice that does not comply with the quality data submission requirements for that FY.

Depending on the amount of the annual update for a particular year, a reduction of 2 percentage points through FY 2023 or 4 percentage points beginning in FY 2024 could result in the annual market basket update being less than zero percent for a FY and may result in payment rates that are less than payment rates for the preceding FY. Any reduction based on failure to comply with the reporting requirements, as required by section 1814(i)(5)(B) of the Act, would apply only for the specified year. In the FY 2022 Hospice Wage Index and Payment Rate Update final rule (86 FR 42552), we finalized two new measures using claims data.

(1) Hospice Visits in the Last Days of Life (HVLDL). And (2) Hospice Care Index (HCI). We also finalized a policy that claims-based measures will use 8 quarters of data in order to report on more hospices.

In addition, we removed the seven Hospice Item Set (HIS) Process Measures from the program as individual measures and public reporting because the HIS Comprehensive Assessment Measure (NQF#3235) is sufficient for measuring care at admission without the seven individual process measures. For a detailed discussion of the historical use for measure selection and removal for the HQRP quality measures, we refer readers to the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142) and the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR 38622). In the FY 2022 Hospice Wage Index and Rate Update final rule (86 FR 42553), we finalized § 418.312(b)(2).

This new provision requires hospices to provide administrative data, including claims-based measures, as part of the HQRP requirements for § 418.306(b). In that same final rule, we provided CAHPS Hospice Survey updates. We finalized temporary changes to our public reporting policies based on the March 27, 2020 memorandum [] and provided another tip sheet, referred to as the Second Edition HRQP Public Reporting Tip Sheet ( https://www.cms.gov/​files/​document/​second-edition-hqrp-public-reporting-tip-sheetpdf.pdf ) on the HQRP Requirements and Best Practices web page ( https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HQRP-Requirements-and-Best-Practices ).

As finalized in the FY 2022 Hospice Wage Index and Payment Rate Update final rule (86 FR 42552), CMS is targeting the May 2022 refresh of Care Compare/Provider Data Catalogue (PDC) for the inaugural display of the two new claims-based quality measures (QMs), the Hospice Visits in Last Days of Life (HVLDL) and the Hospice Care Index (HCI). This rule proposes no new quality measures but proposes updates on already-adopted measures. Table 5 shows all quality measures finalized in the FY 2022 Hospice Wage Index and Payment Rate Update final rule and in effect for the FY 2023 HQRP.

Table 5—Quality Measures Finalized in the FY 2022 Hospice Wage Index Final Rule and in Effect for FY 2023 for the Hospice Quality Reporting ProgramHospice quality reporting programNQF#Hospice item set3235Hospice and Palliative Care Composite Process Measure—HIS-Comprehensive Assessment Measure at Admission includes: 1. Patients Treated with an Opioid who are Given a Bowel Regimen (NQF #1617). 2.

Dyspnea Screening. 6. Treatment Preferences.

7. Beliefs/Values Addressed (if desired by the patient).Administrative Data, including Claims-based Measures3645Hospice Visits in Last Days of Life (HVLDL).Pending NQF endorsementHospice Care Index (HCI).Start Printed Page 19452 1. Continuous Home Care (CHC) or General Inpatient (GIP) Provided.

Early Live Discharges. 4. Late Live Discharges.

5. Burdensome Transitions (Type 1)—Live Discharges from Hospice Followed by Hospitalization and Subsequent Hospice Readmission. 6.

Burdensome Transitions (Type 2)—Live Discharges from Hospice Followed by Hospitalization with the Patient Dying in the Hospital. 7. Per-beneficiary Medicare Spending.

8. Skilled Nursing Care Minutes per Routine Home Care (RHC) Day. 9.

Skilled Nursing Minutes on Weekends 10. Visits Near Death.CAHPS Hospice Survey2651CAHPS Hospice Survey. 1. Communication with Family.

Treating patient with respect. 4. Emotional and spiritual support.

Training family to care for the patient. 7. Rating of this hospice.

Hospice Outcomes &. Patient Evaluation (HOPE) Update As finalized in the FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements final rule (84 FR 38484), we are developing a hospice patient assessment instrument identified as HOPE. HOPE contributes to the patient's plan of care through on-going patient assessments throughout the hospice stay.

HOPE is designed to support the hospice conditions of participation (CoPs), including hospices' quality assessment and performance improvement (QAPI) and provide quality data to calculate outcome and other types of quality measures. Our primary objectives for HOPE are to provide quality data for the HQRP requirements through standardized data collection. Support survey and certification processes.

And provide additional clinical data that could inform future payment refinements. HOPE is an on-going patient assessment instrument designed to capture patient and family care needs throughout the hospice stay. HOPE supports care planning, quality improvement efforts, and health and safety of patients enrolled in Medicare-certified hospices.

HOPE will include key items from the HIS and demographics like gender and race. Some HIS items will be modified for inclusion in HOPE to increase specificity. This approach to include key demographic information reflects stakeholder feedback discussed in the FYs 2017 and 2018 Hospice Wage Index and Payment Rate Update final rules (81 FR 52171 and 82 FR 36669, respectively).

HOPE is multidisciplinary, with the assessment instrument to be completed by nursing, social work, and spiritual care staff. We are undergoing testing with three distinct disciplinary assessments in beta field testing described in this section. We stated in the FY 2022 Hospice Wage Index and Payment Update final rule (86 FR 42528) that while the standardized patient assessment data elements for certain post-acute care providers required under the IMPACT Act of 2014 are not applicable to hospices, it is reasonable to include some of those standardized elements that appropriately and feasibly apply to hospice.

Some patients may move through the healthcare system to hospice. Therefore, tracking key demographic and social risk factor items that apply to hospice support our goals for continuity of care, overall patient care and well-being, interoperability, and health equity that is also discussed in this rule. The draft of HOPE has undergone cognitive, pilot, and alpha testing, and is undergoing national beta field testing to establish reliability, validity, and feasibility of the assessment instrument.

The purpose of the alpha test was to establish preliminary reliability and validity of the draft assessment items, and feasibility of the HOPE assessment. Specifically, the objectives were to. Establish inter-rater reliability (IRR) of the assessment items.

Demonstrate validity of the assessment items. Demonstrate feasibility of the assessment and time points for data collection. HOPE alpha testing completed at the end of January 2021.

Based on the quantitative data analyses and feedback from assessors in alpha testing, the items generally support the feasibility of collecting the data items. Alpha testing also showed that HOPE exhibited acceptable inter-rater reliability ranging from moderate to very good with few exceptions and demonstrated evidence of convergent validity. We used findings of the alpha test to inform decisions about the next draft of the HOPE assessment, which are being tested in the national beta test that began in late fall 2021 and continuing through 2022.

National beta testing allows us to obtain input from participating hospice teams about the assessment instrument and field testing to refine and support the final draft items and assessment time points for HOPE. It also allows us to estimate the time to complete the HOPE data items. We anticipate proposing HOPE in future rulemaking after testing and analyses are complete.

Start Printed Page 19453 We continue HOPE development in accordance with the Blueprint for the CMS Measures Management System. HOPE development is grounded in information gathering activities to identify and refine hospice assessment domains and candidate assessment items. We appreciate the industry's and national associations' engagement in providing input through information sharing activities, including listening sessions, expert interviews, key stakeholder interviews, and focus groups to support HOPE development.

As CMS proceeds with field testing HOPE, we will continue to engage with stakeholders through sub-regulatory channels. In particular, we will continue to host HQRP Forums to allow hospices and other interested parties to engage with us on the latest updates and ask questions on the development of HOPE and related quality measures. We also have a dedicated email account, HospiceAssessment@cms.hhs.gov, for comments about HOPE.

We will use field test results to create a final version of HOPE to propose in future rulemaking for national implementation. We will continue to engage all stakeholders throughout this process that includes a variety of sub-regulatory channels and regular HQRP communication strategies, such as Open Door Forums, Medicare Learning Network (MLN), CMS.gov website announcements, listserv messaging, and other ad hoc publicly announced opportunities. We appreciate the support for HOPE and reiterate our commitment to providing updates and engaging stakeholders through sub-regulatory means.

HOPE updates can be found at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HOPE and engagement opportunities, including those regarding HOPE are at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Hospice-QRP-Provider-Engagement-Opportunities.

3. Update on Future Quality Measure (QM) Development In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we provided updates related to CMS's process for identifying high priority areas of quality measurement and improvement and for developing quality measures that address those priorities. Information on the current HQRP quality measures can be found at.

Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Current-Measures. In this proposed rule, we provide contemplated updates for hospice quality measure concepts based on future use of HOPE and administrative data. In section III.B.6 of this proposed rule, we are seeking public comment from hospices on their health equity initiatives and a structural composite measure concept to inform future measure development.

To support new measure development, our contractor convened two technical expert panel (TEP) meetings in 2021. The TEP considered HOPE-based process measures that may be proposed with HOPE in future rulemaking. The TEP meetings in 2021 included HOPE-based process measures intended to (1) evaluate the rate at which hospices' use specific processes of care.

(2) assist in reducing variation in care delivery. And (3) determine hospices' compliance with practices that are expected to improve outcomes. The TEP also considered potential areas for future quality measure development.

We refer the public to the “2021 Technical Expert Panel Meetings. Hospice Quality Reporting Program Summary Report” available at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Hospice-QRP-Provider-Engagement-Opportunities.

As stated in the FY 2022 Hospice Wage Index and Rate Update final rule (86 FR 42528), we continue to consider developing hybrid quality measures that could be calculated from multiple data sources. For example, claims, assessments (HOPE), or other data sources. Hybrid quality measures allow for a more comprehensive set of information about care processes and outcomes than can be calculated using claims data alone.

As described in the “2021 Technical Expert Panel Meetings. Hospice Quality Reporting Program Summary Report,” the TEP discussed hybrid concepts such as hospitalizations during a hospice election and patterns of live discharge using claims data and HOPE data elements. 4.

Updates to the CAHPS Hospice Survey Participation Requirements for the FY 2023 APU and Subsequent Years a. Background and Description of the CAHPS Hospice Survey The CAHPS Hospice Survey is a component of the CMS HQRP, which is used to collect data on the experiences of hospice patients and the primary caregivers listed in their hospice records. Readers who want more information about the development of the survey, originally called the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 FR 48261.

B. Overview of the “CAHPS Hospice Survey Measures” The CAHPS Hospice Survey measures were re-endorsed by NQF on November 20, 2020. The re-endorsement can be found on the NQF website at.

Https://www.qualityforum.org/​Measures_​Reports_​Tools.aspx. The survey received its initial NQF endorsement on October 26, 2016 (NQF #2651). We adopted 8 survey-based measures for the CY 2018 data collection period and for subsequent years.

These eight measures are publicly reported on a designated CMS website, Care Compare, https://www.medicare.gov/​care-compare/​. c. CAHPS Hospice Survey Mode Experiment CMS recently conducted a mode experiment with the goal of testing the effects of adding a web-based mode to the CAHPS Hospice Survey.

We are examining the impact of a web-based mode on survey response rates and scores. The survey currently has three approved modes without any web component (mail, telephone, and mail with telephone follow-up.). In addition, the test will allow for examination of the effects of a shortened survey (that is, removing existing survey items) on response rate and scores.

Assessment of the measure properties of a limited number of supplemental survey items suggested by stakeholders. And calculation of item-level mode adjustments for the shortened survey in the currently-approved modes of CAHPS Hospice Survey administration, as well as the proposed new web-based mode. The mode experiment design applied all of the existing CAHPS Hospice Survey eligibility criteria, and sampled patients/caregivers across five arms.

The first arm tested a new web-mail mode, in which invitations to the web survey were sent by email to those with email addresses. The email was personalized to the respondent and included a link to the web version of the survey, which can be completed on either a computer or a mobile device such as a smartphone or tablet. If the respondent did not complete the web survey after one week, or did not have a valid email address in which to send an email, up to two surveys were sent by mail.

This arm used a shortened version of the CAHPS Hospice Survey. In the next three arms, the shortened version of the CAHPS Hospice Survey instrument was administered in the three currently-approved modes. Mail only.

Telephone-only. And mixed mode Start Printed Page 19454 (mail with telephone follow up). The fifth arm, in which the current survey instrument was administered via mail only served as a comparison for all other arms.

Across all arms, half of sampled caregivers received a pre-notification letter to examine the effects of such a letter on response rates. Overall (across the five arms), CMS sampled 15,000 eligible caregivers from around 50 hospices over a six- to seven-month period. Caregivers were randomized within each hospice to one of the five arms.

We continue to analyze the results of the mode experiment and will keep stakeholders informed on any plans for changes to the survey content or administration options through our regular stakeholder communication channels. In this proposed rule, there are no changes to the administration procedures or content for the CAHPS Hospice Survey. Any changes to the CAHPS Hospice Survey will be proposed in future rulemaking.

D. Data Sources In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38484), we finalized the participation requirements for the CAHPS Hospice Survey. To meet the CAHPS Hospice Survey requirements for the HQRP, hospice facilities must contract with a CMS-approved vendor to collect survey data for eligible patients on a monthly basis and report that data to CMS on the hospice's behalf by the quarterly deadlines established for each data collection period.

E. Public Reporting of CAHPS Hospice Survey Results We began public reporting of the results of the CAHPS Hospice Survey on Hospice Compare as of February 2018. Before the buy antibiotics PHE, we reported the most recent 8 quarters of data on the basis of a rolling average, with the most recent quarter of data being added and the oldest quarter of data removed from the averages for each data refresh.

As finalized in the FY 2022 Hospice Wage Index and Payment Rule Update (86 FR 42528), we are not reporting Q1 2020 and Q2 2020 data due to the buy antibiotics PHE. Therefore, we have publicly reported the most recently available 8 quarters of CAHPS data that excluded Q1 2020 and Q2 2020 data. These data were publicly reported starting with the February 2022 refresh and will continue through the May 2023 refresh on Care Compare.

The Second Edition HQRP Public Reporting Tip Sheet dated Dec. 2021 on the HQRP Requirements and Best Practices web page ( https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HQRP-Requirements-and-Best-Practices ) summarizes CMS' approach to the HQRP as public reporting has resumed in February 2022. It also explains the HQRP public reporting changes associated with the FY 2022 Hospice Wage Index and Payment Rule Update final rule and provides a summary of the data refreshes.

f. Volume-Based Exemption for CAHPS Hospice Survey Data Collection and Reporting Requirements In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38526), we finalized a policy making a volume-based exemption for CAHPS Hospice Survey Data Collection and Reporting requirements for FY 2021 and every year thereafter. In this proposed rule, there would be no changes to this exemption.

The exemption request form is available on the official CAHPS Hospice Survey website. Http://www.hospiceCAHPSsurvey.org. Hospices that intend to claim the size exemption are required to submit to CMS their completed exemption request form by December 31, of the data collection year.

Hospices that served a total of fewer than 50 survey-eligible decedent/caregiver pairs in the year before the data collection year are eligible to apply for the size exemption. Hospices may apply for a size exemption by submitting the size exemption request form. The size exemption is only valid for the year on the size exemption request form.

If the hospice remains eligible for the size exemption, the hospice must complete the size exemption request form for every applicable FY APU period, as shown in Table 6. Table 6—Size Exemption Key Dates FY 2023 Through FY 2026Fiscal yearData collection yearReference yearSize exemption form submission deadlineFY 2023CY 2021CY 2020December 31, 2021.FY 2024CY 2022CY 2021December 31, 2022.FY 2025CY 2023CY 2022December 31, 2023.FY 2026CY 2024CY 2023December 31, 2024. G.

Newness Exemption for CAHPS Hospice Survey Data Collection and Public Reporting Requirements We previously finalized a one-time newness exemption for hospices that meet the criteria as stated in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52181). In the FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38642), we continued the newness exemption for FY 2023, and all subsequent years. We encourage hospices to keep the letter they receive providing them with their CMS Certification Number (CCN).

The letter can be used to show when you received your number. H. Survey Participation Requirements We previously finalized survey participation requirements for FY 2022 through FY 2025 as stated in the FY 2018 and FY 2019 Hospice Wage Index and Payment Rate Update final rules (82 FR 36670 and 83 FR 38642 through 38643).

We also continued those requirements in all subsequent years (84 FR 38526). Table 7 restates the data submission dates for FY 2023 through FY 2025. Table 7—CAHPS Hospice Survey Data Submission Dates for the APU in FY 2023, FY 2024, and FY 2025Sample months (month of death) *CAHPS quarterly data submission deadlines **FY 2023 APUStart Printed Page 19455CY January-March 2021 (Quarter 1)August 11, 2021.CY April-June 2021 (Quarter 2)November 10, 2021.CY July-September 2021 (Quarter 3)February 9, 2022.CY October-December 2021 (Quarter 4)May 11, 2022.FY 2024 APUCY January-March 2022 (Quarter 1)August 10, 2022.CY April-June 2022 (Quarter 2)November 9, 2022.CY July-September 2022 (Quarter 3)February 8, 2023.CY October-December 2022 (Quarter 4)May 10, 2023.FY 2025 APUCY January-March 2023 (Quarter 1)August 9, 2023.CY April-June 2023 (Quarter 2)November 8, 2023.CY July-September 2023 (Quarter 3)February 14, 2024.CY October-December 2023 (Quarter 4)May 8, 2024.* Data collection for each sample month initiates 2 months following the month of patient death (for example, in April for deaths occurring in January).** Data submission deadlines are the second Wednesday of the submission months, which are the months August, November, February, and May.

For further information about the CAHPS Hospice Survey, we encourage hospices and other entities to visit. Https://www.hospiceCAHPSsurvey.org. For direct questions, contact the CAHPS Hospice Survey Team at hospiceCAHPSsurvey@HCQIS.org or call 1-(844) 472-4621.

i. CAHPS Hospice Survey Star Ratings We previously finalized a policy requiring us to display Hospice CAHPS Survey Star Ratings no sooner than FY 2022 as stated in the FY 2022 Hospice Wage Index and Payment Rule Update rule (86 FR 42528). Star Ratings will be publicly reported on Care Compare on Medicare.gov beginning with the August 2022 refresh.

This start date allowed CMS to conduct a dry run of the Star Ratings with reporting to hospices via preview reports. Hospices first saw their Star Ratings in their preview reports during the November 2021 and March 2022 preview periods for the February 2022 and May 2022 updates of Care Compare on Medicare.gov. However, the CAHPS Hospice Survey Star Ratings will not be publicly reported in February or May 2022.

The reporting period for the dry run covers data from Q4 2018 through Q4 2019 and Q3 2020 through Q1 2021. Detailed information about the calculation and display of Hospice CAHPS Survey Star Ratings can be found on the official CAHPS Hospice Survey website. Http://www.hospiceCAHPSsurvey.org.

There are no changes to the Hospice CAHPS Survey Star Ratings for FY 2023. 5. Form, Manner, and Timing of Quality Data Submission a.

Statutory Penalty for Failure To Report Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. Such data must be submitted in a form and manner, and at a time specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act was amended by the CAA 2021 and the payment reduction for failing to meet hospice quality reporting requirements is increased from 2 percent to 4 percent beginning with FY 2024.

The Act requires that, beginning with FY 2014 through FY 2023, the Secretary shall reduce the market basket update by 2 percentage points and then beginning in FY 2024 and for each subsequent year, the Secretary shall reduce the market basket update by 4 percentage points for any hospice that does not comply with the quality data submission requirements for that fiscal year. Last year, we revised our rule at § 418.306(b)(2) in accordance with this statutory change (86 FR 42605). B.

Compliance HQRP Compliance requires understanding three timeframes for both HIS and CAHPS. (1) The relevant Reporting Year, payment FY and the Reference Year. The “Reporting Year” (HIS)/“Data Collection Year” (CAHPS).

This timeframe is based on the calendar year. It is the same calendar year for both HIS and CAHPS. If the CAHPS Data Collection year is CY 2023, then the HIS reporting year is also CY 2023.

(2) The APU is subsequently applied to FY payments based on compliance in the corresponding Reporting Year/Data Collection Year. And (3) For the CAHPS Hospice Survey, the Reference Year is the CY prior to the Data Collection Year. The Reference Year applies to hospices submitting a size exemption from the CAHPS survey (there is no similar exemption for HIS).

For example, for the CY 2023 data collection year, the Reference Year, is CY 2022. This means providers seeking a size exemption for CAHPS in CY 2023 would base it on their hospice size in CY 2022. Submission requirements are codified in § 418.312.

For every CY all Medicare-certified hospices are required to submit HIS and CAHPS data according to the requirements in § 418.312. Table 8 summarizes the three timeframes. It illustrates how the CY interacts with the FY payments, covering the CY 2021 through CY 2024 data collection periods and the corresponding APU application from FY 2023 through FY 2026.

Table 8—HQRP Reporting Requirements and Corresponding Annual Payment UpdatesReporting year for HIS and data collection year for CAHPS data (calendar year)Annual payment update impacts payments for the FYReference year for CAHPS size exemption (CAHPS only)CY 2021FY 2023 APUCY 2020.CY 2022FY 2024 APU *CY 2021.CY 2023FY 2025 APUCY 2022.Start Printed Page 19456CY 2024FY 2026 APUCY 2023.* Beginning in FY 2024 and all subsequent years, the payment penalty is 4 percent. Prior to FY 2024, the payment penalty is 2 percent. As illustrated in Table 8, CY 2021 data submissions compliance impacts the FY 2023 APU.

CY 2022 data submissions compliance impacts the FY 2024 APU. CY 2023 data submissions compliance impacts FY 2025 APU. This CY data submission impacting FY APU pattern follows for subsequent years.

C. Submission Data and Requirements As finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47192), hospices' compliance with HIS requirements beginning with the FY 2020 APU determination (that is, based on HIS- Admission and Discharge records submitted in CY 2018) are based on a timeliness threshold of 90 percent. This means CMS requires that hospices submit 90 percent of all required HIS records within 30-days of the event (that is, patient's admission or discharge).

The 90-percent threshold is hereafter referred to as the timeliness compliance threshold. Ninety percent of all required HIS records must be submitted and accepted within the 30-day submission deadline to avoid the statutorily-mandated payment penalty. Hospice compliance with claims data requirements is based on administrative data collection.

Since Medicare claims data are already collected from claims, hospices are considered 100 percent compliant with the submission of these data for the HQRP. There is no additional submission requirement for administrative data. To comply with CMS' quality reporting requirements for CAHPS, hospices are required to collect data monthly using the CAHPS Hospice Survey.

Hospices comply by utilizing a CMS-approved third-party vendor. Approved Hospice CAHPS vendors must successfully submit data on the hospice's behalf to the CAHPS Hospice Survey Data Center. A list of the approved vendors can be found on the CAHPS Hospice Survey website.

Www.hospicecahpssurvey.org. Table 9. HQRP Compliance Checklist illustrates the APU and timeliness threshold requirements.

Table 9—HQRP Compliance ChecklistAnnual payment updateHISCAHPSFY 2023Submit at least 90 percent of all HIS records within 30 days of the event date (patient's admission or discharge) for patient admissions/discharges occurring 1/1/21-12/31/21Ongoing monthly participation in the Hospice CAHPS survey 1/1/2021-12/31/2021.FY 2024Submit at least 90 percent of all HIS records or its successor instrument within 30 days of the event date (patient's admission or discharge) for patient admissions/discharges occurring 1/1/22-12/31/22Ongoing monthly participation in the Hospice CAHPS survey 1/1/2022-12/31/2022.FY 2025Submit at least 90 percent of all HIS records or its successor instrument within 30 days of the event date (patient's admission or discharge) for patient admissions/discharges occurring 1/1/23-12/31/23Ongoing monthly participation in the Hospice CAHPS survey 1/1/2023-12/31/2023.Note. The data source for the claims-based measures will be Medicare claims data that are already collected and submitted to CMS. There is no additional submission requirement for administrative data (Medicare claims), and hospices with claims data are 100-percent compliant with this requirement.

Most hospices that fail to meet HQRP requirements do so because they miss the 90 percent threshold. We offer many training and education opportunities through our website, which are available 24/7, 365 days per year, to enable hospice staff to learn at the pace and time of their choice. We want hospices to be successful with meeting the HQRP requirements.

We encourage hospices to use this website at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Hospice-Quality-Reporting-Training-Training-and-Education-Library. For more information about HQRP Requirements, we refer readers to visit the frequently-updated HQRP website and especially the Best Practice, Education and Training Library, and Help Desk web pages at.

Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting. We also encourage readers to visit the HQRP web page and sign-up for the Hospice Quality ListServ to stay informed about HQRP. 6.

Request for Information Related to the HQRP Health Equity Initiative CMS defines health equity as “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.” CMS is working to advance health equity by designing, implementing, and operationalizing policies and programs that support health for all the people served by our programs, eliminating avoidable differences in health outcomes experienced by people who are disadvantaged or underserved, and providing the care and support that our enrollees need to thrive. CMS' goals are in line with Executive Order 13985, on the Advancement of Racial Equity and Support for the Underserved Communities, which can be found at. Https://www.whitehouse.gov/​briefing-room/​presidential-actions/​2021/​06/​25/​executive-order-on-diversity-equity-inclusion-and-accessibility-in-the-federal-workforce/​.

Belonging to an underserved community is often associated with worse health outcomes.[] Such Start Printed Page 19457 disparities in health outcomes are the result of multiple factors. Although not the sole determinants, poor access to care and provision of lower quality health care are important contributors to health disparities notable for CMS programs. Health inequities persist in hospice and palliative care, where Black and Hispanic populations are less likely to utilize care and over 80 percent of patients are White.[] After hospice admission, racial and ethnic disparities appear to impact quality of care and health outcomes.[] Black patients may receive fewer supportive care medications despite higher symptom burdens, experience care less consistent with their expressed preferences, and encounter worse end-of-life communication.[] In response to these disparities, 70 percent of home health organizations, including 22 percent that are hospices, indicated they would increase the resources dedicated to diversity, equity, and inclusion in 2021.[] One important strategy for addressing these disparities is improving data collection to allow for better measurement and reporting on equity across our programs and policies.[] We are committed to achieving equity in health care outcomes for our beneficiaries by supporting providers in quality improvement activities to reduce health inequities, enabling beneficiaries to make more informed decisions, and promoting provider accountability for health care disparities.[] CMS is committed to closing the equity gap in CMS quality programs.

For more information on the portfolio of programs aimed at making information on the quality of health care providers and services, including disparities, more transparent, we refer readers to the FY 2022 Hospice Wage Index and Rate Update proposed rule (86 FR 19700). In the FY 2022 Hospice Wage Index and Rate Update final rule, we received comments supportive of gathering standardized patient assessment data elements and additional SDOH data to improve health equity. In parallel, commenters advocated for education efforts for beneficiaries, providers, and stakeholders on the benefits of collecting and reporting demographic and social risk factor data.

We received many comments about the use of standardized patient assessment data elements in the hospice setting to assess health equity and SDOH, some of which raised concerns there may be unintended consequences. Many commenters noted that hospice patients have different goals of care than non-hospice patients, which does not align with standardized data elements for patient assessment. Commenters encouraged CMS to only utilize certain aspects of standardized data elements for patient assessment (specifically, Z-codes 55-65) in collecting health equity data.

We refer the readers to review the summary of public comments received in the FY 2022 Hospice Wage Index and Rate Update final rule (86 FR 42528). We will continue to take all comments and suggestions into account as we work to develop policies on this important topic. We appreciate hospices and national organizations sharing their support and commitment to addressing health disparities and offering meaningful comments for consideration in the FY 2022 Hospice Wage Index and Rate Update final rule (86 FR 42528).

Given the value of the comments thus far and the ongoing development of activities to improve health equity, we solicit public comment on the following questions. What efforts does your hospice employ to recruit staff, volunteers, and board members from diverse populations to represent and serve underserved populations?. How does your hospice attempt to bridge any cultural gaps between your personnel and beneficiaries/clients?.

How does your hospice measure whether this has an impact on health equity?. How does your hospice currently identify barriers to access in your community or service area?. What are barriers to collecting data related to disparities, social determinants of health, and equity?.

What steps does your hospice take to address these barriers?. How does your hospice collect self-reported data such as race/ethnicity, veteran status, socioeconomic status, housing, food security, access to interpreter services, caregiving status, and marital status used to inform its health equity initiatives?. How is your hospice using qualitative data collection and analysis methods to measure the impact of its health equity initiatives?.

In addition, we are considering a structural composite measure based on information already collected by hospices. Specifically, the structural composite measure could include organizational activities to address access to and quality of hospice care for underserved populations. The composite structural measure concept could include hospice reported data on hospice activities to address Start Printed Page 19458 underserved populations' access to hospice care.

For example, a hospice could receive a point for each domain where data are submitted to a CMS portal, regardless of the hospice's action in that domain (such as, reporting whether or not the hospice provided training for board members, leaders, staff and volunteers in culturally and linguistically appropriate services (CLAS), health equity, and implicit bias). The data could reflect the hospice's completed actions for each corresponding domain (for a total of three points) in a reporting year. A hospice could submit information such as documentation, examples, or narratives to qualify for the measure numerator.

We are also seeking comment on how to score a domain for a hospice that submitted data reflecting no actions or partial actions in the given domain. Examples of the domains we are considering are described in the following outline. We seek comment on each of these domains, including specific suggestions on items that should be added, removed, or revised.

Domain 1. Hospice commitment to reducing disparities is strengthened when equity is a key organizational priority. Candidate domain 1 could be satisfied when a hospice submits data on their actions regarding the role of health equity and community engagement in their strategic plan.

Hospices could self-report data in the reporting year about their actions in each of the following areas, and submission of data for all elements could be required to qualify for the measure numerator. Hospice attests whether its strategic plan includes approaches to address health equity in the reporting year. Hospice reports community engagement and key stakeholder activities in the reporting year.

Hospice reports on any attempts to measure input from patients and caregivers about care disparities they may experience and recommendations or suggestions. Domain 2. Training board members, leaders, staff and volunteers in culturally and linguistically appropriate services (CLAS),[] health equity, and implicit bias is an important step hospices take to provide quality care to diverse populations.

Candidate domain 2 could focus on hospices' diversity, equity, inclusion and CLAS training for board members, employed staff, and volunteers by capturing the following self-reported actions in the reporting year. Submission of relevant data for all elements could be required to qualify for the measure numerator. Hospice attests whether employed staff were trained in CLAS and culturally sensitive care mindful of social determinants of health (SDOH) in the reporting year.

Example data include specific training programs or training requirements for staff. Hospice attests whether it provided resources to staff and volunteers about health equity, SDOH, and equity initiatives in the reporting year. Examples include the materials provided, webinars, or learning opportunities.

Domain 3. Leaders and staff could improve their capacity to address disparities by demonstrating routine and thorough attention to equity and setting an organizational culture of equity. This candidate domain could capture activities related to organizational inclusion initiatives and capacity to promote health equity.

Examples of equity-focused factors include proficiency in languages other than English, experience working with populations in the service area, experience working on health equity issues, and experience working with individuals with disabilities. Submission of relevant data for all elements could be required to qualify for the measure numerator. Hospice attests whether equity-focused factors were included in the hiring of hospice senior leadership, including chief executives and board of trustees, in the previous reporting year.

Hospice attests whether equity-focused factors were included in the hiring of hospice senior leadership, including chief executives and board of trustees, is more reflective of the services area patient than in the previous reporting year. Hospice attests whether equity-focused factors were included in the hiring of direct patient care staff (for example, RNs, medical social workers, aides, volunteers, chaplains, or therapists) in the previous reporting year. Hospice attests whether equity focused factors were included in the hiring of indirect care or support staff (for example.

Administrative, clerical, or human resources) in the previous reporting year. We are interested in developing health equity measures based on information collected by hospices not currently available on claims, assessments, or other publicly available data sources to support development of future quality measures. We are soliciting public comment on the conceptual domains and quality measures described in this section.

Furthermore, we are soliciting public comments on publicly reporting a composite structural health equity quality measure. Displaying descriptive information on Care Compare from the data hospices provide to support health equity measures. And the impact of the domains and quality measure concepts on organizational culture change.

7. Advancing Health Information Exchange Update The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their digital health information. To further interoperability in post-acute care settings, CMS and the Office of the National Coordinator for Health Information Technology (ONC) participate in the Post-Acute Care Interoperability Workgroup (PACIO) to facilitate collaboration with industry stakeholders to develop Health Level Seven International® (HL7) Fast Healthcare Interoperability Resources® (FHIR) standards.[] These standards could support the exchange and reuse of patient assessment data derived from the Minimum Data Set (MDS), Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI), LTCH Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS), Outcome and Assessment Information Set (OASIS), and other sources.

The PACIO Project has focused on HL7 FHIR implementation guides for functional status, cognitive status and new use cases on advance directives, re-assessment timepoints, and Speech Language, Swallowing, Cognitive communication and Hearing (SPLASCH) pathology. We encourage PAC provider and health (IT) vendor participation as the efforts advance. The CMS Data Element Library (DEL) continues to be updated and serves as a resource for PAC assessment data elements and their associated mappings to health IT standards, such as Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED).

The DEL furthers CMS' goal of data standardization and interoperability. Standards in the DEL ( https://del.cms.gov/​DELWeb/​pubHome ) can be referenced on the CMS website Start Printed Page 19459 and in the ONC Interoperability Standards Advisory (ISA). The 2022 ISA is available at https://www.healthit.gov/​isa.

The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted December 13, 2016) required HHS and ONC to take steps to further interoperability for providers and settings across the care continuum.

Section 4003(b) of the Cures Act required ONC to take steps to advance interoperability through the development of a trusted exchange framework and common agreement aimed at establishing a universal floor of interoperability across the country. On January 18, 2022, ONC announced a significant milestone by releasing the Trusted Exchange Framework [] and Common Agreement Version 1 []. The Trusted Exchange Framework is a set of non-binding principles for health information exchange, and the Common Agreement is a contract that advances those principles.

The Common Agreement and the incorporated by reference Qualified Health Information Network Technical Framework Version 1 [] establish the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other—all under commonly agreed to terms. The technical and policy architecture of how exchange occurs under the Trusted Exchange Framework and the Common Agreement follows a network-of-networks structure, which allows for connections at different levels and is inclusive of many different types of entities at those different levels, such as health information networks, healthcare practices, hospitals, public health agencies, and Individual Access Services (IAS) For more information, we refer readers to https://www.healthit.gov/​topic/​interoperability/​trusted-exchange-framework-and-common-agreement. We invite readers to learn more about these important developments and how they are likely to affect hospices.

C. CAA 2021, Section 407. Establishing Hospice Program Survey and Enforcement Procedures Under the Medicare Program.

Provisions Update Division CC, section 407 of the CAA 2021, amended Part A of Title XVIII of the Act to add a new section 1822, and amended sections 1864(a) and 1865(b) of the Act, establishing new hospice program survey and enforcement requirements, required public reporting of survey information, and a new hospice hotline. The law requires public reporting of hospice program surveys conducted by both State Agencies (SAs) and Accrediting Organizations (AOs), as well as enforcement actions taken as a result of these surveys, on the CMS website in a manner that is prominent, easily accessible, searchable, and presented in a readily understandable format. It removes the prohibition at section 1865(b) of the Act of public disclosure of hospice surveys performed by AOs, and requires that AOs use the same survey deficiency reports as SAs (Form CMS-2567, “Statement of Deficiencies” or a successor form) to report survey findings.

The law also requires hospice programs to measure and reduce inconsistency in the application of survey results among all surveyors, and requires the Secretary to provide comprehensive training and testing of SA and AO hospice program surveyors, including training with respect to review of written plans of care. The statute prohibits SA surveyors from surveying hospice programs for which they have worked in the last 2 years or in which they have a financial interest, requires hospice program SAs and AOs to use a multidisciplinary team of individuals for surveys conducted with more than one surveyor to include at least one registered nurse, and provides that each SA must establish a dedicated toll-free hotline to collect, maintain, and update information on hospice programs and to receive complaints. The provisions in the CAA 2021 also direct the Secretary to create a Special Focus Program (SFP) for poor-performing hospice programs, sets out authority for imposing enforcement remedies for noncompliant hospice programs, and requires the development and implementation of a range of remedies as well as procedures for appealing determinations regarding these remedies.

These remedies can be imposed instead of, or in addition to, termination of the hospice programs' participation in the Medicare program. The remedies include civil money penalties (CMPs), suspension of all or part of payments, and appointment of temporary management to oversee operations. In the CY 2022 Home Health Prospective Payment System (HH PPS) final rule (86 FR 62240), we addressed provisions related to the hospice survey enforcement and other activities described in this section.

A summary of the finalized CAA provisions can be found in the CY 2022 HH PPS final rule. Https://www.govinfo.gov/​content/​pkg/​FR-2021-11-09/​pdf/​2021-23993.pdf. We finalized all the CAA provisions in CY 2022 rulemaking except for the special focus program (SFP).

As outlined in the CY 2022 HH PPS final rule, we stated that we would take into account comments that we received and work on a revised proposal, seeking additional collaboration with stakeholders to further develop the methodology for the SFP Since the publication of the CY 2022 HH PPS final rule, we have decided to initiate a hospice Technical Expert Panel (TEP) in CY 2022. Accordingly, CMS plans to use the TEP findings to further develop a proposal on the methodology for establishing the hospice SFP, and we plan to include a proposal implementing a SFP in the FY 2024 Hospice rulemaking proposed rule. IV.

Response to Comments Because of the large number of public comments, we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V.

Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.

Statement of Need This proposed rule meets the requirements of our regulations at § 418.306(c) and (d), which require annual issuance, in the Federal Register , of the hospice wage index based on the most current available CMS hospital wage data, including any changes to the definitions of CBSAs or previously used MSAs, as well as any Start Printed Page 19460 changes to the methodology for determining the per diem payment rates. This proposed rule would also update payment rates for each of the categories of hospice care, described in § 418.302(b), for FY 2023 as required under section 1814(i)(1)(C)(ii)(VII) of the Act. The payment rate updates are subject to changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act.

Lastly, section 3004 of the Affordable Care Act amended the Act to authorize a quality reporting program for hospices, and this rule does not change the requirements for the HQRP in accordance with section 1814(i)(5) of the Act. B. Overall Impacts We estimate that the aggregate impact of the payment provisions in this proposed rule would result in an estimated increase of $580 million in payments to hospices, resulting from the hospice payment update percentage of 2.7 percent for FY 2023.

The impact analysis of this proposed rule represents the projected effects of the changes in hospice payments from FY 2022 to FY 2023. Using the most recent complete data available at the time of rulemaking, in this case FY 2021 hospice claims data as of January 21, 2022, we apply the current FY 2022 wage index with the current labor shares. Using the same FY 2021 data, we apply the FY 2023 wage index and the current labor share values to simulate FY 2022 payments.

We then apply a budget neutrality adjustment so that the aggregate simulated payments do not increase or decrease due to changes in the wage index. Certain events may limit the scope or accuracy of our impact analysis, because such an analysis is susceptible to forecasting errors due to other changes in the forecasted impact time period. The nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon hospices.

We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995.

Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C.

804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule.

(1) (Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”). (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency. (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof.

Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability presents the costs and benefits of the rulemaking. C.

Detailed Economic Analysis 1. Proposed Hospice Payment Update for FY 2023 The FY 2023 hospice payment impacts appear in Table 10. We tabulate the resulting payments according to the classifications (for example, provider type, geographic region, facility size), and compare the difference between current and future payments to determine the overall impact.

The first column shows the breakdown of all hospices by provider type and control (non-profit, for-profit, government, other), facility location, facility size. The second column shows the number of hospices in each of the categories in the first column. The third column shows the effect of using the FY 2023 updated wage index data with a 5-percent cap on wage index decreases.

This represents the effect of moving from the FY 2022 hospice wage index to the FY 2023 hospice wage index with a 5-percent cap on wage index decreases. The aggregate impact of the changes in column three is zero percent, due to the hospice wage index standardization factor. However, there are distributional effects of the FY 2023 hospice wage index.

The fourth column shows the effect of the hospice payment update percentage as mandated by section 1814(i)(1)(C) of the Act, and is consistent for all providers. The proposed hospice payment update percentage of 2.7 percent is based on the proposed 3.1 percent inpatient hospital market basket update, reduced by a proposed 0.4 percentage point productivity adjustment. The fifth column shows the effect of all the proposed changes on FY 2023 hospice payments.

It is projected aggregate payments would increase by 2.7 percent. Assuming hospices do not change their billing practices. As illustrated in Table 10, the combined effects of all the proposals vary by specific types of providers and by location.

We note that simulated payments are based on utilization in FY 2021 as seen on Medicare hospice claims (accessed from the CCW in January 21, 2022) and only include payments related to the level of care and do not include payments related to the service intensity add-on. As illustrated in Table 10, the combined effects of all the proposals vary by specific types of providers and by location. Start Printed Page 19461 Table 10—Projected Impact to Hospices for FY 2023Hospice subgroupHospicesFY 2023 updated wage data >with capFY 2023 proposed hospice payment update (%)Overall total impact for FY 2023All Hospices5,1860.0%2.7%2.7%Hospice Type and Control:Freestanding/Non-Profit581−0.12.72.6Freestanding/For-Profit3,5080.12.72.8Freestanding/Government420.12.72.8Freestanding/Other352−0.12.72.6Facility/HHA Based/Non-Profit347−0.22.72.5Facility/HHA Based/For-Profit200−0.12.72.6Facility/HHA Based/Government79−0.12.72.6Facility/HHA Based/Other77−0.32.72.4Subtotal.

Freestanding Facility Type4,4830.02.72.7Subtotal. Facility/HHA Based Facility Type703−0.22.72.5Subtotal. Non-Profit928−0.12.72.6Subtotal.

For Profit3,7080.12.72.8Subtotal. Government1210.02.72.7Subtotal. Other429−0.12.72.6Hospice Type and Control.

Rural:Freestanding/Non-Profit132−0.12.72.6Freestanding/For-Profit3510.02.72.7Freestanding/Government24−0.62.72.1Freestanding/Other490.02.72.7Facility/HHA Based/Non-Profit135−0.22.72.5Facility/HHA Based/For-Profit47−0.72.72.0Facility/HHA Based/Government62−0.22.72.5Facility/HHA Based/Other46−0.12.72.6Facility Type and Control. Urban:Freestanding/Non-Profit449−0.12.72.6Freestanding/For-Profit3,1570.12.72.8Freestanding/Government180.32.73.0Freestanding/Other303-0.12.72.6Facility/HHA Based/Non-Profit212−0.22.72.5Facility/HHA Based/For-Profit153-0.12.72.6Facility/HHA Based/Government17−0.12.72.6Facility/HHA Based/Other31−0.32.72.4Hospice Location. Urban or Rural:Rural846−0.12.72.6Urban4,3400.02.72.7Hospice Location.

Region of the Country (Census Division):New England149−0.52.72.2Middle Atlantic2820.02.72.7South Atlantic588−0.22.72.5East North Central559−0.42.72.3East South Central256−0.12.72.6West North Central410−0.52.72.2West South Central1,0150.32.73.0Mountain538−0.22.72.5Pacific1,3400.72.73.4Outlying49−0.32.72.4Hospice Size:0-3,499 RHC Days (Small)1,0760.32.73.03,500-19,999 RHC Days (Medium)2,4570.22.72.920,000+ RHC Days (Large)1,6530.02.72.7Source. FY 2021 hospice claims data from CCW accessed on January 21, 2022.Note. The overall total impact reflects the addition of the individual impacts, which includes the overall wage index impact of updating the wage data with a 5-percent cap on wage index decreases, as well as the proposed 2.7 percent hospice payment update percentage.Region Key:New England=Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont.Middle Atlantic Pennsylvania, New Jersey, New York;South Atlantic Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia.East North Central Illinois, Indiana, Michigan, Ohio, Wisconsin.East South Central Alabama, Kentucky, Mississippi, Tennessee.West North Central Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota.West South Central Arkansas, Louisiana, Oklahoma, Texas.Mountain=Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming Pacific= Alaska, California, Hawaii, Oregon, Washington.Outlying=Guam, Puerto Rico, Virgin Islands.

Start Printed Page 19462 2. Regulatory Review Cost Estimation If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this proposed rule.

We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this proposed rule.

We welcome any comments on the approach in estimating the number of entities which will review this proposed rule. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We are soliciting public comments on this assumption.

Using the occupational wage information from the BLS for medical and health service managers (Code 11-9111) from May 2020. We estimate that the cost of reviewing this rule is $114.24 per hour, including overhead and fringe benefits ( https://www.bls.gov/​oes/​current/​oes_​nat.htm ). This proposed rule consists of approximately 20,000 words.

Assuming an average reading speed of 250 words per minute, it would take approximately 0.67 hours for the staff to review half of it. For each hospice that reviews the rule, the estimated cost is $76.16 (0.67 hours × $114.24). Therefore, we estimate that the total cost of reviewing this regulation is $4,036.48 ($76.16 × 53 reviewers).

D. Alternatives Considered Since the hospice payment update percentage is determined based on statutory requirements, we only considered not updating hospice payment rates by the payment update percentage. Payment rates since FY 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent years must be the market basket percentage for that FY.

Section 3401(g) of the Affordable Care Act also mandates that, starting with FY 2013 (and in subsequent years), the hospice payment update percentage will be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. For FY 2023, since the hospice payment update percentage is determined based on statutory requirements at section 1814(i)(1)(C) of the Act, we cannot consider not updating the hospice payment rates by the hospice payment update percentage, nor can we consider updating the hospice payment rates by the hospice payment update percentage. E.

Accounting Statement As required by OMB Circular A-4 (available at https://www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​circulars/​A4/​a-4.pdf ), in Table 11, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of this proposed rule. Table 11 provides our best estimate of the possible changes in Medicare payments under the hospice benefit as a result of the policies in this proposed rule. This estimate is based on the data for 4,957 hospices in our impact analysis file, which was constructed using FY 2021 claims available in January 2022.

All expenditures are classified as transfers to hospices. Table 11—Accounting Statement. Classification of Estimated Transfers and Costs, From FY 2022 to FY 2023CategoryTransfersAnnualized Monetized Transfers$ 580 million* .From Whom to Whom?.

Federal Government to Medicare Hospices.*The increase of $580 million in transfer payments is a result of the 2.7 percent hospice payment update compared to payments in FY 2022. F. Regulatory Flexibility Act (RFA) The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities.

The great majority of hospitals and most other health care providers and suppliers are small entities by meeting the Small Business Administration (SBA) definition of a small business (in the service sector, having revenues of less than $8.0 million to $41.5 million in any 1 year), or being nonprofit organizations. For purposes of the RFA, we consider all hospices as small entities as that term is used in the RFA. The Department of Health and Human Services practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs.

The effect of the FY 2023 hospice payment update percentage results in an overall increase in estimated hospice payments of 2.7 percent, or $580 million. The distributional effects of the proposed FY 2023 hospice wage index do not result in a greater than 5 percent of hospices experiencing decreases in payments of 3 percent or more of total revenue. Therefore, the Secretary has determined that this rule will not create a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a MSA and has fewer than 100 beds.

This rule will only affect hospices. Therefore, the Secretary has determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals (see Table 10). G.

Unfunded Mandates Reform Act (UMRA) Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2022, that threshold is approximately $165 million. This rule is not anticipated to have an effect on state, local, or tribal governments, in the aggregate, or on the private sector of $165 million or more in any 1 year.

H. Federalism Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a Start Printed Page 19463 proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have reviewed this rule under these criteria of Executive Order 13132, and have determined that it will not impose substantial direct costs on state or local governments.

I. Conclusion We estimate that aggregate payments to hospices in FY 2023 will increase by $580 million as a result of the market basket update, compared to payments in FY 2022. We estimate that in FY 2023, hospices in urban areas will experience, on average, a 2.7 percent increase in estimated payments compared to FY 2022.

While hospices in rural areas will experience, on average, a 2.6 percent increase in estimated payments compared to FY 2022. Hospices providing services in the Pacific and West South Central regions would experience the largest estimated increases in payments of 3.4 percent and 3.0 percent, respectively. Hospices serving patients in areas in the New England and West North Central regions would experience, on average, the lowest estimated increase of 2.2 percent in FY 2023 payments.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &. Medicaid Services, approved this document on March 29, 2022. Start List of Subjects Health facilitiesHospice careMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &.

Medicaid Services proposes to amend 42 CFR part 418 as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 418 continues to read as follows.

End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part2.

Section § 418.306 is amended by revising paragraph (c) to read as follows. End Amendment Part Annual update of the payment rates and adjustment for area wage differences. * * * * * (c) Adjustment for wage differences.

(1) Each hospice's labor market is determined based on definitions of Metropolitan Statistical Areas (MSAs) issued by OMB. CMS will issue annually, in the Federal Register , a hospice wage index based on the most current available CMS hospital wage data, including changes to the definition of MSAs. The urban and rural area geographic classifications are defined in § 412.64(b)(1)(ii)(A) through (C) of this chapter.

The payment rates established by CMS are adjusted by the Medicare contractor to reflect local differences in wages according to the revised wage data. (2) Beginning on October 1, 2022, CMS applies a cap on decreases to the hospice wage index such that the wage index applied to a geographic area is not less than 95 percent of the wage index applied to that geographic area in the prior fiscal year. * * * * * Start Signature Dated.

March 29, 2022. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information.

Is zithromax related to penicillin

Shutterstock A bipartisan group of is zithromax related to penicillin zithromax for sale state attorneys general is asking the U.S. Food and Drug Administration for is zithromax related to penicillin a progress report on the fight against opioids. In a letter to FDA Commissioner Stephen Hahn, the attorneys general seek information about what the FDA has done under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) to fight the opioid epidemic, as well as what the agencies future steps are. €œWhile combatting buy antibiotics has, understandably, been is zithromax related to penicillin at the forefront of conversations about health and safety during these last 10 months, we cannot lose sight of the fact that the drug crisis continues to take the lives of Kentuckians,” said Kentucky Attorney General Daniel Cameron.

€œThe FDA plays a critical role in combatting this crisis, and I, and my colleagues in other states, joined together in sending this letter to request an update on the agency’s progress and next steps.”Provisions of the act give the FDA new powers, including implementing safer opioid packaging and disposal features, handling research and issuing new regulations on non-addictive alternatives to opioids, and presenting guidelines for opioid prescribing.Shutterstock Researchers looking at combining two medications to treat methamphetamine disorder think their approach may be a safe and effective way to treat addicted adults. By combining injectable naltrexone and oral bupropion, researchers within the National Institute on Drug Abuse Clinical Trials Network, part of the National Institutes of Health, have seen is zithromax related to penicillin success in treating patients with moderate to severe methamphetamine use disorder in addition to other approaches to treatment, such as cognitive behavioral therapy and contingency management interventions. €œThe opioid crisis and resulting overdose deaths in the United States are now well known, but what is less recognized is that there is a growing crisis of overdose deaths involving methamphetamine and other stimulants. However, unlike for opioids, there are currently no approved is zithromax related to penicillin medications for treating methamphetamine use disorder,” said NIDA Director Nora D.

Volkow. €œThis advance demonstrates that medical treatment for is zithromax related to penicillin methamphetamine use disorder can help improve patient outcomes.”The study, “Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder,” was conducted between 2017 and 2019 at clinics across the country. Using 403 adult volunteers between 18 and 65 with moderate to severe methamphetamine use disorder, the study provided some volunteers with the naltrexone, bupropion combination while is zithromax related to penicillin giving the other placebos. Urine samples were collected throughout the study, and a volunteer was considered successfully treated if three of four urine samples came back without traces of methamphetamine.

The study found that is zithromax related to penicillin participants taking the drug combination were more likely to report that they had fewer cravings for the drug and greater improvements in their lives. Additionally, there were no significant adverse effects associated with buy zithromax azithromycin the drug combination. €œLong-term methamphetamine misuse has been shown to cause diffuse changes to the brain, which can is zithromax related to penicillin contribute to severe health consequences beyond addiction itself,” said Dr. Madhukar H.

Trivedi of the University of Texas Southwestern Medical Center, Dallas, who led the trial is zithromax related to penicillin. €œThe good news is that some of the structural and neurochemical brain changes are reversed in people who recover, underscoring the importance of identifying new and more effective treatment strategies.”Shutterstock Between 2010 and 2017, the rates of pregnant women diagnosed with opioid use disorder spiked 131 percent, and babies born with neonatal abstinence syndrome (NAS) grew 82 percent, according to a U.S. Department of Health and Human Services (HHS) study.Although is zithromax related to penicillin some states had rates as high as one in 20 deliveries affected by opioids, the increases were seen nationwide. Twenty-five states doubled their rates between 2010 and 2017 while rates plateaued in New England.“We found that rural, white, and Medicaid populations continue to have the highest is zithromax related to penicillin rates of maternal opioid-related diagnoses and neonatal abstinence syndrome,” Dr.

Jean Ko, Maternal Health and Chronic Disease Team lead in the Centers for Disease Control and Prevention’s (CDC) Division of Reproductive Health said. €œHowever, large variation by state highlight the importance of state-level strategies and initiatives to address the opioid crisis for pregnant and postpartum women and their infants.”HHS’ Health Resources and Services Administration, the CDC, Vanderbilt University Medical Center, is zithromax related to penicillin and the Agency for Healthcare Research and Quality conducted the study.Researchers examined 11.8 million hospital records for trends in maternal opioid diagnoses and NAS. The records were from community, non-rehabilitation hospitals in 47 states and the District of Columbia.Shutterstock A team of scientists, led by Duke University, have developed a bio-compatible surgical patch that releases nonopioid painkillers directly to the site of a wound.The polymer patch, made of poly(ester urea) homopolymers and co-polymers, lasts for several days and then dissolves. It uses a controlled is zithromax related to penicillin release of a drug that blocks the enzyme COX-2.

The polymer’s surface area and thicknesses control the release of the painkiller.Traditional polymers swell and the medicine is released at once.“If you can get four or five days of pain control out of the patch and not have to take those other pain drugs, not only do you avoid some of the side effects and risks of addiction, you’re concentrating therapy where you need it,” Matthew Becker, Duke’s Pratt School of Engineering professor of mechanical engineering and materials science, said.Becker received a $2 million grant from the state of Ohio at his previous institution to investigate nonopioid pain management as a means of controlling the opioid epidemic. Becker began working at Duke in 2019, and he and is zithromax related to penicillin his research team partnered with Dr. Ru-Rong Ji, a pain control expert, and his team.Researchers originally planned to devise hernia meshes and antimicrobial films..

Shutterstock A bipartisan group of state attorneys general is asking order zithromax online uk the U.S. Food and Drug Administration for a order zithromax online uk progress report on the fight against opioids. In a letter to FDA Commissioner Stephen Hahn, the attorneys general seek information about what the FDA has done under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) to fight the opioid epidemic, as well as what the agencies future steps are.

€œWhile combatting buy antibiotics has, understandably, been at the forefront of conversations about health and safety order zithromax online uk during these last 10 months, we cannot lose sight of the fact that the drug crisis continues to take the lives of Kentuckians,” said Kentucky Attorney General Daniel Cameron. €œThe FDA plays a critical role in combatting this crisis, and I, and my colleagues in other states, joined together in sending this letter to request an update on the agency’s progress and next steps.”Provisions of the act give the FDA new powers, including implementing safer opioid packaging and disposal features, handling research and issuing new regulations on non-addictive alternatives to opioids, and presenting guidelines for opioid prescribing.Shutterstock Researchers looking at combining two medications to treat methamphetamine disorder think their approach may be a safe and effective way to treat addicted adults. By combining injectable naltrexone and oral bupropion, researchers within the National Institute on Drug Abuse Clinical Trials Network, part of the National Institutes of Health, have seen success order zithromax online uk in treating patients with moderate to severe methamphetamine use disorder in addition to other approaches to treatment, such as cognitive behavioral therapy and contingency management interventions.

€œThe opioid crisis and resulting overdose deaths in the United States are now well known, but what is less recognized is that there is a growing crisis of overdose deaths involving methamphetamine and other stimulants. However, unlike for opioids, there are currently no approved medications order zithromax online uk for treating methamphetamine use disorder,” said NIDA Director Nora D. Volkow.

€œThis advance demonstrates that medical treatment for methamphetamine use disorder can help improve patient outcomes.”The study, “Accelerated Development of Additive Pharmacotherapy Treatment order zithromax online uk for Methamphetamine Use Disorder,” was conducted between 2017 and 2019 at clinics across the country. Using 403 adult volunteers between 18 order zithromax online uk and 65 with moderate to severe methamphetamine use disorder, the study provided some volunteers with the naltrexone, bupropion combination while giving the other placebos. Urine samples were collected throughout the study, and a volunteer was considered successfully treated if three of four urine samples came back without traces of methamphetamine.

The study found that participants taking order zithromax online uk the drug combination were more likely to report that they had fewer cravings for the drug and greater improvements in their lives. Additionally, there were no significant adverse effects associated with the drug combination. €œLong-term methamphetamine misuse has been shown to cause diffuse order zithromax online uk changes to the brain, which can contribute to severe health consequences beyond addiction itself,” said Dr.

Madhukar H. Trivedi of order zithromax online uk the University of Texas Southwestern Medical Center, Dallas, who led the trial. €œThe good news is that some of the structural and neurochemical brain changes are reversed in people who recover, underscoring the importance of identifying new and more effective treatment strategies.”Shutterstock Between 2010 and 2017, the rates of pregnant women diagnosed with opioid use disorder spiked 131 percent, and babies born with neonatal abstinence syndrome (NAS) grew 82 percent, according to a U.S.

Department of Health and Human Services (HHS) study.Although some order zithromax online uk states had rates as high as one in 20 deliveries affected by opioids, the increases were seen nationwide. Twenty-five states doubled their rates between 2010 and 2017 while rates plateaued in New England.“We found that rural, white, and Medicaid populations continue to have the highest rates of maternal order zithromax online uk opioid-related diagnoses and neonatal abstinence syndrome,” Dr. Jean Ko, Maternal Health and Chronic Disease Team lead in the Centers for Disease Control and Prevention’s (CDC) Division of Reproductive Health said.

€œHowever, large variation by state highlight the importance of state-level strategies and initiatives to address the order zithromax online uk opioid crisis for pregnant and postpartum women and their infants.”HHS’ Health Resources and Services Administration, the CDC, Vanderbilt University Medical Center, and the Agency for Healthcare Research and Quality conducted the study.Researchers examined 11.8 million hospital records for trends in maternal opioid diagnoses and NAS. The records were from community, non-rehabilitation hospitals in 47 states and the District of Columbia.Shutterstock A team of scientists, led by Duke University, have developed a bio-compatible surgical patch that releases nonopioid painkillers directly to the site of a wound.The polymer patch, made of poly(ester urea) homopolymers and co-polymers, lasts for several days and then dissolves. It uses a controlled release of a drug that order zithromax online uk blocks the enzyme COX-2.

The polymer’s surface area and thicknesses control the release of the painkiller.Traditional polymers swell and the medicine is released at once.“If you can get four or five days of pain control out of the patch and not have to take those other pain drugs, not only do you avoid some of the side effects and risks of addiction, you’re concentrating therapy where you need it,” Matthew Becker, Duke’s Pratt School of Engineering professor of mechanical engineering and materials science, said.Becker received a $2 million grant from the state of Ohio at his previous institution to investigate nonopioid pain management as a means of controlling the opioid epidemic. Becker began working at Duke in 2019, and he and his research order zithromax online uk team partnered with Dr. Ru-Rong Ji, a pain control expert, and his team.Researchers originally planned to devise hernia meshes and antimicrobial films..

What should my health care professional know before I take Zithromax?

They need to know if you have any of these conditions:;

• kidney disease; liver disease
• pneumonia
• stomach problems (especially colitis)
• other chronic illness; an unusual or allergic reaction to azithromycin
• other macrolide antibiotics (such as erythromycin), foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

Zithromax 600mg

The PREP Act was enacted on zithromax 600mg December 30, http://buyingtitles.co.uk/buying-titles-topics/ 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 zithromax 600mg U.S.C.

247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the zithromax and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the antibiotics Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the former Secretary, Alex zithromax 600mg M. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C.

247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the buy antibiotics outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July zithromax 600mg 20, 2021. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against buy antibiotics (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the zithromax 600mg CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm buy antibiotics might otherwise cause. (85 FR 35100, June 8, 2020) zithromax 600mg.

On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. (85 FR 52136, Aug. 24, 2020) zithromax 600mg. On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary's Declaration and authorizations issued by the Department's Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond.

Added an additional category of qualified persons under Section V of the Declaration. Made explicit that the Declaration zithromax 600mg covers all qualified zithromax and epidemic products as defined under the PREP Act. Added a third method of distribution to provide liability protections for, among other things, private distribution channels. Made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections.

Made explicit that there are substantive federal legal and policy issues and interests in having zithromax 600mg a unified whole-of-nation response to the buy antibiotics zithromax among federal, state, local, and private-sector entities. Revised the effective time period of the Declaration. And republished the declaration in full. (85 FR 79190, zithromax 600mg Dec.

9, 2020). On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer buy antibiotics treatments that are covered countermeasures under the Declaration (86 FR 7872, Feb. 2, 2021) zithromax 600mg. On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer buy antibiotics treatments that are covered countermeasures under the Declaration (86 FR 9516, Feb.

16, 2021) and on February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR zithromax 600mg 10588, Feb. 22, 2021). On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration.

(86 FR 14462, zithromax 600mg Mar. 16, 2021). On August 4, 2021, Secretary Xavier Becerra amended the Declaration to clarify categories of Qualified Persons and to expand the scope of authority for certain Qualified Persons to administer seasonal influenza treatments to adults. (86 FR zithromax 600mg 41977, Aug.

4, 2021). Secretary Xavier Becerra now amends section V of the Declaration to add subsection (i) to expand the scope of authority for licensed pharmacists to order and administer and qualified pharmacy technicians and pharmacy interns to administer buy antibiotics therapeutics subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the U.S. Food and zithromax 600mg Drug Administration (FDA). Accordingly, subsection V(i) authorizes.

(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) [] FDA authorized, approved, or licensed buy antibiotics therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements zithromax 600mg are met. I. The buy antibiotics therapeutic must be authorized, approved, or licensed by the FDA.

Ii. In the case of a licensed pharmacist ordering a buy antibiotics therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;Start Printed Page 51162 iii. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the buy antibiotics therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing. Iv.

In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician. V. In the case of buy antibiotics therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of buy antibiotics therapeutics, the recognition and treatment of emergency reactions to buy antibiotics therapeutics, and any additional training required in the FDA approval, authorization, or licensing.

Vi. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers buy antibiotics therapeutics, including informing the patient's primary-care provider when available and complying with requirements with respect to reporting adverse events. Viii.

The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of buy antibiotics therapeutics. Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8). By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B).

First, the amendment clarifies that licensed pharmacists are authorized to order and administer and licensed or registered pharmacy interns and qualified pharmacy technicians are authorized to administer buy antibiotics therapeutics that are Covered Countermeasures under section VI of this Declaration. The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer buy antibiotics therapeutics to address rising buy antibiotics cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible. Rising buy antibiotics cases, largely attributable to the Delta variant, is a public health threat caused by buy antibiotics, placing additional strains on our healthcare system. Pharmacists, pharmacy technicians, and pharmacy interns are well positioned to increase access to therapeutics and have played a critical role in this zithromax in overseeing buy antibiotics testing and treatment administration.

Given their skill set and training, as well as looming provider shortages, pharmacists, pharmacy technicians, and pharmacy interns will quickly expand access to buy antibiotics therapeutics. buy antibiotics therapeutics may be administered as intramuscular injections, subcutaneous injections, or orally and would require minimal, if any, additional training to administer beyond training pharmacists, pharmacy technicians, and pharmacy interns have already received for treatment administration, and would not place any undue training burden on providers. As qualified persons, these licensed pharmacists, qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering buy antibiotics therapeutics or other Covered Countermeasures, such law is preempted.

On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized buy antibiotics diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer Start Printed Page 51163covered countermeasures within its jurisdiction under State law.

The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by buy antibiotics as it will enable States to quickly expand the vaccination, treatment and prevention workforces with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the buy antibiotics countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against buy antibiotics. Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against buy antibiotics, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, as amended on February 2, 2021, as amended March 11, 2021, and as amended on August 4, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as republished at 85 FR 79190 (Dec http://www.svb-burgdorf.de/portfolio-item/willow-mockup/. 9, 2020). 1. Covered Persons, section V, delete in full and replace with.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. €œOrder” as used herein and in guidance issued by the Office of the Assistant Secretary for Health [] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration;[] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. (d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule.

Or (3) FDA authorized or FDA licensed buy antibiotics treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. In the case of a buy antibiotics treatment, the vaccination must be ordered and administered according to ACIP's buy antibiotics treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician.

Vi. The licensed pharmacist must have completed the immunization Start Printed Page 51164training that the licensing State requires for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the ACPE to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

Vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii.

The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.

Xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) buy antibiotics vaccination provider agreement and any other federal requirements that apply to the administration of buy antibiotics- 19 treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a buy antibiotics vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the buy antibiotics treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to.

(i) Documentation of completion of the Centers for Disease Control and Prevention buy antibiotics (CDC) treatment Training Modules [] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the buy antibiotics treatment(s) to be administered. (g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met. The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, Start Printed Page 51165or volunteers are authorized to carry out under this declaration.

And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph. 1. Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a buy antibiotics vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the buy antibiotics treatment covered countermeasure is administered. 2.

Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a buy antibiotics vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the buy antibiotics treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General. 3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a buy antibiotics vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the buy antibiotics treatment covered countermeasure is administered. Subject to the following requirements.

I. The treatment must be authorized, approved, or licensed by the FDA. Ii. Vaccination must be ordered and administered according to ACIP's buy antibiotics treatment recommendation(s).

Iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention buy antibiotics treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering buy antibiotics treatments. Iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the buy antibiotics treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering buy antibiotics treatments.

V. The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; [] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii.

The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) buy antibiotics vaccination provider agreement and any other federal requirements that apply to the administration of buy antibiotics treatment(s). (i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) [] FDA authorized, approved, or licensed buy antibiotics therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are Start Printed Page 51166qualified persons only if the following requirements are met. Ix.

The buy antibiotics therapeutic must be authorized, approved, or licensed by the FDA. X. In the case of a licensed pharmacist ordering a buy antibiotics therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing. Xi.

In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the buy antibiotics therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing. Xii. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician. Xiii.

In the case of buy antibiotics therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of buy antibiotics therapeutics, the recognition and treatment of emergency reactions to buy antibiotics therapeutics, and any additional training required in the FDA approval, authorization, or licensing. Xiv. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] xv.

Made explicit that there can be situations where http://www.em-belle-vue-haguenau.ac-strasbourg.fr/?p=4821 not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration's liability protections order zithromax online uk. Made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the buy antibiotics zithromax among federal, state, local, and private-sector entities. Revised the effective time period of the Declaration.

And republished order zithromax online uk the declaration in full. (85 FR 79190, Dec. 9, 2020).

On February 2, order zithromax online uk 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer buy antibiotics treatments that are covered countermeasures under the Declaration (86 FR 7872, Feb. 2, 2021). On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer buy antibiotics treatments that are covered countermeasures under the Declaration (86 FR 9516, Feb.

16, 2021) and on February 22, 2021, the Department filed a notice of correction to the order zithromax online uk February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, Feb. 22, 2021).

On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered order zithromax online uk countermeasures under the Declaration. (86 FR 14462, Mar. 16, 2021).

On August 4, 2021, Secretary Xavier Becerra amended the Declaration to clarify categories of Qualified Persons and to expand the scope of authority for certain Qualified Persons to administer seasonal influenza treatments order zithromax online uk to adults. (86 FR 41977, Aug. 4, 2021).

Secretary Xavier Becerra now amends section V of the Declaration to add subsection (i) to expand the scope of authority for licensed pharmacists to order and administer and qualified pharmacy technicians and pharmacy interns to order zithromax online uk administer buy antibiotics therapeutics subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the U.S. Food and Drug Administration (FDA). Accordingly, subsection V(i) authorizes.

(i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who order zithromax online uk administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) [] FDA authorized, approved, or licensed buy antibiotics therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met. I.

The buy antibiotics therapeutic must be authorized, approved, or licensed by the order zithromax online uk FDA. Ii. In the case of a licensed pharmacist ordering a buy antibiotics therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;Start Printed Page 51162 iii.

In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the buy antibiotics therapeutic, the therapeutic must be administered order zithromax online uk subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing. Iv. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician.

V. In the case of buy antibiotics therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of buy antibiotics therapeutics, the recognition and treatment of emergency reactions to buy antibiotics therapeutics, and any additional training required in the FDA approval, authorization, or licensing.

Vi. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers buy antibiotics therapeutics, including informing the patient's primary-care provider when available and complying with requirements with respect to reporting adverse events.

Viii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of buy antibiotics therapeutics. Description of This Amendment by Section Section V.

Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act.

42 U.S.C. 247d-6d(i)(8). By this amendment to the Declaration, the Secretary clarifies and expands the authorization for a category of persons who are qualified persons under section 247d-6d(i)(8)(B).

First, the amendment clarifies that licensed pharmacists are authorized to order and administer and licensed or registered pharmacy interns and qualified pharmacy technicians are authorized to administer buy antibiotics therapeutics that are Covered Countermeasures under section VI of this Declaration. The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer buy antibiotics therapeutics to address rising buy antibiotics cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible. Rising buy antibiotics cases, largely attributable to the Delta variant, is a public health threat caused by buy antibiotics, placing additional strains on our healthcare system.

Pharmacists, pharmacy technicians, and pharmacy interns are well positioned to increase access to therapeutics and have played a critical role in this zithromax in overseeing buy antibiotics testing and treatment administration. Given their skill set and training, as well as looming provider shortages, pharmacists, pharmacy technicians, and pharmacy interns will quickly expand access to buy antibiotics therapeutics. buy antibiotics therapeutics may be administered as intramuscular injections, subcutaneous injections, or orally and would require minimal, if any, additional training to administer beyond training pharmacists, pharmacy technicians, and pharmacy interns have already received for treatment administration, and would not place any undue training burden on providers.

As qualified persons, these licensed pharmacists, qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, to the extent that any State law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering buy antibiotics therapeutics or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are “qualified persons” under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized buy antibiotics diagnostic tests.[] The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as “qualified persons” would be rendered a nullity in the absence of such preemption.

This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of “qualified persons” specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F-3(i)(8)(A) of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer Start Printed Page 51163covered countermeasures within its jurisdiction under State law.

The plain language of the PREP Act makes clear that there is preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by buy antibiotics as it will enable States to quickly expand the vaccination, treatment and prevention workforces with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the buy antibiotics countermeasure program. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against buy antibiotics.

Section V of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against buy antibiotics, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, as amended on February 2, 2021, as amended March 11, 2021, and as amended on August 4, 2021, is further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 (Dec. 9, 2020).

1. Covered Persons, section V, delete in full and replace with. V.

Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. €œOrder” as used herein and in guidance issued by the Office of the Assistant Secretary for Health [] means a provider medication order, which includes prescribing of treatments, or a laboratory order, which includes prescribing laboratory orders, if required.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration;[] (b) Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy),[] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) seasonal influenza treatment administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule. Or (3) FDA authorized or FDA licensed buy antibiotics treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met.

I. The treatment must be authorized, approved, or licensed by the FDA. Ii.

In the case of a buy antibiotics treatment, the vaccination must be ordered and administered according to ACIP's buy antibiotics treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. In the case of seasonal influenza treatment administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIP's standard immunization schedule. V.

In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician. Vi. The licensed pharmacist must have completed the immunization Start Printed Page 51164training that the licensing State requires for pharmacists to order and administer treatments.

If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the ACPE to order and administer treatments. Such a training program must include hands on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vii.

The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Viii.

The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. X.

The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. Xi. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.

And xii. The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) buy antibiotics vaccination provider agreement and any other federal requirements that apply to the administration of buy antibiotics- 19 treatment(s). (e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice.

When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. (f) Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer treatments under the law of any State as of the effective date of this amendment, or a pharmacist or pharmacy intern as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a buy antibiotics vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the buy antibiotics treatment covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to.

(i) Documentation of completion of the Centers for Disease Control and Prevention buy antibiotics (CDC) treatment Training Modules [] and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider in preparation and administration of the buy antibiotics treatment(s) to be administered. (g) Any member of a uniformed service (including members of the National Guard in a Title 32 duty status) (hereafter in this paragraph “service member”) or Federal government, employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government service members, employees, contractors, or volunteers are qualified persons if the following requirement is met.

The executive department or agency by or for which the Federal service member, employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that service member, employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that service member, employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such service member, employees, contractors, Start Printed Page 51165or volunteers are authorized to carry out under this declaration. And (h) The following healthcare professionals and students in a healthcare profession training program subject to the requirements of this paragraph. 1.

Any midwife, paramedic, advanced or intermediate emergency medical technician (EMT), physician assistant, respiratory therapist, dentist, podiatrist, optometrist or veterinarian licensed or certified to practice under the law of any state who prescribes, dispenses, or administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a buy antibiotics vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the buy antibiotics treatment covered countermeasure is administered. 2. Any physician, advanced practice registered nurse, registered nurse, practical nurse, pharmacist, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, respiratory therapist, dentist, physician assistant, podiatrist, optometrist, or veterinarian who has held an active license or certification under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a buy antibiotics vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the buy antibiotics treatment covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General.

3. Any medical, nursing, pharmacy, pharmacy intern, midwife, paramedic, advanced or intermediate EMT, physician assistant, respiratory therapy, dental, podiatry, optometry or veterinary student with appropriate training in administering treatments as determined by his or her school or training program and supervision by a currently practicing healthcare professional experienced in administering intramuscular injections who administers buy antibiotics treatments that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a buy antibiotics vaccination effort by a State, local, Tribal or territorial authority or by an institution in which the buy antibiotics treatment covered countermeasure is administered. Subject to the following requirements.

I. The treatment must be authorized, approved, or licensed by the FDA. Ii.

Vaccination must be ordered and administered according to ACIP's buy antibiotics treatment recommendation(s). Iii. The healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention buy antibiotics treatment Training Modules and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering buy antibiotics treatments.

Iv. The healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering vaccinations is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the buy antibiotics treatment(s) to be administered and, if applicable, such additional training as may be required by the State, territory, locality, or Tribal area in which they are prescribing, dispensing, or administering buy antibiotics treatments. V.

The healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation; [] vi. The healthcare professionals and students must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment. And vii.

The healthcare professionals and students comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) buy antibiotics vaccination provider agreement and any other federal requirements that apply to the administration of buy antibiotics treatment(s). (i) A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) [] FDA authorized, approved, or licensed buy antibiotics therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are Start Printed Page 51166qualified persons only if the following requirements are met.

Ix. The buy antibiotics therapeutic must be authorized, approved, or licensed by the FDA. X.

In the case of a licensed pharmacist ordering a buy antibiotics therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing. Xi. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the buy antibiotics therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing.

Xii. In the case of qualified pharmacy technicians, the supervising pharmacist must be readily and immediately available to the qualified pharmacy technician. Xiii.

In the case of buy antibiotics therapeutics administered through intramuscular or subcutaneous injections, the licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of buy antibiotics therapeutics, the recognition and treatment of emergency reactions to buy antibiotics therapeutics, and any additional training required in the FDA approval, authorization, or licensing. Xiv.

The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; [] xv. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers buy antibiotics therapeutics, including informing the patient's primary-care provider when available and complying with requirements with respect to reporting adverse events. Xvi.

The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of buy antibiotics therapeutics. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

2. Effective Time Period, section XII, delete in full and replace with. Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024.

Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on December 9, 2020 and last through (a) the final day the Declaration of Emergency is in effect or (b) October 1, 2024 whichever occurs first.

Liability protections for Qualified Persons under section V(d) of the Declaration who are qualified pharmacy technicians and interns to seasonal influenza treatment to persons aged 19 and older begin on August 4, 2021. Liability protections for Qualified Persons under section V(f) of the Declaration begin on February 2, 2021, and last through October 1, 2024. Liability protections for Qualified Persons under section V(g) of the Declaration begin on February 16, 2021, and last through October 1, 2024.

Liability protections for Qualified Persons who are physicians, advanced practice registered nurses, registered nurses, or practical nurses under section V(h) of the Declaration begins on February 2, 2021 and last through October 1, 2024, with additional conditions effective as of March 11, 2021and liability protections for all other Qualified persons under section V(h) begins on March 11, 2021 and last through October 1, 2024. Liability protections for Qualified Persons under section V(i) of the Declaration who are licensed pharmacists to order and administer and qualified pharmacy technicians and licensed or registered pharmacy interns to administer buy antibiotics therapeutics begin on September 9, 2021. Authority.

Does zithromax treat urinary tract s

New York, NY (December does zithromax treat urinary tract s 09, 2021) Hospitalized buy antibiotics patients who had been chronically exposed in their neighborhoods to higher particulate matter—such as smoke, soot, zithromax 500mg cost and dirt—had increased risks for admission to the intensive care unit (ICU) and death compared to those without such exposure, Mount Sinai-led researchers reported in the American Journal of Respiratory and Critical Care Medicine on December 8.The finding adds to our understanding about environmental factors that increase the risks of buy antibiotics. The researchers does zithromax treat urinary tract s noted that chronic air pollution exposure can alter the pulmonary immune system, may increase systemic inflammation, and can be associated with increased risk for cardiovascular disease and metabolic syndrome. buy antibiotics s and deaths have also disproportionately occurred among Black, Latinx, and Indigenous populations, as well as among individuals with risk factors based on sex, age, and existing comorbid diseases such as diabetes and obesity.“The buy antibiotics zithromax has brought to the forefront the critical role of the environment on health disparities. These data does zithromax treat urinary tract s suggest that long-term exposure to air pollution, even at concentrations below U.S.

Environmental Protection Agency regulatory standards, is associated with higher buy antibiotics morbidity and mortality amongst hospitalized patients,” said corresponding author Alison Lee, MD, MS, Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine), and Pediatrics, at the Icahn School of Medicine at Mount Sinai. €œCritically, air pollution is a modifiable risk does zithromax treat urinary tract s factor. Policies to reduce air pollution must be considered a necessary public health measure, especially in communities that are disproportionately susceptible to air pollution’s deleterious effects.” A team of researchers conducted a retrospective analysis of more than 6,500 buy antibiotics patients admitted to seven New York City hospitals with ethnically diverse patient populations—including Mount Sinai Morningside, Mount Sinai Queens, NYC Health + Hospitals/Elmhurst, and NYC Health + Hospitals/Queens—amid the first peak of the see this website zithromax from March to August 2020. The researchers estimated exposure levels to pollutants including particulate matter, nitrogen dioxide, and black carbon at the residential does zithromax treat urinary tract s addresses of the patients at the time of admission.

The team then assessed patient outcomes including mortality, ICU admission, and intubation. They found that chronic exposure to particulate matter, even at levels below current regulatory thresholds, was associated with an 11 percent higher risk of mortality and 13 percent higher does zithromax treat urinary tract s risk of admission to the ICU. Exploratory analyses suggested that younger people of color may be particularly susceptible.The study was developed through participation in the buy antibiotics Unit for Research at Elmhurst (CURE-19) partnership, an initiative by Mount Sinai’s Arnhold Institute for Global Health and NYC Health + Hospitals/Elmhurst and Queens to research the global zithromax and root causes of health disparities in New York City.“There is a lot we still don’t know about antibiotics, and that is why initiatives like the CURE-19 partnership are of utmost importance in the fight against this zithromax and our continued recovery,” said co-author Stanley Pierre, MD, MPA, NYC Health + Hospitals/Queens Patient Safety Coordinator and Director of the Clinical Centers of Excellence Development Program. “Being able to better understand what and how environmental factors play a role in New Yorkers’ health and buy antibiotics-associated risks not only allow us to better treat patients in the long-term, but also give us the opportunity to advocate does zithromax treat urinary tract s for broader changes that can help prevent serious illness in the future.”In addition to researchers from CURE-19, experts from Columbia University and the University of California, Berkeley contributed to the study.

It was supported by grants from the National Institute on Minority Health and Health Disparities (R01MD013310), the National Institute of Environmental Health Sciences (P30ES023515, P30ES009089), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (P2CHD058486), and the National Heart, Lung and Blood Institute (K23HL135349)..

New York, NY (December 09, 2021) Hospitalized buy antibiotics patients who had been chronically exposed in their neighborhoods to higher particulate matter—such as smoke, soot, and dirt—had increased risks for admission to the intensive care unit (ICU) and order zithromax online uk death compared to those without such exposure, Mount Sinai-led researchers reported in the American Journal of Respiratory and Critical Care Medicine on December 8.The finding adds to our understanding about environmental factors that increase the risks of buy antibiotics. The researchers noted that chronic air pollution exposure can alter order zithromax online uk the pulmonary immune system, may increase systemic inflammation, and can be associated with increased risk for cardiovascular disease and metabolic syndrome. buy antibiotics s and deaths have also disproportionately occurred among Black, Latinx, and Indigenous populations, as well as among individuals with risk factors based on sex, age, and existing comorbid diseases such as diabetes and obesity.“The buy antibiotics zithromax has brought to the forefront the critical role of the environment on health disparities. These data suggest that long-term order zithromax online uk exposure to air pollution, even at concentrations below U.S.

Environmental Protection Agency regulatory standards, is associated with higher buy antibiotics morbidity and mortality amongst hospitalized patients,” said corresponding author Alison Lee, MD, MS, Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine), and Pediatrics, at the Icahn School of Medicine at Mount Sinai. €œCritically, air pollution is order zithromax online uk a modifiable risk factor. Policies to reduce air pollution must be considered a necessary public health measure, especially in communities that are disproportionately susceptible to air pollution’s deleterious effects.” A team of researchers conducted a retrospective analysis of more than 6,500 buy antibiotics patients admitted to seven New York City hospitals with ethnically diverse patient populations—including Mount Sinai Morningside, Mount Sinai Queens, NYC Health + Hospitals/Elmhurst, and NYC Health + Hospitals/Queens—amid the first peak of the zithromax from March to August 2020. The researchers estimated exposure levels to pollutants including particulate matter, nitrogen dioxide, and black carbon at the residential order zithromax online uk addresses of the patients at the time of admission.

The team then assessed patient outcomes including mortality, ICU admission, and intubation. They found that chronic exposure to order zithromax online uk particulate matter, even at levels below current regulatory thresholds, was associated with an 11 percent higher risk of mortality and 13 percent higher risk of admission to the ICU. Exploratory analyses suggested that younger people of color may be particularly susceptible.The study was developed through participation in the buy antibiotics Unit for Research at Elmhurst (CURE-19) partnership, an initiative by Mount Sinai’s Arnhold Institute for Global Health and NYC Health + Hospitals/Elmhurst and Queens to research the global zithromax and root causes of health disparities in New York City.“There is a lot we still don’t know about antibiotics, and that is why initiatives like the CURE-19 partnership are of utmost importance in the fight against this zithromax and our continued recovery,” said co-author Stanley Pierre, MD, MPA, NYC Health + Hospitals/Queens Patient Safety Coordinator and Director of the Clinical Centers of Excellence Development Program. “Being able to better understand what and how environmental factors play a role in New Yorkers’ health and buy antibiotics-associated risks not only allow us to better treat patients in the long-term, but also give us the opportunity to advocate for broader changes that can help prevent serious illness in the future.”In addition to researchers from CURE-19, experts from Columbia University order zithromax online uk and the University of California, Berkeley contributed to the study.

It was supported by grants from the National Institute on Minority Health and Health Disparities (R01MD013310), the National Institute of Environmental Health Sciences (P30ES023515, P30ES009089), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (P2CHD058486), and the National Heart, Lung and Blood Institute (K23HL135349)..

Can you buy zithromax over the counter

Epinephrine dose and flush volumeEvidence for the efficacy and optimal administration of epinephrine during can you buy zithromax over the counter neonatal https://wine-showroom.com/buy-generic-ventolin-online/ resuscitation is hard to come by. Deepika Sankaran and colleagues performed a randomised study to model the use of epinephrine in a complex resuscitation situation that was based on the NRP algorithm. They studied newborn lambs that had been asphyxiated can you buy zithromax over the counter to the point of cardiac arrest by umbilical cord clamping before delivery. Five minutes after cardiac arrest positive pressure ventilation was provided and 1 min later chest compressions were provided and the FiO2 was increased to 1.0. Epinephrine was administered into an umbilical venous catheter 5 min after the onset of resuscitation.

Epinephrine doses of 0.01 mg/kg and 0.03 mg/kg were compared and flush volumes of 1 mL or 3 mL were compared in can you buy zithromax over the counter randomised groups. Epinephrine was repeated at the same dose every 3 min until return of spontaneous circulation. The higher dose of epinephrine was more effective than the lower dose and, with either dose, the response was better can you buy zithromax over the counter after the higher flush volume. The higher flush volume may be more effective at ensuring that the drug gets as far as the right atrium. See page F578Thermal management immediately after birth with and without servo-controlFrancesco Cavallin and colleagues performed a randomised controlled study in 15 Italian tertiary hospitals.

They studied infants with can you buy zithromax over the counter estimated birthweight <1500 g or gestation <30+6 weeks. In one group manually adjusted thermal control was provided during initial stabilisation, with the heater set on full. In the other group servo control was used. There were 450 infants in can you buy zithromax over the counter the study. There was no difference in the rate of normothermia (temperature 36.5–37.5 C) at the time of neonatal unit admission.

All infants were placed in plastic can you buy zithromax over the counter bags. Normothermia rates were relatively low in both groups (39.6% and 42.2%), with hypothermia being more frequent. Very few infants were hyperthermic. Servo control of temperature during initial stabilisation can you buy zithromax over the counter offered no advantage. Low normothermia rates show that initial thermal care is a complex dynamic process challenge that is not solved simply by choice of equipment.

See page F572Osteopathic manipulative treatment to improve breast feedingIt is unusual for the Fetal and Neonatal Edition to receive a trial of a complimentary therapy. Osteopathic manipulative treatment (OMT) has been can you buy zithromax over the counter used to treat various health issues, including breastfeeding difficulties. Marie Danielo Jouhier and colleagues performed a double blinded randomised controlled trial. Mother baby dyads were eligible if can you buy zithromax over the counter there was suboptimal breastfeeding behaviour, maternal cracked nipples or maternal pain. The intervention consisted of two sessions of early OMT.

To preserve blinding the manipulations were performed behind a screen. The primary outcome was the exclusive breastfeeding rate at can you buy zithromax over the counter 1 month. There was no significant difference in the primary outcome, OMT 31/59 (53%), control 39/59 (66%). The trial does not can you buy zithromax over the counter support the use of OMT for this indication. See page F591Time to desaturation during endotracheal intubationRadhika Kothari and colleagues measured the time from the last application of positive pressure until desaturation <90% SpO2 in preterm infants<32 weeks’ gestation who were being electively intubated in the neonatal unit with pre-medication.

There were 78 infants in the study and 73/78 desaturated to below 90% in a median of 22 s. The infants who desaturated to below can you buy zithromax over the counter 80% took a median 35 s to do so. As these were planned intubations in the neonatal unit, the times taken to desaturate may be longer than they would be for delivery room intubations, where the unrecruited lungs would not provide a reservoir of oxygen pending intubation success. The information may assist with the generation of guidelines. See page F603Parenteral lipid emulsions in the preterm infantLauren Frazer and Camilla Martin review current the current evidence and physiological considerations around how to use parenteral lipid emulsions as part of parenteral nutrition for preterm infants can you buy zithromax over the counter.

As with so many areas of current practice, the evidence is weak in many areas. It is useful to learn more about the hypothetical risks and benefits of newer preparations and to have knowledge gaps can you buy zithromax over the counter and research priorities identified so clearly. See page F676Treatment thresholds in extremely preterm infants in the UKFollowing the publication in 2019 by the British Association of Perinatal Medicine of professional guidance for the perinatal management of birth before 27 weeks of gestation, Lydia Mietta Di Stefano and colleagues surveyed UK health professionals to determine the lowest gestation at which they would now be willing to offer active treatment to an extremely preterm infant at parental request and the highest gestation at which they would agree to withhold treatment. The majority of respondents were willing to offer active treatment from 22+0 weeks. The highest gestation at which respondents would offer palliative care at parental request was can you buy zithromax over the counter 23+6/24+0 weeks for 59% of those surveyed (n=172).

The survey data indicate that there has been a shift in practice in relation to both thresholds since the publication of the guidance. See page F596Ethics statementsPatient consent for publicationNot applicable..

Epinephrine dose order zithromax online uk and flush volumeEvidence https://wine-showroom.com/buy-generic-ventolin-online/ for the efficacy and optimal administration of epinephrine during neonatal resuscitation is hard to come by. Deepika Sankaran and colleagues performed a randomised study to model the use of epinephrine in a complex resuscitation situation that was based on the NRP algorithm. They studied newborn lambs that had been asphyxiated to the point of cardiac arrest by umbilical cord clamping order zithromax online uk before delivery. Five minutes after cardiac arrest positive pressure ventilation was provided and 1 min later chest compressions were provided and the FiO2 was increased to 1.0.

Epinephrine was administered into an umbilical venous catheter 5 min after the onset of resuscitation. Epinephrine doses of 0.01 mg/kg and 0.03 mg/kg were order zithromax online uk compared and flush volumes of 1 mL or 3 mL were compared in randomised groups. Epinephrine was repeated at the same dose every 3 min until return of spontaneous circulation. The higher dose of epinephrine was more effective than the lower order zithromax online uk dose and, with either dose, the response was better after the higher flush volume.

The higher flush volume may be more effective at ensuring that the drug gets as far as the right atrium. See page F578Thermal management immediately after birth with and without servo-controlFrancesco Cavallin and colleagues performed a randomised controlled study in 15 Italian tertiary hospitals. They studied infants with estimated birthweight <1500 g or gestation <30+6 weeks order zithromax online uk. In one group manually adjusted thermal control was provided during initial stabilisation, with the heater set on full.

In the other group servo control was used. There were 450 infants in order zithromax online uk the study. There was no difference in the rate of normothermia (temperature 36.5–37.5 C) at the time of neonatal unit admission. All infants were order zithromax online uk placed in plastic bags.

Normothermia rates were relatively low in both groups (39.6% and 42.2%), with hypothermia being more frequent. Very few infants were hyperthermic. Servo control of temperature during initial stabilisation offered order zithromax online uk no advantage. Low normothermia rates show that initial thermal care is a complex dynamic process challenge that is not solved simply by choice of equipment.

See page F572Osteopathic manipulative treatment to improve breast feedingIt is unusual for the Fetal and Neonatal Edition to receive a trial of a complimentary therapy. Osteopathic manipulative treatment (OMT) has been used to treat various health issues, including order zithromax online uk breastfeeding difficulties. Marie Danielo Jouhier and colleagues performed a double blinded randomised controlled trial. Mother baby dyads were eligible if there was suboptimal breastfeeding behaviour, maternal cracked nipples order zithromax online uk or maternal pain.

The intervention consisted of two sessions of early OMT. To preserve blinding the manipulations were performed behind a screen. The primary outcome was the exclusive breastfeeding rate at order zithromax online uk 1 month. There was no significant difference in the primary outcome, OMT 31/59 (53%), control 39/59 (66%).

The trial does not support the use order zithromax online uk of OMT for this indication. See page F591Time to desaturation during endotracheal intubationRadhika Kothari and colleagues measured the time from the last application of positive pressure until desaturation <90% SpO2 in preterm infants<32 weeks’ gestation who were being electively intubated in the neonatal unit with pre-medication. There were 78 infants in the study and 73/78 desaturated to below 90% in a median of 22 s. The infants who order zithromax online uk desaturated to below 80% took a median 35 s to do so.

As these were planned intubations in the neonatal unit, the times taken to desaturate may be longer than they would be for delivery room intubations, where the unrecruited lungs would not provide a reservoir of oxygen pending intubation success. The information may assist with the generation of guidelines. See page F603Parenteral lipid emulsions in the preterm infantLauren Frazer and Camilla Martin review current the current evidence and physiological considerations around how order zithromax online uk to use parenteral lipid emulsions as part of parenteral nutrition for preterm infants. As with so many areas of current practice, the evidence is weak in many areas.

It is order zithromax online uk useful to learn more about the hypothetical risks and benefits of newer preparations and to have knowledge gaps and research priorities identified so clearly. See page F676Treatment thresholds in extremely preterm infants in the UKFollowing the publication in 2019 by the British Association of Perinatal Medicine of professional guidance for the perinatal management of birth before 27 weeks of gestation, Lydia Mietta Di Stefano and colleagues surveyed UK health professionals to determine the lowest gestation at which they would now be willing to offer active treatment to an extremely preterm infant at parental request and the highest gestation at which they would agree to withhold treatment. The majority of respondents were willing to offer active treatment from 22+0 weeks. The highest gestation at which respondents would offer palliative care at parental request was 23+6/24+0 weeks for 59% of those surveyed order zithromax online uk (n=172).

The survey data indicate that there has been a shift in practice in relation to both thresholds since the publication of the guidance. See page F596Ethics statementsPatient consent for publicationNot applicable..

Zithromax online canada

WASHINGTON, DC zithromax online canada – where can i buy zithromax over the counter usa Today, U.S. Secretary of Labor Eugene Scalia zithromax online canada traveled to Johnstown, Pennsylvania, where he joined Congressman John Joyce, M.D. (PA-13) and Congressman Glenn “G.T.” Thompson (PA-15) to highlight workforce development through apprenticeships. Secretary Scalia and the congressmen toured JWF Industries and met with company leadership and apprentices.“I am always encouraged zithromax online canada to see businesses using apprenticeships to equip workers with skills that lead to good paying jobs,” said U.S.

Secretary of Labor Eugene Scalia. €œApprenticeships play a key role in getting Americans back to work zithromax online canada. The President’s actions to expand these programs, along with pro-business policies such as tax cuts, deregulation, and fair and reciprocal trade agreements will bolster our economic recovery. I would like to thank Congressmen Joyce and Thompson for joining me today and being valuable partners in rebuilding Pennsylvania’s economy.” “It was a pleasure to welcome Secretary Scalia to JWF Industries today to showcase a true manufacturing zithromax online canada powerhouse right here in Johnstown," said Congressman Glenn “G.T.” Thompson.

"Workforce development is critically important to the resiliency of our community, our economy, and our national supply chain, and I'm grateful for the role that JWF Industries plays in creating job opportunities in our region.” “It was an honor to welcome Secretary Scalia to Johnstown to witness firsthand the incredible drive and commitment of our workforce. JWF Industries is a shining example of America’s manufacturing excellence,” said Congressman John Joyce, zithromax online canada M.D. €œThe JWF team is part of the long tradition of dedicated Pennsylvanians who have built our nation and forged our defenses. By investing in workers and zithromax online canada creating defense jobs in Johnstown, JWF is producing benefits for our community, our economy, and for our nation.

As he visits Pennsylvania, I thank Secretary Scalia for his partnership and commitment to create American jobs for zithromax online canada American workers.” The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working conditions. Advance opportunities for profitable employment zithromax online canada. And assure work-related benefits and rights.WASHINGTON, DC – Today, U.S.

Secretary of zithromax online canada Labor Eugene Scalia traveled to Mechanicsburg, Pennsylvania, where he visited the Central Pennsylvania Chapter of the Independent Electrical Contractors to meet with apprentices. Earlier in the day, Secretary Scalia joined Congressmen John Joyce, M.D. (PA-13) and Glenn “G.T.” Thompson (PA-15) at JWF Industries in zithromax online canada Johnstown, Pennsylvania, to highlight workforce development and economic recovery.“I was pleased to visit and learn more today about the Independent Electrical Contractors’ work to help men and women develop the skills needed to secure high-paying jobs,” said U.S. Secretary of Labor Eugene Scalia.

€œApprenticeships are a necessary tool to power through our economic recovery and get Americans back to work.” The mission of the Department of Labor is to foster, promote and develop the zithromax online canada welfare of the wage earners, job seekers and retirees of the United States. Improve working conditions. Advance opportunities zithromax online canada for profitable employment. And assure work-related benefits and rights..

WASHINGTON, DC order zithromax online uk http://www.klimaschutzolympiade.at/hallo-welt/ – Today, U.S. Secretary of Labor order zithromax online uk Eugene Scalia traveled to Johnstown, Pennsylvania, where he joined Congressman John Joyce, M.D. (PA-13) and Congressman Glenn “G.T.” Thompson (PA-15) to highlight workforce development through apprenticeships.

Secretary Scalia and the congressmen toured JWF Industries and met with company leadership and apprentices.“I am always encouraged to see businesses order zithromax online uk using apprenticeships to equip workers with skills that lead to good paying jobs,” said U.S. Secretary of Labor Eugene Scalia. €œApprenticeships play a key role in getting Americans order zithromax online uk back to work.

The President’s actions to expand these programs, along with pro-business policies such as tax cuts, deregulation, and fair and reciprocal trade agreements will bolster our economic recovery. I would like to thank Congressmen Joyce and Thompson for joining me today and being valuable partners in rebuilding Pennsylvania’s economy.” “It was a pleasure to welcome Secretary Scalia to JWF Industries today to showcase a true manufacturing powerhouse right here in Johnstown," order zithromax online uk said Congressman Glenn “G.T.” Thompson. "Workforce development is critically important to the resiliency of our community, our economy, and our national supply chain, and I'm grateful for the role that JWF Industries plays in creating job opportunities in our region.” “It was an honor to welcome Secretary Scalia to Johnstown to witness firsthand the incredible drive and commitment of our workforce.

JWF Industries is a shining example of America’s manufacturing excellence,” order zithromax online uk said Congressman John Joyce, M.D. €œThe JWF team is part of the long tradition of dedicated Pennsylvanians who have built our nation and forged our defenses. By investing in workers and creating defense jobs in Johnstown, JWF is producing benefits for our community, our economy, and order zithromax online uk for our nation.

As he order zithromax online uk visits Pennsylvania, I thank Secretary Scalia for his partnership and commitment to create American jobs for American workers.” The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working conditions. Advance opportunities for order zithromax online uk profitable employment.

And assure work-related benefits and rights.WASHINGTON, DC – Today, U.S. Secretary of Labor Eugene Scalia traveled to Mechanicsburg, Pennsylvania, where he visited the Central Pennsylvania Chapter of the Independent order zithromax online uk Electrical Contractors to meet with apprentices. Earlier in the day, Secretary Scalia joined Congressmen John Joyce, M.D.

(PA-13) and Glenn “G.T.” Thompson (PA-15) at JWF Industries in Johnstown, Pennsylvania, to highlight workforce development and economic recovery.“I was pleased to visit and learn more today order zithromax online uk about the Independent Electrical Contractors’ work to help men and women develop the skills needed to secure high-paying jobs,” said U.S. Secretary of Labor Eugene Scalia. €œApprenticeships are a necessary tool to power through our economic recovery and get Americans back to work.” The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States order zithromax online uk.

Improve working conditions. Advance opportunities for profitable order zithromax online uk employment. And assure work-related benefits and rights..