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When a hospitalised patient begins to deteriorate clinically, prompt https://blog.printpapa.com/how-to-buy-cheap-seroquel/ detection and early intervention by trained clinicians seroquel street price is critical for preventing in-hospital cardiac arrest. This is a common event that affects nearly 300 000 patients annually in the USA1 and is associated with a high risk of death and neurological disability among survivors. A broad range of strategies have been proposed for the early detection and management of seroquel street price the deteriorating patient. Early warning systems (EWS) are an example of one strategy.

EWS use clinical prediction models to identify patients who are likely to be deteriorating, with triggers and protocols for detecting and escalating care for such patients.2 3The use of EWS to monitor patients is now seroquel street price widespread, and two papers in this month’s issue of BMJ Quality &. Safety address this topic in different ways. First, Blythe and colleagues conducted a scoping review of real-time automated clinical deterioration alerts, which are part of an EWS, and seroquel street price importantly also sought evidence of their impact on patient outcomes.4 In contrast, Crotty and colleagues reported on implementation of an EWS algorithm and associated virtual nurse monitoring team, and sought to understand nursing perspectives on it using qualitative methods.5The research question for the scoping review asked whether prediction models providing real-time clinical deterioration alerts lead to improved patient outcomes, compared with standard care. The authors followed a rigorous process for selecting studies, extracting data and synthesising the findings of the 18 included studies.

There was heterogeneity in who the alerts were directed to, with some studies sending alerts to nurses in charge, others to seroquel street price a rapid response team, a remote-monitoring nurse, physicians, a bedside nurse or a central nursing station. A range of outcomes were investigated including mortality, in-hospital cardiac or pulmonary arrest, intensive care unit admission and length of stay. Only 5 of the 18 studies used what were deemed robust seroquel street price study designs, and of these, only one reported a statistically significant improvement in patient outcomes. One of the conclusions of this review was that among studies reporting multiple improvements in patient outcomes, the type of EWS was not as important as who the alerts were directed to, and that alerts directed to a dedicated surveillance nurse or the patient’s physician were associated with better outcomes.Crotty and colleagues’ single-site qualitative study investigated EWS from the perspective of bedside nurses.

An EWS had been implemented 1 year previously, supplemented by a centralised team of nurses who virtually monitored seroquel street price alerts and informed nursing staff accordingly. The authors conducted 28 focus groups on six inpatient units, with a total of 227 nursing staff taking part. Units were stratified by alert frequency, ranging from less than 50 alerts per month seroquel street price to over 100 alerts per month. Data were analysed using a grounded theory approach.

Six principal themes emerged seroquel street price. Alert timeliness, lack of accuracy, workflow interruptions, actionability of alerts, underappreciation of core nursing skills and the opportunity cost of deploying the EWS programme.The scoping review was unable to identify a consistent improvement in patient outcomes with an EWS, and the six principal themes noted above offer some possible reasons for why that might be. Another reason seroquel street price might be that we have not paid enough attention to communication among clinicians. Communication is defined as an interpersonal process where shared understanding develops between communicators to generate an effect or action.6 7 Nurses—the 24-hour surveillance system for hospitalised patients—are often the first to detect early signs of patient deterioration.8 9 As suggested by both Blythe and Crotty and their colleagues, the nurse may be aware of the patient’s clinical decline even before the EWS alert.

However, the detection of clinical deterioration must be communicated to others, and this communication can be fraught and/or seroquel street price ineffective.Many factors influence the communication needed to prompt appropriate action. For example, urgency has a major influence on communication but it manifests in different ways, all of which have implications for what gets communicated, to whom and how. First, nurses and physicians may have different perspectives on the same clinical situation that affect their perceptions of what is important or urgent.10 11 Nurses’ sense of urgency is often based on their subjective knowledge of the patient seroquel street price and the context of the situation, whereas for physicians, urgency is often based on objective clinical data.10 11 Second, the experience levels of both nurses and physicians can influence what they perceive to be urgent and worthy of raising the alarm. It is only through experience that clinicians (including both physicians and nurses) learn about the large variation in physiological parameters that constitute ‘normal’ for one patient and severe decline in another.

Third, urgency can be dependent on the relationship between a nurse and seroquel street price a physician. A physician who has a good relationship with a nurse will be more likely to trust that nurse, believe them when they say the situation is urgent and appreciate their core nursing skills. Indeed, this is one of the key findings in the study by Crotty and seroquel street price colleagues. However, the same physician may choose not to respond to another nurse’s message either because their relationship is poor or because they do not know each other at all, with potential implications for patient safety.11 Finally, patient acuity and the number of patients being cared for by a nurse or a physician vary, which can also affect perceptions of urgency.

A hospital nurse usually cares for far fewer patients than a physician seroquel street price. As a result, the sickest patient on the nurse’s panel may not be as sick as the sickest patient on the physician’s panel, so that what is ‘urgent’ becomes relative rather than absolute.Other factors that influence communication include inexperience, and a perceived hierarchy that sometimes places physicians in a ‘superior’ standing relative to nurses. Because of inexperience or fear of speaking up, nurses may have difficulty communicating their concerns (as we have seen in our own work12) using indirect language characterised as ‘hint and hope’13 rather seroquel street price than direct communication.14 15 Nurses’ use of indirect language further suggests uncertainty about next steps, which would influence the actionability of EWS alerts. The use of indirect communication can be confusing to physicians who may also be looking for more objective data.

Communication may be further hampered or rendered ineffective by factors such as limited time, lack of inclination seroquel street price to discuss with others or lack of certainty about the concern, which can lead to poor patient care decisions due to incomplete information.16Finally, any discussion of communication needs to consider the medium used to convey a message. The use of pagers remains prevalent in North American hospitals and the use of other communication technologies continues to grow.17 18 However, there is little evidence that communication technologies facilitate effective communication between health professionals, in part because pagers and other communication technologies that allow information to flow in only one direction are still in use.19 Such technologies do not facilitate communication because they cause unnecessary interruptions, contribute to gaps in information exchange and create workarounds with the potential for adverse events.20All of these issues related to communication have potential to increase conflict between physicians and nurses who prioritise or interpret information differently,11 or disagree on the need for action, such as calling a rapid response team to the bedside.21 22 It’s not just physicians and nurses though. If we want to improve patient outcomes, we must pay attention to dynamics seroquel street price behind professional teams (from all disciplines) working together and acknowledge team dynamics and communication as an integral part of the care delivery process. Unfortunately, effective interventions for improving communication in urgent clinical situations are not yet available, so research in this area is sorely needed.

In summary, technologies such seroquel street price as EWS are useful when considered as adjuncts to the monitoring and surveillance that nurses provide. However, they can never replace nurses or overcome some fundamental interpersonal challenges, such as those affecting clinician communication. We need to talk about communication to bring attention to that critical element, which is responsible for marshalling resources to the bedside when a patient starts to deteriorate.Ethics statementsPatient consent for publicationNot required..

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About This TrackerThis tracker provides current data on the share of seroquel online canada the population having received at least seroquel pregnancy one antidepressant drugs treatment dose by country, income-level, region, and globally. Additionally, this tool estimates future treatment coverage levels if the current rate of first dose administration is maintained going forward and compares these coverage levels to global vaccination targets. These targets include 40% by browse around here the end of 2021 (set by the World Health Organization), 70% by mid-2022 (set seroquel pregnancy by the WHO), and 70% by the United Nations General Assembly in 2022 (set by the U.S.). This tracker will be updated regularly as new data are available.Related Content:.

About This TrackerThis seroquel street price tracker provides current data on the share of the population having received at least one antidepressant drugs treatment dose by country, income-level, region, and globally. Additionally, this tool estimates future treatment coverage levels if the current rate of first dose administration is maintained going forward and compares these coverage levels to global vaccination targets. These targets include 40% by the end of 2021 (set by the World Health Organization), 70% by mid-2022 (set by the WHO), and 70% by the United Nations General Assembly seroquel street price in 2022 (set by the U.S.).

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Start Preamble does seroquel raise blood pressure Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS). Notice. This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act.

The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare &. Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

Meeting Date. Thursday, February 3, 2022 from 12:00 p.m. To 5:00 p.m. Eastern standard time (e.s.t).

Deadline for Meeting Registration, Presentations, Special Accommodations, and Comments. Thursday, January 27, 2022 5:00 p.m. (e.s.t). Meeting Location.

Virtual. All those who RSVP will receive the link to attend. Presentations and Written Comments. Presentations and written comments should be submitted to.

Lisa Carr, Designated Federal Official (DFO), Office of Communications, Centers for Medicare &. Medicaid Services, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov. Registration. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-february-3-2022-virtual-meeting-tickets-212590763697 or by contacting the DFO listed in the FOR FURTHER INFORMATION CONTACT section of this notice, by the date listed in the DATES section of this notice.

Individuals requiring sign language interpretation or other special accommodations should contact the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Start Further Info Lisa Carr, Designated Federal Official, Office of Communications, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov. Additional information about the APOE is available at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​APOE.

Press inquiries are handled through the CMS Press Office at (202) 690-6145. End Further Info End Preamble Start Supplemental Information I. Background and Charter Renewal Information A. Background The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub.

L. 92-463), as amended (5 Start Printed Page 2615 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees. The Panel is authorized by section 1114(f) of the Social Security Act (the Act) (42 U.S.C.

1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a). The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education [] (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare &.

Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub. L. 105-33). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub.

L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. CMS has had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. The successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships.

In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage. In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits. The Patient Protection and Affordable Care Act (Pub.

L. 111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP.

Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace®, or Marketplace® [] ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace®. The APOE (the Panel) allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act. The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub.

L. 111-5). On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2021, and will terminate on January 19, 2023 unless renewed by appropriate action.

B. Charter Renewal In accordance with the January 19, 2021, charter, the APOE will advise the HHS and CMS on developing and implementing education programs that support individuals who are enrolled in or eligible for Medicare, Medicaid, CHIP, or coverage available through the Health Insurance Marketplace® and other CMS programs. The scope of this FACA group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the HITECH Act enacted as part of the ARRA. The charter will terminate on January 19, 2023, unless renewed by appropriate action.

The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The APOE is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

In accordance with the renewed charter, the APOE will advise the Secretary and the CMS Administrator concerning optimal strategies for the following. Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace® and other CMS programs. Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace® consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, partners and stakeholders. Expanding outreach to minority and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, the CHIP and the Health Insurance Marketplace® education programs, and other CMS programs as designated.

Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options. Building and leveraging existing community infrastructures for information, counseling, and assistance. Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act. The current members of the Panel as of September 15, 2021, are as follows.

Julie Carter, Senior Federal Policy Associate, Medicare Rights Center. Scott Ferguson, Director of Care Transitions and Population Health, Mount Sinai St. Luke's Hospital. Jean-Venable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University.

• Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers. Start Printed Page 2616 Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine. Cheri Lattimer, Executive Director, National Transitions of Care Coalition. Cori McMahon, Vice President, Tridiuum.

Alan Meade, Director of Rehabilitation Services, Holston Medical Group. Michael Minor, National Director, H.O.P.E. HHS Partnership, National Baptist Convention USA, Incorporated. Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska.

Morgan Reed, Executive Director, Association for Competitive Technology. Margot Savoy, Senior Vice President, American Academy of Family Physicians. Congresswoman Allyson Schwartz, Senior Advisor, FTI Consulting. Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers.

II. Provisions of This Notice In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the February 3, 2022 meeting will include the following. Welcome and listening session with CMS leadership Recap of the previous (September 15, 2021) meeting CMS programs, initiatives, and priorities An opportunity for public comment Meeting summary, review of recommendations, and next steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. III. Meeting Participation The meeting is open to the public, but attendance is limited to registered participants.

Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-february-3-2022-virtual-meeting-tickets-212590763697 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting. IV.

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. Chapter 35). The Administrator of the Centers for Medicare &.

Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated. January 11, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare &.

Medicaid Services. End Signature End Supplemental Information [FR Doc. 2022-00745 Filed 1-14-22. 8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &.

Medicaid Services (CMS), Department of Health and Human Services (HHS). Updates to and selection of certain codes. This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List of DMEPOS Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements. It also announces the initial selection of HCPCS codes on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and the updates the HCPCS codes on the Required Prior Authorization List.

The implementation is effective on April 13, 2022. Prior authorization will be implemented in 3 incremental phases, with the final phase being national implementation. Phase 1 includes 1 state per jurisdiction and is effective April 13, 2022, Phase 2 includes 4 States per jurisdiction and is effective July 12, 2022, and Phase 3 is nationwide and is effective October 10, 2022. Start Further Info   Susan Billet, (410) 786-1062.

Start Printed Page 2052 Emily Calvert, (410) 786-4277. Stephanie Collins, (410) 786-3100. Jennifer Phillips, (410) 786-1023. Olufemi Shodeke, (410) 786-1649.

End Further Info End Preamble Start Supplemental Information I. Background Sections 1832, 1834, and 1861 of the Social Security Act (the Act) establishes benefits and the provisions of payment for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items under Part B of the Medicare program. Section 1834(a)(1)(E)(iv) of the Act provides conditions of coverage specific to Power Mobility Devices (PMDs). Specifically, it provides that payment may not be made for a covered item consisting of a motorized or power wheelchair unless a physician (as defined in section 1861(r)(1) of the Act), physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS) (as such non-physician practitioners are defined in section 1861(aa)(5) of the Act) has conducted a face-to-face examination of the individual and written a prescription for the item.

Section 1834(a)(11)(B) of the Act requires a physician, PA, NP, or CNS to have a face-to-face encounter with the beneficiary within the 6-month period prior to the written order for certain DMEPOS items (or other reasonable timeframe as determined by the Secretary of the Department of Health and Human Services (the Secretary)). Section 1834(a)(15)(A) of the Act authorizes the Secretary to develop and periodically update a list of DMEPOS items that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization and to develop a prior authorization process for these items. In 2006, we issued Final Rule “Medicare Program. Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles” (71 FR 17021) to implement the requirements for a face-to-face examination and written order prior to delivery for PMDs, in accordance with legislation found in section 302(a)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub.

L. 108-173), as codified in amended section 1834(a)(1)(E)(iv) of the Act. This regulation applied to all power mobility devices—including power wheelchairs and power operated vehicles (hereinafter referred to as PMDs). The requirements for PMDs mandated a 7-element order/prescription for payment.

In the November 16, 2012 Federal Register , we published final rule titled “Medicare Program. Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013” (77 FR 68892) requiring face-to-face encounter and written order prior to delivery for specified DMEPOS items, in accordance with the authorizing legislation found section 6407 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) and amended section 1834(a)(11)(B) of the Act.

The regulation, as codified in 42 CFR 410.38, specified the inclusion criteria for creating a list of DMEPOS items to be subject to face-to-face encounter and written order prior to delivery requirements. It also mandated a 5-element order/prescription for payment of specified DMEPOS items. In the December 30, 2015 Federal Register , we published final rule titled “Medicare Program. Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, and Supplies” (80 FR 81674), in accordance with section 1834(a)(15) of the Act, we established the Master List of Items Frequently Subject to Unnecessary Utilization.

The 2015 Master List included certain DMEPOS items that the Secretary determined, on the basis of prior payment experience, are frequently subject to unnecessary utilization, and created a prior authorization process for these items. On November 8, 2019, we published a final rule titled, “Medicare Program. End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements” (84 FR 60648). The rule became effective January 1, 2020, harmonizing the lists of DMEPOS items created by former rules and establishing one “Master List of DMEPOS Items Potentially Subject to Face-To-Face Encounter and Written Orders Prior to Delivery and/or Prior Authorization Requirements” (the “Master List”).

Items are selected from the Master List for inclusion on the Face-To-Face Encounter and Written Orders Prior to Delivery List and/or Prior Authorization List through the Federal Register. II. Provisions of the Document This document serves to publish three separate lists. First, it provides an update to the Master List of items from which we can select to include on the Required Face to Face Encounter and Written Order Prior to Delivery List, and/or Required Prior Authorization List.

This document also serves to announce the initial selection of items to be included on the Required Face-to-Face Encounter and Written Order Prior to Delivery List. Lastly, it updates the items included on the Required Prior Authorization List. A. Master List of DMEPOS Items Frequently Subject to Unnecessary Utilization The Master List includes items that appear on the DMEPOS Fee Schedule and meet the following criteria, as established in 84 FR 60648.

Have an average purchase fee of $500 or greater that is adjusted annually for inflation, or an average monthly rental fee schedule of $50 or greater that is adjusted annually for inflation, or items identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period, that are also— ++ Identified in a Government Accountability Office (GAO) or Department of Health and Human Services Office of Inspector General (OIG) report that is national in scope and published in 2015 or later as having a high rate of fraud or unnecessary utilization. Or ++ Listed in the 2018 or subsequent year Comprehensive Error Rate Testing (CERT) program's Medicare Fee-for-Service (FFS) Supplemental Improper Payment Data Report as having a high improper payment rate. Any items with at least 1,000 claims and $1 million in payments during a recent 12-month period that are determined to have aberrant billing patterns and lack explanatory contributing factors (for example, new technology or coverage policies that may require time for providers and suppliers to be educated on billing policies). Items with aberrant billing patterns would be identified as those items with payments during a 12-month timeframe that exceed payments made during the preceding 12-months by the greater of— ++ Double the percent change of all DMEPOS claim payments for items that meet the previous claim and payment Start Printed Page 2053 criteria, from the preceding 12-month period.

Or ++ Exceeding a 30 percent increase in payments for the items from the preceding 12-month period. Any items statutorily requiring a face-to-face encounter, a written order prior to delivery, or prior authorization. In the November 2019 final rule noted previously, we described the maintenance process of the Master List as follows. The Master List will be updated annually, and more frequently as needed (for example, to address emerging billing trends), and to reflect the thresholds specified in the regulations.

Items on the DMEPOS Fee Schedule that meet the payment threshold criteria set forth in § 414.234(b)(1) are added to the list when the item is also listed in a CERT, OIG, or GAO report published after 2020, and items not meeting the cost (approximately $500 purchase or $50 rental) thresholds may still be added based on findings of aberrant billing patterns. Items are removed from the Master List 10 years after the date the item was added, unless the item was identified in an OIG report, GAO report, or having been identified in the CERT Medicare Fee for Service Supplemental Improper Payment Data report as having a high improper payment rate, within the 5-year period preceding the anticipated date of expiration. Items are removed from the list sooner than 10 years if the purchase amount drops below the payment threshold. Items already on the Master List that are identified on a subsequent OIG, GAO, or CERT report will remain on the list for 10 years from the publication date of the new report.

Items are updated on the Master List when the Healthcare Common Procedure Coding System (HCPCS) codes representing an item have been discontinued and cross-walked to an equivalent item. • We will notify the public of any additions and deletions from the Master List by posting a notification in the Federal Register and on the CMS Prior Authorization website at https://www.cms.gov/​research-statistics-data-systems/​medicare-fee-service-compliance-programs/​prior-authorization-and-pre-claim-review-initiatives. This document provides the annual update to the Master List of DMEPOS Items Potentially Subjected to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements stated in the November 2019 final rule (84 FR 60648). As noted previously, we adjust the “payment threshold” each year for inflation.

Certain DMEPOS fee schedule amounts are updated for 2021 [] by the percentage increase in the consumer price index for all urban consumers (United States city average) CPI-U for the 12-month period ending June 30, 2020, adjusted by the change in the economy-wide productivity equal to the 10-year moving average of changes in annual economy-wide private non-farm business multi-factor productivity (MFP). The productivity adjustment is 0.4 percent and the CPI-U percentage increase is 0.6 percent. Thus, the 0.6 percentage increase in the CPI-U is reduced by the 0.4 percentage increase in the MFP resulting in a net increase of 0.2 percent for the update factor for CY 2021. For CY 2021, the 0.2 percent update factor was applied to the CY 2020 average price threshold of $500, resulting in a CY 2021 adjusted payment threshold of $501 ($500 × 1.002).

This results in a CY 2021 adjusted purchase price threshold of $501. An update factor of 0.2 percent was applied to the CY 2020 average monthly rental fee of $50, resulting in an adjusted payment threshold of $50.10 ($50 × 1.002). Rounding this figure to the nearest whole dollar amount results in a CY 2021 adjusted monthly rental fee threshold of $50. A total of 31 HCPCS codes (see Table 1) meeting the criteria outlined previously are added to the Master List.

Of these 31 HCPCS codes, 18 are added because these items meet the updated payment threshold and are listed in an OIG or GAO report of a national scope or a CERT DME and DMEPOS Service Specific Report(s) or both, and 13 are added for being identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period. Table 1—Additions to the Master ListHCPCSDescriptionA4352Intermittent Urinary Catheter. Coude (Curved) Tip, With Or Without Coating (Teflon, Silicone, Silicone Elastomeric, Or Hydrophilic, Etc.), Each.A5121Skin Barrier. Solid, 6 x 6 Or Equivalent, Each.A6203Composite Dressing, Sterile, Pad Size 16 Sq.

In. Or Less, With Any Size Adhesive Border, Each Dressing.A6219Gauze, Non-Impregnated, Sterile, Pad Size 16 Sq. In. Or Less, With Any Size Adhesive Border, Each Dressing.A6242Hydrogel Dressing, Wound Cover, Sterile, Pad Size 16 Sq.

In. Or Less, Without Adhesive Border, Each Dressing.A7030Full Face Mask Used With Positive Airway Pressure Device, Each.A7031Face Mask Interface, Replacement For Full Face Mask, Each.E0467Home Ventilator, Multi-Function Respiratory Device, Also Performs Any Or All Of The Additional Functions Of Oxygen Concentration, Drug Nebulization, Aspiration, And Cough Stimulation, Includes All Accessories, Components And Supplies For All Functions.E0565Compressor, Air Power Source For Equipment Which Is Not Self-Contained Or Cylinder Driven.E0650Pneumatic Compressor, Non-Segmental Home Model.E0651Pneumatic Compressor, Segmental Home Model Without Calibrated Gradient Pressure.E0652Pneumatic Compressor, Segmental Home Model With Calibrated Gradient Pressure.E0656Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Trunk.E0657Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Chest.E0670Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Integrated, 2 Full Legs And Trunk.E0675Pneumatic Compression Device, High Pressure, Rapid Inflation/Deflation Cycle, For Arterial Insufficiency (Unilateral Or Bilateral System).E0740Non-Implanted Pelvic Floor Electrical Stimulator, Complete System.E0744Neuromuscular Stimulator For Scoliosis.E0745Neuromuscular Stimulator, Electronic Shock Unit.E0764Functional Neuromuscular Stimulation, Transcutaneous Stimulation Of Sequential Muscle Groups Of Ambulation With Computer Control, Used For Walking By Spinal Cord Injured, Entire System, After Completion Of Training Program.E0766Electrical Stimulation Device Used For Cancer Treatment, Includes All Accessories, Any Type.E1226Wheelchair Accessory, Manual Fully Reclining Back, (Recline Greater Than 80 Degrees), Each.E2202Manual Wheelchair Accessory, Nonstandard Seat Frame Width, 24-27 Inches.E2203Manual Wheelchair Accessory, Nonstandard Seat Frame Depth, 20 To Less Than 22 Inches.E2613Positioning Wheelchair Back Cushion, Posterior, Width Less Than 22 Inches, Any Height, Including Any Type Mounting Hardware.Start Printed Page 2054L0830Halo Procedure, Cervical Halo Incorporated Into Milwaukee Type Orthosis.L1005Tension Based Scoliosis Orthosis And Accessory Pads, Includes Fitting And Adjustment.L1906Ankle Foot Orthosis, Multiligamentous Ankle Support, Prefabricated, Off-The-Shelf.L2580Addition To Lower Extremity, Pelvic Control, Pelvic Sling.L2624Addition To Lower Extremity, Pelvic Control, Hip Joint, Adjustable Flexion, Extension, Abduction Control, Each.L7368Lithium Ion Battery Charger, Replacement Only. The following five HCPCS codes (see Table 2) are removed from the Master List because they no longer have a DMEPOS Fee Schedule price of $501 or greater, or an average monthly rental fee schedule of $50 or greater, and are identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period or both. Table 2—Deletions From the Master ListHCPCSDescriptionA4253Blood Glucose Test or Reagent Strips for Home Blood Glucose Monitor, Per 50 Strips.A4351Intermittent Urinary Catheter.

Straight Tip, With or Without Coating (Teflon, Silicone, Silicone Elastomer, Or Hydrophilic, Etc.), Each.E2369Power Wheelchair Component, Drive Wheel Gear Box, Replacement Only.E2377Power Wheelchair Accessory, Expandable Controller, Including All Related Electronics and Mounting Hardware, Upgrade Provided At Initial Issue.L3761Elbow Orthosis (Eo), With Adjustable Position Locking Joint(S), Prefabricated, Off-The-Shelf. The full updated list is available in the download section of the following CMS website. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​DMEPOS/​Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items. B.

Items Subject to Face-to-Face Encounter and Written Order Prior to Delivery Requirements In the November 2019 final rule, we stated that since the face-to-face encounter and written orders are statutorily required for PMDs, they would be included on the Master List and the Required Face-to-Face Encounter and Written Order Prior to Delivery List in accordance with our statutory obligation, and would remain there. The Required Face-to-Face Encounter and Written Order Prior to Delivery List, as specified in § 410.38(c)(8), is comprised of PMDs and those items selected from the Master List (as described in § 414.234(b)) to require a face-to-face encounter and a written order prior to delivery as a condition of payment. The rule established a process of placing items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List, including that they be communicated to the public and effective no less than 60 days after a Federal Register document publication and CMS website posting. We note that following the publication of the November 2019 final rule (84 FR 60648), the serious public health threats posed by the spread of the 2019 Novel antidepressants (antidepressant drugs) became known, and subsequently the addition of new items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List was placed on hold.

We also note that in an interim final rule with comment period titled “Medicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the antidepressant drugs Public Health Emergency” and published on April 6, 2020 (84 FR 19230), we stated that “to the extent an NCD or LCD (including articles) would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services, those requirements would not apply during the PHE for the antidepressant drugs seroquel.” This language does not apply to the face-to-face encounter and written order prior to delivery requirements stemming from 42 CFR 410.38 and section 1834 of the Act. Therefore, the ongoing direction provided in the April 2020 rule is not affected by this document. The list of DMEPOS items selected and promulgated in this document will require a face-to-face encounter (conducted either via telehealth or in-person), per 42 CFR 410.38, effective after 90 days' notice.

At this time, we believe it appropriate to add a limited list of items that pose a risk to the Medicare Trust Funds, to be subject to additional practitioner oversight via the face-to-face encounter and written order prior to delivery requirements. To assist stakeholders in preparing for implementation of the Required Face-to-Face Encounter and Written Order Prior to Delivery List, we are publishing the proposed code additions and providing 90 days' notice. Per statutory requirements, Table 3 lists DMEPOS HCPCS codes for PMDs. Section 1834(a)(1)(E)(iv) of the Act explicitly requires a face-to-face and written order for PMDs.

Therefore, PMDs require a face-to-face encounter per statute. To reflect this, PMDs will both be placed and will remain on the Required Face-to-Face Encounter and Written Order Prior to Delivery List indefinitely. Section 1834(a)(11)(B) of the Act authorizes the Secretary to select other DMEPOS HCPCS codes that will require a face-to-face encounter and written order prior to delivery as a condition of payment. In addition to PMDs, this Federal Register document announces the addition of seven other DMEPOS HCPCS codes, not required by statute, that are selected from the Master List to be placed on the Required Face-to-Face Encounter and Written Order Prior to Delivery List as listed in Table 4, based on our regulatory authority at 42 CFR 410.38.

Start Printed Page 2055 Table 3—Statutorily Required Power Mobility DevicesHCPCSDescriptionK0800Power Operated Vehicle, Group 1 Standard, Patient Weight Capacity Up To And Including 300 Pounds.K0801Power Operated Vehicle, Group 1 Heavy Duty, Patient Weight Capacity, 301 To 450 Pounds.K0802Power Operated Vehicle, Group 1 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.K0806Power Operated Vehicle, Group 2 Standard, Patient Weight Capacity Up To And Including 300 Pounds.K0807Power Operated Vehicle, Group 2 Heavy Duty, Patient Weight Capacity 301 To 450 Pounds.K0808Power Operated Vehicle, Group 2 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.K0813Power Wheelchair, Group 1 Standard, Portable, Sling/Solid Seat And Back, Patient Weight Capacity Up To And Including 300 Pounds.K0814Power Wheelchair, Group 1 Standard, Portable, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0815Power Wheelchair, Group 1 Standard, Sling/Solid Seat And Back, Patient Weight Capacity Up To And Including 300 Pounds.K0816Power Wheelchair, Group 1 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0820Power Wheelchair, Group 2 Standard, Portable, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0821Power Wheelchair, Group 2 Standard, Portable, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0822Power Wheelchair, Group 2 Standard, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0823Power Wheelchair, Group 2 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0824Power Wheelchair, Group 2 Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0825Power Wheelchair, Group 2 Heavy Duty, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0826Power Wheelchair, Group 2 Very Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0827Power Wheelchair, Group 2 Very Heavy Duty, Captains Chair, Patient Weight Capacity 451 To 600 Pounds.K0828Power Wheelchair, Group 2 Extra Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.K0829Power Wheelchair, Group 2 Extra Heavy Duty, Captains Chair, Patient Weight Capacity 601 Pounds Or More.K0835Power Wheelchair, Group 2 Standard, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0836Power Wheelchair, Group 2 Standard, Single Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0837Power Wheelchair, Group 2 Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0838Power Wheelchair, Group 2 Heavy Duty, Single Power Option, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0839Power Wheelchair, Group 2 Very Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0840Power Wheelchair, Group 2 Extra Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.K0841Power Wheelchair, Group 2 Standard, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0842Power Wheelchair, Group 2 Standard, Multiple Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0843Power Wheelchair, Group 2 Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0848Power Wheelchair, Group 3 Standard, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0849Power Wheelchair, Group 3 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0850Power Wheelchair, Group 3 Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0851Power Wheelchair, Group 3 Heavy Duty, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0852Power Wheelchair, Group 3 Very Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0853Power Wheelchair, Group 3 Very Heavy Duty, Captains Chair, Patient Weight Capacity, 451 To 600 Pounds.K0854Power Wheelchair, Group 3 Extra Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.K0855Power Wheelchair, Group 3 Extra Heavy Duty, Captains Chair, Patient Weight Capacity 601 Pounds Or More.K0856Power Wheelchair, Group 3 Standard, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0857Power Wheelchair, Group 3 Standard, Single Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0858Power Wheelchair, Group 3 Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0859Power Wheelchair, Group 3 Heavy Duty, Single Power Option, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0860Power Wheelchair, Group 3 Very Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0861Power Wheelchair, Group 3 Standard, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0862Power Wheelchair, Group 3 Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0863Power Wheelchair, Group 3 Very Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0864Power Wheelchair, Group 3 Extra Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More. Table 4—Non-Statutorily Required DMEPOS ItemsHCPCSDescriptionE0748Osteogenesis Stimulator, Electrical, Non-Invasive, Spinal Applications.L0648Lumbar-Sacral Orthosis, Sagittal Control, With Rigid Anterior And Posterior Panels, Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Produces Intracavitary Pressure To Reduce Load On The Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L0650Lumbar-Sacral Orthosis, Sagittal-Coronal Control, With Rigid Anterior And Posterior Frame/Panel(S), Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Lateral Strength Provided By Rigid Lateral Frame/Panel(S), Produces Intracavitary Pressure To Reduce Load On Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L1832Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated Item That Has Been Trimmed, Bent, Molded, Assembled, Or Otherwise Customized To Fit A Specific Patient By An Individual With Expertise.L1833Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated, Off-The Shelf.L1851Knee Orthosis (KO), Single Upright, Thigh And Calf, With Adjustable Flexion And Extension Joint (Unicentric Or Polycentric), Medial-Lateral And Rotation Control, With Or Without Varus/Valgus Adjustment, Prefabricated, Off-The-Shelf.L3960Shoulder Elbow Wrist Hand Orthosis, Abduction Positioning, Airplane Design, Prefabricated, Includes Fitting And Adjustment. As previously stated, PMDs are included on the Required Face-to-Face Encounter and Written Order Prior to Delivery List per statutory obligation. For the other DMEPOS items, we considered factors such as operational limitations, item utilization, acute needs, seroquel impacts, cost-benefit analysis (for example, comparing the cost of review versus the anticipated amount of improper payment identified), emerging trends (for example, billing patterns, medical review findings), vulnerabilities identified in official agency reports, or other analysis.

In selecting these items, we must balance our program integrity goals with the needs of patients, particularly those in need of medical devices to assist with functional activities and ambulation within their home. In other words, we must ensure the appropriate application and oversight of the face-to-face encounter requirements. In consideration of access issues, we note that the regulation 42 CFR 410.38 allows Start Printed Page 2056 for use of telehealth, as defined in 42 CFR 410.78 and 414.65, when appropriate to meet our coverage requirements for beneficiaries. We also believe transparency and education will aid in compliance with these payment requirements and continued access.

As such, we will make information widely available to the public at appropriate literacy levels regarding face-to-face encounter requirements, prior authorization, and necessary documentation for items on Required Face-to-Face Encounter and Written Order Prior to Delivery and Prior Authorization Lists. We believe additional practitioner oversight of beneficiaries in need of items represented by these HCPCS codes will help further our program integrity goals of reducing fraud, waste, and abuse. It will also help ensure beneficiary receipt of items specific to their medical needs. For items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List (Tables 3 and 4), the written order/prescription must be communicated to the supplier prior to delivery.

For such items, we require the treating practitioner to have a face-to-face encounter with the beneficiary within the 6 months preceding the date of the written order/prescription. If the face-to-face encounter is a telehealth encounter, the requirements of 42 CFR 410.78 and 414.65 must be met for DMEPOS coverage purposes. Consistent with § 410.38(d), the face-to-face encounter must be documented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, progress notes, treatment plans or other sources of information that may be appropriate). The supporting documentation must include subjective and objective beneficiary specific information used for diagnosing, treating, or managing a clinical condition for which the DMEPOS item(s) is ordered.

Upon request by CMS or its review contractors, a supplier must submit additional documentation to support and substantiate the medical necessity for the DMEPOS item or both. The Required Face-to-Face Encounter and Written Order Prior to Delivery List is available on the following CMS website. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​Medical-Review/​FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment. C.

Items Subject to Prior Authorization Requirements The November 8, 2019 final rule (84 FR 60648) maintained the process established in the December 30, 2015 final rule (80 FR 81674) that when items are placed on the Required Prior Authorization List, we would inform the public of those DMEPOS items on the Required Prior Authorization List in the Federal Register with no less than 60 days' notice before implementation, and post notification on the CMS website. The Required Prior Authorization List specified in §  414.234(c)(1) is selected from the Master List (as described in §  414.234(b)), and those selected items require prior authorization as a condition of payment. Additionally, § 414.234 (c)(1)(ii) states that CMS may elect to limit the prior authorization requirement to a particular region of the country if claims data analysis shows that unnecessary utilization of the selected item(s) is concentrated in a particular region. The purpose of this document is to inform the public that we are updating the Required Prior Authorization List to include six additional Power Mobility Devices (PMDs) and five additional Orthoses HCPCS codes.

To assist stakeholders in preparing for implementation of the prior authorization program, we are providing 90 days' notice. The following six HCPCS codes for PMDs and five HCPCS codes for Orthoses are added to the Required Prior Authorization List. Table 5—Additions to the Required Prior Authorization ListHCPCSDescriptionK0800Power operated vehicle, group 1 standard, patient weight capacity up to and including 300 pounds.K0801Power Operated Vehicle, Group 1 Heavy Duty, Patient Weight Capacity, 301 To 450 Pounds.K0802Power Operated Vehicle, Group 1 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.K0806Power Operated Vehicle, Group 2 Standard, Patient Weight Capacity Up To And Including 300 Pounds.K0807Power Operated Vehicle, Group 2 Heavy Duty, Patient Weight Capacity 301 To 450 Pounds.K0808Power Operated Vehicle, Group 2 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.L0648Lumbar-Sacral Orthosis, Sagittal Control, With Rigid Anterior And Posterior Panels, Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Produces Intracavitary Pressure To Reduce Load On The Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L0650Lumbar-Sacral Orthosis, Sagittal-Coronal Control, With Rigid Anterior And Posterior Frame/Panel(S), Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Lateral Strength Provided By Rigid Lateral Frame/Panel(S), Produces Intracavitary Pressure To Reduce Load On Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L1832Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated Item That Has Been Trimmed, Bent, Molded, Assembled, Or Otherwise Customized To Fit A Specific Patient By An Individual With Expertise.L1833Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated, Off-The Shelf.L1851Knee Orthosis (Ko), Single Upright, Thigh And Calf, With Adjustable Flexion And Extension Joint (Unicentric Or Polycentric), Medial-Lateral And Rotation Control, With Or Without Varus/Valgus Adjustment, Prefabricated, Off-The-Shelf. We believe prior authorization of these six additional HCPCS codes for PMDs and five HCPCS codes for Orthoses will help further our program integrity goals of reducing fraud, waste, and abuse, while also protecting access to care.

For PMDs, the OIG has previously reported that Medicare has inappropriately paid for items that did not meet certain Medicare requirements.[] Lower limb orthoses (LLO) and lumbar-sacral orthoses (LSO) have been identified by CMS' Comprehensive Error Rate Testing (CERT) program as two of the top 20 DMEPOS service types with improper payments over the past several years. Since 2016, LLOs have had an improper payment rate above 60 percent, with projected improper payments ranging between $235 and $501 million. Similarly, LSOs have had an improper payment rate above 32 percent, with projected improper payments ranging between $116 and $177 million, since 2016. Additionally, in 2019, the Department of Justice (DOJ) announced Start Printed Page 2057 federal indictments and law enforcement actions stemming from fraudulent claims submitted for medically unnecessary back, shoulder, wrist, and knee braces[] Administrative actions were taken against 130 DMEPOS companies that were enticing Medicare beneficiaries with offers of low or no-cost orthotic braces.

The investigation found that some DME companies and licensed medical professionals allegedly participated in health care fraud schemes involving more than $1.2 billion in loss.[] These codes will be subject to the requirements of the prior authorization program for certain DMEPOS items as outlined in § 414.234. We will implement a prior authorization program for the six newly added codes for PMDs nationwide and five newly added codes for Orthoses in 3 phases. This phased-in approach will allow us to identify and resolve any unforeseen issues by using a smaller claim volume in phase one before implementing phases 2 and 3. State selection for the three phases was completed based on utilization data for the items selected.

• For phase 1, which begins on the date specified in the DATES section, we selected the State in each DME MAC jurisdiction with the highest utilization. New York, Illinois, Florida, and California. • For phase 2, which begins on the date specified in the DATES section of this document, we selected the next three States with the highest utilization in each DME MAC jurisdiction. Maryland, Pennsylvania, New Jersey, Michigan, Ohio, Kentucky, Texas, North Carolina, Georgia, Missouri, Arizona, and Washington.

• For phase 3, which begins on the date specified in the DATES section of this document, prior authorization expands to all remaining States and territories not captured in phases 1 and 2. The prior authorization program for the 51 codes currently subject to the DMEPOS prior authorization requirement will continue uninterrupted. Prior to providing an item on the Required Prior Authorization List to the beneficiary and submitting the claim for processing, a requester must submit a prior authorization request. The request must include evidence that the item complies with all applicable Medicare coverage, coding, and payment rules.

Consistent with § 414.234(d), such evidence must include the written order/prescription, relevant information from the beneficiary's medical record, and relevant supplier-produced documentation. After receipt of all applicable required Medicare documentation, CMS or one of its review contractors will conduct a medical review and communicate a decision that provisionally affirms or non-affirms the request. We will issue specific prior authorization guidance for these additional items in subregulatory communications, including final timelines customized for the DMEPOS item subject to prior authorization, for communicating a provisionally affirmed or non-affirmed decision to the requester. In the December 30, 2015 final rule (80 FR 81674) we stated that this approach to final timelines provides flexibility to develop a process that involves fewer days, as may be appropriate, and allows us to safeguard beneficiary access to care.

If at any time we become aware that the prior authorization process is creating barriers to care, we can suspend the program. For example, we will review questions and complaints from consumers and providers that come through regular sources such as 1-800-Medicare. The updated Required Prior Authorization List is available in the download section of the following CMS website. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​DMEPOS/​Downloads/​DMEPOS_​PA_​Required-Prior-Authorization-List.pdf.

III. Collection of Information Requirements This document provides updates to the Master List and announces the selection of HCPCS codes to be placed on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and Required Prior Authorization List. Additionally, this document announces the continuation of prior authorization for 51 HCPCS codes, and the addition of six HCPCS codes for PMDs and five HCPCS codes for Orthoses on the Required Prior Authorization List. There is an information collection burden associated with this program that is currently approved under OMB control number 0938-1293, which expires March 31, 2022.

This package accounts for burdens associated with the addition of items to the Required Prior Authorization Lists and assumes a burden for 2021 of approximately $10 million for providers to comply with the required information collection. We will reassess this burden soon and will seek comment on our assessment in a Federal Register notice as required under the Paperwork Reduction Act of 1995. IV. Regulatory Impact Statement We have examined the impact of this regulatory document 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 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). 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).

This regulatory document is not significant and does not reach the economic threshold and thus is not considered a major regulatory document. Per our analysis, the additional items being added to the prior authorization program (excluding PMDs) [] have an estimated net savings of $14.8 million. Gross savings is based upon a 10 percent reduction in the total amount paid for claims in Calendar Year 2019. We deducted from the gross savings the anticipated cost for performing the prior authorization reviews in order to estimate the net savings.

Our gross savings estimate of 10 percent is based on previous results from other prior authorization programs, Start Printed Page 2058 including prior authorization of other DMEPOS items. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $8.0 million to $41.5 million in any 1 year.

Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this regulatory document will not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare an RIA 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 604 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 for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this regulatory document will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 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 2021, that threshold is approximately $158 million.

This regulatory document will have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule or other regulatory document) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulatory document does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this document was reviewed by the Office of Management and Budget.

The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated. January 10, 2022.

Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services. End Signature End Supplemental Information [FR Doc. 2022-00572 Filed 1-12-22.

Start Preamble seroquel street price Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS). Notice. This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S.

Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare &. Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace®, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public. Meeting Date. Thursday, February 3, 2022 from 12:00 p.m.

To 5:00 p.m. Eastern standard time (e.s.t). Deadline for Meeting Registration, Presentations, Special Accommodations, and Comments. Thursday, January 27, 2022 5:00 p.m. (e.s.t).

Meeting Location. Virtual. All those who RSVP will receive the link to attend. Presentations and Written Comments. Presentations and written comments should be submitted to.

Lisa Carr, Designated Federal Official (DFO), Office of Communications, Centers for Medicare &. Medicaid Services, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov. Registration. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-february-3-2022-virtual-meeting-tickets-212590763697 or by contacting the DFO listed in the FOR FURTHER INFORMATION CONTACT section of this notice, by the date listed in the DATES section of this notice. Individuals requiring sign language interpretation or other special accommodations should contact the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

Start Further Info Lisa Carr, Designated Federal Official, Office of Communications, 200 Independence Avenue SW, Mailstop 325G HHH, Washington, DC 20201, 202-690-5742, or via email at APOE@cms.hhs.gov. Additional information about the APOE is available at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​APOE. Press inquiries are handled through the CMS Press Office at (202) 690-6145. End Further Info End Preamble Start Supplemental Information I.

Background and Charter Renewal Information A. Background The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 Start Printed Page 2615 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees.

The Panel is authorized by section 1114(f) of the Social Security Act (the Act) (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a). The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education [] (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare &.

Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub. L. 105-33). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L.

108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. CMS has had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. The successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships. In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage.

In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits. The Patient Protection and Affordable Care Act (Pub. L. 111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L.

111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP. Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace®, or Marketplace® [] ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace®. The APOE (the Panel) allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act. The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub.

L. 111-5). On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2021, and will terminate on January 19, 2023 unless renewed by appropriate action. B.

Charter Renewal In accordance with the January 19, 2021, charter, the APOE will advise the HHS and CMS on developing and implementing education programs that support individuals who are enrolled in or eligible for Medicare, Medicaid, CHIP, or coverage available through the Health Insurance Marketplace® and other CMS programs. The scope of this FACA group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the HITECH Act enacted as part of the ARRA. The charter will terminate on January 19, 2023, unless renewed by appropriate action. The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended.

The APOE is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. In accordance with the renewed charter, the APOE will advise the Secretary and the CMS Administrator concerning optimal strategies for the following. Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace® and other CMS programs. Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace® consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, partners and stakeholders.

Expanding outreach to minority and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, the CHIP and the Health Insurance Marketplace® education programs, and other CMS programs as designated. Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options. Building and leveraging existing community infrastructures for information, counseling, and assistance. Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act. The current members of the Panel as of September 15, 2021, are as follows.

Julie Carter, Senior Federal Policy Associate, Medicare Rights Center. Scott Ferguson, Director of Care Transitions and Population Health, Mount Sinai St. Luke's Hospital. Jean-Venable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University. • Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers.

Start Printed Page 2616 Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine. Cheri Lattimer, Executive Director, National Transitions of Care Coalition. Cori McMahon, Vice President, Tridiuum. Alan Meade, Director of Rehabilitation Services, Holston Medical Group. Michael Minor, National Director, H.O.P.E.

HHS Partnership, National Baptist Convention USA, Incorporated. Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska. Morgan Reed, Executive Director, Association for Competitive Technology. Margot Savoy, Senior Vice President, American Academy of Family Physicians. Congresswoman Allyson Schwartz, Senior Advisor, FTI Consulting.

Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers. II. Provisions of This Notice In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the February 3, 2022 meeting will include the following. Welcome and listening session with CMS leadership Recap of the previous (September 15, 2021) meeting CMS programs, initiatives, and priorities An opportunity for public comment Meeting summary, review of recommendations, and next steps Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. III. Meeting Participation The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/​e/​apoe-february-3-2022-virtual-meeting-tickets-212590763697 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice.

This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting. IV. 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.

Chapter 35). The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated. January 11, 2022.

Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services. End Signature End Supplemental Information [FR Doc. 2022-00745 Filed 1-14-22. 8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &.

Medicaid Services (CMS), Department of Health and Human Services (HHS). Updates to and selection of certain codes. This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List of DMEPOS Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements. It also announces the initial selection of HCPCS codes on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and the updates the HCPCS codes on the Required Prior Authorization List. The implementation is effective on April 13, 2022.

Prior authorization will be implemented in 3 incremental phases, with the final phase being national implementation. Phase 1 includes 1 state per jurisdiction and is effective April 13, 2022, Phase 2 includes 4 States per jurisdiction and is effective July 12, 2022, and Phase 3 is nationwide and is effective October 10, 2022. Start Further Info   Susan Billet, (410) 786-1062. Start Printed Page 2052 Emily Calvert, (410) 786-4277. Stephanie Collins, (410) 786-3100.

Jennifer Phillips, (410) 786-1023. Olufemi Shodeke, (410) 786-1649. End Further Info End Preamble Start Supplemental Information I. Background Sections 1832, 1834, and 1861 of the Social Security Act (the Act) establishes benefits and the provisions of payment for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items under Part B of the Medicare program. Section 1834(a)(1)(E)(iv) of the Act provides conditions of coverage specific to Power Mobility Devices (PMDs).

Specifically, it provides that payment may not be made for a covered item consisting of a motorized or power wheelchair unless a physician (as defined in section 1861(r)(1) of the Act), physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS) (as such non-physician practitioners are defined in section 1861(aa)(5) of the Act) has conducted a face-to-face examination of the individual and written a prescription for the item. Section 1834(a)(11)(B) of the Act requires a physician, PA, NP, or CNS to have a face-to-face encounter with the beneficiary within the 6-month period prior to the written order for certain DMEPOS items (or other reasonable timeframe as determined by the Secretary of the Department of Health and Human Services (the Secretary)). Section 1834(a)(15)(A) of the Act authorizes the Secretary to develop and periodically update a list of DMEPOS items that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization and to develop a prior authorization process for these items. In 2006, we issued Final Rule “Medicare Program. Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles” (71 FR 17021) to implement the requirements for a face-to-face examination and written order prior to delivery for PMDs, in accordance with legislation found in section 302(a)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub.

L. 108-173), as codified in amended section 1834(a)(1)(E)(iv) of the Act. This regulation applied to all power mobility devices—including power wheelchairs and power operated vehicles (hereinafter referred to as PMDs). The requirements for PMDs mandated a 7-element order/prescription for payment. In the November 16, 2012 Federal Register , we published final rule titled “Medicare Program.

Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013” (77 FR 68892) requiring face-to-face encounter and written order prior to delivery for specified DMEPOS items, in accordance with the authorizing legislation found section 6407 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) and amended section 1834(a)(11)(B) of the Act. The regulation, as codified in 42 CFR 410.38, specified the inclusion criteria for creating a list of DMEPOS items to be subject to face-to-face encounter and written order prior to delivery requirements. It also mandated a 5-element order/prescription for payment of specified DMEPOS items.

In the December 30, 2015 Federal Register , we published final rule titled “Medicare Program. Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, and Supplies” (80 FR 81674), in accordance with section 1834(a)(15) of the Act, we established the Master List of Items Frequently Subject to Unnecessary Utilization. The 2015 Master List included certain DMEPOS items that the Secretary determined, on the basis of prior payment experience, are frequently subject to unnecessary utilization, and created a prior authorization process for these items. On November 8, 2019, we published a final rule titled, “Medicare Program. End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements” (84 FR 60648).

The rule became effective January 1, 2020, harmonizing the lists of DMEPOS items created by former rules and establishing one “Master List of DMEPOS Items Potentially Subject to Face-To-Face Encounter and Written Orders Prior to Delivery and/or Prior Authorization Requirements” (the “Master List”). Items are selected from the Master List for inclusion on the Face-To-Face Encounter and Written Orders Prior to Delivery List and/or Prior Authorization List through the Federal Register. II. Provisions of the Document This document serves to publish three separate lists. First, it provides an update to the Master List of items from which we can select to include on the Required Face to Face Encounter and Written Order Prior to Delivery List, and/or Required Prior Authorization List.

This document also serves to announce the initial selection of items to be included on the Required Face-to-Face Encounter and Written Order Prior to Delivery List. Lastly, it updates the items included on the Required Prior Authorization List. A. Master List of DMEPOS Items Frequently Subject to Unnecessary Utilization The Master List includes items that appear on the DMEPOS Fee Schedule and meet the following criteria, as established in 84 FR 60648. Have an average purchase fee of $500 or greater that is adjusted annually for inflation, or an average monthly rental fee schedule of $50 or greater that is adjusted annually for inflation, or items identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period, that are also— ++ Identified in a Government Accountability Office (GAO) or Department of Health and Human Services Office of Inspector General (OIG) report that is national in scope and published in 2015 or later as having a high rate of fraud or unnecessary utilization.

Or ++ Listed in the 2018 or subsequent year Comprehensive Error Rate Testing (CERT) program's Medicare Fee-for-Service (FFS) Supplemental Improper Payment Data Report as having a high improper payment rate. Any items with at least 1,000 claims and $1 million in payments during a recent 12-month period that are determined to have aberrant billing patterns and lack explanatory contributing factors (for example, new technology or coverage policies that may require time for providers and suppliers to be educated on billing policies). Items with aberrant billing patterns would be identified as those items with payments during a 12-month timeframe that exceed payments made during the preceding 12-months by the greater of— ++ Double the percent change of all DMEPOS claim payments for items that meet the previous claim and payment Start Printed Page 2053 criteria, from the preceding 12-month period. Or ++ Exceeding a 30 percent increase in payments for the items from the preceding 12-month period. Any items statutorily requiring a face-to-face encounter, a written order prior to delivery, or prior authorization.

In the November 2019 final rule noted previously, we described the maintenance process of the Master List as follows. The Master List will be updated annually, and more frequently as needed (for example, to address emerging billing trends), and to reflect the thresholds specified in the regulations. Items on the DMEPOS Fee Schedule that meet the payment threshold criteria set forth in § 414.234(b)(1) are added to the list when the item is also listed in a CERT, OIG, or GAO report published after 2020, and items not meeting the cost (approximately $500 purchase or $50 rental) thresholds may still be added based on findings of aberrant billing patterns. Items are removed from the Master List 10 years after the date the item was added, unless the item was identified in an OIG report, GAO report, or having been identified in the CERT Medicare Fee for Service Supplemental Improper Payment Data report as having a high improper payment rate, within the 5-year period preceding the anticipated date of expiration. Items are removed from the list sooner than 10 years if the purchase amount drops below the payment threshold.

Items already on the Master List that are identified on a subsequent OIG, GAO, or CERT report will remain on the list for 10 years from the publication date of the new report. Items are updated on the Master List when the Healthcare Common Procedure Coding System (HCPCS) codes representing an item have been discontinued and cross-walked to an equivalent item. • We will notify the public of any additions and deletions from the Master List by posting a notification in the Federal Register and on the CMS Prior Authorization website at https://www.cms.gov/​research-statistics-data-systems/​medicare-fee-service-compliance-programs/​prior-authorization-and-pre-claim-review-initiatives. This document provides the annual update to the Master List of DMEPOS Items Potentially Subjected to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements stated in the November 2019 final rule (84 FR 60648). As noted previously, we adjust the “payment threshold” each year for inflation.

Certain DMEPOS fee schedule amounts are updated for 2021 [] by the percentage increase in the consumer price index for all urban consumers (United States city average) CPI-U for the 12-month period ending June 30, 2020, adjusted by the change in the economy-wide productivity equal to the 10-year moving average of changes in annual economy-wide private non-farm business multi-factor productivity (MFP). The productivity adjustment is 0.4 percent and the CPI-U percentage increase is 0.6 percent. Thus, the 0.6 percentage increase in the CPI-U is reduced by the 0.4 percentage increase in the MFP resulting in a net increase of 0.2 percent for the update factor for CY 2021. For CY 2021, the 0.2 percent update factor was applied to the CY 2020 average price threshold of $500, resulting in a CY 2021 adjusted payment threshold of $501 ($500 × 1.002). This results in a CY 2021 adjusted purchase price threshold of $501.

An update factor of 0.2 percent was applied to the CY 2020 average monthly rental fee of $50, resulting in an adjusted payment threshold of $50.10 ($50 × 1.002). Rounding this figure to the nearest whole dollar amount results in a CY 2021 adjusted monthly rental fee threshold of $50. A total of 31 HCPCS codes (see Table 1) meeting the criteria outlined previously are added to the Master List. Of these 31 HCPCS codes, 18 are added because these items meet the updated payment threshold and are listed in an OIG or GAO report of a national scope or a CERT DME and DMEPOS Service Specific Report(s) or both, and 13 are added for being identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period. Table 1—Additions to the Master ListHCPCSDescriptionA4352Intermittent Urinary Catheter.

Coude (Curved) Tip, With Or Without Coating (Teflon, Silicone, Silicone Elastomeric, Or Hydrophilic, Etc.), Each.A5121Skin Barrier. Solid, 6 x 6 Or Equivalent, Each.A6203Composite Dressing, Sterile, Pad Size 16 Sq. In. Or Less, With Any Size Adhesive Border, Each Dressing.A6219Gauze, Non-Impregnated, Sterile, Pad Size 16 Sq. In.

Or Less, With Any Size Adhesive Border, Each Dressing.A6242Hydrogel Dressing, Wound Cover, Sterile, Pad Size 16 Sq. In. Or Less, Without Adhesive Border, Each Dressing.A7030Full Face Mask Used With Positive Airway Pressure Device, Each.A7031Face Mask Interface, Replacement For Full Face Mask, Each.E0467Home Ventilator, Multi-Function Respiratory Device, Also Performs Any Or All Of The Additional Functions Of Oxygen Concentration, Drug Nebulization, Aspiration, And Cough Stimulation, Includes All Accessories, Components And Supplies For All Functions.E0565Compressor, Air Power Source For Equipment Which Is Not Self-Contained Or Cylinder Driven.E0650Pneumatic Compressor, Non-Segmental Home Model.E0651Pneumatic Compressor, Segmental Home Model Without Calibrated Gradient Pressure.E0652Pneumatic Compressor, Segmental Home Model With Calibrated Gradient Pressure.E0656Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Trunk.E0657Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Chest.E0670Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Integrated, 2 Full Legs And Trunk.E0675Pneumatic Compression Device, High Pressure, Rapid Inflation/Deflation Cycle, For Arterial Insufficiency (Unilateral Or Bilateral System).E0740Non-Implanted Pelvic Floor Electrical Stimulator, Complete System.E0744Neuromuscular Stimulator For Scoliosis.E0745Neuromuscular Stimulator, Electronic Shock Unit.E0764Functional Neuromuscular Stimulation, Transcutaneous Stimulation Of Sequential Muscle Groups Of Ambulation With Computer Control, Used For Walking By Spinal Cord Injured, Entire System, After Completion Of Training Program.E0766Electrical Stimulation Device Used For Cancer Treatment, Includes All Accessories, Any Type.E1226Wheelchair Accessory, Manual Fully Reclining Back, (Recline Greater Than 80 Degrees), Each.E2202Manual Wheelchair Accessory, Nonstandard Seat Frame Width, 24-27 Inches.E2203Manual Wheelchair Accessory, Nonstandard Seat Frame Depth, 20 To Less Than 22 Inches.E2613Positioning Wheelchair Back Cushion, Posterior, Width Less Than 22 Inches, Any Height, Including Any Type Mounting Hardware.Start Printed Page 2054L0830Halo Procedure, Cervical Halo Incorporated Into Milwaukee Type Orthosis.L1005Tension Based Scoliosis Orthosis And Accessory Pads, Includes Fitting And Adjustment.L1906Ankle Foot Orthosis, Multiligamentous Ankle Support, Prefabricated, Off-The-Shelf.L2580Addition To Lower Extremity, Pelvic Control, Pelvic Sling.L2624Addition To Lower Extremity, Pelvic Control, Hip Joint, Adjustable Flexion, Extension, Abduction Control, Each.L7368Lithium Ion Battery Charger, Replacement Only. The following five HCPCS codes (see Table 2) are removed from the Master List because they no longer have a DMEPOS Fee Schedule price of $501 or greater, or an average monthly rental fee schedule of $50 or greater, and are identified as accounting for at least 1.5 percent of Medicare expenditures for all DMEPOS items over a recent 12-month period or both. Table 2—Deletions From the Master ListHCPCSDescriptionA4253Blood Glucose Test or Reagent Strips for Home Blood Glucose Monitor, Per 50 Strips.A4351Intermittent Urinary Catheter.

Straight Tip, With or Without Coating (Teflon, Silicone, Silicone Elastomer, Or Hydrophilic, Etc.), Each.E2369Power Wheelchair Component, Drive Wheel Gear Box, Replacement Only.E2377Power Wheelchair Accessory, Expandable Controller, Including All Related Electronics and Mounting Hardware, Upgrade Provided At Initial Issue.L3761Elbow Orthosis (Eo), With Adjustable Position Locking Joint(S), Prefabricated, Off-The-Shelf. The full updated list is available in the download section of the following CMS website. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​DMEPOS/​Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items. B. Items Subject to Face-to-Face Encounter and Written Order Prior to Delivery Requirements In the November 2019 final rule, we stated that since the face-to-face encounter and written orders are statutorily required for PMDs, they would be included on the Master List and the Required Face-to-Face Encounter and Written Order Prior to Delivery List in accordance with our statutory obligation, and would remain there.

The Required Face-to-Face Encounter and Written Order Prior to Delivery List, as specified in § 410.38(c)(8), is comprised of PMDs and those items selected from the Master List (as described in § 414.234(b)) to require a face-to-face encounter and a written order prior to delivery as a condition of payment. The rule established a process of placing items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List, including that they be communicated to the public and effective no less than 60 days after a Federal Register document publication and CMS website posting. We note that following the publication of the November 2019 final rule (84 FR 60648), the serious public health threats posed by the spread of the 2019 Novel antidepressants (antidepressant drugs) became known, and subsequently the addition of new items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List was placed on hold. We also note that in an interim final rule with comment period titled “Medicare and Medicaid Programs. Policy and Regulatory Revisions in Response to the antidepressant drugs Public Health Emergency” and published on April 6, 2020 (84 FR 19230), we stated that “to the extent an NCD or LCD (including articles) would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services, those requirements would not apply during the PHE for the antidepressant drugs seroquel.” This language does not apply to the face-to-face encounter and written order prior to delivery requirements stemming from 42 CFR 410.38 and section 1834 of the Act.

Therefore, the ongoing direction provided in the April 2020 rule is not affected by this document. The list of DMEPOS items selected and promulgated in this document will require a face-to-face encounter (conducted either via telehealth or in-person), per 42 CFR 410.38, effective after 90 days' notice. At this time, we believe it appropriate to add a limited list of items that pose a risk to the Medicare Trust Funds, to be subject to additional practitioner oversight via the face-to-face encounter and written order prior to delivery requirements. To assist stakeholders in preparing for implementation of the Required Face-to-Face Encounter and Written Order Prior to Delivery List, we are publishing the proposed code additions and providing 90 days' notice. Per statutory requirements, Table 3 lists DMEPOS HCPCS codes for PMDs.

Section 1834(a)(1)(E)(iv) of the Act explicitly requires a face-to-face and written order for PMDs. Therefore, PMDs require a face-to-face encounter per statute. To reflect this, PMDs will both be placed and will remain on the Required Face-to-Face Encounter and Written Order Prior to Delivery List indefinitely. Section 1834(a)(11)(B) of the Act authorizes the Secretary to select other DMEPOS HCPCS codes that will require a face-to-face encounter and written order prior to delivery as a condition of payment. In addition to PMDs, this Federal Register document announces the addition of seven other DMEPOS HCPCS codes, not required by statute, that are selected from the Master List to be placed on the Required Face-to-Face Encounter and Written Order Prior to Delivery List as listed in Table 4, based on our regulatory authority at 42 CFR 410.38.

Start Printed Page 2055 Table 3—Statutorily Required Power Mobility DevicesHCPCSDescriptionK0800Power Operated Vehicle, Group 1 Standard, Patient Weight Capacity Up To And Including 300 Pounds.K0801Power Operated Vehicle, Group 1 Heavy Duty, Patient Weight Capacity, 301 To 450 Pounds.K0802Power Operated Vehicle, Group 1 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.K0806Power Operated Vehicle, Group 2 Standard, Patient Weight Capacity Up To And Including 300 Pounds.K0807Power Operated Vehicle, Group 2 Heavy Duty, Patient Weight Capacity 301 To 450 Pounds.K0808Power Operated Vehicle, Group 2 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.K0813Power Wheelchair, Group 1 Standard, Portable, Sling/Solid Seat And Back, Patient Weight Capacity Up To And Including 300 Pounds.K0814Power Wheelchair, Group 1 Standard, Portable, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0815Power Wheelchair, Group 1 Standard, Sling/Solid Seat And Back, Patient Weight Capacity Up To And Including 300 Pounds.K0816Power Wheelchair, Group 1 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0820Power Wheelchair, Group 2 Standard, Portable, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0821Power Wheelchair, Group 2 Standard, Portable, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0822Power Wheelchair, Group 2 Standard, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0823Power Wheelchair, Group 2 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0824Power Wheelchair, Group 2 Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0825Power Wheelchair, Group 2 Heavy Duty, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0826Power Wheelchair, Group 2 Very Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0827Power Wheelchair, Group 2 Very Heavy Duty, Captains Chair, Patient Weight Capacity 451 To 600 Pounds.K0828Power Wheelchair, Group 2 Extra Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.K0829Power Wheelchair, Group 2 Extra Heavy Duty, Captains Chair, Patient Weight Capacity 601 Pounds Or More.K0835Power Wheelchair, Group 2 Standard, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0836Power Wheelchair, Group 2 Standard, Single Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0837Power Wheelchair, Group 2 Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0838Power Wheelchair, Group 2 Heavy Duty, Single Power Option, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0839Power Wheelchair, Group 2 Very Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0840Power Wheelchair, Group 2 Extra Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.K0841Power Wheelchair, Group 2 Standard, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0842Power Wheelchair, Group 2 Standard, Multiple Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0843Power Wheelchair, Group 2 Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0848Power Wheelchair, Group 3 Standard, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0849Power Wheelchair, Group 3 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0850Power Wheelchair, Group 3 Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0851Power Wheelchair, Group 3 Heavy Duty, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0852Power Wheelchair, Group 3 Very Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0853Power Wheelchair, Group 3 Very Heavy Duty, Captains Chair, Patient Weight Capacity, 451 To 600 Pounds.K0854Power Wheelchair, Group 3 Extra Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.K0855Power Wheelchair, Group 3 Extra Heavy Duty, Captains Chair, Patient Weight Capacity 601 Pounds Or More.K0856Power Wheelchair, Group 3 Standard, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0857Power Wheelchair, Group 3 Standard, Single Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.K0858Power Wheelchair, Group 3 Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0859Power Wheelchair, Group 3 Heavy Duty, Single Power Option, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.K0860Power Wheelchair, Group 3 Very Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0861Power Wheelchair, Group 3 Standard, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.K0862Power Wheelchair, Group 3 Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.K0863Power Wheelchair, Group 3 Very Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.K0864Power Wheelchair, Group 3 Extra Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More. Table 4—Non-Statutorily Required DMEPOS ItemsHCPCSDescriptionE0748Osteogenesis Stimulator, Electrical, Non-Invasive, Spinal Applications.L0648Lumbar-Sacral Orthosis, Sagittal Control, With Rigid Anterior And Posterior Panels, Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Produces Intracavitary Pressure To Reduce Load On The Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L0650Lumbar-Sacral Orthosis, Sagittal-Coronal Control, With Rigid Anterior And Posterior Frame/Panel(S), Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Lateral Strength Provided By Rigid Lateral Frame/Panel(S), Produces Intracavitary Pressure To Reduce Load On Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L1832Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated Item That Has Been Trimmed, Bent, Molded, Assembled, Or Otherwise Customized To Fit A Specific Patient By An Individual With Expertise.L1833Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated, Off-The Shelf.L1851Knee Orthosis (KO), Single Upright, Thigh And Calf, With Adjustable Flexion And Extension Joint (Unicentric Or Polycentric), Medial-Lateral And Rotation Control, With Or Without Varus/Valgus Adjustment, Prefabricated, Off-The-Shelf.L3960Shoulder Elbow Wrist Hand Orthosis, Abduction Positioning, Airplane Design, Prefabricated, Includes Fitting And Adjustment. As previously stated, PMDs are included on the Required Face-to-Face Encounter and Written Order Prior to Delivery List per statutory obligation. For the other DMEPOS items, we considered factors such as operational limitations, item utilization, acute needs, seroquel impacts, cost-benefit analysis (for example, comparing the cost of review versus the anticipated amount of improper payment identified), emerging trends (for example, billing patterns, medical review findings), vulnerabilities identified in official agency reports, or other analysis. In selecting these items, we must balance our program integrity goals with the needs of patients, particularly those in need of medical devices to assist with functional activities and ambulation within their home.

In other words, we must ensure the appropriate application and oversight of the face-to-face encounter requirements. In consideration of access issues, we note that the regulation 42 CFR 410.38 allows Start Printed Page 2056 for use of telehealth, as defined in 42 CFR 410.78 and 414.65, when appropriate to meet our coverage requirements for beneficiaries. We also believe transparency and education will aid in compliance with these payment requirements and continued access. As such, we will make information widely available to the public at appropriate literacy levels regarding face-to-face encounter requirements, prior authorization, and necessary documentation for items on Required Face-to-Face Encounter and Written Order Prior to Delivery and Prior Authorization Lists. We believe additional practitioner oversight of beneficiaries in need of items represented by these HCPCS codes will help further our program integrity goals of reducing fraud, waste, and abuse.

It will also help ensure beneficiary receipt of items specific to their medical needs. For items on the Required Face-to-Face Encounter and Written Order Prior to Delivery List (Tables 3 and 4), the written order/prescription must be communicated to the supplier prior to delivery. For such items, we require the treating practitioner to have a face-to-face encounter with the beneficiary within the 6 months preceding the date of the written order/prescription. If the face-to-face encounter is a telehealth encounter, the requirements of 42 CFR 410.78 and 414.65 must be met for DMEPOS coverage purposes. Consistent with § 410.38(d), the face-to-face encounter must be documented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, progress notes, treatment plans or other sources of information that may be appropriate).

The supporting documentation must include subjective and objective beneficiary specific information used for diagnosing, treating, or managing a clinical condition for which the DMEPOS item(s) is ordered. Upon request by CMS or its review contractors, a supplier must submit additional documentation to support and substantiate the medical necessity for the DMEPOS item or both. The Required Face-to-Face Encounter and Written Order Prior to Delivery List is available on the following CMS website. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​Medical-Review/​FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment. C.

Items Subject to Prior Authorization Requirements The November 8, 2019 final rule (84 FR 60648) maintained the process established in the December 30, 2015 final rule (80 FR 81674) that when items are placed on the Required Prior Authorization List, we would inform the public of those DMEPOS items on the Required Prior Authorization List in the Federal Register with no less than 60 days' notice before implementation, and post notification on the CMS website. The Required Prior Authorization List specified in §  414.234(c)(1) is selected from the Master List (as described in §  414.234(b)), and those selected items require prior authorization as a condition of payment. Additionally, § 414.234 (c)(1)(ii) states that CMS may elect to limit the prior authorization requirement to a particular region of the country if claims data analysis shows that unnecessary utilization of the selected item(s) is concentrated in a particular region. The purpose of this document is to inform the public that we are updating the Required Prior Authorization List to include six additional Power Mobility Devices (PMDs) and five additional Orthoses HCPCS codes. To assist stakeholders in preparing for implementation of the prior authorization program, we are providing 90 days' notice.

The following six HCPCS codes for PMDs and five HCPCS codes for Orthoses are added to the Required Prior Authorization List. Table 5—Additions to the Required Prior Authorization ListHCPCSDescriptionK0800Power operated vehicle, group 1 standard, patient weight capacity up to and including 300 pounds.K0801Power Operated Vehicle, Group 1 Heavy Duty, Patient Weight Capacity, 301 To 450 Pounds.K0802Power Operated Vehicle, Group 1 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.K0806Power Operated Vehicle, Group 2 Standard, Patient Weight Capacity Up To And Including 300 Pounds.K0807Power Operated Vehicle, Group 2 Heavy Duty, Patient Weight Capacity 301 To 450 Pounds.K0808Power Operated Vehicle, Group 2 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.L0648Lumbar-Sacral Orthosis, Sagittal Control, With Rigid Anterior And Posterior Panels, Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Produces Intracavitary Pressure To Reduce Load On The Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L0650Lumbar-Sacral Orthosis, Sagittal-Coronal Control, With Rigid Anterior And Posterior Frame/Panel(S), Posterior Extends From Sacrococcygeal Junction To T-9 Vertebra, Lateral Strength Provided By Rigid Lateral Frame/Panel(S), Produces Intracavitary Pressure To Reduce Load On Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.L1832Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated Item That Has Been Trimmed, Bent, Molded, Assembled, Or Otherwise Customized To Fit A Specific Patient By An Individual With Expertise.L1833Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated, Off-The Shelf.L1851Knee Orthosis (Ko), Single Upright, Thigh And Calf, With Adjustable Flexion And Extension Joint (Unicentric Or Polycentric), Medial-Lateral And Rotation Control, With Or Without Varus/Valgus Adjustment, Prefabricated, Off-The-Shelf. We believe prior authorization of these six additional HCPCS codes for PMDs and five HCPCS codes for Orthoses will help further our program integrity goals of reducing fraud, waste, and abuse, while also protecting access to care. For PMDs, the OIG has previously reported that Medicare has inappropriately paid for items that did not meet certain Medicare requirements.[] Lower limb orthoses (LLO) and lumbar-sacral orthoses (LSO) have been identified by CMS' Comprehensive Error Rate Testing (CERT) program as two of the top 20 DMEPOS service types with improper payments over the past several years. Since 2016, LLOs have had an improper payment rate above 60 percent, with projected improper payments ranging between $235 and $501 million.

Similarly, LSOs have had an improper payment rate above 32 percent, with projected improper payments ranging between $116 and $177 million, since 2016. Additionally, in 2019, the Department of Justice (DOJ) announced Start Printed Page 2057 federal indictments and law enforcement actions stemming from fraudulent claims submitted for medically unnecessary back, shoulder, wrist, and knee braces[] Administrative actions were taken against 130 DMEPOS companies that were enticing Medicare beneficiaries with offers of low or no-cost orthotic braces. The investigation found that some DME companies and licensed medical professionals allegedly participated in health care fraud schemes involving more than $1.2 billion in loss.[] These codes will be subject to the requirements of the prior authorization program for certain DMEPOS items as outlined in § 414.234. We will implement a prior authorization program for the six newly added codes for PMDs nationwide and five newly added codes for Orthoses in 3 phases. This phased-in approach will allow us to identify and resolve any unforeseen issues by using a smaller claim volume in phase one before implementing phases 2 and 3.

State selection for the three phases was completed based on utilization data for the items selected. • For phase 1, which begins on the date specified in the DATES section, we selected the State in each DME MAC jurisdiction with the highest utilization. New York, Illinois, Florida, and California. • For phase 2, which begins on the date specified in the DATES section of this document, we selected the next three States with the highest utilization in each DME MAC jurisdiction. Maryland, Pennsylvania, New Jersey, Michigan, Ohio, Kentucky, Texas, North Carolina, Georgia, Missouri, Arizona, and Washington.

• For phase 3, which begins on the date specified in the DATES section of this document, prior authorization expands to all remaining States and territories not captured in phases 1 and 2. The prior authorization program for the 51 codes currently subject to the DMEPOS prior authorization requirement will continue uninterrupted. Prior to providing an item on the Required Prior Authorization List to the beneficiary and submitting the claim for processing, a requester must submit a prior authorization request. The request must include evidence that the item complies with all applicable Medicare coverage, coding, and payment rules. Consistent with § 414.234(d), such evidence must include the written order/prescription, relevant information from the beneficiary's medical record, and relevant supplier-produced documentation.

After receipt of all applicable required Medicare documentation, CMS or one of its review contractors will conduct a medical review and communicate a decision that provisionally affirms or non-affirms the request. We will issue specific prior authorization guidance for these additional items in subregulatory communications, including final timelines customized for the DMEPOS item subject to prior authorization, for communicating a provisionally affirmed or non-affirmed decision to the requester. In the December 30, 2015 final rule (80 FR 81674) we stated that this approach to final timelines provides flexibility to develop a process that involves fewer days, as may be appropriate, and allows us to safeguard beneficiary access to care. If at any time we become aware that the prior authorization process is creating barriers to care, we can suspend the program. For example, we will review questions and complaints from consumers and providers that come through regular sources such as 1-800-Medicare.

The updated Required Prior Authorization List is available in the download section of the following CMS website. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Monitoring-Programs/​Medicare-FFS-Compliance-Programs/​DMEPOS/​Downloads/​DMEPOS_​PA_​Required-Prior-Authorization-List.pdf. III. Collection of Information Requirements This document provides updates to the Master List and announces the selection of HCPCS codes to be placed on the Required Face-to-Face Encounter and Written Order Prior to Delivery List and Required Prior Authorization List. Additionally, this document announces the continuation of prior authorization for 51 HCPCS codes, and the addition of six HCPCS codes for PMDs and five HCPCS codes for Orthoses on the Required Prior Authorization List.

There is an information collection burden associated with this program that is currently approved under OMB control number 0938-1293, which expires March 31, 2022. This package accounts for burdens associated with the addition of items to the Required Prior Authorization Lists and assumes a burden for 2021 of approximately $10 million for providers to comply with the required information collection. We will reassess this burden soon and will seek comment on our assessment in a Federal Register notice as required under the Paperwork Reduction Act of 1995. IV. Regulatory Impact Statement We have examined the impact of this regulatory document 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 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). 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). This regulatory document is not significant and does not reach the economic threshold and thus is not considered a major regulatory document. Per our analysis, the additional items being added to the prior authorization program (excluding PMDs) [] have an estimated net savings of $14.8 million.

Gross savings is based upon a 10 percent reduction in the total amount paid for claims in Calendar Year 2019. We deducted from the gross savings the anticipated cost for performing the prior authorization reviews in order to estimate the net savings. Our gross savings estimate of 10 percent is based on previous results from other prior authorization programs, Start Printed Page 2058 including prior authorization of other DMEPOS items. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.

Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $8.0 million to $41.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this regulatory document will not have a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare an RIA 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 604 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 for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this regulatory document will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 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 2021, that threshold is approximately $158 million. This regulatory document will have no consequential effect on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule or other regulatory document) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulatory document does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this document was reviewed by the Office of Management and Budget. The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register.

Start Signature Dated. January 10, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services. End Signature End Supplemental Information [FR Doc.

2022-00572 Filed 1-12-22. 8:45 am]BILLING CODE P.

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Primary healthcare has been a global priority since the 1978 Alma Ata Declaration when it was identified as the most inclusive, seroquel mixed with alcohol effective, and efficient approach to promoting physical and mental health.1 The Astana Declaration of 2018 reaffirmed the central role of primary Buy zithromax pills care as a cornerstone for achieving universal health coverage for all, including children.1Less consensus exists on what primary healthcare concretely entails and which are the health services that can and should be delivered safely at the primary healthcare level for children and adolescents.With the Integrated Management of Childhood Illness (IMCI), launched in the 1990s, the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) set standards for the management of the most frequent causes of preventable mortality in children under 5 years.2However, many important areas of child health are missing from IMCI, for example, non-communicable diseases and adolescent health. In addition, the quality of existing primary healthcare is not seroquel mixed with alcohol always optimal. Health professionals in primary care do not always have the appropriate training, evidence-based information, and resources required for holistic and good quality care.To help solve these problems, the WHO European Regional Office has recently published the WHO Pocket Book of Primary health care for children and adolescents for the European region—based on evidence-based guidelines for health promotion, disease prevention and management (figure seroquel mixed with alcohol 1).Figure 1 The WHO Pocket Book of Primary ….

Primary healthcare has been a global priority since the 1978 Alma Ata Declaration when it was identified as the most inclusive, effective, and efficient approach to promoting physical and mental health.1 The Astana Declaration of 2018 reaffirmed the central role of primary care as a cornerstone for achieving universal health coverage for all, including children.1Less consensus exists on what primary healthcare concretely entails and which are the health services that seroquel street price can and should be delivered safely at the primary healthcare level for children go and adolescents.With the Integrated Management of Childhood Illness (IMCI), launched in the 1990s, the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) set standards for the management of the most frequent causes of preventable mortality in children under 5 years.2However, many important areas of child health are missing from IMCI, for example, non-communicable diseases and adolescent health. In addition, the quality of existing primary seroquel street price healthcare is not always optimal. Health professionals in primary care do not always have the appropriate training, evidence-based information, and resources required for holistic and good seroquel street price quality care.To help solve these problems, the WHO European Regional Office has recently published the WHO Pocket Book of Primary health care for children and adolescents for the European region—based on evidence-based guidelines for health promotion, disease prevention and management (figure 1).Figure 1 The WHO Pocket Book of Primary ….

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Amid reports of Russia's invasion of Ukraine this week, the American Hospital Association raised concerns about potential consequences for can seroquel cause restless legs the healthcare industry, particularly regarding cybersecurity. The organization pointed to wariness that Russia would retaliate against the United States and other countries in an effort to push forward with its objectives."As part of AHA’s efforts, John Riggi, the association’s national advisor for cybersecurity and risk, and a former senior executive in the FBI’s cyber division, remains in close coordination with the FBI, CISA and the Department of Health and Human Services regarding related threats which may pose a risk to U.S. Health care," can seroquel cause restless legs said the AHA in its cybersecurity advisory. WHY IT MATTERS The Russian government has issued warnings about "strong" and "painful" responses to President Joe Biden's sanctions against the country, saying it would target "sensitive" U.S.

Assets. Although the country didn't go into details about what those responses would be, the AHA noted that Russia has used disruptive cyberattacks against Ukraine. The association pointed to three main concerns for the field. Hospitals and health systems may be targeted directly by Russian-sponsored cyber actorsHospitals and health systems may become incidental victims of Russian-deployed malware or destructive ransomware that inadvertently breaches U.S.

Healthcare entities A cyberattack could disrupt hospitals’ mission-critical service providers It advised member organizations to implement several protection and mitigation strategies, including. Increasing network monitoring for unusual trafficHeightening staff awareness of malware-laden phishing emailsImplementing geo-fencing for all inbound and outbound traffic originating from, and related to, Ukraine and its surrounding region Identifying all internal and third-party mission-critical clinical and operational services and technology, and putting into place business continuity plans and downtime proceduresDocumenting, updating and practicing a cyber incident response plan THE LARGER TREND National security experts, including federal legislators, have also warned about potential Russian cyberthreats. Sen. Mark Warner, D-Virginia, told the Washington Post on Thursday that the country could target "the weaker links in NATO." "Phase one is spillover Russian attacks against Ukraine, phase two would be Russian and cyber criminals attacks against the West or NATO nations that have the least amount of cyber defenses," said Warner, who chairs the Senate Intelligence Committee.This past week, the Cybersecurity and Infrastructure Security Agency released a bulletin warning organizations to keep "shields up" against possible attacks.

The bulletin followed another alert in January as the situation heated up between Russia and Ukraine. ON THE RECORD "It is essential at this time to check the redundancy, resiliency and security of your organization’s network and data backups, and ensure that multiple copies exist. Off-line, network segmented, on premises and in the cloud, with at least one immutable copy," said the AHA in its advisory. Kat Jercich is senior editor of Healthcare IT News.Twitter.

@kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.Hospitals and health systems have gotten better at using analytics to fine-tune their clinical, financial and operational improvement strategies. But it's time to revisit and prioritize data that gives the most bang for the buck, said Matt Grahl, a senior advisor at Impact Advisors, a healthcare consulting firm.The Great Resignation has highlighted the need to strategize and prioritize to more fully leverage a leaner staff, encouraging a hyper-focus on key analytical data that could net the most positive impact, instead of being bogged down by focusing on other data that could prove useful but should be deprioritized and placed on the back burner to make the most out of a smaller staff, said Grahl, who has 25 years of analytics, operations and risk management experience.Healthcare IT News sat down with Grahl to discuss his views on the role of healthcare data analytics today and get some lessons on how to approach data analysis.Q. Why do you say it is time to revisit and prioritize data that gives the most bang for the buck?.

A. While the creation of and access to data is rapidly increasing, the internal capacity to turn that data into decision-making tools – analytic products – remains constrained. A good analogy here is a factory that suddenly sees a large amount of excess and varied raw materials dumped on its receiving dock.There's certainly potential there, but all that has truly happened is that work in progress just went up, and nothing more is coming out of the factory in terms of finished products – more than likely less is being produced due to the excess work in progress. More raw materials injected into a production process do not equate to increased production where other parts of the system are constrained.In terms of data, operational leaders, with the help of their supporting analytic teams, need to step back and clarify what decisions need to be enabled through their analytic products.

It's okay to not have that answer cross-walked to every chunk of data generated.Right now, we need to be sure we are enabling decision-making tightly coupled to the enterprise strategy and near-term initiatives. Think about what decisions need to be made that fully support the advancement of the enterprise in alignment with the overall strategy.With those decisions in mind, now prioritize which data to leverage. With this exercise complete, we now have a high-level analytic production plan with a good understanding of the raw material required.Now, what about the rest of it?. As operational leaders consume analytic products in alignment with the overarching business strategy, new questions will be formulated, and there's a great chance data that has been set aside will come into play to help answer those questions.The difference in this approach is that you have addressed the most important pieces first to the best of your knowledge and are now iterating in an orderly fashion.

The order is derived from your strategy and tightly aligned execution of initiatives supporting that strategy.Q. In your opinion, the so-called Great Resignation has highlighted the need to strategize and prioritize to leverage a leaner staff more fully, encouraging a hyper-focus on key analytical data. Please elaborate.A. Everything we just discussed relates to this statement, but there is some more nuance to this, and a huge opportunity for employee engagement that can translate into positive team retention.

The engagement of analytic teams can potentially be damaged when their hard work and expertise go unrealized with an analytic product that just isn't used to any significant degree.The tight coupling of their work with operational stakeholders aligned to the enterprise strategy ensures analytic products will be leveraged once complete and the realization of those efforts fuels an already aligned analytics team and truly connects them to the overall organization.The potential for a true win-win scenario can emerge. The organization has prioritized what is critically important, and at the end of development the analytic team understands the connection between their work and the wider enterprise, while also seeing the fruit of their labor being used to enable decision-making in the march down the organization's strategic path.The other subtle win here is that the analytic team has potentially become even more engaged in their work and the organization as a whole.The Great Resignation has taught some tough lessons around the competitive environment of analytic talent acquisition. You can go a long way in retaining and securing valuable analytic team members simply by aligning their efforts in the laser-focused execution of your desired strategy and the initiatives supporting that strategy.Q. You caution healthcare leaders to avoid "shiny toy syndrome" of new analytics technology that could distract from the most impactful technologies.

Please give an example of this.A. I love shiny new toys as much as anybody, but proceed with caution here. An example of this is when health systems want to focus on artificial intelligence/machine learning solutions without first having a foundation in place and a clear operational use case.I have seen again and again that analytic issues within organizations are rarely a technology gap at the root cause. Lack of a strategy or a strategy that is not well understood is usually problem No.

1. Next up is lack of meaningful data governance. A fully functioning data-governance construct is a foundational element, and the lack of that element will defeat any technology over time.Here's what I would recommend regarding shiny new toys. Focus on what decisions will be enabled, and then first look at your legacy toolbox and see if those tools are being leveraged to the maximum extent possible.

Let the enablement of key decisions lead you to the right technology, and not the other way around. The desire to acquire new technology is also a great opportunity to review your analytic foundations – strategy and data governance – before adding another floor to the house.It is critical to avoid "build it and they will come" as an analytics strategy. If the slickest new analytic platform is implemented without consideration to your analytics program foundation and that implementation isn't coupled to the overall enterprise strategy, you are going to have your new toy lying dormant while incurring the requisite maintenance overhead.If you have gone through all the steps in the right order and decide that the shiny new toy is the tool you need, be sure to also go ahead and plan for the sunset of those legacy platforms with duplicative functionality.Q. With regard to analytics, why should CIOs and other health IT leaders bring operational leaders into the fold?.

A. Simply put, operational leaders are the customer and should know what are the most important decisions that need to be enabled. Chances are analytic development requests need to be prioritized due to constrained resources, and operational leaders need to be at the table during that prioritization.I would contend they need to be the decision-makers regarding what needs to be built next. To inform that decision, analytic leaders need to be transparent and as granular as possible on the capacity side of the discussion.A natural offshoot to these conversations is possible gaps in capability.

Those gaps could be skill gaps or true gaps in supporting technology. When these gaps are highlighted through the lens of true prioritized demand, an emergent gap closure effort becomes clear and easily justified.When it comes to analytic demand management, I have seen a few processes that work well. One was informal and just involved a discussion between the senior analytic leader and the respective VP who owned a particular analytic request immediately after the request was submitted. The discussion was around validating the request, current capacity, and getting approval to go forward or not from that VP.This worked great for a health system on the smaller end of the scale.

On the larger end of the scale, I have seen operational leaders meet with analytics leadership on a three-week cycle in a more formal setting and accomplish the same task.In both cases, operational leaders made the decision on what was most important and approved for development. It is important to note that for either of these methods to work, there absolutely needs to be a defined and disciplined request intake process.Twitter. @SiwickiHealthITEmail the writer. Bsiwicki@himss.orgHealthcare IT News is a HIMSS Media publication.First announced in January 2021, the treatment Credential Initiative – co-founded by MITRE Corporation and others including Cerner, Change Healthcare, Epic, Mayo Clinic, Microsoft, Oracle, Salesforce and others – has made big progress over the past year-plus on new approaches to interoperable record-keeping.The public and private partnership collaborated on developing a standard model for "trustworthy, traceable, verifiable, and universally recognized digital record of vaccination status" – offering individuals digital access to their vaccination records using the open and interoperable SMART Health Cards specification based on W3C Verifiable Credential and HL7 FHIR standards.While initially developed in response to the antidepressant drugs seroquel, those SMART Health Cards – accessible via digital wallet apps or QR codes – were also seen as a key enabler for a larger system to more easily enable access, control and sharing of verifiable vaccination and other records.At HIMSS22 in Orlando next month, Dr.

Brian Anderson, chief digital health physician at MITRE Corporation, and Bryant Karras, chief public health informatics officer and senior epidemiologist at Washington State Department of Health, will offer an update on the progress of the treatment Credential Initiative, and other initiatives like it.They'll describe how VCI and other projects have enabled new advances in public health and patient-centered data exchange as the seroquel has progressed. They'll explain how it's now positioned to move beyond mere immunization status and toward a larger approach to interoperable health records. And they'll show how, through an upcoming collaboration with the World Health Organization and the G20, those advancements can soon be expanding globally.In a discussion – hosted by HIMSS Senior Vice President of Government Relations Tom Leary at the Interoperability Showcase – Anderson and Karras will spotlight recent progress in immunization management, and describe some specific challenges and opportunities as new approaches to interoperable patient records evolve."Up until this point, everything we've been doing within VCI has been about empowering individuals with verifiable, trustworthy copies of their vaccination records," Anderson told Healthcare IT News."What we're beginning to explore now – and certainly talking to a lot of folks in the federal government and in various state governments, as well as in the private sector – is about the additional use cases that SMART Health Cards can be used for. It doesn't have to be just about vaccination credentials."For instance, VCI is working with state public health authorities about how can they use SMART Health Cards to support all vaccination records, offering individuals secure and verifiable records – not just of antidepressant drugs vaccination status, "but the typical treatments that we all get," said Anderson, who noted the potential use case of supporting streamline school enrollment."And then even building out beyond treatments to diagnostic test results," he said.

"And even more broadly, enabling individuals to have portable, trustworthy secure copies to their longitudinal record."VCI is "looking to begin building out those use case opportunities with other interested parties at HIMSS," said Anderson, "building the coalition and the partners that are interested in expanding into those next spaces."Toward that end, VCI is now planning to work with the World Health Organization and the G20 on a new international interoperability effort focused on vaccination credentials as the the initial use case – but but with plans to build out a wider interoperability framework using several data exchange specifications that exist across the globe.VCI will participate in a technical working group convened by the Office of the Chief Scientist of the WHO. It will be co-chaired by the Global Digital Health Partnership and the Organization for Economic Co-operation and Development, in collaboration with the G20. "It's essentially going to establish an international framework to the four major specifications for vaccination credentials that are in use across the world," Anderson explained. "The SMART Health Card [used primarily in the U.S.

And Canada] that is being championed by VCI. The European Union's Digital antidepressant drugs Certificate, or DCC. The DIVOC standard, that's from India. And then the ICAO-VDS standard that's used by Australia and Japan."All of these organizations, representatives from, I think, 20 or 30 member states within the WHO, will be participating in this effort to build a framework for mutual recognition of vaccination credentials in any of those formats across the globe," he said, "and building out an international registry of trusted issuers that can be referenced."It's been a busy year of all-volunteer work on the treatment Credential Initiative, said Anderson, but the lessons learned along the way, and the progress made on new approaches to patient-centered longit interoperability, have been well worth it, said Anderson."One of the things that we learned is the importance of partnering with technology vendors and public health authorities is incredibly powerful, and I think has been an area I'm sure we can all appreciate has been under-invested in for quite some time," he said."The opportunity space that we've been able to develop by taking this new technology and enabling public health authorities to directly engage residents of their states to share this kind of trustworthy health data is a wholly new thing to many states."Another insight, he said, is that this sort of patient-mediated approach to data sharing "creates a virtuous cycle in terms of the accuracy of that data.

If an individual has the ability to go to a state and say, 'I want my SMART Health Card,' and for some reason that data is not there, or it's inaccurate, it enables that individual to correct that data, or to go to their health system or to go to their pharmacy and say, 'Hey, send in that data to the registry.'"When we launched VCI, it was very much rooted in empowering individuals with their health records – the use case absolutely was about vaccination credentials," Anderson added. "But the point of VCI was never about just empowering individuals with copies of their own treatment history. It was about empowering individuals with copies of their health record and enabling them to tell the story with that vaccination credential to whomever they wanted to."Anderson and Karras's HIMSS22 session, "Immunization Interoperability. Catalyzing Public Health Data Exchange Locally &.

Globally," is scheduled for Thursday, March 17, from 9:30-10:30 a.m. At the Interoperability-Showcase, Hall E-Booth 8240, at the Orange County Convention Center. Twitter. @MikeMiliardHITNEmail the writer.

Mike.miliard@himssmedia.comHealthcare IT News is a HIMSS publication.A new report released this week from Bloomberg Intelligence predicted that the telehealth sector could bring in $20 billion in U.S. Revenue by 2027. The Digital Reshaping the Health Care Ecosystem publication said that virtual care is set to "become a staple" of healthcare delivery."The antidepressant drugs seroquel has accelerated the adoption of telehealth by years, providing safe and convenient access to telehealth services," said Duane Wright, senior research analyst at Bloomberg Intelligence. "With more major healthcare providers embracing telehealth services, our analysis finds annual revenue growth for top telehealth providers at 30%," Wright said.

Wright and fellow analysts contended that the industry has reached a "sea change" with the public health crisis, with incumbents and large managed-care companies driving the next growth phase. "Virtual care will [increasingly] become the norm, we believe, after the seroquel pushed patients away from in-person visits," read the report. "A reversion to old practices and business models appears impossible to us after the seroquel forced meaningful change across all the key constituents." The analysts highlighted the potential of remote patient monitoring technology and smart devices, including implantable cardiac monitors and continuous glucose monitors. "The seroquel accelerated the industry's rate of uptake by a factor of years and has created a flywheel effect for the overall virtual ecosystem," they wrote.

"The changes in healthcare delivery necessitated by shelter-in-place edicts raised awareness and showcased the capabilities of the virtual channel across both patients and physicians," they added. "This in turn resulted in increased technology investments by providers and health systems, which are increasingly leveraging the assets to provide care and reduce costs." Although the researchers acknowledged the removal of policy roadblocks, they did not go into detail about the roles federal and state legislation may play in telehealth adoption. They did, however, predict that 15% of total outpatient visits could be virtual within three to five years. "We don't view the 15% estimate as a peak, but rather a waypoint as digital increasingly becomes the front door to healthcare," they wrote.

Who are the telehealth 'super utilizers?. ' Interestingly, a report released this week from Trilliant Health took a somewhat more measured view on the future of virtual care. Noting that telehealth use tapered in 2021 from its wild peak at the beginning of the seroquel, researchers for that report observed that women are driving most of the telehealth utilization. The largest percentage (45%) of telehealth patients only had one virtual visit, with about 14% classified as "high" or "super" utilizers with seven or more visits.

Super utilizers are typically on the younger side, and mostly using behavioral health. They are typically geographically concentrated in areas with higher incomes. Analysts noted that "willful endurers" – those living in the "here and now," health-wise – and "self-achievers" – the most proactive when it comes to wellness – are more likely to use virtual care. From an economic perspective, researchers noted that the number of tech-enabled providers is continuing to grow, with demand likely to decrease post-seroquel.They pointed to Amazon and Walmart as major players who entered the game in 2021, saying that traditional providers are not equipped to compete with retail suppliers.

"Our research indicates that consumer preferences and many of the prevailing narratives on the market outlook for telehealth are seemingly incongruent, reinforcing caution for organizations that are planning their virtual care strategies solely based on industry hype," said Sanjula Jain, Trilliant Health chief research officer and senior vice president of market strategy, in a statement. Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.The National Institute of Standards and Technology's National Cybersecurity Center of Excellence published its final guidance this week on securing telehealth and remote patient monitoring ecosystems.

The guide is intended, according to NCCoE, to help identify risks associated with RPM architecture and ensure healthcare organizations are partnering with appropriate telehealth platform providers. "While [healthcare delivery organizations] do not have the ability to manage and deploy privacy and cybersecurity controls unilaterally, they retain the responsibility to ensure that appropriate controls and risk mitigation are applied," wrote researchers. WHY IT MATTERS In order to develop the guidance and demonstrate how organizations can enhance resiliency, NCCoE collaborated with industry partners to build a laboratory environment – specifically, one where a patient is being monitored by an in-home device capturing biometric data.Those partners included Accuhealth, Cisco, Inova, LogRhythm, MedCrypt, MedSec, Onclave Networks, Tenable. University of Mississippi Medical Center and Vivify Health.

"While the NCCoE used a suite of commercial products to address this challenge, this guide does not endorse these particular products, nor does it guarantee compliance with any regulatory initiatives," noted the experts. "Your organization’s information security experts should identify the products that will best integrate with your existing tools and Information Technology system infrastructure," they continued.The practice guide operated under the assumption that the delivery organization is using a separate telehealth platform provider that manages a distinct infrastructure, applications and a set of services. Using the NIST Risk Management Framework, the NIST Cybersecurity Framework, the NIST Privacy Framework and other relevant standards, the NCCoE analyzed risk factors in an RPM ecosystem and identified measures to safeguard it. It outlined several potential vulnerabilities, including fraudulent uses of health-related information, interruption or inaccuracy of patient diagnoses, disrupted processes and system disruption.

"As organizations consider measures to disrupt threats and adverse actions made against the ecosystem, an opportunity exists where organizations examine threats to identify controls that mitigate adverse actions identified by threat modeling," read the report. The guidance authors noted that, although they used cellular data-based biometric devices and addressed those using broadband communications, a future build may also implement an electronic health record system that would receive automated data from the telehealth platform provider. "The future build may include direct messaging from the RPM systems to the EHR," they wrote. THE LARGER TREND NIST has been offering tips around cybersecurity and telehealth deployments for years.NIST IT Security Specialist Nakia Grayson, who co-authored the guidance, told Healthcare IT News Executive Editor Mike Miliard in April 2021 that the agency began the work in response to an uptick in patient and provider interest in virtual care, particularly amidst the antidepressant drugs seroquel.

"Without adequate privacy and cybersecurity measures, unauthorized users may expose a patient's sensitive data or disrupt the patient monitoring system," Grayson said in a HIMSSTV interview. ON THE RECORD "Technology solutions alone may not be sufficient to maintain privacy and security controls on external environments," wrote NCCoE experts. "This practice guide notes the application of people, process and technology as necessary to implement a holistic risk mitigation strategy," they continued. Kat Jercich is senior editor of Healthcare IT News.Twitter.

@kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication..

Amid reports of Russia's invasion of Ukraine this week, the American Hospital Association raised concerns about seroquel street price potential consequences for the healthcare industry, particularly regarding cybersecurity. The organization pointed to wariness that Russia would retaliate against the United States and other countries in an effort to push forward with its objectives."As part of AHA’s efforts, John Riggi, the association’s national advisor for cybersecurity and risk, and a former senior executive in the FBI’s cyber division, remains in close coordination with the FBI, CISA and the Department of Health and Human Services regarding related threats which may pose a risk to U.S. Health care," said the AHA in its cybersecurity advisory seroquel street price.

WHY IT MATTERS The Russian government has issued warnings about "strong" and "painful" responses to President Joe Biden's sanctions against the country, saying it would target "sensitive" U.S. Assets. Although the country didn't go into details about what those responses would be, the AHA noted that Russia has used disruptive cyberattacks against Ukraine.

The association pointed to three main concerns for the field. Hospitals and health systems may be targeted directly by Russian-sponsored cyber actorsHospitals and health systems may become incidental victims of Russian-deployed malware or destructive ransomware that inadvertently breaches U.S. Healthcare entities A cyberattack could disrupt hospitals’ mission-critical service providers It advised member organizations to implement several protection and mitigation strategies, including.

Increasing network monitoring for unusual trafficHeightening staff awareness of malware-laden phishing emailsImplementing geo-fencing for all inbound and outbound traffic originating from, and related to, Ukraine and its surrounding region Identifying all internal and third-party mission-critical clinical and operational services and technology, and putting into place business continuity plans and downtime proceduresDocumenting, updating and practicing a cyber incident response plan THE LARGER TREND National security experts, including federal legislators, have also warned about potential Russian cyberthreats. Sen. Mark Warner, D-Virginia, told the Washington Post on Thursday that the country could target "the weaker links in NATO." "Phase one is spillover Russian attacks against Ukraine, phase two would be Russian and cyber criminals attacks against the West or NATO nations that have the least amount of cyber defenses," said Warner, who chairs the Senate Intelligence Committee.This past week, the Cybersecurity and Infrastructure Security Agency released a bulletin warning organizations to keep "shields up" against possible attacks.

The bulletin followed another alert in January as the situation heated up between Russia and Ukraine. ON THE RECORD "It is essential at this time to check the redundancy, resiliency and security of your organization’s network and data backups, and ensure that multiple copies exist. Off-line, network segmented, on premises and in the cloud, with at least one immutable copy," said the AHA in its advisory.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.Hospitals and health systems have gotten better at using analytics to fine-tune their clinical, financial and operational improvement strategies.

But it's time to revisit and prioritize data that gives the most bang for the buck, said Matt Grahl, a senior advisor at Impact Advisors, a healthcare consulting firm.The Great Resignation has highlighted the need to strategize and prioritize to more fully leverage a leaner staff, encouraging a hyper-focus on key analytical data that could net the most positive impact, instead of being bogged down by focusing on other data that could prove useful but should be deprioritized and placed on the back burner to make the most out of a smaller staff, said Grahl, who has 25 years of analytics, operations and risk management experience.Healthcare IT News sat down with Grahl to discuss his views on the role of healthcare data analytics today and get some lessons on how to approach data analysis.Q. Why do you say it is time to revisit and prioritize data that gives the most bang for the buck?. A.

While the creation of and access to data is rapidly increasing, the internal capacity to turn that data into decision-making tools – analytic products – remains constrained. A good analogy here is a factory that suddenly sees a large amount of excess and varied raw materials dumped on its receiving dock.There's certainly potential there, but all that has truly happened is that work in progress just went up, and nothing more is coming out of the factory in terms of finished products – more than likely less is being produced due to the excess work in progress. More raw materials injected into a production process do not equate to increased production where other parts of the system are constrained.In terms of data, operational leaders, with the help of their supporting analytic teams, need to step back and clarify what decisions need to be enabled through their analytic products.

It's okay to not have that answer cross-walked to every chunk of data generated.Right now, we need to be sure we are enabling decision-making tightly coupled to the enterprise strategy and near-term initiatives. Think about what decisions need to be made that fully support the advancement of the enterprise in alignment with the overall strategy.With those decisions in mind, now prioritize which data to leverage. With this exercise complete, we now have a high-level analytic production plan with a good understanding of the raw material required.Now, what about the rest of it?.

As operational leaders consume analytic products in alignment with the overarching business strategy, new questions will be formulated, and there's a great chance data that has been set aside will come into play to help answer those questions.The difference in this approach is that you have addressed the most important pieces first to the best of your knowledge and are now iterating in an orderly fashion. The order is derived from your strategy and tightly aligned execution of initiatives supporting that strategy.Q. In your opinion, the so-called Great Resignation has highlighted the need to strategize and prioritize to leverage a leaner staff more fully, encouraging a hyper-focus on key analytical data.

Please elaborate.A. Everything we just discussed relates to this statement, but there is some more nuance to this, and a huge opportunity for employee engagement that can translate into positive team retention. The engagement of analytic teams can potentially be damaged when their hard work and expertise go unrealized with an analytic product that just isn't used to any significant degree.The tight coupling of their work with operational stakeholders aligned to the enterprise strategy ensures analytic products will be leveraged once complete and the realization of those efforts fuels an already aligned analytics team and truly connects them to the overall organization.The potential for a true win-win scenario can emerge.

The organization has prioritized what is critically important, and at the end of development the analytic team understands the connection between their work and the wider enterprise, while also seeing the fruit of their labor being used to enable decision-making in the march down the organization's strategic path.The other subtle win here is that the analytic team has potentially become even more engaged in their work and the organization as a whole.The Great Resignation has taught some tough lessons around the competitive environment of analytic talent acquisition. You can go a long way in retaining and securing valuable analytic team members simply by aligning their efforts in the laser-focused execution of your desired strategy and the initiatives supporting that strategy.Q. You caution healthcare leaders to avoid "shiny toy syndrome" of new analytics technology that could distract from the most impactful technologies.

Please give an example of this.A. I love shiny new toys as much as anybody, but proceed with caution here. An example of this is when health systems want to focus on artificial intelligence/machine learning solutions without first having a foundation in place and a clear operational use case.I have seen again and again that analytic issues within organizations are rarely a technology gap at the root cause.

Lack of a strategy or a strategy that is not well understood is usually problem No. 1. Next up is lack of meaningful data governance.

A fully functioning data-governance construct is a foundational element, and the lack of that element will defeat any technology over time.Here's what I would recommend regarding shiny new toys. Focus on what decisions will be enabled, and then first look at your legacy toolbox and see if those tools are being leveraged to the maximum extent possible. Let the enablement of key decisions lead you to the right technology, and not the other way around.

The desire to acquire new technology is also a great opportunity to review your analytic foundations – strategy and data governance – before adding another floor to the house.It is critical to avoid "build it and they will come" as an analytics strategy. If the slickest new analytic platform is implemented without consideration to your analytics program foundation and that implementation isn't coupled to the overall enterprise strategy, you are going to have your new toy lying dormant while incurring the requisite maintenance overhead.If you have gone through all the steps in the right order and decide that the shiny new toy is the tool you need, be sure to also go ahead and plan for the sunset of those legacy platforms with duplicative functionality.Q. With regard to analytics, why should CIOs and other health IT leaders bring operational leaders into the fold?.

A. Simply put, operational leaders are the customer and should know what are the most important decisions that need to be enabled. Chances are analytic development requests need to be prioritized due to constrained resources, and operational leaders need to be at the table during that prioritization.I would contend they need to be the decision-makers regarding what needs to be built next.

To inform that decision, analytic leaders need to be transparent and as granular as possible on the capacity side of the discussion.A natural offshoot to these conversations is possible gaps in capability. Those gaps could be skill gaps or true gaps in supporting technology. When these gaps are highlighted through the lens of true prioritized demand, an emergent gap closure effort becomes clear and easily justified.When it comes to analytic demand management, I have seen a few processes that work well.

One was informal and just involved a discussion between the senior analytic leader and the respective VP who owned a particular analytic request immediately after the request was submitted. The discussion was around validating the request, current capacity, and getting approval to go forward or not from that VP.This worked great for a health system on the smaller end of the scale. On the larger end of the scale, I have seen operational leaders meet with analytics leadership on a three-week cycle in a more formal setting and accomplish the same task.In both cases, operational leaders made the decision on what was most important and approved for development.

It is important to note that for either of these methods to work, there absolutely needs to be a defined and disciplined request intake process.Twitter. @SiwickiHealthITEmail the writer. Bsiwicki@himss.orgHealthcare IT News is a HIMSS Media publication.First announced in January 2021, the treatment Credential Initiative – co-founded by MITRE Corporation and others including Cerner, Change Healthcare, Epic, Mayo Clinic, Microsoft, Oracle, Salesforce and others – has made big progress over the past year-plus on new approaches to interoperable record-keeping.The public and private partnership collaborated on developing a standard model for "trustworthy, traceable, verifiable, and universally recognized digital record of vaccination status" – offering individuals digital access to their vaccination records using the open and interoperable SMART Health Cards specification based on W3C Verifiable Credential and HL7 FHIR standards.While initially developed in response to the antidepressant drugs seroquel, those SMART Health Cards – accessible via digital wallet apps or QR codes – were also seen as a key enabler for a larger system to more easily enable access, control and sharing of verifiable vaccination and other records.At HIMSS22 in Orlando next month, Dr.

Brian Anderson, chief digital health physician at MITRE Corporation, and Bryant Karras, chief public health informatics officer and senior epidemiologist at Washington State Department of Health, will offer an update on the progress of the treatment Credential Initiative, and other initiatives like it.They'll describe how VCI and other projects have enabled new advances in public health and patient-centered data exchange as the seroquel has progressed. They'll explain how it's now positioned to move beyond mere immunization status and toward a larger approach to interoperable health records. And they'll show how, through an upcoming collaboration with the World Health Organization and the G20, those advancements can soon be expanding globally.In a discussion – hosted by HIMSS Senior Vice President of Government Relations Tom Leary at the Interoperability Showcase – Anderson and Karras will spotlight recent progress in immunization management, and describe some specific challenges and opportunities as new approaches to interoperable patient records evolve."Up until this point, everything we've been doing within VCI has been about empowering individuals with verifiable, trustworthy copies of their vaccination records," Anderson told Healthcare IT News."What we're beginning to explore now – and certainly talking to a lot of folks in the federal government and in various state governments, as well as in the private sector – is about the additional use cases that SMART Health Cards can be used for.

It doesn't have to be just about vaccination credentials."For instance, VCI is working with state public health authorities about how can they use SMART Health Cards to support all vaccination records, offering individuals secure and verifiable records – not just of antidepressant drugs vaccination status, "but the typical treatments that we all get," said Anderson, who noted the potential use case of supporting streamline school enrollment."And then even building out beyond treatments to diagnostic test results," he said. "And even more broadly, enabling individuals to have portable, trustworthy secure copies to their longitudinal record."VCI is "looking to begin building out those use case opportunities with other interested parties at HIMSS," said Anderson, "building the coalition and the partners that are interested in expanding into those next spaces."Toward that end, VCI is now planning to work with the World Health Organization and the G20 on a new international interoperability effort focused on vaccination credentials as the the initial use case – but but with plans to build out a wider interoperability framework using several data exchange specifications that exist across the globe.VCI will participate in a technical working group convened by the Office of the Chief Scientist of the WHO. It will be co-chaired by the Global Digital Health Partnership and the Organization for Economic Co-operation and Development, in collaboration with the G20.

"It's essentially going to establish an international framework to the four major specifications for vaccination credentials that are in use across the world," Anderson explained. "The SMART Health Card [used primarily in the U.S. And Canada] that is being championed by VCI.

The European Union's Digital antidepressant drugs Certificate, or DCC. The DIVOC standard, that's from India. And then the ICAO-VDS standard that's used by Australia and Japan."All of these organizations, representatives from, I think, 20 or 30 member states within the WHO, will be participating in this effort to build a framework for mutual recognition of vaccination credentials in any of those formats across the globe," he said, "and building out an international registry of trusted issuers that can be referenced."It's been a busy year of all-volunteer work on the treatment Credential Initiative, said Anderson, but the lessons learned along the way, and the progress made on new approaches to patient-centered longit interoperability, have been well worth it, said Anderson."One of the things that we learned is the importance of partnering with technology vendors and public health authorities is incredibly powerful, and I think has been an area I'm sure we can all appreciate has been under-invested in for quite some time," he said."The opportunity space that we've been able to develop by taking this new technology and enabling public health authorities to directly engage residents of their states to share this kind of trustworthy health data is a wholly new thing to many states."Another insight, he said, is that this sort of patient-mediated approach to data sharing "creates a virtuous cycle in terms of the accuracy of that data.

If an individual has the ability to go to a state and say, 'I want my SMART Health Card,' and for some reason that data is not there, or it's inaccurate, it enables that individual to correct that data, or to go to their health system or to go to their pharmacy and say, 'Hey, send in that data to the registry.'"When we launched VCI, it was very much rooted in empowering individuals with their health records – the use case absolutely was about vaccination credentials," Anderson added. "But the point of VCI was never about just empowering individuals with copies of their own treatment history. It was about empowering individuals with copies of their health record and enabling them to tell the story with that vaccination credential to whomever they wanted to."Anderson and Karras's HIMSS22 session, "Immunization Interoperability.

Catalyzing Public Health Data Exchange Locally &. Globally," is scheduled for Thursday, March 17, from 9:30-10:30 a.m. At the Interoperability-Showcase, Hall E-Booth 8240, at the Orange County Convention Center.

Twitter. @MikeMiliardHITNEmail the writer. Mike.miliard@himssmedia.comHealthcare IT News is a HIMSS publication.A new report released this week from Bloomberg Intelligence predicted that the telehealth sector could bring in $20 billion in U.S.

Revenue by 2027. The Digital Reshaping the Health Care Ecosystem publication said that virtual care is set to "become a staple" of healthcare delivery."The antidepressant drugs seroquel has accelerated the adoption of telehealth by years, providing safe and convenient access to telehealth services," said Duane Wright, senior research analyst at Bloomberg Intelligence. "With more major healthcare providers embracing telehealth services, our analysis finds annual revenue growth for top telehealth providers at 30%," Wright said.

Wright and fellow analysts contended that the industry has reached a "sea change" with the public health crisis, with incumbents and large managed-care companies driving the next growth phase. "Virtual care will [increasingly] become the norm, we believe, after the seroquel pushed patients away from in-person visits," read the report. "A reversion to old practices and business models appears impossible to us after the seroquel forced meaningful change across all the key constituents." The analysts highlighted the potential of remote patient monitoring technology and smart devices, including implantable cardiac monitors and continuous glucose monitors.

"The seroquel accelerated the industry's rate of uptake by a factor of years and has created a flywheel effect for the overall virtual ecosystem," they wrote. "The changes in healthcare delivery necessitated by shelter-in-place edicts raised awareness and showcased the capabilities of the virtual channel across both patients and physicians," they added. "This in turn resulted in increased technology investments by providers and health systems, which are increasingly leveraging the assets to provide care and reduce costs." Although the researchers acknowledged the removal of policy roadblocks, they did not go into detail about the roles federal and state legislation may play in telehealth adoption.

They did, however, predict that 15% of total outpatient visits could be virtual within three to five years. "We don't view the 15% estimate as a peak, but rather a waypoint as digital increasingly becomes the front door to healthcare," they wrote. Who are the telehealth 'super utilizers?.

' Interestingly, a report released this week from Trilliant Health took a somewhat more measured view on the future of virtual care. Noting that telehealth use tapered in 2021 from its wild peak at the beginning of the seroquel, researchers for that report observed that women are driving most of the telehealth utilization. The largest percentage (45%) of telehealth patients only had one virtual visit, with about 14% classified as "high" or "super" utilizers with seven or more visits.

Super utilizers are typically on the younger side, and mostly using behavioral health. They are typically geographically concentrated in areas with higher incomes. Analysts noted that "willful endurers" – those living in the "here and now," health-wise – and "self-achievers" – the most proactive when it comes to wellness – are more likely to use virtual care.

From an economic perspective, researchers noted that the number of tech-enabled providers is continuing to grow, with demand likely to decrease post-seroquel.They pointed to Amazon and Walmart as major players who entered the game in 2021, saying that traditional providers are not equipped to compete with retail suppliers. "Our research indicates that consumer preferences and many of the prevailing narratives on the market outlook for telehealth are seemingly incongruent, reinforcing caution for organizations that are planning their virtual care strategies solely based on industry hype," said Sanjula Jain, Trilliant Health chief research officer and senior vice president of market strategy, in a statement. Kat Jercich is senior editor of Healthcare IT News.Twitter.

@kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication.The National Institute of Standards and Technology's National Cybersecurity Center of Excellence published its final guidance this week on securing telehealth and remote patient monitoring ecosystems. The guide is intended, according to NCCoE, to help identify risks associated with RPM architecture and ensure healthcare organizations are partnering with appropriate telehealth platform providers.

"While [healthcare delivery organizations] do not have the ability to manage and deploy privacy and cybersecurity controls unilaterally, they retain the responsibility to ensure that appropriate controls and risk mitigation are applied," wrote researchers. WHY IT MATTERS In order to develop the guidance and demonstrate how organizations can enhance resiliency, NCCoE collaborated with industry partners to build a laboratory environment – specifically, one where a patient is being monitored by an in-home device capturing biometric data.Those partners included Accuhealth, Cisco, Inova, LogRhythm, MedCrypt, MedSec, Onclave Networks, Tenable. University of Mississippi Medical Center and Vivify Health.

"While the NCCoE used a suite of commercial products to address this challenge, this guide does not endorse these particular products, nor does it guarantee compliance with any regulatory initiatives," noted the experts. "Your organization’s information security experts should identify the products that will best integrate with your existing tools and Information Technology system infrastructure," they continued.The practice guide operated under the assumption that the delivery organization is using a separate telehealth platform provider that manages a distinct infrastructure, applications and a set of services. Using the NIST Risk Management Framework, the NIST Cybersecurity Framework, the NIST Privacy Framework and other relevant standards, the NCCoE analyzed risk factors in an RPM ecosystem and identified measures to safeguard it.

It outlined several potential vulnerabilities, including fraudulent uses of health-related information, interruption or inaccuracy of patient diagnoses, disrupted processes and system disruption. "As organizations consider measures to disrupt threats and adverse actions made against the ecosystem, an opportunity exists where organizations examine threats to identify controls that mitigate adverse actions identified by threat modeling," read the report. The guidance authors noted that, although they used cellular data-based biometric devices and addressed those using broadband communications, a future build may also implement an electronic health record system that would receive automated data from the telehealth platform provider.

"The future build may include direct messaging from the RPM systems to the EHR," they wrote. THE LARGER TREND NIST has been offering tips around cybersecurity and telehealth deployments for years.NIST IT Security Specialist Nakia Grayson, who co-authored the guidance, told Healthcare IT News Executive Editor Mike Miliard in April 2021 that the agency began the work in response to an uptick in patient and provider interest in virtual care, particularly amidst the antidepressant drugs seroquel. "Without adequate privacy and cybersecurity measures, unauthorized users may expose a patient's sensitive data or disrupt the patient monitoring system," Grayson said in a HIMSSTV interview.

ON THE RECORD "Technology solutions alone may not be sufficient to maintain privacy and security controls on external environments," wrote NCCoE experts. "This practice guide notes the application of people, process and technology as necessary to implement a holistic risk mitigation strategy," they continued. Kat Jercich is senior editor of Healthcare IT News.Twitter.

@kjercichEmail. Kjercich@himss.orgHealthcare IT News is a HIMSS Media publication..