United States: Alston & Bird Health Care Week In Review, November 5, 2021

Below is Alston & Bird's Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, CMS released two annual payment final rules, and the Biden administration issued two interim final rules on COVID-19 vaccination requirements. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On November 1, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, 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, and End-Stage Renal Disease Treatment Choices Model. This final rule updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule updates requirements for the ESRD Quality Incentive Program (QIP), including a measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) as well as suppression of individual ESRD QIP measures for Payment Year (PY) 2022 under the measure suppression policy. This rule also finalizes that CMS will not score facilities or reduce payment to any facility under the ESRD QIP in PY 2022. Further, this rule finalizes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries.
• On November 3, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled, Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff. This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On November 3, 2021, FDA issued final guidance entitled, Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers. The guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components. The guidance, in a question-and-answer format, addresses the most frequently asked questions concerning implementation of the INTERCEPT® Blood System for Platelets and Plasma. The guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device.
• On November 3, 2021, CMS issued a final rule entitled, Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities. This final rule updates the home health and home infusion therapy services payment rates for CY 2022 in accordance with existing statutory and regulatory requirements. This rule also finalizes recalibration of the case-mix weights and updates the functional impairment levels, and comorbidity adjustment subgroups while maintaining the current low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rule finalizes a policy to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts and makes conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. It also finalizes proposed changes to the Home Health Quality Reporting Program (QRP) including finalizing proposed measure removals and adoptions, public reporting, and modification of effective dates. It also finalizes proposed modifications to the effective date for the reporting of measures and certain standardized patient assessment data in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH) QRP. In addition, this final rule codifies certain Medicare provider and supplier enrollment policies. It also makes permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE), and updates the home health conditions of participation regarding occupational therapists assessment completion to implement provisions of the Consolidated Appropriations Act, 2021 (CAA 2021). This final rule also finalizes proposals to expand the Home Health Value-Based Purchasing (HHVBP) Model and to end the original HHVBP Model one year early. Lastly, it establishes survey and enforcement requirements for hospice programs as set forth in the CAA 2021; and finalizes revisions to the infection control requirements for long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as "nursing homes") that will extend the mandatory COVID-19 reporting requirements beyond the current COVID-19 PHE until December 31, 2024.
• On November 3, 2021, CMS issued a final rule entitled, Medicare Program; CY 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-payment Medical Review Requirements. This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and postpayment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA-PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.
• On November 3, 2021, CMS issued a final rule with comment period entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model. This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2022 based on our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, updates Hospital Price Transparency requirements, and updates and refines the design of the Radiation Oncology Model.
• On November 3, 2021, CMS issued an interim final rule with comment period entitled, Medicare Program; Opioid Treatment Programs: CY 2022 Methadone Payment Exception. This interim final rule with comment period (IFC) freezes the payment to Opioid Treatment Programs for methadone in CY 2022 at the CY 2021 rate because it would not be appropriate to implement a decrease to the rate when substance use and overdoses have been exacerbated by the COVID-19 pandemic.
• On November 3, 2021, the Centers for Disease Control and Prevention (CDC) issued an amended order entitled, Amended Order Implementing Presidential Proclamation on Advancing the Safe Resumption of Global Travel During the COVID-19 Pandemic. On October 25, 2021, the President issued a Proclamation, "Advancing the Safe Resumption of Global Travel During the COVID-19 Pandemic." Pursuant to this Proclamation, the President has implemented a global suspension and restriction on entry for noncitizens who are nonimmigrants seeking to enter the United States by air travel and who are not fully vaccinated against COVID-19. The Proclamation directs the Secretary of Health and Human Services (HHS), through the Director of the Centers for Disease Control and Prevention (CDC), to implement the Proclamation as it applies to public health. As such, CDC announces an Amended Order implementing the Proclamation requiring noncitizens who are nonimmigrants seeking to enter the United States by air travel to provide proof of being fully vaccinated against COVID-19 prior to boarding an aircraft to fly to the United States, with only limited exceptions in accordance with the Proclamation.
• On November 3, 2021, CDC issued an amended order entitled, Requirement for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery from COVID-19 for All Airline or Other Aircraft Passengers Arriving into the United States from Any Foreign Country. CDC announces an Amended Order requiring negative pre-departure COVID-19 test results or documentation of recovery from COVID-19 for all airline or other aircraft passengers arriving into the United States from any foreign country.
• On November 4, 2021, CMS issued an interim final rule with comment period entitled, Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination. This interim final rule with comment period revises the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs. These changes are necessary to help protect the health and safety of residents, clients, patients, PACE participants, and staff, and reflect lessons learned to date as a result of the COVID-19 public health emergency. The revisions to the requirements establish COVID-19 vaccination requirements for staff at the included Medicare- and Medicaid-certified providers and suppliers.
• On November 4, 2021, the Department of Labor (DOL), through the Occupational Safety and Health Administration (OSHA), issued an interim final rule entitled, COVID-19 Vaccination and Testing; Emergency Temporary Standard. OSHA is issuing an emergency temporary standard (ETS) to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination. Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.
• On November 5, 2021, FDA issued an amended final rule entitled, New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address. FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.

• November 17, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an introduction of new NAC members and then an update on AHRQ's Subcommittee of the National Advisory Council (SNAC) on Healthcare Quality Measurement. The agenda will also include a discussion on primary care.
• November 29, 2021: The National Institutes of Health (NIH) announced a public meeting of the National Institute of Neurological Disorders and Stroke. The meeting will discuss concept clearance of proposed initiatives.
• December 6-7, 2021: NIH announced a public meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The agenda includes the NICHD Director's report; NCMRR Director's report; Highlighting Pediatric Rehabilitation and Robotics; Concept Clearance; Highlighting Caregiving during COVID; Progress on the NIH Rehabilitation Research Plan; Updates on Equity, Diversity, and Inclusion (NICHD STRIVE initiative); NIH Common Fund Activities; Highlighting Wearable Technologies and Data Analysis; and Agenda Planning for Next Board Meeting in May 2022.
• December 9, 2021: NIH announced a public meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities.
• December 14, 2021: CDC announced a public meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). The Council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis (TB).
• December 16, 2021: HHS announced a public meeting of the National Biodefense Science Board (NBSB). The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
• December 16, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will provide information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
• January 25-26, 2022: NIH announced a public meeting of the National Advisory Council on Aging. The agenda will feature a call to order and report from the Director; discussion of future meeting dates; consideration of minutes of last meeting; reports from Task Force on Minority Aging Research, Working Group on Program; Council Speaker; and Program highlights.

II.  Congressional Hearings

U.S. House of Representatives

• On November 4, 2021, the House Committee on Energy & Commerce held a markup of nine bills that invest in public health and provide resources and support to caregivers, providers, and patients. Legislation under consideration included: H.R. 1193, the Cardiovascular Advances in Research and Opportunities Legacy Act; H.R. 1667, the Lorna Breen Health Care Provider Protection Act; H.R. 3297, the Public Health Workforce Loan Repayment Act of 2021; H.R. 3320, the Allied Health Workforce Diversity Act of 2021; H.R. 3537, the Accelerating Access to Critical Therapies for ALS Act; H.R. 4555, the Oral Health Literacy and Awareness Act of 2021; H.R. 5487, the Stillbirth Health Improvement and Education for Autumn Act of 2021 (SHINE for Autumn Act of 2021); H.R. 5551, the Improving the Health of Children Act; and H.R. 5561, the Early Hearing Detection and Intervention Reauthorization Act.
• On November 4, 2021, the House Committee on the Judiciary held a hearing entitled, The Texas Abortion Ban and its Devastating Impact on Communities and Families. Witnesses present included: Khiara M. Bridges, J.D., Professor of Law, University of California, Berkeley School of Law; Catherine Glenn Foster, M.A., J.D., President & CEO, Americans United for Life; Dr. Ghazaleh Moayedi, DO, OB/GYN, Board Member, Physicians for Reproductive Health, Board Member, Texas Equal Access Fund; and Stephanie Loraine Pineiro, MSW, Co-Executive Director, Florida Access Network.

U.S. Senate

• On November 4, 2021, the Senate Committee on Health, Education, Labor, & Pensions (HELP) held a hearing entitled, Next Steps: The Road Ahead for the COVID-19 Response. Witnesses present included: Rochelle Walensky, MD, MPH, Director, United States Centers for Disease Control and Prevention; Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Janet Woodcock, MD, Acting Commissioner, United States Food and Drug Administration; and Dawn O'Connell, Assistant Secretary for Preparedness and Response, United States Department of Health and Human Services.

III. Reports, Studies & Analyses

• On November 2, 2021, the Congressional Budget Office (CBO) published a presentation entitled, CBO's Budget and Economic Analysis During the Pandemic. Phillip Swagel, Director of the CBO, outlined the agency's budget and economic analysis during the 2020-2021 coronavirus pandemic and described some of the challenges involved in analyzing current economic policy. His remarks focused on CBO's analysis of health policy, the macroeconomic effects of the legislative response to the pandemic, and labor market issues arising from the response and recovery. He also discussed the long-term effects of the recovery on economic growth, jobs, wages, productivity, and climate change.
• On November 2, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicare Part D: A First Look at Medicare Prescription Drug Plans in 2022. During the Medicare open enrollment period from October 15 to December 7 each year, beneficiaries can enroll in a plan that provides Part D prescription drug coverage, either a stand-alone prescription drug plan (PDP) as a supplement to traditional Medicare, or a Medicare Advantage prescription drug plan (MA-PD), which covers all Medicare benefits, including drugs. This issue brief provides an overview of the Medicare Part D marketplace in 2022 and key trends over time, focusing primarily on stand-alone PDPs.
• On November 4, 2021, the Government Accountability Office (GAO) published a report entitled, COVID-19: HHS Agencies' Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives. This report examines (1) stakeholder perspectives on federal programs to distribute and administer COVID-19 vaccines, (2) efforts to inform health officials, providers, and the public about vaccination, and (3) actions HHS agencies are taking to evaluate their vaccine implementation efforts.
• On November 4, 2021, KFF published an issue brief entitled, Rapid Home Tests for COVID-19: Issues with Availability and Access in the U.S. In the brief, KFF examines the various interrelated factors that have contributed to rapid home test scarcity in the U.S. and the barriers that have contributed to the scarcity of rapid home COVID-19 tests in the U.S. Notably, KFF identified the following factors: (1) the regulatory framework; (2) supply chain and the unpredictability of demand; (3) federal investment; (4) federal messaging and guidance; and (5) cost and coverage.

IV.  Other Health Policy News

• On November 1, 2021, HHS announced the start of the HealthCare.gov Open Enrollment Period. This year, on top of providing health care plans at record-low costs, the Biden-Harris Administration has extended the Marketplace Open Enrollment Period by 30 days through January 15 to ensure everyone possible has enough time to get covered. To help communities with disproportionately high uninsurance rates, the Biden-Harris Administration has quadrupled its Navigator footprint of people who can assist with the process of getting covered. More information about this announcement can be found here.
• On November 3, 2021, following FDA's recent action authorizing the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in children 5 through 11 years of age and a recommendation from the Centers for Disease Control and Prevention (CDC), CMS announced it is reminding eligible consumers that coverage is available without cost-sharing under Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and in the commercial market for this critical protection from the virus. As with all vaccines, the Pfizer-BioNTech COVID-19 Vaccine was tested thoroughly in this age group prior to its authorization for emergency use. While the effects of COVID-19 for a child can last for several months, the most commonly reported side effects of the COVID-19 vaccine in the clinical trial participants were generally mild to moderate in severity, and most went away within one to two days. More information about this announcement can be found here.
• On November 4, 2021, the Indian Health Service announced $46.4 million in funding opportunities to address suicide, domestic violence, and substance abuse, and supporting an integrative approach to the delivery of behavioral health services for American Indians and Alaska Natives. More information about this funding can be found here.

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