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, the Food and Drug Administration (FDA) authorized booster shots of Moderna and Johnson & Johnson's COVID-19 vaccines for certain populations. Read more about this action and other news below.

I. Regulations, Notices & Guidance

  • On October 18, 2021, the Office of Personnel Management (OPM) issued a proposed rule entitled, FEDVIP: Extension of Eligibility to Certain Employees on Temporary Appointments and Certain Employees on Seasonal and Intermittent Schedules; Enrollment Clarifications and Qualifying Life Events. This proposed rule expands eligibility for FEDVIP to certain Federal employees on temporary appointments and certain employees on seasonal and intermittent schedules that became eligible for Federal Employees Health Benefits (FEHB) enrollment beginning in 2015. This rule also expands access to FEDVIP benefits to certain firefighters on temporary appointments and intermittent emergency response personnel who became eligible for FEHB coverage in 2012. This rule also updates the provisions on enrollment for active duty service members who become eligible for FEDVIP as uniformed service retirees pursuant to the National Defense Authorization Act of 2017 (FY17 NDAA). In addition, this rule proposes to add qualifying life events (QLEs) for enrollees who may become eligible for and enroll in dental and/or vision services from the Department of Veterans Affairs (VA).
  • On October 19, 2021, the Food and Drug Administration (FDA) issued a final rule entitled, New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship.  FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 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.
  • On October 19, 2021, FDA issued a proposed rule entitled, Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.  FDA is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids, specifically: define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types.
  • On October 19, 2021, FDA issued draft guidance entitled, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. FDA is issuing this updated draft guidance, which supersedes the November 7, 2013, draft guidance. This updated draft guidance is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products.
  • On October 19, 2021, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures.  HHS is proposing to repeal two final rules: "Department of Health and Human Services Good Guidance Practices" and "Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions."
  • On October 20, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Extension of Timeline to Finalize a Rulemaking.  This document announces an extension of the timeline for publication of a Medicare final rule in accordance with the Act, which allows CMS to extend the timeline for publication of the "Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021" final rule under exceptional circumstances.
  • On October 21, 2021, FDA issued draft guidance entitled, Data Standards for Drug and Biological Product Submissions Containing Real-World Data.  This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog (Catalog). FDA is publishing this draft guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making.
  • On October 22, 2021, CMS issued a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2022.  This notice announces a $631.00 calendar year (CY) 2022 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2022 and on or before December 31, 2022.

Event Notices

  • October 26, 2021:  The National Institutes of Health (NIH) announced an amended meeting time for the meeting of the National Heart, Lung, and Blood Advisory Council. The public session is changed from October 26, 2021, 10:00 AM to October 26, 2021, 05:00 PM.
  • November 1, 2021: NIH announced a public meeting of the Board of Scientific Counselors, National Institute on Deafness and Other Communication Disorders. The agenda for the public session includes staff reports on divisional, programmatical, and special activities.
  • November 2-3, 2021:  The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The committee is charged with advising the Director, CDC, on the use of immunizing agents. The agenda will include discussions on adult immunization schedule, child/adolescent immunization schedule, Ebola vaccine, hepatitis vaccines, Orthopoxviruses vaccine and COVID vaccines.
  • November 22, 2021: NIH announced a public meeting of the Interagency Pain Research Coordinating Committee. The meeting will cover committee business items including updates on pain workforce enhancement and pain research concepts. It will include follow up of IPRCC recommendations and member updates.
  • December 2, 2021: NIH announced a public meeting of the Sleep Disorders Research Advisory Board of the National Heart, Lung, and Blood Institute. The purpose of this meeting is to update the Advisory Board and public stakeholders on the research agenda across NIH for the upcoming fiscal year, and the activities of professional societies.
  • December 8, 2021:  CDC announced a public meeting of the Advisory Board on Radiation and Worker Health. The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program.
  • December 9, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include information on support for the mission and work of the Committee, federal advances to address challenges in substance use disorder (SUD); nonfederal advances to address challenges in SUD.

II. Congressional Hearings

U.S. House of Representatives

  • On October 20, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Enhancing Public Health: Legislation to Protect Children and Families.  Legislation discussed included: H.R. 623, the Gabriella Miller Kids First Research Act 2.0; H.R. 1193, the Cardiovascular Advances in Research and Opportunities Legacy Act  (CAROL Act); H.R. 1956, the Increasing Access to Quality Cardiac Rehabilitation Care Act of 2021; H.R. 2161, the Children and Media Research Advancement Act"  (CAMRA Act); H.R. 3749, the Katherine's Law for Lung Cancer Early Detection and Survival Act of 2021; H.R. 4555, the Oral Health Literacy and Awareness Act of 2021; H.R. 4612, the Protecting Access to Lifesaving Screenings Act of 2021 (PALS Act); 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; H.R. 5552, the Lead Poisoning Prevention Act; H.R. 5558, the Prostate Cancer Prevention Act; and H.R. 5561, the Early Hearing Detection and Intervention Reauthorization Act. Witnesses present included: Bruce L. Cassis, D.D.S., M.A.G.D., President, Academy of General Dentistry; Raymond DuBois, M.D., Ph.D., Former President, American Association for Cancer Research; Donald M. Lloyd-Jones, M.D.,Sc.M, President, American Heart Association; Ellyn Miller, President and Founder, Smashing Walnuts Foundation; Rick Nolan, Former U.S. Representative (D-MN); Jenny Radesky, M.D., Assistant Professor of Pediatrics, University of Michigan Medical School; and Stacey Stewart, President and CEO, March of Dimes.

U.S. Senate

  • On October 20, 2021, the Senate Committee on Finance held a hearing entitled, Health Insurance Coverage in America: Current and Future Role of Federal Programs.  Witnesses present included: The Honorable Rick Scott, U.S. Senator, Florida; The Honorable Raphael Warnock, U.S. Senator, Georgia; Frederick Isasi, J.D., MPH, Executive Director, Families USA; Douglas Holtz-Eakin, Ph.D., President, American Action Forum; Sara Collins, Ph.D., Vice President for Health Care Coverage and Access, The Commonwealth Fund; and Linda Blumberg, Ph.D., Institute Fellow, Urban Institute.

III. Reports, Studies & Analyses

  • On October 18, 2021, the Government Accountability Office (GAO) published a report entitled, Rare Diseases: Although Limited, Available Evidence Suggests Medical and Other Costs Can Be Substantial.  GAO found that diagnosis of any disease can be complicated, and diagnosis of rare diseases can be particularly difficult because of a variety of factors. Those with undiagnosed, misdiagnosed, or untreated rare diseases may face various negative outcomes. For example, a person's health can suffer when appropriate, timely interventions are not provided or when interventions based on misdiagnoses cause harm. In addition, multiple diagnostic tests, medical appointments, and ultimately unwarranted interventions can add to the costs of the disease. Research on the costs of rare diseases is limited, in part because of the difficulty of diagnosing them. Nonetheless, the costs can be substantial, and can include direct medical costs, direct nonmedical costs, or indirect costs.
  • On October 18, 2021, the HHS Office of Inspector General (OIG) published a report entitled, Most Medicare beneficiaries received telehealth services only from providers with whom they had an established relationship.  HHS OIG found that most beneficiaries received telehealth services from providers with whom they had an established relationship. Notably, 84 percent of beneficiaries received telehealth services only from providers with whom they had an established relationship. Those enrolled in traditional Medicare were more likely to receive services from providers with whom they had an established relationship, compared to beneficiaries in Medicare Advantage. This pattern persisted among virtually all of the most common telehealth services.
  • On October 19, 2021, the Congressional Budget Office (CBO) published a cost estimate report entitled, Provisions in Reconciliation Legislation That Would Affect Health Insurance Coverage of People Under Age 65.  The relevant sections would extend eligibility for and increase the amount of premium tax credits and cost-sharing reductions available for health insurance through the marketplaces established under the Affordable Care Act (ACA). They also would establish a federal Medicaid program for states that have not expanded Medicaid under the ACA.
  • On October 20, 2021, the RAND Corporation published a report entitled, Transforming Public Health Data Systems: White Papers to Inform Commission. To work toward a modernized health data system, the Robert Wood Johnson Foundation (RWJF) established a National Commission to Transform Public Health Data Systems to reimagine how data are collected, shared, and used, and identify the investments needed to improve health equity. RWJF commissioned the RAND Corporation to produce a series of white papers that anchored this process by describing the current landscape, emerging innovations, and the opportunities for transforming and transitioning to a new public health data system.
  • On October 21, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Tracking Social Determinants of Health During the COVID-19 Pandemic. This brief provides an overview of social determinants of health and a look at how adults are faring across an array of measures as of September 2021 when a portion of the population remained unvaccinated, and hospitalizations and deaths due to the delta variant are surging in some areas even as they wane in others.

IV. Other Health Policy News

  • On October 15, 2021, CMS announced that Medicare Open Enrollment begins October 15, 2021, and now is the time for people with Medicare to review their coverage options and make a choice that meets their health care needs. Medicare's Open Enrollment period gives those who rely on Medicare the opportunity to make changes to their health plans or prescription drug plans, pick a Medicare Advantage Plan, or return to Original Medicare. The Medicare Open Enrollment period occurs every year from October 15 through December 7, with coverage changes taking effect January 1. During this time, people can find a plan that better meets their needs, saves money, or both. More information about this announcement can be found here.
  • On October 20, 2021, FDA took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose of the Moderna COVID-19 Vaccine and the Janssen (Johnson and Johnson) COVID-19 Vaccine; and to allow the use of each of the available COVID-19 vaccines as a heterologous (or "mix and match") booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. More information on this action can be found here.
  • On October 21, 2021, CDCendorsed the CDC Advisory Committee on Immunization Practices' (ACIP) recommendation for a booster shot of COVID-19 vaccines in certain populations. The FDA's authorization and CDC's recommendation for use are important steps forward as CDC works to stay ahead of the virus and keep Americans safe. More information about this announcement can be found here.
  • On October 21, 2021, HHS announced that, in partnership with the Department of Defense, it has awarded over $562 million to a dozen U.S. companies to support manufacturing of supplies like pipette tips, protective packaging, swabs, and reagents used to detect the virus in samples. Supporting manufacturing of needed products like these will help strengthen the supply chain for COVID-19 tests, including rapid at-home tests, with the goal of increasing supply and availability of tests that are high quality and easy to use. These investments come on the heels of President Biden's recent announcements to make testing more available to Americans. Last month, he announced the Administration would invest a total of $3 billion in rapid testing in order to quadruple the supply of at-home tests by December, as well as increase the number of no-cost testing sites, including up to 30,000 pharmacies next month. More information on this announcement can be found here.
  • On October 21, 2021, CMS announced that it launched a new "one-stop shop" for state Medicaid agencies and stakeholders on Medicaid.gov to advance transparency and innovation for home and community-based services. Home and community-based services allow people enrolled in Medicaid to receive services and supports in a preferred setting outside of an institution, such as in their own home. Through this new webpage, state Medicaid agencies and stakeholders can access information about states' plans to enhance, expand, and strengthen home and community-based services across the country using new Medicaid funding made available by the American Rescue Plan Act of 2021 (ARP). More information about this announcement can be found here.
  • On October 21, 2021, CMS announced that the "Medicare & You" handbook is now available in Chinese, Korean, and Vietnamese. The handbook is being released as part of this year's Medicare Open Enrollment Period, which kicked off on October 15, 2021, and ends on December 7, 2021, and provides essential information on enrollment, program benefits, coverage options, and rights. Asian Americans currently represent the fourth largest demographic enrolled in Medicare. This action will provide many of these consumers – along with many who have not yet enrolled – crucial assistance in their preferred languages. More information about this announcement can be found here.

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