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, HHS announced more than $413 million in Provider Relief Fund (PRF) payments to more than 3,600 providers across the country. Read more about this announcement and other news below.
I. Regulations, Notices & Guidance
- On March 21, 2022, the Administration for Children and Families issued a request for information entitled, Technical Assistance Needs and Priorities on Implementation and Coordination of Early Childhood Development Programs in American Indian and Alaska Native Communities. Through this Request for Information (RFI), ACF seeks to further the development, implementation, and coordination of early childhood development programs in American Indian and Alaska Native (AI/AN) communities, by soliciting information and recommendations from a broad array of individuals and organizations with knowledge and expertise around the context and needs of tribal communities and early childhood programs.
- On March 21, 2022, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) entitled, Certain Medical Devices During COVID-19. FDA is announcing the issuance of EUAs for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency.
- On March 22, 2022, FDA issued a final guidance entitled, Certain Ophthalmic Products, Policy Regarding Compliance. This guidance describes FDA's compliance policy with respect to the requirements of FDA regulations that are now applicable to ophthalmic drugs that are packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic use.
- On March 22, 2022, FDA issued a notice with a request for comments entitled, Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket to solicit comments that will assist FDA in determining how best to prioritize the addition of maximum daily exposure (MDE) information for inactive ingredients that do not currently include MDE information in the Center for Drug Evaluation and Research's Inactive Ingredient Database (IID) and whether to restructure the IID by removing dosage form information.
- On March 22, 2022, the Occupational Safety and Health Administration (OSHA) issued a notice entitled, Occupational Exposure to COVID-19 in Healthcare Settings. OSHA is partially reopening the comment period to allow for additional public comment on specific topics and is scheduling an informal public hearing on its interim final rule establishing an Emergency Temporary Standard (ETS), "Occupational Exposure to COVID-19." The public hearing will begin on April 27, 2022.
- On March 24, 2022, the Department of Veterans Affairs (VA) issued an extension of comment period for a proposed rule entitled, VA Pilot Program on Graduate Medical Education and Residency. The VA is extending the comment period of the proposed rule "Pilot Program on Graduate Medical Education and Residency." This action is being taken in response to requests from stakeholders to allow additional time for interested persons to submit comments on the proposed rule.
- On March 25, 2022, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to Serve on the Advisory Committee on Heritable Disorders in Newborns and Children. HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). ACHDNC provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS.
- On March 25, 2022, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Organizational Representatives to the Advisory Committee on Heritable Disorders in Newborns and Children. HRSA is seeking nominations from organizations to send representatives to be a liaison to the ACHDNC. Selections will be based on a review of the organization's subject area of expertise, mission, relevancy, and benefit provided relative to the Committee's purpose. The organizational representatives are non-voting liaisons.
- March 28-29, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Cancer Institute Board of Scientific Advisors. The agenda will include the Director's Report; RFA, RFP, and PAR Concept Reviews; and Scientific Presentations.
- March 30, 2022: The Department of Defense (DOD) announced a public meeting of the Defense Health Board. The DHB provides independent advice and recommendations to maximize the safety and quality of, as well as access to, health care for DoD health care beneficiaries. The purpose of the meeting is to provide briefings to DHB members on current issues related to military medicine and upcoming DHB taskings.
- April 5-7, 2022: VA announced a public meeting of the Veterans' Rural Health Advisory Committee. The agenda will include updates from Department leadership; the Executive Director, VA Office of Rural Health; and the Committee Chair; as well as presentations by subject matter experts on general rural health care access.
- April 6, 2022: FDA announced a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. This meeting will be held to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants.
- April 7, 2022: The Centers for Medicare & Medicaid Services (CMS) announced the next meeting of the Advisory Panel on Outreach and Education (APOE). The Panel advises and makes recommendations to the Secretary of HHS and the Administrator of 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).
- April 7, 2022: NIH issued an amended notice for a public meeting of the National Heart, Lung, and Blood Institute Sleep Disorders Research Advisory Board. The meeting is being amended to change the telephone call in number.
- April 27-28, 2022: HHS announced a public meeting of the Tick-Borne Disease Working Group. For this meeting, the TBDWG will be discussing and voting on recommendations for the 2022 TBDWG Report to the HHS Secretary and Congress.
- May 2-3, 2022: HHS announced a public meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development National Advisory Board on Medical Rehabilitation Research. The agenda will include the NICHD Director's report; NCMRR Director's report; Research talk on Peripheral Nerve Regeneration; Concept Clearance; Mini Symposium on Assessments for Rehabilitation (neurophysiologic and clinical measures).
- Various Dates: HRSA announced a public meeting of the National Advisory Committee on Rural Health and Human Services (NACRHHS). NACRHHS will discuss two topics during the meeting: access to Emergency Medical Services in Rural America and Rural Human Services Programs and Issues.
- Various Dates: The Federal Emergency Management Agency (FEMA) announced that it is holding meetings under the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID-19 and the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Drug Products, Drug Substances, and Associated Medical Devices to Respond to COVID-19, in order to implement the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic.
II. Congressional Hearings
- On March 21, 2022 through March 24, 2022, the Senate Committee on the Judiciary held four hearings on the Nomination of Ketanji Brown Jackson to be an Associate Justice of the Supreme Court of the United States. Witnesses present included: the Honorable Ketanji Brown Jackson.
- On March 23, 2022, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Strengthening Federal Mental Health and Substance Use Disorder Programs: Opportunities, Challenges, and Emerging Issues. Witnesses present included: Miriam E. Delphin-Rittmon, PhD, Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMSHA), Rockville, MD; Carole Johnson, Administrator, Health Resources and Services Administration (HRSA), Rockville, MD; Joshua A. Gordon, M.D., PHD, Director, National Institutes of Mental Health (NIMH), National Institutes of Health (NIH), Bethesda, MD; and Nora D. Volkov, M.D., Director, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).
- On March 23, 2022, the Senate Special Committee on Aging held a hearing entitled, An Economy That Cares: The Importance of Home-Based Services. Witnesses present included: Ms. Lisa Harootunian, Associate Director, Health Program, Bipartisan Policy Center; Ms. Anne Tumlinson, CEO, ATI Advisory and Founder, Daughterhood; Mr. Brandon Kingsmore, Disability Advocate, Public Speaker and Accompanied by Ms. Lynn Weidner, Home Care Worker, United Homecare Workers of Pennsylvania – SEIU Healthcare PA; and Ms. Alene Shaheed, Home Care Recipient and Former Florida Health Justice Project Client.
III. Reports, Studies & Analyses
- On March 21, 2022, Alston & Bird published an advisory entitled, Blockchain & Digital Assets Advisory: Breaking Down Key Areas of Biden's Executive Order on Ensuring Responsible Development of Digital Assets. President's Biden's whole-of-government approach is evident in his Executive Order managing the latest issues surrounding digital assets. In this advisory, Alston & Bird's Blockchain and Digital Assets Team unravels the myriad legal issues across cybersecurity, the payments industry, financial services, environmental concerns, and white collar crime.
- On March 24, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, How Does Use of Mental Health Care Vary by Demographics and Health Insurance Coverage?. In this issue brief, KFF explores how the use of mental health care varied across populations reporting poor mental health before the pandemic using data from the National Health Interview Survey (NHIS) in 2019. In this analysis, KFF finds that leading up to the pandemic, 8.5 million adults reported moderate to severe symptoms of anxiety and/or depression but did not receive treatment either through therapy or prescription drugs in the past year. Among adults reporting moderate to severe symptoms of anxiety and/or depression, receipt of mental health treatment was lowest among several demographic groups – including young adults, Black adults, men, and uninsured people. These data provide a useful baseline for understanding disparities in mental health treatment that were already present before the pandemic, and may have been exacerbated by the public health crisis.
- On March 24, 2022, KFF published an issue brief entitled, Out-of-pocket spending on insulin among people with private insurance. Several legislative proposals in Congress propose a $35 per month cap on what people with health insurance would have to pay out of pocket for insulin, a life-saving hormone taken regularly by many people with diabetes to maintain their health. In this analysis, KFF looks at claims data from private health plans to assess how many insulin users might save money with a $35 monthly cap on out-of-pocket costs in the individual, small group and large group markets. This analysis of insurance claims data finds that such a cap could provide financial relief to at least 1 out of 5 insulin users with different types of private health insurance.
IV. Other Health Policy News
- On March 18, 2022, HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced three funding opportunities to strengthen mental health and substance use services for individuals at risk for or living with HIV/AIDS. Totaling $43.7 million dollars, the funding opportunities reflect the Biden-Harris Administration's commitment to providing accessible, evidence-based, culturally appropriate substance use prevention, treatment and recovery services to all as part of HHS's new Overdose Prevention Strategy. Funding will be awarded in the fall. The grants, which are being deployed to help underserved communities, are supported by the Minority AIDS Initiative and align with the Administration's priority of health equity. The funding targets areas of the country with the greatest disparities in HIV-related health outcomes and aligns with the National HIV AIDS Strategy. More information on this funding can be found here.
- On March 22, 2022, HHS, through the Health Resources and Services Administration (HRSA), announced more than $413 million in Provider Relief Fund (PRF) payments to more than 3,600 providers across the country. This is the fourth round of PRF Phase 4 payments, totaling nearly $12 billion that has been distributed to more than 82,000 providers in all 50 states, Washington D.C., and five territories since November 2021. This is in addition to HRSA's distribution of American Rescue Plan (ARP) Rural payments totaling nearly $7.5 billion in funding to more than 44,000 providers across the country over the past four months. More information on this announcement can be found here.
- On March 23, 2022, HHS released a new report highlighting data on the 2022 Open Enrollment Period and key health care coverage gains made under the Biden-Harris Administration. The "State of the ACA" report, published by CMS, shows that the Affordable Care Act is at the strongest it has ever been. Nationwide, 2.8 million more consumers are receiving tax credits in 2022 compared to 2021. Nearly 6 million new consumers signed up for coverage through the Marketplaces nationwide during the 2021 Special Enrollment Period (SEP) and this year's Open Enrollment Period (OEP). This includes 2.8 million people who newly enrolled during the SEP and more than 3 million who newly enrolled during the OEP. More information on this report can be found here. The full report can be found here.
- On March 24, 2022, HHS, through SAMHSA, announced two Certified Community Behavioral Health Clinics (CCBHCs) funding opportunities to expand and increase access to evidence-based mental health and substance use services for all Americans. This includes providing essential mental health services—such as 24-hour mobile crisis teams, screening, and case management—to vulnerable communities that would otherwise lack access to services. Totaling more than $300 million, these funding opportunities reflect the Biden-Harris Administration's commitments to addressing the nation's mental health crisis and overdose epidemic as part of the President's Unity Agenda. More information on these announcements can be found here.
- On March 24, 2022, HHS Secretary Xavier Becerra and U.S. Education Department (ED) Secretary Miguel A. Cardona reaffirmed their commitment to children and youth by launching a joint-department effort to expand school-based health services, ensuring children have the health services and supports necessary to build resilience and thrive. The COVID-19 pandemic has challenged the health and wellbeing of the Nation's children and youth and further exacerbated preexisting inequities. HHS and the ED have joined together to provide additional technical assistance, resources and support to schools that will provide guidance on the federal funding available for school-based physical and behavioral health services, including how Medicaid can support the delivery of these services; help reduce federal administrative burden for states and localities, including local educational agencies, and barriers to the provision of school-based physical and behavioral health services; and improve and strengthen access to physical and behavioral health services. More information on this effort can be found here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.