Health Care Week in Review March 31, 2023

Health Care Week in Review: Senate Votes to End COVID-19 National Emergency, CMS Releases Rate Notice

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care 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 U.S. Senate passed a bill ending the COVID-19 National Emergency Declaration and CMS released the CY 2024 Medicare Advantage and Medicare Part D Rate Notice. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

Event Notices

  • April 14, 2023: FDA announced a joint public meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS). The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The committees will discuss supplemental new drug application (sNDA) 205422 s009, efficacy supplement for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer’s dementia.
  • April 24, 2023: The National Institutes of Health (NIH) announced a public meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). DMICC meetings, held several times a year, provide an opportunity for Committee members to learn about and discuss current and future diabetes programs in DMICC member organizations and to identify opportunities for collaboration. The topic for this meeting will be “Type 1 Diabetes (T1D): Evolving Concepts in the Pathophysiology, Screening and Prevention”.
  • April 26-28, 2023: The Health Resources and Services Administration (HRSA) announced a public meeting of the National Advisory Committee on Rural Health and Human Services (NACRHHS). The meeting will take place over the course of three days in Bend, Oregon and include discussion of rural health issues.
  • May 4, 2023: 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.
  • May 9-10, 2023: FDA announced a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC). The committees will discuss supplemental new drug application (sNDA) 017031/S-041, for OPILL (norgestrel) Tablet, 0.075 mg, submitted by Laboratoire HRA Pharma. OPILL is proposed for nonprescription use as a once daily oral contraceptive to prevent pregnancy.
  • May 10, 2023: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The agenda will include discussions on current topics related to breast cancer in young women. These will include mental/behavioral health, sexual health, genetics and genomics, and provider engagement.
  • May 11, 2023: FDA announced a public meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC). The committee will discuss new drug application (NDA) 214697, for epinephrine nasal spray, submitted by ARS Pharmaceuticals Inc., for the proposed indication of emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children ≥ 30 kilograms.
  • May 24-25, 2023: HRSA announced a public meeting of the National Advisory Council on Migrant Health (NACMH). NACMH provides advice and recommendations to the HHS Secretary on policy, program development, and other matters of significance concerning the activities under section 217 of the Public Health Service (PHS) Act. During the May 24-25, 2023, meeting, NACMH will discuss issues related to migratory and seasonal agricultural worker health.

II. Hearings & Markups

U.S. House of Representatives

  • On March 28, 2023, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education held a hearing entitled, Budget Hearing – Fiscal Year 2024 Request for the Department of Health and Human Services. The witness for the hearing was the Honorable Xavier Becerra, Secretary, HHS.
  • On March 28, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care. Witnesses present included: Chris Severn, Co-Founder & Chief Executive Officer (CEO), Turquoise Health; Matthew Forge, CEO, Pullman Regional Hospital; Marilyn Bartlett, Senior Policy Fellow, National Association of State Health Policy; Sophia Tripoli, Director of Health Care Innovation, Families USA; and Dr. Benedic Ippolito,Senior Fellow in Economic Policy Studies, American Enterprise Institute.
  • On March 28, 2023, the House Committee on Ways and Means held a hearing entitled, Hearing on President Biden’s Fiscal Year 2024 Budget Request with Health and Human Services Secretary Becerra. The witness for the hearing was the Honorable Xavier Becerra, Secretary, HHS.
  • On March 29, 2023, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education held a hearing entitled, Oversight Hearing – Addressing the Challenges of Rural America. Witnesses present included: Carrie Cochran-McClain, Chief Policy Officer, National Rural Health Association (NRHA); Dr. Tearsanee Davis, Director of Clinical Programs and Strategy, University of Mississippi Medical Center; Dr. Brittany Hott, Associate Professor, University of Oklahoma; The Honorable Lenita Jacobs-Simmons, Deputy Assistant Secretary, Employment and Training Administration (ETA), Department of Labor (DOL); The Honorable Tom Morris, Associate Administrator for Rural Health Policy, HRSA, HHS; and The Honorable Ruth Ryder, Deputy Assistant Secretary for Policy and Programs, Office of Elementary and Secondary Education (OESE), Department of Education (DOE).
  • On March 29, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Fiscal Year 2024 Department of Health and Human Services Budget. The witness for the hearing was the Honorable Xavier Becerra, Secretary, HHS.
  • On March 29, 2023, the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration held a hearing entitled, Budget Hearing - Fiscal Year 2024 Request for the Food and Drug Administration. The witness for the hearing was the Honorable Robert Califf, Commissioner, FDA.
  • On March 30, 2023; the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Reauthorization of the Animal Drug User Fee Programs. Witnesses present included: Tracey Forfa, Director, Center for Veterinary Medicine (CVM), FDA; Rachel Cumberbatch, Director, Regulatory Affairs, Animal Drugs, Animal Health Institute (AHI); Stephanie Batliner, Chair, Generic Animal Drug Alliance (GADA); and Lori Teller, DVM, President, American Veterinary Medical Association (AVMA).

U.S. Senate

  • On March 29, 2023, the Senate Committee on Finance Subcommittee on Health held a hearing entitled, An Oral Health Crisis: Identifying and Addressing Health Disparities. The witnesses present included: Jonathan Forte, President & CEO, RiverStone Health; Dr. Cherae M. Farmer-Dixon; Dean And Professor, School Of Dentistry, Meharry Medical College; Dr. Marko Vujicic, Chief Economist And Vice President, Health Policy Institute; American Dental Association (ADA).
  • On March 30, 2023, the Senate Committee on Finance held a hearing entitled, Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers. Witnesses present included: Robin Feldman, Arthur J. Goldberg Distinguished Professor Of Law And Director Of The Center For Innovation, Hastings College Of Law, University of California; Dr. Karen Van Nuys, Executive Director, Value Of Life Sciences Innovation, University of Southern California; Dr. Lawton Robert Burns, James Joo-Jin Kim Professor Of Health Care Management And Co-Director Of The Roy & Diana Vagelos Program In Life Sciences & Management, Wharton School, University of Pennsylvania; Dr. Matthew Gibbs, President, Capital Rx; and Jonathan Levitt, Founding Partner, Frier Levitt Attorneys at Law.

III. Reports, Studies & Analyses

  • On March 28, 2023, the Congressional Research Service (CRS) published a report entitled, Centers for Disease Control and Prevention (CDC) Funding Overview. The report provides an overview of CDC’s budget and appropriations with a focus on fiscal year (FY) 2023 enacted appropriations and the FY 2024 President’s budget request. The report also discusses supplemental appropriations for CDC and trends in state and local funding for public health. The report notes that from FY 2011 to FY 2021, CDC’s core public health funding level has remained between approximately $6.5 and $8 billion. Funding has increased in recent years with the President’s FY 2024 budget request set at $11.67 billion. CRS also details how analysis shows that public health funding at the state and local level has remained flat or declined over the past decade.
  • On March 28, 2023, CRS published a report entitled, The Dietary Guidelines for Americans: Development, Implementation, and Considerations for Congress. The Dietary Guidelines for Americans (DGA) provides federally developed food-based recommendations designed to promote health and prevent disease, and must be updated every five years as directed by the National Nutrition Monitoring and Related Research Act of 1990. This report describes the history of the DGA, the process by which HHS and the Department of Agriculture (USDA) update the DGA, and implementation of the DGA in selected federal programs. The report also provides an overview of issues that have arisen with the DGA in recent years and discusses the DGA’s impact on the health of the U.S. population. CRS then suggests that Congress could consider legislation that modify the DGA by requiring HHS and USDA to adopt certain recommendations for subsequent editions of the DGA.
  • On March 31, 2023, the Boards of Trustees, Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds published a report entitled, 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. The Social Security Act (SSA) requires that the Board, among other duties, report annually to the Congress on the financial and actuarial status of the Hospital Insurance (HI) and Supplementary Medical Insurance (SMI) trust funds. This year’s report estimates that the HI Trust Fund will be able to pay 100 percent of total scheduled benefits until 2031, three years later than reported last year. Despite the downward revision to economic assumptions outlined in the report, the projected long-term finances of the HI Trust Fund improved since last year’s report. The report notes that the improvement is mainly due to lower projected health care spending stemming from updated analysis that uses more recent data. Also, the SMI Trust Fund is estimated to be adequately financed into the indefinite future because, unlike the other trust funds, its main financing sources – premiums on enrolled beneficiaries and federal contributions from the Treasury – are automatically adjusted each year to cover costs for the upcoming year.
  • On March 31, 2023, the Kaiser Family Foundation (KFF) published a report entitled, How Many Uninsured Are in the Coverage Gap and How Many Could be Eligible if All States Adopted the Medicaid Expansion? This report projects the number and characteristics of uninsured people in the ten Medicaid non-expansion states who could be reached by Medicaid if their states adopted the Medicaid expansion using data from 2021, the most recent year available. Those individuals in non-Medicaid expansion states who are not eligible for Medicaid coverage or subsidies in the ACA Marketplace are referred to as being in the “coverage gap”. KFF found that in the remaining 10 states that have not expanded Medicaid, an estimated 1.9 million individuals, fall into the coverage gap. Further, KFF analysis showed that states that have not implemented the expansion have uninsured rates that are nearly double the rate of expansion states (15.4 percent compared to 8.1 percent). Nationally, over 60 percent of individuals falling in the coverage gap are people of color. KFF concluded that 3.5 million uninsured adults would become newly eligible for Medicaid if the remaining states adopted Medicaid expansion.

IV. Other Health Policy News

  • On March 27, 2023, HHS announced that it was providing Substance Abuse and Mental Health Services Administration (SAMHSA) Emergency Response Grants (SERG) to the state of Ohio to support community wellness and resilience, following the Norfolk Southern freight train derailment and related chemical spill in East Palestine, Ohio, that took place in February 2023. The state will receive an initial 90-day SERG grant of $209,402, with additional funding expected after the 90 days to continue for an additional 12 months to support activities. The grant funding is expected to support the immediate and ongoing behavioral health needs of the community related to the initial incident and subsequent traumatic experiences, to minimize the long-term impacts and foster resilience in the community, and to expand and enhance the capacity of local crisis response systems to ensure adequate and effective intervention in situations of crisis. More information on this funding can be found here.
  • On March 29, 2023, FDA announced that it had approved the first nonprescription, over-the-counter (OTC) naloxone nasal spray, Narcan, which can reverse an opioid-related overdose. HHS stated that Narcan can serve as a critical tool to prevent fatal overdoses, connect more people to treatment for substance use disorder (SUD), and save lives. With FDA approval of nonprescription Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray, HHS will launch a department-wide approach to work with stakeholders to implement the Narcan switch from prescription to nonprescription status, facilitate the continued availability of naloxone nasal spray products during the time needed to implement the transition, and help ensure appropriate coverage and continued access to all forms of naloxone. In addition to being used by healthcare professionals, naloxone is increasingly being distributed to first responders, and family members who may witness and respond to an opioid overdose. The availability of nonprescription and prescription naloxone could help to further increase its distribution and accessibility, potentially saving more lives and reducing the burden of opioid overdose on individuals, families, and communities. More information on this announcement can be found here.
  • On March 29, 2023, the U.S. Senate passed H.J. Res. 7, which terminates the National Emergencies Act declaration concerning COVID-19 made by President Trump on March 13, 2020. The bill was originally introduced by Representative Paul Gosar (R-AZ-9), passing by a vote of 229-197 in the House, and then passing in the Senate by a vote of 68-23. President Biden has already indicated that he intends to sign the bill into law, despite the fact that he had originally planned to end the national emergency declaration on May 11, 2023. The passage of H.J. Res. 7 is more symbolic and will not impact the other COVID-19 emergencies that have been declared, including the HHS Secretary’s COVID-19 PHE declaration or President Trump’s Stafford Act emergency declaration. As a result, the various waivers and flexibilities made available under these authorities, including the 1135 waivers, will remain in effect until the HHS Secretary’s COVID-19 PHE is terminated. Absent any further changes, the COVID-19 PHE is expected to end on May 11, 2023. More information on this bill can be found here.

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