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 several efforts to boost COVID-19 vaccination rates in the U.S. Read more about these initiatives and other news below.

I. Regulations, Notices & Guidance

There were no relevant regulations published in the Federal Register this week.

Event Notices

  • May 11-12, 2021: The Food and Drug Administration (FDA) announced a public meeting entitled, Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the subcommittee is to provide advice and recommendations to FDA on regulatory issues.
  • May 12, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines, including use of the PfizerBioNTech COVID-19 vaccine under the FDA's expanded Emergency Use Authorization (EUA) for adolescents 12-15 years of age. A recommendation vote is scheduled.
  • May 13-14, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). During the meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening.
  • May 18-19, 2021: FDA announced a public meeting entitled, Potential Medication Error Risks with Investigational Drug Container Labels. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.
  • May 28, 2021: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to consider interim recommendations specific to discrimination and xenophobia
  • June 9, 2021: FDA announced a public workshop entitled, Model Informed Drug Development Approaches for Immunogenicity Assessments. The purpose of this public workshop is to discuss the best practices and future directions of quantitative methods for predicting immunogenicity of biological products.
  • June 16-17, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
  • June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
  • June 24, 2021: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for the Clinical Laboratory Fee Schedule for calendar year (CY) 2022. This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for CY 2022. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
  • July 28-29, 2021: CMS announced a public meeting entitled, Meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The purpose of the Panel is to advise the HHS Secretary and CMS Administrator on issues related to clinical diagnostic laboratory tests.

II. Congressional Hearings

U.S. House of Representatives

  • On May 4, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs. Witnesses present included: Therese Ball, Patient; Michael Carrier, Distinguished Professor of Law, Rutgers Law School; Rachel Sachs, Associate Professor of Law, Washington University in St. Louis, School of Law; Dr. Gaurav Gupta, Founder, Ascendant BioCapital; and Khrystal Davis, J.D., Rare Disease Caregiver and Patient Advocate, Texas Rare Alliance Founding President.
  • On May 4, 2021, the House Committee on Oversight and Reform held a hearing entitled, The Urgent Need to Reform the Organ Transplantation System to Secure More Organs for Waiting, Ailing, and Dying Patients. Witnesses present included: Tonya Ingram, Patient; Dr. Dara Kass, Donor; LaQuayia Goldring, Patient; Steve Miller, CEO, Association for Organ Procurement Organizations; Joe Ferreira, President, Association for Organ Procurement Organizations; Matt Wadsworth, President and CEO, Life Connection of Ohio; Dr. Seth Karp, Director, Vanderbilt Transplant Center; and Donna Cryer, President and CEO, Global Liver Institute.
  • On May 5, 2021, the House Committee on Education and Labor Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Lower Drug Costs Now: Expanding Access to Affordable Health Care. Witnesses present included: Dr. Mariana Socal, Associate Scientist, John Hopkins Bloomberg School of Public Health; David Mitchell, Founder and President, Patients for Affordable Drugs Now; Dr. Douglas Holtz-Eakin, President, American Action Forum; and Frederick Isasi, Executive Director, Families USA.
  • On May 6, 2021, the House Committee on Oversight and Reform held a hearing entitled, Birthing While Black: Examining America's Black Maternal Health Crisis. Witnesses present included: the Honorable Ayanna Pressley (D-MA); the Honorable Cori Brush (D-MO); the Honorable Lauren Underwood (D-IL); the Honorable Alma S. Adams (D-NC); Tatyana Ali, Actress and Advocate; Charles Johnson, Founder of 4Kira4Moms; Dr. Veronica Gillispie, Medical Director, Louisiana Perinatal Quality Collaborative; Dr. Joia Adele Crear-Perry, Founder and President, National Birth Equity Collaborative; Dr. Jamila Taylor, Director of Health Care Reform and Senior Fellow, The Century Foundation; and Dr. Tamika Auguste, Board of Directors Member, American College of Obstetricians and Gynecologists.

III. Reports, Studies & Analyses

  • On May 3, 2021, the Kaiser Family Foundation (KFF) published a report entitled, Health Insurer Financial Performance in 2020. The analysis examines insurers' 2020 data for four distinct markets: Medicare Advantage, Medicaid managed care, individual (non-group), and fully insured group (employer). Findings suggest that insurers remained profitable across markets in 2020 due in part to an unprecedented decrease in health spending and utilization in the spring as the COVID-19 pandemic led to massive shutdowns.
  • On May 4, 2021, KFF published an issue brief entitled, Potential Implications of Policy Changes in Medicaid Drug Purchasing. This report examines how leading federal and state policy proposals that increase Medicaid drug rebates, increase price transparency, and target drug prices could affect these entities, which could influence debate over these proposals and what the effects would be.

IV. Other Health Policy News

  • On May 3, 2021, HHS, through HRSA, announced a new program covering costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. More information about this program can be found here.
  • On May 4, 2021, HHS announced the availability of nearly $1 billion in American Rescue Plan Act finds to strengthen COVID-19 response efforts and increase vaccinations in rural communities. This funding will increase the number of vaccines sent to rural communities, expand testing and other COVID-19 prevention services, and work to increase vaccine confidence by empowering trusted local voices with additional funding for outreach efforts in underserved communities. More information about this funding can be found here.
  • On May 4, 2021, HHS announced the availability of approximately $250 million to develop and support a community-based workforce who will serve as trusted voices sharing information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities. This funding will help community-based organizations to hire and mobilize community outreach workers, community health workers, social support specialists and others to conduct on-the-ground outreach to educate and assist individuals in getting the information they need about vaccination, help make vaccine appointments, and assist with transportation and other needs to get to individuals to each of their vaccination appointments. More information about the finding can be found here.
  • On May 5, 2021, HHS Secretary Xavier Becerra and U.S. Housing and Urban Development (HUD) Secretary Marcia L. Fudge announced a joint-agency effort to increase access to COVID-19 prevention and treatment services, including testing and vaccinations, among disproportionately affected communities, including among HUD-assisted households and people experiencing homelessness. This program will leverage the Health Center COVID-19 health Vaccine Program, which currently provides a direct supply of vaccines to nearly 800 health centers across the country. More information about this effort can be found here.
  • On May 5, 2021, CMS announced that it has increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19, continuing coverage under the Medicare Part B COVID-19 vaccine benefit. More information about the increased payment rate can be found here.

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