Alston & Bird Health Care Week in Review, April 16, 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, President Biden signed a bill extending a moratorium on Medicare sequestration through the end of 2021. Read more about the law and other news below.

I. Regulations, Notices & Guidance

• On April 15, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. FDA is issuing this guidance to describe how the agency will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.
• On April 14, 2021, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services. The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise the rules issued on March 4, 2019, establishing standards for compliance by family planning services projects authorized by Title X of the Public Health Service Act. Those rules have undermined the public health of the population the program is meant to serve. HHS proposes to revise the 2019 rules by readopting the 2000 regulations, with several modifications needed to strengthen the program and ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients.
• On April 16, 2021, FDA issued a final rule entitled, Medical Device Classification Regulations to Conform to Medical Software. FDA is amending certain classification regulations to reflect changes to the FD&C Act made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act.

Event Notices 

• April 23, 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 Janssen (Johnson & Johnson) COVID-19 Vaccine Safety. A recommendation vote is scheduled.
• April 30, 2021: 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 mental and behavioral health across the life course.
• May 5, 2021: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on dengue vaccine and rabies vaccines. No recommendation votes are scheduled.
• May 5, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Advisory Committee for Women’s Services (ACWS). The meeting will include discussions on assessing SAMHSA’s current strategies, including the mental health and substance use needs of the women and girl’s population. Additionally, the ACWS will be addressing priorities regarding the impact of COVID-19 on the behavioral health needs of women and children and directions around behavioral health services and access for women and children.
• May 11-12, 2021: The 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 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.
• 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.

II. Congressional Hearings

U.S. House of Representatives

• On Wednesday, April 14, the House Committee on Energy and Commerce Subcommittee on Health held a legislative hearing entitled, An Epidemic within a Pandemic: Understanding Substance Use and Misuse in America. Witnesses present included: Regina LaBelle, Acting Director, White House Office of National Drug Control Policy; Geoffrey Laredo, Principal, Santa Cruz Strategies, LLC; Patricia Richman, National Sentencing and Resource Counsel, Federal Public and Community Defenders; Mark Vargo, Pennington County State’s Attorney, Legislative Committee Chairman, National District Attorneys Association; Dr. Timothy Westlake, Emergency Department Medical Director, Pro Health Care Oconomowoc Memorial Hospital; and Dr. J. Deanna Wilson, Assistant Professor of Medicine and Pediatrics, University of Pittsburgh School of Medicine.
• On Thursday, April 15, the House Committee on Appropriations Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, FY 2022 Budget Request for the Department of Health and Human Services. HHS Secretary Xavier Becerra served as a witness.
• On Thursday, April 15, the House Committee on Education and Labor Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Meeting the Moment: Improving Access to Behavioral and Mental Health Care. Witnesses present included: Dr. Brian Smedley, Chief of Psychology in the Public Interest, Public Interest Directorate, American Psychological Association; Dr. Christine Yu Moutier, Chief Medical Officer, American Foundation for Suicide Prevention; Mr. James Gelfand, Senior Vice President, Health Policy, The ERISA Industry Committee; and Dr. Meiram Mendat, Founder, Psych-Appeal.
• On Thursday, April 15, the House Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Reaching The Light At The End Of The Tunnel: A Science-Driven Approach To Swiftly And Safely Ending The Pandemic. Witnesses present included: Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institute of Health; Dr. David Kessler, Chief Science Officer, COVID Response, HHS; and Dr. Rochelle Walensky, Director, CDC.

U.S. Senate

• On Wednesday, April 14, the Senate Committee on Homeland Security and Governmental Affairs held a hearing entitled, Preparedness for COVID-19: The Initial Pandemic Response and Lessons Learned. Witnesses present included: Dr. Nicole Lurie, Former Assistant Secretary for Preparedness and Response, HHS (2009-2017); Dr. Julie Gerberding, Former CDC Director (2002-2009); Joseph Nimmich, Former Deputy Administrator of the Federal Emergency Management Agency (2014-2017); and Elizabeth Zimmerman, Former Associate Administrator, Office of Response and Recovery, FEMA (2014-2017).
• On Wednesday, April 14, the Senate Committee on Appropriations held a hearing entitled, The Federal Emergency Management Agency’s Response to COVID-19 and Other Challenges. Acting FEMA Administrator Robert J. Fenton, Jr. served as a witness.
• On Thursday, April 15, the Senate Committee on Finance held a hearing to consider the nominations of Andrea Joan Palm to be Deputy Secretary of Health and Human Services and Chiquita Brooks-LaSure to be Administrator of the Centers for Medicare and Medicaid Service.

III. Reports, Studies & Analyses

• On April 14, 2021, RAND Corporation published a research brief entitled, S. Prescription Drug Prices are 2.5 Times Those in Other OECD Countries. U.S. prescription drug costs continue to rise, and prior research shows that the United States spends more per capita on prescription drugs than do other Organisation for Economic Co-operation and Development (OECD) nations. While high U.S. drug prices likely play a central role in driving higher U.S. spending on prescription drugs, the last study to systematically compare drug prices in the United States with those of other countries used data that are now over a decade old. This study used 2018 prescription drug volume and price data to compare U.S. drug prices with those in 32 other OECD nations, both overall and for specific categories of drugs, such as brand-name and generic medications.
• On April 15, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Implications of COVID-19 for Social Determinants of Health. Even as the COVID-19 vaccine roll-out is accelerating across the country, the public health and economic effects of the pandemic continue to affect the well-being of many Americans. The American Rescue Plan Act includes additional funding not only to address the public health crisis of the pandemic, but also to provide economic support to many low-income people struggling to make ends meet. Millions have lost jobs or income in the past year, making it difficult to pay expenses including basic needs like food and housing. These challenges will ultimately affect people’s health and well-being, as they influence social determinants of health. This brief provides an overview of social determinants of health and a look at how adults are faring across an array of measures over a year into the pandemic.

IV. Other Health Policy News

• On April 12, 2021, HHS marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventative care in rural areas to improve maternal health outcomes. HHS Secretary Xavier Becerra announced that Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery. Additionally, Secretary Becerra announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population. More information about these actions can be found here.
• On April 13, 2021, the Office for Civil Rights (OCR), the Administration for Community Living (ACL), and the Office of the Assistant Secretary for Planning and Evaluation (ASPE) at HHS announced several new resources to help states, vaccination providers, and others leading COVID-19 response activities improve access to vaccines for people with disabilities and older adults. These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them – to ensure accessibility. More information about these resources can be found here.
• On April 14, 2021, President Biden signed H.R. 1868 into law. The bill extends a suspension of Medicare sequestration by 9 months and makes other technical changes to Medicare payments and Medicaid eligibility. Note that the Senate cleared the legislation by a vote of 90-2 on March 25 and the House passed the Senate-amended measure on Tuesday by a vote of 384-38.
• On April 16, 2021, the Biden Administration Announced that it will be investing $1.7 billion from the American Rescue Plan Act to help states and other jurisdictions more effectively fight new and potentially dangerous strains of the COVID-19 virus. Funding includes $1 billion to expand genomic sequencing; $400 million to support innovation initiatives including the launch of new innovative Centers of Excellence in Genomic Epidemiology; and $300 million to build and support a National Bioinformatics Infrastructure. More information about the announcement can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.