Alston & Bird Health Care Week in Review, February 4, 2022

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, CMS released its 2023 Medicare Advantage and Part D Advance Notice. Read more about the Advance Notice and other news below.

I. Regulations, Notices & Guidance

• On February 3, 2022, the Food and Drug Administration (FDA) issued a proposed rule entitled, Certain Requirements Regarding Prescription Drug Marketing. FDA is proposing to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from enactment of the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA). This action, if finalized, will remove or revise outdated and conflicting regulatory requirements to align with changes to affected provisions of the FD&C Act following enactment of the DSCSA.
• On February 3, 2022, FDA issued a proposed rule entitled, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers. FDA is proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the DSCSA (Title II of the Drug Quality and Security Act). Pursuant to the FD&C Act, as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.
• On February 3, 2022, FDA issued final guidance entitled, Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act—Questions and Answers. FDA is issuing this guidance to assist industry and State and local governments in understanding the effects of the uniform national policy set forth in the FD&C Act that was added by the Drug Supply Chain Security Act, which was enacted on November 27, 2013. This guidance is intended to help industry and States understand the law as it is currently in effect and clarify its effect on State product tracing.
• On February 3, 2022, FDA issued guidance entitled, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling—Content and Format. This draft guidance provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. Appropriate inclusion and consistent placement of immunogenicity information in the Prescribing Information helps to make clinically relevant information accessible to the health care practitioner and promotes the safe and effective use of prescription drug and biological products.
• On February 3, 2022, FDA issued guidance entitled, Assessment of Pressor Effects of Drugs. This draft guidance is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure is, therefore, an important consideration in risk assessment and product labeling.
• On February 3, 2022, FDA issued guidance entitled, Population Pharmacokinetics. This guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA’s current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs), biologic license applications (BLAs), and abbreviated new drug applications (ANDAs). This guidance also provides expectations regarding the format and content of the population PK report, as well as any labeling recommendations resulting from such analyses.
• On February 3, 2022, the Department of Veterans Affairs issued a proposed rule entitled, VA Pilot Program on Graduate Medical Education and Residency. The Department of Veterans Affairs proposes to revise its medical regulations to establish a new pilot program on graduate medical education and residency, as required by section 403 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Network Act of 2018.
• On February 4, 2022, FDA issued guidance entitled, Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs. This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs.

Event Notices

• February 10, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Cancer Institute Advisory Board. The meeting agenda includes the NCAB Subcommittee Meeting – Ad Hoc Subcommittee on Global Cancer Research, the Director’s and Program reports and presentations; and business of the Board.
• February 15, 2022: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will meet in open session to discuss a request to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 mRNA vaccine for administration to children 6 months through 4 years of age.
• February 23-24, 2022: 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 of the CDC on the use of immunizing agents.
• March 3, 2022: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
• March 7, 2022: The Office of the Assistant Secretary for Preparedness and Response (ASPR) announced a public meeting of the National Biodefense Science Board (NBSB). The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
• March 8, 2022: NIH announced a public meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). The topic for this meeting will be “Opportunities for Research Supported by the Special Statutory Funding Program for Type 1 Diabetes Research.”
• March 16, 2022: NIH announced a public meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. The agenda includes a strategic discussion of NCI’s Clinical and Translational Research Programs.
• April 12, 2022: FDA announced a public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The purpose of the virtual public meeting and the request for comments is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards and electronic submissions initiatives.
• April 13, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will provide information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
• Various Dates: The Health Resources and Services Administration (HRSA) announced several public meetings of the Advisory Committee on Childhood Vaccines (ACCV). The ACCV provides advice and recommendations to the Secretary of HHS on policy, program development, and other issues related to the implementation of the National Vaccine Injury Compensation Program and other matters.

II. Congressional Hearings

U.S. House of Representatives

• On February 2, 2022, the House Committee on Ways and Means held a hearing entitled, American’s Mental Health Crisis. Witnesses present included: Wizdom Powell, Director of Health Disparities Institute and Associate Professor of Psychiatry, UConn Health; Dr. Peggy Johnson, Chief of Psychiatry, The Commonwealth Care Alliance (CCA); Angela Sausser, M.S.W., Executive Director, The Public Children Services Association of Ohio; Deborah Steinberg, J.D., Health Policy Attorney, The Legal Action Center; and Deepa Avula, M.P.H., Director of the North Carolina Division on Mental Health, Developmental Disabilities, and Substance Abuse Services at the North Carolina Department of Health and Human Services.
• On February 2, 2022, the House Committee on Energy and Commerce Subcommittee on Consumer Protection and Commerce held a hearing entitled, Pandemic Profiteers: Legislation to Stop Corporate Price Gouging. Witnesses present included: Alex Harman, Competition Policy Advocate, Public Citizen; Rakeen Mabud, Ph.D., Managing Director of Policy and Research and Chief Economist, Groundwork Collaborative; Sarah Frasch, Chief Deputy Attorney General and Director, Bureau of Consumer Protection, Pennsylvania Office of the Attorney General; and Glenn Richey, Ph.D., Harbert Eminent Scholar and Chair, Department of Supply Chain Management, Auburn University Harbert College of Business.
• On February 3, 2022, the House Committee on Energy and Commerce held a hearing entitled, FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics. Witnesses present included: Dr. Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research, FDA; Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, FDA; Dr. Cartier Esham, Chief Scientific Officer, Executive Vice President, Emerging Companies, Biotechnology Innovation Organization; David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Association for Accessible Medicines; Dr. Reshma Ramachandran, Physician-Fellow, Yale National Clinician Scholars Program, Chair, Doctors for America FDA Task Force; Juliana Reed, Executive Director, Biosimilars Forum; and Dr. Lucy Vereshchagina, Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America.
• On February 3, 2022, the House Committee on Ways and Means Subcommittee on Health held a hearing entitled, Bridging Health Equity Gaps for People with Disabilities and Chronic Conditions. Witnesses present included: Dr. Monica Verduzco-Gutierrez, Professor and Chair of the Department of Physical Medicine and Rehabilitation, University of Texas Health San Antonio, Director of COVID Recovery Clinic at University Health; Dr. Rupa Valdez, Associate Professor of Engineering Systems and Public Health, University of Virginia; Liza Fisher, Member of Long COVID Alliance, Houston, Texas; Bethany Lilly, Senor Director of Income Policy, The Arc; and Dr. Ray Dorsey, Professor of Neurology, University of Rochester Medical Center.

U.S. Senate

• On February 1, 2022, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Mental Health and Substance Use Disorders: Responding to the Growing Crisis. Witnesses present included: Mitch Prinstein, Chief Science Officer, American Psychological Association (APA); Dr. Michelle Durham, Vice Chair of Education, Department of Psychiatry, Clinical Associate Professor of Psychiatry & Pediatrics, Boston Medical Center, Boston University School of Medicine; Sara Goldsby, Director, South Carolina Department of Alcohol and Other Drug Abuse Services; Dr. Jennifer Lockman, CEO, Centerstone Research Institute; and Clair Rhyneer, Mental Health Youth Advocate.
• On February 1, 2022, the Senate Committee on Commerce, Science, and Transportation held a hearing entitled, Stopping COVID-19 Fraud and Price Gouging. Witnesses present included: Samuel Levine, Director, Bureau of Consumer Protection, Federal Trade Commission (FTC); Teresa Murray, Director, Consumer Watchdog Office, U.S. Public Interest Research Group (PIRG); Mary Engle, Executive Vice President (Policy), BBB National Programs; and Todd Leatherman, Program Counsel, National Attorneys General Training & Research Institute Center for Consumer Protection, National Association of Attorneys General (NAAG).
• On February 2, 2022, the Senate Committee on Finance held a hearing entitled, The Hospital Insurance Trust Fund and the Future of Medicare Financing. Witnesses present included: Michael E. Chernew, Ph.D., Chair, Medicare Payment Advisory Commission (MedPAC); Dr. Susan Rogers, MD, FACP, President, Physicians for a National Health Program; Amy Kapczynski, Professor of Law, Faculty Co-Director, Global Health Justice Partnership, Faculty Co-Director Law and Political Economy Project, Yale Law School; Dr. Katherine Baicker, Ph.D., Dean and Emmett Dedmon Professor, Harris School of Public Policy, University of Chicago; and James C. Capretta, Senior Fellow and Milton Friedman Chair, American Enterprise Institute.

III. Reports, Studies & Analyses

• On January 31, 2022, the U.S. Government Accountability Office (GAO) published a report entitled, Biomedical Research: Observations on DOD's Management of Congressionally Directed Medical Research Programs. The Department of Defense (DOD) is among the United States' largest federal sponsors of biomedical research. For fiscal year 2021, DOD's appropriations included about $1.5 billion for 36 research programs known collectively as Congressionally Directed Medical Research Programs (CDMRP). This represents a significant increase from CDMRP's initial appropriation in 1992 of $210 million for a breast cancer program. The Joint Explanatory Statement accompanying the Consolidated Appropriations Act, 2021 includes a provision for GAO to review DOD’s CDMRP. This report provides information on CDMRP’s (1) execution of annual appropriations; (2) efforts to prioritize and assess biomedical research programs and investments; and (3) coordination of biomedical research with NIH and VA.
• On February 1, 2022, the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new findings on Medicare telehealth use in 2021. Using data from the Census Bureau’s Household Pulse Survey (HPS) in 2021, this issue brief analyzes national trends in telehealth utilization across all payers and examines how use of video-enabled vs. audio-only telehealth services differ across patient populations. The study finds notable disparities by race, ethnicity, income, age, and insurance status in access to video-enabled telehealth. The authors of the report conclude that policy efforts to ensure equitable access to telehealth, in particular video-enabled telehealth, are needed to ensure that disparities that emerged during the pandemic do not become permanent. For more information, the report can be accessed here.
• On February 3, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Racial Disparities in Cancer Outcomes, Screening, and Treatment. This brief provides an overview of recent data on cancer incidence and mortality, risk factors, screening, treatment, and outcomes by race and ethnicity. It is based on KFF analysis of United States Cancer Statistics cancer incidence and mortality data (latest available data as of 2018), 2020 Behavioral Risk Factor Surveillance System cancer screening data, and published research. Although this brief focuses on racial disparities in cancer, disparities also occur across other dimensions, including socioeconomic status, exposure to risk factors, geographic location, and receipt of preventive measures.
• On February 4, 2022, KFF published an issue brief entitled, Network Adequacy Standards and Enforcement. This brief reviews background on federal network adequacy regulation, the availability of information about qualified health plans (QHP) networks, and options for strengthening oversight and enforcement.

IV. Other Health Policy News

• On February 2, 2022, the Centers for Medicare & Medicaid Services (CMS) released proposed payment policy changes for Medicare Advantage and Part D drug programs in 2023 that will create more choices and provide affordable options for consumers that meet their unique health needs. The Calendar Year (CY) 2023 Advance Notice for Medicare Advantage (MA) and Part D plans is open to public comment for 30 days. This year, CMS notes that it is specifically soliciting input through a health equity lens on the approach to some future potential changes. Additional information on the Advance Notice can be found here.
• On February 3, 2022, HHS announced the availability of $19.2 million in American Rescue Plan Act funding to support and expand the Health Resources and Services Administration (HRSA) Teaching Health Center Graduate Medical Education (THCGME) program. This most recent THCGME funding opportunity will expand the program by supporting the equivalent of approximately 120 additional full-time resident positions. Additional information about THCGME can be found here. Eligibility information and application instructions can be found here.
• On February 3, 2022, HHS announced a series of new reports and a grant program to address the health needs of pregnant women and children affected by substance use. The reports, which were produced by researchers at HHS ASPE, identify strategies that can reduce the negative health and well-being impacts of substance use (including alcohol use) on families based on a review of existing research and consultation with experts in managing these conditions. The grant program, titled the Services Grant Program for Residential Treatment for Pregnant and Postpartum Women, will provide pregnant and postpartum women and their children with comprehensive substance use treatment and recovery support services across residential and outpatient settings. Additional information about the reports and grant program can be found here.
• On February 3, 2022, CMS announced that starting in early spring, Medicare will begin covering free over-the-counter COVID-19 tests. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA). Additional information about the coverage announcement is available here.
• On February 4, 2022, HHS issued guidance to health care providers on civil rights protections for people with disabilities. The guidance makes clear that in light of the continuing public health emergency, when resources can be scarce, it is vital that individuals with disabilities are not prevented from receiving needed health care benefits and services as this violates federal civil rights laws. Additional information about the guidance can be found here.

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