Alston & Bird Health Care Week in Review, March 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, President Biden delivered the State of the Union, in which he highlighted his administration’s response to COVID-19 and several health care initiatives. Read more about this event and other news below.

I. Regulations, Notices & Guidance

• On February 28, 2022, the Food and Drug Administration (FDA) issued guidance entitled, Medical Devices; Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device. FDA is classifying the screw sleeve bone fixation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the screw sleeve bone fixation device’s classification.
• On March 1, 2022, FDA issued a final guidance entitled, Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders; Guidance for Industry and Food and Drug Administration Staff. This guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification order.
• On March 1, 2022, FDA issued a final guidance entitled, Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry. The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs.
• On March 1, 2022, FDA issued a final guidance entitled, Inclusion of Older Adults in Cancer Clinical Trials; Guidance for Industry. This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this final guidance, older adults are those age 65 years and older. The final guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. Specifically, this final guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population.
• On March 1, 2022, FDA issued a final guidance entitled, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry. This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, allowing for efficient and accelerated drug development.
• On March 1, 2022, FDA issued a final guidance entitled, Pre-Launch Activities Importation Requests; Guidance for Industry. This guidance finalizes FDA’s approach for overseeing requests regarding the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This guidance further describes the procedures for making these requests and FDA’s actions on such requests.
• On March 1, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Vaccines Federal Implementation Plan. This notice announces that the draft Vaccines Federal Implementation Plan 2021–2025 is available for public comment. The Vaccines Federal Implementation Plan is a companion document to the Vaccines National Strategic Plan 2021-2025 (VNSP), which was published in January 2021. The Vaccines Federal Implementation Plan is a compilation of federal agency immunization activities that collectively advance the goals of the VNSP.
• On March 2, 2022, the Executive Office of the President (EOP) issued a Request for Information (RFI) entitled, Request for Information to Support the Development of a Federal Scientific Integrity Policy Framework. This notice announces that the White House Office of Science and Technology Policy (OSTP) seeks information to assist in developing a framework for regular assessment and iterative improvement of agency scientific integrity policies and practices. This effort builds on the Scientific Integrity Task Force’s review of existing scientific integrity policies and practices, released in the January 11, 2022 report, Protecting the Integrity of Government Science.
• On March 3, 2022, HHS issued a notice entitled, Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date. This notice announces that HHS is postponing, pending judicial review, the effective date of a final rule entitled, Securing Updated and Necessary Statutory Evaluations Timely (SUNSET). SUNSET, if implemented, would establish a new process for regulatory review of HHS regulations, which includes the automatic expiration of regulations under certain circumstances.
• On March 3, 2022, EOP issued a memorandum entitled, Maximizing Assistance to Respond to COVID-19. In this memorandum, President Joe Biden directs the Department of Homeland Security (DHS) and the Federal Emergency Management Agency (FEMA) to take several actions to maximize the U.S. response to the COVID-19 pandemic.
• On March 3, 2022, FDA issued a final guidance entitled, Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff. The guidance for industry and FDA staff provides guidance on timely initiation of voluntary recalls of FDA-regulated products. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, the guidance discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.
• On March 3, 2022, FDA issued a notice entitled, Guidance Documents Related to Coronavirus Disease 2019. In this notice, FDA is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). The guidances identified in this notice address issues related to the COVID-19 PHE.
• On March 4, 2022, HHS issued a Request for Information (RFI) entitled, Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID-19 Pandemic Request for Information (RFI). The Office of the Surgeon General requests input from interested parties on the impact and prevalence of health misinformation in the digital information environment during the COVID-19 pandemic. The purpose of this RFI is to understand the impact of COVID-19 misinformation on health care infrastructure and public health more broadly during the pandemic including (but not limited to) quality of care, health decisions and outcomes, direct and indirect costs, trust in the health care system and providers, and health care worker morale and safety, understand the unique role the information environment played in the societal response to the COVID-19 pandemic and implications for future public health emergencies, understand the impact of exposure to health misinformation and how access to trusted and credible health information, particularly during a public health emergency, impacts lifesaving health decisions such as an individual’s likelihood to vaccinate; and use the information requested to prepare for and respond to future public health crises.

Event Notices

• March 30, 2022: HHS announced a public meeting of the National Advisory Committee on Seniors and Disasters (NACSD) and the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). The NACSD and NACIDD evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS to support and enhance all-hazards public health and medical preparedness, response, and recovery. The NACSD provides focus on the unique needs of older adults, while the NACIDD focuses on helping HHS meet the needs of people with disabilities (PWD).
• April 1, 2022: The National Institutes of Health (NIH) announced a public meeting of the Office of the Director’s NIH Clinical Center Research Hospital Board. The meeting agenda will include the following items: Clinical Center CEO Update, Clinical and Safety Performance Metrics, Novel Coronavirus (COVID-19) Update, and other Business of the Board.
• April 19, 2022: 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.

II. Congressional Hearings

U.S. House of Representatives

• On March 1, 2022, the House Committee on Education and Labor held a hearing entitled, Improving Retirement Security and Access to Mental Health Benefits. Witnesses present included: Ms. Amy Matsui, Director of Income Security and Senior Counsel, National Women’s Law Center; Ms. Karen Handorf, Senior Counsel, Berger Montague; Mr. Andrew Biggs, Senior Fellow, American Enterprise Institute; and Mr. Aron Szapiro, Head of Retirement Studies and Public Policy, Morningstar, Inc. and Morningstar Investment Management LLC.
• On March 2, 2022, the House Committee on Ways and Means held a hearing entitled, Substance Use, Suicide Risk, and the American Health System. Witnesses present included: Jonathan M. Metzl, M.D., Ph.D., Professor of Sociology and Psychiatry and Director of the Department of Medicine, Health, and Society, at Vanderbilt University; Edwin C. Chapman, M.D., Private Practice Physician Specializing in Addiction Medicine; Regina LaBelle, J.D., Director of the Addiction and Public Policy Initiative at the O’Neill Institute; Marielle Reataza, M.D., M.S., Executive Director of the National Asian Pacific American Families Against Substance Abuse; and Jessica Hulsey, Founder & CEO at the Addiction Policy Forum.
• On March 2, 2022, the House Committee on Energy and Commerce held a hearing entitled, Lessons from the Frontline: COVID-19’s Impact on American Health Care. Witnesses present included: Megan Ranney, M.D., M.P.H, Emergency Physician, Rhode Island Hospital; Tawanda Austin, M.S.N., R.N., N.E.-B.C., Chief Nursing Officer, Emory University Hospital Midtown; Daniel Calac, M.D., Chief Medical Officer, Indian Health Council, Inc.; Laura E. Riley, M.D., Obstetrician and Gynecologist-in-Chief, New York Presbyterian Hospital; and Lucy McBride, M.D., Internist, Private Practice.

U.S. Senate

• On March 1, 2022, the Senate Committee on Finance held an executive session entitled, Open Executive Session to Consider the Nominations of Robert Michael Gordon to be an Assistant Secretary of Health and Human Services (HHS); January Contreras to be Assistant Secretary for Family Support, HHS; and Rebecca E. Jones Gaston to be Commissioner on Children, Youth, and Families, HHS. All three nominations were favorably reported by the Committee.

III. Reports, Studies & Analyses

• On March 2, 2022, the Government Accountability Office (GAO) published a report entitled, Science & Tech Spotlight: Long COVID. The report discusses what is and isn't known about long COVID—new, returning, or ongoing health problems 4 or more weeks after an initial case of COVID-19.
• On March 4, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Home & Community-Based Services: People Served and Spending During COVID-19. The COVID-19 pandemic brought new focus to the long-standing unmet need for home and community-based services (HCBS) among seniors and people with disabilities and direct care workforce shortages. This issue brief presents FY 2020 state-level data on the number of people receiving Medicaid HCBS and HCBS spending.
• On March 4, 2022, KFF published an issue brief entitled, State Policy Choices About Medicaid Home and Community-Based Services Amid the Pandemic. This issue brief presents findings on key state policy choices about Medicaid HCBS in FY 2020.
• On March 3, 2022, KFF published an issue brief entitled, Analysis of Recent National Trends in Medicaid and CHIP Enrollment. This issue brief looks at national and state-by-state Medicaid and CHIP enrollment data through September 2021.

IV. Other Health Policy News

• On March 1, 2022, President Joe Biden delivered his first State of the Union address. During his address, President Biden highlighted several of his administration’s health care-related actions and initiatives, including: responding to the COVID-19 pandemic; cutting the price of prescription drugs; closing the health care insurance coverage gap; improving the quality of nursing homes; protecting the rights of women; advancing maternal health; supporting veterans; combating the opioid epidemic; prioritizing mental health; and ending cancer. President Biden’s full remarks for the State of the Union can be found here. The White House also released several Fact Sheets to accompany the President’s remarks, including: Protecting Seniors and People with Disabilities by Improving Safety and Quality of Care in the Nation’s Nursing Home; Addressing Addiction and the Overdose Epidemic; President Biden to Announce Strategy to Address our National Mental Health Crisis, As Part of Unity Agenda in his First State of the Union; and The Biden-Harris Administration Advances Equity and Opportunity for Black People and Communities Across the Country.
• On March 2, 2022, HHS Secretary Xavier Becerra announced that he kicked off the National Tour to Strengthen Mental Health in an effort to hear directly from Americans across the country about the behavioral health challenges they're facing and engage with local elected officials and leaders to strengthen the mental health and crisis care system in our communities. Over the next few months, Secretary Becerra will make announcements on new initiatives and various resources provided by HHS, such as increasing the number of behavioral health professionals and community and behavioral health support workers in underserved and under-resourced communities, expanding pediatric mental health care access through telehealth services, and the transition to 988: America's Suicide and Crisis Lifeline. More information on this announcement can be found here.

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