Alston & Bird Health Care Week in Review, February 11, 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, HHS announced $66.5 million to expand COVID-19 vaccination efforts and bought 600,000 monoclonal antibody treatments. Read more about these announcements and other news below.

I. Regulations, Notices & Guidance

• On February 7, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry. The draft guidance provides recommendations for the development of antibody-drug conjugates (ADCs). Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection and adjustment, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs). Currently, there are no FDA guidances outlining the clinical pharmacology considerations for antibody-drug conjugates.
• On February 9, 2022, FDA issued draft guidance entitled, Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry. In connection with the SUPPORT for Patients and Communities Act (SUPPORT Act), the purpose of this guidance is to spur the development of alternatives to opioids for the management of acute pain by providing information about product development-related issues, “opioid-sparing” claims, and expedited programs as they pertain to this purpose.
• On February 9, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice with comment period entitled, Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids. The CDC announced the opening of a docket to obtain comment on the proposed clinical practice guideline, CDC Clinical Practice Guideline for Prescribing Opioids – United States, 2022. The clinical practice guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016, and provides evidence-based recommendations for clinicians who provide pain care.
• On February 10, 2022, the National Institutes of Health (NIH) issued a notice entitled, Request for Information (RFI): Inviting Comments and Suggestions on a Framework for the NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility. This Request for Information (RFI) is intended to gather broad public input to assist NIH in developing the NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA). NIH invites input from stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public, regarding the proposed framework for the NIH-Wide Strategic Plan for DEIA.
• On February 11, 2022, the Office of the Assistant Secretary for Preparedness and Response (ASPR) issued a RFI entitled, National Health Security Strategy. ASPR is soliciting public comment regarding national health security threats, challenges, and promising practices to help inform the development of the 2023-2026 National Health Security Strategy (NHSS).
• On February 11, 2022, FDA issued a final order entitled, Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip. FDA is classifying the spore test strip 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 spore test strip’s classification.
• On February 11, 2022, FDA issued a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator. FDA is classifying the adjunctive predictive cardiovascular indicator 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 adjunctive predictive cardiovascular indicator’s classification.
• On February 11, 2022, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). The BSC NIOSH consists of 15 experts in fields associated with occupational safety and health, such as occupational medicine, occupational nursing, industrial hygiene, occupational safety, engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, biostatistics, psychology, wellness, research translation, and evaluation.
• On February 11, 2022, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis (ACET). The ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery.

Event Notices

• March 7-8, 2022: NIH announced a public meeting of the National Cancer Institute (NCI) Board of Scientific Counselors. The meeting agenda includes remarks from the NCI Director.
• March 9, 2022: NIH announced a public meeting of the NCI Council of Research Advocates. The meeting agenda includes the Chairman’s Remarks, NCI Updates, Legislative Update, and Director’s Update.
• March 15, 2022: FDA announced a public meeting entitled, Food and Drug Administration Hiring and Retention Final Assessment. The topic to be discussed is the FDA Hiring and Retention Final Assessment, which was an independent assessment performed by Booz Allen Hamilton, published on December 10, 2021. There will also be an opportunity for public comment.
• March 15-16, 2022: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). The ACIMM advises the Secretary of Health and Human Services (Secretary) on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy.
• March 24, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the SAMHSA National Advisory Council (NAC). The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of prior meeting minutes; updates on SAMHSA priorities; follow up on topics related to the previous SAMHSA NAC meeting; and council discussions.
• March 24, 2022: CDC announced a public meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The Committee is charged with providing advice and guidance to the Director, Division of Healthcare Quality Promotion (DHQP), the Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Director, CDC, the Secretary, Health and Human Services regarding 1) the practice of healthcare infection prevention and control; 2) strategies for surveillance, prevention, and control of infections, antimicrobial resistance, and related events in settings where healthcare is provided; and 3) periodic updating of CDC guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions.
• May 10, 2022: NIH announced a public meeting of the Board of Regents of the National Library of Medicine. The meeting agenda will include a program discussion.
• Various Dates: HRSA announced several public meetings of the National Advisory Council on the National Health Service Corps (NACNHSC). The NACNHSC consults with, advises, and makes recommendations to the Secretary of Health and Human Services, including on the designation of areas of the United States with health professional shortages and assignment of National Health Service Corps (NHSC) clinicians to improve the delivery of health services in health professional shortage areas.

II. Congressional Hearings

U.S. Senate

• On February 8, 2022, the Senate Committee on Health, Education, Labor, & Pensions (HELP) held a hearing entitled, Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to Employment for People with Disabilities. Witnesses present included: Dr. Lisa Schur, Professor, Labor Studies and Employment Relations at Rutgers University Director, Program for Disability Research; Ms. Jenny Lay-Flurrie, Chief Accessibility Officer, Microsoft; Mr. Francis A. Kineavy, Disability Advocate; and Mr. Brian Dennis, Workforce Program Coordinator, Disability Services, Iowa Workforce Development.
• On February 8, 2022, the Senate Committee on Finance held a hearing entitled, Protecting Youth Mental Health: Part I - An Advisory and Call to Action. Witnesses present included: The Honorable Vivek H. Murthy, M.D., M.B.A., Surgeon General, Office of The Secretary, United States Department of Health and Human Services.
• On February 9, 2022, the Senate Committee on Finance held a hearing entitled, Hearing to Consider the Nominations of Robert Michael Gordon, of the District of Columbia, to be an Assistant Secretary of Health and Human Services and Rebecca E. Jones Gaston, of Oregon, to be Commissioner on Children, Youth, and Families, Department of Health and Human Services. Witnesses present included: Robert Michael Gordon, Of The District Of Columbia, To Be An Assistant Secretary Of Health And Human Services, United States Department of Health and Human Services; January Contreras, Of Arizona, To Be Assistant Secretary For Family Support, United States Department of Health and Human Services; and Rebecca E. Jones Gaston, Of Oregon, To Be Commissioner On Children, Youth, And Families, United States Department of Health and Human Services.
• On February 10, 2022, Senate Aging Committee hearing entitled, Improving Care Experiences for People with both Medicare and Medicaid. Witnesses present included: Dr. Jose Figueroa, MD, MPH, Assistant Professor Of Health Policy And Management, Harvard T.H. Chan School Of Public Health and Associate Physician, Brigham and Women’s Hospital; Ms. Eunice Medina, Chief Of Staff, South Carolina Department of Health & Human Services (DHHS); Mr. Dennis Heaphy, MDiv, MEd, MPH, Policy Analyst, Disability Policy Consortium; and Ms. Jane Doyle, Grandmother.
• On February 10, 2022, the Senate HELP Committee Employment and Workplace Safety Subcommittee hearing entitled, Recruiting, Revitalizing & Diversifying: Examining the Health Care Workforce Shortage. Witnesses present included: Margaret Flinter, PhD, APRN, Senior Vice President and Clinical Director, Community Health Center, Inc., and Chair, Board of Directors, National Nurse Practitioner Residency and Fellowship Training Consortium; Reynold Verret, PhD, President, Xavier University of Louisiana; Norma Quinones, LPN, Nursing Services Manager and National Institute for Medical Assistant Advancement (NIMAA) Site Coordinator, Clinica Family Health; and Rachel Greszler, Research Fellow in Economics, Budget and Entitlements, Institute for Economic Freedom and Opportunity, The Heritage Foundation.

U.S. House of Representatives

• On February 8, 2022, the House Energy & Commerce Committee Health Subcommittee hearing entitled, ARPA-H: The Next Frontier of Biomedical Research. Witnesses present included: Keith R. Yamamoto, Ph.D., Vice Chancellor for Science Policy and Strategy, University of California San Francisco; Esther Krofah, Executive Director, FasterCures and Center for Public Health at the Milken Institute; Geoffrey Shiu Fei Ling, M.D., Ph.D., CEO, On Demand Pharmaceuticals, Professor of Neurology, Johns Hopkins Medicine; Admiral Brett P. Giroir, Former Assistant Secretary for Health, U.S. Department of Health and Human Services; and Brian James Miller, M.D., M.B.A., M.P.H., Professor of Medicine, John Hopkins Medicine.

III. Reports, Studies & Analyses

• On February 7, 2022, the Government Accountability Office (GAO) published a report entitled, COVID-19: Federal Efforts to Provide Vaccines to Racial and Ethnic Groups. In February 2021, CDC, HRSA, and the Federal Emergency Management Agency (FEMA) each launched COVID-19 vaccine programs to supplement state and jurisdictional vaccination efforts. Through these three programs, the agencies took steps to provide COVID-19 vaccines to underserved and historically marginalized racial and ethnic groups, such as by using population data on race and ethnicity when selecting vaccination sites. CDC, HRSA, and FEMA data—although limited in completeness—suggest that the agencies' COVID-19 vaccine programs vaccinated varying shares of racial and ethnic groups.
• On February 7, 2022, GAO published a report entitled, Drug Safety: FDA Should Take Additional Steps to Improve Its Foreign Inspection Program. This report (1) describes the number of inspections prior to and during the COVID-19 pandemic, (2) examines steps taken to address challenges related to preannouncing foreign inspections and language barriers, and (3) examines efforts to maintain a sufficient inspection workforce, among other objectives. GAO recommended that FDA, among other things, develop tailored strategies and time frames to recruit and retain investigators for its foreign inspection workforce, which could help address a backlog of inspections.
• On February 7, 2022, the Congressional Research Service (CRS) published a report entitled, The Provider Relief Fund: Frequently Asked Questions. The Provider Relief Fund (PRF) was established in the Coronavirus Aid, Relief, and Economic Security Act to reimburse, through grants or other mechanisms, eligible health care providers for increased expenses or lost revenue attributable to Coronavirus Disease 2019 (COVID-19). The answers to the frequently asked questions (FAQs) in this report provide overview information on the PRF, how funds have been allocated, and the fund’s requirements for provider reporting. In addition, this report describes the use of the PRF to pay providers for providing coronavirus testing, treatment, and vaccines to uninsured individuals and the use of the fund to pay providers for costs associated with vaccinating individuals who are underinsured.
• On February 9, 2022, the Bipartisan Policy Center published a report entitled, Expanding Access to Obesity Treatments for Older Adults. The prevalence of obesity in the U.S. continues to rise, including in older adults, and is higher among communities of color and historically disadvantaged communities. This poses a significant challenge for public health, health care providers, and public and private payers, all of whom are struggling with the double burden of COVID-19 and rising rates of obesity and chronic disease. Given the serious health and financial ramifications of obesity, policymakers should consider the value of increased investment in obesity prevention and treatment efforts. This policy brief aims to stimulate discussion as to what would be required for policymakers to expand access to obesity treatments in public insurance programs, and in Medicare specifically.
• On February 10, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, Outpatient telehealth use soared early in the COVID-19 pandemic but has since receded. The issue brief finds that telehealth use skyrocketed during the early months of the pandemic. While it has since decreased somewhat from that high, it still represents a much more substantial share of health care than before COVID. The report also looks at telehealth use by chronic condition and by gender and summarizes potential implications for expanded telehealth use for access, costs, and quality of care, as well as the regulatory environment likely to affect telehealth in the future.

IV. Other Health Policy News

• On February 8, 2022, the Department of Health and Human Services (HHS), through HRSA, announced that it is providing $66.5 million in American Rescue Plan funding to eight grantees to expand outreach efforts in 38 states and the District of Columbia to increase COVID-19 vaccine confidence and vaccinations. HHS has provided a total of nearly $390 million to 158 organizations for the Community-based Workforce for COVID-19 Vaccine Program, supporting outreach, events, translation and other enabling services, education, and community health worker support in underserved areas in all 50 states. More information on this announcement can be found here.
• On February 9, 2022, the Centers for Medicare & Medicaid Services (CMS) announced that as part of its commitment to improve transparency and help families and caregivers find the best nursing home care for their loved ones, it is now posting data on COVID-19 vaccine booster shots administered to nursing home residents and staff on the gov Care Compare website. The data will show resident and staff booster rates at the facility level and will include national and state averages. More information on this announcement can be found here.
• On February 10, 2022, HHS Secretary Xavier Becerra announced that the federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. More information on this announcement can be found here.
• On February 10, 2022, CMS announced a national coverage determination (NCD) that expands coverage for lung cancer screening with low dose computed tomography (LDCT) to improve health outcomes for people with lung cancer. Lung cancer is one of the most common cancers and the leading cause of cancer-related death in both men and women in the United States. This screening is aimed at early detection of non-small cell lung cancer. This final decision expands eligibility for people with Medicare to get lung cancer screening with LCDT by lowering the starting age for screening from 55 to 50 years and reducing the tobacco smoking history from at least 30 packs per year to at least 20 packs per year. More information on this announcement can be found here.
• On February 10, 2022, HHS released a new report that highlights the economic impact of the American Rescue Plan (ARP), specifically the role ARP played in reducing poverty. The report, which was produced by researchers in HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE), projects that economic relief efforts—including economic impact payments, unemployment compensation and expanded unemployment compensation (includes federal supplemental benefits), and the monthly Advance Child Tax Credit payments—kept 20.1 million people out of poverty, including 7.8 million children. More information on this report can be found here.

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