Alston & Bird Health Care Week in Review, May 14, 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, CMS issued a rule implementing new COVID-19 vaccine requirements for long-term care facilities. Read more about the rule and other news below.

I. Regulations, Notices & Guidance

• On May 11, 2021, the Food and Drug Administration (FDA) issued guidance entitled, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. This guidance describes FDA’s current recommendations regarding phase 2 or phase 3 trials for drugs or biological products under development for the treatment or prevention of COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency’s good guidance practices. This final guidance revises and replaces the final guidance of the same name issued on May 11, 2020. Revisions were made to address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants and the availability of COVID19 vaccines.
• On May 11, 2021, FDA issued guidance entitled, E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation. This guidance clarifies, updates, and extends the guidance for industry “E9 Statistical Principles for Clinical Trials” issued in September 1998 in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The guidance is intended to better align the choice of statistical methods with questions of regulatory importance and so to improve the reliability of decisions about and representations of the effects of medical products.
• On May 11, 2021, FDA issued guidance entitled, M9 Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation. This guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence (BE) study requirement for certain drug products. The guidance is intended to avoid or reduce the need for human BE trials based on extensive in vitro characterization of the drug substance and drug product properties.
• On May 11, 2021, FDA issued guidance entitled, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation. This guidance, which consists of a Guidance and Annexes, provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/biological products.
• On May 11, 2021, FDA issued guidance entitled, Q3D(R2)—Guideline for Elemental Impurities; International Council for Harmonisation. This draft guidance provides Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration and relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. In addition, error corrections to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route) are provided. The draft guidance is intended to recommend acceptable amounts for the listed elemental impurities in pharmaceuticals for the safety of the patient and provide recommendations for conducting a risk assessment for pharmaceutical products.
• On May 11, 2021, FDA issued guidance entitled, Qualified Infectious Disease Product Designation--Questions and Answers. The Food and Drug Administration Safety and Innovation Act (FDASIA) created incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this final guidance is to provide a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product (QIDP).
• On May 11, 2021, FDA issued guidance entitled, S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals; International Council for Harmonisation. This guidance recommends international standards for the nonclinical safety studies recommended to support the development of pediatric medicines. The guidance provides a weight of evidence approach to determine when nonclinical toxicity studies may be recommended in juvenile animals. If such studies are recommended, the guidance provides appropriate study designs. The guidance is intended to promote harmonization of recommendations for such studies and should facilitate the timely conduct of pediatric clinical trials and reduce the use of animals in accordance with the 3R (replace/reduce/refine) principles. Tissue engineered products, gene and cellular therapies, and vaccines are excluded from the scope of this guidance.
• On May 11, 2021, FDA issued guidance entitled, S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals; International Council for Harmonisation. This guidance provides key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. The guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays.
• On May 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC) entitled, COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff. This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as “nursing homes”) and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.
• On May 14, 2021, CMS delayed the effective date of the final rule entitled, Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary". This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the FDA. The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B. The effective date of the final rule is further delayed until December 15, 2021.

Event Notices

• 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: 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.
• June 29-30, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This meeting will be dedicated to the council’s deliberation and vote on two reports to transmit to the HHS Secretary, the first from the Disparities in Antibiotics Access and Use Working Group, and the second from the Working Group on Antimicrobial Resistance (AMR) in Inter-Professional Education. The remainder of the two-day public meeting will include an update on the status of the antibiotic development pipeline and an open council discussion on provocative questions in AMR (no recommendations will be made), in addition to presentations from subject matter experts on Operationalizing One Health and the Environmental Dimensions of AMR.
• 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. Senate

• On May 11, 2021, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, An Update from Federal Officials on Efforts to Combat COVID-19. Witnesses present included: Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH); Dr. David Kessler, Chief Science Officer, COVID Response, HHS; Dr. Peter Marks, Director, Center for Biologics Evaluation and Research, FDA; and Dr. Rochelle Walensky, Director, CDC.
• On May 12, 2021, the Senate Committee on Finance Subcommittee on Health Care held a hearing entitled, The COVID-19 Pandemic and Beyond: Improving Mental Health and Addiction Services in Our Communities. Witnesses present included: Victor Armstrong, Director of North Carolina Division of Mental Health, Developmental Disabilities and Substance Abuse Services, North Carolina Department of Health and Human Services; Dr. Stephanie Woodard, Senior Advisor on Behavioral Health, Nevada Department of Health and Human Services; Lenette Kosovich, CEO, Rimrock Foundation; and Malkia Newman, Team Supervisor, CNS Healthcare Anti-Stigma Program.

U.S. House of Representatives

• On May 12, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, The Fiscal Year 2022 HHS Budget. Members of the Subcommittee discussed the Biden Administration’s Fiscal Year 2022 HHS Budget Request with HHS Secretary Xavier Becerra.

III. Reports, Studies & Analyses

• On May 10, 2021, the Government Accountability Office (GAO) published a report entitled, Maternal Mortality and Morbidity: Additional Efforts Needed to Assess Program Data for Rural and Underserved Areas. GAO was asked to review maternal mortality and severe maternal morbidity (SMM) outcomes in rural and underserved areas. This report examines, among other objectives, what is known about these outcomes; selected CDC and Health Resources and Services Administration (HRSA) programs that aim to reduce these outcomes, as well as actions to collect and use relevant data; and the extent to which HHS is taking actions to improve maternal health and monitoring progress on its efforts. GAO analyzed HHS data, agency documentation, literature, and interviewed officials from a non-generalizable sample of three states and stakeholders to capture various perspectives.
• On May 12, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Vaccination is Local: COVID-19 Vaccination Rates Vary by County and Key Characteristics. This issue brief builds on that analysis by analyzing how vaccination rates to date vary by counties and identifying key county characteristics that are associated with higher or lower county vaccination rates. It is based on KFF analysis of data from CDC that shows the percent of the population fully vaccinated at the county-level; the data also provides this share for those ages 65 and older. The CDC data, while incomplete (see methods), provides comprehensive data to examine vaccine rollout at the county level. The results in this brief use data as of May 11, 2021 and include 77% of all counties (2,415) in the US.

• On May 11, 2021, HHS announced that it is awarding approximately $40 million in emergency home visiting funds to states, territories, and the District of Columbia to support children and families affected by the COVID-19 pandemic. The Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program supports the delivery of coordinated and comprehensive, high quality, voluntary, evidence-based home visiting services to children and families living in communities at risk for poor maternal and child health outcomes. More information about this funding can be found here.
• On May 11, 2021, the Senate confirmed Andrea Palm to serve as the Deputy Secretary of HHS by a vote of 61-37. Ms. Palm previously headed the Wisconsin Department of Health Services—overseeing its $12 billion budget and over 6,000 employees—and served as the HHS’s chief of staff and as senior counselor to the secretary during the Obama administration.
• On May 13, 2021, CMS published guidance on how states can receive enhanced funding, provided through the American Rescue Plan Act of 2021, to increase access to home and community-based services (HCBS) for Medicaid beneficiaries. The guidance is a key tool to assist states in leveraging federal resources to increase health equity in Medicaid beneficiaries’ access to HCBS, positive health outcomes, and community integration. The guidance can be found here.

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