Alston & Bird Health Care Week in Review, October 23, 2020

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:

On Thursday, HHS announced it is expanding eligibility and updating reporting requirements for the CARES Act Provider Relief Fund. Read more about these changes and other news below.

Regulations, Notices & Guidance

• On October 20, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989. Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format. Forms FDA 3988 and 3989 are published in draft form in Appendix A and B of the draft guidance for comment and are not intended to be used until the forms are finalized. The forms were developed, in part, in response to the recommendations from the Government Accountability Office (GAO) and the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) regarding the need for comparable information across annual status reports (ASRs) on PMRs and PMCs, to eliminate manual data entry, and to enhance FDA’s ability to track PMRs and PMCs. These forms are expected to result in improved accuracy and timeliness of FDA’s identification and review of those submissions containing information on PMRs and PMCs. This draft guidance covers the purpose of each form, when to use these forms, and how to submit these forms. The draft guidance also explains where applicants will be able to find the forms and instructions for their completion once the forms and instructions are finalized.
• On October 21, 2020, FDA issued guidance entitled, Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide Developmental and Reproductive Toxicology: Version 1.1. FDA is announcing that it intends to conduct a Fit for Use (FFU) pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data (SEND) Implementation Guide (IG): Developmental and Reproductive Toxicology v1.1 (SEND-DART). The FDA’s Center for Drug Evaluation and Research (CDER) will test the processing and analysis of nonclinical study data provided electronically in SEND-DART format. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email or in writing.
• On October 22, 2020, FDA issued guidance entitled, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies. This guidance explains that FDA intends to extend the delay in enforcement described in the guidance entitled “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy,” published in the Federal Register on September 24, 2019 (the 2019 Compliance Policy), which relates to Drug Supply Chain Security Act (DSCSA) provisions requiring wholesale distributors to verify the product identifier prior to further distributing returned product beginning on November 27, 2019. In addition, this guidance announces FDA’s intended enforcement policy with respect to DSCSA provisions requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser’s possession or control beginning on November 27, 2020.

Event Notices         

• October 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
• October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
• October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
• October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
• October 30, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Diabetes Mellitus Interagency Coordinating Committee. The topic for this meeting will be “Health Literacy and Numeracy: Considerations for Equity Approaches.”
• November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
• November 6, 2020: FDA announced a public meeting entitled, Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease.
• November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.
• November 16, 2020: FDA announced a public meeting entitled, Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs. The purpose of the meeting is to obtain early input from the public on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. FDA is seeking public input on a potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs.
• November 20, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The agenda will include discussions on current topics related to breast cancer in young women. These will include Mental/Behavioral Health, Sexual Health, Genetics and Genomics, and Provider Engagement.
• December 15-16, 2020: CMS announced a town hall entitled, Meeting on the FY 2022 Applications for New Medical Services and Technologies Add-On Payments. The purpose of the meeting is to discuss FY 2022 applications for add-on payments for new medical services and technologies under the IPPS.

II. Congressional Hearings

U.S. House of Representatives

• On October 20, 2020, the House Committee on Ways and Means Subcommittee on Oversight held a hearing entitled Maximizing Health Coverage Enrollment Amidst Administration Sabotage. Witnesses present included: Marlene Caride, Commissioner, New Jersey Department of Banking and Insurance; Kevin Patterson, CEO, Connect for Health Colorado; Andy Slavitt, Board Chair, United States of Care; and Chris Pope, Senior Fellow, Manhattan Institute.

III. Reports, Studies & Analyses

• On October 19, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, 2021 Premium Changes on ACA Exchanges and the Impact of COVID-19 on Rates. Insurers planning to offer health plans on the Affordable Care Act (ACA) marketplaces must submit filings to state or federal regulators detailing their plan offerings and justifying their premiums for the upcoming year. Rates are finalized in early fall ahead of the annual open enrollment period, set to begin on November 1, 2020. Now that 2021 rates are being finalized, this brief summarizes the most current premium rate filings in all 50 states and the District of Columbia. The authors reviewed rate filings for an overall average premium increase across all plans on the individual market, with a focus on the effect of the pandemic on rate changes. The authors find that the majority of rate changes for 2021 are still moderate, with increases or decrease of a few percentage points.
• On October 19, 2020, KFF published an issue brief entitled, Trends in Overall and Non-COVID-19 Hospital Admissions. Approximately seven months after the coronavirus sparked social distancing measures and concerns about hospital capacity, new medical records data help shed light on the magnitude of the drop in hospital admissions and the more recent rebound in hospitalizations. These new data provide additional information to help assess the economic impact of the COVID-19 pandemic on hospitals and insurers and also provide more information to help assess the extent to which people are still delaying or forgoing care. This brief analyzes trends in total hospital admissions and then separately analyzes non-COVID-19 admissions by patient sex, age, and region. The authors calculate actual admissions as a share of total predicted admissions in 2020 based on trends from past years.
• On October 20, 2020, KFF published an issue brief entitled, Distributing a COVID-19 Vaccine Across the U.S. - A Look at Key Issues. This brief outlines what is currently known about the U.S. COVID-19 vaccine distribution plan and discusses key issues and challenges as well as outstanding questions.
• On October 22, 2020, KFF published an issue brief entitled, How Many Physicians Have Opted-Out of the Medicare Program? This analysis examines the extent to which non-pediatric physicians are opting out of Medicare, by specialty, and by state, based on data published by CMS as of September 2020.

IV. Other Health Policy News

• On October 21, 2020, HHS, through the Assistant Secretary for Health (ASH), issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when made available, and COVID-19 tests, all subject to several requirements. This guidance clarifies that the pharmacy intern must be authorized by the State or board of pharmacy in the State in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the State board of pharmacy. More information about the guidance can be found here.
• On October 22, 2020, HHS announced that the latest Provider Relief Fund (PRF) application period has been expanded to include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions. HHS also announced it will be updating its most recent PRF reporting instructions to broaden use of provider relief funds. More information about these updates to the PRF can be found here.

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