Alston & Bird Health Care Week in Review - September 2021 #2

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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, the Biden Administration issued new COVID-19 vaccination requirements and HHS announced an additional $25.5 billion to support U.S. providers. Read more about these developments and other news below.


I. Regulations, Notices & Guidance

  • On September 8, 2021, the Food and Drug Administration (FDA) issued guidance entitled, S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation. This draft guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. Considerations for interpretation and application of the BD data to support a nonclinical development program and inform the design of clinical trials are also provided. The recommendations in the guidance endeavour to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. The draft guidance is intended to promote harmonization of recommendations for BD studies for investigational GT products and facilitate a more efficient and timely nonclinical development program.
  • On September 8, 2021, FDA issued updated guidance entitled, Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry. FDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency

Event Notices

  • September 13-14, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the National Human Genome Research Institute’s National Advisory Council for Human Genome Research. The meeting will include a report from the Institute Director and program staff, and a review and evaluation of grant applications.
  • September 14-15, 2021: The Department of Health and Human Services (HHS) announced a virtual public meeting of the National Vaccine Advisory Committee (NVAC). During this NVAC meeting, NVAC will hear presentations on vaccine safety, vaccine development, and communication activities.
  • September 17, 2021: FDA announced a virtual public meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.
  • September 17, 2021: FDA issued a meeting correction for the notice of the meeting of the Pediatric Advisory Committee. The document was published with the incorrect docket number and end time of the meeting. This document corrects those errors.
  • September 17, 2021: FDA announced a virtual public meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.
  • September 20-22, 2021: The Department of Veterans Affairs (VA) announced a virtual public meeting of the Veterans’ Rural Health Advisory Committee. The purpose of the Committee is to advise the Secretary of Veterans Affairs on rural health care issues affecting Veterans. The agenda will include updates from Department leadership, the Executive Director Office of the VA Office of Rural Health, and the Committee Chair; as well as presentations by subject-matter experts on general rural health care access.
  • September 23, 2021: HHS announced a virtual public meeting of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The committee will discuss and vote on recommendations to improve the supply chain and data infrastructure that supports the blood industry, especially during public health emergencies. This meeting will build upon the presentations and discussions held during the 53rd ACBTSA meeting from August 17 – 18, 2021.
  • September 23-24, 2021: NIH announced a virtual public meeting of the National Center for Advancing Translational Sciences Advisory Council. The Council will review and evaluate grant applications; hear a report from the Institute Director and other staff; and view and discuss Clearance of Concepts.
  • September 28, 2021: The Centers for Disease Control and Prevention (CDC) announced a virtual public meeting of the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). The purpose of the WTCHP STAC is to review scientific and medical evidence and to make recommendations to the Administrator of the World Trade Center (WTC) Health Program regarding additional WTC Health Program eligibility criteria, potential additions to the List of WTC-Related Health Conditions, and research regarding certain health conditions related to the September 11, 2001, terrorist attacks.
  • September 30, 2021: HHS announced a virtual public meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to present and vote on the final recommendations for mitigating inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.
  • October 13-14, 2021: FDA announced a public workshop entitled, Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis. The purpose of the public workshop is to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a Risk Evaluation and Mitigation Strategy (REMS).
  • October 19-21, 2021: FDA announced a virtual public meeting entitled, “FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers.” The purpose of the public meeting is to engage with stakeholders and invite input on various topics pertaining to the implementation of Core Element 3.1 of the New Era of Smarter Food Safety Blueprint.
  • October 28, 2021: FDA announced a virtual public meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
  • November 4, 2021: FDA announced a virtual public meeting of the Psychopharmacologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues.
  • Various Dates: HHS announced two virtual public meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The October 6, 2021 public meeting will be held virtually and is dedicated to deliberation and vote of the letter with recommendations from the Immediate Action Subcommittee of the Advisory Council. The November 31, 2021 and December 1, 2021 public meeting will be held virtually and will be dedicated to addressing the current situation regarding antimicrobial resistance as well as to a presentation from the National Academies of Sciences, Engineering, and Medicine on their report, Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States.

II. Congressional Hearings

U.S. Senate

  • On September 8, 2021, the Senate Special Committee on Aging field hearing entitled, Living Your Best Life Now: Enjoying Your Golden Years with Physical and Mental Vitality. Witnesses present included: Connie D. Munn, Director, South Carolina Department on Aging (SCDOA); John M. Ciccone, MD, FACC, ABIHM, Associate Chief Medical Officer, Roper St. Francis Mount Pleasant Hospital; Kesha L. Hayes, MA, LPN, Founder, Caring for Aging Beauties; Connie Ross-Karl, Honorary Senior America; Floyd Davidson Spence, Jr, Owner and Instructor, Lake Murray Fitness Cycle, LLC; and Perry A. Bowers, DMin, Founder and President, Focused Living Ministries.

U.S. House of Representatives

  • On September 9 and September 10, the House Committee on Ways and Means held its first markup of certain portions of the reconciliation package, dubbed the Build Back Better Act. The Committee considered the following subtitles:
    • Subtitle A. Budget Reconciliation Legislative Recommendations Relating to Universal Paid Family and Medical Leave
    • Subtitle B. Budget Reconciliation Legislative Recommendations Relating to Retirement
    • Subtitle C. Budget Reconciliation Legislative Recommendations Relating to Child Care Access and Equity
    • Subtitle D. Budget Reconciliation Legislative Recommendations Relating to Trade Adjustment Assistance
    • Part 1 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Pathways to Health Careers
    • Part 2 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Elder Justice
    • Part 3 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Skilled Nursing Facilities
    • Part 4 of Subtitle E: Budget Reconciliation Legislative Recommendations Relating to Medicare Dental, Hearing, and Vision Coverage

III. Reports, Studies & Analyses

  • On September 8, 2021, the Government Accountability Office (GAO) published a report entitled, Medicaid Home- and Community-Based Services: Evaluating COVID-19 Response Could Help CMS Prepare for Future Emergencies. The CARES Act includes a provision for GAO to report on its ongoing COVID-19 monitoring and oversight efforts. In addition, GAO was asked to examine temporary changes to Medicaid in response to COVID-19. This report describes temporary changes to Medicaid home- and community-based services (HCBS) programs, including selected states' experience in making these changes; and examines the Center for Medicare & Medicaid’s (CMS) monitoring and evaluation of the effects of those changes.
  • On September 9, 2021, RAND Corporation published a report entitled, Identifying Strategies to Boost COVID-19 Vaccine Acceptance in the United States. This report presents the results of an evaluation of the root causes of COVID-19 vaccine hesitancy to inform strategies to boost vaccine acceptance among vaccine-hesitant populations in the United States. The authors conducted a literature review of the causes of vaccine hesitancy and vaccine acceptance; focus groups with patients, pre-hospital first responders, and hospital-based health care providers; a social media platform sentiment analysis to review attitudes regarding the COVID-19 vaccine; and a roundtable discussion with experts on vaccine hesitancy.

IV. Other Health Policy News

  • On September 7, 2021, HHS announced that it is distributing an additional $452 million in federal funding through CMS to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers. More information about this announcement can be found here.
  • On September 9, 2021, CMS, in collaboration with the Centers for Disease Control and Prevention (CDC), announced that it will require staff within all Medicare and Medicaid-certified facilities to receive COVID-19 vaccination. CMS explained that the emergency regulations announced on August 18 will now be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs. CMS expects to issue these emergency regulations in October as an interim final rule with comment period. However, they urge health care workers employed by Medicare and Medicaid-certified facilities to begin the vaccination process immediately. More information about this announcement and the impending regulations can be found here. A list of Medicare and Medicaid-certified facilities is available here.
  • On September 9, 2021, HHS Secretary Xavier Becerra released a plan to lower the cost of prescription drugs in the U.S. Specifically, the plan identifies three guiding principles for lowering the cost of prescription drugs: (1) Make drug prices more affordable and equitable for all consumers and throughout the health care system by supporting drug price negotiation with manufacturers and stopping unreasonable price increases to ensure access to drugs that can improve health for all Americans; (2) Improve and promote competition throughout the prescription drug industry by supporting market changes that strengthen supply chains, promote biosimilars and generics, and increase transparency; and (3) Foster scientific innovation to promote better health care and improve health by supporting public and private research and making sure that market incentives promote discovery of valuable and accessible new treatments, not market gaming. The full plan, entitled Comprehensive Plan for Addressing High Drug Prices, can be found here. A high-level summary of the plan is available here.
  • On September 9, 2021, HHS awarded over $5 million to 27 Health Resources and Services Administration (HRSA)-funded health centers to expand services at new or existing Health Center Program service delivery sites located at or on the grounds of a school. School-based service sites are Health Center Program service delivery sites located at a school or on the grounds of a school. More information about the funding can be found here.
  • On September 9, 2021, the Biden Administration On September 9, 2021, the Biden Administration announced it is implementing a comprehensive national strategy to combat the COVID-19 pandemic. The plan, which is intended to protect U.S. citizens while simultaneously keeping schools open and safe and preventing additional lockdowns, will focus on the following six areas: (1) Vaccinating the Unvaccinated; (2) Further Protecting the Vaccinated; (3) Keeping Schools Safely Open; (4) Increasing Testing and Requiring Masking; (5) Protecting Our Economic Recovery; and (6) Improving Care for those with COVID-19.
  • On September 10, 2021, HHS announced that it is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic. This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children's Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic. Consistent with the requirements included in the CARES Act of 2020, PRF Phase 4 payments will be based on providers' lost revenues and expenditures between July 1, 2020, and March 31, 2021. More information about this latest round of funding can be found here.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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