Alston & Bird Health Care Week in Review - May 2021 #4

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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 Senate confirmed Chiquita Brooks-LaSure as the next CMS Administrator, and the Biden Administration released its FY 2022 budget proposal. Read more about these actions and other news below.


I. Regulations, Notices & Guidance

  • On May 24, 2021, the Food and Drug Administration (FDA) issued guidance entitled, FDA Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs. This guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). Early pediatric evaluation of certain molecularly targeted oncology drugs as required by the FD&C Act is expected to accelerate the creation of an informed pediatric development plan and ultimately the development of promising drugs for pediatric patients.
  • On May 24, 2021, FDA issued guidance entitled, Bispecific Antibody Development Programs. This guidance provides recommendations to assist industry and other parties involved in the development of bispecific antibodies. The guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody.
  • On May 25, 2021, FDA issued guidance entitled, Emergency Use Authorization for Vaccines to Prevent COVID-19. FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
  • On May 26, 2021, FDA issued guidance entitled, Tobacco Product User Fees: Responses to Frequently Asked Questions. This draft guidance provides information in response to frequently asked questions related to tobacco product user fees assessed and collected under the FD&C Act.
  • On May 26, 2021, FDA issued guidance entitled, Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order. This draft guidance is intended to update the 2009 guidance to assist stakeholders with understanding post-approval study requirements imposed as a condition of approval of a premarket approval application (PMA). This draft guidance is not final nor is it in effect at this time.
  • On May 26, 2021, FDA issued guidance entitled, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act. This draft guidance is intended to update the 2016 guidance to increase transparency to stakeholders on FDA’s approach to the issuance and tracking of these postmarket surveillance orders, and expectations for timely study completion. This draft guidance is not final nor is it in effect at this time.
  • On May 26, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States. This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements,” published in the December 31, 2020 Federal Register. This proposed rule also proposes to delay for 2 years the April 1, 2022 effective date of inclusion (inclusion date) for U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of “States” and “United States” for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, “Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States,” published in the November 25, 2019 Federal Register to April 1, 2024. In the alternative, CMS is proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received.

Event Notices

  • 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 25, 2021, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a markup of six bipartisan health bills. All six measures passed by voice vote. Legislation included the following:
    • 1675, Maternal Health Quality Improvement Act
    • 1491, Rural Maternal and Obstetric Modernization of Services Act
    • 1662, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act
    • 1301, Promoting Physical Activity for Americans Act
    • 610, Dr. Lorna Breen Health Care Provider Protection Act
    • 1658, Providing Urgent Maternal Protections for Nursing Mothers Act

U.S. House of Representatives

  • On May 25, 2021, the House Committee on Appropriations Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, FY 2022 Budget Request for the National Institutes of Health. Witnesses present included: Dr. Diana Bianchi, Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Dr. Francis Collins, Director, National Institutes of Health (NIH); Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons, Director, National Heart, Lung, and Blood Institute; Dr. Norman Sharpless, Director, National Cancer Institute; and Dr. Nora Volkow, Director, National Institute on Drug Abuse.
  • On May 26, 2021, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, A Shot at Normalcy: Building COVID-19 Vaccine Confidence. Witnesses present included: Nick Offerman, Actor and Woodworker; Dr. Saad Omer, Director, Yale Institute for Global Health, Yale University; Dr. Nadine Gracia, Executive Vice President and CEO, Trust for America’s Health; Amy Pisani, Executive Director, Vaccinate Your Family; and Dr. Karen Shelton, Director, Mount Rodgers Health District, Virginia Department of Health.
  • On May 26, 2021, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing entitled, National Institutes of Health’s FY22 Budget and the State of Medical Research. Witnesses present included: Dr. Francis Collins, Director, NIH; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases; Dr. Diana Bianchi, Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Dr. Ned Sharpless, Director, National Cancer Institute; Dr. Gary Gibbons, Director, National Heart, Lung, and Blood Institute; Dr. Eliseo Perez-Stable, Director, National Institute on Minority Health & Health Disparities; and Dr. Bruce Tromberg, Director, National Institute of Biomedical Imaging and Bioengineering.
  • On May 26, 2021, the House Committee on Appropriations Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies hearing entitled, FY 2022 Budget Request for the Centers for Disease Control and Prevention. Witnesses present included: Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention (CDC); and Dr. Rochelle Walensky, Director, CDC.

III. Reports, Studies & Analyses

  • On May 26, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Mental Health and Substance Use Considerations Among Children During the COVID-19 Pandemic. This brief explores factors contributing to poor mental health and substance use outcomes among children during the pandemic, highlighting groups of children who are particularly at risk and barriers to accessing child and adolescent mental health care. Although data on child and adolescent mental health have historically been limited, where possible, the authors draw upon data from the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, and the National Survey on Drug Use and Health, in addition to surveys conducted during the pandemic.

IV. Other Health Policy News

  • On May 25, 2021, the Senate confirmed Chiquita Brooks-LaSure as the CMS Administrator by a vote of 55-44. This comes after her confirmation vote was delayed due to objections over a revoked Texas Medicaid waiver extension. Ms. Brooks-LaSure previously worked at CMS during the Obama administration and helped implement the Affordable Care Act (ACA). She also drafted pieces of the ACA during her time as a staffer on the House Ways & Means Committee.
  • On May 25, 2021, the U.S. Department of Health and Human Services (HHS) announced that it is dedicating $4.8 billion from the American Rescue Plan (ARP) to support the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program. This funding will allow the program to continue reimbursing health care providers for testing uninsured individuals for COVID-19. As of May 19, 2021, the program has issued nearly $4 billion in testing reimbursements to providers. More information about this funding announcement can be found here.
  • On May 26, 2021, Representative Frank Pallone (D-NJ), Chairman of the House Energy and Commerce Committee, and Senator Patty Murray (D-WA), Chair of the Senate HELP Committee, announced their plans to develop legislation to establish a public option for health coverage to lower health care costs and help families get quality, affordable health care. As part of this process, the Chairs issued a Request for Information (RFI) to solicit public input on the legislation. The RFI can be found here. Responses are due by July 31, 2021.
  • On May 28, 2021, the Biden Administration released its Fiscal Year (FY) 2022 Budget. The spending blueprint proposes $131.8 billion in discretionary budget authority and $1.5 trillion in mandatory funding for HHS, including significant investments in public health and preparedness measures. The HHS Budget in Brief and a breakdown of HHS-related spending can be found here. HHS Secretary Xavier Becerra’s statement on the FY 2022 budget can be found here.

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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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