Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care 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 released guidance on how Part D beneficiaries can pay their out-of-pocket monthly costs over the course of a year and HHS announced that the Medicare Shared Savings Program saved Medicare $1.8 billion in 2022. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On August 21, 2023, the Food and Drug Administration (FDA) issued a notice entitled Product-Specific Guidances; Draft and Revised Draft Guidances for Industry. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications (ANDAs). Comments are due on October 23, 2023.
- On August 21, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to Serve on the Advisory Commission on Childhood Vaccines. HRSA announced that it is seeking nominations for individuals to serve on the Advisory Commission on Childhood Vaccines (ACCV), which advises the Secretary of Health and Human Services on issues related to the implementation of the National Vaccine Injury Compensation Program (VICP). Nominations are being accepted on a continuous basis.
- On August 21, 2023, the Centers for Medicare & Medicaid Services (CMS) released draft guidance on a new program that will allow individuals with Medicare to pay out-of-pocket prescription drug costs in monthly payments. CMS explains that the Inflation Reduction Act (IRA) gives people with Medicare prescription drug coverage (Medicare Part D) the option to pay out-of-pocket costs in monthly payments spread out over the year starting in 2025. In the draft guidance, CMS provides information on topics such as identifying Medicare Part D enrollees likely to benefit from the program, the opt-in process for Part D enrollees, program participant protections, and the data collection needed to evaluate the program. The draft guidance solicits comment on these topics and on strategies to help ensure eligible Part D enrollees benefit from programs like the Medicare Savings Programs and the Medicare Part D Extra Help Program to lower their out-of-pocket prescription drug costs. CMS explains that that this is the first of two guidance documents meant to prepare Part D plans for the new program. Comments on the draft guidance are due on September 20, 2023.
- On August 23, 2023, FDA published a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support ANDAs. Comments on the guidance are due on October 23, 2023.
- On August 23, 2023, the FDA published a notice entitled, Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period. In the notice, the agency announced that it is extending the comment period for the notice announcing the availability of a draft guidance entitled “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry,” that appeared in the Federal Register of July 14, 2023. Comments on the draft guidance are now due on November 13, 2023.
- On August 24, 2023, the FDA published a notice entitled, Notice of Opportunity for Public Comment on Proposal To Withdraw Approval of New Drug Application for PEPAXTO, Equivalent to 20 Milligrams Base per Vial. The agency announced that it is proposing to withdraw approval of the new drug application (NDA) for PEPAXTO, equivalent to 20 milligrams base per vial. FDA notes it originally approved the NDA for PEPAXTO under the accelerated approval pathway and that the NDA approval was conditional on a post-approval study to verify and describe the clinical benefit of PEPAXTO. Because the trial failed to verify the clinical benefit and because available evidence demonstrates PEPAXTO is not shown to be safe or effective under its conditions of use, FDA proposes to withdraw PEPAXTO’s NDA. FDA seeks public comment on its proposal. Comments are due on September 25, 2023.
- On August 25, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the Board of Scientific Counselors, Center for Preparedness and Response. The agency is seeking nominations for membership on the Board of Scientific Counselors, Center for Preparedness and Response. Nominations must be received no later than October 31, 2023.
- On August 25, 2023, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Lead Exposure and Prevention Advisory Committee. The agency is soliciting nominations for membership on the Lead Exposure and Prevention Advisory Committee. Nominations must be received no later than September 30, 2023.
- On August 25, 2023, FDA issued a guidance document entitled, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies. This guidance describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing under section 582(g)(1) of the Food, Drug, & Cosmetic Act that will go into effect on November 27, 2023.
- September 12, 2023: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussion of COVID-19 vaccines and recommendation votes for COVID-19 vaccines are scheduled.
- September 18, 2023: The National Institutes of Health (NIH) announced a public meeting of the Center for Scientific Review Advisory Council. The Council will provide advice to the Director, Center for Scientific Review (CSR), on matters related to planning, execution, conduct, support, review, evaluation, and receipt and referral of grant applications at CSR.
- September 20, 2023: HHS announced a public meeting of the Presidential Advisory Council on HIV/AIDS. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The agenda for this meeting will be posted at a later date.
- September 21, 2023: FDA announced a public meeting regarding the Center for Drug Evaluation and Research’s (CDER’s) proposal to refuse to approve ITCA 650 (exenatide in DUROS device), which is a drug-device combination product that is the subject of a NDA submitted by Intarcia Therapeutics, Inc. for the proposed indication, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
- September 21, 2023: FDA announced a public meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The Committee will discuss the safety and efficacy of ITCA 650 (exenatide in DUROS device), which is a drug-device combination product that is the subject of a NDA submitted by Intarcia Therapeutics, Inc., for the proposed indication, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
- October 5, 2023: FDA announced a public meeting of the Oncologic Drugs Advisory Committee. The meeting will discuss the supplemental new drug application (sNDA) for LUMAKRAS (sotorasib) tablets, submitted by Amgen Inc., for the proposed treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy. The agency explains that Amgen Inc.’s supplement proposes to convert the NDA to full approval based on the confirmatory study, CodeBreaK 200. The Committee will consider the results of the CodeBreaK 200 study and discuss the benefit-risk profile of LUMAKRAS.
- October 5, 2023: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will meet in open session to discuss the strain selection for the influenza virus vaccines for the 2024 Southern Hemisphere influenza season.
- October 12, 2023: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health. The agenda will include discussions on the following: update on Cybersecurity Modernization Initiative; work group and subcommittee reports; update on the status of SEC petitions; and plans for the December 2023 Advisory Board meeting. Written comments received in advance of the meeting will be included in the official record of the meeting and must be received on or before October 5, 2023.
- November 8, 2023: CDC announced a public meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. Presentations and CLIAC discussions will focus on the final report from the Clinical Laboratory Improvement Amendments (CLIA) Regulations Assessment Workgroup, efforts to address the CLIA top 10 laboratory deficiencies, standardization of test result communication, and the role of the laboratory in antibiotic stewardship.
- November 16, 2023: CDC announced a public meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). The agenda will include discussions on the following: (1) carry-over items from June 21, 2023 SPR Meeting including Sandford Cohen & Associates (SC&A) follow-up review of PER-049 (Paducah Gaseous Diffusion Plant) internal dose assessment using hypothetical intakes versus bioassay data and SC&A’s Peek Street memo on the review of two additional cases provided by NIOSH; (2) newly issued SC&A reviews including DCAS-PER-040 “Mallinckrodt TBD Revisions,” DCAS-PER-051 “Weldon Spring Plant,” DCAS-PER-083 “Weldon Spring Plant TBD Revision,” DCAS-PER-067 “Allegheny Ludlum Appendix Q Revisions,” and ORAUT-RPRT-0097 “Breathing Zone to General Area Air Concentration Ratios in Small Workrooms”; (3) preparation for the December 2023 full ABRWH meeting, specifically the review of SPR accomplishments and current activities; (4) preparation for the April 2024 full ABRWH meeting, specifically the review of technical guidance documents ready for full board approval; and (5) newly issued guidance and supplemental topics.
- November 29-30, 2023: FDA announced a public workshop entitled Workshop to Enhance Clinical Study Diversity. This public workshop will satisfy a mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) for FDA to convene one or more public workshops to solicit input from various stakeholders on enhancing diversity in clinical studies.
II. Reports, Studies & Analyses
- On August 21, 2023, the Kaiser Family Foundation (KFF) published updated poll findings on prescription drugs in a report entitled Public Opinion on Prescription Drugs and Their Prices. The poll found that about eight in ten adults say the cost of prescription drugs is unreasonable, and that affordability is a bigger issue for those who are currently taking four or more prescription medicines. Researchers also found that about three in ten individuals report not having taken their medicine as prescribed due to cost.
- On August 21, 2023, KFF published an issue brief entitled Understanding Mergers Between Hospitals and Health Systems in Different Markets. In the issue brief, KFF explains that policymakers have traditionally focused their concerns on consolidation within the same geographical area but noted that there have been many provider mergers between hospitals operating in different markets. KFF notes that there have been nine cross-market mergers announced since June 2021 with combined operating revenues of at least $5 billion. KFF then summarizes the impact of cross-market consolidation, noting that while a smaller hospital merging with a larger hospital could provide a financial backstop to the smaller hospital, it is also possible that consolidation leads to price increases and deceased access to care.
- On August 24, 2023, the Congressional Research Service published a report entitled TRICARE’s Next Generation Contracts: T-5. The report summarizes the request for proposals published in 2021 on the next generation contracts for TRICARE, the Department of Defense’s (DOD) acquisition strategy, and the timeline for awarding the new contract.
III. Other Health Policy News
- On August 22, 2023, the Congressional Budget Office (CBO) announced its Panel of Health Advisors for the upcoming year. The Panel advises CBO in multiple ways, including for advice on how to address analytical questions that arise in the preparation of studies and cost estimates. The Panel members for the upcoming year are as follows: Toyin Ajayi, Katherine Baicker, Sue Birch, Amitabh Chandra, Michael Chernew, Michael Conway, Heather Dlugolenski, Marisa Domino, Craig Garthwaite, Darrell Gaskin, John Haupert, Caprice Knapp, Bill Kramer, Thomas Lee, Patricia MacTaggart, David Meltzer, Vincent Mor, Peter Neumann, Lewis Sandy, Kosali Simon, Neeraj Sood, and Cori Uccello. More information on this announcement can be found here.
- On August 22, 2023, the Department of Health and Human Services (HHS) announced it awarded more than $1.4 billion for Project NextGen, which supports the development of new tools and technologies against COVID-19. HHS notes that the award includes support for clinical trials that will enable the rapid development of effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes. More information on this announcement can be found here.
- On August 23, 2023, HHS announced that it awarded more than $64 million in funding to address the nation’s mental health crisis through the Substance Abuse and Mental Health Services Administration (SAMHSA). Among the awards are $59.4 million in new funding to states and territories through the Community Mental Health Services Block Grant (MHBG) program. This funding is part of the Bipartisan Safer Communities Act (BSCA), signed into law on June 25, 2022, which has provided funding aimed at addressing the nation’s mental health crisis and making communities safer. The funds released by HHS on August 23, 2023 are part of the mental health investment of the BSCA which allocated a total of $250 million in supplemental funding from fiscal years 2022 to 2025. Additionally, HHS awarded more than $5 million – including $1 million from BSCA funds – for Mental Health Awareness Training (MHAT) grants, which are intended to prepare individuals and communities to respond appropriately and safely to persons with mental health challenges and/or disorders. More information on this announcement can be found here.
- On August 24, 2023, CMS announced that in 2022, the Medicare Shared Savings Program (MSSP) saved Medicare $1.8 billion in 2022, which is the sixth consecutive year the program has generated overall savings. CMS further notes that the 2022 savings is the second highest annual savings accrued for Medicare since the program’s inception more than ten years ago. More information on this announcement can be found here.