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 finalized the 2025 Medicare Advantage (MA)/Part D Rate Announcement and MA/Part D Final Rule, as well as the 2025 Notice of Benefit and Payment Parameters.

I. Regulations, Notices & Guidance

• On April 1, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Communications and Public Engagement Workgroup of the Advisory Committee to the Director, CDC; Notice of Extension. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the Communications and Public Engagement Workgroup (CPEW) of the Advisory Committee to the CDC Director. The CPEW consists of approximately 15 members who are experts in fields associated with communications, including public relations, health communication, risk communication, communication research, and marketing; community and partner engagement; public health science and practice, including implementation; and, behavioral science/behavior change campaigns.
• On April 1, 2024, the Food and Drug Administration (FDA) released a notice entitled, Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability. This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies to the FDA Adverse Event Reporting System (FAERS). This guidance finalizes the draft guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies” issued on August 3, 2022.
• On April 2, 2024, FDA released a notice entitled, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies; Draft Guidance for Industry; Availability. The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of BA and BE studies submitted in support of INDs), new drug applications (NDAs, abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting Center for Drug Evaluation and Research-regulated biologic license applications (BLAs), as well as amendments and supplements to these applications. In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. FDA encourages applicants and testing sites to consider these recommendations when conducting other studies, including in vitro and pharmacology and toxicology studies.
• On April 2, 2024, FDA released a notice entitled, Product-Specific Guidance for Oxymetazoline Hydrochloride; Draft Guidance for Industry; Availability. The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of BE studies to support ANDAs for oxymetazoline hydrochloride ophthalmic solution.
• On April 3, 2024, FDA released a notice entitled, New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Comment Request. The draft guidance, when finalized, will provide recommendations to the dietary supplement industry on Master Files for new dietary ingredients. The purpose of this draft guidance, when finalized, will be to help industry comply more easily with the new dietary ingredient notification requirement by providing recommendations on the submission and use of Master Files that contain identity, manufacturing, or safety data that can be used to support a new dietary ingredient notification. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation.
• On April 4, 2024, CDC released a notice entitled, Advisory Board on Radiation and Worker Health. CDC announced the renewal of the charter of the Advisory Board on Radiation and Worker Health (ABRWH).
• On April 4, 2024, FDA released a notice entitled, Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
• On April 4, 2024, FDA released a notice entitled, Request for Nominations on Device Good Manufacturing Practice Advisory Committee. FDA is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.
• On April 4, 2024, FDA released a notice entitled, Request for Nominations for Voting Members for the Patient Engagement Advisory Committee. FDA is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
• On April 4, 2024, the National Institutes of Health (NIH) released a notice entitled, Final Action under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). This notice sets forth final changes to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) as initially outlined in a Federal Register notice issued on August 10, 2023. Following solicitation of public comments, NIH is amending the NIH Guidelines to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMOs) in contained research settings. NIH is updating the NIH Guidelines to clarify minimum containment requirements, provide considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs).
• On April 4, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program. This final rule includes payment parameters and provisions related to the Department of Health and Human Services (HHS)-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans (QHPs) through federally facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to the auto re-enrollment hierarchy; essential health benefits; failure to file Federal income taxes to reconcile advance payments of the premium tax credit (APTC); non-standardized plan option limits in the FFEs and SBE-FPs and a related exceptions process; standardized plan options in the FFEs and SBE-FPs; special enrollment periods (SEPs); direct enrollment (DE) entities supporting Exchange applications and enrollments; the Insurance Affordability Program enrollment eligibility verification process; requirements for agents, brokers, web-brokers, and DE entities assisting Exchange consumers; network adequacy; public notice procedures for section 1332 waivers; prescription drug benefits; updates to the Consumer Operated and Oriented Plan (CO-OP) Program; and State flexibility on the effective date of coverage in the Basic Health Program (BHP).
• On April 5, 2024, CMS issued a final rule entitled, Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All Inclusive Care for the Elderly (PACE). This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.

Event Notices

April 9, 2024: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.

April 10, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). This is a virtual meeting open to the public.

April 9-11, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Committee on Rural Health and Human Services. This is a hybrid meeting open to the public.

April 17, 2024: NIH announced a meeting of the Interagency Autism Coordinating Committee. This is a hybrid meeting open to the public.

April 17, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This is a hybrid meeting open to the public.

April 17, 2024: CDC announced a meeting of the Community Preventative Services Task Force. This is a virtual meeting open to the public.

April 30, 2024: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.

May 6, 2024: CDC announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a virtual meeting open to the public.

May 9, 2024: FDA announced a meeting of the Blood Products Advisory Committee. This is a virtual meeting open to the public.

May 9-10, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a hybrid meeting open to the public.

May 21, 2024: CMS announced a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This is a virtual meeting open to the public.

May 21-22, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a hybrid meeting open to the public.

June 3, 2024: FDA announced a meeting of the AIDS Research Advisory Committee. This is a hybrid meeting open to the public.

II. HEARINGS & MARKUPS

• On April 3, 2024, the Senate Committee on Health, Education, Labor, and Pensions (HELP) Primary Health & Retirement Security Subcommittee held a field hearing entitled, When Health Care Becomes Wealth Care: How Corporate Greed Puts Patient Care and Health Workers at Risk. Witnesses included: Ellana Stinson, MD, MPH, MBA, Emergency Medicine Physician, President, New England Medical Association; Eileen O'Grady, Research & Campaign Director, Healthcare, Private Equity Stakeholder Project; Hannah Drummond, RN, Emergency Department, Mission Hospital, National Nurses Organizing Committee (NNOC) / National Nurses United (NNU); and Donald M. Berwick, MD, MPP, President Emeritus and Senior Fellow, Institute for Healthcare Improvement.

III. Reports, Studies, & Analyses

• On April 1, 2024, the Office of the Inspector General (OIG) released a report entitled, A Lack of Behavioral Health Providers in Medicare and Medicaid Impedes Enrollees’ Access to Care. In the report, OIG found that there is a significant lack of behavioral health providers serving Medicare and Medicaid enrollees, with only about one-third of the total behavioral health workforce actively participating in these programs. Despite high demand for services, treatment rates remained low across traditional Medicare, MA, and Medicaid, posing challenges for enrollees seeking care. Many enrollees also faced geographic barriers, often having to travel long distances for in-person appointments. To address these issues, OIG recommended that CMS take steps to encourage more behavioral health providers to participate, explore options to expand coverage to additional providers, strengthen network adequacy standards, and enhance monitoring of enrollees' utilization of behavioral health services. CMS concurred with the recommendations and recognized the need to improve access to care for Medicare and Medicaid beneficiaries.

• On April 2, 2024, HHS released a white paper entitled, Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States. In the report, HHS overviews steps it has taken to prevent drug shortages, such as establishing a new Supply Chain Resilience and Shortage Coordinator role and bolstering FDA’s capacity to minimize or prevent drug shortages through increased access to data. The report suggests additional proposals that policymakers should consider. Notably, HHS proposes working with Congress to create and implement a Manufacturer Resiliency Assessment Program (MRAP) and a Hospital Resilient Supply Program (HRSP). The MRAP “could measure resilience of manufacturers and bring transparency to the prescription drug supplier base” and the HRSP could bolster demand by “[establishing] demand incentives and/or penalties, facilitating hospital purchasing that prioritizes supply chain resilience, rather than the current structure which generally prioritizes cost alone.” The HSRP would utilize Medicare payments and penalties to incentivize hospitals to prioritize quality management and supply chain reliability when purchasing drugs – a proposal garnering a great deal of attention from the hospital community.
• On April 5, 2024, OIG released a report entitled, CMS Could Improve Its Procedures for Setting Medicare Clinical Diagnostic Laboratory Test Rates Under the Clinical Laboratory Fee Schedule for Future Public Health Emergencies. OIG determined that CMS could improve its rate setting procedures for clinical diagnostic laboratory test (CDLTs) during future public health emergencies (PHEs). Specifically, OIG found that CMS should improve on its communication efforts with lab association groups and Medicare administrative contractors (MACs) pricing coordination and improve procedures to give MACs additional flexibility when establishing CDLT rates during a PHE. The report notes that neither the Clinical Laboratory Fee Schedule statute (CLFS) or its regulations specify how MAC pricing coordinator should quickly set interim rates during a PHE. OIG recommended that CMS: (1) improve communications with relevant stakeholders involved in CDLT rate setting during PHEs, and (2) improve procedures for setting and changing rates for CDLTs during a PHE.

IV. Other Health Policy News

• On April 1, 2024, Senator Gary Peters (D-MI) initiated inquiries into the involvement of private equity firms in hospital emergency departments and the potential implications for patient care. In letters addressed to private equity firms and physician staffing companies, Senator Peters is seeking information regarding business operations, staffing decisions, and patient care and safety at various emergency departments nationwide. These requests for information come in response to concerns raised by over 40 emergency medicine physicians across the country, who have highlighted potential issues related to patient care at private equity-owned physician staffing companies and hospitals, particularly during major emergencies like mass casualty events or pandemics. In a statement to the press, Senator Peters expressed apprehension about the possibility of cost-saving measures compromising patient safety and care, and emphasized the importance of transparency from these companies and their private equity owners. According to the letters, available data has indicated that private equity-owned physician staffing groups manage a significant portion of emergency departments nationwide, and a notable percentage of rural hospitals are owned by private equity firms. Senator Peters underscored the potential risks associated with financial instability and bankruptcies within this sector, which can have severe repercussions on communities and patient care. A press release with more information is available here.
• On April 1, 2024, CMS issued guidance requiring hospitals to receive written informed consent from patients prior to conducting sensitive examinations, including pelvic, breast, prostate, or rectal exams. HHS also sent a letter to medical schools and teaching hospitals reiterating this guidance. CMS explains that the new guidance is in response to increasing concerns about sensitive exams occurring without informed patient consent, especially for patients under anesthesiology.
• On April 3, 2024, Senator Ed Markey (D-MA) released a discussion draft bill called The Health Over Wealth Act to set guardrails on private equity healthcare investment and to require greater transparency in healthcare entity ownership. According to the release, the proposal would:

• Protect patients and providers at for-profit hospitals by requiring private equity to set aside funds to protect access to care.
• Require health care entities owned by private equity to report on their finances, real estate transactions, and dividends delivered to shareholders.
• Require health care entities owned by private equity to report on worker retention, staffing ratios, and average care costs to patients.
• Demand accountability of for-profit health care by directing HHS to block real estate deals that threaten to destabilize health care systems and prohibit private equity companies engaged in price gouging from investing in health care.

The proposal was released following a Senate HELP field hearing in Boston which examined healthcare and for-profit ownership. The discussion draft is open for public comment until May 3, 2024.

• On April 4, 2024, the Biden Administration introduced significant changes to the HRSA National Health Service Corps Loan Repayment Program by increasing initial loan repayment amounts by 50 percent. These changes aim to enhance support for primary care providers in high need and rural areas. Eligible providers, including physicians, nurse practitioners, certified nurse midwives, and physician assistants, can now receive up to $75,000 in initial loan repayment forgiveness in exchange for a two-year service commitment, a notable increase from the previous maximum of $50,000. Additionally, HRSA is extending an extra $5,000 in loan repayment for participants who exhibit fluency in Spanish and agree to serve patients with limited English proficiency in high-need areas. A press release with more information is available here.

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