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, HHS announces response to IV fluid shortage and 233 House members call on leadership to block Medicare physician payment cut.
I. Regulations, Notices & Guidance
- On October 16, 2024, the Food and Drug Administration (FDA) released guidance entitled, Temporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availability. FDA is releasing guidance permitting temporary compounding of certain parenteral drug products as a result of shortages caused by Hurricanes Helene and Milton. The guidance permits outsourcing facilities and compounding pharmacies to compound a set of nine parenteral drugs without first obtaining a prescription. There is also no one-mile radius limit or 24-hour disposal rule in effect for these drugs.
- On October 16, 2024, FDA released guidance entitled, Requests for Reconsideration at the Division Level Under GDUFA: Guidance for Industry. This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and clarifies what matters are appropriate for requests for reconsideration.
- On October 17, 2024, FDA released guidance entitled, Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry. This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.
- On October 17, 2024, FDA released guidance entitled, Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Guidance for Industry. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an ANDA, or a prior approval supplement (PAS) to an ANDA. This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the GDUFA, as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). Specifically, this guidance describes instances when an early assessment, or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which FDA would commence an early assessment of Type II API DMFs 6 months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request.
- On October 17, 2024, FDA released guidance entitled, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development Guidance for Industry. The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable. This guidance will not specifically address efficacy or effectiveness assessments for products primarily intended to improve neurologic outcomes, e.g., neuroprotective agents. This guidance is focused on long-term evaluations of neurodevelopmental safety. Although assessments of nephrotoxicity, pulmonary toxicity, and toxicity to other tissues and organs may also be warranted in neonatal medical product development, the approach to those assessments is outside the scope of this guidance.
- On October 17, 2024, FDA released guidance entitled, Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method. The purpose of this guidance is to provide recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method. This guidance is intended for manufacturers of blood collection, processing, and storage systems. The recommendations in this guidance do not apply to devices used to manufacture platelet rich plasma or similar products used for therapeutic purposes other than transfusion.
- On October 18, 2024, the National Institutes of Health (NIH) released notice of a final policy entitled, Final Scientific Integrity Policy of the National Institutes of Health. The NIH is issuing this Final NIH Scientific Integrity Policy to codify NIH’s expectations to preserve scientific integrity throughout all NIH activities, establish key roles and responsibilities for those who will lead the agency’s scientific integrity program, and, as appropriate, establish relevant reporting and evaluation mechanisms.
Event Notices
October 21, 2024: The Department of Health and Human Services (HHS) announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
October 21-22, 2024: HHS announced a meeting of the Centers for Disease Control and Prevention (CDC)/ Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis, and Sexually Transmitted Disease (STD) Prevention and Treatment. This is a hybrid meeting open to the public.
October 22, 2024: CDC announced a meeting of the Advisory Committee to the Director (ACD). This is a hybrid meeting open to the public.
October 22, 2024: HHS announced a meeting of the Secretary’s Advisory Committee on Human Research Protections. This is a virtual meeting open to the public.
October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a virtual meeting open to the public.
October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual meeting open to the public.
October 31, 2024: FDA announced a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This is a hybrid meeting open to the public.
November 6, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.
November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.
November 12, 2024: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a hybrid meeting open to the public.
November 14, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting that is open to the public.
November 14, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
November 20, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is an in-person meeting open to the public.
November 20, 2024: CDC announced a meeting of the Board of Scientific Counselors, Office of Readiness and Response. This is a virtual meeting open to the public.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This meeting is open to the public.
December 3, 2024: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis. This is a virtual meeting open to the public.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
December 9, 2024: NIH announced a briefing on the National Academies of Science, Engineering, and Medicine’s (NASEM) Assessment of NIH Research on Women’s Health. This is a hybrid meeting open to the public.
II. Reports, Studies, & Analyses
- On October 15, 2024, the National Community Pharmacists’ Association (NCPA) released a national survey of independent pharmacists entitled, Report for Fall Survey of Independent Pharmacy Owners/Managers. The report found that over half of independent pharmacies were strongly considering not stocking drugs that were included in the first round of Medicare drug price negotiations due to concerns over delayed refund payments from manufacturers. NCPA called on the Centers for Medicare & Medicaid Services (CMS) to issue updated guidance that includes provisions addressing “fair and timely” reimbursements for pharmacists for drugs included in the first round of negotiations. NCPA claims that without such guidance, pharmacies that dispense drugs in the program may be left to front $27,000 per month while waiting for manufacturer refunds.
- On October 17, 2024, the Senate Committee on Homeland Security & Governmental Affairs, Permanent Subcommittee on Investigations majority staff released a report entitled, Refusal of Recovery: How Medicare Advantage Insurers Have Denied Patients Access to Post-Acute Care. This report follows up on Subcommittee activity from last year including a May 17, 2023 hearing entitled, Examining Health Care Denials and Delays in Medicare Advantage, which launched an inquiry into the barriers to care that seniors enrolled in Medicare Advantage (MA) face. The report reviewed barriers to care for seniors enrolled in MA, focusing on prior authorization practices by certain health insurance providers. According to the report, insurers frequently deny post-acute care requests, which are essential for recovery after hospital stays. Automation and predictive technologies play a role in increasing denial rates, often prioritizing cost-saving over patient needs. The report calls for enhanced oversight from CMS, including recommendations for the following:
- CMS should begin collecting prior authorization information broken down by service category. The data the agency currently requires insurers to submit leaves it unclear whether insurers are using prior authorization to target particular types of care.
- CMS should conduct targeted audits if insurer prior authorization data reveal notable increases in adverse determination rates. Once the agency has service category data, it could more efficiently allocate resources by targeting audits at insurers whose submissions indicate significant increases in denial rates.
- CMS should expand regulations for insurers’ utilization management committees to ensure that predictive technologies do not have undue influence on human reviewers. Even if predictive technologies are solely used to approve requests, nurses and doctors reviewing cases may face pressure to rubber-stamp the recommendations of algorithms and artificial intelligence.
- The report is available here.
III. Other Health Policy News
- On October 18, 2024, HHS released an updated fact sheet on efforts to address ongoing health care supply issues as a result of Hurricanes Helene and Milton, particularly focusing on restoring IV fluid production at Baxter’s damaged facility in North Carolina. Key efforts include restoring access to Baxter’s facility, moving inventory to safe locations, and expediting regulatory approvals to increase IV fluid imports and production. FDA approved temporary importation of 19 IV solution products, while the Administration for Strategic Preparedness and Response (ASPR) provided an update on the import of product to the U.S. from international facilities. Each flight will carry between 150k and 250k units of international Baxter product and the first flights are scheduled to arrive on October 19, 2024. Additionally, the Biden Administration invoked the Defense Production Act (DPA) to accelerate rebuilding efforts, which allows the federal government to prioritize the production and distribution of critical materials needed for public health and safety. For Baxter’s North Carolina facility, HHS will use DPA authorities to help secure necessary materials and supplies for cleanup, repair, and the restoration of IV fluid production lines. ASPR has issued a priority rating to Baxter for a remediation material the facility was unable to secure, which has been a limiting factor in the facilities’ ability to restart production. By October, product availability had already increased by 50 percent, with further improvements expected in the coming weeks. On October 17, 2024, Representative Lori Trahan (D-MA), along with 47 other co-signers, sent a letter to House and Senate Leadership highlighting the need for additional resources and funding for FDA as part of any potential disaster relief legislation. The fact sheet is available here.
- On October 11, 2024, Representatives Mariannette Miller-Meeks (R-IA), and Jimmy Panetta (D-CA), along with 231 bipartisan House members, signed on to a letter to House leadership urging Congress to a pass a legislative fix to halt the 2.8 percent Medicare physician payment cut slated for January 1, 2024 and take action to comprehensively reform the Medicare Physician Fee Schedule (PFS) to reflect the costs of delivering care. The Representatives note in the letter that the 2025 Medicare PFS proposed rule marks the fifth consecutive year that CMS issued a proposed fee schedule regulation that cuts payments to physicians and other clinicians, and while Congress has taken action to mitigate cuts in the past, permanent payment reform is necessary. The letter is available here.
- On October 16, 2024, CMS announced that the agency approved amendments to expand Medicaid and Children’s Health Insurance Program (CHIP) coverage for traditional health care practices offered at Indian Health Service (IHS) facilities, Tribal facilities, and urban Indian organizations. The initiative is intended to improve access to culturally appropriate care, enhance health outcomes, and address health disparities within American Indian and Alaska Native populations. This marks the first time these practices will be covered under Medicaid and CHIP, benefiting Tribal communities in Arizona, California, New Mexico, and Oregon. A press release with more information is available here.
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