Summary
Big. Picture. Tomorrow is election day. Congress will then return on Monday, November 9, with a full slate of objectives before the 119th Congress comes to an end. Lawmakers will have a little more than a month to address the appropriations continuing resolution (CR), which expires on December 11. Whether or not Congress pursues an omnibus or another short-term CR will largely depend on the outcome of the election. Either way, Congress must address a handful of expiring health care extenders, which may open the door to include additional health care priorities, such as transparency. Impact Health is planning to release a post-election outlook memo as soon as possible.
Health Policy to Watch
- Legal decisions impact Medicaid work requirements, ACA Marketplaces, and more: Last week brought one of the most long-awaited decisions regarding the One Big Beautiful Bill (H.R. 1): a judge struck down key components of the Medicaid work requirements rule pertaining to medical frailty exemptions while allowing the remainder of the regulation to continue, in Commonwealth of Massachusetts et al. v. Oz et al.. Leading medical and public health organizations including the American Medical Association (AMA), American Public Health Association (APHA), and American Cancer Society Cancer Action Network filed amicus briefs in another case challenging Medicaid work requirements, Taylor et al. v. Kennedy, Jr., et al., raising their concerns about the narrow medical-frailty exemption and burdensome documentation and verification requirements that could cause eligible beneficiaries to lose coverage. Litigation also continues in cases challenging the Administration’s rule diminishing access to and the quality of plans sold on ACA Marketplaces in City of Columbus v. Kennedy (Columbus I) as well as the Administration’s moratorium on agents and brokers in the federal marketplace in National Association of Benefits and Insurance Professionals v. Kennedy et al. which shape individuals’ access to support when applying for health coverage through the federal marketplace. The last of these are particularly timely given open enrollment opened yesterday, November 1. See the litigation highlights section below for more details.
- FDA takes actions to support rare disease drugs and peptide compounding – Last week, the Food and Drug Administration issued draft guidance entitled “Individualized Human Genome Editing (GE) Products: Considerations for BLA Submission and Postapproval Management,” which is intended modernize the regulatory framework for such products to safely get more cures and meaningful treatments to all Americans, regardless of the size of the patient population. The FDA also issued final guidance on recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. Additionally, the FDA issued an Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Under this policy, the FDA will not take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using any of the six peptide bulk drug substances identified in the policy (BPC-157, Epitalon, KPV, MOTS-c, Semax, TB-500). The agency asserts that this policy should discourage widespread use of research-only peptides supplied by foreign manufacturers.
- MAHA Update: Last week, the Food and Drug Administration released a proposed rule to update nutrition specifications for eight nutrients in infant formula. The rule would amend the minimum and maximum amounts of four required nutrients, change the unit of measure for certain nutrients, and amend the content of required labeling. FDA also included a comprehensive assessment of four additional nutrients that it is not changing. In addition to comments on the proposals, FDA seeks feedback on potential requirements for nutrients not currently required but commonly added by manufacturers. This proposed rule is the first of three phases of a planned review of infant formula. Subsequent phases will assess the remaining required nutrients, potential new nutrient requirements, and carbohydrates sources. The three phases will be combined into a single final rule. Comments are due by March 2, 2027. The review is part of the Operation Stork Speed initiative to examine infant formula, and was released alongside updated data on formula contamination showing that most samples had now or non-detectable levels of contaminants.
- WISeR Update: As part of its ongoing Freedom of Information Act (FOIA) lawsuit seeking to gain transparency into the Wasteful and Inappropriate Service Reduction (WISeR) Model that tests the use of technology-enabled prior authorization for a select set of services in Traditional Medicare, Electronic Frontier Foundation (EFF) released a second batch of records. The new records show that CMS sought information or corrective action from at least four of six WISeR vendors during the model’s first three months over delayed decisions, potentially inaccurate denials, portal failures, and inadequate provider communication. Vendors described fixes, but EFF argues the records reveal significant rollout problems and insufficient transparency about safeguards. EFF also raises questions about whether the “human in the loop” requirement sufficiently ensures that clinician reviewers have enough time and authority to override AI recommendations and whether vendors’ data sources could introduce bias or give more weight to population-level trends than to an individual patient’s clinical needs. EFF continues to call for greater transparency, oversight, and legal limits on automated decision-making in Medicare.