Health Care Watch: July 11, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 5 – July 11 Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
The House returns to session on July 13.
Senate
On July 6, Appropriations Committee Chair Susan Collins (R-ME) sent a letter to White House Office of Management and Budget (OMB) Director Russell Vought requesting that OMB extend the comment period for its proposed rule, Regulation for Federal Financial Assistance, by at least 90 days, as OMB provided only 45 days to comment. The letter also requests that OMB withdraw portions of the rule that could affect small and rural communities and scientific and biomedical research. Chair Collins expressed concern about a proposal that would allow federal agencies to terminate discretionary grants at any time based on whether the award effectuates federal agency priorities or the national interest, noting that this could disincentivize scientific researchers and institutions from participating in multi-year clinical trials. The letter also raised concerns about a requirement for senior political appointees to conduct pre-issuance reviews of federal awards to consider whether they advance the President's policy priorities, which Chair Collins stated could undermine the merit-based scientific peer review process.
The Senate returns to session on July 13.
REGULATORY UPDATE
On July 6, the Substance Abuse & Mental Health Services Administration (SAMHSA) announced more than $281 million in funding opportunities across 15 grant programs to advance President Trump's Great American Recovery Initiative. The programs address substance use disorder treatment, overdose prevention and response, mental health and suicide prevention, trauma-informed care, integrated care, recovery supports, first responder training, privacy education, and workforce development. The largest funding allocations include $68.2 million for Medication-Assisted Treatment - Prescription Drug and Opioid Addiction grants, $55.7 million for Project AWARE grants supporting school-based mental health programs, $40.6 million for National Child Traumatic Stress Initiative Community Treatment and Service Centers, and $34.7 million for First Responders-Comprehensive Addiction and Recovery Act grants to train first responders in administering U.S. Food & Drug Administration (FDA)-approved opioid overdose reversal medications.
On July 7, the National Institutes of Health (NIH) issued a proposed rule to rescind the existing regulation at 42 CFR Part 52d concerning grants under the National Cancer Institute (NCI) Clinical Cancer Education Program. U.S. Department of Health & Human Services (HHS) and NIH determined that the regulation is obsolete and no longer necessary because it has not been updated significantly since 1980, and the underlying statutory authority (section 404 of the Public Health Service Act) no longer exists. Comments on the rule are due by September 8.
On July 7, FDA approved Trutakna (atacicept-vymj), a subcutaneous injection administered once weekly, to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy at risk for disease progression. Trutakna is the first FDA-approved medicine that targets both B cell activating factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which are involved in the survival and maturation of certain immune cells and decrease production of the abnormal IgA antibody. The FDA granted the approval to Vera Therapeutics, Inc. under the accelerated approval pathway, with continued approval contingent on verification of clinical benefit in a confirmatory trial.
On July 8, HHS and the Centers for Medicare & Medicaid Services (CMS) launched the Make Hospital Food Healthier Pledge, a voluntary initiative inviting hospitals nationwide to serve more nutritious meals. The pledge aligns with the Dietary Guidelines for Americans and follows a March 2026 CMS reminder to hospitals that Medicare requires them to meet each patient’s individual nutritional needs. HHS also launched a dedicated nutrition page at HHS.gov as a hub for related initiatives.
On July 9, the Advanced Research Projects Agency for Health (ARPA‑H) announced up to $160 million in awards under its Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program to advance personalized curative gene‑editing platforms for rare pediatric genetic diseases. THRIVE teams will be led by Children’s Hospital of Philadelphia, University of California Berkeley and its Innovative Genomics Institute, St. Jude Children’s Research Hospital, Broad Institute, genetic medicines company GEMMABio and AI biotech company Profluent Bio, Massachusetts General Hospital, and Stanford University. Over the five‑year award period, these teams are tasked with developing scalable precision genetic medicine platforms and demonstrating gene‑editing technologies capable of generating multiple drug products with shared biodistribution and toxicology profiles, to accelerate clinical development and approval pathways for rare diseases that currently lack effective treatments.
On July 10, FDA issued a proposed rule that would create a streamlined registration pathway for distributed manufacturing establishments operating under a "hub-and-spoke" model. This would allow manufacturers to register as a single establishment rather than each unit separately, with a streamlined process for adding, relocating, or removing units and a new requirement to notify FDA in advance of any unit relocation to improve real-time oversight. The proposed rule would also clarify that certain foreign establishments that manufacture drugs or active pharmaceutical ingredients destined to indirectly enter the U.S. drug supply must register with FDA and report on the drugs they produce. A press release can be found here. Comments on the rule are due by September 11.
WHITE HOUSE
On July 5, the Trump Administration published its 2026 Unified Regulatory Agenda, outlining anticipated regulatory actions across federal agencies including CMS and FDA.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes (CMS-2452); Proposed Rule, 12/31/2025
CY 2027 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1848); Proposed Rule; 04/14/2026
Exchange Pre-Enrollment Eligibility Verification (CMS-9873); Proposed Rule; 04/22/2026
Strengthening the Integrity of Medicaid and CHIP Managed Care, Financing, and Access to Care (CMS-2450); Proposed Rule; 05/12/2026
Short-Term, Limited-Duration Insurance (CMS-9881); Proposed Rule; 05/30/2026
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546); Final Rule; 06/15/2026
Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Specified Sex-Rejecting Procedures Furnished to Children and Youth (CMS-2451); Final Rule; 06/16/2026
FY 2027 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1843); Final Rule; 06/18/2026
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2027 Rates (CMS-1849); Final Rule; 06/24/2026
FY 2027 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1847); Final Rule; 06/24/2026
Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545); Final Rule; 06/26/2026
Cutting Administrative Requirements for Excellence in Patient Care (CMS-3484); Proposed Rule; 07/02/2026
FY 2027 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1845); Final Rule; 07/09/2026
FDA
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Notice; 7/10/25
Substances Generally Recognized as Safe; Proposed Rule; 12/01/25
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
Serotonin-2A Agonists and Related Products: Considerations for Clinical Investigations; Guidance for Industry; Availability; Notice; 04/17/2026
Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods; Final Rule; 04/20/2026
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Notice; 05/22/2026
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability; Notice; 05/27/2026
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Notice; 06/01/2026
New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Notice; 06/02/2026
Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension; Final Rule; 06/03/2026
Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition; Proposed Rule; 06/05/2026
HEARINGS
House
Education & Workforce Committee
Training Activists, Not Physicians: The Impact of DEI on Medical Schools
July 14; 10:15 AM EST; 2175 Rayburn
Witnesses: Dr. Steve Dubinett, Dean, University of California Los Angeles David Geffen School of Medicine; Dr. Sam Hawgood, Chancellor, University of California San Francisco; Dr. Roger Mitchell, Jr., President, National Medical Association; Dr. Enrico Benedetti, Interim G. Stephen Irwin Executive Dean, University of Illinois College of Medicine
Energy & Commerce Committee
Health Subcommittee
July 15; 10:15 AM EST; 2123 Rayburn
Witnesses: TBA
Ways & Means Committee
Expected markup of health policy legislation
Week of July 13
Bills to be considered: TBD but expect a bill to address the use of prior authorization in Medicare Advantage
Senate
Health, Education, Labor, & Pensions Committee
July 15; 10:00 AM EST; 430 Dirksen
Nominees: Sean Kaufman; Dr. Erica Schwartz, M.D.
Judiciary Committee
From Genes to Machines: the Patent Eligibility Debate
July 14; 10:15 AM EST; 216 Hart
Witnesses: Andrei Iancu, Co-Chair, Council for Innovation Promotion, Former Under Secretary of Commerce for Intellectual Property and Director of the USPTO; John Lee, Senior Director, Head of IP Policy, Computer & Communications Industry Association; Dr, Debra Leonard, Professor of Pathology and Laboratory Medicine Emerita; Dr. Robert Larner, College of Medicine, University of Vermont; Sue Peschin, President & CEO, Alliance for Aging Research
Armed Services Committee
Personnel Subcommittee
Hearing on the TRICARE Pharmacy Program
July 15; 2:30 PM EST; 222 Russell
Witnesses: Rear Admiral Dr. David Smith, USN (Ret.), Deputy Director, Defense Health Agency; Dr. Adam Kautzner, President, Express Scripts and Evernorth Care Management; Dr. Micah Lansford, Pharmacist and Owner, Roden-Smith Pharmacy; Greg Reybold, Vice President of Public Policy, American Pharmacy Cooperative, Inc.
Aging Committee
Behind the Label: Foreign Ownership and Control in America's Drug Supply Chain
July 15; 3:30 PM EST; Dirksen G50
Witnesses: The Honorable Nazak Nikakhtar, Partner & Chair of the National Security Practice, Wiley Rein LLP; Stephen Ezell, Vice President for Global Innovation Policy, Information Technology and Innovation Foundation; Edward You, Founder & Principal Consultant, EHY Consulting LLC; Rush Doshi, C.V. Starr Senior Fellow for Asia Studies and Director of the China Strategy Initiative, Council on Foreign Relations, Assistant Professor, Georgetown School of Foreign Service.
REPORTS
Office of Inspector General (OIG)
On July 6, HHS OIG released an audit report titled “New York Should Improve Its Oversight of Nursing Homes’ Compliance With Background Check Requirements.” The report found that New York did not ensure that 6 of 10 selected nursing homes complied with federal requirements prohibiting the employment of individuals with disqualifying backgrounds during calendar year 2023, with 8 of 100 reviewed employees lacking documented compliance. OIG made two recommendations: that New York improve its monitoring procedures for nursing homes' compliance with background check requirements and reinforce guidance to nursing homes on following internal policies for completing background checks and license verifications. New York did not indicate concurrence but described steps it has taken in response.
Congressional Research Service (CRS)
On July 8, the Congressional Research Service published an In Focus guide titled “Connecting Senior Centers to Federal Funding and Resources.” The guide notes that in FY2024, states reported 9,572 senior centers, of which 61% received Older Americans Act (OAA) funding, with most centers relying on 3-8 different public and private funding sources. The guide covers funding across various categories, which includes state Medicaid programs, which may reimburse for certain home- and community-based services provided to senior center participants.
ADDITIONAL POLICY NEWS
On July 7, the U.S. Department of Justice (DOJ) argued before the Third U.S. Circuit Court of Appeals in support of a Trump administration rule that would allow employers to opt out of the Affordable Care Act's (ACA) requirement to offer health insurance covering contraception if employers raise a religious or moral objection. The rule, originally issued during President Trump's first administration in 2017, expanded a religious carveout to apply to any employer regardless of size, structure, or affiliation. Pennsylvania and New Jersey subsequently challenged the rule, and a lower court in Pennsylvania struck it down last summer.
On July 7, Compass Pathways announced 26-week results from its Phase 3 COMP006 trial of COMP360, a synthetic proprietary formulation of psilocybin for treatment-resistant depression (TRD). Compass Pathways stated that a rolling New Drug Application (NDA) submission and initial review with FDA is underway, with final submission on track for completion in Q4 2026, and the company anticipates a commercial launch of COMP360 in the first half of 2027 subject to FDA approval and DEA rescheduling. The trial results come after the FDA granted Compass Pathways and two other companies accelerated reviews for their psychedelic therapies in April 2026 following President Trump's April Executive Order (EO) directing federal agencies to boost research into psychedelic medicine, and psychedelics remain classified by the DEA as Schedule I controlled substances.
On July 8, the Kaiser Family Foundation (KFF) released an analysis of preliminary 2027 rate filings from 77 ACA Marketplace insurers in 16 states and DC, finding a median proposed premium increase of 14%, with most insurers requesting increases of 10–20% and 20 insurers requesting increases above 20%. Insurers cited three primary drivers: the rising cost of health services including hospitalizations and specialty medications such as GLP-1s (with underlying medical care and drug costs rising 10% for 2027, above the recent 8% average); the 2025 expiration of enhanced premium tax credits, which KFF argued caused healthier enrollees to exit the Marketplaces in 2026 and would contribute roughly an additional 4% to 2027 premiums due to a sicker remaining risk pool; and federal regulatory changes including the Notice of Benefit and Payment Parameters and the Marketplace Integrity and Affordability Rule.
On July 10, D.C. District Court Judge James Boasberg issued an order allowing the Federal Trade Commission (FTC) to move forward with its enforcement lawsuit against the World Professional Association for Transgender Health (WPATH) in the Northern District of Texas. The ruling, which denies WPATH’s request to enjoin the Texas action, is procedural rather than a decision on the merits of FTC’s claims that WPATH and its provider members misled parents and minors about the medical necessity and safety of gender‑affirming care.