Holland & Knight Health Dose: August 4, 2026

Looking Ahead

The U.S. Senate has a lengthy to-do list prior to adjourning for the summer recess, with a key focus on appropriations, federal funding and advancing nominations. Highlighting the pending action is release of a continuing resolution (CR) on August 2, 2026, by Senate Committee on Appropriations Chair Susan Collins (R-Maine) and Senate Committee on Appropriations Ranking Member Patty Murray (D-Wash.). Initial procedural votes are scheduled for this week, with a goal to pass the CR prior to adjourning, putting the next steps in the hands of the U.S. House of Representatives leadership.

The Senate CR would fund the federal government through December 11, 2026 – one week later than the CR released by the House, which funds the government through December 4, 2026. In addition, the Senate CR contains a notable provision to delay the Office of Management and Budget (OMB) from moving forward with a proposed rule to make significant changes to the review and distribution of federal grant funding.

Though the Centers for Medicare & Medicaid Services (CMS) collectively released several significant proposed and final payment rules in July 2026, more rulemaking activity is expected through the end of August 2026, such as the release of the U.S. Food and Drug Administration's (FDA) proposed rule to overhaul the process for considering ingredients as generally recognized as safe (GRAS), which cleared OMB review on July 31, 2026.

A number of primary elections are scheduled to take place August 4, 2026, including contests for the Senate in Michigan, gubernatorial races in Kansas and Tennessee, and House seat selections in several other states.

Upcoming Events

Congress

August 4, 2026

• Senate Committee on the Budget – Medicaid: The Reality
• Senate Committee on Finance – Building a Resilient Health Care Future with Biotechnology
• Senate Committee on the Judiciary – Prescribing Sunshine: How Competition and Transparency Lowers Prescription Drug Costs

Federal Agencies

• On September 23-24, 2026, the FDA will hold a hybrid public meeting titled "FDA-CRGC Workshop – Navigating the GLP-1 Generic Drug Pathway."
• The Healthcare Advisory Committee (HAC) announced its virtual meeting schedule for the remainder of 2026 through 2027. The HAC will meet virtually from 8 a.m. to 5 p.m. ET on August 31, 2026, November 9, 2026, February 22, 2027, and May 10, 2027.

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's Health AI Navigator is a centralized, interactive resource designed to help healthcare stakeholders track and interpret the rapidly evolving legal and regulatory landscape for artificial intelligence (AI) in healthcare. It provides regularly updated summaries of federal and state legislative, regulatory and executive activity, including developments from U.S. Congress, the U.S. Department of Health and Human Services (HHS) and the White House. The Navigator also features an interactive state map and curated analysis to support compliance and policy insights.

Executive Order Updates

The Trump Administration has continued to release wide-ranging executive orders (EOs). For the latest updates, see our "Trump's Second-Term Executive Orders (2025-2026)" tracking chart.

Personnel Updates

• The Senate Committee on Health, Education, Labor, and Pensions (HELP) advanced the nominations of Dr. Erica Schwartz to be director of the Centers for Disease Control and Prevention (CDC), Sean Schwartz to be assistant secretary for preparedness and response and Keith Sonderling to be secretary of the U.S. Department of Labor (DOL).

Congressional Updates

Ranking Member of House Oversight Seeks Answers on Outbreak of Cyclospora

House Committee on Oversight and Government Reform Ranking Member Robert Garcia (D-Calif.) on July 27, 2026, sent a letter to a company that voluntarily removed from the U.S. market certain lettuce products due to findings from tests indicating the presence of cyclospora, an infection that can cause sickness and health complications in humans. The letter requests answers to a number of questions, including the company's outreach to and conversations with the White House and various federal agencies in the lead-up to the voluntary recall, as well as whether any political considerations influenced decisions. Investigations into cases related to the infection as a result of consuming products with cyclospora remain ongoing.

New Finance Committee RFI on Health Coverage

Senate Committee on Finance Ranking Member Ron Wyden (D-Ore.) on July 30, 2026, issued a new request for information (RFI) seeking feedback from stakeholders regarding health coverage and outlining potential areas for reform. The RFI details the committee's focuses in a new Congress, including reversing policies advanced by congressional Republicans, simplifying and standardizing healthcare options for individuals and families, and implementing reforms to private insurance. Comments and responses on the RFI are due October 2, 2026.

Regulatory Updates: HHS

New Government-Wide Policy to Prohibit Funds for Certain Biological Research

HHS on July 28, 2026, announced a new federal government-wide policy to prohibit federally funded or supported gain of function research. The announcement follows a March 2026 EO aimed at improving safety and security of biological research and follows concerns stemming from the COVID-19 pandemic. The policy prohibits federal funding for gain of function research conducted in the U.S. and overseas and restricts federal funding for research conducted in countries or institutions without certain biosafety requirements being met.

ACF Finalizes Rule for Family Assistance Programs

The HHS Administration for Children and Families (ACF) on July 30, 2026, issued a final rule to amend regulations governing grants to states for public assistance programs, as well as certain other regulations. The rule takes effect on September 29, 2026. The final rule makes changes to the administration, funding, accountability and oversight of the Temporary Assistance for Needy Families (TANF) program, including for Tribal nations, as well as child support enforcement and related programs.

Regulatory Updates: CMS

CMS Issues Several Final Payment Rules

CMS on July 29, 2026, issued the final rule governing policies and payment under the Skilled Nursing Facilities (SNFs) Prospective Payment System (PPS) and Inpatient Psychiatric Facility (IPF) PPS for fiscal year (FY) 2027. Overall, CMS finalized updated payment rates for SNFs by 2.4 percent based on the final SNF market basket of 3.3 percent, reduced by a 0.9 percent productivity adjustment, for an estimated increase of $882.74 million in aggregate payments to SNFs. In addition, CMS finalized its proposal to remove two measures beginning in FY 2028 from the SNF Quality Reporting Program (QRP), which track COVID-19 vaccine coverage among healthcare personnel and patients/residents.

For the IPF PPS, CMS is updating the IPF PPS payment rates by 2.3 percent based on the 2021-based IPF market basket increase of 3.2 percent, minus a 0.9 percentage point productivity adjustment. CMS finalized its proposal to remove two measure sets from the IPF Quality Reporting Program:

• Alcohol Use Brief Intervention Provided or Offered (SUB-2) and its subset measure, Alcohol Use Brief Intervention (SUB-2a)
• Tobacco Use Treatment Provided or Offered at Discharge (TOB-3) and its subset measure, Tobacco Use Treatment at Discharge (TOB-3a)

CMS also issued the final Inpatient Prospective Payment System (IPPS) rule on July 31, 2026, finalizing a number of policies including implementation of a non-renal cost reconciliation policy for organ procurement organizations (OPOs) and histocompatibility labs, technical modifications to the Transforming Episode Accountability Model (TEAM), adoption of new Unique Device Identifier (UDI) measure for implantable devices and several new quality measures. The finalized increase in the IPPS payment rates is 2.3 percent. This reflects a projected FY 2027 hospital market basket percentage increase of 3.2 percent, reduced by a 0.9 percentage point productivity adjustment. Policies will take effect October 1, 2026, with some provisions to be implemented on a one-to-two-year delay.

Regulatory Updates: FDA

FDA Implements Reorganization

The FDA on July 29, 2026, issued a notice in the Federal Register announcing implementation of a reorganization to consolidate certain staff and terminate specialized inspections staffing. The "Simple Reform" is reported to take effect starting October 1, 2026. As part of the reorganization, the FDA's field inspectors will no longer specialize in specific product areas but conduct inspections across all products under the FDA's medical product areas. In addition, the Office of Applied Science within the FDA's Center for Veterinary Medicine will be eliminated. It is unclear how changes to inspections staffing may impact the receipt and use of user fees, as medical device user fees may be used to support inspections but not post-market activities.

FDA Publishes 17 Product-Specific Guidance for Design of Bioequivalence Studies for ANDAs

The FDA on July 28, 2026, issued revised draft guidance to provide product-specific recommendations on the design of bioequivalence studies to support abbreviated new drug applications (ANDAs). Public comments are due September 27, 2026. In addition to issuance of the draft guidance, the FDA notes it is withdrawing guidance titled "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin" – which was issued in May 2021 – as it "no longer reflects FDA's current scientific thinking." The revised product-specific guidance is for drug products containing various different active ingredients, including three that are used in certain GLP-1 products. Issuance of the product-specific guidance follows previously published guidance on these ingredients, indicating additional efforts on quality in processing and development may be the next focus.

FDA Issues User Fees for FY 2027, with Some Human Product Fees to Drop

The FDA on July 29, 2026, issued user fee rates and payment procedures for a variety of programs in FY 2027, including for animal drugs, animal generic drugs, biosimilars, generic drugs, medical devices, over-the-counter monograph drugs, prescription drugs and certain food safety fees. Prescription drug fees for applications will drop by less than 2 percent in FY 2027 due to an increase in carryover balances the FDA holds in the Prescription Drug User Fee Act (PDUFA) reserve that exceeds statutory limits. Biosimilar user fees for applications will also drop, while generic drug user fee application fees will increase. Issuance of fees for FY 2027 comes as Congress prepares to ramp up consideration of and work on reauthorization for four user fee act programs that are set to expire at the end of September 2027 without action.

Regulatory Updates: HRSA

HRSA Issues 340B Rebate Model Pilot Program Notice

The Health Resources and Services Administration (HRSA) on July 31, 2026, released a notice outlining the new 340B Rebate Model Pilot Program. Manufacturers may apply to participate, with responses due August 24, 2026, to take effect January 1, 2027. The pilot will be limited to drugs selected for initial price applicability years (IPAYs) 2026 and 2027 for the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program. The pilot will allow manufacturers to offer covered entities rebates for 340B drugs rather than up-front discounts. As part of the notice, HRSA notes that it considered but declined to carve any entities from the program and reaffirmed its belief that cash flow and other administrative burdens are not significant. As part of the pilot, manufacturers will cover the costs of and select information technology platforms for data submissions by covered entities. Finally, HRSA writes it considered but would not move forward with a clearinghouse or similar data sharing mechanism, stating HRSA believes a clearinghouse would act as an enhanced claims modifier system, which would not as adequately meet program integrity and evaluation objectives.

Other Healthcare Regulatory Updates

NSCEB Issues Report on Rare Disease Treatments

The National Security Commission on Emerging Biotechnology (NSCEB) issued a new report titled "Bringing Rare Disease Treatments to Patients." The commission is tasked by Congress to complete reviews of key issues impacting biotechnology and making recommendations to Congress. The report touches on several major areas for Congress to consider action on to address barriers to therapeutic development of treatments for rare diseases, including enhanced investments in research and development, data collection and availability to address variance between patients, regulation of novel biotechnologies, as well as the manufacturing and scale-up capacity for new therapeutics.