Holland & Knight Health Dose: July 14, 2026

Looking Ahead

U.S. Congress returns this week following the July Fourth recess, with healthcare activity expected to center on the U.S. House of Representatives Committee on Ways and Means' health-focused markup, where lawmakers are scheduled to consider a package of bipartisan bills addressing remote patient monitoring access in rural communities, prior authorization reform, enhanced Affordable Care Act (ACA) premium tax credits, protections for essential caregivers, rural anesthesia workforce challenges and several additional healthcare measures that have not yet been formally introduced. The House Committee on Energy and Commerce Subcommittee on Health will also hold a July 15, 2026, hearing examining the U.S. Food and Drug Administration's (FDA) role in maintaining U.S. leadership in biomedical innovation and drug development in the lead-up to consideration of four human drug product user fee act (UFA) reauthorization bills next year. In addition, appropriators in both chambers will work to advance fiscal year (FY) 2027 funding bills ahead of the August 2026 recess.

Upcoming Events

Congress

• The House Committee on Veterans' Affairs Subcommittee on Technology Modernization will hold a hearing on July 13, 2026, titled "PACT Act Implementation: Modernizing VA Disability Claims Through Effective Technology."
• The House Committee on Education and Workforce will hold a hearing on July 14, 2026, titled "Training Activists, Not Physicians: The Impact of DEI on Medical Schools."
• The U.S. Senate Committee on the Judiciary will hold a hearing on July 14, 2026, to examine genes to machines, focusing on the patent eligibility debate.
• The House Energy and Commerce Committee Subcommittee on Health will hold a hearing on July 15, 2026, titled "Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Drug Development."
• The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing on July 15, 2026, to consider the nominations of Sean Kaufman to be Assistant Secretary for Preparedness and Response (ASPR) and Dr. Erica Schwartz to be director of the Centers for Disease Control and Prevention (CDC).
• The Senate Committee on Armed Services will hold a hearing on July 15, 2026, to examine the TRICARE Pharmacy Program.
• The Senate Special Committee on Aging will hold a hearing on July 15, 2026, titled "Behind the Label: Foreign Ownership and Control in America's Drug Supply Chain."
• The House Select Committee on Strategic Competition Between the United States and the Chinese Communist Party (CCP) will hold a hearing on July 15, 2026, titled "Protecting American Innovation: The Federal Research Security Enterprise." Witnesses from the National Science Foundation, U.S. Department of Energy (DOE) and the National Institutes of Health (NIH) are expected to testify.
• The House Ways and Means Committee is expected to hold a markup of several healthcare related bills on July 15, 2026, though a formal markup notice has not been published at time of writing.

Administrative Updates

Holland & Knight's Health AI Navigator

Holland & Knight's  is a centralized, interactive resource designed to help healthcare stakeholders track and interpret the rapidly evolving legal and regulatory landscape for AI in healthcare. It provides regularly updated summaries of federal and state legislative, regulatory and executive activity, including developments from 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

• Following a series of public health threats and responses worldwide related to New World screwworm (NWS), hantavirus and a resurgence of Ebola, Dr. Sara Brenner, who previously served as the principal deputy commissioner of the FDA and currently serves as senior counselor for public health at the U.S. Department of Health and Human Services (HHS), will lead the White House Office of Pandemic Preparedness and Response Policy, and Dr. Rachel Idowu, who currently serves as a commissioned officer within the U.S. Public Health Service, will serve as director for bioresponse at the National Security Council (NSC).
• Cassie Weaver has departed the Office of the National Coordinator for Health Information Technology (ONC) to join the HHS Office of Inspector General (OIG) as senior counsel. Weaver played a key role in ONC's interoperability, information blocking and digital health policy work, and she is expected to focus on enforcement matters related to information blocking, healthcare fraud, waste and abuse in her new role.
• Diana DeGette (D-Colo.), the ranking member of the House Energy and Commerce Subcommittee on Health, was defeated in Colorado's Democratic primary by Melat Kiros. Rep. DeGette's loss ends a nearly 30-year congressional career and is expected to create turnover on one of Congress' most influential healthcare panels, reshaping Democratic health policy leadership in the House beginning in the 120th Congress. Efforts to succeed Rep. DeGette as top Democrat on the Health Subcommittee are expected to be significant.
• Sen. Lindsey Graham (R-S.C.) died on July 12, 2026, due to a sudden illness. State officials announced on July 13, 2026, that Sen. Graham's younger sister, Darline Graham Nordone, was appointed to serve the remainder of his term.

Congressional Updates

House Ways and Means Committee Advances Healthcare Legislative Package

The House Ways and Means Committee is expected to mark up a bipartisan package of healthcare legislation on July 15, 2026, addressing several issues affecting Medicare beneficiaries, rural providers and privately insured patients. The package is expected to include Sen. Marsha Blackburn's (R-Tenn.) proposal to expand access to remote patient monitoring services in rural communities, Rep. Mike Kelly's (R-Pa.) prior authorization reform legislation, Rep. Kevin Hern's (R-Okla.) bill extending enhanced ACA premium tax credits, Rep. Diana Harshbarger's (R-Tenn.) and Rep. Claudia Tenney's (R-N.Y.) legislation related to essential caregiver access, and a proposal aimed at addressing anesthesia workforce challenges in rural areas. Additional healthcare measures that have not yet been formally introduced are also expected to be considered.

Reps. Auchincloss, Peters, Joyce Release 340B Reform Bill

Reps. Jake Auchincloss (D-Mass.), Scott Peters (D-Calif.) and John Joyce (R-Pa.) have introduced the bipartisan Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency (SECURE) in 340B Act, a sweeping proposal to overhaul the 340B Drug Pricing Program and establish new guardrails around patient eligibility, transparency and program oversight. The legislation seeks to resolve long-standing disputes between drug manufacturers and 340B-covered entities by creating a statutory definition of a 340B patient, establishing a centralized data clearinghouse, increasing reporting requirements and temporarily pausing manufacturer rebate models while federal infrastructure is developed.

Select CCP Committee Writes Five Drug Manufacturers Regarding Clinical Trials in China

House Select Committee on China Chair John Moolenaar (R-Mich.) sent letters to five drug manufacturers on June 30, 2026, requesting additional details regarding the companies' clinical trials conducted in China. The letters build upon the chair's previous efforts to investigate and seek additional information on clinical trials conducted in China, including trials conducted at or in coordination with certain Chinese military entities. The letters also further highlight the committee's ongoing interest in U.S. competition with China in the pharmaceutical and biotechnology sector, with language included in the House Agriculture-FDA appropriations bill spearheaded by Chair Moolenaar to limit FDA consideration of clinical trial data used in investigational new drug applications (INDs) generated at locations in not only China but other foreign adversaries such as Russia, Iran and North Korea.

Bipartisan Members Detail Concerns on Manufacturer Changes to 340B Policies

Reps. Doris Matsui (D-Calif.) and Jack Bergmann (R-Mich.) led a bipartisan group of members of Congress in writing to HHS and the Health Resources and Services Administration (HRSA) raising concerns on recent changes in policy related to claims data and the 340B Drug Pricing Program. The company instituted a policy to terminate up-front discounts for covered entities participating in the 340B program if the covered entity did not submit claims-level data to the manufacturer. The members request HHS and HRSA take "immediate action" to reinstate covered entities uninterrupted access to 340B pricing for eligible drugs and "use all available authorities" to ensure manufacturers comply with their obligations. With the Trump Administration currently reviewing a pre-rule notice related to the HRSA 340B Rebate Model Pilot Program and additional attention being paid to the 340B program by Congress, additional action in this area should be expected through the end of 2026 and into 2027.

House Democrats Introduce Legislation to Reform MA

A total of 45 House Democrats led by House Ways and Means Committee Subcommittee on Health Ranking Member Lloyd Doggett (D-Texas) introduced legislation called the Saving Medicare Enrollees from Deceptive Insurers and Creating Ample Resources for Everyone (Saving MEDICARE) Act. The legislation aims to implement reforms to Medicare Advantage (MA) and strengthen the original Medicare program, with provisions to address the potential for an insurer to add diagnosis codes that are unsupported by patient records to attempt reimbursement at higher rates, directing new studies on alternative risk adjusted payment systems, improving benchmark payments and enhancing oversight by establishing timelines for the completion of Risk Adjustment Data Validation (RADV) audits. The proposal is estimated to save $2.5 trillion over 10 years as completed by a third-party academic research center.

House, Senate Leaders Release Report on Maternal Healthcare

House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) and Senate Committee on Finance Ranking Member Ron Wyden (D-Ore.) on July 6, 2026, released a report on the state of maternal healthcare. The report, released one year after the One Big Beautiful Bill Act (H.R. 1) was signed into law, outlines findings from states illustrating the closure of maternity wards, reductions in state payments for maternity care services and reductions in hospital services. The full report previews a potential legislative focus for Democrats related to family planning services and provider payments for maternity care in advance of remaining Medicaid and other policy changes taking effect in 2027.

Chair Collins Asks OMB to Extend Comment Window on Financial Assistance Rule, Withdraw Portions of Rule

Senate Committee on Appropriations Chair Susan Collins (R-Maine) on July 6, 2026, wrote to Office of Management and Budget (OMB) Director Russell Vought requesting an extension of the comment period on the proposed rule titled "Regulations for Federal Financial Assistance" and urged Vought to withdraw portions of the rule. The proposed rule – for which comments are due as of time of writing by July 13, 2026 – would make significant changes to the process for reviewing and approving applications for federal funding. Among Chair Collins' concerns with the proposed rule include requiring pre-issuance review by senior appointees, which Collins writes "would undermine the objective that the Federal government fund scientific and biomedical research projects based on scientific merit and value, rather than political ideology." Chair Collins also asks that the OMB extend the comment period "by no less than 90 days" in addition to withdrawing portions of the proposed rule.

The letter comes shortly after more than 140 House Democrats – led by Reps. Jamie Raskin (D-Md.) and Lori Trahan (D-Mass.) – sent a separate letter outlining concerns with the proposed rule.

Regulatory Updates

CY 2027 Hospital OPPS Proposed Rule Released

CMS released the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) proposed rule, which would establish a 2.4 percent payment increase for hospital outpatient departments and ambulatory surgery centers (ASCs) while implementing significant changes to 340B reimbursement, site-neutral payment policies, provider-based department requirements and prior authorization. Holland & Knight provided detailed analysis in an alert, "CMS Issues Sweeping CY 2027 Hospital OPPS/Ambulatory Surgical Center Proposed Rule," July 7, 2026.

Among other proposals, CMS would reduce reimbursement for 340B-acquired drugs to average sales price (ASP) minus 33.4 percent, increase the existing 340B remedy offset from 0.5 percent to 3 percent, expand site-neutral payment policies to certain imaging services furnished in off-campus hospital outpatient departments, continue phasing out the inpatient-only list, expand the ASC Covered Procedures List, implement new provider-based attestation and National Provider Identifier (NPI) requirements beginning in 2028, and add botulinum toxin injection codes to the Hospital Outpatient Department prior authorization program beginning July 1, 2027. Comments are due August 31, 2026.

HHS Terminates COVID-19 Era EUAs

HHS on July 2, 2026, issued a notice announcing it was terminating a long-standing declaration of a public health emergency and revoking the authorization of emergency use of certain drugs and other products, effective June 29, 2027. The original emergency use authorization (EUA) was issued in March 2020 during the COVID-19 pandemic and authorized the use of certain unapproved drugs, devices and unlicensed biological products, as well as approved products for unapproved uses to treat and address COVID-19. In the notice, HHS declares it determines the circumstances no longer exist to justify the emergency use of drugs and other products, citing that EUAs for COVID-19 vaccines and convalescent plasma have already been revoked and access through traditional pathways remain. Sponsors of products have a 12-month transition period during which they may seek to generate data to be submitted in the process of seeking marketing approval or licensure.

CMS Launches Bridge Program for GLP-1 Products

The Centers for Medicare & Medicaid Services (CMS) on July 1, 2026, officially launched the Medicare GLP-1 Bridge program, a short-term demonstration program that will provide eligible Medicare Part D beneficiaries with access to certain GLP-1 drugs. The demonstration program will run from July 1, 2026, to December 31, 2027, and eligible beneficiaries will have a $50 copay for eligible drugs furnished under the program. The program will allow CMS to collect additional data on GLP-1 utilization in advance of "potential" implementation of the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model in Part D, which was initially scheduled to begin in January 2027 but has been delayed by CMS.

FDA Announces Initial Cohort for PreCheck Program

The FDA on June 29, 2026, announced its selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to streamline and improve the development of new domestic pharmaceutical manufacturing facilities. More than 80 companies applied to participate in the program and the seven companies selected range from manufacturers of cell and gene therapies to those producing treatments for rare diseases and active pharmaceutical ingredients (APIs). Companies selected will engage with the FDA through two phases: one focused on receiving early technical guidance from the FDA before a facility becomes operational and the second offering enhanced engagement with the FDA to support expedited evaluation of the new facility.

FDA Schedules Public Meeting to Discuss MDUFA VI Reauthorization Amendments

The FDA will hold a public meeting on August 5, 2026, to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments 2028 (MDUFA VI) for FYs 2028 to 2032. Current authority for MDUFA expires September 30, 2027, making reauthorization necessary to ensure the FDA can continue collecting device user fees in future FYs. The notice in the Federal Register highlights that the draft commitments letter will be posted to the docket for the public meeting. The meeting will provide the first opportunity for public input following formal stakeholder consultations and will address draft recommendations related to review performance goals, pre-submission programs, workforce recruitment and other device review and approval processes. Notably, the proposal includes a new FDA-CMS collaboration pathway for technologies that may benefit from a coverage determination, drawing parallels to the FDA's RAPID Coverage Pathway announced on April 23, 2026

FDA Proposed Rule on Drug Establishments

The FDA issued a proposed rule on July 10, 2026, titled "Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments." The proposed rule, which in part implements provisions of the PREVENT Pandemics Act, would establish a registration pathway for distributed manufacturing establishments (DMEs) and clarify that foreign establishments must list drugs they manufacture, repack, relabel or salvage for commercial distribution, regardless of whether additional processing occurs before importation into the U.S. Comments are due September 11, 2026.

CMS Issues CY 2027 Home Health Proposed Rule

CMS on July 2, 2026, issued the CY 2027 Home Health Proposed Rule, proposing payment policy changes for home health agencies and several other policies related to enrollment in the Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) program and disclosure of certain ownership information. For a detailed analysis, see Holland & Knight's previous alert, "CMS Issues Far-Reaching Calendar Year 2027 Home Health Proposed Rule," July 16, 2025.

DEA Proposes Temporary Scheduling of Certain Substances, Including 7-OH

The U.S. Drug Enforcement Administration (DEA) published in the Federal Register on July 6, 2026, a notice of intent to publish a temporary order that would place several substances under Schedule I of the Controlled Substances Act (CSA), including certain thresholds of 7-Hydroxymitragynine (7-OH) which have come under scrutiny from Congress for its psychoactive and opioid-like effects while being easily accessible to the public. Substances in Schedule I of the CSA are those that are considered to have no currently accepted medical use and have a high potential for misuse. The FDA in 2025 had also warned consumers against using products containing 7-OH and on July 5, 2025, sent warning letters to seven companies for the illegal marketing of products containing the substance. Under the CSA, the Attorney General may for two years place a substance in Schedule I of the CSA if necessary to avoid "imminent hazard to public safety." The temporary scheduling order itself will be published in the Federal Register on or after August 5, 2026.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.