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.
Highlight of the Week
This week, HHS and CMS announced the “Make Hospital Food Healthier Pledge,” a nationwide initiative inviting hospitals to voluntarily pledge to improve the nutrition of their meals and a bipartisan group of House Energy and Commerce Committee members introduced the SECURE 340B Act to establish stricter eligibility requirements for the patients who can receive discounted drugs as part of the 340B program, place restrictions on child sites, and establish stronger audits and potential sanctions for participating hospitals.
Regulations, Notices & Guidance
- On July 6, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act of 1974; Matching Program. In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) and CMS are providing notice of a re-established matching program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), titled, Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act. Under this matching program, CMS will share data with VA to verify if an applicant is enrolled in Minimum Essential Coverage in a VHA Health Care Program. This information from VA will be used to assist CMS to determine if an individual is eligible for insurance affordability programs.
- On July 6, 2026, HHS released a proposed rule entitled, Recission of the National Cancer Institute Clinical Cancer Education Program Regulation. HHS, in consultation with the National Institutes of Health (NIH), is proposing to rescind the existing regulation concerning grants under the National Cancer Institute (NCI) Clinical Cancer Education Program.
- On July 7, 2026, NIH released a notice entitled, Government Owned Invention Available for License: Generating Conditional and Reverse Conditional Loss-of Function Alleles in Mouse Casq2. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is seeking potential licensees interested in further developing or utilizing Casq2 mouse strains.
- On July 7, 2026, NIH released a notice entitled, Government Owned Invention Available for License: Method of Detecting Circulating Cell-Free HPV 6 and 11 DNA in Patients Afflicted With Diseases Caused by Chronic HPV 6 or 11 Infection and Use Thereof. NCI and Frederick National Laboratory for Cancer Research (FNLCR) seek research co-development partners and/or licensees for commercial development of a novel liquid biopsy diagnostic for non-invasive detection of cell free HPV 6 and 11 DNA for recurrent respiratory papillomatosis (RRP).
- On July 8, 2026, CMS released a notice entitled, Secretarial Comments on the Consensus-Based Entity’s (CBE) (Battelle Memorial Institute) 2025 Activities: Report to Congress and the Secretary of the Department of Health and Human Services. This notice acknowledges the HHS Secretary’s receipt and review of Battelle Memorial Institute’s 2025 Annual Activities Report to Congress. The Battelle Memorial Institute is the consensus-based entity (CBE) under a contract with the HHS Secretary, as mandated by section 1890(b)(5) of the Social Security Act. The HHS Secretary has reviewed the Batelle Memorial Institute’s 2025 Annual Report and is publishing the report in the Federal Register together with the HHS Secretary’s comments on the report not later than six months after receiving the report.
- On July 9, 2026, CMS released a notice entitled, Medicare and Medicaid Programs; Application From The Joint Commission for Continued CMS Approval of its Home Health Agency (HHA) Accreditation Program. This notice announces a decision by CMS to approve The Joint Commission for continued CMS recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency (HHA), provided certain requirements are met.
- On July 9, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Charter Re-Establishment for the National Advisory Committee on Rural Health and Human Services. In accordance with the Federal Advisory Committee Act, HHS gives notice that the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been re-established. The effective date of the charter re-establishment is July 17, 2026. NACRHHS is authorized by Section 222 of the Public Health Service (PHS) Act (42 U.S.C. § 217a). NACRHHS provides advice and recommendations to the HHS Secretary on issues related to how HHS and its programs serve rural communities. NACRHHS will focus attention and existing resources on rural health and human service challenges, such as the provision and financing of health care and human services in rural areas.
- On July 10, 2026, the Food and Drug Administration (FDA) released a proposed rule entitled, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments. FDA is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and will align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- July 6-7, 2026: NIH announced a meeting of NCI. This is a virtual meeting with some sessions open to the public.
- July 7, 2026: FDA announced an educational conference entitled, Third Annual Animal Drug User Fee Educational Conference. This is a hybrid event open to the public.
- July 8, 2026: NIH announced a meeting of the National Advisory of Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
- July 14-15, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
- July 15, 2026: NIH announced a meeting of the NCI Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
- July 16, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
- July 23-24, 2026: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open to the public.
- July 29, 2026: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This is a virtual meeting open to the public.
- **July 30, 2026: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This is a virtual meeting open to the public.
- **July 31, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee (IACC). This is a hybrid meeting open to the public.
- August 2-4, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences. This is a virtual meeting with some sessions open to the public.
- **August 5, 2026: FDA announced a meeting entitled, Medical Device User Fee Amendments. This is a hybrid meeting open to the public.
- August 6, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Institute. This is a hybrid meeting open to the public.
- **August 24, 2026: CMS announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.
- August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
- **August 26, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a hybrid meeting open to the public.
- September 2, 2026: NIH announced a meeting of NCI. This is a virtual meeting with some sessions open to the public.
- September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
- September 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
- September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
- September 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a virtual meeting open to the public.
- September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
- September 24, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- **September 28-29, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
- October 14, 2026: NIH announced a meeting of the NICHD National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
- October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
- October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
- **October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual meeting with some sessions open to the public.
- November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
- December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions open to the public.
- December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
- December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
- January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.
Reports, Studies & Analyses
- On July 8, 2026, KFF published a report entitled, How much and why ACA Marketplace premiums are going up in 2027. KFF analyzed individual market filings for plans selling Affordable Care Act (ACA) Marketplace coverage to provide insight into what factors insurers expect will drive health costs for the coming year. For 2027, across 77 insurers participating in the ACA Marketplaces from the 16 states and the District of Columbia with publicly available filings, the KFF analysis demonstrated a median proposed premium increase of 14 percent, which is the second consecutive year of premium increases over 10 percent. KFF found that the premium increases likely stem from underlying health care prices alongside the expiration of the enhanced premium tax credits (EPTCs) at the end of 2025 and a related increase in the risk pool’s morbidity. Among the participating insurers, premium changes range from one percent to 52 percent, with most proposed premium changes for 2027 falling between 10 percent and 20 percent. These filings are preliminary and may change during the rate review process. Rates for 2027 will be finalized in late summer 2026.
Other Health Policy News
- On July 6, 2026, a bipartisan group of House Energy and Commerce Committee members led by Reps. Scott Peters (D-CA) and John Joyce (R-PA) introduced the SECURE 340B Act (H.R. 9599). This bill would establish a statutory definition of a 340B Drug Pricing Program (340B) “patient” and stricter eligibility requirements for the patients who can receive discounted drugs as part of the 340B program, place restrictions on child sites, and establish stronger audits and potential sanctions for participating hospitals. The legislation would also protect contract pharmacy arrangements by prohibiting manufacturer restrictions and directs HRSA to use an independent clearinghouse to securely manage prescription-level data, verify claims, and protect privacy. This legislation would also implement a guaranteed four-year moratorium on retrospective rebate or other post-sale payment models, with the potential for continuation beyond four years if the HHS Secretary, in a public report validated by the HHS Office of Inspector General (OIG), certifies that the clearinghouse has met specified performance benchmarks. The bill would also impose new reporting and compliance obligations on covered entities and additional federal oversight requirements. The bill text can be found here, and a press release from the bill’s sponsors can be found here.
- On July 7, 2026, the CMS Center for Medicaid and CHIP Services (CMCS) issued a CMCS Informational Bulletin (CIB) entitled Implementation of a “Fast Track” Federal Review Process for Section 1115 Medicaid and CHIP Demonstration Extensions. The notice stated that H.R. 1, the Working Families Tax Cut (WFTC) legislation, included a requirement that the CMS Chief Actuary must certify budget neutrality for Section 1115 Demonstrations. CMS noted that the current fast-track extension process may pose difficulties for the agency to evaluate Section 1115 Demonstration renewal applications consistent with the new budget neutrality requirements. Guidance from 2015 implementing the fast-track option was formally rescinded, but the bulletin did not include an effective date. The budget neutrality requirements are set to begin on January 1, 2027.
The bulletin is available here.
- On July 8, 2026, HHS and CMS announced the “Make Hospital Food Healthier Pledge,” a nationwide initiative inviting hospitals to voluntarily pledge to improve the nutrition of their meals. This announcement follows a March 2026 letter sent to hospitals by CMS regarding their obligations under Medicare to meet patient’s nutritional needs, which alluded to an expectation that hospitals align their inpatient meals to the updated Dietary Guidelines for Americans. The pledge includes commitments to:
- Limit ultra-processed foods and sugar-sweetened beverages;
- Use baked, broiled, roasted, stir-fried, or grilled cooking methods instead of deep frying;
- Limit processed meats and foods high in added sugars, sodium, and artificial additives;
- Emphasize whole grains over refined grains; and
- Prioritize minimally processed proteins, including plant-based options.
A press release can be found here. More information on the pledge can be found here.
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