Health Care Watch: June 13, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 7 – June 13. 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
On June 9, the Appropriations Committee approved the Fiscal Year 2027 Labor, Health & Human Services, Education, and Related Agencies Appropriations Act by a vote of 34-28. The bill would provide $189.3 billion in discretionary funding, which is $5.6 billion below the fiscal year 2026 enacted level. Key health allocations include: a $184 million increase for Centers for Disease Control and Prevention (CDC) public health readiness programs, a $105 million increase for the Administration for Strategic Preparedness and Response (ASPR) for medical countermeasures, a $61 million increase for mental health and substance abuse block grants, increased funding for youth suicide prevention and the 988 Lifeline, and elimination of the Agency for Healthcare Research and Quality (AHRQ).
On June 10, the Energy & Commerce Committee held a legislative hearing titled “Lowering Health Care Costs for All Americans: Examining Policies to Increase Health Care Transparency.” The hearing examined nine pieces of legislation surrounding transparency in the health sphere. Members brought up various topics, including price, ownership, and prior authorization (PA) transparency in Medicare Advantage and commercial plans and market consolidation. A summary of the hearing can be found here.
The House will return to session on June 23.
Senate
On June 5, Health, Education, Labor, & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) sent a letter to NYC Health + Hospitals requesting information about a cybersecurity incident in which hostile actors may have accessed the personal health information, biometric information, geolocation data, and Social Security numbers of patients over a three-month period. Chairman Cassidy requested that NYC Health + Hospitals provide answers by June 18 regarding its security protocols, when it became aware of the incident, which federal agencies it notified, and what remedial steps it plans to take.
REGULATORY UPDATE
On June 8, the National Institutes of Health (NIH) released a Request for Information (RFI) on a proposed policy that would cap the number of Research Project Grants an individual can simultaneously serve on as Principal Investigator or Multi-Principal Investigator at either two, three, or four. The RFI requests input on the pros and cons of the policy, the optimal cap level, implementation strategies, and possible unintended consequences. Comments are due by August 3.
On June 8, the U.S. Department of Health & Human Services (HHS) issued a joint statement asserting that international organizations' conclusions on public health should not automatically be treated as definitive in the U.S. and that American regulatory decisions should be made by U.S. institutions. The statement specifically addressed the International Agency for Research on Cancer (IARC), raising questions about the consistency, transparency, and real-world applicability of certain IARC cancer hazard assessments, and stated that IARC's classifications often blur the line between hazard and risk.
On June 8, HHS and the U.S. Department of Education hosted eight medical accreditors, assessors, and medical organizations to announce voluntary commitments to increase nutrition requirements across U.S. medical education, competency-evaluation, training, and residency. The department also announced that 19 additional medical schools have signed the Nutrition Education Pledge.
On June 8, HHS and the General Services Administration (GSA) announced the launch of the Grants Management Special Item Number (SIN) under the Grants Quality Service Management Office (QSMO), a government-wide procurement vehicle for federal agencies to access pre-vetted commercial grants management solutions and services through the GSA Multiple Award Schedule (MAS). According to HHS, vendor solutions and services on the Grants Management SIN must meet Grants QSMO-defined capabilities and adhere to government-wide grants data standards to drive interoperability and improved visibility into grants data.
On June 8, HHS released an RFI seeking input on substance research, policy, and strategies to improve addiction and mental illness prevention, treatment, and recovery. The RFI specifically requests suggestions on how the department can use artificial intelligence (AI) and data analytics to evaluate substance use and mental health programs in real time. Comments are due by July 5.
On June 9, the National Institute of Allergy and Infectious Diseases (NIAID) published a notice of a closed meeting of the Vaccine Research Center Board of Scientific Counselors, scheduled to take place virtually on June 23 from 1:00 to 2:00 p.m. The meeting will be closed to the public.
On June 9, the U.S. Food and Drug Administration (FDA) issued a final administrative order adding bemotrizinol to the list of permitted sunscreen active ingredients, the first new active ingredient added to the over the counter (OTC) sunscreen monograph since the late 1990s. The action follows a proposed order issued on December 12, 2025, in response to an OTC monograph order request submitted by DSM Nutritional Products LLC to add bemotrizinol at concentrations up to 6%.
On June 9, the Boards of Trustees of the Federal Hospital Insurance (HI) and Federal Supplementary Medical Insurance (SMI) Trust Funds released the 2026 Medicare Trustees Report. The report found that the Medicare Hospital Insurance Trust Fund is projected to become depleted in the second quarter of 2033, one quarter earlier than last year. Notable changes affecting Medicare spending include: physician fee schedule changes lowering Part B spending for skin substitutes and higher Part D expenditures due to increased utilization of GLP-1 and specialty drugs and higher cost trends, offset somewhat by lower projected direct and indirect remuneration. The report also includes the effects of three recently enacted laws on Medicare trust funds, including H.R. 1, which lowers revenues into the HI Trust Fund.
On June 10, HHS posted on social media that the "GRACE PERIOD HAS ENDED" and demanded immediate hospital compliance with federal price transparency laws. HHS also indicated that CMS has been actively reviewing compliance since April 1 and has already issued non-compliance notices to over 500 hospitals, explicitly noting that large, well-resourced health systems are not exempt from the requirements. HHS warned that facilities that fail to post actual prices face daily accumulating penalties of up to $2 million per year. LINK
On June 10, CMS published a notice announcing the launch of the Office of Health Technology and Products (OHTP) within CMS, a new component tasked with leading health care technology modernization across Medicare, Medicaid, and CHIP. Specifically, the new office will oversee the design, development, and operation of CMS digital platforms including beneficiary, provider, and state facing systems and lead the modernization of the National Provider Directory, the National Plan and Provider Enumeration System, and the Provider Enrollment, Chain, and Ownership System. Additionally, OHTP is tasked with updating the legacy Medicare claims and payment systems to improve long-term scalability and security.
On June 10, CMS announced that Melissa Fannin has joined the agency as Chief of Workforce Strategy. She was most recently the health sector lead at Deep Water Point & Associates, a consulting firm.
On June 10, CMS issued a memorandum to Part D plan sponsors providing responses and frequently asked questions (FAQs) related to the Medicare GLP-1 Bridge. The memorandum clarifies that the Medicare GLP-1 Bridge operates outside of the Part D coverage and payment flow, that Part D plan sponsors are not participants and do not have a financial or administrative role, and that beneficiaries diagnosed with conditions currently eligible for Part D coverage are not eligible for the Medicare GLP-1 Bridge. CMS stated that participating manufacturers will provide eligible GLP-1 drugs at a net price of $245 per monthly supply with a $50 beneficiary copay, and that the agency will monitor for inappropriate shifting of beneficiaries to the Medicare GLP-1 Bridge and act if Part D plan sponsors fail to comply with their Part D obligations.
On June 10, Dr. John Powers III was appointed as the new Acting Director of NIAID. Dr. Powers previously served as NIAID Deputy Director and as Principal Senior Advisor to the NIAID Director and Director of Collaborative Research with Leidos Biomedical Research in support of the Office of the Director at NIAID.
On June 11, FDA issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old, marking the first generic animal drug authorized for use against NWS. To date, the FDA has issued ten EUAs and three conditional approvals for drugs to combat NWS; the tablets are sponsored by Felix Pharmaceuticals Pvt. Ltd. based in Ireland.
On June 11, CMS issued a State Medicaid Director Letter providing guidance on planned changes to budget neutrality standards for Medicaid Section 1115 demonstrations, previewing a forthcoming proposed rule that would establish more consistent and transparent requirements for demonstration approvals. The guidance reflects a statutory requirement under the Working Families Tax Cut legislation that the CMS Chief Actuary certify budget neutrality for all Section 1115 demonstrations, effective January 1, 2027, after which CMS will not approve new demonstrations, renewals, or amendments without such certification.
On June 11, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced $40 million in funding opportunities across eight grant programs focused on addiction prevention, child trauma, suicide prevention, mental illness treatment, and strengthening the behavioral health workforce. The largest awards include $9.2 million for Behavioral Health and Community Safety Partnerships, $9 million for Tribal Behavioral Health Substance Use Prevention, $8 million for the Screening, Brief Intervention, and Referral to Treatment (SBIRT) program, and $8 million for the National Center for Child Traumatic Stress.
On June 11, NIH announced the selection of Raymond Jacobson as director of NIH's Center for Scientific Review (CSR), effective June 14. Jacobson previously served as CSR's acting director and as Acting Deputy Director of the NIH Office of Extramural Research, where he led efforts to advance centralized peer review and reduce administrative burden for grant applicants
On June 11, new reports indicated that the Trump administration plans to appoint Dr. Mark Shirley, as chair of the U.S. Preventive Services Task Force (USPSTF). HHS denied the report, stating that no decisions have been made regarding future USPSTF membership or leadership and that AHRQ is actively reviewing more than 320 nominations through its established vetting process.
On June 12, FDA cleared for marketing the OTC continuous glucose monitor (CGM) for children, Dexcom Inc.'s Stelo Glucose Biosensor System. The device is an integrated CGM indicated for individuals two years of age and older who do not use insulin, expanding upon its previous clearance for adults. FDA notes that by providing real-time glucose data, the device can help pediatric patients and their caregivers build greater glycemic awareness and track patterns in response to meals and exercise.
On June 12, CMS released a final rule with comment period revising its requirements for the CMS-approved Accrediting Organizations (AOs) that survey health care providers for compliance with health and safety requirements. The rule requires AOs to meet the same standards as State Survey Agencies (SAs), prevents AO conflicts of interest, requires AOs with unacceptable performance scores to submit publicly reported correction plans, aligns AO survey activity and staff training with SAs, and prohibits AOs from conducting mock surveys for providers they survey before initial surveys. A fact sheet can be found here.
On June 12, CMS issued a proposed rule on the Medicare Drug Price Negotiation Program. The proposed rule largely codifies policies established in existing negotiation program guidance for initial price applicability year (IPAY) 2029 and subsequent years. The rule includes a proposal to address what CMS refers to as the fixed combination drug “loophole”: where a fixed‑combination drug shares one or more active moieties, ingredients, or antigen components with another product from the same NDA/BLA holder and the additional component creates a new formulation that enables an alternative route of administration, CMS would treat all dosage forms and strengths with the shared active component as a single potential qualifying single‑source drug. The rule also includes policies related to negotiation‑eligibility timing for former orphan drugs, operationalizes the small‑biotech temporary floor, and formalizes several manufacturer obligations. Comments on the proposed rule are due by August 17. A fact sheet can be found here.
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 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1850); Proposed Rule; 04/13/2026
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
CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1846); Proposed Rule; 04/22/2026
CY 2027 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1844); Proposed Rule; 05/11/2026
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
Request for Information: Pharmacy Benefit Manager Compensation and Data Collection (CMS-4218); Notice; 06/01/2026
Request for Information; Clinical Laboratory Improvement Amendments (CLIA) of 1988 Regulations (CMS-3485); Notice; 06/01/2026
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
Establishment Registration and Product Listing for Tobacco Products; Proposed Rule; 02/19/2026
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments; Rule; 03/04/2026
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
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability; Notice; 04/24/2026
Food Standards of Identity Modernization; Pasteurized Orange Juice; Final Rule; 05/08/2026
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
Expedited Investigational New Drug Pilot Program; Request for Information; Notice; 06/03/2026
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
Senate
HELP Committee
June 17; 10:00 AM EST; 430 Dirksen
Bills to be marked up:
S. 1782, Charlotte Woodward Organ Transplant Discrimination Protection Act;
S. 3799, Healthy Start Reauthorization Act of 2026;
S. 4109, Stem Cell Therapeutic and Research Reauthorization Act;
S. 2339, EARLY Act Reauthorization of 2025;
S. 4472, Accelerating Access to Critical Therapies for ALS Act of 2026;
S. 2658, Medication Affordability and Patent Integrity Act;
S. 3014, Ensuring Timely Access to Generics Act of 2025; and
S. 1954, Biosimilar Red Tape Elimination Act.
Budget Committee
June 16; 10:00 AM EST; 608 Dirksen
Aging Committee
Counting the Cost: Communist China's Toll on Older Americans' Health, Finances, and Security
June 17; 3:30 PM EST; Hart 216
Witnesses: Joshua Hodges, Leland Miller, Reva Price, and Chris Slevin - Commissioners at the U.S.-China Economic and Security Review Commission
REPORTS
Office of Inspector General (OIG)
On June 8, HHS OIG released an audit finding that CMS did not consistently follow its policies and procedures for overseeing states' quarterly reported Medicaid expenditures on Form CMS-64, with review work papers that were not always accurate or consistent, and deferred payments remaining unresolved for years. OIG made four recommendations to CMS, including developing additional training for analysts and revising policies related to CMS-64 oversight and tracking of disallowed expenditures. CMS concurred with all four recommendations.
On June 11, HHS OIG released an audit finding that none of the 100 sampled denied service requests reviewed for Community Behavioral Health (CBH), a Pennsylvania behavioral health Medicaid managed care organization, met all requirements for denying behavioral health service requests requiring PA, with issues including potential delays or denials of medically necessary services, notices sent to incorrect addresses, and unclear denial notices. OIG made five recommendations to CBH to improve how it communicates service denials, and one recommendation to Pennsylvania to improve its denial notice templates. Pennsylvania concurred with its recommendation, while CBH concurred with two findings.
On June 11, HHS OIG released an audit finding that California claimed at least $13.9 million more in federal Medicaid reimbursements for clinical diagnostic laboratory services than was allowed under federal and state requirements during calendar years 2019 through 2023, with an additional $29.3 million in potential overpayments under review. OIG made four recommendations, including that California refund $7.6 million in federal overpayments and strengthen its policies and procedures for reviewing and updating laboratory rates in its claims processing system. California concurred with all four recommendations.
On June 11, HHS OIG released a report finding that among 19 Medicare Advantage organizations (MAOs) reviewed, the three largest by enrollment denied prior authorization (PA) requests for admission to long-term care hospitals (LTCHs) and inpatient rehabilitation facilities (IRFs) at higher rates than most peers in June 2024. The 19 MAOs collectively denied 65% of PA requests for LTCH admissions and 54% for IRFs and overturned 36% of LTCH denials and 43% of IRF denials on appeal. IRF overturn rates ranged from 14-86% across MAOs. OIG recommended that CMS regularly collect request-level PA data and assess reasons for the wide variation in denial and overturn rates across MAOs and contractors. CMS did not explicitly concur with either recommendation.
On June 11, HHS OIG released a report finding that 19 MAOs collectively denied 12% of PA requests for skilled nursing facility (SNF) admission in June 2024, and that MAOs overturned 95% of appealed SNF denials in favor of enrollees. NaviHealth, a contractor and subsidiary of UnitedHealth Group, Inc., processed half of all SNF requests, denied 14% of them, and had 97% of its denials overturned on appeal. OIG made three recommendations to CMS, including that it address breakdowns in initial reviews of SNF admission requests and assess reasons for variation in denial rates across MAOs, contractors, and between nursing home and non-nursing home residents. CMS did not explicitly concur with either recommendation.
Government Accountability Office (GAO)
On June 9, GAO released a report finding that Medicare paid $16.7 billion for hospice routine home care services between 2022 and 2024 for selected beneficiaries, compared to an estimated $9.1 billion if reimbursed under comparable home health per-visit payment rates, driven in part by a daily payment structure that effectively paid low-visit hospices twice as much per visit as high-visit hospices on average. GAO recommended that Congress consider directing the HHS Secretary to revise the hospice payment system for routine home care to better promote payment efficiency, noting that CMS stated the current statute requires daily payment rates and does not provide flexibility for further structural changes.
On June 10, GAO released its annual priority open recommendations letter for HHS, identifying 38 total priority recommendations, including seven new recommendations added in May 2026, with HHS having implemented four recommendations since GAO's May 2025 letter. GAO highlighted two areas warranting timely attention: strengthening Medicare and Medicaid program integrity and oversight and improving public health program oversight and coordination.
On June 11, GAO released a report examining HHS and Department of Justice (DOJ) grant programs that fund behavioral health services for human trafficking survivors, finding that in fiscal year 2025, HHS awarded approximately $7.5 million and DOJ awarded approximately $45 million across their respective programs, collectively assisting approximately 13,900 survivors. GAO found that HHS followed leading practices in assessing program performance and that DOJ did so for its minor survivor assistance program but not for its adult program.
ADDITIONAL POLICY NEWS
On June 9, a bipartisan coalition of 37 state attorneys general and the DOJ announced a $36.5 million settlement with CVS Pharmacy, Inc. to resolve allegations that the company overbilled Medicaid for insulin prescriptions from 2010 to 2020. According to the announcement, the coalition's investigation found that CVS dispensed more insulin to Medicaid recipients than their prescriptions specified, refilled insulin pen prescriptions before they were needed, under-reported the amount of time that the insulin supply would last, and did not comply with certain rules used to calculate refill dates. Under the settlement, CVS will pay $36.5 million to participating state Medicaid programs.
On June 9, the American Medical Association (AMA) announced that Sandra Adamson Fryhofer, M.D., a board-certified internal medicine physician in Atlanta and adjunct associate professor of medicine at Emory University School of Medicine, was selected as president-elect. Dr. Fryhofer has served in AMA leadership roles for over two decades and has previously served as president of the American College of Physicians (ACP) in 2000 and has served as the AMA's liaison to the CDC’s Advisory Committee on Immunization Practices (ACIP). The AMA also inaugurated Dr. Willie Underwood, III, a urologic surgeon based in Buffalo, NY, as its 181st President.