THIS WEEK’S DOSE
- Senate Democrats request information on reforming drug pricing. The request for information focuses on lowering prescription drug pricing and out-of-pocket costs for patients as well as fostering biopharmaceutical innovation.
- Senate HELP Committee advances healthcare bills. Senate Health, Education, Labor, and Pensions (HELP) Committee members discussed eight health-related bills and advanced seven of them, with topics ranging from drug pricing to organ transplantation regulations.
- CMS proposes framework for drug price negotiation. The Centers for Medicare & Medicaid Services (CMS) proposes to codify the Medicare Drug Price Negotiation Program for 2029 and beyond.
- CMS finalizes updates to its accrediting organizations. The final rule would enhance oversight by holding accrediting organizations accountable to the same Medicare standards as state survey agencies.
CONGRESS
Senate Democrats request information on reforming drug pricing. On June 16, 2026, Senate Finance Committee Ranking Member Wyden (D-OR), joined by Sens. Cortez Masto (D-NV), Welch (D-VT), Gallego (D-AZ), Kelly (D-AZ), Baldwin (D-WI), Hassan (D-NH), Merkley (D-OR), Van Hollen (D-MD), Duckworth (D-IL), and Blumenthal (D-CT), released a request for information (RFI) on several proposals aimed at lowering the cost of prescription drugs. The RFI is split into three categories:
- Lowering drug prices. Proposals to further lower prescription drug prices by expanding Medicare negotiation, strengthening inflation rebates, addressing high-cost blockbuster drugs, supporting biosimilars, and exploring subscription models for widely used medications such as GLP-1s.
- Enhancing prescription drug affordability. Feedback on proposals to reduce patients’ out-of-pocket drug costs by expanding Medicare cost-sharing protections, strengthening oversight of pharmacy benefit managers and health plans, reforming generic drug reimbursement, broadening Part D assistance, and addressing pricing incentives across the prescription drug supply chain.
- Bolstering biopharmaceutical innovation in the United States. Options to strengthen US biopharmaceutical innovation by expanding biomedical research funding and incentives, supporting high-risk and unmet-need drug development, improving domestic clinical trials, and cultivating scientific talent to enhance global competitiveness.
The RFI follows a February 2026 request for stakeholder input by Ranking Member Wyden and a number of his colleagues. They received input from more than 70 stakeholder listening sessions and incorporated that feedback into this more robust RFI. The deadline to submit feedback to drugs@finance.senate.gov is August 17, 2026, to help inform future legislative drafting. Their goal is to release a draft legislative proposal in 2027, so this is a longer-term policymaking process. Senate Democrats plan to follow the same process for their ongoing work related to private health insurance marketplace reforms and long-term care reforms.
Senate HELP Committee advances healthcare bills. During the markup, members discussed eight-health related bills, advancing seven of them to the Senate floor with the vote outcomes below:
- S. 1782, Charlotte Woodward Organ Transplant Discrimination Prevention Act, which would prevent hospitals and transplant centers from denying organ transplants to patients solely based on a physical or mental disability.
- Passed en bloc with 22 yeas and 0 nays.
- S. 3799, Healthy Start Reauthorization Act of 2026, which would reauthorize the Healthy Start Initiative at $145,000,000 for each fiscal year (FY) from 2026 – 2030.
- Passed en bloc with 22 yeas and 0 nays.
- S. 4109, Stem Cell Therapeutic and Research Reauthorization Act, which would reauthorize the C.W. Bill Young Cell Transplantation Program at its current appropriated level of $33,009,000 for FY 2027–2031 and reauthorizes the National Cord Blood Inventory at its current funding level through FY 2031.
- Passed en bloc with 22 yeas and 0 nays.
- S. 2339, Young Women’s Breast Health Education and Awareness Requires Learning Young (EARLY) Act Reauthorization of 2025, which would reauthorize the EARLY Act through 2031 and would direct the Centers for Disease Control and Prevention to conduct a national evidence-based education campaign to increase awareness of breast health, breast cancer risks, and other relevant health information among young women.
- Passed en bloc with 22 yeas and 0 nays.
- S. 4472 , Accelerating Access to Critical Therapies for ALS Act of 2026, which would maintains $100,000,000 in funding for the ALS Act for each fiscal year through 2031.
- Passed en bloc with 22 yeas and 0 nays.
- S. 2658, Medication Affordability and Patent Integrity Act, which would require that when a company submits a drug patent to the US Patent and Trademark Office, the information must be consistent with the information submitted to the FDA.
- Agreed to by roll call vote, 16 yeas – 6 nays.
- S. 3014 Sanders Amendment 6, Ensuring Timely Access to Generics Act of 2025, which would allow the US Food and Drug Administration (FDA) to deny citizen petitions against generics or biosimilars that companies have submitted under section 505(q) if there is no scientific or regulatory issue with the biosimilar or generic application.
- Sen. Sanders’ (I-VT) amendment was agreed to by roll call vote 15 yeas – 8 nays.
- Upon the Committee agreeing to amend S. 3014, Chairman Cassidy (R-LA) delayed the final vote on the bill to seek technical assistance before further consideration. The bill is expected to be discussed further in a July markup.
- S. 1954 , Biosimilar Red Tape Elimination Act, which would remove the separate interchangeability determination process that the FDA applies to biosimilars and automatically deems any biological products licensed under the Public Health Service Act (section 351(k)) to be classified as biosimilars.
- Passed en bloc with 22 yeas and 0 nays.
ADMINISTRATION
CMS proposes framework for drug price negotiation. On June 12, 2026, CMS issued a proposed rule to establish a regulatory framework for the Medicare Drug Price Negotiation Program, originally created under the 2022 Inflation Reduction Act to allow Medicare to directly negotiate the prices of certain high-cost drugs and biologics without generic or biosimilar competition. While most of the proposed regulation simply codifies the existing program, the rule also addresses policies for negotiating and renegotiating high-cost, single-source drugs beginning with initial price applicability year 2029.
Comments on the proposed rule are due by August 17, 2026.
CMS finalizes updates to its accrediting organizations. CMS finalized a rule updating its oversight of accrediting organizations, which survey Medicare-certified providers and suppliers for compliance with Medicare health and safety standards.
The final rule is designed to:
- Ensure accreditation standards continue to meet or exceed those of the Medicare program.
- Align accreditation and survey processes with CMS requirements.
- Confirm accrediting organizations’ enforcement of CMS requirements.
- Reinforce that all accredited entities must deliver safe, effective care.
- Prevent accrediting organization conflicts of interest that may arise from related consulting services.
The rule establishes a new process for monitoring accrediting organization performance, creates more consistent standards and definitions, updates validation and performance systems, and requires accrediting organization surveyors to complete the same CMS training as state survey agency surveyors. CMS said the changes are intended to reduce burden on providers, strengthen survey policies, and increase transparency in accrediting organization practices.
The rule also requires accreditation surveys to be conducted without advance notice and limits certain consulting activities, including prohibiting accrediting organizations from conducting mock surveys for providers they accredit before initial surveys and within 12 months of reaccreditation. CMS said these changes are intended to protect the objectivity and integrity of the accreditation process and ensure that all certified facilities are held to consistent Medicare health and safety standards.
QUICK HITS
- MedPAC, MACPAC release June reports. The Medicare Payment Advisory Commission (MedPAC) released an annual report, fulfilling its legislative mandate to evaluate Medicare payment issues and provide a report to the Congress. The Medicaid and CHIP Payment and Access Commission (MACPAC) also released its required recommendations and June 2026 report to Congress.
- FDA approves additional OTC naloxone nasal spray for opioid overdoses. The FDA announced the approval of a new over-the-counter (OTC) intranasal naloxone product for the emergency treatment of opioid overdose, in line with an executive order to improve interagency coordination and approaches for prevention, treatment, and long-term recovery.
- NIH creates Office of Research Innovation, Validation, and Application. The Office of Research Innovation, Validation, and Application will coordinate National Institutes of Health (NIH) efforts to develop, validate, and scale human-based research technologies, as opposed to animal-based methods, across the NIH.
- CBO requests new research on No Surprises Act. The Congressional Budget Office (CBO) seeks additional research on how the No Surprises Act affects provider networks, prices, arbitration outcomes, market competition, and healthcare consolidation.
- GAO reports program integrity concerns within Inspectors General Integrity Committee. The report outlines eight recommendations for the Office of Inspector General to improve oversight and transparency in its investigations, including adhering to policy on conducting secondary reviews of potentially frivolous complaints and improving statutorily required reporting to Congress.
NEXT WEEK’S DIAGNOSIS
The House and Senate are both scheduled to be in session next week, making it one of the few remaining joint legislative weeks before the August recess. Additional details may emerge on House Republican efforts to advance a third budget reconciliation package, which could include health-related provisions.
For committee activity, the House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing on June 25, 2026, on Medicaid fraud featuring state Medicaid directors. We also expect the House Energy and Commerce Health Subcommittee to hold a markup of healthcare transparency bills.
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