Public Sector Healthcare Roundtable: June 21, 2026:
Senate Health, Education, Labor and Pensions Committee Advances Bills to Improve Health Care Access and Affordability
On June 17, the Senate Health, Education, Labor, and Pensions (HELP) Committee advanced eight bipartisan health care bills on organ transplant protections, prescription drug competition, stem cell research, maternal health, and other health care issues. The Roundtable was tracking and encouraged the Committee to advance three of the eight bills under consideration:
- Medication Affordability and Patent Integrity Act (S.2658) to improve patent quality and oversight and prevent delays in the availability of generics by strengthening U.S Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) coordination.
- Ensuring Timely Access to Generics Act (S.3014) to increase oversight of the FDA citizen petition process to prevent system abuse.
- Biosimilar Red Tape Elimination Act (S.1954) to modernize the drug approval process to expedite biosimilar substitution and increase biosimilar competition with brand-name products.
Chairman Bill Cassidy (R-LA) emphasized the importance of moving bipartisan legislation efficiently while criticizing Ranking Member Bernie Sanders’ (I-VT) amendments as unrelated “poison pills.” On the other hand, Ranking Member Sanders argued his proposals addressed urgent priorities including community health center funding, workforce shortages, and prescription drug affordability.
Most of Ranking Member Sanders’ amendments were tabled or defeated; however, one of his amendments was adopted. Ranking Member Sanders’ amendment attached the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act (S.4189), which extends the $35 per month cap to the commercial market, to the Ensuring Timely Access to Generics Act of 2025. Additionally, the Committee also adopted an amendment from Senator Jon Husted (R-OH) to the Medication Affordability and Patent Integrity Act that prevents a Chinese, Cuban, Iranian, North Korean, Russian, or Venezuelan person or business to claim patent infringement.
The Committee passed seven bills, six of which were unanimously approved. The Medication Affordability and Patent Integrity Act advanced on a 16-6 vote, with Senator Alan Armstrong (R-OK), Senator Roger Marshall (R-KS), Senator Tim Scott (R-SC), Senator Tommy Tuberville (R-AL), Senator Jim Banks (R-IN), and Senator Jon Husted (R-OH) voting against and Senator Rand Paul (R-KY) abstaining. Additionally, the Ensuring Timely Access to Generics Act was held for further refinement ahead of a planned July markup. Chairman Cassidy closed the markup by emphasizing continued bipartisan work as the approved legislation moves to the Senate floor for consideration and vote.
The Roundtable appreciates the widely bi-partisan passage of the Medication Affordability and Patient Integrity Act and the Biosimilar Red Tape Elimination Act. Additionally, the Roundtable encourages the HELP Committee to pass the Ensuring Timely Access to Generics Act during the next markup in July. The Roundtable will continue to monitor the progression of the three bills through Congress and advocate for bi-partisan legislation that improves health care and prescription drug affordability and market competition to ensure public sector purchasers can provide affordable, competitive health care benefits to their employees, retirees, and their dependents.
Proposed Rule Establishes Long-Term Structure for Medicare Drug Price Negotiations
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would establish a permanent framework for the Medicare Drug Price Negotiation Program (DPNP) beginning with the 2029 negotiation cycle, replacing the current sub-regulatory guidance-based approach. Further, the proposed rule outlines the proposed requirements for future negotiation cycles. Most of the provisions of the proposed rule codify existing CMS guidance, while the remaining provisions implement the Orphan Drug Exclusion provision from the One Big Beautiful Bill (H.R.1), address minor technical adjustments, and provide procedural clarifications.
In their press release, CMS noted that these changes are intended to provide greater certainty for drug manufacturers, plans, pharmacies, and beneficiaries while strengthening the long-term administration of the program. CMS also pointed to the past success of the Medicare Drug Price Negotiation Program, as they have negotiated prices for 25 high-expenditure drugs across the program’s first two years to generate significant savings for the federal government and Medicare beneficiaries. Public comments on the proposed rule is due by August 17, 2026 at 11:59pm ET. The proposed rule states that CMS anticipates they will publish the final version of the rule in the Fall of 2026.