Top News
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.
Administrative Action
CMS Expands Federal Oversight of Healthcare Accrediting Organizations
On June 12, the Centers for Medicare & Medicaid Services (CMS) released a final rule focused on strengthening oversight of healthcare Accrediting Organizations (AO). The rule ensures that the organizations responsible for oversight of providers and suppliers are compliant with Medicare health and safety standards. To that end, the rule is designed to align accreditation and survey processes between AOs and state survey agencies to will reduce provider burden, strengthen survey policies, and increase transparency.
The rule creates a new framework for monitoring AO performance, standardizes survey processes and definitions, and requires AO surveyors to complete the same CMS training as state surveyors. It also requires accreditation surveys to be conducted without advance notice and updates CMS’ validation process for reviewing AO findings. To address concerns about impartiality, the rule prohibits AOs from conducting mock surveys for facilities they accredit before initial accreditation and within 12 months of reaccreditation. CMS stated that these changes are intended to strengthen patient safety oversight, reduce variation in survey findings, and reinforce the independence and integrity of the accreditation process.
Rural Health Transformation Program Comes Under Increased Federal Oversight
Many states have found that the Centers for Medicare and Medicaid Services (CMS) is exercising significant oversight over the implementation of the Rural Health Transformation Program (RHTP), causing some states to revise or abandon portions of their original proposals. Created as a provision of President Trump’s signature One Big Beautiful Bill Act (H.R.1), the RHTP will distribute $50 billion to states to help bolster rural health care. Over the past six months, states have raced to meet federal deadlines with the immediate goal of finalizing first-year funding commitments by October 30, 2026.
Unlike typical grants, the RHTP utilizes cooperative agreements which require states and receiving entities to work heavily with the federal government. In addition to the cooperative agreements, the federal government has identified and are leveraging multiple avenues of oversight to ensure that contracts are designed, signed, and executed appropriately. To manage the federal oversight of the program, CMS established an Office of Rural Health Transformation with the goal of hiring at least one federal project officer for each state RHTP. These program officers are expected to check in with their assigned state “at least twice a month, if not on a weekly basis.”
As a result of significant federal oversight, Colorado, Maine, Vermont, and Wyoming have been forced to modify or abandon portions of its original plan. In these instances, the federal government stated that the implementation of the state’s plan violates program rules such as funding “minor” renovations to existing buildings or “supplant or modify fee schedule payments for… clinical services”.
Additionally, CMS Administrator Mehmet Oz has threatened to take money back from states who do not execute what they promised to achieve on their RHTP application. National Rural Health Association Chief Executive Officer Alan Morgan shared that the rural health policy community is concerned that facilities and organizations will not apply for the grant money due to fears of the administration retract funds. Currently, it is unclear if CMS can take back money that states have already awarded to rural health organizations.
States disparity in progress to award RHTP funds is in part due to the combination of substantial federal oversight and threats that the money could be revoked. Thus far, Michigan is the only state to have all RFPs awarded, half of states have RFPs in review, and ten states have yet to release an RFP for the RHTP. States must submit a progress report to CMS by August 30, 2026.
MACPAC, MedPAC Release Reports to Congress
On June 15, the Medicaid and CHIP Payment and Access Commission (MACPAC) released the June 2026 Report to Congress. MACPAC’s report consists of seven chapters covering:
- Community engagement requirements in Medicaid;
- Automation in prior authorization;
- Managed care accountability;
- Access to residential behavioral health treatment;
- Children and youth with special health care needs transitions to adult Medicaid coverage;
- Program of All-Inclusive Care for the Elderly (PACE) program audits, transparency, and standardized quality measure set; and
- Provider enrollment and credentialing in Medicaid.
MACPAC called on the Centers for Medicare and Medicaid Services (CMS) to release guidance on monitoring community engagement requirements, a policy that was largely absent from the recent interim final rule released earlier this month. Notably, MACPAC recommended that CMS develop a transparent plan for monitoring and evaluating community engagement requirements in Medicaid, which should provide insight into how such policies affect eligibility and enrollment.
On the same day, the Medicare Payment Advisory Commission (MedPAC) released their Report to Congress on Medicare and the Health Care Delivery System, with chapters discussing:
- Improving payment incentives;
- Complexity of Medicare enrollment decisions for beneficiaries;
- Payment operations and their role in identifying improper payments;
- Association between Medicare Advantage (MA) enrollment and hospitals’ and post-acute care providers’ finances;
- Access to hospice and certain complex palliative services for beneficiaries with end-stage renal disease or cancer; and
- Assessment of the Medicare Ground Ambulance Data Collection System.
When developing its recommendations, MedPAC noted that the commission was guided by the fact that payments should be sufficient to support beneficiary access to high-quality health care in an appropriate clinical setting while ensuring they reflect and incentivize efficient care delivery.
The only recognition of Medicare Advantage (MA) Employer Group Waiver Plans (EGWPs), like those public sector employers offer, in the Report to Congress is a footnote clarifying that EGWPs were not factored into MedPAC’s administrative cost comparison between Original Medicare and MA. The Roundtable continues to advocate for MedPAC to clearly and consistently differentiate between individual MA and MA EGWPs in their reports to Congress. In the June 2026 Report, Chapters 2 through 4 could have benefited from explicit consideration of MA EGWPs.
Judicial Action
Tennessee’s FAIR Rx Act Faces Legal Challenge from Pharmacy Benefit Manager Trade Group
In separate lawsuits, the Pharmaceutical Care Management Association (PCMA), Express Scripts, and CVS Caremark are challenging Tennessee’s Freedom, Access and Integrity in Registered Pharmacy (FAIR Rx) Act. Passed in May but effective in 2028, the FAIR Rx Act prohibits pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state, a policy known as decoupling. State and federal policymakers across the country have considered decoupling legislation to address concerns that vertically integrated PBMs use their ownership of pharmacies to steer patients toward affiliated pharmacies, disadvantaging independent pharmacies through reimbursement practices and other contracting policies.
The PBMs’ lawsuits argue the law violates the U.S. Constitution’s Dormant Commerce Clause by discriminating against out-of-state businesses and is preempted by federal laws governing employer-sponsored health plans and military health benefits, including the Employee Retirement Income Security Act (ERISA) and TRICARE. CVS stated it would be forced to close 136 retail and specialty pharmacies in Tennessee and discontinue its mail-order pharmacy services if the law takes effect. Express Scripts also said it would have to stop shipping medications to Tennessee residents and close its Memphis dispensing facility, which manages a significant portion of the company’s nationwide mail-order operations and holds approximately $900 million in pharmaceutical inventory. The litigation follows similar legal challenges to Arkansas’ 2024 PBM ownership law, which was temporarily blocked in federal court, and comes as at least nine other states consider comparable restrictions on vertically integrated PBMs.
Court Decision Calls into Question CMS Star Rating Methodology
On May 27, a federal district court in the Southern District of Georgia issued a summary judgment ruling in Clover Insurance Co. v. Department of Health and Human Services, finding that the Centers for Medicare and Medicaid Services (CMS) used an improper methodology in calculating Medicare Advantage Star Ratings for Clover Health. The court ruled that ten measures used by CMS in their calculation were unauthorized, specifying that quality ratings could only be calculated using data from HEDIS, HOS, and CAHPS. They also found that CMS failed to follow the required notice-and-comment rulemaking procedures before adopting certain measures into star rating calculations. The ruling threw out an additional ten measures from Clovers’ Star Rating calculation.
Although the ruling applies only to Clover and does not set binding precedent, it could have broader implications for the Medicare Advantage program because Star Ratings affect Quality Bonus Payments, plan benchmarks, marketing activities, and could result in potential contract terminations for plans under 3 stars. The decision provides a legal roadmap that other Medicare Advantage organizations may use to mount similar challenges to their own Star Ratings. CMS must now decide whether to appeal to the Eleventh Circuit or to accept the decision and voluntarily apply the ruling’s principles to other plans. Additionally, the decision may prompt increased scrutiny of CMS’s star rating methodology.
Save the Date: 2026 Annual Conference
HealthCare Roundtable 22nd Annual Conference
November 4-6, 2026
The Mayflower Hotel
Washington, D.C.
