In this update:
- Trump Administration
- Trump Administration Releases Spring 2025 Unified Agenda
- MAHA Commission Releases Second Report
- Federal Agencies
- Members of Congress Send Letter to HHS Opposing 240B Pilot
- CMS Announces IDea Challenge
- FTC to Drop Noncompete Ban and Legal Defense; Issues New RFI
- CBO Report Shows 340B Spending up 5x from 2010-2021
- CMS Issues Guidance on Medicaid State-Directed Payments
- FDA Launches Reforms to Drug Advertising Rules
- Legislative Updates
- Bipartisan Bill to Extend ACA Enhanced Premium Tax Credits Introduced in House
- House Appropriators Cut Prior Authorization Program in Funding Bill
- Other Updates
- MedPAC Presents Findings at September 2025 Meeting
- New York State Updates
- New York State Announces Intention to Terminate Essential Plan Waiver, Revert to BHP 1331 Authority
- Governor Hochul Issues Executive Order to Support Access to Covid-19 Vaccines
- OMH and OASAS Issue Draft Regulations for CCBHCs under the NYS Medicaid Benefit
Trump Administration
Trump Administration Releases Spring 2025 Unified Agenda
On September 4th, the Trump Administration released its Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda), which details changes to federal regulations that are under review. The Unified Agenda is released twice per year and is seen as a bellwether for an Administration’s regulatory priorities. Over 130 announcements were included in the HHS Spring 2025 Unified Agenda. In addition to standard rate setting, the agenda sets out a number of potential CMS rules, including policies related to State Directed Payments, end-stage renal disease (ESRD) models, CMMI payment models, and 1115 demonstration waivers. The Unified Agenda also calls for the Office of the Secretary to address regulations related to Graduate Medical Education (GME) funding and accrediting bodies.
The Unified Agenda can be found here.
MAHA Commission Releases Second Report
On September 9th, HHS Secretary Kennedy released a report titled, Make America’s Children Healthy Again, which calls for a wide range of strategies and policies to address chronic disease in children. The report summarizes 128 recommendations to improve the health of children, including new research, policy changes and regulations, public awareness campaigns, and suggestions for public-private partnerships. These recommendations are intended to address four potential drivers behind rising rates of chronic disease among children, as identified by the Make America Health Again (MAHA) Commission: poor diet, chemical exposure, lack of physical activity and chronic stress, as well as “overmedicalization” – which the commission describes as “a concerning trend of overprescribing medications to children.”
The report can be found here.
Federal Agencies
Members of Congress Send Letter to HHS Opposing 340B Pilot
On September 8th, over 160 members of Congress sent a bipartisan letter to HHS Secretary Kennedy expressing their concerns over the 340B Rebate Model Pilot Program. In the letter, Members outline their apprehension that the new model would “severely undermine” the intended purpose of the 340B program: to enable safety-net providers – like community health centers and safety net hospitals – to provide better care to more patients through the most efficient use of federal resources. The letter also expresses concern that the new Model will require providers to purchase drugs at the wholesale acquisition cost “in the hopes of a rebate being paid,” at an estimated cost of $72.2 million per year from the average Disproportionate Share Hospital. Lawmakers urge HHS to “abandon” the program, or at the very least, to “proceed with the utmost caution and impose stronger guardrails to ensure the 340B program is not entirely dismantled.”
The letter is available here.
CMS Announces IDea Challenge
On September 11th, CMS announced the IDea Challenge, an effort to “combat fraud involving health plan identifiers (IDs) and enhance security of those IDs.” The initiative includes two in-person events focused on developing innovative solutions for protecting patient information. Participants will spend the day working in small teams to develop solutions, pitch concepts to CMS, and vote on a preferred concept. The events will be held on:
- November 5, 2025, 9am-5pm PST (San Francisco, CA)
- November 13, 2025, 9am-5pm EST (New York, NY)
More information, including a link to submit an interest form due September 26th, is available here.
FTC to Drop Noncompete Ban and Legal Defense; Issues Warning Letter to Industry and New RFI
On September 5th, the FTC dropped its lawsuits attempting to maintain a Biden-era ban on noncompete agreements. The agency also voted 3-1 to vacate the April 2024 rule, eliminating Biden’s noncompete regulation altogether. The noncompete ban would have prevented employers from using such agreements to stop most workers from joining a rival organization. The lawsuits – Ryan LLC v. Federal Trade Commission and Properties of the Villages, Inc. v. Federal Trade Commission – led to a nationwide injunction before the regulation was implemented.
Though the Trump Administration has called the Biden-era rule a government overreach, they continue to have concerns about noncompete agreements. On September 10th, the FTC sent letters to a number of large health care companies expressing the Commission’s “commitment to vigorously protecting Americans from anticompetitive conduct” and reiterated its authority to “investigate unfair methods of competition, including noncompete agreements that are unjustified, overbroad, or otherwise unfair or anticompetitive.”
In addition, on September 4th, the FTC issued a Request for Information to better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions. The RFI will be open until November 3, 2025.
The FTC’s letter to industry is available here. The FTC’s Request for Information can be found here.
CBO Report Shows 340B Spending Up 5x from 2010-2021
On September 9th, the CBO issued a new report analyzing drug purchasing trends in the 340B program from 2010 to 2021. The report found spending increased 5x over this decade, from $6.6B in 2010 to $43.9B in 2021. These findings were limited to the 90% of 340B purchasers that use HRSA’s Prime Vendor Program (PVP). Most spending on drugs purchased through the PVP in 2021—87 percent—was on drugs that were administered or distributed in outpatient departments of hospitals and their off-site outpatient clinics. CBO estimates that one-third of the increase in spending in the program from 2010 to 2021 can be attributed to trends in market wide growth in drug spending and disproportionate growth among drug classes that account for more spending in the 340B program than in the overall market. Additional contributing factors include the integration of hospitals and off-site clinics, increased facility participation after the implementation of the Affordable Care Act, and expanded use of off-site pharmacies.
The report can be found here.
CMS Issues Guidance on Medicaid State-Directed Payments
On September 9th, CMS issued preliminary guidance on new federal payment limits for state-directed payments (SDPs) for Medicaid Managed Care. HHS released this guidance ahead of final rulemaking to allow states additional time to ensure compliance with the new requirements outlined in the One Big Beautiful Bill Act (OBBBA). Effective for rating periods beginning on or after July 4, 2025, SDPs for inpatient hospital services, outpatient hospital services, nursing facility services, and qualified practitioner services at an academic medical center are capped at 100% of Medicare rates in Medicaid expansion states, or 110% of Medicare rates in non-expansion states. In the absence of a Medicare rate, the Medicaid state plan rate applies. Select SDPs may qualify for temporary grandfathering until rating periods beginning January 1, 2028, followed by a 10% annual phased reduction until they meet the new payment limits. Thirty-nine states currently use SDPs for Medicaid managed care provider payments.
The preliminary guidance can be found here.
FDA Launches Reforms for Pharmaceutical Advertising Rules
On September 9th, President Trump signed a memorandum directing HHS and FDA to address “misleading direct-to-consumer drug advertisements.” Later that day, the FDA issued a statement that the agency will “aggressively deploy its available enforcement tools” in its surveillance of drug advertisements, noting that “thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads” have already been sent. The FDA is also directed to initiate rulemaking to change the Clinton-era policy that allowed direct-to-consumer drug advertisements on television, as long as the ad included a “major risk statement” with directions on how to seek more information. Instead, under the forthcoming rule, drug manufacturers will be required to include detailed safety information in televised advertisements. Experts anticipate these changes will be challenged in the courts.
The Executive Memorandum can be found here. The FDA news release can be found here.
Legislative Updates
House Appropriators Cut Prior Authorization Program in Funding Bill
On September 10th, the House Appropriations Committee approved an HHS budget bill, setting the legislation up for a full-House floor vote. During the Appropriations markup, the Committee blocked funding for the new Wasteful and Inappropriate Service Reduction (WISeR) Model, and any similar model that requires prior authorization in traditional Medicare. The WISeR pilot was scheduled to begin in January, and invited private companies in certain states to use artificial intelligence to handle prior authorizations for the specified procedures. The companies would then be paid based on their denied claims. The amendment to strip the funding was adopted by voice vote.
More information on the L-HHS appropriations bill is available here.
Bipartisan Bill to Extend ACA Enhanced Tax Credits for One Year Introduced in House
On September 4th, Reps. Jen Kiggans (VA-02) and Tom Suozzi (NY-03) introduced the Bipartisan Premium Tax Credit Extension Act, which extends the enhanced Premium Tax Credit (PTC) for insurance purchased via the Affordable Care Act (ACA) Health Insurance Marketplaces for one year, through December 2026. The American Rescue Plan Act expanded PTC eligibility and amounts to help consumers maintain coverage during the Covid-19 pandemic. These enhanced PTCs were extended by the Inflation Reduction Act. Without Congressional action, the enhanced subsidies are due to expire at the end of 2025. The loss of enhanced PTCs would bring health care costs thousands of dollars higher for most of those in the individual market in households earning up to approximately 700% of the federal poverty level, and it would re-institute the “subsidy cliff” at 400% of the poverty level. The sponsors of the bill state that the one-year extension of the PTC will provide ongoing financial protections for consumers while Congress works on a more “permanent solution” to insurance affordability.
The Bipartisan Premium Tax Credit Extension Act can be found here.
Other Updates
MedPAC Holds September 2025 Meeting
On September 4th and 5th, the Medicare Payment Advisory Commission (MedPAC) held its monthly public meeting. The Commissioners reviewed and discussed information on Medicare’s claims processing operations and the role of Medicare administrative contractors (MACs) in helping to ensure proper Medicare payments. Moving forward, the Comptroller General of the United States will join the Commissioners to discuss GAO’s work on improper payments in the Medicare program and opportunities to improve program sustainability. Commissioners also reviewed and discussed a report detailing Medicare’s overall financial situation and factors contributing to Medicare’s spending growth. Regarding hospice policy, Commissioners reviewed whether Medicare payment is a barrier to hospice care for certain beneficiaries for whom high-cost services might be palliative—specifically, dialysis for beneficiaries with ESRD and radiation, blood transfusions, and chemotherapy for beneficiaries with cancer. Finally, Commissioners reviewed the relationship between growth in MA and urban and rural hospitals’ finances.
The slides for each MedPAC presentation can be found here.
New York State Updates
New York State Announces Intention to Terminate Essential Plan Waiver, Revert to BHP 1331 Authority
On September 10th, Governor Hochul announced her intention to terminate New York’s 1332 State Innovation Waiver that had expanded eligibility for the Essential Plan. This action is expected to allow New York to access a reserve fund frozen during the waiver to replace federal funding lost as a result of the One Big Beautiful Bill Act (OBBBA). The Essential Plan is a health insurance option for adults aged 19 to 64 with incomes too high for Medicaid, or those with lower incomes but who are ineligible for Medicaid (e.g., certain immigrants). The Essential Plan has no monthly premium, no deductible, and minimal cost-sharing for enrollees.
Additional information is available here and SPG’s summary of these changes is available here. Public comment may be submitted to NYSOH.Team@health.ny.gov through October 10th.
Governor Hochul Issues Executive Order to Support Access to Covid-19 Vaccines
On September 5th, Governor Hochul signed an Executive Order that:
- Allows physicians and nurse practitioners to prescribe and order a patient-specific or non-patient-specific regimen for pharmacists to administer Covid-19 vaccines to patients age three or older;
- Authorizes pharmacists to administer Covid-19 vaccines to patients age three or older pursuant to a patient-specific or non-patient-specific order; and
- Allow pharmacists to prescribe and order patient-specific Covid-19 vaccines for patients age three or older.
The Order was issued in response to recent federal changes to vaccine funding and guidance. The Executive Order is in effect for 30 days, during which the State intends to work on “a long-term legislative solution” for vaccine access. The Commissioner of Health will also be issuing a standing order for the Covid-19 vaccine that will allow for non-patient-specific administration and will provide additional guidance for pharmacies, clinicians, and other vaccine administrators.
The Executive Order is available here. The Governor’s press release is available here.
OMH and OASAS Issue Draft Regulations for CCBHCs Under the NYS Medicaid Benefit
The New York State (NYS) Office of Mental Health (OMH) and Office of Addiction Services and Supports (OASAS) have issued draft regulations for the addition of Certified Community Behavioral Health Clinics (CCBHCs) into the Medicaid State Plan. CCBHCs are the behavioral health analogue to the Federally Qualified Health Center (FQHC) model, offering integrated behavioral health care to all individuals regardless of ability to pay. New York was selected as one of the eight CCBHC demonstration sites in 2016, and the program has since been renewed and extended periodically by Congress. However, the federal CCBHC demonstration is currently set to expire on September 30th, absent congressional action. New York has announced its intention to submit a State Plan Amendment (SPA) to CMS to ensure continuation of the CCBHC model and full Medicaid coverage of its services.
The draft regulations establish new standards for the certification, operation, and reimbursement of CCBHCs under the NYS Medicaid benefit. CCBHCs will be jointly certified by OMH and OASAS, and all providers seeking to continue operating a CCBHC or to obtain CCBHC certification must be licensed, certified, or otherwise authorized by both OMH and OASAS. CCBHCs will be certified for up to three years before re-certification is required. Reimbursement for CCBHC services will be based on provider-specific cost-based rates with a bundled daily rate for all CCBHC services provided on a single day. CCBHCs will also be eligible to participate in a Quality Bonus Payment program based on achievement of certain performance measures.
To ensure continuity of care, existing CCBHC demonstration sites will receive provisional certification to continue operations and reimbursement until they are approved under NYS regulations.
The draft regulations are available here.