Read twice and referred to the Committee on Finance.
Last progress March 6, 2025 (11 months ago)
Introduced on March 6, 2025 by Ronald Lee Wyden
Makes wide-ranging health-care changes: it reforms pharmacy benefit manager (PBM) practices and drug-payment transparency, updates Medicaid hospital DSH payment rules, extends and adjusts Medicare telehealth and new multi-cancer screening payment rules, reauthorizes and funds many public‑health and human‑services programs, creates a federal wastewater surveillance grant program, strengthens FDA pediatric and rare‑disease provisions, and preserves a short HDHP safe harbor for telehealth. Many provisions impose new reporting, pricing, and payment requirements and phase in over months to years. The bill combines program authorizations and regulatory reforms that affect hospitals, pharmacies, PBMs, health plans, Medicare and Medicaid beneficiaries, public‑health grantees, drug developers, and state health agencies. It includes new funding authorizations for community health centers and other public‑health programs, deadlines for agency guidance, and a mix of near‑term and delayed effective dates (6–30 months or specified through 2026–2029 for some items).
Sets the general effective date: the amendments apply to Medicaid DSH payment adjustments under section 1923 of the Social Security Act for Medicaid State plan rate years beginning on or after the date the Act is enacted (unless the special State option rule applies).
Gives States an option, for any Medicaid State plan rate year that begins on or after October 1, 2021 and before the Act’s enactment, to use unspent portions of their applicable federal fiscal year DSH allotment to increase hospital payment adjustments for that rate year, if the increase follows the amended section 1923(g) limits and total payment adjustments do not exceed the State’s DSH allotment for the applicable federal fiscal year under section 1923(f).
Prohibits a State from recouping any payment adjustment it already made to a hospital for a covered Medicaid State plan rate year if that payment adjustment was consistent with section 1923(g) as in effect on October 1, 2021.
Allows a State, only to increase a hospital payment adjustment for a covered Medicaid State plan rate year, to retroactively modify its Medicaid State plan, a waiver, or a State plan amendment related to that rate year; and allows the Secretary to approve the modification.
Bars a State from submitting a request to approve a retroactive modification for a Medicaid State plan rate year after the date the State is required to submit the independent certified audit for that rate year.
Who is affected and how:
Safety‑net hospitals (Medicaid DSH hospitals): Revised DSH calculation and reuse of past unspent DSH funds may increase near‑term payment flexibility for eligible hospitals; protections against retroactive clawbacks reduce payment uncertainty. States must manage allotments and reporting and may change DSH payment models within new federal limits.
Pharmacies and PBMs: PBMs face major business model changes—pass‑through pricing, caps on administrative fees, expanded reporting, and new contract requirements. Dispensing pharmacies should see more of the drug purchase price passed through but will need to adapt to new billing and documentation rules. PBMs and plan sponsors will incur compliance costs and potential operational changes; enforcement and HHS reporting will raise transparency.
Group health plans and insurers: Must receive standardized PBM reports and make data available to participants; plan‑sponsor administrative burdens and contract renegotiations are likely. Insurers may face shifts in rebates/fees flow and pricing transparency that affect premiums and benefit design.
Medicare beneficiaries and providers: Telehealth access is extended, including audio‑only options and site flexibility through 2026, improving access for remote and underserved beneficiaries. New MCED coverage rules create access to multi‑cancer screening but impose frequency and age limits; coverage may expand further on strong USPSTF recommendations. Payment changes will affect labs, diagnostic vendors, and providers offering screening.
State Medicaid agencies: Must adapt to DSH rule changes, oversee PBM regulatory compliance at the state level when relevant, and respond to new data and reporting requirements. States may see administrative burdens to align prior years and submit required reports.
Public‑health and community organizations (community health centers, NHSC, teaching health centers): Receive continued or specified funding authorizations and reporting requirements; grant programs and cooperative agreements expand program support but impose accountability and performance reporting obligations.
Federal agencies (HHS/CMS, FDA, Treasury/IRS): Will need to draft and publish extensive guidance, standardized reporting formats, compliance rules, and new implementation guidance; the FDA must administer pediatric/rare disease changes and set up the new international office.
Drug developers and device/diagnostic companies: Pediatric‑study and voucher rules affect clinical-development timelines and incentives; MCED manufacturers will face Medicare coverage/payment rules that shape commercialization strategy.
Employers and plan participants: Employers sponsoring group health plans must obtain PBM reports and may need to renegotiate contracts or revise benefit designs. Participants gain expanded rights to PBM information and clearer transparency about drug costs.
Updated 6 days ago
Last progress February 21, 2025 (11 months ago)
Positive effects and risks:
Risks and operational burdens:
Overall, the legislation is wide‑ranging and operationally complex: it combines immediate program authorizations and protective rules with structural market reforms (PBMs), significant reporting and compliance obligations, and a multi‑year phase‑in that will require active agency rulemaking and state/federal coordination.
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