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.

Positive effects and risks:

• Improved transparency and pass‑through pricing could increase payments to dispensing pharmacies and reduce hidden spread pricing, potentially lowering out‑of‑pocket costs and aligning incentives.
• Telehealth extensions preserve access that many beneficiaries rely on, especially rural and mobility‑limited populations.
• New program funding and wastewater surveillance strengthen public‑health infrastructure.

Risks and operational burdens:

• PBMs and payers will incur compliance costs and may attempt offsetting contractual or pricing changes that could shift costs elsewhere.
• States and providers face administrative complexity matching legacy payments to new DSH rules and increased reporting obligations.
• Medicare payment changes for MCED tests create adoption uncertainty for providers and manufacturers until payment methodology stabilizes in 2031.

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.