The Seniors’ Access to Critical Medications Act of 2025 adds a time‑limited exception to the physician self‑referral prohibition (the Stark Law) to permit certain outpatient prescription drugs covered under Medicare Part D to be prescribed and dispensed through a physician practice, subject to specific conditions. The exception applies for drugs furnished from January 1, 2026 through December 31, 2030 and sets rules on who may prescribe, where drugs may be dispensed, and how they may be billed.
The bill also directs the Government Accountability Office to study shifts in Part D dispensing patterns after enactment — looking for pharmacies or networks that increase dispensing and analyzing contracting, ownership, and prescribing influences — and reduces the Medicare Improvement Fund balance by $18 million as an offset. The combination of a limited Stark carve‑out, targeted reporting, and a small fund adjustment creates a narrow experimental policy with operational, compliance, and market implications for physician practices, Part D plans, and community pharmacies.
At a Glance
What It Does
Creates a four‑year exception (2026–2030) to the physician self‑referral ban for designated health services that are Part D drugs, provided a set of conditions are met: prescription by the referring physician or same‑group practitioner, an ongoing relationship, a qualifying in‑person encounter in the prior year, dispensing from an office building, and billing by the physician/group or a wholly owned entity. It preserves Part D program requirements.
Who It Affects
Medicare Part D beneficiaries taking outpatient prescription drugs; physician practices that dispense medications in‑office (or own dispensing entities); Part D plan sponsors, PBMs, and community pharmacies that may see volumes shift; and CMS, which must respond to GAO data requests and oversight needs.
Why It Matters
The bill temporarily shifts legal risk for physician dispensing of Part D drugs from automatic Stark prohibition to a conditional, compliant pathway — potentially changing where and by whom high‑cost drugs are dispensed, with implications for patient access, pricing, and market concentration in the drug distribution chain.
More articles like this one.
A weekly email with all the latest developments on this topic.
What This Bill Actually Does
The bill inserts a narrowly tailored exception into the Stark statute permitting physician practices to furnish certain outpatient drugs that are defined as covered Part D medications, but only if a series of conditions are satisfied. Those conditions require that the drug be prescribed by the referring physician or another practitioner in the same group practice; that the patient have an “ongoing relationship” with that prescriber as the Secretary defines it; and that the patient had at least one face‑to‑face, in‑person encounter with the physician or a same‑group practitioner in the prior 12 months where non‑designated health services were furnished and paid under Medicare.
Dispensing is limited to the physician, a physician in the same group, or an individual directly supervised by such a physician, and it must occur from a building type referenced elsewhere in the Stark statute (the familiar “office” location). The bill explicitly allows either in‑person pickup, or delivery via mail, courier, or other delivery services.
Billing may be submitted under the physician or group practice billing number, or by an entity wholly owned by the physician or group practice. The text makes clear that nothing in this exception alters Part D program requirements — so Part D plan and network rules still apply.To monitor market effects, the bill requires the Comptroller General to study pharmacies and pharmacy networks participating in Part D that, after enactment, materially increase dispensing of covered Part D drugs relative to their pre‑enactment volumes.
The GAO is to identify common ownership and integration with physician practices, contracting features, specialties most affected, mitigation steps taken to handle conflicts of interest, and any arrangement elements that may influence prescribing. The GAO report is due within three years of enactment and must avoid disclosing proprietary identifiers.Finally, the bill makes a modest statutory change to the Medicare Improvement Fund, reducing the referenced balance by $18 million.
That is a bookkeeping offset in the statute rather than a programmatic appropriation; it is a small, explicit funding adjustment tied to the bill text.
The Five Things You Need to Know
The exception applies only to designated health services that are covered Part D drugs furnished between January 1, 2026 and December 31, 2030.
To qualify, the drug must be prescribed by the referring physician or another practitioner in the same group and the patient must have an ongoing relationship with that prescriber as defined by the Secretary.
The bill requires at least one face‑to‑face, in‑person encounter within the prior 12 months during which non‑designated health services were billed to Medicare under the physician’s group tax identification number.
Dispensing must occur from an office‑type building by the physician, a same‑group physician, or someone under their direct supervision, and may be collected in person or sent by mail/delivery; billing must be filed by the dispensing physician, the group billing number, or a wholly owned entity.
GAO must study post‑enactment increases in Part D dispensing by pharmacies/networks and report to Congress within three years; separately, the Medicare Improvement Fund reference is reduced by $18,000,000.
Section-by-Section Breakdown
Every bill we cover gets an analysis of its key sections.
Time‑limited exception to the Stark self‑referral rule for certain Part D drugs
This provision adds paragraph (6) to the Stark statute establishing a temporary carve‑out for designated health services that are covered Part D drugs for a defined five‑year window (2026–2030). It enumerates five discrete compliance conditions (prescriber identity, ongoing relationship, recent in‑person non‑DHS encounter, dispensing location and personnel, and permitted billing vehicles). Practically, compliance will hinge on documentation: practices must verify the patient relationship, maintain encounter records showing non‑DHS services billed within the prior year, and ensure dispensing occurs from approved locations and under appropriate billing numbers to avoid triggering the general prohibition.
Congressional study of dispensing shifts, ownership, and contracting
The Comptroller General must investigate pharmacies and pharmacy networks that materially increase their dispensing of covered Part D drugs after enactment, identify ownership links to physician/group practices, and analyze arrangement features that may affect prescribing or market behavior. The study mandate targets contracting terms, specialties with growth, integration across the supply chain (PBMs, wholesalers, management firms), and mitigation measures practices use to address conflicts. The report is due within three years and must avoid naming proprietary actors, but its findings could inform future legislative or regulatory action.
No change to Part D program requirements
The bill explicitly states that the Stark exception does not modify Part D program rules. That preserves plan network, formulary, and coverage requirements under part D even when a physician dispenses. In practice, this means a physician who dispenses must still operate within Part D plan contracts and any pharmacy network rules, and cannot rely on the Stark carve‑out to supersede plan or PBM controls over coverage and reimbursement.
Budgetary offset — $18 million reduction to statutory fund figure
Section 3 amends the statutory figure in 1898(b)(1) to lower the cited Medicare Improvement Fund amount by $18,000,000. This is a narrow statutory adjustment rather than a new appropriation. The change reduces the numeric fund reference in the statute and serves as the bill’s listed offset; it does not itself create or authorize program spending, but it does change the statutory baseline used for related accounting.
This bill is one of many.
Codify tracks hundreds of bills on Healthcare across all five countries.
Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Medicare beneficiaries who rely on frequent, specialty, or time‑sensitive Part D medications — the exception can enable faster access and reduce travel by allowing dispensing directly through their physician’s practice or a physician‑owned dispensing entity.
- Physician practices (particularly specialties that ordinarily dispense injectables or specialty oral drugs, such as oncology, dermatology, and rheumatology) — the bill creates a compliant pathway for in‑office dispensing that can restore or expand a revenue stream and practice control over the medication delivery process.
- Rural and underserved practices — those in areas with limited pharmacy access may use the exception to maintain local dispensing capacity and continuity of care for patients who otherwise would face long travel or supply interruptions.
- Physician‑owned dispensing entities or group‑owned pharmacies — the statutory billing permission for wholly owned entities and group billing numbers makes ownership models more viable within the exception window, potentially increasing their business opportunity.
Who Bears the Cost
- Part D plan sponsors and PBMs — potential shifts of dispensing volume into physician channels could complicate network management, affect negotiated pricing, and change cost and utilization patterns that plans must monitor and adapt to.
- Independent community and retail pharmacies — increased in‑office or physician‑owned dispensing may divert volume and revenues, particularly for certain specialty or high‑margin Part D drugs.
- Physician practices — while able to dispense, practices assume new compliance burdens: documenting the required relationship and encounters, ensuring proper dispensing locations and supervision, aligning with Part D plan requirements, and managing billing and inventory risks.
- CMS and oversight bodies — the GAO study and any subsequent enforcement or guidance will require agency resources, data pulls, and potential rulemaking or audit activity to reconcile Stark, AKS, and Part D program rules.
- Medicare Improvement Fund accounting — the $18 million statutory reduction is a small fiscal cost to the referenced fund level and may affect related program baselines used in future calculations or offsets.
Key Issues
The Core Tension
The bill balances improved patient access and convenience against the risk that permitting physician dispensing will introduce financial incentives affecting prescribing and increase market concentration in physician‑owned dispensing channels; resolving faster access for patients while preventing conflicts of interest and cost pressures is the central, unresolved trade‑off.
The bill trades a narrow, time‑limited expansion of physician dispensing for increased congressional visibility into dispensing shifts, but it leaves several implementation questions unanswered. Key definitional gaps — the Secretary’s forthcoming definition of “ongoing relationship,” the interpretation of what counts as a qualifying face‑to‑face encounter (and which services qualify as “not designated health services”), and how group practice attribution is applied for mixed‑TIN practices — will drive whether practices can operationalize the exception without exposure.
The allowance for mail or courier delivery after in‑office dispensing raises tracking questions about routing, chain‑of‑custody, and whether delivery negates the in‑person safeguards the statute envisions.
The interplay with Part D network contract terms and state pharmacy/dispensing laws is also unresolved. The bill preserves Part D program requirements, but it is silent on how plan sponsors should treat physician‑dispensed drugs for formulary placement, prior authorization, or cost‑sharing — creating potential friction points between prescribers and plans.
The GAO study will generate descriptive data, but its three‑year horizon means markets may shift significantly before Congress receives comprehensive findings. Finally, the temporary nature of the exception (through 2030) creates policy uncertainty: participants may invest in dispensing capacity for a limited window, risking stranded investments if the carve‑out is not extended.
Try it yourself.
Ask a question in plain English, or pick a topic below. Results in seconds.