The Centers for Medicare and Medicaid Services published a request for information on September 24 that asks what makes a pharmacy contract reasonable and relevant under the Medicare prescription drug benefit. Buried in a list of more than a hundred specific questions is the one that decides how much the rest matters: whether CMS should establish reimbursement methodologies or rates as part of the standards, or leave payment to negotiation and write rules about process instead.
The agency has until the first Monday in April 2028, which is April 3, to issue the standards, and they apply to plan years beginning on or after January 1, 2029. Comments are due November 23. The statute required the request for information no later than April 1, 2027, so CMS is running roughly six months ahead of its own deadline, and the notice itself says plainly that it exists to inform future rulemaking.
The statute hands CMS a phrase to define and the RFI asks whether the definition has numbers in it
Section 6223 of the Consolidated Appropriations Act, 2026, titled Assuring Pharmacy Access and Choice for Medicare Beneficiaries and signed on February 3, amended the any-willing-pharmacy provisions of the Social Security Act. Part D sponsors already have to contract with any pharmacy that accepts their standard terms and conditions, and the new clause adds that for plan years beginning in 2029 those standard terms have to be reasonable and relevant according to standards the Secretary establishes. The same provision carries a notwithstanding-any-other-provision-of-law clause, which is the language that lets the standards operate past the noninterference provision that otherwise keeps the government out of pharmacy negotiations.
Two regulations already carry the phrase without defining it. Section 423.120(a)(8)(i) requires sponsors to contract with pharmacies that meet their standard terms, and Section 423.505(b)(18) requires those terms to be reasonable and relevant. What the agency is asking for now is the content of a term of art that has sat in the regulation for two decades while the contracts it governs moved in the other direction.
The RFI's first section on reimbursement and dispensing fees runs to twenty items, and the questions inside it describe the contracting practices the agency is trying to see. CMS asks how Part D rates compare to what pharmacies pay for the drugs, which pricing benchmarks reflect acquisition costs most closely, whether pharmacies sharing their acquisition costs with plans or wholesalers would work as an alternative to a benchmark, and how often maximum allowable cost lists change and how those changes get communicated. It asks about lesser-of pricing and how usual and customary pricing is defined, about the use of machine learning to estimate acquisition costs, about contract terms covering 340B claims, and about whether reimbursement rates relate to the presence of pharmacy deserts.
Aggregate guarantees are the part of the contract that separates the claim from the payment
The sharpest set of questions concerns effective-rate guarantees, the generic and brand targets that a plan or its pharmacy benefit manager applies across a contract year. CMS asks the extent to which the negotiated price reported on a pharmacy claim reflects the pharmacy's final reimbursement rather than an aggregate guarantee reconciled after the point of sale, the magnitude of the gap between point-of-sale prices and end-of-year reconciled rates, and whether claim-level reimbursement is meaningfully predictive of what a pharmacy receives over the year.
It also asks whether those guarantee parameters are negotiable, whether they influence which drugs a pharmacy stocks, especially high-cost specialty generics, and whether remittance advice carries enough claim detail for a pharmacy to tell what it was paid after adjustments.
The linkage between Part D rates and commercial rates is where the subsidy math enters
One block of questions asks whether a pharmacy's Part D reimbursement is set or adjusted in relation to its commercial rates, whether a single guarantee covers both books of business, and whether overpayments on one line offset underpayments on the other. CMS then asks the follow-on question directly: whether those arrangements could produce higher Part D negotiated prices than a standalone Part D guarantee would, and what the implications are for CMS subsidy calculations, enrollee cost sharing and Part D bids.
That is a question about the government paying a price that was set in a negotiation it cannot see, and the answer runs through the same premium mechanics we followed when CMS ended the Part D premium stabilization demonstration. A rate floor for pharmacies raises what plans pay, and what plans pay shows up in bids, subsidies and premiums on a two-year lag, which the RFI asks commenters to put evidence behind.
Audits decide what the contract means and the statute puts a complaint process behind them
CMS asks how often pharmacy audits happen, how recoupment methodologies work, whether they are transparent, how extrapolation is used to turn a handful of claims into a recovery, and whether audits reach provider care issues or administrative and clerical errors. It asks whether sponsors validate the claim-level pricing and direct and indirect remuneration data they receive from PBMs, particularly when the PBM is affiliated with a network pharmacy, and whether audits include corrective action and due process.
The contracting-practices section covers the terms that make those audits consequential: provisions that let a sponsor recoup payment or terminate a contract, whether those provisions require an appeal process and how often appeals succeed, the use of deemed acceptance or negative consent so that silence becomes agreement, how much time pharmacies get to review terms and rate sheets before acceptance is required, and how often maximum allowable cost lists or reimbursement parameters change mid-contract. CMS also asks how much of the financial terms sit outside the executed contract, in rate sheets, budget files, side letters or unwritten understandings between affiliated entities, and whether provider manuals and policy bulletins modify contract terms without an amendment.
A separate group asks whether CMS should set minimum review periods, disclosure requirements or affirmative acceptance requirements rather than deemed consent. Each of those is a procedural rule, and each one changes the bargaining position without setting a price.
Section 6223 does not stop at the standard. It creates a complaint process for pharmacies that allege noncompliant contract terms, requires CMS to run it as a standardized submission channel, keeps submissions confidential, and prohibits retaliation or coercion against a pharmacy that files. The agency can impose civil monetary penalties or other intermediate sanctions on Part D sponsors that do not comply, and the law appropriates money to CMS for oversight and enforcement.
The statute also sets reporting obligations that will produce a public record alongside the rulemaking. CMS has to publish biennial enforcement and oversight reports beginning no later than July 1, 2029, including information on essential retail pharmacies, which the law defines around pharmacies that are not affiliated with a PBM and stand in areas without another retail pharmacy within a set distance. The companion section of the law governs how PBMs are paid, restricting compensation to bona fide service fees, prohibiting the recharacterization of drug-based remuneration as an administrative fee, and requiring manufacturer rebates and discounts to pass through to sponsors. CMS asks in this notice how the pharmacy contracting standards should account for the overlap with those PBM disclosure and remuneration restrictions, which are being implemented on the same Medicare timeline.
The noninterference argument underneath all of it is still live
Part D's noninterference provision limits what the Secretary can do about the prices plans and pharmacies agree to, and the pharmacy coalition that has been meeting with CMS on this project asked the agency to make sure its authority operates without limitation from that clause. The coalition, which includes the National Community Pharmacists Association, the National Association of Chain Drug Stores, the American Pharmacists Association and the food industry and specialty pharmacy groups, submitted a memo to CMS listing contracting practices it considers problematic and a separate memo on the authority question, and it is preparing comment templates for independent and long-term care pharmacies.
The industry's own description of the change is narrower. The pharmacy benefit manager trade association's guide to the law describes it as allowing pharmacies that meet Part D requirements to join networks while the Secretary defines what reasonable and relevant means, and the group has raised concerns with state insurance regulators about the format and substance of the implementation work, while continuing to litigate state PBM statutes on preemption grounds. The disputes that produced the statute, in other words, do not stop because a rulemaking has started. The rebate and fee arrangements that Florida's insulin litigation put in front of a court are the same arrangements this notice asks the industry to describe.
What the November deadline decides
The comment record is where the argument that matters gets made. April 2028 is far enough away that a proposed rule has to come first, and the RFI tells commenters what kind of submission it wants: quantitative data, empirical analysis, de-identified contract language, and evidence about enrollee access and outcomes.
A standard that says contract terms have to be reasonable and relevant, and then describes a complaint process for breaches of that standard, is a different regime from a standard that sets a reimbursement methodology. The first leaves the price in the negotiation and moves the burden of proving unfairness onto the pharmacy, which has to file a complaint, wait, and trust that the filing stays confidential and does not cost it a network. The second gives every pharmacy a number to compare against, and gives CMS something to enforce without adjudicating a contract term by term.
CMS has asked which of those it should build. The parties answering the question are the plans, the pharmacy benefit managers and the pharmacies, and the ones with the data will be the ones whose descriptions of current practice survive into the rule. The comment period closes November 23, and the contracts that carry the answer reach pharmacies in 2028.
Primary sources
- Centers for Medicare and Medicaid Services, Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards, 91 FR 60568, September 24, 2026, for the comment deadline, the statutory deadlines of April 1, 2027 and the first Monday in April 2028, the plan-year 2029 application, and the eight topic areas including whether CMS should establish reimbursement methodologies or rates.
- National Association of Chain Drug Stores, Member Memo: Details of the Now-enacted Federal PBM Reforms, February 3, 2026, for the section 6223 and 6224 provisions, the complaint process, the civil monetary penalties, the biennial enforcement reports due by July 1, 2029, the essential retail pharmacy reporting requirement and the $188 million appropriation.
- Ankura, The Consolidated Appropriations Act, 2026: A Primer for Medicare Part D Plans and Pharmacy Benefit Managers, April 15, 2026, for the relationship between Section 6223 and the existing any-willing-pharmacy rules and the phases of the implementation timeline.
- National Community Pharmacists Association, Pharmacy Coalition discusses reasonable and relevant Part D contract terms with CMS, September 3, 2026, for the coalition's noninterference memo and its separate list of contracting practices, and CMS requests public comment for future reasonable and relevant Part D rulemaking, September 24, 2026, for the member comment templates.
- Pharmaceutical Care Management Association, An Industry Transformed: Insider's Guide to Newly Enacted PBM Reform, April 2026, for the PBM side's description of the any-willing-pharmacy provisions and the essential retail pharmacy list.