For years, pharmacists and pharmacy owners have raised concerns about Medicare Part D contracts that can be difficult to evaluate, difficult to negotiate, and complicated by reimbursement formulas, network restrictions, performance measures, audits, and contract terms that may change outside the original agreement.
Now CMS is asking stakeholders to help define what some of those contracts should be allowed to look like in the future.
On September 24, the Centers for Medicare & Medicaid Services published a formal Request for Information seeking public input on what should constitute “reasonable and relevant” contract terms between Medicare Part D plans and network pharmacies. Comments are due November 23, 2026.
At first glance, that sounds like an administrative step buried deep inside the federal rulemaking process.
It is much more important than that.
CMS is asking about reimbursement, dispensing fees, specialty pharmacy designation, preferred and nonpreferred networks, pharmacy performance measures, audits, contract amendments, dispute resolution, white bagging and brown bagging, vertical integration, and whether provider manuals or PBM communications should be able to change pharmacy requirements outside a formal contract amendment.
These are not abstract policy questions.
They are questions about the contracts pharmacies operate under every day.
And for the next several weeks, pharmacists, pharmacy owners, associations, PBMs, plan sponsors, patients, and other stakeholders have an opportunity to give CMS evidence that may help shape the federal standards eventually applied to those contracts.
The law changed. Now the details have to be written.
This process did not begin with the September 24 RFI.
Congress created the next phase earlier this year through Section 6223 of the Consolidated Appropriations Act, 2026.
Medicare Part D regulations already require plan sponsors to contract with pharmacies that meet their standard terms and conditions, and those terms are already required to be “reasonable and relevant.” But CMS acknowledges that it has never established detailed additional standards defining exactly what reasonable and relevant means.
The 2026 law now requires the Department of Health and Human Services to establish those standards no later than the first Monday in April 2028. Beginning with plan years on or after January 1, 2029, standard pharmacy contract terms must meet those federally established standards.
That distinction matters.
Legislation can establish the principle.
Rulemaking determines how that principle works when a pharmacy receives an actual contract.
The phrase “reasonable and relevant” sounds straightforward until someone has to decide what it means in practice.
Is a dispensing fee reasonable if it does not cover the operational cost of dispensing?
Should a pharmacy that meets the same objective accreditation and clinical criteria as another pharmacy be allowed to participate in a specialty network under comparable terms?
How much notice should a pharmacy receive before reimbursement changes?
Should silence be treated as acceptance of a contract amendment?
Can a PBM change obligations through a provider manual rather than amending the underlying contract?
How should performance measures be validated and applied?
What due-process protections should exist when an audit results in recoupment?
Those are the kinds of questions CMS is now putting in front of the industry.
The policy has moved from “something should change” to “what exactly should the rule say?”
That is a very different stage.
CMS is asking about the issues pharmacies actually experience
One of the most striking parts of the RFI is how specific it becomes.
CMS asks whether Part D reimbursement and dispensing fees sufficiently cover pharmacies’ ingredient and operational costs. It asks how reimbursement compares with actual acquisition cost, how maximum allowable cost lists are updated, whether final reimbursement is predictable when the medication is dispensed, and whether CMS itself should establish reimbursement methodologies or rates as part of the new contracting standards.
The agency is also examining how network participation works.
CMS wants information on whether any-willing-pharmacy terms are effectively limited to nonpreferred networks, how “similarly situated” pharmacies are defined, and whether pharmacies that meet comparable criteria are given the same opportunities to participate in specialty networks. It specifically asks about the relationship between limited specialty networks and common ownership among PBMs, plans, and specialty pharmacies.
Then there are the contract mechanics themselves.
CMS asks how much time pharmacies and PSAOs receive to review contracts and amendments, whether negative-consent provisions are used, whether reimbursement information is fully disclosed when the contract is offered, and whether pharmacies have a meaningful opportunity to reject mid-contract changes without losing network participation.
Even provider manuals are on the table.
The RFI asks about the use of provider manuals, policy bulletins, and other PBM or plan communications to modify or supplement contract requirements outside a formal amendment. It also asks whether the financial terms that ultimately determine pharmacy reimbursement may be located in documents outside the executed contract and whether greater transparency is needed.
For pharmacists who have spent years hearing that many of these issues are simply “how the contract works,” it is worth noticing what CMS is doing.
The agency is asking whether those practices should help define what is considered reasonable at all.
Performance measures and audits are part of the conversation too
Contracting is not only about the reimbursement rate printed on a rate sheet.
The RFI devotes an entire section to pharmacy quality and performance measures.
CMS wants to know which measures are being used, how they are incorporated into contracts, whether they are applied consistently across different pharmacy types, whether they affect reimbursement or preferred-network status, how they are validated or risk-adjusted, and whether pharmacies have meaningful access to the data used to evaluate their performance.
That could become particularly important as healthcare continues moving toward value-based payment.
Holding a pharmacy accountable for an outcome can make sense only if the measure is clinically meaningful, appropriately designed, transparent, and reasonably within the pharmacy’s ability to influence.
CMS is effectively asking stakeholders to help explain where that line should sit.
Audits receive similar attention.
The agency is seeking information about audit frequency, recoupment methodologies, minor or clerical errors, extrapolation, corrective-action opportunities, and due-process protections. CMS even asks how Part D plans validate pricing and DIR information received from PBMs when the PBM is affiliated with network pharmacies.
This is why the RFI deserves more attention than the typical federal notice.
CMS is not asking one broad question about whether pharmacy contracts are fair.
It is breaking the contracting relationship into the individual mechanisms that determine how pharmacies participate, how they are paid, how they are evaluated, and what happens when there is a dispute.
This is the implementation stage pharmacists often miss
Pharmacy advocacy understandably focuses heavily on legislation.
A bill gets introduced.
A committee advances it.
Congress passes it.
The president signs it.
Everyone celebrates the policy win.
But legislation is often only the beginning.
Once Congress tells an agency to implement a policy, someone has to translate statutory language into standards, regulations, guidance, definitions, enforcement mechanisms, and operational requirements.
That is where details that can dramatically affect real-world impact are decided.
“Reasonable and relevant” is a good example.
Two people can agree that pharmacy contracts should be reasonable while having completely different definitions of what that requires.
Should reimbursement be tied to acquisition cost?
Should CMS establish a minimum dispensing-fee methodology?
Should different pharmacy types receive different terms?
When are two pharmacies truly similarly situated?
What evidence should support a performance measure?
What notice period is sufficient for an amendment?
What dispute process is adequate?
The eventual answers matter because Part D sponsors, PBMs, PSAOs, chain pharmacies, independent pharmacies, specialty pharmacies, long-term care pharmacies, home infusion providers, and other participants all operate under different business models and may have different perspectives on what a workable standard looks like.
That is exactly why CMS is requesting evidence now rather than simply writing the standards in isolation.
A useful comment needs more than frustration
This is where pharmacists and pharmacy owners can make the process more practical.
A comment that says, “PBMs reimburse pharmacies poorly,” communicates frustration.
It does not give a regulator much information for designing a national standard.
CMS is explicitly encouraging commenters to provide detail where possible, including quantitative data, empirical analyses, de-identified contract language, information broken down by pharmacy type or geographic area, and evidence regarding Medicare beneficiary access and outcomes. The agency also warns commenters not to include proprietary or confidential information because public comments may be posted publicly.
A more useful submission might take one contract provision and explain what actually happens.
Describe the provision.
Explain how it operates.
Show the financial or operational effect on the pharmacy.
Explain what happens to the patient.
Provide data where available.
Then describe what a more workable standard could look like.
For example, imagine a pharmacy believes a particular reimbursement methodology routinely produces payments below its acquisition cost.
The stronger regulatory comment would not simply say reimbursement is inadequate.
It could explain the methodology, provide de-identified examples across multiple claims, quantify the difference between reimbursement and acquisition cost, describe whether the pharmacy has stopped stocking certain products as a result, and explain how that affects Medicare beneficiary access.
That gives CMS something it can analyze.
The same approach works for network participation, audits, performance measures, specialty designation, provider-manual changes, or dispute resolution.
If a contract term creates a problem, show the regulator how the problem works.
Patient access may be the most important part of the argument
Pharmacy contracting can easily sound like a dispute between businesses.
CMS is looking at something broader.
The RFI repeatedly asks how contracting practices affect Medicare beneficiary access.
For example, the agency asks whether reimbursement policies contribute to pharmacy deserts, whether contract terms facilitate or hinder competition, whether network restrictions limit dispensing, and how different contracting arrangements affect access to Part D drugs.
That means pharmacy owners should think about more than what a contract costs their business.
They should also consider what happens downstream.
Does inadequate reimbursement make a high-cost medication impossible to stock?
Does a network restriction force a patient to transfer to a more distant pharmacy?
Does specialty designation prevent a capable pharmacy from continuing care for an established patient?
Does a contract requirement create delays?
Does a performance measure disadvantage pharmacies caring for medically or socially complex populations?
Does an audit recoupment practice make certain services financially unsustainable?
The business impact matters.
The patient impact may make the argument much more complete.
The pharmacy organizations are already preparing
Independent pharmacists will not be approaching this process alone.
Before the RFI was published, NCPA reported that it had met with CMS alongside a broader Pharmacy Coalition that includes the American Pharmacists Association, the National Association of Chain Drug Stores, the National Association of Specialty Pharmacy, the American Society of Consultant Pharmacists, and FMI, The Food Industry Association.
According to NCPA, the coalition has already given CMS examples of contracting practices it believes should be addressed and has been discussing implementation of the new reasonable-and-relevant standards. NCPA also said it plans to provide members with resources for submitting their own comments.
That is useful.
National organizations can provide large datasets, legal analysis, and industry-wide perspectives.
But individual pharmacies can contribute something different.
They can show CMS what a contract provision looks like when it reaches the counter.
They can explain what happens when a pharmacy tries to stock a drug under a particular reimbursement methodology.
They can show what a network limitation means for a patient in a rural community.
They can explain how much staff time an audit or contract amendment consumes.
They can document the difference between the contract on paper and the operational reality of participating in the network.
Those examples can make broad policy questions concrete.
How a pharmacy owner should approach the next several weeks
The first step is not writing a ten-page policy paper.
It is identifying one or two contracting issues your pharmacy understands extremely well.
Pull the relevant contract language, but remember CMS says not to submit proprietary or confidential information. De-identify examples as appropriate.
Then document the effect.
How frequently does the issue occur?
How much does it cost?
How much staff time does it consume?
Does it change which medications you stock?
Does it affect whether you can participate in a network?
Does it create a delay for patients?
Does it affect continuity of care?
If you have numbers, use them.
If you have a specific contract mechanism, explain it.
If you believe a different standard would work better, describe it.
CMS specifically asks commenters to identify which section of the RFI they are addressing and to explain the relevant circumstances, including pharmacy type, network arrangement, geographic setting, drug type, and other factors that may influence the issue.
That structure can make a submission much easier.
You do not need to answer every question in the RFI.
A detailed response to one issue your pharmacy understands intimately may be more useful than superficial responses to twenty.
There is also a career lesson here
This story matters beyond pharmacy ownership.
It is a useful example of a side of healthcare many pharmacists rarely see during school.
Regulatory policy is not created only by government employees sitting in Washington.
Healthcare organizations, professional associations, manufacturers, insurers, PBMs, pharmacies, patient groups, attorneys, economists, researchers, and subject-matter experts all participate in the process.
Someone has to analyze the legislation.
Someone has to interpret the contract language.
Someone has to model the financial impact.
Someone has to collect data from pharmacies.
Someone has to draft comments.
Someone has to evaluate the evidence submitted to CMS.
Someone has to translate the eventual standards into operational systems.
Someone has to ensure contracts comply.
For pharmacists interested in managed care, health policy, regulatory affairs, government affairs, pharmacy economics, consulting, or association work, the rulemaking process itself is another career ecosystem worth understanding.
A PharmD who knows how medication systems operate and also understands regulation, contracts, economics, and policy can contribute far beyond traditional dispensing.
That is another version of Pharmacy Unlocked’s larger message.
Sometimes the career opportunity is hiding inside the process pharmacists usually ignore.
The comment window closes November 23
CMS is accepting comments on the RFI through November 23, 2026. Electronic comments can be submitted through Regulations.gov under docket CMS-2026-3037, using file code CMS-4217-NC. CMS also accepts comments by regular or overnight mail.
The standards themselves will come later.
CMS says this RFI will inform future rulemaking, and the 2026 law gives HHS until the first Monday in April 2028 to establish the standards that will apply beginning with the 2029 plan year.
So no pharmacy contract changes because of this RFI tomorrow.
That is precisely why this is the moment to pay attention.
Once a final standard exists, pharmacists can react to it.
Right now, they can help supply the evidence used to build it.
That is a very different opportunity.
For years, pharmacists have talked about reimbursement, network access, audits, specialty restrictions, contract transparency, and PBM practices after the rules and contracts were already in place.
The next two months offer something less common.
A chance to speak during the part of the process when CMS is still asking what the rules should address.
For pharmacists who have real experience with these contracts, the most valuable response may not be another general statement that the system needs reform.
It may be a specific example, backed by evidence, showing exactly where the current system breaks and what a reasonable alternative could look like.
That is how a complaint becomes regulatory evidence.
And that is how pharmacists can participate not only in working under the rules of Medicare Part D, but in helping the government understand how those rules should be written.
Resources & Citations
- Centers for Medicare & Medicaid Services. “Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards.” Federal Register, September 24, 2026, 91 FR 60568-60572. Primary source for the RFI, November 23 comment deadline, statutory background, requested topics, submission instructions, and CMS’s request for detailed quantitative, contractual, and patient-access evidence.
- Consolidated Appropriations Act, 2026, Section 6223, “Assuring Pharmacy Access and Choice for Medicare Beneficiaries.” Establishes the statutory requirement for HHS to define reasonable and relevant pharmacy contract standards for plan years beginning January 1, 2029, and requires an RFI to inform development of those standards.
- National Community Pharmacists Association. “Pharmacy Coalition discusses reasonable and relevant Part D contract terms with CMS.” September 3, 2026. Describes the Pharmacy Coalition’s discussions with CMS, participating pharmacy organizations, prior submissions to the agency, and NCPA’s plans to provide pharmacies with resources for individual comments.
- CMS Regulations.gov docket CMS-2026-3037. Official electronic submission location for comments on file code CMS-4217-NC. The Federal Register notice states that comments submitted by the November 23, 2026 deadline will be considered and generally made available publicly.
