On September 24, 2026, The Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) on September 24, 2026, seeking input on proposed standards for “reasonable and relevant” pharmacy contract terms and conditions under Medicare Part D. Comments are due November 23, 2026.
For years, pharmacies have been told that Medicare Part D plan sponsors must offer “reasonable and relevant” contract terms, but CMS has not established detailed standards defining what those terms must include. Now, pharmacies have an opportunity to help shape the standards that could govern their Medicare Part D contracts beginning in 2029.
How the Consolidated Appropriations Act, 2026, Could Change Medicare Part D Pharmacy Contracting
Under existing regulations, Medicare Part D plan sponsors must contract with any pharmacy that meets their standard terms and conditions, and those terms must be “reasonable and relevant.” CMS, however, has never established detailed requirements defining what constitutes “reasonable and relevant” contract terms. As a result, pharmacy benefit managers (PBMs) and Part D plan sponsors have largely decided for themselves (and for pharmacies) what suffices as reasonable and/or relevant, and this has placed pharmacies at a severe disadvantage in Part D contracting.
The Consolidated Appropriations Act, 2026 (CAA) seeks to address that disparity. The Act requires that, for plan years beginning January 1, 2029, the standard contract terms Part D plan sponsors offer must be reasonable and relevant according to standards set by the Secretary of the Department of Health & Human Services (HHS). HHS must establish those standards by April 2028.
Why the CMS RFI Matters for Pharmacies
This is not a routine request for public comments. CMS will use the RFI responses to inform and guide the rulemaking that sets the “reasonable and relevant” standards. The resulting standards could significantly affect pharmacy reimbursement, network participation, auditing practices, and other Part D contract provisions beginning in 2029. Because these standards could remain in effect for years, the information CMS receives now may have a lasting impact on Medicare Part D pharmacy contracting.
What Issues are CMS Seeking Input On?
CMS is asking for detailed information about PBM-Pharmacy contracts on:
- Reimbursement and dispensing fees, including the sufficiency of reimbursement to cover the cost to acquire and dispense Part D drugs;
- Network participation and contract integrity, including the extent to which patients are steered from the pharmacy of their choice, whether pharmacies are given a meaningful opportunity to participate in Part D networks, and whether pharmacies are provided fair notice for contract amendments and a fair opportunity to raise contract disputes;
- Pharmacy quality and performance measures, including whether they are applied fairly, risk-adjusted, tied to patient outcomes, and open to appeal;
- Auditing practices and restrictions on dispensing, including audit transparency, recoupment methodologies, due process protections, and limitations on dispensing covered Part D drugs;
- 340B, pharmacy deserts, and patient access in rural and underserved areas; and
- Long-term care pharmacies and how vertical integration among plans, PBMs, and pharmacies affects access and competition.
CMS also asks commenters to explain how their concerns vary by pharmacy type, preferred versus non-preferred network status, geographic location, drug type (including specialty, limited-distribution, and compounded products), plan type, and vertical integration.
How Pharmacies Can Submit Meaningful Comments to CMS
CMS is seeking detailed, real-world information about Medicare Part D pharmacy contracting practices, giving independent, specialty, long-term care, and other pharmacies an opportunity to document the challenges they face. Pharmacies deal with PBM contract terms every day. They are the ones who see below-cost reimbursement, opaque performance metrics, and aggressive audits, and pharmacies’ specific, documented accounts are what can turn a general complaint into an enforceable standard. Their firsthand experiences, supported by specific examples and data, can help CMS evaluate whether existing contracting practices warrant additional regulatory protections.
CMS’s request for detail on pharmacy type, location, drug type, and network arrangement shows that specific, fact-based comments will carry the most weight; CMS has indicated that template comments precisely repeating the same set of issues are of limited value.
How Frier Levitt Can Help
Frier Levitt is currently preparing RFI responses on behalf of clients. We can draft tailored responses for individual pharmacies that address their particular issues, whether those involve reimbursement, network exclusion, performance measures, audits, long-term care or specialty contracting, or the effects of vertical integration. We can help pharmacies evaluate sensitive business information, identify appropriate supporting documentation, and prepare fact-based comments that CMS can consider when developing the new standards.
With the November 23, 2026, deadline approaching, pharmacies must act now. Contact Frier Levitt today to discuss preparing and submitting a tailored response to the CMS RFI and helping shape the future of Medicare Part D pharmacy contracting.
Senior Associate
