CMS proposes $0 Part D copay for poorest dual eligibles and new PBM rules

The Centers for Medicare & Medicaid Services has proposed a package of rules that would lower drug copayments for the poorest Medicare beneficiaries, require Medicare Advantage plans to keep more accurate lists of their doctors, and place new transparency and reporting obligations on the pharmacy benefit managers that handle Part D drug claims. The proposed rule, published in the Federal Register on 20 October 2026, carries the file code CMS-4214-P and would amend regulations covering both the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) programmes [s1].

The rule implements three sections of the Consolidated Appropriations Act, 2026: section 6219 on Part D cost-sharing for low-income individuals, section 6220, titled the Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act, and section 6224 on pharmacy benefit manager accountability [s1]. Each section was enacted by Congress; the proposed rule is the agency's attempt to translate the statutory language into enforceable regulation.

A $0 generic copay for the lowest-income dual eligibles

Under section 6219, CMS proposes to reduce the generic drug copayment "from $1 to $0 for full-benefit dual eligible individuals at or below 100 percent of the Federal Poverty Level, effective for plan years starting January 1, 2028" [s1]. Full-benefit dual eligibles are people enrolled in both Medicare and Medicaid, among the lowest-income beneficiaries in the programme. The change is narrow in dollar terms — a single dollar per generic prescription — but applies to a group that fills prescriptions frequently and for whom small, repeated charges can deter adherence.

Accuracy standards for Medicare Advantage directories

Section 6220, the REAL Health Providers Act, would establish new provider-directory accuracy and accountability requirements for Medicare Advantage organisations beginning in contract year 2028 [s1]. CMS proposes rules on directory verification and maintenance standards, an annual accuracy analysis and report, public reporting of accuracy scores, and cost-sharing protections for enrollees who rely on inaccurate directory information [s1]. The agency also proposes to codify statutory requirements for contract year 2029, under which CMS "must publicly display provider directory accuracy scores in a machine-readable format" and plans "must prominently display those scores in their provider directories" [s1].

Inaccurate directories are a long-standing complaint in Medicare Advantage: beneficiaries who pick a plan on the basis of a listed doctor can find that the physician has left the network or never participated. The cost-sharing protection is the rule's answer to that problem — shielding an enrollee from higher out-of-network charges incurred because the plan's own list was wrong.

New obligations on pharmacy benefit managers

Section 6224 is directed at pharmacy benefit managers, or PBMs — the companies that negotiate drug prices and administer pharmacy claims for Part D plan sponsors. CMS proposes "new and enhanced requirements governing the remuneration that PBMs and their affiliates may receive" for services tied to the use of Part D drugs, along with data reporting by PBMs to plan sponsors and to CMS, transparency in price-guarantee arrangements between PBMs and plan sponsors, and disclosure of the terms of certain agreements between PBMs or their affiliates and drug manufacturers [s1].

The agency also proposes to define key terms and to "establish compliance and enforcement mechanisms, including disgorgement of funds to CMS for violations of the remuneration requirements" [s1]. Disgorgement — making a party hand back money it was not entitled to keep — is a notable enforcement tool to see attached to Part D contracting, and signals that CMS intends the new PBM rules to carry financial consequences rather than disclosure alone.

Timing and comment period

The rule is a proposal, not a final regulation. CMS is taking public comment, and to be assured consideration comments must be received "no later than 5 p.m. Eastern Standard Time on December 15, 2026," referencing file code CMS-4214-P [s1]. Comments may be filed through the rulemaking docket, CMS-2026-2533 [s2]. The agency notes that any new marketing and communications policies in the rule are proposed to apply for all contract year 2028 marketing, beginning 1 October 2027 [s1].

The provisions are written to stand independently: CMS states that if any provision is later held invalid or is stayed, "it shall be severable from this rule and not affect the remainder" [s1]. For now, the fixed points are the proposals themselves — the elimination of the $1 generic copay for the poorest dual eligibles in 2028, the phased directory-accuracy regime for Medicare Advantage in 2028 and 2029, and the PBM transparency and enforcement requirements. Whether each survives in its current form will depend on the comment record and the final rule that follows.