Federal · CMS proposed rule, CMS-4214-P

Medicare proposed rule: $0 generic copays for the lowest-income dual enrollees, accurate Medicare Advantage directories and new limits on drug-middleman pay, starting in 2028

Proposed Oct. 20, 2026 · Comments due Dec. 15, 2026

Published October 20, 2026 · Last updated October 20, 2026

What it does

This is a proposed rule. It would amend the Medicare Advantage (Part C) and Medicare prescription drug (Part D) regulations, 42 CFR parts 422 and 423, to implement sections 6219, 6220 and 6224 of the Consolidated Appropriations Act, 2026, Public Law 119-75, enacted February 3, 2026. (Proposed rule, Summary; Executive Summary; section II.A) It has three parts:

• $0 generic copays for the lowest-income dual enrollees (section 6219). The law reduces “the generic drug copayment from $1 to $0” for full-benefit dual eligible individuals with incomes at or below 100% of the federal poverty level, for plan years beginning on or after January 1, 2028. The $1 base amount has been adjusted each year for inflation: for plan year 2026 the copay is $1.60 for generic drugs and $4.90 for other covered Part D drugs, with no deductible. CMS is not proposing changes to copays for brand-name or other drugs, which would keep their yearly inflation adjustment. (Proposed rule, section II.A)
• Accurate Medicare Advantage provider directories (section 6220, the “REAL Health Providers Act”). Starting with plan year 2028, each Medicare Advantage organization offering a network-based plan must keep an accurate provider directory on a public website; verify each listed provider’s information at least once every 90 days (hospitals and certain other facilities less often, but at least once every 12 months); note in the directory when it could not verify a provider’s information that the information may not be up to date; and remove a provider within 5 business days after it determines the provider is no longer in the plan’s network. (Proposed rule, section II.B.2)
• What a directory must show. At a minimum: the provider’s name, specialty, phone number, office or facility address, whether the provider is accepting new patients, accommodations for people with disabilities, cultural and linguistic capabilities, telehealth capabilities, and whether the provider is owned or controlled, in whole or in part, by the plan’s organization or a related company. (Proposed 42 CFR 422.2, “Provider directory information”)
• Accuracy scores. Plans would analyze their directories’ accuracy each year and report an accuracy score to CMS. Beginning in 2029, CMS would post the scores in a machine-readable file on its website, and plans would have to display their scores prominently in their directories. (Proposed rule, Executive Summary; sections II.B.6 and II.B.9)
• Limits on pharmacy benefit manager pay (section 6224). Pharmacy benefit managers (PBMs) provide services such as drug price negotiation, prescription claims processing, formulary development and pharmacy network contracting for Part D plans. Beginning with contract year 2028, a Part D plan must have a written agreement with any PBM acting on its behalf. Under it, the PBM and its affiliates generally may not receive pay for Part D drug services other than “bona fide service fees”: flat dollar amounts, reflecting fair market value, for an itemized service, and not contingent on rebates or discounts, drug price, or coverage or formulary placement. Manufacturer rebates and discounts are allowed if they are fully passed through to the plan, and certain incentive payments from plans are allowed. (Proposed rule, section II.C.1)
• PBM reporting and enforcement. PBMs would report information each year to plans and to the U.S. Department of Health and Human Services, such as drug prices and utilization, formulary placement of brand and generic drugs, and payment rates at affiliated and unaffiliated pharmacies. CMS also proposes compliance and enforcement tools, including requiring PBMs to pay back (“disgorge”) funds to CMS for violations of the pay rules. (Proposed rule, Executive Summary; section II.C.1)

Who it affects

• Low-income people with both Medicare and full Medicaid. A “full-benefit dual eligible individual” is someone with Part D or Medicare Advantage drug coverage whom the state has found eligible for full Medicaid benefits for the month. (42 CFR 423.772) The $0 generic copay applies to those with income at or below 100% of the federal poverty level. CMS estimates about 6 million enrollees would be affected, based on 2026 enrollment data. (Proposed rule, section II.A)
• People in Medicare Advantage plans that use provider networks, including private fee-for-service plans that meet access standards through a network. (Proposed 42 CFR 422.2, “Specified MA plan”) CMS is considering whether to exempt plans with low enrollment from the yearly accuracy analysis and report. Those plans would still have to follow the verification and updating rules. (Proposed rule, section II.B.7)
• Part D plans and PBMs. The PBM rules apply to the agreements between PBMs and both stand-alone prescription drug plans and Medicare Advantage plans that include drug coverage. (Proposed rule, section II.C.1)

What it means for you

• Nothing changes for 2027 plans. Under the law, the copay, directory and PBM changes start in 2028. (Proposed rule, sections II.A, II.B and II.C.1) Medicare’s Open Enrollment Period runs October 15 to December 7. During it you can join, drop or switch Medicare Advantage and Medicare drug plans, with coverage starting January 1. (Medicare.gov, Joining a plan)
• If a directory points you to the wrong provider (starting 2028). If a provider was listed in your plan’s directory on the date you made the appointment but is out of network when you get care, the plan must charge you no more than the lesser of the in-network cost sharing or the cost sharing that would otherwise apply, for items or services the plan would otherwise cover. You or your representative could ask the plan for this protection verbally or in writing, and the plan would have to apply it on its own when it knows or reasonably should know it applies. The date that counts is the first date the appointment was scheduled, even if it was later rescheduled. If the plan can’t get the records it needs to decide, the protection would be applied in your favor, and the lower amount would count toward your yearly maximum out-of-pocket limit. (Proposed rule, section II.B.10; proposed 42 CFR 422.124)
• Help with drug costs now. “Extra Help” is a Medicare program that helps people with limited income and resources pay Medicare drug coverage premiums, deductibles, coinsurance and other costs. Some people qualify automatically; others have to apply. (Medicare.gov, Help with drug costs)
• Comment if you want to. Submit comments at regulations.gov (docket CMS-2026-2533; refer to file code CMS-4214-P) or by mail. Comments must be received by 5 p.m. Eastern Standard Time on December 15, 2026. CMS does not accept comments by fax. (Proposed rule, “Dates” and “Addresses”)

Current status

Published as a proposed rule October 20, 2026, at 91 FR 66408 (file code CMS-4214-P, RIN 0938-AV88). It is not final. CMS says any new marketing and communications policies in the rule would apply to all contract year 2028 marketing and communications, beginning October 1, 2027. (Proposed rule, header and Executive Summary)

What happens next

CMS is taking comments through December 15, 2026, before it issues a final rule. The requirements themselves were enacted by Congress in Public Law 119-75; the rule sets out how CMS proposes to carry them out. (Proposed rule, “Dates”; section II)

Sources

• Federal Register: “Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026,” proposed rule, FR Doc. 2026-21420 (Oct. 20, 2026)
• Regulations.gov: docket CMS-2026-2533 (comments)
• eCFR: 42 CFR 423.772, definitions (full-benefit dual eligible individual)
• Medicare.gov: Joining a plan
• Medicare.gov: Help with drug costs (Extra Help)

Every statement above is drawn from the official source text linked here; section references are shown in grey. This is a plain-English summary, not legal advice. Spot an error? Tell us.