CMS proposes phased Part D PBM and MA directory implementation

What happened

CMS made proposed rule CMS-4214-P available on public inspection October 16, with formal publication scheduled for October 20. The proposal implements sections 6219, 6220 and 6224 of the already-enacted Consolidated Appropriations Act, 2026. Its posted DATES section requests comments by December 15 at 5 p.m. Eastern Standard Time. For plan years beginning January 1, 2028, the cost-sharing provision would implement a zero copayment for qualifying generic drugs and section 351(k) biological products for full-benefit dual-eligible individuals with income no greater than 100 percent of the federal poverty level. It does not make every drug free for every low-income Part D enrollee.

For specified MA plans, including network-based plans and private fee-for-service plans meeting access standards wholly or partly through provider contracts, proposed directory verification and enrollee protections apply in CY 2028. Verification generally occurs at least every 90 days, while hospitals and specified facility classes receive annual verification. The proposal includes an unable-to-verify flag and removal of nonparticipating providers within five business days after the organization determines nonparticipation. Otherwise-covered out-of-network care listed as in-network when the appointment was made would receive the lesser of in-network or otherwise-applicable cost sharing, with specified evidence, refund and appeal protections. Directory accuracy analysis begins in 2028, with the first annual report due the first Monday of April 2029. Machine-readable public scores and prominent plan display begin in CY 2029. A contemplated low-enrollment waiver is not an adopted exemption from directory duties.

Part D sponsor and PBM contracts would implement the statutory framework from January 1, 2028. Proposed remuneration rules generally limit compensation to qualifying bona fide service fees and specified exceptions, including qualified incentive payments and manufacturer concessions whose full gross economic value reaches the sponsor under the stated conditions. The fee framework addresses flat-dollar amounts, fair market value, actual itemized services and prohibited ties to drug prices, formulary placement or referral value. It preserves specified pharmacy and wholesaler compensation; it is not a blanket prohibition on every pharmacy margin.

Under proposed section 423.2814, annual PBM reports would be due no later than July 1 beginning in 2028 and generally cover the preceding complete plan year. Disgorgement information instead covers June 1 of the preceding calendar year through May 31 of the current year. Annual reporting addresses drug-level spending and reimbursement, affiliate relationships and retained remuneration, with certification, audit and enforcement provisions. Proposed section 423.2812 separately addresses pricing-guarantee transparency. Do not shift the first report to 2029 merely because contract requirements begin in 2028. Separately, proposed CY 2028 marketing and communications policies would start October 1, 2027. These implementing details remain proposed even where the underlying statute already supplies a future duty or date.

Why it matters

Plans, PBMs and provider organizations need separate workstreams for cost sharing, directory data and payment protections, contracts and reporting. Treating the proposal as one 2028 deadline would miss the earlier marketing phase, prior-year PBM data and later public scoring.

Implementation playbook

1. Recommended internal target: map sponsor, PBM, affiliate and provider roles and separate enacted statutory requirements from proposed implementation details. Managed Care · Due 2026-10-30
2. Recommended internal target: assess directory verification exceptions, appointment-date evidence and patient cost-sharing escalation processes. Compliance · Due 2026-11-13
3. Recommended internal target: finish comment and implementation-gap recommendations before the posted December15 comment deadline. Legal · Due 2026-12-04

Sources

• CMS4214P complete public-inspection proposed textOfficial · CMS; Office of the Federal Register
• Official public-inspection filing record for2026-21420Official · Office of the Federal Register