CMS Just Asked to See the Side Letters

Five pages landed in this morning's Federal Register at 91 FR 60568, and one bullet inside them is the whole document.

"The extent to which the financial terms that ultimately determine pharmacy reimbursement are contained in documents other than the executed contract (for example, rate sheets, internal budget files, side letters, or unwritten understandings between affiliated entities)."

That is CMS, in writing, asking the industry to describe the paperwork that sits outside the paperwork.

The document is CMS-4217-NC, a request for information on Medicare Part D reasonable and relevant pharmacy contracting standards, and comments close November 23.

Administrator Oz approved it on September 15 and it published nine days later, roughly six months ahead of the statutory deadline Congress set for issuing it.

If you run a health-system retail or specialty pharmacy, an infusion site, a long-term care operation, or you sit on the payer-relations side of any of them, this is the comment window that decides what your 2029 contract is allowed to say.

The Phrase That Sat There for Twenty-One Years

Part D has always had an any-willing-pharmacy rule with a qualifier attached. Under 42 CFR 423.120(a)(8)(i) a Part D sponsor must contract with any pharmacy that meets its standard terms and conditions, and under 423.505(b)(18) those terms have to be "reasonable and relevant."

CMS said what that meant once, in the January 28, 2005 Part D final rule at 70 FR 4254: payment terms may vary to accommodate geographic areas or types of pharmacies, so long as all similarly situated pharmacies get the same offer.

Then nothing, for twenty-one years. The RFI concedes it in one line: "CMS has not established additional requirements for what constitutes reasonable and relevant terms and conditions."

Section 6223(a) of the Consolidated Appropriations Act, 2026 (Pub. L. 119-75, enacted February 3) ends that. It strikes and replaces section 1860D-4(b)(1)(A) of the Social Security Act, and the operative sentence opens with "notwithstanding any other provision of law": for plan years beginning on or after January 1, 2029, standard contract terms offered by a PDP sponsor must be reasonable and relevant according to standards the Secretary establishes. Those standards are due no later than the first Monday in April of 2028. The RFI was itself a statutory instruction, due by April 1, 2027.

So the clock is real, and today starts the only part of it you get to write on.