Medicare Just Divided a CAR-T Infusion by Twelve

CMS filed a 695-page final rule for public inspection at 4:15 Thursday afternoon, in the same minute it filed the deregulation rule we took apart last night. It codifies the Medicare Drug Price Negotiation Program into a brand new 42 CFR part 429, and it is effective on December 5, twenty-nine days from today.

Deep in the new regulatory text, at § 429.415(a)(2)(v)(E)(2), sits a single number.

Twelve.

"What does Medicare call a month when the drug is given once in a lifetime?"

That number is the denominator the agency will use to price one-shot Part B therapies, and it does the same work on an $80 influenza vaccine and a $506,657 CAR-T claim. CMS told the public the provision costs nothing.

The Rule That Starts in Twenty-Nine Days

The file code is CMS-4215-F, RIN 0938-AV90, and it publishes in the Federal Register on Monday. The proposed version ran in June and comments closed on August 17, so the argument is over.

Three dates set the clock:

• December 5, 2026, effective date, which is inside the 60-day window the Congressional Review Act normally requires for a major rule. CMS invoked 5 U.S.C. 808(2) and waived it.
• February 1, 2027, the statutory deadline for the list of up to 20 drugs payable under Part B or covered under Part D selected for initial price applicability year 2029, plus the list of up to 30 top negotiation-eligible drugs it was drawn from.
• January 1, 2029, when any price agreed in next year's negotiation cycle starts applying.

The waiver is worth reading for its own sake, because CMS explains exactly what it is buying. Biosimilar manufacturers can ask the agency to delay selection of a reference drug, and those Initial Delay Requests are due by the end of December. CMS says it "needs a minimum of approximately seven weeks" to work through them before the February 1 publication deadline, and that a 60-day delay would leave it "a period of less than one month to review such requests, which is approximately half the minimum time that CMS believes is necessary."

So the agency gave itself four extra weeks of calendar by waiving a review period. That is a reasonable trade.

It also tells you the February 1 list is the real deadline in this program, and every provider holding Part B drug exposure should be watching for it.