CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route
- The 60-day comment period on CMS-4215-P closed at 5pm on 17 August 2026. The proposed rule, published in the Federal Register on 16 June 2026, would codify the Medicare Drug Price Negotiation Program for initial price applicability year 2029 and beyond, replacing the program instruction authority that expires after 2028.
- The Small Biotech exception from being a negotiation-eligible drug applied only to IPAY 2026, 2027 and 2028, so CMS did not propose to codify it. What carries forward is the Temporary Floor for Small Biotech Drugs, which newly applies for IPAY 2029 and 2030 only.
- CMS proposes to close what it calls the fixed combination drug loophole. Where a product adds a component enabling an alternative route of administration for a shared active moiety under the same NDA or BLA holder, CMS would treat both as one qualifying single source drug. Its worked example is active ingredient X plus hyaluronidase.
- CMS will select up to 20 drugs per year from IPAY 2029. Manufacturer agreements are due 28 February following each selection publication. Draft guidance on MFP effectuation for 2028 is due in summer 2026, with codification for 2029 onward through separate rulemaking in 2027.
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The public argument was about whether the programme should be made permanent. Statute settled that already: guidance authority expires after 2028, so rulemaking was compulsory. What was genuinely open for comment is narrower, and neither item led the coverage.
- Small biotech protection converts from exemption to floor, then expires. The exception from selection covered IPAY 2026 to 2028 and was not carried forward. From 2029 these drugs can be selected, protected only by a price floor that itself lapses after 2030. Model a 2031 cliff, not a carve-out.
- The subcutaneous reformulation route out of selection closes. From IPAY 2029, CMS would aggregate a co-formulated product with its parent under the same BLA holder, its example being active ingredient X plus hyaluronidase. Every subcutaneous antibody built to sit outside its intravenous parent’s selection perimeter is in scope.
- Bona Fide Marketing timing is where deselection now turns. CMS proposes revising the points at which it checks whether an approved generic or licensed biosimilar is actually marketed, and would keep monitoring it. With agreements signed by 28 February each cycle, that window sets the exit date. Model off the window, not the approval.
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