To CMS: Turning an infusion into an injection is innovation, not repackaging

NCLifeSci filed formal comments urging the Centers for Medicare & Medicaid Services to reconsider part of its Medicare Drug Price Negotiation Program proposal for 2029. One change would treat a newer subcutaneous medicine as the same drug as its intravenous predecessor, starting the pricing clock years early and discounting the science moving patients from the infusion chair to a shot they give at home. NCLifeSci asked CMS to fix that and three related problems in the rule.

Here's the letter:

RE: CMS-4215-P: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program proposed rule for Initial Price Applicability Year 2029 

Dear Administrator Oz, 

On behalf of the North Carolina Life Sciences Organization, thank you for the opportunity to comment on CMS's proposed rule for Initial Price Applicability Year 2029 under the Medicare Drug Price Negotiation Program. 

NCLifeSci represents nearly 275 member companies, most in North Carolina and many headquartered elsewhere in the U.S. and around the world. Our members discover, develop and manufacture medicines, vaccines, diagnostics and the enabling technologies behind them. 

We write on four issues in the proposed rule: how CMS identifies qualifying single-source drugs and the proposed fixed combination modification, the temporary price floor for small biotech drugs, the start of the negotiation clock for orphan drugs and the treatment of Part B vaccines. 

Qualifying single-source drugs and the fixed combination modification 

We urge CMS to withdraw the proposed fixed combination modification and to identify each qualifying single-source drug by its unique New Drug Application or Biologics License Application, as the statute directs. 

Under the proposal, CMS would treat a newer subcutaneous product as the same QSSD as an earlier intravenous product when the added component enables a different route of administration. The subcutaneous product would then carry the same maximum fair price as the infusion, and the negotiation clock would run from the earlier product's approval. This treats a distinct, separately approved medicine as though nothing new was created. 

Moving a therapy from infusion to injection is not repackaging. The change creates measurable value for patients, providers and payers. 

North Carolina-based Lindy Biosciences, a Duke University spinout, developed a proprietary "microglassification" technology, which dries biologic proteins into stable, highly concentrated microparticles suited to small-volume subcutaneous injection. A subcutaneous product goes through its own development program and earns its own FDA approval under a separate application. In 2024, Novartis licensed Lindy's technology under an exclusive global collaboration worth up to $954 million to convert select infused Novartis medicines into injections patients give at home. Lindy points to lower healthcare costs, better patient comfort and stronger treatment compliance as the benefits. A reformulation like this shares the active moiety of the original infused product. Under CMS's practice of grouping every form of a drug with the same active moiety, the newer injection would fall into price setting on the older product's timeline, years before its own approval date. Penalizing a distinct, separately approved product this way devalues the enabling technology behind these conversions, much of which North Carolina companies develop. 

The clinical and economic case is straightforward. A subcutaneous injection moves administration out of the clinic. A five-minute injection replaces hours in an infusion chair, along with the chair time, nursing time, facility fees and pre-medication an infusion requires. Many patients inject at home, which removes a trip to a hospital or infusion center entirely. For patients in rural North Carolina, where the nearest infusion site sits many miles away, home injection is the difference between reliable treatment and missed doses. 

Site-of-care savings reach the whole system. Shifting appropriate patients to home injection frees limited infusion capacity for patients who still need intravenous therapy. This eases bottlenecks in rural and community settings where access is already tight. Subcutaneous options also reduce the need for surgically implanted ports and the infection risk, maintenance and activity limits ports bring. For immunocompromised patients, fewer clinic visits mean lower exposure risk. 

The statute anchors negotiation selection to FDA approval. Congress defined a QSSD by reference to a specific approval or licensure. FDA, not CMS, holds the scientific role of deciding whether a change to a product is significant enough to warrant a new application. When FDA approves a subcutaneous product under a separate BLA, CMS should recognize a distinct QSSD. Collapsing the two substitutes CMS's judgment for FDA's and reaches beyond the authority Congress granted. 

CMS works against its own goal here. The negotiation program exists to lower Medicare spending, and subcutaneous injection lowers spending too. Every dose moved from an infusion suite to a patient's home strips out facility fees, nursing time and monitoring costs Medicare would otherwise pay. More injectables mean lower healthcare costs across the program. A policy starting the negotiation clock early on these products works against the same conversions expected to reduce Medicare spending. CMS would trade a modest, one-product pricing gain for higher system-wide costs and a weaker pipeline of cost-saving formulations. 

The proposal also chills the exact investment CMS's negotiation factors claim to value: lower treatment burden, better access and more efficient care. Companies in North Carolina and elsewhere build the delivery technology behind these conversions, and a policy erasing the reward stalls the work before the field matures. 

We therefore urge CMS to withdraw the fixed combination modification and to identify QSSDs by the unique NDA or BLA under which each product is approved or licensed. 

Temporary price floor for small biotech drugs 

We urge CMS to withdraw its proposed “adjusted” maximum fair price ceiling and to confirm the statutory temporary floor controls for qualifying small biotech drugs. 

Congress recognized a small biotech company often depends on a single Medicare product and faces outsized harm from early negotiation. The Inflation Reduction Act set a temporary floor for 2029 and 2030 so the maximum fair price for a qualifying small biotech drug does not fall below 66% of non-FAMP. CMS now proposes a new “adjusted” ceiling whenever the statutory ceiling falls below the floor. Congress did not authorize a third standard, and the more specific floor should control over the general ceiling. 

This point carries real weight in North Carolina. Our ecosystem runs on emerging companies spun out of institutions such as Duke University, the University of North Carolina, North Carolina State University and Wake Forest University, many built around a single asset. Our members include a growing cluster of gene therapy and rare-disease developers, such as Asklepios BioPharmaceutical, BioCryst and Kriya Therapeutics, whose products serve small patient populations and carry high development costs. The temporary floor is one of the few protections helping these companies attract investment and reach patients. An unauthorized ceiling overriding the floor weakens this protection and chills the early-stage investment the sector depends on. 

We urge CMS to withdraw the adjusted ceiling and to confirm the following: for qualifying small biotech drugs selected for Initial Price Applicability Year 2029 or 2030, the maximum fair price must not fall below 66% of non-FAMP. 

Orphan drug exclusion and the negotiation clock 

We support codifying the orphan drug exclusion as amended by the ORPHAN Cures Act, which covers a drug designated for one or more rare diseases and approved only for those rare diseases. One proposed clarification undercuts the exclusion. CMS would start the 7- or 11-year negotiation clock at the moment FDA first approves a drug for a non-rare indication, even after the manufacturer withdraws the non-rare indication and the drug's only remaining approved uses treat rare diseases. 

This reading works against the statute. A drug qualifies for the exclusion when the drug holds at least one orphan designation and all of its approved indications serve designated rare diseases. CMS already looks only at active designations in applying the exclusion. The agency should apply the same logic to indications and look only at active ones. A product whose non-rare indication is gone, and whose remaining indications all serve rare-disease patients, falls within the exclusion Congress wrote. 

CMS should give the exclusion full effect by pausing the negotiation clock whenever a withdrawn indication leaves a product with only rare-disease indications, for the full period the product qualifies. This protection matters to North Carolina. Our rare-disease and gene therapy developers, including the members named above, build products for small patient populations at high cost and high risk, and an early clock start on a rare-disease-only product penalizes the work Congress moved to protect.Part B vaccines 

We urge CMS to exclude Part B vaccines from the negotiation program and to clarify influenza vaccines do not meet the QSSD definition. 

The statutory text points away from applying the program to Part B vaccines. Part B vaccines are reimbursed under a different methodology from the one the program relies on, and they already carry zero cost sharing for beneficiaries. Negotiating them would produce no financial benefit for CMS or for beneficiaries, the central aim of the program. 

Influenza vaccines raise a separate definitional point. A QSSD must sit at least 11 years past licensure. Seasonal flu vaccines change strain composition every year, so no single formulation stays unchanged for the required period. On the agency's own definition, influenza vaccines do not qualify. 

A clear exclusion would keep the program consistent with the statute and spare CMS the work of negotiating products where no savings are available. NCLifeSci is glad to serve as a resource as the agency refines its approach. 

Our recommendations 

NCLifeSci supports the goal of affordable medicines for Medicare beneficiaries. The changes above would work against this goal by penalizing patient-centered innovation, weakening protections Congress wrote for small companies and sweeping in products Congress did not intend to reach. We urge CMS to withdraw the fixed combination modification, identify QSSDs by their unique FDA applications, preserve the small biotech floor, pause the negotiation clock for products left with only rare-disease indications and exclude Part B vaccines. 

Thank you for considering our comments. Please contact me with any questions. 

Sincerely,  

Laura Gunter
President
North Carolina Life Sciences Organization