House lawmakers are moving to advance legislation that would carve out a longer runway for genetically targeted therapies before they face Medicare drug price negotiations, a bipartisan effort that highlights the tension between fostering innovation and controlling healthcare costs.
Reps. Don Davis (D-N.C.) and Claudia Tenney (R-N.Y.) said Thursday that the House is ready to pass the Maintaining Investments in New Innovation (MINI) Act, which would require genetically targeted technologies (GTTs) to have market approval for at least 11 years before becoming eligible for Medicare negotiation. The bill targets a class of treatments often delivered by injection once or twice a year, offering an alternative to daily pills for conditions such as heart disease.
Speaking at The Hill's “Protecting Patients from America’s Number One Killer” event, Davis emphasized the practical benefits for patients in rural areas like his eastern North Carolina district. “At the end of the day, when you’re able to get advanced medications out there, patients are going to benefit,” he said. “They may not have to make as many visits. I mean, that’s huge especially in rural American areas like where I serve.”
The legislation would effectively lengthen the current timeline set by the Inflation Reduction Act, which allows Medicare to negotiate prices for small-molecule drugs after seven years and for biologics after 11 years. GTTs, while similar to biologics, fall under different federal regulations, creating a gap the MINI Act aims to close. Critics, as noted by The Hill’s contributing editor Kathleen Koch, argue that delaying negotiation could keep these therapies out of reach for patients who need them most.
Tenney pushed back, framing the bill as a necessary incentive for investors. “Right now, you’re seeing an incredible explosion in innovation technology, a lot of it because of AI, a lot of it because we have been able to invest,” she said. “We don’t want to discourage people that are going to be investing.” She argued that a predictable 11-year window gives companies the confidence to recoup their research and development costs.
When asked about Senate prospects, Tenney was candid. “A little bit,” she said, before adding that the real obstacle is not partisan division in the House but the upper chamber’s slow pace. “Right now, it is kind of the joke we have, our enemy is not the Democrats in the House. Our common enemy is the people in the Senate who — we get bills passed and then they get held up over there.” She described the goal as moving the MINI Act from the back burner to the “front burner” by linking it with other bipartisan, non-controversial measures.
The Alliance for Patient Access describes GTTs as treatments “generally delivered via injection” that allow patients to receive care once or twice a year in a medical office rather than managing daily medication at home. This model, supporters say, could reduce hospital visits and improve adherence, particularly for chronic conditions like heart disease.
The push comes as broader healthcare policy debates continue, including recent CDC halts on disease testing and other agency shifts. Meanwhile, the bipartisan nature of the MINI Act stands in contrast to more divisive issues, such as the surge in politically driven book challenges reported by the American Library Association.
With the House ready to act, the fate of the MINI Act now rests on whether Senate leaders will prioritize it. For Tenney and Davis, the message is clear: innovation in gene therapies depends on predictable policy, and the clock is ticking.
