How a Proposed Rule Could Impact Treatment Options for Patients Living With Chronic Disease

If you're one of nearly 200 million Americans living with a chronic disease, Medicare policy debates can often feel far removed from your daily life. But sometimes, a technical-sounding proposal can have real consequences for the treatments you rely on — and that's exactly what's happening right now.

The Centers for Medicare and Medicaid Services (CMS) is considering a change to how it classifies certain drugs under the Medicare Drug Price Negotiation Program (MDPNP) established under the Inflation Reduction Act. Specifically, the agency is looking at whether an IV infusion and a subcutaneous (under-the-skin) injection of the same active ingredient should be counted as one product — not two – for the purposes of price setting. At first, that might sound like a bureaucratic accounting question. But for patients and caregivers, the stakes are very real.

An IV infusion requires patients to travel to an infusion center or hospital outpatient facility, often for appointments lasting several hours. By contrast, a subcutaneous injection can be administered in minutes, typically in a doctor’s office or even at home. Giving patients the choice between treatments – and administration of treatments – is critically important.

Injections are often less costly than IV infusions and far more accessible for many populations, including rural patients who may live hours from an infusion center, individuals without reliable transportation, and elderly patients and caregivers. When given the choice, 71% of patients prefer injection over IV administration (for a given therapy) – but this proposal from CMS effectively eliminates that choice for patients – and sends a signal that could discourage further innovation in this space.

The implications of this proposed rule extend beyond patient experience. Developing an injectable alternative is not a simple modification—it requires years of research, substantial investment, and a separate FDA review process. The FDA, not CMS, has the scientific expertise and statutory authority to determine whether therapies are distinct medicines. When the FDA approves both an IV and a subcutaneous version as separate products, it does so based on independent evaluation of each formulation’s safety, efficacy, and delivery. Treating them as the same product under Medicare policy disregards these distinctions and the meaningful differences they represent for patients. It also risks exceeding CMS’s regulatory role while undermining FDA determinations.

This issue is not about a single therapy or company. It is about the signal this policy sends to researchers and developers about which types of innovation are worth pursuing.

Under the proposed rule, CMS would effectively eliminate financial incentives for pharmaceutical companies to develop more convenient, patient-friendly delivery options. If Medicare policy treats an improved delivery method the same as its predecessor, it raises a fundamental question: why invest in making treatments easier and safer for patients if those improvements are not recognized as meaningful advancements? The likely result is that resources will be redirected elsewhere. Over time, this could slow progress on innovations that make chronic disease more manageable. early evidence already suggests that the Inflation Reduction Act has had negative effects on research and development, which this policy could further exacerbate.

Your voice matters

CMS is accepting public comments on this proposal through August 17. That means patients, caregivers, providers, and advocates have a real opportunity to weigh in before decisions are made.

Policymakers need to hear from the people who live these realities every day — not just the technical arguments, but the human ones. What does it mean to you to have a treatment option that fits your life? What would you lose if those options disappeared or stopped being developed?

Innovation means finding better ways to deliver treatments with less burden, more flexibility, and greater dignity for the people who need them most. Medicare policy should reflect that.

Comments on the Medicare Drug Price Negotiation Program for IPAY 2029 are open through August 17, submit comments here.