This bill establishes a rapid review process for Medicare National Coverage Determinations that restrict access to FDA-approved drugs and prevents Part D plans from using those same restrictive determinations.
Nanette Barragán
Representative
CA-44
The Access to Innovative Treatments Act of 2026 establishes a new, expedited review process for Medicare National Coverage Determinations (NCDs) that restrict coverage for FDA-approved drugs or biologicals. This bill mandates that the Secretary of HHS review challenged NCDs within strict timelines and prevents Part D plans from using these restrictive NCDs to deny coverage for approved treatments. The goal is to ensure Medicare coverage aligns with the drug's official FDA approval status.
Medicare Coverage Update: New Review Process Aims to Fast-Track Access to FDA-Approved Treatments by 2026
The Access to Innovative Treatments Act of 2026 creates a formal mechanism for patients and providers to challenge Medicare when it refuses to cover drugs that the FDA has already deemed safe and effective. Specifically, it targets National Coverage Determinations (NCDs)—the big-picture rules Medicare uses to decide what’s 'reasonable and necessary'—that end up being more restrictive than the drug’s actual FDA label. If a drug is approved for a specific condition but Medicare’s rules still block it, this bill requires the Secretary of Health and Human Services to launch a formal review within 90 days of a request, ensuring that bureaucratic hurdles don't indefinitely override medical approval.
Closing the Coverage Gap
One of the biggest headaches for seniors and their families is finding out that a 'covered' Part D plan won't actually pay for a new medication because of an outdated rule. Under Section 2, the bill prohibits Medicare Part D plans from relying on old NCDs to deny coverage for drugs approved after those rules were written. Imagine a patient, let’s call him Art, who has a rare form of macular degeneration. A new biological treatment gets FDA approval in 2026, but a Medicare rule from 2022 says that class of drug isn't covered. This bill ensures that the 2022 rule can’t be used to block Art’s access to the newer, better treatment, effectively forcing Medicare to keep its playbooks current with modern science.
The Review Clock is Ticking
To keep the government from dragging its feet, the bill sets a strict timeline for these coverage disputes. Once a review is triggered, there’s a 30-day window for the public—doctors, patients, and researchers—to weigh in. After that, the Secretary has 120 days to make a final call to affirm, reverse, or change the coverage rule. If the Secretary ignores the advice of the Medicare Coverage Advisory Committee, they have to show their work by publishing the clinical data they used to justify the decision. This adds a layer of transparency, though it also places a significant new workload on health officials to manage these high-stakes reviews.
Guardrails and Potential Bottlenecks
While the bill aims for speed, it also includes a 'cooling off' period: the Secretary doesn’t have to review the same drug rule more than once every two years. For a patient waiting on a breakthrough, two years can feel like a lifetime if the first review doesn't go their way. Additionally, while the bill is great for getting new drugs to patients, it might lead to higher premiums if Part D plans are forced to cover expensive new biologicals they hadn't budgeted for. By tying Medicare’s hands to the FDA’s licensure, the bill moves the needle toward faster access, but it leaves the Secretary with the final, heavy word on how 'inconsistent' a rule truly is with an FDA approval.