Welcome to the March edition of Terry’s Hot Take, a monthly resource for lawmakers by the Executive Director of Patients Rising, on behalf of the 133 million Americans living with chronic disease.

Concerns over CMS’s Draft National Coverage Determination (NCD) for Alz: Patients Rising Now submitted a letter to CMS in response to the NCD for monoclonal antibodies used to treat Alzheimer’s Disease. Concerns from patients include: CMS overruling the FDA’s authority over drug safety and efficacy; the requirement of clinical trials disregards realities faced by Alzheimer’s patients; stifling of future medical innovation; and more.

Right to Repair puts patient safety at risk: Patients Rising Now has spearheaded a coalition of 24 patient advocacy organizations to underscore patient concerns over misleading “right to repair” legislation across states. This would allow repair technicians not held to the same FDA safety standards as medical device manufacturers to operate on equipment like CT scans. Misdiagnosis and inaccurate scans could occur if allowed. More details in our letter, and in this Feb. 25 Forbes we are quoted in.

Telehealth Policies Needed to Address America’s Digital Healthcare Divide: We’ve heard from patients, particularly those in the rare disease community who need to see specialists not within traveling distance, about the critical need for telehealth. Pay parity and broadband internet access are just two of many underlying barriers for patients, which we outline here

The Latest on the Patients Rising Podcast: On our latest episode, Speedy Rare Disease Drug Reviews, dive into two major issues that impact the rare disease community: the reauthorization of PDUFA and Dr. Califf’s confirmation as FDA Commissioner. For patients with unmet medical needs, PDUFA is vital to expediting timely reviews of necessary drugs.  

Every month we hope to lend a patient lens to legislation and regulation. If Patients Rising can be of assistance to your office, please reach out to me directly via twilcox@patientsrising.org or at 202-750-4331.

Take care,

Terry