Caroline Bradford

NCHR Comments on the CMS Coverage with Evidence Development Proposed Guidance Document

August 21, 2023: We support the refinements to the proposed new criteria regarding the need for proper control groups and blinding in CED studies. However, we have minor suggestions that would strengthen these changes.

NCHR Comments on the CMS proposal to Remove the National Coverage Determination (NCD) for Beta-amyloid Positron Tomography (PET Aß) in Dementia and Neurodegenerative Disease

August 16, 2023: NCHR supported expanded coverage for PET Aß under very limited circumstances, to determine if a patient is eligible for Medicare coverage of an amyloid targeting drug that has FDA approval.

NCHR Comments on CMS’s Proposed Decision Regarding Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery

August 10, 2023: CMS released a draft decision to cover an experimental procedure for stroke prevention on populations who are normally too low-risk to be considered for surgical intervention. There is no evidence that this experimental procedure, a Percutaneous Transluminal Angioplasty (PTA), is a beneficial treatment over optimal medical (non-surgical) care in patients with moderate narrowing of their carotid arteries. Yet, there are many documented risks to this procedure and we are concerned that covering this experimental procedure in a lower-risk stroke population will cause real harm to Medicare patients and increase the cost of medical care.

NCHR Comments on FDA Notice of Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health

August 9, 2023: NCHR supports FDA’s proposed online form for allegations of potential regulatory misconduct pertaining to medical devices. We recommended revisions to preserve anonymity and make the form easier to complete.

Who gets to decide who receives experimental medical treatments?

MIT Technology Review, August 10, 2023: This excellent news article by MIT Technology Review asks “Who decides who receives experimental medical treatments” and are FDA’s standards for accelerated approval too low for Duchenne Muscular Dystrophy, cancer, and other diseases. We call accelerated approval a disaster.