August 22 2023, we testified at the FDA Advisory Meeting on the Paradise Ultrasound Renal Denervation (uRDN) System used to treat hypertension, we attested that the hypertensive efficacy of the Paradise uRDN system is insufficient to justify its use as an adjunct therapy for hypertension.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR Comment on the CMS National Coverage Analysis Evidence Review Proposed Guidance
August 21, 2023: We support the methodological attributes of clinical studies that are described in the NCA guidance. We also strongly agree with CMS’s priorities that emphasize evidence of meaningful health outcomes, particularly morbidity and mortality, since those can be evaluated more objectively.
Read More »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.
Read More »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.
Read More »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.
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