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 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.

Patient, Consumer, and Public Health Coalition Letter to CMS and HHS Regarding the CMS Requirements for Alzheimer’s Treatment Registries

August 2, 2023: The coalition urged CMS that all data collected by any of the registries are made publicly available for research purposes, and available to the public.

NCHR Comments on FDA Guidance Regarding Decentralized Clinical Trials for Drugs, Biological Products, and Devices

August 1, 2023: We asked FDA and those conducting DCTs to recognize how they could inadvertently reduce the enrollment of diverse populations when relying on digital health technologies (DHTs). NCHR then provided strategies and considerations to FDA for implementing decentralized clinical trials, including those that use DHTs.