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.
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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.
Read More »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.
Read More »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.
Read More »Testimony of Diana Zuckerman at the CMS Meeting Regarding Transitional Coverage for Emerging Technologies
August 1, 2023: Dr. Zuckerman urged CMS to uphold its standard for coverage based on evidence that medical products are proven reasonable and necessary for Medicare patients.
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