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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Letter from Experts to CMS and HHS Regarding Data Sharing in Leqembi Registries
July 27, 2023: In a letter to CMS and HHS, policy experts and bioethicists urge CMS to require that registries that make Medicare patients eligible for Leqembi coverage share data with CMS, FDA, and independent researchers to ensure accurate and unbiased data.
Read More »NCHR Comments on the FDA’s Use of Generally Accepted Medical Knowledge Draft Guidance
July 24, 2023: The FDA proposed a draft guidance on using generally accepted medical knowledge (GASK) when conducting nonclinical studies to help streamline product development, decrease costs, and hasten new product approval time. We do not recommend using GASK as the sole source of nonclinical data in new drug applications or biologic license applications as this could jeopardize the safety, toxicology, and efficacy of the product.
Read More »NCHR Comments on FDA’s Bioequivalency for Generic Drug Formulations Draft Guidance
July 18, 2023: FDA draft guidance on bioequivalency is intended to streamline generic drug development and speed up patients’ access to generic medications. But some shortcuts that FDA proposes could result in unsafe generic medications that were not adequately tested. We highlight research standards that will help keep patients safe.
Read More »NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening
June 6, 2023: The U.S. Preventive Services Task force has changed its recommendations for mammography to start at age 40 instead of 50. However, they still recommend mammograms every 2 years instead of every year. We point out that there are racial differences in cancer risk and that mammography guidelines should reflect those racial differences. One size does not fit all.
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