Pink Sheet, August 2, 2023: This news article extensively describes 2 letters sent to CMS about the Leqembi registries: one from policy experts and one from 20 members of the Patient, Consumer, & Public Health Coalition. The article explains what these experts are asking Medicare to require of private registries for patients with mild cognitive impairment caused by early Alzheimer’s.
Read More »Author: Caroline Bradford
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.
Read More »NCHR Public Comment on HHS Draft Framework to Support and Accelerate Smoking Cessation
July 30, 2023: HHS released a draft framework to support and accelerate smoking cessation. NCHR provided a public comment with recommendations to improve the framework, with a focus on evaluating the impact of demographic differences on the safety and efficacy of different smoking cessation strategies.
Read More »