August 28, 2023 The FDA is assessing whether in-home disposal products can reduce opioid nonmedical use and overdose. We recommend user-friendly, accessible in-home disposal systems that rely on deactivation rather than incineration.
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Testimony at the FDA Advisory Committee Meeting on the Recor Paradise Ultrasound Renal Denervation System
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 »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.
Read More »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.
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