The U.S. Centers for Medicare & Medicaid Services (CMS) finalized its national coverage determinations for both artificial hearts and ventricular assist devices (VADs), following through on a proposal to delete the NCD for artificial hearts. The elimination of NCD §20.9 will require that Medicare administrative contractors (MACs) formulate artificial heart coverage policies for their respective jurisdictions, and CMS said it continues to believe that the small number of implants (less than 1% of the Medicare population) calls for a deferral to the MACs. For VADs, the agency is eliminating the criteria for bridge-to-transplant and destination therapy usage, giving cardiologists greater leeway in providing VADs, particularly for patients in need of temporary and/or biventricular support. CMS said it is not changing the facility requirements for VAD implant. Among the requirements for coverage are that the patient be diagnosed with class IV heart failure and a left ventricular ejection fraction of no more than 25%, although the alternative requirement includes failure to respond to optimal medical management after at least 45 days out of the 60 days prior to a decision to implant. An investor’s bulletin by Cowen Washington Research Group indicated that VAD units made by both Medtronic plc of Dublin and Abbott of Abbott Park, Il., will benefit by the new NCD policy. BioWorld will cover this development in greater detail in an upcoming issue.
FDA slaps two companies for illicit COVID offerings
The FDA’s Center for Devices and Radiological Health posted two warning letters to the agency’s website Dec. 1, one of which was for Industry Lab Diagnostic Partners (ILDP), of Nashville, Tenn. The agency advised ILDP that it was in violation of the regulations for its promotion and distribution of a swab-based at-home sample collection kit for testing for the SARS-CoV-2 virus without an emergency use authorization or a conventional premarket review, such as a 510(k) filing. The warning letter to Avazo Healthcare LLC, of Warminster Bucks, Pa., makes similar observations about the company’s offerings for the COVID-19 pandemic, such as rapid antigen test cassettes and CBD products as therapies for COVID-19.
FDA approves new PET imaging agent for prostate cancer
The U.S. FDA has announced the approval of Gallium 68 PMSA-11, said to be the first contrast agent approved for positron-emission tomography (PET) imaging for lesions that are positive for prostate-specific membrane antigen (PMSA). This agent is approved for patients whose prostate cancer is suspected of having metastasized and for those whose prostate cancer may have returned as indicated by a positive outcome for a prostate-specific antigen (PSA) test. The approval was granted to the University of California Los Angeles and the University of California San Francisco.