FDA & CMS LInks about Category B IDE Trials

At the February 17, 2022, FDA town hall on future accelerated coverage, several speakers suggested the simple Category B process might work.  

CMS coverage of Category B trials dates to 1995 (60 FR 4817, https://www.govinfo.gov/content/pkg/FR-1995-09-19/pdf/95-23132.pdf , and resolved lawsuits (example) (example) about coverage or non coverage of these trials at MACs in the 1980s.   The 1995 Fed Reg document is cogent and well-written.     

Since 2015, Category B trials are reviewed centrally by CMS, https://www.cms.gov/Medicare/Coverage/IDE .  

While each is reviewed, they are normally covered per their ClinicalTrials.gov protocols and and in a volume matching the ClinTrials protocol for patient numbers.  Category B trials are the usual FDA status for 510k or PMA clinical studies, few are rated FDA Category B which would be a non covered investigational device.  For more, see FDA guidance document 2017, https://www.fda.gov/media/98578/download .  

Medicare has a “Medical Devices” policy manual which is not about devices in general but rather, about Category B IDE trial devices, https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c14.pdf .

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The Yale cases about IDE reimbursements stem from 1994/1995, and were still in litigation as Yale v Leavitt at least as late as 2006, 22 years later.  https://caselaw.findlaw.com/us-2nd-circuit/1337231.html  See also Jarndyce.