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Attorneys, Insurers Disagree With Manufacturers On Need For Clinical Evidence For MCIT Coverage

CMS says in its MCIT proposal that there’s no obligation for clinical studies, but AHIP is concerned about “clinical appropriateness” of devices

 
• By Sue Darcey

Both insurance group AHIP and the MedPAC group of Medicare advisors are insisting on CMS reimbursement for medical devices only supported by clinical trials. Industry attorneys weigh in.

Medicare, Health Concept

While medical device manufacturers and trade groups fully support a recently proposed Medicare Coverage Of Innovative Technology (MCIT) regulation, commercial insurers are more skeptical, industry attorneys said on 11 November at King & Spalding’s 13th Annual Medical Device Summit.

The MCIT program – once it goes into effect – will supply a glide path for Medicare coverage of any US Food and Drug Administration breakthrough device for a four-year...

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