2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC2
Submitter : Dr. Bruce Quinn Date & Time: 10/05/2006 09:10:24
Organization : NHIC - CA Medicare Part B Contractor
Category : Private Industry
Issue Areas/Comments
GENERAL
GENERAL
I am the medical director for Medicare Part B for California, where a number of multivariate assays are on the marketplace and bill to Medicare. Medicare can only pay for FDA-regulated tests and devices if they are FDA-approved. Therefore, ambiguity regarding FDA domain on the test is extremely difficult for Medicare to resolve, in order to proceed with Medicare's payment decision. It would be extremely helpful to both manufacturers and Medicare (or other payors) if a waiver statement were available. That is, test "A" is submitted for clearance under this regulation, and is cleared for marketing. Test "B" is submitted as NOT falling under the regulation, but under traditional/historic ASR or homebrew testing, and the FDA would give assent to that status. Otherwise Product "B" would go indefinitely with Medicare asserting it ought to be subject to FDA regulation based on this regulation, and the company asserting it isn't, and the FDA silent in regard to both parties.

In addition, the explanatory text of the regulation is coy in stating that the FDA is merely re-stating existing practice to clarify it. It appears for a high-profile test like Oncotype DX, marketed for two years, it has been simply impossible for either the manufacturer or Medicare to find a black and white answer as to whether it "is" or "is not" subject to marketing clearance. If it has always been subject to pre marketing clearance, and did not have it, then no tests for two years have been payable by Medicare, for example. It is coy to say that the regulation merely restates existing practice and principles, when existing practice has been so vague.