Survey Finds Competitive Bidding Restricts Access To Diabetes Products
This article was originally published in The Gray Sheet
The American Association of Diabetes Educators surveyed suppliers participating in the nationwide competitive bidding system for mail-ordered diabetes testing systems and found that they are not offering access to as many brands as they initially promised in their bids.
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The agency for the first time issued distinct guidance documents for blood glucose meters used in professional settings and those issued over-the-counter for self-monitoring tests by lay-persons. FDA is collecting comments on draft versions of the guidelines.
Now that insulin pumps are part of CMS’ competitive bidding program, there is a possibility of reimbursement reductions down the road. And in a separate process, CMS denied Medtronic’s request to establish a new HCPCS code for sensor-augmented insulin pumps.
Certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market, stakeholders agree. FDA is working on the matter, but no clear plan of action was laid out at a Diabetes Technology Society meeting last week.