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MDMA Raises Concerns About Proposed Changes to IDE Process

Friday, September 6, 2013  
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WASHINGTON, DC – MDMA recently filed comments on the CY 2014 proposed rules for the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS). MDMA noted that CMS’ revision in policy regarding coverage for items and services used in investigational device exemption (IDE) clinical studies are significant, and that the agency not finalize them as proposed.

"We believe that the new criteria for establishing coverage for IDE will lead to actual access problems for beneficiaries. Moreover, we also have concerns with the centralized review process and believe that the intended goal of increased administrative efficiencies will not be achieved,” wrote Thomas Novelli, MDMA’s Vice President of Government Affairs. "Given the nature and realities of IDE clinical trials’ use of non-inferiority designs, the lack of clarity for attainment of the 13 proposed criteria, and the lack of administrative guidance and appeals procedures, MDMA does not support CMS proposed revision to the coverage process for medical devices in IDE clinical trials.”

In addition, regarding OPPS, MDMA raised several concerns about the use of data from the comprehensive ambulatory payment classifications (APCs), as well as payments for new technologies and specific codes and APCs.

To read the full comments on OPPS and PFS proposals, click below.

MDMA PFS Comment Letter