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MDMA Statement on OPPS and PFS Final Rules

Thursday, December 5, 2013  
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MDMA Statement on OPPS and PFS Final Rules

WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement regarding CY 2014 final rules for the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS):

"MDMA is pleased that CMS removed the pivotal study and superiority study design coverage requirements from the new IDE study approval process. We remain concerned, however, that a centralized review process may not be more efficient than the current one, and that the new coverage requirements could discourage Medicare beneficiaries from participating in IDE studies. We look forward to working with CMS to support continued access and reimbursement for IDE studies.

"In addition, MDMA is pleased that CMS is taking a careful approach to developing comprehensive APCs for device-dependent procedures and that they will continue to evaluate the concept before implementing changes in 2015. While we also remain concerned that CMS's decision to expand packaging to five more categories of items and services could discourage appropriate use of innovative technologies and lead to inaccurate payment rates, we will continue to work closely with the agency to address these challenges.”