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MDMA Submits Comments on Coverage with Evidence Development Draft Guidance

Monday, January 28, 2013  
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MDMA submitted comments this week to the Centers for Medicare and Medicaid Services (CMS) regarding their draft guidance for Coverage with Evidence Development (CED).

While MDMA support CMS’ efforts to improve the CED process to reduce barriers to innovation and improve health outcomes for Medicare beneficiaries, we noted concerns that such efforts do not inadvertently limit patient access to advanced medical technologies.

MDMA reiterated that our members devote considerable resources and effort to improving and expanding the clinical evidence to help Medicare beneficiaries and providers make the most appropriate diagnostic and therapeutic decisions. Some of our comments included:

  • CMS should adhere to the principles governing the application of CED set forth in its 2006 CED guidance document;
  • CMS should proceed cautiously and in collaboration with manufacturers when considering the use of CED for a particular item or service to ensure that it does not hinder access to appropriate care and the development of clinical evidence through other means, including the local coverage process.

To read the entire comments, click here.