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Capitol Correspondence - 11.10.20

ANCOR Joins Coalition Letter to CMS on Medicare Coverage of Innovative Technology Proposed Rule

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As part of ANCOR’s work with the Independence Through Enhancement of Medicare and Medicaid (ITEM) Coalition, we joined a group letter commenting on a proposed rule from the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) proposed rule is of interest to us because some of our members support individuals who qualify for both Medicare and Medicaid.

As explained in the letter:

“The Proposed Rule includes two major proposals. First, CMS proposes to establish a new coverage pathway to allow nationwide, temporary Medicare coverage for innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). Coverage under the MCIT pathway would begin on the date of FDA market authorization (i.e., the date the device receives Premarket Approval, 510(k) clearance, or the granting of a De Novo classification request) and would continue for up to four years. Manufacturers would have the ability to ‘opt in’ to this Medicare coverage, assuming the device falls under an existing Medicare benefit category and is not otherwise excluded from coverage by statute.

Additionally, the Proposed Rule would codify in regulation a definition of the term ‘reasonable and necessary’ to clarify coverage standards, revising the definition currently cited in the Medicare Program Integrity Manual (PIM). 2 The proposed definition largely tracks the existing definition in the PIM, but modifies it in at least one material respect.”

The ITEM Coalition letter focuses its comments on:

  • Support for the MCIT pathway;
  • Length of coverage under the MCIT pathway;
  • The need for a “look back” period for already approved devices;
  • Limitation of the MCIT pathway to FDA-approved breakthrough devices;
  • Urging CMS to “carefully consider the needs of all Medicare beneficiaries when reviewing items and services for reasonable and necessary determinations.”

We will keep members informed of new developments in this area as they occur.