On July 19, 2013, CMS issued the proposed CY 2014 MPFS rule and suggested significant modifications to its regulations governing Medicare coverage of investigational devices and the routine items and services furnished to beneficiaries during the clinical studies or trials conducted under the FDA Investigational Device Exemption (IDE) regulations.

CMS’s proposed revisions include, among other things, the following:

  • Requiring clinical trials or studies evaluating IDE devices to meet a list of criteria in order for the costs of “routine care items and services” to be eligible for Medicare coverage, which criteria include, but are not limited to, that the principle purpose of the study must be to evaluate whether the item or service can meaningfully improve health outcomes of patients who are represented by the Medicare-enrolled subjects; and
  • Creating a centralized review process to analyze and determine coverage of investigational devices, as well as routine items and services otherwise available to Medicare beneficiaries, as opposed to utilizing local Medicare contractors—the entities that currently manage this function.

The public may submit comments on the proposed rule to CMS no later than September 6, 2013 and the proposed rule is available here.  The King & Spalding client alert providing more background regarding the proposed rule is available here.