On August 26, 2015, the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (hereinafter the “Panel”) held its inaugural meeting.  The Panel was established by the Secretary of Health and Human Services under the authority of Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which prescribes a new market-based payment system for laboratory tests paid under the Clinical Laboratory Fee Schedule.  PAMA directs the Secretary to consult with the expert outside advisory Panel for (1) input on the establishment of payment rates under the new law for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test, (2) input on the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests, and (3) recommendations under the new law.  See Charter for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Test.

The 16-member Panel is chaired by Centers for Medicare & Medicaid Services (“CMS”)  Medical Officer Steve Phurrough.  A full list of the panel members can be found here.

The August Panel meeting occurred in advance of CMS’s implementation of the PAMA payment system, yet the Panel discussed new test codes for 2016, voting to make recommendations on codes relating to molecular pathology, drug of abuse testing, and other areas previously discussed at the Annual Laboratory Public Meeting held in July.  The Panel heard from several presenters discussing these codes, which included representatives from the American Medical Association and the Association for Molecular Pathology.  A full list of the presenters can be found on CMS’s website.  The Panel also considered and made recommendations on requests for reconsideration of 2015 payment decisions.  CMS is expected to release its preliminary decisions for 2016 by the end of September.

With the first Panel meeting now complete, the pathology and laboratory communities continue to wait for CMS to publish regulations implementing PAMA’s new mandates.  The regulations will likely also provide additional information on the scope of the Panel’s role in addressing coverage and payment processes under the market-based pricing system.  Although PAMA required  a final rule to be released by June 30, 2015, CMS has missed the deadline.  CMS announced at the meeting that the proposed rule is almost completed and should be issued in the next several weeks.  The proposed rule has been received by the Office of Management and Budget and can be tracked here.