September 25, 2015

Proposed PAMA Regulations Released

View the rule published in the October 1, 2015, Federal Register
On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released an early copy of the regulations toward implementing laboratory payment reform as required under the Protecting Access to Medicare Act of 2014 (PAMA). That law requires clinical laboratories to report private insurance payment amounts and volumes for laboratory tests. The data reported will be used by CMS to determine Medicare’s new payment rates for laboratory tests beginning January 1, 2017.

According to CMS’s announcement on the rule, in accordance with the PAMA law, the new system being developed for laboratory test rate assessment will update laboratory rates to “market rates” every three years for clinical diagnostic laboratory tests (CDLTs) and every year for advanced diagnostic laboratory tests (ADLTs). The rule defines ADLTs as tests that are furnished by only one laboratory and that either include a unique algorithm and are at a minimum an analysis of RNA or DNA, or are cleared or approved by the U.S. Food and Drug Administration (FDA).

The proposed rule requires laboratories to report private payor rates and test volumes if they receive at least $50,000 in Medicare revenues from laboratory services and more than 50 percent of their Medicare revenues from laboratory and physician services.

The rule outlines a fast-paced timeline with laboratories being required to collect private payor data from July 1, 2015, through December 31, 2015, and report the data to CMS by March 31, 2016. CMS envisions posting the new Medicare rates by November 1, 2016, and making these rates effective on January 1, 2017.

Comments to CMS are due by 5:00 p.m. Eastern Time on November 24, 2015, with a final rule not likely until January 2016.

To view the rule as published in the October 1, 2015, Federal Register, click here.

For a link to the CMS fact sheet, click here.