Final PAMA Rule Released, Implementation Delayed to 2018

By Kelly A. Briganti, Editorial Director, G2 Intelligence

After much lobbying, debate and delay, the Centers for Medicare & Medicaid Services (CMS) final rule implementing the Protecting Access to Medicare Act (PAMA) changes to the Clinical Laboratory Fee Schedule (CLFS) was released last week.

The good news is that the final rule delays the effectiveness of new payment rates under the CLFS to Jan. 1, 2018, rather than a mere six months away in January 2017, as planned in the proposed rule.

The timeline for implementation now requires data be collected for the period Jan. 1 through June 30, 2016 (data collection period) and reporting of that data be accomplished between Jan. 1 through March 31, 2017 (reporting period). In early September 2017, CMS will publish preliminary CLFS rates for public comment with final CLFS rates published in November 2017 and effective Jan. 1, 2018.

Here’s a rundown on some of the key changes in the final rule:

• Applicable labs are those that receive more than 50 percent of total Medicare revenues under the CLFS or Physician Fee Schedule (PFS) (unchanged from proposed rule).
• Applicable labs will be determined using their National Provider Identifier (NPIs) (rather than by Taxpayer Identification Numbers (TINs) as proposed).
• Applicable labs will not include labs paid less than $12,500 under the CLFS during the data collection period (prior threshold was $50,000).
• Hospital outreach laboratories, independently enrolled in Medicare with their own NPI, will need to report if at least 50 percent of Medicare revenues are from CLFS and PFS services, with at least $12,500 from the CLFS.
• The definition of Advanced Diagnostic Laboratory Tests (ADLTs) includes “tests that are solely an analysis of proteins.” (Proposed rule defined ADLT to be an analysis of RNA or DNA and may include proteins but protein-only tests wouldn’t qualify as ADLTs).

For more in depth coverage of the final rule, see future issues of Laboratory Industry Report and National Intelligence Report.

To understand what the final rule requires and how to comply, attend this webinar, June 28, 2016, hosted by G2 Intelligence and the American Clinical Laboratory Association: The PAMA Final Rule: What You Need to Know and Do NOW to Comply with the New Payment Rules and Protect Your Lab Revenue. To register NOW, visit our website or contact customer service at 1-888-729-2315.