Skip to Main Content

PAMA Regulations

CY 2018 CLFS - Final Payment Rates and Crosswalking/Gapfilling Determinations 

CMS has published the final payment rates and supporting documentation for the new private payor rate-based CLFS payment system.  These rates will be implemented on January 1, 2018.  The files include: 

  1. CY 2018 Final Crosswalking/Gapfilling Determinations (for new and existing laboratory test codes for which CMS received no applicable information to calculate a private payor rate-based CLFS payment amount).
  2. CY 2018 Final Private Payor Rate-Based CLFS Payment Rates [ZIP, 413KB]  
  3. HCPCS Codes with Revised Final CY 2018 Private Payor Rate-Based CLFS Payment Rates and Clarifications Regarding the Weighted Median Calculations [PDF, 614KB]   

CLFS preliminary payment rates and supporting documentation:

Request for Nominations to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
Posted on 12/12/2017; Continuous Solicitation 

CMS requests nominations to fill vacancies on the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. See the Notice for nomination criteria, and send nomination packages to CDLTPanel@cms.hhs.gov. We receive nominations on a continuous basis. Visit the Advisory Panel on CDLTs webpage for more information.

 

The Clinical Laboratory Fee Schedule (CLFS) final rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System” (CMS-1621-F) was published in the Federal Register on June 23, 2016.  The final CLFS rule implements section 216 of the Protecting Access to Medicare Act (PAMA) of 2014.

Under the final rule, laboratories, including physician office laboratories, are required to report private payor rate and volume data if they:

  • have more than $12,500 in Medicare revenues from laboratory services on the CLFS and
  • they receive more than 50 percent of their Medicare revenues from laboratory and physician services during a data collection period.

Laboratories will collect private payor data from January 1, 2016 through June 30, 2016 and report it to CMS by March 31, 2017. We will post the new Medicare CLFS rates (based on weighted median private payor rates) in November 2017 that will be effective on January 1, 2018.

Tests that meet the criteria for being considered new advanced tests will be paid at actual list charge during an initial period of three calendar quarters. Once the initial period is over, payment for new, advanced tests would be based on the weighted median private payor rate reported by the single laboratory that performs the new ADLT. Advanced tests are tests furnished by only one laboratory that include a unique algorithm and, at a minimum, are an analysis of RNA, DNA or proteins or are cleared or approved by the U.S. Food and Drug Administration (FDA).

For more Information on PAMA:

For information on the CLFS Data Collection System:

For additional information on:

Submit applications for ADLT status, notifications of FDA clearance/approval and request for level II HCPCS codes for ADLTs and FDA cleared or approved CDLTs to CLFSFormSubmission@cms.hhs.gov.

Submit questions about the CLFS final rule to CLFS_Inquiries@cms.hhs.gov.

.