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, 2019 through June 30, 2019 and report it to CMS by March 31, 2020. We will post the new Medicare CLFS rates (based on weighted median private payor rates) in November 2020 that will be effective on January 1, 2021.
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:
- CMS-1621-F: Final Rule Implementing Section 216 of Protecting Access to Medicare Act (PAMA)
- Press release
- Fact sheet
- Frequently Asked Questions (Updated 3/09/2017) [PDF, 651KB]
- Visit CMS Sponsored Events for links to slide presentations, audio recordings, and written transcripts on the final rule and data reporting.
For information on the CLFS Data Collection System:
- CLFS Data Collection System User Guide [PDF, 4MB]
- MLN Matters® Special Edition Article SE1619 [PDF, 96KB] : Guidance to Laboratories for Data Collection and Reporting
- MLN Matters® Special Edition Article SE17002 [PDF, 184KB] : Additional Guidance for Clinical Laboratories as Data Reporting Begins
For additional information on:
- Advanced Diagnostic Laboratory Tests (ADLTs)
- Notification to CMS of an FDA Cleared or Approved Clinical Diagnostic Laboratory Test (CDLT) under the Medicare Clinical Laboratory Fee Schedule (CLFS)
- Application for Level II HCPCS Code for ADLTs and FDA Cleared or Approved CDLTs
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.
- Page last Modified: 01/22/2019 3:48 PM
- Help with File Formats and Plug-Ins