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Gapfill Pricing Inquiries

Calendar Year 2015 - New Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Gapfill Payment Determinations

This file includes test codes and interim prices, by locality, for clinical diagnostic laboratory tests that CMS determined should be priced by Medicare Administrative Contractors (MACs) for 2015 using the gapfilling methodology.  The criteria and process for gapfilling are specified in 42 CFR 414.508(b).  A reconsideration process for tests that are gapfilled is specified in § 414.509.  The final pricing file will be posted on the CLFS web site around September 2015 and will also include the national limitation amount and midpoint for each test.

If there is no price for a given code by a specific MAC, this may be due to one of several reasons, for example: 

  • There is no benefit category for the test;
  • There is no high quality evidence published in the peer reviewed literature demonstrating clinical utility for the Medicare population;
  • There is a lack of medical necessity: knowing the exact genetic sequencing will not change the treatment or prognosis of a beneficiary;
  • The MAC has not received a technical assessment that qualifies the test for coverage.

For more specific information on why a payment rate is not indicated in this file, please contact the local Medicare Administrative Contractor. 

The public is invited to submit comments on the preliminary pricing decisions.  Please submit any comments to glenn.mcguirk@cms.hhs.gov by July 20, 2015.