The Centers for Medicare and Medicaid Services (CMS) recently published its final payment determination for the new and reconsidered laboratory codes for Calendar Year 2015. Highlights include a decision to use gapfilling to set the pricing for the Genomic Sequencing Procedures (GSPs) codes, CPT 81410 through 81471. Professional societies and industry members had recommended both crosswalking or gapfilling the new GSPs codes at the annual Lab Public Meeting in July. Additionally, the majority of specialty societies also recommended crosswalking the new Tier 1 Molecular Pathology codes (CPT 81246, 81288, and 81313); however, CMS made the decision to gapfill these codes in 2015.

There are a number of implications from these decisions:

  • It would now appear that for new molecular codes (other than infectious disease codes) we are in an era of gapfilling on the clinical laboratory fee schedule.
  • This means that laboratories and providers will need to ensure that both technical and professional costs are incorporated into the pricing they submit to CMS contractors.
  • In addition as payment models evolve over the next few years, NGS laboratories will need to become more savvy about communicating the value they bring via these diagnostic, prognostic and predictive procedures.
  • Last time around the gapfilling procedure was chaotic, resulting in slashed pricing for molecular tests. Laboratories should take note and be well prepared for interactions with the MAC’s and other payers. In order to help prepare its membership, the AMP has engaged TynanDx and Boston Healthcare Associates to develop templates to help laboratories micro-cost some of these assays appropriately. These adaptable templates will be available on the AMP website in mid-January.
  • In addition, the AMP has invested in health economic evaluations for a subset of these tests such that providers and laboratories can communicate effectively with both public and private payers about the value they bring to the system. These models will also be available on the AMP website in January.

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