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Appendix B: Coding: Payment Infrastructure for Biomarker Tests for Molecularly Targeted Therapies
Pages 241-248

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From page 241...
... . Coding for the large number of complex and rapidly evolving biomarker tests for targeted therapies has undergone significant changes over the past 3 years, and is a process that itself continues to evolve.
From page 242...
... AMA's CPT® Editorial Panel adopted a new subsection of the CPT Pathology Section, and created 114 new analyte-specific codes in the Tier 1 category of commonly performed tests. As of January 2013, clinical laboratories are required to report molecular pathology tests using these newly introduced Molecular Pathol ogy CPT codes.
From page 243...
... The requirement that laboratories report molecular pathology tests using the 116 new Molecular Pathology (MoPath) CPT codes took effect in January 2013.1 The development of new codes facilitates appropriate and consistent payment by ensuring greater accuracy and granularity, providing health plans and other payers with a clearer understanding of precisely which tests they are paying for, and may support payers' efforts to assess clinical utility by enabling tracking of the test in claims databases.
From page 244...
... CMS's 2014 Physician Fee Schedule Final Rule2 specified that the rates for the new molecular pathology CPT codes were to be set using the gap-fill process,3 which can take a year to complete, and requires MACs to set payment rates for new advanced tests based on a number of factors, such as local pricing patterns (what laboratories charge, including discounts) , resources required to perform the test, and what other payers pay for the same test.
From page 245...
... The Institute of Medicine's comprehensive study Medicare Laboratory Payment Policy: Now and in the Future, conducted 15 years ago, for example, recommended far-reaching changes to improve the outdated CLFS to ensure it was prepared for the new era of advanced clinical laboratory tests (IOM, 2000)
From page 246...
... Most recently, CMS released the CLFS for 2016, which shifted the pricing process for several Multianalyte Assays with Algorithmic Analyses to the gap-fill method, instead of the crosswalk method CMS had proposed in an earlier draft of the CLFS that would have likely resulted in cuts to the payment rates for those tests. Significant uncertainty as to the precise impact of PAMA's provisions on molecular diagnostics will remain until the regulations are finalized and fully implemented.
From page 247...
... Presentation to the Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies, May 4, 2015, Washington, DC. SACGHS (Secretary's Advisory Committee on Genetics, Health, and Society)


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