Medicare Lab Test Pricing Forum Set for July 10

The Centers for Medicare and Medicaid Services (CMS) will hold a public meeting July 10 at its Baltimore headquarters to hear recommendations on setting Medicare payment rates for new or substantially revised clinical laboratory codes for the Part B lab fee schedule in 2014. The agency announced the meeting in the May 24 Federal Register. Comments on the new or revised codes are due by June 28. CMS will determine pricing of the codes either through crosswalking (mapping to an existing code) or gap-filling (pricing determined by Medicare contractors based on charges, resources, and payment amount determined by other payers). The agency plans to publish proposed determinations for new and reconsidered codes for 2014 by early September. Final fee decisions are expected in November. For the 2014 clinical laboratory fee schedule, there are 16 new Current Procedural Terminology codes and 11 reconsideration requests. (Note: numbering of new codes will be finalized later.)

NEW AND RECONSIDERED CODES FOR THE 2014 MEDICARE LAB FEE SCHEDULE*
NEW TEST CODES
THERAPEUTIC DRUG ASSAYS
801XX1	Caffeine
801XX2	Clozapine
801XX3	Everolimus
801XX4	Gabapentin
801XX5	Lamotrigine
801XX6	Levetiracetam
801XX7	Mycophenolate (mycophenolic acid)
801XX8	Oxcabazepine
801XX9	Tiagabine
802XX	Zonisamide
TIER 1 MOLECULAR PATHOLOGY PROCEDURES
81161	DMD (dystrophin) (eg, Duchenne/Becker muscular dystrophy) deletion analysis, and duplication analysis, if performed
812XX	MGMT (O6-methylguanine DNA methyltransferase) (eg, Brain Cancer) allele specific identification of dense promoter methylation, analysis of the MGMT gene, prognostic/predictive for response for treatment which include alkylating agents such as temozolamide therapy in tumor tissue
MULTIANALYTE ASSAYS WITH ALGORITHMIC ANALYSES
815XX1	Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores
815XX2	Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy
81508	Fetal congenital abnormalities, biochemical assays of two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score
MICROBIOLOGY
876XX	Infectious agent detection by nucleic acid (DNA or RNA); Trichomonas vaginalis, amplified probe technique
RECONSIDERATION REQUESTS
0001M	Infectious disease, HCV, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver
0002M	Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis (ASH)
0003M	Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and nonalcoholic steatohepatitis (NASH)
81500	Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score
81503	Oncology (ovarian), biochemical assays of five proteins (CA-125, apoliproprotein A1, beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score
81506	Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbAlc, insulin, hs-CRP, adoponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reporting a risk score
81509	Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), utilizing maternal serum, algorithm reported as a risk score
81510	Fetal congenital abnormalities, biochemical assays of three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score
81511	Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA) utilizing maternal serum, algorithm reported as a risk score (may include additional results from previous biochemical testing)
81512	Fetal congenital abnormalities, biochemical assays of five analytes (AFP, uE3, total hCG, hyperglycosylated hCG, DIA) utilizing maternal serum, algorithm reported as a risk score
82777	Galectin-3
Source: www.cms.gov/ClinicalLabFeeSched/. Click on “Laboratory Public Meetings” to access the download. *CMS: Any changes to the list will be updated as they occur. CPT codes copyright American Medical Association.