CMS to Delay Pricing New Drug Codes

The Centers for Medicare and Medicaid Services (CMS) will delay pricing 63 new drug codes under the Clinical Laboratory Fee Schedule (CLFS) for 2015, the agency announced earlier this month. In its CLFS preliminary determination, CMS says it is concerned about the potential for overpayment when billing for each individual drug test rather than a single code that pays the same regardless of the number of drugs that are being tested for. Therefore, it intends to delay pricing for these codes at this time, until further information and education is obtained. At this point it’s unclear just how Medicare will pay for drug testing in 2015. Diana Voorhees, chief executive officer of DV & Associates, believes it’s likely that CMS will continue to use G codes. “I think payers who have followed the use of G codes will continue to do so, and that additional commercial payers will follow,” she said in an e-mail. “Other private payers and maybe Medicaid will use new codes and crosswalk pricing to old codes. It may be like molecular coding in 2012.” For many of the other new and revised codes on the CLFS for 2015, CMS agrees with industry recommendations (see chart below).

PRELIMINARY DETERMINATIONS FOR MEDICARE LAB FEE SCHEDULE, 2015
CODE/DESCRIPTOR	PRELIMINARY DETERMINATION	PROPOSED NLA
THERAPEUTIC DRUG ASSAYS
80163 Digoxin; free	Crosswalk to 80162	$18.12
80165 Valproic acid (dipropylacetic acid); free	Crosswalk to 80164	$18.49
MOLECULAR PATHOLOGY PROCEDURES TIER 1
81246 FLT3 (FMS-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis tyrosine kinase domain (TKD) variants (eg, D835, I836)	Gap-fill
81288 (MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis)	Gap-fill
81313 (PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer))	Gap-fill
GENOMIC SEQUENCING PROCEDURES
81410 through 81471	Gap-fill
MULTIANALYTE ASSAYS WITH ALGORITHMIC ANALYSES
0006M (Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein level, algorithm reported as a risk classifier)	Gap-fill if the Medicare contractor determines the code is payable
0007M (Oncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a namogram of tumor disease index)	Gap-fill if the Medicare contractor determines the code is payable
0008M (Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score)	Gap-fill if the Medicare contractor determines the code is payable
81519 (Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score)	Gap-fill if the Medicare contractor determines the code is payable
CHEMISTRY
83006 (Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1))	Crosswalk to 82777	$30.01
MICROBIOLOGY
87505 (Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets)	Crosswalk to 87631	$175.02
87506 (Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets)	Crosswalk to 87632	$291.18
87507 (Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets)	Crosswalk to 87633	$568.60
87623 (Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), low-risk types (eg, 6, 11, 42, 43, 44))	Crosswalk to 87621	$47.87
87624 (Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68))	Crosswalk to 87621	$47.87
87625 (Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed)	Crosswalk to 87621	$47.87
87806 (Infectious agent antigen detection by immunoassay with direct optical observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies)	Crosswalk to 87389	$32.86
REPRODUCTIVE MEDICINE PROCEDURES
89337 Cryopreservation, mature oocytes	This test code represents embryonic storage; therefore, it is not a clinical diagnostic test and should not be priced on the CLFS
G CODES
G0464 (Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3))	Crosswalk to 81315 + 81275 + 82274	$501.78
Source: CMS, Preliminary Determinations, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CLFS-Preliminary-2015-10032014.pdf.