[Date]

[Medicare Administrative Contractor (MAC) Name]

[Address]

[City, State, Zipcode]

RE:Accurate Gapfillingfor Cytogenomic Microarray Analysisunder the 2013 Clinical Laboratory Fee Schedule (CLFS)

Dear Sir/Madam,

On November 6, 2012, the Centers for Medicare and Medicaid Services (CMS) announced that the Tier 1 and Tier 2 molecular pathology (MoPath) CPT®[1] codes (81201-81408) will be gapfilled for Medicare reimbursement under the Clinical Laboratory Fee Schedule (CLFS) in 2013. This includes the following Tier 1 codes for cytogenomic microarray analysis:

81228Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number variants (e.g., Bacterial Artificial Chromosome [BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis)

81229Interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities

These codes are differentiated by the types of genetic variants interrogated – CPT 81228 describes the use of oligonucleotide probes to detect copy number variants (CNVs), whereas CPT 81229 describes the former in addition to the use of single nucleotide polymorphism (SNP) probes to determine zygosity status.

The following clinical vignettes issued by the American Medical Association (AMA) provide examples of common patient scenarios in which each type of test/code may be performed/billed[2]:

CPT / Clinical Vignette
81228 / An 18-month–old male presents to his physician with unexplained developmental delay. The patient has a normal karyotype and his diagnostic evaluation is otherwise unrevealing. A sample of anticoagulated peripheral blood is submitted to the laboratory for cytogenomic constitutional (genome-wide) microarray analysis.
81229 / A newborn female is determined to have multiple congenital anomalies by the attending physician. The patient has a normal karyotype and her diagnostic evaluation is otherwise unrevealing. The parents indicate they are both from the same ethnic background.
A sample of anticoagulated peripheral blood is submitted to the laboratory for cytogenomic constitutional (genome-wide) microarray analysis.

While cytogenomicmicroarray analysis is not a high-volume test within the Medicare patient population, Medicare payment determinations are influential and often used as a benchmark by other payers in developing rates for new CPT codes. Therefore, it is critical that [MAC Name] utilizes the appropriate information and inputs in the gapfiiling process in order to derive accurate payment rates for these codes.

Background on Cytogenomic Microarray Analysis

Cytogenomicmicroarray analysis (CMA) can be used to identify large structural variations throughout an individual’s genome, including single nucleotide polymorphisms (SNPs) and copy number variations (CNVs) that are linked to genetic disorders.

The American College of Medical Genetics (ACMG) guidelines recommend CMA testing for CNV as a first-line test in the initial post-natal evaluation of individuals with the following multiple anomalies not specific to a well-delineated genetic syndrome, apparently nonsyndromicdevelopmental delay and/or intellectual disability, or autism spectrum disorders[3].

Supporting the Gapfilling Process for Cytogenomic Microarray Analysis

To ensure that [MAC Name] has the necessary information to make accurate payment determinations for CPT codes 81228–81229, [Lab Name] is providing the following materials that reflect our own experience in providing these tests (please see enclosed):

[Select only the materials that will be provided to the MAC]

  • Submitted charges and routine discounts to charges
  • Analysis of the costs of resources required to perform the test
  • Payment rates provided by other payers [specify which payers]
  • Previously billed CPT code stacks

Although we are glad to share this information with [MAC Name] to support the gap-filling process, we would like to request that it be kept strictly confidential at this time.

[Lab Name] believes that inaccurate rate setting for the cytogenomic microarray analysiscodes under the Medicare gapfilling process could lead to similarly inaccuraterates being set by Medicaid and other payers, which would ultimately impede patient access to this medically necessary service. Therefore, we ask that [MAC Name] consider the information provided here and adopt an appropriate methodology that will ensure accurate payment rates for these codes.

In summary:

  • Although cytogenomic microarray analysis is not ordered in high volumes for Medicare patients, the outcome of Medicare gapfilling for the relevant CPT codes is likely to influence Medicaid and private payer rate-setting as well.
  • Therefore, accurate Medicare rate setting for CPT 81228–81229 will be critical to ensuring sustainable reimbursement by other payers,and therefore continued patient access to cytogenomic microarray analysis when medically necessary.

[Lab Name] appreciates the opportunity to submit this information to [MAC Name] to support the gap-filling process for CPT codes 81228–81229, and will be glad to assist if any questions arise.

Yours sincerely,

[Name]

[Title]

[Phone Number]

[Email Address]

[1]CPT is a registered trademark of the American Medical Association. ©2012 American Medical Association. All rights reserved.

[2]© American Medical Association 2011. All rights reserved.

[3]Manning M, Hudgins L, Professional Practice and Guidelines Committee. Array-based technology and recommendations for utilization in medical genetics practice for detection of chromosomal abnormalities. Genet Med 2010; 12:742.