[Date] [Payer Name] [Address] [City, State, Zip code] RE: Ensuring Accurate Reimbursement for Cytogenomic Microarray Analysis in 2013 and Beyond Dear Sir/Madam, As you may be aware, American Medical Association (AMA) Current Procedural Terminology (CPT®1) codes 83890–83914 for molecular diagnostic services have been retired as of January 1, 2013. In their place, the AMA CPT established a new set of molecular pathology (MoPath) codes that laboratories such as ours will be using to bill for molecular diagnostic tests moving forward. In light of this, [Lab Name] would like to request clarification on [Payer Name]’s intended process to establish appropriate payment rates for MoPath codes, in particular the following: 81228 Cytogenomic 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) 81229 Cytogenomic interrogation 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 AMA provide examples of common patient scenarios in which each type of test/code may be performed/billed2: 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. 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. Background on Cytogenomic Microarray Analysis Cytogenomic microarray 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 nonsyndromic developmental delay and/or intellectual disability, or autism spectrum disorders3. Clarifying and Supporting the Rate-Setting Process for Cytogenomic Microarray Analysis Given the reimbursement uncertainty created by the recent coding changes, [Lab Name] would like to better understand the process and methodologies that [Payer Name] will employ to identify reimbursement rates for the cytogenomic microarray analysis codes, as well as the associated timelines. If permissible, we would also be interested in providing you with the information necessary to support accurate payment determinations for these codes. As an example, these are the inputs that Medicare Administrative Contractors (MACs) will likely be using to establish local fee schedule rates for each MoPath code (including CPT 81228–81229) in 2013: Charges for the test and routine discounts to charges; Resources required to perform the test; Payment amounts determined by other payers; and Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant4. [Lab Name] believes that inaccurate rate setting for cytogenomic microarray analysis could lead to unsustainable reimbursement rates, which would ultimately impede patient access to this medically necessary service. Therefore, we would very much welcome the opportunity to provide [Payer Name] with the inputs to help support accurate and sustainable reimbursement for the associated CPT codes (81228–81229) in 2013 and beyond. 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. 4 Code of Federal Regulations (CFR) Title 42 - Public Health, Part 414 – Payment for Part B Medical and Other Health Services, Section 414.508 – Payment for a new clinical diagnostic laboratory test. In summary: Cytogenomic microarray analysis is widely recognized as a medically useful postnatal diagnostic tool for conditions such as developmental delay and/or intellectual disability, congenital anomalies, and autism spectrum disorders. Effective January 1, 2013, this service will be reported using CPT codes 81228–81229. Accurate rate setting for CPT 81228-81229 will be critical to ensuring sustainable reimbursement and continued patient access to cytogenomic microarray analysis when medically necessary. [Lab Name] seeks to better understand the rate setting process and methodologies that [Payer Name] intends to adopt for CPT 81228–81229 (or MoPath codes in general), and would welcome the opportunity to share the information necessary to support accurate payment determinations. We thank you for your time, and look forward to learning more about how [Payer Name] will be setting payment rates for the MoPath codes, as well as any next steps that we can take to assist your organization in the rate setting process for CPT 81228–81229 in particular. Yours sincerely, [Name] [Title] [Phone Number] [Email Address]