InVitae (NVTA) Announces Final CMS Pricing for Hereditary Breast Cancer-Related Disorders Under New Billing Process

October 3, 2016 8:27 AM EDT

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Invitae Corporation (NYSE: NVTA) announced that the Centers for Medicare and Medicaid Services (CMS) announced final pricing for genetic testing for hereditary breast cancer-related disorders (e.g. hereditary breast cancer, hereditary ovarian cancer, and hereditary endometrial cancer). The tests are billed under the new current procedure terminology (CPT) code 81432, which became effective on January 1, 2016. CMS had previously announced a temporary payment per test of $622.53, and -- after a public comment period -- the final payment per test is now set at $925. Payments are made by Noridian, CMS’s administrative contractor for California.

“We applaud this historic transition by Medicare which makes genetic testing more affordable and accessible for patients with hereditary breast cancer related disorders,” said Randy Scott, chief executive officer of Invitae. “In the past year, Medicare and the Palmetto MolDX program have significantly reduced the cost of genetic testing, expanded access to multi-gene panels, and restructured their billing and coding policy to a more modern system. We believe this new, improved set of policies apply to all next-generation DNA sequencing assays for breast and ovarian cancer and will result in significant healthcare savings while improving patient care.”

The payments reflect a decision by the Palmetto MolDX program, the Medicare contractor that determines molecular testing policy in about 20 states, including California. According to their recently published guidance titled “Next Generation Sequencing (NGS) and Tier 1 and Tier 2 Coding and Billing Guidelines (M00130, V2),” CPT code 81432 should be used for tests conducted by next-generation sequencing which include BRCA1, BRCA2, and 12 or more other genes relevant to hereditary breast cancer-related disorders, regardless of whether a single gene or multiple genes are selected for testing. Invitae’s test offers detection of single nucleotide variants as well as deletions, duplications, rearrangements, and larger copy number variants all at the same price under a single CPT code.

Invitae offers a transparent pricing structure independent of the number of genes required to provide an accurate diagnosis for any specific clinical indication. For payers and institutions that are in contract with Invitae, the price per indication can be approximately $950, depending on the payer’s administrative requirements and terms of payment. For third-party payers with whom Invitae is out-of-network and for non-contracted institutions, the price per indication is $1,500. In addition, for patients without third-party insurance coverage or who do not meet insurance criteria for coverage, Invitae offers its full test menu for $475 per indication for patients whose clinician orders the testing online and who register online and pay in advance for the testing.

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