Invitae Corporation (NYSE: NVTA), a genetic information company, 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.
Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s belief that Medicare’s new pricing makes genetic testing more affordable and accessible for patients with hereditary breast cancer related disorders; and that Medicare’s 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. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: that Medicare may change the pricing or other terms for reimbursement, or not reimburse the company for other tests in the future; the company’s history of losses; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company’s ability to develop and commercialize new tests and expand into new markets; risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; the company’s ability to compete; laws and regulations applicable to the company’s business, including healthcare policy changes and potential regulation by the Food and Drug Administration; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
Invitae Corporation's (NYSE: NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitae’s goal is to aggregate most of the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower price than many single-gene and panel tests today. The company currently provides a diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics and other rare disease areas. For more information, visit our website at ir.invitae.com.
NOTE: Invitae and the Invitae logo are trademarks of Invitae Corporation. All other trademarks and service marks are the property of their respective owners.
Source: Invitae Corporation