Invitae Announces Medicare Reimbursement For Hereditary Breast Cancer-Related Disorders Under A New CPT Code For Multi-Gene Panels

-- Medicare’s MolDX policy expected to result in cost saving for hereditary cancer testing --

SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE:NVTA), a genetic information company, announced that the Centers for Medicare and Medicaid Services (CMS) have begun providing payments for Invitae’s multi-gene tests for hereditary breast cancer-related disorders (e.g. hereditary breast cancer, hereditary ovarian cancer, and hereditary endometrial cancer). The tests are billed under the current procedure terminology (CPT) code 81432, which became effective on January 1, 2016. Payments are made by Noridian, CMS’s administrative contractor for California.

“We’re pleased to announce that we are now getting paid by CMS, and we believe this decision sends an important message regarding the clinical utility and cost-effectiveness of multi-gene panels when applied in a medically responsible way based on peer-reviewed science and clinical guidelines”

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 other genes relevant to hereditary breast cancer-related disorders, regardless of whether a single gene or multiple genes are selected for testing. The interim payment per test under the new code 81432 is $622.53; CMS will set final pricing for this new code later in 2016, and Invitae has proposed a price of $950 to the agency and its contractors.

“We’re pleased to announce that we are now getting paid by CMS, and we believe this decision sends an important message regarding the clinical utility and cost-effectiveness of multi-gene panels when applied in a medically responsible way based on peer-reviewed science and clinical guidelines,” said Randy Scott, chairman and CEO of Invitae. “Given the scrutiny today over the cost of healthcare, CMS has taken a true leadership role in being able to offer more affordable and accessible genetic testing for appropriately qualified Medicare patients with significant potential cost savings to the healthcare system.”

“Furthermore, we plan to continue working with additional private payers to encourage similar adoption of a more transparent and modern coding and pricing policy based on state of the art technology advances. There is no reason payers should be spending multiple thousands of dollars on genetic tests or paying for code stacking due to serial testing of multiple genes,” continued Scott.

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 as low as $950, depending on the payer’s requirements; this is the price Invitae suggests for the final price for CMS to consider. 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 its reimbursement by CMS supports the clinical utility and cost-effectiveness of multi-gene panels, as well as validates the company’s business model; that CMS will set final pricing for the new CPT code later in 2016; Medicare’s role in being able to offer more affordable and accessible genetic testing for appropriately qualified Medicare patients with significant potential cost savings to the healthcare system; the company’s plan to continue working with additional private payers to adopt similar coding and pricing policy; and the Company’s pricing and its suggestions to CMS and CMS’s contractors for pricing. 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 cease reimbursement for the company’s tests, change the pricing or other terms for reimbursement, or not reimburse the company for additional tests; that other payers may not provide adequate reimbursement for the company’s tests; 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 Annual Report on Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

About Invitae

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.