Palmetto GBA Issues Final Local Coverage Determination on Pharmacogenomic Testing for Medicare Beneficiaries
Myriad Genetics (NASDAQ: MYGN) welcomes Palmetto GBA's final local coverage determination (LCD) for pharmacogenomic (PGx) testing, allowing broad coverage for psychiatric conditions. The LCD covers both single-gene and multi-gene tests but notes limited support for combinatorial tests. President Mark S. Verratti expresses optimism for the GeneSight Psychotropic test's coverage under this LCD. Clinical studies indicate improved outcomes for patients informed by GeneSight compared to standard treatment. This decision responds to increased mental health issues during the COVID-19 pandemic.
- The new LCD enhances coverage for pharmacogenomic testing, expanding access for licensed physicians.
- GeneSight test likely covered under the new LCD, potentially boosting revenue.
- Clinical studies suggest improved patient outcomes with GeneSight testing.
- Palmetto GBA states insufficient data for combinatorial test coverage, which may limit revenue potential.
- Uncertainties around CGS Administrators' actions regarding GeneSight's specific coverage remain.
SALT LAKE CITY, June 11, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, acknowledges the release of a final local coverage determination (LCD) for pharmacogenomic (PGx) testing by Palmetto GBA, one of the administrative contractors for the Centers for Medicare & Medicaid Services (here).
The new LCD does not restrict PGx testing by provider type as long as the provider has the licensure, qualifications, and necessary experience / training to both diagnose the condition being treated and also to prescribe medications. The LCD provides coverage across a range of psychiatric conditions.
The new LCD is a limited coverage policy for PGx testing that establishes coverage for single-gene and multi-gene tests. While Palmetto states that there are insufficient data to support coverage of combinatorial tests, the LCD notes “that combinatorial tests are a subtype of multi-gene PGx tests, and there may be components within those tests that are necessary and reasonable and thus may be covered.” Though this Palmetto GBA LCD is final, details of its application to GeneSight Psychotropic testing await action by CGS Administrators, LLC, the Medicare Administrative Contractor for the GeneSight test.
“We are encouraged by the issuance of a pharmacogenomic LCD with broad coverage of tests ordered by any licensed physician for the treatment of a range of psychiatric conditions,” said Mark S. Verratti, president of Myriad Neuroscience and Myriad Autoimmune. “We believe GeneSight is covered under the new LCD as a multi-gene panel and await a Local Coverage Article for GeneSight and specific action by CGS. Multiple clinical studies have demonstrated the clinical value of the GeneSight Psychotropic combinatorial test.”
In clinical studies, outcomes were improved for patients with major depressive disorder whose care was informed by the GeneSight test compared to treatment-as-usual care.
This coverage decision comes at a time when the COVID-19 pandemic has resulted in a rise in mental health issues being reported. Nearly half (45 percent) of U.S. adults age 65 and older reported that their mental health has been negatively impacted due to worry and stress over the virus.1
About the GeneSight® Psychotropic Test
The GeneSight Psychotropic test is the category-leading pharmacogenomic test for depression medications. The test can help inform doctors about genes that may impact how patients metabolize or respond to certain depression medications. It has been given to more than one million patients by tens of thousands of physicians to provide genetic information that is unique to each patient. The GeneSight test supplements other information considered by a doctor as part of a comprehensive medical assessment. Learn more at GeneSight.com.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to board coverage under the new LCD; awaited action by CGS Administrators, LLC; GeneSight being covered under the new LCD; and the Company’s strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
| Media Contact: | Jared Maxwell | Investor Contact: | Scott Gleason |
| (801) 505-5027 | (801) 584-1143 | ||
| jmaxwell@myriad.com | sgleason@myriad.com |
1 Kaiser Family Foundation, Health Tracking Poll - Coronavirus, Social Distancing, and Contact Tracing, Late April 2020
FAQ
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