BRCA Testing Granted Preventive Care Designation Under the Affordable Care Act
SALT LAKE CITY, March 6, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that three federal agencies including the U.S. Department of Health and Human Services, the U.S. Department of Labor, and the U.S. Department of the Treasury have issued a set of FAQs clarifying BRCA testing as a preventive service under the provisions of the Affordable Care Act. Importantly, this clarification will allow for BRCA testing to be completed with no patient cost sharing for all non-grandfathered private insurance plans when an asymptomatic woman has a qualifying family history.
"We view this clarification as a recognition of the critical value of BRACAnalysis® as a preventive service in women's health," said Pete Meldrum, President and Chief Executive Officer of Myriad Genetics Inc. "This designation goes a long way in ensuring that high-risk women can now have access to the life-saving preventive information provided by BRACAnalysis® without the financial burden of out-of-pocket expenses."
On September 17, 2010, a provision of the Affordable Care Act became effective that required non-grandfathered, private, insurance plans to cover items or services with no patient cost sharing that had a rating of "A" or "B" by the United States Preventive Services Task Force. Screening for deleterious mutations in the BRCA1 and BRCA2 genes was incorporated in the guidelines with a rating of "B" but due to some ambiguous language it was unclear to health plans whether the recommendations included only genetic counseling or the actual test itself. This ambiguity has now been clarified to grant BRCA testing as well as genetic counseling a preventive care designation under the Affordable Care Act.
In 2012, only 48 percent of Americans receiving their health insurance coverage through their employers were enrolled in grandfathered insurance plans; down from 56 percent in 2011, according to Kaiser Family Foundation Employer Health Benefits Survey. According to the same survey, 19% of health plans in 2012 were high deductible plans, which was up from only 8% in 2009. These plans can lead patients to delay important preventive care given the high out-of-pocket costs for healthcare services until deductibles are met. Going forward, women who are members of non-grandfathered insurance plans, who are determined to be high risk by their healthcare providers, will have no out-of-pocket costs including copays, deductibles, and coinsurance when ordering BRACAnalysis® and BART™ as a preventive service. This clarification will take effect immediately and Myriad
looks forward to working with private insurance plans to implement the changes to ensure broader access to patients.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. 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, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. 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 relating to the ability of BRCA testing to be completed with no patient cost sharing for all non-grandfathered private insurance plans when an asymptomatic woman has a qualifying family history; the Company's belief in the contribution of this designation to ensuring that high-risk women can now have access to the life-saving preventive information provided by BRACAnalysis® without the financial burden of out-of-pocket expenses; the Company's belief that women who are members of non-grandfathered insurance plans, who are determined to be high risk by their healthcare providers, will have no out-of-pocket costs including copays, deductibles, and coinsurance when ordering BRACAnalysis® and BART™ as a preventive
service; the Company's belief that this clarification will take effect immediately; the Company's belief that implementing the changes will ensure broader access to patients; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are management's present 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 described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or
achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our 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; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors"
contained in Item 1A in our most recent Annual Report on Form 10-K 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.
CONTACT: Investor Relations
Scott Gleason, Vice President of Investor Relations
Source: Myriad Genetics, Inc.
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