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BRCA Preventive Service Designation to Benefit Myriad

by | Feb 21, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies

In a clarification released last month, the U.S. Department of Health and Human Services, along with the U.S. Department of Labor and the U.S. Department of the Treasury, have designated BRCA testing as a preventive service under the Affordable Care Act. This designation allows for coverage of BRCA testing with no cost sharing for asymptomatic women at high risk for breast and ovarian cancer due to a qualified family history covered under all nongrandfathered private insurance plans. There had been some initial confusion if the Affordable Care Act listed just the genetic screening or both the genetic counseling and the BRCA testing as preventive services. As such, many (nongrandfathered) insurance plans had only waived cost sharing for patient screening for the associated genetic counseling but not for the BRCA test itself. With this ambiguity removed, women who are members of nongrandfathered insurance plans and who are determined to be high-risk for mutations in breast and ovarian cancer susceptibility genes BRCA1 or BRCA2 by their health care providers will have no out-of-pocket costs, including copays, deductibles, and coinsurance, when ordering BRCA testing. This also applies to the increasing number of patients enrolled in high-deductible plans. This designation is expected to have […]

In a clarification released last month, the U.S. Department of Health and Human Services, along with the U.S. Department of Labor and the U.S. Department of the Treasury, have designated BRCA testing as a preventive service under the Affordable Care Act. This designation allows for coverage of BRCA testing with no cost sharing for asymptomatic women at high risk for breast and ovarian cancer due to a qualified family history covered under all nongrandfathered private insurance plans. There had been some initial confusion if the Affordable Care Act listed just the genetic screening or both the genetic counseling and the BRCA testing as preventive services. As such, many (nongrandfathered) insurance plans had only waived cost sharing for patient screening for the associated genetic counseling but not for the BRCA test itself. With this ambiguity removed, women who are members of nongrandfathered insurance plans and who are determined to be high-risk for mutations in breast and ovarian cancer susceptibility genes BRCA1 or BRCA2 by their health care providers will have no out-of-pocket costs, including copays, deductibles, and coinsurance, when ordering BRCA testing. This also applies to the increasing number of patients enrolled in high-deductible plans. This designation is expected to have a positive financial impact on Myriad Genetics (Salt Lake City), the only laboratory offering BRCA analysis testing services. “Given that patient out-of-pocket requirements (particularly for high-deductible plans) are a barrier to adoption in the asymptomatic market, it should help Myriad to continue gaining traction in this underpenetrated market,” writes Amanda Murphy, an analyst at William Blair & Co., in a research note. “While it is difficult to put specific numbers around the opportunity we estimate that each 1 percent increase in asymptomatic market penetration (assuming 52 percent of the patients are covered by non-grandfathered plans) yields incremental revenue of just under $40 million.” This designation is in alignment with a draft guidance the U.S. Preventive Services Task Force (USPSTF) released in early April reaffirming its recommendation of genetic counseling and, if indicated, BRCA testing in asymptomatic women at increased risk of BRCA genetic mutations due to family history of breast or ovarian cancer.

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