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Today there are nearly 67,000 genetic tests. With so many tests available, it can be difficult for MCOs to determine what to cover.
Today there are nearly 67,000 genetic tests representing nearly 5,000 disorders and 5,900 genes, according to GeneTests, a medical genetics information resource. With so many tests available, it can be difficult for MCOs to determine what to cover.
Karen Lewis, MS, MM, CGC, is solution management director, genetic testing, AIM Specialty Health, in Chicago, Illinois, a specialty benefits management company. She says the most important genetic tests to cover are those that provide information that can lead to improved outcomes-including prevention.
“Certain genetic tests can provide information that not only identifies which treatments will be most effective, but also help patients avoid potentially harmful or even lethal treatments and exposures,” she says. “For tests that meet our medical management and outcomes benchmark, morbidity and mortality is sometimes tremendously reduced. Often, genetic information allows for screening that leads to early detection, reducing the medical and financial impact for both the member and health system. Downstream cost of care savings is greatly increased through targeted therapy and prevention.”
Here’s how several health plans make genetic coverage decisions.
Cigna’s approach is to start the coverage evaluation process if it finds that a test is being ordered or completed with some regularity, says Jeffrey Hankoff, MD, medical officer, clinical performance and quality. “We follow the same process for genetic testing coverage policies as we do for all other coverage policies for medications, medical procedures, and medical devices,” he says of the health plan headquartered in Bloomfield, Connecticut. “Policies are based on an extensive examination of peer-reviewed medical and scientific studies, journal articles, and other evidence, as well as suggested guidelines from professional medical societies.”
John Fox, MD, MHA, vice president and associate chief medical officer, Priority Health, in Grand Rapids, Michigan, says that demonstrating analytic validity, clinical validity, and most importantly clinical utility, are critical to coverage of prognostic and predictive laboratory testing. “Clinical utility refers to genetic test results that will change provider decision-making and in doing so change clinical outcomes that are meaningful and relevant to the patient,” he says. “Equally important is a test’s affordability, which is dependent on its cost and the number of people who need it.”
He explains that genetic tests that affect the treatment of fewer individuals (such as one out of every 100 individuals tested), are harder to economically justify than tests that could affect more individuals out of the broader pool (such as one that affects one out of every 10 individuals tested). “A common reason for declining to cover a genetic test is that the cost per treatment impacted is exceptionally high.”
Priority Health covers genetic tests within four categories:
· Predictive, and
John Yao, MD, MPH, MBA, FACP, staff vice president, medical policy development, Anthem, Inc., based in Indianapolis, Indiana, notes that tests may be covered by the payer if clinical criteria are met and include, but are not limited to:
· Hereditary cancer predisposition testing, such as breast cancer susceptibility gene testing for breast and ovarian cancer syndromes;
· Tumor marker analysis for cancer tumor testing to help determine treatment regimens; and
· Prenatal testing, such as cell-free fetal deoxyribonucleic acid testing to evaluate chromosomes and other genetic conditions.
“It is important to have coverage for genetic tests that provide information that can help manage members’ care and have a positive impact on their overall health and well-being,” Yao says. “Unfortunately, there are many genetic tests for conditions in which no treatments currently exist. Genetic tests that provide information only and do not have an impact on treatment or outcomes can significantly increase the overall cost of healthcare for members, employer groups, and the health plan.”
Highmark Inc., a Blue Cross and Blue Shield-affiliated organization operating health plans in Pennsylvania, West Virginia, and Delaware, covers many genetics tests that are medically necessary to guide physicians in the proper treatment of a condition. Generally, it covers tests that assist a treating clinician in monitoring and treating patients so that their medical management is optimally based on the best current knowledge, says Marylou Buyse, MD, senior medical director, medical management and policy.
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.