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Cigna's new policy is an extension of a previous Cigna requirement for the use of certified genetic counselors for breast, ovarian, and colorectal cancer genetic tests.
Mark Robson, MD
Mark Robson, MD, is clinical director of the Clinical Genetics Service at Memorial Sloan Kettering Cancer Center (MSKCC) in New York and a medical oncologist with 20 years’ experience in clinical cancer genetics; however, under Cigna’s new policy on coverage for hereditary genetic testing, Robson is not qualified to order genetic tests for cancer susceptibility. In contrast, a freshly board certified prenatal counselor who has not undergone specialized cancer genetics training is qualified to do so. Robson finds this illogical. “According to Cigna, a prenatal genetic counselor who has never seen a cancer patient is allowed to order and certify a test simply because they have an MGC after their name. Whereas I, who have been doing this for a very long time, am not, because I have an MD after my name. That doesn’t really seem to make much sense to me.”
Cigna’s new policy is an extension of a previous Cigna requirement for the use of certified genetic counselors for breast, ovarian, and colorectal cancer genetic tests. Robson says it is illogical because an understanding of cancer susceptibility testing is an integral part of modern oncology. His position is shared by ASCO. In May, the professional society of those who care for cancer patients issued a statement in opposition to Cigna’s new policy, which it said “introduces an unnecessary barrier to the appropriate use of genetic testing services and has the potential to negatively impact care provided to patients with cancer.” The group contends that adding this requirement may result in patients opting out of potentially beneficial genetic testing because of the barrier of the additional referral. ASCO also contends that unnecessary additional services may increase costs.
“The question is ‘Who is capable of obtaining that informed consent or providing patients with enough information to give that informed consent?’” Robson said. “ASCO has stated quite firmly that medical oncologists are very much trained and capable of obtaining informed consent for genetic testing for cancer patients. It’s part of what we’re trained to do. It’s part of what the organization educates its membership to do, and it’s a part of oncologic care.”
Cigna counters that genetics testing has become exponentially more complicated over the years, to the point where many hours of training and regular updates are needed for healthcare professionals to have a reliable understanding of how to fully prepare patients for tests and provide the necessary interpretation afterward. The payer contends that not all oncologists have time to keep up with rapid advances in the field or to give patients all of the counseling that they need. In addition, the payer contends that physicians are increasingly ordering large panel gene tests that cost more and yield information that may not have value.
“We’re not trying to be a barrier here,” said Jeffrey Hankoff, MD, a medical officer at Cigna. “We’re not trying to interrupt the physician/patient relationship. We’re really trying to get to the point where we have an educated, knowledgeable patient and consumer who very well understands the implications of testing, what the tests mean, and, when the results come back, what the implications are not only for them but for everyone else in their family, and not just their children, but their sisters, their brothers, their aunts, their uncles, and so on.”
According to ASCO, other payers have introduced requirements for the use of certified genetic professionals. However, the organization notes that The Centers for Medicare & Medicaid Services has decided not to institute such a requirement for genetics testing. Robson said that in New York he has the convenience of having a number of certified genetic counselors on staff, but physicians elsewhere in the country do not have that luxury, he said, adding that shortages of certified counselors exist, especially in rural areas and in institutions caring for underserved populations. Cigna provides a list of available counselors in each state and also recommends the use of telephone-based counseling. Professional counselor organizations say their members are amply available geographically and by phone. Hankoff said the payer is not trying to make it difficult to find people who can qualify for acceptance as certified counselors.
“One doesn’t have to be a genetic counselor to achieve certification and qualify to work with patients under the Cigna policy,” he said. “Nurses can undergo specialized training, and Cigna also will allow medical geneticists to do the counseling. Physicians who enroll in specialized courses also may qualify. City of Hope [a California-based healthcare system], which is one of the premier facilities for treating malignancy, offers a 100 hour course for oncologists or for anyone else who wants to take that, to bring people up to speed in terms of the entire area. There are additional segments they can do to make sure that they stay current.”
Robson noted that ASCO has compiled a substantial body of material to help physicians gain sufficient competency in understanding genetic tests and do the counseling. In addition, “Every [ASCO] annual meeting has multiple sessions discussing various aspects of genetic testing,” Robson said. “Genetic testing and genetic counseling for cancer susceptibility is part of the core competency in the fellowship training for medical oncology. Medical oncologists can digest the information that’s necessary to provide chemotherapy. I think that it’s not a stretch to say that they can digest the information that’s necessary for them to provide a diagnostic test, particularly if that diagnostic test is clearly indicated by the patient’s presentation itself.”
Cigna’s position is that even equipped with the knowledge needed for effective counseling, oncologists may not have enough time to review essentials with patients. “Physician resources are really stretched, and Cigna’s position is that even equipped with the knowledge needed for effective counseling, oncologists may not have enough time to review essentials with patients. “Physician resources are really stretched, and particularly around patient care activities,” Hankoff says. “To spend the same amount of time that a genetic counselor would spend to conduct a thorough counseling session—that’s asking a lot of a busy practicing physician.”
Cigna recommends that patients spend at least 45 minutes in the initial meeting with a certified counselor and the same amount after the test results become available. Robson said his opinion is that oncologists will spend as much time as is necessary to deliver essential information to patients. “If an ovarian cancer patient needs this test to determine whether they’re eligible for a PARP inhibitor, an FDA approved drug, certainly that’s something that can be explained, just like you can explain an Oncotype test. If the breast surgeon needs to explain that they need this information because it helps determine contralateral risk and therefore decisions about mastectomy versus lumpectomy and radiation, that’s something that is part of the workup.”
Furthermore, physicians are capable of exercising discretion so that counseling is appropriately tailored to the situation, Robson said. “You can split up the model a little bit, focus on the thing that’s important to the patient right now, focus on why the information is relevant to them right now, and defer the other elements of it until later.”
In some cases a full-blown counseling session is well justified, such as when an unaffected patient needs to be prepared for the possibility of a positive result, Robson said. “So it may well be that there are places where the information that’s required for a patient to understand why he or she is undergoing a genetic test is delivered better by different providers. But I just don’t think there’s a one-size-fits-all solution, and particularly if that one-size-fits-all solution provides a barrier to getting something that’s necessary for oncologic care,” he said.
Those who go for the additional training required to become a certified counselor are not in opposition to Cigna’s policy, Hankoff said. In addition, part of the goal is to ensure that patients are empowered to participate in their own treatment decisions. “The push has been for the patient to be a meaningful part of the conversation, so we’re having an educated patient who is getting intimately involved and fully educated. We didn’t do this because we were trying to save money. It was really about improving the quality.” That said, there is concern at Cigna that not enough restraint is being applied in the use of the newer and more sophisticated tests that have become available. “More and more, we’re seeing panels being ordered, and the panels are having an increasing number of individual genetic tests on them, some of which don’t really have any proven actionable information that comes out of the results. We’re asking the people ordering the tests to be more discriminating,” Hankoff said. The American Board of Genetic Counseling (ABGC) believes that certified genetic counselors should be involved in genetic testing, including ordering and pre- and post-test counseling, said Sheila O’Neal, executive director of the organization. Citing studies by Cigna and the National Society of Genetic Counselors, O’Neal said “genetic testing is most cost effective and efficient when a genetics professional is involved in determining what specific tests to order, as it decreases the number of incorrect or inapplicable tests.”
She said policies by Cigna and UnitedHealthcare have substantially increased utilization of certified counselors, whose numbers have swelled roughly 80% over the past 10 years and continue to rise 6% to 7% annually.