CEO SUMMARY: For three years, Cigna has required genetic counseling for members seeking genetic testing for hereditary breast, ovarian, and colorectal cancer, and for a particular heart condition. Such counseling increased member satisfaction, causing Cigna to expand the program. It now requires genetic counseling with an independent board-certified genetics specialist for members considering whole exome sequencing, additional hereditary cancers, heart disease, and pediatric microarray analysis.
IT TURNS OUT THAT PATIENT SATISFACTION INCREASES when genetic counseling is done in advance of genetic testing for certain hereditary cancers and health conditions. That is one lesson learned by Cigna, which was the nation’s first major health insurer to require such genetic counseling three years ago. (See TDR, August 19, 2013.)
It was this positive patient experience that encouraged Cigna, as of June 15, to expand that program. It now requires genetic counseling with an independent board-certified genetics specialist for members considering whole exome sequencing (WES), hereditary cancers and heart disease, and pediatric microarray analysis for children with certain developmental delays or intellectual disabilities.
Three years ago, Cigna became the first national health insurer to require genetic counseling before it would approve coverage for members getting genetic tests for hereditary breast, ovarian and colorectal cancer and for long QT syndrome, a heart condition. Counseling for members with these conditions was necessary because those genetic tests were complex and frequently misunderstood, leaving patients bewildered, Cigna said at the time.
That state of bewilderment continues today because members do not know which genetic test is appropriate for their particular condition, family medical history, and risk factors, explained Jeffrey F. Hankoff, MD, Cigna’s medical officer for clinical performance and quality.
“Further confusing patients are clinical laboratories that offer multiple tests in panels,” he added. “Genetic counselors, therefore, minimize confusion by helping people make decisions about testing based on their individual circumstances and clinical guidelines.
“Genetic counseling helps ensure that individuals get appropriate, high quality care,” explained Hankoff, who gave several reasons why the program has been successful. For one, more than 32,000 Cigna customers have had genetic counseling since 2013, while the average number of monthly claims for genetic counseling more than doubled during this time.
Cigna’s genetic counseling program has also been successful according to customer satisfaction data. Among individuals who underwent genetic counseling, 95% said they are satisfied with genetic counseling and thought they were more informed about their genetic risks; 94% said they were more informed about their hereditary risks; and 97% said the counselors answered their questions and addressed their concerns, Cigna said.
No Data Yet on Cost Impact
“Another benefit is that the initiative helped to keep genetic testing costs lower than they would have been without such counseling,” noted Hankoff. “However, Cigna does not yet have data on the effects of genetic counseling on the amount spent for genetic testing.
“We started this program in 2013 because at that time there were dramatic changes in coding for genetic tests that mostly eliminated the stacked codes,” he explained. “Stacked codes were replaced with individual CPT codes for some 50 or more of the most common genetic tests. That change allowed Cigna to distinguish between genetic and other testing, which means we can manage testing with more precision.
“At first, Cigna’s guidelines for genetic counseling were only for those three types of tests because it had to start somewhere,” continued Hankoff. “Now that we have this experience under our belt and have been successful in ensuring appropriate testing, we can add a relatively small number of tests compared to what we are already doing without putting a huge burden on our customers or providers.
“It was not necessary to add a significant number of tests because we already required genetic counseling for about 90% of the genetic tests that doctors order,” commented Hankoff. “Adding this handful of new tests means that slightly over 90% of genetic test orders will involve genetic counseling.”
Cigna pays for the counseling under a contract with InformedDNA, a company in St. Petersburg, Fla., that offers clinical genetic counseling, genetic test utilization management, and hereditary risk assessment for individuals.
“We limit the counseling to certified genetic counselors, board-certified and board-eligible medical geneticists, certified nurses who have the additional genetic-testing credentials, and physicians who have added training or coursework to be knowledgeable in this area,” Hankoff explained.
“As a rule, physicians don’t have the 45 minutes or so that a genetic counselor will spend with a patient before the testing or the 45 minutes afterward to explain the results,” he said.
“Also, counselors cannot be tied to any laboratory that has a stake in this kind of testing,” added Hankoff. “For example, if a proprietary lab has a specific genetic test, Cigna will not accept a report from the genetic counselor who might work for that lab because there’s an inherent conflict of interest.
“Counselors follow our posted coverage policies and we ask them to do a three-generation pedigree, meaning the individual, the parents, and the grandparents, aunts, and uncles,” explained Hankoff. “We want them to look for anything that might affect the genetic disorder in question.
pursuing Appropriate Care
”If the genetic counselor says the test should be done, then Cigna covers that test,” he said. “In addition, we ask coun- selors to make a recommendation on which genetic test might be appropriate or no test if that’s the right choice. If the counselor doesn’t agree with our coverage policy, we ask why.
“In this program, Cigna is not focusing on the cost of genetic testing,” noted Hankoff. “This effort was never put into place with the idea of controlling costs, even though some genetic tests cost as much as $8,000 or $12,000.
In Guidelines to Cover Whole Exome Sequencing, Cigna Has Counselors Look for Clinical Significance
BY BECOMING ONE OF THE FIRST MAJOR HEALTH INSURERS TO HAVE A COVERAGE POLICY for whole exome sequencing, Cigna is at the forefront of precision medicine. But this introduces the challenge shared with other insurers as to how to approve large panels of genetic tests in support of patient care.
Cigna is no different, stated Jeffrey F. Hankoff, MD, Cigna’s medical officer for clinical performance and quality. To help ensure that members get appropriate genetic tests, it requires genetic counseling for members seeking certain tests for hereditary conditions and whole exome sequencing.
“Cigna covers these tests, including whole exome sequencing (WES), when the required criteria are met and the test result will directly affect clinical decision making in terms of patient outcomes for the individual,” noted Hankoff.
“To approve WES testing, the protocol requires several conditions to be met,” he continued. “The patient must have two of the following criteria: One would be an abnormality affecting a single organ system. The other would be significant intellectual disability symptoms of a complex neuro-developmental disorder.
“Should either of these criteria be met, then the next qualification is that the patient must have a family history strongly implicating a genetic etiology,” he noted. “The patient must also have a period of unexplained development regression.
“The patient needs to meet two of those four criteria or the patient needs to have multiple abnormalities affecting unrelated organ systems,” said Hankoff. “Further, for exome sequencing, the clinical presentation shouldn’t fit a well-described scenario in which a single genetic test or a very small panel of tests would be available.
“These provisions might be confusing for most lay people, but certainly genetic counselors understand them and recognize that Cigna is looking to make a real difference in how these patients are managed clinically,” he added.
Genetic Test panel Criteria
For genetic test panels, Cigna applies similar criteria, but again, Hankoff said, the insurer wants to ensure that every test included in a panel will affect clinical decision making.
“Back in 2011 and 2012, genetic tests were ordered one at a time,” he explained. “But then we started to see panels of two to three genetic tests combined together. Now, we see genetic testing panels with as many as 95 to 100 individual tests.
“Unfortunately, many of the tests included within these multi-gene test panels have unknown clinical significance,” Hankoff stated. “Not only is it difficult for a clinician to explain what that means, but it could cause more worry for patients. These genetic test results also become a permanent part of that individual’s medical record, which could affect a life insurance application, for example, and lead to more testing—including invasive tests without any clear benefit.
“These points illustrate how Cigna, like other insurers, struggles with how to make appropriate coverage decisions regarding genetic test panels,” he concluded.
“Instead, we look at the value that genetic counseling brings. We started this program with the idea of improving quality, and we think we’ve accomplished that,” stated Hankoff.
Pathologists and clinical laboratory directors may wonder what happens when a doctor orders a genetic test without getting the required genetic counseling first. “I understand that concern among labs,” Hankoff responded. “Very often when a doctor sends the lab order, that doctor expects the lab to run it and does not know pre-certification is required. That was a complicating factor in 2013, but we have moved past that now.
Systems In place
“Currently, with most network laboratories, Cigna has systems in place to allow genetic counseling and pre-certification to occur before the test is run,” he stated. “Because the specimen won’t spoil, the lab can hold it while the counseling is done. ”
Clinical labs also may ask if Cigna always covers genetic counseling. Hankoff responded, saying the insurer follows its employer-clients’ medical benefit plans, and only rarely do some of those plans not include coverage for genetic testing.
“If a patient has a medical benefit plan that excludes genetic counseling, that would be the only possible exception because most people who have an exclusion on genetic counseling also have an exclusion on genetic testing,” he said. “And, about 85% of our business is for employers who hire us to manage their benefit plans according to their benefit policy designs. Those contracts are called administrative services only (ASO).
Benefit plan Language
“If an ASO client does not want to pay for genetic testing, Cigna must follow their benefit plan language,” he added.
“Genetic counselors do more than give the patient the implications of the test before the testing,” he observed. “They meet with patients after the testing to explain what the results mean, not only to them, but to their parents, their brothers, sisters, and children.
“Also, the genetic test a doctor might order may not be the most appropriate one for that patient,” continued Hankoff. “For example, a patient’s mother may have a specific genetic abnormality following her cancer diagnosis and that’s the one for which we need to test.
“There are times when a doctor might recommend a whole panel, and the genetic counselor will find that a test for just one gene is best,” he added. “Also, it could go the other way. The doctor may order a single genetic test and the counselor would suggest more comprehensive testing with three or four genetic tests.
“This is what I mean by saying Cigna follows what the genetic counselors recommend,” Hankoff said. “In fact, a genetic counselor may say a patient doesn’t need genetic testing at all. At that point, we hope that the genetic counselor will act as a consultant and explain to the ordering physicians the implications of not doing any genetic testing.
Yearly Increase In Testing
“For all these reasons, when it comes to genetic counseling and testing, Cigna does not focus on adding costs or requiring genetic counseling,” noted Hankoff. “It’s about improving quality in a rapidly-advancing area of medicine. We knew, starting before 2013, that the number of genetic tests ordered would increase year after year. And, that’s exactly what’s happening.
“Having said that, we believe that we have at least blunted the increase in costs associated with genetic testing,” he added. “We can’t prove that. Also, we can’t compare our expenditures for genetic testing to other health insurer’s genetic testing costs because the information is not available.
“Another reason why it’s difficult to know exactly how much Cigna spent before 2013 is because claims were sub- mitted that used stacking codes,” noted Hankoff. “Thus, Cigna couldn’t isolate out how much money spent on lab tests was for actual genetic tests.”
Contact Mark Slitt at Cigna, 860-226-2092 or firstname.lastname@example.org.