CEO SUMMARY: Cigna launched a program that requires genetic counseling for patients and pre-authorization of genetic tests. Its partner is InformedDNA, a firm that provides genetic counseling services. The goals include better patient engagement, improved test utilization, and a process to evaluate the clinical effectiveness of new genetic tests. Cigna customers getting genetic tests for breast cancer, colon cancer, and the long QT syndrome will be provided with genetic counseling.
IN RESPONSE TO THE RAPID YEAR-OVER- YEAR INCREASE in the utilization of genetic tests, Cigna is the latest health insurer to implement a program to require patients to undergo genetic counseling. Pre-authorization of genetic tests will be part of this program.
Cigna will administer the Genetic Testing and Counseling Program. It is working with InformedDNA of St. Petersburg, Florida, which will provide genetic counseling services to Cigna customers by telephone. Also, InformedDNA will provide technical advice about emerging tests and other technical assistance.
Cigna announced the new program and its agreement with InformedDNA on July 23, 2013. Cigna wants to get ahead of what is becoming a major clinical, administrative, and financial challenge for health insurers: the rapid uptake of genetic testing by physicians.
Spending on genetic tests totaled about $5 billion in 2010. It is projected to increase to as much as $25 billion by 2020, according to a 2010 study published by UnitedHealthcare.
Recognizing the value of genetic testing, health insurers want to ensure that spending on these tests is appropriate. In its 2010 report, UHC noted that insurers had no way to assess the clinical value of each of the 2,000 genetic tests available at that time.
Assessing Clinical Utility
Cigna wants to use its genetic counseling and genetic test pre-authorization program to ensure the appropriate utilization of these genetic tests. When the program begins next month, customers will be required to undergo genetic counseling when getting genetic tests for breast cancer, colon cancer, and for long QT (LQTS) syndrome, a rare inherited heart condition.
In an interview with THE DARK REPORT, David Finley, M.D., Cigna’s National Medical Officer for Enterprise Affordability and Policy, said, “The growth trend in genetic testing is considerably higher than the actual growth trend in medical services.” He would not disclose the rate of genetic test volume that Cigna has seen in recent years.
“InformedDNA, our partner in this initiative, recommended that we begin with these three tests because they are relatively high volume and there is confusion about them,” said Finley. “Genetic counselors from InformedDNA will consult with Cigna customers by phone as part of this program.
“We plan to add other tests to this program for which genetic counseling would be appropriate,” he added. “That list of tests is much longer.”
In addition to the need to alleviate confusion among physicians and their patients about the appropriate use of these genetic tests, Cigna has also found a lack of transparency in how much time, effort, and resources labs put into genetic testing. “One source of this lack of transparency was the use of stacking codes by labs when submitting claims,” observed Finley. “This was common before January 1 of this year, the implementation date for the new molecular and genetic test CPT codes.
“When a lab submitted a claim that used stacked codes, we couldn’t tell which tests were done,” he explained. “That is because, for each genetic test, the lab would report different codes for DNA extraction, for DNA amplification, for DNA sequencing, and so on.
“Unless a molecular or genetic test had a specific CPT or HCPCs code, we could not tell which specific test the lab had performed,” he stated.
“But the stacking codes were deleted as of January 1,” said Finley. “Because the American Medical Association has assigned CPT codes to the 114 new tier 1 and tier 2 codes, we have an idea about the level of resource intensity that labs put into each genetic test.
“It’s not ideal because there are 10 levels of resource intensity,” he added. “But it’s better than it was. There is much more specificity now. As a payer, when processing these claims from laboratories, Cigna now has a higher comfort level about what genetic test it is paying for.
“Currently, if a physician requests a genetic test, we will use the criteria now in place to either: 1) pay for that test or not; or 2) to require genetic counseling or medical review,” noted Finley. “Our primary goal is to help ensure that individuals get appropriate genetic testing and quality care.
“In this first phase of our genetic counseling program, we will rely on the genetic counselors for the three tests mentioned earlier, “ he continued. “For other genetic tests, we will rely on our own policy department to make coverage determinations.”
Going forward, Cigna understands the need to evaluate new genetic tests. “Cigna has a rigorous process in place for making coverage determinations,” Finley stated. “If we get a request for a certain test and have a coverage policy for that test, we will apply it.
“But if we don’t have a policy for that genetic test, we will research it, meaning we will review what’s published in the peer-reviewed medical literature, and consult with the experts at InformedDNA,” he said. “If this test is requested once every year or so, we may leave it at that.
“In cases where a genetic test is requested several times a year, we will bring that published information to our medical technology assessment committee,” continued Finley. “About 15 doctors of different specialties make up the committee.
“This committee will make a determination about whether to cover that genetic test or not,” he noted. “Cigna does this for all new technology, including molecular tests, other lab tests, and new technology.
“Contrary to what some people believe, Cigna does not always follow what Medicare does with regard to covering genetic tests or other coverage decisions,” emphasized Finley. “We notice what Medicare does, but we make our own decisions by following the evidence. Cigna covers genetic tests only if they are associated with beneficial clinical outcomes.”
Cigna is making progress on establishing guidelines for the new molecular test CPT codes. “We are in the process of submitting a number of the tier 1 and tier 2 tests for coverage decisions,” stated Finley. “We currently have coverage decisions in place for about 50 of those tests.
“In addition, this is an ongoing process,” he said. “That is because, every month, many new genetic tests come out and the labs that developed these tests ask us to make coverage determinations. It is important that these genetic tests be properly reviewed.”
There is ample evidence that physicians themselves are struggling to stay current with all the genetic tests that are available. Studies show that physician ordering of genetic tests based on a prior indication of cancer in a patient’s family history was inappropriate about 60% of the time. That statistic was mentioned by Trisha Brown, MS, LGC, a genetic counselor and founder of Shama Consulting, during her presentation at last May’s Executive War College on Laboratory and Pathology Management, which took place in New Orleans.
Managing Patients’ Fears
Finley agreed that a certain number of genetic tests are indeed inappropriate. “The rate of inappropriate ordering may be in the 20% to 30% range,” he said. “While it’s not 60%, there is a problem with unmanaged requests for genetic tests and there is a problem if patients do not get counseling for these tests.
“It’s understandable, for example, when female patients worry that they might get breast cancer—particularly if there is a history of breast cancer in their family,” observed Finley. “But even women with no known history of breast cancer worry. They think they should have the BRCA test to make sure they are not at risk. We know there are a lot of faulty assumptions in that logic.
“First, at most, the BRCA mutation accounts for only about 5% of breast cancer in the United States,” he stated. “Thus, 95% of the cases of breast cancer have nothing to do with the BRCA mutation.
“Second, the fact that a patient tests negative for the BRCA mutation doesn’t mean she is not at risk for having breast cancer,” explained Finley. “In fact, that woman’s risk is still about the same as the risk for every other woman in the United States. The risk that a woman in the United States will get breast cancer at some point in her life is somewhere between 1-in-8 and 1-in-7.
Patients Want Screening Test
“These are the facts,” he continued. “Yet patients still want to get the screening test because they have heard about it and believe the results will help put them at ease.
“The second problem genetic counselors can address is the percentage of patients who have indeterminate test results,” noted Finley. “That means there is some kind of mutation in the gene but no one knows if that mutation is associated with an increased risk of cancer or not.
“This indeterminate result can make the patient uncomfortable and provoke anxiety,” he commented. “A genetic counselor is adept at addressing this issue and has more time to spend with the patient than a physician does.
“The third problem addressed by genetic counseling is that physicians may not be the ideal sources of information about these tests,” he noted. “Oncologists know the genetics of the tests they order. But many physicians have trouble keeping up with the latest information on many of the genetic tests available today.
“For these reasons, making genetic counselors available helps Cigna improve patient care and manage the growing volume of these genetic tests,” stated Finley. “But I want to emphasize that Cigna didn’t come to this decision on its own.
“Several of the specialty societies— including the National Cancer Institute—have made very definitive recommendations that genetic counseling should be done before certain tests,” he emphasized. “That includes the first three tests that we have identified.
“It’s important to note two factors about this program. First, the requirement for genetic counseling is the high profile element of Cigna’s efforts,” he said. “However, these three tests account for only about 20% of all the genetic tests that we will be assessing.
“The other 80% are mostly among the tier 2 codes,” said Finley. “We will make coverage decisions on those tests to ensure that they are associated with beneficial clinical outcomes.
Better Educated Patients
“The second factor I want to emphasize is that this requirement of genetic counseling will result in patients being better educated and better informed about the genetic tests done on their behalf,” continued Finley. “That means they will be able to play a larger part in their own healthcare decision making, which is an important part of providing good patient care.”
Here’s Why Genetic Counseling Is Needed: 50% of Genetic Test Orders Are Inappropriate
ABOUT HALF OF ALL GENETIC TESTS that physicians order are inappropriate for the patients involved, according to a genetic counselor. This is one reason why genetic counseling can be useful to both patients and physicians.
“With certain complex tests, we have found that up to 52% of genetic tests ordered may be inappropriate before a health insurer implements any type of prior authorization procedure,” observed Amber Trivedi, a genetic counselor and Senior Vice President of Provider and Client Services for InformedDNA, a company that provides genetic counseling services. “Further, even with a prior authorization process in place, it may be that the health insurer continues to see that 25% to 33% of genetic tests are ordered inappropriately. That’s why health insurers are interested in genetic counseling.
“There is a good reason why this happens,” continued Trivedi. “Typically most doctors are unable to get a detailed family history in the 15 minutes they have for each patient’s office visit. Contrast that with the one hour that a genetic counselor would spend with each patient. This session would review the patient’s history and the family history for three generations.
“Many insurers have policies in place to manage genetic testing, such as requiring pre-authorization,” she noted. “Cigna is the only major insurer to require genetic counseling prior to testing and for now that is limited to just three different genetic tests. Cigna has indicated that if this part of the program proves successful, it may require genetic counseling for additional genetic tests.
“We recommended that Cigna begin with these three genetic tests for the following reasons: 1) they are complex tests; 2) they are commonly ordered inappropriately; and, 3) these are three high-dollar tests, priced at $3,000 to $5,000 per test,” Trivedi concluded.