Cigna To Require Counseling Before Extensive Genetic Tests For Cancer

Original article by Matthew Sturdevant, The Hartford Courant, 8/19/13

Cigna Corp. will require customers to get genetic counseling before the health insurer pays for extensive testing to determine if they have genes associated with breast cancer, ovarian cancer, colorectal cancer or a heart condition called Long QT syndrome.

The Bloomfield company is the first major health insurer to adopt such a policy. The change takes effect Sept. 16.

The new policy reflects a shift in thinking among medical societies and cancer groups who now believe that far more people are getting tested than those who are at risk of having genes associated with various cancers or Long QT syndrome.

In medicine, there's a wide variety of genetics testing, and Cigna will continue to pay for many tests, said David Finley, national medical officer for enterprise affordability and policy at Cigna Corp. Some tests are applicable for some patients and not others, he said.

Cigna decided to manage genetic tests for breast cancer, ovarian cancer, colorectal cancer and Long QT syndrome because the tests are commonly requested and frequently misunderstood, Finley said.

In the current system, a patient tells her doctor that she is interested in getting genetic testing to see if she has a gene associated with breast cancer. The doctor then sends Cigna some of the patient's personal medical history, and the insurer makes a determination, "yes" or "no," about the genetic testing. The insurer would inform the patient of her appeal rights, if the testing is declined.

"That standard way of doing it, we did not feel met the needs of our customers because it didn't help to educate them, and this is a very complicated test, which a lot of people — meaning doctors and patients — don't fully understand," Finley said.

Finley said there's an increasing consensus among doctors that genetic counseling should be a part of genetic testing. For one thing, board-certified genetic counselors, on average, are better informed about genetics tests than doctors, especially as the field of study grows rapidly, Finley said.

The tests, Finley said, "are coming at a fast and furious rate."

"They have a lot of implications for patients and their families, and they are hard to understand. It's a new field," he said.

The new policy requires a consultation with a trained genetic specialist to determine a patient's risk of having a gene associated with breast cancer, ovarian cancer, colorectal cancer or Long QT syndrome.

Patients may either find a genetics specialist in Cigna's network, or have a consultation over the phone through InformedDNA of St. Petersburg, Fla. The telephone counseling will take an estimated 60 to 75 minutes before the genetic testing and 30 to 60 minutes after any test deemed necessary. Before the conversation even happens, the patient provides the genetic counselor with a medical history and a family history.

Cigna will rely heavily on the recommendation of the genetics counselor when determining whether a genetic test is necessary, and what type the patient should have, the company said. A patient will still be able to appeal Cigna's decision.

The CEO of InformedDNA, David Nixon, said in a phone interview Monday that genetic counselors are master's-level experts who are board-certified in genetics.

Nixon added, "There's a wide body of literature supporting that fact, that, when it comes to genetics, the vast majority of doctors recognize that genetics is important and the vast majority of doctors self-reported that they are not prepared to offer genetics services. So, they know what they don't know."

It might be that the specialist refers the patient for a different test than the one requested. For example, a patient might be aware of testing for mutations in the BRCA gene related to breast cancer. The gene has been in the news often and recently.

"Why are the medical societies, and others that have been thoughtful about this, why are they recommending genetic counseling?" Nixon said. "One: They know what they don't know and they know they need help. Two: The physicians don't want the liability of doing it wrong."

Additionally, there is little U.S. Food and Drug Administration oversight in genetics testing compared with that of the pharmaceutical industry or other medical fields, Nixon said.

"So, it's that much more difficult for a physician that's not a specialist in genetics to know what tests, what labs, what circumstances or scenarios are appropriate," he said.

Through the years, tens of thousands of Cigna's customers have received genetic testing, which is a new and evolving field. The most extensive testing can cost between $3,000 and $4,000, although less extensive genetic testing can cost hundreds of dollars. Cigna, however, expects that the money it will save from fewer people getting tests will offset the greater cost of providing genetic counseling, Finley said.

One of the companies that does genetic testing, Myriad Genetics Inc. of Salt Lake City, conducts testing for BRCA gene mutations.

"Myriad agrees that it is important to have appropriate controls for utilization of health care in place, but there is no evidence that doctors have been over-utilizing BRCA testing for their patients," Myriad spokesman Ronald Rogers wrote in a prepared statement. "In fact, we have been working closely with Cigna to ensure appropriate testing for patients who need it, and as a result 100 percent of Cigna's patients who receive testing for BRACAnalysis meet Cigna's testing criteria."

The Angelina Jolie Effect

Dr. Otis Brawley, chief medical officer of the American Cancer Society, said that Cigna's move is the right one.

"What Cigna's doing is what everybody ought to do," he said. "We have a large number of women who are concerned that they have a mutation that puts them at risk of breast cancer, and a very small percent of them who actually do."

In recent years, Brawley said, he has received calls from women who learned that they have genetic mutations of "unknown significance." Panicked, they get a double mastectomy. Sometimes, scientific advances later reveal that those same mutations posed no increased risk.

The recent publicity about Angelina Jolie's double mastectomy has also led to an increase in women concerned about the BRCA1 and BRCA2. Jolie had the two genes, which increased her risk of breast cancer by 85 percent, Brawley said. But the news of it has caused many women to focus on the BRCA genes exclusively and ignore other risk factors. Besides the two BRCA genes, there are three genetic mutations strongly linked to increased risk of breast cancer.

"Because of Angelina Jolie, you have people with the other three mutations going to get tested for BRCA1 and BRCA2, because they've heard of them," he said.

A genetic counselor, he said, can go through a patient's family history of disease and determine whether there is cause to test for BRCA1 and BRCA2. What patients might find, instead, he said, is that they should be tested for other mutations. For instance, a family with a history not only of breast cancer but of sarcomas and leukemia would suggest a greater risk of Li-Fraumeni syndrome, a hereditary disorder with a close link to breast cancer.

Another benefit to getting counseling is cost. If a patient knows that he or she is at risk for a specific gene, Brawley said, a test that focuses solely on that one gene costs only about $400.

Brawley said there have been effective efforts to increase awareness about breast cancer in recent years. Although much good has come out of this, he said, it has also led to some anxiety about breast cancer.

"We are very concerned about some of the emotions that go into this," he said. "I think women are best served if we take a deep breath and do things in a very rational and informed manner. I think going to a genetic counselor is part of that rational and informed manner."

Dr. Ellen T. Matloff, director of cancer genetic counseling at the Yale Cancer Center, said, "Thirty [percent] to 40 percent of these tests are likely ordered in error." That's because many of the health care providers who ordered the tests, and interpreted the results, don't have a background in genetics.

Matloff said that there have been documented cases of patients who have undergone preventive procedures — such as a double mastectomy — based on genetic tests' results, only to find that those results were misinterpreted.

Other Health Insurers

Cigna Corp. is the first of the large, national insurance carriers to adopt a policy requiring genetic counseling before the tests.

UnitedHealthcare spokesman Ben Goldstein said, "We believe it's always a good idea to check with a genetic counselor" before getting the test done.

WellPoint Inc., parent company of Anthem Blue Cross and Blue Shield in Connecticut, has a policy "that genetic testing is appropriate only when offered in a setting with adequately trained health care professionals to provide appropriate pre- and post-test counseling," said company spokeswoman Jill Becher.

Amanda Mueller, a spokeswoman for the regional insurer ConnectiCare, said: "ConnectiCare does require genetic counseling as part of our genetic testing benefit, which includes coverage for BRCA and colorectal cancer. ConnectiCare's health plans are designed to support early detection, diagnosis and care management support for our members facing the challenge of cancer."
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