Hit by Many New Genetic Tests, Health Insurers Just Say ‘No’

OVERWHELMED WITH REQUESTS TO PAY for new genetic tests, health insurers, particularly smaller and regional insurers, find it easier to simply deny payment for such tests.

This is one of the insights shared during a panel discussion involving several managed care executives at the 20th annual Executive War College that took place in New Orleans last May.

To this point, panelist Paul von Ebers, formerly CEO of Noridian Mutual Insurance Company (which does business as Blue Cross and Blue Shield of North Dakota), explained that medical directors for smaller health insurers such as regional Blue Cross plans and regional non-Blue plans, cannot keep up with the scientific developments behind genetic testing.

“One Blue Cross medical director told me that the science is changing so fast and so many new genetic tests are being offered, that he and his colleagues are just overwhelmed,” commented von Ebers, who is CEO of Prospective Health, LLC, a consulting firm in Fargo, North Dakota. “When an insurer is not sure if it is paying for value, they make their best efforts to understand the science but the science is moving so fast that if they don’t have enough evidence they’ll deny it,” explained von Ebers.

“As health plans manage costs and quality today, they are mostly concerned with improving patient outcomes,” he continued.

“That is why insurers are much less concerned about such lab metrics as turnaround time. By itself, that’s not important to an insurance company. Instead, health plans want to know the scientific value of tests, meaning can a test produce a difference in clinical outcomes?

“Thus, any lab seeking to get health plans to pay for new genetic tests will need to show a relationship to clinical outcomes on a targeted basis,” emphasized von Ebers. “This is linked to personalized medicine, which means that health insurers are not going to pay for broad-brush testing approaches. Insurers will only want to pay for targeted testing where clear clinical indications exist that each genetic test is going to help a particular patient and change the treatment pattern.

“When clinical labs seek payment for new genetic tests, insurers want to know whether the scientific literature can be used to support a lab’s assertion that targeted testing will improve outcomes,” von Ebers explained. “I’ve talked to health insurance medical directors around the country and find that, yes, clinical literature makes a difference.

Peer review required

“And, I would go one step further. If a test for a particular genetic variation has been demonstrated to be related to a patient’s ethnic background, for example, then insurers will want to see evidence that the person being tested is from that demographic group,” he continued. “In other words, giving a genetic test to all patients would be inappropriate when the test is best for particular patients with a specific ethnic background. So the scientific literature is important but there are usually more specific rules that go beyond the literature.”

Affirming the need for medical evidence to guide appropriate use of genetic tests was panelist Richard J. Gentleman, Senior Director for National Contracting for Aetna Inc. in Blue Bell, Pennsylvania.

“Any literature used to support a particular test should be of high quality and peer-reviewed, noted Gentleman. “We use evidence-based guidelines, which means there’s got to be a credible article published in a peer-reviewed journal.

“The challenge with molecular testing is that not every marker and not every panel is going to give a clinician a clear direction of what he or she needs to do for that patient,” he added. “Not every genetic test provides a result that is actionable and where it is known that the action taken results in improved health outcomes for the member. Some tests have the potential to provide this value to patients, but they are too complex for the patient or the physician to know how to use them properly. Therefore, genetic counseling — which is not being used as much as it should be — needs to be a part of all discussions about genetic tests.

Use of Genetic Counselors

“Genetic counselors should be involved on the front end to explain to patients what genetic tests are available and clinically valuable to them and to help those patients understand their options. They also need to explain what the patient’s health plan covers so patients can make informed decisions,” he noted. “Aetna spends more than $1 billion annually on lab testing, and most of it is done in hospital-based labs. By contrast, very little genetic counseling is used to support testing, despite its availability as a covered benefit.”

Panelist Lynne Currie, Senior Director Statewide Networks and North Florida Regional Market, for Florida Blue in Jacksonville, also emphasized the role of genetic counselors when genetic tests are involved. “There is not enough expertise within health plans to identify which molecular or genetic test is appropriate in which setting and for which patients, because it seems there is a new test introduced everyday. Further, one of our challenges in making genetic counseling available is that it is most frequently provided via teleconference, which isn’t always a covered benefit.

Florida Toxicology Labs Drive Up Testing Costs

IN RECENT YEARS, EXECUTIVES at Florida Blue have seen growth in two worrisome trends, said Lynne Currie, Senior Director Statewide Networks and North Florida Regional Market, for Florida Blue.

“In Florida, toxicology labs seem to be coming out of the woodwork, and the administrators in these labs are finding innovative new ways to attract customers for toxicology testing,” she stated. “In recent years, we’ve seen rapid growth in the number of ‘sober houses.’ Entrepreneurs in South Florida have converted empty condominium buildings into sober houses that are very closely tied to specific toxicology labs.

“These sober houses advertise in the Northeast, in Michigan, and in Indiana in the winter when it’s cold and snowing. ‘Wouldn’t you rather be here for your drug rehab program in sunny Florida?’ they ask. ‘We have jet skis, volleyball.’ The FBI raided one sober house that had advertised that its residents would use a million-dollar boat as part of their rehab,” observed Currie. “These sober houses offer shuttle vans to take residents to local mental health counseling centers for Alcoholics Anonymous meetings.

“In many instances, the toxicology labs are doing full panel screenings every day — including quantitative and qualitative analysis — on the residents of these sober houses,” added Currie. “We had one member from another Blues plan come to Florida and his lab spend exceeded the cost of a 30-day stay in the sober house!

“For our own Florida Blue members, we updated our guidance on the appropriate frequency for qualitative and quantitative testing and that helped to control the spending,” noted Currie. “But we have many members from other Blues plans that don’t have the rules we have. These out-of-network sober houses refer to out-of-network labs, making it difficult for us to control appropriate utilization.”

“We need to come up with a solution to the genetic counseling problem, especially for esoteric tests,” added Currie. “Health insurers need trained experts who are totally independent of labs but who are expert in gene sequencing to help insurers identify the clinical differences from one patient to the next and which genetic test might be right for one patient but not the other.

Expert Guidance Needed

“Also, health insurers need guidance from experts on when it is appropriate to use these genetic tests,” she said. “For a woman diagnosed with breast cancer, when is it appropriate to have the BRCA test?

“Not every woman needs to have the BRCA test, but most women would rather have that test before a lumpectomy rather than afterward and then risk a second surgery,” explained Currie. “With so many genetic tests, health insurers do not have the answers to these types of questions.

“How do we, as health plans, especially one as big as Florida Blue is in Florida, determine what is the appropriate test by the appropriate lab and the appropriate continuum of care that will change the clinical outcome for the member for the better?” asked Currie. “This is why health insurers ask for evidence of clinical effectiveness, especially such evidence that is published in peer-reviewed journals.

“With the limited resources we have, how do we balance coverage for genetic testing with the need to design benefit plans that keep costs down?” she continued. “Another issue is that some health insurers still have a few legacy plans that don’t cover genetic testing.

“The reason those plans don’t cover genetic testing is because, in the past, when there was a broad panel test, we would evaluate the panel and determine that those tests had no effect on a patient’s clinical outcome,” noted Currie. “But those rules are not relevant for personalized medicine, when a genetic test may have great clinical value for a small number of patients.”
Turning to the practical aspects of payer guidelines for genetic testing in today’s healthcare system, Gentleman noted that, “Of course, when anyone is denied coverage, that patient can appeal the determination. Each appeal is handled case by case because, at the moment, determining whether to cover genetic tests is very challenging for insurers. In order for Aetna to expand coverage to a new genetic test, it must be demonstrated in the published, peer-reviewed literature to be clinically valid and clinically useful.

“Additionally, Aetna is often asked to look at specific genetic tests that may have some clinical utility but that do not make a difference in how physicians treat patients,” stated Gentleman. “For example, Quest Diagnostics Laboratories has a great test that can determine some level of risk for whether certain patients will have Alzheimer’s disease.

“But what does a physician do with that test result that shows a patient has a marker showing he or she has a 5% chance of having Alzheimer’s disease?” he asked. “Maybe for some people, that’s a great test. But that information currently has no effect on the patient’s treatment protocol.”

Pathologists as Consultants

To address these issues, von Ebers suggested that pathologists could provide more consulting services to providers. “Pathologists could consult with health systems on appropriate ordering and appropriate use of tests, particularly in accountable care organizations,” he said. “ACOs already need to develop national sources of expertise that they can share, just as Blue Cross plans have created national sources of expertise that they share.”

Contact Paul von Ebers at 701-306-1579 or paul.vonebers@prospectivehealthllc.com; Richard J. Gentleman at 215-775-6510 or gentlemanrj@aetna.com; Lynne Currie at 904-316-3313 or lynne.currie@bcbsfl.com.


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