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United Healthcare Issues Prior Notification Requirement for Myriad's BRACAnalysis Test


This story has been corrected from a previous version to note that United Healthcare is providing access to genetic counseling to any member requesting BRCA testing.

By Turna Ray

United Healthcare is requiring that Myriad Genetics first inform the insurer before testing policy holders on its BRACAnalysis test to establish their hereditary genetic risk for breast and ovarian cancer.

"During the current difficult economic environment, United Healthcare recently instituted a prior notification requirement for BRACAnalysis," Gregory Critchfield, president of Myriad Genetics Laboratories, told analysts and investors during an earnings call this week. "We have been working very closely with United Healthcare to assist physicians [with regard to] UHC's prior notification policy."

Furthermore, Critchfield added that United Healthcare has designated Myriad to "act on behalf of the patient and ordering physician to initiate the insurance notification directly" with the insurance company. Under the prior notification policy, United Healthcare "has agreed that physicians do not need to complete any special forms or extra genealogy charts, but that the current Myriad test request form is adequate for their purposes," Critchfield said.

By instituting a prior notification policy and placing Myriad in charge of determining which patients get tested, United Healthcare can monitor more closely which of its policy holders are receiving testing on BRACAnalysis. This type of strategy suggests that in the future, if United Healthcare finds that too many women are being unnecessarily tested on BRCA testing, the insurer may renegotiate its contract with Myriad.

In a July bulletin, United Healthcare informed Myriad that as of Aug. 16, the company must record and submit for verification the information required to assess a patient's genetic risk for the BRCA mutation and to make a coverage determination.

"In certain circumstances, physicians may be contacted following notification for additional information," United Healthcare informed in the bulletin. "The coverage determination made regarding BRCA testing for your patient will be based on the United Healthcare medical policy for BRCA testing, which is aligned with criteria developed by the organizations listed above." United Healthcare bases its reimbursement criteria on National Comprehensive Cancer Network and US Preventive Services Task Force guidelines.

Lee Newcomer, senior vice president of oncology at United Healthcare, recently cited data suggesting that without precertification and mandatory genetic counseling procedures many patients that should not be tested on BRACAnalysis would be unnecessarily tested. Myriad's BRCA test costs upwards $3000 [see PGx Reporter 08-12-09].

The insurer, which covers 70 million individuals in the US, has begun holding diagnostics companies responsible for ensuring the right people are getting tested with their products. At the same meeting, Newcomer said that it has instituted a similar policy with Genomic Health, where the company is responsible for making sure the right women are getting tested on Oncotype DX. Under the terms of its agreement with Genomic Health, if the insurer sees the test is being "erroneously used" in too many instances, then United Healthcare may renegotiate its reimbursement contract for Oncotype DX.

In its updated policy for BRCA testing, United Healthcare is also making available "improved access to independent and American Board of Genetic Counseling-certified genetic counselors." A telephone-based service through Informed Medical Decisions will provide genetic counseling to any member requesting BRCA testing, regardless of whether such testing is ultimately covered by United Healthcare.

According to Newcomer, the lack of patient and physician education is what often leads to unnecessary testing or inaccurate interpretation of tests. United Healthcare's expansion of genetic counseling services for BRCA testing is an effort to help improve doctors' and patients' comfort levels with genetic tests and genetic risk information.

For the time being, Myriad officials seem relieved that United Healthcare did not further tighten their reimbursement criteria for BRACAnalysis.

Under the prior notification policy, "we currently do not believe that United Healthcare's prior notification requirement will have a significant impact on our revenues," Critchfield said. "In fact, we are seeing an overall improvement in the patient reimbursement criteria from insurers," he added.

According to Critchfield, insurance coverage in the OB/GYN sector is beginning to approach rates seen in the oncology sector.

In reporting its fourth-quarter and fiscal year 2009 earnings this week, Myriad reported that revenue growth slowed in the second half of the year, due to the economic downturn. Sales of BRACAnalysis tests saw the most deceleration in the OB/GYN primary care market, since fewer women were going for their yearly checkups (see related story, in this issue).

"This makes sense, as patients not yet affected by cancer — which is the great majority of those in the OB/GYN segment — do not have as much urgency to be tested as those who are affected by cancer and who need the information to know what to do next for immediate treatment decisions," Critchfield said.

Myriad estimates the annual oncology market for BRACAnalysis to be around $450 million. Approximately, 70 percent of revenue from BRACAnalysis comes from the oncology sector, while 30 percent comes from the OB/GYN or asymptomatic screening sector.

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