Originally published on Feb. 9.
By Turna Ray
Myriad Genetics last week defended its practice of urging doctors to counsel patients before they get genetically tested for their risk for hereditary breast and ovarian cancer, instead of referring them to genetic counselors.
Responding to a government advisory panel's request for comment on its educational and marketing practices, the diagnostic firm marketing the BRACAnalysis test maintained that urging doctors to conduct genetic counseling in house instead of referring patients to an outside genetic counselor is legally sound, follows professional medical societies' standards, and accommodates the shortage of cancer genetics professionals.
In a letter to the HHS Secretary's Advisory Committee on Genetics, Health, and Society, Myriad stated last week that the company's sales reps avoid conflicts of interest by not taking part in patient education about BRCA testing. Furthermore, Myriad said that the company encourages doctors to refer patients to genetic counselors for "complex cases."
The letter was in response to criticism from a patient advocacy group that last fall cited reports that Myriad had discouraged doctors from referring their patients to genetic counselors and requested federal agencies to monitor the marketing practices of diagnostics companies [see PGx Reporter 10-14-2009].
“Based on what we have witnessed it is our opinion and belief that Myriad’s sales representatives discourage doctors and other healthcare providers from referring patients to genetics experts,” Lisa Schlager, outreach coordinator at Facing Our Risk of Cancer Empowered, said before SACGHS last October. During her presentation, Schlager also urged the committee to recommend that doctors be required to inform patients of genetic counseling options prior to ordering genetic tests.
When this issue was aired at last year's SACGHS meeting, committee members responded to Schlager's presentation with concern and invited Myriad to respond to the charges. Myriad's letter, submitted on Jan. 15 to SACGHS, was made publicly available at a SACGHS meeting held in Washington, DC, last week.
Responding to FORCE's main allegation that patients received incorrect genetic testing information from their healthcare provider as a result of Myriad's marketing practices, the company requested SACGHS to study the severity of these occurrences and suggest management strategies. "Such anecdotes point out the fact that not all patients receive the best medical care," Myriad wrote in its letter. "They are, nonetheless, anecdotes and require extensive study in order to determine their actual frequency and magnitude of impact."
While in the letter Myriad provides support for its policy of encouraging doctors to perform genetic counseling due to a dearth of genetics experts, nowhere in the document does the company discuss the availability of nationwide telephonic counseling, which several national payors have implemented due to concerns with inappropriate testing or overtesting with Myriad's BRACAnalysis tests.
United Healthcare and Aetna have instituted prior notification and prior authorization coverage policies for Myriad's BRACAnalysis tests [see PGx Reporter 11-04-2009]. Both payors also require patients receive telephonic genetic counseling through Informed Medical Decisions, a nationwide network of genetics experts available by telephone.
Amber Trivedi, senior genetic counselor at Informed Medical Decisions, told Pharmacogenomics Reporter this week that Myriad's sales reps probably don't highlight the availability of telephone-based genetic counseling to the oncologists and OB-GYNs with which they interact. Informed Medical Decisions has in the past attempted to partner with Myriad with little success, according to Trivedi.
However, following a recently inked partnership between Informed Medical Decisions and a health insurer in Michigan called Priority Health, Myriad will be required to provide doctors in the state information about Informed Medical Decisions' genetic counseling services, she said.
SACGHS also asked three federal agencies in charge of marketing and regulatory oversight of laboratory-developed tests — the US Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the Federal Trade Commission — to review Myriad's response letter and issue their own statements to the committee.
Since BRACAnalysis is a laboratory-developed test, CMS is responsible for ensuring laboratory quality under the Clinical Laboratory Improvement Amendments program. CMS noted that it works with FDA to conduct complex analytical validation reviews, but did not say it was reviewing Myriad's labs. The FDA explained it practices enforcement discretion over LDTs, and therefore "has not applied any oversight over Myriad or its tests." The FTC acknowledged it has jurisdiction to review advertising claims made by genetic testing companies directly to consumers, but said it does not clear ads ahead of their market launch.
In Line With ASCO Guidelines
At an investors conference last year, Myriad Genetics CEO Peter Meldrum said that the company's sales representatives urge OB-GYNs and oncologists to genetically counsel patients they would recommend for BRCA testing, instead of having them speak to a genetic counselor [see PGx Reporter 09-23-2009].
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According to Meldrum, the company initially perceived genetic counseling as a "bottleneck" to physician adoption of BRACAnalysis. However, Myriad worked with the American Medical Association and the Oncology Nurses Society to develop a course for physicians and nurses on how to perform genetic counseling within their practices. Furthermore, he noted that current payor policies favor genetic counseling by MDs over genetic counselors. While CMS reimburses licensed doctors who provide genetic counseling, the agency does not compensate genetic counselors who are not MDs.
In its letter to SACGHS, Myriad seems to suggest that state laws requiring a medical professional to order genetic tests means that they are also the best people to conduct genetic counseling. "In almost every state, a certified genetic counselor is not authorized to order a test and must do so through an ordering physician," Myriad said in the letter. "Individual state licensing statutes dictate not only who can order laboratory tests, but also who can engage in the practice of medicine."
Although many states require that a licensed medical professional order genetic tests, state requirements tend to be more flexible about who performs genetic counseling. Recognizing that many medical professionals lack genetics expertise, state laws generally allow counseling to be conducted by a doctor, nurse, or a licensed genetics expert.
With the growing prevalence of direct-to-consumer genetic testing, and the increasing availability of pharmacogenomic tests that discern drug response and adverse events, the need for increasing physician education in genetics has been recognized by health regulators, payors, and medical professional societies.
A survey of more than 10,000 doctors by Medco Health Solutions and the American Medical Association reported last year that while most docs believe that personal genomic information can be useful in their care for patients and help them make treatment decisions, the majority said they do not know enough about such tests.
Earlier this year, the American Society of Clinical Oncology issued a policy update on genetic and genomic testing for cancer susceptibility, in which it urged oncologists to educate themselves in advances in cancer genetics. "Forthcoming educational efforts by ASCO should focus on increasing preparedness among oncologists and other healthcare providers to administer genetic tests and to recommend appropriate follow-up care," ASCO states in that document.
Citing the above comment in its letter, Myriad said that by educating doctors on how to set up genetic counseling services within their practices, it is simply following ASCO guidelines and helping improve physicians' genetics knowledge.
However, ASCO's new statement, an update to its 2003 guidelines, addresses the availability of genetic tests with limited clinical benefit and direct-to-consumer genetic testing services, such as those provided by 23andMe, Navigenics, and Decode Genetics. With the above recommendation cited by Myriad, ASCO is generally urging doctors to educate themselves about the lack of clinical utility of certain cancer susceptibility mutations, become aware of tests not provided through a healthcare professional, and refer patients asking about such tests to independent genetic counselors when appropriate.
"Not all DTC testing companies offer counseling, and they may only offer counseling to consumers who pay additional fees," the ASCO guidelines state. "Where counseling is provided, there is some concern that advice offered by counselors employed by testing companies may be biased in favor of testing." Nowhere in the updated recommendations does ASCO express a preference for or against genetic counseling from an independent, licensed genetics expert.
Furthermore, although Myriad does engage in DTC advertising for its BRACAnalysis test, the company would not place itself in the same category as DTC genomics firms, since consumers cannot go to an online website and get tested on BRACAnalysis. A doctor must order Myriad's test on behalf of the patient.
The Gray Area: 'Complex Cases'
Myriad's 300 sales reps visit OB-GYNs and oncologists in geographic areas where the company has launched a DTC campaign for BRACAnalsyis, and educate doctors and nurses on how to conduct genetic counseling within their practices. Lately, Myriad's DTC sales push has been among OB-GYNs, who serve as the primary care doctor for many women.
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However, Myriad highlighted in its letter to SACGHS that its sales reps avoid conflicts of interest by not participating in patient education about BRACAnalysis and genetic susceptibility for hereditary breast and ovarian cancer. Additionally, there are circumstances when Myriad will tell doctors to turn to an outside genetics counselor, the company acknowledged.
"As in all areas of medical practice, when a healthcare professional feels a need to refer a patient to an individual who possesses more expertise, this should be done," Myriad states in its letter, adding that the company "encourages" physicians to refer "complex cases" to genetics experts.
However, Myriad doesn't illustrate the circumstances that would constitute a "complex case." According to Informed Medical Decisions' Trivedi, figuring out when a doctor might need the expertise of an outside genetics specialist may not be so black and white.
"If doctors don't have expertise in genetics then they aren't going to know what they don't know," Trivedi said. "A positive test result is fairly a straightforward, but there is lots of confusion on what to do with negative results. There are more instances of doctors inappropriately saying [that] if you have a negative result you're fine.
"But we know that BRCA isn't the be-all, end-all of breast and ovarian cancer risk," Trivedi continued. "Their family history, medical history, the presence of other risk mutations may still mean they have an increased risk of cancer. So, in such cases, doctors who aren't genetics experts might miss at-risk patients."
The fact the several national insurers have instated prior authorization policies for Myriad's test suggests that payors are also not entirely confident of physicians' abilities to discern these "complex cases." Data from several insurers show that around 20 percent of requests for BRACAnalysis do not meet requirements for BRCA testing under their policy. A United Healthcare official has cited competitors' data suggesting that as much as 80 percent of requests for Myriad's BRCA test are withdrawn after pre-certification and genetic counseling procedures are conducted.
"Sometimes it is difficult for providers to know what they do not know, and the use of certified counselors maximizes the member's experience and access to appropriate testing and minimizes the chance of incorrect or inappropriate testing," Karen Lewis, a medical policy and technology administrator at Priority Health, told Pharmacogenomics Reporter this week. "This is also a benefit to our providers as they, too, are able to access these services for consultation and it minimizes their burden to provide what is almost always a complex and time-consuming process."
Priority Health, a regional health insurance provider serving approximately 500,000 Michigan residents and more than 12,000 doctors in its network, recently began working with Informed Medical Decisions to offer telephonic genetic counseling services to its enrollees.
Priority Health’s decision to use Informed Medical Decisions as a provider for genetic counseling "arose from the need to be able to offer appropriate genetic counseling to more of our members who for various reasons (i.e.; distance, time, etc.) were either unable or unwilling to receive traditional face-to-face genetic counseling," Lewis said via e-mail. "We review all requests for genetic testing and it became evident to us that there were simply too many members for whom the appropriate genetic counseling was not being done prior to testing or the information was not complete and or accurate."
Physicians Can Do It
Contrary to the concern of some payors and the doctors' self-reported discomfort interpreting genetic tests, Myriad insisted in its letter to SACGHS that community-based physicians are capable of interpreting BRACAnalysis test results.
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Myriad cited a December 2008 study published in the Journal of Clinical Oncology by Keating et al., which surveyed 611 nonacademic community physicians who ordered BRCA1/2 testing and concluded that "community-based physicians appeared to be successful incorporating BRCA1/2 testing into their practices.
"Clearly, this is evidence that community physicians can capably perform genetic counseling and deliver genetic service to patients in their practices," Myriad stated, adding that its critics are focusing on what was "appropriate" in "yesterday's" guidelines.
However, Myriad does not mention in its letter that in the study by Keating et al., researchers also found that "physicians who were assisted by genetic counselors, nurse geneticists, or others (versus counseling by themselves), those who spent more than 60 minutes in counseling, and medical oncologists (versus surgeons or geneticists) were more likely to discuss all six [counseling] items."
This means that doctors who sought the help of genetic counselors were more likely to conduct a more thorough genetic counseling session. Approximately 34 percent of doctors surveyed conducted the counseling alone, while 35 percent of physicians were assisted by genetic counselors or nurse geneticists; 27 percent of doctors were assisted by other counselors.
For this survey conducted between August 2004 and December 2005, Myriad offered a $20 cash incentive to participating doctors and distributed the survey questionnaires. Furthermore, more than half of those who completed the survey were oncologists, while just over 10 percent were OB-GYNs.
Although the majority of Myriad's revenues for BRACAnalysis come from medical oncologists' offices, sales of the test took a hit in the primary care/OB-GYN market last year due to the downturn in the economy. This is when Myriad decided to bolster its sales push for BRACAnalysis in the primary care sector [see PGx Reporter 08-26-2009].
Based on Myriad's most recent sales figures, the company's sales strategy appears to have translated into increased profits. Myriad reported earlier this month that its second quarter revenues climbed 11 percent due to its sales teams and DTC marketing in the South and Mid West.
Since Myriad's sales reps are focusing more on the primary care market for women, another study published in Cancer Epidemiology, Biomarkers & Prevention by White et al. in November 2008, provides another view of how family physicians are handling BRCA testing. In that study, a web-based survey completed in 2006 of more than 1,000 family physicians found that 92 percent inappropriately referred a hypothetical patient for BRCA1/2 testing, 50 percent of physicians referred to a genetic counselor, and 8 percent did not refer for genetic testing.
The hypothetical patient was not appropriate for referral based on US Preventative Services Task Force guidelines. "Despite scarce and costly genetic services, family physicians were likely to inappropriately refer a low-risk patient who requested BRCA1/2 testing," the study authors concluded. "The implications of this inappropriate referral on women's screening behavior, genetic services, and health care costs are unknown. Clinicians and patients could benefit from education about the appropriate use of genetic services so that both are more comfortable with a decision against referral."
Furthermore, the study authors noted that "DTC marketing of BRCA1/2 testing and the tendency among American women to overestimate their risks of breast cancer create consumer demand as women 'self refer' to primary care clinicians and request genetic testing. Traditionally, genetic testing is provided in the context of appropriate genetic counseling or education, yet clinical genetic services in the US remain relatively scarce."
The dearth of certified genetics counselors is another argument in favor of urging more doctors to become proficient in genetic counseling. According to Myriad there are 200,000 primary care providers, around 3,000 genetic counselors, and fewer than 500 full-time cancer genetics professionals in the US.
With the advent of telephone-based genetic counseling, however, Informed Medical Decisions has the capacity to accommodate an additional 6,000 appointments annually, Trivedi said. The firm currently employs 25 genetic counselors with the ability to provide appointments throughout the entire week and is in the process of adding 20 more counselors. "So, we don't feel that Myriad's argument that there is a lack of genetic counselors is valid," Trivedi said.
The National Society of Genetic Counselors is currently evaluating how to best increase patients' access to genetic counseling services, including evaluating collaboration with other health care professionals and implementing telemedicine options similar to Informed Medical Decisions. "Ultimately, we want to help patients get the best care possible and help doctors provide high-quality care as efficiently as possible given the demands on their time," said Elizabeth Kearney, NSGC president-elect.