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Tough Insurance Climate, Costly Gene Dxs Prompt Rise in Reimbursement Advocacies

Facing a tough reimbursement environment, diagnostic testing companies are increasingly launching programs to help patients interface with their health insurance companies with the goal of improving customers' chances of getting coverage for genetic tests.
Signature Genomic Laboratories is the latest diagnostic services firm to launch such a program. Under its “patient advocacy program,” Signature helps doctors and patients garner reimbursement for the genetic tests it provides by conducting benefits investigations, submitting pre-authorization claims, securing “out-of-network” coverage for medically necessary tests, and filing appeals against coverage decisions.
“Our goal is to educate insurance companies in regards to the benefits of our testing and improve claim outcome,” Catherine Kashork, Signature's director of operations, told Pharmacogenomics Reporter this week. “This may require a letter of medical necessity or just a brief description of the utility of our assay in comparison to other similar genetic technologies.”
Signature, a Spokane, Wash.-based firm, launched its patient-advocacy program in March. The company began offering its array comparative genomic hybridization-based cytogenetic testing service four years ago. The service currently offers testing for adult and pediatric patients, as well as a prenatal screening service.
The company's insurance advocacy program will encourage authorized healthcare providers to request a benefits investigation directly. According to Kashork, the investigation may include a pre-authorization if the insurance carrier requires one prior to testing, or patients can proceed with testing and Signature can file a claim with the insurance company. The company will also appeal an insurer's unfavorable decision up to three times, and offers customers a payment plan for costs not covered by insurance. Signature's tests cost between $1,500 and $2,000.
“Our patient advocacy team is taking the burden off the healthcare provider and keeping the patients informed of their benefit coverage,” Kashork said. Signature encourages healthcare providers and patients to use its service prior to sample submission for testing, and has developed a series of responses for different claim denials.
However, given insurers’ increasingly stringent evidence demands on genetic test makers to prove their products' clinical utility and validity, it remains unclear to what extent such insurance advocacy programs will improve patients' chances of garnering coverage for a given test.
Growing Trend
While many of the large pharmaceutical companies have been offering insurance assistance through patient advocacy programs for the last 10 to 15 years, the concept is still fairly new in the emerging molecular diagnostics industry. A behemoth like Pfizer can have significant clout when tussling with insurance companies over claims. However, given the evolving state of the science, the tentative regulatory environment, and the lack of randomized clinical data for many genetic tests, reimbursement is an uphill battle for most diagnostic companies.
Roche officials have spoken out against insurance companies that hold diagnostics to the same evidence standards as drugs and other medical products, which the Swiss giant believes results in too-stringent coverage requirements for genetic tests [see PGx Reporter 04-25-2007].
In contrast, Genomic Health is one company that has attempted to meet insurers evidence demands for its Oncotype DX breast cancer recurrence test, by conducting the necessary studies, publishing the data in peer-reviewed journals, and receiving inclusion in treatment guidelines from oncology professional groups. According to company officials, while reimbursement still remains a barrier, Genomic Health has had significant success convincing payors to provide coverage for Oncotype DX [see PGx Reporter 05-23-2007]. 
Most likely as a result of the difficult reimbursement environment, patient insurance assistance programs are beginning to take hold in the diagnostic industry. Kashork acknowledged that while Signature’s program is new for the company, the firm isn't the first genetic testing company to launch such an effort.
Myriad Genetics' Reimbursement Assistance Program, or MRAP, offers patients help with insurance billing and reimbursement issues associated with testing for hereditary cancer risk. The company's program offers customers three choices for payment: insurance payment with pre-authorization, insurance payment without pre-authorization, and patient payment, in which the customer is responsible for the full cost of the test.
If the patient chooses to be tested without pre-authorization from the insurer, and then the insurer refuses to pay, then the customer is responsible for the full cost of the test. This could be costly: Myriad's BRACAnalysis test to gauge breast and ovarian cancer risk costs more than $3,000.
Laboratory Corporation of America also has a multi-pronged approach to ensuring coverage for its tests.
According to an assessment of LabCorp's system by the HHS Secretary's Advisory Committee on Genetics, Health, and Society the company begins the process by informing insurance plans about a new genetic test before or as soon as it is launched.
Then the company tries to establish the clinical utility and validity of its products by providing insurers with peer-reviewed documentation, evidence of improved health outcomes, cost assessments, professional society endorsements or comments, federal agency opinions or recommendations, CMS coverage decisions, and public or political mandates to assist in the plans’ technology review processes.

“In regards to other genetic testing, I am not aware of Kaiser's coverage or need for patients to get testing outside of our system.”

Additionally, LabCorp provides physicians and patients with educational materials about its tests “in advance [of] beneficiary notices to prepare patients for potential out-of-pocket costs they might incur if the test cost is not reimbursed by their health insurance plan,” SACGHS said last year in a report, entitled “Coverage and Reimbursement of Genetic Tests and Services.”
After insuring there are appropriate CPT codes for its testing services, and “once coverage and payment are established, the company will monitor payment and denial trends to correct any deficiencies in payment and resolve issues related to the medical necessity of testing,” the report states.
Although genetic testing companies have put in place such extensive advocacy programs in an effort to maximize reimbursement for its customers, they tend to paint a rosy picture of their experience garnering reimbursement for their genetic tests.
While Myriad warns on its website that “some insurers may not pay for testing without pre-authorization,” and that “each [reimbursement] situation is unique,” the company reassures that “most insurance carriers cover genetic testing services [and] the average patient pays only 10 percent of the test price out-of-pocket.”
Similarly, as reported in Pharmacogenomics Reporter sister publication BioArray News, Signature also claims to have received a “positive response” from health-insurance companies.
And although many large insurers do not yet cover genetic testing to dose warfarin, in previous interviews with Pharmacogenomics Reporter, LabCorp has maintained that it has not encountered any difficulty garnering insurance coverage for its CYP2C9 and VKORC1 tests.
Despite these companies' optimism, several insurers have publicly expressed their unwillingness to cover certain marketed genetic tests without more clinical evidence of the efficacy and utility of the assays [see PGx Reporter 12-19-2007]. 
Is Patient Advocacy Working?
According to the SACGHS report, “obtaining prior authorization or advance payment [of genetic tests] can require significant time and effort by the patient and/or provider. In instances where the patient’s health insurance plan will not pay the total charge, the outstanding charge is billed to the patient.
“This amount can be prohibitively expensive depending on the cost of the test and the insurer’s reimbursement rate,” SACGHS notes.
Amid a difficult reimbursement environment coupled with the high cost of genetic testing, it is understandable why diagnostic testing companies are launching reimbursement assistance programs. Still, it is currently unclear to what extent the companies' advocacy actually improves the customer's chances of being reimbursed for a genetic test.
The SACGHS report states: “Although such efforts improve the likelihood of adequate payment, problems such as denial of or partial payment persist.” Furthermore, it appears that at least two major insurers go by their own assessments and studies to determine what genetic tests to cover.
Kaiser Permanente, the nation's largest managed care company, has “not made the genetic tests specific to warfarin patients widely available to [its] practitioners outside of research ...” The “usefulness [of such tests] is still unclear,” Mary Beth Dowd, a clinical pharmacy specialist in anticoagulation at Kaiser, told Pharmacogenomics Reporter this week.
“In regards to other genetic testing, I am not aware of Kaiser's coverage or need for patients to get testing outside of our system,” Dowd said. “If a patient requires some type of genetic test, we would process most of our tests in house, which includes genetic tests for thrombophilias and the genetic tests for the [warfarin] research study.”
She continued that "negotiations" with diagnostic companies on behalf of patients, like Signature's, for instance, “just don't happen or happen infrequently.”
Kaiser is conducting its own studies to look at the genetic underpinning of drug response. Last year, Kaiser's Northern California Division of Research announced plans to create a large repository of genetic material in order to examine the genetic and environmental factors affecting disease and patient response to medications [see PGx Reporter 02-28-2007]. 
Another company, Aetna, an insurer that covers 15 million lives, late last year began offering confidential telephone and web-based genetic counseling services for cancer patients belonging to plans that cover genetic testing [see PGx Reporter 01-02-2008]. After counseling, if the counselor determines genetic testing to be necessary for the patient, then a printed report is sent to the primary care physician, who can then order a test for the patient.
Aetna provides genetic counseling only for the tests it covers. Therefore, “if those counseling conversations ultimately recommend that a test be done, those tests are already covered benefits for Aetna members,” Joanne Armstrong, Aetna’s senior medical director and an architect of the company’s genetic-counseling program, has previously told Pharmacogenomics Reporter.
Given this policy, it is unclear to what extent Aetna would be willing to accept appeals from diagnostics companies' patient advocacy programs to reimburse for tests it doesn't already cover. Aetna did not answer questions about its reimbursement policies prior to deadline.
WellPoint, another insurer that, along with Aetna and Kaiser, does not cover genetic testing for warfarin due to lack of clinical utility evidence, also has an extensive internal process for making “medical necessity and experimental/investigational determinations for certain new medical technologies,” a classification many genetic tests would fall under.
According to a WellPoint spokesperson, the company's “medical policy development” process for such products is determined by its Medical Policy and Technology Assessment Committee, a multidisciplinary group of physicians, who meet three times a year to review scientific literature and consult the medical community about the company's new policies.
“The principal component of the [medical policy development] process is the review for medical necessity and experimental/investigational determinations for certain new medical technologies and/or procedures and/or for new uses of existing technologies and/or procedures,” the company states in a document outlining its procedure. “Medical policies are intended to reflect the current scientific data and clinical thinking.”
However, WellPoint does review individual cases if a medical policy on a particular non-medically necessary or investigational product is unavailable. In this situation – which many company-administered patient advocacy programs may have to face – “a physician designated by the health plan, will review the request using the technology assessment criteria and appropriate standards that may include ... peer-reviewed literature, other organizations' technology evaluations including the Blue Cross Blue Shield Association, Agency for Health Research and Quality, various medical specialty societies' guidelines, and assessment and the clinician's professional judgment.”
The WellPoint spokesperson added that the company “recognizes the emergence and importance of certain genetic tests to diagnose and predict disease, as well as to potentially save thousands of lives through early detection and treatment.
“As we become aware of new genetic tests, we determine whether there is sufficient evidence to suggest that their use is medically necessary,” the spokesperson said.

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