Cynaburst
01-09-2008, 08:12 PM
Featured Story January 8, 2008
Article found here: http://www.aishealth.com/Bnow/hbd010808.html
Insurers Are Considering Changes to Coverage for Genetic Testing and Related Patient Counseling Services
Reprinted from HEALTH PLAN WEEK (formerly Managed Care Week), the industry's leading source of business, financial and regulatory news of health plans, PPOs and POS plans.
The increasing availability and growing clinical role for genetic tests and related counseling services is pushing health insurers to fine-tune clinical coverage policies. One example is the FDA's recent decision to update the labeling for the popular anti-clotting drug warfarin to include information about how patients' genetic makeup affects their response to the drug. Still, insurers vary widely in their coverage policies for genetic testing and counseling, and most still approve coverage for genetic tests on a case-by-case basis, one expert says. Some insurers are pushing for greater use of genetic counseling services, however. A new program launched last month by Aetna, Inc., for example, is aimed at expanding the availability and utilization of genetic counseling.
"It's a highly variable approach as to how insurers are proceeding with coverage decisions [for genetic tests]," says Drew Fromkin, CEO of Clinical Data, Inc., which provides comprehensive molecular and pharmacogenomics services.
Genetic tests available in the market today fall into four categories, he says:
(1) Direct-to-consumer tests such as whole genome scans. These tests are least likely to be covered by insurers.
(2) Tests that predict the risk of developing a condition for which there is no clear clinical intervention. For example, there are genetic tests that can predict the risk of developing Parkinson's or Alzheimer's disease, but there is no clinical treatment available for people found to be at higher risk. Insurers also rarely cover these tests.
(3) Tests that identify "hard-to-diagnose diseases that do have major impacts on the costs of care," Fromkin says. For example, Clinical Data, Inc.'s FAMILION test detects mutations that can cause cardiac channelopathies, which are rare, potentially lethal heart conditions such as Long QT Syndrome. That condition primarily affects people under the age of 45 and can cause sudden cardiac death. The genetic test can not only help diagnose the condition, but also aid providers in determining whether the best course of treatment is an implantable device or medication, he explains.
(4) Pharmacogenetic tests that use genetic markers to help physicians make treatment choices, such as by predicting a patient's response to a specific drug. The test used to assess patients' response to warfarin is one example.
Insurers are more likely to cover the third and fourth categories, Fromkin says, but he adds that payers still are making these decisions on a case-by-case basis rather than developing broad reimbursement policies that reduce the burden on the provider or testing company to obtain approval and collect payment. His firm has seen insurers start to cover FAMILION in a broader fashion, he adds, and the company is starting to sign contracts with health insurers that allow for an in-network supplier relationship.
Insurers Say They Are Studying Warfarin Test
Following the unanimous backing of an FDA advisory panel, the FDA said on Aug. 16 that it had approved an updated label for warfarin with genetic-testing information. According to FDA estimates, about 2 million people a year begin taking the drug, which is also known by the brand name Coumadin, to prevent blood clots, heart attacks and stroke. Patients' genetic makeup is one factor that helps determine how they will metabolize the drug. The updated labeling cites data related to these gene variants.
A month later, the FDA said it approved a genetic test that will help physicians assess patients' genetic makeup and therefore their potential response to the drug itself. The test costs range from about $125 to $500.
These tests that provide a "diagnostic/therapeutic link" are a "very, very promising area of medicine, says Joanne Armstrong, M.D., Aetna's senior medical director who developed the insurer's genetic counseling program. She says Aetna spent a "fair amount of time looking at this area" and has integrated genetic testing into medical management policies for some conditions, such as the hepatitis C virus. But for warfarin, she says, "the piece of information that is not clear is the clinical utility — how we use the test results to change treatment."
Many other health plans also don't cover genetic testing to establish the initial warfarin dose. Among them is Highmark Inc., which considers the test investigational, says Virginia Calega, M.D., the insurer's vice president of medical management and policy. "The studies [to establish effectiveness] are just starting," she says.
By comparison, these insurers do cover genetic testing for breast cancer patients who are candidates for Genentech, Inc.'s breast cancer drug Herceptin. That's because the drug is effective in treating tumors with too much HER2 protein; those tumors affect about 25% of breast cancer patients.
Armstrong says Aetna is starting to take a closer look at HER2 genetic testing, however. She notes that a recent study found that 14% of people on Herceptin never received the HER2 genetic testing, which costs about $100 for the test itself and another $50 to $150 for processing. "We're going to repeat that [study] among our members," she says. Another challenge with Herceptin treatment, she says, is that the American Society of Clinical Oncology (ASCO) and the College of American Pathologists recently warned that as many as 20% of positive HER2 tests are false positives, and as many as 10% of negative results are false negatives. "We are working on a number of strategies to drive clinician awareness" of possible inaccuracies in test results, she says. Aetna also plans to steer testing to labs that have demonstrated no more than a 5% false-positive and false-negative rate, as recommended by ASCO, Armstrong adds.
Meanwhile, another Aetna initiative seeks to boost genetic counseling. The insurer said Nov. 27 that it would make confidential telephone and Web-based genetic counseling services available to members whose benefit plans include coverage for genetic testing, as the vast majority does. The service will focus on colorectal, breast and ovarian cancers, and will be offered through Palm Springs, Calif.-based Informed Medical Decisions, a national genetic counseling company.
The new offering is intended to improve access to genetic counseling, Armstrong explains. There are only 2,000 trained genetic counselors in the U.S., she says, and most are based near academic medical centers. Moreover, many primary care physicians, whom patients might turn to for services, aren't trained in genetic counseling, she adds.
Patients start by completing a prescreening questionnaire on Informed's Web site. Members whose personal health or family history suggests an increased risk for an inherited cancer are urged to complete a more detailed family medical history and schedule a telephone consultation with a genetic counselor. That counselor helps members determine their risk level and assess whether genetic tests are appropriate. Informed charges patients not covered by Aetna $375 for such initial genetic counseling by phone.
Informed's genetic counselors also work with primary care physicians to order the genetic tests and interpret the results. The counselors also provide a second consultation with patients to review the information and discuss next steps, including any preventive health measures patients might take to reduce risks.
"We expect an increase in utilization of genetic counseling" as a result of greater availability of services, she says. The insurer also may see an increase in the utilization of medically appropriate testing, Armstrong adds, but says she has no specific projections. She notes that utilization of genetic testing now is fairly low.
Article found here: http://www.aishealth.com/Bnow/hbd010808.html
Insurers Are Considering Changes to Coverage for Genetic Testing and Related Patient Counseling Services
Reprinted from HEALTH PLAN WEEK (formerly Managed Care Week), the industry's leading source of business, financial and regulatory news of health plans, PPOs and POS plans.
The increasing availability and growing clinical role for genetic tests and related counseling services is pushing health insurers to fine-tune clinical coverage policies. One example is the FDA's recent decision to update the labeling for the popular anti-clotting drug warfarin to include information about how patients' genetic makeup affects their response to the drug. Still, insurers vary widely in their coverage policies for genetic testing and counseling, and most still approve coverage for genetic tests on a case-by-case basis, one expert says. Some insurers are pushing for greater use of genetic counseling services, however. A new program launched last month by Aetna, Inc., for example, is aimed at expanding the availability and utilization of genetic counseling.
"It's a highly variable approach as to how insurers are proceeding with coverage decisions [for genetic tests]," says Drew Fromkin, CEO of Clinical Data, Inc., which provides comprehensive molecular and pharmacogenomics services.
Genetic tests available in the market today fall into four categories, he says:
(1) Direct-to-consumer tests such as whole genome scans. These tests are least likely to be covered by insurers.
(2) Tests that predict the risk of developing a condition for which there is no clear clinical intervention. For example, there are genetic tests that can predict the risk of developing Parkinson's or Alzheimer's disease, but there is no clinical treatment available for people found to be at higher risk. Insurers also rarely cover these tests.
(3) Tests that identify "hard-to-diagnose diseases that do have major impacts on the costs of care," Fromkin says. For example, Clinical Data, Inc.'s FAMILION test detects mutations that can cause cardiac channelopathies, which are rare, potentially lethal heart conditions such as Long QT Syndrome. That condition primarily affects people under the age of 45 and can cause sudden cardiac death. The genetic test can not only help diagnose the condition, but also aid providers in determining whether the best course of treatment is an implantable device or medication, he explains.
(4) Pharmacogenetic tests that use genetic markers to help physicians make treatment choices, such as by predicting a patient's response to a specific drug. The test used to assess patients' response to warfarin is one example.
Insurers are more likely to cover the third and fourth categories, Fromkin says, but he adds that payers still are making these decisions on a case-by-case basis rather than developing broad reimbursement policies that reduce the burden on the provider or testing company to obtain approval and collect payment. His firm has seen insurers start to cover FAMILION in a broader fashion, he adds, and the company is starting to sign contracts with health insurers that allow for an in-network supplier relationship.
Insurers Say They Are Studying Warfarin Test
Following the unanimous backing of an FDA advisory panel, the FDA said on Aug. 16 that it had approved an updated label for warfarin with genetic-testing information. According to FDA estimates, about 2 million people a year begin taking the drug, which is also known by the brand name Coumadin, to prevent blood clots, heart attacks and stroke. Patients' genetic makeup is one factor that helps determine how they will metabolize the drug. The updated labeling cites data related to these gene variants.
A month later, the FDA said it approved a genetic test that will help physicians assess patients' genetic makeup and therefore their potential response to the drug itself. The test costs range from about $125 to $500.
These tests that provide a "diagnostic/therapeutic link" are a "very, very promising area of medicine, says Joanne Armstrong, M.D., Aetna's senior medical director who developed the insurer's genetic counseling program. She says Aetna spent a "fair amount of time looking at this area" and has integrated genetic testing into medical management policies for some conditions, such as the hepatitis C virus. But for warfarin, she says, "the piece of information that is not clear is the clinical utility — how we use the test results to change treatment."
Many other health plans also don't cover genetic testing to establish the initial warfarin dose. Among them is Highmark Inc., which considers the test investigational, says Virginia Calega, M.D., the insurer's vice president of medical management and policy. "The studies [to establish effectiveness] are just starting," she says.
By comparison, these insurers do cover genetic testing for breast cancer patients who are candidates for Genentech, Inc.'s breast cancer drug Herceptin. That's because the drug is effective in treating tumors with too much HER2 protein; those tumors affect about 25% of breast cancer patients.
Armstrong says Aetna is starting to take a closer look at HER2 genetic testing, however. She notes that a recent study found that 14% of people on Herceptin never received the HER2 genetic testing, which costs about $100 for the test itself and another $50 to $150 for processing. "We're going to repeat that [study] among our members," she says. Another challenge with Herceptin treatment, she says, is that the American Society of Clinical Oncology (ASCO) and the College of American Pathologists recently warned that as many as 20% of positive HER2 tests are false positives, and as many as 10% of negative results are false negatives. "We are working on a number of strategies to drive clinician awareness" of possible inaccuracies in test results, she says. Aetna also plans to steer testing to labs that have demonstrated no more than a 5% false-positive and false-negative rate, as recommended by ASCO, Armstrong adds.
Meanwhile, another Aetna initiative seeks to boost genetic counseling. The insurer said Nov. 27 that it would make confidential telephone and Web-based genetic counseling services available to members whose benefit plans include coverage for genetic testing, as the vast majority does. The service will focus on colorectal, breast and ovarian cancers, and will be offered through Palm Springs, Calif.-based Informed Medical Decisions, a national genetic counseling company.
The new offering is intended to improve access to genetic counseling, Armstrong explains. There are only 2,000 trained genetic counselors in the U.S., she says, and most are based near academic medical centers. Moreover, many primary care physicians, whom patients might turn to for services, aren't trained in genetic counseling, she adds.
Patients start by completing a prescreening questionnaire on Informed's Web site. Members whose personal health or family history suggests an increased risk for an inherited cancer are urged to complete a more detailed family medical history and schedule a telephone consultation with a genetic counselor. That counselor helps members determine their risk level and assess whether genetic tests are appropriate. Informed charges patients not covered by Aetna $375 for such initial genetic counseling by phone.
Informed's genetic counselors also work with primary care physicians to order the genetic tests and interpret the results. The counselors also provide a second consultation with patients to review the information and discuss next steps, including any preventive health measures patients might take to reduce risks.
"We expect an increase in utilization of genetic counseling" as a result of greater availability of services, she says. The insurer also may see an increase in the utilization of medically appropriate testing, Armstrong adds, but says she has no specific projections. She notes that utilization of genetic testing now is fairly low.