Managed Care - February 2009 - (Page 25) with 5 to 10 codes,” says Hochheiser. “These are normal lab codes, but you can’t tell what test was done. We want to link the diagnosis to the code so we can follow people and see what’s going on. Hopefully at some time the CPT code will catch up. The OncotypeDX test has a specific code,” he adds, and new ones like it are badly needed. The first CPT code for genetic counseling didn’t even arrive until 2007, says Shappell. “If you can’t bill and institutions can’t get paid for what you do, it’s hard for them to want to hire you.” The test makers and marketers say that outdated coding has also hurt them. Many of the codes were created for tests that have been around for years. That can make it tough to gain payment for the new tests that often come at a higher price. “CPT codes and reimbursement schedules are antiquated, not consistent with the value a pharmacogenetic test can bring,” says Drew Fromkin, the CEO of Clinical Data, which markets tests that calculate a person’s likely response to drugs. “There are clearly constraints in the coding system. Even Mike Leavitt, secretary of health and human services in the Bush administration, acknowledged that the reimbursement system has to be overhauled. Payment has to become more commensurate with the value of the product. These are very complex tests, and in some instances the value proposition is high.” Direct-to-physician arrives These days, drug representatives are also sharing doctors’ time with sales people from the genetic test makers. Myriad Genetics touted its first quarterly profit ever in November after boasting of expanding its sales force to 250 for a direct-to-physician marketing campaign that complemented its consumer advertising campaign. Its products include a slate of genetic tests for a person’s risk of melanoma and of breast, ovarian, colorectal, endometrial, and pancreatic cancer. In 2007, Myriad underwent sharp criticism of a consumer campaign that highlighted its genetic test for a risk of ovarian and breast cancer. The test cost more than $3,000 and critics felt a direct-toconsumer effort would lead to overuse and needless anxiety for women. “It really preys on the fears of our society, and one of those fears is getting breast cancer,” Ellen T. Matloff, director of cancer genetic counseling at the Yale Cancer Center, told the New York Times. Myr- iad defended itself, saying that it had simply mounted an educational program. The company did not respond to queries from MANAGED CARE. While Myriad’s marketing tactics have come under fire, no one accuses the company of bad science. Its test detects mutations in the BRCA1 and BRCA2 genes, which can signal an increased risk of breast cancer ranging from 35 percent to 84 percent and a 10 percent to 50 percent risk of ovarian cancer — far higher than the norm. For now, Hochheiser adds, insurers are tackling the field individually, each one working to develop its own guidelines, learn about new tests, and classify which should or should not be covered. A new administration and new leadership at HHS may change all that, says Fromkin. But he’s not looking for any sudden turnaround. “I’ve been in health care 20 years,” says the CEO, “and usually things don’t happen overnight.” “Perhaps the new Obama administration can help change things,” offers Hochheiser, “so that the analysis can be done by a central group, much the way the U.K. and other European countries handle new medical technology. If a third-party payer says no, you’re suspect for denying based on cost alone. We have a lot of budget and pride at stake, and yet we’re suspect.” Still, Hochheiser says change is inevitable. “A new era is coming. Genetic testing will be a big part of it. MC For further reading Eckman MH, Rosand J, Greenberg SM, Gage BF. Costeffectiveness of using pharmacogenetic information in warfarin dosing for patients with nonvalvular atrial fibrillation. 2009. Ann Intern Med.150(2):73–83. Fleisher TA, Oliveira JB. Functional testing: An emerging approach for the evaluation of genetic disease. 2009. Clin Chem. Jan. 15 (published at http://www.clinchem.org/ ahead of print). Sanderson S, Zimmern R, Kroese M, Higgins J, Patch C, Emery J. How can the evaluation of genetic tests be enhanced? Lessons learned from the ACCE framework and evaluating genetic tests in the United Kingdom. 2005. Genet Med. 7(7): 495–500. Burke W. Clinical validity and clinical utility of genetic tests. 2004. Curr Protoc Hum Genet. Chapter 9: Unit 9.15. The Website www.genetests.org, maintained by the University of Washington and funded by the National Institutes of Health, keeps a running update on genetic tests and the labs that offer them. FEBRUARY 2009 / MANAGED CARE 25 http://www.clinchem.org/ http://www.genetests.org
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