|Keegan Murphy was born with a rare genetic disease. His mother, Kara Murphy, underwent genetic counseling. |
Genetic testing raises some vexing ethical questions, like whether it will cause unnecessary anxiety or lead to more medical procedures, including abortions.
Now, as the number of tests and the money to be made from them are exploding, another question is being asked by professionals in the field themselves. Is it ethical for genetic counselors, who advise patients on whether to undergo testing, to be paid by the companies that perform the tests?
While it might not always be immediately obvious to patients, some counselors offering them advice in hospitals and doctors’ offices work for the commercial genetic testing companies, not for the hospitals or doctors themselves.
Critics say the arrangement poses a potential conflict of interest, in that the company-employed counselors might have an incentive to recommend more testing than necessary or not to recommend a test offered by a rival laboratory. The practice, they contend, could undermine trust in the profession just as genetic counselors are poised to play a growing role in medicine, helping patients sift through an ever-increasing array of available genetic tests.
“Ultimately, the success of a corporate lab depends on the utilization of their tests, and therefore, so too does the job security of the genetic counselor,” Katie Stoll, a genetic counselor at the Madigan Health Care System, a government medical center in Tacoma, Wash., wrote recently on the DNA Exchange, a Web site for genetic counselors. Ms. Stoll said she worried that in some cases “the line between genetic counselor and sales representative is blurred.”
There are genetic tests for more than 2,500 diseases, up from fewer than 800 diseases in 2001, according to GeneTests, a database supported by the federal government. UnitedHealth, the big insurer, recently projected that spending on genetic testing in the United States would grow to as much as $25 billion in 2012, up from $5 billion in 2010.
Some leaders in the genetic counseling profession say that testing companies have supplied counselors to medical practices for more than 10 years with no evidence that patients have been harmed.
“I’ve never heard it being raised as a real issue in the quality of patient care,” said MaryAnn W. Campion, director of the master’s program in genetic counseling at Boston University.
Doctors who defend the arrangement say that they cannot afford to hire counselors on their own because reimbursement for counseling is low.
While Medicaid, Medicare and private insurers often pay for genetic tests, they are less likely to pay for the counseling sessions, sometimes lasting an hour or longer, that can precede and follow such testing. Most states do not license genetic counselors, and it can be hard for a nonlicensed practitioner to obtain reimbursement.
But testing companies can subsidize the typical $65,000 annual salary of the genetic counselors from testing revenues.
“The problem is that genetic counseling is a time-consuming, labor-intensive process that fundamentally is a money loser,” said Dr. Mark I. Evans, director of Comprehensive Genetics, a Manhattan practice dealing with high-risk pregnancies.
While Dr. Evans employs his own counselors, he said the use of company-employed counselors “allows patients who would not get access to this information to have it.”
About 9 percent of the nation’s approximately 3,000 genetic counselors now work for testing laboratories, up from 2 percent in 1990, according to the National Society of Genetic Counselors. However, the society estimates that only one-third of those directly counsel patients, with many others advising only doctors.
The company most known for placing counselors inside hospitals and medical offices is Genzyme Genetics, which was acquired by LabCorp in 2010 and renamed Integrated Genetics. Integrated Genetics says it has about 140 counselors offering services at 200 locations. These counselors deal primarily with prenatal testing.
Stephen Anderson, a spokesman for LabCorp, said the counseling was part of the testing service and that counselors were not compensated based on how many tests were ordered.
“Genetic counselors are not sales people,” he said “Our counselors are trained professionals that are looking to provide appropriate care, period.”
Mr. Anderson said doctors and hospitals using the counselors were not required to send samples to LabCorp.
Still, some doctors and executives in the testing business say LabCorp needs a certain volume of testing to justify placing a counselor in a doctor’s office. And the genetic testing industry certainly perceives that those counselors help bring testing to LabCorp.
Another testing company, Bio-Reference Laboratories, recently started hiring its own counselors to place in prenatal medical practices. “You can’t compete if you don’t go in and do it,” said Dr. Marc D. Grodman, chief executive.
Many genetic counselors say there is little risk for patients since genetic counselors are trained to discuss options with patients but not to make recommendations. Also, there are guidelines from medical societies as to which tests are appropriate.
Doctors who use the LabCorp counselors say that the counselors disclose the relationship to patients and bill patients separately. Also, some doctors say, they order the tests, not the counselors.
“I order a test because I want to order a test, not because they do,” said Dr. Lawrence Platt, director of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles. He said LabCorp paid rent to the practice for the space occupied by the counselors.
Still the American College of Obstetricians and Gynecologists, in an opinion published in 2008, stated that neutral counseling “may be compromised through the use of patient education material or counselors that are provided by a company that might profit from a patient’s decision to undergo testing.”
Dr. Richard Fischer, chairman of maternal fetal medicine at Cooper University Hospital in Camden, N.J., while saying he was pleased over all with the LabCorp counselors, said that he to resist the company’s counselors to offer a test to all pregnant women that was not recommended by ACOG.
Dr. Cathleen Harris of Scottsdale Perinatal Associates in Arizona said that after discussions with LabCorp, she opted not to use its counselors “in part because we didn’t want to have an exclusive agreement with them for all our lab tests.”
Kara Murphy of Fanwood, N.J., saw a Genzyme counselor after an ultrasound at a hospital suggested something might be wrong with her fetus. She said she thought the counselor worked for the hospital.
“Even if she handed me a card that said Genzyme on it, I have no idea what Genzyme is,” Ms. Murphy recalled. The counselor discussed numerous testing options, which Ms. Murphy said would have cost her $2,500 out of pocket, and, in retrospect, would not have found what was wrong.
She eventually went to Elena Ashkinadze, a genetic counselor at the Robert Wood Johnson Medical School and president of the Human Genetics Association of New Jersey. Ms. Ashkinadze, after ordering tests from various labs that cost Ms. Murphy $600 out of pocket, figured out the rare disease Ms. Murphy’s son would have.
Ms. Ashkinadze said it was not clear if Ms. Murphy had received bad advice from the Genzyme counselor. But Ms. Ashkinadze said having testing companies provide such advice could raise suspicions among patients. “We shouldn’t be pawns in the marketing scheme,” she said.
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