So far, major insurance companies, citing limited studies about the tests’ accuracy and impact on patient care, consider them to be experimental and do not cover them. (Sequenom, the marketer of the MaterniT 21 Plus test, asserted this month that 15 percent of the U.S. population is covered by plans that will pay for the test, though it did not identify those plans.)
‘Not a clear endorsement’
The American College of Obstetricians and Gynecologists published its first opinion on the tests Nov. 20 and concluded they “should not be part of routine prenatal laboratory assessment.” However, ACOG said, the tests can be offered to patients at increased risk of having a baby with a trisomy, as long as they are counseled beforehand about the tests’ limitations. Previously, the National Society of Genetic Counselors and the International Society for Prenatal Diagnosis reached similar conclusions.
Because research has not yet proved that the new tests are as accurate as the standard invasive tests, all three organizations recommend that women with a positive result undergo amniocentesis or chorionic villus sampling to be sure.
“We clearly take ACOG’s opinion into consideration as we evaluate coverage policy,” says Julie Kessel, senior medical director of Cigna’s coverage policy unit. But, she adds, “it’s not a clear endorsement.”
Cigna typically reviews coverage of technologies annually, unless a “sentinel event,” such as firm new guidelines about their use, suggests the company needs to take another look sooner, Kessel says. The ACOG opinion is not such an event, she says, so the company likely won’t revisit the blood tests until July.
Aetna spokeswoman Tammy Arnold says her company is awaiting the results of more research into the tests’ accuracy and how testing affects women’s decisions about amniocentesis. Once studies of patients prove that the tests add value, Arnold says, “cost savings to the health-care system would be a welcomed bonus.”
Women are asking for the tests right now, however. “I don’t think anybody really anticipated that the consumers would drive this as much as they’re doing,” Bianchi says.
For now at least, the companies that market the new tests appear to be eating much of the cost. For example, the most that women with insurance have to pay out of pocket is $235 for the MaterniT21 Plus test (list price $1,900) and $200 for Verifi (list price $1,200), even if their plan declines to cover the test. Both companies offer self-pay options for women without insurance: The price is $450 to $500 for MaterniT21 Plus and an “introductory price” of $495 for Verifi.
Jeffrey Spencer, Ramona Burton’s OB-GYN at the Anne Arundel Medical Center in Annapolis, says that although questions remain about how best to use the tests, he needs to make his patients aware of them. “It’s so new we’re not sure the best way to do it. I feel I have an ethical obligation to make patients aware of the option.” (Spencer says he is a member of the speakers’ bureau of Sequenom, which markets the MaterniT21 Plus test, and is paid a fee when he speaks at the company’s request.)
Burton is one of several hundred higher-risk patients in his practice who have opted for MaterniT 21 Plus, Spencer says.
Mark Evans, a Manhattan OB-GYN, says his patients want to skip the standard screening tests and go right to the new tests. “My patients are the average New Yorkers,” he says, “who want their answers yesterday.”
Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.