NEW YORK (GenomeWeb) – Aetna updated its medical policy for noninvasive prenatal testing this week, choosing not to cover screening for average-risk pregnancies. It will continue to cover NIPT for high-risk pregnancies.
In a research note published by investment bank Piper Jaffray, Senior Research Analyst William Quirk wrote that the "decision by Aetna is disappointing." The payor covers around 17.9 million lives.
The decision will impact all NIPT providers, but may particularly impact Natera, which has targeted its NIPT, Panorama, especially to the average-risk pregnancy market and has seen sales of its test in that market grow.
In its revised policy, Aetna wrote that it considers cell-free DNA testing "medically necessary for testing for fetal aneuploidy (trisomy 13, 18, and 21) in pregnant women with single gestations" who are at an elevated risk. Aetna defines that as have ultrasound findings, a history of fetal aneuploidy, a positive first trimester screening test, or women who are aged 35 years or older.
Aetna considers NIPT for average risk pregnancies, microdeletions, and rare autosomal fetal aneuploidies to be investigational and experimental because its "effectiveness has not been established" for those indications.
Quirk wrote that other insurers will also be revising their medical policies, including UnitedHealth in January. That insurer currently does not cover NIPT for average-risk pregnancies.
He added that there has been "less commercial payor progress in covering average-risk NIPT this year," though there has been progress in obtaining Medicaid reimbursement for NIPT.
"We believe Aetna (along with other payers holding out covering average risk) are waiting for [the American College of Obstetrics and Gynecologists] to formally endorse NIPT in women under 35," Quirk wrote. Currently, ACOG guidelines state that doctors may use NIPT in those women.
Shares of Natera were down around 3 percent at $10.62 in Friday afternoon trade on the Nasdaq.