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UnitedHealthcare to Cover NIPT for Average-Risk Pregnancies

NEW YORK – UnitedHealthcare on Tuesday updated its medical policy to cover noninvasive prenatal testing for pregnant women with an average risk for carrying babies with trisomies 21, 18, and 13.

The Minnetonka, Minnesota-based insurer, the largest private health insurer in the US, had previously covered NIPT testing only for high-risk pregnancies. The change takes effect on Jan. 1, 2021.

In its revised policy, UHC said that it will cover DNA-based NIPTs for women with a singleton pregnancy of maternal age or oocyte age of 35 years or older at the time of delivery, or if a fetal ultrasound indicates an increased risk of aneuploidy.

It will also cover NIPT if a prior pregnancy had a history of a trisomy; for a positive screening test during the first or second trimester that indicates an increased risk for T13 or T21; or for screening after pretest counseling from a board-certified genetic counselor or from the prenatal care physician or healthcare professional using shared decision-making.

It will not cover testing for other conditions, such as multiple gestation pregnancies; twin zygosity; or repeat testing because of low fetal fraction. It also will not cover screening for trisomies other than T21, T18, or T13; or for microdeletions, single-gene disorders, or fetal RhD status.

UHC's policy change follows similar decisions by Humana, Centene, and Aetna to also cover NIPT for average-risk pregnancies. During the summer the American College of Obstetricians and Gynecologists issued new guidelines recommending prenatal aneuploidy screening for all pregnant women regardless of their age or other risk factors.

SVB Leerink analyst Puneet Souda said in a research note on Tuesday that UHC's new policy affects about 37 million covered lives and should be a positive for companies that provide NIPT for average-risk pregnancies, such as Illumina, "potentially Invitae," and especially Natera.

"With what we believe is a majority of lives now covered for average risk pre-natal testing, we expect Natera's focus to shift on driving adoption in the market," Souda wrote, adding about 80 percent of all pregnancies are considered average risk with NIPT reaching only about 20 percent of that market.

In a statement, Natera CMO Paul Billings also said that the average-risk NIPT space is "significantly underpenetrated and lack of payor coverage has been the primary barrier for broad adoption. …Today's announcement has the potential to have a positive impact on health outcomes for pregnancies in the US." 

"Natera is in a strong position to capitalize on the significant volume growth opportunity and improved test economics resulting from these policy changes," added Natera General Manager of Women's Health business Ramesh Hariharan. "We believe we are on track to achieve profitability in our Women's Health business in 2021."

Craig-Hallum's Alex Nowak said he expects that average-risk pregnancy coverage by UHC could add about $11 million of revenues immediately to Natera due to unpaid volume already run. For all payors, including UHC, Aetna, and Medicaid, the number is about $50 million.

"But more importantly, widespread coverage of average-risk prenatal testing, combined with the ACOG guideline, should dramatically increase prenatal penetration," Nowak said.

Shares of Natera were up 4 percent at $92.21 in late morning trade on the Nasdaq, while Invitae shares were up 5 percent at $52.37, and Illumina gained 4 percent to $334.80.