OBJECTIVES : Illumina and Harvard Pilgrim Healthcare (HPHC) entered a performance-based risk sharing (PBRS) agreement specific to expanding coverage for cell-free DNA non-invasive prenatal testing (NIPT), a test for the most common chromosomal abnormalities, to pregnant women under the age of 35 years. This interim study assessed the change in use of screening and diagnostic utilization and expenditures in the post-expansion year beginning March 1, 2018 and the agreed upon baseline year of 2016 for all women under the maternal age of 35 years.

METHODS : We leveraged the HPHC claims database to identify women with at least one diagnostic or procedure code indicating a pregnancy event from January 1, 2016 to December 31, 2016 and from March 1, 2018 to February 28, 2019. We estimated total NIPT orders, total expenditures for all maternal screening and diagnostic testing, and all invasive procedures (i.e., amniocentesis, chorionic villus sampling) and compared these estimates between the baseline and coverage change year, after adjusting for number of unique pregnancies. Estimates are presented as percentage changes between the coverage change year relative to the baseline number of pregnancies and testing.

RESULTS : We identified 12,327 and 7,149 unique pregnancies in the baseline and coverage change years, respectively. After adjusting for unique pregnancies, coverage expansion for maternal age of 35 years or younger was associated with an increase in NIPT use of 63%, an increase in total pregnancy-related screening and diagnostic testing expenditures of 4%, and a decrease in invasive procedures of 16% during the change year as compared to the baseline year.

CONCLUSIONS : The PBRS agreement to expand NIPT was associated with a considerable increase in NIPT use, a modest increase in total testing and diagnostic expenditures, and a decrease in invasive procedures over the baseline year. These interim results will be continually updated with new claims adjustments.