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Some Call for Expanded Payor Coverage of NIPS but Reluctance Remains

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The story previously stated that Anthem only covers NIPS testing for trisomies 21, 18, and 13 for high-risk patients. In fact, the insurer covers testing for the trisomies for all singleton pregnancies. We regret the error.

NEW YORK – Sure, if they build it, they will come. But who will pay for it?

As noninvasive prenatal screening (NIPS) tests become more popular with mothers-to-be, there is a growing push to expand payor coverage of the technology to a wider patient population, including average-risk expectant mothers. 

But to date, insurers have been reluctant to do so, and a new analysis, which suggests that expectant mothers want access to the technology, may not convince payors to change their policies.

In the preliminary analysis, researchers found that offering NIPS tests to a broader group of patients could result in greater uptake of the tests. Taking it one step further, the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, where the preliminary analysis was done, said in a statement that the work "provides evidence to support expansion of insurance plan coverage of" NIPS testing. 

The analysis is of a joint risk-sharing agreement between biotechnology company Illumina and insurer Harvard Pilgrim Health Care, under which Harvard Pilgrim expanded NIPS coverage for women younger than 35. Analyzing data claims for a one-year period, the researchers found a 42 percent increase in NIPS tests ordered, along with a 15 percent decrease in invasive tests for trisomy syndromes, such as chorionic villus sampling and amniocentesis. 

Brett McQueen, a researcher at the University of Colorado involved in the study, emphasized that because of the preliminary nature of the work, it might be premature to say that NIPS should be expanded to include pregnancies beyond high-risk pregnancies. He also warned that the changes in tests ordering behavior can't causally be attributed to the NIPS coverage change yet — part of the next leg of research will focus on finding the causes, which could have a significant impact on expanding NIPS coverage for all payors.  

After the risk-sharing agreement with Illumina finished, HPHC decided to extend coverage for average-risk patients beyond the agreed year. Michael Sherman, HPHC's chief medical officer, said in an email that the agreement with Illumina is unique, since the company took on the financial risk if the expected cost offsets didn't occur, which contributed to HPHC's decision to extend the agreement. HPHC also did an initial assessment of baseline costs to provide a point of comparison with the effects of the agreement, but he declined to provide details about the evaluation

While some insurers cover NIPS testing for patients younger than 35, many major private payors only reimburse for patients older than 35. Average-risk patients are covered in some states under Medicaid, but not all, since it's state-specific and depends on preauthorization requirements. 

One possible reason average-risk patients aren't covered for NIPS by payors is the lack of endorsement from the American College of Obstetricians and Gynecologists, said William Quirk, an analyst at Piper Jaffray who has kept an eye on NIPS coverage. ACOG currently recommends coverage of NIPS testing for high-risk patients, and there's no telling when or if their guidance document will be updated, although Quirk said he's optimistic, given the strong data supporting expanded offerings. Earlier this year, Natera published a study in the Journal of Clinical Medicine showing its Panorama NIPS test had an overall positive predictive value of 93.1 percent and that PPV differed minimally between average- and high-risk women. 

However, he also noted the potential disincentive for ACOG to endorse more widespread NIPS testing despite the fact that NIPS testing is generally more accurate than traditional prenatal screening. When ACOG endorsed NIPS testing in high-risk women, there was an associated decline in invasive procedures, Quirk said, which could have led to some physicians ending up with less volume and thus a decline in revenues. 

The medical industry's conservatism could be another reason, said Paul Billings, chief medical officer at Natera, which has advocated for NIPS testing for average-risk mothers-to-be. "It's hard to change an economic system which has kind of been tuned to the payors," Billings said, "even when better technology exists." 

While some of ACOG's hesitance to update its guidance may be due to a lack of data surrounding the benefits of expanding coverage, Billings said that stance ignores the thousands of women who are having their pregnancies screened via NIPS. 

Some payors may also be concerned about an increase in costs by expanding coverage, said Jim Goldberg, the chief medical officer for women's health at Myriad Genetics, which offers its Prequel Prenatal Screen. But the increased cost of expanding NIPS testing will likely be accompanied by a decrease in invasive procedures, which require more time and resources, and have increased clinical risks, he noted.

Research was presented at the ISPOR Europe conference in Copenhagen this week that looked at the impact of expanding NIPS testing on healthcare budgets. McQueen noted in an interview that there are challenges with doing an economic analysis based on claims data from one health plan since payment rates are contract-specific and could change depending on the insurer. 

One potential blind spot of the study is that it's limited to billing and claims data, he said. If the researchers had access to lab values and results, appropriate and inappropriate screening could be identified and they'd be able to determine whether patients received the appropriate recommended next course of action. 

Another issue with the claims data is that there are factors outside of researchers' control, an issue inherent when working with real world data. There's no way to know what role benefits managers played in accepting or denying claims, and if members move out of network, it can be difficult to follow up on that data. 

One advantage of the approach taken by the researchers, however, is that the data generated is much broader than what would be seen in a typical clinical trial, since it comes from HPHC's broad network of physicians, Sherman said.

Henry Garlich, the director of healthcare value solutions and enhanced clinical programs at Blue Shield of California, also noted that most health plans have a three-year life cycle, which limits payors' ability to track cost changes and monitor the impact of patients' long-term healthcare resource utilization. Blue Shield chose to provide coverage for average-risk patients after speaking to thought leaders in the field and reviewing evidence on coverage for all patients, rather than looking at the cost impact. 

"In this particular situation, we did not conduct any economic modeling or healthcare economic analysis," Garlich said. "This decision was about quality of care, irrespective of the costs."

Company standpoints

Yet, most major private insurers have chosen to largely limit coverage of NIPS testing to high-risk patients. Several did not respond to requests for comment, including UnitedHealthcare and Anthem. UnitedHealthcare only covers NIPS testing for high-risk patients, but Cigna and Anthem cover the tests for the three trisomies (13, 18, and 21) regardless of risk. However, Cigna and Anthem do not cover tests for sex chromosome aneuploidies or microdeletions. A Cigna spokesperson said in an email that the insurer follows the recommendations of ACOG in its coverage. 

An Aetna spokesman said in an email that the insurer covers NIPS tests in cases where there is a high risk for Down syndrome. For average-risk patients, the insurer covers screening with serum analytes combined with fetal ultrasounds, which could help identify a wider range of issues than NIPS tests, including obstetric complications and open fetal neural tube defects.

From the perspective of diagnostics companies that offer NIPS tests, including Natera, Myriad, and Invitae, the decision by payors to cover a broader group of pregnancies should be a no-brainer. NIPS testing isn't a perfect method, especially in cases of abnormal placentas or patients with a high maternal weight where the quality of the results could be impacted, but it's widely seen to be safer and more accurate than the alternatives, and Billings said its false positive and negative rates are far superior to previous methods.

"You should apply the test that has the highest quality, because you'll have fewer false positives," Billings said. NIPS testing can decrease the number of invasive procedures, such as amniocentesis, by limiting invasive testing only if a NIPS test is positive. When that happens, patients usually receive one of the more invasive tests to determine further details about the abnormality. 

"There's a tragedy in a miscarriage or a fetal anomaly caused by an unnecessary procedure," Billings said. "We should try to avoid as many of those as we can."

To be sure, expanding payor coverage of NIPS to average-risk patients would also boost the bottom lines of companies such as Natera. In an analyst note, Quirk estimated Natera's unreimbursed NIPS volume is worth $65 million. He also estimated that Myriad could gain approximately $27.1 million if their test volume was fully reimbursed. 

Natera, Myriad, and Invitae's tests all detect autosomal trisomies 13, 18, and 21, along with monosomy X and five major microdeletions. Natera currently has a study in progress looking at 20,000 patients to evaluate the clinical utility of its Panorama NIPS test, the results of which Billings said would likely be available in the second quarter of 2020. The company's SMART (SNP-based Microdeletion and Aneuploidy Registry Trial) study has enrolled 20,000 pregnant women at 21 medical centers and will look at both common trisomies and microdeletions.

Robert Nussbaum, Invitae's chief medical officer, emphasized the importance of NIPS as a screening test, not as a diagnostic test. Despite data showing NIPS is more reliable than traditional screening, Nussbaum warned it shouldn't be the only method when deciding whether to terminate a pregnancy. Instead, a positive NIPS test should encourage patients to undergo the more invasive procedures to learn more about the potential chromosomal deficiency and defend against potential false positives.