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CombiMatrix Aims to Boost Reimbursement for Miscarriage Test

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NEW YORK (GenomeWeb) – Amid a growing body of clinical evidence supporting microarray-based miscarriage analysis testing, CombiMatrix is stepping up its efforts to win reimbursement for its own such test among the handful of payors that have yet to cover it.

Meanwhile, the company continues to see growth among its offerings with lower reimbursement risk, namely its recently launched CombiPGS preimplantantion genetic screening test for women undergoing in vitro fertilization.

Although CombiMatrix's pregnancy-loss business has been growing, with recently reported fourth quarter revenues from these tests increasing 31 percent year-over-year, the firm has encountered some resistance among a small number of payors.

"The lion's share of the payors see the efficacy of what we're doing, the quality we're delivering, [and] how we're saving money," CombiMatrix President and CEO Mark McDonough told GenomeWeb this week.

However, a "handful" continue to issue non-coverage decisions for the recurrent pregnancy-loss test, siding with a committee opinion from the American Congress of Obstetricians and Gynecologists (ACOG) that deems data on the clinical utility of chromosomal microarray analysis (CMA) for first- and second-trimester pregnancy losses as too limited to recommend the approach, he said.

But since that opinion was issued in 2013, "there has been a litany of articles … talking about the efficacy of miscarriage analysis and why recurrent loss testing using microarrays is very important," McDonough said.

"We think [these payors and ACOG] are working off of a little bit older data," he added. "It's a challenge we're going to work through."

Indeed, a number of publications have appeared in the literature over the past year and a half pointing to the benefits of microarray analysis over the standard karyotyping for identifying chromosomal abnormalities in miscarriage tissue.

For instance, in July 2013 a team from the University of Birmingham reported that the results of a meta-analysis found an increased detection rate of chromosomal abnormalities with CMA compared with karyotyping.

And in October, CombiMatrix presented data showing that chromosomal microarray analysis of more than 4,000 miscarriage analyses yielded a successful result over 85 percent of the time. In contrast, standard karyotyping methods are successful at analyzing miscarriage tissue only about 60 percent of the time.

To McDonough, a key task for CombiMatrix is to educate payors about the benefits of CMA for pregnancy loss and win reimbursement from the few holdouts.

To that end, the company has recently hired Karen Warner, formerly director of payor relations at Bake Integrated Physician Solutions, to serve as CombiMatrix's vice president of reimbursement

Warner told GenomeWeb that, when it comes to making reimbursement decisions, payors primarily focus on what is known as the "triple aim" — a framework created by the Institute for Healthcare Improvement founder Donald Berwick that focuses on improving the experience of care; improving the health of populations; and reducing the per capita cost of healthcare.

CombiMatrix sees itself hitting this care/health/cost target with its miscarriage analysis test, and so "it's my job to pull in all of that internal and external data together to secure coverage by consistently engaging key contracted payors to drive adoption and payment," she explained.

At the same time, CombiMatrix hopes to influence key opinion leaders in the maternal-fetal medicine and obstetrics communities, as well as women's health pathologists, to effect changes in the official stance of ACOG on CMA for pregnancy loss.

"We're asking them to speak up on our behalf within the committee and to the payors and their own societies," McDonough said. "All we really want is the data and story to be told in the appropriate way, and hopefully encourage the committee to, in our opinion, keep a little more current on tests like [these]."

At the same time, CombiMatrix is looking to bolster its bottom line with products that aren't as susceptible to reimbursement issues. In November, the company launched CombiPGS, which is sold through fertility clinics and a purely cash-pay offering.

"We are 100 percent committed to recurrent [pregnancy] loss … [and] growing that business," McDonough stressed. Still, "we are very pleased … we're getting paid well for those tests in cash-based situations," he said.

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