Reimbursement Advice for Labs Running Molecular Diagnostics

5月 15th, 2019 / Molly Frazier

CLP Magazine article offers pro tips and a look at the current landscape

If you work with molecular diagnostics, you probably also spend a good amount of time thinking about reimbursement. A new article in the March issue of CLP Magazine from Luminex’s resident reimbursement expert, Stephanie Ibbotson, offers practical advice and education about how to manage in times of uncertain coverage for diagnostic testing.

The article explores several relevant concepts, including the rationale behind Palmetto GBA’s decision not to cover certain syndromic-panel molecular diagnostics, trends in new test availability, and recent effects of the Protecting Access to Medicare Act.

Increase Reimbursement

Most importantly, the article focuses on steps laboratories can take to improve the likelihood of reimbursement. For example, running clinical utility studies can generate data that may help payors understand “the medical necessity and reasonableness of a test,” Ibbotson writes. “Clinical utility studies—particularly those offering strong evidence for better health outcomes—provide an essential stepping stone toward securing high-value reimbursement coverage.” These studies are often run by clinical laboratories and funded by the test developer.

Ibbotson also recommends turning to test developers for information about optimizing reimbursement strategies, since these companies often work closely with payors as well as guideline-setting organizations. In addition, engaging with payors and with professional societies can be helpful — both for appealing coverage determinations and for learning about ongoing advocacy efforts related to reimbursement issues.

“While it is tempting to become pessimistic about the prospects for molecular diagnostics reimbursement, there are some glimmers of hope,” Ibbotson reports. “As more clinical utility studies are published for molecular diagnostics, there will be mounting evidence that such tests are important not only for clinical decision-making but also for improving patient outcomes.”

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