Kotlier Jacob L, Fathi Amir, Ong Meng-Yung, Feingold Cailan L, Lurie Benjamin M, Freshman Ryan D, Mayfield Cory K, Petrigliano Frank A, Liu Joseph N
Keck School of Medicine of USC, Los Angeles, CA, USA.
HSS J. 2025 Aug 5:15563316251357013. doi: 10.1177/15563316251357013.
Regenerative therapies are being studied for use in several orthopedic conditions, but as these approaches gain in popularity, insurance coverage denials have become a critical issue for patients, physicians, hospitals, and payers.
We sought to analyze the references commercial payers use to support their policies denying coverage for orthopedic applications of mesenchymal stem cell (MSC) therapy.
We reviewed the policies regarding orthopedic applications of MSC therapy of the top 11 national commercial health insurance payers, 5 of which had publicly accessible policies. Supporting references were screened by title and/or abstract. Selected references were categorized by type of reference and reviewed for level of evidence (LOE), anatomic location under investigation, and type and source of MSC. Studies that were not LOE I or II were defined as low LOE. Finally, efficacy of the therapy was recorded in a binary fashion.
To support denial of coverage for MSC use in orthopedics, the 5 insurance companies cited a majority of level IV evidence, despite available and pertinent level I and II studies on the subject. The knee was the most common anatomic location investigated and, along with the spine, the most likely to report favorable outcomes with MSC use. Primary journal articles and studies with higher LOE were more likely to report favorable outcomes than review articles or those with lower LOE.
This analysis of 5 commercial insurance payers' policies found that they substantiate their denial of coverage for MSC use in orthopedic applications primarily with low-level evidence. It also found that higher-level evidence, when cited, often points to the potential efficacy of MSCs.
再生疗法正在多种骨科疾病中进行研究，但随着这些方法越来越受欢迎，保险覆盖范围的拒绝已成为患者、医生、医院和支付方的一个关键问题。
我们试图分析商业支付方用于支持其拒绝为间充质干细胞（MSC）疗法的骨科应用提供保险覆盖的参考文献。
我们审查了11家全国性商业健康保险支付方中关于MSC疗法骨科应用的政策，其中5家有可公开获取的政策。通过标题和/或摘要筛选支持性参考文献。选定的参考文献按参考文献类型分类，并审查证据水平（LOE）、所研究的解剖部位以及MSC的类型和来源。非LOE I或II级的研究被定义为低LOE。最后，以二元方式记录该疗法的疗效。
为了支持拒绝为骨科使用MSC提供保险覆盖，5家保险公司引用了大多数IV级证据，尽管有关于该主题的可用且相关的I级和II级研究。膝关节是研究最常见的解剖部位，并与脊柱一起，是使用MSC最有可能报告良好结果的部位。与综述文章或LOE较低的文章相比，主要期刊文章和LOE较高的研究更有可能报告良好结果。
对5家商业保险公司政策的分析发现，它们主要以低水平证据来证实其拒绝为骨科应用中使用MSC提供保险覆盖。还发现，当引用更高水平的证据时，往往指向MSC的潜在疗效。
