March 9, 2020: AcuOA to Inform Medicare Coverage Decisions on Acupuncture: An Interview With Dr. Karen Sherman and Dr. Lynn Debar

Evidence supporting the safety and effectiveness of treatments for chronic low back pain in older adults is lacking. Although acupuncture is known to be effective in younger adults, clinical trials of acupuncture have rarely included older adults, a population with greater comorbidity and different healthcare needs.

The Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (AcuOA), a new NIH Collaboratory Demonstration Project, will address this evidence gap by comparing acupuncture with usual care in a population of older adults with chronic low back pain. We spoke with co–principal investigators Dr. Karen Sherman and Dr. Lynn DeBar about the study at the NIH Collaboratory PRISM kickoff meeting in November.

“In an efficacy trial, you would sort out people—they would have to be healthy enough, they maybe wouldn’t have any comorbidities—and they’d get a specified course of treatment, everything would be dictated,” said Dr. Sherman. “But with older adults,” she explained, “most of the individuals would not be eligible for that kind of trial. So a pragmatic trial allows us to ask questions that are valuable to the population.”

Dr. DeBar added, “We’re really interested in how this plays out across different kinds of healthcare systems. We’re looking at this across varied delivery systems with a hope that what we find is very generalizable.”

Another aim of AcuOA is to conduct a cost-effectiveness analysis of the study’s acupuncture interventions. The study team will also conduct qualitative evaluations to describe barriers to and facilitators of the adoption, implementation, and sustainability of acupuncture treatment for older adults.

“Another interesting piece of this is that this is also for [the Centers for Medicare & Medicaid Services] to evaluate whether acupuncture will be one of the covered services under Medicare,” added Dr. DeBar. “So we will be working in some partnership with them on that,” she said.

The AcuOA trial is a project of the PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center.

“The Collaboratory has a great deal of experience doing all kinds of things, and they also seem to be quite interested in new challenges and the idea that we’re going to be giving them some new challenges,” said Dr. Sherman. “We hope to learn more about pragmatic clinical trials and moving the methodology forward,” she said.

Dr. DeBar added, “It’s also really exciting that there are 4 of these [new Demonstration Projects] that are focused on similar populations of patients, a lot of non-pharmacotherapy treatment. So, while we’re the only ones focusing exclusively on acupuncture, I think we have a lot of synergies and a lot of ability to learn from one another.”

AcOA and the NIH Collaboratory PRISM Resource Coordinating Center are supported by the National Center for Complementary and Integrative Health. Support is also provided by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.