On Monday, the Centers for Medicare and Medicaid Services (CMS) issued a proposed decision to cover acupuncture for Medicare patients with chronic low back pain (cLBP) who are enrolled participants either in clinical trials sponsored by the National Institutes of Health (NIH) or in CMS-approved studies.
Currently, acupuncture is not covered by Medicare. You may recall that earlier this year, CMS opened a national coverage analysis (NCA) to complete a review of evidence to determine if acupuncture for cLBP is reasonable and necessary under the Medicare program. One of the goals of the NCA was to determine if acupuncture could help reduce reliance on prescription opioids.
CMS recognized that the evidence base for acupuncture has grown in recent years. However, questions regarding the effective nature of acupuncture remain. Therefore, CMS issued the proposed decision and will be monitoring outcomes for Medicare beneficiaries receiving acupuncture to understand the efficacy of this therapeutic and non-pharmacological approach.
The proposed decision provides some interesting statistics regarding low back pain. Specifically, in the United States it has been reported that 25 million individuals experience the cLBP, which is associated with the loss of ability to perform daily activities, opioid dependence, increased anxiety, depression and an overall reduced quality of life.
Moreover, chronic pain in general continues to be a widespread and sometimes debilitating condition. The Centers for Disease Control and Prevention analyzed data from a 2016 national health survey that estimated that 50 million U.S. adults 18 years or older experience chronic pain (which has been defined as pain on most days or every day in the past six months), and 19.6 million experience high impact chronic pain (chronic pain that has limited life or work activities on most days or every day for six months).
In addition, the survey showed that approximately 1.4 million of dual enrolled beneficiaries (with both Medicare and Medicaid) experience chronic pain, and approximately 800,000 experience high impact chronic pain. Of those individuals enrolled in Medicare only, approximately 2.1 million experience chronic pain, and more than 900,000 experience high impact chronic pain.
Of note, the CMS-approved studies have detailed specific parameters in order for acupuncture for cLBP to be covered, and acupuncture provided outside of clinical trials supported by the NIH or CMS-approved studies will continue to be non-covered. By conducting these studies, CMS hopes to have a broad enrollment group of Medicare beneficiaries to maximize diversity and minimize intentional or unintentional exclusions based upon risk, age, demographics or expected adherence.
The CMS-approved studies must address at least one of the following research questions:
In addition, CMS will review the studies to determine if 13 additional criteria have been met, which are listed in the proposed decision. If CMS determines that the study meets the criteria, the study will be posted on CMS’ CED website.
The goal of the proposed decision is to provide Medicare patients who suffer from cLBP with access to a nonpharmacologic treatment option, and to determine the effectiveness. While addressing chronic pain overall seems to be goal for CMS in the long term, for now this study is limited to two specific groups, and the effects of acupuncture on cLBP are the only focus.
For our readers, it is important that we note that if acupuncture becomes a Medicare-covered expense for chronic low back pain, Medicare set-asides (MSAs) will be impacted. However, acupuncture is relatively inexpensive, with costs very similar to physical therapy, and the results of these studies may prove that acupuncture is a very viable, noninvasive chronic pain treatment option.
We will continue to update our readers as results of the studies become available, and any possible and potential impact on claims.
Jean S. Goldstein is senior legal counsel for Medval. This post from the Medval blog is republished with permission.
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