In 2010 a report by the Therapeutic and Technology Assessment Subcommittee of the American Academy of Neurology concluded that use of a TENS unit was ineffective in the treatment of chronic low back pain, which was defined as back pain lasing three months or longer. Yet, such units continued to be prescribed and used as a treatment method for many individuals asserting chronic back pain. The report prompted the Center for Medicare & Medicaid Services (CMS) to begin a National Coverage Determination process to confirm whether or not the cost of TENS use should be covered by §1862(l) of the Social Security Act.
In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Section 1862(a)(1) of the Social Security Act also provides that no payment shall be made for any expenses incurred for items or services: “which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (§1862(a)(1)(A))…”
Essentially, CMS Medicare asked the following questions about TENS use for chronic low back pain: whether it produced a clinically meaningful reduction in pain, a clinically meaningful improvement in function, and/or a clinically meaningful improvement in any other health outcome? In response, CMS received over 600 comments and considered multiple studies.
According to CMS, the TENS device was “marketed prior to the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act” so its market approval was “grandfathered.” TENS for pain relief was never “premarket approved” by the FDA. Since TENS was not premarket approved, CMS noted that the FDA never determined that its use had a “reasonable assurance of safety and effectiveness” or was “effective [or had] clinical benefit for pain relief.” CMS’ own investigation determined that TENS use was not effective. Specifically, CMS found that TENS use for chronic low back pain did not produce a “clinically meaningful improvement in any of the considered health outcomes.” At one point in its analysis, CMS stated that the “sham (placebo) TENS produces equivalent analgesia as active TENS.”
What It Means to You
According to a CMS memo dated August 1, 2012, the ruling on TENS use will have the following effect on the Worker’s Compensation Medicare Set Aside (WCMSA) proposal review process:
For workers’ compensation cases settled prior to June 8, 2012, and where the settlement included pricing for TENS for chronic low back pain, CMS will consider funds spent for TENS as being an appropriate expenditure of funds as part of the WCMSA.
For cases settled after June 8, 2012, and where the WCMSA’s proposal includes funding for TENS for chronic low back pain, CMS will re-review the cases and remove pricing for TENS. After CMS performs the re-review, beneficiaries and claimants may not use funds from their WCMSA to pay for TENS as this will be considered an inappropriate expenditure of set aside funds.
For a further discussion of what the TENS decision means to your particular case, contact one of our Workers’ Compensation attorneys at Cipriani & Werner.