Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say that in order to support additional research on the use of TENS for CLBP, we will cover this item 
under section 1862(a)(1)(E) of the Social Security Act (the Act) subject to all of the following conditions: 
 
    Coverage under this section expires three years after the publication of this decision on the CMS website. 
    The beneficiary is enrolled in an approved clinical study meeting all of the requirements below. The study 
must address one or more aspects of the following questions in a randomized, controlled design using validated 
and reliable instruments. This can include randomized crossover designs when the impact of prior TENS use is 
appropriately accounted for in the study protocol. 
        Does the use of TENS provide clinically meaningful reduction in pain in Medicare beneficiaries with 
CLBP? 
        Does the use of TENS provide a clinically meaningful improvement of function in Medicare beneficiaries 
with CLBP? 
        Does the use of TENS impact the utilization of other medical treatments or services used in the medical 
management of CLBP? 
 
These studies must be designed so that the patients in the control and comparison groups receive the same 
concurrent treatments and either sham (placebo) TENS or active TENS intervention. 
 
The study must adhere to the following standards of scientific integrity and relevance to the Medicare 
population: 
 
    The principal purpose of the research study is to test whether a particular intervention potentially improves 
the participants health outcomes. 
    The research study is well supported by available scientific and medical information or it is intended to 
clarify or establish the health outcomes of interventions already in common clinical use.     The research study does not unjustifiably duplicate existing studies. 
    The research study design is appropriate to answer the research question being asked in the study. 
    The research study is sponsored by an organization or individual capable of executing the proposed study 
successfully. 
    The research study is in compliance with all applicable Federal regulations concerning the protection of 
human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it 
must be in compliance with 21 CFR parts 50 and 56. 
    All aspects of the research study are conducted according to appropriate standards of scientific integrity (see 
http://www.icmje.org). 
    The research study has a written protocol that clearly addresses, or incorporates by reference, the standards 
listed here as Medicare requirements for CED coverage. 
    The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy 
individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet 
this standard only if the disease or condition being studied is life threatening as defined in 21 CFR  312.81(a) 
and the patient has no other viable treatment options. 
    The clinical research study is registered on the ClinicalTrials.gov website by the principal 
sponsor/investigator prior to the enrollment of the first study subject. 
    The research study protocol specifies the method and timing of public release of all prespecified outcomes to 
be measured including release of outcomes if outcomes are negative or study is terminated early. The results 
must be made public within 24 months of the end of data collection. If a report is planned to be published in a 
peer reviewed journal, then that initial release may be an abstract that meets the requirements of the 
International Committee of Medical Journal Editors (http://www.icmje.org). 
    The research study protocol must explicitly discuss subpopulations affected by the treatment under 
investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and 
exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said 
populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the 
recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are 
necessary 
    The research study protocol explicitly discusses how the results are or are not expected to be generalizable to 
the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate 
discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or 
Medicaid eligibility. 
 
    Nationally Non-Covered Indications 
 
TENS is not reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Act. 
 
You can find this information in Medicare's National Coverage Determination (NCD): Transcutaneous 
Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP) (160.27). 
 
The rules say that coverage for NMES/FES for walking will be covered in SCI patients with all of the 
following characteristics: 
 
    Persons with intact lower motor units (L1 and below) (both muscle and peripheral nerve); 
    Persons with muscle and joint stability for weight bearing at upper and lower extremities that can 
demonstrate balance and control to maintain an upright support posture independently; 
    Persons that demonstrate brisk muscle contraction to NMES and have sensory perception electrical 
stimulation sufficient for muscle contraction; 
    Persons that possess high motivation, commitment and cognitive ability to use such devices for walking; 
    Persons that can transfer independently and can demonstrate independent standing tolerance for at least 3 
minutes; 
    Persons that can demonstrate hand and finger function to manipulate controls;     Persons with at least 6-month post recovery spinal cord injury and restorative surgery; 
    Persons without hip and knee degenerative disease and no history of long bone fracture secondary to 
osteoporosis; and 
    Persons who have demonstrated a willingness to use the device long-term. 
 
NMES/FES for walking will not be covered in SCI patient with any of the following: 
 
    Persons with cardiac pacemakers; 
    Severe scoliosis or severe osteoporosis; 
    Skin disease or cancer at area of stimulation; 
    Irreversible contracture; or 
    Autonomic dysflexia. 
 
The only settings where therapists with the sufficient skills to provide these services are employed, are 
inpatient hospitals; outpatient hospitals; comprehensive outpatient rehabilitation facilities; and outpatient 
rehabilitation facilities. The physical therapy necessary to perform this training must be part of a one-on-one 
training program. 
 
Additional therapy after the purchase of the DME would be limited by our general policies in converge of 
skilled physical therapy. 
 
You can find this information in Medicare's National Coverage Determination (NCD): Neuromuscular 
Electrical Stimulation (NMES) (160.12). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.