Electrostimulation has become well established as an important tool in neuromuscular rehabilitation, and therapies based on electrical stimulation are being used to treat a growing number of medical conditions. In addition, research has been or is being conducted on the use of electrostimulation for a wide variety of purposes, ranging from reducing symptoms associated with drug withdrawal to treating chronic prostatitis and certain pediatric ear infections.

However, despite the growing acceptance of electrical stimulation therapy in mainstream medicine, Medicare coverage of electrostimulation remains limited. The Centers for Medicare and Medicaid Services began paying for electrostimulation for treatment of wounds in certain select situations last year, but only after several years of delay and a lawsuit by the American Physical Therapy Association.

This limited coverage of wound treatment by electrostimulation does not include home treatment. Medicare coverage of HME for electrostimulation is confined to transcutaneous electrical nerve stimulation (TENS) units, non-implantable pelvic floor stimulators, and neuromuscular electrical stimulation (NMES) devices. Coverage criteria for all of these devices are quite restrictive.

Medicare and TENS
In the case of TENS, the supplier must have a written physician’s order prior to delivery of the equipment, and the physician ordering the unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit. The only conditions for which a TENS unit may be covered are acute post-operative pain and chronic, intractable pain.

Medicare coverage of TENS for acute post-operative pain is on a rental basis only. Medicare will ordinarily cover a TENS unit for only 30 days from the date of the surgery, although payment may be made for a longer period if documentation of continued medical necessity from the attending physician is submitted.

Medicare policy considers TENS not medically necessary for acute pain other than post-operative pain. For purposes of TENS coverage, it defines acute pain as pain of less than 3 months’ duration. When pain has continued for more than 3 months, it is considered chronic pain. Medicare may cover TENS for treatment of certain kinds of chronic pain, if other kinds of treatment have been tried and have failed. However, the pain must be of a type that is recognized as responding to TENS therapy. Medicare policy considers TENS therapy not medically necessary for other kinds of pain, including headache and temporomandibular joint (TMJ) pain.

Record Keeping
For Medicare to cover TENS therapy, there are also specific requirements for medical necessity documentation that must be present in the medical record. The medical record must contain documentation of the location of the pain and the cause of the pain, and must reflect that the pain has continued for at least 3 months. There also must be documentation of the other treatments that have been tried. In addition, if the physician orders a four-lead TENS unit, the medical record must document why a two-lead TENS unit would not be adequate.

Also keep in mind that before Medicare will pay for purchase of a TENS unit, the unit must be rented for at least 1 month, but not more than 2 months, for use by the patient on a trial basis. The physician must monitor the effectiveness of the TENS unit during the trial period to determine whether the unit is likely to provide significant therapeutic benefit to the patient over a long period of time. The physician must reevaluate the patient at the end of the trial period, and must document in the medical record how often the patient used the TENS unit, the typical duration of use each time, and the results of the treatment.

The supplier must obtain a certificate of medical necessity (CMN) before the trial period, and must obtain a second CMN after the end of the trial period for submission with a claim for purchase of the TENS unit. The second CMN is considered a new initial CMN, not a revised or recertification CMN. Claims for the rental and purchase of the TENS unit may not be submitted on the same claim form.

Other Forms of Electrostimulation
Medicare began covering pelvic floor electrical stimulators in 2001 for treatment of stress urinary incontinence and urge urinary incontinence. In order for a pelvic floor stimulator to be covered, there must be documentation that the patient has failed a 4-week trial of pelvic muscle exercise training. A pelvic floor stimulator is covered if there is no significant improvement in urinary continence after 4 weeks of training.

Coverage criteria for NMES are very restrictive. Medicare coverage of NMES is limited to two purposes: to treat disuse atrophy of muscles and to enhance the ability of patients with spinal cord injuries to walk. NMES is not covered for other purposes such as relieving back or neck pain, healing of decubitus ulcers or other wounds, reducing swelling, increasing range of motion, or preventing deep venous thrombosis.

Coverage of NMES to treat muscle atrophy is subject to an important limitation. NMES is covered for this purpose only if the nerve supply to the muscle is intact. NMES may be covered for treating muscle atrophy that results when a patient is in a cast for a long time, or when burn scarring leads to contracture. It may also be covered following hip replacement surgery, but usually only until gait training is started. However, if muscle atrophy results from neurological injury, Medicare will not cover NMES. Therefore, if the patient’s diagnosis is listed simply as “muscle atrophy” or “disuse atrophy,” the DMERC will require additional documentation before approving the claim. The patient’s medical record must contain evidence that NMES is prescribed to treat disuse atrophy where the nerve supply is intact. A diagnosis of disuse atrophy following a fracture or following joint replacement surgery may be sufficient. A diagnosis of stroke or other neurological condition or injury will generally result in a denial.

Medicare also places strict limits on coverage of functional electrical stimulation (FES), the form of NMES that is used to assist spinal cord injury patients in walking. Among the specific criteria that a patient must meet to qualify for coverage are muscle and joint stability for weight bearing at upper and lower extremities; balance and control to maintain an upright support posture independently; ability to transfer independently and stand independently for at least 3 minutes; and high motivation and commitment to use the device. A patient may not have a cardiac pacemaker, severe scoliosis, severe osteoporosis, skin disease at the area of stimulation, or irreversible contracture.

If a patient meets all of these criteria, FES may be covered, but only after the patient has completed a training program consisting of at least 32 physical therapy sessions with the device over a period of 3 months. The training sessions must be conducted in a hospital (on an inpatient or outpatient basis), a comprehensive outpatient rehabilitation facility, or an outpatient rehabilitation facility. A physical therapist must personally provide the training on a one-on-one basis. The goal of the therapy must be specifically to train the patient in the use of the FES device for walking.

These restrictions impose strict limits on Medicare coverage of electrostimulation, and suppliers must pay close attention to coverage criteria and documentation requirements to avoid claim denials.

Timothy Webster, JD, is an attorney with the health care group of Brown & Fortunato PC, Amarillo, Tex. He is board certified in health law by the Texas Board of Legal Specialization, and represents HME companies, pharmacies, and other health care providers throughout the United States. He can be reached at (806) 345-6347 or twebster@bf-law.com.