Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

TENS units are covered when medically necessary for pain control.

All units other than TENS units should be pre-authorized and may be denied as being experimental/investigational.

1.    Transcutaneous electrical nerve stimulators (TENS) are considered medically necessary durable medical equipment (DME) when used as an adjunct or as an alternative to the use of drugs in the treatment of acute post-operative pain in the first 30 days after surgery, or chronic, intractable pain not responsive to other methods of treatment.

Note:

a.    When TENS is used for acute post-operative or chronic intractable pain, QualChoice considers use of the device medically necessary initially for a 1-month trial.

b.    After this 1-month trial period, continued TENS treatment may be considered medically necessary if the treatment significantly alleviates pain and if the attending doctor or physical therapist documents that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time.

c.    If the TENS unit produces incomplete relief, further evaluation with percutaneous electrical nerve stimulation (PENS) may be indicated.

d.    This coverage policy is consistent with CMS`s guidelines.

2.    QualChoice considers form-fitting conductive garment medically necessary DME   for use in delivering covered TENS when any of the following criteria is met:

a.    The member cannot manage without the conductive garment due to the large area or the large number of sites to be stimulated, and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes, and lead wires; or

b.    The member has a skin problem or other medical conditions that precludes the application of conventional electrodes, adhesive tapes, and lead wires; or

c.    The member requires electrical stimulation beneath a cast to treat disuse atrophy, where the nerve supply to the muscle is intact; or

d.    The member has a medical need for rehabilitation strengthening following an injury where the nerve supply to the muscle is intact.

3.    QualChoice considers percutaneous electrical nerve stimulation (PENS) (also known as percutaneous neuromodulation) medically necessary DME for up to a 30-day period for the treatment of members with chronic low back pain secondary to degenerative disc disease when PENS is used as part of a multi-modality rehabilitation program that includes exercise.

4.    QualChoice considers peripherally implanted nerve stimulators medically necessary DME for treatment of members with intractable neurogenic pain when all of the following criteria are met:

a.    Member has chronic intractable pain, refractory to other methods of treatment (e.g., analgesics, physical therapy, local injection, surgery), and

b.    There is objective evidence of pathology (e.g., electromyography), and

c.    There is no psychological contraindication to peripheral nerve stimulation, and

d.    Member is not addicted to drugs (per ASAM guidelines), and

e.    A trial of percutaneous stimulation was successful (resulting in at least a 50 % reduction in pain).

5.    QualChoice considers H-WAVE ® type stimulators medically necessary DME for members who have failed to adequately respond to conventional treatments of diabetic peripheral neuropathy.

Codes Used In This BI:

A4595      TENS supply, 2 lead per month

E0720      TENS device, 2 lead, localized stimulation

E0730      TENS device, 4 or more leads, for multiple nerve stimulation

E0731      Form-fitting conductive garment for delivery of TENS or NMES

L8682       Implantable neurostimulator radiofrequency receiver

L8685       Implantable neurostimulator pulse generator, single array rechargeable,

                  Includes extension

L8686       Implantable neurostimulator pulse generator, single array nonchargeable,

                  Includes extension

L8687       Implantable neurostimulator pulse generator, dual array, rechargeable,

                  Includes extension

L8688       Implantable neurostimulator pulse generator, dual array, nonchargeable,

                  Includes extension

1.    Peripheral nerve stimulation is not eligible for coverage in the treatment of post-herpetic neuralgia as it has not been shown to be effective.

2.    TENS units are not eligible for coverage for acute and chronic headaches, deep abdominal pain, pelvic pain and temporomandibular joint (TMJ) pain because there is inadequate scientific evidence to support its efficacy for these specific types of pain.

3.    QualChoice considers H-WAVE ® type stimulators experimental and investigational for any of the following indications because their effectiveness for these indications has not been established.

a.    To reduce pain from causes other than chronic diabetic peripheral neuropathy; or

b.    To reduce edema; or

c.    To accelerate healing; or

d.    To treat chronic pain due to ischemia.

4.    QualChoice considers stellate ganglion blockade using TENS experimental and investigational because its clinical value has not been established.

5.    QualChoice considers interferential stimulation (e.g., RS-4i Sequential Stimulator) experimental and investigational for the reduction of pain and edema because its effectiveness for these indications has not been established

6.    QualChoice considers intramuscular stimulation experimental and investigational for the management of members with soft-tissue or neuropathic pain because its effectiveness has not been established.

7.    QualChoice considers sympathetic therapy (Dynatronics Corporation, Salt Lake City, UT) experimental and investigational since its effectiveness has not been established.

8.    QualChoice considers electroceutical therapy (also known as bioelectric nerve block) experimental and investigational for the treatment of acute pain or chronic pain (e.g., back pain, diabetic pain, joint pain, fibromyalgia, headache, and reflex sympathetic dystrophy) because there is a lack of scientific evidence regarding the effectiveness of this technology.

Note: Other terms used to refer to electroceutical therapy devices include “non-invasive neuron blockade” devices, “electroceutical neuron blockade” devices, and “bioelectric treatment systems.”

9.    QualChoice considers BioniCare (pulsed electrical stimulation) experimental and investigational for the treatment of osteoarthritis because its effectiveness has not been established.

10. QualChoice considers the Electro-Acuscope Myopulse Therapy System for the treatment of pain and tissue damage experimental and investigational because its effectiveness has not been demonstrated in the peer-reviewed scientific literature.

Transcutaneous Electrical Nerve Stimulation (TENS) is characterized by biphasic current and selectable parameters such as pulse rate and pulse width. In theory, TENS stimulates sensory nerves to block pain signals; it also stimulates endorphin production to help normalize sympathetic function. Most TENS units produce current of 1 to 80 microampere (mA), 9 V (average), 2 to 1000 Hz, with a pulse width of 250 to 400 microseconds (mS).

Interferential Stimulation (IFS) is characterized by two alternating-current sine waves of differing frequencies that “work” together to produce an interferential current that is also known as a beat pulse or alternating modulation frequency. One of the two currents is usually held at 4000 Hz, and the other can be held constant or varied over a range of 4001 to 4100 Hz. Interferential currents reportedly can stimulate sensory, motor, and pain fibers. Because of the frequency, the interferential wave meets low impedance when crossing the skin to enter the underlying tissue. This deep tissue penetration can be adjusted to stimulate parasympathetic nerve fibers for increased blood flow. According to proponents, interferential stimulation differs from TENS because it allows a deeper penetration of the tissue with more comfort (compliance) and increased circulation.

Percutaneous Electrical Nerve Stimulation (PENS) (also known as percutaneous neuromodulation) uses acupuncture-like needles as electrodes. These needles are placed in the soft tissues or muscles at dermatomal levels corresponding to local pathology (needles are usually inserted above and below and into the central area of pain). A 5-Hz frequency with a pulse width of 0.5 mS is usually used. If relief is not attained within 15 minutes, the frequency may be lowered to 1 Hz. According to PENS proponents, the main advantage of PENS over TENS is that it bypasses the local skin resistance and delivers electrical stimuli at the precisely desired level in close proximity to the nerve endings located in soft tissue, muscle, or periosteum of the involved dermatomes.

Peripherally Implanted Nerve Stimulation entails the placement of electrodes around a selected peripheral nerve. The stimulating electrode is connected by an insulated lead to a receiver unit that is inserted subcutaneously at a depth not greater than half an inch. Stimulation is elicited by a generator that is connected to an antenna that is attached to the skin surface over the receiver unit. Sciatic and ulnar nerves are often the sites of such an implantation.

H-Wave Stimulation delivers electrical stimulation in the form of milliamperage. H-wave stimulation is intended to emulate the H waveform found in nerve signals (Hoffman Reflex) and therefore enables greater and deeper penetration of a low frequency current, while using significantly less power than other machines. This allegedly makes H-Wave stimulation much safer, less painful and more effective than other forms of electrotherapy to date. The H-wave signal is a bipolar, exponential decaying waveform that overcomes the disadvantages of other electrotherapy machines. It allows the therapist to apply two treatments at the same time: (i) low-frequency muscle stimulation and (ii) high-frequency deep analgesic pain control (a “TENS” effect). Note: H-wave stimulation must be distinguished from the H-waves that are a component of electromyography.

TENS/PENS:

1. McQuay HJ, Moore RA, Eccleston C, et al. Systematic review of outpatient services for chronic pain control. Health Technol Assess. 1997; 1(6): i-iv, 1-135.
2. Moore SR, Shurman J. Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: A double-blind, repeated measures comparison. Arch Phys Med Rehabil. 1997; 78(1):55-60.
3. Lampl C, Kreczi T, Klingler D. Transcutaneous electrical nerve stimulation in the treatment of chronic pain: Predictive factors and evaluation of the method. Clin J Pain. 1998; 14(2):134-142.
4. Chabal C, Fishbain DA, Weaver M, Heine LW. Long-term transcutaneous electrical nerve stimulation (TENS) use: Impact on medication utilization and physical therapy costs. Clin J Pain. 1998; 14(1):66-73.
5. Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: A randomized crossover study. JAMA. 1999; 281(9):818-823.
6. Kaye V, Brandstater ME. Transcutaneous electrical nerve stimulation. eMedicine J. 2002; 3(1).
7. Medicare coverage database: NCD publication 100-3 at : http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd#PT

Peripheral Nerve Stimulation:

1. Cauthen JC, Renner EJ. Transcutaneous and peripheral nerve stimulator for chronic pain states. Surg Neurol. 1975; 4(1):102-104.
2. Meyerson BA, Hakansson J. Alleviation of atypical trigeminal pain by stimulation of the Gasserian ganglion via an implanted electrode. Acta Neurochir Suppl (Wien). 1980; 30:303-309.
3. Racz GB, Browne T, Lewis R Jr. Peripheral stimulator implant for treatment of causalgia caused by electrical burns. Tex Med. 1988; 84(11):45-50.
4. Leak WD, Ansel AE. Neural stimulation: Spinal cord and peripheral nerve stimulation. In: Pain Medicine. A Comprehensive Review. PP Raj, ed. St. Louis, MO: Mosby; 1996; Ch. 32: 327-333.
5. Taub E, Munz M, Tasker RR. Chronic electrical stimulation of the gasserian ganglion for the relief of pain. J Neurosurg. 1997; 86(2):197-202.
6. American Society of Addiction Medicine (ASAM). Definitions related to the use of opioids for the treatment of pain. Public Policy of ASAM. Chevy Chase, MD: ASAM; February 2001. Available at: http://www.asam.org/ppol/paindef.htm.

Intramuscular Stimulation:

1. Chu J. Twitch-obtaining intramuscular stimulation (TOIMS) in acute partial radial nerve palsy. Electromyogr Clin Neurophysiol. 1999; 39(4):221-226.
2. Chu J. The role of the monopolar electromyographic pin in myofascial pain therapy: Automated twitch-obtaining intramuscular stimulation (ATOIMS) and electrical twitch-obtaining intramuscular stimulation (ETOIMS). Electromyogr Clin Neurophysiol. 1999; 39(8):503-511.
3. Chu J. Early observations in radiculopathic pain control using electrodiagnostically derived new treatment techniques: Automated twitch-obtaining intramuscular stimulation (ATOIMS) and electrical twitch-obtaining intramuscular stimulation (ETOIMS). Electromyogr Clin Neurophysiol. 2000; 40(4):195-204.
4. Chu J, Gozon BS, Schwartz I. Twitch-obtaining intramuscular stimulation in reflex sympathetic dystrophy. Electromyogr Clin Neurophysiol. 2002; 42(5):259-266.

Sympathetic Therapy (Dynatron):

1. Dynatronics Corp. Dynatron Sympathetic Therapy System (STS): Revolutionary Breakthrough in the Treatment of Pain [website]. Salt Lake City, UT: Dynatronics; 2001. Available at: http://www.chronicpainrx.com/dynatron/
2. Washington State Department of Labor and Industries, Office of the Medical Director. Dynatron STS. Technology Assessment. Olympia, WA: Washington State Department of Labor and Industries; updated April 30, 2002. Available at: http://www.lni.wa.gov/omd/PdfDoc/DYNATRON.pdf

Electroceutical Therapy:

1. Empire Medicare Services NJ. Facet joint nerve block. Medical Policy Bulletin Freedom of Information. Medicare News Brief - New Jersey (Part B). MNB-NJ-2001-2. New York, NY: Empire; April 2001. Available at: http://www.empiremedicare.com/NJBULL/njb2001-2/s129.htm
2. GHI Medicare Division. Nerve blocks/ paravertebral nerve blocks. Local Medical Necessity Policy. Policy No. SUR-1233. New York, NY: GHI Medicare; July 30, 1999. Available at: http://www.ghimedicare.com/lmrp2/sur-1233.html

BioniCare (Pulsed Electrical Stimulation):

1. Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995; 22(9):1757-1761.
2. Hulme J, Robinson V, DeBie R, et al. Electromagnetic fields for the treatment of osteoarthritis. Cochrane Database Syst Rev. 2002 ;( 1):CD003523.