Humana Electrothermal Intradiscal Therapies - Medicare Advantage Form

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Electrothermal Intradiscal Therapies Page: 2 of 4

• NCD
• Thermal Intradiscal (TIPs) Procedures
• 150.11

Description

Electrothermal intradiscal therapies (also referred to as thermal intradiscal procedures [TIPs]) are percutaneous, minimally invasive spinal procedures that are designed to treat back pain utilizing heat that is applied to the disc or disc wall (annulus). Examples of electrothermal intradiscal therapies include, but may not be limited to, the following:

• Intradiscal electrothermal therapy (IDET), also known as intradiscal electrothermal annuloplasty (IDTA), uses a catheter and a flexible electrode which is inserted into the affected disc in order to heat the entire posterior edge of the annulus. This technique has been proposed for the treatment of lower back pain caused by internal disc disruption. IDET was designed to reduce pain via two mechanisms: heat-induced changes in the structure of the collagen within the disc and ablation of the nerve endings in the outer third of the annulus. The procedure is conducted using fluoroscopic guidance in which a heating element is inserted via a catheter into a disc. The disc is heated to 90 degrees Celsius for up to 20 minutes, which may result in the contraction and shrinkage of the fibers that comprise the disc wall. The procedure is suggested to be an alternative to spinal fusion surgery in which the disc is destroyed, and the two vertebrae are fused together.
• Disc nucleoplasty (also known as percutaneous radiofrequency thermomodulation, percutaneous plasma discectomy or plasma disc decompression [PDD]) is proposed to treat an individual with symptomatic low back and leg pain caused by herniated discs. This procedure relies on a patented technology referred to as Coblation, in which a high-frequency electric current is applied directly to the saline medium inside the disc, generating a tightly focused field of highly energized molecules around the tip of the wand. These particles have sufficient energy to convert soft tissue within the disc into a gas at relatively low temperatures and this gas escapes through the wand. The wand is introduced through a small needle into the intervertebral disc which is then advanced and withdrawn across the diameter of the disc several times, alternately dissolving disc material and thermally coagulating the channels left behind after removal of tissue.
• Intradiscal biacuplasty (also referred to simply as biacuplasty) is another example of an intradiscal radiofrequency technique that is proposed as treatment for back pain. This technique utilizes the TransDiscal System. During the procedure, 2 probes are inserted into each side of the disc. Internally circulated water-cooled radiofrequency (RF) energy is delivered between the 2 probes, which heats the area immediately around them and within the disc. As the RF energy heats the tissue, internally circulating water helps cool the tissue to prevent damaging nearby tissue.
• Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) is a similar technique to IDET. PIRFT, however, uses a radiofrequency probe that is placed into the center of the disc rather than around the annulus. The device is activated for 90 seconds at a temperature of 70 degrees Celsius. PIRFT does not ablate the disc material but instead alters the biomechanics of the disc or destroys nociceptive pain fibers.

An example of a device used to perform PIRFT is the DiscTRODE.

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Targeted disc decompression (TDD) uses thermal energy to treat herniated discs directly at the site of the actual herniation. A catheter is inserted into the disc and coiled inside until it lies directly adjacent to the disc herniation. The heat energy applied through the coil purportedly shrinks the disc, thereby theoretically reducing discal pressure.

This policy addresses intradiscal electrothermal procedures only and should be distinguished from radiofrequency neuroablation, which is the destruction of nerves using heat.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

Electrothermal Intradiscal Therapies

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage