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Intensity Modulated Radiation Therapy

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• Type: LCD
• Title: Intensity Modulated Radiation Therapy (IMRT)
• ID Number: L36711
• Jurisdiction Medicare Administrative Contractors (MACs): JH Novitas Solutions, Inc. (Part A/B MAC)
• Applicable States/Territories: AR, CO, NM, OK, TX, LA, MS

• Type: LCA
• Title: Therapy (IMRT)
• ID Number: A56725
• Jurisdiction Medicare Administrative Contractors (MACs): JL - Novitas Solutions, Inc. (Part A/B MAC)
• Applicable States/Territories: DE, D.C., MD, NJ, PA

• Type: LCD LCA
• Title: Intensity Modulated Radiation Therapy (IMRT) PY
• ID Number: L36773 AS56746 Aer'
• Jurisdiction Medicare Administrative Contractors (MACs): IN- First Coast Service Options, Inc. | (Part A/B MAC)
• Applicable States/Territories: FL, PR, U.S. VI

• Type: LCD LCA
• Title: Prostate Rectal Spacers P
• ID Number: 137885 AS6539
• Jurisdiction Medicare Administrative Contractors (MACs): J6 - National Government Services, Inc. (Part eMac! JK - National Government Services, Inc. (Part A/B MAC)
• Applicable States/Territories: IL, MN, WI CT, NY, ME, MA, NH, RI, VT

Description

Intensity modulated radiation therapy (IMRT) is an advanced form of external beam radiotherapy that uses computer-controlled linear accelerators to deliver precise radiation doses to specific areas within a tumor. This therapy allows for increased precision by conforming radiation to the planned target site while significantly reducing the amount of radiation to surrounding healthy tissues. Image-guidance in the form of computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US) or X-rays may be utilized to direct delivery of the radiation beams.

Different techniques are utilized to control the radiation amount given during IMRT. The most common approach is the use of multileaf collimators (MLCs). These devices are attached to the linear accelerator. The MLCs are composed of computer-controlled tungsten leaves or panels that move while the radiation beam is directed toward the target. The leaves function as filters that block out certain areas. This modifies the beam’s intensity so that the radiation is distributed according to the treatment plan.

Another delivery approach is compensator based IMRT. This approach utilizes custom made (based on three dimensional (3D) images and the treatment plan) high-density blocks to control the administration of the radiation. The blocks are placed into position according to the treatment plan and the radiation is delivered.

Intensity Modulated Radiation Therapy

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Tomotherapy and volumetric modulated arc therapy (VMAT) are types of IMRT. In these forms of treatment, the machines combine the linear accelerator with MLCs and CT scanners in an effort to provide IMRT with increased precision to select tumors. The frame that houses the treatment and scanning devices rotates in a 360-degree fashion around the individual to deliver a focused beam of radiation to the tumor. Tomotherapy involves obtaining a CT scan prior to each treatment session to identify any changes to tumor shape or position so that adjustments can be made. The radiation is delivered in smaller beams (beamlets) which deliver varying doses of radiation to the target. In VMAT, one or more beams of radiation are delivered in an uninterrupted arc delivered as the housing rotates. The radiation beams may be modified according to the shape of the tumor.

The placement of a transperineal biodegradable spacer also known as prostate rectal spacers (eg, Barrigel, SpaceOAR, SpaceOAR Vue) positions the anterior (frontal) section of the rectal wall away from the prostate during external beam radiotherapy treatments for prostate cancer with the goal of limiting the radiation exposure to the anterior rectum. Because this material is biodegradable, it is absorbed over time by the individual’s body.

SpaceOAR is comprised of a synthetic, absorbable polyethylene glycol-based hydrogel. SpaceOAR Vue contains PEGylated iodine, which is designed to enhance visibility via CT scan. Barrigel injectable gel is similar to the SpaceOAR product; however, it is made of stabilized hyaluronic acid.

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:

IMRT will be considered medically reasonably and necessary when all the following requirements are met:

• An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision59; OR
• Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment59; OR
• The target volume is concave or convex, and the critical normal tissues are within or around that convexity or concavity59; OR
• The target volume is in close proximity to critical structures that must be protected59; OR
• The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures59

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Based on the above conditions demonstrating medical necessity, IMRT may be considered reasonable and necessary for the following indications:

• Abdominal malignancies when dose constraints to small bowel or other normal abdominal tissue are exceeded and present administration of a therapeutic dose59; OR
• Lymphoma for the following indications:
  • Eye (primary monocular)71; OR
  • Head and neck (eg, nasal cavity, paranasal sinuses, parotid or other salivary gland)98; OR
  • Lung98; OR
  • Mediastinum, in proximity to lung and heart98; OR
  • Thyroid71; OR
  • Stomach98; OR
• Other pelvic or retroperitoneal malignancies59; OR
• Pelvic malignancies (eg, prostatic, gynecological, anal carcinoma)59; OR
• Primary, metastatic, benign or recurrent head and neck malignancies (eg, orbits, sinuses, skull base, aero-digestive tract, salivary glands)59; OR
• Primary, metastatic or benign tumors of the central nervous system including the brain, the brain stem, and spinal cord59; OR
• Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated59; OR
• Thoracic malignancies59

Other malignancies not delineated in the above can be supported with submission of documentation for medical necessity should a denial occur. The determination of appropriateness and medical necessity for IMRT for any site shall be found in the documentation from the radiation oncologist and must be available when requested or submitted in the appeals process.59

Transperineal biodegradable spacer also known as prostate rectal spacers (eg, Barrigel, SpaceOar, SpaceOAR Vue) will be considered medically reasonable and necessary for use during prostate cancer radiation therapy.61

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.

Intensity Modulated Radiation Therapy

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Coverage Limitations

US Government Publishing Office.

Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

IMRT is not considered reasonable and necessary when at least 1 of the criteria listed above and 1 of the applicable ICD-10-CM diagnosis codes are not present.59

• Where IMRT does not offer an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity;32,59 OR
• Clinical urgency, such as spinal cord compression, superior vena cava syndrome or airway obstruction32,59; OR
• Palliative treatment of metastatic disease where the prescribed dose does not approach normal tissue tolerances32,59; OR
• Inability to accommodate for organ motion, such as for a mobile lung tumor32,59; OR
• Inability of the patient to cooperate and tolerate immobilization to permit accurate and reproducible dose delivery32,59; OR

There must be documented rationale of the advantage of IMRT versus the use of other radiation therapy methods in the medical record of each patient for whom IMRT is provided.59

A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatments. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.