Summary Of Evidence

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Analysis of Evidence

N/A

Intensity Modulated Radiation Therapy (IMRT) is a computer-based method of planning for, and delivery of generally narrow, patient specific, spatially and often temporally modulated beams of radiation to solid tumors within a patient. IMRT planning and delivery uses an approach for obtaining the highly conformal dose distributions needed to irradiate complex targets positioned near, or invaginated by, sensitive normal tissues, thus improving the therapeutic ratios. IMRT delivers a more precise radiation dose to the tumor while sparing the surrounding normal tissues by using non-uniform radiation beam intensities that are determined by various computer-based optimization techniques.

The computer based optimization process is referred to as ‘inverse planning'. Inverse planning develops a dose distribution based on the input of specific dose constraints for the planned treatment volume (PTV) and nearby clinical structures and is the beginning of the IMRT treatment planning process. The gross tumor volume (GTV), the PTV and surrounding normal tissues must be identified by a contouring procedure and the optimization must sample the dose with a grid spacing of 1 centimeter or less.

Covered Indications:

IMRT is clinically indicated when highly conformal dose planning is required. IMRT planning may be clinically indicated when one or more of the following conditions are present:

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

On the basis of the above conditions demonstrating medical necessity, disease sites that may support the use of IMRT include the following:

• Primary, metastatic or benign tumors of the central nervous system including the brain, the brain stem, and spinal cord
• 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 irradiated
• Primary, metastatic, benign or recurrent head and neck malignancies, including: orbits, sinuses, skull base, aero-digestive tract, and salivary glands
• Thoracic malignancies
• Abdominal malignancies when dose constraints to small bowel or other normal abdominal tissue are exceeded and present administration of a therapeutic dose
• Pelvic malignancies including: prostatic, gynecological and anal carcinoma
• Other pelvic or retroperitoneal malignancies.

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.

Limitations:

IMRT is not considered reasonable and necessary when at least one of the criteria listed in the "Coverage Indications, Limitations, and/or Medical Necessity" section of this LCD are not present.

Clinical scenarios that would not typically support the use of IMRT include:

• where IMRT does not offer an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity
• clinical urgency, such as spinal cord compression, superior vena cave syndrome or airway obstruction
• palliative treatment of metastatic disease where the prescribed dose does not approach normal tissue tolerances
• inability to accommodate for organ motion, such as for a mobile lung tumor
• inability of the patient to cooperate and tolerate immobilization to permit accurate and reproducible dose delivery

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.

The CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, section 13.5.4 outlines that reasonable and necessary services are ordered and/or furnished by qualified personnel; IMRT services will be considered reasonable and necessary only when performed by appropriately trained providers. Hence, a qualified physician for this service is defined as follows: Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/ subspecialty, i.e., Radiation Oncology.

It is expected that all personnel involved in administering, supervising, and treating patients for the indications outlined in this LCD meet the regulations set forth by each state or district, as well as for Medicare and the Nuclear Regulatory Commission (NRC), as applicable. These personnel include the radiation oncologist or other qualified physician radiation/medical physicist, radiation technologist and radiation assistant. These compliances must be made available when requested.

Free standing facilities (office or clinic), hospital based practices, and mobile delivery units affiliated with a place of service (POS) must meet Federal and local (state) radiation protection guidelines in regard to patient safety and quality assurance as well as the physician supervision requirements.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.