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.