Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.  
  
 **History/Background and/or General Information  
  
** 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 one centimeter or less.  
  
 **Covered Indications  
  
** IMRT is clinically indicated (i.e., medical necessity criteria will be met)
when highly conformal dose planning is required. IMRT planning may be
clinically indicated when one or more of the following conditions are present:

  1. An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision.
  2. Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.
  3. The target volume is concave or convex, and the critical normal tissues are within or around that convexity or concavity.
  4. The target volume is in close proximity to critical structures that must be protected.
  5. 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**

  1. IMRT is not considered reasonable and necessary when at least one of the criteria listed above and one of the applicable ICD-10-CM diagnosis codes are not present. Refer to Billing and Coding: Intensity Modulated Radiation Therapy (IMRT), A56725, for applicable CPT/HCPCS codes and diagnosis codes.
  2. ASTRO IMRT Model Policy outlines clinical scenarios that would not typically support the use of IMRT. These 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 cava 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.  
  
This policy outlines documentation requirements which if not met may lead to
denials. These requirements are noted in the "Documentation Requirements"
section below.  
  
During an episode of care of IMRT, additional ancillary services will be used.
However, this LCD will only address services directly described for IMRT. The
ancillary services (for example: basic dosimetry, physician clinical treatment
planning, block check simulation, weekly treatment management and others)
which may be used in other modalities will be needed in the overall episode of
IMRT care. Some IMRT procedures/services have included services and the
provider should be mindful of the included services and timing of the
services. Please refer to the "Documentation Requirements" section below.  
  
 **Place of Service (POS)  
  
** Free standing facilities (office or clinic), hospital based practices and
mobile delivery units affiliated with a 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.  
  
**Provider Qualifications  
  
** Refer to the CMS IOM, Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4 for information regarding reasonable and
necessary provisions in an LCD. Consistent with the manual, IMRT services will
only be considered reasonable and necessary when performed by appropriately
trained providers.  
  
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.

  * The IMRT treatment delivery is performed by qualified technical personnel following the treatment protocol devised by the qualified radiation oncology physician. This protocol includes the initial evaluation of the patient, the physician's clinical treatment plan outlining the medical necessity for performing the course of IMRT therapy, simulation and dosimetry procedures to specify the precise area to be treated, and an appropriate treatment schedule.
  * The radiation oncology physician's treatment protocol must indicate parameters under which treatment may proceed at the discretion of the qualified technical personnel, and clearly indicate situations under which the qualified radiation oncology physician must be contacted before treatment is provided.
  * The qualified radiation oncology physician, if not physically present in the radiation treatment center, must be immediately available by telephone or other electronic means of communication and must be able to receive and remotely review guidance images allowing the qualified physician to provide advice and/or treatment modification before treatment is provided in situations requiring radiation oncology physician contact.
  * The qualified radiation oncology physician must review and approve guidance images that were produced prior to each daily treatment within 24 hours or prior to the next treatment delivery.
  * The qualified radiation oncology physician must personally evaluate each patient undergoing radiation treatment on a weekly basis, and provide direct supervision of radiation treatment delivery of all patients being treated at least twice during each calendar week of therapy.

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 or fellowship program in the applicable specialty/subspecialty,
i.e., radiation oncology. IMRT planning and Multileaf collimator device for
IMRT design and construction are highly technical services and expected to be
performed only by radiation oncologists. The delivery of treatment services
included in this LCD should be supervised as outlined above.  
  
N **otice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.
Refer to Billing and Coding: Intensity Modulated Radiation Therapy (IMRT),
A56725 for applicable CPT/HCPCS codes and diagnosis codes.