Intensity Modulated Radiation Therapy (IMRT)

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Intensity Modulated Radiation Therapy (IMRT) services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify, or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for IMRT services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies services may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
  • Chapter 6, Section 20.5.3 Coverage of Outpatient Therapeutic Services Incident to a Physician's Services Furnished on or After January 1, 2020 - Changes to Supervision Requirements
• CMS IOM Publication 100-04, Medicare Claims Processing Manual
  • Chapter 4, Section 200.3 Billing Codes for Intensity Modulated Radiation Therapy (IMRT) and Stereotactic Radiosurgery (SRS); and Section 200.3.1 Billing Instructions for IMRT Planning and Delivery
  • Chapter 13, Section 70.5 Radiation Physics Services
• CMS IOM 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

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.

Notice: 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.

N/A

N/A

Please refer to the Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy, A56725, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and must be made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. Medical record documentation maintained by the provider must indicate the medical necessity for IMRT as outlined in this policy, and must include all of the following for IMRT planning and delivery:
   • The treatment plan/prescription must define the goals and requirements of the treatment, including the specific dose constraints for the target(s) and nearby critical structures.
   • A statement by the treating physician documenting the special need for performing IMRT on the patient in question, rather than performing conventional or three-dimensional treatment planning and delivery. The physician must address the other organs at risk or adjacent critical structures.
   • Review (signed and dated) by the radiation oncologist of the CT or MRI based images of the target and all critical structures with representative isodose distributions that characterize the three-dimensional dose. This would apply to those services based on PET-CT as well.
   • Radiation oncologist review of dose-volume histograms for all targets and critical structures.
   • Description of the number and location of each treatment step/rotation or portal to accomplish the treatment plan.
   • Documentation of dosimetric verification of treatment setup and delivery, signed by both the radiation oncologist and the medical physicist.
   • For compensator-based IMRT, the unique compensator design should be documented for each step or portal.
   • Documentation of fluence distributions recomputed in a phantom, or an equivalent methodology consistent with patient specific IMRT treatment verification.
   • Target verification methodology documentation to include documentation of the clinical treatment volume (CTV) and the planning target volume (PTV); documentation of immobilization and patient positioning, and means of dose verification and secondary means of verification.
   • Other procedures performed during the episode of care must have documentation that supports the professional and technical components as applicable by identifying the place of service, the date of service, the supervising physician, and proof of work provided.
   • Documentation must be made available upon request of provider qualifications and appropriate training for each IMRT service performed. Documentation must support that all supervision requirements as outlined in this policy were met for each IMRT service performed.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice, current medical literature.

When services are performed in excess of established parameters, they may be subject to review for medical necessity.

The frequency of procedures provided in the episode of care and the units on a given day must meet standards of care.

Medicare expects that services for IMRT planning or Multileaf collimator device for IMRT design and construction would be performed only by qualified radiation oncologists.

Contractor is not responsible for the continued viability of websites listed.

Other Contractor's Policies

First Coast Service Options, L33378-Intensity Modulated Radiation Therapy (IMRT)

Noridian, DL34217-Intensity Modulated Radiation Therapy (IMRT)

Contractor Medical Directors

1. ACR-ASTRO Practice Parameter for Intensity Modulated Radiation Therapy (IMRT). Practice Guideline. Amended 2014 (Resolution 39); 1-11.
   
   
2. ASTRO Model Policies for Intensity Modulated Radiation Therapy (IMRT), 2015.
   
   
3. ASTRO Model Policies for Stereotactic Body Radiation Therapy (SBRT)
   
   
4. Stereotactic Body Radiation Therapy (SBRT) CPT Codes 77373, 77435. ASTRO Radiation Oncology Coding Resource. 2015; Chapter 15.