Intensity-Modulated Radiotherapy (IMRT): Cancer of the Head and Neck or Thyroid

POLICY NUMBER

A.8.01.48

DESCRIPTION

Radiotherapy is an integral component in the treatment of head and neck cancers. Intensity-modulated radiotherapy (IMRT) has been proposed as a method to allow adequate radiation to the tumor, minimizing the radiation dose to surrounding normal tissues and critical structures.

Head and Neck Cancers

This policy focuses on cancers affecting the oral cavity and lip, larynx, hypopharynx, oropharynx, nasopharynx, paranasal sinuses and nasal cavity, salivary glands, and occult primaries in the head and neck region.

Radiotherapy Techniques

Radiation therapy may be administered externally (ie, a beam of radiation is directed into the body) or internally (ie, a radioactive source is placed inside the body, near a tumor). External radiotherapy (RT) techniques include "conventional" or 2-dimensional (2D) RT, 3-dimensional (3D) conformal RT, and intensity-modulated radiation therapy (IMRT).

Conventional External-Beam RadiotherapyMethods to plan and deliver radiotherapy (RT) have evolved that permit more precise targeting of tumors with complex geometries. Conventional 2D treatment planning utilizes X-ray films to guide and position radiation beams. Bony landmarks visualized on X-ray are used to locate a tumor and direct the radiation beams. The radiation is typically of uniform intensity.

Three-Dimensional Conformal RadiotherapyRadiation treatment planning has evolved to use 3-dimensional images, usually from computed tomography (CT) scans, to more precisely delineate the boundaries of the tumor and to discriminate tumor tissue from adjacent normal tissue and nearby organs at risk for radiation damage. Three-dimensional conformal RT (3D-CRT) involves initially scanning the patient in the position that will be used for the radiation treatment. The tumor target and surrounding normal organs are then outlined in 3D on the scan. Computer software assists in determining the orientation of radiation beams and the amount of radiation the tumor and normal tissues receive to ensure coverage of the entire tumor in order to minimize radiation exposure for at risk normal tissue and nearby organs. Other imaging techniques and devices such as multileaf collimators (MLCs) may be used to "shape" the radiation beams. Methods have also been developed to position the patient and the radiation portal reproducibly for each fraction, and immobilize the patient, thus maintaining consistent beam axes across treatment sessions.

Intensity-Modulated RadiotherapyIntensity-modulated radiotherapy is the more recent development in external radiation. Treatment planning and delivery are more complex, time consuming, and labor-intensive for IMRT than for 3D-CRT. Similar to 3D-CRT, the tumor and surrounding normal organs are outlined in 3D by a scan and multiple radiation beams are positioned around the patient for radiation delivery. In IMRT, radiation beams are divided into a grid-like pattern, separating a single beam into many smaller "beamlets." Specialized computer software allows for “inverse” treatment planning. The radiation oncologist delineates the target on each slice of a CT scan and specifies the target’s prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally reconstructed radiographic image of the tumor, surrounding tissues, and organs at risk, computer software optimizes the location, shape, and intensities of the beam ports to achieve the treatment plan’s goals.

Increased conformality may permit escalated tumor doses without increasing normal tissue toxicity and is proposed to improve local tumor control, with decreased exposure to surrounding, normal tissues, potentially reducing acute and late radiation toxicities. Better dose homogeneity within the target may also improve local tumor control by avoiding underdosing within the tumor and may decrease toxicity by avoiding overdosing.

Other advanced techniques may further improve RT treatment by improving dose distribution. These techniques are considered variations of IMRT. Volumetric modulated arc therapy delivers radiation from a continuous rotation of the radiation source. The principal advantage of volumetric modulated arc therapy is greater efficiency in treatment delivery time, reducing radiation exposure and improving target radiation delivery due to less patient motion. Image-guided RT involves the incorporation of imaging before and/or during treatment to more precisely deliver RT to the target volume.

In general, IMRT systems include intensity modulators, which control, block, or filter the intensity of radiation; and RT planning systems, which plan the radiation dose to be delivered.

A number of intensity modulators have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Intensity modulators include the Innocure Intensity Modulating Radiation Therapy Compensators (Innocure) and Decimal Tissue Compensator (Southeastern Radiation Products, now called decimal), cleared in 2006 and 2004, respectfully. FDA product code: IXI. Intensity modulators may be added to standard linear accelerators to deliver IMRT when used with proper treatment planning systems.

Radiotherapy treatment planning systems have also been cleared for marketing by the FDA through the 510(k) process. They include the Prowess Panther (Prowess) cleared in 2003, TiGRT (LinaTech) cleared in 2009, and the Ray Dose (now RayStation, RaySearch Laboratories) cleared in 2008. FDA product code: MUJ.

Fully integrated IMRT systems also are available. These devices are customizable and support all stages of IMRT delivery, including planning, treatment delivery, and health record management. One such device cleared for marketing by the FDA through the 510(k) process is the Varian IMRT system (Varian Medical Systems). FDA product code: IYE

POLICY

Intensity-modulated radiotherapy may be considered medically necessary for the treatment of head and neck cancers.

Intensity-modulated radiotherapy may be considered medically necessary for the treatment of thyroid cancers in close proximity to organs at risk (esophagus, salivary glands, and spinal cord) and 3D-CRT planning is not able to meet dose volume constraints for normal tissue tolerance. (see Policy Guidelines).

Intensity-modulated radiotherapy is investigational for the treatment of thyroid cancers for all indications not meeting the criteria above.

POLICY EXCEPTIONS

Federal Employee Plan: Effective January 1, 2010, prior approval for outpatient IMRT is required. As of July 1, 2010, prior approval is no longer required for outpatient IMRT provided for the treatment of head and neck cancers.

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

For this policy, head and neck cancers are those arising from the oral cavity and lip, larynx, hypopharynx, oropharynx, nasopharynx, paranasal sinuses and nasal cavity, salivary glands, and occult primaries in the head and neck region.

Organs at risk are defined as normal tissues whose radiation sensitivity may significantly influence treatment planning and/or prescribed radiation dose. These organs at risk may be particularly vulnerable to clinically important complications from radiation toxicity. The following table outlines radiation doses that are generally considered tolerance thresholds for these normal structures in the area of the thyroid. Clinical documentation based on dosimetry plans may be used to demonstrate that radiation by 3-dimensional conformal radiotherapy without intensity-modulated radiotherapy would exceed tolerance doses to structures at risk.

Radiation Tolerance Doses for Normal Tissues

^aTD 5/5, the average dose that results in a 5% complication risk within 5 years.^bTD 50/5, the average dose that results in a 50% complication risk within 5 years.NP: not providedTD: tolerance dosecm = centimeters

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

5/26/2009: Policy added.

7/16/2009: Approved by Medical Policy Advisory Committee (MPAC).

12/28/2009: Added Prior Approval for FEP members effective January 1, 2010. Also corrected a typographical error, changed CPT Code 77148 to 77418.

07/16/2010: Policy Exceptions section revised to state that as of July 1, 2010, prior approval is no longer required for outpatient IMRT provided for the treatment of head and neck cancers for FEP members.

08/17/2010: Add CPT code 77338 to the Covered Codes table.

12/30/2010: Policy statement revised to indicate that intensity-modulated radiation therapy is considered investigational for the treatment of thyroid cancers.

07/19/2012: Policy statement on head and neck cancers unchanged. Policy statement on thyroid tumors changed from investigational to the following:  Intensity-modulated radiation therapy is considered medically necessary for the treatment of thyroid cancers in close proximity to organs at risk (esophagus, salivary glands, and spinal cord) and 3-D CRT planning is not able to meet dose volume constraints for normal tissue tolerance. Policy guidelines updated regarding radiation tolerance doses for normal tissues (esophagus, salivary glands, spinal cord). Added ICD-9 code 193 to the Covered Codes table.

08/13/2012: Added ICD-9 code 195.0 to the Covered Codes table.

10/23/2013: Policy reviewed; no changes.

08/12/2014: Policy title changed from "Intensity-Modulated Radiation Therapy (IMRT) Head and Neck Cancers" to "Intensity-Modulated Radiotherapy: Cancer of the Head and Neck or Thyroid." Policy description updated regarding radiation techniques. Second medically necessary policy statement revised to change "is" to "may be." Added the following statement: Intensity-modulated radiation therapy is not medically necessary for the treatment of thyroid cancers for all indications not meeting the criteria above.

12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77385 and 77386. Added the following new 2015 HCPCS codes to the Code Reference section: G6015 and G6016.

08/25/2015: Medical policy revised to add ICD-10 codes. Added ICD-9 diagnosis code range 190.0 - 190.9 to the Code Reference section.

10/29/2015: Policy description updated regarding devices. Policy statements updated to change "radiation therapy" to "radiotherapy." Policy guidelines updated to add medically necessary and investigative definitions.

05/26/2016: Policy number A.8.01.48 added. Removed deleted CPT codes 77418 and 0073T from the Code Reference section.

09/16/2016: Policy description updated regarding radiotherapy techniques. Policy statements unchanged. Code Reference section updated to make correction: ICD-10 diagnosis code C69.0 should be C69.00.

08/14/2017: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding clinical documentation.

08/14/2018: Policy description updated regarding the focus of this policy. Policy statements unchanged.

08/21/2019: Policy reviewed; no changes.

08/21/2020: Policy description updated regarding radiotherapy techniques. Policy statements unchanged.

12/03/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/24/2022: Policy reviewed; no changes.

08/15/2023: Policy reviewed. Policy statement updated to change "not medically necessary" to "investigational."

08/15/2024: Policy reviewed; no changes.

09/15/2025: Policy description updated regarding intensity modulators and radiotherapy treatment planning systems. Policy statements unchanged.

SOURCE(S)

Blue Cross & Blue Shield Association policy # 8.01.48

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.