Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Medical Policy

Intensity Modulated Radiation Therapy, Outpatient Policy Number: OCA 3.81 Version Number: 14 Version Effective Date: 10/01/16

Product Applicability

All Plan+ Products

Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program

Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options

only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary

The Plan considers intensity modulated radiation therapy (IMRT) with or without stereoscopic x-ray guidance to be medically necessary when Plan medical criteria are met. Prior authorization is required for IMRT when it is provided in an outpatient setting, as specified in the Medical Policy Statement section of this policy. All inpatient admissions require Plan prior authorization, as stated in the Prior Authorization/Notification Requirements matrix available at www.bmchp.org for BMC HealthNet Plan members and www.wellsense.org for Well Sense Health Plan members. IMRT conducted during an authorized inpatient stay does not require a separate Plan authorization.

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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It will be determined during the prior authorization process if the service is considered medically necessary for the requested indication. See the Plan’s medical policy, Medically Necessary (policy number OCA 3.14), for the product-specific definitions of medically necessary treatment.

Description of Item or Service

Intensity Modulated Radiation Therapy (IMRT): An advanced mode of high-precision radiotherapy that utilizes computer-controlled linear accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor. IMRT breaks the radiation beam into thousands of thin, tightly focused beams that enter the body from many angles to intersect on the cancer. These tiny radiation beam-shaping devices (called collimators) can be stationary or can move during treatment, allowing the intensity of the radiation beams to change during treatment sessions. This kind of dose modulation allows different areas of a tumor or nearby tissues to receive different doses of radiation. Unlike other types of radiation therapy, IMRT is planned in reverse. In inverse treatment planning for IMRT, the radiation oncologist chooses the radiation doses to different areas of the tumor and surrounding tissue, and then a high-powered computer program calculates the required number of beams and angles of the radiation treatment. In contrast, during traditional (forward) treatment planning, the radiation oncologist chooses the number and angles of the radiation beams in advance and computers calculate how much dose will be delivered from each of the planned beams. The goal of IMRT is to increase the radiation dose to the areas that need it and reduce radiation exposure to specific sensitive areas of surrounding normal tissue. Compared with 3-dimensional

conformal radiation therapy (3D-CRT), IMRT can reduce the risk of some side effects. However, with IMRT, a larger volume of normal tissue overall is exposed to radiation than with 3D-CRT. Whether IMRT leads to improved control of tumor growth and better survival compared with 3D-CRT is not yet known. (Source: National Cancer Institute.)

Medical Policy Statement

According to the American Society for Radiation Oncology (ASTRO), IMRT should be considered the standard of care for radiation therapy for some anatomical sites such as nasopharynx, oropharynx, hypopharynx, larynx (except for early true vocal cord cancer), prostate, anus, and central nervous system; for other anatomical sites, documentation of benefit using IMRT is required. The Plan considers intensity modulated radiation therapy (IMRT) with or without stereoscopic x-ray guidance to be medically necessary when billed with a covered CPT code and/or HCPCS code (as specified in the Applicable Coding section of this Plan policy) and EITHER of the following criteria is met and documented in the member’s medical record, as specified below in item 1 or item 2:

1. Prior authorization is NOT required for IMRT provided in an outpatient setting, either with or without stereoscopic x-ray guidance, when IMRT is used to treat for ANY of the following conditions, as specified below in items a through d, and when the service is billed with a waived primary diagnosis code included the Applicable Coding section of this Plan policy:

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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a. Malignant lesions (carcinoma) of the anus/anal canal; OR b. Malignant lesions (carcinoma) of the prostate; OR c. Primary tumors, metastatic tumors, and/or benign tumors of the central nervous system

including the brain, brain stem, and/or spinal cord; OR

d. Primary tumors and/or metastatic tumors to the head and neck area including orbits, lens, retina, optic chiasm, cochlear, sinuses, skull base, salivary glands, thyroid, larynx (except true vocal cord cancer since the use of IMRT for early true vocal cord cancer is NOT considered a standard of care), and/or the aero-digestive tract (i.e., lips, mouth, tongue, nose, throat, vocal cords, trachea, and upper third of the esophagus); OR

2. Plan prior authorization is REQUIRED for all other uses of IMRT provided in an outpatient

setting and ALL of the following criteria must be met, as specified below in items a through c: a. The member has a radiosensitive tumor; AND b. The treatment plan and delivery of IMRT will the customized based on the member’s

medical condition/physical status according to standards that are consistent with current, applicable practice guidelines recommended by the American College of Radiology (ACR), the American Society for Radiation Oncology (ASTRO), and/or the National Comprehensive Cancer Network (NCCN); AND

c. At least ONE (1) of the following criteria is met, as specified below in item (1) or item (2):

(1) The treating provider has determined that the member’s true vocal cord cancer meets

BOTH of the following criteria, as specified below in items (a) and (b):

(a) True vocal cord cancer has progress beyond the early stage and is categorized as T3 or greater and N1 or greater according to the AJCC staging system for the glottis, as specified in the Definitions section of this policy (rather than early true vocal cord cancer categorized as T1/T2 and N0); AND

(b) IMRT is a more appropriate treatment option than conventional radiotherapy;

OR

(2) The use of standard external beam radiation therapy or 3D conformal radiation therapy is NOT appropriate for the member because at least ONE (1) of the following conditions is present, as specified below in items (a) through (e):

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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(a) The target volume is in close proximity to critical structures that must be protected and a 3D conformal plan cannot safely deliver the desired dose of radiation without exceeding dose constraints (i.e., dose restriction to maintain adequate level of protection) for those critical structures; OR

(b) The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures and a non-IMRT technique would substantially increase the probability of clinically meaningful normal tissue toxicity; OR

(c) An immediately adjacent area has been previously irradiated and abutting

portals must be established with high precision; OR (d) The target volume is concave or convex, and the critical normal tissues are

within or around that convexity or concavity and a non-IMRT technique would substantially increase the probability of clinically meaningful normal tissue toxicity; OR

(e) Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.

Limitations

Prior authorization is NOT required for IMRT with or without stereoscopic x-ray guidance when used for ANY of the following conditions: (1) anal cancer; (2) prostate cancer; (3) primary, metastatic and/or benign tumors of the central nervous system (including brain, brain stem, and/or spinal cord); and/or (4) primary, metastatic, and/or benign tumors of the head and neck area. Because IMRT is an emerging field, all other uses of IMRT provided in an outpatient setting require Plan prior authorization.

Definitions

3-Dimensional Conformal Radiation Therapy (3D-CRT): Also called 3-dimensional radiation therapy, 3D-CRT is a procedure that uses computer-generated, 3-dimensional images of the tumor and is a type of external-beam radiation therapy. This type of radiation therapy allows physicians to give the highest possible dose of radiation to the tumor, while sparing radiation exposure on normal tissue. (Source: National Cancer Institute.) American Joint Committee on Cancer (AJCC) TNM Staging System for the Glottis and Regional Node Involvement (7th ed., 2010): The TNM staging system reflects tumor size, extension, and nodal involvement. The stage at diagnosis determines treatment recommendations established by the National Comprehensive Cancer Network (NCCN) for head and neck cancers. (Nonepithelial tumors such as those of lymphoid tissue, soft tissue, bone, and cartilage are not included.)

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Glottis: T1: Tumor limited to the vocal cord(s); may involve anterior or posterior commissure with normal mobility. T1a: Tumor limited to one (1) vocal cord. T1b: Tumor limited to both vocal cords. T2: Tumor extends to supraglottis and/or subglottis and/or with impaired vocal cord mobility. T3: Tumor limited to the larynx with local cord fixation and/or invasion of paraglottic space, and/or inner cortex of the thyroid cartilage. T4a: Moderately advanced local disease. Tumor invades through the outer cortex of the thyroid cartilage and/or invades tissues beyond the larynx (e.g., trachea, soft tissue of the neck including deep extrinsic muscle of the tongue, strap muscles, thyroid, or esophagus. T4b: Very advanced local disease. Tumor invades prevertebral space, encases carotid artery, or invades mediastinal structures.

Regional Lymph Node Involvement (N): NX: Regional lymph nodes cannot be assessed. N0: No regional lymph node metastasis. N1: Metastasis in a single ipsilateral lymph node, 3 cm or less in greatest dimension. N2: Metastasis in a single ipsilateral lymph node, more than 3 cm but not more than 6 cm in greatest dimension; or in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension; or in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension. N2a: Metastasis in a single ipsilateral lymph node, more than 3 cm but not more than 6 cm in greatest dimension. N2b: Metastasis in multiple ipsilateral lymph nodes, none more than 6 cm in greatest dimension. N2c: Metastasis in bilateral or contralateral lymph nodes, none more than 6 cm in greatest dimension. N3: Metastasis in a lymph node, more than 6 cm in greatest dimension.

Brachytherapy: Also called implant radiation therapy, internal radiation therapy, and radiation brachytherapy, brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor. Approximately half of all cancer patients receive some type of radiation therapy during the course of treatment. Radiation may be delivered with brachytherapy/internal radiation therapy, external-beam radiation therapy, or using systemic radiation therapy using radioactive substance that travel in the bloodstream. (Source: National Cancer Institute.) Electron Beam Therapy: A type of external-beam radiation therapy that uses a stream of electrons (small negatively charged particles found in atoms) for therapy. Electron beams are used to irradiate superficial tumors, such as skin cancer or tumors near the surface of the body, but they cannot travel very far through tissue and therefore cannot treat tumors deep within the body. (Source: National Cancer Institute.)

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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External-Beam Radiation Therapy: External-beam radiation used to shrink tumors and kill cancer cells. External-beam radiation therapy is most often delivered in the form of photon beams (either x-rays or gamma rays). A photon is the basic unit of light and other forms of electromagnetic radiation. Types of external-beam radiation include the following: 3-dimensional conformal radiation therapy (3D-CRT), image-guided radiation therapy (IGRT), intensity-modulated radiation therapy (IMRT), tomotherapy, stereotactic radiosurgery, proton therapy (using protons rather than photon beams), and electron beams. Approximately half of all cancer patients receive some type of radiation therapy during the course of treatment. Radiation may be delivered with external-beam radiation therapy, internal radiation therapy/brachytherapy, or using systemic radiation therapy using radioactive substance that travel in the bloodstream. (Source: National Cancer Institute.) Glottis: The vocal apparatus of the larynx, consisting of the true vocal cords and the opening between them. Image-Guided Radiation Therapy (IGRT): A type of external-beam radiation therapy where repeated imaging scans (CT, MRI, or PET) are performed during treatment. These imaging scans are processed by computers to identify changes in a tumor’s size and location due to treatment and to allow the position of the patient or the planned radiation dose to be adjusted during treatment, as needed. Repeated imaging can increase the accuracy of radiation treatment and may allow reductions in the planned volume of tissue to be treated, thereby decreasing the total radiation dose to normal tissue. (Source: National Cancer Institute.)

Primary Tumor (Primary Cancer): The original, or first, tumor in the body. Cancer cells from a primary tumor may spread to other parts of the body and form new, or secondary, tumors (metastasis). These secondary tumors are the same type of cancer as the primary tumor. Proton Therapy: A type of external-beam radiation therapy delivered by proton beams (rather than photon beams used with other types of external beam radiation therapy). Proton beams differ from photon beams mainly in the way the beams deposit energy in living tissue; photons deposit energy in small packets all along their path through tissue, and protons deposit much of their energy at the end of their path and deposit less energy along the way. In theory, use of protons should reduce the exposure of normal tissue to radiation, possibly allowing the delivery of higher doses of radiation to a tumor, but the effectiveness of proton therapy when compared with standard external-beam radiation therapy has not yet been documented. (Source: National Cancer Institute.) Stereotactic Radiosurgery (SRS): A type of external-beam radiation therapy that uses extremely accurate image-guided tumor targeting and patient positioning to deliver one or more high doses of radiation to a small tumor; this allows a high dose of radiation to be given without excess damage to normal tissue. SRS can only be used to treat small tumors with well-defined edges. It is most commonly used in the treatment of brain or spinal tumors and brain metastases from other cancer types. For the treatment of some brain metastases, patients may receive radiation therapy to the

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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entire brain (called whole-brain radiation therapy) in addition to SRS. (Source: National Cancer Institute.) Stereoscopic X-Ray Guidance: An imaging tool that is used to define the localization of target volumes in certain anatomical sites for the purpose of improving the accuracy of radiation dosing immediately prior to IMRT or 3D conformal radiation therapy. Stereoscopic x-ray guidance is also used with stereotactic radiosurgery (SRS), which is not surgery in the conventional sense but a treatment for brain tumors (both cancerous and non-cancerous) where the patient receives a single high dose of radiation, focusing radiation directly to the area of the abnormality with very little reaching normal brain structures or tissue (and is particularly useful for difficult to reach areas within the brain and inoperable brain tumors). Tomotherapy: A type of image-guided IMRT (and considered a type of external-beam radiation therapy) that uses a machine that is a hybrid between a CT imaging scanner and an external-beam radiation therapy machine. The part of the tomotherapy machine that delivers radiation for both imaging and treatment can rotate completely around the patient in the same manner as a normal CT scanner. Tomotherapy machines can capture CT images of the patient’s tumor immediately before treatment sessions, to allow for very precise tumor targeting and sparing of normal tissue. Like standard IMRT, tomotherapy may be better than 3D-CRT at sparing normal tissue from high radiation doses. However, results from clinical trials comparing 3D-CRT with tomotherapy are not available. (Source: National Cancer Institute.) Vocal Cords (Vocal Folds): A combination of muscle and ligament located within the larynx, stretching horizontally across it and attached to its cartilages, and it sits on the top of the trachea.

Applicable Coding

The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Because the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service. Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

CPT Codes Description: Codes Covered for IMRT-Related Services When Medically Necessary

77301 Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications

77338 Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan (Do not report 77338 in conjunction with 77385 for compensator based IMRT. Do not report 77338 more than once per IMRT plan.)

77385 Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple

Plan note: This code should only be used for the technical component of the service.

77386 Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex Plan note: This code should only be used for the technical component of the service.

HCPCS Codes Description: Codes Covered for IMRT-Related Services When Medically Necessary

G6015 Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session

Plan note: This code should only be used for the technical component of the service.

G6016 Compensator-based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session Plan note: This code should only be used for the technical component of the service.

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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ICD-10 Diagnosis Codes

Description: Applicable Diagnosis Codes That Do NOT Require Prior Authorization Plan note: No prior authorization is required when IMRT is used for the treatment of one (1) of the following diagnoses and is billed with a covered CPT code and/or HCPCS code (as specified above in this section); to qualify for a waiver of the prior authorization requirement, one (1) of the listed diagnosis codes in this Applicable Coding section must be billed in the principal diagnosis field (i.e., diagnosis field 1 on the UB04 or HCFA claim form). All other diagnosis codes or any of the following diagnosis codes billed in any other diagnosis field REQUIRE Plan prior authorization for IMRT provided in an outpatient setting.

C00.0-C14.8 Malignant neoplasm of lip, oral cavity and pharynx

C15.3 Malignant neoplasm of upper third of esophagus

C21.0-C21.8 Malignant neoplasm of anus and anal canal

C30.0-C30.1 Malignant neoplasm of nasal cavity and middle ear

C31.0-C31.9 Malignant neoplasm of accessory sinuses

C33 Malignant neoplasm of trachea

C41.0-C41.1 Malignant neoplasm of bones of skull, face and mandible

C43.0-C43.4 Malignant melanoma of skin of head and neck

C44.00-C44.09 Other and unspecified malignant neoplasm of skin of lip

C44.101-C44.199

Other and unspecified malignant neoplasm of skin of eyelid, including canthus

C44.201-C44.299

Other and unspecified malignant neoplasm of skin of ear and external auricular canal

C44.300-C44.399

Other and unspecified malignant neoplasm of skin of other and unspecified parts of face

C44.40-C44.49 Other and unspecified malignant neoplasm of skin of scalp and neck

C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck

C61 Malignant neoplasm of prostate

C69.00-C69.92 Malignant neoplasm of eye and adnexa

C70.0-C71.9 Malignant neoplasm of meninges and brain

C72.0-C72.59 Malignant neoplasm of spinal cord, cranial nerves and other parts of the central nervous system

C73 Malignant neoplasm of thyroid gland

C75.0-C75.3 Malignant neoplasm of parathyroid, pituitary and pineal glands and craniopharyngeal duct

C76.0 Malignant neoplasm of other and ill-defined sites of head, face and neck

C77.0 Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

C79.31-C79.32 Secondary malignant neoplasm of brain and cerebral meninges

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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C81.01, C81.11, C81.21, C81.31, C81.41, C81.71, C81.91

Hodgkin lymphoma, lymph nodes of head, face, and neck

C82.01, C82.11, C82.21, C82.31, C82.41, C82.51, C82.61, C82.81, C82.91

Follicular lymphoma, lymph nodes of head, face, and neck

C83.01, C83.11, C83.31, C83.51, C83.71, C83.81, C83.91

Non-follicular lymphoma, lymph nodes of head, face, and neck

C84.01, C84.11, C84.41, C84.61, C84.71, C84.91, C84.A1, C84.Z1

Mature T/NK-cell lymphomas, lymph nodes of head, face, and neck

C85.11, C85.21, C85.81, C85.91

Other and unspecified types of non-Hodgkin lymphoma, lymph nodes of head, face and neck

D00.00-D00.08 Carcinoma in situ of lip, oral cavity and pharynx

D02.0 Carcinoma in situ of larynx

D02.1 Carcinoma in situ, trachea

D03.0 Melanoma in situ of lip

D03.10-D03.12 Melanoma in situ of eyelid, including canthus

D03.20-D03.22 Melanoma in situ of ear and external auricular canal

D03.30-D03.39 Melanoma in situ of unspecified part of face

D03.4 Melanoma in situ of scalp and neck

D04.0-D04.4 Carcinoma in situ of skin of head and neck

D07.5 Carcinoma in situ of prostate

D09.20-D09.22 Carcinoma in situ of eye

D32.0-D32.9 Benign neoplasm of meninges

D33.0-D33.9 Benign neoplasm of brain and other parts of central nervous system

D35.2 Benign neoplasm of pituitary gland

D35.3 Benign neoplasm of craniopharyngeal duct

D35.4 Benign neoplasm of pineal gland

D43.0-D43.9 Neoplasm of uncertain behavior of brain and central nervous system

D44.3 Neoplasm of uncertain behavior of pituitary gland

D44.4 Neoplasm of uncertain behavior of craniopharyngeal duct

D44.5 Neoplasm of uncertain behavior of pineal gland

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Clinical Background Information

During external beam radiation therapy, a beam (or multiple beams) of radiation is directed through the skin to the cancer and the immediate surrounding area to destroy the tumor and any nearby cancer cells. Several special types of external beam radiotherapy used for specific types of cancer include the following: Three-dimensional conformal radiation therapy, intensity modulated radiation therapy (IMRT), image guided radiation therapy (IGRT), stereotactic radiation therapy, intraoperative radiation therapy, proton beam therapy, and neutron beam therapy. According to the American College of Radiology (ACR) and the Radiological Society of North America (RSNA), intensity modulated radiation therapy (IMRT) is an advanced mode of high-precision radiotherapy that utilizes computer-controlled linear accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor. IMRT allows for the radiation dose to conform more precisely to the three-dimensional (3-D) shape of the tumor by controlling the intensity of the radiation beam in multiple small volumes. IMRT also allows higher radiation doses to be focused on regions within the tumor while minimizing the dose to surrounding critical structures. Stereoscopic x-ray guidance is an imaging tool that is used to define the localization of target volumes in certain anatomical sites for the purpose of improving the accuracy of radiation dosing immediately prior to IMRT or 3D conformal radiation therapy. Stereoscopic x-ray guidance allows the radiation oncologist to more accurately ensure that the target volume is treated to the planned dose of radiation and sparing of normal tissues. At the time of the Plan’s most recent policy review, no clinical guidelines were found from the Centers for Medicare & Medicaid Services (CMS) for IMRT. Determine if applicable CMS criteria are in effect for the specified service and the indication for treatment in a national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request for a Senior Care Options member. CMS references a published report by the Agency for Healthcare Research and Quality (AHRQ) on the comparative effectiveness of radiotherapy for clinically localized prostate cancer (as specified in the References section of this policy).

References

Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review Surveillance Program. Surveillance Report. CER # 13: Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer. 2012. Accessed at: http://www.effectivehealthcare.ahrq.gov/ehc/products/9/80/TX-for-Localized-Prostate-Cancer_SurveillanceAssesment_20120614.pdf American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO). Practice Guideline for Intensity Modulated Radiation Therapy (IMRT). Revised 2011. Accessed at: http://www.acr.org/~/media/EABB986BC4FF4A78B53B001A059F27B3.pdf

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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American College of Radiology (ACR). Chang JY, Kestin LL, Barriger RB, Chetty IJ, Ginsburg ME, Kumar S, Loo BW Jr, Movsas B, Rimner A, Rosenzweig KE, Stinchcombe TE, Videtic GM, Willers H, Expert Panel on Radiation Oncology-Lung. ACR Appropriateness Criteria® nonsurgical treatment for locally advanced non-small-cell lung cancer: good performance status/definitive intent [online publication]. Reston (VA): American College of Radiology (ACR); 2014. 18 p. Accessed at: http://www.guideline.gov/content.aspx?id=48303 American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO). ACR–ASTRO Practice Parameter for Intensity Modulated Radiation Therapy (IMRT). 2014. Amended 2014 (Resolution 39):1-11. Accessed at: http://www.acr.org/~/media/eabb986bc4ff4a78b53b001a059f27b3.pdf. American Joint Committee on Cancer (AJCC). Edge S, Byrd D, Compton C, et. al. AJCC Staging Manual. AJCC TNM Staging System for the Larynx. 7th ed. New York: Springer; 2010. American Society for Radiation Oncology (ASTRO). ASTRO Model Policies. Intensity Modulated Radiation Therapy (IMRT). Approved November 13, 2013. Accessed at: https://www.astro.org/uploadedFiles/Main_Site/Practice_Management/Reimbursement/IMRT%20MP.pdf American Society for Radiation Oncology (ASTRO). Clinical Practice Statements. Accessed at: https://www.astro.org/Clinical-Practice-Statements.aspx American Society for Radiation Oncology (ASTRO). RT Answers. Treatment Types. External Beam Radiation Therapy. Accessed at: http://www.rtanswers.org/treatmentinformation/treatmenttypes/externalbeamradiation/ Bankhead C. IMRT Benefits in Prostate Cancer Questioned. MedPage Today. May 20, 2013. Accessed at: http://www.medpagetoday.com/HematologyOncology/ProstateCancer/39287 Bauman G, Rumble RB, Chen J et al. Intensity-modulated radiotherapy in the treatment of prostate cancer. Clin Oncology 2012; 24(7):461-73. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/22673744 Bezjak A, Rumble RB, Rodrigues G, Hope A, Warde P, IMRT Indications Expert Panel. The role of IMRT in lung cancer. National Guideline Clearinghouse. Toronto (ON): Cancer Care Ontario (CCO); 2010 Nov 22. Various p. (Evidence-based series; no. 21-3-5). Bhatnagar AK et al. Initial outcomes analysis for large multicenter integrated cancer network implementation of intensity modulated radiation therapy for breast cancer. Breast J. 2009 Sep-Oct;15(5):468-74. Epub 2009 Jul 13.

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Cahlon O, Hunt M, Zelefsky MJ. Intensity-modulated radiation therapy: supportive data for prostate cancer. Semin Radiat Oncol 2008; 18:48-57. Centers for Medicare & Medicaid Services (CMS). Comparative evaluation of Radiation treatments for clinically localized prostate cancer: an update. Accessed at: https://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=69&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Massachusetts&KeyWord=radiation&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d& Centers for Medicare & Medicaid Services (CMS). Local Coverage Determination (LCD). Radiation Oncology Including Intensity Modulated Radiation Therapy (IMRT) (L30316). National Government Services, Inc. Accessed at: http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=30316&ContrId=268&ver=51&ContrVer=1&SearchType=Advanced&CoverageSelection=Local&ArticleType=SAD%7cEd&PolicyType=Final&s=24&CptHcpcsCode=77301&kq=true&bc=IAAAABAAAAAAAA%3d%3d& Centers for Medicare & Medicaid Services (CMS). Welcome to the Medicare Coverage Database. Accessed at: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx Chen AL, Kim J, Boucher K, Terakedis B, Williams B, Nickman NA, Gaffney, DK. Toxicity and cost-effectiveness analysis of intensity modulated radiation therapy versus 3-dimensional conformal radiation therapy for postoperative treatment of gynecologic cancers. Gynecol Oncol. 2015; Epub. Children’s Oncology Group. Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers. CureSearch. Version 3.0. October 2008. Accessed at: http://www.survivorshipguidelines.org/pdf/ltfuguidelines.pdf Choi et al. Image-Guided Radiation Therapy for Stereotactic Radiosurgery in Lung Tumor: P3-042. Journal of Thoracic Oncology. August 2007;2(8):S624-S625. Chuong MD, Freilich JM, Hoffe SE, Fulp W, Weber JM, Almhanna K, Dinwoodie W, Rao N, Meredith KL, and Shridhar R. Intensity-Modulated Radiation Therapy vs. 3D Conformal Radiation Therapy for Squamous Cell Carcinoma of the Anal Canal. Gastrointest Cancer Res. 2013 Mar-Apr; 6(2): 39–45. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3674462/ Dearnaley D, Syndikus I, Sumo G et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomized controlled trial. Lancet Oncol 2012; 13(1):43-54. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3388303/

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Ferrigno R, Santos A, Martins LC, Weltman E, Chen MJ, Sakuraba R, Lopes CP, and Cruz JC. Comparison of conformal and intensity modulated radiation therapy techniques for treatment of pelvic tumors. Analysis of acute toxicity. Radiat Oncol. 2010; 5: 117. Published online 2010 Dec 14. doi: 10.1186/1748-717X-5-117. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3009969/ Hayes Health Technology Brief. Postoperative Intensity-Modulated Radiation Therapy for Sinus Cancers. Winifred Hayes, Inc. December 26, 2013. Annual Review December 14, 2015. Hayes Medical Technology Directory. Accelerated Partial Breast Irradiation for Breast Cancer Using Conformal and Intensity-Modulated Radiation Therapy. Winifred Hayes, Inc. March 12, 2012. Annual Review February 29, 2016. Hayes Medical Technology Directory. Intensity Modulated Radiation Therapy (IMRT) for Anal or Rectal Cancer. Winifred Hayes, Inc. June 30, 2015. Hayes Medical Technology Directory. Whole Breast Irradiation for Breast Cancer Using Three-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy. Winifred Hayes, Inc. March 8, 2012. Annual Review February 12, 2015. Hayes Search & Summary. Intensity-Modulated Radiation Therapy (IMRT) for Endometrial Carcinoma. Winifred Hayes, Inc. November 12, 2015. Hayes Search & Summary. Intensity-Modulated Radiation Therapy (IMRT) for Left-Sided Breast Cancer to Minimize Damage to Heart and Lungs. Winifred Hayes, Inc. September 17, 2015.

Hayes Search & Summary. Intensity-Modulated Radiation Therapy for Urinary Bladder Cancer. Winifred Hayes, Inc. June 11, 2015. He Z, Wu S, Zhou J, Li F, Sun J, Lin Q, Lin H, Guan X. Accelerated partial breast irradiation with intensity-modulated radiotherapy is feasible for Chinese breast cancer patients. J Breast Cancer. 2014; 17(3):256-64. International RadioSurgery Association (IRSA). Radiotherapy Overview. IMRT. 2015. Accessed at: http://www.irsa.org/imrt.html. Kupelian P et al. Image-guided radiotherapy for localized prostate cancer: treating a moving target. Semin Radiat Oncol. 2008 Jan;18(1):58-66. Kupelian P et al. Impact of image guidance on outcomes after external beam radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1146-50.

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Kupelian P et al. Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1088-98. Lin Y, Wang B. Dosimetric absorption of intensity-modulated radiotherapy compared with conventional radiotherapy in breast-conserving surgery. Oncol Lett. 2015; 9(1):9-14. Lo SS, Teh BS, Lu J, Schefter TE. Series Editors. Stereotactic Body Radiation Therapy. Springer-Verlag Berlin Heidelberg. 2012. Narayana A, Yamada J, Berry S et al. Intensity-modulated radiotherapy in high-grade gliomas: clinical and dosimetric results. Int J Radiation Oncology Biol Phys 2006; 64(3):892-7. Accessed at: https://www.ncbi.nlm.nih.gov/m/pubmed/16458777/?i=4&from=/20097489/related National Cancer Institute. Laryngeal Cancer Treatment–for health professionals (PDQ®). July 31, 2014. Accessed at: http://www.cancer.gov/types/head-and-neck/hp/laryngeal-treatment-pdq National Cancer Institute. Radiation Therapy for Cancer. June 30, 2010. Accessed at: http://www.cancer.gov/about-cancer/treatment/types/radiation-therapy/radiation-fact-sheet National Comprehensive Cancer Network (NCCN). NCCN Guidelines®. NCCN Guidelines for Treatment of Cancer by Site. Accessed at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site National Comprehensive Cancer Network (NCCN). Policy Update: Joint Statement by Members of the

National Comprehensive Cancer Network Prostate Cancer Guidelines Panel. October 24, 2013. Accessed at: http://www.nccn.org/professionals/meetings/oncology_policy_program/article/nejm.aspx

National Institutes of Health (NIH). National Cancer Institute. Definition of Primary Tumor. Accessed at: http://www.cancer.gov/Common/PopUps/popDefinition.aspx?id=45847 Nutting CM et al. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2011 Feb;12(2):127-36. Epub 2011 Jan 12. Pollack A, Hanlon A, Horwitz EM, et al. Radiation therapy dose escalation for prostate cancer: a rationale for IMRT. World J Urol. 2003; 21(4):200-208. Skala M, Rosewall T, Dawson L, et al. Patient-assessed late toxicity rates and principal component analysis after image-guided radiation therapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2007;68:690-698.

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Sura S. et al. Intensity-modulated radiation therapy (IMRT) for inoperable non-small cell lung cancer: the Memorial Sloan-Kettering Cancer Center (MSKCC) experience. Radiother Oncol. 2008 Apr;87(1):17-23. Epub 2008 Mar 17. U.S. Food and Drug Administration (FDA). 510K Summary. Calypso 4D Localization System. Accessed at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080726.pdf U.S. National Institutes of Health. Clinical Trial: Positioning and Tracking the Prostate during External Beam Radiation. Accessed at: http://clinicaltrials.gov/ct2/show/NCT00123838?term=NCT00123838&rank=1 Vora SA, Wong WW, Schild SE, et al. Analysis of biochemical control and prognostic factors in patients treated with either low-dose three-dimensional conformal radiation therapy or high-dose intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2007; 68(4):1053-1058. Yong, JH, Beca J, McGowan T et al. Cost-effectiveness of intensity-modulated radiotherapy in prostate cancer. Clin Oncol 2012: 24(7):521-31. PubMed 21029717. Accessed at: https://www.ncbi.nlm.nih.gov/m/pubmed/22705100/?i=4&from=/21029717/related

Original Approval Date*

Original Effective* Date and Version

Number Policy Owner Approved by

Regulatory Approval: N/A Internal Approval: 02/19/08: MPCTAC 02/26/08: UMC 03/12/08: QIC

06/01/08 Version 1

Medical Policy Manager as Chair of Medical Policy, Criteria, and Technology Assessment Committee (MPCTAC) and member of Quality Improvement Committee (QIC)

MPCTAC, QIC, and Utilization Management Committee (UMC)

*Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12

*Effective Date for the Well Sense Health Plan Product(s): 01/01/13 *Effective Date for the Senior Care Options Product(s): 01/01/16

This policy replaced the Stereoscopic X-Ray Guidance for Radiation Therapy policy.

Policy Revisions History

Review Date Summary of Revisions

Revision Effective Date and Version

Number

Approved by

01/27/09 Updated references.

Version 2 01/27/09: MPCTAC 01/27/09: UMC

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Policy Revisions History

03/24/09 Updated clinical criteria and coding, removed authorization requirement for prostate, brain, head and neck cancers, added authorization requirement for all other diagnoses. Effective date of these changes is 07/01/09.

07/01/09 Version 3

03/24/09: MPCTAC 03/24/09: UMC 04/17/09: QIC

05/01/10 Updated references. Version 4 06/30/10: MPCTAC 07/28/10: QIC

06/01/11 Added information for IMRT, updated clinical background information, coding and references.

Version 5 06/29/11: MPCTAC 07/27/11: QIC

06/01/12 Updated CPT code definitions and added applicable code, updated references, and revised the introductory paragraph in Applicable Coding section. Updated policy to include IMRT with and without stereoscopic x-ray guidance; formerly the policy specified IMRT with stereoscopic x-ray guidance.

Version 6 06/20/12: MPCTAC 07/25/12: QIC

08/01/12 Off cycle review for Well Sense Health Plan. Revised title to specify IMRT in the outpatient setting. Revised Summary section and Limitations section. Reformatted Medical Policy Statement section and move criteria from Clinical Background Information section to Medical Policy Statement section.

Version 7 08/17/12: MPCTAC 09/06/12: QIC

08/14/13 and 08/15/13

Off cycle review for Well Sense Health Plan and merged policy format. Incorporate policy revisions dated 08/01/12 (as specified above) for the Well Sense Health Plan product using the merged policy format.

Version 8 08/14/13: MPCTAC (electronic vote) 08/15/13: QIC

07/17/13 and 08/21/13

Review for effective date 12/01/13. Revised title to specify the outpatient setting. Moved medical criteria from the Clinical Background Information section to the Medical Policy Statement section. Updated and added references. Revised applicable code list.

12/01/13 Version 9

07/17/13: MPCTAC 08/21/13: MPCTAC 09/19/13: QIC

06/01/14 and 06/30/14

Review for effective date 10/01/14. Revised text in the Policy Summary, Description of Item or Service, Medical Policy Statement, and Limitations sections without changing criteria. Added code-specific notes in the Applicable Coding section. Deleted CPT code 77421 because stereoscopic x-ray guidance also used with other services not included in

10/01/14 Version 10

06/30/14: MPCTAC (electronic vote) 07/09/14: QIC

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Policy Revisions History

this policy. Revised title for ICD9 code range 192.0-192.9 and removed ICD9 codes 192.1, 192.2, and 192.3 (since these codes are included in the code range 192.0-192.9). Updated references.

12/01/14 Review for 2015 code changes effective 03/01/15. Updated applicable code list.

03/01/15 Version 11

12/02/14: MPCTAC (electronic vote) 12/10/14: QIC

06/01/15 Review for effective date 10/01/15. Removed Commonwealth Care, Commonwealth Choice, and Employer Choice from the list of applicable products because the products are no longer available. Updated language in the Applicable Coding section and updated applicable code list. Revised criteria in the Medical Policy Statement and Limitations sections. Updated Summary, Definitions, and References sections.

10/01/15 Version 12

06/17/15: MPCTAC 07/08/15: QIC

11/25/15 Review for effective date 01/01/16. Updated template with list of applicable products and notes. Revised language in the Applicable Coding section.

01/01/16 Version 13

11/18/15: MPCTAC 11/25/15: MPCTAC (electronic vote) 12/09/15: QIC

06/01/16 Review for effective date 10/01/16. Revised Definitions, Clinical Background Information, References, and Reference to Applicable Laws and Regulations sections. Removed ICD-9 diagnosis codes and added Plan notes to applicable CPT codes. Revised criteria in the Medical Policy Statement section.

10/01/16 Version 14

06/15/16: MPCTAC 07/13/16: QIC

Last Review Date

06/01/16

Next Review Date

06/01/17

Authorizing Entity

QIC

Intensity Modulated Radiation Therapy, Outpatient + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Other Applicable Policies

Medical Policy - Medically Necessary, policy number OCA 3.14

Reference to Applicable Laws and Regulations

78 FR 48164-69. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. August 7, 2013. Accessed at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

Disclaimer Information: +

Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs.

Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members.

The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.