Stereotactic body radiation therapy (SBRT) will be covered on a case by case basis for primary and metastatic tumors of the liver, kidney, adrenal gland, pancreas and prostate and for primary stage I and II non-small cell lung cancer provided that each of the following criteria is met. Medical necessity must be specifically documented in the patient’s medical record. 

1. The patient’s general medical condition (notably, the performance status) justifies aggressive treatment to a primary cancer or, for the case of metastatic disease, justifies aggressive local therapy to one or more discreet deposits of cancer within the context of efforts to achieve total clearance or clinically beneficial reduction in the patient’s overall burden of systemic disease. Typically, such a patient would have also been a potential candidate for alternate forms of intense local therapy applied for the same purpose (e.g., surgical resection, radiofrequency ablation, cryotherapy, etc);
2. Other forms of radiotherapy, including but not limited to external beam and IMRT, cannot be as safely or effectively utilized and the tumor burden can be completely targeted with acceptable risk to critical normal structures;
3. Other forms of focal therapy, including but not limited to radiofrequency ablation and cryotherapy, cannot be as safely or effectively utilized. 

Refer to Medical Policy Bulletin S-138 for information on cryosurgery of the liver.

Refer to Medical Policy Bulletin S-141 for information on radiofrequency thermal ablation of liver tumors.

Refer to Medical Policy Bulletin S-158 for information on cryosurgical ablation and radiofrequency ablation of renal tumors.

Stereotactic body radiation therapy (SBRT) with a gamma knife, Cyberknife, or linear accelerator (LINAC) is considered medically necessary for localized malignant conditions within the body where highly precise application of high-dose radiotherapy is required to avoid surrounding normal tissue exposure.

Other Covered Indications

• If the tumor histology is germ cell or lymphoma, effective chemotherapy regimens have been exhausted or are otherwise not feasible;
• Lesions that have been treated previously with radiotherapy or are immediately adjacent to previously irradiated fields will be covered on an individual basis. This includes:
  • bony lesions of the spine that have failed external beam radiation;
  • recurring or previously irradiated cancers of the spine and spinal cord;
  • non-radiosensitive melanoma; and,
  • renal cell cancer with metastasis to the spine. In this instance, the additional precision of SBRT is required to avoid unacceptable tissue radiation;
• Recurring or previously irradiated tumors of the head and neck with metastasis to other critical organs or structures. 

SBRT for carcinoma of the prostate may be considered for coverage on an individual basis. However, the patient's medical records must include clinical documentation explaining the circumstances and medical necessity for SBRT rather than other treatment modalities. These records must be available for review upon request.

• Clinical documentation of the patient's condition, such as the stage and other clinical factors.
• Documentation confirming that the patient was informed of the range of therapy choices, including the risks and benefits, and documentation of the specific reasons why SBRT was the treatment of choice for that patient.

SBRT treatment management (code 77435) is eligible once per course of treatment with the entire course not to exceed five fractions, and includes the work of imaging guidance during treatment. 

SBRT is considered experimental/investigational for the following. In these instances, it is not covered:

• Treatment that is unlikely to result in clinical cancer control and/or functional improvement;
• Patients with wide-spread cerebral or extra-cranial metastases;
• Lesions in other anatomic sites not listed as eligible. 

The available scientific literature does not support improved outcomes over other conventional radiation therapy treatment modalities. Additional short and long-term studies are needed to analyze the efficacy of SBRT compared to other radiation therapy modalities, its impact on physician decision-making in treatment protocols, and long term health outcomes achieved through the use of SBRT. A participating, preferred, or network provider can bill the member for a service denied in these situations.

Description

SBRT is a fractionated method of stereotactically guided radiation therapy applied over several days, typically to areas of the body other than cranial. It is available today through the technological advances made in radiation therapy treatment delivery, such as the anatomic positioning devices to locate and/or track the tumor. To successfully accomplish treatments outside of the brain, a combination of immobilization or repositioning systems, or devices capable of compensating for internal organ or tissue motion are typically used, with or without imaging guidance. These devices take the place of the headframe that is often used in treating intracranial tumors stereotactically. This treatment methodology is based on the radiobiologic principle that fractionation decreases the short- and long-term side effects of radiation therapy.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

08/2010, Stereotactic body radiation therapy covered for select conditions
02/2011, Coverage for stereotactic radiosurgery and stereotactic body radiation therapy expanded
12/2011, Stereotactic body radiation therapy covered on a case-by-case basis

Facility Bulletin: Commercial Medical Policies R-14 and R-21 Apply to Facility Business Effective April 2, 2012.

ASTRO/ACR Guide to Radiation Oncology Coding. 2010. Chapter 14:Stereotactic Body Radiation Therapy (SBRT):141-146.

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