Stereotactic Body Radiation Therapy (SBRT) is a treatment that couples a high degree of anatomic targeting accuracy and reproducibility with very high doses of extremely precise, externally generated, ionizing radiation, thereby maximizing the cell-killing effect on the target(s) while minimizing radiation-related injury in adjacent normal tissues.
The adjective “stereotactic” describes a procedure during which a target lesion is localized relative to a known three-dimensional reference system that allows for a high degree of anatomic accuracy and precision. Examples of devices used in SBRT for stereotactic guidance may include a body frame with external reference markers in which a patient is positioned securely, a system of implanted fiducial markers that can be visualized with low energy (kV) X-rays and Computed Tomography (CT) -imaging-based systems used to confirm the location of a tumor immediately prior to treatment.
All SBRT is performed with at least one form of image guidance to confirm proper patient positioning and tumor localization. To minimize intratreatment tumor motion associated with respiration or other motion, some form of motion control or “gating” may be used.
SBRT may be fractionated (up to five fractions). Each fraction requires an identical degree of precision, localization and image guidance.
Since the goal of SBRT is to intensify the potency of the radiotherapy by completing an entire course of treatment within an extremely accelerated time frame, any course of radiation treatment extending beyond five fractions is not considered SBRT and is not to be billed using these codes.
Since the goal of SBRT is to intensify the potency of the radiotherapy by completing an entire course of treatment within an extremely accelerated time frame, any course of radiation treatment extending beyond five fractions is not considered SBRT and is not to be billed using these codes.
Indications for SBRT for Lung, Liver, Kidney, Adrenal Gland or Pancreas Neoplasms
This LCD covers primary and metastatic tumors of the lung, liver, kidney, adrenal gland or pancreas when and only when each of the following criteria are met, and each is specifically documented in the medical record:
- 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.).
- Other forms of radiotherapy, including but not limited to external beam and Intensity-Modulated Radiation Therapy (IMRT), cannot be as safely or effectively utilized.
- The tumor burden can be completely targeted with acceptable risk to critical normal structures.
- If the tumor histology is germ cell or lymphoma, effective chemotherapy regimens have been exhausted or are otherwise not feasible.
- Other forms of focal therapy, including but not limited to radiofrequency ablation and cryotherapy, cannot be as safely or effectively utilized.
Other neoplasms:
Lesions of bone, prostate, breast, uterus, ovary and other internal organs not listed above are not covered for primary definitive SBRT as literature does not support an outcome advantage over other conventional radiation modalities, but may be appropriate for SBRT in the setting of recurrence after conventional radiation modalities.
Malignant lesions of the head and neck or paranasal sinuses may be appropriate for SBRT following other conventional radiation modalities to complete initial definitive therapy.
Other Indications for SBRT:
Except as indicated above, any lesion with a documented necessity to treat using a high dose per fraction of radiation may be indicated. When using high radiation doses per fraction, high precision is required to avoid surrounding normal tissue exposure.
Lesions which have received previous radiotherapy or are immediately adjacent to previously irradiated fields where the additional precision of stereotactic radiotherapy is required to avoid unacceptable tissue radiation will be covered when other conditions of coverage are met (see Limitations below) and this necessity is documented in the medical record.
Limitations – Coverage will be denied for each of the following:
Malignant lesions of the head and neck or paranasal sinuses may be appropriate for SBRT following other conventional radiation modalities to complete initial definitive therapy.
Other Indications for SBRT:
Except as indicated above, any lesion with a documented necessity to treat using a high dose per fraction of radiation may be indicated. When using high radiation doses per fraction, high precision is required to avoid surrounding normal tissue exposure.
Lesions which have received previous radiotherapy or are immediately adjacent to previously irradiated fields where the additional precision of stereotactic radiotherapy is required to avoid unacceptable tissue radiation will be covered when other conditions of coverage are met (see Limitations below) and this necessity is documented in the medical record.
Limitations – Coverage will be denied for each of the following:
- Treatment unlikely to result in clinical cancer control and/or functional improvement.
- Patients with widespread cerebral or extra-cranial metastases.
- Patients with poor performance status measured on an appropriate scale such as the Karofsky Performance Status Scale (a measurement of less than 40) or the Eastern Cooperative Oncology Group Performance Status Scale (a measurement of less than 3).
CPT 77435 will be paid only once per course of treatment of SBRT.
CPT 77373 will be paid only once per day of treatment regardless of the number of sessions or lesions.
Other radiation oncology services (professional and technical) are coded separately and are addressed in the separate LCDs.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, 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.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
- Furnished in a setting appropriate to the patient’s medical needs and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient’s medical need.
- At least as beneficial as an existing and available medically appropriate alternative.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 85X
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances, Revenue Codes are purely advisory; unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD . Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/orRevenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Publication 100-04, Claims Processing Manual, for further guidance.
0333
CPT/HCPCS Codes
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Note:
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Providers are reminded to refer to the long descriptors of the CPT codes in their CPT books. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
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77373©
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Sbrt delivery
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77435©
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Sbrt management
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Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment
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G0340
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Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment
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ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 77373 and 77435, G0339 and G0340:
Covered for:
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146.0–146.9
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Malignant neoplasm of oropharynx
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147.0–147.3
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Malignant neoplasm of nasopharynx
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147.8–147.9
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Malignant neoplasm of nasopharynx
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155.0–155.2
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Malignant neoplasm of liver and other intrahepatic bile ducts
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157.0–157.4
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Malignant neoplasm of pancreas
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157.8–157.9
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Malignant neoplasm of pancreas
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160.0–160.5
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Malignant neoplasm of nasal cavities, middle ear and accessory sinuses
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160.8–160.9
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Malignant neoplasm of nasal cavities, middle ear and accessory sinuses
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162.0
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Malignant neoplasm of trachea
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162.2–162.5
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Malignant neoplasm of trachea, bronchus and lung
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162.8–162.9
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Malignant neoplasm of trachea, bronchus and lung
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189.0–189.1
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Malignant neoplasm of kidney and other and unspecified urinary organs
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194.0
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Malignant neoplasm of adrenal gland
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194.6
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Malignant neoplasm of aortic body and other paraganglia
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197.0
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Secondary malignant neoplasm of lung
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197.7
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Secondary malignant neoplasm of liver
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197.8
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Secondary malignant neoplasm of other digestive organs and spleen
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Note: 197.8 is limited to secondary malignant neoplasms of pancreas and may not be used for other diagnoses.
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198.0
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Secondary malignant neoplasm of kidney
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198.3–198.5*
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Secondary malignant neoplasm of other specified sites
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198.7
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Secondary malignant neoplasm of adrenal gland
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198.89*
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Secondary malignant neoplasm of other specified sites
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227.6
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Benign neoplasm of aortic body and other paraganglia
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234.8*
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Carcinoma in situ of other specified sites
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237.3
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Neoplasm of uncertain behavior of paraganglia
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239.7*
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Neoplasm of unspecified nature of endocrine glands and other parts of nervous system
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990
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Effects of radiation unspecified
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Note: 990 may only be used where prior radiation therapy to the site is the governing factor necessitating SBRT in lieu of other radiotherapy. An ICD-9-CM code for the anatomic diagnosis must also be used.
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*Note: ICD-9-CM codes 198.4, 198.5, 198.89, 234.8 and 239.7 are all limited to use for lesions occurring either above the neck or in the spine.
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
N/A
ICD-9-CM Codes That DO NOT Support Medical Necessity
N/A
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
The patient’s record must support the necessity and frequency of treatment. Medical records should include not only the standard history and physical but also the patient’s functional status and a description of current performance status (Karnofsky Performance Status or Eastern Cooperative Oncology Group Performance Status as described in the “Indications and Limitation of Coverage and/or Medical Necessity” section above.)
Documentation should include the date and the current treatment dose. A radiation oncologist must evaluate the clinical and technical aspects of the treatment and document this evaluation as well as the resulting management decisions.
When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
Appendices
N/A
Utilization Guidelines
This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.
CPT 77435 will be paid only once per course of treatment of SBRT.
CPT 77373 will be paid only once per day of treatment regardless of the number of sessions or lesions.
CPT 77373 will be paid only once per day of treatment regardless of the number of sessions or lesions.
Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.
