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DESCRIPTIONStereotactic radiosurgery (SRS) is a method of delivering high doses of ionizing radiation to small intracranial targets. The technique differs from conventional radiotherapy, which involves exposing large areas of intracranial tissue to relatively broad fields of radiation over a number of sessions. SRS entails delivering a highly focused ionizing beam so that only the desired target is radiated, sparing adjacent structures.
Two main methods of this technology exist:
1. Gamma-ray radiosurgery (Gamma Knife®)
2. Linear-accelerator radiosurgery (LINAC, CyberKnife®)
The Gamma-ray radiosurgery (Gamma Knife®) and Linear-accelerator radiosurgery systems (LINAC, CyberKnife®) are similar in concept; both use multiple photon radiation beams or arcs that intersect at a stereotactically determined target, thus permitting higher doses of radiation delivery with sparing of surrounding normal tissues. The differences between them relate to how the energy is produced (i.e., through decaying cobalt or from x-rays) and the number of energy sources used (i.e., multiple energy sources in the gamma knife versus one in the linear accelerator system).
The radiosurgical procedure is preceded by a process of localizing the target, which can be performed with one or more of the following techniques: skull x-ray, cerebral angiography, computed tomography (CT), and magnetic resonance imaging. SRS is typically performed in one session, usually requiring no more than an overnight stay. Stereotactic body radiation therapy (SBRT) refers to stereotactically guided radiation therapy applied over several days. This fractionated form of radiation therapy is made possible by the recent availability of noninvasive repositioning devices that can be used in lieu of a head frame. SBRT is based on the basic radiobiologic principle that fractionation decreases the short-and long-term side effects of radiation therapy. In some settings, this permits higher total dosage to be given.
Applications of Stereotactic Radiosurgery (SRS):
The most common applications of SRS include treatment of intracranial tumors and malignancies, including primary and metastatic tumors, acoustic neuromas, and other benign intracranial tumors such as meningiomas or pituitary adenomas. SRS has been used for trigeminal neuralgia that is resistant to other therapies. It is also an established treatment for arteriovenous malformations (AVMs). More recently, SRS has been investigated as a treatment of functional disorders, which are defined as conditions having no detectable organic cause. Examples of functional disorders include chronic pain. SRS is also being studied for treatment of extracranial sites including lung tumors, liver tumors, and spinal lesions.
Intracranial metastases have been considered ideal targets for radiosurgery due to their small spherical size and non-infiltrative borders. Brain metastases are a frequent occurrence, seen in 25%–30% of all patients with cancer, particularly in those with lung, breast, or colon cancer or melanoma. The treatment of primary brain tumors such as gliomas is more challenging, due to their generally larger size and infiltrative borders.
Acoustic neuromas are benign tumors originating on the eighth cranial nerve, and they can be seen in association with neurofibromatosis. Although these tumors are benign, they are associated with significant morbidity and even death if their growth compresses vital structures. Treatment options include complete surgical excision using microsurgical techniques, but radiosurgery has also been used extensively, either as a primary treatment or as a treatment of recurrence after incomplete surgical resection. In fact, acoustic neuromas were one of the first indications for SRS, dating back to 1969.
Pituitary adenomas are benign tumors with symptoms that are related to hormone production (i.e., functioning adenomas) or to neurologic symptoms due to their impingement on surrounding neural structures. Treatment options for pituitary adenomas include surgical excision, conventional radiation therapy, or SRS. Surgical excision is typically offered to patients with functioning adenomas, since complete removal of the adenoma leads to more rapid control of autonomous hormone production. The effects of SRS on hormone production are delayed or incomplete. In patients with nonfunctioning adenomas, treatment goals are to control growth; complete removal of the adenoma is not necessary. Conventional radiation therapy has been used in this setting with an approximate 90% success rate with few complications.
Arteriovenous malformations consist of a tangled network of vessels in which blood passes from arteries to veins without intervening capillaries. They range in size from small, barely detectable lesions to huge lesions that can occupy an entire hemisphere. SRS incites an inflammatory response in the vessels, which results in ongoing fibrosis with eventual complete obliteration of the lesion over a course of months to years. This latency period is variable, depending on the size of the AVM and the dose distribution of the radiosurgery. During this latency period, there is an ongoing but declining risk of hemorrhage. In contrast, surgical excision provides an immediate effect on the risk of hemorrhage. Total surgical extirpation of the lesion, if possible, is the desired form of therapy to avoid future hemorrhage. However, a small subset of AVMs because of their size or location cannot be excised without serious neurological sequelae. SRS is an important alternative in these patients.
Trigeminal neuralgia is a disorder of the fifth cranial (i.e., trigeminal) nerve that causes episodes of intense, stabbing pain in the face. Although trigeminal neuralgia is initially treated medically, in a substantial number of cases, drug treatment is either ineffective or the adverse effects become intolerable. Neurosurgical options include microvascular decompression, balloon compression, and rhizotomy. SRS has been investigated as an alternative to these neurosurgical treatments. Seizure disorders are initially treated medically. Surgical treatment is only considered in those rare instances when the seizures have proven refractory to all attempts at aggressive medical management, when the seizures are so frequent and severe as to significantly diminish quality of life, and when the seizure focus can be localized to a focal lesion in a region of the brain that is amenable to resection. SRS has been investigated as an alternative to neurosurgical resection. For chronic pain that is refractory to a variety of medical and psychological treatments, there are a variety of surgical alternatives. Neurodestructive procedures include cordotomy, myelotomy, dorsal root entry zone (DREZ) lesions, and stereotactic radiofrequency thalamotomy. SRS targeting the thalamus has been considered an investigative alternative to these neurodestructive procedures.
Studies are also being conducted to evaluate SBRT for a number of extracranial sites including spinal lesions and lung and liver tumors. This approach is being studied to better target lesions (sparing surrounding normal structures) and to shorten the length of time needed to complete the treatments.
Indications for the therapeutic use of charged particle (proton or helium ion) radiation are addressed in Proton or Helium Ion Radiation Therapy.
POLICYStereotactic radiosurgery using Gamma-ray radiosurgery (Gamma Knife®) or Linear-accelerator radiosurgery (LINAC, CyberKnife®) units may be considered medically necessary for the following indications:
Stereotactic Body Radiotherapy (SBRT) may be considered medically necessary for the following indications:
When stereotactic radiosurgery or stereotactic body radiation therapy are performed using fractionation (defined in the Policy Guidelines) for the medically necessary indications described above, it is considered medically necessary.
Stereotactic radiosurgery is considered investigational for applications that include, but are not limited to, the treatment of seizures (epilepsy) and functional disorders other than trigeminal neuralgia, including chronic pain and the treatment of uveal melanoma.
Stereotactic body radiation therapy is investigational for primary and metastatic tumors of the liver, pancreas, kidney, adrenal glands and prostate.
POLICY EXCEPTIONSFederal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
The 1995 TEC Assessment on SRS for multiple brain metastases found that the evidence was sufficient to show that radiosurgery improved health outcome for up to 3 metastases in the presence of good performance status and no active systemic disease. While evidence continues to demonstrate the importance of good performance status and absence of active systemic disease, it appears that the number of metastases may not be as predictive of outcome. Thus, patients with more than 3 metastases who otherwise have good performance status and no evidence of active systemic disease may still benefit from SRS.
Many patients with brain metastases can either receive whole-brain radiation therapy (WBRT) along with SRS or the WBRT may be delayed for use as salvage therapy for recurrent intracranial disease.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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 HISTORY9/1992: Approved by Medical Policy Advisory Committee (MPAC)
9/1994: Reviewed and updated by MPAC
10/1996: Reviewed and updated by MPAC
2/2001: Reviewed by MPAC; Proton beam therapy for prostate cancer considered investigational
4/3/2001: Code Reference updated
5/8/2001: Proton Beam is medically necessary for early stage, surgically inoperable non-small cell lung cancer.
9/5/2001: Trigeminal Neuralgia refractory to medical management added as covered indication
2/13/2002: Investigational definition added
3/5/2002: Prior authorization added
3/12/2002: New 2002 codes added
5/8/2002: Type of Service and Place of Service deleted
9/20/2002: Policy reviewed, Hayes report number added
12/4/2002: Hayes report number deleted
12/11/2002: HCPCS S8030 added
1/17/2003: Policy section updated
3/7/2003: Code Reference section updated
8/20/2003: ICD-9 procedure code range 92.30-92.39 listed separately, ICD-9 diagnosis code ranges 162.0-162.9, 191.0-191.9 listed separately
6/3/2004: HCPCS G0338, G0339, G0340 added to covered codes
2/11/2005: CPT code 61795 Note: "It is appropriate for providers to report 61795 when performed in conjunction with ENT, head, and neck procedures, including functional endoscopic sinus surgeries (FESS). Some examples would include those procedures described by codes 31254-31256, 31267, 31276, 31287, 31288, 31290-31294, and 61548" added, for clarification of CPT code 61795 "Note" added to See "Policy"section for specific coverage of Stereotactic Radiosurgery
3/14/2006: Coding updated. HCPCS 2005 revisions added to policy
7/20/2006: Policy reviewed, prior authorization removed
8/18/2006: Policy and description rewritten and clarified; investigational status of extracranial sites added
9/5/2006: Code reference section udpated. CPT code 61795 deleted. ICD9 procedure codes 92.31, 92.32, 92.33, 92.39 deleted. ICD9 diagnosis codes 162.0, 162.2, 162.3, 162.4, 162.5, 162.8, 162.9, 197.0, 231.2, 237.0, 237.1, 253.0, 255.0, 332.0, 333.1, HCPC S8030 deleted
1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
9/18/2007: Policy reviewed, no changes
12/19/2007: Coding updated per 2008 CPT/HCPCS revisions
12/31/2008: Code reference section updated per the 2009 CPT/HCPCS revisions
10/21/2009: Coding Section Updated to add CPT4 code 61795 back to Covered Codes Table, and to add HCPCS code S8030 back to the Covered Codes Table
10/29/2009: Policy Title revised to include, "and Stereotactic Body Radiation therapy (SBRT), Description Section updated with energy sources and characteristics for gamma-ray radiosurgery and linear-accelerator radiosurgery, removed Helium ion radiosugery, Proton-beam radiosurgery, and Neutron-beam radiosurgery, removed description information for the three radiation-delivery devices, added applications for SRS, added link to Proton or Helium Ion Radiation Therapy medical policy. Policy Statement Section revised to include SBRT is now considered medically necessary in specific cases of both non-small cell lung cancer and spinal or vertebral body tumors. Coding Section revised to include coding information guidelines for describing the procedure and delivery reporting, added verbiage to CPT4 code 20660 "(this code may have been used previous to 1-1-2009 to code the attachment of the head frame), added verbiage to CPT 4 codes 61795- 61799 "(Use for clinical treatment management by the neurosurgeon)", moved CPT4 codes 63620- 63621 from Non-Covered Codes Table to the Covered Codes Table and added verbiage "(Use specifically for stereotatic radiation treatment delivery)", added verbiage to CPT4 code 77299 "(Use for clinical treatment planning)", added verbiage to CPT4 codes 77371- 77372 "(Use specifically for stereotatic radiation treatment delivery)", added CPT 4 codes 77373 and 77435 to Covered Codes Table with verbiage "(Use specifically for stereotactic body radiation treatment delivery)", added verbiage to CPT4 code 77399 "(Use for medical radiation physics)", added CPT4 codes 77402- 77416 to Covered Codes Table with verbiage "(Use for treatment delivery)", added verbiage to CPT4 code 77432 "(Use for concurrent treatment management performed by the radiation oncologist)", added ICD9 procedure codes 92.31- 92.39 to Covered Codes Table, added verbiage to ICD9 procedure code 93.59 "(May use for stereotactic head frame application)", added ICD9 diagnosis codes 162.2- 162.9 to Covered Codes Table, added ICD9 diagnosis code 170.2 to Covered Codes Table, corrected description of ICD9 diagnosis code 198.3, removed deleted HCPCS code G0243 from Covered Codes Table, removed deleted CPT4 code 61793 from Covered Codes Table, removed the Non-Covered Codes Table, Removed CPT4 Codes 77520, 77522, 77523, 77525 from Covered Codes Table, HCPCS code S8030 removed from Covered Codes Table
04/28/2010: Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
12/30/2010: Policy statement regarding non-small cell lunger cancer updated to state "T1 or T2a non-small cell lung cancer (not larger than 5 cm)" is considered medically necessary.
02/28/2011: Added new CPT codes 61781-61783 to the Code Reference section.
07/19/2012: Policy statement revised to indicate that SRS may be considered medically necessary for craniopharyngiomas and glomus tumors, and SBRT may be considered medically necessary for spinal or vertebral metastases that are radioresistant (e.g., renal cell carcinoma, melanoma and sarcoma). Deleted the following statement: Stereotactic body radiation therapy (SBRT) is considered investigational in the treatment of extracranial sites, except for cases of spinal tumors after prior radiation therapy and stage 1 non-small cell lung cancer as noted above. Added policy statement to state that when stereotactic radiosurgery or stereotactic body radiation therapy are performed using fractionation for the medically necessary indications described, it is considered medically necessary. Policy statement added to state that SBRT is considered investigational for primary and metastatic tumors of the liver, pancreas, kidney, adrenal glands and prostate. Removed deleted CPT code 61795 from the Code Reference section, and added the following ICD-9 codes as covered: 194.6, 198.3, 237.0, 237.3.
12/13/2013: Policy statement updated to state that SRS is considered investigational for uveal melanoma.
12/31/2014: Code Reference section updated to revise the description of the following CPT codes: 77402, 77407, and 77412. Added the following new 2015 HCPCS codes: G6003, G6004, G6005, G6006, G6007, G6008, G6009, G6010, G6011, G6012, G6013, G6014.
08/27/2015: Code Reference section updated to add ICD-10 codes.
06/07/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Hayes Medical Technology Directory
Blue Cross Blue Shield Association policies # 6.01.10 and # 8.01.10
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.
Coding for SRS typically consists of a series of CPT codes describing the individual steps required:
The codes used for treatment delivery will depend on the energy source used.
The SRS surgical CPT codes are reported per lesion not to exceed 5 lesions in the cranial SRS coding or 3 lesions in the spinal SRS coding per course of treatment.