Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Stereotactic radiation uses multiple beams of focused radiation to destroy deep tumors that cannot be treated by standard surgery. Stereotactic body radiation therapy (SBRT) and stereotactic radiosurgery (SRS) are radiation therapies delivered via stereotactic guidance to a small, precise target. It largely spares the surrounding tissue by multiple non-parallel radiation beams converging into one sharply defined target. It greatly reduces the amount of radiation to which the surrounding tissue is exposed. SBRT is used to treat extra-cranial sites and can be performed in one to five sessions (fractions). SRS is used to treat intra-cranial and spinal targets. SRS is typically performed in a single session but can be performed in a limited number of sessions, up to a maximum of five. Gamma-ray photons, X-ray photons, protons, helium ions, and neutrons have all been used for SBRT and SRS.

2)     SRS and SBRT require pre-authorization.

1.    SRS with a gamma knife, Cyber knife, or linear accelerator (LINAC) for up to 5 sessions is considered medically necessary for any of the following indications:

A.   For treatment of members with symptomatic, small (less than 3 cm) arterio-venous (AV) malformations, aneurysms, and benign tumors such as: acoustic neuromas (vestibular schwannomas), meningiomas, hemangiomas, pituitary adenomas, craniopharyngiomas, and neoplasms of the pineal gland when the lesion is considered unresectable due to its deep intracranial location or if the member is unable to tolerate conventional operative intervention HAYES B; or

For the palliative treatment of initial or recurrent brain metastases in members with good performance status (Karnofsky 80 or higher)*

B.   For treatment of primary brain malignancies either initial or recurrent or

C.   Intracranial lesions where the patient refuses surgery and the member is otherwise in relatively good health (Karnofsky status 80 or higher)*; or

D.   For treatment of non-operable primary central nervous system (CNS) tumors invading the spine. or

E.   Localized malignant conditions within the body where highly precise application of high-dose radiotherapy is required or

F.    A booster treatment for larger cranial or spinal lesions that have been treated initially with external beam radiation therapy or surgery. (Avoid SBRT when in close proximity to cranial nerves II and VIII if the maximal dose delivered exceeds 10 Gy)

G.   Relapse in previously irradiated cranial or spinal field where additional stereotactic precision is required to avoid unacceptable vital tissue radiation; or

H.   Inoperable spinal tumors causing compression or intractable pain or

I.     Severe, sustained trigeminal neuralgia not responsive to other treatments.

2.    Fractionated cranial stereotactic radiotherapy is considered medically necessary for treatment of intracranial tumors in hard-to-reach locations, tumors with very unusual shapes, or for tumors located in such close proximity to a vital structure (e.g., optic nerve or hypothalamus) that even a very accurate high-dose single fraction of stereotactic radiosurgery could not be tolerated.

3.    Stereotactic Proton beam radiotherapy. See Proton Beam Radiotherapy policy BI016.

4.    *The Karnofsky performance status scale is widely used to evaluate the functional status of cancer patients to determine their eligibility for clinical trials and their prognosis.
80 = normal activity with effort, some signs or symptoms of disease
90 = Able to carry on normal activity; minor signs or symptoms of disease
100 = Normal; no complaints; no evidence of disease.

5.    Stereotactic Body Radiation Therapy (SBRT) for a maximum of 5 sessions is considered medically necessary for members with the following:

A.   Early stage non-small cell lung cancer (i.e., stage I-II, NO)  showing no nodal or distant disease and who are not candidates for surgical resection;

B.   Primary or metastatic malignant lesions of the spine or paraspinal regions.

C.   Localized malignant conditions in the body where highly precise application of high-dose radiotherapy is required, including tumors of any type arising in or near previously irradiated regions;

D.   Hepatocellular carcinoma, as an alternative to ablation/embolization techniques or when these therapies have failed or are contraindicated.

6.    Stereotactic radiosurgery with a gamma knife or Cyber knife is considered medically necessary for trigeminal neuralgia when:

A.   Condition has been present for greater than 6 months; and

B.   Treatment with medication such as Baclofen or Tegretol has failed.

Codes Used In This BI:

1.    Stereotactic radiosurgery is considered experimental and investigational for treatment of Parkinson`s disease and epilepsy (except when associated with treatment of AV malformations or brain tumors) HAYES C.

2.    Stereotactic radiosurgery for the treatment of cluster headaches is considered experimental and investigational.

3.    SRS and SBRT for any other indications besides the ones listed above are considered Experimental and Investigational.

With any external beam radiation therapy, the highest dose of radiation develops where multiple beams intersect.  Thus, the fewer beams there are, the greater the dose reaching other areas traversed by the beams.  For example, if only two beams are used, the highest dose would develop at the site where the beams intersect, but a significant portion of the dose would be distributed to fields anterior and posterior to the intersection.

Stereotactic radiosurgery (SRS) uses the above principle to deliver a highly focused ionizing beam so that the desired target is obliterated, leaving adjacent structures nearly unaffected. Guidance is provided by a variety of imaging techniques, including angiography, computerized tomography (CT), and magnetic resonance imaging (MRI).  The key to SRS is immobilization of the patient so that targeting can be accurate and precise.  SRS has been attempted in extracranial sites; however, it is considered experimental and investigational for extracranial indications because of unresolved difficulties in immobilizing the patient, since merely breathing can move a pulmonary or abdominal tumor by more than 1cm.  A body frame has been designed to immobilize patients for such treatment, but there are few reports of its effectiveness.

The radioactive particles used in SRS may come from various sources.  Technologies that are used to perform SBRT and SRS include Gamma Knife, LINAC, CyberKnife and proton beam or heavy-charged-particle radiosurgery. In order to enhance precision, various devices may incorporate robotics and real time imaging.

Gamma Knife: Standard gamma knife uses 192 or 201 beams of highly focused gamma rays all aiming at the target region. The Gamma Knife is ideal for treating small to medium size lesions.

Linear accelerator- (LINAC): LINAC machines deliver high-energy x-rays, also known as photons. It can provide treatment on larger tumors in a single session or during multiple sessions (fractionated SRT). The principles of LINAC are identical to GammaKnife. CyberKnife: This device combines a mobile LINAC machine with an image guided robotic system that delivers either a single large dose or fractionated radiation therapy. The overall length of time of treatment on a CyberKnife is typically longer than with other radiation therapy modalities. 

Proton beam radiosurgery derives its advantage from the so-called "Bragg peak", a term that describes the pattern of deposition of proton beam radiation. Protons decelerate as they travel though tissue, depositing disproportionately more radiation at greater depths.  The protons deposit most of their energy at their depth of maximal penetration, resulting in a "peak" of radiation at that tissue depth.  The depth of peak radiation can be precisely defined by the energy the cyclotron imparts to the proton beam.

1)    Hayes, Medical Technology Directory; Stereotactic Radiosurgery for Trigeminal Neuralgia and Movement Disorders, Jul. 25, 2002

2)    Hayes, Medical Technology Directory; Stereotactic Radiosurgery for Arteriovenous Malformations and Intracranial Tumors; Aug. 16, 2002.

3)    Hailey D. Stereotactic radiosurgery: An update. Information Paper. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); July, 2002.

4)    Medical Services Advisory Committee (MSAC). Gamma knife radiosurgery. Assessment Report. MSAC Application 1028. Canberra, Australia: MSAC; October 2000.

5)    Hassen-Khodja R. Gamma knife and linear accelerator stereotactic radiosurgery. Montréal, QC: Agence d`Evaluation des Technologies et des Modes d`Intervention en Sante (AETMIS); 2002.

6)    Swedish Council on Technology Assessment in Health Care (SBU). Stereotactic radiosurgery in treating arteriovenous malformations of the brain - early assessment briefs (Alert). Stockholm, Sweden: SBU; 2002.

7)    Chang SD, Main W, Martin DP, et al. An analysis of the accuracy of the Cyber Knife: A robotic frameless stereotactic radio surgical system. Neurosurgery. 2003; 52(1):140-146; discussion 146 – 147.

8)    Stieber VW, Bourland JD, Tome WA, Mehta MP. Gentlemen (and ladies), choose your weapons: Gamma knife vs. linear accelerator radiosurgery. Technol Cancer Res Treat. 2003; 2(2):79-86.

9)    Gerosa M, Nicolato A, Foroni R. The role of gamma knife radiosurgery in the treatment of primary and metastatic brain tumors. Curr Opin Oncol. 2003; 15(3):188-196.

10) Yamakami I, Uchino Y, Kobayashi E, Yamaura A. Conservative management, gamma-knife radiosurgery, and microsurgery for acoustic neurinomas: A systematic review of outcome and risk of three therapeutic options. Neurol Res. 2003; 25(7):682-690.

11) National Institute for Clinical Excellence (NICE). Stereotactic radiosurgery for trigeminal neuralgia using the gamma knife. Interventional Procedure Guidance 11. London, UK: NICE; September 2003. Available at: http://guidance.nice.org.uk/IPG85

12) Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat. Gamma knife. Health Technology Scientific Literature Review. Toronto, ON: Ontario Ministry of Health and Long-Term Care; May 2002. Available at: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_gknife_050102.pdf

13) Regis J, Rey M, Bartolomei F, et al. Gamma knife surgery in mesial temporal lobe epilepsy: A prospective multicenter study. Epilepsia. 2004; 45(5):504-515.

14) Beitler JJ, Makara D, Silverman P, Lederman G. Definitive, high-dose-per-fraction, conformal, stereotactic external radiation for renal cell carcinoma. Am J Clin Oncol. 2004; 27(6):646-648.

15) Donnet A, Valade D, Regis J. Gamma knife treatment for refractory cluster headache: Prospective open trial. J Neurol Neurosurg Psychiatry. 2005; 76(2):218-21.

16) Nagata Y, Takayama K, Matsuo Y, et al. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame.  Int J Radiat Oncol Biol Phys. 2005; 63(5):1427-1431.

17) McGarry RC, Papiez L, Williams M, et al. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: Phase I study. Int J Radiat Oncol Biol Phys. 2005; 63(4):1010-1015.

18) Hiraoka M, Nagata Y. Stereotactic body radiation therapy for early-stage non-small-cell lung cancer: The Japanese experience.  Int J Clin Oncol. 2004; 9(5):352-355.

19) Lee SW, Choi EK, Park HJ, et al. Stereotactic body frame based fractionated radiosurgery on consecutive days for primary or metastatic tumors in the lung. Lung Cancer. 2003; 40(3):309-315.

20) Timmerman R, Papiez L, McGarry R, et al. Extracranial stereotactic radio ablation: Results of a Phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003; 124(5):1946-1955.

21) Whyte RI, Crownover R, Murphy MJ, et al. Stereotactic radiosurgery for lung tumors: Preliminary report of a phase I trial. Ann Thorac Surg. 2003; 75(4):1097-1101.

22) Hara R, Itami J, Kondo T, et al. Stereotactic single high dose irradiation of lung tumors under respiratory gating. Radiother Oncol.  2002; 63(2):159-163.

23) Uematsu M, Shioda A, Suda A, et al. Computed tomography-guided frameless stereotactic radiotherapy for Stage I non-small cell lung cancer: A 5-year experience. Int J Radiat Oncol Biol Phys. 2001; 51(3):666-670.

24) Schefter TE, Kavanagh BD, Timmerman RD, et al. A phase I trial of stereotactic body radiation therapy (SBRT) for liver metastases. Int J Radiat Oncol Biol Phys. 2005; 62(5):1371-1378.

25) Hoyer M, Roed H, Sengelov L, et al. Phase-II study on stereotactic radiotherapy of locally advanced pancreatic carcinoma. Radiother Oncol. 2005; 76(1):48-53.

26) Wersall PJ, Blomgren H, Lax I, et al. Extracranial stereotactic radiotherapy for primary and metastatic renal cell carcinoma. Radiother Oncol. 2005; 77(1):88-95.

27) McGarry RC, Papiez L, Williams M, et al. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: Phase I study. Int J Radiat Oncol Biol Phys. 2005; 63(4):1010-1015.

28) Hiraoka M, Nagata Y. Stereotactic body radiation therapy for early-stage non-small-cell lung cancer: The Japanese experience.  Int J Clin Oncol. 2004; 9(5):352-355.

29) Lee SW, Choi EK, Park HJ, et al. Stereotactic body frame based fractionated radiosurgery on consecutive days for primary or metastatic tumors in the lung. Lung Cancer. 2003; 40(3):309-315.

30) Timmerman R, Papiez L, McGarry R, et al. Extracranial stereotactic radio ablation: Results of a Phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003; 124(5):1946-1955.

31) Whyte RI, Crownover R, Murphy MJ, et al. Stereotactic radiosurgery for lung tumors: Preliminary report of a phase I trial. Ann Thorac Surg. 2003; 75(4):1097-1101.

32) Hara R, Itami J, Kondo T, et al. Stereotactic single high dose irradiation of lung tumors under respiratory gating. Radiother Oncol.  2002; 63(2):159-163.

33) Uematsu M, Shioda A, Suda A, et al. Computed tomography-guided frameless stereotactic radiotherapy for Stage I non-small cell lung cancer: A 5-year experience. Int J Radiat Oncol Biol Phys. 2001; 51(3):666-670.

34) Nieder C, Grosu AL and Gaspar LE. Stereotactic radiosurgery (SRS) for brain metastases: a systematic review. Radiation Oncol. 2014; 9:155

35) Yamamoto M, Serizawa T, Shuto T, et al. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol 2014. S1470-2045