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)    Proton beam radiotherapy (PBRT) is a form of radiation treatment used to treat certain tumors that are located near vital organs.

2)    PBRT requires pre-authorization.

1)    Proton beam radiotherapy (PBRT) is considered  medically necessary in any of the following radiosensitive tumors:

a)    Uveal melanomas confined to the globe (i.e. not distant metastases) (HAYES B); or

b)    Chordomas or chondrosarcomas arising at the base of the skull or along the axial skeleton without distant metastases; or

c)     Pituitary neoplasms; or

d)    Other central nervous system tumors located near vital structures.

2)     Proton beam radiotherapy may be used either with or without stereotactic guidance. Stereotactic administration of proton beam radiotherapy is considered medically necessary only for the above-listed lesions that are located intracranially. Stereotactic administration of proton beam radiotherapy for extracranial lesions (i.e., stereotactic body radiosurgery) is not considered medically necessary.

3)    Proton beam radiotherapy is considered medically necessary in the treatment of intracranial arteriovenous malformations, with or without stereotactic guidance.

Codes Used In This BI:

77520 Proton treatment simple w/o comp
77522 Proton treatment simple w/comp
77523 Proton treatment intermediate
77525 Proton treatment complex
 

1)    Proton beam radiotherapy is considered experimental and investigational and is not covered for the following conditions;

A.    Age-related macular degeneration

B.    Non-uveal melanoma.

C.    Hepatocellular carcinoma

D.    Other forms of cancer such as; bladder, cervical, breast, esophageal and non-small cell lung

1)    Proton beams have less scatter than other sources of energy such as gamma rays, x-rays, or electrons.  Because of this feature, proton beam radiotherapy (PBRT) has been used to escalate radiation dose to diseased tissues while minimizing damage to adjacent normal tissues. Proton beams have been used in stereotactic radiosurgery of intracranial lesions; the gamma knife and linear accelerator have also been used in BI196 Stereotactic Radiosurgery.  PBRT has been shown to be particularly useful in treating radiosensitive tumors that are located next to vital structures, where complete surgical excision or administration of adequate doses of conventional radiation is difficult or impossible.  Examples include uveal melanomas, Chordomas and chondrosarcomas at the base of the skull, and inoperable arteriovenous malformations. 

2)    There is inadequate data on the application of PBRT for the treatment of non-uveal melanoma.

3)    The only randomized controlled clinical trial comparing proton beam therapy to conventional radiotherapy published to date found no advantage of proton beam therapy in overall survival, disease-specific survival, or total recurrence-free survival (Shipley, 1995) in prostate cancer.  Two hundred two patients with Stage T3-T4 prostate cancer were randomly assigned to a standard dose of conventional radiotherapy plus a 25.2 Gy equivalent proton beam radiotherapy boost or to a standard dose of conventional radiotherapy with a 16.8 Gy boost of conventional radiotherapy. After a median follow-up of 61 months, there were no significant differences between the two groups in overall survival, disease-specific survival, total recurrence-free survival, or local control. Local control was better with the proton beam boost only among the subgroup of patients with poorly differentiated carcinoma.  Patients receiving the proton beam boost had increased rates of late radiation sequelae.

4)     Loma Linda University’s most recent experience with PBRT of prostate cancer was reported in an article published in 1999 by Rossi, et al.  The investigators reported the results of an uncontrolled study of PBRT treatment of 319 patients with biopsy-proven early-stage prostate cancer, with no patient having an initial PSA of greater than 15.  Because the study was uncontrolled, one is unable to determine whether the results of PBRT are superior to conventional forms of radiation therapy. 

1)    Hayes, Medical Technology Directory; Proton Beam Therapy for ocular tumors, hemangiomas and macular degeneration, Jul 16, 2004

2)    Hayes, Medical Technology Directory; Proton Beam Therapy for Thoracic and Abdominal Organs; Oct. 24, 2006

3)    Hayes, Medical Technology Directory; Proton Beam Therapy for Prostate Cancer; Oct 28, 2006

4)    Arkansas BlueCross BlueShield, Coverage Policy Manual; Proton Beam Radiotherapy Treatment for Carcinoma of the Prostate. At: http://www.arkansasbluecross.com/members/report.aspx?policyNumber=1999006

5)    Arkansas BlueCross BlueShield, Coverage Policy Manual; Stereotactic Radiosurgery (Gamma Knife Surgery, Linear Accelerator, Proton Beam) at: http://www.arkansasbluecross.com/members/report.aspx?policyNumber=1997210

6)    Habrand JL, Schlienger P, Schwartz L, et al. Clinical applications of proton therapy. Experiences and ongoing studies. Radiat Environ Biophys. 1995; 34(1):41-44. 

7)    Tsuji H, Inada T, Maruhashi A, et al. Clinical results of fractionated proton therapy. Int J Radiat Oncol Bio Phys. 1993; 25(1):49-60. 

8)    Hug EB, Slater JD. Proton radiation therapy for Chordomas and chondrosarcomas of the skull base. Neurosurg Clin N Am. 2000; 11(4):627-638. 

9)    Munzenrider JE.  Uveal Melanomas. Conservation treatment.  Hematol Oncol Clin North Am.  2001; 15(2):389-402.

10) Noel G, Habrand JL, Jauffret E, et al.  Radiation therapy for Chordomas and chondrosarcoma of the skull base and the cervical spine. Prognostic factors and patterns of failure.  Strahlenther Onkol.  2003; 179(4):241-248.

11) Egger E, Zografos L, Schalenbourg A, et al.  Eye retention after proton beam radiotherapy for uveal melanoma.  Int J Radiat Oncol Biol Phys.  2003; 55(4):867-880.

12) Noel G, Habrand JL, Helfre S, et al.  Proton beam therapy in the management of central nervous system tumors in childhood: The preliminary experience of the Centre de Protontherapie d`Orsay.  Med Pediatr Oncol.  2003; 40(5):309-315.

13) Robertson DM.  Changing concepts in the management of choroidal melanoma.  Am J Ophthalmol. 2003; 136(1):161-170. 

14) Li W, Gragoudas ES, Egan KM.  Tumor basal area and metastatic death after proton beam irradiation for choroidal melanoma.  Arch Ophthalmol. 2003; 121(1):68-72. 

15) Ciulla TA, Danis RP, Klein SB, et al.  Proton therapy for exudative age-related macular degeneration: A randomized, sham-controlled clinical trial.  Am J Ophthalmol.  2002; 134(6):905-906.

16) Sivagnanavel V, Evans JR, Ockrim Z, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2004 ;( 3):CD004004.

17) Zietman AL, DeSilvio ML, Slater JD, et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: A randomized controlled trial. JAMA. 2005; 294(10):1233-1239.

18) Kawashima M, Furuse J, Nishio T, et al. Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma. J Clin Oncol. 2005; 23(9):1839-1846.

19) Al-Shahi R, Warlow CP. Interventions for treating brain arteriovenous malformations in adults. Cochrane Database Syst Rev. 2006 ;( 1):CD003436.