Notification

Proton Beam Radiation Therapy


Notification Issue Date: 11/30/2018

This version of the policy will become effective 03/01/2019.

Notable Revisions

Policy

Language was revised under the Medically Necessary, Not Medically Necessary, and Experimental/Investigational headings.

The following indication was added as Experimental/Investigational:

  • For the treatment of laryngeal cancer [stage T1 or T2, cancer has not spread to lymph nodes (N0), and the disease has not metastasized (M0)]


Coding

The following CPT narrative has been revised in this policy: 77387


Medical Policy Bulletin


Title:Proton Beam Radiation Therapy

Policy #:09.00.49k

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

This policy only applies to members for whom Independence Administrators serves as the claims administrator, as well as those self-funded groups for whom eviCore's Radiation Therapy Services program is not applicable. For all other Independence members, refer to the policy entitled Radiation Therapy Services.


MEDICALLY NECESSARY

Proton beam radiation therapy is considered medically necessary and, therefore, covered for the curative treatment of the following tumors:
  • Chordomas and chondrosarcomas of the base of the skull, localized and in the postoperative setting
  • Uveal melanoma, when proton beam radiation therapy is considered preferential compared to brachytherapy
  • Localized unresectable hepatocellular carcinoma (HCC)
  • Stage IIA seminoma

NOT MEDICALLY NECESSARY

Proton beam radiation therapy is considered not medically necessary and, therefore, not covered for the curative treatment of the following tumors because current evidence indicates that proton beam radiation therapy is no more effective than other forms of radiation therapy (e.g., IMRT):
  • Prostate cancer
  • Head and neck cancer (not including the brain)
  • Esophageal cancer

EXPERIMENTAL/INVESTIGATIONAL

Proton beam radiation therapy is considered experimental/investigational and, therefore, not covered for all other indications including the following because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature:
  • Prostate cancer after prostatectomy
  • When delivered in an ablative manner (i.e., Stereotactic Body Radiation Therapy (SBRT))
  • In combination with photon therapy for any tumor
  • For the treatment of laryngeal cancer [stage T1 or T2, cancer has not spread to lymph nodes (N0), and the disease has not metastasized (M0)]

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

The following Healthcare Common Procedure Coding System (HCPCS) is not eligible for separate reimbursement, as the service is included in the treatment planning:
  • S8030 Scleral application of tantalum ring(s) for localization of lesions for proton beam therapy


REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, proton beam radiation therapy is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are several proton beam therapy systems approved by the FDA for administering proton beam radiation.

Description

Proton beam radiation therapy is a type of radiation therapy that utilizes protons to deliver ionizing damage to a target. Protons are positively charged, subatomic particles that deposit the bulk of their radiation energy at the end of their range of penetration (e.g., into the tumor). This peak of energy deposition is referred to as the Bragg peak. Proton beam radiation therapy allows for targeted dosing of proton radiation to a particular tumor site, with minimal dose delivery to surrounding normal tissue, theoretically offering an advantage over the delivery of photons (i.e., gamma-rays, X-rays, conventional electromagnetic radiation therapy), which deposit their energy along a more disseminated distribution.

This dose-targeting advantage of proton beam radiation therapy may be an improvement over conventional radiation therapy because conventional treatment modalities do not provide adequate local tumor control. Local tumor response depends on the dose of radiation delivered, and delivery of an adequate radiation dose to the tumor is limited by the proximity of vital radiosensitive tissues or structures. However, advances in photon-based radiation therapy, such as 3-D conformal radiation therapy, intensity-modulated radiation therapy, and stereotactic body radiotherapy, do allow for improved targeting of conventional radiation therapy.

Proton beam radiation therapy can best treat tumors that are localized and have not spread to distant areas of the body, tumors that are not amenable to surgical excision or other conventional forms of radiation treatment (e.g., tumors in close proximity to vital organs and structures), and tumors that are difficult or dangerous to treat with surgery (e.g., tumors of the eye, head, neck). Proton beam radiation therapy is being used to treat pediatric tumors in or near the brain and when it is necessary to lessen the risk for secondary tumors due to the individual's potentially long lifespan after radiation treatment, which involves risk for radiation-induced malignancies.

Proton beam radiation therapy has been used in the treatment of two general categories of tumors or abnormalities. The first category includes tumors located near vital organs, such as intracranial lesions or those along the axial skeleton, e.g., uveal melanoma, brain tumors, chordomas, and other chondrosarcomas at the base of the skull and along the axial skeleton. The second category currently under investigation involves tumors with a high rate of recurrence despite maximal doses of conventional radiation therapy, e.g., stages C or D1 of locally advanced prostate cancer (without metastases; and not stage T4).

Current evidence supports the use of proton beam radiation therapy in the treatment of chordomas and chondrosarcomas of the base of the skull, uveal melanoma, localized unresectable hepatocellular carcinoma (HCC), and stage IIA seminoma.

For previously untreated prostate cancer, head and neck cancer, and preoperative and definitive treatment of esophageal cancer, current evidence indicates that proton beam radiation therapy is no more effective than other forms of radiation therapy (e.g., IMRT).

For all other conditions, further research is needed on proton beam radiation therapy to establish its safety and effectiveness.
References


Abdel-Wahab M, Mahmoud O, Merrick G, et al. ACR Appropriateness Criteria® external beam radiation therapy treatment planning for clinically localized prostate cancer. J Am Coll Radiol. 2012 Apr;9(4):233-8.

Agency for Healthcare Research and Quality (AHRQ). Particle beam radiation therapies for cancer. September 2009. Available at: https://www.effectivehealthcare.ahrq.gov/topics/cancer-radiation/technical-brief. Accessed March 28, 2018.

Al-Mefty O, Borba LAB. Skull base chordomas a management challenge. J Neurosurg. 1997;86(2):182-9.

Allen AM, Pawlicki T, Dong L, et al. An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. Radiother Oncol. 2012;103(1):8-11.

American Society for Radiation Oncology (ASTRO). Model Policy: Proton Beam Therapy (PBT). June 2017. Available at: https://www.astro.org/uploadedFiles/_MAIN_SITE/Daily_Practice/Reimbursement/Model_Policies/Content_Pieces/ASTROPBTModelPolicy.pdf. Accessed March 28, 2018.

Amichetti M, Cianchetti M, Amelio D, et al. Proton therapy in chordoma of the base of the skull a systematic review. Neurosurg Rev. 2009;32(4):403-16.

Barker FG II, Butler WE, Lyons S, et al. Dose-volume prediction of radiation-related complications after proton beam radiosurgery for cerebral arteriovenous malformations. J Neurosurg. 2003;99(2):254-63.

Bechrakis NE, Foerster MH. Neoadjuvant proton beam radiotherapy combined with subsequent endoresection of choroidal melanomas. Int Ophthalmol Clin. 2006;46(1):95-107.

Benk VA, Adams JA, Shipley WU, et al. Late rectal bleeding following combined X-ray and proton high dose irradiation for patients with stages T3-T4 prostate cancer. Int J Radiat Oncol Biol Phys. 1993;26(3):551-7.

Bishop AJ, Greenfield B, Mahajan A, et al. Proton beam therapy versus conformal photon radiation therapy for childhood craniopharyngioma: multi-institutional analysis of outcomes, cyst dynamics, and toxicity. Int J Radiat Oncol Biol Phys. 2014;90(2):354-361.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Charged particle (proton or helium ion) irradiation for uveal melanoma and for chordoma or chondrosarcoma of the skull base or cervical spine. 1996; Volume 11, Tab 1.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Proton Beam Therapy for Non-Small-Cell Lung Cancer. 2010; Volume 25, Tab 7.

Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Proton beam therapy for prostate cancer. TEC Assessments 2010;Volume 25, Tab 10.

Brada M, Pijls-Johannesma M, De Ruysscher D. Current clinical evidence for proton therapy. Cancer J. 2009;15(4):319-24.

Bush DA, Cheek G, Zaheer S, et al. High-dose hypofractionated proton beam radiation therapy is safe and effective for central and peripheral early-stage non-small cell lung cancer: results of a 12-year experience at Loma Linda University Medical Center. Int J Radiat Oncol Biol Phys. 2013;86(5):964-968.

Bush DA, McAllister CJ, Loredo LN, et al. Fractionated proton beam radiotherapy for acoustic neuroma. Neurosurgery. 2002;50(2):270-3.

Chang JY, Jabbour SK, De Ruysscher D, et al. Consensus statement on proton therapy in early-stage and locally advanced non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2016;95(1):505-516.

Ciezki JP, Hsu IC, Abdel-Wahab M, et al. American College of Radiology Appropriateness Criteria(®)--locally advanced (high-risk) prostate cancer. Clin Oncol (R Coll Radiol). 2012;24(1):43-51.

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.

Cotter SE, McBride SM, Yock TI. Proton radiotherapy for solid tumors of childhood. Technol Cancer Res Treat. 2012;11(3):267-278.

Courdi A, Caujolle JP, Grange JD, et al. Results of proton therapy of uveal melanomas treated in Nice. Int J Radiat Oncol Biol Phys. 1999;45(1):5-11.

Cox JD. Dose escalation by proton irradiation for adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 1995;32(1):265-6.

Cozzi L, Fogliata A, Lomax A. A treatment planning comparison of 3D conformal therapy, photon therapy, and proton therapy for treatment of advanced head and neck tumors. Radiother Oncol. 2001;61(3):287-97.

Damato B, Kacperek A, Chopra M, et al. Proton beam radiotherapy of choroidal melanoma: the Liverpool-Clatterbridge experience. Int J Radiat Oncol Biol Phys. 2005;62(5):1405-11.

Damato B, Kacperek A, Chopra M, et al. Proton beam radiotherapy of iris melanoma. Int J Radiat Oncol Biol Phys. 2005;63(1):109-15.

Damato B, Lecuona K. Conservation of eyes with choroidal melanoma by a multimodality approach to treatment an audit of 1632 patients. Ophthalmology. 2004;111(5):977-83.

De Ruysscher D, Mark Lodge M, Jones B, et al. Charged particles in radiotherapy: a 5-year update of a systematic review. Radiother Oncol. 2012;103(1):5-7.

Dendale R, Lumbroso-Le Rouic L, Noel G, et al. Proton beam radiotherapy for uveal melanoma results of Curie Institut-Orsay proton therapy center (ICPO). Int J Radiat Oncol Biol Phys. 2006;65(3):780-7.

Desjardins L, Lumbroso-Le Rouic L, Levy-Gabriel C, et al. Combined proton beam radiotherapy and transpupillary thermotherapy for large uveal melanomas a randomized study of 151 patients. Ophthalmic Res. 2006;38(5):255-60.

Duttenhaver JR, Shipley WU, Perrone T, et al. Protons or megavoltage X-rays as boost therapy for patients irradiated for localized prostatic carcinoma. An early phase I/II comparison. Cancer. 1983;51(9):1599-604.

Efstathiou JA, Trofimov AV, Zietman AL. Life, liberty, and the pursuit of protons an evidence-based review of the role of particle therapy in the treatment of prostate cancer. Cancer J. 2009;15(4):312-8.

Egger E, Schalenbourg A, Zografos L, et al. Maximizing local tumor control and survival after proton beam radiotherapy of uveal melanoma. Int J Radiat Oncol Biol Phys. 2001;51(1):138-47.

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):867-80.

Feuvret L, Noel G, Calugaru V, et al. Chondromyxoid fibroma of the skull base differential diagnosis and radiotherapy two case reports and a review of the literature. Acta Oncol. 2005;44(6):545-53.

Fitzek MM, Linggood RM, Adams J, Munzenrider JE. Combined proton and photon irradiation for craniopharyngioma long-term results of the early cohort of patients treated at Harvard Cyclotron Laboratory and Massachusetts General Hospital. Int J Radiat Oncol Biol Phys. 2006;64(5):1348-54.

Fitzek MM, Thornton AF, Harsh G, et al. Dose-escalation with proton/photon irradiation for Daumas-Duport lower-grade glioma results of an institutional phase I/II trial. Int J Radiat Oncol Biol Phys. 2001;51(1):131-7.

Fuss M, Hug EB, Schaefer RA, et al. Proton radiation therapy (PRT) for pediatric optic pathway gliomas: comparison with 3D planned conventional photons and a standard photon technique. Int J Radiat Oncol Biol Phys. 1999;45(5):1117-1126.

Gardner BG, Zietman AL, Shipley WU, et al. Late normal tissue sequelae in the second decade after high dose radiation therapy with combined photons and conformal protons for locally advanced prostate cancer. J Urol. 2002;167(1):123-6.

Gragoudas ES, Egan KM, Seddon JM, et al. Intraocular recurrence of uveal melanoma after proton beam irradiation. Ophthalmology. 1992;99(5):760-6.

Gragoudas ES, Lane AM, Regan S, et al. A randomized controlled trial of varying radiation doses in the treatment of choroidal melanoma. Arch Ophthalmol. 2000;118(6):773-8.

Gragoudas ES, Li W, Goitein M, et al. Evidence-based estimates of outcome in patients irradiated for intraocular melanoma. Arch Ophthalmol. 2002;120(12):1665-71.

Grutters JP, Kessels AG, Pijls-Johannesma M, et al. Comparison of the effectiveness of radiotherapy with photons, protons and carbon-ions for non-small cell lung cancer a meta-analysis. Radiother Oncol. 2010; 95(1):32-40.

Gudjonsson O, Blomquist E, Nyberg G, et al. Stereotactic irradiation of skull base meningiomas with high energy protons. Acta Neurochir (Wien). 1999;141(9):933-40.

Guyer DR, Mukai S, Egan KM, et al. Radiation maculopathy after proton beam irradiation for choroidal melanoma. Ophthalmology. 1992;99(8):1278-85.

Hanks GE. A question filled future for dose escalation in prostate cancer. Int J Radiat Oncol Biol Phys. 1995;32(1):267-9.

Harsh GR, Thornton AF, Chapman PH, et al. Proton beam stereotactic radiosurgery of vestibular schwannomas. Int J Radiat Oncol Biol Phys. 2002;54(1):35-44.

Hart KB, Porter AT. A rational approach to the treatment of prostate cancer with radiation therapy Lessons for the future. Semin Oncol. 1997;24(6):745-55.

Hazard LJ, Jensen RL, Shrieve DC. Role of stereotactic radiosurgery in the treatment of brain metastases. Am J Clin Oncol. 2005;28(4):403-10.

Hoffman KE, Yock TI. Radiation therapy for pediatric central nervous system tumors. J Child Neurol. 2009;24(11):1387-1396.

Hug EB, Fitzek MM, Liebsch NJ, Munzenrider JE. Locally challenging osteo and chondrogenic tumors of the axial skeleton results of combined proton and photon radiation therapy using three-dimensional treatment planning. Int J Radiat Oncol Biol Phys. 1995;31(3):467-76.

Hug EB, Loredo LN, Slater JD, et al. Proton radiation therapy for chordomas and chondrosarcomas of the skull base. J Neurosurg. 1999;91:432-9.

Hug EB, Muenter MW, Archambeau JO, et al. Conformal proton radiation therapy for pediatric low-grade astrocytomas. Strahlenther Onkol. 2002;178(1):10-17.

Hug EB, Slater JD. Proton radiation therapy for chordomas and chondrosarcomas of the skull base. Neurosurg Clin N Am. 2000;11(4):627-38.

Hug EB, Sweeney RA, Nurre PM, et al. Proton radiotherapy in management of pediatric base of skull tumors. Int J Radiat Oncol Biol Phys. 2002;52(4):1017-24.

Igaki H, Tokuuye K, Okumura T, et al. Clinical results of proton beam therapy for skull base chordoma. Int J Radiat Oncol Biol Phys. 2004;60(4):1120-6.

Kagan AR, Schulz RJ. Proton-beam therapy for prostate cancer. Cancer J. 2010;16(5):405-9.

Kim YJ, Cho KH, Pyo HR, et al. A phase II study of hypofractionated proton therapy for prostate cancer. Acta Oncol. 2013;52(3):477-485.

Kirsch DG, Tarbell NJ. New technologies in radiation therapy for pediatric brain tumors the rationale for proton radiation therapy. Pediatr Blood Cancer. 2004;42(5):461-4.

Kjellberg RN. Stereotactic Bragg peak proton beam radiosurgery for cerebral arteriovenous malformations. Ann Clin Res. 1986;18:17-19.

Kjellberg RN, Hanamura T, Davis KR, et al. Bragg-peak proton-beam therapy for arteriovenous malformations of the brain. N Engl J Med. 1983;309:269-74.

Kjellberg RN, Shintani A, Frantz AG, Kliman B. Proton-beam therapy in acromegaly. N Engl J Med. 1968;278:689-95.

Kodjikian L, Roy P, Rouberol F, et al. Survival after proton-beam irradiation of uveal melanomas. Am J Ophthalmol. 2004;137(6):1002-10.

Konski A, Speier W, Hanlon A, et al. Is proton beam therapy cost effective in the treatment of adenocarcinoma of the prostate? J Clin Oncol. 2007;25(24):3603-08.

Kozak KR, Adams J, Krejcarek SJ, et al. A dosimetric comparison of proton and intensity-modulated photon radiotherapy for pediatric parameningeal rhabdomyosarcomas. Int J Radiat Oncol Biol Phys. 2009;74(1):179-186.

Kuban D, Pollack A, Huang E, et al. Hazards of dose escalation in prostate cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2003;57(5):1260-8.

Leroy R, Benahmed N, Hulstaert F, et al. Proton therapy in children: a systematic review of clinical effectiveness in 15 pediatric cancers. Int J Radiat Oncol Biol Phys. 2016;95(1):267-278.

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.

Lodge M, Pijls-Johannesma M, Stirk L, et al. A systematic literature review of the clinical and cost-effectiveness of hadron therapy in cancer. Radiother Oncol. 2007;83(2):110-22.

Lumbroso L, Desjardins L, Levy C, et al. Intraocular inflammation after proton beam irradiation for uveal melanoma. Br J Ophthalmol. 2001;85(11):1305-8.

Lumbroso-Le Rouic L, Delacroix S, Dendale R, et al. Proton beam therapy for iris melanomas. Eye. 2006;20(11):1300-5.

Luu QT, Loredo LN, Archambeau JO, et al. Fractionated proton radiation treatment for pediatric craniopharyngioma. Cancer J. 2006;12(2):155-9.

MacDonald SM, Safai S, Trofimov A, et al. Proton radiotherapy for childhood ependymoma: initial clinical outcomes and dose comparisons. Int J Radiat Oncol Biol Phys. 2008;71(4):979-986.

MacDonald SM, Trofimov A, Safai S, et al. Proton radiotherapy for pediatric central nervous system germ cell tumors: early clinical outcomes. Int J Radiat Oncol Biol Phys. 2011;79(1):121-129.

Matloob SA, Nasir HA, Choi D. Proton beam therapy in the management of skull base chordomas: systematic review of indications, outcomes, and implications for neurosurgeons. Br J Neurosurg. 2016:1-6.

Mayahara H, Murakami M, Kagawa K, et al. Acute morbidity of proton therapy for prostate cancer the Hyogo Ion Beam Medical Center experience. Int J Radiat Oncol Biol Phys. 2007;69(2):434-43.

McAllister B, Archambeau JO, Nguyen MC, et al. Proton therapy for pediatric cranial tumors preliminary report on treatment and disease-related morbidities. Int J Radiat Oncol Biol Phys. 1997;39(2):455-60.

Mehdorn HM, Grote W. Non-invasive follow-up of patients with intracranial arteriovenous malformations after proton-beam radiation therapy. Acta Neurochir. 1988;42:98-102.

Merchant TE. Proton beam therapy in pediatric oncology. Cancer J. 2009;15(4):298-305.

Merchant TE, Hua CH, Shukla H, et al. Proton versus photon radiotherapy for common pediatric brain tumors: comparison of models of dose characteristics and their relationship to cognitive function. Pediatr Blood Cancer. 2008;51(1):110-117.

Michalski JM, Winter K, Purdy JA, et al. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004;58(3):735-42.

Mishra KK, Quivey JM, Daftari IK, et al. Long-term Results of the UCSF-LBNL randomized trial: charged particle with helium ion versus iodine-125 plaque therapy for choroidal and ciliary body melanoma. Int J Radiat Oncol Biol Phys. 2015;92(2):376-383.

Moeller BJ, Chintagumpala M, Philip JJ, et al. Low early ototoxicity rates for pediatric medulloblastoma patients treated with proton radiotherapy. Radiat Oncol. 2011;6:58.

Munzenrider JE, Gragoudas ES, Seddon JM, et al. Conservative treatment of uveal melanoma probability of eye retention after proton treatment. Int J Radiat Oncol Biol Phys. 1988;15(3):553-8.

National Association for Proton Therapy (NAPT). Medical Policy: Coverage of Proton Beam Therapy. 2015. Available at: http://www.proton-therapy.org/documents/Final_2015_Model_Policy.pdf. Accessed March 28, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bone Cancer. Version 1.2018. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/pdf/bone.pdf. Accessed March 28, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology- Central Nervous System Cancers. Version 1.2017. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/pdf/cns.pdf. Accessed March 28, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology-Head and Neck Cancers. Version 2.2017. [NCCN Web site]. Available at:http://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf. Accessed March 28, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 2.2018. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed March 28, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Prostate Cancer. Version 1.2018. [NCCN Web site]. Available at:http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed March 28, 2018.

National Institute for Health and Clinical Excellence (NICE). Improving outcomes for people with brain and other CNS tumours --- evidence review. June 2006. Available at http://www.nice.org.uk/guidance/csgbraincns/resources/improving-outcomes-for-people-with-brain-and-other-cns-tumours-the-manual2. Accessed March 28, 2018.

Nguyen PL, Aizer A, Assimos DG, et al. ACR Appropriateness Criteria(R) Definitive External-Beam Irradiation in stage T1 and T2 prostate cancer. Am J Clin Oncol. 2014;37(3):278-288.

Nihei K, Ogino T, Ishikura S, et al. Phase II feasibility study of high-dose radiotherapy for prostate cancer using proton boost therapy First clinical trial of proton beam therapy for prostate cancer in Japan. Jpn J Clin Oncol. 2005;35(12):745-52.

Nilsson S, Norlen BJ, Widmark A. A systematic overview of radiation therapy effects in prostate cancer. Acta Oncologica. 2004;43(4):316-81.

Noel G, Feuvret L, Calugaru V, et al. Chordomas of the base of the skull and upper cervical spine. One hundred patients irradiated by a 3D conformal technique combining photon and proton beams. Acta Oncol. 2005;44(7):700-8.

Noel G, Habrand JL, Helfre S, et al. Proton beam therapy in the management of central nervous system tumors in childhood. Preliminary experience of the Centre de Protontherapie d'Orsay. Med Pediatr Oncol. 2003;40(5):309-15.

Noel G, Habrand JL, Jauffret E, et al. Radiation therapy for chordoma and chondrosarcoma of the skull base and the cervical spine. Prognostic factors and patterns of failure. Strahlenther Onkol. 2003;179(4):241-8.

Noel G, Habrand JL, Mammar H, et al. Combination of photon and proton radiation therapy for chordomas and chondrosarcomas of the skull base the Centre de ProtonthD'Orsay experience. Int J Radiat Oncol Biol Phys. 2001;51(2):392-8.

Noel G, Habrand JL, Mammar H, et al. Highly conformal therapy using proton component in the management of meningiomas. Preliminary experience of the Centre de Protontherapie d'Orsay. Strahlenther Onkol. 2002;178(9):480-5.

Olsen DR, Bruland OS, Frykholm G, Norderhaug IN. Proton therapy a systematic review of clinical effectiveness. Radiother Oncol. 2007;83(2):123-32.

Park SS, Daftari I, Phillips T, et al. Three-year follow-up of a pilot study of ranibizumab combined with proton beam irradiation as treatment for exudative age-related macular degeneration. Retina. 2012;32(5):956-966.

Patel SH, Wang Z, Wong WW, et al. Charged particle therapy versus photon therapy for paranasal sinus and nasal cavity malignant diseases: a systematic review and meta-analysis. Lancet Oncol. 2014;15(9):1027-1038.

Pijls-Johannesma M, Grutters J, Verhaegen F, et al. Do we have enough evidence to implement particle therapy as standard treatment in lung cancer? A systematic literature review. Oncologist. 2010;15(1):93-103.

Ronson BB, Schulte RW, Han KP, et al. Fractionated proton beam irradiation of pituitary adenomas. Int J Radiat Oncol Biol Phys. 2006;64(2):425-34.

Rossi CJ. Conformal proton beam therapy of prostate cancer update on the Loma Linda University medical center experience. Strahlenther Onkol. 1999;175(Suppl 2):82-4.

Rossi CJ Jr, Slater JD, Reyes-Molyneux N, et al. Particle beam radiation therapy in prostate cancer Is there an advantage? Semin Radiat Oncol. 1998;8(2):115-23.

Rundle P, Singh AD, Rennie I. Proton beam therapy for iris melanoma a review of 15 cases. Eye. 2007;21(1):79-82.

Schulte RW, Slater JD, Rossi CJ Jr., Slater JM. Value and perspectives of proton radiation therapy for limited stage prostate cancer. Strahlenther Onkol. 2000;176(1):3-8.

Seifert V, Stolke D, Mehdorn HM, Hoffmann B. Clinical and radiological evaluation of long-term results of stereotactic proton beam radiosurgery in patients with cerebral arteriovenous malformations. J Neurosurg. 1994;81:683-9.

Shipley WU, Verhey LJ, Munzenrider JE. Advanced prostate cancer the results of a randomized comparative trial of high dose irradiation boosting with conformal photons compared with conventional dose irradiation using protons alone. Int J Radiat Oncol Biol Phys. 1995;32(1):3-12.

Silander H, Pellettieri L, Enblad P, et al. Fractionated, stereotactic proton beam treatment of cerebral arteriovenous malformations. Acta Neurol Scand. 2004;109(2):85-90.

Slater JD. Clinical applications of proton radiation treatment at Loma Linda University review of a fifteen-year experience. Technol Cancer Res Treat. 2006;5(2):81-9.

Slater JD, Rossi CJ, Yonemoto LT, et al. Conformal proton therapy for early-stage prostate cancer. Urology. 1999;53(3):978-84.

Slater JD, Rossi CJ, Yonemoto LT, et al. Proton therapy for prostate cancer the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004;59(2):348-52.

Slater JD, Yonemoto LT, Rossi CJ Jr, et al. Conformal proton therapy for prostate carcinoma. Int J Radiat Oncol Bio Phys. 1998;42(2):229-304.

Spatola C, Privitera G, Raffaele L, et al. Clinical application of proton beams in the treatment of uveal melanoma The first therapies carried out in Italy and preliminary results (CATANA Project). Tumori. 2003;89(5):502-509.

Suit HD, Goitein M, Munzenrider JE, et al. Definitive radiation therapy for chordoma and chondrosarcoma of base of skull and cervical spine. J Neurosurg. 1982;56:377-85.

Suit HD, Urie M. Proton beams in radiation therapy. J Natl Cancer Inst. 1992;84(3):155-64.

Sun F, Oyesanmi O, Fontanarosa J, et al. Therapies for Clinically Localized Prostate Cancer: Update of a 2008 Systematic Review. December 16, 2014. Available at: https://effectivehealthcare.ahrq.gov/topics/prostate-cancer-therapies-update/executive. Accessed March 28, 2018.

Timmermann B. Proton beam therapy for childhood malignancies: status report. Klin Padiatr. 2010;222(3):127-133.

Vargas C, Fryer A, Mahajan C, et al. Dose-volume comparison of proton therapy and intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008;70(3):744-51.

Vernimmen FJ, Harris JK, Wilson JA, et al. Stereotactic proton beam therapy of skull base meningiomas. Int J Radiat Oncol Biol Phys. 2001;49(1):99-105.

Wang Z, Nabhan M, Schild SE, et al. Charged particle radiation therapy for uveal melanoma: a systematic review and meta-analysis. Int J Radiat Oncol Biol Phys. 2013;86(1):18-26.

Weber DC, Chan AW, Bussiere MR, et al. Proton beam radiosurgery for vestibular schwannoma tumor control and cranial nerve toxicity. Neurosurgery. 2003;53(3):577-86.

Weber DC, Rutz HP, Pedroni ES, et al. Results of spot-scanning proton radiation therapy for chordoma and chondrosarcoma of the skull base the Paul Scherrer Institut experience. Oncol Biol Phys. 2005;63(2):401-9.

Wenkel E, Thornton AF, Finkelstein D, et al. Benign meningioma partially resected, biopsied, and recurrent intracranial tumors treated with combined proton and photon radiotherapy. Int J Radiat Oncol Biol Phys. 2000;48(5):1363.

Wilson MW, Hungerford JL. Comparison of episcleral plaque and proton beam radiation therapy for the treatment of choroidal melanoma. Ophthalmology. 1999;106(8):1579-87.

Wilt TJ, Shamliyan T, Taylor B, et al. Comparative effectiveness of therapies for clinically localized prostate cancer: An update of a 2008 Comparative Effectiveness Review. March 29, 2013; Available at: https://effectivehealthcare.ahrq.gov/topics/prostate-cancer-therapies-update/research-protocol. Accessed March 28, 2018.

Yonemoto LT, Slater JD, Rossi CJ Jr, et al. Combined proton and photon conformal radiation therapy for local advanced carcinoma of the prostate preliminary results of a phase I/II study. Int J Radiat Oncol Bio Phys. 1997;37(1):21-9.

Yuh GE, Loredo LN, Yonemoto LT, et al. Reducing toxicity from craniospinal irradiation using proton beams to treat medulloblastoma in young children. Cancer J. 2004;10(6):386-90.

Zenda S, Kawashima M, Arahira S, et al. Late toxicity of proton beam therapy for patients with the nasal cavity, para-nasal sinuses, or involving the skull base malignancy: importance of long-term follow-up. Int J Clin Oncol. 2015;20(3):447-54.

Zietman AL. The Titanic and the iceberg prostate proton therapy and health care economics. J Clin Oncol. 2007;25(24):3565-6.

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):1233-9.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPRESENT PROTON BEAM RADIATION TREATMENT DELIVERY:


77520, 77522, 77523, 77525

THE FOLLOWING CODES ARE USED TO REPRESENT SERVICES ASSOCIATED WITH PROTON BEAM RADIATION THERAPY:

77014, 77263, 77290, 77293, 77295, 77300, 77301, 77307, 77321, 77331, 77332, 77333, 77334, 77336, 77370, 77387, 77427, 77470



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

C22.0 Liver cell carcinoma

C22.1 Intrahepatic bile duct carcinoma

C22.2 Hepatoblastoma

C22.3 Angiosarcoma of liver

C22.4 Other sarcomas of liver

C22.7 Other specified carcinomas of liver

C22.8 Malignant neoplasm of liver, primary, unspecified as to type

C22.9 Malignant neoplasm of liver, not specified as primary or secondary

C41.0 Malignant neoplasm of bones of skull and face

C41.9 Malignant neoplasm of bone and articular cartilage, unspecified

C62.00 Malignant neoplasm of unspecified undescended testis

C62.01 Malignant neoplasm of undescended right testis

C62.02 Malignant neoplasm of undescended left testis

C62.10 Malignant neoplasm of unspecified descended testis

C62.11 Malignant neoplasm of descended right testis

C62.12 Malignant neoplasm of descended left testis

C62.90 Malignant neoplasm of unspecified testis, unspecified whether descended or undescended

C62.91 Malignant neoplasm of right testis, unspecified whether descended or undescended

C62.92 Malignant neoplasm of left testis, unspecified whether descended or undescended

C69.30 Malignant neoplasm of unspecified choroid

C69.31 Malignant neoplasm of right choroid

C69.32 Malignant neoplasm of left choroid

C69.40 Malignant neoplasm of unspecified ciliary body

C69.41 Malignant neoplasm of right ciliary body

C69.42 Malignant neoplasm of left ciliary body

C69.90 Malignant neoplasm of unspecified site of unspecified eye

C69.91 Malignant neoplasm of unspecified site of right eye

C69.92 Malignant neoplasm of unspecified site of left eye


NOT MEDICALLY NECESSARY

C01 Malignant neoplasm of base of tongue

C02.0 Malignant neoplasm of dorsal surface of tongue

C02.1 Malignant neoplasm of border of tongue

C02.2 Malignant neoplasm of ventral surface of tongue

C02.3 Malignant neoplasm of anterior two-thirds of tongue, part unspecified

C02.4 Malignant neoplasm of lingual tonsil

C02.8 Malignant neoplasm of overlapping sites of tongue

C02.9 Malignant neoplasm of tongue, unspecified

C03.0 Malignant neoplasm of upper gum

C03.1 Malignant neoplasm of lower gum

C03.9 Malignant neoplasm of gum, unspecified

C04.0 Malignant neoplasm of anterior floor of mouth

C04.1 Malignant neoplasm of lateral floor of mouth

C04.8 Malignant neoplasm of overlapping sites of floor of mouth

C04.9 Malignant neoplasm of floor of mouth, unspecified

C05.0 Malignant neoplasm of hard palate

C05.1 Malignant neoplasm of soft palate

C05.2 Malignant neoplasm of uvula

C05.8 Malignant neoplasm of overlapping sites of palate

C05.9 Malignant neoplasm of palate, unspecified

C06.0 Malignant neoplasm of cheek mucosa

C06.1 Malignant neoplasm of vestibule of mouth

C06.2 Malignant neoplasm of retromolar area

C06.80 Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89 Malignant neoplasm of overlapping sites of other parts of mouth

C06.9 Malignant neoplasm of mouth, unspecified

C07 Malignant neoplasm of parotid gland

C08.0 Malignant neoplasm of submandibular gland

C08.1 Malignant neoplasm of sublingual gland

C08.9 Malignant neoplasm of major salivary gland, unspecified

C09.0 Malignant neoplasm of tonsillar fossa

C09.1 Malignant neoplasm of tonsillar pillar (anterior) (posterior)

C09.8 Malignant neoplasm of overlapping sites of tonsil

C09.9 Malignant neoplasm of tonsil, unspecified

C10.0 Malignant neoplasm of vallecula

C10.1 Malignant neoplasm of anterior surface of epiglottis

C10.2 Malignant neoplasm of lateral wall of oropharynx

C10.3 Malignant neoplasm of posterior wall of oropharynx

C10.4 Malignant neoplasm of branchial cleft

C10.8 Malignant neoplasm of overlapping sites of oropharynx

C10.9 Malignant neoplasm of oropharynx, unspecified

C11.0 Malignant neoplasm of superior wall of nasopharynx

C11.1 Malignant neoplasm of posterior wall of nasopharynx

C11.2 Malignant neoplasm of lateral wall of nasopharynx

C11.3 Malignant neoplasm of anterior wall of nasopharynx

C11.8 Malignant neoplasm of overlapping sites of nasopharynx

C11.9 Malignant neoplasm of nasopharynx, unspecified

C12 Malignant neoplasm of pyriform sinus

C13.0 Malignant neoplasm of postcricoid region

C13.1 Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect

C13.2 Malignant neoplasm of posterior wall of hypopharynx

C13.8 Malignant neoplasm of overlapping sites of hypopharynx

C13.9 Malignant neoplasm of hypopharynx, unspecified

C14.0 Malignant neoplasm of pharynx, unspecified

C14.2 Malignant neoplasm of Waldeyer's ring

C14.8 Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx

C15.3 Malignant neoplasm of upper third of esophagus

C15.4 Malignant neoplasm of middle third of esophagus

C15.5 Malignant neoplasm of lower third of esophagus

C15.8 Malignant neoplasm of overlapping sites of esophagus

C15.9 Malignant neoplasm of esophagus, unspecified

C30.0 Malignant neoplasm of nasal cavity

C30.1 Malignant neoplasm of middle ear

C31.0 Malignant neoplasm of maxillary sinus

C31.1 Malignant neoplasm of ethmoidal sinus

C31.2 Malignant neoplasm of frontal sinus

C31.3 Malignant neoplasm of sphenoid sinus

C31.8 Malignant neoplasm of overlapping sites of accessory sinuses

C31.9 Malignant neoplasm of accessory sinus, unspecified

C32.0 Malignant neoplasm of glottis

C32.1 Malignant neoplasm of supraglottis

C32.2 Malignant neoplasm of subglottis

C32.3 Malignant neoplasm of laryngeal cartilage

C32.8 Malignant neoplasm of overlapping sites of larynx

C32.9 Malignant neoplasm of larynx, unspecified

C33 Malignant neoplasm of trachea

C47.0 Malignant neoplasm of peripheral nerves of head, face and neck

C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck

C61 Malignant neoplasm of prostate

C76.0 Malignant neoplasm of head, face and neck

C77.0 Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

D07.5 Carcinoma in situ of prostate




HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

G6001 Ultrasonic guidance for placement of radiation therapy fields

G6002 Stereoscopic x-ray guidance for localization of target volume for the delivery of radiation therapy

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

S8030 Scleral application of tantalum ring(s) for localization of lesions for proton beam therapy


Revenue Code Number(s)

0333 Radiation therapy

Coding and Billing Requirements


Cross References


Policy History

Revisions from 09.00.49k
03/01/2019Notable Revisions

Policy

Language was revised under the Medically Necessary, Not Medically Necessary, and Experimental/Investigational headings.

The following indication was added as Experimental/Investigational:
    • For the treatment of laryngeal cancer [stage T1 or T2, cancer has not spread to lymph nodes (N0), and the disease has not metastasized (M0)]

Coding

The following CPT narrative has been revised in this policy: 77387

Revisions from 09.00.49j
10/01/2018Notable Revisions
  • The following Medically Necessary indications were removed:
    • Primary therapy for melanoma of the uveal tract (i.e., iris, choroid, ciliary body), with no evidence of metastasis or extrascleral extension, when the tumors are no more than 24 mm in largest diameter, and 14 mm in height.
    • Postoperative therapy (with or without conventional high-energy X-rays) in individuals who have undergone biopsy or partial resection of chordoma, or low-grade (I or II) chondrosarcoma of the basisphenoid region (skull-base chordoma or chondrosarcoma) or cervical spine. Individuals eligible for this treatment must have residual localized tumor without evidence of metastasis.
    • Central nervous system tumors (i.e., tumors within the skull, skull-based tumors, spinal cord tumors)
    • Benign or malignant intracranial tumors
    • Intracranial arteriovenous malformations
    and replaced with the following indications:
    • Chordomas and chondrosarcomas of the base of the skull, localized and in the postoperative setting
    • Uveal melanoma, when proton beam radiation therapy is considered preferential compared to brachytherapy
    • Localized unresectable hepatocellular carcinoma (HCC)
    • Stage IIA seminoma
  • The following language was added to the policy:
    NOT MEDICALLY NECESSARY
    Proton beam radiation therapy is considered not medically necessary and, therefore, not covered for the treatment of the following tumors because current evidence indicates that proton beam radiation therapy is no more effective than other forms of radiation therapy (e.g., IMRT):
    • Previously untreated prostate cancer
    • Head and neck cancer (not including the brain)
    • Preoperative and definitive treatment of esophageal cancer
  • All language regarding Coverage With Study Participation was removed from the policy.
  • Under Experimental/Investigational, the following language was removed:
    All other uses for proton beam radiation therapy are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.
    and replaced with the following language:
    Proton beam radiation therapy is considered experimental/investigational and, therefore, not covered for all other indications including the following because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature:
    • In the treatment of prostate cancer after prostatectomy
    • When delivered in an ablative manner (i.e., Stereotactic Body Radiation Therapy (SBRT))
    • In combination with photon therapy for any tumor
  • The following CPT Code was added to this policy: 77301
  • The following CPT Codes were removed from this policy because they are not used for Proton Beam billing: 76376, 76377, 77261, 77262, 77280, 77285, 77306, 77417
  • The following ICD-10 Diagnosis Codes were added to this policy:
      Medically Necessary
      C22.0, C22.1, C22.2, C22.3, C22.4, C22.7, C22.8, C22.9, C41.0, C41.9, C62.00, C62.01, C62.02, C62.10, C62.11, C62.12, C62.90, C62.91, C62.92, C69.30, C69.31, C69.32, C69.40, C69.41, C69.42, C69.90, C69.91, C69.92
      Not Medically Necessary
      C01, C02.0, C02.1, C02.2, C02.3, C02.4, C02.8, C02.9, C03.0, C03.1, C03.9, C04.0, C04.1, C04.8, C04.9, C05.0, C05.1, C05.2, C05.8, C05.9, C06.0, C06.1, C06.2, C06.80, C06.89, C06.9, C07, C08.0, C08.1, C08.9, C09.0, C09.1, C09.8, C09.9, C10.0, C10.1, C10.2, C10.3, C10.4, C10.8, C10.9, C11.0, C11.1, C11.2, C11.3, C11.8, C11.9, C12, C13.0, C13.1, C13.2, C13.8, C13.9, C14.0, C14.2, C14.8, C15.3, C15.4, C15.5, C15.8, C15.9, C30.0, C30.1, C31.0, C31.1, C31.2, C31.3, C31.8, C31.9, C32.0, C32.1, C32.2, C32.3, C32.8, C32.9, C33, C47.0, C49.0, C61, C76.0, C77.0, D07.5

Revisions from 09.00.49i
07/02/2018The policy was updated to communicate that this policy applies to self-funded groups for whom eviCore's Radiation Therapy Services program is not applicable.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 03/01/2019
Version Issued Date: 03/01/2019
Version Reissued Date: N/A

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