Download Proton Beam Therapy - Providers - Select Health of South Carolina

Clinical Policy Title: Proton beam therapy
Clinical Policy Number: 05.02.01
Policy contains:
Effective Date:
Initial Review Date:
Most Recent Review Date:
Next Review Date:
December 1, 2013
August 17, 2013
September 21, 2016
September 2017
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Related policies:
CP# 05.02.02
CP# 05.02.03
CP# 05.02.04
CP# 05.02.05
CP# 05.02.06
Brachytherapy

Intensity modulated radiation therapy
Immunotherapies for cancer
Tumor treatment fields
Radium Ra 223 dichloride injection for prostate cancer
Proton beam therapy.
Particle or hadron therapy.
Cancer (adult and pediatric).
Brain arteriovenous
malformations (AVM).
[Insert bullet(s) of specific
items contained by this
policy and put periods after
each bulleted item.]
ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health
of South Carolina’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services
(CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional
literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including
any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Select Health of
South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal
laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of
South Carolina’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other
health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina’s clinical policies are
reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies
as necessary. Select Health of South Carolina’s clinical policies are not guarantees of payment.
Coverage policy
Select Health of South Carolina considers the use of proton beam therapy (PBT) to be clinically proven and,
therefore, medically necessary when the patient record documents why PBT is considered the treatment of
choice, and at least one of the following clinical conditions are present:
1. Benign or malignant conditions otherwise not suitable for intensity-modulated radiation
therapy (IMRT) or three-dimensional conformal radiation (3DCR): base of skull or axial skeleton
but not limited to chordoma or chondroscarcoma.
2. Solid tumors in children up to age 16: primary and variant forms of medulloblastoma;
astrocytoma; glioblastoma; arteriovenous malformations (AVMs); acoustic neuroma;
0
craniopharyngioma; benign and atypical meningiomas; pineal gland tumors; intraocular
melanoma.
3. As primary therapy for melanoma of the uveal tract (iris, choroid, or ciliary body) involving
tumors of up to 24 mm in largest diameter and 14 mm in height, and with no evidence of
metastasis or extrascleral extension.
4. As postoperative therapy for individuals who have undergone biopsy or partial resection of a
chordoma or low-grade (I or II) chondrosarcoma of the basisphenoid region (for example, skullbase chordoma or chondrosarcoma) or cervical spine and have residual, localized tumor
without evidence of metastasis.
5. Pituitary adenoma when conventional stereotactic radiation is not an available option.
6. Metastatic lesions, for which expectation of long-term (≥ two years) benefit unobtainable with
conventional therapy, and expectation of complete eradication of the lesion is otherwise not
obtainable.
Other criteria for coverage includes, when applicable:
1. Dose constraints to normal tissues limit total dose safely deliverable to the tumor by other means.
2. There is reason to believe that doses thought to be above those attainable by other means may
improve tumor control.
3. Higher precision associated with proton beam is clinically relevant.
4. Treatment of primary tumors has a curative intent.
Background
PBT is a form of radiotherapy that uses beams of charged subatomic particles in contrast to the photon
beams of conventional radiation (X-rays). Proton beams have potential benefits for the treatment of
tumors in cases where surgical excision is deemed impossible or unacceptably risky.
The first published use of PBT was in 1954; however, the extremely high cost of producing charged particles
inhibited its widespread use. There are now 27 U.S. centers for PBT, 23 operating and 4 under construction
(National Association of Proton Therapy, 2016), up from 11 in 2009, at a cost of $100 million to $225 million
per center (Trikalinos (2009).
PBT is classified among particle or hadron therapies, which have different properties than X-rays.
Theoretical advantages of particle beams include more precise delivery of higher doses of radiation to
tumor targets and less exposure to surrounding tissues; in other words, more effective cancer treatment
with fewer adverse effects. Due to the large investment for building a PBT facility, treatment costs are
higher than with conventional radiation. Therefore, it is important to evaluate whether the medical
benefits of PBT are large enough to balance the higher costs.
PBT is not suitable to all tumor types but may be of particular benefit treating superficial lesions (such as
those of the eye), intermediate-depth lesions (such as of the head and neck), and tumors where
conventional radiotherapy would damage surrounding tissue to an unacceptable level (optical nerve, spinal
cord, central nervous system, head, neck, and prostate). In addition, PBT may be ideal for use in pediatric
patients.
PBT may be useful for treating arteriovenous malformations (AVMs). While many AVMs cause no
symptoms and are discovered only at autopsy, those in the brain can be associated with headaches,
epilepsy, hemorrhagic stroke, or death. They are treated by embolization (cutting off the blood supply with
a coil, balloon, particle, or glue via catheter), neurosurgery, or radiation.
Searches
Select Health of South Carolina searched PubMed and the databases of:
 UK National Health Services Center for Reviews and Dissemination.
 Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other
evidence-based practice centers.
 The Centers for Medicare & Medicaid Services (CMS).
We conducted searches on August 16, 2016. Search terms were “PBT (MeSH)” and the free text term
“proton beam.”
We included:
 Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and
greater precision of effect estimation than in smaller primary studies. Systematic reviews use
predetermined transparent methods to minimize bias, effectively treating the review as a scientific
endeavor, and are thus rated highest in evidence-grading hierarchies.
 Guidelines based on systematic reviews.
 Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost
studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which
also rank near the top of evidence hierarchies.
Findings
Professional medical societies have reviewed the literature to determine the efficacy of PBT, especially
compared to other types of radiation therapy for cancer. The American Society of Radiation Oncology
assembled a Proton Task Force, and found that efficacy of the treatment depended on the condition.
Specifically, PBT demonstrated clearly superior outcomes for pediatric central nervous system cancers,
large ocular melanomas, and chordomas; less convincing superiority for helatocellular and prostate cancer;
and no superiority for lung, head/neck, gastrointestinal, and non-central nervous system pediatric cancers
(Allen, 2012).
PBT has also been the subject of a number of meta analyses and systematic reviews, often based on
particular conditions, especially cancer types.
One systematic review of 76 studies found PBT efficacy of management of skull base chordomas,
specifically local control and survival appeared to be superior compared to other treatment modalities
(Matloob, 2016). Another review of 47 studies found PBT had better outcomes than did photon irradiation
over 10 years, with few significant complications (Amichetti, 2009).
Other reviews concluded that PBT produced similar outcomes to other radiation techniques for cancer
treatment. In a review of 23 studies on cranial-based chordomas, outcomes for PBT patients were equal to
those treated with carbon ion and photon radiation therapy, in terms of progression-free survival and
overall survival (DiMaio, 2011). Another systematic review of five-year survival rates for Stage I inoperable
non-small cell lung cancer found that five-year survival rates for PBT exceeded conventional radiation
therapy (40% to 20%), but were no different than stereotactic radiation therapy and carbon-ion therapy,
each at 42% (Grutters, 2010a). A systematic review of 86 observational studies and 8 comparative studies
found that tumor control and survival for head and neck cancer patients were similar for patients in the PBT
and IMRT groups (Raemakers, 2011).
A combination of PBT and IMRT was found to produce significantly higher disease free survival (RR=1.44)
and locoregional control (RR=1.26) than did other interventions for patients with paranasal sinus and nasal
cavity malignancies, in a systematic review of 41 observational studies (Patel, 2014).
Flynn (2010) cataloged systematic reviews published through April 2010, excluding Trikalinos (2009), and
concluded evidence to that date did not definitively support efficacy or comparative effectiveness (versus
other interventions) of PBT for any cancer indication. The evidence picture has not changed substantively
since these reviews concluded searches.
There is still a lack of standards for determining whether the outstanding dose distribution and conformity
achieved with proton irradiation translates into improved clinical outcome with respect to increased tumor
control and/or reduced treatment-associated complications (Bekelman, 2013).
A Cochrane review found no randomized trials to confirm the superiority of any AVM treatment over
alternatives (Ross, 2010).
Cost-effectiveness of PBT has also been assessed. A recent systematic review of eight studies found that
while PBT is as efficacious and has similar levels of toxicity as brachytherapy and stereotactic body radiation
therapy, is more costly and thus less cost-effective than the other two therapies (Muralid, 2016). This
finding was similar to a comparison of various radiation therapies for prostate cancer from 2000-2013
(Amin, 2014). A comparison of Medicare patients treated for prostate cancer in 2008-2009 found that
reimbursement for PBT greatly exceeded that for IMRT ($32,428 vs. $18,575), even though there was no
difference in genito-urinary toxicity for the two groups 12 months post-operatively (Yu, 2013).
Policy updates:
In the September, 2016 update, nine (9) additional references have been added, three (3) of which are
included in the Summary of Clinical Evidence section.
The Coverage section has been expanded to include patients:
1. Given photon beam therapy as primary therapy for melanoma of the uveal tract
2. Who have had biopsy or chordoma/chondrosarcoma resection
3. With pituitary adenoma when stereotactic radiation is not an option
4. With metastatic lesions for which other therapies are not expected to exceed two years of benefits.
The policy title has been changed from “proton therapy” to “proton beam therapy” since it is often
interchangeably used as “proton therapy,” “beam therapy” and “proton beam therapy.”
Summary of clinical evidence:
Citation
Content, Methods, Recommendations
Verma (2016)
Key points:
Cost effectiveness of
proton beam radiotherapy
(PBT) for various
conditions
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Dionisi (2014)
Effectiveness of PBT for
hepatocellular carcinomas
Allen (2012)
Systematic review, 18 studies, PBT compared to other treatments
PBT cost-effective for regional/advanced, but not early stage lung cancer
Cost-effective in selected head/neck cancer patients at high risk for mucosal toxicity,
patients with uveal melanoma, several pediatric brain tumors
More costly for breast cancer patients, cost-effective for those at high risk for accelerated
partial breast irradiation
Key points:
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5 articles; one nonrandomized controlled study, four case series; low-quality evidence.
900+ patients with heterogeneous disease stages treated with fractionation schedules.
Local control 80% at 3-5 years; average 5 year overall survival = 32%; data comparable
to surgery in the most favorable groups. Toxicity was low (mainly gastrointestinal).
 Normal liver V0Gy < 30%volume and V30Gy < 18 – 25%volume suggested as cut-off
values for hepatic toxicity.
Key points:
Establishment of
effectiveness of PBT vs.
other treatments for
various cancers
DeMaio (2011)
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Survival among patients
given various treatments
for cranial base
chordomas
Ramaekers (2011)
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American Society of Radiation Oncology, Proton Task Force
PBT not superior for lung, head/neck, GI, pediatric non-central nervous system cancers
PBT superior for pediatric CNS cancer, large non-ocular melanomas, chordomas
PBT somewhat superior for hepatocellular, prostate cancer
Key points:
23 studies, 807 patients, progression free survival (PFS) and overall survival (OS)
No difference in five-year OS by type of adjuvant radiation, including PBT
PFS lower only for Gamma Knife surgery
Key points:
Citation
Content, Methods, Recommendations
Verma (2016)
Key points:
Cost effectiveness of
proton beam radiotherapy
(PBT) for various
conditions



Flynn (2010)
Systematic review, 18 studies, PBT compared to other treatments
PBT cost-effective for regional/advanced, but not early stage lung cancer
Cost-effective in selected head/neck cancer patients at high risk for mucosal toxicity,
patients with uveal melanoma, several pediatric brain tumors
More costly for breast cancer patients, cost-effective for those at high risk for accelerated
partial breast irradiation
 86 observational, 8 comparative studies, 1990 – 2010
 Carbon ions associated with longer survival for mucosal melanoma vs. protons.
 Tumor control and survival similar for IMRT and protons except for para- and sino-nasal.
 Carbon ions and protons associated with lower toxicity rates than IMRT.
Key points:
Research on effectiveness
of PBT therapy for various
cancers

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Outcomes for various
types of radiotherapy in
head and neck cancers

Systematic reviews, guidelines, or technology assessments: searches to April 2010
12 reviews, lung, base of skull, ocular, prostate, head and neck cancers, brain AVMs.
Only prostate cancer and uveal melanoma represented by CCTs, with serious
methodological weaknesses.
Economic evaluations premature, overall insufficient evidence for effectiveness
Grutters (2010a)
Key points:
Mortality for therapies for
Stage I inoperable nonsmall cell lung cancer
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30 studies (n=2611), 1994 – 2008, five-year survival rates
Lowest was conventional radiation therapy (20%)
Equal survival for PBT (40%), stereotactic radiotherapy, and carbon-ion therapy (42%).
Glossary
Arteriovenous malformation (AVM) — An abnormal connection between arterial and venous systems that
can occur anywhere in the body but is most dangerous in the brain.
Intensity-modulated radiation therapy (IMRT) — Along with conformal therapy (defined below), these are
radiation oncology techniques developed in the 1990s to capitalize on computers’ abilities to plan radiation
delivery more precisely, thus maximizing exposure of tumors while avoiding surrounding tissues.
Proton beam therapy (PBT) — A type of radiation treatment that uses protons rather than x-rays to treat
cancer. At high energy, protons can destroy cancer cells.
References
Professional society guidelines/others:
Adelaide Health Technology Assessment (AHTA). Proton beam therapy for the treatment of cancer.
Australian Government Department of Health and Aging. June 2006.
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjV8M6J5sjOAhVH0i
YKHWxgCWQQFggoMAA&url=http%3A%2F%2Fwww.horizonscanning.gov.au%2Finternet%2Fhorizon%2Fpu
blishing.nsf%2FContent%2F84C1091198F8C1CFCA2575AD0080F357%2F%24File%2FProton%2520Beam%25
20Therapy%2520for%2520the%2520treatment%2520of%2520cancer%2520June2006.pdf&usg=AFQjCNGri
Fidc-E4heo7RdmccXGu3Cp3hg&bvm=bv.129759880,d.dmo. Accessed August 17, 2016.
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.
Australia and New Zealand Horizon Scanning Network (ANZHSN). Proton beam therapy for the treatment of
neoplasms involving (or adjacent to) cranial structures. Royal Australasian College of Surgeons. May
2007.(a)
Australia and New Zealand Horizon Scanning Network (ANZHSN). Proton beam therapy for the treatment of
uveal melanoma. Royal Australasian College of Surgeons. May 2007.(b)
Chang JY, Kestin LL, Barriger RB, et al. ACR Appropriateness Criteria® nonsurgical treatment for locally
advanced non-small-cell lung cancer: good performance status/definitive intent. Oncology (Williston Park).
2014;28(8):706 – 14. https://uncch.pure.elsevier.com/en/publications/acr-appropriateness-criterianonsurgical-treatment-for-locally-ad-2. Accessed August 17, 2016.
National Association of Proton Therapy, 2016. http://www.proton-therapy.org. Accessed August 16, 2016.
Nguyen PL, Aizer A, Assimos DG, et al. ACR Appropriateness Criteria® Definitive External-Beam Irradiation in
stage T1 and T2 prostate cancer. Am J Clin Oncol. 2014;37(3):278 – 88.
Rosenzweig KE, Chang JY, Chetty IJ, et al. Expert panel on radiation oncology – Lung. ACR appropriateness
criteria® nonsurgical treatment for non-small-cell lung cancer: poor performance status or palliative
intent.[online publication]. Reston (VA): American College of Radiology (ACR); 2012.
https://acsearch.acr.org/docs/69349/Narrative. Accessed August 17, 2016.
Peer-reviewed references:
Amichetti M, Cianchetti M, Amelioi D, Enrici RM, Minniti G. Proton therapy in chordoma of the base of the
skull: a systematic review. Neurosurg Rev. 2009;32:403 – 16.
Amin NP, Sher DJ, Konski AA. Systematic review of the cost effectiveness of radiation therapy for prostate
cancer from 2000 to 2013. Appl Health Econ Health Policy. 2014;12(4):391 – 408.
Bauman G, Rumble RB, Chen J, Loblaw A, Warde P. IMRT indications expert panel. The role of IMRT in
prostate cancer. Toronto (ON): Cancer Care Ontario (CCO); October 27, 2010.
https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=86979. Accessed August 18, 2016.
Bekelman JE, Hahn SM. The body of evidence for advanced technology in radiation oncology (editorial). J
Natl Cancer Inst. 2013;105(1):6 – 7.
Bekkering G, Rutjes AWS, Vlassov VV, Aebersold DM, von Bremen K, Kleijnen J. The effectiveness and safety
of proton radiation therapy for indications of the eye: a systematic review. Strahlentherapie und Onkologie.
2008;185:211 – 21.
Brada M, Pijls-Johannesma M, de Ruysscher D. Current clinical evidence for proton therapy. Cancer J. 2009;
15(4):319 – 24.
DiMaio S., Temkin N, Ramanathan D, Sekhar LN. Current comprehensive management of cranial base
chordomas: 10-year meta-analysis of observational studies. J Neurosurg. 2011.115(6):1094 – 1105.
Dionisi F, Ben-Josef E. The use of proton therapy in the treatment of gastrointestinal cancers: liver. Cancer
J. 2014;20(6):378 – 86.
Efstathiou JA, Gray PJ, Zietman AL. Proton beam therapy and localized prostate cancer: current status and
controversies. Br J Cancer. 2013;108: 1225 – 30.
Flynn K, Adams E, Alligood E, Curran S, Lawrence V. Proton therapy for cancer. Veterans Health
Administration Office of Patient Care Services. Technology Assessment Program. Boston (MA). April 2010.
Grutters JP, Kessels AG, Pils Johannesma M, De Ruysscher D, Joore MA, Lambin P. Comparison of the
effectiveness of radiotherapy with photons, protons and carbon-ions for non-small cell lung cancer: a metaanalysis. Radiother Oncol. 2010; 95(1): 32 – 40. (a)
Grutters JP, Pils-Johannesma M, Ruysscher DD, et al. The cost-effectiveness of particle therapy in non-small
cell lung cancer: exploring decision uncertainty and areas for future research. Cancer Treat Rev. 2010;
36(6):468 – 76.(b)
Hayes, Inc., Hayes Medical Technology Report. Proton beam therapy for prostate cancer. Search &
Summary. Lansdale, PA. Hayes, Inc. May 28, 2015.
https://www.hayesinc.com/subscribers/displaySubscriberArticle.do?articleId=22546&searchStore=%24sear
ch_type%3Dall%24icd%3D%24keywords%3D%22proton%20beam%20therapy%22%24status%3Dall%24pag
e%3D1%24from_date%3D%24to_date%3D%24report_type_options%3D%24technology_type_options%3D
%24organ_system_options%3D%24specialty_options%3D%24order%3DasearchRelevance. Accessed
August 18, 2016.
Hayes, Inc., Hayes Medical Technology Report. Proton beam therapy for medulloblastoma in children.
Search & Summary. Lansdale PA. Hayes, Inc. June 27, 2015.
https://www.hayesinc.com/subscribers/displaySubscriberArticle.do?articleId=16641&searchStore=%24sear
ch_type%3Dall%24icd%3D%24keywords%3D%22proton%20beam%20therapy%22%24status%3Dall%24pag
e%3D1%24from_date%3D%24to_date%3D%24report_type_options%3D%24technology_type_options%3D
%24organ_system_options%3D%24specialty_options%3D%24order%3DasearchRelevance. Accessed
August 18, 2016.
Jarosek S, Elliott S, Virnig BA. Proton beam radiotherapy in the U.S. Medicare population: growth in use
between 2006 and 2009. Rockville, MD: Agency for Healthcare Research and Quality; May 2012.
http://www.ncbi.nlm.nih.gov/books/NBK97147/. Accessed August 18, 2016.
Lodge M, Pijls-Johannesma, M, Stirk L, Munro AJ, De Ruysscher D, Jefferson T. A systematic review of the
clinical and cost-effectiveness of hadron therapy in cancer. Radiother Oncol.2007; 83(2):110 – 22.
Lundkvist J, Ekman M, Ericsson SR, Jönsson B, Glimelius B. Proton therapy of cancer: potential clinical
advantages and cost-effectiveness. Acta Oncol. 2005; 44: 850 – 61.
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; doi:
10.1080/02688697.2016.1181154.
Mohr JP, Parides MK, Stapf C, et al. Medical management with or without interventional therapy for
unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial.
Lancet. 2014;383(9917):614 – 621.
Muralidhar V, Nguyen PL. Maximizing resources in the local treatment of prostate cancer: A summary of
cost-effectiveness studies. Urol Oncol. 2016; doi: 10.1016/j.urolonc.2016.06.003.
Olsen DR, Bruland ØS, Frykholm G, Norderhaug IN. Proton therapy: a systematic review of clinical
effectiveness. Radiother Oncol. 2007;83(2):123 – 32.
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):1027-38.
Petitti DB. Meta-Analysis, Decision Analysis, and Cost-Effectiveness Analysis: Methods for Quantitative
Synthesis in Medicine. Monographs in Epidemiology and Biostatistics (#24). Oxford University Press. New
York. 1994.
Pijls-Johannesma M, Grutters JPC, Verhaegen F, Lambin P, de Ruysscher D. Do we have enough evidence to
implement particle therapy as standard treatment in lung cancer? A systematic literature review.
Oncologist.2010;15:93 – 103.
Ramaekers BL, Pils-Johannesma M, Joore MA, et al. Systematic review and meta-analysis of radiotherapy in
various head and neck cancers: comparing photons, carbon-ions, and protons. Cancer Treat Rev. 2011;
37(3):185 – 201.
Ross J, Al-Shahi SR. Interventions for treating brain arteriovenous malformations in adults. Cochrane
Database Syst Rev. December 2, 2009.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003436.pub3/full. Accessed August 18, 2016.
Van Beijnum J, van der Worp HB, Buis DR, et al. Treatment of brain arteriovenous malformations: a
systematic review and meta-analysis. JAMA.2011;306(18):2011 – 19.
Verma V, Mishra MV, Mehta MP. A systematic review of the cost and cost-effectiveness studies of proton
radiotherapy. Cancer. 2016;122(10):1483-1501.
Wink KC, Roelofs E, Solberg T, et al. Particle therapy for NSCLC tumors: where do we stand? A systematic
review of the literature. Frontiers in Oncology. 2014;4:292.
Yu JB, Soulos PR, Herrin J, et al. Proton versus intensity-modulated radiotherapy for prostate cancer:
patterns of care and early toxicity. J Natl Cancer Inst. 2013;105(1):25-32.
Zirtman AL, DeSilvio ML, Slater JD, et al. Comparison of conventional-dose vs high-dose conformal radiation
therapy in clinically localized adenocarcinoma of the prostate. JAMA. 2005;294(10):1233 – 9.
Clinical trials:
Searched clinicaltrials.gov on August 27, 2015 using term “Proton Beam Therapy” cancer. | Open Studies.
83 studies, three (3) relevant.
M.D. Anderson Cancer Center. Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy
(IMRT) Trial. ClinicalTrials.gov web site.
https://clinicaltrials.gov/ct2/show/NCT01512589?term=%22proton+beam+therapy%22+cancer&recr=Open
&rank=7. Last updated April 20, 2016. Accessed August 16, 2016.
Massachusetts General Hospital. Proton therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer.
ClinicalTrials.gov web site.
https://clinicaltrials.gov/ct2/show/NCT01617161?term=%22proton+beam+therapy%22+cancer&recr=Open
&rank=9. Last updated April 21, 2016. Accessed August 16, 2016.
Radiation Therapy Oncology Group, National Cancer Institute. Comparing Photon Therapy To Proton
Therapy To Treat Patients With Lung Cancer. ClinicalTrials.gov web site.
https://clinicaltrials.gov/ct2/show/NCT01993810?term=%22proton+beam+therapy%22+cancer&recr=Open
&rank=29. Last updated June 10, 2016. Accessed August 16, 2016.
CMS National Coverage Determinations (NCDs):
No NCDs identified as of the writing of this policy.
Local Coverage Determinations (LCDs):
L34282 Radiology: Proton Beam Therapy. Cahaba Government Benefit Administrators® LLC. CMS website.
https://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?LCDId=34282&ver=10&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&Key
Word=%22proton+beam+therapy%22&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAA
AAAAA%3d%3d&. Accessed August 18, 2016.
L34684 Proton Beam Therapy. Wisconsin Physicians Service Insurance Corporation. CMS website.
https://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?LCDId=34634&ver=12&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&Key
Word=%22proton+beam+therapy%22&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAA
AAAAA%3d%3d&. Accessed August 18, 2016.
L35075 Proton Beam Therapy. National Government Services Inc. CMS website.
https://www.cms.gov/medicare-coverage-database/details/lcddetails.aspx?LCDId=35075&ver=5&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&Key
Word=%22proton+beam+therapy%22&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAA
AAAAA%3d%3d&. Accessed August 18, 2016.
Commonly submitted codes
Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not
an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill
accordingly.
CPT Code
Description
77520
Proton treatment delivery; simple, without compensation
77522
Proton treatment delivery; simple, with compensation
77523
Proton treatment delivery; intermediate
77525
Proton treatment delivery; complex
ICD-10 Code
Description
C41.0
Malignant neoplasm of bones of skull and face
C41.2
Malignant neoplasm of vertebral column
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
C70.0
Malignant neoplasm of cerebral meninges
C70.9
Malignant neoplasm of meninges, unspecified
C71.0
Malignant neoplasm of cerebrum, except lobes and ventricles
C71.1
Malignant neoplasm of frontal lobe
C71.2
Malignant neoplasm of temporal lobe
C71.3
Malignant neoplasm of parietal lobe
C71.4
Malignant neoplasm of occipital lobe
C71.5
Malignant neoplasm of cerebral ventricle
C71.6
Malignant neoplasm of cerebellum
C71.7
Malignant neoplasm of brain stem
C71.8
Malignant neoplasm of overlapping sites of brain
C71.9
Malignant neoplasm of brain, unspecified
C75.3
Malignant neoplasm of pineal gland
Comment
Includes particle, hadron
therapy
Comment
D32.0
Benign neoplasm of cerebral meninges
D32.9
Benign neoplasm of meninges, unspecified
D33.3
Benign neoplasm of cranial nerves
D35.4
Benign neoplasm of pineal gland
D42.0
Neoplasm of uncertain behavior of cerebral meninges
D42.1
Neoplasm of uncertain behavior of spinal meninges
D42.9
Neoplasm of uncertain behavior of meninges, unspecified
D44.3
Neoplasm of uncertain behavior of pituitary gland
D44.4
Neoplasm of uncertain behavior of craniopharyngeal duct
D44.5
Neoplasm of uncertain behavior of pineal gland
Q28.2
Arteriovenous malformation of cerebral vessels
Q28.3
Other malformations of cerebral vessels
HCPCS Level
II
N/A
Description
Comment