Clinical Policy Title: Proton Therapy

Clinical Policy Title: Proton Therapy Clinical Policy Number: 05.02.01 Effective Date: Dec. 1, 2013 Initial Review Date: Aug. 21, 2013 Most Recent Review Date: Aug. 20, 2014 Next Review Date: August, 2015 Policy contains: Proton therapy. Particle or hadron therapy. Cancer (adult and pediatric). Brain AVM. RELATED POLICIES: (IF ANY) None ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First 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 Keystone First 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. Keystone First 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. Keystone First clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First clinical policies are not guarantees of payment. Coverage policy Keystone First considers the use of proton therapy to be clinically proven and therefore medically necessary when any of the following criteria are met: 1.) Clinical conditions o Benign or malignant conditions otherwise not suitable for intensity-modulated radiation therapy (IMRT) or 3-dimensional conformal radiation (3DCR): base of skull or axial skeleton but not limited to chordoma or chondroscarcoma; OR o Solid tumors in children up to age 16: primary and variant forms of medulloblastoma, astrocytoma, glioblastoma, AVMs, acoustic neuroma, craniopharyngioma, benign and atypical meningiomas, pineal gland tumors, intraocular melanoma; OR o Primary tumors (curative intent) OR metastatic lesions: expectation of long-term ( 2 years) benefit unobtainable with conventional therapy, and expectation of complete eradication of the lesion otherwise not obtainable. 2.) Treatment concerns 1

o o o Dose constraints to normal tissues limit total dose safely deliverable to tumor by other means; OR Reason to believe that doses thought to be above those attainable by other means may improve tumor control; OR Higher precision associated with proton beam is clinically relevant. 3.) Mandatory documentation: The patient record documents why proton is considered treatment of choice for this individual. Limitations: Use on hematogenous malignancies (e.g., leukemias and lymphomas) is considered investigational and therefore not medically necessary. Case-by-case decisions for metastases of the primary malignancies. Alternative Covered Services: Standard surgical therapies, radiation therapies and chemotherapies as appropriate for the clinical condition. Background Proton beam therapy is a form of radiotherapy which 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 proton beam therapy was in 1954. However, the extremely high cost of producing charged particles inhibited its widespread use. Trikalinos (AHRQ; 2009) reports 7 US centers for proton therapy and an additional 4 under construction, at costs per center of $100 to $225 million. Proton therapy 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 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 proton therapy facility, treatment costs are higher than with conventional radiation. It is therefore important to evaluate whether the medical benefits of proton therapy are large enough to balance the higher costs. Proton beam therapy is not suitable to all tumor types but may be of particular benefit treating superficial lesions (such as those of the eye) and intermediate depth lesions (such as in the head and neck), as well as 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, proton beam may be ideal for use in pediatric patients. This policy focuses on adult cancers or brain arteriovenous malformations (AVMs). 2

Methods Searches Keystone First searched PubMed and the databases of: UK National Health Services Centre 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. Searches were conducted on multiple occasions during July and August 2014, using the terms proton therapy. Included were: 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 evidencegrading 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 Lack of standards for determining whether the outstanding dose distribution and conformality achieved with proton irradiation translates into improved clinical outcome with respect to increased tumor control and/or reduced treatment-associated complications (Bekelman, 2013) is still the case in 2014. Flynn (2010) cataloged systematic reviews published through April 2010 [excluding Trikalinos (AHRQ; 2009), then in-progress but not yet available] and concluded that evidence to that date did not definitively support efficacy or comparative effectiveness versus other interventions of proton therapy for any cancer indication. The evidence picture has not changed substantively since these reviews concluded searches. Summary of Clinical Evidence Citation Content Cancer reviews Hayes Inc. (2013) Yu (2013) Proton beam for prostate cancer: Abstracts provide conflicting evidence. Full text review not conducted for this publication and pending status not noted. No CMS coverage decisions identified. Cross-sectional: All Medicare patients with prostate cancer receiving proton or IMRT, 2008 9. Multivariate logistic regression to identify factors associated with receipt of proton. 27,647 men: 2% received proton, 98% IMRT. Proton patients: younger, healthier, from more affluent areas than IMRT. Median reimbursement: proton, $32,428; IMRT, $18,575. Proton associated with significantly lower genitor-urinary toxicity at 6 months: 5.9% Vs 9.5% (OR, 0.60; CI, 0.38-0.96); no difference at 12 months. 3

Citation Ramaekers (2010) Bauman (Cancer Care Ontario; 2010) Flynn (2010) Grutters (2010) Grutters (2010a) Content NS differences in GI or other toxicity at 6 or 12 months. Radiotherapy (IMRT, carbon ion or proton) in head and neck cancers: 1990 2010: English-language clinical studies with 10 subjects. Cancers: naso-pharyngeal; oro-pharyngeal; para-nasal; sino-nasal; mucosal melanoma; adeno-cystic carcinoma. Ns with each stage, radiation dose, mean/median age and proportion receiving chemotherapy varied among studies. Reporting of adverse effects varied. 86 observational studies; 8 comparative; Ns, 10-323. Inclusion of small observational studies and overall heterogeneity of studies may have adversely affected reliability. Main results: 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. Intensity modulated radiation therapy in prostate cancer: 2000 Mar. 2009. Systematic reviews, clinical practice guidelines, health technology assessments, randomized Phase II or III trials. 50 patients reported in English. IMRT recommended over 3DCRT for localized prostate cancer where dose escalation (>70 Gy) is required. Insufficient evidence for post-operative use. Are there cancer diagnoses for which rigorous research has shown proton therapy to be effective? Systematic reviews, guidelines or technology assessments: searches updated to April 2010 for evidence to confirm or refute conclusions of published reviews. 12 reviews on a variety of cancers (lung. base of skull, ocular, prostate, head and neck) and on brain AVMs. Reviews concur: most published studies are observational. Only prostate cancer and uveal melanoma represented by CCTs with serious methods weaknesses. Economic evaluations premature. Overall: insufficient evidence for effectiveness. Radiotherapy with photons, protons and carbon ions for non-small cell lung cancer: 1994 Aug 2008. Studies with 20 patients published in English or Dutch and reporting 2- or 5- year survival by stage and adverse events. 30 studies (n = 2611); 5 for proton (180); all case series without controls. Survival with particle therapy higher than conventional radiation for Stage I inoperable; may reduce adverse events in Stage III. Further RCT evidence needed. CEA: particle therapy in non-small cell lung cancer: Decision analytic Markov model to synthesize all available evidence (Grutters, 2010; row above) for inoperable Stage I NSCLC. Inoperable Stage I: carbon-ion cost 67.257/QALY gained compared to SRS. Considerable uncertainty to results: more evidence is needed. 4

Citation Trikalinos (AHRQ; 2009) Brain AVMs Van Beijnum (2011) Ross (Cochrane; 2010) Content Particle beam radiation therapies for cancer: Medline, July 2009. Any study design. > 10 subjects and describing outcomes or adverse events. English, German, French, Italian, Japanese. 243 eligible studies; proton alone or in combination with other interventions for common (prostate) or uncommon cancers (skull base or uveal melanoma). N, 10-2645; median 63. FU, 5-157 months; median 36. 9 non-randomized comparisons reported in 13 papers with 4086 unique patients. Overall: no study found particle therapy significantly better than alternatives for patient-relevant outcomes. Brain AVMs: 2000 March 2011. Consecutive case series with 15 patients of any age receiving microsurgery, stereotactic radio-surgery or embolization. English, French, German, Italian or Spanish language and reporting: length of FU; rates of post-op hemorrhage and death. Main results: 137 studies with 142 cohorts (13,698 subjects with 46,314 patient-years FU). No RCTs published or included. Case fatality: o Microsurgery, 1.1(CI, 0.87-1.3)/100 patient-years FU. o Stereotactic radio-surgery, 0.50 (CI, 1.5-1.8). o Embolization, 1.7 (1.3-2.3). Complications leading to permanent neurologic deficits or death: o Microsurgery, median 7.4% (range 0-40). o SRS, 5.1% (0-21). o Embolization, 6.5% (0-28). AVM obliteration: o Microsurgery, 96% (0-100). o SRS, 38% (0-75). o Embolization, 13% (0-94). Insufficient evidence and too much variation among studies for valid conclusions. Interventions for brain AVMs in adults: 1980 Nov 2009. RCTs comparing interventions against each other or with usual medical management and reporting relevant clinical outcomes (partial obliteration or total eradication). One ongoing/unpublished RCT (ARUBA; enrolling patients with AVMs that never bled) meets selection criteria; 2 others (1 published) tested embolic procedures against each other but did not report outcomes required for this review. 5

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. 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. A Cochrane review (Ross, 2010) found no randomized trials to confirm the superiority of any AVM treatment over alternatives. Searches for this policy (August 2014) confirmed that no more recent publications change that conclusion. The single ongoing review-eligible trial, A Randomized Trial of Unruptured Brain AVMs (ARUBA), cited by the Cochrane reviewers, is still not published as of August 10, 2014. ARUBA began in October 2006 and is investigating invasive interventions (endovascular procedures, neurosurgery or radiotherapy, alone or in combination) versus medical management. The ARUBA protocol available at www.clinicaltrials.gov does not explicitly include proton therapy in the list of invasive procedures. Carcinoma A malignant and invasive tumor of epithelial (skin or other body surface) cells that spreads by metastasis and can recur after surgery. Chordoma An uncommon and relatively slow-growing tumor of the brain or brain stem arising from remnants of an embryonic structure, the notochord, which otherwise disappears during fetal life. Cochrane Collaboration An international effort by 31,000 clinicians, researchers and staff, most of whom contribute their time to conducting and updating the highest quality systematic reviews to support informed health care decision-making. The collaboration also maintains a large collection of clinical trial records. Reviews and trial records are published as the Cochrane Library. The Collaboration is named for Archie Cochrane (1909 88), a Scottish physician and early proponent for adopting the scientific method (randomized controlled trials) in clinical research. Decision analysis The methods and procedures for formalizing decision-making: analyzing options, consequences and uncertainties by probabilities and often representing the process graphically by a tree, algorithm or other diagram. In health care policy formulation, meta-analysis (in systematic reviews), decision analysis and economic evaluation are related methods to quantitatively synthesize information in order to arrive at a summary conclusion, e.g., on efficacy or effectiveness, and to resolve uncertainty about resource allocation (Petitti, 1994). Efficacy vs. effectiveness Efficacy is impact on clinical outcomes in a research setting; effectiveness is impact in the less controlled real world setting of widespread clinical use. Randomized controlled trials (RCTs) demonstrate the former but are designed to optimize internal validity rather than generalizability to other settings. Gray (Gy) Unit of absorbed radiation dose. Hemangioma A benign tumor of tiny blood vessels (capillaries). They may be present at birth or appear during the first 6 months. They may occur anywhere in the body, on the skin as strawberry birthmark and 6

on structures near the eye may cause vision problems. Many hemangiomas regress spontaneously; for those requiring treatment, steroids, propanolol or lasers are used with variable effectiveness and adverse effect profiles. Intensity-modulated radiation therapy (IMRT) Along with conformal therapy (defined below), 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. Macular degeneration A major cause of visual impairment and blindness in older adults, age-related macular degeneration (ARMD) damages the macula (central area) of the retina and causes central visual field vision loss. ARMD can make it difficult to read or recognize faces, although enough peripheral vision may remain for other activities of daily life. Markov decision process A mathematical model used in decision analysis. Medically Necessary- A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Non- small-cell lung cancer (NSCLC) Referring to microscopic characteristics. Any type of lung cancer other than small cell, including squamous cell, large cell and adenocarcinoma. Lung cancer in never smokers is almost universally NSCLC, the majority adenocarcinoma, versus squamous cell or small cell, which are associated with tobacco use. NSCLCs are relatively insensitive to chemotherapy and are treated by surgery. Particle therapies External beam radiation with charged subatomic particles such as protons, neutrons, or carbon ions (also known as hadrons), as opposed to X-rays, which use photons (light waves). Performance status A measure of cancer patients general well-being and ability to perform activities of daily living; used in clinical practice and research to estimate patient ability to tolerate treatment and determine appropriate treatment dose or intensity of palliation. A frequently used adult performance status scale, the Karnofsky score (KPS) runs from 100 (perfect health) to zero (death): Karnofsky score (%) Description 100 Normal: no complaints, no sign of disease 90 Normal activity levels; few symptoms or signs of disease 80 Normal activity with some difficulty, some signs or symptoms 70 Caring for self but not capable of normal activity or work 60 Requires some help but can take care of most personal requirements 7

50 Frequent need for help and medical care 40 Disabled: requires special help and care 30 Severely disabled: hospital admission indicated but no risk of death 20 Very ill: requires urgent admission with supportive measures or treatment 10 Moribund: rapidly progressive fatal disease Quality-adjusted life year (QALY) An outcome measure used in economic analyses; it incorporates both quantity and quality of life gained through treatment. Sarcoma A malignant tumor arising from tissues originating as embryonic mesenchyme or mesoderm: bone, cartilage, fat, muscle, vascular or blood. They are named for the tissues they most closely resemble microscopically and behave with various levels of aggressiveness. Stereotactic radiosurgery (SRS) A form of radiation treatment that uses a 3-dimensional external coordinate system to locate small lesions within the body for intervention. It requires a reliable and stable frame of reference, e.g., bone landmarks with a constant spatial relationship to soft tissues. Hence SRS applications have generally been restricted to the brain, although stereotactic breast biopsy is also performed. Ross (Cochrane; 2010) classifies proton therapy among SRS procedures but found no completed RCTs for any brain AVM interventions meeting eligibility criteria for review. Three-dimensional conformal therapy (3DCRT ) Computed tomography-based techniques to deliver radiation more accurately and with higher doses. These techniques include the use of conformal particle beams, intensity-modulated photon (X-ray) beams and proton beams. Conformal photon-beam therapy has become the standard external radiation therapy, although the more technically challenging intensitymodulated radiation is becoming more widely used. Uveal tract A collective term for internal structures of the eye: iris, ciliary body and choroid. Uveal melanoma is a malignant tumor arising from pigmented cells (melanocytes) that produce eye color. References Professional society guidelines/other: Adelaide Health Technology Assessment (AHTA). Proton beam therapy for the treatment of cancer. Australian Government Department of Health and Aging. June 2006. 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. Australia and New Zealand Horizon Scanning Network (ANZHSN). Proton beam therapy for the treatment of uveal melanoma. Royal Australasian College of Surgeons. May 2007b. 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. Hayes, Inc. Proton beam therapy for prostate cancer. Search and summary. March 25, 2013. 8

Moran BJ, DeRose P, Merrick G, Hsu IC, Abdel-Wahab M, Arterbery VE, Ciezki JP, Frank SJ, Mphler JL, Roswnthal SA, Rosi CJ, Yamada Y. Expert panel on radiation oncology-prostate. ACR appropriateness criteria definitive external beam radiation in stage T1 and T2 prostate cancer. [Online publication]. Reston (VA): American College of Radiology (ACR). 2007. Rosenzweig KE, Chang JY, Chetty IJ, Decker RH, Ginsburg ME, Kestin LL, Kong PM, Lally BE, Langer CJ, Movsas B, Videtic GMM, Willers H, 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. 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. Neurosurgical Review. 2009; 32:403 16. 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); 2010 Oct 27. Bekelman JE, Hahn SM. The body of evidence for advanced technology in radiation oncology (editorial). Journal of the National Cancer Institute. 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. Van Beijnum J, van der Worp HB, Buis DR, Al-Shahi SR, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vanderop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. Journal of the American Medical Association. 2011;306(18):2011 19. Brada M, Pijls-Johannesma M, de Ruysscher D. Current clinical evidence for proton therapy. Cancer Journal.2009; 15(4):319 24. Efstathiou JA, Gray PJ, Zietman AL. Proton beam therapy and localized prostate cancer: current status and controversies. British Journal of Cancer. 2013;108:1225 30. Grutters JP, Kessels AG, Pils JohannesmaM, 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. Radiotherapy and Oncology. 2010; 95(1):32-40. Grutters JP, Pils-Johannesma M, Ruysscher DD, Peeters A, Reimoser S, Severens JL, lambin S, Joore MA. The cost-effectiveness of particle therapy in non-small cell lung cancer: exploring decision uncertainty and areas for future research. Cancer Treatment Reviews. 2010a; 36(6):468 76. Jarosek S, Elliott S, Virnig BA. Proton bean radiotherapy in the U.S. Medicare population: growth in use between 2006 and 2009. Proton beam radiotherapy. Data points #10(prepared by the University of 9

Minnesota DEcIDE Center, under Contract No. HHSA 290201000131). Rockville, MD: Agency for Healthcare Research and Quality ; May 2012. 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. Radiotherapy and Oncology.2007;l83(2):110 22. Lundkvist J, Ekman M, Ericsson SR, Jönsson B, Glimelius B. Proton therapy of cancer: potential clinical advantages and cost-effectiveness. Acta Oncologica. 2005;44: 850 61. Olsen DR, Bruland ØS, Frykholm G, Norderhaug IN. Proton therapy: a systematic review of clinical effectiveness. Radiotherapy and Oncology. 2007;83(2):123 32. 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. The Oncologist. 2010.15:93 103. Ramaekers BL, Pils-Johannesma M, Joore MA, van den Ende P, Langendijk JA, Lambin P, Kessels AG, Grutters JP. Systematic review and meta-analysis of radiotherapy in various head and neck cancers: comparing photons, carbon-ions, and protons. Cancer Treatment Reviews. 2011;3793):185 201. Ross J, Al-Shahi SR. Interventions for treating brain arteriovenous malformations in adults. Cochrane Database of Systematic Reviews. 2010, Issue 7. Zirtman AL, DeSilvio ML, Slater JD, Rosssi CJ, Miller DW, Adams, JA, Shipley, WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate. JAMA. 2005; 294(10) :1233 9. Moran BJ, DeRose P, Merrick G, Hsu IC, Abdel-Wahab M, Arterbery VE, Ciezki JP, Frank SJ, Mphler JL, Roswnthal SA, Rosi CJ, Yamada Y. Expert panel on radiation oncology-prostate. ACR appropriateness criteria definitive external beam radiation in stage T1 and T2 prostate cancer. [Online publication]. Reston (VA): American College of Radiology (ACR). 2007. Rosenzweig KE, Chang JY, Chetty IJ, Decker RH, Ginsburg ME, Kestin LL, Kong PM, Lally BE, Langer CJ, Movsas B, Videtic GMM, Willers H, 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. Clinical Trials: On August 12, 2014, searching www.clinicaltrials.gov using proton therapy yielded 1024 studies. Many of these are diagnosis-specific, with protocols defining other specific clinical eligibility criteria, and conducted at one or more hospitals or universities, not all of which would be geographically accessible to every patient otherwise eligible. Physicians interested in supporting research participation should consult the website for studies relevant to their individual patients. 10

Centers for Medicare & Medicaid Services (CMS) determinations CMS local coverage determination L29263. Proton beam radiotherapy. Wisconsin Physicians Service Insurance Corporation(Contractor 0952). Illinois. Oversight Region V. Effective 3/17/2012. CMS local coverage determination L31617. Proton beam radiotherapy. First Coast Service Options (Contractor 09102). Florida. Oversight Region IV. Effective 2/2/2009; revised 10/1/2011. CMS local coverage determination L31617. Proton beam radiotherapy. First Coast Service Options (Contractor 09102). Florida. Oversight Region IV. Effective 2/2/2009; revised 10/1/2011. 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 Comment 77520 Proton treatment delivery; simple, without compensation 77522 Proton treatment delivery; simple, with compensation 77523 Proton treatment delivery; intermediate 77525 Proton treatment delivery; complex Includes particle, hadron therapy ICD-9 Code Description Comment 170.0 Malignant neoplasm, skull 190.9 Intraocular melanoma 192.1 Meningioma, malignant 194.4 Pineal gland tumor, malignant 225.1 Acoustic neuroma 225.2 Meningioma, benign 227.4 Pineal gland tumor, benign 237.0 Craniopharyngioma 747.81 Arteriovenous malformation, brain ICD-10 Code Description Comment HCPCS Level II Description Comment 11

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