Superseded Local Coverage Determination (LCD)

Proton Beam Therapy

L36658

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Contractor Information

LCD Information

Document Information

LCD ID
L36658
LCD Title
Proton Beam Therapy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36658
Original Effective Date
For services performed on or after 10/24/2016
Revision Effective Date
For services performed on or after 09/26/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
09/08/2016
Notice Period End Date
10/23/2016
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CMS National Coverage Policy

Italicized font represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national NCD language/wording.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Pub 100-03 Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 310.1 - Routine Costs in Clinical Trials.

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, Section 69.6 – Requirements for Billing Routine Costs of Clinical Trials.

CMS Pub 100-20 One-Time Notification, Transmittal 310, Date: JANUARY 18, 2008, Change Request 5790 - Requirements for including an 8-Digit Clinical Trial Number on Claims.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

In conventional external beam radiation therapy (EBRT), the targeted tissue usually receives 95-100% of the intended dose. A major limitation of EBRT is that in some situations, because critical normal tissues cannot be completely protected from the radiation, a curative dose cannot be used.

Proton beam radiotherapy is a form of conformal external beam radiation treatment. Protons are positively charged atomic particles and have similar biological effects as conventional x-ray beams, but have very different energy disposition or physics profiles. Conventional x-ray beams give off the most energy a short distance below the skin surface (entrance dose) and continue to deposit some dose throughout the path of the beam even beyond the target (exit dose). Conventional EBRT delivers radiation to a more broad range of diseased and normal tissues with targeted tissue receiving approximately 95-100% of the intended dose but a larger volume of normal/unintended tissue receiving a significantly higher dose of radiation that is approximately 20-60% of the dose. In short, there is a higher integral dose to the normal tissue with conventional external beam therapy.

In contrast, proton particles deposit a smaller amount of radiation energy as they enter the body (lower entrance dose), culminating in an intensity dose peak, also called the Bragg Peak. There is no further energy deposition beyond the Bragg peak (no exit dose). The depth of the peak can be controlled by the amount of the proton's energy. While the unaltered Bragg Peak is measured in millimeters, it can be spread out to encompass whole or partial volumes of a tumor. Like other conformal radiation modalities, proton beams can be precisely delivered to the tumor volume without harming surrounding healthy tissue or critical organs. Proton beams typically deposit less radiation in normal non-targeted tissues than conventional radiation therapy and have been used to escalate the radiation dose to diseased tissues while minimizing damage to adjacent normal tissues. Proton beam therapy will typically have a significantly lower integral dose (dose to the whole body of the patient) compared to conventional x-ray therapy. Intensity-modulated radiation therapy (IMRT), gives integral radiation dose to normal tissues compared to proton beam therapy. Due to reduction in integral dose with protons the most important benefits can be expected for pediatric patients.

Proton beam therapy is of particular value in those tumors located close to vital organs (or organs at risk) where a small local overdose can cause fatal complications such as tumors close to the spinal cord. Irregular shaped lesions near critical structures are well suited for protons. In general, proton beam radiotherapy is not indicated for cancers that are widely disseminated, such as leukemias or malignancies with hematogenous metastases or as a short term palliative procedure. Proton beam therapy is also not indicated in the treatment of very radiosensitive tumors such as lymphomas or germ cell neoplasms. The intent of treatment should be curative. If proton beam radiotherapy is used for a patient with metastatic disease, evidence should be provided to justify the expectation of a long-term benefit (> 2y), as well as evidence of a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy. Due to the reduction in integral dose with protons, the most important benefits can be expected for pediatric patients. In adults, proton beam therapy should be reserved to treat patients that have clinically apparent disease (by exam or medical imaging).

Protons provide a dosimetric advantage compared to x-rays for many tumor treatment sites. In general, x-rays give 1.5 to 3 times more integral dose outside the target volume than protons, primarily in the low and medium dose range. There is no benefit to irradiating normal tissues outside of the intended treatment volume, and treatment to larger volumes of normal tissues is associated with increased toxicity, including an increased risk of second malignancies.

Stereotactic techniques are sometimes used with proton beam therapy especially for skull based, uveal tract tumors and others.

The proton beam therapy system must be FDA approved.

Indications:

Proton beam therapy will be considered medically reasonable and necessary for the following conditions:
Group 1

    1. Unresectable benign or malignant central nervous system tumors to include but not limited to primary and variant forms of astrocytoma, glioblastoma, medulloblastoma, acoustic neuroma, craniopharyngioma, benign and atypical meningiomas, pineal gland tumors, and arteriovenous malformations

 

    1. Intraocular melanomas

 

    1. Pituitary neoplasms

 

    1. Chordomas and chondrosarcomas

 

    1. Advanced staged and unresectable malignant lesions of the head and neck

 

    1. Malignant lesions of the Para nasal sinus, and other accessory sinuses

 

    1. Unresectable retroperitoneal sarcoma

 

  1. Solid tumors in children


In addition to the criteria in Group I, Proton Beam Therapy indications must demonstrate that:

    • The Dose Volume Histogram (DVH) one or more critical structures or organs protected by the use of Proton Beam Therapy;

 

    • The dose to control or treat the tumor cannot be delivered without exceeding the tolerance of the normal tissue;

 

    • There is documented clinical rationale that doses generally thought to be above the level otherwise attainable with other radiation methods might improve control rates; or

 

  • There is documented clinical rationale that higher levels of precision associated with Proton Beam Therapy compared to other radiation treatments are clinically necessary.


For the treatment of primary lesions, the intent of treatment must be curative. For the treatment of metastatic lesions, there must be

    1. the expectation of a long-term benefit (greater than 2 year of life expectancy) that could not have been attained with conventional therapy, or

 

  1. the expectation of a complete eradication or improved duration of control of the metastatic lesion that could not have been safely accomplished with conventional therapy, as evidenced by a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy.
      • The patient’s record demonstrates why Proton beam radiotherapy is considered the treatment of choice for the individual patient. Specifically, the record must address the lower risk to normal tissue, the lower risk of disease recurrence, and the advantages of the treatment over IMRT or 3- dimensional conformal radiation. Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be maintained.

        If the above provisions are met and the patient is treated in a protocol that is designed for evidence development and for future publication, it is expected that future published data will support an outcome advantage for Medicare patients for continued coverage of the specific diagnosis. The protocol in and by itself does not constitute criteria for coverage. The presence of an Institutional Review Board (IRB) review when appropriate and patient informed consent are also expected.


Group 2
This section defines conditions that are still under investigation and would be covered when part of a clinical trial, registry or both. (See details in coding section)

    1. Unresectable lung cancers and upper abdominal/peri-diaphragmatic cancers

 

    1. Advanced stage, unresectable pelvic tumors including those with peri-aortic nodes or malignant lesions of the cervix

 

    1. Left breast tumors

 

    1. Unresectable pancreatic and adrenal tumors

 

    1. Skin cancer with macroscopic perineural/cranial nerve invasion of skull base

 

    1. Unresectable Malignant lesions of the liver, biliary tract, anal canal and rectum

 

  1. Prostate Cancer, Non-Metastatic.


Prostate Cancer
There is as yet no good comparative data to determine whether or not Proton Beam Therapy for prostate cancer is superior, inferior, or equivalent to external beam radiation, IMRT, or brachytherapy in terms of safety or efficacy.

The prostate cancer should be locally contained and not be an advanced prostate cancer (i.e. T3 or T4 where the tumor has spread through the capsule or has invaded seminal vesicles or other structures) and not any N disease (i.e. no spread to lymph nodes or there has been spread to the pelvic lymph nodes). Note: spread into pelvic lymph nodes is considered metastatic disease.

Coverage and payments of Proton Beam Therapy for prostate cancer will require:

    1. Physician documentation of patient selection criteria (stage and other factors as represented in the NCCN guidelines); and

 

  1. Documentation and verification that the patient was informed of the range of therapy choices, including risks and benefits.


Other factors considered favorable for coverage include enrollment of the patient in an appropriate clinical registry for planned assessment and publication, clinical trials.

In addition to the criteria in Group II, Proton Beam Therapy indication must demonstrate that:

    • T and N Staging must be documented by CT or MRI scan findings;

 

    • The Dose Volume Histogram (DVH) illustrates one or more critical structures or organs protected by the use of Proton Beam Therapy;

 

    • The dose to control or treat the tumor cannot be delivered without exceeding the tolerance of the normal tissue;

 

    • There is documented clinical rationale that doses generally thought to be above the level otherwise attainable with other radiation methods might improve control rates; or

 

  • There is documented clinical rationale that higher levels of precision associated with Proton Beam Therapy compared to other radiation treatments are clinically necessary.


For the treatment of primary lesions, the intent of treatment must be curative.

For the treatment of metastatic lesions, there must be

    1. the expectation of a long-term benefit (greater than 2 year of life expectancy) that could not have been attained with conventional therapy; or

 

  1. the expectation of a complete eradication of the metastatic lesion that could not have been safely accomplished with conventional therapy, as evidenced by a dosimetric advantage for proton beam radiotherapy over other forms of radiation therapy (IMRT or 3-D radiation therapy). An IMRT or 3-D radiotherapy plan will need to be generated and compared to the Proton plan for target volume coverage and toxicity analysis.


The patient's record demonstrates why Proton beam radiotherapy is considered the treatment of choice for the individual patient. Specifically, the record must address the lower risk to normal tissue, the lower risk of disease recurrence, and the advantages of the treatment over IMRT or 3-dimensional conformal radiation. Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be maintained.

If the above provisions are met and the patient is treated in a protocol that is designed for evidence development and for future publication, it is expected that future published data will support an outcome advantage for Medicare patients for continued coverage of the specific diagnosis. The protocol in and by itself does not constitute criteria for coverage. The presence of an Institutional Review Board (IRB) review when appropriate and patient informed consent are also expected.

If the patient cannot clearly meet the criteria for coverage but desires Proton beam radiotherapy based on a marketed theoretical advantage, the claim should be billed with the appropriate modifier appended to the treatment delivery code. (See Coding Guidelines).

Summary of Evidence

n/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation Requirements

    1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.

 

    1. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.

 

    1. The submitted medical record should support the use of the selected diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed.

 

    1. Each claim must be submitted with diagnosis codes that reflect the condition of the patient, and indicate the reason(s) for which the service was performed. Claims submitted without diagnosis codes will be returned.

 

    1. Documentation in the patient medical record must support the reasonable and necessary requirements as outlined under the Coverage Indication, Limitations, and/or Medical Necessity section of this LCD.

 

  1. Documentation must include the planned course of therapy, type and delivery of treatment, level of clinical management involved and ongoing documentation of any changes in the course of treatment, and DHV as noted in the covered indications section.



Utilization Guidelines

Sources of Information

Agency for Healthcare Research and Quality; AHRQ; Particle Beam Radiation Therapies for Cancer Publication No. 09-EHC019-EF; Revised November 2009

Agency for Healthcare Research and Quality; Comparative effectiveness of therapies for clinically localized prostate cancer; Feb 2008

Allen A et al., Fatal Pneumonitis Associated With Intensity-Modulated Radiation Therapy For Mesothelioma. Int. J. Radiation Oncology Biol. Phys. 2006, 65(3):640-5.

American College of Radiology (ACR) - ASTRO practice parameter for the performance of proton beam radiation therapy, Resolution 39, Amended 2014: 1-8.

American Medical Association (AMA) (2013). Proton beam therapy, ASTRO model policy. Approved May 20, 2014: 1-15.

ASTRO/ACR Guide to Radiation Oncology 2010.

Baumert BG, et al; A comparison of dose distributions of proton and photon beams in stereotactic conformal radiotherapy of brain lesions; International Journal of Radiation Oncology, Biology, Physics, (2001)49(5): 1439-49.

Bjöork-Eriksson T et al., The Potentials Of Proton Beam Radiation Therapy In Malignant Lymphoma, Thymoma and Sarcoma. Acta Oncologica 2005. 44:913-17.

Bonnet R et al, Effects of Proton and Combined Proton/Photon Beam Radiation On Pulmonary Function In Patients with Resectable But Medically Inoperable non-small Cell Lung Cancer. 2001. Chest. 120(6):1803-10.

Bradley J et al., A Phase I/II Radiation Dose Escalation Study With Concurrent Chemotherapy For Patients With Inoperable Stages I To II Non-small-cell Lung Cancer: Phase I results of RTOG 0117. 2010. Int. J. Radiation Oncology Biol. Phys. 77(2):367-72.

Bradley J et al., Primary Analysis of the Phase II Component of a Phase I/II Dose Intensification Study Using Three-Dimensional Conformal Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable Non-Small-cell Lung Cancer: RTOG0117. 2010. J. Clin Oncology. 28(14):1475-80.

Bush D et al, Proton-Beam Radiotherapy For Early-Stage Lung Cancer. 1999 Chest. 116(5):1313-9.

Bush D et al., Hyofractionated Proton Beam Radiotherapy For Stage I Lung Cancer. 2004. Chest. 126(4):1998-2003.

Chang J et.al., Toxicity and Patterns of Failure of Adaptive/Ablative Proton Therapy For Early-Stage, Medically Inoperable Non-Small Cell Lung Cancer. Int J. Radiation Oncology Biol. Phys (2011) 80(5):1350-7.

Chang J et al., Phase 2 Study of High-Dose Proton Therapy With Concurrent Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer. Cancer 2011:1-10.

Chang Joe et al., Significant Reduction of Normal Tissue Dose By Proton Radiotherapy Compared With Three-dimensional Conformal Or Intensity-Modulated Radiation Therapy In Stage I Or Stage III Non-small-cell Lung Cancer. Int. J. Radiation Oncology Biol. Phys., 2006. 65(4):1087-96.

Chen JCT, Girvigian M.R.; Stereotactic radiosurgery; instrumentation and theoretical aspects-part 1; Perm Jour; 2005 Fall 9(4) 23-26.

Chera B et al., Dosimetric Comparison Of Three Different Involved Nodal Irradiation Techniques For Stage II Hodgkin’s Lymphoma Patients: Conventional Radiotherapy, Intensity-Modulated Radiotherapy, and here Dimensional Proton Radiotherapy; Int. J. Radiation Oncology Biol. Phys., 2009. 75(4):1173-80.

Chung CS, et al., Comparative Analysis of Second Malignancy Risk in Patients Treated With Proton Therapy vs. Conventional Photon Therapy, Int. J. Radiation Oncology Biol. Phys. 2008, 72 (1):S8.

Cooper JS, et. Al., Chemoradiotherapy of Locally Advanced Esophageal Cancer. Long-term Follow-up of a Prospective Randomized Trial (RTOG 85-01), JAMA. 1999, 281(17):1623-1627.


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; Radiotherapy and Oncology.2001; 61: 287-297.

Gagliardi G, et al., Radiation Dose-Volume Effects in the Heart, Int. J. Radiation Oncology Biol. Phys. 2010, 76(3):S77-S85.

Gayed IW, et al., The Prevalence of Myocardial Ischemia after Concurrent Chemoradiation Therapy as Determined by Gated Myocardial Perfusion Imaging in Patients with Esophageal Cancer, J. Nucl. Med. 2006, 46:1756-62, 2006.

Gomez D and Komaki R, Technical Advances of Radiation Therapy For Thymic Malignancies, J of Thoracic Oncology 2010. 5(10; Sup 4)S336-S343.

Graham M et al., Clinical Dose-Volume Histogram Analysis For Pneumonitis After 3D Treatment For Non-Small Cell Lung Cancer (NSCLS); Int. J. Radiation Oncology Biol. Phys. 1999, 45(s):323-9.

Hata M et al., Hypofractionated High-Dose Proton Beam Therapy For Stage I Non-small-cell Lung Cancer: Preliminary results Of a Phase I/II Clinical Study. 2007. Int. J. Radiation Oncology Biol. Phys. 68(3):786-93.

Heidenreich PA, Schnittger I, Strauss HW, et.al, Screening of Coronary Artery Disease after Mediastinal Irradiation of Hodgkin’s Disease, J. Clin. Oncol (2007) 25:43-49.

Hodgson D, Dong L, Proton therapy for Hodgkin lymphoma: does a case report make the case?; Leukemia & Lymphoma. Aug 2010; 51(8): 1397–1398.

Hoppe B et al., Double-scattered Proton-based Stereotactic Body Radiotherapy For Stage I Lung Cancer: A Dosimetric Comparison With Photon-based Stereotactic Body Radiotherapy. Radiotherapy and Oncology 2010 97:425-30.

Hoppe B et.al, Effective Dose Reduction to Cardiac Structures Using Proton Compared with 3DCRT and IMRT in Mediastinal Hodgkin Lymphoma, Int J Radiation Oncol Bio Phys. 2012. (no volume or number listed):1-7.

Hoppe B et al., Cardiac Sparing With Proton Therapy In Consolidative Radiation Therapy For Hodgkin Lymphoma. Leukemia & Lymphoma 2010. 51(8):1559-62.

Hull MC, et.al., Valvular Dysfunction and Carotid, Subclavian, and Coronary Artery Disease in Survivors of Hodgkin Lymphoma Treated with radiation Therapy, JAMA (2003) 290:2831-2837.

Isacsson U, et al., Comparative Treatment Planning Between Proton and X-Ray Therapy in Esophageal Cancer, Int. J. Radiation Oncology Biol. Phys. 1998 41(2): 441-450.

Kirkpatrick JP, et al., Radiation Dose-Volume Effects in the Spinal Cord, Int. J. Radiation Oncology Biol. Phys. 2010, 76(3):S42-S49.

Kirkwood, M. (Mar 2013). ASTRO Board of Directors approves the states on use of proton beam therapy for prostate cancer, American Society for Radiation Oncology: 1.

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

Komaki R et al., Reduction of Bone Marrow Suppression for Patients With Stage III NSCLC Treated By Proton and Chemotherapy Compared With IMRT and Chemotherapy, Unknown date. Unknown presentation.

Liao Z et al., Analysis of Clinical and Dosimetric Factors Associated With Radiation Pneumonitis (RP) In Patients With Non-small Cell Lung Cancer (NSCLC) Treated with Concurrent Chemotherapy (ConChT) and Three Dimensional Conformal Radiotherapy (3D-CRT) Unknown date. Presented at 47th Annual ASTRO Meeting.

Lin S, et al., Proton Beam Therapy and Concurrent Chemotherapy For Esophageal Cancer. Int J. Radiation Oncology Biol. Phys (2012)(no volume or number given):1-7.

Li J et al., Rationale For and Preliminary Results Of Proton Beam Therapy For Mediastinal Lymphoma. Int. J. Radiation Oncology Biol. Phys. 2011. 81(1): 167-74.

MacDonald, SM, et al; Proton beam radiation therapy; Cancer Invest.; 2006,Mar; 24(2):199-208.

Marks LB, et al., Radiation Dose-Volume Effects in the Lung,” Int. 3. Radiation Oncology Biol. Phys. 2010, 76(3):S70-S76.

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.

Mizumoto M, et al., Clinical Results Of Proton-Beam Therapy For Locoregionally Advanced Esophageal Cancer, Strahlenter Onkol 2010, (unknown volume and number):1-7.

Mizumoto M, et al., Hyperfractionated Concomitant Boost Proton Beam Therapy for Esophageal Carcinoma. Int J. Radiation Oncology Biol. Phys (2011). 81(4)e601-6.

Nakayama H et al., Proton Beam Therapy for Patients With Medically Inoperable Stage I Non-small-cell Lung Cancer At the University of Tsukuba. 2010. Int. J. Radiation Oncology Biol. Phys. 78(2):467-71.

Nihei K et al., High-dose Proton Beam Therapy For Stage I Non-small-cell Lung Cancer. 2006. Int. J. Radiation Oncology Biol. Phys. 65(1):107-111

Noel G, et al; Combination of Photon and Proton Radiation Therapy for Chordomas and Chondrosarcomas of the Skull Base: The Centre de Protontherapie D'Orsay Experience. Int. J. Radiat. Oncol. Biol. Phys., 51(2)392-398, 2001.

Nguyen, Paul l. et al; Proton-Beam vs Intensity-Modulated Radiation Therapy Which Is Best for Treating Prostate Cancer?; ONCOLOGY. Vol. 22 No. 7; 06/01/2008

Olsen D.R et al;. Proton therapy - a systematic review of clinical effectiveness; Radiother Oncol 2007; 83:123-132.

Paganetti, Harald and Bortfeld, Thomas; Proton Beam Radiotherapy - The State of the Art;
Massachusetts General Hospital, Boston, MA, USA

Petit, Joshua H. et al; Proton Stereotactic Radiotherapy for Persistent Adrenocorticotropin-Producing Adenomas; J Clin Endocrinol Metab, February 2008, 93(2):393-399 jcem.endojournals.org

Register S et al., Proton Stereotactic Body Radiation Therapy For Clinically Challenging cases of centrally and Superiorly Located Stage I Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2011. 80(4):1015-22.

Roelofs E et al., Results Of a Multicentric In Silico Clinical Trial (ROCOCO). Comparing Radiotherapy With Photons and Protons For Non-small Cell Lung Cancer. Journal of Thoracic Oncology 2012 7(1)165-176.

Sejpal S et al., Early Findings On Toxicity Of Proton Beam Therapy With Concurrent Chemotherapy for Nonsmall Cell Lung Cancer. Cancer, 2011. (no volume or number given):1-10.

Sejpal S et al., Does Proton Beam Radiotherapy (PBT) Reduce Treatment Related Pneumonitis (TRP) Compared to Intensity Modulated Related Radiation Therapy (IMRT) In Patient With Locally Advanced Non-small-cell Lung Cancer (NCLC) Treated With Concurrent Chemotherapy?” Unknown date. Unknown presentation.

Schneider U, et.al., “The Impact of IMRT and Proton Radiotherapy on Secondary Cancer Incidence,” Strahlenter Onckol (2006) 182: 647-652

Seppenwoolde Y et al., “Comparing Different NTCP Models That Predict the Incidence of Radiation Pneumonitis.”; Int. J. Radiation Oncology Biol. Phys.; 2003 55(3):724-35.

Sheets N, Goldin G, Meyer A, et al, Intensity-Modulated Radiation therapy, Proton Therapy, Or Conformal Radiation Therapy and Morbidity and Disease Control In Localized Prostate Cancer. JAMA. (2012) 307; 15:1611-9.

Slater, Jerry; Clinical Applications of Proton Irradiation Treatment at Loma Linda University: Review of a Fifteen Year Experience; Technology in Cancer Research and Treatment ISSN 1533-0346. Vol. 5 No. 2 April 2006

Smith RP; Modern radiation treatment planning and delivery from Röntgen to real time; Hematol Oncol Clin North Am.; 2006 Feb;20; (1):45-62.

Sugahara S, et al. Clinical results of proton beam therapy for cancer of the esophagus; Int J Radiat Oncol Biol Phys. 2005 Jan 1; 61(1):76-84.

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U.S. Food and Drug Administration (FDA) 510(k) summary; Hitachi's PROBEAT k053280; Mar 9, 2006; www.fda.gov

U.S. Food and Drug Administration (FDA) 510(k) summary; Optivus proton beam therapy system k992414; July 21,2000.

Vogelius I et al., Estimated Radiation Pneumonitis Risk, After Photon Versus Proton Therapy Alone Or Combined With Chemotherapy For Lung Cancer; Acta Oncologica 2011 50:772-6.

Vosmik M et. al., Technological Advances in Radiotherapy For Esophageal Cancer, World Journal of Gastroenterology (2010) 16(44)5555-5564.

Welsh J et. al., Update: Modern Approaches to the Treatment of Localized Esophageal Cancer. Curr Oncol Rep (2001) 13:157-167.

Welsh J et.al., Intensity-Modulated Proton Therapy Further Reduces Normal Tissue Exposure During Definitive Therapy For Locally Advanced Distal Esophageal Tumors: A Dosimetric Study. Int J. Radiation Oncology Biol. Phys. (2011)81(5):1336-1342.

Yorke E et al., Correlation Of Dosimetric Factors and Radiation Pneumonitis For Non-small-cell Lung Cancer Patients In a Recently Completed Dose Escalation Study. Int. J. Radiation Oncology Biol. Phys. 2005, 63(3):672-682.

Zhang X et al., Intensity-modulated Proton Therapy Reduces the Dose To Normal Tissue Compared With Intensity-Modulated radiation Therapy Or Passive Scattering Proton Therapy and Enables Individualized Radical Radiotherapy For Extensive Stage IIIB Non-small-cell Lung Cancer: A Virtual Clinical Study;Int. J. Radiation Oncology Biol. Phys. 2009; (unknown volume and number);1-10.

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Bibliography

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Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
09/26/2019 R8

R8

Revision Effective: N/A

Revision Explanation: Annual review, no changes

09/30/2020:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review)
09/26/2019 R7

R7

Revision Effective: N/A

Revision Explanation: Annual review, no changes made.

08/25/2020:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
09/26/2019 R6

R6

Revision Effective: 09/23/2019 Revision Explanation: Annual review, no changes made.

09/23/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review, no changes made)
09/26/2019 R5

R5

Revision Effective: 9-26-2019

Revision Explanation: Removed coding and converted to new policy template that no longer includes coding section based on CR 10901.

DATE (09/23/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
10/01/2018 R4

R4

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

DATE (08/27/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/01/2018 R3

R3

Revision Effective: 10/01/2018

Revision Explanation: During the ICD-10 annual update the following codes were deleted from group 2: C44.102, C44.109, C44.112, C44.119, C44.122, C44.129, C44.192, and C44.199. These were replaced with the following codes: C44.1021, C44.1022, C44.1091, C44.1092, C44.1121, C44.1122, C44.1191, C44.1192, C44.1221, C44.1222, C44.1291, C44.1292, C44.1921, C44.1922, C44.1991, and C44.1992.

DATE (09/19/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
08/28/2017 R2

R2

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

DATE (08/13/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
08/28/2017 R1

R1

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

DATE (08/28/2017): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.


  • Other (annual review)

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
09/22/2021 09/26/2019 - N/A Currently in Effect View
09/30/2020 09/26/2019 - N/A Superseded You are here
08/25/2020 09/26/2019 - N/A Superseded View
09/23/2019 09/26/2019 - N/A Superseded View
09/23/2019 09/26/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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