Local Coverage Determination (LCD)

Proton Beam Radiotherapy

L33937

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33937
Original ICD-9 LCD ID
Not Applicable
LCD Title
Proton Beam Radiotherapy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 12/16/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Proton Beam Radiotherapy. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Proton Beam Radiotherapy and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • 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.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

Proton beam radiotherapy is a type of particle beam radiation therapy that delivers high dose radiation to a localized site. Proton beams theoretically 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. Historically, proton beam radiotherapy has most commonly been used for tumors that are difficult or dangerous to treat with surgery or for tumors that are located next to vital structures, where administration of adequate doses of conventional radiation is difficult or impossible.

Covered Indications

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

Group #1 Conditions

  • Benign or malignant conditions otherwise not suitable for intensity modulated radiation therapy (IMRT) or 3- dimensional conformal therapy involving the base of the skull or axial skeleton, including but not limited to chordomas and chondrosarcomas.
  • Solid tumors in children up to age 18.
  • Benign or malignant central nervous system tumors to include primary and variant forms of medulloblastoma, astrocytoma, glioblastoma, arteriovenous malformations, acoustic neuroma craniopharyngioma, benign and atypical meningiomas and pineal gland tumors.
  • Intraocular melanomas

Because many radiological oncologists believe that proton beam therapy is a legitimate treatment option in certain circumstances where 3-dimensional conformal or intensity modulated radiation therapy (IMRT) is deemed medically necessary, proton beam therapy will be considered as medically reasonable and necessary for certain other conditions (i.e., Group #2 of ICD-10-CM Codes that Support Medical Necessity) not listed above, as long as the following criteria are met:

Either #1, #2, or #3 must be present and

Either #4 or #5 must be present and

#6 must always be present.

1.  When dose constraints to normal tissues limit the total dose of radiation safely deliverable to the tumor with other indicated methods

2.  When there is a reason to believe that doses generally thought to be above the level otherwise attainable with other methods might improve control rates

3.  In circumstances when the higher levels of precision associated with proton beam therapy as compared to other radiation methods are necessary, i.e., clinically relevant

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

5.  For the treatment of metastatic lesions, there must be

  1. the expectation of a long-term benefit (> 2y) that could not have been attained with conventional therapy
  2. 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

6.  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 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 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 review, when appropriate, and patient informed consent are also expected.

Proton beam treatment of the following conditions may be considered medically reasonable and necessary only if the above criteria are met as specified.

Group #2 Conditions

  • Malignant lesions of the head and neck when the intent of treatment is to be curative.
  • Malignant lesions of the Para nasal sinus, and other accessory sinuses
  • Malignant lesions of the prostate
  • Malignant advanced stage, non-metastatic tumors of the bladder
  • Advanced pelvic tumors including malignant lesions of the cervix
  • Left breast tumors
  • Pancreatic and adrenal tumors
  • Skin cancer with perineural/cranial nerve invasion
  • Unresectable retroperitoneal sarcoma and extremity sarcoma
  • Cancers of the lung and upper abdominal/peri-diaphragmatic cancers
  • Malignant lesions of the liver, biliary tract, anal canal and rectum 

Limitations

In general, proton beam radiotherapy is not indicated for cancers that are widely disseminated, such as leukemias, have hematogenous metastases or as a short-term palliative procedure. 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.

All other indications are not considered reasonable and necessary and will be denied.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Proton Beam Radiotherapy (A57669) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Proton Beam Radiotherapy (A57669) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number – L29470

American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice. Role of radiation therapy.

American College of Radiation Oncology (ACRO), Practice Management Guide; Proton Therapy in the United States (2004).

Barker, FG, Butler, WE, Lyons, S, Cascio, E, Ogilvy, CS, Loeffler, JS, Chapman, PH (2003). Dose-volume prediction of radiation-related complications after proton beam radiosurgery for cerebral arteriovenous malformations. Journal of Neurosurgery, 99(2): 222-3; discussion 223-4.

Baumert BG, Lomax AJ, Miltchev V, Davis JB (2001). A comparison of dose distributions of proton and photon beams in stereotactic conformal radiotherapy of brain lesions. International Journal of Radiation Oncology, Biology, Physics, 49(5): 1439-49.

Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-Dose Proton Radiotherapy of Hepatocellular Carcioma: Preliminary Results of a Phase II Trial. Gastroenterology 2005:128:S189-S193

Cozzi L, Fogliata A, Lomax A, Bolsi A. A treatment planning comparison of 3D conformal therapy, intensity modulated photon therapy, and proton therapy for treatment of advanced head and neck tumours. Radiotherapy and Oncology 61: 287-297, 2001.

Hug EB, Nevinny-Stickel M, Fuss M, Miller DW, Schaefer RA, Slater JD. Conformal Proton Radiation Treatment for Retroperitoneal Neuroblastoma: Introduction of a Novel Technique. Medical and Pediatric Oncology 37: 36-41, 2001.

Kawashima M, Furuse J, Nishio T, Konishi M, Ishii H, Kinoshita T, Nagase M, Nihei K, Ogino T. Phase II Study of Radiotherapy Employing Proton Beam for Hepatocellular Carcinoma. J Clin. Oncol., Vol. 23(9)1839-1846, 2005

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

National Cancer Institute, Fact Sheet [On-line].

Noel G, Habrand JL, Mammar H, Pontvert D, Haie-Meder C, Hasboun D, Moisson P, Ferrand R, Beaudre A, Boisserie G, Gaboriaud G, Mazai A, Kerody K, Schlienger M, Mazeron JJ. 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.

Rundle P, Singh AD, Rennie I (2006). Proton beam therapy for iris melanoma: a review of 15 cases. Eye,

Slater JD. Clinical Applications of Proton Radiation Treatment at Loma Linda University: Review of a Fifteen-year Experience. Technology in Cancer Research and Treatment, Vol. 5(2) 81-89, April 2006.

Weber DC, Chan AW, Bussiere MR, Harsh GR, Ancukiewicz M, Barker FG, Thornton AT, Martuza RL, Nadol JB, Chapman PH, Loeffler JS. Proton Beam Radiosurgery for Vestibular Schwannoma: Tumor Control and Cranial Nerve Toxicity. Neurosurgery 53: 577-588, 2003.

Weber DC, Rutz HP, Pedroni ES, Bolsi A, Timmermann B, Verwey J, Lomax AJ, Goitein G. Results of Spot-Scanning Proton Radiation Therapy for Chordoma and Chondrosarcoma of the Skull Base: The Paul Scherrer Institut Experience. Int. J. Radiat. Oncol. Biol. Phys., Vol. 63(2)401-409, 2005.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
12/16/2019 R2

Revision Number: 2
Publication: November 2019 Connection
LCR B2019-032

Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes,” “Revenue Codes,” “CPT/HCPCS Codes,” “ICD-10 Codes that Support Medical Necessity,” “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. In addition, the Social Security Act and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

Also, based on review of the newly created billing and coding article, the following ICD-10-CM diagnosis code was added to the “ ICD-10 Codes that Support Medical Necessity/Group 1 Codes” section: D43.3. The following ICD-10-CM diagnosis codes were removed from the “ICD-10 Codes that Support Medical Necessity/Group 1 Codes” section: C40.00, C40.01, C40.02, C40.10, C40.11, C40.12, C40.20, C40.21, C40.22, C40.30, C40.31, C40.32, C40.80, C40.81, C40.82, C40.90, C40.91, C40.92, C41.9, C47.0, C47.10, C47.11, C47.12, C47.20, C47.21, C47.22, C47.3, C47.4, C47.5, C47.6, C47.8, C47.9, C49.0, C49.10, C49.11, C49.12, C49.20, C49.21, C49.22, C49.3, C49.4, C49.5, C49.6, C49.8, C49.9, C64.1, C64.2, C64.9, C69.00, C69.01, C69.02, C69.10, C69.11, C69.12, C69.20, C69.30, C69.40, C69.50, C69.51, C69.52, C69.60, C69.80, C69.90, C69.91, C69.92, C70.9, C71.9, C72.20, C72.30, C72.40, C72.50, C72.9, D32.9, D33.2, D42.9, and D43.2. The following ICD-10-CM diagnosis codes were added to the “ICD-10 Codes that Support Medical Necessity/Group 2 Codes” section: C02.0, C02.1, C02.2, C02.4, C02.8, C14.8, C15.5, C16.0, C16.1, C16.2, C16.3, C16.4, C16.8, C26.1, C40.01, C40.02, C40.11, C40.12, C40.21, C40.22, C40.31, C40.32, C40.81, C40.82, C47.0, C47.11, C47.12, C47.21, C47.22, C47.3, C47.4, C47.5, C49.0, C49.11, C49.12, C49.21, C49.22, C49.3, C49.4, C49.5, C49.8, C50.022, C50.122, C50.222, C50.322, C50.422, C50.522, C50.622, C50.812, C50.822, C54.0, C54.1, C54.2, C54.3, C54.8, C57.01, C57.02, C57.11, C57.12, C57.21, C57.22, C57.3, C57.7, C57.8, C74.01, C74.02, C74.11, C74.12, C7A.026, C7A.090, C7B.02, C79.49, C79.71, and C79.72. The following ICD-10-CM diagnosis codes were removed from the “ICD-10 Codes that Support Medical Necessity/Group 2 Codes” section: C04.9, C05.9, C06.80, C06.9, C10.9, C11.9, C13.9, C14.0, C21.0, C25.9, C31.9, C32.9, C34.00, C34.10, C34.30, C34.80, C34.90, C34.91, C34.92, C44.00, C44.101, C44.1021, C44.1022, C44.1091, C44.1092, C44.111, C44.121, C44.131, C44.191, C44.201, C44.202, C44.209, C44.211, C44.221, C44.291, C44.300, C44.301, C44.309, C44.310, C44.320, C44.390, C44.40, C44.500, C44.501, C44.509, C44.601, C44.602, C44.609, C44.611, C44.621, C44.691, C44.701, C44.702, C44.709, C44.711, C44.721, C44.791, C44.80, C44.90, C44.91, C44.92, C44.99, C50.011, C50.019, C50.111, C50.119, C50.211, C50.219, C50.311, C50.319, C50.411, C50.419, C50.511, C50.519, C50.611, C50.619, C56.9, C67.9, C76.1, C76.2, and C78.00. The effective date of these revisions is for dates of service on or after December 16, 2019.

In addition, the following ICD-10-CM diagnosis codes under the “ICD-10 Codes that Support Medical Necessity/Group 2 Codes” section of the billing and coding article now require a dual diagnosis: ICD-10-CM diagnosis code C44.01, C44.02, C44.09, C44.1121, C44.1122, C44.1191, C44.1192, C44.1221, C44.1222, C44.1291, C44.1292, C44.1321, C44.1322, C44.1391, C44.1392, C44.1921, C44.1922, C44.1991, C44.1992, C44.212, C44.219, C44.222, C44.229, C44.292, C44.299, C44.311, C44.319, C44.321, C44.329, C44.391, C44.399, C44.41, C44.42, C44.49, C44.510, C44.511, C44.519, C44.520, C44.521, C44.529, C44.590, C44.591, C44.599, C44.612, C44.619, C44.622, C44.629, C44.692, C44.699, C44.712, C44.719, C44.722, C44.729, C44.792, C44.799, C44.81, C44.82 and C44.89 must be billed with ICD-10-CM diagnosis code C79.49. The effective date of this revision is for dates of service on or after December 16, 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 LCD.

  • Other (Revision based on CR 10901)
10/01/2018 R1

Revision Number: 1

Explanation of Revision: Based on CR 10847 (Annual 2019 ICD-10-CM Update), the LCD was revised to indicate that diagnosis codes were added and deleted within existing diagnosis code ranges. In addition, the sources of information section was revised to be in alphabetical order. The effective date of this revision is based on date of service.

  • Revisions Due To ICD-10-CM Code Changes
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Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/25/2019 12/16/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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