PROTON BEAM THERAPY
HS-140
Easy Choice Health Plan, Inc.
Harmony Health Plan of Illinois, Inc.
Missouri Care, Inc.
‘Ohana Health Plan, a plan offered by
WellCare Health Insurance of Arizona, Inc.
WellCare Health Insurance of Illinois, Inc.
WellCare Health Plans of New Jersey, Inc.
WellCare Health Insurance of Arizona, Inc.
WellCare of Florida, Inc.
WellCare of Connecticut, Inc.
WellCare of Georgia, Inc.
WellCare of Kentucky, Inc.
WellCare of Louisiana, Inc.
WellCare of New York, Inc.
WellCare of South Carolina, Inc.
Proton Beam Therapy
Policy Number: HS-140
WellCare of Texas, Inc.
WellCare Prescription Insurance, Inc.
Windsor Health Plan
Windsor Rx Medicare Prescription Drug Plan
Original Effective Date: 11/5/2009
Revised Date(s): 8/12/2011; 4/5/2012;
4/11/2013; 2/6/2014; 2/5/2015
APPLICATION STATEMENT
The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS)
National and Local Coverage Determinations and state-specific Medicaid mandates, if any.
PROTON BEAM THERAPY
HS-140
DISCLAIMER
The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of
Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions
related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes
the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans
and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the
benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid
mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.
BACKGROUND
External beam radiation is used to reduce recurrence of a tumor after surgical excision or as a primary treatment for
an inoperable mass. The ability of radiation therapy to eradicate a tumor largely depends on the dose delivered to
the cancer; the necessity of delivering high radiation doses to improve local control rates has been demonstrated
for a variety of tumor types. However, high-energy photon beams from x-rays or gamma rays used for conventional
radiotherapy are characterized by a near-exponential decay of dose with depth. This property results in delivery of
a significant dose to structures in the exit region of individual beams, and structures in the entrance region receive
an equal or greater dose than the target volume. The collateral dose to normal tissues can cause serious,
debilitating, or even fatal side effects. In addition, the radiation dose to the proximal region of the target volume is
greater than in the distal region, resulting in non-homogeneous treatment, particularly for larger lesions.
In contrast, proton beam radiation therapy (PBT) deposits the energy of the proton beam at the end of its path; this
region of maximum energy release is known as the Bragg peak. Since the depth of penetration of the proton beam
can be controlled, the radiation can be targeted almost exclusively to the tumor volume, with minimal exposure of
surrounding tissue. Thus, the improved dose distribution possible with PBT has the potential to permit the delivery
of higher tumor doses while delivering less radiation to sensitive normal tissues. The relative biologic effect (RBE)
of protons is similar to that of x-rays and cobalt gamma rays, and is considered appropriate for treatment of human
tissues and tumors.
The proton beam facility involves a synchrotron, a beam transport system, a beam delivery system, isocentric
gantries, and a patient alignment and imaging system, all under the operation of a facility control system. The
synchrotron is a particle accelerator, which increases the velocity of the protons to a level sufficient to position the
Bragg peak into the cancerous tissue. It is composed of a large ring of magnets that operate in a vacuum. Protons
are generated by an ion source and then accelerated up to approximately 2 million electron volts (MeV) in a
radiofrequency quadripole. The beam then enters the synchrotron where, as the protons complete each trip around
the synchrotron, the proton’s energy is increased by the addition of radiofrequency energy. The magnetic field of
the synchrotron is likewise increased to maintain the protons in a constant radial orbit. Energy levels when the
beam leaves the synchrotron and enters the transport system are between 70 and 250 MeV. The beam transport
system consists of additional magnets that focus and direct the beam from the synchrotron to the delivery system.
The beam delivery system is mounted on very large steel gantries capable of rotating 360° around the patient, thus
providing great flexibility in exact delivery of the proton beam. Because it is essential that the patient’s position not
change during the procedure, the patient is immobilized in a polyvinyl mold. Computed tomography (CT) scans,
magnetic resonance imaging (MRI), and positron emission tomography (PET), along with conventional x-rays, can
be utilized to visualize the tumor, and a computer generated, three-dimensional (3D) model of the cancerous tissue
is constructed. This model, the digitally reconstructed radiograph (DRR), is used to decide the plan of treatment.
POSITION STATEMENT
Applicable To:
Medicaid – Hawaii
Medicare –Hawaii
Medicare – Arizona
Clinical Coverage Guideline
Original Effective Date: 11/5/2009 - Revised: 8/12/2011, 4/5/2012, 4/11/2013, 2/6/2014
page 2
PROTON BEAM THERAPY
HS-140
Proton beam therapy is considered medically necessary for the following conditions:
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Melanoma of the uveal tract (iris, choroid, or ciliary body) not amenable to surgical excision or other forms
of conventional treatment; involving tumors of up to 24 mm in diameter and 14 mm in height with no
evidence of metastasis or extrascleral extension; OR,
Intracranial arteriovenous malformations not amenable to surgical excision; OR,
Chordromas OR
Chondrosarcomas at the base of the skull or along the axial skeleton; OR,
Pituitary neoplasms; OR,
Central nervous system tumors located near vital structures not suitable for intensity-modulated radiation
therapy
Proton beam therapy for certain other conditions not listed above is considered medically necessary IF the
following criteria are met:
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When dose constraints to normal tissues limit the total dose of radiation safely deliverable to the tumor with
other indicated methods; OR,
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; OR,
In circumstances when the higher levels of precision associated with proton beam therapy as compared to
other radiation methods are necessary
AND,


For the treatment of primary lesions, the intent of treatment must be curative; OR,
For the treatment of metastatic lesions there must be:
o Expectation of a long-term benefit (> 2 years) that cannot be attained with conventional therapy; AND,
o 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
therapy over other forms of radiation therapy
AND,

The member’s record demonstrates why proton beam therapy is considered the treatment of choice for the
individual. 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 the reduced normal tissue toxicity and/or improved tumor control must be
maintained.
Proton beam therapy is considered medically necessary for the following conditions if the above criteria are met:
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

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Malignant lesions of the Para nasal sinus and other accessory sinuses; OR,
Malignant lesions of the prostate; OR,
Malignant advanced stage, non-metastatic tumors of the bladder; OR,
Advanced pelvic tumors including
Malignant lesions of the cervix; OR,
Left breast tumors; OR,
Pancreatic and adrenal tumors; OR,
Skin cancer with perineural/cranial nerve invasion; OR,
Unresectable retroperitoneal sarcoma and
Extremity sarcoma; OR,
Clinical Coverage Guideline
Original Effective Date: 11/5/2009 - Revised: 8/12/2011, 4/5/2012, 4/11/2013, 2/6/2014
page 3
PROTON BEAM THERAPY
HS-140
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Cancers of the lung and upper abdominal/peri-diaphragmatic cancers; OR,
Malignant lesions of the liver, biliary tract;
Anal canal, and
Rectum
Proton beam therapy is considered experimental and investigational for the following conditions:
 362.50 - 362.52
Age-related macular degeneration; OR,
 228.09
Choroidal hemangioma; OR,
 150.0 - 150.9
Esophageal cancer; OR,
 160.1, 160.8, 238.8, 212.0 Tumors of the vestibular system; OR,
 All other indications not listed above in the medically necessary sections
CODING
CPT ®* Codes
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-9-CM Procedure Codes
92.24 Teleradiotherapy using photons
HCPCS Codes
S8030 Scleral application of tantalum ring(s) for localization of lesions for proton beam therapy
Non-Covered ICD-9-CM Diagnosis Codes
150.0 - 150.9 Malignant neoplasm of esophagus
160.1
Malignant neoplasm of auditory tube, middle ear and mastoid air cells
212.0
Benign neoplasm of nasal cavities, middle ear and accessory sinuses
228.09
Hemangioma, of other sites
238.8
Neoplasms of uncertain behavior, other specified sites
362.50
Macular degeneration (senile), unspecified
362.51
Nonexudative senile macular degeneration
362.52
Exudative senile macular degeneration
Covered ICD-9-CM Diagnosis Codes
List may not be all inclusive. Proton beam therapy is considered medically necessary for the following conditions if the above criteria are met:
154.1
Malignant neoplasm of rectum
154.2
Malignant neoplasm of anal canal
154.3
Malignant of anus, unspecified
155.0 - 155.2 Malignant neoplasm of liver and intrahepatic bile ducts
156.0 - 156.9 Malignant neoplasm of the gallbladder and extrahepatic bile ducts
157.0 - 157.9 Malignant neoplasm of the pancreas
158.0
Malignant neoplasm of retroperitoneum
160.2
Malignant neoplasm of maxillary sinus
160.3
Malignant neoplasm of ethmoidal sinus
160.4
Malignant neoplasm of frontal sinus
160.5
Malignant neoplasm of sphenoidal sinus
160.9
Malignant neoplasm of accessory sinuses, unspecified
162.0 - 162.9 Malignant neoplasm of trachea, bronchus and lung
170.0
Malignant neoplasm of bones of skull and face, except mandible
170.2
Malignant neoplasm of vertebral column, excluding sacrum and coccyx
170.3
Malignant neoplasm of ribs, sternum and clavicle
174.0 - 175.9 Malignant neoplasm of the breast (limited to left breast tumors as per above criteria)
180.0 - 180.8 Malignant neoplasm of cervix uteri
185
Malignant neoplasm of prostate
188.0 - 188.8 Malignant neoplasm of bladder
189.0 - 189.9 Malignant neoplasm of kidney and other and unspecified urinary organs
190.0
Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid
190.6
Malignant neoplasm of choroid
191.0 - 191.9 Malignant neoplasm of brain
Clinical Coverage Guideline
Original Effective Date: 11/5/2009 - Revised: 8/12/2011, 4/5/2012, 4/11/2013, 2/6/2014
page 4
PROTON BEAM THERAPY
HS-140
192.0 - 192.9
194.0
194.3
195.0
195.2
195.2
195.3
195.4
195.5
196.0 - 196.9
197.0
197.1
197.2
197.3
197.6
197.7
198.0 - 198.7
198.81
213.0
213.2
213.3
225.0 - 225.9
227.0
227.3
747.81
Malignant neoplasm of other and unspecified parts of the nervous system
Malignant neoplasm of adrenal gland
Malignant neoplasm of pituitary gland and craniopharyngeal duct
Malignant neoplasm of head, face, and neck
Malignant neoplasm of thorax
Malignant neoplasm of abdomen
Malignant neoplasm of pelvis
Malignant neoplasm of upper limb
Malignant neoplasm of lower limb
Secondary and unspecified malignant neoplasm of lymph nodes
Secondary malignant neoplasm of lung
Secondary malignant neoplasm of mediastinum
Secondary malignant neoplasm of pleura
Secondary malignant neoplasm of other respiratory organs
Secondary malignant neoplasm of retroperitoneum
Secondary malignant neoplasm of liver, specified as secondary
Secondary malignant neoplasm of other specified sites
Secondary malignant neoplasm of breast (limited to left breast tumors as per above criteria)
Benign neoplasm of bones of skull and face
Benign neoplasm of vertebral column, excluding sacrum and coccyx
Benign neoplasm of ribs, sternum and clavicle
Benign neoplasm of brain and other parts of nervous system
Benign neoplasm of adrenal gland
Benign neoplasm of pituitary gland and craniopharyngeal duct (pouch)
Anomalies of cerebrovascular system, congenital
Covered ICD-10-CM Diagnosis Codes
List may not be all inclusive.Proton beam therapy is considered medically necessary for the following conditions if the above criteria are met:
C20
Malignant neoplasm of rectum
C21.0 - C21.8 Malignant neoplasm of anus and anal canal
C22.0 - C22.9 Malignant neoplasm of liver and intrahepatic bile ducts
C23
Malignant neoplasm of gallbladder
C24.0 - C24.9 Malignant neoplasm of other and unspecified parts of biliary tract
C25.0 - C25.9 Malignant neoplasm of pancreas
C31.0 - C31.9 Malignant neoplasm of accessory sinuses
C33
Malignant neoplasm of trachea
C34.00 - C34.92 Malignant neoplasm of bronchus and lung
C41.0
Malignant neoplasm of bones of skull and face
C41.2
Malignant neoplasm of vertebral column
C41.3
Malignant neoplasm of ribs, sternum and clavicle
C48.0
Malignant neoplasm of retroperitoneum
C50.012
Malignant neoplasm of nipple and areola left female breast
C50.022
Malignant neoplasm of nipple and areola left male breast
C50.112
Malignant neoplasm of central portion of left female breast
C50.122
Malignant neoplasm of central portion of left male breast
C50.212
Malignant neoplasm of upper-inner quadrant of left female breast
C50.222
Malignant neoplasm of upper-inner quadrant of left male breast
C50.312
Malignant neoplasm of lower-inner quadrant of left female breast
C50.322
Malignant neoplasm of lower-inner quadrant of left male breast
C50.412
Malignant neoplasm of upper-outer quadrant of left female breast
C50.422
Malignant neoplasm of upper-outer quadrant of left male breast
C50.512
Malignant neoplasm of lower-outer quadrant of left female breast
C50.522
Malignant neoplasm of lower-outer quadrant of left male breast
C50.612
Malignant neoplasm of axillary tail of left female breast
C50.622
Malignant neoplasm of axillary tail of left male breast
C50.812
Malignant neoplasm of overlapping sites of left female breast
C50.822
Malignant neoplasm of overlapping sites of left male breast
C53.0 - C53.9 Malignant neoplasm of cervix uteri
C61
Malignant neoplasm of prostate
C64.1 - C68.9 Malignant neoplasm of urinary tract
C69.30 - C69.32 Malignant neoplasm of choroid
C69.40 - C69.42 Malignant neoplasm of ciliary body
C71.5
Malignant neoplasm of cerebral ventricle
C71.7
Malignant neoplasm of brain stem; i.e. fourth cerebral ventricle
C72.50 - C72.59 Malignant neoplasm of other and unspecified cranial nerve
Clinical Coverage Guideline
Original Effective Date: 11/5/2009 - Revised: 8/12/2011, 4/5/2012, 4/11/2013, 2/6/2014
page 5
PROTON BEAM THERAPY
HS-140
C74.00
C75.1
C76.0
C76.1
C76.2
C76.3
C76.40
C76.50
C77.0
C78.00
C78.1
C78.2
C78.30
C78.6
C78.7
C79.81
D16.00
D33.0
D35.00
D35.2
Q28.2
Q28.3
- C74.92 Malignant neoplasm of adrenal gland
Malignant neoplasm of pituitary gland
Malignant neoplasm of head, face and neck
Malignant neoplasm of thorax
Malignant neoplasm of abdomen
Malignant neoplasm of pelvis
- C76.42 Malignant neoplasm of upper limb
- C76.52 Malignant neoplasm of lower limb
- C77.9 Secondary & unspecified malignant neoplasm of lymph nodes
- C78.02 Secondary malignant neoplasm of lung
Secondary malignant neoplasm of mediastinum
Secondary malignant neoplasm of pleura
- C78.39 Secondary malignant neoplasm of other and unspecified respiratory organs
Secondary malignant neoplasm of retroperitoneum and peritoneum
Secondary malignant neoplasm of liver and intrahepatic bile duct
Secondary malignant neoplasm of breast
- D16.9 Benign neoplasm of bone and articular cartilage
- D33.9 Benign neoplasm of brain and other parts of central nervous system
- D35.02 Benign neoplasm of adrenal gland
Benign neoplasm of pituitary gland
Arteriovenous malformation of cerebral vessels
Other malformations of cerebral vessels
Non-Covered ICD-10-CM Diagnosis Codes
C153.3 - C15.9
Malignant neoplasm of esophagus
C30.1
Malignant neoplasm of middle ear
D14.0
Benign neoplasm of middle ear, nasal cavity and accessory sinuses
D18.00 - D18.09 Hemangioma
D48.7
Neoplasm of uncertain behavior of other specified sites
H35.30
Unspecified macular degeneration
H35.31
Nonexudative age-related macular degeneration
H35.32
Exudative age-related macular degeneration
*Current Procedural Terminology (CPT) 2015 American Medical Association: Chicago, IL.®©
REFERENCES
1.
2.
3.
4.
5.
6.
American Academy of Orthopedic Surgeons (AAOS). Chordoma. October 2007. Available at:
http://orthoinfo.aaos.org/topic.cfm?topic=A00084
American Urological Association (AUA). Prostate cancer. Guidelines for the management of clinically localized prostate cancer: 2007
Update.
Centers for Medicare and Medicaid Services. Local Coverage Determination for Proton Beam Radiotherapy (L29263). First Coast Services
Options. February 2, 2009.
Hayes Directory. (2013, March 25). Proton beam therapy for prostate cancer. Retrieved from http://www.hayesinc.com
Wilt, T.J., Shamliyan, T., Taylor, B., & et al. (2008). Comparative effectiveness of therapies for clinically localized prostate cancer. Agency
for Healthcare Research and Quality, Review No. 13.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Available at:
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp?button=I+Agree#site
MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS
Date
Action
2/5/2015
2/6/2014


4/11/2013
4/5/2012
12/1/2011
8/12/2011




Approved by MPC. No changes.
Approved by MPC. Coverage change – applicable to Hawaii , and to Arizona and Missouri markets until
3/31/2014.
Approved by MPC. No changes.
Approved by MPC. No changes.
New template design approved by MPC.
Approved by MPC. No changes.
Clinical Coverage Guideline
Original Effective Date: 11/5/2009 - Revised: 8/12/2011, 4/5/2012, 4/11/2013, 2/6/2014
page 6