Coverage Indications, Limitations, and/or Medical Necessity
Background
A major limitation of external beam radiation therapy (EBRT) is a curative dose cannot be used because normal tissues cannot be completely protected from the radiation.
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). 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).
Stereotactic techniques are sometimes used with proton beam therapy.
Indications
Proton beam therapy is considered medically reasonable and necessary for the following conditions:
Group 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.
Intraocular melanomas.
Pituitary neoplasms.
Chordomas and chondrosarcomas.
Advanced staged and unresectable malignant lesions of the head and neck.
Malignant lesions of the paranasal sinuses.
Unresectable retroperitoneal sarcoma.
Pediatric CNS malignancies under 19 years of age.
Group 2
This section defines conditions that are still under investigation and may be covered when the patient is:
enrolled in an IRB-approved clinical trial which meets the ‘standards of scientific integrity and relevance to the Medicare population’ described in the CMS Internet Only Manual (IOM): Medicare National Coverage Determinations (NCD) Manual (Pub. 100-03), Chapter 1, Section 20.32 B.3.a-k;
or,
enrolled in a national or regional clinical registry compliant with the principles established in AHRQ’s ‘Registries for Evaluating Patient Outcomes: A User’s Guide’, such as the Registry for Prostate Cancer Radiosurgery (RPCR). Additionally, the claim must contain the Q0 (zero) modifier.
Whether in a clinical trial or in a national or regional registry, the information about the trial or registry must be included in the clinical record / progress notes.
Unresectable lung cancers and upper abdominal/peri-diaphragmatic cancers.
Advanced stage, unresectable pelvic tumors including those with peri-aortic nodes or malignant lesions of the cervix.
Unresectable breast tumors in proximity to the heart.
Unresectable pancreatic and adrenal tumors.
Skin cancer with macroscopic perineural/cranial nerve invasion of skull base.
Unresectable malignant lesions of the liver, biliary tract, anal canal and rectum
Prostate cancer, non-metastatic.
Limitations
For the treatment of primary lesions, the intent of treatment must be curative.
For the treatment of metastatic lesions, there must be the expectation of a long-term benefit (greater than 2 years of life expectancy).
Conditions not listed under the above Indications for Group 1 or Group 2 will remain noncovered.
CPT/HCPCS Codes
Group 1 Codes:
77520 Proton trmt simple w/o comp
77522 Proton trmt simple w/comp
77523 Proton trmt intermediate
77525 Proton treatment complex
ICD-10 CODE DESCRIPTION
C00.0 – C14.8 – Opens in a new window Malignant neoplasm of external upper lip – Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx
C30.0 – C32.9 – Opens in a new window Malignant neoplasm of nasal cavity – Malignant neoplasm of larynx, unspecified
C41.0 – C41.2 – Opens in a new window Malignant neoplasm of bones of skull and face – Malignant neoplasm of vertebral column
C44.00 – C44.49 – Opens in a new window Unspecified malignant neoplasm of skin of lip – Other specified malignant neoplasm of skin of scalp and neck
C45.1 Mesothelioma of peritoneum
C47.0 Malignant neoplasm of peripheral nerves of head, face and neck
C48.0 – C49.0 – Opens in a new window Malignant neoplasm of retroperitoneum – Malignant neoplasm of connective and soft tissue of head, face and neck
C69.00 – C72.9 – Opens in a new window Malignant neoplasm of unspecified conjunctiva – Malignant neoplasm of central nervous system, unspecified
C75.1 – C75.3 – Opens in a new window Malignant neoplasm of pituitary gland – Malignant neoplasm of pineal gland
C76.0 Malignant neoplasm of head, face and neck
C79.31 Secondary malignant neoplasm of brain
D16.4 – D16.5 – Opens in a new window Benign neoplasm of bones of skull and face – Benign neoplasm of lower jaw bone
D32.0 – D33.9 – Opens in a new window Benign neoplasm of cerebral meninges – Benign neoplasm of central nervous system, unspecified
D35.2 – D35.4 – Opens in a new window Benign neoplasm of pituitary gland – Benign neoplasm of pineal gland
D42.0 – D43.2 – Opens in a new window Neoplasm of uncertain behavior of cerebral meninges – Neoplasm of uncertain behavior of brain, unspecified
D43.4 Neoplasm of uncertain behavior of spinal cord
D44.3 – D44.5 – Opens in a new window Neoplasm of uncertain behavior of pituitary gland – Neoplasm of uncertain behavior of pineal gland
D49.6 – D49.7 – Opens in a new window Neoplasm of unspecified behavior of brain – Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system
G95.9 Disease of spinal cord, unspecified
Q28.2 – Q28.3 – Opens in a new window Arteriovenous malformation of cerebral vessels – Other malformations of cerebral vessels
Showing 1 to 20 of 20 entries in Group 1
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Group 2 Paragraph: Group 2
ICD-10 CODE DESCRIPTION
C19 – C25.9 – Opens in a new window Malignant neoplasm of rectosigmoid junction – Malignant neoplasm of pancreas, unspecified
C33 – C34.92 – Opens in a new window Malignant neoplasm of trachea – Malignant neoplasm of unspecified part of left bronchus or lung
C38.4 Malignant neoplasm of pleura
C39.0 – C39.9 – Opens in a new window Malignant neoplasm of upper respiratory tract, part unspecified – Malignant neoplasm of lower respiratory tract, part unspecified
C45.0 Mesothelioma of pleura
C50.011 – C58 – Opens in a new window Malignant neoplasm of nipple and areola, right female breast – Malignant neoplasm of placenta
C61 Malignant neoplasm of prostate
C64.1 – C64.9 – Opens in a new window Malignant neoplasm of right kidney, except renal pelvis – Malignant neoplasm of unspecified kidney, except renal pelvis
C74.00 – C75.0 – Opens in a new window Malignant neoplasm of cortex of unspecified adrenal gland – Malignant neoplasm of parathyroid gland
C75.4 – C75.9 – Opens in a new window Malignant neoplasm of carotid body – Malignant neoplasm of endocrine gland, unspecified
C76.3 Malignant neoplasm of pelvis
C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct
C79.32 Secondary malignant neoplasm of cerebral meninges
D44.10 – D44.12 – Opens in a new window Neoplasm of uncertain behavior of unspecified adrenal gland – Neoplasm of uncertain behavior of left adrenal gland
Showing 1 to 14 of 14 entries in Group 2
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