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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 CFR 422.101.
The rules say that 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
2. Intraocular melanomas
3. Pituitary neoplasms
4. Chordomas and chondrosarcomas
5. Advanced staged and unresectable malignant lesions of the head and neck
6. Malignant lesions of the Para nasal sinus, and other accessory sinuses
7. Unresectable retroperitoneal sarcoma
8. Solid tumors in children
In addition to the criteria in Group I, Proton Beam Therapy indications must demonstrate that:
o The Dose Volume Histogram (DVH) one or more critical structures or organs protected by the use of
Proton Beam Therapy;
o The dose to control or treat the tumor cannot be delivered without exceeding the tolerance of the normal
tissue;
o 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
a. the expectation of a long-term benefit (greater than 2 year of life expectancy) that could not have been
attained with conventional therapy, or
b. 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.
1. 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
2. Advanced stage, unresectable pelvic tumors including those with peri-aortic nodes or malignant lesions of
the cervix
3. Left breast tumors
4. Unresectable pancreatic and adrenal tumors
5. Skin cancer with macroscopic perineural/cranial nerve invasion of skull base
6. Unresectable Malignant lesions of the liver, biliary tract, anal canal and rectum
7. Prostate Cancer, Non-Metastatic.
You can find this rule in the Local Coverage Determination (LCD): Proton Beam Therapy (L36658) effective
September 26, 2019.
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.