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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 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that 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, intensity-modulated radiation 
therapy (IMRT), or brachytherapy in terms of safety or efficacy. 
 
The prostate cancer should be locally contained and not be an advanced prostate cancer and not any N disease. 
 
Coverage and payments of Proton Beam Therapy for prostate cancer will require: 
a. Physician documentation of patient selection criteria (stage and other factors as represented in the NCCN 
guidelines); and 
b. 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 computed tomography (CT) or magnetic resonance imaging (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 
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 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. 
 
You can find this information in the Local Coverage Determination (LCD): Proton Beam Therapy (L36658). 
 
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.