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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 say that medically necessary services are those that are reasonable and necessary for the diagnosis or treatment of an illness or injury. Medically necessary services include services to improve the functioning of a malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A).

PBT is considered reasonable in instances where sparing the surrounding normal tissue cannot be adequately achieved with photon-based radiotherapy and is of added clinical benefit to the patient. Examples of such an advantage might be:
1. The target volume is in close proximity to one or more critical structures and a steep dose gradient outside the target must be achieved to avoid exceeding the tolerance dose to the critical structure(s).
2. A decrease in the amount of dose inhomogeneity in a large treatment volume is required to avoid an excessive dose "hotspot" within the treated volume to lessen the risk of excessive early or late normal tissue toxicity.
3. A photon-based technique would increase the probability of clinically meaningful normal tissue toxicity by exceeding an integral dose-based metric associated with toxicity.
4. The same or an immediately adjacent area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.
PBT may offer dosimetric advantages as well as added complexity over conventional radiotherapy, 3D Conformal Radiation Therapy (3-D CRT) or Intensity Modulated Radiation Therapy (IMRT). Before applying PBT techniques, a comprehensive understanding of the benefits and consequences is required. In addition to satisfying at least one of the four selection criteria noted above, the radiation oncologist's decision to employ PBT requires an informed assessment of the benefits and risks including:
- Determination of patient suitability for PBT allowing for reproducible treatment delivery
- Adequate definition of the target volumes and OARs
- Equipment capability, including ability to account for organ motion when relevant
- Physician, physicist and staff training
- Adequate quality assurance procedures.
It is important to note that normal tissue dose volume histograms (DVHs) must be demonstrably improved with a PBT plan to validate coverage. Therefore, coverage decisions must extend beyond ICD-10 codes to incorporate additional considerations of clinical scenario and medical necessity with appropriate documentation. The final determination of the appropriateness and medical necessity for PBT resides with the treating radiation oncologist who should document the justification for PBT for each patient. Group 1 On the basis of the above medical necessity requirements and published clinical data, disease sites that frequently support the use of PBT include the following:
- Ocular tumors, including intraocular melanomas
- Tumors that approach or are located at the base of skull, including but not limited to:
o Chordoma
o Chondrosarcomas
o Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated
- Unresectable benign or malignant central nervous system tumors to include but not be limited to primary and variant forms of astrocytoma, glioblastoma, medulloblastoma, acoustic neuroma, craniopharyngioma, benign and atypical meningiomas, pineal gland tumors, and arteriovenous malformations
- Primary hepatocellular cancer treated in a hypofractionated regimen
- Primary or benign solid tumors in children treated with curative intent and occasional palliative treatment of childhood tumors when at least one of the four criteria noted above apply
- Patients with genetic syndromes making total volume of radiation minimization crucial such as but not limited to NF-1 patients and retinoblastoma patients
- Pituitary neoplasm
- Advanced staged (e.g., T4) and/or unresectable malignant lesions of the head and neck
- Malignant lesions of the paranasal sinus, and other accessory sinuses
- Unresectable retroperitoneal sarcoma.
PBT is one of the acceptable forms of external beam radiation therapy that may be used to administer Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Radiosurgery (SRS). When PBT is used to administer SBRT or SRS, the delivery and management codes relevant for SBRT or SRS apply, and the same clinical indications apply as for those treatment strategies. Group 2 Coverage of proton beam therapy in Group 2 is limited to providers who have demonstrated experience in data collection and analysis with a history of publication in the peer-reviewed medical literature.
- 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
- Breast cancers
- 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, without distant metastases
- Hodgkin or Non-Hodgkin Lymphoma involving the mediastinum or in non-mediastinal sites where PBT has the potential to reduce the risk of pneumonitis or late effects of radiation therapy (secondary malignancy, cardiovascular disease, or other chronic health conditions)
- Re-irradiation where prior radiation therapy to the site is the governing factor necessitating PBT in lieu of other radiotherapy.
Prostate Cancer 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);
b. Documentation and verification that the patient was informed of the range of therapy choices, including risks and benefits.
You can find this rule in the Local Coverage Determination (LCD): Proton Beam Therapy (L35075).
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.