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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.
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.
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 Centers for Medicare and Medicaid Services, 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.