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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).
The rules say that TREATMENT
PBT Treatment Planning
PBT can allow for radiation treatment plans that are highly conformal to the target volume. PBT planning
defines the necessary field sizes, gantry angles and beam energies needed to achieve the desired radiation dose
distribution.
An assessment of patient suitability for PBT is an important step in the process of care. Changes in the density
and composition of tissues in the path of the beam have much greater impact on the delivered dose for protons
than photons. Tissue interfaces, especially those with large differences in electron density, can lead to larger or
unacceptable dosimetric uncertainties in PBT for certain patients.
PBT treatment planning is a multi-step process and shares functions common to other forms of external beam
radiotherapy planning:
1.Simulation and Imaging: Three-dimensional image acquisition of the target region by simulation
employing CT, CT/ PET and/or MR scanning equipment is an essential prerequisite to PBT treatment planning.
If respiratory or other normal organ motion is expected to produce significant movement of the target region
during radiotherapy delivery, the radiation oncologist may additionally elect to order multi-phasic treatment
planning image sets to account for motion when rendering target volumes.
2. Contouring: Defining the target and avoidance structures is a multi-step process:
a. The radiation oncologist reviews the three-dimensional images and outlines the treatment target on each
slice of the image set. The summation of these contours defines the Gross Tumor Volume (GTV).
b. The radiation oncologist draws a margin around the GTV to generate a Clinical Target Volume (CTV)
which encompasses the areas at risk for microscopic disease (i.e., not visible on imaging studies).
c. A final margin is then added to create a Planning Target Volume (PTV).
d. Nearby normal structures that could potentially be harmed by radiation (i.e., "organs at risk'; or OARs)
are also contoured.
e. Radiation Dose Prescribing: The radiation oncologist assigns specific dose coverage requirements for
the CTV which will be met even in the presence of expected positional and range uncertainties. A typical
prescription may define a dose that will be delivered to at least 99% of the CTV. Additionally, PBT
prescription requirements routinely include dose constraints for the OARs (e.g., upper limit of mean dose,
maximum allowable point dose, and/or a critical volume of the OAR that must not receive a dose above a
specified limit).
f. Dosimetric Planning and Calculations: The qualified medical physicist or a supervised dosimetrist
calculates a treatment plan to deliver the prescribed radiation dose to the CTV and simultaneously satisfy the
normal tissue dose constraints by delivering significantly lower doses to nearby organs. Delivery mechanisms
vary, but regardless of the delivery technique, all delivery parameters and/or field specific hardware are
developed by a medical physicist or supervised dosimetrist and an expected dose distribution is calculated for
the treatment plan.
g. Patient Specific Dose Verification: An independent dose calculation and/or measurement should
confirm that the intended dose distribution for the patient is physically verifiable and feasible.
Documentation of all aspects of the treatment planning process is essential.
PBT Treatment Delivery
Proton delivery methods can be described in one of two forms: scattering or scanning.
1. In scattered deliveries, the beam is broadened by scattering devices, beam energies are combined by
mechanical absorbers and the beam is shaped by placing material such as collimators and compensators into
the proton path.
2. In scanning deliveries, the beam is swept laterally over the target with magnets instead of with
scattering devices. Collimators and range compensators are still sometimes used for lateral and distal beam
shaping, but field specific hardware is not always required because the scanning magnets allow the lateral
extent of the beam to be varied with each energy level, a technique sometimes called intensity-modulated
proton therapy (IMPT).
The basic requirement for all forms of PBT treatment delivery is that the technology must accurately
produce the calculated dose distribution described by the PBT plan. PBT dose distributions are sensitive to
changes in target depth and shape and thus, changes in patient anatomy during treatment may require repeat
planning. Such a change must be documented.
Precise delivery is vital for proper treatment. Therefore, imaging techniques such as stereoscopic X-ray or
CT scan (collectively referred to as Image Guided Radiation Therapy or IGRT) should be utilized to verify
accurate and consistent patient and target setup for every treatment fraction.
Indications For Coverage
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:
Chordoma
Chondrosarcomas
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 information in Medicare's 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.