Recently, John Muir Health agreed to pay $550,000 to resolve false claims allegations surrounding proper supervision of radiation therapy. The Department of Justice noted that such supervision is a condition of payment for Medicare. Specifically, the Federal government alleged that for a four (4) year period, physicians who were contracted with John Muir Health to delivery radiation therapy failed to adequately supervise the treatment. Failure to properly supervise clinical staff can result in large penalties for organizations; however, the actual requirements for supervision of radiation therapy can be complex.
The complexity relates to the fact that there are actually two (2) different benefit categories that relate to radiation oncology services. Those categories include (a) incident to services in an outpatient hospital setting; and (b) radiation therapy services in an office or free standing therapy center. There are different requirements for diagnostic tests, but that would be a separate service outside of radiation therapy.
Incident to Services in an Outpatient Hospital Setting
These types of services provided to patients are considered therapeutic services that are provided “incident to” a practitioners (Physician or Advanced Practice Provider) treatment of patients. A primary example of this would be actual radiation therapy services in the outpatient setting. Radiation therapy is incident to professional services whereas an MRI is directly covered as a diagnostic test.
Specifically, Medicare Part B pays for therapeutic hospital or CAH services and supplies furnished incident to a physician’s or nonphysician practitioner’s service, which are defined as all services and supplies furnished to hospital or CAH outpatients that are not diagnostic services and that aid the physician or nonphysician practitioner in the treatment of the patient, including drugs and biologicals that cannot be self-administered if they are furnished:
- by or under arrangements made by a hospital or critical access hospital;
- as an integral although incidental part of a physician’s or nonphysician practitioner’s services;
- in the hospital or critical access hospital or in a department of the hospital; and
- under the direct supervision of a physician or nonphysician practitioner;
- If in a hospital or in the outpatient department, both on and off campus, direct supervision means that the physician or nonphysician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure.
- Certain services can be assigned general supervision or personal supervision. General supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the nonphysician personnel who actually perform the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician. Personal supervision means a physician must be in attendance in the room during the performance of the procedure.
- Nonphysician practitioners can only provide supervision of services that they may personally furnish in accordance with State law.
- Finally, for certain extended duration services, the regulations state that direct supervision is required during the initiation of the service which ends when the patient is stable. At that point, general supervision can occur. The list of services that may be furnished under general supervision or that are defined as non-surgical extended duration therapeutic services is available on the OPPS Website.
So what does all of this mean? First, in order to bill for therapeutic services falling under this definition, the above requirements need to be met. Second, organizations need to be mindful of supervision. Direct supervision means that a practitioner CANNOT be doing something else that cannot be interrupted. An example would be surgery. In addition, the supervising practitioner must be “immediately available” which means they should be physically present within 10 or less minutes. It does not mean they are on-call at home. Finally, the services can only be provided under the order of the physician or nonphysician practitioner.
Radiation Therapy in the Office or Free Standing Therapy Center
This is one area in which many radiation services are provided to patients. These types of facilities are either called community based cancer centers or simply are physician group offices that offer these types of services. Although this is a major occurrence across the United States, the actual requirements for these services are different in the “office” setting as compared to the hospital setting.
Specifically, direct personal supervision is required. Direct personal supervision is slightly different than the supervision labeled above because it requires that the auxiliary personnel actually providing the service is an expense to the physician or legal entity billing for the services or supplies. In addition, the physician needs to be immediately available and in the building. If no physician is available, then the service cannot be billed. However, these are the only true distinctions.
What Can We Learn From This?
Most organizations continue to offer the same services and miss the changes in the regulations, laws, statutes, and guidance from the Federal government. Of course this creates a burden for organizations but this exact situation may have formed a basis into the investigation of John Muir Health. This is not isolated to this instance, Adventist Health System resolved False Claims Act allegations that in part were based upon radiation oncology supervision. Therefore, it is absolutely paramount that every organization analyzes the risks associated with billing for these services, especially the supervision requirements for auxiliary staff.