ACR Analysis of Radiation Oncology Services, Supervision Rules and Regulations

In the hospital outpatient setting, covered radiation therapy services require the direct supervision of a physician or qualified non-physician practitioner. In the hospital outpatient setting, direct supervision means that the physician or non-physician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician or non-physician practitioner must be present in the room when the procedure is performed.

The Code of Federal Regulations (CFR) states that the physician must be available to furnish assistance and direction throughout the performance of the procedure and therefor the supervising physician or non-physician practitioners is required to have and maintain the ability to perform the service under supervision according to both hospital-based privileges and state scope of practice.

While CMS does not specify that radiation therapy services should be supervised by a radiation oncologist; it is the opinion of the ACR that a board-certified/board-eligible radiation oncologist is the clinically appropriate physician to supervise these procedures. This position is supported by guidance from the Conference of Radiation Control Program Directors (CRCPD) training requirements for therapeutic radiation machines, which closely mirrors the U.S. Nuclear Regulatory Commission’s regulations for teletherapy, sealed source therapy and HDR after loading brachytherapy. Further, ACR Radiation Oncology Practice Accreditation program requirements specify that “a radiation oncologist should be available for direct care and quality review and should be on the premises whenever radiation treatments are being delivered. The radiation oncologist, facility, and support staff should be available to initiate urgent treatment within a medically appropriate response time on a 24-hour basis or refer to a facility that is available to treat on a 24-hour basis. When unavailable, the radiation oncologist is responsible for arranging appropriate coverage.”

In the calendar year (CY) 2010 Hospital Outpatient Prospective Payment System (HOPPS) final rule, CMS stated that non-physician practitioners (NPP) may directly supervise all hospital outpatient therapeutic services they may perform themselves within their State scope of practice and hospital-granted privileges. Included among the list of applicable NPPs are physician assistants and nurse practitioners.

These regulations apply to services performed both on and off campus. More information on the supervision of therapeutic services in the hospital outpatient setting can be found here.

In the calendar year 2009 HOPPS final rule, CMS clarified previous guidance on hospital supervision requirements, stating that the aforementioned regulation did indeed apply to Critical Access Hospitals (CAH). The hospital community, in particular CAHs and small rural hospitals, expressed concerns that they would have difficulty meeting these requirements and in response, CMS instructed all Medicare Administrative Contractors (MAC) not to evaluate physician supervision requirements for outpatient therapeutic services CAHs and small rural hospitals.

This non-enforcement was extended by CMS through 2012 and 2013. In 2013 legislative actions taken by Congress mandated further non-enforcement in the CAH and rural hospital settings and this mandate has been continued yearly since.

In the CY 2018 HOPPS final rule, CMS has finalized a proposal to reinstate non-enforcement of direct supervision for outpatient therapeutic services for CAHs and small rural hospitals having 100 or fewer beds for CY 2018 and 2019. This two year period is designed to provide CAHs and small rural hospitals with time to comply with the supervision requirements for outpatient therapeutic services and to give all parties time to submit specific services to be evaluated by the Advisory Panel on Hospital Outpatient Payment for a recommended change in the supervision level.

Non-enforcement continues in the CAH and rural hospital setting; however for settings where supervision of outpatient therapeutic services is still enforceable, health systems and practitioners alike have faced numerous lawsuits under the False Claims Act. Issues commonly cited along with failure to properly supervise radiation therapy include failure to meet medical necessity, and overbilling and double billing issues. Please see the Department of Justice website for examples of litigation regarding supervision of outpatient therapeutic services.

Physician supervision of radiation therapy services in free standing therapy centers also require the direct supervision, but CMS notes in its guidance that this supervision must be performed by a physician excluding non-physician practitioners. While CMS does not further elaborate on the term physician, the Social Security Act defines a physician as a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the state in which he performs such function. As with the hospital outpatient setting, the physician need not be in the same room, but must be in the area and immediately available to provide assistance and direction throughout the time the procedure is being performed.

While CMS does not specify that radiation therapy services should be supervised by a radiation oncologist; it is the opinion of the ACR that a board-certified/board-eligible radiation oncologist is the clinically appropriate physician to supervise these procedures. This position is supported by guidance from the Conference of Radiation Control Program Directors (CRCPD) training requirements for therapeutic radiation machines, which closely mirrors the U.S. Nuclear Regulatory Commission’s regulations for teletherapy, sealed source therapy and HDR after loading brachytherapy. Further, ACR Radiation Oncology Practice Accreditation program requirements specify that “a radiation oncologist should be available for direct care and quality review and should be on the premises whenever radiation treatments are being delivered. The radiation oncologist, facility, and support staff should be available to initiate urgent treatment within a medically appropriate response time on a 24-hour basis or refer to a facility that is available to treat on a 24-hour basis. When unavailable, the radiation oncologist is responsible for arranging appropriate coverage.”

With very few exceptions, diagnostic X-ray and other diagnostic tests payable under the physician fee schedule must be furnished under at least a general level of physician supervision and some require direct or personal supervision. More information regarding the supervision of diagnostic tests can be found here.

As defined by the Social Security Act, “services… furnished as an incident to a physician’s professional service, of kinds which are commonly furnished in physicians’ offices and are commonly either rendered without charge or included in the physicians’ bills” are covered under Medicare. Among the services included under the “incident to” provision are therapeutic services provided to hospital outpatients. All “Incident To” services performed by auxiliary personnel must be done under the direct supervision of a physician as defined above.

In order to be covered under the “Incident to” provision, services must be all of the following:

1. An integral part of the patient’s treatment course
2. Commonly rendered without charge
3. Of a type commonly furnished in a physician’s office or clinic
4. Occur at the physician’s expense 

Additionally, because “Incident To” services must be performed in a non-institutional setting to non-institutional patients, hospitals, off campus sites owned by hospitals and provider-based facilities must limit these services to discrete and separately identifiable parts of the facility. The CY 2016 Medicare Physician Fee Schedule (MPFS) final rule contained additional clarifications regarding who may bill for “Incident To” services. For a detailed summary of those changes please see the ACR CY 2016 MPFS final rule detailed summary.