Over the past few years we've been tracking the updates and clarifications to the physician supervision requirements for therapeutic services delivered in the hospital outpatient department. We've got a new round of updates for you courtesy of the recently released final payment rule from CMS. We'll provide a deeper analysis of the final payment changes for cancer services in a later blog post, but I wanted to get this out to you now.
Services not requiring direct supervision
In the final rule they have essentially affirmed what they wrote in the proposed rule, namely:
- Creation of a group of services, defined as "nonsurgical extended duration therapeutic services" which would only require direct suprevision at the start of the service, followed by general services for the remainder.
- Services included are those with a significant monitoring component that can extend for a lengthy period of time, that are not surgical and that have a low risk of complication after assessment at the beginning.
- General supervision means the procedure is furnished under a physician's overall direction and control, but the physcian's presence is not required during the performance of the procedure
- Chemotherapy and blood transfusions are explicitly excluded from the list of services - CMS speaks to this decision specifically stating, "these services would require the physician's or nonphysician practitioner's recurrent physical presence in order to evaluate a patient's condition in the event it is necessary to redirect the service." Notably, radiation therapy is also excluded, although they do not discuss why.
New definition of "immediately available"
There is one major change from the proposed rule and that is the definition of what it means to be "immediately available." Previously it was implied that supervising practitioner must be on the hospital campus, specifically stating, "the supervisory physician or nonphysician practitioner must be present on the same campus and immediately available to furnish assistance..." In the final rule, CMS is changing the language simply to require immediate availability but without reference to any physical boundary:
"For services furnished in the hospital or CAH or in an outpatient department of the hospital or CAH, 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. It does not mean that the physician or nonphysician practitioner must be present in the room when the procedure is performed."
Additional guidance on services within the physicianss "scope of practice"
Another key area of confusion for hospitals was which physicains were able to provide coverage - could an emergency room physician provide supervision for chemotherapy, or a medical oncologist for radiation therapy? CMS received numerous question on this issue and answers them directly. As a reminder, the original language says the supervisory practitioner, "must have, within his or her State scope of practice and hospital-granted privileges, the ability to perform the service or procedure." CMS responds to questions, specifically stating,"In order to furnish assistance and direction, we believe that a physician would have to be State licensed and possess hospital privileges to perform the procedure.... [but] in many circumstances, we believe that the supervising physician can furnish assistance and direction within their State scope of practice and hospital granted privileges without being the same specialty as the service being peformed."
More Than Step In During an Emergency
Initially, many had interpreted the rule to mean that the supervisory physician only had to be able to step in during an emergency - this is not the case, "we have been clear that we require the supervisory practitioner to be knowledgeable enough about the services to be able to furnish assistance and direction, and not merely manage an emergency... We do not believe it is sufficient or consistent with our rules for direct supervision for the individual on site to be capable of only emergency management. The supervisory practitioner or nonphysician practitioner who is physically present should have the training and knowledge to clinically redirect the service or provide additional orders."
Protocols Not Enough
CMS goes onto clarify another point of confusion - whether having standardized protocols in place for dealing with emergencies would be sufficient. This is not the case, and does not replce the need for a qualified supervising physician, "We are concerned with the number of comments we received suggesting that protocols, processes, and procedures may substitute for evaluation by a physician or nonphysician practitioner and orders for treatment."
Strict interpretation for radiation oncology
Radiation oncologists have been especially concerned by the recent clarifications; particularly those managing two radiation therapy sites. All too often one physician provides coverage for two sites - splitting their time between the two, while patients are treated throughout the day at both. CMS addresses radiation oncology specifically, reiterating what they stated earlier that having a non-specialist practitioner that could step in during an emergency, with access to a specialist by phone or tele-medicine link is not sufficient. They are implying a radiation oncologist, or trained NP, must be immediatley available. This could have major implications for many radiation therapy centers - particularly in rural areas.
The Rules Apply to Critical Access Hospitals
There's one last point I want to raise relating specifically to Critical Access Hospitals (CAH). Apparently CMS received numerous comments from CAHs and small rural hospitals indicating their belief that the supervision rules should not apply to them due to language within their conditions of participation. I won't go into detail on this issue, but the bottom line here is that CMS states that these rules do in fact apply. That said, the standard will not be enforced for CAHs and small rural hospitals with 100 beds or fewer through CY2011 to give them time to comply.