On May 28, 2010, CMS clarified the physician supervision requirements for diagnostic and therapeutic services provided to hospital outpatients. Transmittal 128 provides further explanation regarding two elements of direct supervision that were inadequately addressed in the CY 2010 Outpatient Prospective Payment System (OPPS) Final Rule (OPPS Final Rule): (1) the concept of "immediately available," and (2) the credentials, knowledge, skills, ability and privileges that the supervisory practitioner must possess in order to be qualified to perform a given service or procedure. For more information on the OPPS Final Rule, please see the November 12, 2009, issue of the Health Law Update.
CMS defines "direct supervision" as requiring a physician to be: (1) "present on the premises of the location," and (2) "immediately available to furnish assistance and direction throughout the performance of the procedure." 42 C.F.R. § 410.27(f). In the OPPS Final Rule, CMS attempted to clarify the term "immediately available" but did not specifically define the word "immediate" in terms of time or distance. Rather, CMS noted that the general definition of the word means, much to the alarm of many commenters, "without interval of time." While Transmittal 128 does not use the term "without interval of time," it does not otherwise clarify the standard; CMS merely restates examples used in the OPPS Final Rule. CMS reiterates that "an example of a lack of immediate availability would be situations where the supervisory physician is performing another procedure or service that he or she could not interrupt" and "for services furnished on-campus, the supervisory physician may not be so physically far away on-campus from the location where hospital outpatient services are being furnished that he or she could not intervene right away."
Another controversial issue was the OPPS Final Rule "clarification" that furnishing assistance and direction throughout the performance of the procedure means "the physician or nonphysician must be prepared to step in and perform the service, not just respond to an emergency." (emphasis added). Thus, the supervisory physician or nonphysician practitioner "must have, within his or her State scope of practice and hospital-granted privileges, the ability to perform the service or procedure." We found this particularly problematic for highly specialized fields, such as chemotherapy and radiation oncology, where physicians rely on team-member technicians to perform dedicated functions. However, in response to comments to the OPPS Final Rule which argued that this standard was too stringent, CMS dismissed such concerns, stating that "[i]t would be unreasonable to think that a physician or nonphysician practitioner could competently assist and direct a procedure for which they do not have sufficient knowledge and skills to perform or redirect the procedure or service." Through Transmittal 128, it appears CMS now recognizes the reality that:
Specially trained ancillary staff and technicians are the primary operators of some specialized diagnostic testing equipment, and while in such cases CMS does not expect the supervisory physician to operate this equipment instead of a technician, the physician that supervises the provision of the diagnostic service must be knowledgeable about the test and clinically appropriate to furnish the test. (emphasis added).
Thus, while the supervisory physician must still have, within his or her state scope of practice and hospital-granted privileges, the knowledge, skills, ability and privileges to perform the service or procedure, the Transmittal sums up the standard as "the supervisory physician must be clinically appropriate to supervise the service or procedure."