The Provider-Based Rule (PBR) is codified by the Centers for Medicare & Medicaid Services (CMS) at 42 CFR §413.65, along with the supervision regulations at 42 CFR §410.27. Guidance for the PBR has morphed since the rule was formally established through the April 7, 2000 Federal Register.

Guidance relative to the PBR continues to evolve, with the CMS regional offices (ROs) focusing on different issues. For instance, interpretations of the propriety of shared space and under-arrangement operations have occasionally become issues. Sometimes hospitals must establish policies without specific guidance, even at the subregulatory level.

Thus, maintaining compliance with the PBR and associated requirements is difficult because hospitals are dealing with a moving target.

Consider two somewhat interrelated questions that have recently been posed:

  1. Can nursing staff provide injections at a provider-based clinic without a physician being present?
  2. Can CMAs (certified medical assistants) provide injections in a provider-based clinic?

Both of these questions can and should be generalized. Developing answers and then establishing policies and implementing procedures becomes a compliance challenge because of possibly differing interpretations.

The first question really involves the matter of whether qualified healthcare professionals can provide services such as injections in a provider-based clinic without direct physician supervision. What appeared to be a direct statement on the matter showed up in the April 7, 2000 Federal Register, which featured the requirement that direct physician supervision was necessary only for off-campus, provider-based clinics. 

Starting in about 2009, CMS began clarifying guidance relative to direct physician supervision, and today, virtually all outpatient therapeutic services require it. However, in this process CMS also developed a mechanism for identifying services that required only general supervision – or, in theory, services that may require personal supervision.

This listing of services that require only general supervision (e.g., a physician or qualified practitioner is contactable) can be found at the CMS Outpatient Prospective Payment System (OPPS) website. Within this listing is injections (i.e., CPT 96372), so it appears that qualified healthcare personnel can provide injections in a provider-based clinic without direct physician supervision. Because CMS has generalized the physician supervision requirements, this mandate extends to all hospital outpatient therapeutic services, including those provided in a provider-based clinic. Provider-based clinics are truly a part of the hospital, as required in the PBR.

Note that this same situation is not present in freestanding clinics. When a supervising physician directs subordinate personnel to perform a service such as an injection, the physician must provide direct supervision (i.e., physically be in the office suites). Thus, in a freestanding clinic the physician must be present in order to perform incident-to billing; that is, the physician bills as if the physician performed the service. For hospitals that have both freestanding clinics and provider-based clinics, care must be taken to maintain proper compliance, depending upon the classification of the clinic.

The second question can be generalized to outline how providers who are not physicians or not qualified non-physician practitioners become qualified to provide services. In order to analyze this situation, care must be taken to compare and contrast freestanding clinics with provider-based clinics.

For freestanding clinics, basically, the supervising physician determines who is qualified to perform a given service. The physician takes medical/legal liability for the provision of the service. Obviously, physicians should consider personal competencies along with any state-level scope-of-practice limitations.

For provider-based clinics, it’s another story. We are now in a hospital setting. The determination of who is qualified (that is, using CPT terminology) and who is a qualified healthcare professional eligible to provide services becomes a process. This is particularly true if the qualified staff goes beyond nursing staff to other designations such as certified medical assistants (CMAs). Among the considerations are:

  • Personal competence, training, education, certifications;
  • State scope-of-practice (SOP) regulations;
  • Conditions of participation (CoPs);
  • Hospital policies; and
  • Medical staff organization (MSO).

For hospitals, there is no simple answer to this question. This issue can arise when a freestanding clinic, in which CMAs are utilized to provide services such as injections, are converted to provider-based clinics. Hospitals will have to carefully analyze the situation and make certain that everything is in order relative to this list of considerations if the CMAs are to be qualified. Note that state SOPs will vary. Also, the medical staff may or may not be inclined to approve non-nursing personnel to provide such services.

The bottom line is this: analyze carefully and be watchful for any subregulatory guidance or differing interpretations from the CMS Medicare Administrative Contractors (MACs) or regional offices. Be certain to carefully craft written policies and procedures delineating and justifying whatever decisions are made.

About the Author

Duane C. Abbey, Ph.D., CFP, is an educator, author and management consultant working in the healthcare field. He is president of Abbey & Abbey Consultants, Inc., which specializes in healthcare consulting and related areas. His firm is based in Ames, Iowa. Dr. Abbey earned his graduate degrees at the University of Notre Dame and Iowa State University.

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