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Consultation Corner

Consultation Corner: Direct Supervision Requirements in PBDs

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This month’s Consultation Corner topic pertains to “direct supervision” requirements in hospital-owned outpatient wound management provider-based departments (PBDs).


Although the PBD direct supervision requirements were included in the original Medicare Outpatient Prospective Payment System (OPPS) Final Rule that became effective in the year 2000, this consultant has conducted over 20 teleconsultations pertaining to this topic in the first 2 months of 2019. Following are some of the beliefs that PBDs shared with this consultant:

  • Our wound certified nurses know more about wound management than physicians. Therefore, the PBD is run by nurses. The PBD has a medical director who reviews our clinical practice guidelines, but does not actually see the patients. 
  • Our PBD is run by wound certified nurses who receive referrals from physicians throughout our community to evaluate and treat. 
  • Our PBD does not need physicians. Our wound certified nurses call the patients’ physicians and receive telephone orders. 
  • Our PBD direct supervision is provided by surgeons. Although they are in the hospital, surgeons are not immediately available when they are in the middle of an OR procedure. 
  • Our PBD direct supervision is provided by the emergency room physicians. Although physicians are in the hospital 24 hours a day, 365 days a year, they are not immediately available when they are taking care of emergencies. 
  • We were told that our PBD wound care nurses could apply negative pressure wound therapy (NPWT), durable medical equipment and disposable NPWT without direct supervision.

In many of the instances above, the PBDs were audited and incurred significant repayments to the Medicare program. Many others received requests for additional documentation, which they did not have because physicians did not assess the patients and/or did not write orders for the work before it was performed by the wound nurses. 

Facts to Consider

  • Medicare requires direct supervision of all hospital outpatient therapeutic services unless the Centers for Medicare & Medicaid Services (CMS) makes an assignment of either “general supervision” or “personal supervision” for a particular service/procedure. The 2000 OPPS Final Rule applies to all PBDs (e.g., the emergency department and the outpatient wound management PBD) that are paid by OPPS. The only exceptions to the direct supervision regulation are the critical access hospitals and small rural hospitals. 
  • Physicians and non-physician practitioners (NPPs)—e.g., physician assistants, nurse practitioners, and clinical nurse specialists—may directly supervise all hospital outpatient therapeutic services that they may perform themselves in accordance with their state law, scope of practice, and hospital-granted privileges.
  • The professional providing direct supervision is not required to be of the same specialty as the procedure/service being performed but must have, within his/her state scope of practice and hospital granted privileges, the ability to perform the service.
  • The 2009 and 2010 OPPS Final Rules restated and clarified the requirement for direct supervision. 
  • The 2011 OPPS Final Rule clarified “immediately available” as: “physically present, interruptible, and able to furnish assistance and direction throughout the performance of the procedure but without reference to any particular physical boundary.”  
    • The direct supervisor does not need to be in the room where the patient is having the service. 
    • The CMS did not define “immediate” by either time or distance but stated that PBDs must keep in mind the safety and quality of care of the patient. 
    • The CMS stated they do not consider availability by means of telecommunication to be an acceptable means of providing direct supervision.
    • In educational webinars, the CMS also stated that they doubt if physicians who are performing surgery or are working in the emergency department meet the “immediately available” requirements. 
  • The 2012 OPPS Final Rule restated the CMS position about not recognizing availability by phone or modes other than in-person as direct supervision: “We believe that the requirement for physical presence distinguishes direct supervision from general supervision because the regulations define general supervision as ‘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.’” 
  • In 2012, the CMS established a committee and an independent review process to review requests to move therapeutic services performed in PBDs from direct supervision to general supervision.  As of this date, the only wound management related services that have been moved to general supervision are: 
    • 29580 Application of paste boot
    • 29581 Application of multilayer compression to lower leg
    • 99406-99407 Smoking/tobacco cessation counseling

Another wound management related service, 97597 Debridement of devitalized tissue, was requested but denied twice: first in 2014 and again in 2015. 


  • This consultant began each teleconsultation by listening to the exact scenario(s) that caused the PBD to reach out for assistance. Many PBD directors said they called other PBD directors throughout the country (rather than research the OPPS Final Rules) and received a variety of responses (some correct and some incorrect), which caused them to be very confused. 
  • In every case, this consultant asked if the PBDs’ hospitals had emergency departments, and every one did. Then this consultant asked if the emergency department was required to have direct supervision 24 hours a day, 365 days a year, and every one did. Then this consultant reminded the teleconsultation participants that the emergency department and the outpatient wound management PBD were both paid by the same Medicare OPPS and were required to follow the same direct supervision regulations. At that point, the participants usually had “a-ha” moments. 
  • Then we usually took a few minutes to review the guidance provided by the OPPS Final Rules and discussed that the PBD should work with their medical director and administration to:
    • Identify the professionals who will directly supervise the PBD;
    • Write a policy and procedure about a) who is qualified to perform direct supervision of the PBD, b) scheduling and posting the schedule of the direct supervisors, c) the hospital’s acceptable definition of “immediately available,” and d) what to do on days when the scheduled direct supervisor is unable to work; and
    • Educate everyone who works in the PBD about the specific wound management related services that require direct supervision and those services that can be performed under general supervision. 
  • Finally, this consultant reminded the participants that the burden of proof is on the PBD to document that proper physician supervision is provided at every patient encounter that requires direct supervision. 


This consultant hopes all outpatient wound management PBDs and all physicians and other qualified health care professionals who work in PBDs will proactively examine their compliance with the direct supervision regulations of the OPPS. Do not wait until you are audited and face large repayments due to non-compliance. 

Kathleen D. Schaum oversees her own consulting business and is a founding member of the Today’s Wound Clinic editorial advisory board. She can be reached for consultation and questions at 

Consultation Corner
Kathleen D. Schaum, MS
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