Direct Supervision in the Provider-Based Department: What’s Required?

Seventeen years ago, the Centers for Medicare & Medicaid Services (CMS) implemented the Outpatient Prospective Payment System (OPPS) for hospital-based outpatient departments (HOPDs) such as the emergency department (ED) and the HOPD wound/ostomy care department. In the OPPS Final Rule for the year 2000, CMS stated that direct supervision is required at all times when patients are receiving care in the ED or the HOPD. As a whole, EDs throughout the United States adapted to this direct supervision regulation very quickly – they all have direct supervision 24/7. Unfortunately, some HOPDs to this day still do not have direct supervision at all times when patients receive wound and ostomy care! At the most recent Symposium on Advanced Wound Care (SAWC) conference in San Diego, CA, the topic of direct supervision was frequently discussed, especially because the U.S. government has tightened its oversight and investigation of false claims. Therefore, the editorial board of Today’s Wound Clinic requested that this edition of Business Briefs cover the various questions that those in the wound care industry tend to have pertaining to direct supervision and the HOPD. All readers should carefully study the questions and answers that follow and make adjustments to direct supervision and staffing in their clinics, if needed. NOTE: Medicare is now defining HOPDs as “provider-based departments” (PBDs). Therefore, moving forward we will use this terminology in Business Briefs as opposed to “HOPD.”

Frequently Asked Questions (And Answers) for the PBD 

Q: Our certified wound, ostomy, and continence nurses (CWOCNs) are very knowledgeable and highly skilled. They see and bill for wound and/or ostomy patients in our nurse-directed PBD. The CWOCNs do not need physicians or qualified healthcare professionals (QHPs) to tell them how to manage wounds and ostomies. While discussing our PBD model with our peers at SAWC, we were told that we may have to repay Medicare, and possibly other payers, for all of our PBD encounters because we did not have direct supervision. Is this true?  

A:  Yes, this is definitely true for Medicare. Direct supervision is the minimum standard for supervision of all Medicare hospital outpatient therapeutic services, unless CMS makes an assignment of either “general supervision” or “personal supervision” for an individual service.   

Q: Is it true that when working in PBDs, a physician order must be written before CWOCNs make any wound care product, service, or procedure change?

A: Yes, hospital outpatient therapeutic services and supplies must be furnished under the order of a physician or other practitioner practicing within the extent of the Social Security Act, the Code of Federal Regulations (CFR), and state law. Therapeutic services and supplies must be furnished by hospital personnel under the appropriate supervision of a physician or non-physician practitioner as required in the Medicare Benefit Policy Manual and by 42 CFR 410.27 and 482.12. This does not mean that each occasion of service by a non-physician needs to also be the occasion of the actual rendition of a personal professional service by the physician responsible for the care of the patient. However, during any course of treatment rendered by auxiliary personnel, the physician must personally see the patient periodically and sufficiently often to assess the course of treatment, the patient’s progress, and, when necessary, to change the treatment regimen. A hospital service or supply would not be considered incident to a physician’s service if the attending physician merely wrote an order for the services or supplies and referred the patient to the hospital without being involved in the management of that course of treatment. 

Q: What exactly does CMS mean by “therapeutic services”?

A:  Therapeutic services and supplies that hospitals provide on an outpatient basis are those services and supplies (including the use of hospital facilities and drugs and biologicals that cannot be self-administered) that are not diagnostic services, are furnished to outpatients incident to the services of physicians and practitioners, and that aid in the treatment of patients. These services include clinic services, ED services, and observation services. The services and supplies must be furnished as an integral (although incidental) part of the physician or non-physician practitioner’s professional service in the course of treatment of an illness or injury

Q:  What exactly does CMS mean by “direct supervision”?

A: 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. The physician is not required to be present in the room where the procedure is performed or within any other physical boundary as long as he or she is immediately available. 

Q: Who may provide direct supervision in the PBD?

A: Physicians, clinical psychologists, licensed clinical social workers, physician assistants, nurse practitioners (NPs), clinical nurse specialists, and certified nurse midwives may furnish the required supervision of hospital outpatient therapeutic services that they may personally furnish in accordance with state law and all additional rules governing the provision of their services, including those specified at 42 CFR Part 410. These non-physician practitioners are specified at 42 CFR 410.27(g). Considering that hospitals furnish a wide array of complex outpatient services and procedures, including surgical procedures, CMS expects hospitals to have the credentialing procedures, bylaws, and other policies in place to ensure that outpatient services furnished to Medicare beneficiaries are being provided only by qualified practitioners in accordance with all applicable laws and regulations. For services not furnished directly by a physician or non-physician practitioner, CMS expects that these hospital bylaws and policies ensure that the therapeutic services are being supervised in a manner commensurate with their complexity, including personal supervision where appropriate.

Q: What does CMS mean by “immediately available”?

A: Immediate availability requires the immediate physical presence of the supervisory physician or non-physician practitioner. CMS has not specifically defined the word “immediate” in terms of time or distance; however, an example of a lack of immediate availability would be situations in which the supervisory physician or non-physician practitioner is performing another procedure or service that he or she cannot interrupt. Also, for services furnished on campus, the supervisory physician or non-physician practitioner may not be so physically distant on campus from the location where hospital/critical access hospital (CAH) outpatient services are being furnished that he or she cannot intervene immediately. The hospital should have: 1) a written policy and procedure that includes the definition of “immediately available” and 2) a posted schedule of the supervisory physician or non-physician for each day and hour that the PBD is caring for patients. A supervisory practitioner may furnish direct supervision from a physician office or other non-hospital space that is not officially part of the hospital or CAH campus where the services are being furnished, as long as he or she remains immediately available. Similarly, an allowed supervisory practitioner can furnish direct supervision from any location in or near an off-campus hospital or CAH building that houses multiple hospital PBDs where services are being furnished if the supervisory practitioner is immediately available.

Q: Does the supervisory practitioner need to know how to manage wounds or ostomies?

A: The supervisory physician or non-physician practitioner must have, within his or her respective state’s scope of practice and hospital-granted privileges, the knowledge, skills, and ability to perform the service or procedure. Specially trained ancillary staff and technicians are the primary operators of some specialized therapeutic equipment, and while in such cases CMS does not expect the supervisory physician or non-physician practitioner to operate this equipment instead of the technician, CMS does expect the physician or non-physician practitioner to be knowledgeable about the therapeutic service and be clinically able to furnish the service. The supervisory responsibility is more than the capacity to respond to an emergency and includes the ability to take over performance of a procedure or provide additional orders. CMS does not expect the supervisory physician or non-physician practitioner to make all decisions unilaterally without informing or consulting the patient’s treating physician or non-physician practitioner. In summary, the supervisory physician or non-physician practitioner must be clinically able to supervise the service or procedure

Q: Are there any exceptions to “direct supervision” in outpatient wound and ostomy PBDs? 

A: Yes, upon provider request, CMS has reviewed a variety of hospital outpatient therapeutic services to determine if they may be furnished under “general supervision” (the procedure or service is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure), or if they require “personal supervision” (the physician must be in attendance in the room during the performance of the service or procedure). As of press time, only 4 wound/ostomy care-related procedures/services are permitted to be performed in PBDs with general supervision. (See Table 1.) 

Q: How does CMS determine the level of supervision required for a service/procedure performed in a PBD?

A: CMS determines if there is a significant likelihood that the supervisory practitioner would need to reassess the patient and modify treatment during or immediately following the therapeutic intervention, or provide guidance or advice to the individual who provides the service. To answer that question, CMS considers the following factors, but may also consider others as appropriate: complexity of the service, acuity of the patients receiving the service, probability of unexpected or adverse patient events, expectation of rapid clinical changes during the therapeutic service or procedure, recent changes in technology or practice patterns that affect a procedure’s safety, and the clinical context in which the service is delivered.

Summary

Providers can test their knowledge about PBD direct supervision in Table 2. (The answers are provided following the table.) Finally, providers should carefully examine the practices at their PBDs to be sure they will pass any audit that pertains to direct supervision and immediately make adjustments to comply with direct supervision regulations as needed. 

 Kathleen D. Schaum, MS, is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL; and director, medical products, reimbursement, at Smith & Nephew, Fort Worth, TX.