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Privileging For Novel Procedures Or Treatments

Practitioners often assume that because they are privileged to do X, they automatically also should be privileged to do Y, and are frustrated when they encounter new or different privileging requirements for Y, arguing that it is just an extension of what they already are authorized to do.

This can come up in many different situations (collectively referred to as "new services"), including:

  • Novel surgical procedures or techniques
  • Novel treatments
  • Procedures or treatments new to particular practitioners
  • Research or experimental treatments (including drugs/devices not FDA-approved for marketing)
  • Newly-FDA approved devices or drugs
  • New uses for FDA approved devices or drugs

For example, many hospitals have spent millions of dollars on Da Vinci technologies for robotic surgeries in the past few years although the training and experience required of physicians who perform such surgeries may vary among medical staffs of different hospitals. In August, the Food and Drug Administration (FDA) approved Addyi (the pink pill) as a novel drug to treat female hypoactive sexual desire disorder, but practitioners are required to complete a training course before prescribing the new drug.

While there may be differences of opinion regarding the effectiveness of new services, hospitals rightly are concerned about liability and risks they may face if they offer procedures or treatments that may be unfamiliar. At the same time, hospitals, medical staffs, and practitioners want to keep current with medical advances. How should they balance these considerations and when should a medical staff grant practitioner requests for privileges for new services?

Regulatory and Accrediting Requirements

The Centers for Medicare and Medicaid Services' (CMS) Medicare Conditions of Participation require that a hospital's medical staff ensure that practitioners meet approved criteria for both medical staff membership and privileges, including character, competence, training, experience and judgment (See 42 C.F.R. § 482.22(a)(6)). This applies both to initial membership and to privilege requests, as well as to requests for new privileges. Likewise, accrediting bodies like The Joint Commission set forth criteria to determine a practitioner's ability to provide a service. These criteria must be consistently evaluated across all practitioners, since all patients are entitled to receive the same standard of care, regardless of which type of practitioner provides the service (See Joint Commission Standards MS.06.01.01 and MS.06.01.05).

Thus, when a practitioner wants to perform a new service - whether new in general or simply new to that practitioner - the medical staff must ask if the procedure or treatment is part of the privileges the practitioner already has, or if it is something different. In doing this, the medical staff should evaluate if the new procedure or treatment involves different training, skills, judgment, techniques, equipment, or infrastructure, among other questions.

Determining Whether to Consider Privileging for a New Procedure or Treatment

The medical staff may consider adopting policies and procedures addressing when to consider a new service, what steps will be followed to develop criteria for the new service, how the new service will be operationalized, what steps will be followed to assure that practitioners meet the new criteria, and what steps will be followed for Board approval. The medical staff may wish to create a subcommittee or task force specifically for this purpose.

As a first step, the medical staff may begin by gathering information from the practitioner(s) seeking to perform the new procedure or treatment. This includes descriptions of the procedure or treatment, new equipment or other resources that will be required, results, complications, and other pertinent information in scientific literature, and background and training required, as well as a proposed monitoring and quality review plan to assess overall experience and a proposed proctoring requirements to verify competence. 

The medical staff's primary consideration then would become whether to offer the new service. To this end, the medical staff may wish to set up an ad hoc committee to evaluate the risks and benefits of offering the new service. For example, if it is a drug or device, has it been approved by the FDA, and is the proposed use consistent with that approval? Is there supportive scientific literature? Does it involve "research," as defined by state and federal laws, and if so, does the hospital have an Institutional Review Board? Does the hospital have space, staffing, and financial resources to perform the service? Is taking the steps to perform the service a good investment? Will practitioners be able to perform a sufficient number to retain competency? Is offering the service consistent with the hospital's mission and vision? Do similar organizations offer the service? What is the quality data like where the service is performed? Will the new service affect other practitioners or the call pool? Only if the anticipated benefits outweigh the risks and possible disadvantages would the medical staff likely want to recommend offering the service and creating new privileges.

Developing Criteria for and Operationalizing New Services

Once a value analysis has been completed and it has been determined that the hospital may want to offer the new service, the logical next step is to develop criteria for privileges for the new service. It is important to remember that physicians who trained at different times may have learned different techniques, but all physicians must provide services within the standard of care. Resources that may be consulted in developing these criteria include Credentialing Resource Center white papers, organizations of similar size to the hospital, training facilities and organizations with more experience, specialty societies, academic training programs, experienced clinicians, industry representatives, and regulatory requirements.

The medical staff may want to consider implementing a policy and procedure for passing the proposed criteria for new privileges by department chairs, medical directors, and practitioners seeking to perform the service for comment. In particular, the stakeholders may want to verify and assess requirements for licensure, training, certification, eligible specialties, capacity, liability history, minimum threshold volume, professional references, and focused and ongoing professional practice evaluation for competence.

Once stakeholders have had their say, the medical staff should submit the proposed privileging criteria to the Credentialing Committee, the Medical Executive Committee, and, following any proposed modifications by each committee, the Governing Body. Each level of review should constitute an independent assessment, and be wary of rubber stamping.

Following approval of privileging criteria, the new procedure or treatment is ready to be operationalized. This includes training and support of nursing staff for the new procedure or treatment, ensuring that proper supply chain support (e.g., inventory and vendors) is in place, dealing with political issues such as exclusive contracts and call coverage, and ensuring that competence evaluation is ongoing.

Privileging for new procedures or technologies should be done in a thoughtful, thorough, and ongoing way to ensure that the hospital and medical staff have considered all angles, understand the risks associated with the new services, and are fully prepared to operationalize the new service.

For additional information about updating your policies for privileging for new services, please contact Katherine Dru in Los Angeles at (310) 551-8111, Jennifer Hansen in San Diego at (619) 744-7300, or Harry Shulman in San Francisco at (415) 875-8500.

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