Guidance on new procedure for CME

This appendix will provide credit certificate language for all 4 levels of new procedures and skills training, and guide provider development of formal instruction (courses) and defined clinical preceptorships for this type of education. Ideally, providers will use both learning modalities and, further, arrange for post-course observation of the physician in his or her own practice setting as a means to evaluate both overall program effectiveness and the individual physician’s mastery of the new skills. 

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Providers offering new procedures training will need to assess, at the activity’s conclusion, the participant physician’s level of achievement. The credit certificates for these 4 levels can be used by relevant credentialing bodies to determine physician eligibility for new or expanded clinical privileges that recognize this training.

Formal courses designated for AMA PRA Category 1 Credit™ in new procedure training must meet the following requirements:

Each activity must meet the AMA definition of CME, include stated learning objectives that conform to accepted specialty or subspecialty practice, and be clearly designated for a specific level classification. The provider will define the skills to be taught beforehand and assess the physician’s skill acquisition at the course’s conclusion, prior to awarding a credit certificate.

The site of the educational activity must be physically adequate to meet the program’s stated objectives. Likewise, providers will ensure that participants work in facilities and with teaching materials appropriate to accomplishing the activity’s learning objectives.

The director and the faculty for the educational activity must:

• Know educational methodology and command the necessary clinical or laboratory expertise necessary to teach the course’s subject matter.
• Present qualifications that meet specialty and subspecialty society specifications.
• Provide a ratio of clinical faculty to trainees small enough to satisfy course objectives, and to accurately document whether each participant physician achieves these objectives.
• Disclose to participants any prior or existing relationship with industry.

The faculty director alone, under the provider’s guidance, must take responsibility for setting course objectives, developing the curriculum, overseeing faculty and determining the criteria by which to evaluate trainees.

The trainees will be expected to demonstrate sufficient background knowledge, skills and experience to successfully participate in the course. Physicians may be asked to document their qualifications or to complete a pretest to enroll in the course.

The providers will develop a written curriculum which lists the skills to be acquired, defines the skill levels, describes the incremental skill levels by which trainees will advance, and includes supplemental resources (reprints, citations, etc.). These materials will be included in a syllabus given to all participants.

The activity must feature didactic instruction, supported by peer-reviewed data, in the following areas:

• Patient selection
• Indications and contraindications
• Instrumentation
• Techniques and adjunctive techniques
• Content validity
• Cost considerations
• Managing complications
• Documenting methodology
• Pre- and post-procedural care
• Follow-up policies
• Outcome analysis

To better frame the learning experience for the physician trainees, providers may want to address historical considerations and current research as topics for instruction.

Appropriate methodologies for teaching may include:

• Reading articles
• Didactic sessions
• Practice with inanimate models
• Animated laboratory instruction and practice
• Learning control and appropriate use of equipment
• Video and computer instruction
• Observing procedures
• Simulated and virtual reality models
• Interactive computer programs
• Self-assessment exercises

The formal educational activity should allow enough time for trainees to learn the skills, to demonstrate they have achieved the defined objectives and to develop good working knowledge of the pathology that the procedure mediates.

The director of the educational activity must provide each trainee with a written summary that verifies attendance and the physician’s achievement of course objectives. This summary must detail how the physician’s attainment of program objectives was evaluated. Providers will retain, for no less than 6 years, records for each physician and share these, as requested, with appropriate credentialing bodies.

The clinical preceptorship must start with a program outline that states the learning objectives and details the tasks and skills to be covered during the training period.

Preceptorship site facilities, and patient volume, must meet trainee learning needs. The preceptorship must be sponsored by an appropriately accredited (e.g., JCAHO) health care organization, a Liaison Committee on Medical Education-accredited medical school or a recognized medical society accredited by the ACCME.

The physician preceptor must present appropriate credentials and verifiable clinical experience in the procedure to be taught. The preceptor sets objectives, develops the curriculum, oversees instruction and practice of skills, demonstrates technique and clinical procedures, and evaluates the trainee, all under the aegis of the accredited provider. In addition,

• The preceptor must disclose, in advance and directly to the trainee, any relationship with industry.
• The preceptor must exercise primary responsibility for patient care, not only supervising procedures in which the trainee participates but also overseeing the appropriate peri-procedure care.
• The provider must keep written evidence on file of patients’ specific informed consent or an institutional review board’s research approval, which allows trainee involvement in patient care.

The trainee must command the background knowledge, skills and experience necessary to learn the assigned tasks. Trainees should be required to document their qualifications, including:

• A current and valid license to practice medicine or meet local requirements for waiver of licensure
• Evidence of both current liability coverage and current clinical privileges in an accredited health care institution (unless this is impossible for legitimate reasons)
• Successful completion of an accredited residency training program or its equivalent as determined by the provider of the activity, or verifiable evidence of ABMS member board certification

Providers must base preceptorship training on clinical experience, with both didactic and technical components. Of vital importance, the preceptorship needs to include an appropriate number of opportunities for the trainee to assist and serve as the primary operator in the procedure under instruction.

Training should be long enough for trainees to develop and then demonstrate that they have achieved the program’s defined objectives, including familiarity with the disease requiring the procedure.

The preceptor must document qualitative and quantitative descriptions of the trainee’s experiences. This documentation should detail the skills acquired and the number of procedures in which the trainee assisted or served as primary operator. Providers must document, for the trainee, that the procedures were satisfactorily performed. Upon the physician’s written request, this information may be provided to the credentials committee of a health care organization. A log of activities kept by the trainee, and reviewed by the preceptor or credentialing body, can assist in the privileging process.

Providers must maintain permanent records of preceptees and make these available, on request, to appropriate credentialing bodies. If appropriate, providers may issue a continuing medical education credit certificate.

Both the preceptor and the trainee share responsibility for securing appropriate authorization from the host institution, and any necessary indemnity coverage.

Health care institutions awarding new or expanded privileges to physicians on the basis of newly acquired skills should establish a program that continuously reviews physician performance as part of their overall quality assurance program.

To ensure that their educational activity prepares qualified practitioners, providers should document their evaluations. For example, providers can request that the preceptee report the number of procedures performed and what the outcomes were. The assessment process must include the trainees’ evaluation of the course and its faculty.

Every provider who certifies new skill and procedure educational activities for AMA PRA Category 1 Credit™ must regularly evaluate whether their overall outcomes meet program goals. They must also report this data, on request, to appropriate organizations, such as the AMA or ACCME.

The provider can designate the preceptorship for that number of AMA PRA Category 1 Credits™ that represents their best and most reasonable estimate of those hours the preceptee will spend in meeting the activity’s learning objectives.

The AMA established a system of 4 levels of new procedure education, to reflect the level of training a physician has accomplished in an individual program. To verify the physician’s level of achievement in the new procedure or skill, providers may use the following language for credit certificates issued to U.S. licensed physicians. The physician can present this certificate to appropriate credentialing authorities as documentation of his or her education and training.

The 4 Levels are:

The physician attended and completed the course.

The [name of provider] verifies that this physician has earned [number of credits] AMA PRA Category 1 Credits™ by attending and completing the level 1 classification [name of course] course, in accordance with the AMA Guidelines for Continuing Medical Education on New Procedures and Skills.

The physician satisfactorily met all specified learning objectives.

The [name of provider] verifies that this physician has earned [number of credits] AMA PRA Category 1 Credits™ by satisfactorily meeting all specified learning objectives for the level 2 classification [name of course] course, in accordance with the AMA Guidelines for Continuing Medical Education on New Procedures and Skills.

The physician is "proctor ready," which subsumes levels 1 and 2 and asserts the physician can successfully perform the procedure under proctor supervision.

The [name of provider] verifies that this physician has earned [number of credits] AMA PRA Category 1 Credits™ by completing the level 3 classification [name of course] course and is able to perform the procedure under proctor supervision, in accordance with the AMA Guidelines for Continuing Medical Education on New Procedures and Skills.

Competence asserts the physician can successfully perform the procedure without further supervision.

The [name of provider] verifies that this physician has earned [number of credits] AMA PRA Category 1 Credits™ by completing the level 4 classification [name of course] course and is competent to perform the procedure without further supervision, in accordance with the AMA Guidelines for Continuing Medical Education on New Procedures and Skills.