Life sciences chief compliance officers are not taking many vacations these days. Regulations are requiring compliance departments to delve progressively deeper into interactions with health care professionals (HCP’s) and health care institutions (HCI’s). The physician speaking bureau is one such HCP interaction which has come under increased regulatory scrutiny.
Speaking Bureau → Training → Programs → Events. Great compliance programs will ensure “compliance entry gates” are in place prior to each stage of a speaking bureau. Long before a HCP has delivered on her speaking engagement, a series of best processes must be in place; they must be enforceable, repeatable and reportable. Not only will these procedures protect a high risk corporate work-stream, but these same procedures will serve as proof of organizational training that is aligned with your company’s compliance policies.
Entry Stage. A speaking bureau allows for the organization of life sciences marketing objectives, key opinion leaders, speaking events, regions of coverage and all of their associated details. Much the same as a folder is used to organize paperwork, the bureau is used to group similar topics with a specific purpose. To maximize the bureau’s effectiveness, acceptance into the speaking bureau should be dependent on the following categories and the proper auditable documentation of the following:
- Good professional standing. Includes verifying: state and federal licenses to practice, Office of Inspector General excluded individuals, and generally sound existing public relations.
- Curriculum Vitae. A potential speaker’s career should illustrate a consistent track record to be given the opportunity to present to highly skilled peer groups, including areas of specialization and clinical experiences.
- Fair Market Value Compensation. A consistent method or tool used to calculate payment standards for honoraria both within the organization and pan-industry. Notice should also be taken to ensure payment maximums are not exceeded and, when exceptions do occur, a clear supporting explanation with executive level approvals provided.
- Contract or Agreement. A fully executed contract with the primary or secondary speakers defining: scope of services, expected dates of program performance and completion, honoraria (gathered through the Fair Market Value process described above), travel and lodging reimbursement policies.
- Compliance Certification. An additional but recommended step to clearly presenting your compliance department’s policy to your potential speakers. This additional certification clause brings special attention to important matters such as: non-approved, or “off label”, questions and answers, mandatory use of pre-approved materials and slide decks, and procedures to ask clarifying questions prior to the actual event occurring.
Training Stage. Once a speaker or HCP has passed the entry criteria for a bureau, proper training is required to meet regulatory training guidelines and ensure the speaker is fully prepared to facilitate speaking sessions on behalf of your Life sciences organization. Proper record keeping and documentation of the following activities is a must have.
- Attendance & Understanding. A speaker must attend a training session (either live or web-based) and present an understanding of the materials covered through interactive feedback.
- Pre-Approved Materials. The importance of using only pre-approved materials and slide decks should be reinforced during training. Deviations from pre-approved materials has proven to lead to an increase in speaking infringements.
- “Off Label” Discussions. Another priority of your training sessions with speakers will be to reinforce the proper dialogue and communication around non-approved, or “off label” questions and answers during actual events. It should come as no surprise that this particular area has come under much regulatory scrutiny over the past several years. The ability or inability to execute controls in this one area should be treated very seriously and given top priority by compliance organizations.
Program & Event Stage. Only after meeting the above criteria and passing thru the Training Stage should a speaker be allowed to conduct or facilitate an actual event. Now your policies and processes are put to the test. This final stage represents a delicate balancing of your organization’s sales and marketing efforts with regulatory and compliance requirements.
- Aggregated Spend. Spend must be tracked not only on honoraria for the speaking training and program participation but also, due to newly enacted regulation PPACA, expenses such as airfare, lodging, and meals will be reportable for speakers and attendees.
- Monitoring. Sample or risk based auditing by field compliance team members allow a “boots on the ground” approach to learning about complexities, potential bottlenecks, compliance improvement areas and reporting issues, as necessary. This monitoring exercise may also extend into other related areas of HCP interactions such as office visits, training and advisory boards.
- Attendee Lists. In addition to the actual speakers, processes should also capture the participants’ attendance for the proper allocation and recording of items such as #1 above, Aggregate Spend capture.
- Attestation & Feedback Forms. Your compliance reach will go only so far, and help from your field representatives who will be attending the speaking events provides an opportunity to push your policies to the level of direct daily interactions. An attestation to the delivered program’s compliance effectiveness provides another level of ownership and buy-in. This follow-through will enable your organization to react quickly to gaps and facilitates continued improvements in future sessions.
Due to their federal promotional categorization and direct interaction with HCP’s, speaker bureaus lie directly in the crosshairs of regulatory scrutiny, creating a high risk environment for Life sciences compliance departments. Compliance officers need to orchestrate a symphony of risk mitigating processes with extremely varied departments such as: marketing, commercial, clinical, legal, and information systems in order to produce the elite outcomes necessary for meeting the “New Compliance Normal” of their speaker-physician bureaus.
