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Audit prep expert Lisa Keilty, CMP, HCC, president /owner of the pharma compliance consulting firm PMC2 (Professional Meeting Compliance Connection), explored what the OIG is looking for, and how pharma planners can prepare for an audit, during a session on audit preparation and standard operating procedures at the 2013 Pharma Forum in Orlando.
Four Stages of Risk
Documenting as you go means developing a consistent thread of compliance documentation for each planning stage, said Keilty.
Stage 1/Meeting Development and Venue Sourcing: During the preliminary stage, you need to know how to qualify a meeting request, and you need to be able to show that the request went through the proper process. The meeting’s objective should drive everything that follows, so be sure to emphasize the key words of that objective when you talk with your meeting owners. There needs to be a business rationale for holding the meeting—which healthcare professionals you are inviting and why—a cost analysis, and a signed pre-approval form as required by SOPs. Get the proper authorization for your budget and the program’s dates, location, and attendee list.
While sourcing the venue, make sure the hotel understands and can comply with internal corporate rules and state and federal pharma regulations involving HCP meetings. “Make sure the venue isn’t on your hotel exclusion list, and that it can accommodate your spend caps,” she said. Also make sure all your vendor, venue, and speakerare compliant. “It’s a red flag if you always use one hotel chain,”said Keilty. “Document that you got three bids. If you didn’t, document why you didn’t. Make sure the dates and budgets line up with what’s in your . Let your vendors know that you have to be able to audit everything.”
Also make sure you are complying with policies around air, ground transport, production, materials, presentations, and off-site events. “Think like an auditor and you’ll get through it,” she said.
Stage 2/Meeting Execution: Document everything, from the pre-con to on-site management. “Tell the venue what you need—let them know not to upgrade attendees without asking you, and not to upgrade you—ever. And know your company’s policy on what to do with frequent flier miles and hotel points. “If it’s in your SOPs, it should be in your addendum so the hotel knows what to do,” she said. And make sure the operations and program management by any third-party you use support your company’s SOPs.
Stage 3/Budget Reconciliation: Be sure you can tell the full story of everything that happened at the meeting, from the invoice and expense payments to the travel manifest to capturing the transfers of value—meaning direct or indirect payments—to HCPs. And be sure to include any compliance exceptions and violations. “Did Dr. X receive a bottle of wine? Did a spouse come to dinner? Even the best-laid plans can go awry. If you went over the variance, say why. Even if you were under the variance, explain why—an auditor might take that as a sign that you didn’t plan appropriately. Write down everything that happens.”
Stage 4/Audit: Have a checklist and review everything in a timely manner, according to your SOPs. If your SOP says the review should take place in 60 days and at 90 days you’re still working on it, an auditor might see that as a problem, said Keilty. Remediate any issues that arise, and be sure to have a repository to store the documentation, whether it’s electronic, paper, or both. If you don’t already have policies and procedures to handle document storage, develop them.
Auditors will look at the specifics: Have you adhered to your SOPs? Are there any deviations from SOPs? Did you do your due diligence in documenting and reporting? They also will look at compliance training policies and procedures. Who is trained, and when was the last time you updated your training? How do you monitor third-party compliance? Look at what your company agreed to in its CIA, if you have one. “Educate all your internal stakeholders—planners, accounting, compliance, legal—and consistently monitor what they are doing. Meet with vendors quarterly,” said Keilty. “You need to continually assess and evaluate—build due diligence into your processes.”