Audit Preparation and SOP s Pharma Forum Lisa Keilty, CMP HCC

Transcription

1 Audit Preparation and SOP s Pharma Forum 2013 Lisa Keilty, CMP HCC 1

2 Audit: A Component of Compliance OIG identifies: 7 Core Elements of an Effective Compliance Program Written policies and procedures Designated compliance officer and compliance committee Effective training and education Effective lines of communication Internal monitoring and auditing Enforcement of standards through well-publicized disciplinary guidelines Prompt response to detected problems through corrective actions 2

3 Types of Audits Completed by Internal / External Personnel Financial Audits and Reviews Operational Audits Information Systems Department Reviews Integrated Audits Investigative Audits or Reviews 2

4 What is the big deal? You and your company, can be impacted in many ways: Substantial Fines and Penalties OIG enforced Corporate Integrity Agreements (CIA) Public perception/bad publicity Loss of jobs We are accountable! 3

5 GOT YOUR DUCKS IN A ROW? 4

6 Assess Risk At Each Planning Stage PRELIMINARY VENUE SOURCING PROGRAM APPROVAL CONTRACTS & PROPOSALS LOGISTICS & PLANNING Request Qualify Business Rational Cost analysis Pre Approve HCP/GO Compliant Corporate Compliant Authorization of budget Authorization of program dates, location and attendees Country specific approvals Venue Vendors (MSA s vs. bid process) Speakers HCP Engagement documents Hotel Air Ground Production Off site events Materials Presentations EXECUTION RECONCILIATION AUDIT On site management Pre Con Invoice & Expense payments Travel Manifest Compliance Exceptions and violations Evaluations Budget vs Actual costs HCP cost capture (TOV) Meeting End Documents Checklist Review Remediate Repository 5

7 Assessment Activity Federal and Int l Laws Specifics Adherence Deviations SOPs Process Reviews Risks: Legal Financial Other Awareness Due Diligence Documentation Reporting Trainingg 6

8 Lining up your ducks Internal Monitoring and Assessment Continually Assess and Evaluate Be Resourceful: Align with ih Stakeholders Set Expectations and Communicate Build due diligence into processes Define Greatest Risk: Look at Historical Reports 7

9 Helpful Hints Get yourself organized and focused it is here to stay! Understand why you something is expected of you Makes doing the task easier Will improve you communication with an auditor and other stakeholders Document, Document, Document! Immediate note to file Keep it simple and to the point Tell the story Date and time stamp Keep a paper trail 8

10 More Hints Be proactive, not reactive Educate your audience Meeting Host / Project Team Country Office Contacts Other colleagues Vendors (hotels, 3 rd party planners, content vendors, etc.) Attendees Communicate compliance policies Templates: invite, confirmation, welcome letter, expense report) What is/is not acceptable will expedite reimbursement and minimize consequences Be Careful Though! 9

11 Open Discussion Has anyone gone through and internal or OIG audit? If so, share the experience. What policies or organizations changes has your company implemented that impacted your job function/structure? While planning a meeting, what situations have you encountered which made you take action to avoid a compliance violation (e.g. turning away a a spouse se for dinner, denying payment on an expense report, refusing an upgrade). Something which maybe in the past would not have been an issue Share best practices to help someone struggling with these changes 11

12 Question What Is The Sunshine Act? A law that requires Punxsutawney Phil to annually declare the end of winter in the Northeast by March 1 st. 2. A company policy that t encourages us to sing You are my Sunshine to our bosses daily A regulation that specifies how Physician payments are reported.

13 Answer 3). A regulation that specifies how Physician payments are reported. Spend includes all payments/items of value to be tracked and reported. Transparent open to public observation State Law may vary. Some states require full disclosure of all spend, while others may be $ value limits on what is required to report. Regardless, know your company policy so that you comply.

14 True or False? Payments and Transfer of Value Reporting applies only to y p g pp y Healthcare Professionals.

15 Answer False Payments to Healthcare Organizations are also reportable. HCO s may provide Healthcare, such as a hospital or medical center. Or an HCO can be an organization that provides industry leadership and direction, such as an Institute of Higher Learning or an industry association (AHA, ASCO, etc.)

16 Question Dr. Jones, who attended XYZ Advisory Board, request that, y, q his fee of $2,000 be payable to Giants Medical Center on his behalf. Is this reportable?

17 Answer Yes The Sunshine Act requires the reporting of all Transfer of The Sunshine Act requires the reporting of all Transfer of Values made to institutions on behalf of a HCP to be reported to the HCP.

18 Question As a third party logistics provider, your new client, Blue Moon Biometrics has requested an HCP meeting take place at the Embassy Suites in Phoenix in April. There are 8 HCPs from US an one international physician from Dublin. What steps do you take to advise your client in sourcing this property?

19 Question Dr. Flaherty became ill while attending an FDA Advisory Committee meeting. His input is highly critical, yet he needs to fly home early and takes an earlier flight back to New York. What documents should be reconciled to show due diligence on your part regarding fulfillment of obligation and no enticement flying Dr. Flaherty home early?

20 Answer Due Diligence / Documentation Sign in / sign out sheets Note / documentation with host signature Travel Manifest: Arrival & Departures Air / train Ground HCP Expense Report HCP Contract: Does he get paid if he leaves early?

21 Question Sally is a new Meeting Manager to Shade Medical Device organization. She has never done a Clinical consultant meeting before and only has three weeks to plan this 20 person program. Attendees are both domestic and international. The clinician is pushing Sally to send out the invitations so that the HCPs can be locked in and airfares will be cost effective. What does Sally need to do?

22 Answer Check on approval of all HCPs prior to inviting Have all contracts been executed per HCP prior to invite or booking travel Send Save the date if contracts have not been fully executed Review International laws and guidelines per country to ensure attendee(s) meet obligations of their country (Visa, Employee letter etc) Review meal caps and other criteria per country prior to sourcing * Know your client / organization s policy on this!!

23 Question Dr. Case, an orthopedic surgeon with offices in Connecticut and Mexico, is engaged as a speaker for an upcoming training in Cancun. Since the meeting is outside the U.S. are his fees reportable?

24 Answer Yes Regardless of where the event took place, Dr. Case is still considered a U.S. HCP.

25 Question Dr. O Reilly attendance at a DSMB is required June 22 nd. He requests to travel to Chicago on June 15 th so that he can visit with relatives. The airfare is $ regardless of which day he travels. Would booking his travel for the earlier date a compliance violation?

26 Answer This depends on the policy specific to your company. If the fare was higher for the deviated flight, who would pay this difference? Document the request and explanation for approval so that it can be clarified in an audit. Seek assistance from internal leadership.

27 Question Marketing manager, Jennifer desperately wants Dr. Adams, a leading Oncologist to participate in an upcoming Advisory Board. Your company s Fair Market Value indicates he should be paid $5,000 to attend. Jennifer executes a contract for $7500 for him yet other HCPs are contracted for $5,000. What should you do? a) Pretend you don t know what Jennifer did b) Nothing Jennifer, not you, is responsible for engaging Dr. Adams. c) Query Jennifer to understand the rationale d) Document and escalate this activity accordingly

28 Answer c) Query Jennifer to understand the rationale d) Document and escalate this activity accordingly There are instances where an HCP can be paid more than the FMV, however understand the role of the HCP at the program and whether pre or post work will be done (i.e. Chairman, Preliminary slide prep) p) and document. If there is no justification, do not pay the sum until you escalate the activity to your manager or ask client for documentation. * Done for the sake of protecting yourself against any claims of violations, but also to protect your company against impropriety. Once the issue is escalated, you have done your due diligence and leadership will manage the situation appropriately.

29 Question Improper payments to foreign officials is considered an violation of: a) FCPA b) The Sunshine Act c) AdvaMed Code of Ethics

30 Answer a) FCPA Foreign Corrupt Practices Act The Foreign Corrupt Practices Act is a US Federal law that addresses accounting transparency requirements and the bribery of foreign officials.

31 Question Your company is hosting an IM in Spain. Jacques, who works out of your country office in France, insists that he coordinate the travel for the French delegation thus leaving this responsibility out of your control. What are some of the steps you should take to ensure he complies with company policy? a) Review your needs with him, put it in b) Educate him on current policies c) Continuously follow up and document d) Do nothing he, alone, is accountable

32 Answer a) Review your needs with him, put it in b) Educate him on current policies c) Continuously follow up and document You are both accountable to ensure compliance! Take every action to make certain the appropriate documentation ti is included in your audit files.

33 Question Dr. Mullen was enroute to JFK when his plane was diverted just minutes before landing. As a result, this caused a 2 hour delay. His transfer vehicle could not be cancelled since it was already at the airport expecting his arrival. Why should this scenario be documented? a) Because I have nothing better to do b) Additional fees will be incurred c) This is a trick question

34 Answer b) Additional fees will be incurred Your ground transfer invoice i will include many consistent charges. A red flag to an auditor will be the transfer that t was priced at a higher dollar value than the others. Tell the story through concise documentation

35 Are You Prepared? Remember an internal audit assesses: How your department adheres to existing policies and procedures Risk associated with outdated policies or non-existent ones, lack of knowledge How your department is self-auditing Therefore, some activity may be risky, but if a policy doesn t exist, you are not considered to be non-compliant. This doesn t mean your company still can t be in violation of some laws. Chances are a new policy soon will be implemented to mitigate such risk in the future.

36 Get your ducks in a row We are Accountable for Demonstrating Due Diligence and Laudable Efficiencies 3 6

37 Contact Lisa Keilty, CMP, HCC Direct Cell