AHIA: Mitigating Risk through Auditing and Monitoring. Grants and Educational Activities

Transcription

1 AHIA: Mitigating Risk through Auditing and Monitoring Grants and Educational Activities October 18, 2007 Heather J. Stewart Dir., Corporate Compliance Counsel MedImmune

2 Disclaimer My opinions are based on general industry experience as both in-house and outside counsel. My opinions are not necessarily the opinions of MedImmune.

3 Agenda CME & Industry Support Government Scrutiny Continues Understanding the risks Applicable legal and regulatory framework External Standards Role of Auditing & Monitoring in mitigating risk and enhancing Compliance Program

4 CME and Industry Support Industry spends over a billion annually in support of ACCME accredited programs (Senate Finance Cmt.) Reasons for Industry Support: Support advancements in science Support medical education and improvement in standards of care in therapeutic areas of interest General Goodwill But, CME cannot be used to: Market products (on-label or off-label) Reward or influence customer purchasing/prescribing habits Reward or influence professional/medical organizations with influence over prescribing (e.g., independent treatment guidelines)

5 Congressional Scrutiny Industry supported educational activities have long been a focus of the OIG, DOJ and state AGs In 2005, the Senate Finance Committee joined the party June 05 and January 06: Two rounds of requests for information to 23 Companies December 06: Request for information to ACCME 2007 Senate Report: This report shows some separation between medical education and marketing efforts, but this process still isn t clean enough.

6 Grants: Nature of the Risk Promotional Risk Off-label Promotion Pre-approval Promotion Kickback Risk: Rewarding Customers Influencing use/purchase of products Pricing Risk: Grants in lieu of price discounts (e.g., undisclosed discount)

7 Regulatory and Legal Framework Independent Education is not regulated by FDA: Recognition of academic freedom and value of unhindered scientific exchange Industry supported CME is not considered promotion by FDA as long as activities are independent of the influence of the supporting company Compromising independence of CME can result in regulation as promotion and potential liability under the Food Drug & Cosmetic Act (FDCA) and False Claims Act (FCA) Use of grants to reward/influence prescribing/purchasing can result in potential liability under Anti-kickback Act (AKA) and FCA Use of grants as de facto price discounts can result in potential l liability under Medicaid Best Price and FCA

8 Evaluating and Maintained Independence Guidance on Markers of and Strategies for Independence: 1994 FDA Guidance on Industry Supported Scientific and Educational Activities 2001 PhRMA Code on Interactions with Healthcare Professionals 2003 OIG Compliance Guidance for Pharmaceutical Manufacturers 2004 ACCME Standards for Commercial Support

9 FDA: Multiple Factors Considered for Independence Control of content/selection of speakers Disclosures (financial, sig. relationships, unapproved uses) Independent and non- promotional program focus Relationship b/w provider and supporting company Provider involvement in sales & marketing Provider s failure to meet standards of independence, balance, objectivity Multiple presentations Audience selection Opportunities for discussion Dissemination of information about supporting company s product other than in response to unsolicited request Ancillary promotional activities Complaints

10 PhRMA Code Conference organizer is responsible and has control over content, faculty, educational methods, materials and venue No Industry support of travel or lodging costs, or other expenses of non-faculty (except for HCPs-in in- training where selected by learning institution)

11 OIG Guidance Identified concerns: Grants to support educational activities can c be used as kickbacks and/or inappropriate marketing purposes Recommended Controls: Separate grant making functions from sales and marketing functions Establish objective criteria for making grants unrelated to recipient s purchases/prescribing and that ensure that only bona fide activities are funded Manufacturer should have no control over the speaker or content of the educational presentation Procedures should be documented and regularly monitored

12 ACCME Guidelines on Industry Support CME Provider must ensure that certain decisions are made free of the control of a commercial interest: Identification of CME needs Determination of educational objectives Selection and presentation of content Selection of all persons/organization that will control the content of the CME Selection of educational methods Evaluation of the activity The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. Presentations must give a balanced view of therapeutic options...

13 Other Resources Requirements on training, policies and processes for grants expressed in Corporate Integrity Agreements or Consent Decrees Pfizer I and II Eli Lilly Serono Jazz Pharmaceuticals Note: Terms of CIAs and Consent Decrees are based on individuals circumstances and apply only to the company that is party to the agreement or covered by the decree. They are useful guidance, not law.

14 Grants: Mitigating Risk Underlying strategies for mitigating risk: CME Providers Content not controlled or influenced by industry Content not endorsed/pushed by industry Industry Supporters Industry Supporters Separation of sales and marketing functions from grant decisionmaking Standardized process and procedures for grant applications, review and documentation/retention Objective criteria for review Disclosure of all forms of support (financial or otherwise) of a particular CME program Monitoring

15 Role of Monitoring & Auditing: One Non-auditor s Perspective Auditing Testing adherence to established policies and procedures across company functions based on one snapshot in time Individual audits are part of routine and regular audit plan Usually conducted by separate and independent audit function Formalized procedures for conducting audit and reporting findings Generally not privileged Monitoring Evaluating particular activity/process over a certain time-period or periodically May be part of normal compliance program activities or in response to specific risk Monitoring protocol may be tailored to particular activity; protocol can be refined May be conducted by separate auditing function or by Compliance Can identify trends over time and/or in areas Can help assess adequacy of training and communication, awareness of policies and procedures, efficiency and workability of procedures, gaps, management support and buy-in by affected constituents

16 Monitoring: Upfront Time Well Spent What s the objective? What information are you seeking? Evaluation of a new program or activity? Awareness of current policies and procedures? Adherence to current policies and procedures? Adequacy of current training and communication? Gaps in current policies and procedures? What are the potential risks in the area being monitored? What s the scope? Does it match the objectives? Does it address the key risks? Maturity of Policy and Procedures in target area? Amenable to assessment through monitoring Who is directing the monitoring activity? Who is monitoring? Will this be limited to a certain time period or continual? What resources are required? Is the protocol sustainable? How will findings be documented? How will they be used? With whom will findings be shared and how?

17 Monitoring: Planning & Preparation Once Scope and Objectives are determined: Once Scope and Objectives are determined: Identify key policies, procedures, functions and people and assemble documents Identify sources of data and information Grants database? Query-able? Other available grant application, review/approval records? Budget forecasts/planning documents (where did CME funding come from? How was it allocated) Attendance at grant review meetings? CME events? Other sources of feedback from grant applicants, the field, homeoffice? Review documents and sources of available information and interview a few key people to confirm you understanding of how the process works in practice, whether there are other sources of information and/or opportunities for live observation, as well as the accessibility of particular kinds of records and information. Re-evaluate resources required based on above

18 Monitoring: Planning & Preparation Partner with Compliance to design Monitoring Protocol: Subjects of review? Substantive areas to consider: Application Process Review Process How are therapeutic areas and/or education needs identified? What criteria are used to evaluate individual requests? (Program and Recipients) How are the criteria applied Who is part of the review Process and Nature of Information (if any) communicated to the Field, Commercial and/or Senior Management Grants Budgeting Process Process for handling requests from grant applicants (e.g., faculty recommendations, review of data, handing out invitations, etc.) Process (if any) for evaluation of supported programs Programs supported: Therapeutic Focus versus Pre-set Goals Multi-sponsorship Grants related investigations/complaints Documentation/retention procedures

19 Monitoring: Planning & Preparation Partnering with Compliance to develop protocol (cont d) Criteria by which substantive areas will be evaluated? What qualifies as an exception? What type of findings are desired as to each criteria? (Yes/No, substantive description, etc.) Sample size? Frequency of monitoring cycle? Referral and/or response to potential exceptions noted during monitoring? Document protocol

20 Monitoring: Planning & Preparation Advance notification of affected functions (Grants Department, Medical Affairs if within Scope, Commercial functions if within Scope, Finance if within Scope, etc.) Ensure that Legal is aware of monitoring activities and protocol Consider doing a pilot first... And modify protocol (and/or resources, scope) as required

21 Monitoring: End(?) Game Analysis of findings with Compliance: Trends? What gaps or weaknesses are revealed? Develop recommendations with Compliance based on findings Process improvements? Training improvements? Policy gaps? Resource issues? Lack of Accountability or Delineation of Responsibilities? Sharing findings and recommendations with affected functions Feedback on recommendations Commitment and accountability for implementation Monitoring implementation (the cycle continues)

22 Monitoring External Grant Activities Review of Grant Recipient Activities Review of Grant Recipient Activities Note: Proceed with caution and consult Legal/Compliance Quality of content, participant satisfaction or whether identified educational needs were met should be left to the CME organizer s self-evaluation Other areas of performance may be appropriate for review: Did the planned activity take place (bona fide activity) Budget adherence Complaints Disclosure of Company support Evaluation of provider s self-evaluation (did participants view the program as unbiased, scientifically rigorous, credible, valuable)

23 Closing Thoughts When monitoring, if you come across egregious misconduct, contact t Compliance/Legal so that the issue can be dealt with immediately. If you are not sure whether the situation qualifies as egregious, call Compliance/Legal and ask. Limit findings to objective facts and circumstances and avoid making conclusions or commenting on legality of conduct, potential consequences to the company or recommendations as to individuals involved. Your company s policies and procedures are based on the external standards and legal framework in this area, but that there are many different approaches to mitigating risk in this area and approaches may vary from company to company. (Different?Wrong) An individual instance of non-compliance with a policy or process does not necessarily mean that there has been a legal violation. Leave liability assessment to the lawyers. Partner closely with Compliance/Legal, talk early and often, especially ecially when developing a new monitoring protocol or engaging in monitoring activities for a new area.

24 Resources April 25, 2007 Senate Finance Committee Staff Report on pharmaceutical industry funding of CME, available at ACCME Standards for Commercial Support, available at FDA Guidance: Industry-Supported Scientific and Educational Activities 62 Fed. Reg OIG Compliance Guidance for Pharmaceutical Manufacturers 68 Fed. Reg Copies of Company Corporate Integrity Agreements available at