Developments in Recent Corporate Integrity Agreements (CIAs)

Transcription

1 Developments in Recent Corporate Integrity Agreements (CIAs) Jonathan Levy PDMA Alliance Board Member Summer 2015 The following has been prepared by The PDMA Alliance for use by its Members as educational information of general interest, and should not be construed as legal advice, official guidance or opinion on specific matters.

2 Contents

3 Board of Directors Governance Must include independent (non-executive) member Meet quarterly to review/oversee Compliance Program, including but not limited to the performance of the Compliance Officer and Compliance Committee Adopt annual signed resolutions summarizing its review and oversight of compliance with Federal health care program requirements, FDA requirements, and the obligations of this CIA

4 Management Certifications Governance Certain Certifying Employees expected to monitor and oversee activities within their areas of authority and annually certify that their business unit is compliant with applicable Federal health care program and FDA requirements and with the obligations of the CIA CEO Commercial Head Marketing Managed Markets Sales Medical Affairs President Business Development Supply Chain/Technical Operations R&D

5 Recoupment Executive Financial Recoupment Program Requires financial recoupment program putting at risk of forfeiture or recoupment an amount of up to 3 years of annual incentive compensation for Covered Executives Triggered by significant misconduct relating to sales/ marketing in the BU for which Covered Executive had responsibility Obligation to pursue recoupment from former employees, through court proceedings if necessary

6 Board of Directors Training Specific training for BOD, addressing the responsibilities of board members and corporate governance topics (in addition to general training) - BMS: BOD received General course only

7 Existence of CIA Disclosures General payments Relationship status Clinical, etc.

8 Existence of CIA Disclosures - Notify customers/payers about existence of CIA - Instructions on how to submit questions about the CIA General payments Relationship status Clinical, etc.

9 Existence of CIA Disclosures - Notify customers about existence of CIA - Instructions on how to submit questions about the CIA General payments - HCP/HCI payments ( Sunshine like reporting) Relationship status Clinical, etc.

10 Existence of CIA Disclosures - Notify customers about existence of CIA - Instructions on how to submit questions about the CIA General payments - HCP/HCI payments ( Sunshine like reporting) Relationship status - Disclosure of consulting work and authorship disclosures Clinical, etc.

11 Existence of CIA Disclosures - Notify customers about existence of CIA - Instructions on how to submit questions about the CIA General payments - HCP/HCI payments ( Sunshine like reporting) Relationship status - Consulting and authorship relationship Clinical, etc. - Post trial results to clinicaltrials.gov - Info regarding post-marketing commitments on company website

12 R&D/Medical Product Related Functions definition includes contracting for postmarketing studies/isrs, and authorship of articles Policies/monitoring to ensure research activities fulfill legitimate scientific question or need Policies/procedures around sponsorship/support of post-marketing research Decision to fund; publication of information; uses made of publications Policies around authorship of journal articles and other publications (e.g., follow International Committee of Medical Journal Editors [ICMJE] standards)

13 R&D/Medical Separation of Medical/Commercial Policies/procedures requires research to be approved by medical and/or research organization All requests for information about off-label uses must be referred to Medical

14 Compendia Policies/procedures around submission of information about products to compendia used in connection with coverage decisions (both as to initial submission and updates, including any changes based on company s discovery of erroneous or scientifically unsound information or data and the publication of new study results). Policies/procedures to include requirement that company conduct: (i) a review at the time of submission of information to Compendia, to verify that the information submitted to the Compendia (including information about clinical studies and other research) is complete and accurate; (ii) an annual review of all product listings and monographs within the compendia designed to identify errors and ensure the information is complete and accurate; and (iii) an annual review of all arrangements, processing fees, or other payments or financial support (if any) provided to any compendia. Company s legal or compliance personnel shall be involved in this review

15 Samples, coupons, vouchers Policies/procedures around plans for distribution of samples, coupons and vouchers Including review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples, coupons, or vouchers

16 Social Media/DTC Policies/procedures around materials and information that may be distributed or made available through social media and/or direct to consumer advertising channels

17 Definition: Payor Interactions Entities that provide a drug health benefit program for Government Reimbursed Products, including but not limited to government payors (e.g., Medicaid and Medicare) or individuals or entities under contract with or acting on behalf of government payors and commercial health plans Included within scope of Product Related Functions Policies/procedures around how Medical Affairs personnel interact with or participate in meetings or events with HCPs, HCIs, or Payors

18 Risk Assessment/Mitigation Implement annual risk assessment/mitigation process (RAMP) - Compliance, legal and business unit leaders evaluate and identify risks associated with each product - Develop, implement and track specific plans designed to mitigate or reduce the identified risks - Independent Review Organization review of RAMP

19 Monitoring by Manufacturers: Monitoring used to be narrow in scope; now it can include some or all of the following, and continues to expand - In-depth product reviews - s - Call notes - Samples distributions - Post-marketing studies - Investigator initiated studies - Publication activities - Speaker programs frequency (varies: ) - Field monitoring frequency (varies: 30-60)

20 RECENT CIA TRENDS 20

21 Topics CIAs from 2014 and early 2015 Newer CIA provisions in 2014 requirements/areas of focus thought to be new standard omitted from more recent CIAs Settlements/Fines without Accompanying CIAs Exclusion from Participation in Federal Healthcare programs for Breach of CIA requirements The Shape and Focus of Future CIAs and enforcement

22 Latest CIA Trends No blockbuster settlements with the U.S. Government in 2014 From $3.4 Billion in 2013 to $852 Million in 2014 Why? Many pharmaceutical Companies currently under CIAs Many current CIAs are for smaller healthcare concerns; DOJ is looking at lower revenue targets

23 Newer CIA provisions New term of Chief Compliance and Risk Officer (CCRO) HCP Spend Disclosure Requirements Align with Sunshine Rule Independent Medical Education (IME) and Charitable Contributions - Quarterly Reporting; Grants Management System Successor Liability

24 HCP Spend Disclosure Track Sunshine HCP payment or other transfer of value (POTV) Published annually on searchable Company Website physician full name and address aggregate annual value to physician CIA definition of Payment mirrors Sunshine Act Final Rule, including Indirect and Third-Party Payments CIA links definition of reportable payments to Sunshine FAQs on CMS website

25 Independent Medical Education (IME) and Charitable Contribution Reporting Now called Third Party Educational Activity Require Company to develop processes around award of, and report out, IME and Charitable Giving Spend: *Way for OIG to track educational spend - a category currently exempt from reporting under Sunshine Grants Management System track from request/award, to disclosure & monitor Quarterly posting of IME grants and healthcare charitable contributions: name of recipient program name amount of grant or donation

26 Successor Liability Provision Formerly referred to as Changes to Business Units or Locations If Company under CIA proposes to sell any of its business units or locations, Company is to notify OIG 30 days prior to proposed sale with a brief description of terms of proposed sale- whether transaction to occur through sale of assets, sale of stock, or any other type of transaction OIG appears to be stressing that no legal entity maneuvering will shield successor Co from CIA liability/obligation/ adherence

27 Certain Provisions missing from more recent CIAs Provisions/topic areas of focus added to CIAs in omitted from some CIAs entered at same time: No required notification to HCPs about Company being under CIA (Shire) Not sever Sales Representatives Incentive Compensation Structure (Daiichi; Shire) Recoupment/Claw Back Provisions Not Included (Shire; Daiichi) Minimal discussion around Research Monitoring or Policy Promulgation (Daiichi)

28 Fines/Settlements WITHOUT a CIA AstraZeneca (2014) - 2 prior CIAs Medtronic Subsidiary ev3- March 2015 Why no accompanying CIAs? especially since CIA provides OIG oversight Possible reasons for no CIA with settlement: Company may already have compliance program in place Conduct was limited in scope; activity time-bound

29 Use of Non-Monetary Penalties to Promote Compliance US Dept of Justice and OIG committed to use non-monetary penalties to encourage entities to operate in a compliant manner, and Government enforcement agencies have put a renewed emphasis on non-monetary remedial measures that will help prevent misconduct from happening again. Stuart Delery, Ass t US Atty General, DOJ Civil Division, at ABA 10 th Nat l Instit. on FCA Enforcement, June 5, 2014 See

30 Exclusion for Breach of CIA Although rare, OIG can exercise exclusion authority - preclude company under CIA from participation in federal healthcare program if company breaches CIA provisions - E.g., in 2014, Church Street Health Management (CSHM-pediatric dental management chain providing dental services to children on Medicaid) enter into 5 yr. exclusion agreement with OIG

31 Future Enforcement Landscape Blockbuster settlements over $1B likely to be rare (none in 2013 or 2014) OIG likely to focus enforcement on smaller to mid-level healthcare companies Pace/Frequency of Settlements likely to continue at same pace given high filing volume (hundreds/per year) of qui tam/whistleblower suits DOJ is obligated to investigate relators continue to pursue suit even when DOJ declines to intervene Criminal charges against individuals where conduct has been egregious Caronia decision (US Court of Appeals, 2 nd Circuit): DOJ to go after promotional activity that involves both false and misleading presentation of off-label information; versus truthful, non-misleading (albeit off-label) promotional activities

32 For more information on this topic, attend the workshop Corporate Integrity Agreements & Regulatory Enforcement Trends at the Sharing Conference this September. Alliance Members may also visit the archive section to view past conference presentations on this subject and others. Register here. This document has been developed by The PDMA Alliance for use by its Members as educational information of general interest, and should not be construed as legal advice, official guidance or opinion on specific matters. Please address any questions or comments to Deb Segura, Alliance Executive Director,