While it has been a few months since the last large settlement involving the off-label promotion of pharmaceutical products, the Department of Justice and the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) recently announced a $95 million settlement with Boehringer Ingelheim Pharmaceuticals Inc (or BIPI).
The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $13.8 billion, and are another product of the government’s Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of HHS, in May 2009.
The settlement resolves allegations relating to the improper promotion of the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease (COPD) drugs Atrovent and Combivent, and the hypertension drug Micardis, the Justice Department announced in late October.
According to the government’s allegations, Boehreinger promoted each of the three drugs for uses that were not medically accepted indications and were not covered by federal health care programs. Specifically, the settlement resolves allegations that Boehreinger promoted Aggrenox for certain cardiovascular events such as myocardial infarction and peripheral vascular disease; that Combivent was marketed for use prior to another bronchodilator in treating COPD; and that Micardis was marketed for treatment of early diabetic kidney disease. The uses were not for medically accepted indications and were not covered by federal health care programs.
Additionally, the settlement resolves allegations that Boehringer knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs and that Boehringer knowingly made unsubstantiated claims about the efficacy of Aggrenox, including that it was superior to Plavix. Finally, the agreement resolves allegations that the company paid kickbacks to health care professionals to induce them to prescribe Aggrenox, Atrovent, Combivent and Micardis.
Typical with other large off-label settlements, Boehringer has agreed to enter into an expansive Corporate Integrity Agreement (CIA) that provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to the settlement. Inspector General Daniel Levinson noted that, “OIG is overseeing a Corporate Integrity Agreement to improve the transparency of company relationships with physicians and accountability of Board members and corporate executives.”
Corporate Integrity Agreement
OIG’s CIA with Boehringer contains the typical boilerplate provisions and definitions as other pharmaceitucal company CIA’s. Below is a brief summary of some of the relevant provisions in the CIA.
The CIA defines “Third Party Educational Activity” as “any continuing medical education (CME), disease awareness, or other scientific, educational, or professional program, meeting, or event supported by Boehringer, including but not limited to, sponsorship of symposia at medical conferences.”
Boehringer’s CIA requires that the Board of Directors of the company be “responsible for the review and oversight of matters related to compliance for the review and oversight of matters related to compliance.” In addition, a number of executive employees of the company are required to certify in writing compliance with the CIA.
The CIA also requires Boehringer to have policies and procedures in place regarding the sponsorship or funding of grants (including educational grants) or charitable contributions. The policies and procedures must be designed to ensure that BIPI’s funding and/or sponsorship complies with all applicable Federal health care program and FDA requirements. Similarly, the company must have policies and procedures in place regarding the “funding of, or participation in, any Third Party Educational Activity.” Such policies and procedures must “be designed to ensure that BIPI’s funding and/or sponsorship of such programs satisfies all applicable Federal health care program and FDA requirements. Specifically, their policies and procedures require:
- Boehringer disclose its financial support of the Third Party Educational Activity and, to the extent feasible consistent with subsection III.B.3.l.4 below, any financial relationships with faculty, speakers, or organizers at such Activity;
- as a condition of funding, the third party shall agree to disclose Boehringer’s financial support of the Third Party Educational Activity and to require faculty, speakers, or organizers at such Activity to disclose any financial relationship with Boehringer
- the Third Party Educational Activity have an educational focus;
- the content, organization, and operation ofthe Third Party Educational Activity be independent of Boehringer’s control;
- Boehringer supports only Third Party Educational Activity that is non-promotional in tone/nature; and
- Boehringer’s support of a Third Party Educational Activity shall be contingent on the provider’s commitment to provide information at the Third Party Educational Activity that is fair, balanced, accurate and not misleading
The CIA also requires policies and procedures regarding authorship of journal articles or other publications about Government Reimbursed Products or about therapeutic areas or disease states that may be treated with Government Reimbursed Products, including, but not limited to, the disclosure of any and all relationships between the author and Boehringer, the identification of all authors or contributors (including professional writers) associated with a given publication, and the scope and breadth of research results made available to each author or contributor.
Field Force Monitoring and Review Efforts
The company must also fulfill a number of requirements regarding Field Force Monitoring and Review Efforts. First, Boehringer must maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use BIPI approved materials and may not directly or indirectly promote the product for off-label uses.)
In addition, BIPI must maintain a centralized electronic system through which all speaker programs are administered. This system must establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by BIPI. BIPI must maintain a comprehensive list of speaker program attendees through its centralized system. In addition, BIPI must track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. The company will also have to conduct live audits of 75 speaker programs each year.
Monitoring of Non-Promotional Activities
Boehringer will have to conduct audits of 30 Publication Activities; 20 Researcher arrangements with healthcare providers; 20 advisory board arrangements; and 20 other types of Consultant arrangements. The targeting of each of these activities will be done on both a risk-based targeting approach and on a sampling approach.
The company will also have to conduct audits on at least 30 medical education grants. Monitoring Personnel conducting the Grants Monitoring Program must review proposal documents (including grant requests), approval documents, contracts, payments and materials relating to the grant office’s review of the requests, and documents and materials relating to the grants and any events or activities funded through the grants in order to assess whether the activities were conducted in a manner consistent with BIPI’s Policies and Procedures. Results from the Grant Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Ethics and Compliance Department for review and follow-up as appropriate.
Reporting of Physician Payments and Other Transparency
The CIA, mostly consistent with the Physician Payment Sunshine Act proposed regulations, requires the company to also post certain payments on a public website.
BIPI must also post on its company website the following information with respect to both grants and charitable contributions to U.S.-based HCPs and HCIs: 1) the ultimate recipient organization’s name, to the extent known by BIPI; 2) a brief description of the program for which the grant or charitable contribution was requested; and 3) the amount of the grant or charitable contribution.