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Microsoft word - baratz may 2010 newsletter.doc

UPDATES FROM BARATZ & ASSOCIATES, P. A.
FOR THE HEALTHCARE INDUSTRY
ASTRAZENECA PAYS $520 MILLION PLUS 5 YEARS CORPORATE The Department of Justice (DOJ) announced on April 27, as authors of articles written by AZ and its agents”. Also, 2010 that AstraZeneca LP (AZ) and AstraZeneca AZ “offered and paid illegal remuneration to doctors to Pharmaceuticals LP will pay $520 million to resolve travel to resort locations to “advise” AZ about marketing allegations that AZ illegally marketed the anti-psychotic messages for unapproved uses of Seroquel, and paiddrug Seroquel for uses not approved as safe and effective doctors to give promotional lectures to other health care by the Food and Drug Administration (FDA). AZ signed a professionals about unapproved and unaccepted uses of civil settlement to resolve allegations that, by marketing Seroquel” and “that these payments were intended to Seroquel for unapproved uses, AZ caused false claims for induce the doctors to prescribe Seroquel for unapproved payment to be submitted to federal insurance programs uses in violation of the federal Anti-Kickback Statute.” including Medicaid, Medicare and TRICARE programs, and tothe Department of Veterans Affairs, the Federal Employee If we think through the logic and thought process of the Health Benefits Program and the Bureau of Prisons. government’s contentions, it can be applied to a vast areaof the health care industry and not just “off-label” use of In this discussion, we are not going to focus on the main pharmaceuticals. The inference is that HCPs and HCIs are issue of “off-label” use, but instead, discuss the role of in a position to influence the flow of health care dollars Health Care Professionals (HCPs) and Health Care and, therefore, are prime targets for vendors, suppliers, Institutions (HCIs) and the requirements outlined in the 5 manufactures, medical facility providers, etc. to impact on year Corporate Integrity Agreement (CIA) that was required In the CIA that AZ agreed to, there are very specific areas The United States contends that AZ promoted the that address the financial relationships and dealings with unapproved uses “by improperly and unduly influencing the HCPs and HCIs. content of, and speakers, in company-sponsored continuing medical education programs. The Company also Below we have summarized some relevant areas of the CIA engaged doctors to give promotional speaker programs on that we think clearly delineates the government’s unapproved uses for Seroquel and to conduct studies on approach to relationships with HCPs or HCIs. These compliance polices required, clearly outline the government’s position that duties and responsibilities be The DOJ release stated, “in addition, the company recruited clearly defined, be appropriate and in compliance with doctors to serve as authors of articles that were applicable federal health care program and FDA ghostwritten by medical literature companies and about requirements, and that fair market value rates be studies the doctors in question did not conduct. AZ then determined and preset. In addition, an ongoing review of used those studies and articles as the basis for promotional the arrangements should be performed to insure that the messages about unapproved uses of Seroquel” and “that AZ actual work is performed appropriately. violated the federal Anti-Kickback Statute by offering andpaying illegal remuneration to doctors it recruited to serve Page 2 UPDATES FROM BARATZ & ASSOCIATES, P.A. The CIA states that the policies and procedures of AZ must address the following areas as it relates to HCPs and HCIs: 1) Consultant or other fee for service arrangements entered into with Health Care Professionals (HCP) or Health Care Institutions (HCI) (including but not limited to speaker programs, speaker training programs, presentations, consultant task force meetings, advisory boards, and ad hoc advisory activities and any other financial engagement or arrangement with an HCP or HCI and all events and arrangements. These Policies and Procedures shall U.S. based Physicians and related entities. be designed to ensure that the arrangements andrelated events are used for legitimate and lawful The above information gives valuable insight as to purposes in accordance with applicable Federal what the government believes companies should be health care program and FDA requirements The doing while conducting business. To ignore this insight Policies and Procedures shall include requirements is at your own peril. At the end of the day you must about the content and circumstances of such be able to appropriately answer the following: 2) Programs to educate sales representatives, including but not limited to presentations by HCP’s at sales meetings, preceptorships, tutorials and experience Compensation (including through salaries, bonuses and contests) for Relevant Covered Persons who are sales representatives shall be designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in improper promotion, sales and marketing of AZ government objectively in advance and reviewed at the To the extent that AZ engages U.S. based HCP’s orHCI’s for services other than for speaker programs, If you do the above, it will go a long way to ease your tutorials, preceptorships, or research related functions that relate to Promotional Functions or to Product Related Functions (e.g., as a member of an Ending note: The whistleblower in the qui tam lawsuit advisory board or to attend consultant meetings), will receive more than $45 million from the federal such HCPs or HCIs shall be referred to herein as consultants. AZ shall require all consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the consultants. Consultants shall be www.justice.gov/opa/pr/2010/April/10-civ-487.html paid according to a centrally managed, preset rate structure that is determined based on a fair market NOTE: FOR ADDITIONAL INFORMATION AND RESOURCES MAKE SURE YOU CHECK OUT OUR WEBSITE: http://www.baratzcpa.com
Copyright 2009 Baratz & Associates, P.A. E-mail: simmonsc@baratzcpa.com 4A Eves Drive, Suite 106 Marlton, NJ 08053 (856) 985-5688 Clifford Simmons, CPA Disclaimer: The information included in this correspondence is for reference use only and does not constitute the rendering of legal, financial or other professional advice by Baratz & Associates, P.A.

Source: http://www.baratzcpa.com/pdf/AstraZeneca-settlement-05-10.pdf

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