PRS 105 REGULATORY COMPLIANCE CASE STUDIES PRS 105.7: THE WHISTLEBLOWER DR. BRUSHWOOD S MONOGRAPH

PRS 105 REGULATORY COMPLIANCE CASE STUDIES PRS 105.7: THE WHISTLEBLOWER DR. BRUSHWOOD S MONOGRAPH

PRS 105.7 THE WHISTLEBLOWER ACTIVITY DESCRIPTION This monograph presents the case study of United States ex rel. Fox v Omnicare. This is a qui tam case alleging fraudulent actions by two pharmacies in the submission of claims for payment of Medicare Part D prescriptions. The alleged fraud is related to the dispensing of medications prescribed for off-label indications, prescription splitting, failure to obtain prior authorization, and failure to charge mandatory co-payments. The court reviews a motion by the pharmacies to dismiss the case. This monograph can be taken as a standalone 1 credit hour home study in law (ACPE accredited) but is also a component of the Pharmacy Regulatory Specialist curriculum. To qualify as a PRS, one must enroll in each of the five (5) live PRS pharmacy law webinars given throughout the year and successfully complete twenty-six (26) one-credit monographs. Once all requirements have been completed, the participant must pass a final comprehensive exam (70% or higher) and pay $199 for the recording and issuing of the Pharmacy Regulatory Specialist Certificate. TARGET AUDIENCE The target audience for this activity is pharmacists and pharmacy technicians in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist and pharmacy technician will be able to: List the types of fraudulent activities that may constitute a false claim Discuss the rule of the qui tam relator in whistleblower lawsuits Describe the process through which courts review a Medicare Part D fraud claim ACCREDITATION PHARMACY PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. NURSING PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number 50-3515). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit http://www.nursecredentialing.org/renewalrequirements.aspx Universal Activity No.: 0798-0000-14-125-H03-P&T Credits: 1 contact hour (0.1 CEU) Release Date: July 14, 2014 Expiration Date: July 14, 2016 ACTIVITY TYPE Knowledge-Based Home Study Monograph FINANCIAL SUPPORT BY Pharmaceutical Education Consultants, Inc. 1

ABOUT THE AUTHOR David Brushwood is professor of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy. A graduate of the schools of pharmacy and law at the University of Kansas, professor Brushwood practiced both professions prior to entering academia. Professor Brushwood has developed error prevention programs for several pharmacy chains. His research interests are in the areas of regulating for outcomes, medication error prevention, and pain management policy. He has received grant funding from numerous agencies including the Robert Wood Johnson Foundation, the National Institutes of Health, and the National Community Pharmacy Foundation. Professor Brushwood received the 2012 Pellegrino Medal. The award honors nationally-recognized leaders for contributions to healthcare ethics in the selfless spirit of Edmund D. Pellegrino. He also has twice been selected as a Mayday Scholar in Pain Policy by the American Society of Law, Medicine & Ethics. Professor Brushwood is a frequent contributor to pharmacy journals and to law journals. He developed, and serves as an advisor for the UF online Master of Science in Pharmacy, a graduate program offering seven areas of specialization in regulatory pharmaceutical fields. David Brushwood, JD, RPh Professor, University of Florida School of Pharmacy FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. David Brushwood reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, authors may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient or pharmacy management. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this monograph and other unrelated sources. 2

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ACTIVITY TEST 1. In the case of United States ex rel. Fox v Omincare, in what practice setting were the alleged fraudulent services provided? A. Long-term care facilities. B. Community pharmacies. C. University wellness centers. D. Hospital pharmacies. 2. In the case of United States ex rel. Fox v Omnicare, what drugs were allegedly prescribed and dispensed for off-label uses? A. Benzodiazepines. B. Atypical antipsychotics. C. Opioids. D. Biphosphonates. 3. In the case of United States ex rel. Fox v Omincare, the defendant pharmacies were alleged to have partially filled prescriptions, requiring Part D beneficiaries to seek multiple refills for the same prescription. What is this practice called in the case? A. Partial filling. B. Multiple refilling. C. Prescription splitting. D. Prescription kiting. 4. In the case of United States ex rel. Fox v Omnicare, the defendant pharmacies were alleged to have dispensed Part D beneficiary prescriptions without having authorization to do so as required by the plan sponsor s CMS approved formularies. What is the authorization called in the case? A. Positive authorization. B. Principle authorization. C. Program authorization. D. Prior authorization. 5. In a qui tam action, what is the whistleblower officially called? A. Relator. B. Relative. C. Rogue. D. Renegade. 12

6. By whom may a qui tam action be brought on behalf of the United States? A. A person, but not a business. B. A business, but not a person. C. Either a person or a business. D. Neither a person nor a business. 7. What can be done to reduce the likelihood of a qui tam action? A. Implement an effective regulatory compliance program. B. Require a loyalty oath from all employees. C. Hire only professional employees. D. Nothing can be done to reduce the likelihood of a qui tam action. 8. When a report of a problem is submitted by an employee, what should be done to avoid a qui tam action? A. Take the report seriously, but a response need not be provided to the employee. B. A response to the employee should be provided, but the report need not be taken seriously. C. The report should be taken seriously and a response should be provided to the employee. D. The report need not be taken seriously and a response need not be provided to the employee. 9. In the case of United States ex rel. Fox v Omnicare, why did the court dismiss the defendant pharmacy s argument that it had no duty to determine if a drug has been ordered off-label? A. Nobody ever claimed the pharmacy had such a duty. B. The statute creates no such duty. C. The regulations create no such duty. D. Litigation has never recognized such a duty. 10. If several people are aware of fraudulent conduct, which one will be entitled to maintain a qui tam action? A. The person who first learned of the fraudulent conduct. B. The most senior person to have learned of the fraudulent conduct. C. The first person to file a legal claim alleging fraudulent conduct. D. The person with the best knowledge of the fraudulent conduct. Please submit your final responses on freece.com. Thank you. 13