PHA 6290 Pharmaceutical Fraud & Abuse

Fall B 2012

3 Semester Credit Hours

Course Purpose: Through this course students will learn the fundamentals of the United States laws and regulations pertaining to pharmaceutical fraud, waste, and abuse. The course will examine existing and emerging mechanisms to combat fraud, waste, and abuse, allowing students to gain enough understanding to assess actual or potential fraudulent and wasteful practices and consider ways to correct these practices in the pharmaceutical, pharmacy benefit management, and pharmacy industries.

Course Faculty and Office Hours Course Coordinator: Mary Jo Carden, RPh, JD [email protected] 202-744-2773

Teaching Assistants Danny J. Crudo, Pharm.D., M.S. [email protected] 239-298-1461

Lyndsy Pinchevsky Pharm.D., M.S. [email protected]

Office Hours Office hours will be online in a meeting room or via phone, Skype, text, email or whatever new technology may emerge to allow a virtual meeting. As long as I can use it, I will be happy to try it. Please contact instructor 2 days in advance via email requesting an “official” meeting date and time. Students may submit questions via email or text at any time and they will be answered within 24 hours, if not sooner.

Place and Time of Class Sessions Classes will be held in the virtual Adobe Connect classroom on Thursday and Sunday evenings from 8:30-10 pm. Classes will begin on Thursday, October 18, 2012 and the last official class will be held on Thursday, December 6, 2012.

Course Objectives Cognitive Objectives

Upon successful completion of this course, the student will be able to: 1. Describe the differing laws that affect fraud, waste, and abuse, including the False Claims Act, Medicare and Medicaid Antikickback Statutes, Title XVIII provisions, Fraud Enforcement and Recovery Act and Patient Protection and Affordable Care Act (ACA). 2. Describe the roles of the Department of Health and Human Services Office of the Inspector General (HHS-OIG) and the Department of Justice (DoJ) in combating fraud, waste, and abuse. 3. Define a false claim. 4. Define violations of the federal Antikickback Statute and the safe harbor exceptions to this statute. 5. Define Title XVIII offenses and the relationship to other laws and regulations. 6. Understand new laws that focus on reducing pharmaceutical waste and the implications to other fraud, waste, and abuse laws and regulations. 7. Describe the responsibilities for Medicare and Medicaid contractors in combating fraud and abuse. 8. Discuss requirements for Medicare Part D fraud, waste, and abuse training and compliance programs. 9. Describe the role of technology and data mining in fraud, waste, and abuse efforts. 10. Describe the role of Medicare Recovery Audit Contractors (RAC) under the Medicare Payment Integrity Programming in reducing fraud, waste, and abuse. 11. Discuss new and pending cases by HHS-OIG and DoJ related to fraud and abuse, including Qui Tam actions. Discuss the level of recent recoveries. 12. Discuss efforts to empower citizens in combating Medicare and Medicaid waste, fraud and abuse with a focus on the Health Care Fraud Prevention and Enforcement Action Team (HEAT). 13. Discuss recent activity to reduce waste in the health care system with a special focus on areas related to pharmacy and pharmaceuticals. 14. Discuss the fraud, waste, and abuse in relationship to drug pricing and discuss suitable alternatives to the existing pharmaceutical pricing benchmarks. 15. Review state efforts to combat Medicaid fraud in conjunction with federal government initiatives.

Skill Objectives Upon successful completion of this course, the student will be able to: 1. Design a marketing campaign for a pharmaceutical company that does not violate existing fraud, waste, and abuse regulations. 2. Develop a request for a safe harbors exception to the Antikickback Statute. 3. Analyze issues associated with a fraud, waste and abuse case currently under consideration in a case. 4. Provide a marketing program for a specialty product from the perspective of reducing fraud, waste, and abuse. 5. Develop a compliance plan for a pharmacy with potential fraud and abuse violations

Pre-Requisite Knowledge and Skills While no pre-requisite knowledge base is required, students must read and understand complex

laws, regulations, legal cases, and official government documents pertaining to fraud, waste, and abuse.

Course Structure & Outline

Course Structure.

a) Students will be required to attend live virtual lectures on Thursday and Sunday evenings.

b) Multiple self-directed learning activities are required (eg, videos, readings, web-based learning)

c) Exams and quizzes will be administered online. Exams and quizzes will be administered in the form of multiple choice, short answer, and essays.

Course Outline/Activities. Refer to Appendix A.

Textbook

Busch, Rebecca S, Healthcare fraud: Auditing and Detection Guide [2d Edition]. John Wiley & Sons, Inc., Hoboken, NJ (2012) ISBN978-1-118-17980-2.

Please refer to Appendix B and detailed list of assignments for additional reading materials from websites, federal documents, and for videos. Also, given the constant changes and activity in the area of fraud, waste, and abuse, students should expect new, late-breaking material to be provided throughout the semester.

Student Evaluation & Grading Evaluation Methods

Weekly Quizzes (4-5) 20% Problems (4) 20% Class Participation and Discussion Board 10% Midterm Exam 25% Final Exam 25%

Grading Scale:

A: 93.0 - 100 A- 90.0 – 92.9 B: 80.0 – 89.9 C+: 76.6 – 79.9 C: 73.3 – 76.5 C-: 70.0 – 73.2 D+: 66.6 – 69.9 D: 63.3 – 66.5

D- 60.0 – 63.2 E: <60

Please refer to the UFL Graduate School Catalog website for more Information regarding grading policy. http://gradschool.ufl.edu/catalog/current-catalog/catalog-general-regulations.html#grades

Class Attendance Policy

Class Participation: Full credit for class participation requires three (3) postings weekly on discussion board; one posting must be original threads, and two must be responsive postings in a thread started by someone else. Each of these postings should be relevant to the class and original to the student. Full credit for class participation also requires attendance at every virtual class, adequate preparation for class, and appropriate participation in class.

Students must attend classes or receive prior approval if they cannot attend. If the class is changed from the regular date and time for any reason, students will have an excused absence if they cannot attend, but will be responsible for the material covered. Students with more than 2 unexcused absences will automatically receive a 10-point deduction from his or her final class average.

Class participation and on discussion board is mandatory and graded pursuant to the policy listed above. Students who do not participate as outlined will receive a deduction from their final grade. Point deductions for lack of participation will be in addition to deductions based on unexcused absences.

Extra credit and bonus points will not be offered.

Quiz/Exam Policy and Make-up Policies Students who have excused absences must ensure that quizzes and problems assigned for the class are submitted on the date due unless other arrangements have been made with the instructor. Life happens, but please note, that only under extenuating circumstances will changes be made for a due date for an assignment, quiz, or exam.

Policy on Old Quizzes and Assignments Students will not receive access to old quizzes or exams, but the format of quizzes and problems given throughout the semester will be representative of the information contained in the exams.

Assignment Deadlines See Make-up Policies above. Unless the student has been granted specific permission, no make- up quizzes, exams, or problems will be allowed. Students who fail to submit assignments in a timely manner will not receive credit.

General College of Pharmacy Course Policies The College of Pharmacy has a website that lists course policies that are common to all courses. This website covers the following:

1. University Grading Policies 2. Academic Integrity Policy 3. How to request learning accommodations 4. Faculty and course evaluations 5. Student expectations in class 6. Discussion board policy 7. Email communications 8. Religious holidays 9. Counseling & student health 10. How to access services for student success

Please see the following URL for this information: http://www.cop.ufl.edu/wp- content/uploads/dept/studaff/policies/General%20COP%20Course%20Policies.pdf

Complaints

Should you have any complaints with your experience in this course please visit: http://www.distancelearning.ufl.edu/student-complaints to submit a complaint.

Appendix A: Schedule of Course Activities/Topics

Classes are held at 8:30-10 pm on Sundays and Thursdays.

Activity Dates Reading Video Assignments Learning Assignment Responsibilities

Orientation Class Oct. 18 --Chapts 1 and 2 2011 Stop Medicare Overview of Busch Fraud health care fraud, waste and abuse -GAO Report: Health regulations and Care Providers oversight Involved in FWA

Module I Oct. 21- --DoJ/HHS Annual Health Care Reform: --Quiz # 1 on 25 Fraud, Waste, and Fraud, Waste and Abuse October 25 New Requirements under the Abuse Report HHS Staff Discussion ACA --HHS-OIG Workplan: Table of Contents

Module II Oct 28 --FERA from Qui $295 Billion Sought in - What is a false Tam 101 Blog FWA claim? Discussion The False Claims Act board -Overview of the -- Problem #1 due False Claims Act on Oct 28

Module III Nov 1 -HHS-OIG website - None - Discussion archive on safe Board Antikickback Statute & Safe Nov 4 harbors/Antikickback - Quiz #2 Nov 1 Harbors Overview statute Nov 8 - Problem #2 due on November 1 Please see specific present a scenario detail below or to HHS-OIG reading assignments seeking an on Antikickback advisory opinion. statute - Quiz #3 Nov 8 -J&J settlement - Problem #3 due on Nov 8: Develop -Antipsychotic Use an appropriate Off-Label marketing scheme for a specialty drug product

Midterm Exam Posted 10 pm on November 8 due by midnight on November 11. No class on November 11.

No class on November 22: Happy Thanksgiving Note, please begin reading Chapters 3-8, 11, 14, and 17-20 in the Busch book in preparation for discussions beginning on November 25.

Module IV Nov 15 --Glumson article - Discussion Board - Quiz #4 : due Stark Law Overview Nov 18 --Overview of Stark November 18 Laws

Module V Nov. 25 -Proceedings from Qui Tam Whistleblower - Discussion Board Omnicare case Cases Explained Qui Tam and Whistleblowers --AMP Whistleblower case

Module VI Nov 29 -Make sure to have - Discussion Board read Chapters 3-6 in - Quiz #5 Dec 2 Medicare and Medicaid Fraud Dec 2 Busch (Nov 25) Medicare Fraud and Abuse --Problem #4: due Dec 6 -Read Chapter 11, on December 6 14, 17-20 for Dec 2 Provide and Dec 6 recommendations Medicare and Medicaid Drug for a pharmacy Pricing - Medicare Part D with potential Fraud, Waste and fraud and abuse

Abuse Manual, allegations Using analytic models to Chapt 9 detect and uncover FWA -HHS-OIG workplan

--Pharmacists offer Course wrap-up solutions to Medicare Part D fraud and abuse enforcement

--Cost of drug abuse in Medicare Part D

-Improving utilization controls in Medicare Part D

-NADAC or PAC article

-AMCP audit guidelines

--FirstDataBank

Drug Pricing Policy

-2009 Pharmacy Pricing Survey (or updated info if available)

--RACS, MACs article

Overview of Classes and Modules Please refer to grid above for reading assignments and any updates provided in class

Overview of Introduction Class: October 18:

The purpose of this class is to provide students with an overview of various fraud and abuse regulations. These regulations derive from the False Claims Act, federal Antikickback Statute, Medicare and Medicaid Statute, criminal statutes, FERA, the Stark Laws and the recently-enacted ACA.

As students prepare for this class, they should begin to distinguish among the different regulations but also draw comparisons and how each relates to the others. Students should also begin to ponder the efficiencies or the inefficiencies of the current infrastructure for fighting fraud, waste, and abuse.

Module I: New Requirements under ACA: October 21-25

These classes are designed to provide an overview of new provisions enacted under the ACA, or health care reform bill. The new provisions building upon existing provisions but also enact new, more stringent provisions.

Students should consider the real implications for health care providers and manufacturers. Do the new provisions make compliance impossible? Does it set the bar too high? What will the market implications be if these stringent provisions are implemented? Will the government continue to reap monetary benefits from fraud and abuse efforts or will enhanced enforcement costs outweigh any true gain to the federal deficit?

Quiz #1 on October 25

Module II False Claims Act and FERA Updates: October 28

Overview of Class

This class will provide an overview of the False Claims Act and recent amendments under FERA that update the False Claims Act. Recent changes to the False Claims Act increase the types of activities considered a false claim.

While preparing for this class students should consider the scope of the False Claims Act, understand a false claims and consider the new definitions of false claims. Question: do new false claims definitions define too many actions as a false claim? What should be the appropriate definition of a false claim?

Problem #1 due on October 28: A False Claim or not a False Claim: You Decide and You Analyze

Module III Antikickback Statute and Safe Harbor Provisions and Pharmaceutical Marketing Implications: November 1, 4, 8

Your reading should focus on the following issues related to the Antikickback statute:

• 1991 rule • Definition and scope of advisory opinions • Discount safe harbor/provision of free goods and services (1991) • Electronic prescribing (2006) • Waiver of beneficiary co-insurance and deductibles (2002) • Pharmaceutical marketing programs (2003) • Joint ventures (1991) • Use of coupons and discounts in Medicare Part D program • Gain sharing/swapping arrangements

The purpose these classes is review the federal Antikickback Statute and the implications to health care providers and to pharmaceutical manufacturers. The antikickback statute contains several safe harbors to allow certain appropriate transactions and activities that might otherwise be considered a kickback or improper. These exceptions are granted in the form of safe harbors and entities that seek to implement the safe harbor must ensure that all of the criteria are met for according to the exception.

Entities may also seek an advisory opinion from HHS-OIG to determine whether a business practice falls under an exception to the Antikickback statute. In order to be granted an advisory opinion, the entity must provide the exact details of the situation and also provide appropriate paperwork. Providing this information does not grant immunity from the Antikickback statute and therefore, entities must be careful when seeking an advisory opinion.

These classes will also discuss recent government focus on implications of the Antikickback statute on marketing and off-label drug use, a recent focus of government enforcement. Students should consider the relationship between marketing and the antikickback statute and the government’s goal in pursuing off-label drug use. Do these new enforcement actions create confusion for providers and beneficiaries? What is the government’s real motivation and does a better mean exist to achieve it?

Problem #2 due on November 1, 2012. Use the facts of one of three scenarios to seek an advisory opinion from HHS-OIG. Students must determine which scenario presents the best option for which to seek an advisory opinion, should provide the rationale for selecting that scenario, but also identify the potential downfalls when selecting that scenario.

Quiz #2 due on November 1

Quiz #3 on November 8

Problem #3 due on November 8: Develop and appropriate marketing scheme for a specialty drug

Module IV Stark Law Overview: November 15-18

The Stark Laws are specific to physicians and hospitals “self-referring business” to themselves. While these laws are not related directly to pharmacy or the pharmaceutical industry, certain interactions with physicians and pharmacies and the industry may have implications for the Stark Laws. It is important to have a brief understanding of these laws and regulations.

Do not forget to post to the discussion board.

Quiz #4 on November 18

No class on November 22—Happy Thanksgiving!

Module V Qui Tam and Whistleblowers: November 25

Qui Tam or whistleblower actions occur when an individual or a group of individuals within a company report potentially fraudulent, wasteful, or abusive behavior in violation of laws and regulations to the government. Individuals successful in these pursuits receive a portion of the settlements. These actions are long and often complicated. Some famous whistleblower cases have heralded individuals as heroes for the taxpayer, but not every whistleblower is so lucky, many lose their jobs and status within companies. Despite the risk, whistleblower actions are becoming more popular. As you prepare for this class consider the reasons for the increase in whistleblower actions. What are the motivations for the whistleblower? Are these actions always altruistic or does something else occur? Is an increase in whistleblower cases a good idea? Why or why not?

Do not forget to post to discussion board.

Module VI Medicare and Medicaid Prescription Fraud and Abuse and Drug Pricing Issues: November 29 and December 2-6

Prescription drug fraud issues facing the pharmaceutical industry, prescribers, and pharmacists and pharmacies are ever increasing. With the implementation of the Medicare Part D program, the implications for entities that participate directly in the program or provide contracted services are vast. Prescribers, the pharmaceutical industry, and pharmacists and pharmacies may all be held responsible for fraudulent activities that occur within the program either directly or indirectly because of their actions. Plan sponsors are at risk of fraud and abuse implications for the actions of contracted pharmacies and pharmacy benefit managers. Given these implications, it is important to understand the fraud and abuse issues associated with the Medicare Part D program.

The Medicaid program is a joint program sponsored by the federal and state governments. Therefore, fraud and abuse efforts center around both HHS-OIG, DoJ, as well as state attorneys general and Medicaid fraud enforcement units. Medicaid prescription drug fraud is an area of focus, particularly in states where declining revenues have caused attorneys general to increase enforcement against prescribers, manufacturers, and pharmacies. These efforts are important to understand, particularly the intersection of federal and state laws.

One way to combat prescription fraud and abuse is implementation of a change in the payment benchmark for Medicaid-dispensed generic medications. Other efforts to change the payment benchmark from average wholesale price, AKA “ain’t what’s paid” to another benchmark are also being implemented. Will these changes actually reduce fraud, waste, and abuse and increase transparency or will other levels of bureaucracy be created?

As students prepare for these lectures, they should consider both the direct and indirect implications on prescribers, the pharmaceutical industry, and pharmacies and pharmacists in these areas.

Quiz #5 on December 2.

Problem #4 due on December 6: Provide recommendations for a compliance plan for a pharmacy faced with fraud and abuse allegations.

Appendix B: Additional Reading Assignments

Websites to Bookmark

HHS Medicare Fraud http://www.stopmedicarefraud.gov/

HHS-OIG website https://oig.hhs.gov/

HHS-OIG 2013 Workplan https://oig.hhs.gov/reports-and-publications/workplan/index.asp

Qui Tam 101 Blog http://false-claims-act.net/tag/fera/

FDA Law Blog http://www.fdalawblog.net/fda_law_blog_hyman_phelps/

Safe Harbor Regulations: Archived Website https://oig.hhs.gov/compliance/safe-harbor-regulations/index.asp

Overview of Stark Laws

http://starklaw.org/

Supplemental Reading Assignments

GAO Report: Types of Health Care Providers Involved with Medicare and Medicaid Fraud, Waste, and Abuse http://www.gao.gov/assets/650/647849.pdf

DoJ/HHS 2011 Annual Fraud and Abuse Report https://oig.hhs.gov/reports-and-publications/hcfac/index.asp

Medicare Part D Fraud, Waste, and Abuse. Chapter 9, Medicare Prescription Drug Benefit Manual http://www.cms.gov/PrescriptionDrugCovContra/Downloads/PDBManual_Chapter9_FWA.pdf Safe Harbor Regulations: Archived Website (specifics provided later) https://oig.hhs.gov/compliance/safe-harbor-regulations/index.asp

Overview of the False Claims Act http://www.justice.gov/usao/pae/Documents/fcaprocess2.pdf

New Twists and Turns in Off-Label Marketing http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/09/new-twists-and-turns-in-off-label- marketing.html

J&J Settlement Restricts Distribution of Journal Articles http://www.cohealthcom.org/2012/09/10/jj-settlement-restricts-marketing-distribution-of-journal- article-reprints/

MA Relaxes Laws on Offering Prescription Drug Coupons and Meals to Health Care Practitioners http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/07/massachusetts-relaxes-laws-on-the- offering-of-prescription-drug-coupons-and-meals-to-health-care-practitioners.html

Overview of AMP False Claims Case http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/07/lack-of-regulatory-guidance-fatal- to-some-but-not-all-claims-in-amp-false-claims-act-case.html

Glusman, DH. Overview of Stark Regulations. Physician’s News Digest: January 2008. http://www.physiciansnews.com/business/108glusman.html

Medicare Part D: Instances of Questionable Access to Prescription Drugs, October 4, 2011 http://www.gao.gov/products/GAO-12-104T

AMCP Audit Guidelines for Pharmacies http://www.amcp.org/audit/

Pharmacists Offer Recommendations to Fight Medicare Part D Fraud http://www.ncpanet.org/index.php/news-releases/1162-pharmacists-offer-recommendations-to-fight- medicare-part-d-waste-fraud-and-abuse

Cost of Prescription Drug Abuse in Medicare Part D Program http://www.hhs.gov/asl/testify/2011/10/t20111004a.html

Use of Antipsychotics in the Medicare Part D Program; Impact of Protected Classes and Fraud http://rxoutcomesadviser.wordpress.com/2011/01/20/off-label-medicare/

Improving Utilization Controls in Medicare Part D http://www.cms.gov/Medicare/Health- Plans/MedicareAdvtgSpecRateStats/downloads/Announcement2013.pdf

NDAC or PAC: Examining Better Options for a Pricing Standard http://www.goldstandard.com/2012/04/nadac-or-pac-examining-options-for-a-better-drug-price- standard/

First DataBank Drug Pricing Policy http://www.firstdatabank.com/support/drug-pricing-policy.aspx

2009 Pharmacy Benefit/Drug Pricing Survey Summary and Report of Results. Pharmaceutical Strategies Group, July 2009. http://www.psgconsults.com/2009_PSG_Drug_Pricing_Survey_Report.pdf