A Focus on Off-Label Issues
|
|
- Ami Townsend
- 6 years ago
- Views:
Transcription
1 A Focus on Off-Label Issues Stephen F. Mohr Deputy Compliance Officer AstraZeneca Pharmaceuticals Sheryl Vacca West Coast Practice Leader Life Science Regulatory Practice Deloitte & Touche LLP
2 Disclaimer The information presented represents the opinions of the authors and does not necessarily reflect the views of AstraZeneca Pharmaceuticals LP or Deloitte & Touche LLP
3 Topics discussed 2005 Headlines Off-label promotion defined Governing Law Key Risk Areas The Neurontin case Other current investigations Serono settlement Impact on Compliance Departments
4 2005 Headlines From Rx Compliance Report Lew Morris, Chief Counsel HHS OIG Legal problems associated with off-label promotion have the potential to get even worse under the new Part D benefit About half the pharma companies have truly effective compliance programs in place, and half of them are just giving it lip service. Morris says companies may seek to put on manufacturer-sponsored conferences, get doctors to participate as medical experts, or hire them as consultants in order to push products for off-label uses, knowing that they may be reimbursed under the new Medicare Part D benefit
5 2005 Headlines From Rx Compliance Report Mary Riordan, Sr. Counsel, HHS OIG With Medicare Part D looming, OIG and Department of Justice will be vigilant in their coordination concerning evaluation of off-label cases
6 What is Off-label Promotion Marketing of a pharmaceutical product for uses not included in its FDA-approved labeling. Can include information as to unapproved: Indications Dosing Route of administration Patient population
7 Governing Laws Food Drug and Cosmetic Act False Claims Act Federal Anti-Kickback Statute
8 Food Drug and Cosmetic Act In order to obtain FDA approval to sell a pharmaceutical product, the manufacturer must demonstrate the safety and effectiveness of the product for its intended uses. Promoting a drug for uses outside of its approved indications constitutes the introduction of an unapproved new drug into interstate commerce in violation of the FD&C Act, 21 USC Sec. 331(d)
9 False Claims Act Prohibits knowingly presenting or causing to be presented a false or fraudulent claim for payment or approval by the federal government, 31 USC Sec In USA ex rel. Franklin v. Parke-Davis, 2003 WL (D. Mass.), district court held that the Relator need not prove that Parke-Davis lied to physicians about Neurontin s off-label efficacy in order to state a claim under the False Claims Act. [T]ruthful off-label marketing (ineligible for federal safe harbors) and financial incentives like kickbacks would suffice.
10 Federal Anti-Kickback Statute Makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce the purchasing or recommending of any item or service that the federal government may purchase or otherwise pay for under Federal health care programs. 42 U.S.C. Sec. 1320a-7b(b). Many cases of off-label promotion also involve allegations of kickbacks, for example consulting programs that are used inappropriately as a venue to deliver off-label messages
11 Off-Label Implications of Medicare Part D Implementation Formulary activities Expansion of coverage
12 Business Practices That Can Create Off-Label Risk Sales representative activities Field medical activities Reprint use Third party relationships Pharmacy benefit manager/gpo interactions Use of Consultants
13 Business Practices That Can Create Off-Label Risk (continued) Use of Speakers Clinical research grants Continuing Medical Education Publications Sampling Activity
14 The Neurontin Case Neurontin developed by Warner-Lambert (later acquired by Pfizer). Approved by the FDA in 1993 as an adjunctive anti-seizure medication for adult epileptics. Market began to plateau, so Warner- Lambert chose to pursue more off-label sales. Percentage of off-label use grew from 15% in 1994 to 94% in 2002.
15 The Neurontin Strategic Plan (as described in the Neurontin Sentencing Memorandum) Home office implemented strategic plan to maximize Neurontin opportunities in emerging applications Elements of the plan Educate the medical profession on emerging use areas Expand the user base beyond those treating epilepsy Expand communication regarding different types of uses of Neurontin Support publications regarding expanded uses of Neurontin Groom thought leaders for peer to peer selling in expanded use areas
16 Specific Tactics Used to Implement the Neurontin Strategic Plan (according to the Sentencing Memorandum) Direct selling on off-label indications Use of field medical personnel to push off-label use Preceptorships with physicians where off-label uses were discussed Lavish consultant meetings at which off-label uses were discussed Frequent teleconferences at which doctors were paid to speak about off-label topics Sponsoring allegedly independent CME events with extensive input from Warner-Lambert as to content
17 Neurontin Settlement Settled in June $430 million settlement payment Criminal guilty plea by Warner-Lambert to violation of the Food Drug & Cosmetic Act Detailed Corporate Integrity Agreement signed with OIG
18 Other current investigations Schering-Plough (May 2003) disclosed that the U.S. Attorney s Office in Boston is investigating its sales and marketing practices in a number of areas, including possible off-label promotion Johnson & Johnson (December 2003) disclosed that it received a subpoena from the U.S. Attorney s Office in Boston regarding promotional activities for one of its products, including alleged off-label marketing GSK (February 2004) disclosed that the U.S. Attorney s Office in Colorado is investigating its sales and marketing practices for a number of its drugs; the allegations include off-label promotion Eli Lilly (March 2004) disclosed that the U.S. Attorney s Office in Philadelphia was investigating its US marketing and promotional practices for several drugs, including its communications to physicians Bristol-Myers Squibb (August 2005) disclosed that it has received a subpoena from the U.S. Attorney s Office in Boston relating to alleged off-label promotion of one of its products Genentech (August 2005) disclosed that it is under investigation by the U.S. Attorney s Office in Philadelphia for alleged off-label promotion
19 Serono Settlement Case involved allegations of illegal sales and marketing activities surrounding the drug Serostim, approved for the treatment of a condition known as AIDS wasting. October 17, 2005 settlement includes $704 million settlement payment, a guilty plea to criminal conspiracy, exclusion for five years from participation in federal health care programs and a comprehensive Corporate Integrity Agreement In addition to allegations of kickbacks to physicians, the government asserted that Serono had caused the submission of false claims for reimbursement, which were based on tests developed by Serono to diagnose the condition of AIDS wasting that the government found to be inaccurate
20 Latest Views from DOJ Jeffrey Bucholtz, Dep. Asst. Attorney General at Department of Justice Activities raising red flags Paying doctors to attend meetings in expensive restaurants, sporting events or exotic locales to hear presentations about off-label uses Paying large fees to thought leaders to give speeches touting off-label uses Directing sales reps to market a drug to doctors who, because of their specialty, are very unlikely to ever prescribe the drug for the approved use Using medical liaisons to recommend off-label uses Making promotional claims that are not truthful, balanced or substantiated
21 Conclusion (Part I) Off-label marketing remains a prime focus of government investigations of the pharmaceutical industry Government is highly focused on cases where the generation of off-label sales is a home office approved strategy
22 Impact on Compliance Department Activities
23 Compliance Program Structure Governance Compliance Professional Employee Training Reporting Monitoring & Auditing Policies & Procedures Corrective Action
24 Compliance Perspective Board & Executive Committee Corporate Compliance Program Financial Risk Regulatory Risk Systems/IT Risks Operational Risks Code of Conduct Corporate Policies Compliance Standards Standard Operating Procedures Day-to-Day Operations Departmental Procedures
25 The Compliance Program Design Dilemma Designing an integrated compliance program that operates as one unit rather than many silos is challenging The business s processes and operations often function in silos The compliance-related risks touch every aspect of the organization s business & are difficult to compartmentalize The design should be based upon the organization s business strategies The design should result in an organization-wide compliance monitoring plan Risk Mitigation Business Processes Business Strategy Monitoring
26 Drivers of an Effective Compliance Program Federal Sentencing Guidelines OIG Guidance PhRMA Code Governmen t Price Reporting FDA - GxPs Pre-Approval Inspections (PAI) and PAI responses FDA - Promotional Practices Quality System (QSR) Compliance Structure /Governance X X Chief Compliance or Risk Officer X X Code of Conduct or Ethics Code Employee X X X Employee Training X X Reporting System X X Auditing & Monitoring X X Policies & Procedures X X X Corrective Action X X
27 The Role of Compliance in the Off-Label Crisis Primary Purpose Prevent illegal conduct related to off-label activities Protect the assets of the company Secondary Purpose Minimize adverse consequences to the company in the event illegal offlabel promotion conduct is identified Get Out Of Jail Free Card Examining the Evidence Intentional Acts Reckless Acts Innocent Mistakes The Key Objective of the Compliance Program The ability to identify the elements in action Making sure the program works The Critical Success Factors Scaling the approach Not biting off more than you can chew
28 Identify Business Gaps and Risks Identify the regulations, guidelines, standards that apply to the respective process Identify existing process from a-z, ie: sales rep makes a sales call, customer requests off-label information, etc. Include all business functions that relate to the activity Once the as is process is outlined, identify controls that are missing in the process, ie: clearly defined roles, objective policies, systems which have controls validated throughout the process, IT/manual systems for collecting data, duplications etc. Policies, ie: CME, Grants, Handling Off-label discussions, Med Ed, expenses, et. Systems, ie: data integrity, function, checks and balances Define to be process and identify action steps to address the gaps in the as is process
29 Risk Identification & Ranking Process Identify risks Rank risk criticality Locate risk potential in business Evaluate risk management status Determine risk likelihood Incorporate management of risk into compliance program
30 Locate Risk Potential in Business Product Information Dissemination Commercial Activities Promotional Materials Sales Calls Advisory Boards Convention Booths Third Party (CME) Grants Standards Food, Drug & Cosmetic Act FDA Promotional Regulations FDA Guidance on Industry-Supported Scientific and Educational Activities ACCME Guidelines for Commercial Support of Continuing Medical Education Government Investigation Settlements and Corporate Integrity Agreements PhRMA Code on Interactions with Healthcare Professionals (2002) HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers Reprint Dissemination Court Decisions Food and Drug Administration Modernization Act of 1997 There are numerous inherent risks and those risks touch aspects of every business process within the commercial organization
31 Compliance Approaches to Mitigating Off-Label Risk Is there a committee that reviews issues related to off-label activities? Compliance Committee Is there an employee handbook, code of conduct or operational policies and procedures that addresses off-label activities? Compliance Standards Are there training programs around off-label activities? Employee Education Is there a hotline or reporting mechanism for off-label complaints? Anonymous Complaint System Is there a mechanism to review compliance with company policies on offlabel activities? Auditing & Monitoring Is there an employee discipline system for unauthorized off-label activities? Corrective Action
32 Getting Started - Implementing Off- Label Compliance Strategic Decisions: Will the company prohibit all off-label communications? Will the company allow off-label communications that meet the safe harbor requirements? The company s decision will impact all compliance program components
33 Getting Started - Implementing Off- Label Compliance Risk Assessment Identify the off-label risks that are potentially critical or significant and require incorporation into the formal compliance program Rank risk criticality based on: Risk potential in business Risk likelihood Status of risk management currently in the company
34 Getting Started - Implementing Off-Label Compliance Compliance Committee Integrate off-label-related compliance structure into the company s enterprise-wide Compliance Program Off-Label Compliance Standards Develop compliance policies and procedures addressing off-label activities Employee Education Develop training materials which address off-label compliance Identify participants and roll out mandatory training Anonymous Complaint System Build a communication channel to find out about off-label compliance-related complaints or issues Monitoring Conduct audits or self-assessments as part of an ongoing auditing and monitoring cycle Corrective Action Keep track of employee discipline that relates to a failure to comply with company policies on off-label compliance
35 Create a Compliance Crosswalk Monitoring plan should be designed with the Compliance Program dilemma in mind. Monitoring creates the crosswalk between the Business Strategies and the Risk Areas. Vaccines will be available for the public Monitoring Quality Control and Drug Safety Business Strategy Will be impacted by many risk areas Monitoring Risk Area Apply to more than one business strategy
36 Auditing and Monitoring Cycle Define Review Scope & Assumptions Reaudit Develop Review Criteria Define Review Sample Define Methodology Education, Remedial Action Finalize Report & Corrective Action Plan Review Process for Each Risk Area Test Inter-rater Reliability with Multiple Reviewers Conduct Review Obtain Management Response Validate Findings Document Observations & Findings
37 Practical Considerations Related to Auditing and Monitoring Strategy
38 Practical Considerations Related to Auditing and Monitoring Strategy Developing your Auditing and Monitoring Plan Deciding what to monitor Prioritize Risk Areas Internal Factors, i.e. any system changes, people changes, new practice, etc. External Factors, i.e. new regulation, national and local enforcement activity Compliance Program evaluation Identify controls that make the process work : PROCESS AUDIT Determine overall purpose effective: OUTCOMES AUDIT Resources available to execute plan Consider integration with Internal Audit Plan Identify timeframes for audits Communication and Commitment to Plan
39 Developing Your Audit Approach Deciding the scope Narrow down the purpose of the audit Avoid scope creep before you start Resources available to execute the audit Methodology Sample size determination Communication/Reporting Results
40 Sampling Methodology What should you consider before you decide what your sample size will be? Who do you expect to share the information with and what is their frame of reference? Are you trying to figure out whether there is really a problem? What is the organization s perspective on fixing problems? What resources are available to audit this area? Does Senior Management agree this risk area is important? What is the worst case scenario if this audit reflects unfavorable outcomes? Attorney/Client Privilege?
41 Continuous Monitoring Cycle Monitoring never ends each review leads to the next, and the monitoring plan and unplanned issues drive additional monitoring activities. It is a continuous process Re-audit and add new audits to the cycle Finalize Report & Corrective Action Plan Define Review Scope & Assumptions Finalize Report & Corrective Action Plan Develop Review Criteria Define Review Scope & Assumptions Develop Review Criteria Finalize Report & Corrective Action Plan Define Review Scope & Assumptions Obtain Management Response Obtain Management Response Define Review Sample Document Observations & Findings Define Review Sample Develop Review Criteria Document Observations & Findings Conduct Review Document Observations & Findings Test Interrator Reliability Conduct Review Conduct Review Test Interrator Reliability Define Review Sample Re-audit and add new audits to the cycle
42 Corrective Action Plan Area of Focus Finding Recommendation Management Action Plan Acct/Timeframes 1. Contract load 1. 20% data errors in contract load Periodically review data entry Develop a periodic review system Accountable Party: 2. Etc. Etc. John Smith, VP Timeframe: 2 nd Quarter
43 Training Corporate compliance training Online Classroom CD-ROM Online courses include: Code of Ethics Code of Conduct Interactions with Healthcare Professionals Now You re A Manager Careful Communication Upcoming: Marketing & Promotion Basics 100% completion of online courses
44 Integration into Business Strategy Use monitoring findings to develop and document ROI Assist the business process owners to identify root cause of findings Use corrective action to enhance efficiency and mitigate risk Organization-wide (vs. silo) allow program leverage
45 Sample Report Card Develop the Report Card Department Privacy Inducements Risk Area Privacy Notice Employee Training Admissions Customer Service Or Complaints Employee Discipline Authorizations Minimum Necessary Access to Records Marketing Amendment of Records Confidential Communications Facility Directory Medical Records Business Associate Agreements
46 Summary An effective Auditing and Monitoring approach provides a method to: Assist in identifying risk to the business that may have been otherwise undetected internally Assist by identifying if the controls developed to remediate a risk are working and have actually helped to mitigate the risk Assist with preventing a real and/or potential risk from escalating by early detection through auditing which may help avoid additional harm to the company s business Provides a good faith organization the ability to approach their real and/or potential risk weaknesses with a reasonable, scaleable method Auditing and Monitoring is a critical element for an effective compliance program which helps to drive compliance and behavior.
47 Sheryl Vacca, CHC West Coast Practice Leader Life Sciences and Health Care Regulatory Deloitte & Touche LLP (714) Ms. Vacca is the West coast Leader for Deloitte & Touche s National Life Sciences and Health Care Regulatory practice. She has assisted several life science companies develop their compliance programs, investigations, perform risk assessments and develop auditing and monitoring plans for the compliance department. She has significant experience consulting with life sciences and health care organizations on compliance issues including self disclosure, writing plans of correction, implementing systems in response to plans of correction, implementing QA systems and general regulatory compliance.
Compliance Auditing & Monitoring
November 16, Compliance Auditing & Monitoring 3.02 Auditing and Monitoring for Compliance Karen R. Lines, Esq. Associate General Counsel Genentech, Inc. South San Francisco, CA Sheryl Vacca, CHC West Coast
More informationOff-Label Promotion: Risks, Controls and Assessment
7 th th Annual National Pharmaceutical Congress November 9, 2006 Off-Label Promotion: Risks, Controls and Assessment John T. Bentivoglio Co-Leader FDA/Healthcare Group jbentivoglio@kslaw.com 202.626.5591
More informationAmerican Academy of Orthopaedic Surgeons 2010 Annual Meeting
American Academy of Orthopaedic Surgeons 2010 Annual Meeting Off-Label Device Use: When Clinical Need Outpaces Regulatory Approval The Legal Parameters of Off-Label Use March 10, 2010 Kathleen McDermott
More informationRules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders
Rules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders Daniel Snyder, PhD Medical Director, Neurology North America Medical Affairs Ipsen Biopharmaceuticals, Inc.
More informationFourth Annual Pharmaceutical Regulatory and Compliance Congress
Fourth Annual Pharmaceutical Regulatory and Compliance Congress Preconference I A Compliance Primer for the Pharmaceutical Sector Michael P. Swiatocha November 12, 2003 Agenda for Preconference I Introduction
More informationWORKSHOP B Monitor MSL and Field Force Compliance
WORKSHOP B Monitor MSL and Field Force Compliance Jeremy Lutsky Sr. Legal & Compliance Counsel Theravance Biopharma US, Inc. Alison Benincasa Associate Director, Specialty Markets Compliance Christine
More informationARNOLD & PORTER UPDATE
ARNOLD & PORTER UPDATE Pharmaceutical Sales and Marketing Practices Government Also Cautions Medical Device Companies on Such Practices April 2003 On April 28, 2003, the Office of Inspector General, Department
More informationCompliance Plans. Kelly S. McIntosh July 20, 2017
Compliance Plans Kelly S. McIntosh July 20, 2017 Roadmap The importance of compliance and compliance programs Common compliance issues know your risk areas! Guidance for drafting or updating your compliance
More informationTriple C Housing, Inc. Compliance Plan
Triple C Housing, Inc. Compliance Plan Adopted by Board of Directors on draft November 13, 2014 Overview Triple C Housing, Inc. is committed to its consumers, employees, contractual providers, vendors,
More informationTrends in Pharma Enforcement and Compliance
Pharmaceutical Compliance Forum Trends in Pharma Enforcement and Compliance September 15, 2009 Discussion Topics Key Enforcement Trend: Beyond Sales and Marketing Compliance Trends Oversight and Accountability
More informationA. Establish compliance standards and system-wide policies and procedures;
WellSpan Health Manual of Administrative Policy Page 1 of 10 PURPOSE The WellSpan Health Compliance Program (Program) has been designed, adopted (1999), and implemented as a voluntary program to address
More informationPresentation Overview
How to Reasonably & Effectively Implement Compliance Programs for Small Group Physician Practices Andrea Merritt, Director of Compliance & Audit Services Ashlie Heald, Compliance Specialist Nova Compliance
More informationAfter approval, a biotechnology product continues to be subject to regulation
Chapter XVI Legal Requirements After Approval Areta L. Kupchyk, Esq. Reed & Smith, LLP Washington, D.C. After approval, a biotechnology product continues to be subject to regulation in that it must be
More information2/12/2014. Physician Hospital Integration 1. Physician-Hospital Integration Compliance Considerations. Agenda
Physician-Hospital Integration Compliance Considerations Frank E. Sheeder III Chair, Health Care Enforcement and Compliance Practice DLA Piper LLP (US) 214-743-4560 frank.sheeder@dlapiper.com Agenda 1.
More informationCode of Business Conduct
Code of Business Conduct High Ethical Standards: The Key to Our Success Our Code of Business Conduct is part of our way of life at Blue Cross Blue Shield of Michigan and Blue Care Network. Corporate ethics
More informationDeclaration Pursuant to California Health and Safety Code (e)
Declaration Pursuant to California Health and Safety Code 119402(e) Bausch + Lomb is committed to upholding the highest standards of business conduct and ethics in its relationships with its customers,
More informationINTRODUCTION. Overview of Compliance Program. I. Leadership and Structure. GSK Ethics & Compliance Program US Operations
GSK Ethics & Compliance Program US Operations INTRODUCTION GlaxoSmithKline (GSK) is one of the world s leading research-based pharmaceutical and healthcare companies. GSK s global mission is to improve
More informationToo Much of a Good Thing?
Regulatory s Role in Reviewing External Corporate Communications Too Much of a Good Thing? By John Driscoll Every regulatory professional is a reviewer. One could even say that the majority of our work
More informationMeasuring Compliance Program Effectiveness
Measuring Compliance Program Effectiveness Measuring Compliance Program Effectiveness: A Resource Guide HCCA Hawaii Regional Debbie Troklus, CHC-F, CCEP-F, CCEP-I, CHRC, CHPC Aegis Compliance and Ethics
More informationWhen the Government Knocks:
GHBER February 2, 2011 When the Government Knocks: The Impact of Compliance/Ethics Programs in Real Cases Win Swenson, Compliance Systems Legal Group www.cslg.com My Background and Where My Non- Public
More informationAllergan plc COMPREHENSIVE COMPLIANCE PROGRAM
Allergan plc COMPREHENSIVE COMPLIANCE PROGRAM 1. Compliance with Law All colleagues, officers and directors of the Company shall respect and comply with all applicable federal, state, local and foreign
More informationPatient Protection and Affordable Care Act (H.R. 3590) Approval Pathway for Biosimilar Biological Products
Approval Pathway for Biosimilar Biological Products On December 24, 2009, the U.S. Senate passed the, its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives
More informationGUIDELINES. Corporate Compliance. Kenneth D. Gibbs President & Chief Executive. Martin A. Cammer Senior Vice President & Corporate Compliance Officer
GUIDELINES Corporate Compliance Kenneth D. Gibbs President & Chief Executive Martin A. Cammer Senior Vice President & Corporate Compliance Officer Joyce Leahy Executive Vice President for Legal Affairs
More informationBUILDING AN EFFECTIVE COMPLIANCE PROGRAM
BUILDING AN EFFECTIVE COMPLIANCE PROGRAM April 22, 2010 Joseph L. Barloon Partner Litigation & Government Enforcement, Skadden Arps Slate Meagher & Flom LLP WMACCA Conference Julie A. Bell April 22, 2010
More informationYour Guide to the Compliance Process
Your Guide to the Compliance Process Our Commitment and Your Responsibilities Disciplinary Action Guidelines Guidance for Managers Investigations Process Overview US Reporting Process Overview Corporate
More informationOIG Increases Auditing of Pharmaceutical Manufacturers: Coupons, Part D Remuneration and Medicaid Rebate Administration
For Discussion Purposes Only; Not Intended as Legal Advice. BEIJING BOSTON BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG HOUSTON LONDON LOS ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE
More informationCompliance Strategies for Sample Management under PDMA
Compliance Strategies for Sample Management under PDMA Arjun Rajaratnam, GlaxoSmithkline Second Annual Pharmaceutical Industry Regulatory and Compliance Summit, June 11, 2001 1 Compliance Strategies for
More informationCODE OF CONDUCT A MESSAGE FROM OUR CEO. Dear Colleagues:
CODE OF CONDUCT A MESSAGE FROM OUR CEO Dear Colleagues: Few things are as important as your reputation. That s true for companies and individuals alike. Logitech s ethical reputation is the foundation
More informationNYSARC/CP Compliance Seminar: Risk Assessments. May 2, 2016 Robert Hussar and Melissa Zambri
NYSARC/CP Compliance Seminar: Risk Assessments May 2, 2016 Robert Hussar and Melissa Zambri rhussar@barclaydamon.com mzambri@barclaydamon.com Agenda Introductions Compliance Risk Assessment Process OMIG
More informationSouthwest Airlines Co. Code of Ethics
Southwest Airlines Co. Code of Ethics Introduction Southwest Airlines Co. is committed to maintaining the highest standards of ethical business practices and legal and regulatory compliance. We place a
More information2. The name of a private person bringing a civil action in the name of the U.S. is. 3. Medicare Part A pays primarily for.
Intro & Basics of the Law to Antitrust Laws (Possible 12 Continuing Education Units with 75% correct) 1. Name two benefits of a Compliance Program? 2. The name of a private person bringing a civil action
More informationHopedale Medical Complex. Document Title: Corporate Compliance Program Document Type: Plan. Owner: Chief Compliance Officer Committee Review:
Page id 25 The purpose and goals of the Program are to: PURPOSE & GOALS program significantly reduces the risk of unlawful improper conduct. waste from HMC, it is believed a sincere effort (via the Program)
More informationArc of Onondaga Corporate Compliance Plan
Arc of Onondaga Corporate Compliance Plan The Corporate Compliance Plan consists of eight key elements as well as a wide array of policies and procedures that address key risk areas, to guide our best
More informationCompliance Program Effectiveness Guide
Compliance Program Effectiveness Guide June 2017 This Guide is a comparison of: Compliance Program Elements New York State, Social Services Law 363-D Office of Inspector General (OIG) Compliance Program
More informationThe Company seeks to comply with both the letter and spirit of the laws and regulations in all jurisdictions in which it operates.
1. Policy Statement CRC HEALTH GROUP, INC. CRC HEALTH CORPORATION CODE OF BUSINESS CONDUCT AND ETHICS It is the policy of CRC Health Group to conduct its business affairs honestly and in an ethical manner.
More informationMARICOPA INTEGRATED HEALTH SYSTEM Code of Conduct and Ethics
MARICOPA INTEGRATED HEALTH SYSTEM Code of Conduct and Ethics Date: November 12, 2015 11.12.2015 Page 1 Code of Conduct and Ethics Revised and Effective November 12, 2015 I. PURPOSE This Code of Conduct
More informationCODE OF BUSINESS CONDUCT AND ETHICS
CODE OF BUSINESS CONDUCT AND ETHICS RESPONSIVE. RELIABLE. RESPECTED. TABLE OF CONTENTS Letter from the Chief Executive Officer...3 A Message from the Ethics & Compliance Department... 4 We Act Responsibly
More informationGuide to North America Healthcare Compliance 2016/2017
Guide to North America Healthcare Compliance 2016/2017 Dr. Reddy s Laboratories, Inc. NOTICE: this information is provided pursuant to the requirements of California Health & Safety Code 119400, 119402,
More informationCORE VALUES AND CODE OF CONDUCT
CORE VALUES AND CODE OF CONDUCT CORE VALUES AND CODE OF CONDUCT Colorado Access, its subsidiaries and affiliated entities, are dedicated to providing access to high quality healthcare services to members
More informationMEASURING & MONITORING RISK USING ANALYTICS
MEASURING & MONITORING RISK USING ANALYTICS APRIL 13, 2017 2017 HURON CONSULTING GROUP INC. PRESENTERS Brian Bohnenkamp Partner King & Spalding BBohnenkamp@KSLAW.com Jack Tanselle Managing Director Huron
More informationCorporate Compliance Program
June 26, 2001 Revision Approved June 26, 2002 Revision Approved by QMT December 9, 2003 Revision Approved by SLT December 12, 2007 Minor Revision August 25, 2008 TABLE OF CONTENTS INTRODUCTION...1 PURPOSE...1
More informationMedicare Compliance and Fraud, Waste and Abuse Detection and Prevention Program
Medicare Compliance and Fraud, Waste and Abuse Detection and Prevention Program Date Approved by Quality & Compliance Committee of the Governing Body: Effective Date: January, 2017 UAM Compliance Program
More informationChecklist for Higher Education
Checklist for Higher Education The following section contains a checklist addressing issues of particular relevance to higher education. The guidance is considered best practice for higher education. The
More informationAdvertising and Marketing Genetic Tests New Pathways or Old Roads?
Advertising and Marketing Genetic Tests New Pathways or Old Roads? Kathleen M. Sanzo, Morgan Lewis FDLI Advertising & Promotion Conference Wednesday, September 28, 2016 Context for Use of Genetic Tests
More informationDelta Dental of Michigan, Ohio, and Indiana. Compliance Plan
Delta Dental of Michigan, Ohio, and Indiana Compliance Plan Procedure #: 420-29 Issue Date: 5/15/2013 Last Revised Date: 5/23/2016 Last Review Date: 5/23/2016 Next Review Date: 5/23/2017 Title: Compliance
More informationUniversity of Florida, Pediatric Integrated Care System. Compliance Program. Policy: Ped-I-Care Program Integrity Plan Number: CD-0003
University of Florida, Pediatric Integrated Care System Compliance Program Policy: Ped-I-Care Program Integrity Plan Number: CD-0003 Programs: Title XIX and Title XXI Effective Date: Title XIX January
More informationCOMPOUNDING PHARMACIES: STEPS TO AVOID ISSUES WITH THE FDA, DEA, PHARMACY BOARDS, AND PATENT HOLDERS. Denise Leard, Esq Brown & Fortunato, P.C.
COMPOUNDING PHARMACIES: STEPS TO AVOID ISSUES WITH THE FDA, DEA, PHARMACY BOARDS, AND PATENT HOLDERS Denise Leard, Esq. 2017 Brown & Fortunato, P.C. INTRODUCTION 2 INTRODUCTION In the fall of 2012, a meningitis
More informationTHE CHATTANOOGA-HAMILTON COUNTY HOSPITAL AUTHORITY d/b/a ERLANGER HEALTH SYSTEM
THE CHATTANOOGA-HAMILTON COUNTY HOSPITAL AUTHORITY d/b/a ERLANGER HEALTH SYSTEM 2004 CORPORATE COMPLIANCE PROGRAM ERLANGER CORPORATE COMPLIANCE PROGRAM DESCRIPTION OF THE 2004 COMPLIANCE PROGRAM Purpose
More informationPharmaceutical Congress Spring Preconference Symposia Compliance 101 for Pharmaceutical Manufacturers
Pharmaceutical Congress Spring 2003 Preconference Symposia Compliance 101 for Pharmaceutical Manufacturers Michael P. Swiatocha June 8, 2003 Agenda Introductions & Objectives Overview of Industry Practices
More informationThe Company seeks to comply with both the letter and spirit of the laws and regulations in all countries in which it operates.
1. Policy Statement ROOT9B HOLDINGS, INC. CODE OF BUSINESS CONDUCT AND ETHICS The Nasdaq listing standards require that the Company provide a code of conduct for all of its directors, officers and employees.
More informationCode of Conduct. 1 P age
Code of Conduct 2013 1 P age Dear Colleagues, At INSYS, we believe in doing the right thing for our patients, customers, employees, communities and business partners. Our patients and customers trust the
More informationMarch 1, Ms. Selena Cuffee-Glenn Chief Administrative Officer
March 1, 2016 Ms. Selena Cuffee-Glenn Chief Administrative Officer The Office of the Inspector General (OIG) has completed an investigation of travel, training, and education expenditures of an employee
More informationHelping Pharmas Manage Compliance Risks for Speaker Programs
COGNIZANT 20-20 Helping Pharmas Manage Compliance Risks for Speaker Programs By taking a rigorous and thoughtful approach that pivots around key performance indicators, pharmaceuticals companies can proactively
More informationAMETEK, Inc. Code of Ethics and Business Conduct
AMETEK, Inc. Code of Ethics and Business Conduct Code of Ethics and Business Conduct A Message from the Chairman of the Board and Chief Executive Officer Dear AMETEK Colleague: AMETEK has been in business
More informationMount Sinai Health Partners and Initiatives Compliance Education
Mount Sinai Health Partners and Initiatives Compliance Education 2016 Audit and Compliance Services (ACS) Introduction 3 Welcome to the MSHP Compliance Education program The following presentation reviews
More informationDISCLAIMER. Remember! Please Be Respectful of Other Attendees by Turning Off Ringers on your Cell Phones/Pagers! AAPC Regional Conference
Is Your Compliance Program Compliant? Tips on Monitoring and Auditing the Effectiveness of Your Compliance Plan Michael D. Miscoe, JD, CPC, CASCC, CUC, CCPC, CPCO, CHCC DISCLAIMER DISCLAIMER This presentation
More informationRoundtable Webinar. Presenters. April 6, Managed Care Contracting Risks: An Antitrust, Government Pricing and Fraud & Abuse Analysis
Roundtable Webinar Managed Care Contracting Risks: An Antitrust, Government Pricing and Fraud & Abuse Analysis April 6, 2017 Seth Lundy John Shakow John Carroll Presenters Seth Lundy +1 202 626 2924 slundy@kslaw.com
More informationThe 14 Questions You Must Include In An Emergency Medicine Billing RFP
The 14 Questions You Must Include In An Emergency Medicine Billing RFP THE 14 QUESTIONS YOU MUST INCLUDE IN AN EMERGENCY MEDICINE BILLING RFP The standard process for evaluating organizations you re considering
More informationAudit Committee Presentation FY2011 Audit Plan (annual risk assessment) August 16, 2010
Audit Committee Presentation FY2011 Audit Plan (annual risk assessment) August 16, 2010 INTERNAL AUDITS ACADEMIC ENTERPRISE Are research and development expenses expended in accordance with the terms of
More informationBRONX ACCOUNTABLE HEALTHCARE NETWORK IPA INC., D.B.A. MONTEFIORE ACO PIONEER ACO CORPORATE COMPLIANCE PLAN
BRONX ACCOUNTABLE HEALTHCARE NETWORK IPA INC., D.B.A. MONTEFIORE ACO PIONEER ACO CORPORATE COMPLIANCE PLAN Approved by: The ACO Board of Directors Date: December 11, 2012 Introduction In cooperation with
More information10/10/2013. Hawaii Regional Annual Conference Conflicts of Interest Never End. Conflicts of Interest: Disclosure, Monitoring and Auditing
Hawaii Regional Annual Conference 2013 Conflicts of Interest: Disclosure, Monitoring and Auditing SHERYL VACCA, CHC-F, CCEP-I, CCEP-F, CHRC, CHPC SVP/CHIEF COMPLIANCE AND AUDIT OFFICER UNIVERSITY OF CALIFORNIA
More informationCorporate Compliance & the Antitrust Division
GLOBAL ANTITRUST ENFORCEMENT SYMPOSIUM Corporate Compliance & the Antitrust Division Kathryn Hellings Partner, Hogan Lovells Corporate Compliance & the Antitrust Division A. Guidance Antitrust practitioners
More informationPharmamarketing - strategic challenges
Pharmamarketing - strategic challenges Biomedicine Master Program Lund University Course: Biomedicine the Profession Anna Chérouvrier Hansson, MSc. December 16th, 2014 1. Pharmamarketing - definitions
More informationCOMPLIANCE PROGRAM MANUAL
2017 AUDIT & COMPLIANCE SERVICES Rev Date 20170526 COMPLIANCE PROGRAM MANUAL TABLE OF CONTENTS Section Title Page Preface 2 I. INTRODUCTION 3 A. Objective of the Compliance Program 3 B. Mission Statement
More informationCONFLICT OF INTEREST STATEMENT AND DISCLOSURE
CONFLICT OF INTEREST STATEMENT AND DISCLOSURE This statement is a summary of the Boyd Gaming Code of Business Conduct and Ethics and the Boyd Gaming policy regarding fraternization. For a complete version
More informationILLINOIS PERSONNEL RECORD REVIEW ACT
ILLINOIS PERSONNEL RECORD REVIEW ACT EMPLOYMENT (820 ILCS 40/) Personnel Record Review Act. (820 ILCS 40/0.01) (from Ch. 48, par. 2000) Sec. 0.01. Short title. This Act may be cited as the Personnel Record
More informationLiving Our Purpose and Core Values CODE. Code of Business Ethics and Conduct for Vendors
Living Our Purpose and Core Values CODE Code of Business Ethics and Conduct for Vendors December 2016 HCSC Vendor Code of Business Ethics and Conduct Since 1936, Health Care Service Corporation, a Mutual
More informationAN AUDIT OF INTERNAL CONTROL THAT IS INTEGRATED WITH AN AUDIT OF FINANCIAL STATEMENTS: GUIDANCE FOR AUDITORS OF SMALLER PUBLIC COMPANIES
1666 K Street, NW Washington, D.C. 20006 Telephone: (202) 207-9100 Facsimile: (202) 862-8430 www.pcaobus.org PRELIMINARY STAFF VIEWS AN AUDIT OF INTERNAL CONTROL THAT IS INTEGRATED WITH AN AUDIT OF FINANCIAL
More informationTrends in CMS Audits and Enforcement Actions Against Medicare Advantage and Part D Plans
ATTAC consulting Group LLC Lippincott Law Firm PLLC Trends in CMS Audits and Enforcement Actions Against Medicare Advantage and Part D Plans Anne Crawford, ATTAC Consulting Group LLC Elizabeth Lippincott,
More informationBenchmarking 101: Shaping your E&C Program for Maximum Value
Benchmarking 101: Shaping your E&C Program for Maximum Value Presented on November 15, 2016 Copyright 2016NAVEXGlobal,Inc. AllRightsReserved. Page 0 Presented by Mary Bennett Vice President, Advisory Services,
More informationSAMPLE COMPLIANCE PLAN. Last revised. Sample only for educational purposes/does not constitute legal advice
SAMPLE COMPLIANCE PLAN Last revised COMPLIANCE PLAN TABLE OF CONTENTS 1. INTRODUCTION... 1 1.1 COMPANYNAME S COMMITMENT TO COMPLIANCE... 1 1.2 BENEFITS OF THE COMPLIANCE PLAN... 1 2. COMPLIANCE WITH LAWS,
More informationCOMPLIANCE AT LARGER INSTITUTIONS. November 11 13, Robert F. Roach Chief Compliance Officer New York University
COMPLIANCE AT LARGER INSTITUTIONS November 11 13, 2009 Robert F. Roach Chief Compliance Officer New York University I. Introduction - What is Compliance? We re Watching You! In a University setting, the
More informationOver the last ten years, Congress has appropriated hundreds
Information Bulletin #23 RM RISK MANAGEMENT Series Jacqueline C. Leifer, Esq. Adam J. Falk, Esq. Feldesman Tucker Leifer Fidell LLP Washington, DC For more information contact: Betsy Vieth National Association
More informationMiMedx Group, Inc. Code of Business Conduct and Ethics
MiMedx Group, Inc. Code of Business Conduct and Ethics 1. Introduction. 1.1 The Board of Directors of MiMedx Group, Inc. (together with its subsidiaries, the "Company") has adopted this Code of Business
More informationSharp HealthCare s 2017 Compliance Education. Compliance and Ethics Module 1
Sharp HealthCare s 2017 Compliance Education Compliance and Ethics Module 1 1 Learning Objectives In this module you will learn about the following: Sharp HealthCare s Compliance and Ethics Program The
More informationVITAL SIGNS. Code of Business Conduct and Ethics
VITAL SIGNS Code of Business Conduct and Ethics TABLE OF CONTENTS Letter from the Chief Executive Officer...3 A Message from the Ethics & Compliance Department... 4 We Act Responsibly Toward Each Other
More informationWe have come a long way!
The Eighth Element of an Effective Compliance Program Presented by Kenneth L. Blickenstaff, BlickenWolf LLC and Kevin Bennett, StoneTurn Group LLP Scottsdale, Arizona Health Care Compliance Association
More informationCompliance with Laws, Rules and Regulations
R1 RCM Inc. (hereafter, R1 or the Company ) is committed to the conduct of its business in an ethical, legal, and transparent manner. In turn, the Company expects that all employees, contractors and vendors
More informationEuropean CEI. Compliance 101
European CEI Compliance 101 Debbie Troklus, CHC-F, CCEP-F, CHRC, CHPC, CCEP-I Managing Director Aegis Compliance and Ethics Center dtroklus@aegis-compliance.com Sheryl Vacca, CHC- F, CCEP-F, CCEP-I, CHRC,
More informationCompliance & Audit Rocks On
Compliance & Audit Rocks On Shawn DeGroot, CHC-F., CCEP Vice President of Corporate Responsibility Regional Health Lynda Hilliard, CCEP, CHC Deputy Compliance Officer Office of the President University
More informationDISCLAIMER: EDUCATIONAL ONLY
Good Intentions Are Not Enough: How to Re-Energize Your Compliance Program Through Focus, Support, and Accountability 2016 TPCA ANNUAL LEADERSHIP CONFERENCE Adam J. Falcone, Esq. Partner DISCLAIMER: EDUCATIONAL
More informationPromotion & Advertising of Combination Products: Key Postmarket Considerations
Combination Products Regulation, Policy, & Best Practices It s A Whole New Ballgame Are You All In? June 8, 2017 Promotion & Advertising of Combination Products: Key Postmarket Considerations Moderated
More informationTACKLING HEALTH CARE FRAUD, WASTE, AND ABUSE WHERE DO YOU START?
TACKLING HEALTH CARE FRAUD, WASTE, AND ABUSE WHERE DO YOU START? William Gedman CPA, CIA Vice President Quality Audit, Fraud & Abuse UPMC Insurance Services Division Pittsburgh, PA Session Outline Elements
More informationConflicts of Interest in Payor and Managed Care Organizations
in Payor and Managed Care Organizations Vickie McCormick Halleland, Lewis, Nilan, Sipkins & Johnson vmccormick@halleland.com 612.204.4156 Robert Freeman Associate General Counsel and Compliance Officer
More informationFRAUD SCHEMES. South Carolina HFMA Finance & Reimbursement Forum. November 13, 2012 WITH RELATED INTERNAL CONTROLS
FRAUD SCHEMES WITH RELATED INTERNAL CONTROLS South Carolina HFMA Finance & Reimbursement Forum November 13, 2012 2 Fraud Facts: Estimated loss of 5% of annual revenues to occupational fraud Financial statement
More informationCorporate Code of Business Conduct and Ethics
Corporate Code of Business Conduct and Ethics A MESSAGE FROM OUR CHAIRMAN, PRESIDENT AND CHIEF EXECUTIVE Honesty and integrity are paramount values at TRC. Our commitment to strict ethical standards has
More informationTable of Contents I. Introduction... 3 II. URAC Values and Business Ethics... 3 Values... 3 Business Ethics... 3 III. Compliance with Laws and
URAC Code of Conduct December 10, 2015 Table of Contents I. Introduction... 3 II. URAC Values and Business Ethics... 3 Values... 3 Business Ethics... 3 III. Compliance with Laws and Regulations... 4 IV.
More information.COM. Pharmaceutical Brand Management Achieving Managed Care Pull-Through Performance
Pharmaceutical Brand Management Achieving Managed Care Pull-Through Performance www.healthcaremedicalpharmaceuticaldirectory.com Healthcare Medical Pharmaceutical Directory.COM Pharmaceutical Brand Management
More informationCODE OF BUSINESS CONDUCT PENN NATIONAL GAMING, INC.
CODE OF BUSINESS CONDUCT PENN NATIONAL GAMING, INC. (as amended March 27, 2015) INTRODUCTION The reputation and integrity of Penn National Gaming, Inc. and its subsidiaries (the Company ) are valuable
More informationTransparency Debate in PBM Industry Consumer Driven Healthcare Summit Sept , 2006 in Washington, DC. Marina Tackitt PBMI
Transparency Debate in PBM Industry Consumer Driven Healthcare Summit Sept. 13-15, 2006 in Washington, DC Marina Tackitt PBMI Session Objectives Summarize Complexity of Drug Benefit Management Define Concept
More informationAccelerated Learning Healthcare Compliance and Policy Applications
Accelerated Learning Healthcare Compliance and Policy Applications Pamela Hrubey Crowe Horwath LLP Sergio Alegre Osmotica Pharmaceutical Dan O Connor PharmaCertify by NXLevel Solutions L. Stephan Vincze
More informationCommercial Speech and the First Amendment
Commercial Speech and the First Amendment Commercial speech (advertising products, etc.) does enjoy certain free speech rights, although it is not protected to the same extent as political speech. Initially,
More informationINTERNAL AUDIT Fraud Investigation Process Campus Administrative Training Series April 24, 2017
INTERNAL AUDIT Fraud Investigation Process Campus Administrative Training Series April 24, 2017 Stewart Cobine, CPA AVP & Chief Audit Officer Maggie Harrell, CFE Senior Investigative Auditor FOCUS OF SESSION
More informationAntitrust and Healthcare. Cory A. Talbot (4 15)
Antitrust and Healthcare Cory A. Talbot (4 15) What are we going to talk about? The (very) basics of antitrust enforcement How antitrust enforcement works in the healthcare arena Examples to help identify
More informationPharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance U.S. Department of Health and Human Services Food and Drug Administration Center for
More informationImplementing a Compliance Monitoring Program. January 29, 2014
Implementing a Compliance Monitoring Program January 29, 2014 1 Agenda 1. Mission and Purpose 2. Scope 3. Situational Analysis 4. Best Practices 5. Questions Mission and Purpose 3 Mission and Purpose Mission
More informationCODE OF ETHICS AND CONDUCT
CODE OF ETHICS AND CONDUCT PREFACE Green Mountain Power s Code of Ethics and Conduct is about doing the right thing acting honorably, treating each other with respect, and following the law. It s built
More informationEPCOR Utilities Inc. Ethics Policy
ETHICS POLICY Contents 1. APPLICATION... 2 2. POLICY REQUIREMENTS... 2 Fundamental Principles... 2 Respectful Workplace... 2 Use of EPCOR Property and Resources... 2 Appropriate Use of Technology and Electronic
More informationLIFEBRIDGE HEALTH INTEGRITY PROGRAM CODE OF EXCELLENCE
LIFEBRIDGE HEALTH INTEGRITY PROGRAM CODE OF EXCELLENCE I. MESSAGE FROM THE PRESIDENT It is the mission of LifeBridge Health to provide a broad array of high quality, cost effective health and health related
More information