Orange Guide (also known as the Field Guide ... - Pfizer

1 Dear Colleagues, At Pfizer , we are committed to our purpose of breakthroughs that change patients lives, which means upholding the highest standards when we interact with physicians, healthcare organizations, patients, and other stakeholders. The Orange Guide (also known as the Field Guide ) provides an overview of the laws, regulations, Pfizer policies and guidelines that govern our Field colleagues in the biopharmaceutical business. A revised edition of the Orange Guide is now available on MyPfieldNet. It is essential that you familiarize yourself with the Orange Guide . Every colleague is accountable for understanding and meeting our company s compliance requirements. Do not hesitate to consult with your team attorney or the Orange Guide team at if you have any questions. By acting with integrity every day and always embodying our values of Courage, Excellence, Equity and Joy, we believe we will make great progress in leading the conversation and becoming known as the most patient-centric company.

2 To access the tools and resources you need to act with integrity, visit Rady A. Johnson Douglas M. Lankler The Orange Guide Living our value of Equity requires that we act with integrity. One way we demonstrate our commitment to integrity is by complying with laws and the rules governing our business. Compliance with these laws builds trust with patients, Healthcare Professionals, institutions, purchasers, and the government. It is also critical to achieving our purpose of breakthroughs that change patients lives. Copyright 2020 Pfizer Inc. All rights reserved Orange Guide Chapter and Appendix Rev. 12/20 Page 2 of 414 CONTENTS CHAPTER #1 OVERVIEW AND KEY PRINCIPLES .. 2 CHAPTER #2 INTERACTIONS WITH HCPs AND HEALTH SYSTEMS .. 23 CHAPTER #3 SUPPORT OF EXTERNAL ORGANIZATIONS .. 60 CHAPTER #4 FEDERAL EMPLOYEE INTERACTIONS AND LOBBYING .. 81 CHAPTER #5 INTERACTIONS WITH HEALTH SYSTEMS .. 106 CHAPTER #6 CLINICAL RESEARCH AND CLINICAL RESEARCH COLLABORATIONS.

3 134 CHAPTER #7 P&T COMMITTEE INTERACTIONS .. 143 CHAPTER #8 PRIVACY: PROTECTING PERSONAL INFORMATION .. 154 CHAPTER #9 SPEAKER PROGRAMS FOR HCPS .. 173 CHAPTER #10 STARTERS .. 206 CHAPTER #11 THE Pfizer PATIENT ASSISTANCE PROGRAM, DONATIONS TO INDEPENDENT CHARITY PATIENT ASSISTANCE PROGRAMS, AND PATIENT SUPPORTPROGRAMS .. 222 CHAPTER #12 DISCOUNT ARRANGEMENTS AND CONTRACTING .. 242 CHAPTER #13 HEALTH SCREENINGS .. 251 CHAPTER #14 ORGANIZED CUSTOMER AND PAYER TOOLS AND RESOURCES .. 259 CHAPTER #15 SERVICE AGREEMENTS AND OTHER NON-DISCOUNT ARRANGEMENTS WITH ACCOUNTS .. 267 CHAPTER #16 CONSUMER, PATIENT, AND EMPLOYEE INTERACTIONS .. 277 CHAPTER #17 STATE LAWS: HCP AND STATE EMPLOYEE RESTRICTIONS .. 288 CHAPTER #18 MEALS, EDUCATIONAL ITEMS, GREENSTONE GIVEAWAYS, AND HCP PAYMENT DISCLOSURE .. 326 CHAPTER #19 HEALTH INFORMATION TECHNOLOGY ENGAGEMENTS .. 349 CHAPTER #20 SPECIAL TYPES OF SERVICES AGREEMENTS INTERACTIONS WITH SPECIALTY 364 CHAPTER #21 PATIENT SUPPORT ROLES.

4 371 CHAPTER #22 INDEPENDENT MEDICAL GRANTS .. 384 APPENDIX ACRONYM LIST .. 394 Chapter and Appendix CHAPTER #1 OVERVIEW AND KEY PRINCIPLES Orange Guide Chapter 1: Overview and Key Principles Rev. 12/20 Page 4 of 414 Chapter #1 OVERVIEW AND KEY PRINCIPLES CONTENTS 6 Field Commercial Colleague Roles .. 7 Sales Colleagues .. 8 account Managers .. 8 Patient Support Roles .. 9 Overview of Key Healthcare Laws and Regulations .. 11 Anti-Kickback Laws .. 11 Safe Harbors from the Federal Anti-Kickback 12 Federal Health Care Programs .. 13 Medicaid Best Price Law .. 14 Medicare Part D Regulations .. 14 FDA Laws and 15 15 Promotional Labeling .. 16 Starters (Samples) .. 16 Federal and State Pharmaceutical Disclosure and Compliance Laws .. 17 Overview of Other Key Laws and Regulations .. 17 False Claims Act .. 17 Privacy Laws .. 18 State Consumer Protection Laws .. 18 Foreign Corrupt Practices Act .. 18 Industry Codes, Guidance, and Our Government Agreements .. 19 PhRMA Code.

5 19 PhRMA Guiding Principles Direct To Consumer Advertisements About Prescription Medicines .. 19 OIG Compliance Program Guidance for Pharmaceutical Manufacturers .. 20 Pfizer s Government Agreements .. 20 Overview and Key Principles Orange Guide Chapter 1: Overview and Key Principles Rev. 12/20 Page 5 of 414 Pfizer s Corporate Integrity Agreements .. 20 Pfizer s State Attorneys General Agreements .. 21 Violations and Penalties .. 21 Pfizer s Compliance 22 For More Information .. 22 Orange Guide Chapter 1: Overview and Key Principles Rev. 12/20 Page 6 of 414 Chapter #1 Overview and Key Principles Living out our value of Equity requires that we act with integrity. One way we demonstrate our commitment to integrity is by complying with laws and regulations that govern our business. Compliance with these laws builds trust with patients, Healthcare Professionals (HCPs), institutions, purchasers, and the government. It is also critical to achieving our purpose of breakthroughs that change patients lives.

6 All Pfizer colleagues must understand how laws, regulations, guidance, and industry codes that govern our business apply to their roles; including, but not limited to: Key Healthcare Laws Anti-Kickback Laws (state and federal); Medicaid Best Price Law & Medicare Part D Regulations; FDA Laws & Regulations; and Federal and State Pharmaceutical Disclosure and Compliance Laws. Other Key Laws False Claims Act; Privacy Laws; State Consumer Protection Laws; and Foreign Corrupt Practices Act. Industry Codes, Guidance, and Government Agreements PhRMA Code on Interactions with Healthcare Professionals; PhRMA Guiding Principles on Direct to Consumer Advertising; OIG Compliance Program Guidance for Pharmaceutical Manufacturers; and Pfizer 's Corporate Integrity Agreement and State Attorneys General Agreements. Introduction Orange Guide Chapter 1: Overview and Key Principles Rev. 12/20 Page 7 of 414 This Chapter provides an overview of some of the key laws, regulations, guidance, and industry codes that apply to our business.

7 The policies contained in this Guide are designed to help ensure that your activities comply with these laws, regulations, guidance, industry codes, any applicable CIAs and State Attorneys General Agreements. Alternative approaches may be permissible in particular circumstances if approved by Legal. Non-compliance with these policies can subject Pfizer colleagues to disciplinary action up to and including termination of employment. Further, improper activities that violate one or more of these laws and regulations could result in criminal and civil penalties for you and the Company. If the application of any policy is unclear to you, discuss the issue with your manager or team attorney. While integrity is required of, and the laws discussed in this Chapter apply to, all Pfizer colleagues, the Orange Guide is designed specifically for Field commercial colleagues ( Field Commercial Colleagues ) to help Guide them in the appropriate conduct of their responsibilities.

8 Field Commercial Colleagues are Pfizer colleagues whose primary responsibility is to interact with Pfizer customers. Field Commercial Colleagues include, but are not limited to, Pfizer Sales Colleagues ( Sales Representatives, Area Business Managers (ABMs), District Business Managers (DBMs), Regional Business Directors Makes it illegal to offer to pay or provide anything of value knowingly and willfully in order to induce an individual or entity to recommend or prescribe a product or service that is reimbursed by the government. It is also illegal to ask for or receive a payment in exchange for prescribing or recommending a product or service that is reimbursed by the government. Anti-Kickback Laws: Prohibits charging Medicaid more than the lowest price ( , best price ) at which Pfizer offers a product to any other customer. Pfizer must calculate and report to the federal government our best price for each product. Best Price Law: Prohibits making, or inducing someone else to make, a false claim for reimbursement from the federal government.)

9 False Claims Act: Field Commercial Colleague Roles Orange Guide Chapter 1: Overview and Key Principles Rev. 12/20 Page 8 of 414 (RBDs), account Managers ( Key account Managers (KAMs), Vaccines account Managers (VAMs), Vaccines account Directors (VADs), PCA account Directors, and Patient Support Roles ( Field reimbursement managers). Sales Colleagues Sales Colleagues generally refers to those Field Commercial Colleagues, and their managers, who are charged with the promotion of Pfizer products to drive sales in assigned accounts and with assigned targets. Sales Colleagues engage, influence, and educate customers throughout the selling process. For Sales Colleagues, customers are generally individual HCPs. In this context, HCP is a broad term that includes any individual who directly interacts with patients or has a role in patient diagnosis or treatment. Most crucially, Sales Colleagues are typically compensated based in part on sales credit and quota.)

10 Sales Colleagues include, but are not limited to, Sales Representatives, Territory Managers, Area Business Managers, and Regional Business Directors. Sales Colleagues focus on individual HCPs and the way Sales Colleagues are compensated differs from account Managers, as discussed below. account Managers The term account Manager refers to Field Commercial Colleagues whose primary focus is calling on and developing productive relationships with key decision makers at health systems, Integrated Delivery Networks (IDNs), medical groups, specialty and retail pharmacies, health plans [ , Health Maintenance Organizations (HMOs), Pharmacy Benefit Managers (PBMs), and other managed care entities], state departments of health, county/city health departments, purchasing groups, Group Purchasing Organizations (GPOs), military accounts (VA/DoD), Medicare, Medicaid, and advocacy groups/coalitions ( Accounts ). Key decision makers may include persons serving in an executive or administrative capacity at an account but would not typically include individual prescribing HCPs.