White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide - Chapter 1: Overview and Key Principles
pertaining to discounting and price reporting, see Orange Guide Chapter 12: Contracting and White
Guide Chapter 6: Government Health Care Programs.
Medicare Part D Regulations
The Medicare program provides a drug benefit to Medicare beneficiaries through Medicare “Part D.”
There are two types of Medicare health plans. “Medicare Advantage Prescription Drug” plans (also
called “MA-PD” plans) provide both medical coverage (for hospital and physician charges) as well as
drug coverage. Alternatively, stand-alone “Prescription Drug Plans” (also called “PDPs”) only provide
drug coverage. Beneficiaries who enroll in PDPs can still receive broader medical coverage through
Medicare.
MA-PDs and PDPs are private health plans which contract with the Centers for Medicare and Medicaid
Services (CMS), the federal agency that administers Medicare and Medicaid. CMS regulates these
health plans closely and has become increasingly vigilant in monitoring their interactions with
manufacturers. In particular, CMS has expressed concern that Medicare health plans not be
overcharged for prescription drugs and that all formulary placement and prescribing decisions be made
based on appropriate considerations. As a result, MA-PDs and PDPs are required to report their costs
to the government, and in so doing, must disclose any “direct or indirect remuneration” which they
receive from pharmaceutical companies. Accordingly, Pfizer should be vigilant in monitoring the
payments that it makes to MA-PDs and PDPs, as well as in its general relationship with these plans.
FDA Laws and Regulations
The Food and Drug Administration (FDA) regulates almost every aspect of our business, from research
and development to sales and marketing. FDA regulation of product advertising and promotion
directly affects our customer relationships. Therefore, all colleagues must understand the basic rules
we must follow to ensure compliance with FDA laws and regulations.
FDA: A federal agency responsible for the safety regulation of most foods, dietary supplements,
drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting
devices, veterinary products, and cosmetics.
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