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White Guide and Orange Guide Formatting Project - Pfizer

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<strong>Orange</strong> <strong>Guide</strong> - Chapter 10: Starters<br />

By law, pharmaceutical companies may provide starters only to licensed HCPs with authority to<br />

prescribe medication or, at the prescriber’s direction, to the pharmacy of the institution in which the<br />

licensed HCP works. Only a licensed HCP may sign a request for starters. The authority to prescribe<br />

<strong>and</strong>/or accept starters varies by state. Certain restrictions may apply to mid-level HCPs (e.g., NPs <strong>and</strong><br />

PAs) <strong>and</strong> their ability to prescribe <strong>and</strong>/or receive starters within their state.<br />

In addition, some states have particular limitations on distributing starters for controlled substances<br />

like Lyrica. Sales Colleagues should check with their manager, Starter Operations, or their Regional<br />

Attorney if they have questions about who can receive particular <strong>Pfizer</strong> starters in their state.<br />

Starters cannot, under any circumstances, be provided to an HCP:<br />

If the HCP intends to seek reimbursement from the government for the starter;<br />

If the HCP is within an excluded medical specialty;<br />

If the HCP intends to use the starter for his or her personal use;<br />

To reward the HCP for past prescribing or as a financial inducement for future prescribing;<br />

If it is reasonably certain that the HCP intends to prescribe the starters for an off-label use;<br />

or<br />

If the prescriber’s license number has not been verified in iCUE.<br />

Sales Colleagues may not initiate any starter transactions with an HCP until the State License Number<br />

(SLN) for that HCP is “verified” as valid in iCUE.<br />

In the past, other pharmaceutical companies <strong>and</strong> individuals have been charged under the False Claims<br />

Act <strong>and</strong> the anti-kickback laws, <strong>and</strong> fined hundreds of millions of dollars, for encouraging HCPs to bill<br />

government programs for starters. For this reason, HCPs must confirm their underst<strong>and</strong>ing <strong>and</strong><br />

acceptance of the fact that starters “cannot be sold, traded, bartered, returned for credit or utilized<br />

to seek reimbursement” by signing the eSAF (or paper SAF, in those limited circumstances where<br />

paper SAFs are permitted).<br />

<strong>Pfizer</strong> policy further provides that Sales Colleagues must witness the signature on Starter Activity<br />

Forms.<br />

184<br />

Rev. 09/12<br />

Page 8 of 17

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