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Under the 2003 Medicare reform law, Part D sponsors must negotiate maximum price concessions from pharmaceutical manufacturers on behalf of beneficiaries, and then provide beneficiaries access to the negotiated prices. Plans also must report to CMS on a quarterly basis data with respect to rebates received, even if they use pharmacy benefit managers (PBMs) for that purpose. And CMS and OIG will hold the sponsors responsible not only for passing on the rebates to beneficiaries but also for any fraud and abuse regarding rebates on the part of the sponsors’ PBMs.

Three of the industry’s leading experts show you how to:

• Identify potential fraudulent and abusive situations in the drug-rebate negotiation process;
• Apply the 2003 Medicare reform law to contractual arrangements, including discounts, rebates and administrative fee arrangements; and
• Structure drug-rebate negotiations to avoid potentially fraudulent situations and stay in compliance with Part D requirements.

Among the topics covered are:

• What is the definition of a “negotiated price,” and what is included and excluded?
• How much of drug-company rebates must be reported to CMS?  
• How much of direct or indirect remuneration realized by a PBM must be allocated to the plan?
• What are the consequences if a plan sponsor fails to disclose or misrepresents rebates, discounts, price concessions, or other value-added gifts, including concessions offered by pharmaceutical manufacturers?
• What are the consequences to a plan sponsor if a contracted PBM fails to offer beneficiaries negotiated prices of Part D drugs?
• What are the best practices plans should follow when negotiating drug prices and rebates with drug manufacturers, including discounting drugs in the six protected classes?

Speakers

Gina M. Smith, of counsel, is in the litigation department of Ballard Spahr Andrews & Ingersoll, LLP, where she is a member of the white collar litigation group. Ms. Smith focuses her practice on developing corporate compliance and governance programs for public and private clients of all sizes and across all industry segments. She conducts sensitive, internal investigations and defends corporations and individuals facing criminal investigation and prosecution from federal, state and regulatory authorities. Prior to joining Ballard Spahr, Ms. Smith served for 18 years as an assistant district attorney in the Philadelphia District Attorney’s Office.

Sam Rajan, R.Ph. is vice president of clinical operations for MemberHealth, a pharmacy benefit manager and national Medicare Part D sponsor that offers Medicare prescription drug plans under the Community Care Rx brand in 49 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands and under the Community Pharmacists Care Rx brand in Oklahoma. Mr. Rajan is responsible for clinical program development, identifying and diagnosing clinical impediments. Mr. Rajan earned a bachelor of science degree in pharmacy from the University of Toledo. He also serves on the Leadership Board of Directors for the American Diabetes Association of North East Ohio.

Daniel Best is the director of manufacturer trade relationship for PBM and Part D plan sponsor MemberHealth and is responsible for developing, negotiating and managing strategic contract/business relationships with pharmaceutical manufacturers. Mr. Best has 13 years of experience in the pharmaceutical industry focusing on sales, management, marketing, and business development. He previously worked at Pfizer Pharmaceuticals, where he created Pfizer Pfriends, the first pharmaceutical benefit card for uninsured Americans. Prior to joining MemberHealth, Mr. Best founded AmendRx, Inc., a management company focused on creating transparency in pharmaceutical pricing. 

Moderator: Barbra Golub, JD, managing editor of AIS's Medicare Part D Compliance News.

Designed Especially For

Compliance officers, government relations managers, pharmacy and marketing directors and other managers with Part D responsibilities at:

• Health plans
• Pharmacy benefit management companies
• Pharmaceutical companies
• Pharmacy chains
• Hospitals and health systems
• Attorneys and consultants

*Please note that shipping of CDs and materials will begin within three weeks of the conference.

Written Materials