3rd National
In-House Counsel Forum on

Prescription Drug Pricing

Monday, February 28, 2005

About

The pharmaceutical industry is still under siege by public, private and political forces for alleged indiscretions in its pricing practices. Pricing changes under the MMA are causing new anxiety.

Does your company have the strategies that it now needs to comply with current pricing regulations and defend against new pricing allegations?

The Medicare Modernization Act ("MMA") has in iconoclastic fashion created a new payment system for pharmaceutical products. This new system known as Average Sales Price or ‘ASP' is at the moment causing some consternation. Many in the industry are finding that the related regs for ASP provide little guidance and the ASP reimbursement structure is unfair. Also, many drug makers are troubled by the certification requirement for ASP. There is fear that this requirement may be used as new ammunition to fuel the government's existing stockpile of allegations concerning the industry's pricing practices and violations of the antikickback law.

However, as the industry contemplates the new anxieties of ASP, it cannot ignore existing pricing dilemmas. Recent activity in ongoing pricing actions involving other payment systems have led to steep fines, creative government enforcement theories, FTC and SEC scrutiny, new class action suits concerning 340B pricing, and crushing blows in existing AWP class action litigation. Moreover, on the political side, just as the industry is beginning to adjust to the new pricing scheme devised by the MMA and prepare for its impact on other reimbursement systems, it is bracing itself for the potential economic changes contemplated by the proposed drug importation/reimportation bills in the Senate as well any legislative corrections to the MMA.

In this unsettled, evolving and high risk environment, counsel to the pharmaceutical industry and their advisors must have in-depth knowledge and complete understanding of the latest legal, regulatory, legislative and political developments affecting prescription drug pricing today. This Third National American Conference Institute In-House Counsel publication on Prescription Drug Pricing will arm you with the latest information from those at the forefront of Medicare pricing reform, antitrust activity, federal and state investigations and enforcement actions, and private and public litigation.

Contents & Contributors

About

The pharmaceutical industry is still under siege by public, private and political forces for alleged indiscretions in its pricing practices. Pricing changes under the MMA are causing new anxiety.

Does your company have the strategies that it now needs to comply with current pricing regulations and defend against new pricing allegations?

The Medicare Modernization Act ("MMA") has in iconoclastic fashion created a new payment system for pharmaceutical products. This new system known as Average Sales Price or ‘ASP' is at the moment causing some consternation. Many in the industry are finding that the related regs for ASP provide little guidance and the ASP reimbursement structure is unfair. Also, many drug makers are troubled by the certification requirement for ASP. There is fear that this requirement may be used as new ammunition to fuel the government's existing stockpile of allegations concerning the industry's pricing practices and violations of the antikickback law.

However, as the industry contemplates the new anxieties of ASP, it cannot ignore existing pricing dilemmas. Recent activity in ongoing pricing actions involving other payment systems have led to steep fines, creative government enforcement theories, FTC and SEC scrutiny, new class action suits concerning 340B pricing, and crushing blows in existing AWP class action litigation. Moreover, on the political side, just as the industry is beginning to adjust to the new pricing scheme devised by the MMA and prepare for its impact on other reimbursement systems, it is bracing itself for the potential economic changes contemplated by the proposed drug importation/reimportation bills in the Senate as well any legislative corrections to the MMA.

In this unsettled, evolving and high risk environment, counsel to the pharmaceutical industry and their advisors must have in-depth knowledge and complete understanding of the latest legal, regulatory, legislative and political developments affecting prescription drug pricing today. This Third National American Conference Institute In-House Counsel publication on Prescription Drug Pricing will arm you with the latest information from those at the forefront of Medicare pricing reform, antitrust activity, federal and state investigations and enforcement actions, and private and public litigation.

Contents & Contributors


MEDICARE AND MEDICAID: PROGRAMS IN THE POLITICAL CROSSHAIRS
Kathleen E. Means, Patton Boggs LLP

THE IMPACT OF THE MMA ON DRUG PRICING
Patrick Morrisey, Sidley Austin Brown & Wood LLP

THE IMPACT OF THE MMA ON PRESCRIPTION DRUP PRICING
Brian P. Carey, Foley Hoag LLP

MEDICARE PRESCRIPTION DRUG PRICING UNDER THE MMA
Marie C. Infante, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.

ONCOLOGY DRUG PRICING ISSUES UNDER THE MMA
Carolyn J. McElroy, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.

PRICING AND PRICE REPORTING CHALLENGES UNDER PROGRAMS THAT PRE-DATE MMA
Larri A. Short, Arent Fox

THE FTC'S PHARMACEUTICAL CASES
Markus H. Meier, Federal Trade Commission

"AUTHORIZED GENERICS": WINDFALL TO CONSUMERS OR NEW STRATEGY TO HARM COMPETITION?
David A. Balto, Robins Kaplan Miller & Ciresi

OFF-LABEL USAGE
Nathan C. Sheers, Sidley Austin Brown & Wood LLP

PBM AND GOVERNMENT CONTRACTING
Michael F. Sexton, Ropes & Gray

A BRIEF REVIEW OF PRICING FRAUD ENFORCEMENT THEORIES
Brien O'Connor, Ropes & Gray

STATE ANTITRUST ENFORCEMENT EFFORTS IN THE PHARMACEUTICAL INDUSTRY
Meredyth Smith Andrus, Office of the Maryland Attorney General

MEDICAID OVERCHARGE AND DELAYS IN GENERIC ENTRY
Hampton Finer, New York State office of the Attorney General Eliot Spitzer
Lisa Vura-Weis, New York State office of the Attorney General Eliot Spitzer
Presented by: Robert L. Hubbard, New York State Department of Law

STATE INITIATIVES IN PRESCRIPTION DRUG PRICING: WHERE ARE THE STATES NOW AND WHERE ARE THEY GOING
Judith M. Whiting, Office of the Attorney General, State of Massachusetts

PHARMACEUTICAL MANUFACTURERS AND THE 340B PROGRAM – SALES, RISKS, AND QUESTIONS
Albert L. Dessertine, Ph.D., Envision Consulting Group LLC

BENCHMARKING YOUR 340B COMPLIANCE PROGRAM: THE MASTER CLASS ON MAXIMIZING VALUE AND MINIMIZING RISK ASSOCIATED WITH PARTICIPATION IN THE PHS 340B PROGRAM
Bill von Oehsen, Powers Pyles Sutter & Verville PC

BENCHMARKING YOUR 340B COMPLIANCE PROGRAM
Donna Lee Yesner, McKenna, Long & Aldridge

BENCHMARKING YOUR 340B COMPLIANCE PROGRAM
Dr. Paul L. Jeffrey, Parm.D., MassHealth



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