Audio CD and written materials of AIS's audioconference on May 11, 2006

Part D Fraud, Waste & Abuse: How to Comply With CMS's April 25 Guidance

With CMS's final guidance on how to control fraud, waste and abuse (FWA) under Medicare Part D now out, every Part D plan sponsor is under a tremendous time crunch to install an effective FWA compliance program that meets dozens of CMS specifications. These new Part D requirements have been called everything from "unprecedented" and "onerous" to "terrific," but one thing that's certain is they are "now," as plans must design and implement full-blown compliance programs by year-end 2006. What elements must plans include? Where are the major risk areas? How should plans address Medicare Drug Integrity Contractors (MEDICs) and subcontractors in their FWA compliance programs?

Sponsored by Atlantic Information Services, Inc., publisher of Medicare Part D Compliance News and Report on Medicare Compliance.

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The final guidance creates an urgent need for plan sponsors to design and implement effective FWA compliance programs that, among other things: include written policies and procedures, and training and education programs; establish effective communication lines; and ensure prompt responses to detected offenses.

The failure to implement effective FWA compliance programs that conform to the CMS guidance would be devastating to plan sponsors and their partners, as it could lead to violations of the complex Part D provisions.

Among the hot spots that are likely to produce the greatest compliance risks and should be addressed:

Also, sponsors must set up an effective system of communication among compliance officers, employees, and subcontractors, and develop as part of their work plan a strategy to monitor and audit subcontractors.

Prior to release of the April 25 CMS guidance, fraud, waste and abuse was already a high priority in Medicare Part D compliance. CMS has named eight MEDICs to fight fraud and abuse connected with Part D by analyzing data; investigating potential fraud surrounding enrollment, eligibility determination or distribution of the drug benefit; and conducting fraud complaint investigations. These MEDICs will refer their findings of violations to the HHS Office of Inspector General and the FBI for review and potential government enforcement action. Fines, sanctions and even jail sentences are likely outcomes for non-compliant activities, whether performed by the plan sponsor or a subcontractor, such as a PBM.

Hear two of the nation's leading Part D compliance and fraud-prevention experts as they discuss strategies to help you comply with CMS's complicated new guidance and structure effective Part D FWA compliance programs. You will also hear valuable tips and tactics that can help plans and their partners avoid becoming Part D enforcement targets. You'll find out:

Speakers

Keith M. Korenchuk is a partner in the law firm McGuireWoods LLP. Mr. Korenchuk counsels and advises pharmaceutical, life sciences and medical device companies in the U.S. and around the world, focusing his work on compliance and regulatory challenges confronting these sectors under federal, state and international laws. He provides guidance and assistance on matters ranging from design and implementation of compliance systems, internal and external investigations, the clinical trials research process, specific product launch, sales/marketing and other compliance issues, and negotiation and implementation of strategic relationships to enable companies to achieve their business objectives in a complex operating and regulatory environment.

Debjit A. Ghosh is a senior manager in the Fraud Investigation & Dispute Services branch of the Health Sciences division at Ernst & Young. In that role, Mr. Ghosh helps develop strategies to pre-empt, manage and resolve the risks of business conflict that can emerge across with regard to fraud. Specifically, he assists clients develop regulatory compliance strategies, manage health care investigations and compliance reviews, investigate alleged fraud and illegal activities, examine financial source documents for fraud, and provide crisis management and contingency planning.

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

 

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

 

Written Materials