Wednesday, January 06, 2010

Government Programs Summit

I am pleased to welcome our first sponsor—IIR’s Third Annual Government Programs Summit. This event will be held in Baltimore on February 8-10, 2010.

The event will be moderated by Chris Cobourn, Vice President of Regulatory Compliance at CIS and a friend of Drug Channels. CIS’ Pharma Compliance Blog is included in our blog roll.

Drug Channels readers understand the importance of government programs and pricing issues, so I encourage you to check out this event. Below are some details courtesy of IIR. Click here to see the agenda and list of speakers, which includes many folks from agencies such as the Center for Medicare & Medicaid Services (CMS) and Department of Veterans Affairs.


Government programs are growing increasingly complicated and risky for any pharmaceutical manufacturer, especially with the changes proposed in Healthcare Reform from the Obama Administration. Beginning in Q1 2010, every manufacturer’s pricing methodologies and calculations will significantly be impacted due to the adoption of the proposed legislation.

This event is your unique opportunity for access to top agency officials to discuss topical issues. Now in its third year, this forum has become the “talk of the town” as the place to have a working dialog between your peers in the GP environment, including the agencies, law firms and industry. The unique venue is designed for experienced GP professionals, fostering discussion on operational issues and challenges across the programs.

The GP Town Hall forum begins with a discussion on the current status of health care legislation, including the policy and operational impacts on Government Programs. Each subsequent session throughout the day focuses on general topics across programs as well as specific programs. There are no formal slides or presentations. Each program session covers topical issues and challenges and will have various perspectives, including those from agencies, legal, industry and consultants. Attendees are invited to participate in the discussion and to ask questions to the panel members.


Moderator: Christopher Cobourn, Vice President, Regulatory Compliance, COMPLIANCE IMPLEMENTATION SERVICES

Town Hall Members:
  • Robert Vito, Regional Inspector General for Evaluation and Inspections, Office of the Inspector General, Department of Health and Human Services (invited)
  • Mel Noel, Contract Staff Attorney, Office of General Counsel, Department of Veterans Affairs (invited)
  • Devin Williams, U.S. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Office of Pharmacy Affairs
  • Kimberly Howell, Medicaid Policy, Centers for Medicare and Medicaid Services
  • Tamara Bruce, Technical Director, Drug Rebate Operations, Centers for Medicare and Medicaid Services
  • John Warren, Medicare Part B, Centers for Medicare and Medicaid Services
  • Joe Metro, Partner, Reed Smith
  • Katie Lapins, Director, Compliance Implementation Services
  • William Baxter, GP Consultant, Compliance Implementation Services
New Challenges in Managing the Government Business – What does healthcare reform mean to the government and commercial businesses? What is the timing of any reform and what are the key considerations for manufacturers when making projections?

Restatements and Recalculations – What are the rules and guidelines for recalculations and restatements across the programs? How do the requirements of the programs differ? What are the operational challenges associated with a recalculation and restatement?

Mergers, Acquisitions and Divestitures – How do companies manage their reporting responsibilities in the complex environment of the acquisition of companies and/or products, as well as sales and divestiture of products? What level of due diligence in GP should companies do when they are contemplating M&A activity?

Topical Policy and Operational Issues – What are the “hot topics” in policy and operational issues across Medicaid, Medicare Part B, OPA/PHS and the VA?
  • Quantify the impact by product for your company of the new Health Care Reform
  • Streamline your auditing, monitoring and processing operations for compliance with government contracts
  • Identify the changes to government price reporting entities processes and how they interrelate
  • Map the impact of the chargeback process on government programs
  • Ensure compliance with implementation of the changes to Tricare, 340B, MDRP
  • Clarify Class of Trade designation and validation and lessons to clean up bad data
  • Avoid a false claims act violation from incorrect policies, procedures, and systems providing inaccurate information to the government
  • Implement effective vigilance and management of wholesaler reverse chargeback processes and criteria validation that is currently decreasing your company’s bottom line
  • Prevent overpayments for chargebacks from wholesalers and incentive rebates from pharmacies
  • Discuss how to recover lost chargeback dollars and learn new strategies to create more operational process awareness for wholesalers and manufacturers


  1. Adam - Congratulations on getting a sponsor. Just don't go soft on us, OK?

  2. Adam,

    Thank you for your support of the Government Programs Summit that Chris and some of the other Commercial Compliance team here at CIS are going to be leading in February. We hope that you and all the Drug Channels readers are able to join us for a great event focused on gaining insights from various Government agencies and industry experts.


    Clarissa Crain
    Commercial Compliance Consultant
    Compliance Implementation Services, LLC