In May, I had the pleasure of sitting down with Mark Linver, Managing Director at Huron Life Sciences Group to discuss the current state of Government Programs. In anticipation for the Final Rule to come out, here's what Mark had to say:
CBI: What are the top 3 issues you are seeing within the industry surrounding Government Programs?
The top 3 issues that I see surrounding Government Programs relate to the uncertainty stemming from the final rule. Without final guidance, manufacturers are in waiting to address:
• How will manufacturers obtain data required to calculate AMP if CMS requires the buildup methodology vs. the current Gross-to-Net?
• Can the current infrastructure (procedures, data validation, systems) support the requirements of the changes to the AMP calculation?
• How should manufacturers conduct 340b audits to identify areas of revenue leakage?
CBI: What should GP Professionals be doing now to help prepare for the AMP Final Rule?
To prepare for potential AMP calculation methodology changes, manufacturers should review and identify data distribution channels that may provide documentation of transactions to RCP customers; Develop an action plan for making proposed methodology and system
updates, if included in the Final Rule, addressing:
• What does the proposed change affect?
• What specific changes will need to be made?
• How and who will be making the changes?
• How does this affect our current day to day business operations?
• How long it will take to implement the change?
• How much will it cost (infrastructure and resources) to implement the change?
• What impact will this have moving forward on the business operations?
To ensure accurate, consistent and well-documented Fair Market Value criteria, manufacturers should document reasonable assumptions the manufacturer proposes to use for determination of Fair Market Value; Perform a Fair Market Value assessment to ensure the existing approach is accurate, consistent, and well documented; Calculate Bona Fide Fees for Service in accordance with Fair Market Value criteria established in accordance with the Proposed Rule.
CBI: What do you see the market looking like in 2014 and beyond with Medicaid expansion?
For 2014 and beyond my colleagues and I see clarification but also more uncertainty. For clarification, CMS will provide final guidance on the AMP rule. However, for uncertainty will there be more cases similar to Texas Medicaid and overall reporting. In addition, some states
are deciding not to participate in Medicaid expansion. This makes it difficult to plan for modifying and implementing appropriate change.
CBI: Just for fun…what was your favorite book you read recently?
Fool by Christopher Moore, a retelling of the King Lear story.
CBI: Just for fun…where is the most interesting place you have visited and why?
Mogadishu, Somalia. While in the military my squadron flew missions in and around Mogadishu--it was my first experience being in a country with a non-functioning government.
Mark Linver has been Managing Director at Huron Consulting Group Inc. since May 2011. Mr. Linver focuses on helping clients with government price reporting, and transparency and disclosure requirements of life sciences companies. Mr. Linver has more than 20 year of experience, works with clients to address regulatory issues involving aggregate spend requirements, merger integration requirements, contract management, government pricing, and accrual analysis solutions for pharmaceutical, medical device, and biotechnology companies.