Tuesday, September 10, 2013

MDRP 2013: Day 1 Recap

The first morning session for the AMP Final Rule- What it says, What it Means and How to Implement it kicked off today with opening remarks from Alice Valder Curran, Partner at Hogan Lovells LLP. Curran discussed possible dates for the AMP rule, as well as how you should prepare for it. Some of her key takeaways? Read the statute and regulations, and locking in your consulant before the rule is released. Developing a relationship with your consultant early can help you both hit the ground running once the rule is released.

Following Curran was Ven Adamov, Senior Manager for Government Contract Services at Ernst & Young discussing Product Master Issues. Adamov covered issues such as, Product Master Influence on Government Price Reporting, varifying both data uses and organizations, systems changes, and data fragmantation. Also, because every company is different, understanding the field definitions may vary by team. 

Our next session, Authorized Generics and AMP lead by Kave Niksefat and Cynthia Hwang from IMS Health. Niksefat and Hwang covered key questions to answer before including authorized generics in AMP, as well as what makes up an authorized generic. They also discussed how sales and discounts to second manufacturers can be accounted for, and the impact AG will have on Brand AMP.

Rick Zimmer, Partner at KPMG LLP, concluded our morning session with Clarifications to the Bundled Sales Definition. Zimmer discussed the importance of identifying the bundle, as well as self-allocating bundles, and the impact of nestled bundles. 

Before the last networking break of the day, John Shakow, Partner at King & Spalding, presented on, 340B Refund Management and Implications for Reported Price Points. Shakow discussed the impact on CMS pricing when a 340B covered entity attempts to make a repayment arising out of violations of a program prohibition, or losing 340B program eligibility. He ended the session advocating that CMS adopt a helpful rule: "once a 340B sale, always a 340B sale."

Alice Valder Curran, session chair, began one of the last presentations of the day, Independent Pricing Reporting Issues Related to Texas. Curran covered both statutory and regulatoary requirements, as well as trade and calcuation questions and methodology documentation.

The last and final presentation of the day, Preparing for the Final Rule, was lead by Katie Lapins and Clay Willis from Huron Life Sciences. Although there is no definite date, many industry experts believe the final rule will be relased sometime between December and January. So what should you do to prepare? Lapins and Willis suggest educating and coordinating with internal teams in your company, as well as evlauating GP availability to help determine bandwith. They also reccomend documenting all assumptions and modeling potential changes for big areas of your organization.

That concludes day 1 of MDRP 2013, stay tuned for Day 2 updates!

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