MDRP 2016: Day One - Government Agency Sessions

The 2016 MDRP Summit is officially underway, and the theme of the morning was Government Agencies.  IIR always does an excellent job recruiting key members of the agencies with which we interact to provide updates and answer questions, and this year was no exception.  Sometimes these government updates take place at the end of Day Two, when we might not be quite as fresh or ready to absorb information as we would be, say, had we not spent most of the night in the lobby bar, so I really appreciated kicking Day One off with these detailed sessions.  No matter how much we read and dissect the statues, regs, and FAQs, there is no substitute for getting information directly from the horse’s mouth.  There is also the immediate gratification of standing up, asking a question, and getting an answer right away, as opposed to waiting months (or years) before our comments are addressed via rulemaking. 

This year’s Opening Keynote Address: A Conversation with Scott Gottlieb: Health Care Policy Winds in an Election Year: Payment, Reform, Data Sharing, and Patient Access was delivered by the aforementioned Scott Gottlieb, and covered in today’s Drug Pricing in Today’s Environment blog by Katie Lapins.  The keynote was followed by CMS Update: Update on the Final Regulation Implementation by John Coster, Director, Division of Pharmacy, CMS.  John, who called in remotely, covered CMS’ talking points on the AMP Final Rule, and opened the floor up to questions – a move he may have regretted after he was subjected to cross-examination on Puerto Rico’s Departamento de Asuntos del Consumidor (DACO) program by John Shakow, Partner at King & Spalding.  Finally, Commander Krista Pedley, Director, Office of Pharmacy Affairs (OPA), Health Resources and Services Administration (HRSA), delivered her annual HRSA 340B Update, which included information on the Audit Plan, and a Q&A session where some attendees expressed their concerns about elements of the 340B program. 

Following the agency sessions, Alice Valder Curran, Partner, Hogan Lovells presented a much-anticipated session entitled Oversight: Time to Get Ready.  Alice’s presentation was a helpful follow up to the morning sessions, because it provided information on recent government office studies and industry trends.  She touched on the topic of counting patient coupons in ASP, citing the recent U.S. Government Accountability Office (GAO) study on Medicare Part B coupon discounts.  She also discussed price changes among generic drugs covered under Medicare Part B, noting GAO study results showing that generic drug prices under Part D fell 59% from 2010 to 2015, with the exception of certain lower use drugs with complex manufacturing requirements that witnessed “extraordinary” price increases during this period.  Alice also discussed the PHS/340B program, describing the various audit functions performed by the OIG’s Office of Audit Services (OAS) and Office of Investigations (OI), noting that there have been no audit findings this year, and reminding manufacturers that a revised Pharmaceutical Pricing Agreement is coming, and that it must be signed.  Alice offered a number of strategic suggestions for manufacturers, recommending that they keep their management teams in the loop regarding these industry trends, identify areas of pricing risk (especially for drugs with high Medicaid or Part B spend), ensure that bundles, authorized generics, and line extensions are treated appropriately in GP calculations, maintain thorough documentation, and hire an outside firm to do a test audit to identify potential problem areas.  Alice also encouraged everyone to be nice to John Coster at CMS, a comment that was surely unrelated to the above-mentioned Q&A exchange.

Come back for more recaps of IIR’s 2016 MDRP Summit throughout the week and after the show, and for those of you who are here in person, keep coming to these fantastic sessions!

  

About the Author: Dana Z. Collins has worked in the Government Pricing space for almost a decade, as both a consultant and an in-house compliance professional.  As a GP consultant, Dana’s areas of primary focus are audits/assessments, training, ongoing calculations, Medicaid rebate processing, and policies/procedures – oh, and blogging.  After working with Katie Lapins, Principal/Owner of Government Pricing Specialists (GPS), on and off over the years, Dana joined GPS in 2016 and has never looked back.