Monday, September 16, 2013

MDRP 2013 Day 2 Keynote Presentations

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Dana Zelig, recaps day 2 Keynote Presentations

You Can’t Please Everyone..

But, as Keynote Speaker, former RNC Chair, and MSNBC Policy Analyst Michael Steele pointed out, you can make them all angry at the same time. His address put the roles of everyone involved in the Medicaid Drug Rebate Program into perspective, by reminding us all that whether we are policy makers, State Medicaid representatives, or GP professionals, we are all helping people in the margins of society who need the assistance of the MDRP.

This is something that I, as a GP consultant, don’t often stop to think about. My responsibility is to ensure that my clients, the pharmaceutical manufacturers, are able to comply with the statutes, regulations, and guidance provided by government entities like CMS and HRSA. Based on comments I have heard during the conference, it seems that these agencies know what it’s like to make everyone angry. But as Mr. Steele asked, “at the end of the day, who is being served?” I think most of us come to MDRP year after year not only to refresh our GP knowledge, but to vent our frustration that we are not being served by the policies made in Washington. But maybe we need to realize that we aren’t the group the much-anticipated AMP Final Rule is meant to serve. Maybe our jobs would be less frustrating if we occasionally reminded ourselves that, for a growing number of people, Medicaid isn’t a 9 to 5 problem, it’s a life or death program.

As Mr. Steele observed, the Affordable Care Act is unlikely to be overturned, so we all need to be prepared to roll with the punches as we implement the Final Rule when it is (hopefully) released in January. He urged the audience to think outside the box and be prepared to make tough decisions, even if it makes some people within your organization uncomfortable. Politics, he reminded us, should be about service, and I think the same is true for pharma. Even if we aren’t in the lab developing new blockbusters, orphan drugs, or biologics, we the Medicaid professionals can still make a difference to people in need. So next time you get a 5 lb. stack of Medicaid rebates in the mail, remind yourself who is being served.  

                             What’s New in the 340B Program 

The second portion of this morning’s Keynote Address was provided by Commander Krista Pedley of HRSA. Cmdr. Pedley outlined the efforts the OPA is undertaking to ensure the integrity of the PHS 340B Program by focusing on validating eligibility of covered entities, avoiding diversion, and preventing duplicate discounts. If you participate in the 340B program (and you’re at a Medicaid conference, so I know you do), you already know the requirements for pharmaceutical manufacturers, so I’ll just recap the recent and new activities highlighted by Cmdr. Pedley.

One new development is that HRSA is now pushing notifications to manufacturers every quarter to let them know if any entities have purchased at 340B prices after their eligibility expires. This does not replace your need to validate your 340B sales, but it does provide a great resource to cross-check. Another development is the new electronic process for registering contract pharmacies, which notifies covered entities of any pharmacies that are applying for status under their name. If the covered entity rejects the application or does not reply to the notification, the contract pharmacy’s application is not approved. The number of covered entity audits HRSA being performed is also new, up from 51 in 2012 to 94 in 2013. Finally, as HRSA finalizes its annual recertification process, it has required hospitals to provide their recertification data by this Friday the 13th, or they will be terminated from the program without exception.

As a takeaway, Cmdr. Pedley provided some useful references, including the new Program Integrity page on HRSA’s website and a list of relevant program releases since 2011. She also highlighted HRSA’s partnership with CMS to tackle issues that impact both programs such as the impact of repayments to manufacturers by covered entities on AMP and Best Price calculations. Anyone with specific questions is encouraged to submit them to HRSA via the following website:

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