This week, we're live from Chicago reporting on the current trends and latest information that matters do the Medicaid Drug Rebate Program industry. Over the week, you'll find highlights from a few of the sessions in addition to the key tweets from the day. To join monitor and join the conversation, be sure to reference #MDRP12.MDRP 2012: Maintain Federal & State Government Program Compliance
Moderator: Jim Abrams, Mylan Pharmaceuticals
Speakers: LynneLeone, Hospira
Sanjida Chowdhury, Fresenius Kabi USA
Annamarie Lee, Upsher-Smith Labratories
Highlights of this presentation:
- - By creating a document map showcasing layers of documentation including policies, procedures, SOP, training material, companies can then identify gaps can be identified in the procedures. What’s the narrative of a product? It is key to the documentation.
- - When a company has documents with rules and exceptions can prove beneficial during product transitions in addition to challenges requiring documentation including new regulations and other things will cause fluctuations and documentations will successfully address those.
- - What kind of documentation needs to be kept when there a designation of trade? Everything. And the challenge of acquiring generic products and without acquiring the right documentation? It’s nearly impossible for the acquiring companies to go back and do that.
- - Another topic brought up in the session was the coverage gap program. A company should know what amount they are really paying in relation to the current price of the drug on the market. Often times, older product agreements were paying large coverage gaps that weren't applicable in today’s market.
- - When parts of Medicaid run out of money, they may transfer to other parts. A speaker noticed Part D Coverage but you didn’t sign the agreement. One of the speakers faced the situation where the company had never signed up for Part D, but the loophole if Part B runs out of money, then they move it over to Part D. recommendation for NDA: it’s a provision within their program. There’s no new way to determine if your product needs to have an ASP. Is there a way to determine if you need to file to it?
- - When competitors change, the category of your drug does too. Are competitors who are joining? CMS doesn’t identify that. They want drug companies to notify them of competitors coming to market.
MDRP Senior Leadership Forum
Participants: Sabrina Yohai, Pfizer
David Brown, GlaxoSmithKline
Sanijida Chowdhur, Fresenius Kabi USA
The running theme in the MDRP Senior Leaderships Forum was collaboration and communication among all teams involved in the Government Programs part of the business. Chowdhur believed that policies and SOPs, creating robust history are keys to success in maintaining a successful government programs. She also suggests that trade reviews and audits are a great way to stay on top of the programs as well as a continually evolving system that will identify loopholes problems that could arise.
At GSK all contracts are looked at and approved looking at legal, finance and commercial. In addition the IT team meets regularly to assess changes and address them. During the presentation, Yohai of Pfizer encouraged attendees who felt like they needed additional support to in terms of documentation, go ask someone to help.
The date the Affordable Care Act was passed was the starting point for regulation. A new set of standards were set out. In Pharma companies this started the discussion through comments on the proposed rule. When the final rule comes out next year, there has been enough collaboration and communication for a company to company will know the ramifications and that they’re aware that there is a cost for compliance Yohai at Pfizer believes.
Here are some of the top tweets of the day:
#mdrp2012 GDUFA goals: improve performance, address drug shortages (maintain a shortage list), improve quality & security, increase staff
— Healthcare Business (@healthcarebiz) September 10, 2012
#mdrp12 Shakow: Authorized generics: ACA expanded definition of "wholesaler"
— Healthcare Business (@healthcarebiz) September 10, 2012
#MDRP2012 CMS wants drug companies to notify them of competitors coming to market so they can change documents, but it's not a requirement.
— Healthcare Business (@healthcarebiz) September 10, 2012
No comments:
Post a Comment