MDRP 2016: Final Agenda Available!

Medicaid Drug Rebate Program
September 20-22, 2016 | Chicago, IL
Download the final agenda: http://bit.ly/1TY7XCQ 

Now in its 21st year, IIR's MDRP Summit (http://bit.ly/1ZdEll3) has continued to be THE authoritative MDRP Event for Everything Government Pricing, Rebates and Regulation. MDRP provides unparalleled access to the government regulators creating the rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them.

Don't miss out on your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs.

Why should you attend MDRP?

Learn:
• AMP Final Rule Implementation
• 120+ Speakers
• 6 Keynote Presentations
• 340B Guidance Updates

Benchmark:
• State Dispute Resolution Meetings
• New Executive Leadership Boardroom
• Town Hall between Manufacturers and States

Connect:
• 14+ Federal and State Agencies
• 600+ MDRP Executives
• 20+ States
• 30+ Solution Providers

Access the final agenda: http://bit.ly/1TY7XCQ

$400 savings ends Friday, July 1st! Click here to register: http://bit.ly/1RNJ5rF

Celebrate July 4th with 30% Off to MDRP 2015!

Take advantage of this special July 4th offer and save 30% to MDRP! Register with code XP2058SAVE30 to activate your 30% discount off the standard rates to IIR’s 20th Annual Medicaid Drug Rebate Programs Summit taking place September 30-October 2nd, 2015 in Chicago, IL. Visit the website for full details.

This limited-time offer expires on Monday, July 6th | Register here.

The 20th Annual Medicaid Drug Rebate Programs Summit continues to be the authoritative gathering for everything pricing, rebates, contracting, and collaboration. You’ll get unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them. Collaborate with your peers to benchmark best industry practices and navigate regulatory hurdles, minimize wasted resources and optimize finances.

Don't miss out on getting essential regulatory updates from CMS, HRSA, OIG, VA and more!

Activate your 30% savings now with code XP2058SAVE30! Offer expires 7/6

Qualifications, rules and regulations: 
Offer cannot be applied retroactively to confirmed or pending registrations from today's date and prior. 30% discount cannot be combined with any team discounts or other promotions and/or discount offers. Discount is only valid from July 2 – July 6, 2015. All registrations are subject to IIR approval.

Prepare for VA Contract Negotiations at MDRP 2015 | Last Chance to Save $500 is Friday

Last Chance to save up to $400 to MDRP 2015 is THIS Friday, 6/26. PLUS! Take an additional $100 off when you use the code XP2058BLOG | $500 in total savings! Register now.

Your successful compliance with the VA's contractual and statutory requirements can spell the difference between profitable partnerships and drawn-out audits.

At the 20th Annual Medicaid Drug Rebate Program Summit, join us during the Pre-Conference event titled, "Pharmaceutical VA Contracting and Compliance Summit." This half-day summit is ideal for pharmaceutical and biotech manufacturers looking to comprehensively tackle the challenges of designing and complying with the complex - but highly lucrative - contracts in this sector.

You will touch upon key steps necessary to ensure you are ready for 2015 and beyond. Below are just a few session highlights:

• The Ins and Outs of a VA Audit: Comprehensive Overview of the Review Process
• Restating non-Federal Average Manufacturing Prices (NFAMP) and VA Federal Ceiling Prices (FCP)
• Panel Discussion: Prepare for Contract Negotiations

Download the updated MDRP brochure for more Summit details.

This half-day summit is part of the Platinum Pass, which gives you access to the full three days of the Medicaid Drug Rebate Program Summit - the best value! Registration rates go up after this Friday, June 26th. Save up to $500 off standard registration, be sure to use priority code XP2058BLOG | Register here.

Ensure you have the most comprehensive educational experience over three days with unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them.

This is your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs. Reserve your seat today at the most comprehensive MDRP event to date!

See you in Chicago!

MDRP 2015 Brochure is Now Available for Download

The MDRP 2015 Brochure is Now Ready for Download!

Don't miss out on the largest MDRP event in the space, with the most speakers, government representations and MDRP executives all under one roof!

Ensure you have the most comprehensive educational experience over three days with unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them.

Join us and celebrate 20 years of MDRP this September 30-October 2, at the Chicago Marriott Downtown Magnificent Mile in Chicago, IL. See What's New for 2015!

Deep Dive Pre-Conference Summits: 
• Fundamentals of Government Pricing Programs + MDRP 101
• Pharmaceutical VA Contracting and Compliance Summit
• Town Hall between Manufacturers and States

Tailor-Made Content: 
• State Policy Changes and Updates
• Executive Leadership Boardroom
• Business Leadership Workshop on "Embracing Generational Diversity"

Interactive Session Formats: 
• Think Tanks/Innovator Showcase
• Fireside Chats
• Roundtable Discussions
• Rapid-Fire Sessions
• Benchmark Best Practices

AND MORE! Download the Full Brochure For More Information.

Register now with the code XP2058BLOG and save $100 off the current rate | Register today and lock in a $500 savings, click here to register.

This is your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs. Reserve your seat today at the most comprehensive MDRP event to date!
 

Look Who's Attending IIR's 7th Annual Government Programs Summit

Sneak-Peek List of the 2015 Attendees Below

 

IIR's 7th Annual Government Programs Summit is just 2 weeks away! Get the most comprehensive, up-to-date information on the key government programs affecting your operations including an update from CMS on operational issues affecting the Medicaid Pharmacy Program and HRSA on key 340B updates.

In addition, you will gain critical insights on Medicare Part D & Coverage Gap, Part B, MDRP, TRICARE, VA, OIG and more. Register now to reserve your seat at this leading industry event.

Everyone who's anyone is here! Here's just a snapshot of companies already confirmed to be in Arlington,with many more slated to join us: (as of 3/11/15)

• Actavis
• Actelion Pharmaceuticals
• Afaxys Inc
• Amneal Pharmaceuticals
• Ariad Pharmaceuticals
• Baxter International Inc
• Bayer HealthCare Pharmaceuticals
• Bristol Myers Squibb
• Celgene Corporation
• Chiesi USA
• Daiichi Sankyo Inc
• Eli Lilly & Co
• Ferring Pharmaceuticals Inc
• Fresenius Kabi
• Genentech
• GlaxoSmithKline
• Glenmark Generics Inc USA
• Health Resources & Services Adminstration    •    Hospira
• Impax Laboratories
• Jazz Pharmaceuticals
• Johnson & Johnson
• Mylan Inc
• National Association of Chain Drug
• National Council for Prescription Drug Programs NCPDP
• Novartis Pharmaceuticals
• Salix Pharmaceuticals Inc
• Sanofi
• Shire
• Sunovion
• Taro Pharmaceuticals USA Inc
• United Therapeutics
• US GAO

Add your name to this list and join in on this one-stop-shop for all things government programs in Arlington on March 23-25, 2015.

Register online now to receive 50% off! Be sure to use XP205150OFF

IIR's Government Programs Summit Keynote Announced!

Announcing: Chief White House Correspondent, Mike Allen

IIR's 7th Annual Government Programs Summit is the most comprehensive government programs event to date! This year, we're merging together regulatory compliance and financial calculations to help you navigate through legal, compliance, strategic and financial updates of ACA expansion!

Plus, for the first time under one roof, hear from CMS, HRSA, VA/DOD, OIG, NCPDP, GAO, NACDS, SNHPA as they join keynote Mike Allen, Chief White House Correspondent, Politico and Creator, Playbook and Morning Money at the gold-standard government programs event. In his session “Political Issues of the Day”, gain perspective on what's going on in Washington behind closed doors, as he shares insights into how healthcare reform may shift due to political changes.


Download the agenda for more details and speaker line-ups.

Join us March 23-25, 2015 in Arlington and register now to save $400. Be sure to use the code XP2051BLOG – Click here to register.

If you have any questions about the event, please contact Ryan Geswell at rgeswell@iirusa.com

HRSA Cmdr. Krista Pedley Provides 340B Update Preceding June Regulation

This March, IIR’s 6th Annual Government Programs Summit will once again welcome Cmdr. Krista M. Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, who will provide an update on the 340B program. The timing could not be better as a Memorandum Report released by the OIG this week spotlights inconsistencies within the 340B program.**

With the U.S. Department of Health and Human Services publishing the 340B proposed rule in June triggering an increase in transparency to the 340B program, you'll best prepare for the impact of these changes in the track - 340B Summit for Manufacturers, in collaboration with Apexus' 340B University. Hear updates and learn about the latest details in these key hot topic areas: Contract Pharmacies, Orphan Drugs, GPO Prohibition, Covered Outpatient Drugs, Audits, and more!

To learn more, download our agenda.

Register with code XP1951BLOG and receive 15% off of the standard rate. If you have any questions about the event, feel free to contact Kate Devery (Kdevery@iirusa.com) For more information visit our homepage. We hope to see this March!

Cheers,
The Government Programs Team

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MDRP 2013 Keynote Presentation: OIG Work Updates

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Rajiv Mehrotra, recaps our day 3 Keynote Presentation on OIG Work Updates 

The last day at the 2013 MDRP Annual Summit saw Mr. David Tawes from the OIG present on the “Recent OIG Work Involving Prescription Drug Pricing and Payments”. The presentation discussed the recent work and analyses that the OIG is performing especially around the Medicare Part B program.

As part of its recent work, the OIG looked at the current Medicaid Drug Rebates Program and evaluated how a similar program might work in a Medicare Part B setting with respect to rebate recoupments (unlike Medicaid, Medicare has no requirement for manufacturers to pay rebates for prescription drugs). To perform the analysis, the OIG included 60 drugs that accounted for 85% of Part B expenditures (approx. $13.9 billion) in 2011 and performed a rebate calculation similar to the Medicaid Drug Rebate Program using AMPs or ASPs for these drugs. The analysis showcased that such a program could potentially provide anywhere from 21-26% recoupments of the Part B expenditures for these drugs using a Medicaid Drug Rebate Program structure.

Though this recommendation was not entertained by the CMS at this time (CMS could not devote the necessary resources for a Part B rebate program evaluation ) it, nonetheless, doesn’t take away from the fact that this is something really big that was suggested by the OIG and this could be a huge deal for manufacturers. Manufacturers should definitely keep an eye out if something like this or a variant thereof picks back up in the future.

This is a must-have presentation for manufacturers. For more information, either grab a version from the MDRP website or visit the OIG website at for more details. See you all next year!

MDRP 2010 Conference - Government Pricing Program Audits, Restatements, Adjustments, and Disclosures: The Needle has Moved – Have You?

Speaker:
Constance Wilkinson, Member – Epstein Becker & Green

The Health and Human Services agency has released the Fiscal Year 2010 work plan for their audits of the pharmaceutical industry. If you are an eligible participant in a government program, you are also an eligible participant for their audit groups. This additional participation means that you may want to make adjustments and become compliant before you get that knock on the door.

The first focus will be on the AMP Calculations and will be done by the Office for Audit Services. One of the issues that may trigger an audit would be if you restated with a significant change to the number. But having said that it is not a certain trigger and far from the complete list of reasons for an audit. With many areas of AMP being left to reasonable assumptions it is imperative that you document, document, document! When the auditor does come to your door and asks you why the AMP calculation was done the way it was done in Q303, you better be able to not only justify your reasons for the calculation actions, but also be able to recreate them.

The second focus will be done by the Office of Evaluation and Inspections to look for those companies who are participating in the Medicaid Reimbursement Program with Unapproved Drugs. There are drugs out there that are so old (e.g., grandfathered drug) they do not have an NDA and the company has failed to submit a new one to the FDA bringing their product into the Approved drug category. If the state is reimbursing pharmacies for this drug, with the assumption that it is approved and you are allowing that action, it can be considered fraud. There has already been one settlement on this issue and with future audits coming, it is imperative that you update your drugs with the FDA and ensure you are compliant with all government program participation.

The last area of focus will be for the Impact on Medicaid Rebates for Authorized Generic Drugs and will also be done by the Office of Evaluations and Inspections. There are still some companies that do not understand the difference between an Authorized and an Unauthorized Generic and how each should be treated differently. If you think you may be treating your generic incorrectly, and thus paying the incorrect rebate amount, you need to take action to restate those rebate numbers and true-up any monetary adjustments as a result. Be sure to work with your regulatory department to understand how your product is categorized in the eyes of the FDA and thus CMS, and then make any necessary changes.

Be sure to understand that with the tight budgets we have all seen these past few years, it is more and more important for the government to ensure they are getting all the discounts and reimbursements they are owed. And with the new money being funneled into the offices that do the overseeing and auditing of the pharmaceutical industry, you can bet there will be more chances for your door to be next on which to be knocked. Make sure you are prepared.