CIS Hosts Advanced GP Forum at the 2015 IIR Government Programs Summit

Via Chris Cobourn, Senior Vice President of Commercial Compliance, CIS

It is nearly March again, and although spring is decidedly not in the air, it is not too early to make plans to attend the CIS Advanced GP Forum on the IIR Government Programs Summit Pre-Conference day, March 23rd.

This forum has grown and evolved over the years.  It is a PowerPoint-free day, with open discussion on current and topical issues for the GP professional.  CIS facilitates the day, posing questions to our esteemed panel of experts.

The discussion has always been intriguing and informative, especially for the GP Geek in each of us, and it is amazing how quickly the day goes.

Our panel this year includes:

• Sabrina Yohai, Assistant General Counsel, Pfizer
• Michael Hepburn, Senior Director, Government Contracts, Janssen R&D, LLC
• Jennifer Norton, Senior Director, Pricing & Contract Administration – Managed Markets, Vertex Pharmaceuticals, Inc.
• John Shakow, Partner, FDA and Life Sciences Practice Group, King & Spalding

If you have participated in CIS thought leadership venues, such as our monthly GP Forum call or our ongoing GP Webinar series, you know that we strive to foster dialogue in the GP community.  This all day forum began 6 years ago now and has become a mainstay of IIR’s GP Summit as a venue for the GP professional to meet with their peers.

Venues like this are even more critical this year, with the AMP Final Rule now being published possibly in April.  Additionally, there are the deep and complex topics that continue to vex us, such as bundling, smoothing, BFSF/FMV, Gross to Net, Medicaid Expansion, and the PHS program.  We hope to see you this year at the Advanced GP Forum, and I welcome any inquiries in advance of topics you would like to discuss there!

Register and save $100 off the current rate with the code XP2051BLOG - Click here.

AMP Final Rule - How Should You Prepare?

Chris Coburn, Senior Vice-President, CIS & Erika Scholl, Senior Manager, GP Consulting, CIS discuss how to prepare for the final AMP Rule now, in terms of reengagement, bona fide service fee assessments, and recalculations, so that the transition is as smooth as possible this winter. Join Chris at MDRP 2014 for his highlighted session below...



A What, When, Why and How Guide to the Complexities of Recalculations and Restatements; Complying with Guidance and Protocols and Minimizing Risks

Recalculations and restatements have become common for manufacturers, but they still pose significant compliance risks. Various events can trigger the need for a recalculation, and the resulting change or correction in methodology or data can impact the accuracy of historically reported prices, which in turn can create pricing changes that ripple across programs. When performed correctly, a recalculation/ restatement demonstrates that a manufacturer is proactively identifying and mitigating identified issues and errors within its government programs. However, when the proper procedures are not followed, this can further complicate and aggravate already problematic issues that put the manufacturer in greater risk of noncompliance. To further complicate matters, each agency has its own guidance and expectations related to recalculations that are not often officially documented. In this session, we explore the ins and outs of recalculations and offer insights on how to effectively communicate with the agencies and how to minimize your compliance and financial exposure.

Session topics include:
• Common triggers for a recalculation
• Guidance and protocols across programs and agencies
• Key financial and compliance risks
• Management response and planning
• Methodology considerations and key data components
• Known roadblocks in data and systems
• Internal and external resource needs

Chris Cobourn, Senior Vice President, Compliance Implementation Services (CIS)

 Download the complete agenda here.

Register for MDRP 2014 now and as a blog reader, receive $100 off when you use the code: XP1958BLOG - Register here. 

Medicaid Expansion and Healthcare Exchanges

Last year at MDRP, Richard Holsapple, Pharmacy Services Manager, HP Enterprise Services, Oregon MMIS, sat down with MDRP TV to discuss Medicaid Expansion and Healthcare Exchanges – watch the video above to hear what Richard had to say on this topic. And remember to join us at the 19th Annual MDRP Summit, September 15-17 in Chicago to hear Richards revised 2014 ideas and predictions…

Session Spotlight: 

Explore the Impact of Medicaid Expansion on Exchange Enrollment

Moderator: Sharon H. Greeson, R.Ph., GP Consultant, Compliance Implementation Services (CIS)

Panel:
• Jennifer Boyd, Florida
• Sam Trigillo, Illinois
• Richard Holsapple, Oregon
• Cindy Laclair, Kansas
• Andy Vasquez, Texas

Remember to register for MDRP 2014 with the code XP1958BLOG to save and EXTRA $100 off of the current rate! $300 in total savings.

See you in Chicago!

The Advanced GP Forum, IIR GP Summit Pre-Conference Day, March 26th in Alexandria! Let’s talk GP!

Today's guest post has been provided by Chris Cobourn, Senior Vice President, Commercial Compliance.

 If I were to ask a Government Programs (GP) Professional “what’s on your mind?” I am pretty sure I would get an earful!

We are all pretty busy, facing significant challenges now while also trying to be prepared for the changes that will come with the CMS AMP Final Rule and HRSA’s Mega Rule. We have a lot to talk about, and the Advanced GP Forum is a great place to do it.

Over the last six years the Advanced GP Forum has become a must-attend event for anyone seeking in-depth, comprehensive examination of current and complex GP issues. The Advanced Forum breaks away from traditional presentations and provides insights from your peers in an open forum. As you know, there is a lot of gray area when it comes to guidance, yet the bar for compliance is set pretty high. That is why so many of you come to GP Summit and attend sessions like the Advanced GP Forum. It helps to promote dialog with your peers and understand the issues and how industry is dealing with them.

Myself and Erika Scholl from CIS facilitate the discussion, posing topics and questions to the panel, as well as seeking input from the audience. Some of the topics we will be discussing include:

• Shifts in the Payer mix with MMCO and HCX, and the expansion of Medicaid
• Medicaid and Medicare: An Overview of Healthcare Reform Impacts on Accruals and Liability
• Key components of the Final Rule and performing company specific Fiscal Impact analyses
• Key methodology topics across the programs
• Bona Fide Service Fee evaluations
• 340B Program Integrity initiatives, including manufacturer audits
• GP systems assessment and audit to validate the integrity of the calculations, both historical and prospective under the Final Rule

Panelists for this year’s Forum include: 

Tom Evegan, Senior Director, Commercial Contracting, CIS
Sharon Greeson, R.Ph., Strategic Consultant, Government Pricing and Programs and CIS State Medicaid Initiative leader
Jennifer Norton, Senior Director, Pricing & Contract Administration - Managed Markets, Vertex Pharmaceuticals, Inc.
Sabrina Yohai, Senior Corporate Counsel, Pfizer Inc.
Michael Hepburn, Sr. Director, Government Contract Compliance, Janssen Pharmaceuticals, Inc.
Paula Martins, Director, Contract Operations, Daiichi Sankyo

We in the industry take pride in the label “GP Geek.” We enjoy what we do, and we appreciate the opportunity to be with our fellow GP Geeks to discuss our shared challenges (as you know, there are not too many people who understand what we do!) We hope to see you there!

To hear more from Chris and CIS, join us for IIR's 6th Annual Government Programs Summit taking place March 26-28, 2014 in Alexandria, VA. Register with code GPBLOG25 and save 25%, offer ends 3/13 at midnight! To learn more, download our brochure. We hope to see you in a few weeks!

HRSA’s 340B Program Update, Managing the Coverage Gap, and a Full-Day of Final Rule Insight at IIR’s 6th Annual Government Programs Summit

At IIR’s 6th Annual Government Programs happening March 26-28, 2014 in Alexandria, prepare for the impact of the U.S. Department of Health and Human Services June publishing of the 340B proposed rule and get practical solutions to manage the Coverage Gap Discount Program (CGDP) challenges.

Understand the rebates and forecasting involvement with the new Part D requirements in the session, Practical Solutions Manufacturers can use to Manage Coverage Gap Discount Program Challenges and hear from Cmdr. Krista M. Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration, update the 340B program. Want more? Learn about the latest hot topic areas: Contract Pharmacies, Orphan Drugs, GPO Prohibition, Covered Outpatient Drugs, and Audits in the track — 340B Summit for Manufacturers, in collaboration with Apexus' 340B University.

New Podcast: Preview the Advanced GP Forum and Get Industry Insights from Chris Cobourn, SVP at CIS as he provides industry insights to:

• How manufacturers can navigate the challenge of forecasting Medicaid and Medicaid Managed Care
• Lessons learned on Bona Fide Service Fees and Fair Market Value
• The role of the GP professional evolving in a merger acquisition

Plus! Get a sneak preview from Chris on the one-of-a-kind Advanced GP Forum — Fiscal and Methodological Considerations of the Final Rule pre-conference day workshop, where you will receive a unique opportunity to obtain insights on critical GP issues from a panel of industry thought leaders. This full-day panel discussion will prepare for the individual components of the Final Rule and also discuss obtaining intelligence for planning and forecasting.

Listen to the full podcast.

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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Download the GP podcast featuring Chris Cobourn

Today's podcast features Chris Cobourn, Senior Vice President of Commercial Compliance for CIS. Cobourn discussed his thoughts on the industry, as well as the challenge of forecasting Medicaid and Medicaid Managed Care, Bona Fide Services Fees and Fair Market Values, and mergers and acquisitions.

View our highlights below:

So before we begin, what are your thoughts on what’s going on in the industry today, Chris?

Chris: We are very much all in a “hurry up and wait” mode, especially from the pharmaceutical manufacturer perspective with continued delays of the final rule. But yet it is still really important to be as proactive as possible in your planning because when it hits, it could be significant and you really have to be in a comfortable position feeling that you‟ve planned for it.

Why is it important to conduct a company-specific impact analysis of the final rule?

Chris: At a high level, I think if you were to take a look at the question that we get increasingly from the CEO and CFO level, especially in smaller-sized companies where they are more involved, the simple question is: “What will the final rule mean to us and what will it take to implement it?”

When you look at all the variables and the proposed rule, if they all happen – and some of the significant things happen like the build-up rule, expansion of Medicaid to Puerto Rico, some of those types of things – it‟s significant. It‟s significant system changes, it‟s significant data that you‟ll need, it‟s significant materiality impact. So, how do you plan when you don't know which of those components will be in the final rule?

To hear more, download the full podcast.

Want to join Chris and CIS this March at IIR's 6th Annual Government Programs Summit? Register with code XP1951BLOG and receive 15% off of the standard rate. To view our full program, download our brochure. We hope to see you March 26-28 in Philadelphia, PA!

Prepare for 340B Program Changes and the AMP Final Rule

As the clock ticks down on the few months left before the AMP Final Rule is released, IIR's 6th Annual Government Programs Summit in March will be your last opportunity to hear from colleagues who have prepared for the impact of each individual component of the rule:

This full day panel discussion will prepare for the individual components of the Final Rule and also address the combined GP and Finance concerns that manufacturers are facing for planning and forecasting. Because Q2 publication of the long-awaited CMS AMP Final Rule will have a financial impact and affect forecasting, gross-to-net, and accruals, it is no longer exclusively a GP issue and is just as important for a company's Finance organization to prepare for the changes.

Panelists:
Jennifer Norton, Senior Director, Pricing & Contract Administration - Managed Markets, Vertex Pharmaceuticals
Sabrina Yohai, Senior Corporate Counsel, Pfizer
Michael Hepburn, Sr. Director, Government Contract Compliance, Janssen Pharmaceuticals

CIS Speakers:
Chris Cobourn, Senior Vice President, Commercial Compliance
Erika Scholl, Senior Manager, Government Programs Consulting
Tom Evegan, Commercial Contracting Services

340B Summit for Manufacturers - In collaboration with Apexus' 340 University

The 340B universe is changing and this means various things for manufacturers. There is increased scrutiny as to the level of 340B compliance for all stakeholders, including manufacturers' compliance with pricing as well as covered entities' compliance with program requirements. OPA has begun publishing audit results from 340B covered entities, promising crucial information on covered entities' compliance with the program. Get access to the experts in an interactive session tailored for manufacturers. Learn the latest in these key hot topic areas: Orphan Drugs, GPO Prohibition, Covered Outpatient Drugs, Audits, and more!

Speakers:
Cmdr. Krista M. Pedley, PharmD, MS, CDR, USPHS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration
Christopher Hatwig, MS, RPh, FASHP, President, Apexus, 340B Prime Vendor Program
Larry Stepp, Vice President, National Accounts, AmerisourceBergen
Perry Knight, Senior Counsel, Johnson & Johnson
Robert Nahoopii, PharmD, MS, BCPS, CEO/Co-Founder, Turnkey Pharmacy Solutions, A 340B Management Company

To learn more, download our agenda.

Register with code XP1951BLOG by this Friday (1/24) and receive up to $400 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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