Are you ready for first quarter-end close?

Be Ready for First Quarter-End Close and Earnings Announcements!

Your time is valuable, that's why this year's Gross-to-Net Accounting Forum is moving to a JAM-PACKED, one-day summit on March 23rd - minimizing the disruption to your work week.

Get a comprehensive overview of the entire pharmaceutical GTN process and minimize liability impacting your bottom line with industry experts such as:

• Amy Ramazio, Finance Director, GlaxoSmithKline
• Mila Tartakovsky, Sr. Director, Corporate Financial Analytics, Daiichi Sankyo
• Larry Breen, Director of Revenue Analytics, Sunovion Pharmaceuticals
• And more!

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

Plus! Tailored Discussion Groups are back! Brainstorm issues, concepts and solutions related to your company size and function in the Gross-to-Net Roundtable Wine and Dinner.

Join us March 23, 2015 in Arlington and click here to register now.

If you have any questions about the event, please reach out to me at rgeswell@iirusa.com 

Gross-to-Net Accounting Forum for Pharmaceutical Manufacturers is Moving!

Here's the good news. IIR's Gross-to-Net Accounting Forum is back and better than ever and has moved in with  IIR's 7th Annual Government Programs Summit!

Be ready for first quarter-end close and earnings announcements by joining us for a JAM-PACKED, one-day summit on March 23rd! Get a comprehensive overview of the entire pharmaceutical GTN process and minimize liability impacting your bottom line.

Plus, take a step further in understanding how government pricing and contracting functions impact your company's financials beyond Gross-to-Net by adding IIR's Government Programs Summit to your registration. Take advantage of our best savings of the year!

For additional information on this event and all it has to offer, please download the agenda.

Don't hesitate-start 2015 right by crossing off some professional goals with IIR's Gross-to-Net Accounting Forum now occurring alongside IIR's gold-standard Government Programs Summit. Register now and save up to $400! Use the code XP2051BLOG

I hope you join us in March in Arlington.

How to Address Commercial Ops, Commercial Contracting and Government Pricing

At MDRP 2013, Mark Linver, Director, Huron Life Sciences discusses addressing government and commercial pricing operations during mergers and divestitures. Below are two highlighted sessions from MDRP 2014 that will look into Commercial Ops, Commercial Contracting and Government Pricing.


Session Highlight:
Spillover Effects Between Government Pricing, Commercial Business & Contracting Strategies

• Discuss healthcare reforms impact on contracting & emerging contracting practices
• Evaluate the impact of government pricing changes on commercial accounts
• Reevaluate and restructure rebate and discount agreements

David Chan, Practice Leader, Compliance & Audit, Managed Markets Services, IMS Health


Session Highlight:
Improving Effectiveness of Revenue Analytics by Using GP Forecasting

The continual growth of the government channel has increased the importance of understanding the cross-channel impact of the commercial pricing and contracting decisions that drive liabilities. Along with increasing pressure to understand, forecast and accurately accrue for revenue line items as part of the GTN process, an expanding government channel means contracting and pricing functions have a greater need for pricing and forecasting outputs from the GP department. The “modern” GP team is tasked with providing “what if” analyses and forecasts for a wide variety of company specific and industry wide events, and is looked upon as a critical resource when pricing and contracting decisions are being made. Today’s GP team must be adept at developing quick yet sophisticated models to assess how any given event may affect Revenue lines that are driven by a Government payer.

This session will take a look at how to effectively incorporate commercial strategies and market events into the forecast of GP price points. We will explore how to:

• Manage and align data for analytical needs
• Consider price increases and commercial contracting strategies
• Incorporate channel shifts into forecasts
• Evaluate regulatory and market events in scenario modeling
• Identify what you know and what you don’t know, and how both should be considered and modeled

Jeffrey Baab, Senior Director, Life Sciences, daVIZta

Download the agenda to see a complete list of speakers and sessions.

Register by Friday 8/8 to save $300! Make sure you use the code XP1958BLOG | Register Now!

Q&A with Amy Ramazio of GlaxoSmithKline – A Speaker at IIR’s Gross-to-Net Accounting Forum

At IIR's 2nd Annual Gross-to-Net Accounting Pharmaceutical Manufacturers, Amy Ramazio, Finance Director at GlaxoSmithKline will be the Big Pharma Chairperson, in our all new tailored discussion groups for your specific company size and function!

Below Amy sat down to do a quick Q&A session with us...enjoy!


Q&A:

1. How feasible is collaboration between managed markets, commercial, government programs and Finance?

Successful collaboration will largely depend on the particular individuals involved.  The key is for everyone to have an enterprise view.

2. Key questions to ask before investing and building an automated GTN system?

- What functionality is most important to your organization?
- How much are you willing to invest?
- When do you need the system to go live?

3. How to accrue and forecast patient/ payer related items? What critical/essential information is required and what aspects you can’t afford to overlook.

Forecasting and accruals are typically based on past history with some adjustments where there are specific changes expected in the future.  Having information to develop these adjustments is critical and could include: segment lives and expected trends, TRX data, formulary changes, legislation changes.   


To hear more from Amy, please join us in Philadelphia, June 17-18 for the 2nd Annual Gross-to-Net Accounting Forum. Plus register with the code XP1911BLOG to receive $100 off the current rate!

Register Now!

Online Exclusive - IIR Healthcare Events Memorial Day Flash Sale! How can you save 26% off the Full Access Pass? Details here!

To celebrate Memorial Day, we're throwing a healthcare sale!

For the next three days, we're offering you a chance to attend a select number of our healthcare events for 26% off the standard full access pass rates*!

What events are included?



Gross-to-Net Accounting Forum | June 17-18, 2014 | Philadelphia | Download the agenda

This offer is EXCLUSIVE to online registrations. Click Here to register and be sure to use code XP1911MDAY* to receive the discount. This limited-time offer expires Monday, May 26, 2014 at 11:59PM ET.

If you have any questions, reach out to Jennifer Pereira at jpereira@iirusa.com.

Rules and Regulations Apply:
• Registrants will receive 26% off the standard registration rates
• This offer only applies to passes purchased on Thursday, May 22, 2014 to Monday, May 26, 2014
• This offer only applies to online registration

*This offer cannot be retroactively applied on existing registrations nor combined with other offers, discounts or promotions. Offer only valid between May 22 - May 26, 2014.



Healthcare Data Insights | June 23-25, 2014 | Chicago | Download the agenda

This offer is EXCLUSIVE to online registrations. Click Here to register and be sure to use code XP1902MDAY to receive the discount. This limited-time offer expires Monday, May 26, 2014 at 11:59PM ET.

If you have any questions, reach out to Jennifer Pereira at jpereira@iirusa.com.

Rules and Regulations Apply:
• This offer is only available for the Full Access (All 3 Days)
• This offer is not eligible for Main Conference Only (June 23-25)
• Registrants will receive 26% off the standard registration rate.
• This offer only applies to passes purchased on Thursday, May 22, 2014 to Monday, May 26, 2014
• This offer only applies to online registration

*This offer cannot be retroactively applied on existing registrations nor combined with other offers, discounts or promotions. Offer only valid between May 22 - May 26, 2014.



Annual Summit for Oncology Management | July 21-23, 2014 | Philadelphia | Download the agenda

This offer is EXCLUSIVE to online registrations. Click Here to register and be sure to use code XP1914MDAY to receive the discount. This limited-time offer expires Monday, May 26, 2014 at 11:59PM ET.

If you have any questions, reach out to Jennifer Pereira at jpereira@iirusa.com.

Rules and Regulations Apply:
• This offer is only available for the Full Access (All 3 Days)
• This offer is not eligible for Main Conference Only (July 21-23)
• Registrants will receive 26% off the standard registration rate.
• This offer only applies to online registration

*This offer cannot be retroactively applied on existing registrations nor combined with other offers, discounts or promotions. Offer only valid between May 22 - May 26, 2014.



Specialty Pharmacy Collaboration Summit | September 15-17, 2014 | Boston | Download the agenda

This offer is EXCLUSIVE to online registrations. Click Here to register and be sure to use code XP1968MDAY* to receive the discount. This limited-time offer expires Monday, May 26, 2014 at 11:59PM ET.

If you have any questions, reach out to Jennifer Pereira at jpereira@iirusa.com.

Rules and Regulations Apply:
• Registrants will receive 26% off the standard registration rates
• This offer only applies to passes purchased on Thursday, May 22, 2014 to Monday, May 26, 2014
• This offer only applies to online registration

*This offer cannot be retroactively applied on existing registrations nor combined with other offers, discounts or promotions. Offer only valid between May 22 - May 26, 2014.

Q&A with David A. Mericsko, GE Healthcare Life Sciences

 At the 2nd Annual Gross-to-Net Accounting Forum for Pharmaceutical Manufacturers, David Mericsko, GE Healthcare Life Sciences will be presenting a case study. The case study will be followed up by a panel discussion on chargebacks, David will moderate the panel.

Case Study: Chargeback Reserve Estimates and Methodology
• Reserve True-up methodology
• Developing point of sale accrual rates for products
• Various operational metrics used by accounting and FP&A departments to analyze and monitor reserve balances
• Using external channel data in our true up and monthly metrics analysis
• Picking an external inventory channel vendor and monitoring and maintaining the data received from the wholesalers; setting up wholesaler 852/867 fees
• Leading internal and external audit teams through the wing to wing chargeback process

Follow-up Chargeback Panel Discussion
• What are key complexities to the chargeback process and how are these managed?
• What are considerations for contractual renewal, reporting requirements and discounts between commercial and governmental customers?
• Process considerations for validation activities

Moderator:
• David A. Mericsko, Assistant Commercial Controller, GE Healthcare Life Sciences

Panelists:
• Marijo G. Bustos, Manager, Chargebacks, Fresenius Kabi USA, LLC
• Jeff Miller, Senior Manager - Financial Accounting, Impax Laboratories Inc.
• Rosemary Schaab, Controller/Director, Chargebacks Administration, AmerisourceBergen
• Jon Brier, Product Manager, Revenue Manager, Revitas



Q&A:

1. How feasible is collaboration between managed markets, commercial, government programs and Finance? 

Constant dialogue between departments is a necessity.  From my an accounting point of view, we here at GE Life Sciences promote this through a variety of measures including:

• Monthly GTN meetings with commercial, finance and accounting department leaders to discuss point of sale rates and operational results/ metrics;
• Monthly GTN accrual meetings with commercial and government teams;
• Commercial contract “workflows” that ensure the impact of new/ revised contracts are reviewed/approved by each of these groups;
• Daily adhoc communications via email, phone etc. to ensure new issues are communicated to each group.

2. Key questions to ask before investing and building an automated GTN system?
 
Key questions would include:
• Is this a global or US IT solution?
• How is data integrity maintained?  How can data be traced to the GL/ be audited?
• How will the solution interact with our current systems?
• Who are the report users?  Do the reports meet their needs?

3. How to accrue and forecast patient/payer related items? What critical/essential information is required and what aspects you can’t afford to overlook. 

Patient/ payer accruals is not really applicable for our distribution chain.  Our products are diagnostic agents used by hospitals for various imaging scans.



To hear more from David, please join us at the Gross-To-Net Accounting Forum, June 17-18 in Philadelphia, PA. 

Register now and save an additional $100 off the current rate when using the code: XP1911BLOG - $300 in total savings! Register now because these rates expire Friday 5/23.


Register here and save $300!

Download Archived Webinar – Revenue Leakage: Industry Definition, Insight and Best Practices to Mitigate Risk

The term ‘Revenue Leakage’ is used widely in the pharmaceutical industry and is creating management buzz!  In Gross-to-Net the term most commonly references lost net sales as a result of unintentional internal or external data, process and system issues. 

This webinar is to further explore the term Revenue Leakage and what it means to branded pharma, start-ups, generics, and biotechs.  In Gross-to-Net, Revenue Leakage can arise in any customer segment (Government and Commercial) and any customer channel (Medicaid, VA, 340B, Managed Care, Specialty, Part D, etc.). 

The key to mitigating Revenue Leakage is to recognize, assess and continuously improve.  The industry has made large investments in adjudication systems and performed numerous audits to temper the hemorrhaging.  There is no substitute to a strong cross-functional process with continuous analytics to ultimately control the risk.

Jennifer Sharpe from daVIZta, a Revenue Analytics firm, will moderate the Revenue Leakage discussion.  Jennifer is joined by her fellow co-chairs for the upcoming IIR GTN conference in June:  Larry Breen from Sunovion, Roxana Santiago from Hospira and Courtney Callihan from GSK.

The webinar addresses and provides insight on the following components of Revenue Leakage:

• Collective Industry Definition
• Customer Segment and Channel impacts
• Financial Statement impacts (accruals, cash flow, forecasting)
• The industry risk between adjudication and audit – the need for continuous improvement.
• Industry best practices and next steps for mitigating risk and continuous improvement.

Download the webinar here. 

To hear more from Jennifer, Larry, Courtney, and Roxana, make sure you join them at the Gross-to-Net Accounting Forum, June 17-18 in Philadelphia, PA. Save $100 off the current rate when registering with the code: XP1911BLOG

Register Here.

Q&A with Miree Lee of M. Lee Consulting, LLC - A Speaker at IIR's Gross-To-Net Accounting Forum

• 
  

At the 2nd Annual Gross-To-Net Accounting Forum, Miree Lee will be leading a workshop on the Impact of the MDRP AMP Final Rule on Accruals. With the CMS AMP Final Rule scheduled to be released in May, attendees of this workshop will learn about the many variables within the rule that alter government payer forecasting, gross-to-net and accrual calculations. Different types of manufacturers must also consider how their products and their distribution model are specifically impacted.

Key considerations of the final rule, impact for each:

• Pharmaceutical Price Points (AMP, BP, ASP, NFAMP, 340B, etc.)
• Overview of Various Government Programs
• Requirements under Medicaid Drug Rebate Program
• What is AMP?
• What are the inclusion and exclusion filters?
• How is AMP used?
• What is BP?
• What are the inclusion and exclusion filters?
• How is BP used?
• What is the URA?
• What are some potential changes in AMP, BP and URA?
• How do companies accrue?
• How does Medicaid expansion impact accruals?
• Managed Care Medicaid and Duplicate Discounts
• Other changes in Medicaid that may impact accruals

Q&A:

1. How feasible is collaboration between managed markets, commercial, government programs and Finance?  

Collaboration takes on different forms for different companies.  There isn't a "one size fits all" methodology except that the core principle of collaboration is a critical necessity for government pricing/program compliance.  Some companies identify and memorialize the collaboration process via formal process methodology document which outlines the tactical activities of collaboration (e.g. roles, responsibilities, timelines, specific reports and data, meeting schedule, etc.).  Other companies may adopt a less formal process whereby key persons of each department are involved in providing the proper information to the pricing department or responsible individual to ensure government pricing/program compliance.  Depending upon the size, structure, product mix, complexity of business and various other factors, cross functional collaboration may look different company-to-company. 

2. Key questions to ask before investing and building an automated GTN or GP system? 

Number of products, number of NDCs, annual sales, number of direct and indirect customers, classes of trade for direct and indirect customers, number and types of discount contracts, rebate or chargeback, tiered or market share based contracts, volume based contracts, formulary status requirements, bundles, stacked discounts, types of fees - bona fide or not. 

3. How to accrue and forecast patient/ payer related items? What critical/ essential information is required and what aspects you can’t afford to overlook.

• Intimate knowledge of the competitive market
• Shifts in market share and causes for the shifts (pricing, special contracts, supply, reimbursement)
• Thorough understanding of payers and changes in payor reimbursement
• Changes in payor coverage and patient population (e.g. Medicaid expansion, shifts in payor mix)
• Changes in mandatory discount/rebate liability (e.g. Medicaid URA increases substantially or 340B or FSS price decreases substantially)
• Price protection and how price protection is calculated

To hear more from Miree, please join us at the Gross-To-Net Accounting Forum, June 17-18 in Philadelphia, PA. 

Register now and save an additional $100 off the current rate when using the code: XP1911BLOG

Get the Complete GTN Perspective | Last Chance to Save $400 is This Friday, May 2nd

 

The 2nd Annual Gross-to-Net Accounting Forum is less than 2 months away, and I couldn't be more excited about the enthusiasm and excitement surrounding the event. Join the growing list of attendees to see why timely and imperative GTN content is and how crucial it is to your business.

We've got a packed agenda including in-depth coverage on chargebacks and the impacts of healthcare reform on Medicaid accruals and liability to ensure you leave with the complete GTN perspective. You will hear directly from experts at big and small pharma, and branded and generic companies on key areas such as:

• Automation
• Pipeline Strategy
• Medicaid Liability
• Chargebacks
• Returns
• Managed Care
• Loss of Exclusivity   

   
Click here to download the updated brochure.

Seats are filling up rapidly, so hurry and register today! This Friday, 5/2 will be your last chance to save up to $400! Be sure to use code: XP1911BLOG

Click here to register.

I look forward to meeting you in Philadelphia this June.

Reminder - Complimentary Revenue Leakage Webinar | Register Now

Revenue Leakage:  Industry Definition, Insight and Best Practices to Mitigate Risk
Join us for a Webinar on April 14th—space is limited!
Reserve your Webinar seat here.
Mention Priority Code: XP1911WEB

Understand what ‘Revenue Leakage’ means to branded pharma, start-ups, generics, and biotechs with IIR’s 2nd Annual Gross-to-Net Accounting Forum’s discussion group chairs! 
• Collective Industry Definition
• Customer Segment and Channel impacts
• Financial Statement impacts (accruals, cash flow, forecasting)
• The industry risk between adjudication and audit —the need for continuous improvement.
• Industry best practices and next steps for mitigating risk and continuous improvement.   

MODERATOR:
Jennifer Sharpe, Revenue Analytics Gross-to-Net, daVIZta

PRESENTERS:
From Big Pharma – Courtney Callihan, Finance Director, GlaxoSmithKline
From Small to Mid-Sized Pharma – Larry Breen, Director of Financial Planning and Analysis/Revenue Analytics, Sunovion Pharmaceuticals
From Generics – Roxana Santiago, Senior Finance Director, Gross to Net, Hospira Worldwide, Inc.

After registering you will receive a confirmation email containing information about joining the Webinar.

Keep the discussion going with our Chairs at IIR's 2nd Annual Gross-To-Net Accounting Forum

2014 Conference Highlights include:
• New tailored discussion groups to collaborate across Managed Markets, Commercial, Government Programs and Finance for Big, Small to Mid-Sized Pharma, and Generics
• First opportunity to get up close and personal with the AMP Final Rule at the pre-conference workshop
• Never-before-heard case studies on GTN automation and chargeback methodology, in addition to strategic forecasting panel discussions
• Quantifying approaches for the impact of Medicaid, 340B and Healthcare Reform

Register by 5/2 and save up to $400 off standard registration rates

If you have any questions about the agenda or event, please contact Ryan Geswell at rgeswell@iirusa.com or visit our webpage.

We look forward to seeing you June 17-18 in Philadelphia!


Opt-in for updates

Follow us on Twitter

MDRP 2013: Day 2 Recap (part 1)

Edward McAdam, Daiichi Sankyo kicked off opening remarks for day 2 of MDRP 2013, leading us into our morning Keynotes. 

The first Keynote: Healthcare Policy into 2014 - Medicaid's Downstream Effect on a Financially Struggling United States Government lead by Michael Steele, former Chairman of the Republican National Commitee and Poly Analyst at MSNBC was our first session of the day. Steele asked questions such as, "What are our priorities as a nation?" and reminding the audience to think about what it is you do in the context of a service provider, and service given.

Steele also touched on the future of problem solving, or rather, the problem solvers, millennials, describing their dependency on apps, but also their ability to create new ones to solve problems. Steele's overall message was that you're going to have to adapt to create a new environment, while still dealing with the same old issues, especially with our healthcare system changing so drastically. He closed with asking the audience, how are you going to fit into the future? Steele reminded them that it doesn't matter if you like the ACA or not, it's here, and it's happening. The old rules no longer apply, so you must adapt to the new ones, create new conversations, because our decisions will become the strategic links as to how we solve problems in the future. 

Commander Krista Pedley, Director at the Office of Pharmacy Affairs, kicked off the next session, Annual Update on 340B Program Regulations, Processes and Enforcement Answers from PHS. Pedley discusssed the components that make up the HRSA audits of entities, including volume of purchase, length of program, and targeting entities. She also touched on the process of audit results, noting that entities have opportunity for notice and hearing, and once agreed, the final report is posted to the website. 

Another topic Pedley covered was the purpose of annual recertification, which is required by statute to ensure program intergrity, compliance, transparencey, and accountability. Perhaps one of the biggest benefits from the resertification is the accuracy of covered entity information for 340B data bases that it produces.

The last issue Pedley addressed was the 340B user fee, although some people may not necessarily agree with it, but it's the only way the program can continue to improve and evolve, without the fee there would be no resources for the program.

Our next session, Taxpayer Dollars and Corresponding Oversight Requirements, lead by Alice Valder Curran, Partner at Hogan Lovells LLP, discussed the '340B Program Reconsidered'. She answered the question, program savings or program profit? Stating that program savings is really program profit, if 340B were restricted, manufacturers would get more money. And in terms of protecting the taxpayer- which one are we protecting? 340B saves taxpayers money, aren’t manufacturers taxpayers too? It’s not a question of we are better at where we are, its that we're nowhere near where we need to be. Should 340B discounts be viewed as taxpayer dollars? And if not, why not?

Another topic that Curran covered was entity recertification, more importantly, changing how it's determined. Also asking, should covered entities have any accountability for how they use 2 billion dollars a year?  She also discussed the fact that covered entities face extremely limited penalties in terms of interest and exclusion from programs. Currans bottom line? Stop complaining and start looking into your liabitlity. Start overseeing your exposure to the 340B program, analyze your 340B book of business and gross-to-net impact. GTN has suffered from 'benign neglect' for far too long, and it's time to take a closer look. Also, do your homework now, know the issues important to your company, the mega-rule will be your chance to ensure your concerns are addressed regarding compliance and operational issues. So keep an eye on the legislation this fall and be prepared!

Kathleen Peterson, Special Counsel at Cooley LLP, finished up our morning session with AMPs, NARPs, NADACs and FULs Oh My! Peterson discussed the outcome of the proposed rule. If finalized, it would replace each professional dispensing fee with actual acquisition cost plus professional dispensing fee. Historically, the dispense fee for Medicaid has been primarily low, this would increase the fee substantially. Peterson also discussed the impact of marketplace changes on rebate payments. In closing, she advised to learn from your past, and always evaluate possible legal issues. 

Stay tuned for coverage from our afternoon track sessions!