MDRP 2013: Day 3 recap

The third and final day of MDRP 2013 kicked off with opening remarks from Edward McAdam, Daiichi Sankyo and the MDRP Lifetime Achievement Award. Congratulations to the 2013 recipient, Miree Lee!

Following the award announcement, Mark Myers, Office of the Inspector General and Mel Noel, Compliance Implementation Services, led us into the first Key Note session, Veteran Affairs Pricing Compliance and Management Updates. They covered drug pricing, transferred cover drugs, and data issues. What is the best way to signify adherence to statutory requirements? Signing a master and pharmaceutical agreement. In terms of transferred covered drugs and new drugs, one of the biggest issues is lack of timely submission. The bottom line? Make sure that you file on time, manufacturers will be responsible for overchargers based on late filing.

Myers and Noel also covered the issues of placing patented drugs on FSS contracts. They explained that, in a world where covered drugs are more frequently manufactured or have API sourced in India or China, it has become impossible for VA to place many patented covered drugs on FSS contracts of MFRS trying to comply with VHCA. So what is the solution?

VA FSS managers have tried unsuccessfully to obtain a waiver from GSAs guidance to allow FSS listing of patented covered drugs that are manufactured in or have API sourced in countries that are not TAA designated countries.

Rick Zimmerer, KPMG LLP, closed out the morning session with Operational Excellence with Minimal Resources. Zimmerer discussed some important elements to successful optimization. So what are some of the key components? Make sure it's competitive, marketable, and profitable. It's also important to remember what executives are looking for - GP as a strategic function, so where do you start?

Start by defining the issue, clearly state what decisions are required. Is legal guidance required? What's the organizational, financial impact? Potential solutions to problem? Provide a recommendation and then develop a communication plan. Once you've created a tool, it's vital you provide both training and guidance to other GP professionals on how to use it. So overall, the key steps to apply for successful optimization are: record, analyze, present, decide, and communicate. 

The final session of MDRP 2013 was the Current Legal Trends Affecting Pharmaceutical Manufacturers - Manufacturers Perspective panel moderated by Connie Wilkinson, Epstein Becker Green. Panelists included Sabrina Yohai, Pfizer and Christoper Jackson, Otsuka Pharmaceutical, Inc.

  

The panelists all specified the importance of planning accordingly, something that seem to be an overall theme of the conference. They reminded the audience that if something looks like a red flag, take action. They also discussed the impact on an organizations resources now that the final rule has been delayed. The panel agreed that the final rule will be a priority for everyone and knowing your portfolio, and the fact that people have the context already will hopefully help to expedite the process once the rule is released.  

They also recommended pulling  together a cross functional group of colleagues. Dissect the rule, what will it change? What operations/legal questions do you have? This will help you realize what you have, and figure out what you need. Everyone weighing in, leaves no room for surprise.

We hope you enjoyed the 2013 MDRP Conference, see you next year!

MDRP 2013: Day 2 Recap (part 2)

The second half of MDRP 2013 Day 2 began with our track sessions, which were split into four segments: Methodology, Finance, State, and Systems. The first session of the Systems track, It's Almost Here - Now What? Operationalizing the AMP Final Rule was led by Marcy Imada, Deloitte and Touche, LLP.

Imada covered the topic that's on everyones mind, the AMP final rule. Her advice? Start by assembling the right team, it's important to keep an open line of communication throughout the entire process. Also, in terms of tackling the uncertainty of the AMP final rule, analyze, prioritize, and implement. It's imparative to analyze all possible outcomes to ensure a smooth transition when the final rule is released, prepare ahead of time! Also, prioritizing will help you save time, as well as stay organized, which are both important components to approaching the final rule.

One of the later afternoon Methodology sessions, Government Pricing Policies & Methodologies --Methodology Foundation of Compliance, was led by John Shakow, King & Spalding. Shakow covered important topics such as, why documentation is a compliance requirement, as well as a practical necessity. He also discussed the elements of a comprehensive set of methodologies, and the best practices.

So why is documentation a compliance requirement? Price reporting methodology documents are always at the top of the list of documents requested from auditors, investigators and prosecutors, that's why it's necessary to keep all documents organized and updated. The legal resources on which we rely to govern pricing reporting are detailed and exacting, but not nearly detailed enough to reliably and consistently guide the calculations. Comprehensive, thoughtful and well-articulated methodological documents are our first defense against allegations of ‘reckless’ treatment in price reporting.

Shakow also reviewed the elements of a comprehensive set of methodologies: product master, price type narratives, inclusion/exclusion schema by price type (transaction type), reasonable assumptions by price type, non-price type methodologies, record of communications with authorities and implementation SOPs/crosswalks to system coding.

Specific Methodology documents are critical tools in coding and testing GP systems. The creation and maintenance of these methodologies is an internal education tool for use by personnel new to GP, the certifier, and all other business related aspects, so if there are any errors it will impact various groups.

Shakow closed with some advice about the final rule. While you're waiting for the final rule, use it as an opportunity to examine, review and tighten methodology documentation, especially because it is highly unlikely the Final Rule will be retrospective in its application.

Stay tuned for our recap of the final day of MDRP!

Achieving MDRP compliance while protecting your bottom line

Today's guest post has been provided by Lise Neely, Director of Product Marketing at Revitas

Year after year, the Medicaid Drug Rebate Program (MDRP) Summit brings together government regulators, pharmaceutical executives, and industry leaders to discuss new regulations and best practices for maneuvering through the Medicaid Drug Rebate Program. Compliance is top of mind for many summit attendees, as companies struggle to meet government needs without sacrificing their bottom line.

For organizations to overcome regulatory hurdles in a complex rebate system, they have to extend beyond compliance and incorporate revenue management in their MDRP process. Only then can they ensure their processes are auditable and reportable while maintaining profitability. But actually implementing and evolving such business rules is a struggle for many organizations, especially given ever-shifting regulations.

Achieving perfect MDRP compliance and implementing effective business rules are not easy, but Revitas is leading two presentations addressing best practices for sifting through these processes at the upcoming MDRP Summit. First, Barry Hansen, Product Manager for Revitas Government Pricing, and Michael Panicaro, Manager of Solution Engineering at Revitas, will present “Take a Product through the Rebate System” on September 9 at 4:30 p.m. CDT. They’ll walk through each step of the MDRP process to teach you how to move your product through the MDRP pipeline, from initial claim to validation to disbursement, while avoiding margin erosion and maintaining compliance.

Hansen and Panicaro will also address how to identify and implement business rules within an organization in a presentation titled “Translating Business Rules into System Processing” on September 10 at 3:30 p.m. CDT. In an age of increasingly complex government pricing mandates, business rules develop and evolve through multiple outlets, from federal and state governments to security and system requirements. You’ll learn how to successfully manage the influx of business regulations by understanding the source of business rules, learning how to interpret these rules, and then discovering how they can be expressed as requirements.

We’ll also be exhibiting at booth #23 during the conference, so please stop by if you’d like to hear more!

To learn more about the 18th Annual Medicaid Drug Rebate Program, download the agenda. We hope to see you next week in Chicago!

MDRP Podcast: Bill Baxter, Retired after 38 years, Johnson & Johnson

MDRP has teamed up with several of the speakers at this year's Medicaid Drug Rebate Program to share some of their insights on the current healthcare reform and how it will effect the industry leading up to the conference.

Bill Baxter, Retired after 38 years, Johnson & Johnson, and MDRP Conference Track Chair shared his insights on these questions with us:

• Bill has been attending MDRP since it's inception in 1990, and he shares the biggest changes he has seen in your career with the MDRP.
• The number one mistake people make in staying compliant with the MDRP.
• He tells us about the impact of HCR on manufacturers.
• He tells us why this conference is important to him.

To download the podcast, visit the MDRP Podcast webpage.
For a transcript of the podcast, click here.

Healthcare's impact on Pharma companies

According to Drug Store News, Merck will see significant losses from the passage of the healthcare bill. They cite :

Medicaid rebates would cause it to incur costs of $35 million in first quarter 2010 and $170 million for the full year, while the elimination of a tax benefit for retiree prescription drug coverage would cause it to take a non-cash charge in the first quarter of $150 million.

Event through this, they project growth through the year 2012. Is your company facing the same thing when it comes to healthcare reform?