Missourians Advised To Resist Health Care Law

Over the past few months the government has been spending millions on advertising to create awareness for the upcoming Health Insurance Marketplace, which opens for enrollment on October 1st. The new marketplace will help millions of Americans customize a healthcare plan that best suits their needs. Although open enrollment is less than a week away, some state officials continue to discourage residents in participating.

Lt. Gov. Peter Kinder has a message for the thousands of Missourians looking for health insurance: Don't get it through an online marketplace that launches next week. "I would hope there would be active resistance to this law — that people would not sign up," Kinder said Monday. 

Later today President Obama and Bill Clinton will meet to discuss the value of the new exchange. With open enrollment just days away, how many people do you think will purchase their plan through an online marketplace?

Want to learn more about the future of the marketplace? At IIR's HIX Reloaded, we'll help you shape your strategy for the ever evolving marketplace. To learn more, download our agenda.

As a reader of this blog you'll receive 15% off the standard rate when you use code XP1810BLOG to register. We hope to see you November 14-16 in Baltimore, MD!

Arkanasas Insurance Department unveils premiums

Arkansas Insurance Department has been evaluating premiums for quite some time, concluding they would vary by age, the size of the family, tobacco usage and geography. However, the premiums are actually lower than what was originally projected. The state will provide three separate plans - bronze, silver, and gold.

Arkansas Insurance Commissioner Jay Bradford announced premium rates for the 71 qualified health insurance plans that will be sold on the individual market in the new Health Insurance Marketplace. The qualified Health Plan issuers offering plans are Celtic Insurance Company d/b/a Arkansas Health and Wellness Solutions, Arkansas Blue Cross and Blue Shield, Blue Cross and Blue Shield Multi-State, and QCA Health Plans, Inc. d/b/a QualChoice Health Insurance of Arkansas.

The plans will be sold on the Health Insurance Marketplace beginning October 1st. Examples of the premium rates can be found here.

Want to learn more about the future of the marketplace? At IIR's HIX Reloaded, we'll help you shape your strategy for the ever evolving marketplace. To learn more, download our agenda.

As a reader of this blog you'll receive 15% off the standard rate when you use code XP1810BLOG to register. We hope to see you November 14-16 in Baltimore, MD!

MDRP 2013 Day 3: Current criminal and civil Enforcement Activities to improve Corporate Compliance

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Sam Woronoff, covers day 3 of MDRP 2013. 

Leading legal representatives from a law firm, a major manufacturer, and US Attorney’s office shared their insights and gave examples of recent lawsuits in connection with Government Pricing. GP department have definite role and responsibilities in the awareness of commercial activities and enforcing compliance policies to protect the company from unnecessary lawsuits. They pointed out some of the red flag items and key indicators that GP can look for as warning signs for potentially illegal activities.

Some of the key topics involving Anti-kickback being focused on today include: Market Share Rebates, Active Intervention Programs, and Transparency in Bundling /Volume Discounts. Also, some questionable contracting and sales activity examples such as retroactive discounts, and discounts disguised as sampling were shared. GP may not have a great visibility in the communications between the sales representatives and customers, but GP can review the contract structure to ensure that the discounts are legitimate and no side agreements are in place. Also, GP can look out for increased sampling activity of billable products which is a big red flag for the DA’s office.

The legal world relies on the “Collective Knowledge Doctrine” which means if one employee of the company is aware of an illegal activity, the company as a whole attributed to it. Be sure a firm corrective action plan is in place and enforced within the company because usually violation of internal policies precedes any illegal contracting practices.

For more detailed information and examples shared today, download the presentation from the IIR website.

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 2013 Track 4: Systems

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 2 Track Session: Systems 

With the expectation of the AMP Final Rule being published in January 2014 (or even later this year according to some speakers), the life sciences industry is eagerly as well as apprehensively looking to all the changes it would bring to existing rules and regulations. The changes would inevitably need to be translated into amendments in methodology and operations as well as to the existing systems. With special regards to systems, manufacturers must start thinking today so that they are in a position to appropriately “Analyze”, “Prioritize”, and “Implement” the necessary systems in time and comply with the new requirements.

During the Systems Track at the 2013 MDRP Annual Summit, several speakers shared examples of some of the expected changes that may come with the AMP Final Rule and which would need to be included/updated within the respective systems. Some of the examples discussed potential base date AMP recalculations according to the new regulations while others suggested proactively thinking about bundling arrangements especially in light of any new definitions/understanding that may be provided by the CMS. Several vendors alluded to being able to provide software solutions that could help manufacturers with implementation of such changes and automation of solutions for the new requirements. 

In order for vendors to be able to provide successful solutions it, however, becomes extremely important for manufacturers to take a more involved approach in the implementation. To this end, many vendor presentations aimed at educating the manufacturers on the need to critically think about these implementations. One vendor discussed the importance of appropriately defining business rules and requirements upfront and how that could serve as the building blocks for a successful system implementation. Another vendor added that manufacturers must think about system implementation more holistically – this meant identifying current issues and shifts in focus (e.g. moving from a Fee-for-Service Medicaid model to a Managed Medicaid model), transferring processes to systems, performing validations and evaluating impact of these changes, among others.

To round up the presentations, one vendor discussed its view of systems implementation in 2020. According to the vendor, the systems implementation model should shift toward a transformational model, a concept that is based upon understanding the current as well as the future trends of the industry and the manufacturer while also paying special attention not just to systems needs but also people and process needs. This “Transformational Journey Roadmap” would allow manufacturers to build a much broader view of not only how their business needs are met by the systems but also how the systems fit into the overall company’s people and process environment. Promising better efficiency and flexibility, this new transformational model would allow manufacturers to effectively change and improve based upon a future state vision and roadmap.

The 2013 MDRP Conference was a great event. Tons of exciting presentations and lots of new information to absorb. Kudos to the organizers! If you haven’t already, do provide your evaluations of what you thought of the conference to the organizers.

MDRP 2013 Track 3: State

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Sam Woronoff, recaps day 2 Track Session: State

A Panel of manufacturers and state representatives shared their thoughts on the recent online surveys were sent to states regarding how the states are validating the MDRP rebate claims data. Based on 32 states’ responses, the survey suggested that in regards to FFS claims data, majority of the state had confidence in their claims data validation process. However, when it comes to the MCO claims data, majority of the states responded that either no validation process was in place or had serious deficiency. As for the 340B claims, some states are relying strictly on voluntary disclosure from contract pharmacies participating in stock replacement as an only source for excluding claims. With the growing trend of MCO claims in MDRP and serious lack in states’ ability to validate the MCO claims data, the manufacturers need to be aware of this gap and be proactive in their invoice validation efforts.

Kudos for the MDRP Collaborative Workgroup for their efforts to create and standardize the electronic formats for claims level details (CLDs) and ROSI/ PQAS! Their efforts will accommodate both the manufacturers and the states to improve invoice validation and dispute resolution efforts, as well as efficiency in processing quarterly invoices! It was great to see the collaborative efforts of the manufacturers and states. Thank you guys!

To this date, the workgroup has developed a standardized CLD format as well as improving the electronic data file for ROSI/ PQAS. The standardized CLD format will be using common language for CLD data to decrease data manipulation, improve operational efficiencies, resource management and compliance control. In addition, they have included 340B indicators into the CLD format. The improved electronic ROSI/PQAS data file was created to minimize both manufacturer and the states’ manual efforts and speed up the rebate process and reduce operating costs. The proposed data file will include the EFT payment information as well.

The workgroup now needs manufacturer’s participation and assistance in pushing this effort into the next level by reviewing and providing feedback for the CLD and ROSI/PQAS data file drafts and reaching out to CMS directly to enforce the importance of this effort for the benefit of the entire MDRP rebate stakeholders.

For more information or to review the proposed CLD format, contact:

Stefano Paoloni Stefano.paoloni@dhs.state.nj.us 
Lynn Lewis llesix@us.imshealth.com  

One pharmaceutical manufacturer has shared their experience in implementing the Texas reporting process and their effort in overcoming challenges. They shared their stance and their methodology for addressing the timing issue, price change definition, and the price point determinations. For detailed information, reach out to IIR for a copy of Michael Hepburn’s presentation deck.

A representative from a leading manufacturer shared their vast insights and experiences in Medicaid Supplemental Contracting. There are many details and nuances in each state’s supplemental bids to understand and to consider. She has shared detailed tips and examples useful for manufacturers to refer to when completing a bid.

Also, some great tips and tools for disputing questionable utilization in Medicaid rebate invoices were shared today. Be sure to know your product, communicate readily with states, and be proactive for the effective dispute resolution process. States are just as eager as manufacturers to reach resolution. The industry is moving forward in the positive direction to work together to become more efficient and knowledgeable as well as resourceful. This track provided great insights and practical knowledge applicable to manufacturers involved in the day to day operation of MDRP.

MDRP 2013 Track 2: Finance

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Dana Zelig, recaps our Track 2 Session: Finance 

As anticipated, attendance at MDRP 2013 was both impressive and diverse, with delegates from pharma manufacturers, external counsel, consultants and system providers, state Medicaid agencies, and Federal programs. To keep so many people interested and engaged, IIR organized Tuesday afternoon’s sessions to allow attendees to move seamlessly between tracks to catch presentations on their hot topics, or by their favorite presenters. This was evident in the Financial Implications to Government Pricing Programs track, where the dynamics of the room changed with each session.

David Chan and Ari Ilan from IMS Health provided their insights on the commercial process and how it impacts GP. Sometimes, especially at large organizations, people are put in a silo and have little visibility to processes outside of theirs. But as IMS outlined, Commercial and GP must go hand in hand to maximize profitability and reduce risk.

Jennifer Lospinoso of KPMG spoke about her experience assisting pharma clients with Accruing and Forecasting. Her insight extended not just to traditional accruals performed by Finance functions, but also to incorporating Medicaid payments, and preparing for the AMP Final Rule.

Jennifer Norton of Vertex Pharmaceuticals discussed the difference between Fee for Service and Managed Care Organization rebates, and how it can impact manufacturers. She emphasized the importance of looking at these rebates from all angles, because they are viewed differently by people in different parts of your organization. It’s an issue that could affect people at every level of your organization, so make sure you know what questions to ask.

Stephen Ruscus from Morgan Lewis presented on the Branded Prescription Drug Fee, and provided background on the genesis of the fee as well as steps for calculating it. He fielded questions from manufacturers with very real concerns about where to get the data they needed to perform the calculations.

Finally, Chris Cobourn of CIS wrapped up the track by giving the GP professionals in the room the steps they need to stand on their GP soapbox and take ownership of requirements impacting their organizations. He aptly noted that even though we are waiting for the AMP Final Rule, we are by no means sitting on our hands with nothing to do. We are busy now, and we’re going to get busier once the Final Rule comes out, so we might as well get our ducks in a row.

Complimentary HIX Webinar: Partnering with Stakeholders for Health Reform Outreach

It’s getting closer and closer—your opportunity to rapidly increase membership by participating in your state’s health insurance exchange is just around the corner. Your opportunity to grow enrollment is dependent on how educated potential new members are, and given the timelines you need to educate community members now. Based on the compressed timelines, I wanted to remind you to sign up for the complimentary HIX webinar on: Identifying and Engaging Stakeholders in Health Reform Outreach taking place this Wednesday, September 18, 2013 from 2:00PM-3:00PM EST featuring John Lovelace President, Government Programs and Individual Advantage, UPMC Health Plan.

This webinar will cover strategies to:

• Increase awareness of the general public in regards to health insurance marketplaces
• Develop understanding of how the Health Insurance Marketplace will work in your state(s)
• Identify what information consumers need in order to make informed decisions
• Understand the role of Navigators, Certified Applications Counselors and others who can assist consumers in enrollment

And more!

Space is limited, register today!

To learn more about HIX Reloaded, download our agenda. We hope to see you November 14-15 in Baltimore, MD! 

MDRP 2013 Track 1: Methodology

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Clay Willis recaps our day 2 Methodology track. 

Another great day at the MDRP 2013 Conference. In the afternoon session, the Methodology track (Track 1) covered a lot of interesting topics that are relevant for manufacturers today. In the first session, David Buckley of GlaxoSmithKline kicked off the track by discussing how to use State Invoices to Validate CMS Unit Rebate Amounts (URA). There was a general theme that manufacturers calculate their own URA’s internally and validate them when they receive the invoices from the states. David provided numerous considerations that manufacturers should look in to. This was a great session and topic to kick off the methodology session.

In the next session, there was a diverse panel with a lot of experience within the industry and on the topic. Jeff Park of Genentech, Mark Linver of Huron Life Sciences, and Robert LaPorte of West-Ward Pharmaceuticals each discussed how to Plan and Effects of Acquiring or Divesting a Product. Based on their experience they stressed that when going through an acquisition or divesting, they key is having a plan in place ahead of time and ensuring Government Pricing methodologies are in sync prior to selecting a system. There is a soft people side of these situations and it is a much easier process if you have buy-in from the business and IT.

In the next session, John Shakow of King and Spalding focused on Government Pricing Policies and Methodologies – The Foundation of Compliance. John’s key theme was that “Documentation is a Compliance Requirement” and provided various OIG guidance as to why this was the case. John provided a very thorough presentation where he covered all types of Government Pricing documentation and what would be included in each of these document. This presentation is a must get because it is a great reference to have internally and do reference on how to develop that element of a compliant Government Pricing department for manufacturers.

In the second to last session, Rick Moore of CIS covered Lessons Learned on Bona Fide Service Fees and Fair Market Value. This is one of the hottest areas within the industry right now and there were a lot of interest from the audience. Rick covered his thoughts on the four part test, the FMV definition, and lesson learned based on recent projects. There is not much guidance around this area but one thing is clear “ Manufacturers must do their due diligence and document everything around service fees.

In the last session, there was a panel of Miree Lee of M. Lee Consulting and Tom Evegan of CIS who covered Understanding Company Needs when Acquiring and Authorized Generic. They covered a lot of interesting perspective and real life examples of how this affects the various calculations. Interesting enough, this is one presentation you must download due to the checklist they provide for manufacturers at the end.

This track was great and the main topics within this track were pretty consistent throughout the day, which resulted in the audience being very interested in what the sessions offered. Great job to IIR and to each of the presenters around their topics. As a take away, manufacturers should look into ways of being proactive and always document what they are doing. Cannot wait to wake up tomorrow for another great day of sessions.

MDRP 2013 Day 2 Keynote Presentations

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Dana Zelig, recaps day 2 Keynote Presentations

You Can’t Please Everyone..

But, as Keynote Speaker, former RNC Chair, and MSNBC Policy Analyst Michael Steele pointed out, you can make them all angry at the same time. His address put the roles of everyone involved in the Medicaid Drug Rebate Program into perspective, by reminding us all that whether we are policy makers, State Medicaid representatives, or GP professionals, we are all helping people in the margins of society who need the assistance of the MDRP.

This is something that I, as a GP consultant, don’t often stop to think about. My responsibility is to ensure that my clients, the pharmaceutical manufacturers, are able to comply with the statutes, regulations, and guidance provided by government entities like CMS and HRSA. Based on comments I have heard during the conference, it seems that these agencies know what it’s like to make everyone angry. But as Mr. Steele asked, “at the end of the day, who is being served?” I think most of us come to MDRP year after year not only to refresh our GP knowledge, but to vent our frustration that we are not being served by the policies made in Washington. But maybe we need to realize that we aren’t the group the much-anticipated AMP Final Rule is meant to serve. Maybe our jobs would be less frustrating if we occasionally reminded ourselves that, for a growing number of people, Medicaid isn’t a 9 to 5 problem, it’s a life or death program.

As Mr. Steele observed, the Affordable Care Act is unlikely to be overturned, so we all need to be prepared to roll with the punches as we implement the Final Rule when it is (hopefully) released in January. He urged the audience to think outside the box and be prepared to make tough decisions, even if it makes some people within your organization uncomfortable. Politics, he reminded us, should be about service, and I think the same is true for pharma. Even if we aren’t in the lab developing new blockbusters, orphan drugs, or biologics, we the Medicaid professionals can still make a difference to people in need. So next time you get a 5 lb. stack of Medicaid rebates in the mail, remind yourself who is being served.  

                             What’s New in the 340B Program 

The second portion of this morning’s Keynote Address was provided by Commander Krista Pedley of HRSA. Cmdr. Pedley outlined the efforts the OPA is undertaking to ensure the integrity of the PHS 340B Program by focusing on validating eligibility of covered entities, avoiding diversion, and preventing duplicate discounts. If you participate in the 340B program (and you’re at a Medicaid conference, so I know you do), you already know the requirements for pharmaceutical manufacturers, so I’ll just recap the recent and new activities highlighted by Cmdr. Pedley.

One new development is that HRSA is now pushing notifications to manufacturers every quarter to let them know if any entities have purchased at 340B prices after their eligibility expires. This does not replace your need to validate your 340B sales, but it does provide a great resource to cross-check. Another development is the new electronic process for registering contract pharmacies, which notifies covered entities of any pharmacies that are applying for status under their name. If the covered entity rejects the application or does not reply to the notification, the contract pharmacy’s application is not approved. The number of covered entity audits HRSA being performed is also new, up from 51 in 2012 to 94 in 2013. Finally, as HRSA finalizes its annual recertification process, it has required hospitals to provide their recertification data by this Friday the 13th, or they will be terminated from the program without exception.

As a takeaway, Cmdr. Pedley provided some useful references, including the new Program Integrity page on HRSA’s website and a list of relevant program releases since 2011. She also highlighted HRSA’s partnership with CMS to tackle issues that impact both programs such as the impact of repayments to manufacturers by covered entities on AMP and Best Price calculations. Anyone with specific questions is encouraged to submit them to HRSA via the following website: apexusanswers@340bpvp.com

Growing Membership at IIR’s HIX Reloaded

It's no secret-we are all in the business of making money, and health insurance exchanges offer a huge opportunity to increase membership, and therefore increase revenue. Regardless of whether or not you're planning on participating in an exchange in 2014, your bottom line will be affected by exchanges. If you're participating in an exchange, you need to continue to increase marketing efforts throughout enrollment to ensure brand recognition to increase membership.

To ensure your membership growth strategy is aligned for success, join all members of the exchange ecosystem (plans, governments, pharma, community organizations and more) at IIR's HIX Reloaded taking place November 14-15, 2013 in Baltimore. At the event, you will engage with early adopters and HIX entrants as they share first-hand experiences and insight about open enrollment and coverage expansion for January 2014.

VOTE NOW!

Want to learn more? Download our agenda.

As a member of the HIX Linkedin group, mentioned code XP1810BLOG when registering to save 15% off of the standard rate. Questions about the event? Feel free to email Kate Devery (KDevery@IIRUSA.com) or check out our homepage.

We look forward to seeing you November 14-15 in Baltimore, MD!

Cheers,
The HIX Reloaded Team

HIX Reloaded Homepage
Follow us on Twitter
Join us on Linkedin

P.S. You are invited to sign-up for our complimentary webinar on Identifying and Engaging Stakeholders in Health Reform Outreach taking place on September 18th, be sure to use priority code 00R0MK4XB when registering.

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!

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!

MDRP 2013: Day 1 Recap

The first morning session for the AMP Final Rule- What it says, What it Means and How to Implement it kicked off today with opening remarks from Alice Valder Curran, Partner at Hogan Lovells LLP. Curran discussed possible dates for the AMP rule, as well as how you should prepare for it. Some of her key takeaways? Read the statute and regulations, and locking in your consulant before the rule is released. Developing a relationship with your consultant early can help you both hit the ground running once the rule is released.

Following Curran was Ven Adamov, Senior Manager for Government Contract Services at Ernst & Young discussing Product Master Issues. Adamov covered issues such as, Product Master Influence on Government Price Reporting, varifying both data uses and organizations, systems changes, and data fragmantation. Also, because every company is different, understanding the field definitions may vary by team. 

Our next session, Authorized Generics and AMP lead by Kave Niksefat and Cynthia Hwang from IMS Health. Niksefat and Hwang covered key questions to answer before including authorized generics in AMP, as well as what makes up an authorized generic. They also discussed how sales and discounts to second manufacturers can be accounted for, and the impact AG will have on Brand AMP.

Rick Zimmer, Partner at KPMG LLP, concluded our morning session with Clarifications to the Bundled Sales Definition. Zimmer discussed the importance of identifying the bundle, as well as self-allocating bundles, and the impact of nestled bundles. 

Before the last networking break of the day, John Shakow, Partner at King & Spalding, presented on, 340B Refund Management and Implications for Reported Price Points. Shakow discussed the impact on CMS pricing when a 340B covered entity attempts to make a repayment arising out of violations of a program prohibition, or losing 340B program eligibility. He ended the session advocating that CMS adopt a helpful rule: "once a 340B sale, always a 340B sale."

Alice Valder Curran, session chair, began one of the last presentations of the day, Independent Pricing Reporting Issues Related to Texas. Curran covered both statutory and regulatoary requirements, as well as trade and calcuation questions and methodology documentation.

The last and final presentation of the day, Preparing for the Final Rule, was lead by Katie Lapins and Clay Willis from Huron Life Sciences. Although there is no definite date, many industry experts believe the final rule will be relased sometime between December and January. So what should you do to prepare? Lapins and Willis suggest educating and coordinating with internal teams in your company, as well as evlauating GP availability to help determine bandwith. They also reccomend documenting all assumptions and modeling potential changes for big areas of your organization.

That concludes day 1 of MDRP 2013, stay tuned for Day 2 updates!