Celebrate Memorial Day with 30% off the Standard Rates to MDRP 2015!

 
Register with code XP2058SAVE30 to activate your 30% discount off the standard rates to IIR’s 20th Annual Medicaid Drug Rebate Programs Summit taking place September 30-October 2nd, 2015 in Chicago, IL.

This limited-time offer expires on Tuesday, May 26th | Register here

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

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

Activate your 30% savings now with code XP2058SAVE30! Offer expires 5/26

Qualifications, rules and regulations: Offer cannot be applied retroactively to confirmed or pending registrations from today's date and prior. 30% discount cannot be combined with any team discounts or other promotions and/or discount offers. Discount is only valid from May 22– May 26, 2015. All registrations are subject to IIR approval.

The 340B Program Reconsidered

With IIR’s 19th Annual Summit on the Medicaid Drug Rebate Program just one week away, we wanted to flashback to one of our expert keynote addresses from the 2013 event. Alice Valder Curran, Partner, Hogan Lovells US LLP presented her keynote address on “The 340B Program Reconsidered: Taxpayer Dollars and Corresponding Oversight Requirements, plus some thoughts on the President's Budget proposals for MDRP”. Take a look at her session below and make sure you join us next week in Chicago to hear everything government pricing, rebates, and regulation.

Remember, blog readers receive an extra $100 off the current rate when registering with the code XP1958BLOG – Register here.

See you in Chicago!

Healthcare Policy into 2014: Medicaid's Downstream Effect on A Financially Struggling United States Government

Healthcare Policy into 2014: Medicaid's Downstream Effect on A Financially Struggling United States Government 

A presentation by MDRP 2013 Keynote Speaker, Michael Steele, Former Chairman, Republican National Committee; Policy Analyst, MSNBC OPA.

Download the updated MDRP 2014 brochure to see who will be giving this years keynote address.

Live from MDRP 2012: September 12, 2012

This week, we're live from Chicago reporting on the current trends and latest information that matters do the Medicaid Drug Rebate Program industry.  You'll find highlights from a few of the sessions in addition to the key tweets from the day.  To join monitor and join the conversation, be sure to reference #MDRP12.

OIG Work Updates

David Tawes, Department of Health and Human Services
Stephanie Yeager, Department of Health and Human Services
Edward Bailey, Department of Health and Human Services

One of the recently completed is the Affordable Care Act Expansion of the Rebate Requirement: Medicaid managed care organizations are required to report drug utilization data to Sates and States are required to collect rebates from manufacturers for drugs paid through MCO

Current Medicaid Drug Projects include:

• -Zero dollar URAs
• -State Experiences with Rebate Disputes
• -Federal Upper Limits under ACA
• -State MAC Programs
• -Supplemental

Ongoing Part B and D Drug Payments include:

• -Quarterly ASP-AMP Comparisons
• -Retail Pharmacies with Questionable Part D Billing

Ongoing Evaluations Involving Medicare Drugs:

• -Least costly alternative policies for certain prostate cancer drugs
• -Payments for DME Infusion Drugs
• -Potential rebates under Medicare Part B
• -Annual fee on brand drug manufacturers
• -Part D Payments for Drugs included in discount generic programs
• -Manufacturer copay coupons

OIG Work Plan will be coming out in October. But it is now based on reviews with requests from Congress and OIG management. Just because the OIG asks CMS to do something it doesn’t mean they have to do it. Medicaid Drugs in the works are updates in manufacturer AMP reporting, authorized generics an detail pharmacies discount generic drug programs. All reports are available at www.oig.hhs.gov.

Current Criminal and Civil Enforcement Activities to Improve Corporate Compliance
Marilyn May, US DOJ
Virginia Gibson, Hogan Lovells

Current issues include the over payments and their repayment as well as the  New Statue and Proposed Rule. What’s new? An overpayment that has been identified (identified: when you look for it and you find it, if someone else looks for it and finds it? What?) Proposed rule highlights: a person who has received an overpayment must report and return it within 60 days of identification. Meaning the CMS it will be implemented using current monetary process.

Large resolutions: GSK Global Settlement: Many criminal counts. Why is this decade of investigation so costly to the company? First time in a precaution that the company entered into a plea agreement with reporting obligations in addition to the corporate integrity agreement.

Plea vs Probation: Plea agreement makes GSK subject to the DOJ enforcement for violation of the compliance provisions in the plea agreement.

Legal Roundtable: Current Legal Trends Affecting Pharma Manufacturers
Constance Wilkinson, Epstein Becker Green
Sabrina Yohai, Pfizer
Steven Benz, Eli Lilly
Harvey Kaish, BMS

Government pricing is the cost driver than generator. It’s not always fully embraced by companies. What are the greatest challenges you face in making sure government pricing is important for the company. Benz: At one time, no one paid attention. How much do you really want people involved. Managing risks is building relationships with people. Lawyers do their thing and don’t really network. Important drive: how well you know that person. BMS: Pharma is not in the market to do price reporting, but in the market to market and sell their products. It’s important to have a formal process Thai allows a company to have visibility in their transactions. Lilly: If you look at ht GP team, it’s very detailed and it goes to the heart of the national healthcare issue.

Kaish says Government Programs should be involved upfront with certain programs. Formal documents such as SOPs when they relate to the government function. He also suggests cubinging, managed care systems and others are transactions that get missed.  Yohai thinks legal can help the GP team know what’s going on when and where. It’s a great way to catch the holes. Bent: The GP team should be told that they are like the lawyers. Pfizer: GP reality: Current filing and additional jobs. It's important to value the time and energy of the team members.

GP 3.0: From Reactive to Proactive
Richard Zimmerer, KPMG
Jeremy Docken, KPMG

Businesses find it difficult when a behavior needs to be changed in order to make them successful tomorrow. They point to Apple.  When they needed to, they developed the iPod which lead to other products that has lead it to the most successful company in the world.

GP is becoming a core strategic function. The walls between GP and Commercial is coming down. GP is a core function within an organization.

Pricing metrics management should understand the reimbursement landscape, establish objectives by price type, and evaluate tools and options. When you work to make your price calculations more understandable and responsive to the government, your calculations are more understandable.

How do you incentivize innovation:

• • Job rotation – financing/strategy/GP
• • Train everyone
• • Offer serious and smart prizes (Gate Foundation, Google, Netflix, Nasa)

Developing a Pricing Committee: Managing Government Program Risk
Michael Hepburn, Janssen Pharmaceuticals

What is a pricing committee?
It’s a governance body that provides oversite. They can be structured as a company sees fit.
A few parts of developing this committee:

• • Charter: Cover the scope of the pricing committee – franchise, company level. Hepburn believes the higher scope the better. Commercial and/or government contracts
• • Presentation requirements – develop standard template so that everything looks the same
• • Approval process
• • Documentation and Communications process – how does everybody get the information
• Membership and Roles and responsibilities. Who should participate? Sales/Marketing, Account Management,  Finance Rep, Contract admin rep, Healthcare compliance rep, Government Compliance •Rep, Legal rep, Gate keeper
• •Meeting frequency
• •Review process

Veterans Affairs Pricing Compliance and Management Updates
Mark Myers, Department of Veterans Affairs

There were 15 reports issued through September 15, 2012. There were $3.3 million in recoveries, with the average being $220,000.The number one thing they looked at was the treatment of new covered drugs and covered drugs purchased from another manufacturer.

For new cover drugs, you are required to develop the temporary FCP. The due date is within 45 days, the due date is 75 days after the launch. The Permanent FCB is based on just the first full quarter. Transferred covered drugs – when you buy it from another vendor, you must have it in the agreement that you get the data from them.


Payment and Service Delivery Reform in Medicaid
Michael Hales, State Medicaid Director Utah

In Utah, they have 75% of the population in four counties around Salt Lake City. 75% are enrolled in a healthplan. Medicaid drug programs are state and federally run, but the state determines how much the payment will be. Hospitals get close to the Medicare upper payment and physicians are closer to 75%. Hospitals get reimbursed better.

Goals focused on in Utah Healthcare Reform:

• -Target the areas of highest growth (inpatient and outpatient hospitalization)
• -Restructure reimbursement to pay for quality rather than billable events. They wanted to get away from volume outputs.
• -Incentives for collaboration. The hospital and physicians should have the same incentives as each other to provide better care for patients
• -Provide a risk-based methodology
• -Restructure cost sharing and provide new incentives to reward clients for personal efforts to maintain or improve their health
• -Keep the same funding in the system

What they developed:
Utah Medicaid ACO Model changes included meeting established standards, distribute payments across the spectrum of covered benefit providers, and additions to healthcare effectiveness and data information set, and specific quality targets  specific to to the state that it will develop.

Limited Pharmacy Benefit was allowed under the Affordable Care Act to have MCO Pharmacy Claims eligible for rebates. They are keeping the mental health drugs out of the physical health drugs in this. It will require the ACOs to exchange encounter data on what the ACO prescribes and dispenses in the network so that Utah can work out the rebates with the manufacturers.

Where can the state of Utah innovate? They restructure the reimbursement rates to the provider groups. They want to enhance the medical home concept – what does the patient need instead of reimbursement? And better care coordination among providers just to identify a few.

Timeline: Waver submitted on June 30, 2011, began content discussions with CMS on August 25, 2011, CMS decision in 2012 and scheduled implementation on January 1, 2013.

Look Who's Attending the Medicaid Drug Rebate Program Summit

Who can you meet at Medicaid Drug Rebate Program this September?

Here are a few companies that will be joining us in September:

Eli Lilly & Company, Allergan, Novartis Pharmaceuticals Corporation, Cornerstone Biopharma Inc , Lundbeck LLC, Cornerstone Biopharma Inc, Daiichi Sankyo Inc, Takeda Pharmaceuticals USA Inc, West -Ward Pharms, Prasco, Upsher Smith Laboratories, Baxter International Inc, Teva Neuroscience Inc, BD Medical Pharmaceutical Systems, Becton Dickinson Medical - Diabetes Care, Purdue Pharma LP, Alexion Pharmaceuticals Inc, Jazz Pharmaceuticals, Forest Laboratories Inc, Bio Marin Pharmaceutical Inc, Pfizer Inc - Legacy King, Mylan Pharmaceuticals Inc, Shire Pharmaceuticals, Elan Pharmaceuticals, Gilead Sciences Inc, Perrigo Pharmaceuticals, Vertex Pharmaceuticals Inc and more!

View the Complete Attendee List including Attendee titles.

So many of your peers have registered for the 17th Annual Medicaid Drug Rebate Program Summit that the Swissotel Chicago is almost completely sold out. That’s including the rooms not in our block! We’ve been able to secure some additional rooms but in order to take advantage you must register now.  As a reader of this blog, you receive an exclusive discount of 25% off of the standard rate when you register to join us this September 10-12, 2012 in Chicago, IL. Simply use priority code XP1758BLOG. Do you have any questions about the event? Feel free to email Jennifer Pereira.

PPACA and Supreme Court Decision: What Happens to Us???

Today's guest post is contributed by Miree Lee of M. Lee Consulting, LLC.  Miree will be presenting at the Medicaid Drug Rebate Program Summit this September 10-12, 2012 in Chicago, IL.  If you'd like to join Miree at MDRP, register today and mention code XP1725BLOG to save 25% of the standard rate!

It's going to be a hot summer and it's not just because we are based out of Scottsdale, Arizona where temperatures regularly reach 115+ in July. That temperature is hot any way you cut it but what will really heat things up this summer in the midst of BBQs, fly fishing and summer vacations will be the U.S. Supreme Court decision on the constitutionality of the Patient Protection and Affordable Care Act ("PPACA").

Since the enactment of PPACA and supplemental legislation, "health care reform" has been an incredibly divisive topic, which makes for interesting dinner conversations particularly after a cocktail or two. From the constitutionality of the individual mandate and the possibility of the individual mandate to be severed from PPACA, to the constitutionality of Medicaid expansion, we expect the highest court to come to a decision shortly and the finish line for PPACA is in sight. Or is it?

The court's decision may have a profound impact on the industry from legal, policy, operational and financial perspectives particularly if PPACA is struck down materially or in totality. Following are some areas to consider:

• • Increase in Medicaid Rebates: For non-innovator multiple source drugs, the Medicaid rebate increased from 11% of AMP to 13% of AMP. For single source and innovator multiple source drugs, the "greater of" calculation remains in effect (e.g. greater of AMP less Best Price and AMP multiplied be x%). However, the x% increased from 15.1% of AMP to 23.1% of AMP with the exception of blood clotting factors and drugs exclusively with pediatric indications where the x% is now 17.1% of AMP. The benefit between the difference between the "new" and "old" rebate rates goes to the Feds presumably to help offset federal expenditures associated with PPACA.
• o Policy: Do methodology documents need to be revised? What impact will this change have on 340B drug pricing since the 340B ceiling price is directly tied to AMP and the Medicaid rebate from two quarters prior?
• o Operations: Do systems need to be revised once again to accommodate changes to the URA calculations? Is CMS going to revise the URAs and submit to the state, which would precipitate hundreds of PQAS?
• o Finance: Will we be entitled to refunds due to overpayments associated with the rebate rate change? How should we accrue for Medicaid rebates going forward (e.g. temporary decrease in accruals and expect additional legislation)?

• • Managed Care Medicaid Rebates: Post-PPACA, Managed Care Medicaid Utilization is subject to the Medicaid rebate. To date, there are some key states, such as California, that have yet to submit Managed Care Medicaid utilization. If PPACA is struck down, will this be the end of the Medicaid rebates for Managed Care Medicaid utilization? My prediction would be "no" given prior legislative actions such as the Drug Rebate Equalization Act of 2009 that attempted to require manufacturer rebates for Managed Care Medicaid utilization. An interesting question will be whether the states will further revise the pharmacy benefit to be carved in or carved out of Managed Care Medicaid. From a manufacturer perspective, does this once again change the relationship between manufacturers and its contracting relationships with Managed Care Medicaid organizations?

• • Line extensions and alternative rebate calculation: For companies that have implemented the alternative URA methodology, if PPACA is struck down, can such manufacturers recover the difference in rebates paid post-PPACA vs. rebates that would have been due pre-PPACA? In addition, manufacturer systems would likely need to be reconfigured to revert to the pre-PPACA URA calculation. Lastly, what impact would there be to 340B pricing?

• • AMP definition: Perhaps one of the most complex ramifications associated with PPACA was the change in the AMP definition. If the law is declared unconstitutional, do we revert back to the Deficit Reduction Act of 2005 AMP methodology and the Final Rule of 2007. But wait...was not the Final Rule of 2007 withdrawn? Where does that leave us? Do we revise AMP inclusion and exclusion filters on a prospective basis? If so, do we need to restate prior period AMPs? Do we need to re-calculate smoothing of lagged price concessions to only includes discounts to pre-PPACA AMP eligible entities? What is the financial impact of reverting to the prior AMP definition? What are the costs associated with changing AMP filters and systems reconfigurations? What impact will the change to AMP have on 340B pricing?

• • Federal Upper Limit: Post-PPACA the FUL is no less than 175% of average weighted AMP for pharmaceutically equivalent and therapeutically equivalent multiple source products that are available for purchase by retail community pharmacies on a nationwide basis. However, the DRA FUL was 250% of lowest AMP in a group of 2 or more multi-source drugs with the DRA FUL subject to litigation. How will the change to the FUL impact reimbursement?

• • 340B New Covered Entities: PPACA included the following new covered entities Children's Hospitals (impact of Medicare and Medicaid Extenders Act of 2010 and ability to purchase orphan drugs at 340B ceiling prices), Free Standing Cancer Hospitals, Critical Access Hospitals, Rural Referral Centers and Sole Community Hospitals. If PPACA is struck down, do manufacturers who have sold single source and innovator multiple source covered outpatient drugs at 340B ceiling prices now a Best Price issue? What happens to all of the 340B program integrity provisions (manufacturer and covered entity compliance)?

• • Medicare Part D Coverage Gap Discount Program: Beginning January 1, 2011, participating manufacturers of branded drugs agreed to provide a 50% of negotiated price (excluding dispensing fee) POS discount to Part D patients in the Part D coverage gap. Does the coverage gap discount program now cease to exist? Is this a contracting opportunity for Part D Plan Sponsors?
• • Annual Branded Drug Fee: If PPACA is overturned, are manufacturers in a position to request a refund from the IRS? After all, the industry paid $2.5B in 2011 and will pay an additional $2.8B in 2012. 

Now before we all cancel summer vacations to the Jersey Shore (definitely not referring to the MTV gang), Outer Banks or fly fishing trips to Montana or Maine, a big deep breath or two or three is in order. Given the potential material impact of the Supreme Court decision on the industry, it is not too late to analyze and assess the potential legal, policy, operational and financial impact of the decision to your organization. Over the course of the past several months, there have been some incredibly insightful discussions and presentations from counsel of the law firms of Epstein Becker Green, Hogan Lovells, King & Spalding, and Reed Smith. It might be a great opportunity to engage in discussions and commence contingency planning.

Closing Brain Teaser: Retail Community Pharmacy Chain Warehouses...a retail community pharmacy, right?

Settle Your Disputes at the Medicaid Drug Rebate Program and Get Back Millions

No one knows better than you that working in the Medicaid Drug Rebate space can get complicated. With 50 states + DC participating in the MDRP, that's 50 sets of invoices and more than 50 rebate payments (for those states that require separate payment for J Code, MCO and other programs) that need to be made on a quarterly basis. That means there are 50+ opportunities for overpayments and underpayments.

At the 17th Annual Medicaid Drug Rebate Program Summit, taking place this September 10-12, 2012 in Chicago, we know that a little information can go a long way, which is why we have our custom track, “State Contracts, Reporting and Operations Issues and Strategies,” so that you can hear from the States themselves about how they deal with challenges including:

• - Accounting and Accruing for Rebate Claims When Invoices are Delayed to Prevent Liability
• - Walk away with tools to deal with an challenges in forecasting overall rebate liability from representatives from North Carolina, Illinois and Kansas.
• - Developing Best Practices for Dispute Resolution – Avoid needing dispute resolution by learning what States are grappling with and how to work with, rather than against them

Find or more about these sessions and the rest of the program download the brochure.

We also give you the chance to meet with State Representatives for Dispute Resolutions!

For the past 10 years, MDRP has facilitated dispute resolution – so that pharmaceutical manufacturers and states can get up close and personal, and put an end to those disputes potentially worth millions of dollars. Who are the confirmed State Representatives so far? Texas, Oregon, New Jersey, Florida, North Carolina, Illinois, and Kansas.

Register now to reserve your spot with your State Representative! As a reader of this blog, you receive an exclusive discount of 25% off of the standard price when you register to join us this September 10-12, 2012 in Chicago, IL. Simply use priority code XP1726BLOG. Do you have any questions about the event? Feel free email Jennifer Pereira.

MDRP 2012 Session Spotlight: Annual Update on 340B Program Regulations, Processes and Enforcement Answers from PHS

At the Medicaid Drug Rebate Program Summit 2012, our annual update will help you determine the 340B pricing as it relates to Medicaid rebate formulas for BP and AMP. Hear current issues and how to work collaboratively with OPA (and the Prime Vendor Program). Specific discussion include how to calculate the 340B Ceiling Price, the process for which OPA, wholesalers, and covered entities get pricing information, and understand eligibility verification.

For more information the Medicaid Drug Rebate Program Summit, download the brochure.  If you'd like to join us September 10-12 in Chicago, register today! As a reader of this blog, when you mention code XP1758BLOG, you'll receive a discount of 25% off the standard rate.

Featured Session: Annual Update on 340B Program Regulations, Processes and Enforcement Answers from PHS

Featured Speakers: Krista Pedley, Director, Health Resources and Services Administration, Office of Pharmacy Affairs
Christopher Hatwig, MS, RPh, FASHP, Vice President, APEXUS/340B Prime Vendor Program
Lisa Scholz, PharmD, RPh, HRSA’s Pharmacy Services Support Center, American Pharmacists Association

About the session: This session defines the Office of Pharmacy Affairs Mission/ Functions/Administration and helps you determine the 340B pricing as it relates to Medicaid rebate formulas for BP and AMP. Hear current issues and how to work collaboratively with OPA (and the Prime Vendor Program). Specific discussion surrounds how to calculate the 340B Ceiling Price, the process for which OPA, wholesalers, and covered entities get pricing information, and understand eligibility verification. Specific discussion around:

• • OPA Program Integrity Efforts
• • 340B audits of covered entities
• • FY 2013 user fee proposal

MDRP 2012 Session Spotlight: Point/Counterpoint: Impact of the Election on Healthcare Reform—What’s Coming and How Will it Affect the Pharmaceutical Industry?

The government has the power to completely overhaul the way the pharmaceutical industry does business. With healthcare reform, we saw a huge increase in the number of people eligible for Medicaid and the 340B program, a redefinition of pricing calculations, and the addition of Managed Medicaid to the rebate system. All of these things had a huge impact on the financials of each manufacturer. Healthcare reform is a hot button topic at every election and this year will likely be no different. The outcome of either candidate’s election could mean a slew of new laws on Medicaid or Medicare, significantly impacting the way government reimbursement programs function. These keynote speakers presenting the "Point/Counterpoint: Impact of the Election on Healthcare Reform—What’s Coming and How Will it Affect the Pharmaceutical Industry?" session are experts in the Healthcare landscape and will give an insider’s view to how each party will approach current healthcare legislation, and potentially move forward if elected.

The Medicaid Drug Rebate Program Summit will take place September 10-12, 2012 in Chicago, IL.  For more information on the program, download the brochure here.  If you'd like to join us, register today and mention code XP1758BLOG and save 25% off the standard rate!

Featured Session: Point/Counterpoint: Impact of the Election on Healthcare Reform—What’s Coming and How Will it Affect the Pharmaceutical Industry?

Featured Speaker representing the Democrats: Paul Begala, Political Analyst & Commentator, CNN; Columnist, Newsweek & The Daily Beast
About Paul:  He is a political analyst for CNN, and part of a political team that won an Emmy for its coverage of the 2006 elections and a Peabody Award for its coverage of the 2008 Presidential election. He served as counselor to President Clinton in the White House, where he helped define and defend the Administration's agenda, from the State of the Union Address to the economic, domestic and International issues the White House faces each day. He helped launch the political magazine George and is the author of several New York Times best-selling books, including Is Our Children Learning? The Case Against George W. Bush and Buck Up, Suck Up, and Come Back When You Foul Up. He is also a columnist for Newsweek and The Daily Beast.

Featured Speaker representing the Republicans: Dan Crippen, Fmr. Director, Congressional Budget Office, Executive Director, National Governor’s Association
About Dan: Dan Crippen serves as the executive director of the National Governors Association (NGA). As executive director, he works with governors to identify and prioritize the most pressing issues facing states and oversees the day-to-day operations of the association. Prior to his work at NGA, Crippen served as the director of the Congressional Budget Office from 1999 to 2002, supporting the Congressional budget process and providing expert analysis to guide and inform economic decision making. Since CBO, Crippen has worked in the private and nonprofit sectors primarily on health care—including Medicaid, health IT, and health care for elderly and complex patients.