Medicaid Drug Rebate Program Summit (MDRP) 2015 Wrap Up!

• John Shakow highlighted the “hot topics” from the various presentations that were provided prior to the conference. Some of the slides he referenced included:

• From Miree Lee’s Government Pricing Basics, the numerous pharmaceutical price points, including AAC, EAC, UAC, MAC, SMAC, NADAC, AMP, FUL, BP, URA, 340B, ASP, NFAMP, and FCP. 

• Alice Leiter (Hogan Lovells) highlighted the critical components of a 340B policy that can be applied to other GP Policies.

• Steven Ruscus (Morgan Lewis) presented the only slide about biosimilars and Part B, highlighting how they will be reimbursed which is a special hybrid arrangement. This could define the next generation of reimbursement.

• Chris Cobourn (Huron) discussed the recent results/trends of a GP diagnostic survey showing many companies have insufficient resources, inconsistent documentation, and no G/L reconciliations.

• Connie Wilkinson & Alan Arville (Epstein Becker) highlighted the recent guidance regarding an the definition of an eligible patient for the 340B program.

• Bill Sarraille (Sidley Austin) went over what that he’ll be looking for if/when the Final Rule is released.

• Alice Valder Curran (Hogan Lovells) showed how manufacturers should be evaluating the Final Rule by looking at it with the thought, “Potential challenges if the Final Rule says…” Manufacturers should know that litigation is an option, but as John Shakow noted, only if you submitted a comment to the Proposed Rule, or potentially if you are part of an associated such as PhRMA that submitted comments.

• David Tawes from the OIG, discussing the future work involving Medicaid drugs and the possibility of attaching an inflation penalty to generic products.

• John Shakow’s own slide on the 340B Proposed Rule and the comments from the covered entities that an instance of overcharging should be defined as per unit, not per order.

This year’s MDRP was full of information for manufacturers and as always, there’s a lot going on in the government programs, so if you need help or are overwhelmed by all of the information, give me a call. I can help you figure out what is relevant and how to ensure you’re ready for the Final Rule! Katie Lapins, Government Pricing Specialists, LLC, 303.993.6456, K.Lapins@GP-Specialists.com.

Center for Drug Evaluation and Research, New Drug Review: 2013 Update

FDA/CMS Summit 2014 speaker John K. Jenkins, M.D., Director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.

 




Below you can access his presentation from last December at the FDA/CMS Summit. In his presentation, Dr. Jenkins addresses these key topics:

•    How is CDER doing with regard to meeting PDUFA goals?
•    What are the trends in new drug approvals?
          o    IND activity, NME submissions, and NME approvals
•    Implementation of PDUFA V/FDASIA
          o    “Program” for NME review
          o    Breakthrough Therapy Designation Program
•    Update on PMCs/PMRs


Dr. Jenkins also addresses the main themes in new drug review:

•    Continuing resolution – the new normal
•    PDUFA V; hold the additional resources
•    FDASIA implementation; what new resources?
•    The “Program” takes off
•    Breakthroughs breaking out
•    Sequestration bites
•    Shutdown shuffle
•    Patient-focused drug development refocused
•    “Slow down?” in NME approvals – not really
•    Despite challenges, new drug review program successes continue!

To access the complete presentation from Dr. Jenkins, click here.

Join us this December 11-12 in Washington D.C. to hear Dr. Jenkins address these challenges for the upcoming year. This is an event you do not want to miss. Register now and save $300 off the standard rate, just use the code XP1917BLOG at checkout. To register, click here.

Celebrate Columbus Day! Register for FDA/CMS Summit for Payers by Monday & save $300!

Register for the following IIR event and receive $300 off*

Mention code COLUMBUSBLOG to save on the following:

Register here for IIR’s FDA/CMS Summit for Payers event taking place December 11-12, 2014 in Washington D.C., visit the website for full details.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid October 10th-13th 2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.

Behavioral Economics: Consumer and Patient Engagement & New Models of Care

Extensive work in behavioral economics has demonstrated ways in which people are predictable irrational. This work is now being applied to better understand ways to increase healthier behaviors in a wide range of contexts ranging from health insurance benefit design, cafeteria food layout, smoking cessation, weight loss, medication adherence, and chronic disease management using wireless devices.

At the FDA/CMS Summit for Payers in Washington D.C. this December, Dr. Kevin Volpp, MD, PhD, Founding Director of the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute will briefly discuss some of the key principles of behavioral economics before talking about elements of choice architecture, incentive design, and 'automated hovering' that are being tested in field settings around the United States with the goal to increase consumer and patient engagement. In his sessions, you will:

- Understand how behavioral economics differs from traditional economics
- Learn ways to apply defaults and choice architecture to drive behavior change
- Understand the core concepts to optimize incentive design
- Be familiar with emerging trends of 'automated hovering'

Below you will find a video of a talk Dr. Volpp did in 2012 at Wharton on Behavioral Economics and Automated Hovering....

Make sure you join Dr. Volpp this December in Washington D.C. to hear what comes next. Download the updated FDA/CMS Summit for Payers agenda now to see who else will be speaking on the program.

And remember, blog readers receive a special $100 off the current rate when registering with the code XP1917BLOG - Register now! 

Specialty Drug Distributor 'Diplomat Pharmacy' Sets Terms for $200M IPO

Via NASDAQ

Operating as the fourth largest specialty pharmacy in the US – Diplomat Pharmacy has announced terms for its IPO on Monday. The company plans to offer 13.3 million shares at a price range of $14-$16.

Diplomat distributes drugs that require coordinated regimens by patients with complex chronic diseases. On top of distributing these drugs, they also provide support services to health systems related to the complexity of administering the treatments. The company has a national distribution network with one main facility and seven regional locations.

In terms of other specialty pharmacies, Diplomat hangs behind the likes of multinational pharmacies like Express Scripts, Walgreens, and CVS Caremark – but they are the largest independent specialty pharmacy in the US.

With a majority of specialty pharmacy revenue coming from government programs including Medicare and Medicaid, can the high cost of these specialty drugs be changed? For example, the high price and extraordinary demand for Gilead’s Sovaldi has prompted calls from insurers and other health care stakeholders for action on the specialty drug pricing model. What is the potential public policy response?

Join us at FDA/CMS Summit for Payers this December in Washington D.C. to learn the answers to these questions and many more. Hear from the FDA, CMS, Health Plans, and other industry game changers all under one roof, as they discussion the challenges facing payers and pharma. Download the updated agenda here and register with the code XP1917BLOG to save $100 off the current rate - $300 in total savings!

AHIP CEO Ignagni to headline FDA/CMS Summit for Payers

IIR is pleased to announce that Karen Ignagni, President and CEO of AHIP has been added to the speaking faculty at the upcoming FDA/CMS Summit for Payers. Ignagni, the voice of health insurance plans, will headline a keynote session on Pricing and Reimbursement - The Tipping Point in the Future of Healthcare. Recognized as one of the strongest and most effective lobbyists in Washington, Ignagni will provide compelling insights and a valuable perspective. Download the newly updated brochure here.

The Inaugural FDA/CMS Summit for Payers, scheduled for December 11-12 at the Fairmont Washington, will bring together the FDA, CMS and C-Level health plan and pharma executives to collaborate on important industry issues, including innovative technology, pricing and personalized medicine. Together we will tackle monumental issues facing the healthcare industry—such as the approval of the Hepatitis C drug, Sovaldi, as well as the impact of the ACA and the significant changes it has brought about to your daily operations.

Plus, if you register by this Friday September 26th you will save $500! Click here to reserve your seat and please mention the code XP1917BLOG for your special savings.

What are the biggest pain points that GP Professionals in pharma are dealing with?

Q&A with Chris Cobourn, Vice President of Regulatory Compliance, Compliance Implementation Services
 
Beyond waiting for AMP, what do you think are the biggest pain points that GP professionals in pharma are dealing with right now?

Chris: That’s a good question. I’ll hone in on that word choice – “pain point”. I think pharma compliance in general and GP specifically, we think of that term a lot. When I think “pain point” I think of what keeps CEOs or CFOs up at night. Or what keeps a GP professional up at night. So, let’s remember the intense level of compliance and accountabilities and risk – the expectation that manufacturers get this right and the risk if they don’t. The level of scrutiny out there by the Office of Inspector Generals and the Department of Justice will continue to grow and become intense. There is a huge focus on program integrity. So, the expectation is clear. Manufacturers have to get it right. The visibility across the organization increases. CEOs and CFOs understand the risk. They are certifying these calculations. That’s what we’ve seen really dramatically increase over the years.
 
The level of visibility in the organization and the understanding of the need to get this right. So, now you start introducing uncertainty and change into that, especially the C-chains that can come with AMP final rule, 340B Program integrity initiatives, constant complicated things that are hitting us – like the recent Texas reporting requirement. So, you’ve got organizations struggling with how to implement it all, understand it all, yet very high-level visibility. So, you’ve got CEOs and CFOs looking at a GP professional and saying: “You’ve got to protect the organization here. You’ve got to make sure we’re compliant. What does all this mean? How are we doing it? Tell me what to anticipate. Tell me the financial impact.” That’s, I think, the pain point at the C-level. And I think worry about some big pieces of it, especially such as will the final rule have the build-up methodology or not? We certainly hope not. But, there are a lot of changes that are going to ripple through the industry and it’s all going to start with a GP professional needing to educate their organization with what it means.
 
So, what are the biggest pain points? I think that’s what really drives people to attend conferences like this and the importance of GP professionals as a community having that dare-to-open dialogue.



To hear more from Chris, download the complete Q&A or listen to the recording.

Join us September 15-17 in Chicago for IIR's 19th Annual MDRP Summit. And when you register with the code XP1958BLOG you can take an EXTRA $100 off the current rate - Register now!

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.

Health Insurance Exchange Update: Wednesday, June 13, 2012

In the latest news on health insurance exchanges, there seems to be a problem with exactly who should have the coverage and the ever increasing feeling of the money being contributed to the coverages for residents.

In Massachusetts, a New York Times article discusses a system in place for health insurance exchanges. There was a legislation passed in 2006 called the Health Connector. Under that law, most residents are required to purchase health insurance and it creates an online marketplace to simplify buying a coverage plan that the residents can afford. Only is Utah the only other state that had health insurance exchange before the Affordable Care Act was mandated.  Last year, we had the chance to sit down with Glen Shor of the Massachusetts Health Exchange and discuss the exchange.  Listen to the podcast here.

But the fear that Health Connector has is that they need more people paying full premium price for their coverage. Of the 224,000 people insured through Connector, 82% pay next to nothing because of government subsidies. However, if the ACA legislature is upheld, then those low income households could shift to Medicaid under law’s expansion system.

But there is still a pressing issue with healthcare that lies with the possibility of covering immigrants.

In Oregon, Medicaid and other lawmakers tend to ignore the issue of providing primary medical care to immigrants. Immigrants may be able to find work (low-waged work at that) however the employer-sponsored coverage’s would not apply to them according to The Lund Report.  

Despite the fear of paying for such exchanges and the problem of coverage for immigrants, some states are still continuing to develop plans to implement the exchanges necessary by the January 2014 start date, presuming the ACA is upheld.

In Washington, the Center for Medicare and Medicaid Services (CMS) plan to develop verification data, services to support coverage and eligibility insurance exchanges and seeks industry information about applications that are available, according to HealthCare IT News. In addition, due to limited access to employer-sponsored health insurance and restrictions with Medicaid, 47 percent of immigrants are uninsured. ACA would increase options for some immigrants and citizens.

In Arkansas, the Arkansas Advocates for Children and Families developed a report entitled "Making Sure the Health Insurance Exchange Works for Families." The report will be used to help residents through the exchange process based on their income and what plan fits for them, according to a blog post on the Arkansas Times. 

This November, the Health Insurance Exchange Congress will be held November 13-14, 2012 in Chicago, IL.  Here, state officials and health plans with the only opportunity to come together to discuss PPACA and strategize on how to make this a successful opportunity for all.  As a reader of this blog, when you register to join us and mention code XP1710BLOG, you'll receive 15% off the standard rate!