This Won’t Be Like Your Father’s MDRP!

Are you still trying to decide if you’ll attend IIR’s 20th Annual MDRP in Chicago later this month? Do you need a few good reasons to give your boss so you can get approval? Trust me, this is one year you don’t want to miss. As always, it will be the largest event in the Government Pricing space, with the most speakers, government representations and MDRP executives all under one roof! But there are even more reasons to attend…

We all know that training is part of a solid compliance program and this year’s event can help meet that requirement. IIR has filled the agenda to ensure you’ll have the most comprehensive educational experience over the three days. You’ll hear from the actual government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them. And at the same time, you can compare notes with your peers to gain insight into industry best practices.

MDRP 2015 is also a platform to develop your company-specific comments on the 340B Mega Guidance, enabling your organization to potentially influence the outcome. In addition, we’re expecting the AMP Final Rule expected to be released this year and at MDRP 2015, you can get a head start on your compliance operations for the impending guidance implementation.

As always, there will be Pre-Conference Summits, providing a deeper dive into such topics as:
• Fundamentals of Government Pricing Programs + MDRP 101
• Pharmaceutical VA Contracting and Compliance Summit
• Town Hall between Manufacturers and States

If you, or someone you know, is new to Government Pricing, these are an excellent opportunity to learn a lot in a short span of time.

And best of all, there are new session styles and formats, including:
• Think Tanks/Innovator Showcase
• Fireside Chats
• Roundtable Discussions
• Rapid-Fire Sessions
• Benchmark Best Practices

If you need more reasons to attend, or more ammunition to convince your boss you should attend, please feel free to reach out to me. Katie Lapins, Government Pricing Specialists, LLC, 303.993.6456, K.Lapins@GP-Specialists.com. Save $100 off the current rate with the code XP2058BLOG - Register here. I look forward to seeing you in Chicago at MDRP!

Katie Lapins

Katie Lapins has worked in the pharmaceutical and medical device industries in the areas of commercial and government contracting, compliance, finance and sales operations for 15 years. As a consultant, Katie’s areas of primary focus are government programs, corporate compliance and commercial operations. Within these areas, she has developed policies and procedures, assisted manufacturers with voluntary disclosures/restatements, led audits and assessments, calculated and submitted statutory pricing requirements (AMP, BP, ASP, Non-FAMP, PHS and TRICARE), processed Medicaid/ SPAP/ Supplemental invoices, validated PHS eligibility, handled Class of Trade projects with over 100K entities, and created training for onsite and web-based instruction for 2 – 200 employees. Katie’s experience within the industry includes government contract administration, pricing analysis, commercial operations, specialty pharmaceutical distribution agreements and commercial contract management.

Update on 340B Rules

Guest Author: Katie Lapins

The long-awaited “Mega” Rule related to the 340B Program may soon be released. In the past, the 340B Program has been primarily administered without formal regulations, establishing the rules that govern the 340B program primarily through policy releases, informal guidance, and FAQs. However, when the Patient Protection and Affordable Care Act (ACA) / Health Care and Education Reconciliation Act (HCERA) was passed, Health Resources and Services Administration (HRSA) was mandated to specifically address certain topics that require clarity or further guidance.

Before any rule can be published, it is submitted to the Office of Management and Budget (OMB) who must first clear it which normally takes about 90 days. The “Mega” Rule was submitted in June, making its release in September likely. Although rules can be held up at OMB for months, or longer, most experts do not expect that to happen with this one. So what are a few of the “hot topics” in the 340B Program?

Orphan Drug Rule
You may remember that HRSA had previously submitted a Proposed Rule regarding Orphan Drugs to the OMB but withdrew it in November 2014 after a court ruled that HRSA had overstepped its authority 1. This rule was later reissued as “interpretive,” PhRMA has challenged it (again), and we still are waiting for a ruling from the courts. This case has been important as the court’s decision implies that an agency must have the specific authority from Congress to issue rules that change those items established through statute. However, this interpretive guidance could ultimately be the foundation for enforcement against manufacturers, creating a conundrum for them since that would mean HRSA’s interpretation would have the same impact as a rule. The next court decision in this matter could clarify this situation, making the procedures of HRSA as important as the content in this case.

The “Mega” Rule
Earlier this year, HRSA issued a Proposed Rule regarding the calculation of 340B ceiling prices and CMPs and public comments are due within 60 days (August 17, 2015). So what’s left for the 340B Program and why is there still a pending “Mega” Rule? Many people believe it will contain components related to the 340B Program that remain vague and require clarity for all stakeholders, including:

1. Definition of a 340B patient
2. Hospital eligibility requirements, including off-site facilities
3. Contract pharmacy arrangements
4. Price reporting/transparency
5. Duplicate discounts and procedures for manufacturer refunds

Many of these topics are related to the overall intent, and potentially unintended outcomes, of the program. In recent years, the growth of the program has been rapid for a few reasons; many hospitals have acquired other facilities that are 340B eligible and also, as of March 2010, covered entities can use multiple contract pharmacies. As this growth has occurred, questions have arisen regarding the intent of the program and the profits of various stakeholders. Congress has issued letters to some of the stakeholders and held special hearings, and the General Accounting Office and Office of the Inspector General have also raised concerns about the program’s integrity. Even without diversion or duplicate discounts, the ability to purchase drugs at deeply discounted prices and administer them to patients who may have health insurance provides a large “spread” or profit to the covered entity. The retail outlets serving as contract pharmacies also have the potential to see significant revenue from this role, beyond what was originally imagined. HRSA’s mission is to, “improve[e] access to health care by strengthening the health care workforce, building healthy communities and achieving health equity.”2. At issue to many is if the way the 340B Program is currently functioning follows the intent of the program.

The “Mega” Rule will be issued as a Proposed Rule, allowing 60 days for comments from stakeholders. It’s important that manufacturers read the entire document and involve the appropriate personnel and departments to determine the potential impact on their own company’s operations and ultimately, their bottom line. This will include not only the legal and policy areas but also the procedural and administrative ones, as well.

Clearly, the 340B Program continues to be one of great change and important considerations must be weighed by all of its stakeholders. The 20th MDRP Summit by IIR is filled with 340B-related topics and includes a full day workshop on this important topic. Hear from colleagues, attorneys, and government officials who have expertise in the 340B Program to find out about the implications for your organization of these impending changes. Download the agenda to see a complete topic list.

Katie Lapins

Katie Lapins has worked in the pharmaceutical and medical device industries in the areas of commercial and government contracting, compliance, finance and sales operations for 15 years. As a consultant, Katie’s areas of primary focus are government programs, corporate compliance and commercial operations. Within these areas, she has developed policies and procedures, assisted manufacturers with voluntary disclosures/restatements, led audits and assessments, calculated and submitted statutory pricing requirements (AMP, BP, ASP, Non-FAMP, PHS and TRICARE), processed Medicaid/ SPAP/ Supplemental invoices, validated PHS eligibility, handled Class of Trade projects with over 100K entities, and created training for onsite and web-based instruction for 2 – 200 employees. Katie’s experience within the industry includes government contract administration, pricing analysis, commercial operations, specialty pharmaceutical distribution agreements and commercial contract management.


1 - In brief, HRSA’s Orphan Drug Proposed Rule said that the free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals purchasing orphan-designated drugs are entitled to purchase those drugs at the 340B ceiling price when they are used for an indication other than the orphan indication.

2 - http://www.hrsa.gov/about/index.html

340B Changes Are Coming - Are You Prepared?

With the completed review of HRSA's latest Proposed Rule: "340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations" by the White House Office of Management and Budget (OMB) and the long-awaited proposed "Mega" Guidance under review and slated to come out later this year, are you prepared for the compliance requirements brought on by these policy and procedure changes?

At the 20th Annual Medicaid Drug Rebate Program Summit, we've got an entire day dedicated to just 340B. Join us during the pre-conference day on Wednesday, September 30th to get key 340B compliance information, with sessions on:

• • Key Highlights and Updates on HRSA, OPA 2015 Rulemaking
• • Getting it Right: 340B Policy & Procedure Compliance Checklist
• • Panel: Navigating the 340B Drug Pricing Program Database
• • Ensuring Compliance & Conducting Monitoring and Internal Auditing
• • Panel: 340B Hot Topics
• • And More!

Download the MDRP brochure for Summit details and the complete agenda.

PLUS! Get 340B Updates directly from HRSA on Thursday, October 1st during the main conference from Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA.

This full-day summit is part of the Platinum Pass, which gives you access to the full three days of the MDRP Summit - the best value! Register now and save up to $300 off standard registration. Be sure to use priority code: XP2058BLOG

See you in Chicago this September!

Is Medicaid Extension Really Feasible?

The following excerpt is from a Podcast recorded by the MDRP Summit with Grace-Marie Turner, President of the Galen Institute last June. Access the complete MP3 and Transcript here.

Is Medicaid extension really feasible?

Grace-Marie: I just think that it’s going to be very difficult to convince those other states that have resisted so far because more and more evidence is coming down to show that expanding Medicaid as a traditional program as it is currently structured is real harmful to people. And it’s really harmful to the most vulnerable citizens who are on Medicaid today. If people have many chronic conditions, many of them have no place else to go. They are basically not insurable in the private marketplace. If they are under 100 or 138% of poverty, Medicaid really is their only option. As a result, you wind up with more people competing for the same limited number of doctors who will see Medicaid patients and making it even more difficult for people on Medicaid today to find a doctor to see them.

I had a father write to me recently who has a daughter who is on Medicaid – many chronic conditions and in a wheelchair. He said: “It takes me sometimes six weeks to get an appointment with her urologist”. He said: “Do they even think about how much more difficult it’s going to be to get an appointment with the urologist if there are a million more people competing for those same appointments?” So, we must fix it so that it allows the safety net to be intact for the most vulnerable people and give those who have the option to get private coverage to do so, so that they are not competing.

And then finally, I think that the states who want to expand the program need to guarantee that providers will be paid enough that they will be able to see a Medicaid patient. In some states like New Mexico that have a very high match rate, Medicaid pays at very close to Medicare rates. In other states, a doctor may be paid $5 or $7 for an office visit – not even enough to begin to cover expenses. Doctors want to take care of these patients, but they can only keep so many and keep the lights on and pay their own bills. So, we’ve got to be able to pay providers more and that’s the kind of leverage that I think that the states would be able to have if they were not so constrained by an avalanche of federal rules and all the “Mother May I?” waiver requests that they have to get to make any changes to their plan.

If they had more flexibility, then they could make sure that patients on the program today could actually find a doctor to see them and also make sure that those who may be in an expansion population have the option of coverage that looks more like the private insurance and the private marketplace so that it’s a track and a platform to private coverage rather than the cliff that Medicaid is today – either in or out. If you make $1 too much money then you’re out of Medicaid or $1 less and you’re in. It needs to be a smoother ramp to private coverage and there are a lot of ideas to do that, including giving people the option of basically taking their Medicaid allotment as a voucher to buy into private coverage. There are a lot of ideas out there to improve this program, but we need to remember that we’re doing it for the most vulnerable citizens who are on the program today, who have no place else to go, competing for a limited number of appointments with a shrinking number of doctors to actually get appointments.

We can do so much better and I think you’re going to see many more governors actually demanding those kinds of changes and that kind of flexibility in exchange for any expansion.


Join us at the 2015 MDRP Summit for complete coverage on all things pricing, rebates, contracting and collaboration. Register now and save $300 when you use the code: XP2058BLOG. 

This Week in Healthcare: 6/22 - 6/26

Top news from around the healthcare industry this week:

What people are saying about the health care subsidy ruling
Here’s a look at what lawmakers and others are saying about the U.S. Supreme Court’s ruling this morning on allowing people in Ohio and other state’s to keep their health care subsidies under the Affordable Care Act.

OSHA cracks down on healthcare employers
The Occupational Safety and Health Administration announced Thursday that it would crack down on hospitals and nursing homes for workplace hazards that aren't protected by formal rules. Experts say politics have complicated efforts to formalize workplace regulations.

Healthcare IoT, Apple Watch ready to change patient care
IT consultant and IoT thinker Frank Palermo, in the second part of a two-part Q&A, says patient satisfaction is the main benefit of healthcare IoT.

Happy reading! Have a great weekend.

Prepare for VA Contract Negotiations at MDRP 2015 | Last Chance to Save $500 is Friday

Last Chance to save up to $400 to MDRP 2015 is THIS Friday, 6/26. PLUS! Take an additional $100 off when you use the code XP2058BLOG | $500 in total savings! Register now.

Your successful compliance with the VA's contractual and statutory requirements can spell the difference between profitable partnerships and drawn-out audits.

At the 20th Annual Medicaid Drug Rebate Program Summit, join us during the Pre-Conference event titled, "Pharmaceutical VA Contracting and Compliance Summit." This half-day summit is ideal for pharmaceutical and biotech manufacturers looking to comprehensively tackle the challenges of designing and complying with the complex - but highly lucrative - contracts in this sector.

You will touch upon key steps necessary to ensure you are ready for 2015 and beyond. Below are just a few session highlights:

• The Ins and Outs of a VA Audit: Comprehensive Overview of the Review Process
• Restating non-Federal Average Manufacturing Prices (NFAMP) and VA Federal Ceiling Prices (FCP)
• Panel Discussion: Prepare for Contract Negotiations

Download the updated MDRP brochure for more Summit details.

This half-day summit is part of the Platinum Pass, which gives you access to the full three days of the Medicaid Drug Rebate Program Summit - the best value! Registration rates go up after this Friday, June 26th. Save up to $500 off standard registration, be sure to use priority code XP2058BLOG | Register here.

Ensure you have the most comprehensive educational experience over three days with unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them.

This is your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs. Reserve your seat today at the most comprehensive MDRP event to date!

See you in Chicago!

The Future of Medicaid Reform

The following excerpt is from a Podcast recorded by the MDRP Summit with Grace-Marie Turner, President, Galen Institute in June of 2014. Access the complete MP3 and Transcript here.

June 12, 2014: I am distressed that more states did not demand more flexibility with this program in exchange for expanding Medicaid. Half of the states have decided to expand it; half have not after the Supreme Court re-wrote the ACA and made expansion of Medicaid up to 138% of poverty an option for the states. As of last June, about 24 states were resisting expansion for a number of reasons.

Medicaid is a program desperately in need of reform. Back in 2005/2006, I served on the Medicaid Commission – we did hearings around the country to look at the Medicaid program – to learn about it – because each state runs its own, it’s really 50 different programs. In our findings, people desperately dependent upon Medicaid and yet it was not serving them. If states were given more flexibility, they could make a significant amount of Medicaid dollars go much further to cover more people.

With this said, states are going to increasingly resist expansion of Medicaid unless they get more flexibility to control the program themselves and be able to save money and be able to provide better benefits to their citizens often in giving them the option of private coverage.

So what is the future of Medicaid? More governors demanding more flexibility; and then more patients on Medicaid getting more options for private coverage.



Join us at MDRP Summit 2015 for complete coverage on all things pricing, rebates, contracting and collaboration. Register now and save $500 when you use the code: XP2058BLOG.

MDRP 2015 Brochure is Now Available for Download

The MDRP 2015 Brochure is Now Ready for Download!

Don't miss out on the largest MDRP event in the space, with the most speakers, government representations and MDRP executives all under one roof!

Ensure you have the most comprehensive educational experience over three days with unparalleled access to government officials creating regulatory rules, the industry leaders interpreting them, and the pharmaceutical executives implementing them.

Join us and celebrate 20 years of MDRP this September 30-October 2, at the Chicago Marriott Downtown Magnificent Mile in Chicago, IL. See What's New for 2015!

Deep Dive Pre-Conference Summits: 
• Fundamentals of Government Pricing Programs + MDRP 101
• Pharmaceutical VA Contracting and Compliance Summit
• Town Hall between Manufacturers and States

Tailor-Made Content: 
• State Policy Changes and Updates
• Executive Leadership Boardroom
• Business Leadership Workshop on "Embracing Generational Diversity"

Interactive Session Formats: 
• Think Tanks/Innovator Showcase
• Fireside Chats
• Roundtable Discussions
• Rapid-Fire Sessions
• Benchmark Best Practices

AND MORE! Download the Full Brochure For More Information.

Register now with the code XP2058BLOG and save $100 off the current rate | Register today and lock in a $500 savings, click here to register.

This is your opportunity to benchmark best practices and gain solutions to overcome new operational challenges brought on by AMP Final Rule, 340B, Medicaid Expansion, Class of Trade, Fair Market Value, FSS, VA, OIG, and other critical government programs. Reserve your seat today at the most comprehensive MDRP event to date!
 

Today Only! Register for MMCC & Save $400

It’s Friday the 13th but you are actually about to get lucky!

 

Today is the last day you can save up to $400 for IIR’s Medicaid Managed Care Congress (MMCC). Use the code XP2026BLOG to redeem your savings. Register now!

Download the updated agenda.

Hope to see you in Baltimore his May!

Back by Popular Demand at MMCC | 4 Crowd Favorites

"Anyone involved in Medicaid policy or a stakeholder they should be there."
- Russell Harper, Aetna

2014 was about strategy and understanding Obamacare and the ACA. Now implementation begins. 2015 is the year for tactical execution. How are payers, providers and vendors going to collaborate effectively?

As a Medicaid stakeholder, MMCC provides you the tools and insight to develop cost-efficient programming with 3 jam-packed days of health plan case study presentations, face time with government officials and up-to-the-minute information from CMS.

Back by popular demand, attend the Medicaid Managed Care Congress and check out our unique programming and formats that continues to make MMCC the must-attend event year after year:


CMS Presentations
Receive clarification from federal regulators for additional insights on new managed care regulations

Government Roundtable Discussions
Participate in off-the-cuff conversations with government officials who create the regulations you're currently implementing, and get a sneak peak of what you'll be tasked with implementing in the future

State Medicaid Officials' Panel
Gain access to Medicaid Directors across the country to proactively prepare for future programming and learn how other states have prospered in the era of Reform Implementation

State Spotlights
Take a deep dive into programs states have rolled out in the past year (hits and misses) to better understand state regulations that may be in your near future.


Download the complete agenda.

Register now and save $400 - Use the code: XP2026BLOG

Have any questions about the event? Reach out to Ryan Geswell at rgeswell@iirusa.com

See What’s New at MMCC 2015

The Medicaid Managed Care Congress is in its 23rd year, and there is a reason why we have been around so long—we consistently provide the newest and freshest insights on the topics that matter most to you and your business. For the 2015 event taking place on May 20-22 in Baltimore.

Here is a sneak peek of what’s new:

8+ New Health Plan Case Studies
Evaluate opportunities to grow membership, increase quality and decrease costs by learning from victories (and lessons learned) from speakers who haven’t presented in the past, including representation from Humana, Community Health Choice, Molina Healthcare executives on a national and regional level, plus many more.

Dual Eligibles Summit
It’s not just a few sessions anymore; we now have an entire day focused on increasing revenue by successfully navigating the very complex but extremely lucrative duals market.

A 360º view
The popular Medicaid Managed Care 101 pre-conference summit has been reformatted to give you multiple perspectives on the areas that have the highest impact on your bottom line. A unique 360º view from health plans, government officials, solution providers and other perspectives for a well-rounded understanding of the topics that will grow your skill set, such as ACA implementation, improving quality, the long-term industry outlook and more.

Customize your Agenda (coming soon!)
Create a personal agenda to select which sessions will increase your ROI the most. Prepare your networking strategy in advance to optimize your time at the event and coordinate attendance with colleagues to ensure you get maximum expertise. Stay tuned as we will make this feature available in the coming weeks!

Download the preliminary agenda for more details.

Register now and save $400! Use code XU2026BLOG - Register here.

Medicaid Managed Care Congress is Back | Save $600 Now!

MMCC is back for the 23rd year, bigger and better than ever before, helping you grow membership, decrease expenditures and improve outcomes with advanced Medicaid Managed Care programming.

 Join us in 2015 for...

• The 411 from CMS as they provide clarity on government initiatives to better prepare you for this year and beyond

• 15+ case studies that demonstrate what's working for MCOs so you can strategically grow your business

• 10+ state government officials that share unique programming so you know how states are improving care & access in their states
    

Download the preliminary agenda for more details.

Register by Friday, 2/6 and save $600 when you use the code XP2026BLOG – Register here.

Register for the FDA/CMS Summit for Payers by Friday 11/14 to Save $300!

Attend the FDA/CMS Summit for Payers to initiate the collaboration, with top government and key regulatory bodies working closely with healthcare leadership to join forces and build an open culture of harmonization to provide efficient and affordable healthcare to all patients.


This meeting stemmed from the infamous Solvaldi case, as the FDA approved the specialty drug to go to market but with it being so expensive, it caused major problems for the CMS and health plans. No longer can regulatory bodies work in silos, it's time for collaboration!

But hurry—time is running out! Register by this Friday 11/14 and save up to $300 off the two-day rate. Or, if budgets and time are tight, choose the one-day option and attend for only $895. Be sure to use the code XP1917BLOG to save.

Register Now! 

If you haven’t already done so, download the brochure to see the full speaking faculty, including some of the most influential people in health care.

See you this December!

Rising Drug Costs

Welcome to this FDA/CMS Summit for Payers podcast.

Below is a teaser from our podcast with Bill Winkenwerder, Former CEO, Highmark Inc.

Access the complete podcast and transcript here.

How should manufacturers determine drug prices and what consideration should there be?

Bill: Well, certainly manufacturers need to recover their costs – their investment in R&D – and it’s important that they make a profit. Nobody can be in business for any period of time without being able to make a profit. Now, more recently – especially with respect to certain manufacturers that have brought very expensive medications to the market – have been criticized and have been identified as charging too much. That’s the common perception, but I see the immediate evidence that the prices for these medications – given the relatively small population of people that would benefit from them – that there is a serious over-charging that’s going on. But, certainly we need to sit down and talk and determine if there is a better way to arrive at the price. What is a fair price? What is a good, market-based price? That’s what this Conference is about.


To see more from Dr. Winkenwerder, download the complete podcast here.

Download the updated event brochure here. 

Bill will be joining us at the FDA/CMS Summit for Payers in Washington D.C. for his closing keynote address "An Industry Perspective: Payment Policy for Clinically Valuable But Very Expensive Pharmaceuticals" on Friday December 12th.

Register now to save an extra $100 off the current rate with the code XP1917BLOG.

See you in Washington D.C.

Health Care Insights | Weekly Round Up

Health Care Insights brings you your weekly healthcare round up. Below you will find relevant articles on key industry topics that we thought our readers would benefit from - enjoy.


 Top Stories:

4 Principles Guiding Healthcare’s Age of Enlightenment
There are many emerging themes and movements driving healthcare innovation and evolution, which is comparable to the Age of Enlightenment with its new discoveries and ways of solving problems.

“There’s no mystery, no magic… you can access all patient data at the bedside“
 Katleen Smedts, Project Manager ICT at University Hospital Antwerp (UZA) and Bernard Algayres, GM Radiology IT EMEA, GE Healthcare, discuss how vendor neutral archiving can improve access to patient data, facilitate clinical collaboration and drive up quality of care.

Experts say Texas needs more than specialized centers to fight Ebola
Dr. Thomas Geisbert, a scientist at the University of Texas Medical Branch at Galveston, was at a conference in Germany in 2000 when he and a Canadian collaborator decided to work together on a vaccine against the deadly Ebola virus.

Avalere Analysis: Medicaid Managed Care Enrollment Set to Grow by 13.5 Million
A new analysis from Avalere Health projects that enrollment of Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries in managed care – i.e., state payment of private companies to provide benefits – will increase by 13.5 million individuals from 2013 to 2016.

CMS launches $840M effort to spur medical practice ‘transformation’
The effort, called the Transforming Clinical Practice Initiative, is a first-of-its kind effort from the public sector and large-scale investment dedicated solely to sharing information among physicians. CMS estimates that only about 185,000 of the country’s doctors take part in similar programs that strive to transform industry practices through the use of collaboration and technology.

Relaunched health IT company offers MDs chronic condition patient data between visits
A health IT company that previously provided migraine patient data to pharmaceutical companies, Ubiqi Health, has relaunched as Klio Health. The new business, which CEO Jacqueline Thong started earlier this year,  aggregates data from patients with chronic conditions with the goal of assessing effectiveness of treatment between visits through a portal.


Have a great weekend!

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.

mhpa2014, Medicaid Health Plans of America’s event for the Medicaid managed care industry

mhpa2014, the annual conference of Medicaid Health Plans of America and a must-attend for Medicaid MCOs, is on October 26-28 in Washington, DC.

mhpa2014’s sessions, expert insights, and networking receptions will provide health plan attendees all they need to succeed in the new age heralded by the ACA. 

Meet health plan executives, policy experts, state and federal Medicaid officials, and business leaders to discuss the latest in Medicaid managed care.

Speakers include CMS’s Barbara Edwards, CMO Dr. Steve Miller of Express Scripts, and John Lovelace, president of UPMC for You.

mhpa2014 also features Thomas Duncan, CEO of Trusted Health Plan, William S. George, CEO of Health Partners Plans, and Karen Clark, President, Horizon NJ Health, fielding questions from Forbes writer Bruce Japsen.

mhpa2014 will close with a discussion with Medicaid Directors from Kentucky, Louisiana, Tennessee, and Virginia.

For details, visit http://bit.ly/mhpa2014 
 
Questions? Contact Sarah Swango at 202-857-5772

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! 

Last Chance to Register for IIR's Specialty Pharmacy Collaboration Summit

 

Hurry! There's still time left to register for
IIR's Specialty Pharmacy Collaboration Summit!
Online registration closes this Sunday, September 14th
Register Now >>

IIR's Specialty Pharmacy Collaboration Summit is in 4 days! Don't miss out on the only event in the industry offering you the opportunity to partner directly with all the key stakeholders in the specialty pharmacy value chain to increase patient adherence, expand distribution and improve bottom line.


Across three days, you will:

• Hear never-before-heard case studies on accountable care impact on payer provider relations from BCBS, Tufts Health Plan, Denver Health Medical Plan, and more!
• Learn how to overcome the four key challenges in the specialty pharmacy ecosystem:
       o Adherence
       o Managing Costs and Determining Value of Specialty Drugs
       o Distribution of Specialty Drugs and Channel Management
       o Sustainability of the Specialty Pharmacy Model
• Improve operations and enhance compliance in the Pre-Conference Workshop with TWO specialty pharmacy accreditations - URAC and CPPA
• Facilitate more face-to-face meetings to foster meaningful engagement and build relationships with the event specific partnering360 networking tool

Download the updated brochure for full agenda and speaker details.

Don't forget! Online registration closes this Sunday, September 14th! Click here to register. Please be sure to use code XP1968BLOG in order to save $100 off you registration.

Last Chance to Register for MDRP 2014

Hurry! There is still time left to register for the
19th Annual Medicaid Drug Rebate Program Summit!
Online registration closes this Sunday, September 14th.
Register Now >>

 

 

MDRP 2014 begins in just 4 days! Don't miss out on THE authoritative event for everything government pricing, rebates and regulation. Join 70+ speakers, 500+ MDRP executives, 20+ solution providers in the only event where the government programs and pricing industry comes together each year to debate and create a roadmap to operational solutions.

Don't miss out on these key highlights on the MDRP 2014 agenda:

• 2 Keynote speakers discussing the true impact of the ACA and Medicaid reform
• Legal & Compliance Track dedicated to overcoming challenges in the current legal landscape and ensuring compliance with government program mandates affecting manufacturers
• CLE Accreditation - Earn continuing Legal Education (CLE) credits
• Four pharma case studies from AstraZeneca, Mylan and GSK
• Pre-conference workshop dedicated to Generic Drug Manufacturers
• Direct access to State Rebating Representatives in State Dispute Resolution Meetings
• And more!
 

Create Your Own Personal Agenda Here to Follow All the Exciting Details.

 
Online registration will close Sunday, September 14th so register now! Remember to take an extra $100 off registration rates with the code XP1958BLOG. On-site registration will be available all three days of the conference.

Don't miss out! Be part of the go-to industry event and leave armed with the tools and ideas to optimize your government pricing operations.