Thursday, July 16, 2015

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!

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!




Tuesday, July 14, 2015

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





Friday, July 10, 2015

This Week in Healthcare: 7/6 - 7/10

Top news from around the healthcare industry:

California Receives Failing Grad for Health Care Cost Transparency
California was one of 45 states to receive a failing grade for health care cost transparency, according to the third annual report by the Catalyst for Payment Reform and the Health Care Incentives Improvement Institute, Modern Healthcare reports.

FDA Strengthens Heart Safety Warning on Popular Pain Relievers
Federal health regulators are bolstering warning labels on popular pain relievers to reflect new information about their risks of heart attack and stroke.

Obama's CMS Nominee Slavitt Could Face Rough Road to Confirmation
President Barack Obama has nominated Andrew Slavitt as administrator of the CMS, the position he has held on an interim basis since Marilyn Tavenner stepped down in February.

 Happy reading! Have a great weekend.




Thursday, July 2, 2015

Celebrate July 4th with 30% Off to MDRP 2015!


Take advantage of this special July 4th offer and save 30% to MDRP! 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. Visit the website for full details.

This limited-time offer expires on Monday, July 6th | 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 7/6

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 July 2 – July 6, 2015. All registrations are subject to IIR approval.




Friday, June 26, 2015

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.




Wednesday, June 24, 2015

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


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!




Wednesday, June 17, 2015

A Message from Edward McAdam, Chairman, IIR’s MDRP Summit


Government rules and regulations affect every department at a pharmaceutical company. However, few areas are as directly—and as frequently—affected as the government pricing and reimbursement space. Those working in this segment need to be knowledgeable about several different government agencies whose updates impact the way manufacturers conduct their government-related operations.

We’re still thinking about Medicaid expansion and how many states will ultimately expand, thereby adding more weight to the Medicaid Drug Rebate Program. Along with HRSA’s 340B Proposed Mega Rule and CMS’ Final AMP Rule—both set to come out this year—this will fundamentally change how we do our calculations.

There’s only one event that I know that really addresses these questions providing a forum to debate and create a roadmap for manufacturers to follow—IIR’s Medicaid Drug Rebate Program Summit. I’m pleased to once again be chairing this industry-leading event—the largest in the country—taking place September 30-October 2 in Chicago.

I invite you to join us. 

The MDRP Chicago Summit has anticipated what manufacturers are dealing with on a day-to-day basis and provides essential content you won’t find anywhere else. It is THE largest MDRP event where industry, state and federal government professionals come to share information, get updated on regulatory issues, and have a good time doing it.

When you download the agenda, you’ll see why the MDRP Summit stands out: 
  • Six pre-conference symposium including the all-new Town Hall between Manufacturers and States 
  • The annual update on 340B Program Regulations and Processes from Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA 
  • The only event facilitating Dispute Resolution Meetings with at least 20 participating States 
  • The all-new Pharmaceutical VA Contracting and Compliance Summit where you will get updates on FSS, NFAMP, FCP and more

There’s a reason 550+ MDRP executives (including myself!) come back year after year. Take a look at the agenda by downloading it here and register today!

I look forward to meeting you in Chicago. (I’ll be the guy up front introducing our opening keynote, Ezra Klein, Editor-in-Chief, Vox.com; Columnist, Bloomberg News, Policy Analyst/Contributor, MSNBC!)

Sincerely,

Edward J. McAdam, Sr. 
Daiichi Sankyo, Inc. 
Chairman, IIR’s Medicaid Drug Rebate Program Summit




Friday, June 12, 2015

This Week in Healthcare: 6/8 – 6/12

Top news from around the healthcare industry this week: 

Walgreens, MDLive expand telehealth collaboration to three more states 
Walgreens has expanded its relationship with telehealth service provider MDLive, bringing remote physician access to customers in three new states and, for the first time, to PCs as well as mobile devices. Users of Walgreens mobile apps and the walgreens.com portal in Colorado, Illinois and Washington state now can consult 24/7 with board-certified MDLive physicians for $49 per encounter, the two companies announced Tuesday.

Outraged, engaged patient takes aim at paternalistic physician 
It’s hard to know how many patients out there are truly “empowered,” and I suspect it is a relatively small number, but one of the louder voices out there is Duncan Cross, a longtime engaged patient with Crohn’s disease.

Arizona hospitals, doctors avoid 5 percent Medicaid pay cut 
Arizona hospitals, doctors and other health providers will get a reprieve after the state's Medicaid program announced it will cancel a planned 5 percent payment cut because of lower-than-expected use among enrollees and a prescription-drug rebate.

One nation, under sedation: Medicare paid for nearly 40 million tranquilizer prescriptions in 2013 
In 2012, Medicare’s massive prescription drug program didn’t spend a penny on popular tranquilizers such as Valium, Xanax and Ativan. The following year, it doled out more than $377 million for the drugs. While it might appear that an epidemic of anxiety swept the nation’s Medicare enrollees, the spike actually reflects a failed policy initiative by Congress.

Game Changer: CMS’ Proposed Medicaid Managed Care Regulation 
The Centers for Medicare and Medicaid Services (CMS) released its long awaited Medicaid managed care proposed rules on May 26; the rules were published in the Federal Register on June 1 (80 Fed. Reg. 30198-31297). The last time the federal government seriously tackled Medicaid managed care was in a 2002 regulation (67 Fed. Reg. 40989, June 14), a response to the Balanced Budget Act of 1997 (Pub. L. 105-33), which itself amounted to a major new chapter in Medicaid’s relationship to what by then had become known as managed care.


Happy reading! Have a great weekend. 




Tuesday, June 9, 2015

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.




Tuesday, June 2, 2015

MDRP 2015 Brochure is Now Available 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!