MDRP Pre-conference Day - Recap on the AMP Final Rule

A recap from the MDRP pre-conference Day on the AMP Final Rule by John Bliss, an independent government pricing consultant.


I spent most of the day in Symposia C. The focus was on the ”AMP rule: Application, Implementation and Impact of the Final Rule.” The first session was a panel of manufacturer representatives, and the rest of the sessions were led by members of various legal and consulting firms.

The panel discussed the various components of the final rule, and pointed out that 2016-2017 will be a transitional year. It will be critical to provide and archive a record of all the activities surrounding the actions taken to implement the final rule, including legal sources, consulting recommendations, policies and procedures, and contract changes. The goal is to also steer documentation into “non-privledged” files, to prevent complications if audited in the future.

Topics addressed by the panel were:

• Retail Community Pharmacies (RCP) and Specialty Pharmacies
• Oral Dosage Forms
• Specialty Pharmacies Class of Trade Issues
• 5I Drugs
• Line Extensions
• Best Price – Offered or Achieved?
• Authorized Generics – who is doing the repackaging?

The rest of the day was spent digging into these topics, and others (Bundles and BFSF).

Comments:

Retail Community Pharmacies (RCP)

• Do not set up Specialty Pharmacy Class of Trade (COT) – not defined in rule
• If set up, set up two…mail and non-mail
• Learn the customer – pick up the phone

Oral Dosage Forms:

May need to go to the “Ship To” level

5i Drugs

• CMS does not understand them - may need to write it up and present it to CMS
• 70/30 ratio may be difficult to ascertain - evaluate status monthly
• Need created by NACDS lawsuit to limit AMP to RCP activities
• Not generally distributed through RCP
• Filter by Class of Trade (COT) only
• Restatements not requires

Line Extensions

• Waiting for CMS to finalize rule
• “We are clarifying” – scary words
• Congress wanted to captue dollars based on original base AMP
• Anti Dependency Formula disqualifies line extension status

Bundled Sales

• Bundles are pricing conditions based on products and performance
• Plenty of ambiguity within the definitions
• Communication critical among GP, Legal and Contracting

Bona Fide Service Fees

• Conceptually difficult

• Bona Fide = Ignore, not included in AMP
• Non Bona Fide = Include in AMP = reduce AMP

• Avoid putting legal definitions in contracts
• Look forward – involved Contracting personnel
• Critical – must have 4-part testing set up
• Review existing, catalog itemized services

OVERALL:

The main take away for all of these sessions is clear. Make the assumptions when required, and Document, Document, Document.


About the author:

John Bliss is a contributing writer for the Medicaid Drug Rebate Program Summit. He has extensive experience in the pharmaceutical industry, including AstraZeneca, Sanofi Aventis, Merck, Pfizer, Daiichi Sankyo, and Bristol-Myers Squibb (BMS). The bulk of John’s career was at BMS. When OBRA90 hit, Government Pricing took over his life. Government pricing, managed care contracting, rebates, and chargebacks continue to extend challenges and provide meaningful employment. John now works as a consultant, primarily subcontracted by other consulting firms, providing value added services to each of them and their clients.

Read more on this topic and about MDRP 2016 here:

• MDRP 2016 Pre-Conference, Track C: The AMP Final Rule
• Track D: 340B Guidance for Pharmaceutical Manufacturers: Fundamentals, Operations, and Compliance
• Drug Pricing is Today's Environment
• MDRP 2016: Day One - Government Agency Sessions
• A Review with Some of the Top GP Legal Experts
• Farewell to 2016's MDRP Summit

MDRP 2016: Why You Can’t Miss It

It’s hard to believe that we’re only about two weeks away from the 21st Annual Summit on the Medicaid Drug Rebate Program (MDRP 2016), arguably the biggest Government Pricing event of the year. This event always provides invaluable insight into the challenges facing the GP community, and this year is no different. Here are a few things that set MDRP 2016 apart from all the others.

First, the biggest names in Government Pricing will be in attendance. Not only will subject matter experts from law firms, consulting firms, and third party vendors be speaking, Knect365 (former IIR) has also secured a number of pharma industry speakers and panelists to share their experiences. Additionally, members of key federal agencies like HHS, HRSA and a number of state Medicaid agencies will provide clarity into their rules, regulations, and processes. Are you looking for assistance from external counsel but don’t know anyone? This is the perfect opportunity to get to know the true experts in the field. If you are looking for a GP system provider, in the process of implementing a system, or want to ensure your system has been updated to reflect recent rulemaking, walk through the exhibit hall and strike up a conversation with one of the many vendors who offer these types of services. And besides the great networking opportunity to find out how your organization compares to your peers, or to larger or smaller manufacturers, there are opportunities to attend panel discussions that present multiple viewpoints. And if you want to hear more about recent rulemaking directly from agency heads, this is the place.

Second, the MDRP 2016 offerings are more innovative and exciting than ever. This year, Knect365 (former IIR) has organized its sessions into streams like Fundamentals of Government Pricing Programs, 340B Guidance Symposia for Pharmaceutical Manufacturers, Generic Drug Manufacturers Workshop, and the AMP Rule Symposia. But you’re not “stuck” to one track. To help you pick the sessions that will best meet your needs, Knect365 has created a fantastic Interactive Agenda to allow you to mix and match the presentations right for you. The agenda even allows you to select the format, to allow you to identify presentations, panel discussions, and networking events. Don’t just pick a track and hope it tells you what you want to know. Pull up the interactive agenda before you head to MDRP and build your own customized track. If you are representing your GP team at the conference, you can also ask your teammates to pull up the agenda and create a wish list of sessions they would like you to attend. With its new agenda, Knect365 has given you the tools to ensure you won’t miss out – take advantage of it!

And last but not least, you just can’t miss MDRP 2016 because this year, after 6 years of holding our breaths, we finally got the AMP Final Rule we’d been waiting for! But it’s not just the AMP Rule GP teams have been talking about, this year we also got the 340B Drug Pricing Program Ceiling Price Proposed Rule, as well as a number of CMS Manufacturer Releases and FAQs that have been included in alerts by GPS. If all these changes in such a short period of time make your head spin, you’re not alone. Come to MDRP 2016 to make sure none of this information falls through the cracks, potentially putting your organization at risk.

We look forward to seeing you at MDRP 2016 at the Palmer House Hilton in Chicago. If you have not already registered, do so today and use code XP2158MISC to get an additional $100 off of the current registration fee. GPS will be onsite and blogging for the 2nd year in a row, so we look forward to seeing you there!

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.

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.

Earn a FREE Pass to the IIR’s MDRP Summit in Chicago, IL – Become a Guest Blogger.

Earn a complimentary all-access pass to the IIR’s Medicaid Drug Rebate Program Summit by serving as a Guest Blogger at the event. As a Guest Blogger, you’ll have access to the IIR’s MDRP event’s comprehensive agenda attracting the best insights from around the world, right in Chicago, Illinois in September.

MDRP Summit

September 30 - October 2, 2015

Chicago Marriott Downtown Magnificent Mile

Chicago, IL

We are looking for an industry expert to be the face of our IIR’s MDRP Summit social media campaign. The premise is to provide government pricing, rebates and regulations related articles, whitepapers, and overall original content with a strong focus on a whole pharmaceutical industry.

The IIR’s MDRP Summit guest blogger’s responsibilities will include but not limited to submitting one post per week to the Health care Insights blog http://bit.ly/1cnQyjK between now and the conference and attending specifically assigned sessions at the event and blogging live or same day.

This is a great opportunity for you to earn a complimentary Silver pass to attend IIR’s 20th Annual Medicaid Drug Rebate Programs Summit on Thursday, October 1-Friday, October 2.
You will get an exclusive access to a networking community of world's largest gathering of pharmaceutical manufacturers, state and federal government representatives, and service providers in the industry of your interest!

You also have a chance to GAIN exposure through our blog and more than 20 healthcare LinkedIn groups.

Learn more about the IIR’s MDRP Summit event by visiting our website:

http://bit.ly/1LRWSw6

To APPLY Please contact Roxana Siu at rsiu@iirusa.com . Feel free to share your short biography, links to your blog or writing samples, along with a few sentences about why we should choose you to become the Guest Blogger for the IIR’s 20^th MDRP Summit!

*Guest Bloggers are responsible for their own travel and lodging.

*All content is subject to IIR approval.

 We hope to have you join us in Chicago!

Cheers,
The IIR’s MDRP Summit Team
@healthcarebiz
#MDRP15
MDRP Summit official website: http://www.iirusa.com/medicaiddrugrebates/home.xml
Health care Insights Blog http://healthcareinsightsblog.iirusa.com/