Showing posts with label GP. Show all posts
Showing posts with label GP. Show all posts

Friday, September 23, 2016

Farewell to 2016's MDRP Summit

It’s Thursday night, the 2016 Medicaid Drug Rebate Program (MDRP) Summit has come to a close, and hopefully you are all safely at home and asleep in your beds – unless you took the opportunity to extend your stay in beautiful downtown Chicago, in which case I hope you have a wonderful stay! (If you are still at the lobby bar, my hat is off to you.)

It had been a few years since I’d attended the MDRP Summit, having spent some time broadening my healthcare compliance horizons, but this week felt like coming home. Throughout my consulting career I’ve witnessed many new analysts crash against the rocks of Government Pricing, only to request an immediate transfer as soon as their assignment on a GP project is complete. But once in a while you find the rare holdouts: the few, the proud, the GP geeks. My incomparable boss, Katie Lapins, tells the story of a former employer stopping by her desk to tell her she was going to have to do “something with Medicaid;” little did she know that it was the genesis of an illustrious GP career. Mine was the first time I took data files and a methodology grid, and tied my ASP calculation exactly to a client’s. Until that moment, I thought there were surely too many variables to expect to reach the same number independently. But then I did. I “found” ASP. To three decimal places. And that “ah ha” moment was all I needed – I was hooked.

To me, there is still no GP feeling better than tying out a parallel calculation; it feels like the ultimate assurance that you have done your job correctly. But even failing to tie out can be rewarding, because then you get to dig into your various data buckets, inclusions and exclusions, and formulas, and determine which model to adopt. On some level, that is what we do in Chicago every September. Although we all come in with the same statutes, regulations, and guidance, what we decide to do with them can feel profoundly different. Rival GP system providers vie for your business, consulting firms recommend their data analytics platforms, pundits make political predictions, and lawyers offer up (sometimes conflicting) legal advice.

There is no one-size-fits-all solution for the panoply of large and small, branded and generic pharmaceutical manufacturers that attend the Summit, and there is not always one right answer, so we are told repeatedly to draft policies and procedures, develop reasonable assumptions, and document our methodologies. To help shape your policy and methodology decisions, and to ensure that you continue to benefit from the Summit in the coming months, Knect365 will be providing the presentation slides to all attendees, so keep an eye on your inbox, and continue to check the Health Care Insights Blog for more updates in the coming weeks.

I hope you were able to glean some valuable insights from the MDRP Summit and receive helpful answers to all your questions. More than that, I hope you were able to meet a few new people, finally put faces to names, and reconnect with colleagues and friends. To my friends, thank you for welcoming me back to the GP community with such open arms – let’s not wait another year to do this again.


About the Author: Dana Z. Collins has worked in the Government Pricing space for almost a decade, as both a consultant and an in-house compliance professional. As a GP consultant, Dana’s areas of primary focus are audits/assessments, training, ongoing calculations, Medicaid rebate processing, and policies/procedures – oh, and blogging. After working with Katie Lapins, Principal/Owner of Government Pricing Specialists (GPS), on and off over the years, Dana joined GPS in 2016 and has never looked back.




Wednesday, August 5, 2015

Breaking News: AMP Rule Submitted to OMB for Final Review

BREAKING NEWS: AMP Final Rule has been sent to OMB and is expected to be released at the end of August - Just in time for IIR's MDRP Summit!

At the 20th Annual Medicaid Drug Rebate Program Summit, we've got you covered on all things AMP related across three days of the conference! Join us on September 30-October 2, 2015 for:

Wednesday, September 30th: The AMP Rule Full-Day Pre-Conference | Understand the Application, Implementation and Impact of the Final Rule
  • • Brace Yourself: The AMP Final Rule is Here! What To Do, What Not To Do & What To Do First
  • • PANEL: Deconstructing the AMP Final Rule: A Step by Step Analysis of the Key Implications of the Final Rule
  • • Identify Line Extensions & Implement Alternate Rebate Formula
  • • Clarification to the Re-definition of Bundled Sales & Its Implications
  • • How to Categorize & Calculate the 5i's
  • • Implications of the Expansion of RCP
  • • Impact of the Final Rule on Class of Trade & Innovator Products
  • • PANEL: Implementation: Constructing a Final Rule Application Checklist
Thursday, October 2nd:
  • • CMS Pharmacy Updates from John Coster, Director, Division of Pharmacy, CMS
  • • The AMP Final Rule: Operationalizing for MDRP by Alice Valder Curran, Partner, Hogan Lovells US LLP
  • • Track One: Impact of AMP on Government Pricing
  • • Track Two: Post AMP Panel Navigating the Regulatory Framework
  • • Track Three: Financial Implications of the AMP Final Rule on GP Calculations
  • • Track Four: Re-assessing GP Methodology post AMP
Friday, October 3rd:
  • • Keynote Fireside Chat with External Counsel focusing on the legal implications of the AMP Final Rule and how to remain compliant
  • • Townhall to answer all your AMP related questions moderated by John Shakow, Partner, King & Spalding  
Download the MDRP brochure for complete details.

Register now and save up to $300 off standard registration.
Be sure to use priority code: XP2058BLOG

Read the OMB Submission Here.




Monday, July 7, 2014

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!




Monday, January 16, 2012

How Important is Clarification On Current Government Guidance's To Your Organization?

Post Healthcare Reform, not only are Government Programs in a seemingly constant state of flux, but many of the most complicated programs are in a regulatory vacuum period – we know something is coming down the pipe, but have no idea when and how it will affect us.

So what can we do to help? At the Government Programs Summit, we bring together both the key government officials who can offer the most clarity about what to do NOW to prepare for what may come LATER and leading pharmaceutical and generic manufacturer executives who will leave you with practical information on how they are coping with the uncertainty.

In two short days you will:
  • - Have unparalleled access to CMS authorities from the Policy, Technical, and Operations Departments, in the session, “CMS AMP Guidance Answers and Next Steps for Medicaid Drug Rebate Program,” as well as the opportunity for one on one, personalized attention in the CMS meeting room.
  • - Get an update on 340B guidance directly from HRSA officers, including definitions of “Eligible Patient” under the PHS program in the session, “340B PHS Guidance, Definitions and Oversight Update.”
  • - Learn to accrue for the potential 4 million new beneficiaries to Medicare Part D who may fall in to the Donut Hole in 2012 in the session, “Medicare Part D for the Donut Hole: Guidance Updates, Invoicing, Disputes and Appeals Processes.”

Staying up to date on current proposed rules, interpretations, and implementations of government programs is of paramount importance to branded and generic manufactures.

Government Programs and Pricing Compliance Summit will take place March 7-9, 2012, in Baltimore, Maryland. For more information on the program, download the brochure here.




Thursday, September 16, 2010

MDRP 2010 Conference - Government Pricing Program Audits, Restatements, Adjustments, and Disclosures: The Needle has Moved – Have You?

Speaker:
Constance Wilkinson, Member – Epstein Becker & Green

The Health and Human Services agency has released the Fiscal Year 2010 work plan for their audits of the pharmaceutical industry. If you are an eligible participant in a government program, you are also an eligible participant for their audit groups. This additional participation means that you may want to make adjustments and become compliant before you get that knock on the door.

The first focus will be on the AMP Calculations and will be done by the Office for Audit Services. One of the issues that may trigger an audit would be if you restated with a significant change to the number. But having said that it is not a certain trigger and far from the complete list of reasons for an audit. With many areas of AMP being left to reasonable assumptions it is imperative that you document, document, document! When the auditor does come to your door and asks you why the AMP calculation was done the way it was done in Q303, you better be able to not only justify your reasons for the calculation actions, but also be able to recreate them.

The second focus will be done by the Office of Evaluation and Inspections to look for those companies who are participating in the Medicaid Reimbursement Program with Unapproved Drugs. There are drugs out there that are so old (e.g., grandfathered drug) they do not have an NDA and the company has failed to submit a new one to the FDA bringing their product into the Approved drug category. If the state is reimbursing pharmacies for this drug, with the assumption that it is approved and you are allowing that action, it can be considered fraud. There has already been one settlement on this issue and with future audits coming, it is imperative that you update your drugs with the FDA and ensure you are compliant with all government program participation.

The last area of focus will be for the Impact on Medicaid Rebates for Authorized Generic Drugs and will also be done by the Office of Evaluations and Inspections. There are still some companies that do not understand the difference between an Authorized and an Unauthorized Generic and how each should be treated differently. If you think you may be treating your generic incorrectly, and thus paying the incorrect rebate amount, you need to take action to restate those rebate numbers and true-up any monetary adjustments as a result. Be sure to work with your regulatory department to understand how your product is categorized in the eyes of the FDA and thus CMS, and then make any necessary changes.

Be sure to understand that with the tight budgets we have all seen these past few years, it is more and more important for the government to ensure they are getting all the discounts and reimbursements they are owed. And with the new money being funneled into the offices that do the overseeing and auditing of the pharmaceutical industry, you can bet there will be more chances for your door to be next on which to be knocked. Make sure you are prepared.