CMS Announces AMP Final Rule Delayed Until May

On Friday, CMS announced via reginfo.gov that the final rule revising the requirements pertaining to Medicaid reimbursement for covered outpatient drugs has been postponed until at least a May 2014 date. This rule also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program. 

With a new 2014 Q2 release, the wait continues for clarity on the new regulations, but does give pharmaceutical labelers valuable time to implement methodologies for areas the new regulations will impact. 

IIR’s 6th Annual GP Summit convenes regulators, pharma industry leaders and insiders on how to stay compliant during the rapid ACA expansion, including how to best utilize these final few months to prepare the critical business processes that will change on account of the AMP Final Rule. 

Join us March 26-28, 2014 in Virginia, where you'll learn how to properly manage rebates for drugs under all government programs, including: 

• The 340B Program and 340B "Mega" Rule 

• The Medicaid Drug Rebate Program 

• Medicare Part B & D • The VA and DoD 

• TRICARE • State Supplemental Programs 

• Medicaid Managed Care 

Use code XP1951BLOG to register by 12/13 and save up to $700. If you have any questions about the event, feel free to contact Kate Devery (Kdevery@iirusa.com) For more information visit our homepage. We hope to see you this March! 

Cheers, 

The Government Programs Team 

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Look Who’s Attending the Government Programs Summit

In just three weeks the 5th annual Government Programs Summit will bring together the most drug pricing, contracting and compliance executives on the east coast. These executives come to Baltimore each year to get the most comprehensive, up to date information on the reimbursement programs affecting your business, including MDRP, 340B, Medicare Part D, Part B, TRICARE, VA, and OIG. Branded and generic manufacturers, large and small pharma all come together for this exciting event.

340B Prime Vendor Program/Apexus * Acorda Therapeutics * Afaxys * Akrimax Pharmaceuticals * Alliance Life Science Consulting Group * AmerisourceBergen Drug Company * APP Pharmaceuticals * Argus Health Systems * Banner Pharmacaps * Baxter International * Blue Fin Group * Capital Wholesale Drug * Cardinal Health * Celgene * Children's Hospital * CHKD * CIS * Daiichi Sankyo * Dendreon Corporation * Department of Veteran Affairs * Eli Lilly * Epstein Becker & Green PC * Forest Laboratories * Fresenius Kabi * Genzyme * GlaxoSmithKline * Gold Standard * Hersa ORO * HighPoint Solutions * Horizon Pharma * Hospira * Janssen * JHP Pharmaceuticals * John Hopkins * Johnson & Johnson * Keenan* LEO Pharma * McKesson * MedImmune * Merck * Merck Sharp & Dohme* Mercy St. Vincent Medical Center * MLEE Consulting * Morgan Lewis & Bockius * Myers & Stauffer * Mylan Pharmaceuticals * New Hanover Regional Medical Center * New York Downtown Hospital * North Carolina Medicaid * Novartis * Office of Pharmacy Affairs HRSA * Outlaw Group * Paragon Solutions * Pfizer * Prince George's County Health Department * Procter & Gamble * Reckitt Benckiser Pharmaceuticals * Revitas * Roper St. Francis * Sandoz * Sanofi * Script Care * Shire Regenerative Medicine * Smith Drug Company * Sunovion * Teva Health Systems * UCB Pharma * University of Virginia * Upsher Smith Laboratories * UVA Health System * Vertex Pharmaceuticals * Walgreens * West -Ward Pharms * Wockhardt * Xerox State Healthcare *

The event is just weeks away, don’t forget to register AND remember to book your hotel room, as we are close to selling out! To learn more, download our full agenda.

Government Programs Summit will take place March 11-13, 2013 in Baltimore, MD. As a reader of this blog, you get a 15% discount off the standard rate when using code XP1851BLOG to join. If you have any questions about the agenda or event, please contact Kate Devery at kdevery@iirusa.com or visit our webpage.

Cheers,
The Government Programs Summit Team

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Who can you meet at the GP Summit this month?

In just two weeks the Government Programs Summit will bring together hundreds of drug pricing and compliance executives from dozens of pharmaceutical and generic companies eager to get the most comprehensive, up to date information on the reimbursement programs affecting your business.

Here's who has registered to join us:

340B Prime Vendor Program/Apexus * Acorda Therapeutics * Afaxys Inc * Akin Gump Strauss Hauer & Feld * Akrimax Pharmaceuticals LLC * Allergan Inc * Alliance Life Science Consulting Group * Alvogen Inc * American Pharmaceutical Association * Amneal Pharmaceuticals * Amylin Pharmaceuticals Inc * Apexus * APP Pharmaceuticals * Aptalis Pharma * Aurobindo Pharma USA * Azur Pharma * Banner Pharmacaps Inc * Baxter International Inc * Bayer HealthCare * Bristol Myers Squibb Company * Brookings Institution * Cangene BioPharma * Celgene * Centers for Medicare & Medicaid Services * Cephalon Inc * CIS * CMS * Compliance Implementation Services * Cornerstone Biopharma Inc * Daiichi Sankyo * daVIZta Incorporated * Department of Health & Human Services * Dey Pharma LP * EDS * Eisai Inc * Eli Lilly & Company * Endo Pharmaceuticals * Ernst & Young * Forest Laboratories * Fresenius Medical Care * Galderma Laboratories * Gilead Sciences Inc * Government Pricing Specialists * HighPoint Solutions * Hospira Worldwide Inc * HP Enterprise Services * HP NC Medicaid * HRSA Office of Pharmacy Affairs * Huron Life Sciences * Impax Laboratories * Janssen * Jazz Pharmaceuticals Inc * JHP Pharmaceuticals LLC * Johnson & Johnson * Kadmon Pharmaceuticals * LEO Pharma Inc * Loma Linda Univ Med Ctr * McKesson Packaging Services * Medicis Pharmaceutical * MLEE Consulting * Model N * Mylan Pharmaceuticals Inc * National Association of Chain Drug Stores * Navigant Consulting * Nephron Pharmaceuticals Corporation * Novartis Pharmaceuticals Corporation * Office of Pharmacy Affairs HRSA * Optimer Pharmaceuticals * Perrigo Pharmaceuticals * Pfizer * Procter & Gamble * Purdue Pharma * Revitas * Sanofi Aventis * Shire Pharmaceuticals * Sigmapharm Laboratories, LLC * Sigma-Tau Pharmaceuticals Inc * Sunovion Pharmaceuticals * Takeda Pharmaceuticals North America * Teva Pharmaceuticals * Triax Pharmaceuticals LLC * UCB Pharma Inc * Upsher Smith Laboratories * Vertex Pharmaceuticals Inc * West -Ward Pharms * Zydus Pharmaceuticals USA

For more information on the event, download the brochure.  The Government Programs Summit is taking place March 14-16, 2012, in Baltimore, Maryland. For an exclusive discount of 25% to join us at the event, join the Government Programs LinkedIn Group. If you have any questions, feel free to email Jennifer Pereira.

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.