Friday, February 03, 2012

More Analysis of the Proposed AMP Rule

In Monday’s New AMP Rule Targets Bona Fide Service Fees, I highlight just a few of the many issues raised by the proposed rule regarding Average Manufacturer Price (AMP).

By April 2, CMS will receive many detailed comments. But who can wait that long?

So, here’s my pre-Super Bowl round-up of 5 especially useful and insightful analyses of the proposed rule. These reports and articles are written by lawyers and government pricing experts, so they are scarily-specific and have many more details than my cursory overview.

As a bonus, I also include a look at how much Americans will be eating (by food type!) on Sunday and share the new Ferris Bueller commercial. Ooooh yeah.

1) Chris Cobourn of CIS has a compliance perspective on the rule in The Proposed AMP Rule: Some Initial Thoughts. CIS is hosting a free webinar next Thursday (2/9/2012) at 2:00pm EST called "A GP Geek's Guide to the Proposed AMP Rule." Apparently, CIS's first choice title—"A Defensive Tackle's Guide to the Proposed AMP Rule"—is already  being used by the New England Patriots.

2) Marina Consulting has a very nice summary of the practical implications for manufacturers in Operational Considerations for Manufacturers in Light of the 2012 Medicaid Drug Rebate Program Proposed Rule. I especially like the color-coded summary of each proposed item, including “likelihood change will be adopted as-is in final rule” and “overall financial impact.”

3) A team of 5 Arnold and Porter lawyers breaks down the proposed rule into understandable chunks in Medicaid Rebates: CMS Releases The Long-Anticipated Proposed AMP Rule. It’s a bit dry, but very thorough.

4) Meanwhile, a team of only 3 Reed & Smith lawyers provides us with CMS Releases Long-Awaited Proposed Rule to Implement ACA Medicaid Manufacturer Rebate and Pharmacy Reimbursement Provisions, a shorter but more amply-titled overview.

5) Can’t wait for the regulations to be published? Then check out King and Spalding’s unofficial redline of Medicaid Drug Rebate Program Regulations for a sneak peek at the proposed future.

6) If AMP is your thing, you should plan a trip to IIR’s Government Programs Summit in March. You'll also hear first-hand from 25 Government officials from CMS, OIG, OPA, PVP, PSSC, VA, DoD, and State pharmacy boards. Since IIR is a Drug Channels sponsor, you’ll get a 25% discount if you register with the VIP code XP1751DRUG.


I’m sure you’ll be reading these reports during the Super Bowl commercials. Here’s the Wall Street Journal’s summary of what else Americans will be consuming on Sunday.

  • 111 million gallons of beer
  • 100 million lbs. of chicken wings
  • 45.8 million lbs. of potato chips
  • 43.2 million lbs. of tortilla chips
  • 4.4 million pizza pies

P.S. As someone who sorta remembers the '80s, I'm lovin' the new Ferris Bueller Super Bowl ad. Joyful nostalgia. Just try explaining to you kids why your enjoy it.

Aren't you glad that I could handle blogging on a day like today?


  1. Chris CobournFebruary 03, 2012

    Thanks Adam, nice job pulling together some of the internet resoruces already compiled.  It is interesting that here we are, just 1 week removed from the Proposed Rule being published, and many of us have studied the document and pulled together our thoughts.  From the pharmaceuticl manufacturer perspective, I think you will see common themes and common responses so far.  A big question is what, if anything, should a manufacturer do now?  My initial feeling is NOT to make substantive methodlogy changes now.  We have been operating under an "Intirim AMP" since October 2010, when the PPACA AMP Legisltavie mandate becme effective.  The 2012 Proposed Rule presents some broad and controversial changes, and there will certainly be many comments by both Manfucturers and the Retail industry, so who knows that the Final Rule will be in the end.  Also, in its press release CMS speaks of a Final Rule in 2013, so this is going to take time.  I would hesitate, therefore, to change your Oct 2010 Intirim Rule with a 2012 Proposed AMP Intirim Rule.  I think each manufacturer should work with resources such as legal counsel and their consultants to evalaute specific changes that may be appropriate.