Friday, November 21, 2014

Surprise? Once Again, FULs and AMP Final Rule Delayed

In what has become a semi-annual ritual, the Centers for Medicare & Medicaid Services (CMS) last night announced plans to delay the Federal Upper Limits (FUL) and the Final Rule on Covered Outpatient Drugs, a.k.a., the Average Manufacturer Price (AMP) Final Rule. Full text of the non-announcement email below.

You can read about the previous delays here…and here…and here…and, oh yes, here, too.

In its email, CMS confirms that it will do something, at some point in the future, and that it looks forward to partnering with stakeholders whenever it does the thing that it may or may not ever do.

Meanwhile, we'll all just muddle along without clarity on AMP computations, bona fide service fees, the definition of retail pharmacy, and more. It's enough to make any cat grumpy about the Affordable Care Act's implementation.

Here’s the latest CMS email, which is a genuine masterpiece of bureaucratic nonspeak. Caveat lector.
“This notification is to update stakeholders on the anticipated finalization of the Affordable Care Act federal upper limits (FUL) for multiple source drugs as provided in the recently released CMCS Informational Bulletin.

The Centers for Medicare & Medicaid Services (CMS) previously announced to stakeholders in June 2014 that we would not be finalizing the Affordable Care Act FULs in July 2014. We also indicated that we would provide detailed guidance to states with sufficient lead time to implement the Affordable Care Act FULs, and that we would provide a new finalization date for the FULs in this guidance.

We expect to release the finalized Affordable Care Act FULs at or about the same time that we publish the Medicaid Covered Outpatient Drug final rule (CMS-2345-F). At that time, we also plan to issue formal detailed guidance to the states to implement the Affordable Care Act FULs. This will include the information that the states will need to include in their state plan amendments, including detailed timelines for compliance.

We will continue to analyze the draft monthly Affordable Care Act FULs data, including the relationship of these FULs to the National Average Drug Acquisition Cost pricing, as we continue to work to implement the FULs provisions of sections 1927(e)(4) and (e)(5) of the Social Security Act. We will also continue to post the draft monthly Affordable Care Act FUL files on Medicaid.gov.

We look forward to continuing to partner with you as you apply the provisions of the Affordable Care Act.”
If you’re curious, my June 2014 note highlights a some important implications about AMP and FULs. Manufacturers and wholesalers should see my discussion of bona fide service fees on pages 50-52 of  the 2014-15 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

4 comments:

  1. Good perspective on this non-decision from Chris Cobourn at CIS: CMS Bulletin on AMP-based FULs and the AMP Final Rule. Chris makes an interesting point about timing:

    Given that the Proposed AMP Rule was published in February of 2012, that three year window closes this February, 2015. Does that mean a rule is coming out before then or does that mean that CMS allows the three year deadline to lapse and goes back to the drawing board? There’s also the possibility that CMS will seek extensions to the deadline until it is ready to publish a final rule.

    Stay tuned?

    ReplyDelete
  2. On this question, the 3-year window applies only for Medicare regs, not Medicaid. It was put into place (for Medicare) to encourage timely implementation of Part D.

    ReplyDelete
  3. UPDATE: Optimistic readers should note that CMS has now published an April 2015 date. See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201410&RIN=0938-AQ41.


    We'll see.

    ReplyDelete

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