Naloxone, the Antidote, and the Effect on CMS Approvals

CMS, Medicare Set-Aside Blog, Medicare Set-Asides, MEDVAL News on September 1, 2016
Posted by Jean S. Goldstein, JD, CMSP

It is well known that we are still in an opioid crisis.  As reported, opioids were involved in16,235 deaths in 2013 and 28,647 deaths in 2014 and overdoses from opioids have quadrupled since 2000.  Yet, we consistently continue to see Claimants provided with prescriptions for opioids, even with the CDC’s issued guidelines for opioid prescriptions for chronic pain, and the recent crackdown on prescription opioids.  An additional trend as related to opioids, is the prescription recommendation for naloxone.  It is important to note that the CDC guidelines support naloxone use when certain risk factors are present and this is a medication that can save many lives. Naloxone is an opioid antagonist or antidote for opioid analgesic emergencies such as an overdose.  The medication works to temporarily reverse effects of opioid analgesics, and recently we have begun to see physicians including naloxone as part of prescription medication treatment plans.  As a result, we have begun to see the CMS review contractor including this medication in recommended WCMSA proposals, even when naloxone could possibly be contraindicated for the claimant.  What this means for our clients, is that while a physician may be recommending naloxone for use as part of a weaning regimen, just the mere recommendation, mention, or one time fill of naloxone, increases the possibility of inclusion of naloxone over a Claimant’s entire life expectancy, which can be quite significant as the AWP for each pre-filled syringe is over $2K.

We recently received a CMS approval wherein the CMS review contractor included Evzio, a take home naloxone auto injector, over the course of Claimant’s entire life expectancy, resulting in a very significant counter.  However, we advocated that because of a possible contraindication with a scheduled medication that the Claimant was co-prescribed later on, Evzio should not be included in Claimant’s future prescription medication plan.  In this case, because the medication had been mentioned, and filled once, the medication was allocated over Claimant’s entire life expectancy.  As a reminder, naloxone, is an antidote for opioid analgesic overdose, and while the medication expires even if not utilized, there other underlying concerns and issues as indicated in the CDC guidelines which should be addressed prior to prescribing naloxone over a Claimant’s entire life expectancy.  In this recent case we challenged, we advocated for removal of this medication based solely upon the contraindications.  We were successful upon re-review in having CMS remove the medication, resulting in significant savings of over $60,000 for our client.  At MEDVAL, we believe in firmly advocating for our clients, particularly on re-review, and when it is clear that CMS has made an error, which we believe should not unjustly cost our client.  For more information about current CMS trends, particularly as related to use of naloxone, please feel free to reach us at