DEA Classification Change for Tramadol

Tramadol (brand name Ultram) is a centrally-acting “opioid-like” analgesic. It was approved by the FDA in 1995.  Since then, generic, combination, and extended release formulations have also been approved.   Per the PMSI 2013 Annual Drug Trends Report for Workers’ Compensation, tramadol (brand name Ultram and Ultram ER) was ranked number 3 under the top 20 medications by total transactions and number 12  under the top 20 medications by total spend. When it was initially approved by the FDA, it was classified as a non-scheduled medication as it was considered a “safe opioid.”  However, on July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule in the Federal Register which reclassified all medications containing Tramadol as a Schedule IV controlled substance due to evidence presented of possible abuse, dependence and diversion.  The Final Rule can be found here.

What are Controlled Substances and How are They Classified?

Controlled Substances are categorized into “schedules.” Schedule I drugs are considered highly addictive with no medicinal purpose, whereas a schedule IV drug has a relatively low potential for abuse, as well as dependence and is recognized for its accepted medicinal use. Prior to the DEA ruling, several states had already taken the initiative to classify tramadol as a schedule IV controlled substance at the state level due to its potential for abuse and addictive properties.  Consequently, the reclassification of this drug to a controlled substance on the federal level is not surprising.

How Will the Reclassification of Tramadol Impact Medicare Set Asides (MSAs)? 

As a controlled substance, prescriptions for tramadol will now have restrictions on the length of time the prescription remains valid and on the number of refills allowed during this time frame.  Previously, a prescription for tramadol was valid for one year from the date it was written with no limitation on the number of refills.  As a controlled substance, prescriptions will be valid for only 6 months from the date they are written with 6 total fills allowed (original & 5 refills).  If only 4 fills are used in 6 months, the prescription is no longer valid and the patient would not be allowed to obtain the remaining two refills.

Due to this change, claimants may need to increase office visits to maintain use of this medication. Urine toxicology screens may also be required to monitor for compliance, abuse, and possible diversion of tramadol. Both will ultimately result in increased costs to insurance carriers as well as the medical portion of MSAs.

The industry may also see a decrease in the number of prescriptions written for tramadol (ex.,tramadol 50mg, $0.08/tab) as it was most often utilized when a physician wished to avoid the prescribing of a scheduled, controlled substance or narcotic medication.  This may lead to the prescribing of alternative medications, which had previously been avoided, to increase.  This could include the different hydrocodone/APAP formulations (ex.,generic Norco 5/325 $0.19/tab or Vicodin 5/300 $1.97/tab, etc) as well as the  buprenorphine tab (ex., 2mg, $4.14/tab) and buprenorphine/naloxone (8mg-2mg, $10.01/tab) products  which are often utilized off-label for pain due to less potential for abuse. There may also be increased utilization of NSAIDs (non-steroidal anti-inflammatory drugs such as Celebrex 200mg, $8.42/cap) to continue to avoid the use of narcotic medications for treatment of pain and whose long-term use could lead to other health issues such as GERD. If this occurs, insurance carriers could see an increase in prescription as well as medical costs depending on which alternative medication is prescribed, which again would lead to an increase in the medical portion as well as the prescription allocation within the MSA.

Due to tramadol’s change in status to a scheduled IV controlled substance, the manufacturers of all products containing tramadol will have to implement changes required for the proper labeling, handling, and storage of tramadol. The DEA has acknowledged they are aware these changes will take time to implement and have given the manufacturers until August 18, 2014 to comply.

PMSI and Progressive Medical will continue to follow any further changes to tramadol’s use and classifications as well as other common drugs in workers’ compensation claims.  As a leader in providing solutions for cost containment, we understand that these changes could greatly impact prescription drug costs in claims.

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