August 27, 2014
Last week the DEA released a final rule on the rescheduling of hydrocodone removing it from the schedule III controlled substances list in favor of a schedule II designation. To be clear, this decision specifically addresses hydrocodone combination products (i.e., hydrocodone-acetaminophen formulations such as Vicodin) as hydrocodone by itself has always been a schedule II drug.
The new parameters surrounding the prescribing of hydrocodone under the more restrictive schedule II classification will go into effect on October 6, but the decision by the DEA in conjunction with the Assistant Secretary for Health of the U.S. Department of Health and Human Services has been a long time coming. Hydrocodone combination products (HCP’s) have been schedule III since the Controlled Substances Act was passed in 1970 despite, as mentioned, the fact that hydrocodone itself has always been a schedule II drug. The thought initially was that by combining hydrocodone with another substance such as acetaminophen would diminish the abuse potential, but in the DEA’s final order they actually point to several different statistics that definitively portray just the opposite. Perhaps the most eye opening of these statistics tells us that high school aged children have actually abused Vicodin at twice the rate of Oxycontin, a more tightly controlled schedule II drug that has in the past, grabbed a lot more of the headlines.
Not surprisingly, there was a lot of pushback from the pharmaceutical community as well as some from the medical community throughout this process which has taken 15 years to come to fruition (the original petition was submitted by a physician in 1999). This dissent however, is misplaced and perhaps even irresponsible considering hydrocodone is the most prescribed drug in the United States. Last I checked, heart disease was the biggest killer in this country, not pain, yet hydrocodone is prescribed more than even ACE inhibitors (for hypertension) or statin drugs (to lower cholesterol). And if that is surprising to you try to wrap your head around this: the United States is comprised of about 4% of the world’s population yet we use 99% of the world’s hydrocodone.
The affect this will have on the workers compensation industry could prove to be significant. In terms of PBM’s who commonly push for mail order distribution, schedule II drugs have restrictive policies not conducive to this type of service. It would therefore be a good idea to check with your PBM to ensure that they are actively transitioning all applicable injured workers.
A second implication could be in regards to the widely utilized Official Disability Guidelines (ODG) which have long classified several HCP’s as Y drugs (recommended for first line treatment) within their workers compensation formulary. If changed to N drugs, those HCP’s would be subject to immediate utilization review in states such as Texas and Oklahoma that have instituted a closed formulary.
In my world of Medicare Secondary Payer compliance, it’s tough to say exactly where the effect of this rescheduling will be felt, but there are some trends that I hope we begin to see starting with less hydrocodone on MSA’s. It is easy to get caught up in cost drivers and how to mitigate unnecessary medical treatment in my line of work, and rightfully so when a prescription that was never meant to be maintained long term must be allocated for because it is part of the current treatment plan. But oftentimes, payers tend to overlook or not focus on HCP’s due to their relative low cost in comparison to some of their counterparts such as Oxycontin, Opana or Actiq. The result of that is we are consistently including long term use of hydrocodone-acetaminophen (for example) within MSA allocations in spite of the fact that no opioid has ever been recommended for long term use. This sort of tradeoff is unavoidable at times, but I will still hold out hope that the DEA’s most recent stance to reschedule hydrocodone combination products will prove to have a significant impact on the misuse and abuse of prescription painkillers, not just in our little world of work comp, but far reaching into our society as a whole.