The DEA Finally Decides To Reschedule Hydrocodone

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.

How Will State Boards of Pharmacy Respond to Senate Committee’s Compounding Inquiry?

December 13, 2012

On November 19th, Chairman Tom Harkin (D-IA), Ranking Member Mike Enzi (R-WY) and members of the Senate Health, Education, Labor and Pensions Committee sent letters to all fifty state boards of pharmacy, the entities responsible for maintaining registries of pharmacies operating within their state. The HELP Committee is investigating the New England Compounding Center (NECC) for its production of tainted drugs that caused the recent outbreak of fungal meningitis, which has resulted in 33 deaths and more than 480 illnesses.

The letters were sent as a follow up to a hearing on November 15th in which Senators heard a very troubling account of NECC’s oversight record, which highlighted the gaps and grey areas that complicate the law establishing regulatory authority over such companies. In the course of the investigation, committee staff found that compounding pharmacies like NECC are required to register with their state of residence, and not with the U.S. Food and Drug Administration. This inquiry will help lawmakers to assess the scope of these companies nationwide. Today’s letters will also assist the committee as it determines what changes need to be made to ensure that compounded drugs are safe and available for patients and hospitals who need them.

“The outbreak raises serious questions about the level of oversight that a large-scale compounding pharmacy was subject to, both by state and federal regulators, and what if any additional steps need to be taken to prevent such a tragedy in the future. Therefore, as part of our investigation, we write to request information regarding general oversight of compounding pharmacies in your state and what actions you have taken to address this meningitis outbreak,” the Senators wrote.

Key Points Made in the Inquiry
As foundation for its request for information, HELP noted that the Centers for Disease Control and Prevention (CDCP) linked the recent meningitis outbreak to three lots of preservative-free methylprednisolone acetate produced by the New England Compounding Center (NECC) — a compounding pharmacy in Massachusetts. According to the CDCP, the three lots consisted of 17,676 products distributed to 23 states, exposing approximately 14,000 patients since May 21, 2012. As of November 16, 2012, at least 480 patients have become ill throughout the country, of which 33 have died as a result of the contamination.
In order to better understand how states address the potential issue of compounding pharmacies distributing large quantities of drugs throughout the country and whether additional federal oversight may be necessary, HELP requested that each state’s board of pharmacy provide information responsive to its requests as noted below:

    1. Does your agency require compounding pharmacies to identify if they produce large volumes of drugs, if they compound sterile injectable products and/or ship their products across state lines? Do your inspection procedures vary based upon the production of sterile drugs, or large quantities of drugs, or drugs shipped across state lines?
    2. Does your state require that pharmacies engaged in sterile compounding comply with USP and if so what is your procedure for ensuring compliance with the standard?Are compounding pharmacies in your state required to have a patient-specific prescription prior to producing a compounded drug or are they able to produce batches of products without a prescription?
    3. Please provide the name and address of all pharmacies in your state that hold licenses or waivers or other exceptions that permit the pharmacy to operate in the absence of providing a full service retail pharmacy and meet all of the following three criteria (to the extent that you have information that allows you to identify pharmacies this way):
      • engage in sterile compounding;
      • hold licenses in other states; and
      • engage in compounding as opposed to dispensing.

Assuming the states responded, information should have been available no later than Friday, December 7, 2012.  Unfortunately, no responses have been published at this point, but it will be interesting to see how each state views its responsibilities to oversee compounding pharmacies at the state level.

Join Us In Vegas… Ask How Tower Triage Can Save Millions

October 29, 2012

Vegas ConferenceWednesday, Nov 7-9 Las Vegas Convention Center.

For 20 years, the National Workers’ Compensation and Disability Conference® & Expo has been the industry’s leading training event. And this year’s event is taking it to the next level – making it the best ever!

Key NWCD presentation tracks include the following:

  • A new full set of sessions will explore and deliver tangible, actionable solutions to the opioid crisis in workers compensation.
  • New ‘Regional Differences Sessions’ will each tackle the most challenging issues in a particular area of the country and provide you with practical strategies to overcome them.
  • New interactive ‘Think Tanks’ give attendees an opportunity to exchange innovative ideas with industry peers and leaders.
  • Enhanced legal track for attorneys and non-attorneys via partnership with LexisNexis.

Click here for more info on NWCD.

And for those who seek the latest in optimized settlement and Pre-MSA intervention strategies, stop by Booth #936 to learn more about the challenges of the current CMS review model and what Tower MSA Partners is doing to save clients millions.

Tower Triage enables employers and carriers to:

  • Mitigate CMS exposure
  • Optimize patient care
  • Expedite settlement

For more information , or to request a meeting with one of our executive team members,  email us at