Future Considerations for Controlled-Release Oxycodone

Oxycodone CR is a slow release opioid narcotic currently indicated for use in moderate and moderate-to-severe pain. When initially released to the market, the indicated use was for pain management in cancer patients and for control of postoperative pain. As the use of controlled-release Oxycodone expanded, problems with addiction and abuse escalated.

In an effort to bring the use of Oxycodone CR under more effective control, H.R. 1366 cited as the “Stop Oxy Abuse Act of 2013” was introduced March 21, 2013 “to direct the Commissioner of Food and Drugs to modify the approval of any drug containing controlled-release (CR) oxycodone hydrochloride, to limit such approval to use for the relief of severe-only instead of moderate-to-severe pain, and for other purposes”. The introduction of the bill followed a petition filed by Physicians for Responsible Opioid Prescribing (PROP) calling for the FDA to modify opioid labeling such that future approval would exclude the term “moderate” from an indicated use for non-cancer pain. As such, approval for use would be limited to severe pain only within this population. However, the bill does not restrict the drug’s use to non-cancer pain but, rather, seeks to limit approval for use to “severe-only pain” for any patient population.

If H.R. 1366 passes, it will operate to remove use of the controlled-release oxycodone drugs for management of any form of moderate pain type diagnoses as an approved indication by the FDA. The prescribing of Oxycodone CR for “moderate” or “moderate-severe” pain would then be considered an “Off Label” use. Within the world of Medicare Set-Aside, provision of controlled-released Oxycodone for such diagnoses would be excluded from the plan of care. Any continued use of Oxycodone CR would require medical documentation and diagnosis of “severe” pain.

The Opioid Medication Crisis

William F. BellNearly15,000 people die each year from overdose of prescription medications (CDC Vital signs 2011). Deaths attributed to prescription drug overdoses are America’s fastest growing drug-related problem and outnumber deaths from both heroin and cocaine, combined. The problem has no boundaries.  Each day, it seems, we hear about another celebrity death from prescription medications. We may even have family and/or friends who have been personally affected by the abuse of prescription medications, especially opioids.

One sobering statistic is that the United States of America represents only 4% of the total world’s population; however, the U.S. consumes close to 80% of the world’s opioid supply. To put that into perspective, the CDC report states that “Enough prescription pain killers were prescribed in 2010 to medicate every American adult around the clock for a month.” Hydrocodone/APAP is routinely in the top five of medications dispensed yearly by pharmacies, accounting for 132 million prescriptions annually. The workers’ compensation arena is not immune to this epidemic, as the use of opioid medications is at an all-time high in the industry.

There have been many blog postings and articles on effective ways to reduce opioid use in workers’ compensation cases advocating education, along with prescription drug monitoring and control. This is a good first step. We have seen REMS introduced as a way to educate physicians, patients, and other healthcare providers on the risks and benefits with these types of medications. Many states have now adopted prescription drug monitoring programs to electronically track prescriptions with the goal to decrease “Doctor shopping” and filling at multiple pharmacies. Recently, the DEA suspended the licenses of a major wholesaler and pharmacy chain due to the excessive quantities of opioids dispensed. As a practicing pharmacist, I applaud states that decide to develop comprehensive prescription drug monitoring programs (PDMPs). This is long-overdue and should prove beneficial moving forward.

Last year the White House released a paper entitled, “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” The report cited more statistics quantifying the problem and offered four main areas that could help to solve it: Education, Tracking and Monitoring, Proper Disposal of Medications, and Enforcement.  I recommend that you read the report.

Healthcare professionals must be held accountable during this crisis, as well. Physicians have a responsibility to properly prescribe medications and pharmacists have the duty to properly fill those prescriptions, while ensuring that a patient’s health is not compromised and the physician order is appropriate.

The inaugural National Rx Drug Abuse Summit will be held in Orlando, Florida next month. The purpose of this summit is to bring together experts in the healthcare field to discuss this problem and effective ways to solve it.  My next blog posting will report on this conference and the results of it.

There is a long ways to go in workers’ compensation with the prescription drug issue. Recognition of this problem is a good first step to achieving long-term goals and solutions. It is my hope that both awareness and education are instrumental in curbing inappropriate opioid usage which can lead to preventable death.


About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC.  His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.

Carisoprodol to Receive Federal Controlled Status

William F. BellOf all the medications utilized in Workers’ Compensation claims, none has the abuse potential of Carisoprodol. Known by its brand names Soma or Soma Compound, Carisoprodol is a skeletal muscle relaxant FDA indicated for the relief of acute, painful musculoskeletal conditions in adults.[1]

On the market for close to 50 years, Carisoprodol is available in 250mg and 350mg tablets, along with a 200mg tablet in combination with aspirin and codeine phosphate. The abuse potential  exists because of the way Carisoprodol is metabolized in the body.  It may cause an individual to become addicted.

For this reason, on December 12, 2011, the Drug Enforcement Administration (DEA) issued a final ruling on the status of Carisoprodol making it a Schedule IV controlled substance effective January 12, 2012. Already classified as a controlled substance in 17 states, this ruling will make Carisoprodol a scheduled medication in all other states for which specific handling and dispensing rules must be followed.

When this ruling takes effect in January 2012, some of the changes which will occur include:

  • New and refill prescriptions of Carisoprodol must be treated as a controlled substance, impacting the number of refills which can be authorized at one time.
  • All facilities handling and dispensing Carisoprodol must include it on every controlled substance inventory.

What this means is that Carisoprodol has been identified as a medication with an abuse potential. Classifying Carisoprodol as a Schedule IV controlled substance may allow for lower utilization, which in turn may result in alternative, non-addicting medications (Tizanidine/Baclofen) to be used appropriately and with better clinical outcomes.

About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Gould & Lamb is a global leader of MSA/MSP Compliance Services in the country, serving domestic and international insurance companies, third-party administrators and self-insured entities.


[1] Facts and Comparisons Online. Carisoprodol. Wolters Kluwer Health, Inc. 2008.

Workers’ Compensation Medicare Set-Aside (WCMSA) – Prescription Drugs Challenges

William F. BellCarriers face enormous challenges when attempting to settle cases with Workers’ Compensation Medicare Set-Aside (WCMSA) arrangements.  Currently, one of these challenges is the appropriate use of prescription medications and their proper allocation. The Center for Medicare and Medicaid Services’ (CMS) operating memo of April 2009 changed the entire landscape as we know it, especially with regard to the management and allocation of prescription medications.

CMS Decisions Regarding Prescriptions Drug Therapy

I travel across the country educating carriers, attorneys, physicians, Workers’ Compensation judges, and even a state senator about these changes and how to best handle the ever-rising prescription drug costs and utilization in a WCMSA in the hope of a favorable decision by CMS.

A recent audit by Gould & Lamb has found that in a six month period, CMS has agreed to an alteration of prescription drug therapy that resulted in approval for nearly 51% of the submitted files. Considering how the April 2009 memo changed everything with Part-D allocations, this is very encouraging. Could it be the realization by CMS of inappropriate drug therapy, contraindications, or other factors which account for these approvals? Or, could it once again show the value of Pharmacists as a member of the multi-disciplinary approach to WCMSA?

Value-Added with Pharmacists Involvement

Some may say that use of a Pharmacist in WCMSA reviews is both useless and senseless. As the Senior Clinical Pharmacist for Gould & Lamb, I differ with this notion.  Pharmacists bring a unique perspective and training that is a valuable asset to both carrier and organization alike. Who can best explain whether a medication can be identified as off-label, compensable, or contraindicated as part of a claimant’s long-term drug regimen? Who can best engage the prescribing physician in dialogue concerning the long-term impact of a claimant’s pharmacotherapy regimen?

For many Pharmacists, daily responsibilities center on both off-label review and Part-D allocations, while they spend hours reading medical journals, and presenting relevant pharmacy information to keep those involved with WCMSA educated and informed on the ever-changing Part-D rules.

As prescription utilization continues to escalate in the Workers’ Compensation industry, carriers will continue to rely on Pharmacists for guidance and recommendations on how to best handle rising costs and cost-containment strategies in order to settle claims.

Handling WCMSA Through Multi-Disciplinary Approach – Best Solution

As the favorable decisions from CMS continue, it is prudent for carriers to use a vendor with the proper professions on staff, including Pharmacists.  WCMSA are best handled through a multi-disciplinary approach that involves input and skill from many different professions, not just pharmacy. Although Part-D represents a huge slice of the total MSA allocation, other disciplines are needed as well to ensure both the appropriateness and accuracy of them.

Don’t listen to the nay-sayers!  Pharmacists will continue to play an important part in WCMSA reviews. As a licensed pharmacist for close to twenty years, I cannot give you legal advice, but I can give you pharmacy advice. You wouldn’t go to an accountant to fill a prescription, would you??


About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers’ Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.

Generic Medications and the Struggle with “Dispense as Written”

Generic Medications Translate to Potential Medical Savings

William F. BellIt’s hard to escape the news these days… debt ceilings, tax hikes, and targeted spending cuts. Cost of living expenses continue to increase at an alarming rate and we all search for ways to trim our own budgets or look for less expensive alternatives.

A potential bright side, which may affect millions of people everyday and their pocketbooks, is the anticipated arrival of generic medications for seven of the top 20 best-selling medications (Chain Drug Review 2011).  As mentioned in a prior blog, use of generic medications is a key way carriers can contain their overall drug spending and pass it down to the consumer through lower co-pays and affordability. Lower cost for generic medications can also lead to better adherence rates, resulting in decreased hospital stays and unnecessary medical costs as financial barriers commonly seen with brand name medications are eliminated.

Over the next 16 months, generic medications will become available for Lipitor (Atorvastatin), Clopidogrel (Plavix), and Risperdal (Risperidone). Over the next 2 years, Esomeprazole (Nexium) and Celecoxib (Celebrex) will also become available as generic medications. Approximately 100 current brand name medications will lose their patent protection and market exclusivity (Medco Health Solutions) over the next decade. With average prices ranging from $72 for generics to roughly $200 for brand name medications (Wolters Kluwer), the potential savings are a welcome sign of relief for both payers and cash-paying consumers.

These are just a few of the medications that will lose patent protection; all are likely to impact total workers’ compensation costs. As Part-D costs are projected over a lifetime when preparing a Medicare Set Aside (MSA), allocating a lower generic cost when one did not exist previously can have a significant impact on the settlement as well as potentially lowering other medical costs. Thousands of dollars can be saved through the use of generic medications when settlement was impossible due to high cost-brand name medications in a MSA.

Financial Implications of “Dispense as Written” Designation

No savings will be realized, however, unless physicians and patients allow for generic substitution of prescription medications. A study conducted by researchers at CVS Corporation, Brigham and Women’s Hospital, and Harvard University concluded that when physicians and/or patients demand a brand name medication to be dispensed through a “Dispense as Written” designation, overall costs to payers rise dramatically. The clinical research study by lead author William Shrank titled “The Consequences of Requesting Dispense as Written” examined some of the financial implications of brand name dispensing when generic medications exist.

Although each state has its own generic substitution laws, refusal by a patient at time of fill or a “Dispense as Written” designation by a prescribing physician cannot be superseded by the aforementioned state substitution laws.

Some of the highlights of the study included:

  • A reduction of approximately $7.7 billion in costs to the overall healthcare system if generic medications were dispensed in lieu of brand-names.
  • One out of five physicians who write prescription medications indicate “Dispense as Written” with no generic substitution allowed was due to a negative perception of generic medications.
  • Approximately 2% of all prescriptions are filled with brand name medications due to patient refusal.

What can be learned from all of this?

  • Ultimate payers of workers’ compensation pharmacy expenses should work closely with their respective Pharmacy Benefit Manager (PBM) to ensure they are maximizing generic equivalent potential.
  • If physician requested or patient requested brand name medications are dispensed, the PBM should communicate with the physician or patient to determine the exact reason why a generic medication was refused.
  • Payers should be familiar with their state specific generic substitution laws and understand common medications which have generic medication equivalents.

If there is to be any sort of approach to the ever-increasing workers’ compensation costs, the dispensing of generic medications will continue to be at the top of the list of any cost-containment strategy.


About the Author: William F. Bell, Jr. is the Senior Clinical Pharmacy Specialist for Gould & Lamb, LLC. His primary responsibility is the review of a claimant’s pharmacotherapy regimen and the identification of off-label medications in a Medicare Set Aside Allocation.  He has given numerous presentations on the subject of medication management and how it relates to Workers Compensation and Medicare Set Aside Claims.  Bill has also authored two continuing education articles for the Pharmacist’s Letter, a nationally known education resource for practicing pharmacists.