Two strategies are routinely sought after in healthcare: positive clinical outcomes for the patient and controlling the costs.  The proper use of generic medications is one way to manage costs. Another way costs can be controlled, while simultaneously achieving positive clinical outcomes, is through the use of Over-the-Counter (OTC) medications.

Controlling Costs with OTC Medications

Because OTC medications do not require visiting a physician or a physician’s prescription, the cost of going to a doctor’s office is eliminated and there is greater and easier access to the medications. Over the last two decades, the notion of “self-care”, a program where the patient can treat conditions they normally would not due to perceived barriers, such as socio-economic factors or the inability to see a physician, has increased. The greater access to OTC medications to treat conditions prevents unnecessary ER or hospital visits, thereby allowing physicians to focus their time and energy on more serious conditions.

A recent study released by the Consumers Healthcare Products Association (CHPA) concluded that for every $1 spent on an OTC medication, a $7 in savings to the overall healthcare system is realized.

Potential Savings Recognized in Workers’ Compensation Cases

In the Workers’ Compensation insurance sector, use of OTC medications is an under utilized standard of care and makes good sense. Factors such as the lack of formulary management allow for the prescription version of OTC medications to continue to be prescribed with the payer ultimately absorbing the costs. As an example, the chart below illustrates the AWP for two common GI medications and the potential savings as measured against the OTC version. We see these medications commonly prescribed in the Workers’ Compensation industry secondary to NSAID usage (Meloxicam, Ibuprofen) or with opioids (Hydrocodone/APAP) to alleviate upset stomach or other GI effects.

*AWP based on 30 day supply. BC/BS Michigan Pharmacy Sheet.

Although this may not seem significant or substantial, use of an OTC medication to take the place of a prescription can yield substantial savings to a Workers’ Compensation Medicare Set-Aside and could make the difference between settling the file or having to keep it open.  Keep in mind, both Omeprazole and Lansoprazole are not indicated to be utilized for chronic periods. Thus, it makes sense to utilize OTC versions of these products once or twice yearly as opposed to funding a Workers’ Compensation Medicare Set-Aside monthly for the prescription versions.

In today’s Workers’ Compensation claims handling setting, each and every dollar must be managed appropriately. OTC medication utilization is one way that Part-D allocations can be significantly reduced and properly funded in a Workers’ Compensation Medicare Set-Aside, providing both positive outcomes while being cost effective as well.

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.

Of 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.

• Refills will require physician evaluation and follow up every six months.

• 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.

Carriers 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 Translate to Potential Medical Savings

It’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.

As I travel across the county speaking to clients on prescription medications and how they affect Medicare Set-Aside arrangements, I am invariably asked “Why are there so many Pharmacies being built?” Many different reasons can be given, from access to care, competition, economics, to even the prominence prescription drug medications play in the United States Healthcare System. In 2009, prescription drugs sales topped $300 billion dollars (IMS Health).

On the flip side, however, is the dark side and opposite intentions prescription drug medications create. One only needs to do a Google search to find all kinds of stories on the crisis our communities face today concerning the increasing drug abuse and accidental deaths through overdose with prescription medications. The one story I read with the most shock is that 1 person from Staten Island, New York dies every 13 days due to a prescription drug overdose, with opioids as the leading cause (NY Dept. Health/Mental Hygiene 2011). Recent deaths of celebrities Heath Ledger, Michael Jackson, and Anna Nicole Smith, have put the spotlight back on this “hidden” problem.

Recently, the White House released a report entitled “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.” The report acknowledges that prescription drugs are the second most-abused category of drugs after marijuana and that 70% of abusers are not those for whom the original prescription was written for. As opioids are very prominent in the worker compensation arena, these issues are of concern. The report also cites four areas that can potentially reduce abuse. These areas include education, monitoring, proper disposal, and enforcement.

Although this report is encouraging as potential solutions to the problem are addressed, it still comes with many questions and concerns. Think about this- the United States of America represents ~ 4% of the world’s total population, and consumes ~ 80% of the world’s opioid supply (Sciame 2010). Where do we start in all of this?

As a practicing healthcare professional, I agree with the notion that more education is an important first step. The Risk Evaluation and Mitigation Strategy REMS is a plan which arose from the Food and Drug Administration Amendments of 2007 for biologics or drugs which pose a safety risk to the general public. The REMS program was designed to allow patients continued access to medications, while lowering the potential to abuse, overdose, misuse and addiction.

Maybe the economics of medications is a prescription for a dilemma. Will programs, such as REMS, actually curb inappropriate drug use and subsequent deaths or create a barrier for those who truly need medications? Can states, such as Florida, impose some strong language and regulation to stop “pill mills” or can electronic drug monitoring programs help curtail diversion and misuse?

Prescription drug abuse is a dilemma all healthcare professionals and medical boards must recognize. However, there is some light at the end of the tunnel and one worth watching in the months and years to come.