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9 Key Factors for Drug Formularies

These remarks were prepared for testimony at a recent Assembly hearing in Sacramento on California’s consideration of a workers’ comp drug formulary.

Thank you for the opportunity to be part of this hearing on the potential development of a prescription drug formulary in California. My name is Mark Pew, senior vice president of PRIUM, a nationwide medication management company based in Duluth, GA, that has conducted business in California for more than 15 years and been a utilization review organization since 2009. I have followed the development of workers’ compensation drug formularies in other states since 2010 and, through observation and dialogue and corresponding deployment of services, have come to identify success criteria. I spoke on the subject at the National Workers’ Compensation and Disability Conference in November 2012 and at that time opined that California should consider a drug formulary. Since 2013, I have had several conversations with various California stakeholders to further that discussion, so I’m very pleased to see progress being made towardsthat goal.

Because I value the time of this committee hearing, I will be brief in what I consider to be important foundational tenets when constructing a drug formulary. I will forego any statistics or rationale for a drug formulary as that has already been well articulated in the bill’s analysis.

  1. A drug formulary should be about better patient clinical outcomes, not cost. My opinion is that if you do what’s right for the patient, all other stakeholders win by side effect. While much of the discussion leading up to this hearing has been about cost savings, it would be shortsighted to think that should be the criteria for success. In my opinion, true success from a drug formulary would be a decrease in disability, a decrease in addiction and dependence, an increase in return-to-work and an increase in the use of less dangerous treatment options. If the focus is on better patient clinical outcomes, there should be no stakeholder in California workers’ compensation that can argue that this isn’t a good thing.
  2. A drug formulary should rely on evidence-based medicine. Robust clinical studies that indicate what drugs should be used when, and what non-pharmacological treatment options should be tried in advance, should dictate which drugs require additional evaluation before prescribing. There are some very dangerous drugs that are generic and inexpensive, so the trigger should be what produces the best clinical outcomes in proper sequence. Step therapy, the idea that you start with the most effective, least dangerous option, is built into evidence-based medicine and should be the template for prescribers. The optimal approach to evidence-based medicine is the adoption of third-party, peer-reviewed standards that are regularly updated to reflect contemporary medical practice standards.
  3. A drug formulary should not handle new and legacy claims in the same manner. By “legacy claims,” I mean those claims that exist before the formulary rules come into effect. A patient taking his first opioid is different than a patient who has taken opioids for many years. While new claims require primarily process education for the stakeholders, there should be a remediation period for “legacy” claims to allow time for appropriate weaning and development of alternative treatment methods. Based on my observations, there should be a one- to two-year period between the rollout of a drug formulary for new claims vs. “legacy” claims. Both implementation dates should be unchangeably enforced to ensure action is taken. To be clear, any formulary that applies to new claims should also apply to legacy claims, albeit at a later date. Not applying the formulary to legacy claims would result in two different standards of care for injured workers in California depending on when the worker was injured. This is clinically inconsistent with the application of evidence-based medicine.
  4. A drug formulary will change prescribing behavior. The extra steps required for a drug that is not allowed by the formulary requires the prescriber to think through the best options as opposed to just maintaining past practice patterns (however they were developed). For example, if carisoprodol was excluded from the formulary, the prescriber either needs to validate the medical necessity through a preponderance of evidence or choose a muscle relaxant that is included (which likely means it has less dangerous side effects, has proven to be more effective for certain conditions and does not have dangerous drug-to-drug interactions). Given experience in other states, the prescriber will often choose the less dangerous drug included in the formulary, which should result in better clinical outcomes for the patient.
  5. A drug formulary should be enforced at the point-of-sale. Allowing drugs to be given to the patient and THEN deciding whether they are clinically appropriate allows the start of a potentially dangerous path to polypharmacy regimens that create more harm than good. A workers’ compensation drug formulary, just like those we see in group health plans, should be implemented at pharmacies within their point-of-sale system. The information provided to pharmacists will help them better communicate with the patient and prescriber as necessary for an option that is allowed by the drug formulary. One advantage for California is that pharmacy benefit managers (PBMs) and pharmacy chains already have experience with implementing a workers’ compensation formulary in other states. If California is modeled after that same process, there should be less up-front time required to develop processes for California.
  6. A drug formulary should be the result of consensus among all stakeholders. While reaching consensus takes longer, providing a seat at the table for every workers’ compensation stakeholder in a very transparent process will ensure a smoother implementation. It’s extremely important to the ultimate success of a drug formulary that everyone be part of the deliberation process. And if everyone is involved in developing the drug formulary, ultimate implementation will be more easily achieved. A point of clarification: while the process surrounding the drug formulary should be based on stakeholder consensus, the medical treatment guidelines upon which the formulary is built should NOT be based on consensus, but rather on the best contemporary medical evidence available. California stakeholders should focus negotiations on the rules governing the formulary, not on the medical principles that underpin it.
  7. A drug formulary should educate all stakeholders clearly and consistently. Clear (and free) education needs to be provided to all prescribers, all attorneys, all payers, all employers and preferably all injured workers as to how the drug formulary was constructed, how it will be implemented and how best to comply. Preferably, this would be led by the Division of Workers’ Compensation. This education should not stop in the lead-up to implementation but should continue in a feedback loop during and after to ensure that issues are identified and resolved quickly.
  8. A drug formulary should be simplified for ease of implementation. States with workers’ compensation drug formularies have made the choice of drugs relatively binary. For instance, a drug may be classified as one that is recommended for first line therapy (“Y” drug) or a drug that is not recommended as first line therapy (“N” drug) and should not be used unless it has been reviewed and approved by a second clinical opinion. The definition of what is and is not included in the formulary should not be narrative or interpretive, but something easy to read and — more importantly — to program into pharmacy benefit management (PBM), utilization review (UR), independent medical review (IMR) and bill review systems.
  9. Drug formulary rules should include a well-defined dispute resolution process and expedited appeal process. The goal of a closed formulary is to ensure that there are safeguards in place to prevent unnecessary medications from being dispensed to injured workers. The exclusion of a drug from the formulary (for example, an “N” drug) should not mean it cannot be utilized, only that the prescriber should be required to validate its medical necessity vs. drugs that are included. California obviously already has that infrastructure, which is why I felt in 2012 that California was a candidate for a workers’ compensation drug formulary. The onus should be on the prescriber to provide necessary evidence as to why this particular drug is required for this patient at this time. If that can be established, then that drug should be allowed to be given to the patient.

If the above steps are taken and appropriate time is given for their completion, a properly constructed and implemented drug formulary in California should result in cost savings to the system. The primary savings will emerge over time as fewer and fewer of California’s injured workers are lost to dependence, addiction and overdose. The ability to settle and close claims more quickly will be a positive result for both employers and employees.

A workers’ Compensation drug formulary could have a lasting and significant change in how prescription drugs are prescribed in California. I truly believe that by making everyone in the system think before prescribing, the injured workers will receive better care, and stress on the workers’ compensation system in California will be reduced.

I would enjoy being a continued resource to this committee as deliberations evolve. Thank you again for the opportunity to be part of this hearing.

Guidelines for Marijuana at Work

ACOEM/AAOHN recently published some guidance for employers on how to deal with the rapidly expanding legalization of marijuana in individual states across the U.S. that I believe are very important and that I wanted to share.

Because “presence” — having marijuana-related chemicals in the worker’s body — does not necessarily mean impairment, and presence lasts a lot longer than impairment, there is a conundrum on how to deal with workplace injuries and on what safety policies to enact to prevent injuries.

Many legal issues arise because individual states have policies around medical and recreational use (related to age, amount, location, etc.) that are inconsistent with cannabis’ illegal status at the federal level.

So we all need to be thinking about the issues. To quote myself from an article on Lexis-Nexis: “I personally think this should be required reading by general counsel and human resources at every employer, especially in states where legalization has already occurred but even for those where it isn’t, because it’s coming. Clear and proactive policies are absolutely required, and those can only be created by knowing every aspect of federal laws and their intersection with individual state laws (and not just your state, but surrounding states). To quote Facebook, ‘It’s complicated.’”

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The Right Way to End Opioid Addiction

Psychosocial issues can influence chronic pain just as much as the biologic damage from an injury. Job or financial concerns, depression and anxiety, feelings of helplessness, family problems, enabling environments, substance abuse,and past physical or sexual abuse top the list of factors contributing to extended disability. Yet, workers’ compensation has traditionally downplayed psychosocial impacts on the claimant’s motivation to get better and focused instead on “medicalizing” treatment through physician visits, surgery, chiropractic care, a round of physical therapy and especially drugs that, ironically, often make the situation worse.

About 19% of the medical cost of a workers’ compensation claim goes to pharmacy, and a disproportionate amount of those drugs—between 21% and 34%—are opioids. Although neither the Food and Drug Administration (FDA) nor any other treatment guideline recommends opioids for long-term chronic pain, 55% to 86% of claimants are taking them just for that, according to the white paper “Opioids Wreak Havoc on Workers’ Compensation Costs,” published by Keith E. Rosenblum in August 2012.

Its research also found that one-third of claimants who start taking opioids are still on them after a year. Studies show that claimants who take opioids longer than 90 days are not likely to return to work. Patients using prescription painkillers for a long time typically suffer side effects, such as opioid-induced constipation, and experience related diseases such as kidney or liver damage from non-steroidal anti-inflammatory drugs.

There also are side effects from the medications prescribed to combat the side effects of the original prescriptions (for example, Nuvigil often is prescribed to wake patients from over-sedation). Ironically, opioids themselves can create an increased sensitivity to pain (hyperalgesia), thereby feeding the exact problem they are designed to solve. There needs to be a better way.

Behavioral Therapy

All patients bring psychological baggage—both good and bad—to their workers’ compensation injuries. Self-motivation, discipline, self-esteem, a sense of entitlement or victimhood, addictive behaviors and a true desire to get better are factors in recovery.

Some claimants recover and return to work with medical treatment alone; many do not. Claims with unaddressed psychosocial issues are the ones that go off the tracks, drag on for years and pile up costs. In workers’ compensation, “psych” is a four-letter word, but, unless you consider it in the treatment plan, the chances of full restoration are reduced.

Workers’ compensation is just beginning to venture into the psychosocial realm with cognitive behavioral therapy (CBT) to address opioid addiction. CBT’s use is fairly new because of the deep-seated, industry-wide phobia of owning a psych claim. Payers fear never-ending psychiatrist visits and a new set of drugs and costs likely to accompany a psych diagnosis.

However, CBT is not the same as traditional psychotherapy. It is a psychotherapeutic treatment tool that does not produce an additional diagnosis. Plus, CBT is surprisingly affordable. Provided in-person or telephonically—both requiring extensive “homework”—it is usually limited to eight to 12 visits at $100 to $150 per visit. In many cases, a payer’s total investment in CBT is less than the claim’s monthly drug spending.

The science and success of CBT are still evolving, but some studies and anecdotal outcomes show that it is a helpful tool, both in workers’ compensation and the healthcare industry in general. The focus is on patients who seem stuck in their treatment plans. CBT works on the concept that a person’s thoughts are the primary cause of that individual’s behaviors and feelings. Thought patterns—not circumstances, events or other people—dictate the individual’s motivation and sense of well-being.

A psychologist or other therapist asks questions and poses statements to help patients open up and self-identify the psychological elements standing in the way of their recovery. In that way, CBT gets to the root of motivation issues. Some claimants hate their jobs or bosses and consciously or subconsciously resist returning to work.

Family members can be motivation-killers and enablers, as in a case where a claimant took so much Celebrex that he developed cirrhosis of the liver. He and his doctor wanted to reduce his opioid intake, which also was damaging his liver, but his wife resisted. She said he was easier to manage when sedated and had to be convinced that he would die prematurely before she acquiesced.

The belief that “I don’t deserve to feel better” churns the cycle of pain for some. Many pain patients have low self-esteem that stems from any number of factors, including: hyper-critical parents, absent or neglectful parents, past sexual or physical abuse or other traumatic experiences.

The goal of CBT is for the patient to self-identify the issue through prompting by a professional and then correct fundamental errors in thinking, such as victimization, generalization or catastrophizing.

To be clear, CBT does not cure motivation problems. Instead, this “talk therapy” helps patients identify barriers to recovery and replace negative thoughts with positive, empowering ones.

Functional Restoration

While CBT is provided as a standalone, it also figures prominently in functional restoration programs (FRP), which help patients work through psychosocial issues while detoxifying and participating in physical therapy and other exercise programs that increase their physical activity and capability.

The whole functional restoration process enables individuals to acquire the knowledge and skills to make the behavioral changes needed to take primary responsibility for their own physical and emotional well-being after an injury. The ultimate goals of FRP and CBT are to implement lifestyle changes that will last a lifetime and manage pain.

A functional restoration clinic should be multidisciplinary, preferably with an addictionology, orthopedic or pain management and rehabilitation (PM&R) specialty, a psychologist and licensed physical therapist acting as a team to customize and coordinate treatment for the patient. Other treatments such as yoga, chiropractic and biofeedback also can be included, along with services like vocational counseling. The best programs involve between 120 and 160 total hours of therapy.

An initial assessment should predict the person’s anticipated compliance, and the better functional restoration clinics have high denial rates (50% or more). Applicants may not be in good enough health, or they may lack the motivation to change. There’s no point in spending $30,000 on a program if the claimant refuses to work or accept responsibility for his health and outcomes. A pre-emptive CBT program can help weed out unmotivated patients.

Vital signs and physical capabilities need to be measured and objectively managed, and a baseline should be taken upon admission, followed by daily to weekly measurements and adjustments. Following patients upon discharge is just as important. Best practices show one year of follow-up, by telephone or in-person, achieves the best results in cementing lifelong change. Without consistent encouragement and personal instruction, claimants may relapse and turn back to drugs.

When selecting an FRP, access to an inpatient program or a strong alliance with a hospital or other inpatient detox facility can be critical. It cannot be overstated how vital the appropriate venue for detoxification is to overall success. Often, the treating physician who prescribed the drug cocktail in the first place is ill-equipped to develop a discontinuance strategy or provide the clinical oversight needed to wean patients off the drugs. Initial inpatient care may be needed if respiratory depression or cardiac issues could significantly complicate the weaning process.

Power of Yoga

Many functional restoration programs offer yoga, an interesting combination of physical and mental/emotional exercise. Studies show that it improves flexibility, strength and balance on the physical side. Its focus on “centering” helps participants calm their minds and relax their bodies, relieving pain and giving them an empowering sense of control.

An Austin, Texas, clinic saw such a positive response to its once-a-week yoga class that it expanded it to five days a week. Not only was patient satisfaction high, but overall functional outcomes improved. Patients say it helps them cope with pain, improves flexibility and increases their functionality, and they plan to make it a permanent part of their lifestyle. Yoga by itself is typically not sufficient, but incorporating it into the multidisciplinary functional restoration strategy can yield very positive results.

A holistic pain management approach can get runaway claims back on track. Weaning a claimant off an opioid-laden cocktail, which often does much more harm than good, is a great thing. Stopping the financial losses on a claim is a great thing. Returning a clear-headed, self-directed employee to work is a great thing.

Adjusting Mindsets

The focus of workers’ compensation, when it was originally created more than 100 years ago, was to return an injured worker to health and function and work as quickly as possible. Historically, it has been an insurance function; after all, workers’ compensation is part of the property/casualty industry. However, over time, workers’ compensation became part of the healthcare industry because restoring function and health is entirely related to the competency of the clinical and psychological strategies employed.

As evidence mounts that patient motivation is vital to actual recovery, it’s time for another transition from a “medicalization-only” mindset to a holistic approach that takes into account all the variables that affect recovery. It’s time for all stakeholders within the system to think more broadly and be open to new concepts that comply with best practices and correspond with treatment guidelines.

In other words, maybe the injured workers are not the only ones who need to have their motivations adjusted.

 

SIDEBAR

Prevention Is Key

Keep claims from going off track in the first place by having treating physicians conduct risk management before prescribing opioids. Some questions include:

  • Has there been past substance abuse?
  • Is the patient receiving narcotics from other physicians?
  • How many other physicians are prescribing medications?
  • Is there depression or anxiety involved?
  • Did the claimant experience sexual or physical abuse (a prime predictor of addictive behavior)?
  • Will the patient submit to random urine drug tests?

Additionally, there are a number of screening tools to identify potential drug dependency and addiction. Some examples include:

  • For prior substance abuse: Diagnostic Criteria for Substance Dependence – DSM-IV from the American Psychiatric Association
  • For potential addiction/dependence issues: Opioid Risk Tool (ORT) or Screener and Opioid Assessment for Patients with Pain  (SOAPP)
  • For depression: Patient Health Questionnaire (PHQ-9)
  • For general psychological analysis: Minnesota Multiphasic Personality Inventory (MMPI)

Unfortunately, most payers do not have a mechanism for reimbursing physicians for conducting a detailed risk analysis. This needs to change. Payers could assign a CPT code for physicians to use to conduct a thorough risk analysis. Spending a few hundred dollars up front can save hundreds of thousands of dollars on a long-term, opioid-laden claim. The assessment would also shed light on the physician’s capabilities to manage a chronic pain situation.

Redefining Detox in Workers’ Comp

When most people in workers’ compensation hear the term “detox” they think of chemical detox, the process of removing or reducing the prescription drugs patients are taking to deal with their pain. Indeed, injured workers on drug regimens with questionable clinical efficacy (low function, low quality of life) need to go through a process to lower the dosage and number of drugs they’re taking or eradicate them entirely. Chemical detox can be very complicated; a benzodiazepine like Valium or Xanax can take as long as 18 months to wean and should typically be the final drug weaned because of how this category of drugs complicates the medication regimen and causes side effects. Methodone or Suboxone might be added to help facilitate the weaning, but they come with their own issues — significant clinical complications for Methodone and becoming a long-term maintenance drug for Suboxone.

However, if you think of detox only as a chemical weaning process, you can miss the most important component in affecting permanent change: the psychosocial aspect. Removing dangerous drugs without any plan for addressing how claimants can physically and mentally cope with their pain can lead to relapse.

Folks in the functional restoration field say that 75% of patients remain off 75% of their original drugs after 12 months if they are involved in a best-practices clinic. I’ve researched this issue over the past two years, visiting many detox and functional restoration programs. Functional restoration and detox facilities are not created equally, and not all physicians are knowledgeable or proficient in weaning.

I am absolutely convinced that best practices involve an interdisciplinary treatment approach. If you do not have a team composed of a licensed MD/DO to manage the medical and addiction issues, a licensed physical therapist to increase function, flexibility and stamina and a licensed psychologist to address psychosocial issues, the injured worker won’t make all the behavioral and mental changes required to stay off inappropriate drugs.

Work comp is deathly afraid of a psych-compensable diagnosis because it can open doors well beyond vocational, but we cannot ignore what happens in a patient’s conscious and subconscious mind. If you ignore the psychology behind addiction and dependency and neglect to address things like low self-esteem, catastrophizing and perceived injustice, the patient isn’t likely to truly and permanently change. Two to three months after being discharged as clean, the patient is likely to resume old habits of overusing or abusing prescription drugs. Relapse may also occur if the patient fails to learn non-pharmacological pain-coping skills like yoga, Pilates, stretching and other physical exercise.

It is tempting to try to close a claim upon receipt of a clean discharge from a detox facility. After all, the drug regimen will look as good then as it ever will, and it would be naïve to think that isn’t a driver in some cases. But if the goal is to truly restore claimants to as close to pre-injury condition as possible for the long term, do your homework on those conducting the weaning and take into consideration the body-mind connection.

Redefining Success

Redefining Success in Workers’ Comp

As is often said, beauty is in the eye of the beholder. To me, that means your personal context colors your perspective; similar people can look at similar circumstances and reach dissimilar conclusions. In workers’ comp, that axiom applies to “success.”

Various stakeholders define success differently. To an injured worker, success could be regaining health to his or her pre-injury state while building a retirement nest egg. To a treating physician, success could be restoring health to the patient at a fair price. To an employer, success could be the quick and safe return to work of a colleague that does not raise its workers’ comp premiums. To a carrier or third-party administrator (TPA), success could be the proper management of a claim that yields a satisfied customer while maximizing profit. To an attorney representing the injured worker, success could be maximizing the financial payoff for the client and the law firm. To a vendor (pharmacy benefit manager, bill review, utilization review, transportation/translation or surveillance company), success could be providing services that provide recognized value to a customer.

In some cases, the definition of success can be both positive (appropriate services for a fair price) and negative (maintaining the revenue stream through means that might be inconsistent with “appropriate services” or “fair prices”). It is the business conundrum in workers’ comp – how to balance the need to provide appropriate services with the need to stay financially viable in a system that sometimes rewards the latter more than the former.

Let’s simplify what true success is for workers’ comp: restoring the health of the injured worker and settling the claim efficiently.

Realistically, the worker might not be restored fully to pre-injury health, but regaining as much as possible is certainly the goal. When it comes to managing chronic pain that will likely never completely go away, good treatment can be inadvertently sabotaged by issues of tolerance, dependence and addiction. The prescription drug abuse epidemic illustrates that the outcome of overtreatment and inappropriate treatment can often create more problems than it resolves.

For those who have received inappropriate treatment with sub-optimal results, success may be less about a full return to health and more about a return to some level of function. That could be something as simple as taking 500 steps a day (thewalkingsite.com offers guidelines for 10,000 steps a day). Maybe return to work is no longer viable, so success is now more about being a meaningful member of family and community. Maybe detoxification is appropriate, but abstinence is not attainable, so finding a lower number and dosage of appropriate drugs is success. For those stuck in a cycle of victimization, low self-esteem and poor socioeconomic circumstances, perhaps success is more about acquiring skills to properly cope with pain and change (and life in general).

In other words, maybe success is a lot simpler than we think – if the injured worker wins by regaining health and function, then everyone else wins too.