Tag Archives: prium

The WC Mistakes That States Make

As 2017 gets rolling, state legislatures are convening all over the country. Several of them are about to make mistakes in the area of medication management in workers’ compensation.

My colleague, Mark Pew, and I have written and spoken extensively on the topic of drug formularies. And we’re currently working, formally and informally, with regulators and other stakeholders in jurisdictions across the country on approaches that make sense for employers, doctors, pharmacists and, most importantly, injured workers. While there’s not a lot to be gained for any of us in calling out individual states, there’s a great deal at stake for all of us in the successes and failures of drug formulary implementations. A failure (perceived or real) in one jurisdiction can lead another jurisdiction to delay its own attempt at a formulary — or to scrap it altogether.

So how can we tell if a law or rule set is headed in the right direction? Or, alternatively, if a state’s efforts are more likely to lead to sub-optimal results? Here’s a quick litmus test that you can apply to make your own determination:

1. Will the formulary rely on independent, third-party medical treatment guidelines?

There’s a great deal of industry discussion surrounding this topic, mostly focused on the definition of “evidence-based medicine.” While that conversation is interesting, it’s not the critical factor in overall formulary success. The crucial questions are twofold: First, will there be room for political influence in the formation of the guidelines? Second, will the guidelines be updated with sufficient frequency?

See also: How Should Workers’ Compensation Evolve?  

2. Does the formulary process build off of existing dispute resolution processes?

States that have successfully implemented drug formularies thus far have done so by relying on existing rules regarding resolution of medical treatment disputes. States that try to simultaneously create a formulary and new dispute resolution processes to support it are, in reality, trying to do two things at once. Not impossible, but certainly creates execution risk.

3. Does the formulary allow for a remediation period for legacy claims? 

On the one hand, a single effective date creates chaos as employers and physicians try to figure out how to address legacy claims, which tend to be more complicated. On the other hand, applying new rules to new injuries creates two standards of care within a workers’ compensation system, where an injured worker’s treatment plan is driven entirely by the date on which he was injured (which makes no clinical sense). I look for regulatory language that takes a balanced approach — an initial implementation date for new injuries, followed by a remediation period for legacy claims, followed by a fully effective date for new rules and all claims.

4. Is the formulary process scalable?  

I always look to see if the dispute resolution process can stand up to a significant volume of cases. While the goal of any formulary adoption should be to streamline access to medically necessary medications for injured workers, states should take a “hope for the best, plan for the worst” approach. Dispute resolution processes that rely on one individual or one office for ultimate resolution may lead to bottlenecks and, in a worst-case scenario, undue influence. I always ask myself, what will this look like if there are more disputes than the state expects?

See also: Five Workers’ Compensation Myths

One bad apple can spoil the bunch. Let’s get this right.

The article was originally published here.

The Next Opioid Epidemic: Fentanyl

Fentanyl has been in the news:

In 2014, it began being reported on the U.S. East Coast that heroin was being laced with fentanyl, creating a combination that is “untenably addictive.”

The Sacramento Bee reported in April that 51 overdoses, including 11 deaths, had been reported thus far in the Sacramento area in 2016; toxicologists tied eight of the deaths directly to fentanyl (watch the short video in the article that describes “death as collateral damage” to the drug dealers interested in market dominance).

Later in April, the L.A. Times reported the issue had migrated to the San Francisco area, where fentanyl pills made to look like Norco were a primary culprit.

The chief health officer in British Columbia proclaimed a Canadian public health emergency because of more than 200 overdose deaths during the first three months of 2016; a large portion of them involved “greenish pills purporting to be OxyContin 80 mg tablets.”

In June, it was confirmed that Prince died from an accidental overdose of fentanyl, unbelievable because he was an outspoken advocate of clean living (from having a “swear jar” to not consuming alcohol)

One of the common threads throughout these stories is China’s involvement. The Wall Street Journal published a front-page article on June 23 titled “China’s Role in U.S. Opioid Crisis.” The opening paragraph sets the stage:

Last spring, Chinese customs agents seized 70 kilograms of the narcotics fentanyl and acetyl fentanyl hidden in a cargo container for Mexico. The synthetic opium-like drugs were so potent that six of the agents became ill after handling them. One fell into a coma.

The article goes on to describe how fentanyl often is disguised as hydrocodone and Xanax on the black market — dangerous drugs by themselves but not nearly as potent or fatal as fentanyl. Because China does not regulate fentanyl or analogs used to create fentanyl, there is a significant financial incentive for the drug dealers — $810 of materials can create 25 grams of fentanyl and yield as much as $800,000 in pills sold on the black market.

See also: Opioids Are the Opiates of the Masses

According to the Canadian Globe’s expose on the issue (an excellent look at the black market), accessing fentanyl can be as easy as “Sign up for an account, choose a method of payment, and receive the package in three to four business days.” Reinforcing the financial model: “A kilogram ordered over the internet – an amount equal in weight to a medium-sized cantaloupe – sells on the street in Calgary for $20 million, making it a drug dealer’s dream.”

So, fentanyl is a problem. It’s 25 to 50 times more potent than morphine. It’s highly addictive. It’s available fairly easily on the black market. And it is prescribed by doctors. Way too often.

Approved by the FDA and on script pads supplied by the DEA, its federal legitimacy adds to the lack of stigma associated with use. Which is one reason why I think Prince could rationalize his use. A doctor likely prescribed it for his chronic pain — and other patients fall into that same trap (with fentanyl and other dangerous prescription drugs).

According to the FDA’s own warnings (as reported on drugs.com):

Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Fentanyl Transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.

See also: How to Help Reverse the Opioid Epidemic  

In my opinion, fentanyl should be used to help people die with dignity during end-of-life care. Period. It’s that dangerous. And yet we see it being prescribed, used and paid for.

Month. After. Month.

If you are prescribing fentanyl: Why?

If you are being prescribed fentanyl: Why?

If you are paying for someone’s fentanyl: Why?

Too many people are overdosing and dying not to ask a simple question: Why?

How to Find Jobs in the Insurance Industry

When Elizabeth and Ryan graduated from college, they didn’t have jobs and, frankly, didn’t know what jobs would fit their skills and abilities. Elizabeth was a psychology and history double major who didn’t want to pursue graduate school; Ryan was a biology major, with a minor in chemistry but had no interest working in a laboratory. 

When they applied for jobs, they were like a lot of new grads. Both were bright and motivated, but they lacked an understanding of what value they brought to the workforce and which employers would have an interest in their backgrounds. Further, they had a lot of questions about how to conduct a job search. As CEO of a national firm that hires over a thousand new grads every year, I see stories like this every day.

According to our research, they are not alone. Only about 20% of graduating seniors actively use career services during their senior years. Further, 60-70% of new grads don’t know where their education and skills fit in the workforce. Combine these stats with the fact that over 75% of new jobs are created by employers with 500 or less employees, companies that typically don’t interview at campuses, and it’s easy to see that the entry-level job market is highly inefficient.

Other trends are also having an impact. For example, the larger companies that typically dominate college recruiting significantly reduced on-campus recruiting after the recession. Now, college recruiting is much more targeted, with advances in technology making direct interaction with college students much easier. Initial contacts are often made through social media, and interviews are often completed using video interviewing techniques.

See also: The First Step in Recruiting Millennials

Further, corporate college recruiters are also focused on high-demand majors in computer science, math and engineering or high performers in other majors with high GPAs. They know the majority of college grads can be easily hired through less expensive conventional recruiting methods after they graduate. The net result of all these factors is that fewer than 30% of graduating seniors have a professional job at graduation.

This has led innovators to develop a variety of ways to make the entry-level job market more efficient. From job posting sites targeted on the entry-level to online skills assessment and career counseling to third-party recruiting and placement firms, this market is seeing a high level of activity.

Since new grads typically don’t have direct experience in the positions they are seeking, one way to solve this problem is to match the transferrable (or soft) skills possessed by the candidate with positions that require those same skills. Important transferrable skills include critical thinking, time management, effective communication, leadership and initiative.

Since the beginning of 2012, Prium Inc., a provider of managed care and medical intervention services located in Duluth, Georgia, has used a third-party career matchmaking firm to recruit, interview and select qualified candidates on behalf of Prium for their entry-level positions.

Michael Gavin, Prium’s president, says, “Outsourcing helps take the college recruiting burden off our shoulders. More importantly, it’s incredibly effective for finding the skills and talents we need.”

Prium’s experience underscores the value employers see in the outsourced college-recruiting model. Most small and medium employers like Prium don’t hire in the volume to justify building their own college recruiting programs. Using this approach, positions are filled quickly with highly qualified candidates.

See also: How Colleges Can Work With Insurers  

Since January 1, 2014, candidates from many of Georgia’s great colleges and universities, as well as candidates from other regional and national colleges, have started careers at Prium. For colleges and universities throughout the country, the “matchmaking” model helps them offer their students a proven job search option.

Both Elizabeth and Ryan are thriving in their roles at Prium. Reflecting on being placed at Prium, Elizabeth said, “I never thought I would be working in the healthcare industry, and I hadn’t heard of Prium prior to interviewing. I never would have found this job on my own.”

The labor market is changing rapidly at every stage of the process. Colleges, job-seeking grads and prospective employers all need a more efficient way to evaluate and select the right entry-level hires. Hearing success stories from young grads such as Elizabeth and Ryan show how effective an outsourced college-recruiting model can be in matching great candidates with rewarding careers in industries like insurance and healthcare — careers that most new grads would never consider.

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.

An Argument for Physician Dispensing

A January 2015 Workers’ Compensation Research Institute (WCRI) study that focused on three new medication strengths has again questioned the practice of physicians dispensing medications.  Some analysts argue that the new strengths are designed to skirt price controls and generate exorbitant profits for doctors and drug manufacturers and repackagers. But another explanation is possible: that doctors and drug companies have identified new strengths that patients want. In any case, competition will, over time, drive down prices on the new medications just as it did on ones that have been in the market for a long time.

The study titled, “”Are Physician Dispensing Reforms Sustainable?” prompted Michael Gavin, president of PRIUM, a subsidiary of Ameritox, to write an article titled “Physician Dispensing: I’ve Changed My Mind” on this website. He said: (1) ”that drug repackagers in California created novel dosages of certain medication to evade the constraints of the physician dispensing regulations”; (2) “allowing repackagers to create new NDC codes and charging exorbitant amounts of money for drugs that would have been substantially cheaper had they been secured through a retail pharmacy”; and (3) “Worse, utilization of these medications skyrocketed as a result of the revenue incentives for physicians (my conclusion, not WCRI’s)”.

This article analyzes the Cyclobenzaprine HCL medication, with emphasis on the new generic 7.5mg strength that was reviewed in the WCRI study and cited in the article, “Loophole for Doctors on Drug Dispensing,” that Ramona Tanabe from WCRI wrote for this website.

The 7.5mg Cyclobenzaprine HCL was first made available as a generic by the pharmaceutical company “KLE 2 Pharmaceuticals” ((www.kle2.com). The company’s mission statement reads: “It is our goal to provide new therapies via unique strengths, delivery methods and/or new formulations.” KLE 2 identified a marketing opportunity to meet the needs of those who found that the 5mg strength was not effective enough and that the 10mg was too strong. There is evidence on the Internet of people attempting to split a Cyclobenzaprine HCL tablet to reduce its strength, with limited success.

From late 2011 through early 2013, KLE 2 was the only manufacturer of the generic Cyclobenzaprine HCL 7.5mg strength, which was included in the Medi-Cal formulary and used for California workers’ compensation claims. In April 2013, the manufacturer Mylan released a generic 7.5mg strength, and it was also included in the Medi-Cal formulary. KLE 2 has a Medi-Cal price of $3.2153 per tablet; Mylan, $3.99. The brand name “Fexmid,” by Sciele Pharma, owned by Shionogi, has a Medi-Cal price of $4.4383 per tablet.

Pharmaceutical pricing in the U.S. is unregulated; the more manufacturers there are, the lower the price to the consumer. In the case of the 7.5mg strength Cyclobenzaprine HCL, there are currently only two manufacturers, so the price will remain high until more manufacturers produce this strength or there is less demand for it. The 10mg strength, in comparison, has currently around 17 manufacturers. The average Medi-Cal price for 10mg is $0.1035. The lowest Medi-Cal price is $0.0468, from the manufacturer KVK Tech. (Refer to page 7 of “Understanding Pricing of Pharmaceuticals,” available here under the Dialogue tab, for a Medi-Cal price comparison of 10mg Cyclobenzaprine HCL).

The 5mg strength is manufactured by about 11 pharmaceutical companies. The average Medi-Cal price is $0.1586 — that is down from Mylan’s price of $1.3616 in 2006. The current lowest Medi-Cal price for a 5mg strength tablet is $0.0468, again from KVK Tech.

I mentioned earlier that attempts to split either a 5mg or 10mg tablet in half have not been successful. It has been well documented that the coating applied to the 5mg and 10 mg Cyclobenzaprine HCL tablets does not allow them to be easily cut, regardless of the device used. The opportunity therefore for cutting a 5mg in half to take 1½ tablets of 5mg of Cyclobenzaprine HCL and accurately administer a strength of 7.5mg is not possible. The release of the 7.5mg strength addresses this need.

Although the 5mg, 10mg and now 7.5mg strengths are the most commonly dispensed Cyclobenzaprine HCL medications, there are also other strengths, such as the 15mg and 30mg extended-release capsules manufactured by Mylan, which have a Medi-Cal price of $8.7899 per capsule. There are also the brand name “Amrix” extended-release 15mg and 30mg capsules manufactured by Cephalon, a subsidiary of Teva Pharmaceuticals, which have a Medi-Cal price of $25.0163 per capsule for both strengths. These 15mg and 30mg strengths further illustrate how a lack of competition for a specific medication leads to higher prices.

Medi-Cal prices apply to all dispensers of California workers’ compensation medications, including pharmacies and physicians, and the same Medi-Cal maximum price has applied since 2007, as explained in my article, “The Paradox on Drugs in Worker’s Comp.” But the average prices paid, according to the WCRI study, are significantly higher than the Medi-Cal prices. The WCRI said prices paid for the 5mg and 10mg strengths were 35 to 70 cents a tablet, yet we find that the average Medi-Cal price was 10 cents for 10mg and 16 cents for 5mg. This discrepancy requires further clarification, because it appears that claims administrators have been paying significantly more than Medi-Cal’s maximum price.

The WCRI reported a range of between $2.90 and $3.45 for the 7.5mg strength. The $2.90 price is lower than Medi-Cal’s prices and indicates that a competitive price was paid by claims administrators.

If, as some have suggested, new strengths such as the 7.5mg are medically inappropriate, have claims administrators moved to remove the doctors who prescribe those strengths from their medical provider networks (MPNs)? Have claims administrators reported those doctors to the California Fraud Assessment Commission?

Gavin said in the second point I pulled from his article that medications dispensed by physicians cost more than those in retail pharmacies, but obtaining prices of Cyclobenzaprine HCL from a number of retail pharmacies on the website goodrx.com are higher than the average Medi-Cal price paid for the same medications to dispensing physicians. (Prices on the website can change at any time and cited here for illustration purposes only. The Medi-Cal formulary can also change at any time in both its suppliers of medications and prices paid.)

This analysis of the Cyclobenzaprine HCL medication further reinforces the need for claims administrators to be vigilant when dealing with pharmaceuticals. Let the buyer beware, too, when interpreting studies produced by organizations such as the WCRI.