Tuesday, December 27, 2016

A Florida Formulary?

This blog recently featured a post on "progress." The central focus of progress is the necessity of having goals. Without goals, or a destination, it is practically impossible to ascertain progress versus regress. After I published that piece, Judge Anderson sent me a apropos quote from G.K. Chesterton -- “progress is a comparative of which we have not settled the superlative.” That says it all, and far more eloquently than I am capable. 

Just before Christmas, news broke regarding the published materials for January's meeting of Florida's Three Member Panel in Tallahassee. The Three Member Panel is a body created by statute (Section 440.13(12), Fla. Stat.), and charged with determining reimbursements under Florida's Worker's Compensation system. It periodically offers suggestions and recommendations for the system. The panel is currently comprised of by 2 members, and is operating without a labor/worker representative. 

In the published working papers, the Panel describes its recent history of recommendations, and the Legislative progress. The Panel now boldly proposes Florida workers' compensation's transition to a pharmaceutical formulary. The formulary process was pioneered by Texas, and has since been adopted in various other states. When potential for a Florida effort was featured on Friday at WorkCompCentral.com, the focus of the formulary concept seemed to be on cost savings associated therewith. That analysis, and conversations since, have led me back to the original supposition that progress cannot be measured without a goal.

By April 2015, only four states had adopted formularies. From Texas' original idea, the concept spread to Washington, Ohio, and Oklahoma. Then California joined the club in 2015, and Tennessee and North Carolina in 2016. As Arlo Guthrie might say, it is perhaps becoming a movement. Florida is arguably the largest American workers' compensation system without a formulary. 

The concept is reasonably simple. The state adopts a list of "approved" medication for the treatment of workers' compensation injuries. When a physician prescribes one of those listed medications, the path to dispensing and therefore administering the medication is intended to be smoother and faster. Simple fact about medication: it always works better when it is taken and taken as directed; the sooner the better in most instances. 

The fact that a drug is not listed as approved will not foreclose the prescription and dispensing of that medication. These unlisted drugs are referred to as "n drugs" (not pre-approved). These exceptional cases are still afforded consideration under formulary plans. However, these unlisted pharmaceuticals require explanation, justification, and pre-approval prior to dispensing. There is some inclination to perceive this as a system discriminating against certain medications. 

But, in either manner, pre-approved or specially approved, it is a thoughtful process. The listed drugs acquire their "approved" status through a thoughtful consideration, review and endorsement process. Drugs that do not go through this filter, are not on the list. They have not been vetted and thus are not on the list. But, they remain available following a similarly thoughtful process regarding their specific authorization, prescription, and dispensing in a particular case. The process is not necessarily discriminatory, as long as the process is thoughtful and uniformly applied. 

There are multiple factors which might drive a transition to the formulary process. There have been instances in the war on Opioids, in which formulary regulations were of assistance. The war on Opioids is tragic, with thousands dying each year from overdose. Unfortunately, the volume of American overdose death seems to be increasing. This is discussed in What's Hot in Workers' Compensation, and E-FORCSE and KASPER, Cousins with a Cause. Control of Opioids is an admirable goal. This country has to do something to stem the tide of overdose deaths. Workers' compensation cannot conclude that overdose death is an acceptable side-effect of work injuries. 

Another goal expressed for formularies is control of individualized and specialized medications for particular patients. This process has been the alleged focus of "compounding pharmacies," which combine medications in a particular case, for administration to a particular patient. There are those who see benefit in that specialization, and there are others who see no benefit and only cost. As with anything in society, the hand-made specialty product (McLaren F-1 at $900,000) will be more expensive than the mass-produced product (Chevrolet Corvette at $55,450). Thus, there are those who advocate for the formulary as a tool to further constrain specialized compounds and creams in the majority of cases. 

Others will express the goal of cost control. With the medication spectrum in a case: (1) identified, (2) understood and investigated, and (3) thus subject to high-volume use and thus inventory economy of scale, the probability of cost-saving is clear. The states that have adopted formulary have demonstrated cost-savings associated with the listed drugs. There are also marked decreases in the prescription of "n-drugs." 

This corollary effect, decrease in usage of non-approved medications ("n-drugs"), is interesting. The Texas experience has taught that prescriptions for n-drugs decreased markedly following implementation of a formulary process. There was an expectation that there would be a corollary, increased prescription of other listed drugs. But, that did not materialize in the Texas experience. The decrease in "n-drug" scripts, without any substitute has raised questions about why those n-drugs were ever prescribed previously, and whether they were ever necessary in those cases. Some say the decrease in "n-drugs" proves prescribing was unnecessary to begin with in those cases. Others claims that this decrease represents necessary care being deprived by bureaucratic red tape (the individual pre-authorization process). 

There will also be those who will profess the formulary as a solution to all else that they perceive as hurting workers' compensation. This is perhaps too broad an endorsement. A formulary seems unlikely to fix everything that ails us. The concept behind formulary pharmacy is simple, and it it may have benefits. But, it is not going to solve all of everyone's problems or concerns. In part, this is because we do not have unanimity as to what the problems are. Again, goals and perspective will define what one sees as progress or regress. 

So, there is much to consider, including cost and money. Everyone recognizes that costs drive a great many decisions in workers' compensation.

I am reminded of a familiar family comedy starring Robin Williams, R.V. In it, sales and marketing guru Bob Monro (Williams) is sidelined for a merger sales pitch. A young protégé instead attempts to push the benefits of merger upon the owners of Alpine Soda. These owners are a pair of new-age, earth-focused, small town "flower-children." A few sentences into the protégé's financial presentation, one of these owners interrupts and a bit disdainfully asks the critical question "is this going to be all about money?" 

A valid question, which leaves the protégé speechless, stammering, and confused. He is frankly incapable of understanding that money might not be someone's only (or at least primary) motivation. As he stammers and stutters, in jumps Robin Williams, with a historical homily regarding American values in a broad general sense (describing I Love Lucy, frisbee, and more). The presentation is saved. The owners are intrigued, by appealing to something more than "just money."

On Friday I received an email from a national figure in the opioid wars (sounds like a reference to Star Wars?) He noted the WorkCompCentral.com story, and suggested that there is merit in the argument that financial savings can be a benefit of formulary. He cautioned however that it must not be the primary driver. In the same manner as the Hollywood exposition in R.V., there must be a way to consider the proposal for formulary from a standpoint of delivery of better care to those injured at work. That has to be the system goal: better care, faster/better medication administration, better recovery and the restoration of function. And, if financial savings follow, that is certainly a benefit, but is not perhaps the best driving force for change.

In other words, keep the focus on the true goal of the formulary process. This is clearly simplification of process, leading to the more rapid and certain deployment of pharmaceutical assistance to injured workers. This is less time spent by physicians, hospitals, carriers, and attorneys, in dispute processes regarding reimbursement and authorization. The decrease in friction leads to greater time and resources available for more significant matters, including patient care: doctors spending less time on authorization of medication, and thus more time is available to spend with patients, answering questions, providing care. 

The 2017 Three Member Panel documentation suggests two things. First, that the Tallahassee officials have concluded that there is a potentiality for benefit to the system from implementation of a Florida drug formulary. Second, that those same officials have concluded that the current statutory structure does not afford them the necessary foundational authority for implementation at this time. 

Therefore, any implementation of a formulary in Florida will require multiple steps. There will have to be discussion and debate regarding legislative delegation of authority. That is, there will have to be statutory change through which the Legislature will empower the regulators to adopt a formulary. That Legislative process will certainly afford interested indivicuals and groups the opportunity to testify, support, oppose, explain, compliment or compain. 

If that Legislative process results in regulator empowerment, then there will be a rulemaking process. Implementation of a formulary pursuant to this new legislative power will likewise require public input and access in the rulemaking process. There will have to be workshops or meetings, proposals and discussions. 

Thus, the Three Member Panel discussion is only a beginning.  It makes a suggestion that will inspire discussion. And there will be no Florida formulary without opportunities for significant public discussion and input. Florida may join the ranks of the drug formulary jurisdictions, but the path to that outcome is lined with opportunities for conversations about what goals the formulary is intended to satisfy. Now is the time to decide how we each perceive the goals, and where we each may perceive issues or concerns. It is likely that debate and discussion are coming, and your opportunity to voice your thoughts. 

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