Showing posts with label regulatory. Show all posts
Showing posts with label regulatory. Show all posts

Monday, January 16, 2017

The 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, 3rd 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 two-fold: First, will there be room for political influence in the formation of the guidelines? Second, will the guidelines be updated with sufficient frequency?  

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, only 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 they were 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?  

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

Michael
On Twitter @PRIUM1  

Tuesday, November 8, 2016

A New Regulatory Approach to Opioids

The New York Workers' Compensation Board has announced a new avenue for payers to challenge the appropriateness of long-term opioid use.  Published last week, the notice begins:
Opioid addiction is a major public health crisis in the state that deeply affects many of New York’s injured workers. The New York Non-Acute Pain Medical Treatment Guidelines (NAP MTG) adopted by the Chair in 2014 present a comprehensive approach to the management of chronic pain, and include best practice recommendations for the appropriate use of narcotics. 
As the NAP MTG makes clear, long-term opioid use is only recommended in limited circumstances, and must involve constant clinical monitoring and re-evaluation. The NAP MTG also includes best practices for safely weaning injured workers from opioids and other narcotics.
A workers’ compensation hearing can now be scheduled to determine whether continuing opioid usage is necessary or whether weaning from opioids is recommended.
This is an important development, but it's not a panacea.  This new type of hearing is specifically designed to "consider opioid weaning."  If opioid weaning is to be considered, then the payer would be well served to have a suggested weaning plan documented.  While the actual implementation of a tapering schedule may differ from the suggested plan, the prescribing physician should at least be aware of the guidelines associated with the drugs requiring weaning.  As always, the turning of the tide against opioid misuse and abuse requires preparation.  

The potential outcomes are fairly concrete.  According to the Board: 
When the WCLJ rules that the claimant must be weaned from the opioid medication, the insurer will be required to cover the cost of the claimant’s addiction treatment program or weaning protocol, as directed. If the claimant is to be weaned without addiction services, the insurer will remain liable for the claimant’s medications for the duration of the weaning process. If an addiction treatment program has been directed, then after 30 days, the insurer will only be liable for payment of narcotic prescriptions written by an addiction treatment program physician.
We'll be watching closely.

Michael
On Twitter @PRIUM1 

Tuesday, October 20, 2015

What Happens When Regulators Don't Trust Clinicians?

USA Today published an interesting point/counterpoint this week on the question of whether doctors should be forced to check a prescription drug monitoring database prior to writing a prescription for an opioid.  The advocates for such an approach (me included) argue that fundamental public health concerns trump the arguments against mandatory checks, primarily that this new step in the process of clinical delivery presents privacy and convenience hurdles.

But if one examines the true concerns of clinicians that have pushed back against mandatory PDMP checks, one would find a deeper, more meaningful, more consequential issue: when it comes to prescription drug misuse and abuse, government regulators are exhibiting ever higher levels of distrust of the medical community.   

Perhaps nowhere else has this been laid more plain than in Massachusetts.  Governor Charlie Baker, a former physician group and health plan CEO, has proposed an aggressive set of measures to stem the opioid epidemic in his state.  I'm not using the term "aggressive" lightly here...

Among several other potentially controversial provisions, the proposed bill would limit new prescriptions for opioids to 72 hours (with very limited exceptions for emergency situations).  A patient in Massachusetts might go to the doctor, complain of low back pain, and receive a script for pain management.  But the max a doctor would be able to write is a 3-day script.  After that, the patient would need to come back to the doctor for an additional script if the continuation of the medication is deemed necessary.

As expected, the reaction of Massachusetts doctors appears to range from supportive to skeptical to deeply concerned.

I haven't decided whether or not this is a good idea.  I'll be researching the approach and discussing it with others for a while before I come to any conclusions.

What strikes me is that regulatory bodies ranging from state work comp agencies (think "closed formularies") to state legislators (think "mandatory PDMP checks") to state governors (think "Charlie Baker's plan") are essentially saying: Enough of this.  It's gone on too long and too many people are dying.  The clinical community has had their chance.  It's time for us to step in and shut this down.

Will there be unintended consequences?  Yes.  Will it result in the mitigation of prescription drug misuse and abuse for which we all hope?  TBD.

Might the clinical community awake and recognize the necessity for them to self-correct this problem to avoid further unwelcome intrusion into clinical practice from the regulatory community?

I hope so.

Michael
On Twitter @PRIUM1

Wednesday, September 16, 2015

CDC Opioid Guidelines: Poor Process for Public Participation

The CDC held a public comment webinar on a set of 12 proposed opioid prescribing guidelines.  I bet you'd like to know what those 12 recommendations are, right?  I wish I could tell you.  Here's how the webinar went:

The recommendations were not (and will not be) published.  Therefore, they cannot be circulated to anyone not able to join the webinar.  I tried to take good notes, but I didn't catch the recommendations with precision (and it's clear CDC is aiming for precision in its language).  Because I can't share them exactly as written, I'm not going to paraphrase from my notes.

But the webinar was recorded, right?  Yes, it was.  But "for archive purposes only."  The webinar recording will not be made available to the public.

No one could ask questions.  We were reminded several times that the webinar presenters couldn't answer questions.  We could only make comments.  To which there were, of course, no responses.

About 30 minutes in, there were technical difficulties and we had to start over.

Ugh.

If this is how the Centers for Disease Control and Prevention is going to handle the process of addressing the largest man-made epidemic in history, we're in trouble.  No dialogue, no exchange of ideas, no questions.  This webinar was about "checking a box" so CDC could say they solicited public comment - this was NOT about actually getting valuable feedback. 

A few observations I did make on the recommendations:

  • It's not clear whether these recommendations are useful for those patients already on chronic opioid therapy.  
  • There's no explicit discussion about informed consent or pain management agreements.  
  • CDC is suggesting "additional precautions" should be taken above 50 mg MED and dosages above 90 mg MED should be avoided.  What are those "additional precautions"?  They don't say.  
  • CDC appears to be suggesting naloxone should be considered for any long term opioid patient. This is going to be expensive.  
  • There's no discussion of weaning or tapering opioid (or polypharmacy) regimens.  
  • These guidelines are pointed in the right direction, but CDC's attempt at specificity has actually led to ambiguity.  Nearly every recommendation leaves several, critical open questions.  
  • This process is moving fast: CDC plans to submit these recommendations to HHS in early November and will be published in January.  
Here's my one comment:

Dear CDC: 
Make these recommendations publicly available, in written form, so doctors, patients, and other stakeholders can study them and offer you informed comment.  

Michael 
On Twitter @PRIUM1




Monday, September 14, 2015

The Rule of Law: Laws Require Rules

Remember these two from when you were a kid?


Watching the video brings back fond memories... and highlights some pretty significant gaps in the process, as well.  

So it looks like California is putting the concept of a drug formulary into law (thanks, in no small part, to PRIUM's own Mark Pew and host of others that stayed close to the process, educated the stakeholders, answered a multitude of questions, and made the case clear that formularies are in the best interest of injured worker safety).  Assembly Bill 1124 passed through the California state legislature late on Friday night and will likely be signed by the governor sometime in the next few weeks.

Then what?

Then the hard work starts.  Where the charming childhood educational video ends, the real work of governing and public policy begins.  Most (though admittedly not all) laws are conceptual in nature.  AB 1124 is a good example.  The law instructs "the Administrative Director of the Department of Workers' Compensation to create an evidence-based drug formulary, with the maximum transparency possible, for use in the workers' compensation system..."  There are some other instructions and caveats in the bill, but this sums it up.

Perhaps you're wondering about that phrase "with the maximum transparency possible."  That language is a reminder to the DWC that the real work of creating regulatory infrastructure around the drug formulary needs to be an open, transparent process so that stakeholders throughout the system not only understand what's going to happen, but also have an opportunity to influence the ultimate outcome.

Some key questions that the rule-making process needs to address:

  • What guidelines will we use?  In other words, what will be the "source" for determining inclusion / exclusion for specific drugs?
  • How will the formulary leverage (or not) the existing utilization review and dispute resolution processes in California?  
  • How will we deal with the concepts of dependence and addiction for long term, but medically inappropriate, opioid use?  
  • How will the formulary balance the concepts of "authorization" and "access"?
  • How will we measure the success or failure of the formulary?  
California needs a formulary.  The DWC now has a legislative mandate to create one.  Now we have to decide what it will look like and how it will work.  

Michael
On Twitter @PRIUM1 

Tuesday, September 8, 2015

California's Formulary: An Update from the Field

[Mark Pew, Senior Vice President of PRIUM, has been following, working, talking, meeting, eating, sleeping, and breathing California formulary for months - actually, years.  Mark's latest update below.]
The language has been approved (published late on Sep 4) for a bill to establish a Work Comp drug formulary in California - I will let you read it for yourself rather than restating it's contents here. AB 1124 should have its third reading on Sep 8, a vote on either Sep 9 or Sep 10, and with enough AYE votes Governor Brown will sign it into law shortly thereafter. I certainly don’t want to jinx it by unequivocally stating that a drug formulary will be implemented in California by July 1, 2017, but that possibility is as promising as it has ever been.
But … It hasn’t been easy. And I and others at PRIUM have had a front row seat to the entire process:
  • In November 2009, we started following the development of the Texas drug formulary, staying engaged through the 9/1/11 and 9/1/13 implementations.
  • On November 8, 2012 at the National Work Comp & Disability Conference in Las Vegas, I presented an overview of the Texas drug formulary and opined that California was a logical candidate to consider something similar.
  • In December 2013, I had my first meeting with California’s Department of Workers’ Compensation (DWC) to present the concept of a drug formulary.
  • In January 2014, I had my first meeting with leaders in the Assembly, Senate and Labor to discuss the concept of a drug formulary.
  • In October 2014, the first major milestone in California’s discussion of a drug formulary came after the California Work Comp Institute (CWCI) published a whitepaper “Are Formularies a Viable Solution to Controlling Prescription Drug Utilization and Cost in California WC” with a tentative answer of “yes”.
  • On March 5, 2015, the second major milestone occurred when Assemblyman Henry Perea (D-Fresno) introduced AB 1124 to direct the DWC’s Administrative Director to adopt a formulary (read about it in thisWorkCompCentral article that requires subscription.
Since that date, the process of filling in the details has been a consuming priority for me and many others involved in Work Comp in California. There have been many formal and informal meetings involving almost every stakeholder and constituent. There was a public hearing in the Assembly and then in the Senate, both interesting in their content and participants, from praise to guarded optimism to limited opposition. An advisory committee has been working directly with Assemblyman Perea’s office in July and August to develop the content of the bill. It has been an adventure in spirited dialogue and compromise in a decidedly non-antagonistic environment (though one not totally devoid of disagreement). The committee was comprised of representatives from every possible corner of Work Comp in California, and while the final version of the bill does not reflect all of the suggestions, the dialogue has been extremely helpful in establishing what will need to be addressed in the rule-making process. In collaboration with the DWC, the focus has been on crafting a bill to become law that mandates action but provides flexibility.
The third major milestone? July 23, 2015 at the CCWC conference in Anaheim where David Lanier (Secretary of the Labor and Workforce Development Agency) stated “Based on the work to date and the urgent need I have instructed Christine [Baker, Director of the Division of Industrial Relations] to move forward with creating a formulary as expeditiously as possible". This strategic statement sent an unmistakable message that a formulary was going to happen. Period. I still recall seeing people in the audience turning their heads and whispering to each other “did I just hear that right?” while I was writing notes to myself with exclamation marks.
And it got done (well, almost done). Think about it – from March 5, 2015 until now, all constituents in the California Work Comp system have basically agreed that a drug formulary is needed. In California! In less than six months! Amazing!
Of course, there is much work still to be done. And likely the hardest work to be done. Deciding on the concept of a drug formulary and some general parameters is one thing – crafting the actual rules and process to initiate intended consequences and mitigate unintended consequences are yet another. My July 2015 article on Claims Management magazine, "A Formulary for Success", will provide some insights into guiding principles that should be taken into account.
The first step to that is September 8, 2015 from 10:00am till Noon when a public hearing will be held to establish the goals of the DWC and listen to feedback from all interested parties. This meeting will just be the start of a long journey, and I will continue to be a technical adviser as the rules are developed. Unfortunately, I will not be able to attend as I had previously committed to speak at a North Bay Work Comp Association event in Santa Rosa, but if you’re interested go to the Elihu Harris State Office Building (Room 2, Second Floor, 1515 Clay Street, Oakland, CA 94612) on Tuesday.
The stated goals of the DWC are:
  • Improve appropriate care through the dispensing of evidenced-based medicine
  • Expedite pharmaceutical treatment for ill and injured workers
  • Reduce delays, including reducing the need for elevated utilization review and independent medical review
  • Improve efficient delivery of medical benefits and reduce administrative costs
Those are the lofty goals that have driven this entire process since the beginning, and one reason why consensus through compromise has been achieved so quickly.
The common theme I’ve heard throughout this process has been to ensure injured workers receive appropriate treatment with a renewed focus to limit the damage prescription drugs with very dangerous and even life-threatening effects can wreak. Part of that is to ensure those who have become reliant / dependent upon / addicted to dangerous polypharmacy regimens are not suddenly thrust into withdrawal but allowed to thoughtfully and carefully be tapered to a more appropriate drug regimen while being equipped with more robust coping skills to deal with the pain that remains.
In other words, whether it’s Labor or applicant attorneys or defense attorneys or physician groups or carriers or self-insured employers or legislators or PBM's or any other interested party, the focus has been squarely on combating the epidemic of over/misuse of prescription drugs and creating a path to less dangerous and more efficacious pain management for those that need it. And who can argue with that? Apparently, nobody.
Because there have been so many people integral to this process, I won’t even try to name them all. So, instead, I will just say “Kudos Cali”!
Mark
On Twitter @RxProfessor

Thursday, September 3, 2015

Formularies to the Right of Them, Formularies to the Left of Them

Formularies in front of them
Volleyed and thundered.

Everyone wants a formulary these days.  Louisiana, Nebraska, North Carolina, and South Carolina are the latest to make at least public mention of exploring a drug formulary for their respective states' workers' compensation systems.  They join California, Montana, Maine, Tennessee, and Arkansas, all of which are also thinking about formularies.  And this movement, of course, builds on varying degrees of success observed in those states that already have formularies: Texas, Washington, Oklahoma, and Ohio. 

Tennyson's Charge of the Light Brigade, to which I allude above, is a celebration of a very brave group of six hundred cavalry soldiers who fought in the Crimean War in the mid-19th century.  The British soldiers depicted in the poem didn't quite realize what they were getting themselves into. Neither do some state regulators who are contemplating formulary implementation.   

Formularies are an absolutely essential tool to mitigate prescription drug misuse and abuse within any workers' compensation system.  But they're not easy to implement and some of the states contemplating it have not done the work necessary to implement such a measure.  As I've stated time and time again, both here on this blog and in presentations and panels around the country, Texas passed HB 7 in 2005 - and finally got a formulary implemented in 2011 (and didn't get it fully implemented until 2013).  What took so long?  The hard work of creating, implementing, adopting and communicating critical prerequisites like pre-authorization processes, dispute resolution processes, medical treatment guidelines, and stakeholder acceptance. 

I recall presenting on the topic of formularies at the South Carolina Work Comp Education Conference back in February of 2013.  I talked about the concept generally and shared some of the early data coming out of Texas.  My enthusiasm for formularies must have been obvious... because the backlash was swift.  Several doctors in the room vowed they would cease taking work comp patients if such an approach was ever attempted in South Carolina.  Several adjusters commented that it sounded great, but they couldn't imagine how it would work in their state.  Defense attorneys told me they thought it was great... in theory.  And the applicant attorneys just chuckled.  

The desire to exercise better control of prescription drugs in work comp doesn't start with a formulary.  A formulary is the fruition of appropriate regulatory groundwork.  

My fear is that one or two bad formulary implementations at the state level will set the national movement toward formularies back several years.  We can't afford any setbacks in the fight against prescription drug misuse and abuse.  Better to do it right than to rush into something that a state lacks the infrastructure and experience to accomplish.  

One step at a time. 

Michael 
On Twitter @PRIUM1      


Wednesday, August 12, 2015

Marijuana: If We Paid, How Would it Work?

[Excellent guest post from PRIUM's Mark Pew on the medical marijuana issue in New Mexico.  Lots of great questions to ponder here...]
New Mexico could become to medical marijuana Work Comp reimbursement what Colorado has been to recreational legalization – an experiment.
I attended the public hearing in Albuquerque on August 6 where work comp rule changes proposed by the Workers’ Compensation Administration (WCA) were discussed. The reason why I flew from Atlanta to Albuquerque was the changes to chapter 4, part 7 to address the mechanism by which employers will reimburse injured workers for their use of medical marijuana.
I first learned of these proposed rule changes when I was interviewed by WorkCompCentral’s Greg Jones for his July 21 article “To Add or Not to Add Marijuana to Fee Schedule.” Greg quoted me as saying "It's not a huge surprise that New Mexico is going down that path, primarily because of those past decisions. The legal writing is on the wall in regards to requiring employers to reimburse medical marijuana in New Mexico."
As fortune would have it, I met Darin Childers, the New Mexico WCA Director, at the SAWCA conference in Williamsburg VA the following week and I posed the following question:
When he affirmed that was at least one of the initiating causes for these proposed rules, I knew I needed to be in Albuquerque. While the proposed rules essentially just provide the authority for the WCA to establish this structure, they raise many questions. For me, the biggest questions are in establishing medical appropriateness and creating a fee schedule for reimbursement.
While each of the court decisions had unique circumstances, they all affirmed that the use of medical marijuana by an injured worker could be classified as “reasonable and necessary” care and thus the employer was responsible for reimbursement. The new rules state “Medical cannabis may be a reasonable and necessary medical treatment only when an authorized health care provider certifies that other treatment methods have failed.”
  • But what does “other treatment methods” mean? It doesn’t say “all”, so does that mean the search for “other” does not need to be exhaustive? 
  • Does “certify” mean it’s solely at the health care provider’s discretion without any need to provide evidence-based proof that medical marijuana is the best/only solution? Effective July 1, 2013 Official Disability Guidelines (ODG) is to be used to judge “reasonable and necessary” medical treatment, but since ODG does not recommend cannabinoids for pain …
So could the introduction of these rules lead to increased medical use of marijuana in work comp? Possibly, and one reason is how medical marijuana is currently being used in New Mexico (note, not specifically for work comp). Per their own statistics, the Medical Cannabis Program had 16,236 total patients as of July 30, 2015. Of those, the top five conditions cited as the rationale for its use are:
  1. PTSD (7,439 or 46%)
  2. Chronic pain (4,377 or 27%)
  3. Cancer (1,431 or 9%)
  4. Painful peripheral neuropathy (684 or 4%)
  5. HIV / AIDS (369 or 2%)
Cancer, peripheral neuropathy and HIV / AIDS are all very concrete diagnoses but very rarely associated with work comp. PTSD may not be as easily objectively measured but is certainly a definitive diagnosis once confirmed. With the continuing expansion of presumptions for public safety officers, PTSD is an increasingly frequent compensable work comp injury. But given the subjective nature of “chronic pain” and its overwhelming prevalence in work comp, doesn’t that scare you just a little bit? Isn’t that how our opioid epidemic got started, by physicians trying to alleviate chronic pain and determining those drugs were “reasonable and necessary” absent definitive scientific evidence?
Since ODG is only used for approval (not denial) of treatment, the dispute resolution process revolves around Utilization Review, Independent Medical Examinations or Peer Review. Essentially one opinion vs. another. Which means the courts will likely remain very busy, and judges could continue to be a primary method of resolving medical decisions and determining “reasonable and necessary”.
While the new rules outline what cannot be reimbursed -- "paraphernalia" (not defined in the rules), expenses for personal production -- and that an itemized receipt will be the billing mechanism, they generally reference a “fee schedule” in regards to how and how much. Obviously, the details will be embedded in the fee schedule, which is not included in the proposed rules. But how will that be determined?
While sharing some nachos afterwards with my friend and colleague Lisa Anne Forsythe, we contemplated the implications of establishing a fee schedule. The questions are endless so I will only list the most obvious:
  • Who pays? Is it direct from the employer, or will their insurance carrier or TPA or bill review vendor be handling it?
  • Does reimbursement, by whomever and whatever means, run counter to marijuana’s continued illegal status at the federal level?
  • For reimbursement purposes, will this be classified as medical treatment, a drug, or a pass-through?
  • If medical treatment, a CPT will be required (currently non-existent).
  • If a drug, a NDC will be required (other than Marinol® and Cesamet®, likewise currently non-existent).
  • If a pass-through, similar to mileage reimbursement, then the fee schedule cannot be applied through any automated means (the carrier or TPA or bill review vendor just generate a check). And without automation, everything is an exception and obviously open to errors. Additionally, the normal benchmarking mechanisms for assessing system-wide medical costs will be thwarted as the expenses will not be ear-marked as “medical” expenses.
  • How will appropriate pricing be determined? The goal is to price it at a gram or ounce. With so many blends/variations and levels of potency and forms ("medical cannabis" is defined in the new rules as “flower, bud, cannabis derived products, edibles, oils, tinctures, or any other form regulated by the department of health”), how deep and wide can a fee schedule actually be?
New Mexico has an enormous task ahead and a short time to accomplish the task. The new rules will be effective on October 1, which happens to be the date by which the first draft of the all-important fee schedule will be made available for public comment. Then, effective January 1, 2016, New Mexico will be the first state to codify work comp reimbursement for medical marijuana. If you manage work comp claims in New Mexico -- or any other state that has legalized medical marijuana and has not explicitly excluded employer reimbursement -- this is a “canary in the coal mine” moment.
Stay tuned because I’m watching with great interest. And I will likely be back in Albuquerque.
Mark Pew - On Twitter @RxProfessor

Monday, July 27, 2015

Fear Not, Be Smart: How to Deal with Medical Marijuana

The headline from workcompcentral today is Comp Industry Urged to Prepare for Medical Marijuana.  As usual, it's a solid and informative article from a great source (and I'm not just saying that because PRIUM's own Mark Pew is quoted throughout).  Nonetheless, I'm always concerned when I hear talk of medical marijuana that takes on a foreboding and troubling tone.  I'm sure Sedgwick's Mr. Canavan meant no harm.  And I have to admit that I wasn't present.  But comments like, "You can blame New Mexico the next time you pay for medical marijuana" strike me as fodder for filling hotel ballrooms at conferences and not reflective of the actual medical and legal realities with which we're dealing.

Back in April, I wrote the following:

"Did you know that of the 24 states with medical marijuana laws, most have either explicit or implicit provisions allowing for commercial payers to avoid reimbursement for medical marijuana?

Did you know that most of these states have a list of allowable conditions that provide a second layer of potential protection for commercial payers? 

Did you know that most of these states have medical treatment guidelines that address the use of medical marijuana?

Did you know that the New Mexico cases that have most of our industry concerned about this issue exhibit systemic failure on the part of the payers in those cases to take advantage of these various provisions and protections?" 


So let's all take a deep, cleansing breath.  If we're smart about this - if states are thinking about evidence based guidelines and payer carve outs, if payers are thinking about UR and peer review, if doctors are thinking about what's best for patients - we can keep medical marijuana in the box in which it belongs.  Mark Pew is right that the legalization of medical marijuana is inevitable and the advent of recreational marijuana is upon us.  But the risk management issue should be in the areas of drug-free work place issues and on-the-job safety.  

When it comes to injured worker treatment, we're not suggesting that medical marijuana is a non-event that deserves no attention.  We're suggesting that smart payers with smart medical management strategies need not fear being overwhelmed with medical marijuana spend.  

Michael 
On Twitter @PRIUM1

Tuesday, July 14, 2015

Unpacking the California Closed Formulary

With ever greater frequency, I'm encountering questions regarding California's legislative attempt to create a closed formulary.  "What do you think?" is the intentionally loaded question.  This is one of those interrogatives that requires unpacking, like a suitcase that's been the companion of a traveler on a long road trip.  There are a lot of layers, some messier and more complicated than others.  Courage is required to unload the suitcase and it'll take a while to sort through all the laundry.  And yes... the "baggage" metaphor is intentional.  So much baggage.  

Should California adopt a closed formulary?
Of course they should.  All state workers' compensation systems should.  A well designed formulary, properly implemented, is the best and fastest way to disseminate clinical best practices and contemporary medical evidence throughout the provider community (a community that is, I might add - through no fault of their own - perennially behind the curve on the latest science regarding appropriate, safe, and efficacious use of medications).  Doctors and patients clearly benefit from the "guide rails" of a formulary.   

What will the California closed formulary look like?  How will it work?
I have no idea.  No one does.  And should you encounter someone that claims to know, tread carefully and remain skeptical.  The sausage-making process is in full swing in Sacramento and everyone wants a seat at the table.  What's clear at this point is that the usual suspects have taken their predictable positions (Chamber of Commerce likes it, applicant attorneys don't, etc.)  Also clear is that each amendment added to the current bill creates significant swings in support.  At this point, it's hard to even ascertain the score, much less who has the momentum.  

If (emphasis on that word "if) this happens, when will it go into effect?
Likely not until mid-year 2017 at the earliest.  Keep in mind that the Texas closed formulary was phased in starting in September of 2011 and applied to legacy claims in September of 2013... after the legislative mandate for the formulary was signed into law via HB 7 in 2005.  These things take time.  
What will this mean to you?
Well, CWCI says it could mean injured workers are treated more appropriately... to the tune of $120 million - $420 million in annual savings.  That's a lot of prescriptions never dispensed... a lot of drugs never taken... a lot of addiction never rearing its ugly head... a lot of injured workers saved from greater pain and suffering brought on by inappropriate treatment.

What are the chances?
Perhaps the most complicated question of all... because it's really two different questions.  What are the chances of something passing... something the state calls a "formulary"?  Pretty good, I think. What are the chances the resulting regulatory approach really creates a safer medical treatment environment for injured workers that subsequently saves payers millions of dollars?  It's possible... but not probable.  Like any major legislative/regulatory change, this will be flawed.  Let's hope it's not so flawed that it's not worth doing.  

Michael
Follow us on Twitter @PRIUM1  

Wednesday, April 1, 2015

Medical Marijuana: Fear Not

Ben Roberts and David Price, who head up PRIUM's regulatory and compliance consulting team, have authored a great piece on medical marijuana rules and statutes across the country.  The article is data-driven, well-researched, and should have a calming effect on payer organizations concerned about the potential need to reimburse for medical marijuana.

Did you know that of the 24 states with medical marijuana laws, most have either explicit or implicit provisions allowing for commercial payers to avoid reimbursement for medical marijuana?

Did you know that most of these states have a list of allowable conditions that provide a second layer of potential protection for commercial payers?

Did you know that most of these states have medical treatment guidelines that address the use of medical marijuana?

Did you know that the New Mexico cases that have most of our industry concerned about this issue exhibit systemic failure on the part of the payers in those cases to take advantage of these various provisions and protections?

We're not suggesting that medical marijuana is a non-event that deserves no attention.  We're suggesting that smart payers with smart medical management strategies need not fear being overwhelmed with medical marijuana spend.

Check out the full article here.

Michael
On Twitter @PRIUM1

Monday, March 2, 2015

Inconsistent Standards of Care, Judicially Mandated

Very little good has ever come from judges attempting to interpret legislative intent in the face of disputed medical treatment.

Barbara Shepard injured her back, neck, and left shoulder in 2005 while employed with the Oklahoma Department of corrections.  The OK Work Comp Court ordered that the carrier pay for treatment, inclusive of office visits and (you guessed it) pain management medications.  "This provision," stated the order, "shall be reviewed by the Court upon application of either party for good cause shown."  

Turns out evolving contemporary medical evidence and the risks of opioid medications do not amount to "good cause."  

Despite Oklahoma's adoption of the Official Disability Guidelines as of March 1, 2012, the Court found that those guidelines do not retrospectively apply to Shepard's case.  Simply because of the date on which she was injured, Shepard is subject to a different (and, frankly, inferior) standard of care.   While physicians on both sides of the dispute agree that the guidelines indicate she should not receive the pain management medications she has been taking, the Court instead relied on a purely legal framework to make its decision.  Thus, not only has the Court failed to contemplate the growing body of medical knowledge from which the patient could benefit, but it has also created two standards of medical care for Oklahoma work comp patients that depends entirely on one's date of injury.   

Let's consider an admittedly controversial analogy: Instead of being injured in 2005, let's pretend for a moment that Shepard was hurt in 1917.  And instead of an injured back, she had a work-induced cough.  During this time, she might have been prescribed a popular cough suppressant manufactured and sold by Bayer pharmaceuticals.  The chemical compound was diacetylmorphine, but it was marketed under its trade name: heroin.      

Seven years later, in 1924, in the face of a public health crisis and mounting evidence of heroin's harmful properties, Congress passed the Heroin Act, which outlawed the sale, importation, and even the manufacture of heroin.  

According to the Oklahoma Supreme Court, however, Shepard should still get heroin for her cough... despite the evolving medical evidence and the statutory support for recognizing that medical evidence, Shepard should still get her heroin, simply because she developed her cough seven years before we knew that heroin was more likely to harm her than help her.

Opioids, thankfully, are not illegal.  There are many patients, particularly the terminally ill, that benefit greatly from these medications.  But it's also true that we didn't know in 2005 everything we now know about opioids in the treatment of chronic, non-cancer pain.  For instance, in 2005, the National Safety Council had yet to publish this informative graphic:



We cannot create a sustainable system of medical care for injured workers that does not allow for the incorporation of the best available medical evidence.  

Michael
On Twitter @PRIUM1

Monday, February 23, 2015

Opt Out: A Tale of Two Tweets

[A guest post from Ben Roberts, PRIUM's General Counsel]

When I checked my twitter feed one morning last week, two tweets caught my attention:

1. ARAWC: Tennessee Legislators Introduce Workers’ Comp Option Legislation http://goo.gl/fb/Wt7hWh 
2. Supreme Court Asked to Review Constitutionality of Opt-Out Process. Full story at: http://ow.ly/JeAlt 

I find the juxtaposition interesting: Tennessee legislators are trying to create an opt-out process in their state; meanwhile, attorneys in Oklahoma are trying to undo their opt-out process by challenging its constitutionality.  

Oklahoma’s opt-out provision was created by the passage of SB 1062 in 2013 and, at the time, several constitutional challenges were made.  But now a group of attorneys is again taking the constitutional challenge directly to the Oklahoma Supreme Court, hoping to have the opt-out provision struck down. 

The Tennessee legislation, SB 721, requires employers who choose to opt-out of the system to set up their own plans meeting certain requirements.  This is similar to the opt-out provision in Oklahoma, and while we haven’t heard any constitutional objections from Tennessee, I am sure they will follow.

It appears as though OK and TN are trying to replicate the results of Texas -- the only other state that permits “opting-out”.  The Texas non-subscriber provision has been in place for nearly 100 years, and many companies have seen significant cost savings and better claim outcomes in that state.

The goals associated with providing employers with the option of opting out are well outlined by the Association for Responsible Alternatives to Workers’ Compensation (ARAWC):
• An Option can reduce the overall costs of treating employee injuries and support local job growth and economic development.
• An Option can deliver better medical outcomes and higher satisfaction for injured workers.
• Employers in Option states see significant savings and improved medical outcomes.

But, these changes aren’t made overnight.  

I often equate making changes to the workers’ compensation system to changing a tire on a moving vehicle.  The solution has to fit an ever-changing system.  It’s not something that can be done easily, and in order to be successful, it must be well thought out, well planned, and well executed.

Ben Roberts
Ben is PRIUM's General Counsel.  You can follow him on Twitter @WC_Compliance
As always, you can follow PRIUM @PRIUM1