Showing posts with label legislation. Show all posts
Showing posts with label legislation. 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  

Monday, August 29, 2016

Standing Orders: Are You Prepared?

The Missouri PDMP watch goes on... I think CNN should have a clock for it.  Instead of counting down to an event, the clock would continually count up, marking the years, months, days, hours, and minutes since Missouri became the only state without a law creating a Prescription Drug Monitoring Database.  For the record, the District of Columbia enacted its own PDMP legislation on Saturday, February 22, 2014.  So by my count, the clock would read: 2 years, 6 months, 7 days, 10 hours, 59 minutes, 32 seconds... 

But the state did make some progress recently.  Missouri HB 1568 creates a "standing order" for naloxone.  There's a legitimate debate regarding standing orders for naloxone, but regardless of where you stand in that debate, there's little doubt we're going to see more and more of these across the country.  So let's establish some definitions and pose some interesting questions for the payer community.

First, looking up "standing order" in an average dictionary isn't terribly useful.  We're looking for a clinically oriented definition and I found the best one at medical-dictionary.com:
"a written document containing rules, policies, procedures, regulations, and orders for the conduct of patient care in various stipulated clinical situations. The standing orders are usually formulated collectively by the professional members of a department in a hospital or other health care facility. Standing orders usually name the condition and prescribe the action to be taken in caring for the patient, including the dosage and route of administration for a drug or the schedule for the administration of a therapeutic procedure. Standing orders are commonly used in intensive care units, coronary care units, and emergency departments."
Translation: Pre-approved treatments that can be dispensed and administered by non-physicians because a doctor said it was ok ahead of time.

The language in Missouri is indicative of what we're likely to see elsewhere: "Notwithstanding any other law or regulation to the contrary, any licensed pharmacist in Missouri may sell and dispense an opioid antagonist under physician protocol" and "Notwithstanding any other law or regulation to the contrary, it shall be permissible for any person to possess an opioid antagonist."  Additonally, the bill also contains language that relinquishes pharmacists from any liability associated with dispensing naloxone as well as protection of individuals who administer naloxone.  This is an important component of any legislation in this area.

Translation: Want naloxone?  Show up at a pharmacy in Missouri with some money and you can have some.  No questions asked.  And no one is going to get arrested or sued for dispensing or administering the drug.  

But this begs several important questions for the work comp payer community.

First: How much is naloxone going to cost?  Are we talking generic syringes?  Or EVZIO auto-injector pens?  This "standing order" in Missouri spells out the ingredient a patient can obtain, but not any preferred form of administration.  Notably, the cost of this stuff is skyrocketing.

Second: Who is going to pay for this, ultimately?  If an injured worker pays for EVZIO pens out of pocket via a standing order, will he submit for reimbursement to the employer/carrier?  How will this be handled?

Third: Will we submit this to utilization review?  Are the guidelines sufficiently thorough to cover this type of scenario?  (I can answer that one, actually: no, they're not).  So where does that leave us? Do we really want to deny payment and then have the unthinkable happen?  Imagine the headlines. "Work Comp Screws Up Again: Injured Worker Dies of Overdose After Employer Denies Payment for Life Saving Antidote."

No one wants that.  But we also want to ensure we're addressing the underlying issue.  Why do we have injured workers on sufficiently high doses of opioid medications that the patient (or, likely, a loved one) feels the need to take advantage of a "standing order" and obtain naloxone from the local pharmacy?

Which brings us to a fourth question: Does the employer have an obligation (ethically, not necessarily legally) to inform the prescribing physician that the injured worker has obtained naloxone via a standing order?  "Hey doc, just thought you'd be interested to know... Injured Worker Joe?  Yeah, his wife just picked up a pack of two EVZIO pens at Walgreens.  We're going to reimburse them the $800, but thought you might interested in your patient's perception of overdose risk."  That's a pickle: the reality is that the adjuster may be the only one that knows about both the opioid scripts and the naloxone secured via a standing order.

Unintended consequences abound.

Michael
Follow me on Twitter @PRIUM1

Thursday, July 14, 2016

What Will $180 Million Buy Us?

The Senate just voted 92-2 to pass a piece of legislation, one already passed by the House 407-5.  Can you remember the last time you saw a vote tally like that in Congress?

The President will now sign the Comprehensive Addiction and Recovery Act (CARA), a new law intended to stem the tide of drug misuse and abuse in this country.  Given the ubiquitous and devastating nature of the epidemic, it's no wonder the vote was such a slam dunk.  Better three hours too late than a minute too soon, I suppose, but this Congress after all.

And yet, this bill nearly died an ignominious death before reaching the President's desk.  Even though we all agree that something must be done (and our representatives in Congress see it the same way, at least in principle), there remained the issue of how to pay for it.  Obama asked for $1 billion.  Lots of numbers were tossed around with respect to appropriations... $500 million... $300 million... $600 million.  This surprised even those who watch the sausage making process as a full time profession (from thehill.com: "But the fight over funding threatened to doom the bill, surprising longtime policy watchers who expected the legislation to coast through both chambers as the country faces an epidemic of opioid overdose deaths.")

The final bill allows for $180 million per year for the programs it creates.  The Department of Health and Human Services will dole out grants to treatment programs, law-enforcement assisted diversion, prisons, educational programs, and increase the number of patients able to receive medication assisted treatment (MAT).

So how far can we stretch $180 million?  What can we expect the public health impact to be? Let's do some simple math.

If we just take the 16 million people in the US who suffer from some form of substance use disorder... that leaves us with about $11 per person per year.

If we just look at the most vulnerable subset of the substance use disorder population, those with concomitant mental health disorders - of which there are 8 million in the US - we're left with about $22 per person per year.  

If we take the number of counties (the public health departments of which often compete for and implement these grants), of which there are about 3,000, we get $60,000 per county per year, probably enough to hire a single new public health worker to help those struggling with addiction.

And if we take the population of chronic, non-cancer pain patients in the US, a group at high risk for opioid dependence and addiction - of which there are approximately 38 million - well, that's a little less than $5 per person per year.

Think the math is unfair?  Think my analysis isn't framed correctly?  I'd love to see an alternative approach that shows this investment can and will make a difference.  From my perspective, it's woefully insufficient.

But it's a start... which is why President Obama is going to sign it.

Michael
On Twitter @PRIUM1


Wednesday, June 29, 2016

Lawmakers Dictate to Doctors: New Legislative Approaches to Opioids

Amidst all the talk of 7-day initial opioid script limits in New York, Massachusetts, and New Hampshire (with New Jersey, Connecticut and others likely not far behind), we appear to have missed a piece of legislation that, in my view, represents the single most stringent legal construct for opioid prescribing in the country.   Before we get to Maine's new law, a quick aside on the new approach sweeping the northeastern US: These new limits are extremely helpful, but not the panacea some are making them out to be.  A 7-day limit for new scripts (in most states, for acute pain only) will absolutely help limit black market diversion and over-utilization generally... but we'll also see more office visits (on day 8!) and not enough progress on long term chronic pain cases.  A necessary step, no doubt, but insufficient to address the entirety of the problem.  

Back to Maine: Guess what they did back in April that no one noticed?  They put a statutory cap on morphine equivalent dosage per day.  The state legislature passed it, the governor signed it, it goes into effect on January 1, 2017... and not a lot of people are talking about it.

The cap is 100 mg MED per day.  Specifically, a licensed practitioner in Maine "may not prescribe... to a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day."  But what if a patient is already on more than 100 mg MED per day?  Doctors cannot prescribe to such individuals opioid pain medication in excess of 300 mg MED per day between January 1, 2017 and July 1, 2017.  But starting July 1, 2017, even those individuals need to be weaned down to at or below 100 mg MED per day.

Enforcement mechanisms?  They thought of that, too.  "An individual who violates this section commits a civil violation for which a fine of $250 per violation, not to exceed $5,000 per calendar year, may be adjudged. The Department of Health and Human Services is responsible for the enforcement of this section."    

The bill also includes several other requirements including mandatory PDMP checks, mandatory electronic prescribing, and mandatory education for prescribers (3 hours of CE) to be renewed every 2 years.  There are exceptions, of course, but the exceptions are logical and do not undermine the intent and broad application of the bill (active treatment for cancer, hospice care, inpatient settings, etc. are all exempt - as they well should be).

What does all of this mean?

Some will see this as a huge step forward in fighting the most significant public health crisis of a generation.  Some will see this as a vast government overreach into the practice of medicine.

It's both, really,  And it's what we get when the clinical community fails to educate and police itself. "Our remedies oft in ourselves do lie..."  And when they don't, we get new laws.  Look for this approach in a state legislature near you...

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 

Thursday, August 20, 2015

We Have to Do Better Than Statistically Significant

Researchers from the Bloomberg School of Public Health at Johns Hopkins have published a paper in the Journal of the American Medical Association looking at the impact of opioid prescribing in Florida after PDMP and pill mill reforms were put in place.  The results are "statistically significant." But statistical significance and public health impact are clearly two different things.

(You can read the abstract and purchase the study here.  You can read a synopsis here.)

The study compared opioid prescribing in Florida and Georgia, an attempt to measure one state's behavior vs. a "control" state that did not implement the reforms that Florida did (at least during the period of study from July 2010 to September 2012).  The results, in a nutshell:

  • 1.4% decrease in opioid prescriptions
  • 2.5% decrease in opioid volume
  • 5.6% decrease in MED per transaction
While we should be celebrating any decrease in opioid use, these statistically significant reductions aren't altogether different than the data we're seeing from our industry's PBM drug trend reports measuring national changes in opioid use.  My reaction to both this study and the PBM drug trend reports is the same: We need to be doing much more to reduce medically unnecessary medications in the treatment of chronic pain.  

Leaving aside some of the shortcomings of this study (the data is from retail pharmacies only) and the frequent confusion among media and industry readers between correlation and causation (something the researchers address, but which is often ignored)... is this really the best we can do?  

It's possible the decreases will accelerate over time.  I'm hopeful that will be the case.  But the detailed results of the study show an interesting phenomena: the reduction in opioid prescriptions written by docs and the reduction in opioid use among patients is very much isolated to high prescribers (80th percentile and above) and high utilizers (80th percentile and above), respectively.  Docs and patients below the 80th percentile actually showed small increases in scripts and use.  

Maybe this shows we're striking the right balance.  Those with legitimate needs still have access while pill mills are being shut down?  Or maybe it shows we still have a lot of work to do... and that PDMPs and pill mill legislation, while absolutely necessary, will be nowhere near sufficient to fix the problem.  

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