Closed Formularies Control Drug Utilization

In July of 2012 we took a look at the early results of the prescription drug formulary in Ohio and in Texas.  Both were showing signs of favorable results.

Where do we sit 18 months later?  In a word, progress.

The Ohio Bureau of Workers Compensation has recently reported a reduction in prescription drug costs by $22.2 million (16%) since the formulary went into effect. Included in that curtailment is an 18.1% reduction in narcotic prescriptions and a 36.4 % reduction in skeletal muscle relaxants for the first half of 2013 as compared to the first half of 2012.  (BWC Annual Report)

Texas has seen even greater results between its two categories of claims.  For injured workers’ with dates of injury after September 2011, prescription rates of drugs not recommended by the Texas closed formulary dropped 56% - a number matched by a cost reduction of over 81%.  Legacy Claims posted similar results with a 23 % reduction in prescriptions and a 21% reduction in cost. (TDI, Workers’ Compensation Research and Evaluation Group, 2013.)

While the closed formularies are clearly having a meaningful impact on prescription drug costs in these states, the approaches differ quite drastically.  Ohio, a monopolistic work comp state, has implemented a closed formulary that it developed on its own.  Texas is relying on its well established utilization review process and a third party set of guidelines (ODG’s N drugs) for its implementation of a closed formulary.  Take-away: there are different ways of implementing the concept that have been proven to work.    

Closed formularies aren’t implemented over night.  If other states want to start making meaningful impacts to their prescription drug costs at any point in the near future, decision makers had better have some big plans for their upcoming legislative sessions.

Michael
On Twitter @PRIUM1

Fighting Over Fee Schedules

Referencing a new draft bill in Wisconsin seeking to establish a medical fee schedule for workers’ compensation, Mark M. Grapentine, a senior vice president of government relations for the Wisconsin Medical Society, is on the record as saying, “This will cause a holy war at the capital.”

Might have phrased it differently, but I get his point.  He might not even be far off the mark.  There are some big stakeholders involved and one of them (the physicians) wasn’t invited to the table.

A fee schedule seems like a straightforward way to combat medical inflation and workers’ compensation reimbursement severity, but a glance at price and utilization numbers out of Wisconsin wouldn’t suggest such a legislative move is necessary.  The linked article points out, courtesy of the National Council on Compensation Insurance, Wisconsin ranks in the top third of all states considered with one of the lowest average costs per medical claim filed between 2010 and 2012.  Similarly Wisconsin can boast the fewest work days lost to disability by total disability claim of any state.

To some extent, we know what to expect with the implementation of a fee schedule: a negligible impact on utilization and an inelastic price response.  The recent WCRI study on the impact of a fee schedule adjustment in Illinois serves as an excellent case study.  While there was a 30 percent reduction in the Illinois medical fee schedule enacted in 2011, medical prices on average fell 24 percent.  This was accompanied, however, by more frequent billing of costlier and more complex offices visits.

My guess?  This is a result of income targeting.

An implementation of a fee schedule in Wisconsin might similarly leave providers to pursue income targeting – increasing the amount of services provided to maintain the previous income level.  Or it might cause providers to exit the business.  As always time will tell and hopefully someone’s keeping track.

The economic recovery, while slow, is still ongoing.  As employment numbers rise, so do workers’ compensation claims and expenditures.  A fee schedule is a means of controlling costs, but it may do so at the cost of quality services and overburdened physicians.  And lest we forget, the full impact of the Affordable Care Act has yet to play itself out as well.

I’d be surprised if Wisconsin legislators were eager to move on a new fee schedule.

Michael
On Twitter @PRIUM1

The Truth About Lost Prescriptions

If you live in Stillwater, Oklahoma and you lose your prescription drugs, the police will be happy to help you.  You just have to take a lie detector test first. 


Seriously.


Police in Stillwater have begun keeping a database of any citizen reporting lost prescription drugs.  Turns out that local doctors are refusing to replace lost prescriptions without a police report detailing the theft of the original prescription.  And some citizens have apparently filed false police reports in order to secure additional prescriptions.  Now, if you've already filed one report, police will require a polygraph test before any subsequent police report can be made. 


While I'm honestly ambivalent, this policy highlights one of the key factors we often gloss over in the public discussion of prescription drug misuse and abuse: community risk.  Often, our dialog, debate, and discourse are focused on individual patient risk and the clinical safety, or lack thereof, of long term opioid use for chronic non-cancer pain.  Policies such as Stillwater's place appropriate emphasis on the overall risk to the community of over-prescribing opioids. 


The two most common inconsistencies we see from drug test results on our files are a) too much of a particular medication or b) a medication that's supposed to show up that doesn't.  Whenever we see "a", we worry about the clinical risk to the patient.  Whenever we see "b", we worry about the risk to that patient's community, including their immediate family.  Let's face it, those drugs are likely going somewhere.  Even if the injured worker isn't engaged in illegal activity (most often, they're not), those medications not consumed by the injured worker can end up in the hands of friends, neighbors, children, or spouses.  This puts our communities at risk. 


I suspect Stillwater won't be the last place we see this policy enacted.
So... should police require polygraph tests to file a police report for prescription drugs?   
Or have they gone a step too far?


Michael
On Twitter @PRIUM1 

Closed Formularies: Not All Created Equal

Oklahoma is getting ready to launch a "closed formulary."  Among the many reasons Oklahoma is pursuing this regulatory change must be the success enjoyed by its neighbor Texas. 


Texas has seen an 80% drop in the cost of "N" drugs for new injuries as of September 1, 2011.  For those injuries that occurred prior to September of 2011 (referred to as "legacy claims" in the rules), Texas provided for a two year remediation period (September of 2011 to September of 2013) for payers and providers to communicate with one another regarding the applicability of the closed formulary on a claim by claim basis.  This process led to the weaning/discontinuation of "N" drugs on 47% of legacy claims.  Impressive. 


Unfortunately, Oklahoma's version of the closed formulary has zero chance of replicating these results. 


To quote from PRIUM's public comments, submitted to the Oklahoma Workers' Compensation Commission last week:


"The proposed rules identify two groups of claims that will be subject to the closed formulary rules: 
            1.)  Those with a date of injury on or after 11/1/14, and
            2.)  “Legacy claims” – those with a date of injury on or after 2/1/14, but
                   before 11/1/14.

It appears that claims with a date of injury prior to 2/1/14 will not be governed by the closed formulary rules.  If this is the case, this distinction will effectively create two standards of care for injured workers based on their date of injury. 

Other states have countered this problem by applying new laws retroactively with a sufficient transition period for older claims (often referred to as “legacy claims”).  While the proposed rules do identify a particular group of claims as “legacy claims” and allow these claims to benefit from a transition period before they are subject to the closed formulary rules, claims with a date of injury prior to 2/1/14 do not fall within the proposed definition of “legacy claims” and are not made subject to the closed formulary rules.   Because of this, the inclusion of a transition period for legacy claims fails to remedy the problem of disparate standards of care, as older claims (those with a date of injury prior to 2/1/14) do not become subject to the closed formulary rules at any point, not even after legacy claims have become subject to the closed formulary rules on 11/1/16.

We acknowledge that the Administrative Workers’ Compensation Act limits the authority of the Commission, but we sincerely hope that legislature will either authorize the Workers’ Compensation Court of Existing Claims to adopt the Commission’s closed formulary rules, or that the legislature will authorize the Commission to extend the closed formulary rules to affect claims with a date of injury prior to 2/1/14."

So don't get your hopes up regarding the Oklahoma closed formulary.  They have a long way to go, legislatively speaking, before the state can claim to have adequately addressed the problem of prescription drug misuse and abuse within the work comp system.


Michael
On Twitter @PRIUM1

A Critique of the American College of Physicians Position Paper on Prescription Drug Abuse

The American College of Physicians (ACP) just published a “position paper” on prescription drug abuse.  While one might find fault in the details of such exercises (and I do… please read on), one should also commend such organizations for attempting to tackle this very difficult issue.  As the paper states, “the challenge for physicians and public policymakers is how to deter prescription drug abuse while maintaining patient access to appropriate treatment.”  A challenge, indeed.  In fact, it’s one of the most significant public health challenges in a generation. 

The paper includes several very helpful statements, including recommendations for:

-          A national prescription drug monitoring program (PDMP)

-          Consideration by physicians of “the full array of treatments available for the effective treatment and management of pain.”

-          A comprehensive national policy on prescription drug abuse

-          The adoption of evidence-based medical treatment guidelines

On the other hand, several of the other recommendations come with caveats that are hard to explain given the breadth and depth of the prescription drug abuse epidemic.  For instance:

The ACP “supports efforts to education physicians… on the appropriate medical uses of controlled drugs and the dangers of both medical and nonmedical use of prescription drugs.”  However, the ACP goes on to say that “it does not support additional legislative mandates or DEA registration prerequisites specifying education requirements regarding prescribing controlled substances.”  Why not?  “The prevention, identification, and treatment of prescription drug abuse take time, and the significant extra time required to adequately perform this task is not reimbursed.”  I find that a relatively weak rationale for the avoidance of mandatory education in light of the largest man-made epidemic in history. 

Education isn’t the only area where the economics of physician practice run afoul of potential best practices.  “ACP favors a fair and balanced approach to permit safe and effective medical treatment utilizing controlled substances and efforts to reduce prescription drug abuse.  However, educational, documentation, and treatment requirements toward this goal should not impose excessive burdens on prescribers or dispensers.”  I’m not suggesting that it’s ok for the provider community to bear excessive administrative burdens, but the position paper goes on to state that the real issues are potential loss of DEA licensure, state disciplinary actions, loss of medical license, and potential criminal sanctions based on failure to comply with documentation and treatment requirements.  We have reviewed thousands of pages of medical records here at PRIUM and I can vouch for the fact that most of them are awful.  The documentation related to chronic opioid therapy is critical to the physician education the ACP says it supports.  Lives are stake.  Our view: At a minimum, make sure documentation is thorough, accurate, and in compliance with legislative and regulatory standards.  Do it right or face penalties. 

The ACP appears to reluctantly support random drug testing when Medicare, Medicaid, private insurance, or law enforcement authorities identify patients as being at significant risk of drug abuse.  They emphasize that the 3^rd party requiring such testing should pay for that testing (to which I have no objection), but go on to point out that when a third party mandates drug testing, the patient should be informed that the testing will occur on a random basis, patient consent should be obtained, and the procedure should be implemented in a manner that helps maintain the patient’s dignity.  Finally, the ACP points out that this recommendation only applies to third party mandated testing rather than a situation in which a physician includes monitoring as part of an overall treatment plan developed to meet the evaluated needs of a given patient.  Not one mention of the necessity of random drug monitoring to ensure both patient and community safety. 

The ACP position paper is a start, but rather than balancing deterrence of prescription drug abuse with access to appropriate treatment, the ACP appears more focused on balancing deterrence of prescription drug abuse with physician practice processes and economics. 

Michael
On Twitter @PRIUM1

California: What's Working, What's Not

I spent some time recently visiting PRIUM's customers in California, a state that might as well be its own country when it comes to workers compensation (and lots of other things).  Some specific observations based on my interactions with carriers, self-insured employers, TPAs, and attorneys around the issues of chronic pain management and prescription drug utilization:

The IMR backlog is as frustrating as it is predictable.  While the DWC has recently called for a public meeting to gather input on process optimization, the case load continues to mount at Maximus.  My own reading of the publicly available IMR decisions has uncovered some disturbing results (like Maximus case number CM13-0000947, the summary of which states that Valium, Duragesic, and Norco are all "medically necessary and appropriate."  Read further into the detail of the report, however, and each of these three drugs is actually deemed NOT medically necessary and appropriate.  A typo, yes... but a pretty critical one).  The results of the medication-related cases that are being acted upon appear favorable amongst PRIUM's customers that have used our peer review, oversight, and utilization review services.  Until the process is somehow changed, its incumbent upon payers to have an airtight process to avoid procedural errors and ensure predictable, accurate results that are in the best interest of injured worker health. 

Payers are spending way too much on ineffective urine drug monitoring services.  I see broad-based intellectual acknowledgement by payers that drug testing should be a part of any chronic opioid therapy regimen.  But there remains confusion around implementation, pricing, and what to do with the results.  Best practice here is not just to secure a contracted rate with a national drug monitoring vendor, but to develop a process to ensure optimization of the testing process.  This means that injured workers are tested at the right time, in the right place, using the best technology and that the results are communicated to the provider and payer as actionable intelligence that informs treatment decisions (not just a diagnostic test that gets thrown in a file).  We have a long way to go before this kind of methodical approach is commonplace. 

The use of independent medical exams allowed under Labor Code Section 4050 varies widely, but should be used more often.  If PRIUM is unable to engage the prescriber in a peer to peer conversation, we ask ourselves, "is there another way to gather information about the injured worker's care?  Without having to go directly to UR/IMR and all of its timelines, technicalities, and backlogs?"  Several payers in California use these 4050 exams to do just that.  What's more, the results of a 4050 exam may be used in the UR/IMR process later and may (under certain circumstances) be admissible in the AME/QME process (if applicable).  We're always looking for ways to inject independent, objective, evidence-based views on complex cases and this is another tool available to payers in California - more of whom, in our opinion, should be using 4050 exams.

"Functional Restoration Programs" in California are fast becoming a routine, expensive, and ineffective answer to prescription drug overutilization.  Some payers talk about these programs with such disdain and disappointment that it's downright depressing.  I asked every customer we met with, "who do you like?  where should we send them?"  I got a few suggestions, but not many.  The few I got are probably familiar to most payers, but in a state with as big an issue as California, there's a dearth of effective alternative treatment centers for injured workers.

By the way, should anyone disagree with that last point and wish to share other treatment programs in California that have great outcomes... I'm more than willing to listen. 

Michael
On Twitter @PRIUM1

Why Do Doctors Keep Prescribing?

The New Yorker published a great piece on the prescription drug epidemic this week.  The article is written by Celine Gounder, a physician with personal experience dealing with chronic pain patients. 

I found one section of the article particularly helpful in explaining why doctors prescribe these powerful medications even when many of them know it's wrong for the patient:

"The pain-pill epidemic has also forced doctors like me to consider our own role. Doctors have a duty to relieve suffering, and many of us became doctors to help people. But giving that help isn’t straightforward, especially when it comes to chronic pain. Try explaining the downsides of narcotics to a patient while declining to give him the medication he wants. He might accuse you of not understanding because you’re not the one in pain; he might question why you won’t give him what another doctor prescribed; he might give you a bad rating on a doctor-grading Web site. He might even accuse you of malpractice. None of this is rewarding for doctors: we’re frustrated that we can’t cure the pain, and that our patients end up upset with us.

Doctors have a hard time saying no, whether a patient is asking for a narcotic to relieve pain or an antibiotic for the common cold. We are predisposed to say yes, even if we know it isn’t right. Some of us just don’t want to take the extra time during a busy day to explain why that prescription for a narcotic isn’t a good idea. Some of us also use the promise of prescription narcotics to persuade patients to keep their medical appointments, or to take their other medications."

This is the reality in the average physician's office today.  These are the cold hard facts of dependence and addiction.  And this is why the inappropriate use of prescription pain killers isn't going away any time soon. 

This is also why we have to come at these prescribers with more than just medical treatment guidelines that suggest the current drug regimen is inappropriate.  Many of these doctors (whether they openly acknowledge it or not) are already aware that the treatment is outside the boundaries of contemporary medical evidence.

So what do we do?
1) Prevent the inappropriate use of these medications in the first place.
2) Where dependence or addiction has arisen, offer the doctor and injured worker alternatives.  Cognitive behavioral therapy, functional restoration, referrals to a specialist, comprehensive pain programs, etc. 

Is the quality of these various options highly variable?  Yes. 
Are they potentially expensive?  Some more than others, but yes, there's cost associated with these paths. 

But as PRIUM's own Nurse Linda likes to say, "If you're going to take away my Hershey Kisses, you have to give me something else."  

Michael
On Twitter @PRIUM1

FDA 2013: A Study in Inconsistency

Let's review the recent activities of the Food and Drug Administration in the area of prescription opioids.  If you're scratching your head as you read this, know that you won't be alone:

April 16, 2013:
The FDA announced two related decisions simultaneously.  First, they approved updated labeling (i.e., extended the patent for) Purdue Pharma's Oxycontin ER in light of its new abuse-deterrent formulation.  Second, the FDA determined that the original formulation of the same drug was pulled from the market in August of 2010 due to concerns about safety.  This means that the FDA will not accept or approve any generic forms of the original Oxycontin ER.  I wrote about this back in May.

This isn't great news for payers, but it's not the worst possible outcome.  Yes, we'll all be paying more for a patent-protected extended release opioid, but I've spoken to many that believe a cheap generic version of this same drug would have created more patient safety issues and more expensive claims over the long term. 

My view: Good news. 

May 7, 2013:
The FDA approves the generic form of Opana ER, despite the fact that the maker of Opana, Endo Pharmaceuticals, had reformulated the drug with its own abuse-deterrent technology.  The FDA claimed the new formulation wasn't more likely to deter abuse than the original formulation.  Yes, extended release oxymorphone will be a lot cheaper.  But it will also be a lot easier to abuse, it's street price will be attractive for those who might think of diverting medication, and the consequences (both clinical and financial) will be significant. 

My view: I'm confused. 

But wait, the message gets even more muddled...

September 10, 2013:
The FDA announced label changes to extended release / long acting opioids to indicate that these drugs are appropriate only for "the management of pain severe enough to require around the clock, long-term opioid treatment and for which alternative treatment options are inadequate."  The FDA also mandated label changes to include warnings to pregnant women and a requirement for additional post-market studies on drug safety.  While these changes are unlikely to impact prescribing behavior in the near term, they at least offered a signal from the government that the FDA understood the issue.

My view: Good news. 

October 24, 2013
The FDA formally recommended that the Department of Health and Human Services tell the Drug Enforcement Agency to reclassify products containing hydrocodone to from Schedule III to Schedule II, placing more controls on these drugs.  There are pros and cons to this recommendation and I've talked with many pharmacists who have legitimate concerns about patient access.  That said, the overwhelming consensus appears to be that patient safety and public safety demand that these drugs be more tightly controlled. 

My view: More good news.

October 25, 2013 (the very next day!):
The FDA announced the approval of Zohydro ER, an extended release form of hydrocodone that is likely to come in doses 5-10 times more powerful than existing products containing hydrocodone and which lacks any abuse-deterrent technology.  This approval comes over the objection of the FDA's own advisory panel, which voted in December (11-2) against the approval of the drug.  Further, the study methods used in the approval process were questionable, at best. 

My view: Wait... what? 

I'm certain the FDA holds the view that in each of these cases, the agency responded directly and objectively to the data that was presented.  But historical experience, public health data, and common sense tell us that the FDA still doesn't get it.

I wonder what 2014 will bring.

Michael
On Twitter @PRIUM1

Close to Home: Tragedies Continue

I came to work Friday to learn that a family friend of two PRIUM employees had passed away from a heroin overdose after a year-long struggle with prescription pain pills.  This morning, I found a note in my inbox from one of our physician reviewers about an incredibly sad (and similar) story about a 25-year old New York man who overdosed on heroin after a battle with prescription drugs. 

Sitting on my desk is the latest copy of Business Insurance with a front page article about the risks facing physicians who attempt to wean or discontinue prescription drugs.  Some doctors feel threatened by some addicts who appear to be willing to inflict physical harm or engage in violence in order to get what they want.  The story was light on actual statistics, but the phenomenon is real.  We hear about it all the time among the prescribers we engage. 

I read last week about Joe Paduda's survey on opioids in work comp.  "Here's the key takeaway," he wrote, "most respondents understand the problem and know (generally) what needs to be done, but their organizations aren't doing many of the things they should be."  I couldn't possibly agree more with that statement. 

Depressing, right? 

Time to roll up our sleeves and work harder.  We have to do more to educate, to engage, to change this destructive pattern of "treatment."

The note from PRIUM's physician reviewer summed it up: "Please, please, please keep pushing your message.  I keep trying to tell my [peer to peer] providers that this is not about the money!"

There's no doubt in my mind our efforts help save payers money.  There's no avoiding that, frankly.  But we're helping to improve people's lives and, in some cases, save people's lives. 

Happy Monday.  Let's get to work.

Michael
On Twitter @PRIUM1

Rx Abuse: Where Does Your State Stand?

The National Safety Council just released its report on state efforts to combat prescription drug abuse.  The news is not good.  According to the report, only three states (Washington, Kentucky, and Vermont) met the standards outlined in the report. 

A few observations:

First, the standards established by the report are a good, solid start for preventing prescription drug abuse.  They include assessment of Prescription Drug Monitoring Programs (PDMPs), how states deal with pill mills, whether states have clear prescribing guidelines, and what states are doing to educate prescribers.  Let's keep in mind, these are the basic building blocks of prevention, not aspirational, unattainable goals.  And yet we have 47 states that can't get their act together.

Second, ask yourself why that is?  What's preventing those 47 other states from enacting the legislative and regulatory changes needed to help prevent prescription drug abuse.  Ask yourself which groups are standing in the way of necessary change. 

Third, ask yourself why workers' comp carriers and self-insured employers can't lead out on this issue at the state level?  I know, laughable.  Work comp leading the way?  In what parallel universe am I living?

Think about it, though. 

Work comp experiences this problem in a very unique way.  The vast majority of medical issues faced in our industry are fundamentally related to pain.  We should be getting better at managing it, right?  At a minimum, we should be learning from our mistakes. 

We have great guidelines.  Some are better than others, but overall, we've spent a lot of time in work comp over the last several years developing the tools we need to assess the medical necessity of medications.

We have a somewhat insulated regulatory bubble that allows us to experiment with new ideas.  The Texas Closed Formulary is a great example.  Look what happens when you require pre-authorization for a certain set of drugs.  Lots of those drugs never get prescribed.  How can we translate that idea into the broader fight against drug abuse?

PDMPs are a great concept, but only insofar as prescribers are using them.  Outside of Kentucky, New York, Massachusetts, and Tennessee, consulting the PDMP before writing a script is optional.  How can work comp payers (and their vendors) influence the voluntary use of PDMPs?  We ask about it on every peer review we conduct.  If the information is there, why wouldn't you look?

Think about it.

Michael    
On Twitter @PRIUM1

 

FDA Mandates Opioid Label Changes

The FDA yesterday announced that it will require fairly significant changes to the labeling of all extended release and long acting opioid analgesics.  First, the good news:

A drug's "label" is the tool the FDA uses to inform the physician community of the approved uses, risks, and safety concerns of all drugs it approves for use.  Going forward, the labels for all extended release and long acting (ER/LA) opioid analgesics will include the following changes:

1) "ER/LA opioid analgesics are indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate." 

This effectively removes the current indication for ER/LA opioid analgesics for moderate pain and focuses the indication for ER/LA opioids on severe pain only.  This may not seem like a big deal (and as you'll read later, it may lead to little change in prescribing behavior), but the FDA has taken a clear stand here - ER/LA opioids are dangerous and should not be used for anything but severe pain. 

2) "The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief."

This statement is essentially reflective of the FDA catching up with what we've practically known for some time - these drugs are dangerous at any dose and should only be used to treat patients for whom all other potential treatments have been tried and failed.  Now, however, conversations with prescribing physicians who have not tried alternative treatments can be based, at least in part, on a conversation around why they're prescribing ER/LA opioids "off-label".  While they have every right to do so, this creates an opportunity to educate the physician community about the new FDA label language. 

Finally, the new labeling will also include warnings about the potential for Neonatal Opioid Withdrawal Syndrome (NOWS), one of the saddest consequences of the opioid epidemic.  And FDA is also going to require more post-market safety studies focused on addiction and abuse issues. 

All great news, right?  It's a good sign, but its unlikely to impact prescribing behavior in the short term.

The FDA does not regulate the practice of medicine.  While the new label language will slow down pharmaceutical marketing efforts (albeit temporarily), prescribing physicians are still free to use medications as they see fit, even beyond what the FDA label indicates.

So there's still a great deal of work to do.  But the FDA has used its authority, however limited, to help us fight the battle against prescription drug misuse and abuse.

Michael
On Twitter @PRIUM1

Surveys and Guides: Mapping Out Opioids in Work Comp

I just finished reviewing two of the most recent industry pieces on opioids in workers' compensation: first, CompPharma's Tenth Annual Survey on Prescription Drug Management in Workers' Compensation and second, the IAIABC's Policy Guide for Reducing Inappropriate Opioid Use in Treatment of Injured Workers (you have to register to get a copy).

The most significant insight from Joe Paduda's CompPharma survey is that despite the appearance of the industry having drug spend under control, respondents to the survey still see opioids as a "very significant problem, giving it an average of 4.8 [on a scale of 1 to 5].  This remains the highest score for any question in the history of the survey." 

My take: While the most of the PBM drug trend reports and industry trade journals seem to celebrate when opioid spend is flat or slightly declining year over year, the payer community is smart enough to realize that a 2-3% drop in opioid spend isn't nearly sufficient to stem the long term clinical and economic impact of inappropriate utilization.  Letters to physicians, generic conversion programs, and peer reviews aren't enough.  I don't think we'll see that 4.8 score come down until we're seeing opioid utilization dropping by double digits in year over year results.

As the report concludes, "If the industry and individual companies within the insurance and reinsurance industry do not meet this challenge head-on, acknowledge it and develop effective programs to prevent, identify and treat abuse, misuse, addiction and dependency, we will almost
certainly see the bankruptcy of several workers’ comp insurers over the next decade.  It remains to be seen if insurers grasp the seriousness of this issue before it is too late."

Regarding the IAIABC Policy Guide, I have been tough on this organization over the last year due to the fact that the Executive Committee shelved the model legislative and regulatory language it had worked on for a year.  That said, this new policy guide will serve as an a solid conversation starter in state capitals through the country.  Policy recommendations include inter-agency coordination, adoption of treatment guidelines, exploration of pre-authorization and formulary requirements, the necessity of drug tapering, the need for continuing education for physicians, the need for every state to have a functioning prescription drug monitoring program, and a discussion of what a "fast track" dispute resolution process should look like when questions of medical necessity cannot be collegially determined.  The guide also includes many helpful references to specific and successful state programs. 

The IAIABC Policy Guide isn't perfect.  Perhaps out of sheer necessity and obvious resource constraints, the guide glosses over the gritty detail in its examples of certain legislative language and regulatory programs - and as we all know, that's where the success or failure of such things if often determined.  That said, the guide is a great overview of the topics that a state workers' compensation program or legislative body needs to consider and it contains enough detail to inform conversations about how best to deal with the crisis of opioid misuse and abuse within the system. 

Michael
On Twitter @PRIUM1

Contrasts: Overdose Awareness Day and Doctors Who Still Don't Get It

Overdose Awareness Day is Saturday, August 31.  Events are scheduled all over the world to remember those who have fallen victim to drug overdoses and to try to prevent future human tragedy.  This is a day that should remind all of us that there are risks associated with opioids that must be dealt with in clinically responsible ways - or such human tragedy will find its way to your company, your claims organization, your desk. 

Contrast this forthcoming day or remembrance with a letter PRIUM received today from a treating physician with whom we were attempting to conduct a peer-to-peer conversation. 

Many of PRIUM's employees have inserted into the signature block of their emails the following quote of mine from a previous blog post:  "We must do everything we can to stop addiction before it starts, provide alternative non-pharmacological therapy whenever we can, and help safely wean those already addicted to medications that are doing more harm than good.  This won't be easy, and it won't be cheap, but we have to do it anyway." 

Today, I was handed a letter from a treating physician that read, in part: "The goal of the PRIUM review process is to force medication changes by the treating physician, whether or not those changes are in the best interest of the patient or the best judgment of the treating physician.  This policy, exemplified by the inflammatory mission statement on PRIUM's correspondence [and he quotes the above statement]."

Other than being a poor excuse to avoid what would have otherwise been a helpful peer to peer conversation, this doctor completely misses the point of my statement.  Not to mention that I made those comments at the end of a post about a young man that had overdosed on Adderall - a drug prescribed by his physician despite his physician's awareness of his addiction. 

I want to be perfectly clear on this point:  the quote does NOT say "we must do everything we can to stop an opioid prescription before it starts..."  Rather, it says "we must do everything we can to stop addiction before it starts."  PRIUM physicians routinely suggest that opioid medications be continued for patients exhibiting documented functional improvement along with reduction of pain.  And we'll continue to do so. 

We simply see too many instances in which opioids are being prescribed, dispensed, and potentially consumed without any clinical evidence that the drugs have any positive impact on the patient's quality of life and ability to function. 

So... I'll take time to reflect on Overdose Awareness Day about what we're currently doing and all the work that still needs to be done to mitigate the risks of prescription drug misuse and abuse.  And I'll hope that doctors like the one that wrote this letter will have the courage to engage, to listen, to learn.

Michael  
On Twitter @PRIUM1

Exciting News from PRIUM and Ameritox

This press release went out this morning.  Lots more to come, but our collective fight against prescription drug misuse and abuse got a lot stronger as of this morning...

Ameritox Acquisition of PRIUM Expands Suite of Services

BALTIMORE, Aug. 6, 2013 /PRNewswire/ -- Ameritox, the nation's leader in pain medication monitoring, is proud to announce the acquisition of PRIUM, a leading provider of medical cost management services currently serving the Workers' Compensation market.

"We are extremely excited about the opportunity to bring the unique capabilities of these two great companies together," said Ameritox CEO Scott Walton. "Employers are increasingly aware and concerned about the quality-of-life issues and financial ramifications that the epidemic of prescription drug abuse and misuse is having on their employees, particularly the injured worker. Just as Ameritox pioneered the market for prescription drug monitoring, PRIUM has pioneered a unique set of services on the medical management side of the equation."

Ameritox's mission is to help improve clinical care for patients while at the same time preventing the human tragedy associated with the misuse, abuse and diversion of prescription drugs. Similarly, PRIUM is focused on helping to reduce inappropriate use of prescription medications in the Workers' Compensation market, where more than 20% of claims include a prescription for narcotics such as pain medications.

"The proper use of prescription medication is central to each of our missions," said Michael Gavin, President of PRIUM. "By combining our expertise we can each have a greater impact on quality clinical care. PRIUM is an outstanding fit for Ameritox's expanding business portfolio and we look forward to broadening our services."

Both companies will continue to function as separate entities. Aiding the acquisition, Katten Muchin Rosenman provided legal advice to Ameritox. For PRIUM, SunTrust Robinson Humphrey acted as exclusive financial advisor and Nelson Mullins Riley & Scarborough LLP provided legal counsel.

About PRIUMPRIUM sets the industry standard for workers' compensation medical interventions through its ability to secure higher agreement rates and enforce modified treatment plans. The hallmark of the medical intervention company's success is a collaborative physician engagement process encompassing evidence-based medicine, clinical oversight, and jurisdictional guidelines to ensure optimal financial and clinical outcomes, particularly for patients on chronic opioid therapy. PRIUM eliminates unnecessary treatment through a comprehensive approach that includes complex medical interventions and utilization reviews. Based in Duluth, Ga., PRIUM can be reached at www.prium.net or 888-588-4964. For insight on workers' compensation medical issues, read PRIUM's blog at www.priumevidencebased.com.

About AmeritoxAmeritox is the nation's leader in Pain Medication Monitoring Solutions^SM, offering specialized laboratory testing and reporting services. Ameritox's expertise and innovative science provide physicians with the information and support they need to enhance and optimize the care of chronic pain patients. Monitoring through prescription drug testing can help physicians make more informed clinical decisions while also helping to reduce the possible risk of misuse, abuse or diversion of powerful medications. Ameritox is headquartered in Baltimore, Md. with laboratory facilities in Midland, Texas and Greensboro, N.C.Ameritox can be found online at www.ameritox.com, on Twitter @Ameritox, on Facebook at facebook.com/ameritox, and on YouTube at www.youtube.com/ameritox.

© 2013 Ameritox Ltd. All rights reserved. Ameritox, Ameritox-Medication Monitoring Solutions, Rx Guardian, Rx Guardian INSIGHT and Rx Guardian CD are trademarks of Ameritox. Other trademarks are the property of their owners.

SOURCE Ameritox

On Twitter @PRIUM1

IMS Report on Responsible Medication Use is Irresponsible

The IMS Institute for Healthcare Informatics published a report last month entitled "Avoidable Costs in the US Healthcare System: The $200 Billion Opportunity from Using Medicines More Responsibly."  My initial reaction, before reading a single word of the report, was the $200 billion seemed a little low in light of what we know about the opioid misuse epidemic in this country and it's relation to chronic pain - a condition that the Institute of Medicine has labeled a $600 billion per year problem by itself. 

So you can imagine my surprise when I didn't find a single mention of opioids, pain killers, chronic pain, or medication abuse in any of the 58 pages published.  Instead, I found an advertisement for the broader pharmaceutical industry disguised as a research piece.  "Using Medicines More Responsibly," it turns out, is code for "Use More Medicine... and Let's Temporarily Forget About the $56 billion Global Pain Management Component of the Pharmaceutical Industry and the additional $600 billion in Medical Spend, Lost Work, Criminal Justice, and Destroyed Lives it Costs Us." 

On the IMS web site, you can look at the Top 20 Therapeutic Classes in 2012.  Pain is #2 on the list... yet we see no mention of it in this report. 

The report is focused almost entirely on promoting medication adherence for chronic diseases like diabetes, congestive heart failure, hypercholesterolemia, and osteoporosis.  No doubt this is an important set of strategies for managing costs in the overall healthcare system, but to claim that a report is focused on cost savings derived from responsible medication use and to avoid any and all mention of chronic pain and it's attendant misuse of opioids, muscle relaxants, antidepressants, and several other classes of medications is absolute nonsense.   The only recommendation in the report that could possibly lead to lower revenues for the pharma industry is in the area of misuse of antibiotics.  Seriously.  The other five areas of recommendations will either lead to more prescription drugs in the healthcare system or maintain the rate of prescriptions already being written.  I was temporarily optimistic when I read the title of one particular section, "Delayed Evidence-Based Treatment Practice," hoping to read something about the fact that the medical evidence suggests little to no benefit for long term opioid use.  But alas this section speaks mainly to the need for diabetes research to work its way into clinical practice more rapidly.

IMS has unparalleled access to data.  I wish they'd use that data to help us better understand the true economic magnitude of the opioid epidemic in this country.  I don't think they'll do that, though.  A primary source of revenue for IMS... is the pharmaceutical industry. 

Michael
On Twitter @PRIUM1

Obesity as a Disease: All About the Economics

The American Medical Association has decided to recognize obesity as a disease.  This is a mistake, but not for the reasons you might initially think.

Let’s establish the logic behind the AMA’s decision.  There is no new study, no new statistic, no new discovery that has led the AMA to this decision.  This is about money, plain and simple.  And while I don’t object to the decision on these grounds (economic incentives can be powerful tools for behavior change), I’m not convinced the AMA has thought this all the way through. 

There is increasing frustration in the physician community around the expectation of doctors to “treat” what was previously the symptom or co-morbid condition known as obesity.  The time spent counseling patients on diet, exercise, weight loss programs, and underlying behaviors impacting weight has not been adequately reimbursed by government or commercial payers.  Thus, physicians are left with the need to treat a condition without an explicit payment mechanism for such treatment.  I understand and acknowledge that this has a negative impact on physician practice economics and/or on the overall health of obese injured workers and other patients. 

But calling obesity a disease will result in a plethora of unintended consequences. 

First, we risk creating a new fee stream to doctors that may yield little progress in the fight against obesity.  Altering physician behavior through economic incentives doesn’t necessarily translate to altering patient behavior.  This decision by the AMA (and the subsequent legislation introduced in Congress to mandate Medicare coverage of obesity treatments) is emblematic of the most basic flaw in our health care system: placing the physician at the center of the system instead of the patient.  We've been on this path for several decades now and it's not working for us.  If we're going to have a discussion about economics and obesity, let's center that discussion around the patient, not the doctor.    

Second, the economic basis for this decision is deeply rooted in the fee-for-service world in which we currently live.  While I believe the death of the fee-for-service model is greatly exaggerated by some, there is an undeniable movement toward outcomes-based payment structures for providers, both hospitals and individual doctors (the rise of the Accountable Care Organization being the most notable among such structures).  I don't know how long the transition will take, but I do believe the AMA will some day regret the classification of obesity as a disease.  When the time comes that physicians are paid NOT for mere diagnosis and treatment, but rather based on the actual weight loss of obese patients, doctors will face the harsh reality that physician accountability and patient accountability are not one in the same. 

Most physicians (but not all) would rather get paid for the treatment they render or suggest.  In a fee-for-service model, obese patients aren't likely to experience issues with provider access.  But when payment streams are linked to outcomes, will that remain the case?  When a physician's paycheck is subject to whether a 300 lb. patient can drop meaningful weight, how many physicians will be willing to see that patient?  Accountable Care Organizations will develop risk-adjusted models for measuring outcomes, but these models will be inherently complicated and difficult for the average physician to grasp.  The point here: in an attempt to create access and funding for the treatment of obesity in a fee-for-service world, the AMA may have inadvertently thwarted future access and funding for obesity in an outcomes-based payment environment.

The fight against obesity should be about accountability and responsibility, but we should be focused on the accountability and responsibility of the patient, not the doctor. 

Michael
On Twitter @PRIUM1

September 16, 1877: The Ghosts of Opioid Addiction

September 16, 1877
A letter written by Tom Barlow, catcher for the Hartfords:
“It was on the 10th of August, 1874, that there was a match game of baseball in Chicago between the White Stockings of that city and the Hartfords of Hartford, now of Brooklyn. I was catcher for the Hartfords, and Fisher was pitching. He is a lightning pitcher, and very few could catch for him. On that occasion he delivered as wicked a ball as ever left his hands, and it went through my grasp like an express train, striking me with full force in the side. I fell insensible to the ground, but was quickly picked up, placed in a carriage, and driven to my hotel. The doctor who attended me gave a hypodermic injection of morphine, but I had rather died behind the bat then [sic] have had that first dose. My injury was only temporary, but from taking prescriptions of morphine during my illness, the habit grew on me, and I am now powerless in its grasp. My morphine pleasure has cost me eight dollars a day, at least.  I was once catcher for the Mutuals, also for the Atlantics, but no one would think it to look at me now.”

Sound familiar? 

Tom Barlow (who is credited, by the way, with the invention of the bunt) was hurt on the job, received care from a physician that, while well intended, resulted in dependence and addiction.  The only difference is that, in 1874, his employer didn't pick up the tab for his addiction like employers do today.

While the scope of the issue is broader and more complicated today, we would do well to keep in mind that addiction is not a new phenomenon - and that we have a responsibility to stop it before it starts or, once a patient is in its grasp, to do everything we can to treat that addiction. 

Michael
On Twitter @PRIUM1

Opioid Education Resources

[Guest post from Scott Yasko, PRIUM Account Executive]

The work comp industry is a relatively small universe and one where a lot of us are very familiar with each other. So I am sure that a lot of you who read this blog received the same email recently from Phil LeFevre of the Work Loss Data Institute. Perhaps the most notable work that this organization does is with the Official Disability Guidelines (ODG) with which we at PRIUM utilize on a daily basis.

LeFevre’s email begins with the line, “I’ll sum up the statistics on opioids in two words: Ruined Lives.” The purpose of his email was to promote ODG’s Opioid Flyer (found here) and at the same time raise continued awareness for the epidemic our industry and this country is currently facing. ODG are of course evidence based guidelines and Michael Gavin has written on this same page a handful of times about how important it is to utilize evidence based medicine as a baseline for care.

But what struck a chord with me and what compelled me to want to share my thoughts is the passion and frustration that shows through in the way in which it was written. This is the same passion and frustration I know that a lot of us share on a daily basis when dealing with this issue. An issue that is front and center in our little corner of the world, and one where the problem is well documented everywhere else, but yet the adherence and desire to work together to combat the opioid epidemic is surprisingly lacking in our society.

It pains me to know that Missouri still does not see the necessity of having a prescription drug monitoring program.  It is frustrating that there are still physicians out there passing out painkiller prescriptions to patients’ outstretched hands as if Rx Halloween comes once a month. Especially considering the well documented cases of bad actors like Dr. Lisa Tseng who was arrested on murder charges and linked to at least 19 overdose deaths; or that of Dr. Rolando Lodevico Atiga who was arrested after writing a prescription for an opioid and a muscle relaxant to an undercover agent who presented him with an x-ray showing injuries to the neck and back … of a dog.

Perhaps what motivates me (and comforts me) is the fact that there are those willing to raise their hand when the questions is posed: What are we going to do? Dr. Andrew Kolodny, President of Physicians for Responsible Opioid Prescribing (PROP) is one such individual taking action against this epidemic. This group’s mission? “To reduce morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe and responsible opioid practices.” We need individuals and organizations like this and we need more calls to action like the one that was expressed in Phil LeFevre’s email. And this is the advice given to the readers about the opioid flyer: “Share it, save it, print it, tape it to the wall if it helps you, your MPN providers, or your loved ones.”

That’s good advice because if you needed a reminder - this IS an epidemic and it is one that dwarfs the size of any we have seen in this country. Prescription drugs are now responsible for more overdose deaths than heroin and cocaine combined. But the transformation of this industry even in just the last couple of years to recognize this issue is commendable. And there is definitely a long way to go and a lot more that needs to be done, but every small effort like forwarding an email or typing up a blog rant is a step in the right direction.

Scott E Yasko
On Twitter @PRIUM1

Abuse-Deterrent Opioids: Great Solution, Wrong Problem

I was asked recently what PRIUM's plan will be when the "opioid crisis" passes.  My first thought was that I'll probably be dead and gone by then (I'm not that old, mind you).  The answer I gave (and which I wholeheartedly believe) is that workers' compensation is the ultimate tail claim business and whether it's opioids or something else entirely, the need for medical expertise on complex claims isn't going away.  Nevertheless, the question got me thinking about the fact that this particular medical management crisis is, in fact, different from past waves of over-utilization exhibited by providers treating injured workers. 

One of the significant factors perpetuating the current struggle with opioid over-utilization is the source of the pills themselves: giant, multi-national pharmaceutical companies with huge marketing budgets and armies of sales reps.  Pain meds are a $7.3 billion market projected to grow 15% by 2017 to $8.4 billion (according to Cowen & Co).  These companies are not inherently evil - in fact, any discussion regarding pain management medications must begin with the fact that there exists a legitimate need for these drugs in the world today.  There is little doubt, however, that our society is experiencing a public health crisis related to the misuse and abuse of these medications.  The pharmaceutical companies themselves, while perhaps suffering from a public relations fiasco, are nonetheless generating incredible economic profit driven, at least in part, by the inappropriate and medically unnecessary use of their products.  (Anticipating objection, let me point out that I am aware of the efforts being made by Purdue, Endo, Pfizer and others to stem misuse and abuse of opioid medications.  I find the effort laudable, albeit largely ineffective). 

This 15% projected market growth is driven by a simple equation that relies on two variables, price and utilization.   How much do the pills cost?  How many of the pills are sold?  If you know both variables, it's easy to arrive at the dollars at stake.  Billions of them, in this case.  In the world of pharmaceuticals, price is a function of patents.  And as Timothy Martin of the Wall Street Journal points out, those patents are being extended in the interests of medication abuse-deterrence. 

I wish to be perfectly clear on this point: I am 100% supportive of abuse-deterrent formulations of prescription opioids.  These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication.  But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).  There is legitimate debate on this point.  I know several well respected clinicians who believe the work comp system would derive greater benefit from the drop in price of the drugs driven by generic conversion than from the protection of patents for branded drugs less likely to be abused by patients. 

To me, though, this conversation is a distraction.  While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem.  The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed.  Very little pill crushing.  Very little intravenous injections.  Very little drug dealing. 

The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins. 

Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue. 

Michael
On Twitter @PRIUM1

On My Desk: A Litany of Legislation

The past couple of weeks have seen a significant number of legislative and regulatory efforts that warrant the attention of anyone working in our industry.  I couldn't decide which one to dig deeply into first, so here's an overview of what's sitting on my desk.  Look for deeper dives into each one over the next couple of weeks.

Florida has managed once again to snatch defeat from the jaws of victory in the battle over repackaged medications.  Senate Bill 662 (and companion House Bill 605) stipulate a compromise approach to pricing for repackaged drugs - 112.5% of the original manufacturer's AWP plus an $8 dispensing fee.  Setting aside for a moment the lack of logic behind differential pricing models for pharmacies and physicians, the larger impact of the legislation will be felt from the repeal of 440.13(12)(c) which smart payers were using to re-price these repackaged medications.  Senator Alan Hays is celebrating the compromise and while I give him credit for leading the fight over the last several years, the outcome is not a victory for Florida payers. 

Minnesota is attempting to update its approach to long term use of opioids.  Senate Bill 1603 (and its companion House Bill 1799) call for the adoption of "rules establishing standards for health care provider treatment."  Such rules are already in draft form and could quickly follow the adoption of the legislation.  Rules could govern such practices as opioid agreements between doctors and patients, frequency and content of follow up visits, and referrals to pain management specialists.

New York is asking for comment on newly proposed medical treatment guidelines for non-acute pain.  Comments are due by June 10.  At first glance, the guidelines appear comprehensive (the document is 90 pages with a sole focus on non-acute pain management).  The question will be: are they sufficiently specific to actually make an impact in prescribing behavior. 

Last, but certainly not least, is Oklahoma's Senate Bill 1062 (all 556 pages of it).  While I do not believe the adoption of this bill will lead to either widespread "opting out" within Oklahoma or widespread adoption of similar legislation in other states, it's nonetheless indicative of broader systemic issues and frustration around the workers' compensation. 

Michael
On Twitter @PRIUM1