New ACOEM Opioid Guidelines: I Hope You're Sitting Down

Reed Group has published revised ACOEM Opioid Guidelines.  I hope you’re sitting down. 

These new guidelines are comprehensive, impressive, and should change the way you think about opioid use.  The question is no longer whether or not the medical evidence supports the view that long term opioid use is rarely appropriate.  The question now is: will your claims organization have the courage and wherewithal to use these guidelines to ensure patient safety and improve clinical outcomes?

A few highlights: 

Remember all of the discussion, education, and effort your claims organization went through to understand the concept of morphine equivalent dosage (MED) and the threshold of 120 mg MED daily, above which the risk of negative health consequences (like, for instance, death) rose significantly?  Well, after reviewing 960 references and 157 separate studies with 27 external peer reviewers, ACOEM has given us a new threshold…

50 mg daily MED. 

And they’re right.  The 120 mg MED threshold often comes too late in the treatment process to make meaningful impact and the clinical risks are observable at much lower dosage.   Here’s the proof (in laymen’s terms, the hazard ratio is the comparative or relative risk associated with a certain treatment vs. the control group.  In this case, MED at 50 mg/day suggests a death rate 3-5 times that of the control group). 

Remember how I’m always going on about the fact that there are no studies that support the long term use of opioids for non-malignant chronic pain management?  It’s nice to put some data around that statement:  the longest placebo-controlled trial lasted only…

4 months.

Specifically, of the 67 high-to-moderate quality placebo-controlled clinical trials addressing opioid use for chronic pain, 52% lasted a single month, 12% lasted 1-2 months, and 34% lasted 3 months.  There was a single trial that lasted longer than three months (and it lasted only 4 months). 

You know the pharmaceutical commercials that list all of the adverse side effects one might experience while on the medication?  The new ACOEM guidelines provide a list of those side effects in relation to long term opioid use.  Ready?

Heart attack or sudden death

Fainting on standing up
Sudden death
Nausea, abdominal pain, early satiety
Constipation, bowel obstruction
Abdominal pain
Urinary retention
Impotence or reduced sex drive and erectile dysfunction, osteoporosis, feminization, reduction of muscle mass, reduced strength
Reduced or abnormal menstrual periods
Fatigue, low blood pressure, electrolyte changes
Hastening of death if cancer is present
Rash, shortness of breath, itchy skin, edema
Outbursts, inappropriate behavior, limit testing, violence, reduced impulse control
Alterations in executive function, emotional response
Slight to severe impairments if an overdose occurs
Problems thinking clearly
Headache
Increased pain sensitivity, increasing doses of opioids/dose escalation
Reduced pleasure in eating, weight loss
Seizures
Increased accident risks and unclear thoughts
Crash risk and reduced functioning
Unsafe operation of machinery, motor vehicles, motor vehicle crashes
Unsafe operation of machinery, falls
Mistaken judgment, changed interactions with other people
Altered mood, depressed feelings,
Suicidal feelings
Birth defects, miscarriage
Newborn babies of mothers on opioids go through opioid withdrawal
Reduced ability to breath during sleep; daytime sleepiness
New or increased problems with obstructive sleep apnea; daytime sleepiness
Pneumonia
Worsening asthma and chronic obstructive pulmonary disease (COPD)

I think I better understand why opioid manufacturers don’t advertise on television. 

Michael
On Twitter @PRIUM1

Abuse-Deterrent Zohydro is NOT the Answer

Purdue Pharma is apparently working on an tamper-resistant formulation for stand-alone hydrocodone that may bump Zogenix's new extended release hydrocodone formulation, Zohydro, from the market.  Purdue's drug has been through final stage trials and the drug company is now pushing for expedited FDA review.  Zogenix is also working on an abuse-deterrent formulation, but that drug won't be ready for FDA review until 2016. 


So is this good news?  One of the most significant concerns about Zohydro is its lack of abuse-deterrent formulation.  Is Purdue going to save the day?


Not from my perspective. 


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).  

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

Where Physicians MUST Check the PDMP

Oklahoma is inching closer to joining the small number of states that require physicians to check the prescription drug monitoring database in a given state prior to writing certain prescriptions.  This isn't a mere reporting requirement; this is a requirement to consult the database and document the results in the medical record prior to writing a script (see section E on page 4 of the bill text). 


Oklahoma Senate Bill 1821 has successfully passed through a senate committee and now heads to the full senate.  The governor's office issued a press release on this, so I'm assuming the bill has a solid chance of ending up on Governor Fallin's desk. 


Should she sign the bill into law, Oklahoma would join Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications.  Like in similar legislation elsewhere, SB 1821 creates exemptions for hospice and other end-of-life care situations.  Further, the bill prohibits lawsuits against physicians for not checking the database.  While a patient couldn't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, prosecution, punishment, etc.


Mandating that pharmacies report prescription drug data into the PDMP is a start.  Mandating that physicians sign up as users of the PDMP is a step.  But mandating that doctors utilize the PDMP before they write a script and mandating they include evidence of database consultation as part of the patient medical record is the key to successful implementation of a PDMP program. 

Otherwise, it's just data sitting in a database. 


Michael
On Twitter @PRIUM1

Research: Weaning Works Wonders

I hear skepticism all the time about the difficulty of weaning patients off of high doses of opioids in the outpatient environment.  Frankly, I hear skepticism about being able to wean them at all, but especially in the outpatient environment.  And when the alternative involves inpatient detox (and its associated price tag), the claim handler often feels stuck. 


New research suggests that not only is outpatient weaning possible, even in light of extremely high doses of opioids, but that the weaning has a positive clinical effect on the patient in terms of pain scores, depression levels, and activities of daily living.


In an admittedly small sample (16 patients), doctors weaned patients on an average of 945 mg morphine equivalent dosage - or MED (with a range of 300 mg MED to 2,960 MED) down to an average of 275 mg MED (with a range of 0-750 mg MED) over an average of 17.4 weeks. 


The patients' average pain scores (measured via the Brief Pain Inventory) dropped from 7.2 to 4.9 and their average depression score (measured via the Patient Health Questionnaire-9) dropped from 13.5 to 9.5.  The results were statistically significant. 


The next step is clearly to replicate the research on a broader set of patients.  That said, this research confirms what we're seeing at PRIUM among the legacy claim work comp population on high doses of opioids. 


We can wean these patients.  We can do it on an outpatient basis.  They will get better as a result.  They will cost less as a result. 


Michael
On Twitter @PRIUM1

Doctors No Longer Allowed to Take Patients' Blood Pressure

Ok, that's not true.  But an analogous and equally dangerous law suit is unfolding in Indiana.

In response to our nation’s prescription opioid epidemic, several states have enacted laws to help stem the tide of opioid misuse and abuse.  Notably, Indiana has passed a law requiring that patients prescribed opioids must submit to urine drug testing at the beginning of treatment and at least once a year thereafter.  This type of testing is best practice, guidelines driven, and in the best interests of patient safety.

The American Civil Liberties Union (ACLU) disagrees.  They’ve sued the state on behalf of a chronic pain patient who has been prescribed opioids for 18 years and doesn’t want to submit to mandatory urine drug testing.  The ACLU claims such testing is a violation of this man’s 4^th amendment rights, which bar illegal searches and seizures.

This is like a patient with diabetes suing over a doctor’s assessment of his hemoglobin a1c levels.  Or a patient with high blood pressure suing over a nurse actually putting a blood pressure cuff on the patient to assess his current BP.  Or a patient on warfarin… or a statin… or any other drug that requires constant clinical monitoring to ensure patient safety and efficacy of the medication therapy. 

Urine drug testing isn’t a “gotcha!”  Healthcare providers and patients both benefit from the information collected from such testing.  Important clinical decisions about dosage, efficacy, and side effects are influenced by urine drug testing results.  Though rare, genetic abnormalities involving the metabolism of opioid medications can be discovered through urine drug testing. 

These drugs are some of the most potent and dangerous medications ever devised.  And they are miracle drugs for those who legitimately need them to function on a daily basis or to provide comfort in the waning days of life.  But to ensure safe, proper, and efficacious use of these medications, testing such as that which Indiana mandates is more than just good public policy – its good medicine.

Michael     
On Twitter @PRIUM1

When Judges Get in the Way

Louisiana is a troubled state.

With five Circuit Courts of Appeal, a state law may be interpreted in five different ways.  A new law may be found unconstitutional in one circuit, constitutional in another, and it may be that no constitutional question in raised in the others.  As a result, when the legislature makes a change to the law, it has to anticipate not just one unintended interpretation, but, potentially, five distinct interpretations existing simultaneously.  It also has to anticipate the possibility that none of those interpretations will allow the new law to do what it was intended to do.

Again, Louisiana is a troubled state. 

This is especially true when it comes to workers’ compensation.  The Louisiana State Legislature has made several attempts to promote responsible treatment of injured workers, but it seems that each attempt has been undermined by at least one of the five Circuit Courts of Appeal.

The legislature authorized independent medical examinations (IMEs), but the Fourth Circuit ruled that an injured employee can’t be compelled to attend an IME unless the employer already has medical evidence in its possession showing that an IME is necessary.

The legislature authorized utilization review, but the Third Circuit ruled that utilization review by itself was an insufficient basis for denying treatment.

The legislature authorized the Workers’ Compensation Administration to promulgate treatment guidelines in order to ensure that all injured workers were treated according to a single standard of care based on current medical evidence, but as of January 22nd, all but one of the appellate courts have effectively ruled that Louisiana has two standards of care for workers’ compensation claims.

On January 22^nd, the Second Circuit Court of Appeals found that the medical treatment guidelines authorized by § 23:1203.1 did not apply to those cases because the date of injury in each case predated the effective date of the guidelines: July 13, 2011.

Following this ruling, a doctor treating an employee who was injured on July 13, 2011 will have to comply with an enumerated standard of care based on current medical research .  A doctor treating an employee who was injured on July 12, 2011 will have no such responsibility.

Louisiana law says that there will be new treatment guidelines with new effective dates every two years.  As Judge Caraway’s dissent points out, the majority’s interpretation would create different sets of law for each two year period.

Decisions like these are upsetting -- not just because they fail to address the problem of irresponsible treatment… not just because they create a new problem by creating (at least) two very different standards of care… but because they bind the hands of the only people who can fix that problem.

Michael
On Twitter @PRIUM1

Addiction: Not About "Good Guys" vs. "Bad Guys"

I recently read an appeal by Dr. Kelly Erola, CMO for Hospice Savannah.  She wrote about halting the attack on pain pills and argued on behalf of legitimate uses for opioids – cancer patients undergoing chemotherapy, hospice patients, and patients with serious injuries and acute pain.

She makes an important point.  Opioids are an effective and powerful tool that bring immeasurable relief to individuals suffering severe pain.  Let’s be sure that those individuals always have a means of getting the care and the drugs that they need.

What struck me was the contrast she drew between “law-breaking addicts” and “law-abiding patients.”  In my view, this is a component of our societal struggle with opioids, but misses the most fundamental and dangerous aspect of the opioid crisis: the group that lies in the middle – “law-abiding addicts”. 

Yes, pill mills are a problem.  So is drug diversion.  So is the unintended consequence of illicit drug use.  But the group most in danger is, in fact, the law-abiding patient whose physician is prescribing high doses of opioids to treat conditions such as non-specific low back pain.  Millions of patients are losing out on the benefits of what contemporary medical evidence tells us is most appropriate for the treatment of chronic pain: get up, move, exercise, lose weight, sleep better.  Instead, physicians continue to write prescriptions for powerful pain relievers, leaving us with millions of “law-abiding addicts”. 

Any clinician will rightfully point out that I’m taking certain liberties with the word “addict” here.  Addiction is a real disease characterized by aberrant, drug-seeking behaviors – the very behaviors that often lead to illegal activity on the part of the patient.  The point I’m trying to make is that many of these “addicts” didn’t start out as criminals.  And there are millions of patients not technically addicted, but nonetheless entirely dependent on prescription opioids on a daily basis.  Dr. Erola highlights a single battle in the opioid crisis, but this is where we’re losing the war.

If the public policy distinction was as black and white as Dr. Erola suggests, the solutions would be simpler.  In reality, the problem of prescription drug misuse and abuse goes well beyond a simple matter of “good guys vs. bad guys”.  Any public health or regulatory discussion around opioids has to acknowledge that there are lots of “good guys” (i.e., law-abiding patients) being hurt, too. 

Michael
On Twitter @PRIUM1

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