The Demise of American Medicine: Lawsuits and Federal Legislation

I recently read two news items back to back, one regarding a lawsuit and the other a physician-written editorial in Forbes.  My coincidental consumption of these two items left me wondering about the fundamental practice of medicine in the 21st century.  

Much has been made in the last couple of days regarding the lawsuit filed by two California counties against five large drug makers for waging a "campaign of deception" to inappropriately promote use of potent painkillers like Oxycontin.  Tom Lynch provided an insightful overview of the suit, particularly in his emphasis on the lawsuit's intentional and powerful analogy to the tobacco fight of the last century. 

Irrespective of the lawsuit's legal standing and chances of success, I find the nature of the suit itself to be a sad commentary on the nature of the medical profession.  No one directly employed by any of these pharma companies ever wrote a single script for an opioid.  Physicians wrote the scripts.  Some were ill-informed (purposefully, the suit claims).  Some were improperly influenced (despite their better judgment, one can only assume).  And some openly championed the broader use of opioids as Key Opinion Leaders (KOLs), paid handsomely by the pharma companies to do so (leading, no doubt, to the aforementioned ill-informed group of physicians).      

Add to this Dr. Scott Gottlieb's piece in Forbes, "How American Doctors Lost Their Professional Autonomy."  He outlines the practical implications of the Sunshine Act, which requires doctors and pharma companies to disclose virtually every interaction they have with one another, from the ubiquitous giving away of simple pens to the $50,000 consulting fees paid to some doctors.  Gottlieb points out that this act is emblematic of a broader principle: "Underneath the imposition of the Sunshine Act is a far more troubling revelation: Washington has little faith in American physicians, and sees a need and a license to regulate just about every aspect of medical practice, even trinkets doctors receive.  There's a clear view that doctors can't be trusted to have any financial interactions with drug and device makers, no matter how small or simple these transactions."  He further cites the fundamental failure of professional medical societies to engage in any meaningful self-regulation, thus ceding that duty to the federal government.  Gottlieb calls this "the demise of American medicine."   

There are many, many more good doctors than bad.  But the bad doctors are certainly making it harder on the good ones to operate with the professional autonomy most doctors believe is required to deliver sound medical care.  

So where does that leave us?

Michael 

Follow me on Twitter @PRIUM1

Medical Marijuana: The Decision that Never Should Have Happened

Two of the biggest questions around the legalization of marijuana are: 1) whether or not the carrier or self-insured employer is going to have to pay for it; and 2) whether or not that payment violates federal law.

New Mexico just answered the first question for payers in their state.  The Court of Appeals just released its decision in the Vialpando v. Ben’s Automotive Services and Redwood Fire and Casualty case, in which they upheld the WCJ’s decision to require the carrier to reimburse the injured worker for his medical marijuana expense.

Under the New Mexico Workers’ Compensation Act, an employer is required to provide the injured worker “reasonable and necessary healthcare services from a health care provider.” Section 52-1-49(A)  The decision focuses on the definition of health care provider, and whether or not marijuana is a prescription drug or a service.  At no time does the court bring up the fact that the treatment with medical marijuana might not be medically necessary nor in line with evidence based medicine. 

New Mexico recently adopted medical treatment guidelines, and on July 1, 2013, the Official Disability Guidelines went into effect and all medical services rendered pursuant to the most current version of ODG is presumed reasonable and necessary. 

With respect to the use of medical marijuana, the Official Disability Guidelines state that medical marijuana is “not recommended for pain” treatment.  Therefore, it is unlikely that a health care provider in that state could consider it reasonable and necessary treatment.

Perhaps the issue of reimbursement, which could potentially violate federal law, could have been avoided altogether by making an evidence based medical argument first, and the legal/procedural argument next.  After all, we are ultimately talking about appropriate medical treatment, which is a clinical issue that should be discussed and determined by clinicians, not lawyers and judges.

Your thoughts?

Michael

Follow me on Twitter @PRIUM1

Great Data/Studies to Start Your Week

A paper published this week by Accident Fund Holdings and Johns Hopkins University on physician-dispensed medications offers incredible insight into the costs associated with doctors dispensing medications directly from the office to injured workers.  The work is particularly valuable not only because it's so thorough, but because it examines total cost of claims.  There are lots of great statistics here, but the one that jumped out at me: the average claim in the study for which there was never a physician-dispensed medication incurred total claim costs (medical + indemnity + other) of about $33,000.  The average cost incurred on a claim for which there was at least one physician-dispensed opioid?  Almost $57,000.  That's a 70% increase.  (With the analysis controlling for gender, age, acuity, etc.)  Wow.

CWCI has published a research update on use of Schedule II and III medications in the CA work comp system.  The analysis is great, the results are not.  The use of both S-II and S-III opioids ticked up through the first half of 2013 from levels observed in 2012 (19.3% of all prescriptions were S-III, up from 19.0% in 2012... and 7.3% of all scripts were S-II, up from 7.2% in 2012).  Perhaps most notable is that CWCI estimates that nearly half of S-II opioids used in workers' compensation are for minor injuries, where medical evidence doesn't support the use of opioids (nor do the FDA labels on long-acting/extended-released opioids).  If we're spending approximately $1.5 billion on opioids in work comp and we estimate that $750 million of that is inappropriate... What does that mean for injured workers?  What does that mean for state workers' compensation systems?  What does that mean for the PBM industry?  What does that mean for your business?   The implications are significant.  

Finally, there was a piece last week that aired on NPR that should be required listening/reading for everyone in workers' compensation.  We've known for some time that low back injuries are frequent, surgeries (and subsequent surgeries) often don't appear to help, and that long term opioid use is a typical result.  We also have studies that suggest what injured workers with low back pain need to do: move!  Don't fear the pain. Get up and exercise.  This piece puts a human voice behind that logic.  Imagine if all injured workers with low back pain (even those who have suffered failed back surgeries) went through this program.  

Have a great week.

Michael
On Twitter @PRIUM1

What if it's the Opioids Causing the Pain?

Roberto Ceniceros wrote a great piece this week on R&I regarding opioid-induced hyperalgesia.  This is a phenomenon observed in some patients on long term opioid therapy in which the opioids actually increase the sensation of pain.

Among prescribers unaware or uneducated on the topic, the patient's legitimate report of increased pain can lead to increased dosage of opioid analgesics, which thus leads to increased pain.  This creates a vicious cycle that can lead to significant adverse effects, including dependence, addiction, and potentially death.

Dr. Marcos Iglesias, medical director for Midwest Employers Casualty, said, "A lot of claimants who are on high doses of opioids are still in a lot of pain.  A big reason for that is the opioids.  Once they are weaned off the opioids, they feel much better and their pain will actually decrease.  So ironically, one of the ways to help their pain is to take away their painkiller."

Add to this recent findings that weaning opioids, even high doses of opioids, in the outpatient environment is not only possible, but leads to decreases in pain scores, depression scores, etc. and we can begin to see the absolute necessity of questioning the medical appropriateness of high dose chronic opioid therapy.

The graphic below is from the CDC.  I wonder to what extent this cascade of negative clinical and social consequences started with an otherwise well-intentioned physician failing to notice signs of opioid-induced hyperalgesia.  

You didn't need any more evidence than you already had to question the medical necessity of long term opioid therapy.  Nonetheless, if you haven't already, it's time to focus on ensuring injured workers under your stewardship aren't being harmed by the very drugs intended to help them.  

Michael 

On Twitter @PRIUM1

Getting past cynicism

For my younger readers who did not understand the Star Trek references in my introductory blog, I will footnote this time!

Objectivity and logic is very important when making medical and financial decisions.  Obviously the TV commercials that give you not one, but two, of the widgets if you buy in the next 10 minutes count on your impulsive nature overriding your logical assessment as to whether you really need the widget.  But the last thing a patient, or Payer, needs is for a treatment plan to be based on the impulse of treating a subjective complaint without thoroughly, logically, and objectively evaluating every potential option available, starting with (and possibly returning to repeatedly) the plan that has the best outcomes with the least side effects.  In this case, you need the capacity of Mr. Spock's dispassionate assessment.

But, on the other hand, a passionate approach to decisions and the way one lives life is also very important.  Not to the extent that some sports fans go, like the Giants fan that was beaten by Dodgers fans after the baseball season opener in 2011.  But the intense desire to do the right thing, sometimes when the right thing is not logical or easy.  In this case, you need the ability to move forward against all odds, like Captain Kirk.

In our Work Comp industry, the easy claims (slight injury, patients motivated to return to health and work quickly) are not the ones that occupy the time of the various stakeholders.  Instead, the claims where the patient is unmotivated, or the treating physician is a “bad actor”, or the plaintiff’s attorney is litigating everything … those are the ones that occupy the most time, create the most frustration, and can create an attitude of cynicism or ambivalence.  Then it is easy to lose both objectivity and passion, which reduces the ability to make good decisions.

Our organization received a compliment (at least from my perspective) yesterday from one of our clients.  When asked why he was impressed (and he does not impress easily), the immediate response was “because you care”.  Our passion to do the right thing, clinical for the patient and financial for the Payer, was evident to him during our interactions.  The challenge, for all of us, is to maintain both objectivity and passion even though our daily circumstances might try to steal that away.

In this together – Mark Pew

On Twitter @PRIUM1

PDMP: From Data Collection to Meaningful Action

PDMP's:  Transitioning from data collection to action

There has been a lot of discussion regarding Prescription Drug Monitoring Programs (PDMPs) lately and the steps that states (other than Missouri) are taking to implement programs and collect prescription data.  This is a great step in the right direction and we at PRIUM believe that data collection is instrumental in addressing the opioid epidemic.  But this is only the first step and almost every state has a long way to go.  In order for participants in the workers' compensation system to make a difference, stakeholders are going to need to push state legislatures to demand action in relation to the data being collected.

Kentucky is moving in the right direction.  Kentucky is one of only four states in the country that have a requirement for physicians to consult the PDMP prior to writing certain prescriptions (NY, TN, and MA are the others).  The state is also using that data to identify providers that may be improperly prescribing.  So far, 46 providers have been identified and reported to the KY Medical Board, resulting in 23 sanctions.

Washington State is sharing PDMP data with the Department of Labor and Industries to inform claims managers and assist in appropriate treatment.  They have initiated an Early Opioid Intervention Pilot with the goal of identifying injured workers' who were being prescribed opioids prior to their workplace injury.  3-4% of new claims each month are falling into this category, representing between 350-500 new claims each month.

Additionally, last July, the Dept. of L&I used data collected through the state PDMP to inform and give insight to the update of their Opioid Guidelines.

Kentucky and Washington have begun the conversion from mere data collection to meaningful action, and both States are reporting significant positive results from their efforts.

Which states will be next?

Michael
On Twitter @PRIUM1

Zohydro: Politicians, Doctors, and Common Sense

In recent months considerable controversy has surrounded the release of Zohydro – a newly patented form of hydrocodone from drug maker Zogenix Inc.  The new formulation was approved by the FDA for sale in the United States last October despite objections by the FDA's own advisory committee (which voted 11-2 to not approve the drug).  Since that time:

• A coalition of addiction treatment experts has urged the FDA to revoke its approval of Zohydro
• Congressmen and Attorneys General from 28 states and the District of Columbia have asked the FDA to reconsider its decision
• Governor Deval Patrick of Massachusetts declared a public health emergency to ban the prescribing and sale of Zohydro (which has since been stayed by a federal court judge)
• A New Hampshire Senate committee introduced legislation that would impose an 18-month moratorium on Zohydro
• Vermont Governor Peter Shumlin devoted his entire annual address to the “full-blown heroin crisis” in the state of Vermont.

While approval and sale of Zohydro is meeting with popular and political objection, medical opinion on the new drug is less congruous.  Zohydro doesn’t contain acetaminophen (like many of the most popular forms of hydrocodone-containing products that preceded it).  Many physicians look to Zohydro for an important clinical tool that might serve as relief for those at risk for liver toxicity and suffering from severe pain.  This is a valid clinical view. 

However…

Annual ED visits resulting from acetaminophen overdose: 56,000

Annual ED visits resulting from opioid overdose: 500,000… 10X that of acetaminophen.

Annual hospitalizations from acetaminophen overdose: 26,000

Annual hospitalizations from opioid overdose: 1,300,000… 50X that of acetaminophen.

Annual deaths resulting from acetaminophen overdose: 450

Annual deaths resulting from opioid overdose: 16,000… 35X that of acetaminophen.

People addicted to acetaminophen: 0

People addicted to opioids: millions

PRIUM has begun to see Zohydro in our peer reviews.  We've only seen a few scripts, but it's clear in the cases we've seen thus far that acetaminophen concerns are not the driving factor for the doctors prescribing the new drug.  Rather, it seems they're simply trying the market's newest opioid analgesic. 

Is the safety profile of Zohydro, due to its lack of acetaminophen, sufficiently compelling for us to ignore the inclusion of yet another opioid in the midst of this epidemic? 

Michael
On Twitter @PRIUM1

Unintended Consequences: Utilization Review and Litigation

It took about a year, but that's about how long these things usually take.  When SB 863 went into effect, many parties, including PRIUM, expressed some concern around the IMR process and whether or not it  would stand up to the challenges that we knew would come.   Claimant attorneys in the state have been busy and we are starting to see the expected results.

In Dubon v. World Restoration, Inc., (cite) the WCAB took back much of the authority that the legislature tried to take away.  UR determinations that suffer from a material procedural defect that undermines the integrity of the utilization review determination no longer fall under IMR's jurisdiction.  Those determinations will now rest with judges and as the WCAB so eloquently put it "a prudent employee" that wishes "to challenge the [...] procedural validity of a UR decision before the WCAB ... will also file a timely request for IMR.  If the employee elects not to file ... the employee does so at his or her own peril".

What does this mean?  We are going to see more requests for both IMR and hearings, as "prudent" attorneys will want to cover all bases, and we will see additional confusion around what constitutes a material defect.  Another case decided last week brought this point up as well.

In Weilmann v. United Temporary Service, the WCAB held that UR decisions must be signed by the reviewer and that they must be provided sufficient information necessary to make the determination on medical necessity.  In this case the insurance carrier failed to provide the AME report to the UR reviewer, now whether or not the burden rests on the physician requesting the treatment or the insurance carrier is a post for another day.  Based on the totality of the circumstances in this case, the UR decision was found to be invalid and the treatment request should be granted (if the judge finds it to be reasonable and necessary).

Lastly, and potentially most impactful, is Stevens v. State Compensation Insurance Fund, being heard by the First District Court of Appeals, in which Ms. Stevens, who is 100% disabled, was denied medical care.  The underlying argument is the one that we were most concerned with from the outset of SB863 and the IMR process: the inability of the injured worker to make an appeal following an IMR denial.

It's been a busy few weeks in California and I don't expect it to slow down.  We will be anxiously watching to see what's next.

Michael
On Twitter @PRIUM1

Zohydro: Let the Lawsuits Begin

Zohydro is here.  The first and only analgesic with hydrocodone as the sole active ingredient, comes to us in non-tamper resistant formulation.  As expected, the debate has been heated.  What may not have been expected are the moves some state leaders are making in attempts to preempt the drug's potentially negative impact. 


A couple of weeks ago, Massachusetts Governor Deval Patrick took a particularly bold step when he declared a public health emergency and, among other things, prohibited the sale of Zohydro within the state. 


Zogenix, maker of Zoyhdro, is now suing the Governor to block the ban. 


FYI... Zogenix stock is up 62% from this time last year, though down significantly from its high in late February (when it was up 210% from April 2013... before the public health community, state and federal politicians, and right-minded doctors starting pushing back.  Since hitting its high of $4.93 on February 25, the stock is down 47% at $2.60 as of this afternoon). 


So who wins?  A well-intentioned governor trying to protect the citizens of his state?  Or the pharma company with a new drug that has FDA approval?


Michael
On Twitter @PRIUM1

Studies You Should Know About

Here's a quick run down on recently published and forthcoming studies to which you should be paying close attention:


On the heels of the recent Kaiser study that showed the safety and effectiveness of outpatient weaning, even among patients on high doses of opioids, comes another (slightly larger) study with similar results.  A study presented at the 35th annual meeting of the American Academy of Pain Medicine showed "patients receiving high doses of opioids show no worsening of pain scores or aberrant drug behaviors after significant dose reductions compared with patients who do not have dose reductions."  Lead author Dr. David DiBenedetto from the Boston Pain Care Center noted, "Despite significant reductions in their opioid doses and the fact that doses were often actually increased in the control group, the outcomes in the areas of perceived functionality and aberrant behaviors were no different between the two groups."  The minimum starting dose of the high dose group was 200 mg MED per day and the average was 508 mg MED/day.


Once again... we can do this... we can do it on an outpatient basis... we can relieve pain, increase functionality, and improve health... we just have to lower the opioid dose. 


My last post on the new ACOEM guidelines highlighted the fact that the longest, placebo-controlled study of opioid use lasted 4 months.  Obviously, nowhere near good enough.  Keep an eye out for the forthcoming POINT study (the Pain and Opioids In Treatment study).  A quick overview:


"The Pain and Opioids In Treatment (POINT) study is a unique study that aims to: 1) examine patterns of opioid use in a cohort of patients prescribed opioids for chronic non-cancer pain (CNCP); 2) examine demographic and clinical predictors of adverse events, including opioid abuse or dependence, medication diversion, other drug use, and overdose; and 3) identify factors predicting poor pain relief and other outcomes. Methods: The POINT cohort comprises around 1,500 people across Australia prescribed pharmaceutical opioids for CNCP.  Participants will be followed-up at four time points over a two year period. POINT will collect information on demographics, physical and medication use history, pain, mental health, drug and alcohol use, non-adherence, medication diversion, sleep, and quality of life."

This could provide very helpful data.

Finally, CWCI is studying the potential impact of a Washington/Texas-like closed formulary on workers' compensation prescription drug costs in California.  I'll be fascinated to see the results.  I believe two things are nearly certain:
1) The potential savings number will be huge.
2) The fight over this in Sacramento will be even bigger. 

Michael
On Twitter @PRIUM1

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