Friday, May 22, 2015

A Warning to Work Comp Payers

This new ruling from West Virginia's Supreme Court reminded me of a post I first wrote almost exactly three years ago.  I decided to re-post it here today.  This WV case, in a nutshell, says that the illegal acts of the plaintiff (in this case, addicted opioid users) does not disqualify them from taking legal action against the defendants (in this case, physicians and pharmacies) for being at fault for their own harmful acts.  And as Stephanie Goldberg points out in the linked article, work comp payers should be on alert.  It's not a big leap in logic to apply this same line of reasoning to a payer who chooses to finance the addictive behavior of an injured worker instead of intervening to do something about it.

Here's my post from May 25, 2012:

We Know Too Much: New Liabilities Associated with Opioid Abuse

A new ruling from Texas adds to the list of states that have found payers liable for a range of opioid-related side effects ranging from addiction to death. In this particular case, the payer was found liable for death benefits in light of the injured worker's death caused by hydrocodone overdose. This adds to recent rulings in several other jurisdictions (e.g., Pennsylvania, Texas, North Carolina - these are the ones I've seen, I believe there are others) in which payers have found themselves on the hook for death benefits due to drug overdose.

Prediction: This is just the beginning. Why? Because we know too much. And our unwillingness (or inability), as an industry, to apply what we know is going to cause a lot of financial pain over the next several years.

We really do know too much. We have sound, evidence-based clinical guidelines. We have peer reviewed studies (many of which are incorporated into the guidelines) that suggest the limited benefits (and significant harm) that results from chronic opioid therapy. We have thought leaders, in both the clinical and business realms, offering a constant drumbeat of warnings that solutions are needed. We have industry conferences devoted entirely to this issue. We have a growing body of regulatory mechanisms intended to help control opioid misuse (e.g., Texas closed formulary rules, new Tennessee UR rules, Washington's guidelines, etc.) We have public health agencies, including the CDC, calling the issue of prescription drug abuse an "epidemic" and a "public health crisis".

I hear various excuses for why payer organizations aren't attacking the problem with greater force. "Look," they say, "this is really complicated... these people are addicted". Or "we don't have sufficient clinical resources"... or "we're pretty sure plaintiff's counsel is going to come at us pretty hard"... or "we're working on it"... or "our PBM has a handle on it".

Enough. There's going to be noise. Deal with it. We're on the right side of this fight. By taking aggressive action, we have the opportunity to improve overall patient health while simultaneously saving money. This is exactly what our health care system needs.

Let's get to work.

Michael
On Twitter @PRIUM1

Tuesday, May 12, 2015

Two Reasons You Should Care About Hepatitis C

Let's talk about Hepatitis C for just a moment.  

Hep C is a disease of the liver.  It can be mild, nearly asymptomatic... or it can be a lifelong battle, requiring a potential liver transplant.  Hep C isn't genetic or environmental - rather, it's contagious. The virus is spread when the blood of someone with Hep C enters the body of someone who is not infected.  The two most common methods of transmission both involve needles and both impact workers' compensation: 1. accidental needle stick injuries in a health care setting; 2. the sharing of needles and syringes among drug addicts.  

Regarding injuries to healthcare workers... while most payers won't see many Hep C cases that are work comp related, it's best for payers to be prepared if and when a case does arise.  Why?  Because treatment is both complex and enormously expensive.  The recently released Drug Trends Report from pharmacy benefit manager Healthcare Solutions has an excellent section on specialty drugs and a very informative sub-section on Hep C.  "The new Hepatitis C medications, such as Harvoni, Olysio, and Sovaldi, have a treatment success rate of 94-100%, or double that of previous therapies," says the report. "These medications cost $90,000 to $226,000 for a 12 to 24 week course of therapy.  Effectively, a client with a $1 million drug spend could experience a 2% increase in overall drug spend with one claimant receiving these medications." (Emphasis added).  

Regarding Hep C transmission among drug abusers... the CDC's Morbidity and Mortality Weekly published a piece on Friday regarding the growth of Hep C in Kentucky, Tennessee, Virginia, and West Virginia.  Surveillance data from these four states showed a 364% increase in Hep C cases from 2006 to 2012 among persons <= 30 years of age.  This rise was strongly correlated with opioid misuse and abuse rates as well as substance abuse treatment admissions.  While I've often pointed out that the work comp population is not a primary driver of the type of drug abuse that involves drug tampering and needle sharing, we should nonetheless recognize that work comp is a significant source of diversion (both intentional and unintentional), and therefore the drugs being paid for by work comp payers are, at some level, likely contributing to the rise in Hep C cases.

Hep C is complicated and expensive.  Two lessons for payers:
  1. When a work-related Hep C case pops up, put your best clinical resources to work on that claim to ensure prompt, appropriate, adherent, and thorough care; 
  2. Make sure you're doing everything you can to stem the tide of prescription drug misuse and abuse. 

Michael   
Follow me on Twitter @PRIUM1
   



Monday, May 11, 2015

Free Speech, FDA, and Short Selling

I was entertained by an article this morning on workcompcentral regarding a drug manufacturer that is suing the FDA for infringing its right to free speech.  Amarin Pharma is upset that it cannot market its fish oil drug for "off-label" uses.  You can't make this stuff up.

A quick refresher (admittedly oversimplified) on the FDA's role as a regulatory body:  A drug manufacturer discovers (or purchases) a chemical entity which they believe has a therapeutic benefit for a particular disease state.  The drug manufacturer runs studies (typically across three phases) to test both the safety and efficacy of the chemical entity for that specified disease state.  Application is made to the FDA and the FDA evaluates all of the evidence.  If the application is approved, the FDA mandates that the drug only be marketed to doctors, patients, and other stakeholders for the specified disease state on which the research and development were conducted.  The FDA does this through the drug's "label" and any marketing for uses not contained on the label (or "off-label" uses) is a violation of federal law.  

So... if you come up with a drug to manage, say, prostate enlargement... and you conduct years worth of studies on the safety and efficacy of the drug for prostate enlargement... and it turns out, after all that, the drug is also causing men with male pattern baldness to grow new hair... you can't simply change your mind and market the drug for male pattern baldness instead of prostate enlargement.  You have to go back through the phase I, II, and III development process (or, at least, recast the data drawn from those studies) to create sufficient evidence for FDA approval to allow you to market the drug for that purpose.  (This actually happened, by the way.  Ever heard of Propecia?)

The argument being made by Amarin is a great example of unintentional comedy: they feel their free speech rights are being infringed because the off-label uses which they'd like to communicate are "truthful" and "non-misleading."  They should be able to market fish oil for off-label usage... because it really works... trust them.

This comes down to a fundamental question of regulatory oversight:  "Truthful" and "non-misleading" according to whom?  

This is why the FDA exists.  I have been a vociferous critic of the agency for its lack of consistency, its approval of questionable medications, and its lack of emphasis on the public health effects of its approval process.  But I have never questioned the necessity of a third party regulatory agency intended to protect Americans from potentially delusional and dangerous claims of safety and efficacy from the pharmaceutical industry.

By the way, Amarin is publicly traded (NASDAQ: AMRN.)  My investment advice is worth exactly what you're paying for it... but I might think about a short position on any company willing to waste money on this kind of frivolous lawsuit.

Michael  

Wednesday, May 6, 2015

A Legal Challenge to Prescription Drug Monitoring Databases?

Dr. Alwin Lewis was investigated by the Medical Board of California because of an odd diet he had apparently advised patients to undertake.  (The “five bite” diet… don’t eat breakfast, then eat five bites of food for the rest of the day.  I would have demanded an investigation, too.)  During the course of the investigation, the Medical Board uncovered inappropriate prescription patterns in California’s PDMP (the CURES database).  The Medical Board found that he had kept poor medical records and had over-prescribed medications to two patients.  He was placed on three years’ probation. 

And that’s when all heck broke loose…

Dr. Lewis took the case to court, arguing that the Board had gone too far in using information from the PDMP against him.  There’s a lot of confusion here, even by California standards.  Here are some key points to keep in mind:

First, the ACLU, civil rights attorneys, the California Medical Association (CMA), and several other groups are making a lot of noise about this case.  All of them are trying to push this issue far beyond the scope of the challenge that is actually being raised by the Dr. Lewis.  If Lewis prevails, the result will be a revision of the Medical Board’s investigation/disciplinary process, not an invalidation of the CURES statute.

Second, this case is not about protecting patients’ privacy; it’s about protecting patients’ privacy when doing so protects the doctor from a Board investigation.  Lewis has made it clear that this is not a facial challenge to the CURES statute; in fact, he concedes that in most instances, such as in an administrative audit of a pharmacist (but not a physician), pulling a patient’s prescription info is constitutional.  His position is that when a CURES audit is performed “for the express purpose of investigating physician practices,” the auditor should not be able to access patient records without a subpoena, warrant, or good cause.

Third, it’s also about protecting the doctor’s right to privacy.  Lewis is arguing that he has a direct, personal, right to privacy in regards to his prescribing patterns, and that the Board violated that right when they performed the CURES audit of his prescribing history without an administrative subpoena.  While that may sound like a terrible argument, this is California, and so there is actually appellate case law that supports him on that point.  This is actually a central theme in his petition.  He argues that when a pharmacy auditor looks at the medications dispensed to a patient by that pharmacist, neither the rights of the pharmacist nor the rights of the patient are violated; when a physician auditor views the medications prescribed to a patient by that physician, both the rights of the patient and the rights of the prescriber are violated.  Makes complete sense, right?  

The Board’s conduct – however excessive – was aimed at protecting patients.  The PDMP rules are aimed at protecting patients.  The only real danger to the patients’ interests came from the guy that is now trying to pose as their protector in order to get out of a disciplinary action. 

This case, regardless of what you might read elsewhere, shouldn't have a significant impact on PDMP use in California or any other state. 

Michael
Follow us on Twitter @PRIUM1 


Tuesday, April 28, 2015

A Terrible Excuse for a Formulary

I'm sitting in New Orleans, Louisiana at the annual RIMS conference and right down the road in Baton Rouge, the state is about to do something that will put a lot of injured workers at risk.  Ironic, right?

Louisiana Senate Bill 256 is scheduled for a hearing at 10 am central tomorrow.  I hope someone at that hearing points out the following:

1) Evidence based medicine isn't produced by a panel.  The bill calls for a panel (made up of one doctor and four pharmacists) to meet regularly and, by majority vote, decide what changes should be made to the formulary.  This is an awful idea.  Evidence based medicine is developed through peer reviewed research and should be adopted as the evidence dictates, not according to a majority vote.  For a brief glimpse into how guidelines adoption by committee works (or, rather, doesn't work) in Lousiana, check this out.

2) But should the state insist on a committee, we need to move beyond a single doc and four pharmacists.  Where is the voice of the employer on this proposed panel?  Where is the voice of the injured worker?  Wh y does a single doc and four pharmacists get to decide?

3) Worst of all... and the point that will lead to the greatest risk to injured workers... and the part of the bill that shows how very little its authors know about medical management: All "non-narcotic drugs" will be approved and not require pre-authorization.  Since when are narcotics the only dangerous drugs in work comp?  Hydrocodone might require authorization under this bill, but injured workers can have all the benzodiazepines, antidepressants, antipsychotics, anticonvulsants, sleep aids,  muscle relaxants, etc that they'd like.  The distinction between drugs that require authorization vs those that do not shouldn't be based on the drug's class.  Rather, good formularies assess the appropriateness of a given medication for first line therapy, regardless of class.  The approach outlined in SB 256 is worse than silly; it's dangerous.

A closed formulary is a great idea in concept and I genuinely hope to see Louisiana adopt one.
Just not this one.

Michael
Follow us on Twitter @PRIUM1

Tuesday, April 21, 2015

The Worst Kind of "Whack-a-Mole"

I've heard the "whack-a-mole" analogy applied to nearly every facet of business.  Frankly, it's a tired and worn out analogy.  But it's also an image that paints a clear picture of a common issue and, thus, we can't seem to escape its constant use.  We're always solving one problem only to create a myriad of unanticipated and unintentional consequences that require ever greater effort to address.  Hit one "mole" on the head and another quickly pops up elsewhere to take its place.

Yesterday, the Journal of the American Medical Association released a study that highlights the worst kind of "whack-a-mole" imaginable.

The good news: After the introduction of an abuse deterrent formulation of Oxycontin and the discontinuation of propoxyphene in the latter half of 2010, overall opioid prescriptions appear to have declined 19% vs. where we would have expected them to be.  Mind you, that's not a 19% reduction in scripts; rather, it's a 19% reduction vs. a statistical forecast of a line that was trending up.

So where did the next mole pop its head up?

During the same period, there was a 23% increase in heroin overdose.  

We can add this to the list of reasons abuse deterrent opioids are not the answer.

The study does not establish a causal link between the reduction in opioid scripts and the increase in heroin overdoses, but this phenomenon has been a recurring theme in various reports and studies across the country for some time now.  When Massachusetts Governor Deval Patrick declared a public state of emergency in March of 2014, he cited both prescription opioid abuse and heroin overdoses as grounds for his decision.  Is it any wonder that just a week later, Blue Cross Blue Shield of Massachusetts released an 18 month "check up" on its first-in-the-country program requiring pre-authorization for prescription opioids?  In it, BCBS brags that, starting in July 2012, they decreased claims for short acting opioids by 20% and long acting opioids by 50%.  And yet, the Governor is declaring a state of emergency in early 2014?  Could that be due to at least some portion of BCBS members whose Oxycontin was cut off turning to cheap street drugs?  Perhaps because the insurer, in an effort to stem the tide of prescription drug spend (instead of prescription drug abuse) failed to address the underlying medical issues faced by its members?

PRIUM's own parent company, Ameritox, produced a very compelling piece of research based on our own data that shows:

  • 4 out of 5 heroin users abused prescription drugs first
  • 56% of the time, in heroin positive samples, the opioid prescribed to the patient was not found
  • 66% of heroin users abused both heroin and prescription painkillers in the last month
The most cynical among us in workers' compensation will think (though never say publicly), "Fine with me.  I'm not paying for heroin and I can either settle or cease benefits on this claim with relative ease."  

Those of you that care about injured workers will see this data for what it really is - a warning.  A warning that we must be careful and measured and caring in our approach to issues of prescription drug misuse and abuse in workers' compensation. 

We haven't really solved a problem until we've addressed the underlying issues of dependence and addiction.   

Michael
Follow us on Twitter @PRIUM1 

Monday, April 20, 2015

Don't Be Fooled: Abuse Deterrence Isn't the Answer

One of the consistent themes of this blog is a critique of abuse deterrent formulations of opioids.  While absolutely necessary as one tool among many to stem the tide of prescription drug misuse and abuse, such technology runs the risk of creating a perception of safety among both patients and prescribers that is downright dangerous.

The best discussion I've seen on the topic came out last week on Forbes.  In an article and video by Matthew Herper, the pros and cons, risks and rewards of abuse deterrent opioids are covered quite thoroughly.  The video, in particular, is worth 5 minutes of your time.

And, of course, I would never miss a chance to restate my own position on the matter:

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
@PRIUM1 on Twitter

Monday, April 6, 2015

The Fight Comes to My Own Back Yard

Fulton County, Georgia has filed a lawsuit against several of the major drug distribution companies (McKesson, Cardinal, etc.) seeking damages related to the prescription drug abuse epidemic.  I haven't read the full court filing, but it appears this action is similar to West Virginia's approach (i.e., to sue the distributors and not the manufacturers, as the City of Chicago and Orange/Santa Clara Counties in California chose to do).

This suit is interesting for two reasons:

1) It's politically cleaner than the West Virginia law suit.  In that state, the primary law suit left out (at least initially) McKesson and Cardinal, the two largest drug distributors.  Turns out the Attorney General in West Virginia used to be a lobbyist for McKesson and his wife is a lobbyist for Cardinal.  While the legal concept being used by Fulton County of focusing law suits on distributors is similar to West Virginia's, the potential conflicts of interest are absent.

2) I live in Fulton County, Georgia.  I'll have a front row seat for this battle.  My county is a politically, racially, and economically diverse county; but like the rest of America, we have more in common than we have differences.  Among the things residents of Fulton County have in common is that many of us have felt, witnessed, or experienced the impact of prescription drug misuse and abuse.

My community is a lot like yours, probably.  Except that we now have an aggressive and creative legal strategy we're pursuing that may offer a pathway for communities across the country to recoup at least some of the costs we've expended in public health, our judicial system, and our law enforcement agencies.

Or... this could fall flat on its face and prove a waste of taxpayer resources.  I'm not taking a position either way, but I'm fascinated to see how this plays out.

Michael
Follow us on Twitter @PRIUM1

Wednesday, April 1, 2015

Medical Marijuana: Fear Not

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

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

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

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

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

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

Check out the full article here.

Michael
On Twitter @PRIUM1

Monday, March 23, 2015

Data Suggests We Still Have a Long Way To Go

A quick scan of this morning's news shows we have a long way to go in the fight against prescription opioid misuse and abuse.

From a survey conducted by the National Safety Council we learned that:

  • Nine in 10 opioid painkiller users are not concerned about addiction as a side effect, though 60 percent of users have at least one addiction risk factor 
  • 69 percent of opioid painkiller users feel opioids are the most effective medications to treat pain, though research shows this is not true
  • Americans mistakenly believe gun violence, severe weather and commercial airline travel are more significant threats to their safety than opioid painkillers
  • Many Americans do not realize they have taken opioids


  • 42.9% of the 1,285 patients on long term opioid therapy had signed a treatment agreement
  • 62.8% of those patients had been subject to a urine drug test within the last year. 
  • The study's lead author, Laila Khalid, told workcompcentral, "It should be 100% adherence."  

So once more unto the breach, dear friends, once more.  Another week in the battle against prescription drug abuse.  Lots of work to do.  

Michael
Follow us on Twitter @PRIUM1