Showing posts with label legal. Show all posts
Showing posts with label legal. Show all posts

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

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 


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 2, 2015

Inconsistent Standards of Care, Judicially Mandated

Very little good has ever come from judges attempting to interpret legislative intent in the face of disputed medical treatment.

Barbara Shepard injured her back, neck, and left shoulder in 2005 while employed with the Oklahoma Department of corrections.  The OK Work Comp Court ordered that the carrier pay for treatment, inclusive of office visits and (you guessed it) pain management medications.  "This provision," stated the order, "shall be reviewed by the Court upon application of either party for good cause shown."  

Turns out evolving contemporary medical evidence and the risks of opioid medications do not amount to "good cause."  

Despite Oklahoma's adoption of the Official Disability Guidelines as of March 1, 2012, the Court found that those guidelines do not retrospectively apply to Shepard's case.  Simply because of the date on which she was injured, Shepard is subject to a different (and, frankly, inferior) standard of care.   While physicians on both sides of the dispute agree that the guidelines indicate she should not receive the pain management medications she has been taking, the Court instead relied on a purely legal framework to make its decision.  Thus, not only has the Court failed to contemplate the growing body of medical knowledge from which the patient could benefit, but it has also created two standards of medical care for Oklahoma work comp patients that depends entirely on one's date of injury.   

Let's consider an admittedly controversial analogy: Instead of being injured in 2005, let's pretend for a moment that Shepard was hurt in 1917.  And instead of an injured back, she had a work-induced cough.  During this time, she might have been prescribed a popular cough suppressant manufactured and sold by Bayer pharmaceuticals.  The chemical compound was diacetylmorphine, but it was marketed under its trade name: heroin.      

Seven years later, in 1924, in the face of a public health crisis and mounting evidence of heroin's harmful properties, Congress passed the Heroin Act, which outlawed the sale, importation, and even the manufacture of heroin.  

According to the Oklahoma Supreme Court, however, Shepard should still get heroin for her cough... despite the evolving medical evidence and the statutory support for recognizing that medical evidence, Shepard should still get her heroin, simply because she developed her cough seven years before we knew that heroin was more likely to harm her than help her.

Opioids, thankfully, are not illegal.  There are many patients, particularly the terminally ill, that benefit greatly from these medications.  But it's also true that we didn't know in 2005 everything we now know about opioids in the treatment of chronic, non-cancer pain.  For instance, in 2005, the National Safety Council had yet to publish this informative graphic:



We cannot create a sustainable system of medical care for injured workers that does not allow for the incorporation of the best available medical evidence.  

Michael
On Twitter @PRIUM1

Monday, October 20, 2014

A Name You Should Know: Jack Conway

David Armstrong has written a piece on Bloomberg.com that should be required reading.  Not only does it recap the overarching legal strategies currently being pursued by various municipalities against manufacturers of painkillers, but it dives keep into Kentucky's battle - by far the longest and potentially most successful suit thus far.

Recall that in 2007, Purdue Pharma paid a $634 million fine in connection with inappropriate marketing of Oxycontin.  Of that fine, $160 million was specifically earmarked to reimburse the federal government and state governments for damages suffered by the Medicaid program.  Kentucky's share of that fine was to be $500,000.

Kentucky said "no thanks" and filed its own lawsuit.

Seven years later, we're as close as we've ever been to a trial and it's more likely than not that we'll see this trial play out at "ground zero" (Pike County prosecutor Rick Bartley's phrase, not mine) of the opioid epidemic.  For Purdue, whose chief financial officer is on record as saying that this could be a billion dollar case and would have a "crippling effect on Purdue's operations and jeopardize Purdue's long-term viability," this is nothing less than a "save the company" moment.

On the opposite side of the courtroom will be Kentucky Attorney General Jack Conway, a rising political star in the state.  He lost the 2010 US Senate Race to Rand Paul, but remains an up and comer in the Democratic party in Kentucky.  This is one of those cases in which an Attorney General can set himself up for future political wins.  And beyond that, I think he genuinely wants to do the right thing here.  And the right thing, according to Mr. Conway, is to hold Purdue accountable.  I met Mr. Conway and got to talk with him for a few minutes at last year's National Prescription Drug Abuse Summit in Atlanta.  He's the real deal.  He cares about the issue of prescription drug misuse and abuse.

The most interesting take-away from the article: Purdue hired an outside consultant to assess the likelihood of getting a fair trial in Kentucky.  The findings?

  • 40% of Pike County residents knew someone who had run into criminal trouble because of an Oxycontin addiction;
  • 33% knew someone who overdosed to was otherwise seriously hurt by the drug;
  • 29% knew someone who had died;
  • 90% agreed that Oxycontin had a "devastating effect" on the community.  
I'm not a legal expert.  I don't know if Purdue can get a fair trial in Pike County or not.  But either way, it sounds to me like there's going to be a fight - and a very public and very ugly fight at that.

Michael
On Twitter @PRIUM1