Thursday, July 31, 2014

PDMPs: At Least Someone in Missouri is Paying Attention

Missouri is the last state in the union without an approved Prescription Drug Monitoring Program.  While that's inexcusable and embarrassing, it also has real consequences for the state.  Past legislative attempts to create a database have met with resistance from Dr. Robert Schaaf, a family practice physician and Missouri state senator.  The St. Louis Post Dispatch published an op-ed on the topic yesterday, which reads, in part:
"Sen. Schaaf, a family practice physician, said his opposition to the database is about freedom. The drug database would infringe on patients’ personal liberty, he says.
Of course, his opposition makes life easier for greedy doctors and unscrupulous pill-pushers, and more dangerous for drug addicts.
Dr. Schaaf is not opposed to all databases or impinging on the freedom of poor people. He voted in favor of legislation in 2011 that required the state Department of Social Services to set up a database to screen some welfare recipients for drug use.He also voted last session for a bill that would have required the state Division of Workers’ Compensation to develop and maintain a database allowing employers access to workers’ compensation records. 
So much for freedom, eh, Dr. Schaaf?"
I've spoken to Senator Schaff directly on this topic and asked him to explain the inconsistency of his positions.  I'm not sure he understands the importance of the issue at hand.  
You can find a front page article from the NY Times on this here.
The St. Louis Post Dispatch op ed is here
My past critique of Sen. Schaaf is here and here
Hopefully this national media attention will get things moving in Missouri... and convince Sen. Schaaf to change his position.  
On Twitter @PRIUM1

Wednesday, July 30, 2014

H.R. 4709 Offers Little Help in the Fight Against Prescription Drug Abuse

If you want to bill that purports to mitigate prescription drug misuse and abuse, but actually has no hope of doing so - well, look no further than the 113th Congress.  Turns out they can be counted on for something.

Rep. Tom Marino (R-PA) is sponsoring H.R. 4709 which passed the House yesterday and now heads to the Senate.  The bill's purpose is to "improve enforcement efforts related to prescription drug diversion and abuse..."  It does so by amending the Controlled Substances Act (CSA) to more clearly define that certain drugs may represent an "imminent danger" to the public (though it doesn't name those medications, it just makes it possible to designate such medications) and to make it easier for the DEA to leverage the CSA to suspend certain medications that pose a substantial public health risk (though, of course, pharma companies are given the opportunity for remediation with the Attorney General before a drug is actually suspended).  The bill also calls for the Department of Health and Human Services to report back to Congress on law enforcement activities related to patient medication access and, in so doing, consult with every possible constituency and stakeholder on the planet (including tribal law enforcement agencies).

I wonder if anyone in Congress will ever have the courage to do what's actually needed.  Namely:

  • Take on the American Medical Association around the issue of mandatory physician education for pain management and opioid prescribing.  The AMA consistently argues such a measure would infringe upon the practice of medicine.  That ship has sailed.  The good doctors want this education and seek it out anyway.  Doctors who either aren't aware of the need for education or are willfully ignorant of best practices in opioid prescribing should be required to engage in such education before prescribing opioids.  
  • Provide more federal funding for state level Prescription Drug Monitoring Programs (PDMPs) and additional funding for a fully integrated, national PDMP database.  We're seeing regional efforts along these lines that are promising (see Ohio and Kentucky collaborating on PMIX), but more needs to be done in the areas of standardization, integration, data sharing, access, etc.  The federal dollars currently flowing to these initiatives are minuscule given the severity of the problem.  The Harold Rogers Prescription Drug Monitoring Program and the National All Schedules Prescription Electronic Reporting Act are both under-funded and under-utilized.  California legislators fought tooth and nail over $3 million to fund its CURES database and it's still woefully under-funded and under-utilized. The federal government's FY2015 HHS budget contains $10 million through the Substance Abuse and Mental Health Services to "help state substance abuse authorities develop comprehensive prevention approaches through collaboration with state partners and integration of health information exchange systems with strategic plans."  A) I don't know what that means; B) It's not enough.  
  • Leverage data and surveillance from the Medicare and Medicaid programs to identify and deal with high prescribers of opioid medications.  To be fair, the federal government is already working toward this.  See page 73 of the HHS budget overview.    
  • Take on the pharma companies through better Congressional oversight of the FDA approval process.  FDA is and should be an independent agency, but serious doubts have been cast regarding the agency's independence and consistency regarding approval of opioid analgesic formulations.  
More needs to be done.  More can be done.  HR 4709 has little chance of moving the needle.  

On Twitter @PRIUM1

Monday, July 28, 2014

Abuse Deterrent Opioids: Technology vs. Medical Necessity

Last week, the FDA approved Targiniq ER, an extended release / long acting opioid with abuse deterrent properties.  In this case, the Purdue Pharma medication contains naloxone, which blocks the euphoric effects of the oxycodone when the pill is crushed and snorted (or crushed, dissolved, and injected).

I've posted thoughts along these lines before, but I'd like to remind everyone that abuse deterrent opioids are an excellent solution to a limited set of misuse and abuse issues posed by prescription analgesics.

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.

On Twitter @PRIUM1

Friday, July 18, 2014

Utilization Review: Tough Love is Best Practice

[A guest post from David Price, PRIUM's Compliance Counsel.  I'll direct any comments you might to have for response.]

“If you would persuade, you must appeal to interest rather than to intellect.”
                                                                                                            -- Benjamin Franklin

Promoting change is hard.  I feel like it’s particularly difficult in the sphere of workers’ compensation.  Between physicians, injured workers, payers, employers, and attorneys, there are multiple competing interests at stake, and policy makers are hesitant to change the existing laws and risk inviting backlash from the groups that don’t feel like they’re benefiting from the change.  The people that shape workers’ compensation law – whether they’re legislators, administrative officers, or judges -- want to promote the public good, but most importantly, they want to make sure that the system is fair.  They want to make sure that no one is getting cheated.  Once they feel like someone is getting cheated by the law, change suddenly becomes much easier.

When a new law is being discussed, there’s always a temptation for us to discuss only the aspects of the changes that benefit us – to only consider our side of the overall story.  What we say might be true, but it’s not always persuasive, particularly if we don’t discuss how the change will benefit other interested groups.  When we only talk about how the change benefits us, it’s no surprise when some of those other groups start to complain that the change is unfair… or when policy makers start to believe them.

Promoting good policy requires honesty, but more importantly, it requires effective honesty. 

I recently had the opportunity to attend the annual Tennessee Workers' Compensation Educational Conference.  This year, the conference was set up so that audience members could text their comments and questions to the speakers throughout each presentation.  This way, audience members could ask their questions while they were still fresh in their minds, and the speakers could finish their presentations without interruption and then come back to address the questions afterward.  As a bonus, because the comments were submitted anonymously, people weren't afraid to ask questions or offer their perspective on each issue.

For better or worse, there was a lot of honesty in the room.

Dr. Robert Snyder, the Medical Director of the DWC, discussed the DWC's plan to adopt treatment guidelines by 2016.  Additionally, several presenters made reference to Tennessee's current UR process, and there was some brief discussion of what the UR process would look like once the treatment guidelines were implemented.  

The comments from the audience, understandably enough, were more concerned with how UR could be used effectively to reduce medical costs.  Unfortunately, many of the comments were essentially expressions of outrage at the irresponsibility and attitude of entitlement of injured workers.  Commenters made a strong case for how UR (and by extension, the guidelines) could be a useful tool to beat drug-seeking claimants.  That may not have been the most effective form of honesty.

With legislators and workers' compensation judges in attendance, commenters touted UR and the guidelines as purely cost-reduction tools and, at one point, a presenter, in response to a question, made the suggestion that in 2016, adjusters, not UR physicians, should apply the new treatment guidelines, and that any request complying with the guidelines should not be subject to UR.  

The overall message was clear: the point of treatment guidelines is to reduce medical costs.  Since they’re really just a tool for the adjuster to use to “beat” the injured worker, maybe we should let the adjustor apply them directly, without getting a medical opinion.

If you ask any claimant's attorney, they'll tell you that all injured workers (or at least their clients) have a legitimate medical need for whatever treatment their doctors recommend, and that payors are just using treatment guidelines and UR as tools to get out of paying for treatment in order to save money.  UR and treatment guidelines are just tools to “beat” the injured workers -- at least, that’s how they tell the story.  Notably, their version frames UR and treatment guidelines as tools aimed solely at saving payors money.  They do this because they know that if they can show UR and treatment guidelines as being implemented solely to benefit the payor by harming the injured worker, it makes the whole process seem unfair.  Any policy maker with the slightest sense of empathy will try to find a way to undermine or limit application of the guidelines.

So here's where I say something that may be controversial:  The primary goal of UR and evidence-based treatment guidelines is to ensure proper treatment for the patient.  Cost reduction is a bonus -- a secondary effect.

Don't get me wrong: from the perspective of insurance carriers and self-insured employers, cost reduction is going to be the primary goal.  Most payers are for-profit entities, and their focus is (and should be) on reducing costs.  That said, policy makers have a different role.  Their focus should be on the public good, and if we continue to allow the debate to be framed as "patients' medical need vs. payers' bottom line," payors will lose every time.  If we talk about treatment guidelines as something that only benefits payers, we can expect to see those guidelines undermined at every opportunity.

We need to be careful in how we tell the story.

There is a very real public policy battle here, and not just in Tennessee.  In Louisiana, several courts have limited the application of the state's treatment guidelines.  In California, the infamous Dubon decision is being used by injured workers' attorneys as a means to attempt to escape the UR/IMR process.  Oklahoma has implemented a closed formulary based on the Official Disability Guidelines, but the state legislature has effectively limited application of the formulary based on date of injury.  (Only claims under the jurisdiction of the new Workers’ Compensation Commission – those claims with a date of injury of 2/1/14 or later – are subject to the closed formulary).  In multiple jurisdictions, we're seeing judges and other policy makers limit the opportunities to apply objective medical standards.  

Why?  The primary reason is a concern for due process.  At the risk of greatly over-simplifying the points raised in each of these instances, the general underlying concern is that the objective medical standards aren't really objective at all (or at least aren't being applied objectively), and so a "fair" determination of medical necessity can only come from a judge.

Now, in Tennessee, the DWC is planning to adopt treatment guidelines by 2016, but which guidelines will be adopted -- or how they will be utilized -- remains to be seen.  We can be certain that the way we talk about treatment guidelines and the UR process now will greatly affect the way the process is shaped as the guidelines are implemented, and whether or not policy makers see application of the guidelines as an "unfair" intrusion onto injured workers' right to due process.

We can be just as certain that when the guidelines are implemented, work comp and appellate judges will see a host of objections.  No doubt, many of those objections will echo the arguments that have been made in other jurisdictions.

If we talk about treatment guidelines as something designed to benefit only the payer -- and especially if we promote them as something that payers should be able to use without requiring a physician’s opinion (I don’t envy the attorney that has to defend a non-medically-trained adjusters determination that a physician’s recommended treatment isn’t medically necessary) -- we’re buying into a very dangerous story.  It’s the same story every injured worker’s attorney will tell in 2016 when the guidelines are applied.

To be honest, treatment guidelines do reduce overall medical costs, but that's not the whole story.  If that's how we allow the discussion to be framed, we can expect to see more limitations on when and how guidelines are applied -- in Tennessee and elsewhere.

The vital part that’s missing from that story is that, in reality, evidence-based treatment guidelines are designed to benefit injured workers, and that’s precisely what they do.

The reality is that injured workers usually don't know what treatment is appropriate; they only know what their doctors tell them.  The reality is that treating physicians are torn between their duty to help the patient recover as quickly as possible and the lingering financial incentive toward excessive treatment.  The very nature of the workers’ compensation system, and sometimes even the patients, can pressure physicians to treat in ways that contradict their best medical judgment.  At the same time, even the most honest and strong-willed treating physicians are hard-pressed to keep abreast of current medical evidence as they try to operate a successful practice, and many are particularly under-educated regarding the proper prescription of opioids for pain.  The reality is that evidence-based treatment guidelines provide an objective standard of care and, when used correctly, can protect the injured worker from improper treatment, overdose, and addiction.

That's the truth, and that's how we should tell the story.

On Twitter @PRIUM1

Thursday, July 10, 2014

Senate Bill 526 overwhelmingly passed the Missouri Senate on February 13, (26-7).  Not exactly a predictable outcome based on what we know about Missouri.

The bill calls for the development of a database of work comp claims that could be accessed by employers when hiring job candidates.  It will next be considered by the state House, and if passed the database would be implemented on July 1, 2015.

Creating a database of work comp claims could potentially allow employers to assess in a pre-employment screening process whether their prospective employee has submitted work comp claims.  It’s not the same as asking your age or your marital status that could potentially be used to discriminate, but that past history could certainly influence an employer’s willingness to hire you.  I’m all for transparency in the hiring process so you can make a well-informed decision on a very expensive process.  

Here's the odd part: if Missouri is willing to create this database, why are they unwilling to create a PDMP (prescription drug monitoring program) that could yield very important information about an individual’s entire drug regimen that has potential life and death consequences?  The primary obstacle to the PDMP in Missouri has been state senator Rob Shaaf, who has argued that "letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives."  He voted in favor of SB 526, perhaps because the bill includes a provision that requires employee consent for an employer to search the database.  Nonetheless, the database will be contain sensitive information on Missouri citizens, will be run by the government, and will have a much wider potential audience (all employers) than a PDMP (clinicians and law enforcement). 

Still waiting

On Twitter @PRIUM1

Saturday, July 5, 2014

I like David DePaolo.  A lot.  He is a voice of reason in our industry and I've enjoyed his musings, both personal and professional, for years.

But on the issue of urine drug monitoring, I think he's off the mark.  On the one hand, I'm coming at this from an admittedly self-interested perspective (PRIUM is a wholly owned subsidiary of Ameritox), but on the other hand, the context and conclusions of David's recent post on drug monitoring beg for someone to clear up the confusion.

What did he miss?  Nowhere in his piece did he mention that:

  • People are dying.  Overdose deaths from prescription opioids now outpace deaths from traffic accidents and have tripled since 1990; 
  • The CDC has identified the opioid crisis as an epidemic, a term the CDC does not use lightly; 
  • More than 12 million people reported using prescription painkillers nonmedically in 2010; 
  • Urine drug monitoring technology is relatively new.  David's quote from the CWCI data that suggests 192X growth in spend on urine drug monitoring in CA doesn't recognize the point at which the health care community sat on the adoption curve for this technology in 2004.  Nor does it recognize that we still didn't realize the enormity of the opioid crisis in 2004.  And don't tell me we knew in 2004 how bad this was going to get.  I came into this industry in 2010 and spent my first two years here at PRIUM trying to convince payers there was an opioid problem in the first place.   
  • There's a distinction between point-of-care testing in a doctor's office and reference lab testing. Failing to make this distinction leads the reader to conclude that all inappropriate behavior rests with reference labs and fails to recognize that some physician practices are by themselves driving inappropriate utilization.  Physicians who partner with experienced and capable reference labs that understand payers' perspectives and expectations can help align stakeholders (injured worker, physician, lab, and payer).   
  • There are guidelines for the appropriate use of urine drug monitoring and these guidelines are based on risk stratification of the patient.  We follow these guidelines.  We help payers follow these guidelines. Testing beyond the guidelines is as inappropriate as not testing patients that should be tested.  
  • Even in light of these guidelines, WCRI data tells us that less than 25% of injured workers on long term opioid therapy are being tested at all.   David states "we know [the guidelines] are specific case recommendations particular to a certain set of medical facts, not to be applied universally."  Agreed.  Perhaps David doesn't realize how many injured workers fit that "certain set of medical facts."  A lot more than he apparently realizes.  
  • Not all companies offer direct financial incentives to physicians.  He lumps an entire industry together and does so just a couple of paragraphs after he details that Millennium's practices were found by a jury to be illegal and that all counterclaims against Ameritox were dismissed.  Perhaps David missed the most important take-away: there's at least one company trying to do it right
Bottom line: what David blithely dismisses as "nonsense" is, in fact, a critical patient safety tool, a mechanism for effective claims management, and a necessary application of clinical technology that isn't going anywhere. To suggest otherwise in light of the largest man-made epidemic in the history of the world is simply irresponsible.  

On Twitter @PRIUM1

Wednesday, July 2, 2014

CDC Reports: First Substantial Decline in Overdose Deaths in any State in the Last 10 Years

New reports from the CDC show that progress is possible in the fight against prescription drug misuse and abuse.  Highlights from each of two reports released yesterday:

From Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines:
States can take other actions that will affect prescribers. Developing or adopting existing guidelines for prescribing OPR and other controlled substances can establish local standards of care that might help bring prescribing rates more in line with current best practices. State Medicaid programs can manage pharmacy benefits so as to promote cautious, consistent use of OPR and benzodiazepines. In addition, a number of states have passed laws designed to address the most egregious prescribing excesses. Florida, for example, enacted pain clinic legislation in 2010 and prohibited dispensing by prescribers in 2011. It subsequently experienced a decline in rates of drug diversion (17) and a 52% decline in its oxycodone overdose death rate (18). Guidelines, insurance strategies, and laws are promising interventions that need further evaluation.

And from Decline in Drug Overdose Deaths After State Policy Changes, Florida 2010-2012:
This analysis showed that policy changes in Florida were followed by declines in the prescribing of drugs, especially those favored by Florida prescribing dispensers and pain clinics, as well as by declines in overdose deaths involving those drugs. Florida has reported that approximately 250 pain clinics were closed by 2013, and the number of high-volume oxycodone dispensing prescribers declined from 98 in 2010 to 13 in 2012 and zero in 2013 (2). Law enforcement agencies in Florida also reported that rates of drug diversion (i.e., channeling of prescription drugs to illicit markets) declined during 2010–2012 (6). Preliminary data for the first half of 2013 from the FMEC indicate a continued decline in oxycodone and alprazolam overdose deaths (4). These changes might represent the first documented substantial decline in drug overdose mortality in any state during the past 10 years.

Progress is possible.  Guidelines, insurance strategies, regulatory/legislative action, and common sense education are the keys to mitigating this epidemic.  The CDC reports yesterday put data behind what we already knew to be true.

On Twitter @PRIUM1