IAIABC Draft Rules on Opioids: Progress, But Work Still Needed

PRIUM submitted feedback on the original release of IAIABC draft rules on opioid prescribing back in May.  Last week, IAIABC revised those draft rules and we're pleased to see significant progress on the items we outlined as areas of concern based on the original version. 

Additional comment and feedback on the new has been submitted as follows:

On behalf of PRIUM, a URAC-accredited utilization review company based in Duluth, GA, I’d like to commend the IAIABC on its efforts to address the epidemic of prescription drug over-utilization in workers’ compensation systems throughout the country. We have reviewed both the model statutory language as well as the model regulatory language IAIABC developed and would like to provide the following comments:

Regarding the model rules, the translation from statute to regulatory approach is well defined. We found the “drafting notes” to be particularly helpful in guiding lawmakers in the development of these critical rules. There are a few areas, however, that we believe require more nuanced thinking prior to launching the regulatory model.

1) [Section 1, (3): Effective Date]: Our industry learned a valuable lesson from the creation, adoption, and implementation of the Texas Closed Formulary Rules. Texas implemented these new rules in two stages: starting 9/1/11 for all new injuries as of that date, and starting 9/1/13 for all “legacy” claims, effectively providing a two year remediation period for the insurance carriers and treating physicians to address difficult cases in preparation for the 9/1/13 requirement for preauthorization of all N drugs. This is smart public policy. Contrast this with New York where adoption of medical treatment guidelines as of a single, “line in the sand” effective date has created a judicial and legislative battle that has yet to resolve itself. On the one hand, a single effective date creates chaos as carriers and physicians try to figure out how to address legacy claims, which tend to be more complicated. On the other hand, only applying new rules to new injuries creates two standards of care within a workers’ compensation system, where an injured worker’s treatment plan is driven entirely by the date on which they were injured (which makes no clinical sense). We recommend model regulatory language that mirrors the Texas Closed Formulary approach – an initial implementation date for new injuries, followed by a remediation period for legacy claims, followed by a fully effective date for new rules and all claims. 

2) [Section 1, (5): Evidence-based Treatment Guidelines]: We particularly appreciate the emphasis in the drafting note indicating that the model would be "most effective if there was a specific guideline on treatment of opioids that was presumptively correct".  However, in order to achieve the presumption of correctness, we believe the medical treatment guidelines adoption process is critical and should rely on one of the two following approaches:

a. Define the treatment guidelines to be adopted within the statutory language itself (as opposed to leaving it to the state agency to determine); or

b. Provide a more thorough definition of appropriate medical treatment guidelines, perhaps through a series of criteria that must be met. Such criteria might include requirements that the medical treatment guidelines:

                                                               i. Rely on specified, comprehensive, systematic review of medical literature;

                                                             ii. Include transparent criteria for rating the strength of evidence, including individual medical studies;

                                                            iii. Remain current and incorporate contemporary studies;

                                                           iv. Address frequency, duration, intensity, and appropriateness of treatment;

                                                             v. Have been adopted by at least one other state.

2) [Section 7: Continuing Education]: Our view is that the absolute onslaught of marketing dollars spent by the pharmaceutical industry to “educate” doctors should, in fact must, be countered by mandated, unbiased continuing education focused on the risks associated with chronic opioid therapy. In 2011, the pharmaceutical industry generated $11 billion from the sale of opioids, a full $3 billion just from Oxycontin. The #1 source of information for physicians regarding these drugs remains the drug company sales representative. This must change. PRIUM is disappointed that state medical societies and the American Medical Association are opposed to such measures. We strongly recommend that IAIABC remain committed to mandated continuing education.

3) [Section 9, Preauthorization Required]: PRIUM believes that the best possible way to eliminate the over-utilization of prescription drugs in workers’ compensation is to engage the treating physician in the creation of a revised treatment plan. Mandated preauthorization should not be the first step taken by an insurance carrier when a particular claim is brought under scrutiny due to the prescription medication regimen. That being said, if the treating physician refuses to participate in the creation of a revised treatment plan and continues to prescribe, in some cases, dangerous levels of medications, mandated preauthorization can be a powerful tool to protect patient safety and ensure positive clinical outcomes.  While the updated draft rules recognize the recent success of the Texas Closed Formulary, the example restrictions are of little value in light of what Texas has actually implemented.  Requiring pre-authorization of all drugs indicated as "N" in the Official Disability Guidelines Appendix A Formulary is a bold and necessary statement that only medically necessary drugs will be used to treat occupational injury.   

We appreciate the opportunity to provide this feedback and commend IAIABC for the transparency and collaboration that have been emblematic of this process thus far.

Respectfully submitted,

Michael Gavin

Chief Strategy Officer

PRIUM

On Twitter @PRIUM1

Work Comp and Illicit Drug Use: A Physician's View

Last week, I wrote about an analysis from Ameritox that suggested the rate of illicit drug use in workers' compensation was comparably lower than in other payer classes.  I asked readers to weigh in on one of two possible explanations:

A) Injured workers, generally speaking, have a goal to return to work and dealing with chronic pain through medication therapy is something injured workers, because they are "workers", do responsibly. We know this isn't true for 8.6% of them, but those are bad apples and shouldn't spoil our view of the bunch.

B) Injured workers in chronic pain enjoy a higher rate of iatrogenic (physician-caused) tolerance, dependence, and addiction. Work comp claimants don't need illicit drugs because they're getting all the narcotics they need from their physicians. The existence of an indemnity benefit (which doesn't exist in the other payer classes) drives patient-directed care and higher levels of narcotics use without the need to seek out illicit drugs. 
The overwhelming response (via direct blog comments, emails to me, and LinkedIn group comments) was B.  A few of you weighed in with an "A... then B" perspective that suggested a lot of claims start out on the right track and then get derailed due to a number of factors ranging from legal representation to iatrogenic causes. 

One of PRIUM's physician reviewers, Dr. Bob Taber, offered an option "C":

Many WC chronic pain patients have learned by research (info readily available on internet sites), word of mouth or personal experience that many drugs (licit and illicit) are quickly cleared by the body. A Urine Drug Test (UDT) will not be able to detect the presence of such drugs if it has been more than 5-7 days since the drug was last used/abused. UDTs are recommended to be performed randomly on chronic pain patients receiving opioid therapy but this almost never happens. The patient knows that the only time s/he will possibly be subjected to a UDT is on the day of a scheduled follow up appt with their Doc. They know this date a month or two ahead of time. They are free to use their illicit drug of choice until about a week before their appt date without risk of detection. THC can linger much longer in the body than other drugs so frequent users risk a positive UDT for THC if they continue using until a week before their appt. (assuming that THC is in the test panel).

Dr. Taber suggests that the solution is to make UDT testing truly random and to ensure real, enforceable consequences for positive tests and/or non-participation.  In fact, he suggests that such an approach would mitigate the use of illicit drugs across payer classes, not just workers' compensation.

Many thanks to Dr. Taber for his insights.

Michael
On Twitter @PRIUM1

Where Are They Now? The "Oxycontin Seven" from 1998

For those of you who have seen my educational presentation on chronic opioid therapy, you know I'm fond of playing a video clip in which Dr. Alan Spanos says, among other things, that opioids are "our best, strongest pain medicines" and that "in fact, the rate of addiction amongst pain patients who are treated by doctors is much less than 1%".  He concludes by suggesting that opioids "should be used much more than they are for patients in pain".  This usually leads to audible gasps in the audience, many of whom see claims every day that fly in the face of this supposed medical wisdom. 

This clip is from a 1998 promotional video produced by Purdue Pharma that highlights the experiences of seven individual patients taking Oxycontin at the time.  The Milwaukee Journal Sentinel has just published a very well done "where are they now?" on these seven patients. 

Here's a summary of what happened to the seven: "Two of the seven patients were active opioid abusers when they died.  A third became addicted, suffered greatly, and quit after realizing she was headed for a overdose.  Three patients still say the drug helped them cope with their pain and improved quality of life.  A seventh patient declined to answer questions." 

As for Dr. Spanos, he's backed down considerably from his original stance on opioids.  He now says, "We don't know whether success stories like this are one in five, one in 15, one in 100, one in a thousand.  They may be quite rare." 

Quite rare, indeed.

Interestingly, Bob Twillman, Director of Policy and Advocacy for the American Academy of Pain Management, posted a link to this article on Twitter.  His take on the outcomes for the seven patients?  "... film shows that 3 of 6 chronic pain patients had really good results!"

While we can't fault Bob for trying his best to do his job, I can't imagine any rational member of the clinical community taking such a "glass half full" view of these outcomes, particularly when there is no reliable, replicable way to determine which patients will end up with positive clinical outcomes... and which patients will end up dead. 

Michael
On Twitter @PRIUM1

Work Comp and Illicit Drug Use: What Do You Think?

A new study from Ameritox indicates that work comp claimants are less likely than other payer groups to engage in illicit drug use. 

Ameritox looked at 2 million samples for 1.5 million chronic pain patients over a 2 year span from July of 2010 to June of 2012.  They found that rates of illicit drug use by payer class varied as follows:
- Medicaid (17.1%)
- Self-pay (14.8%)
- Commercial insurance (9.7%)
- Medicare (8.9%)
- Work comp (8.6%)

This finding likely runs contrary to assumptions I've heard many claims executives make about the chronic pain cases on adjusters' desks. 

So, while there are a range of potential explanations, I'll offer two possible perspectives and ask readers to weigh in.

A) Injured workers, generally speaking, have a goal to return to work and dealing with chronic pain through medication therapy is something injured workers, because they are "workers", do responsibly.  We know this isn't true for 8.6% of them, but those are bad apples and shouldn't spoil our view of the bunch.

B) Injured workers in chronic pain enjoy a higher rate of iatrogenic (physician-caused) tolerance, dependence, and addiction.  Work comp claimants don't need illicit drugs because they're getting all the narcotics they need from their physicians.  The existence of an indemnity benefit (which doesn't exist in the other payer classes) drives patient-directed care and higher levels of narcotics use without the need to seek out illicit drugs. 

What say you?  A or B?
I'll post the (informal) results in a few days. 

Michael
On Twitter @PRIUM1

Real Data: Prescription Drug Monitoring Works

A new retrospective study out of Canada helps paint a picture of the impact a real-time prescription drug monitoring program can have. 

Back in 1995, British Columbia was the first Canadian province to introduce a real-time prescription drug monitoring system (called PharmaNet).  This week, analysis of data gathered since the program's introduction was published in the journal of the Canadian Medical Association. 

The study finds that duplicate or inappropriate opioid prescriptions fell from 3.2 percent to 2.1 percent of total prescriptions after the system was put in place.  And inappropriate prescriptions for benzodiazdepines fell from 1.2 percent to 0.71 percent.

Contrast this with the following:

- While 49 states in the US have adopted legislation to authorize the creation of a Prescription Drug Monitoring Program, only 37 are up and running.  Of note: Missouri is the lone hold out.  See my post from June on the sorry state of affairs in that state.

- Funding in many of the 37 states is lacking.  California apparently has a single person responsible for administering the entire state program.

- We have yet to find a way to coordinate data sharing (or even data access) across state lines, severely inhibiting our ability, as a nation and as a collection of state work comp systems, to properly manage and leverage prescribing information. 

We have a long way to go on prescription monitoring.  But we have data that suggests it works.  Colin Dorumut, the epidemiologist at the University of British Columbia that led the research, put it best: "The cost of implementing these networks in terms of hardware and resources to build them is probably trivial compared to the millions of inappropriate prescriptions that can be prevented."

Michael
On Twitter @PRIUM1

Michigan Moves on Repackaged Drugs

State regulators in Michigan are working on draft rules to address drug repackaging in work comp.  Several weeks ago, I wrote a post on the 6 core tenets of any strong statutory/regulatory action in this area.  Let's see how Michigan's newly proposed rules stack up.

1) The rule doesn't ban physician dispensing. There are legitimate reasons a doctor may need to dispense medications to a patient and the rule allows for those limited circumstances.

Michigan = check. 

2) The rule focuses on the financial remuneration tied to physician dispensing and fixes such fees at the Average Wholesale Price (AWP) of the medication plus a reasonable dispensing fee.

Michigan = check. (AWP - 10% + $3.50 for brands and AWP - 10% + $5.50 for generics)

3) The rule clearly specifies the source for the AWP (Medi-Span, Redbook, etc.). Many states are silent to the AWP source and this creates a lot of noise in the system.

Michigan = check.  (Redbook)

4) The rule specifies that fees are determined by "a) the NDC for the underlying drug product from the original manufacturer, or b) the therapeutic equivalent drug product from the original manufacturer/labeler NDC." This leaves no room for physicians or other agents to create new NDC codes as a result of repackaging.

Michigan = check. 

5) If the underlying NDC isn't known or isn't shared, discretion rests with the payer to determine the most appropriate NDC code. There is a dispute resolution process outlined if the provider disagrees.

Michigan = unclear.  The Michigan rules stipulate that if a pharmaceutical bill is submitted for more than $35 using an unlisted or "not otherwise specified" code, then the bill must be accompanied by an invoice.  Not sure I follow, but at least they're thinking about it. 

6) Perhaps most importantly, this is a regulatory change, not a statutory change.  This won't be possible in all states, but where it is, it's the way to go. 

Michigan = check.

A great start for Michigan.  Well done.

Michael
On Twitter @PRIUM1

Massachusetts Prescription Drug Monitoring Program: A Critique

Massachusetts has a problem with prescription drugs in work comp.  Despite its relatively small geographic footprint, the state's doctors prescribe a lot of narcotics.  According to WCRI's report from last summer, Interstate Variations In Use of Narcotics, which studied narcotics use in 17 states, MA had the highest rate of schedule II narcotic usage among cases for which narcotics had been prescribed (for non-surgical cases experiencing >7 days of lost time). 

So I was pleased to read that Governor Patrick signed legislation recently that will strengthen the state's prescription drug monitoring program (PDMP).  A strong PDMP program is a necessary tool(albeit insufficient by itself) to help stem the over-utilization of prescription narcotics.

The law (SB 01125) requires doctors to register and pharmacists to report prescriptions to the PDMP.  And at first glace, the law requires doctors to consult the PDMP database before the issuance of a prescription for a Schedule II or III narcotic.  This would make Massachusetts only the second state to require such a step (Kentucky being the other).  A closer reading, however, shows there are nuances to the bill...

The bill reads: "The department shall promulgate rules and regulations relative to the use of the prescription monitoring program by registered participants that shall include requiring participants to utilize the prescription monitoring program prior to the issuance of a prescription for a narcotic drug contained in Schedule II or III to a patient for the first time."

So close. 

I understand the theory here.  If each prescriber must check the database at the outset of narcotic therapy, any previous prescriptions should show up.  But I fear that requiring a single consultation with the database that occurs only at the beginning of narcotic therapy will allow some patients to slip through the cracks.  The law also doesn't indicate what enforcement mechanisms will be available to the department of workers compensation to ensure compliance with the new rules (once those rules are developed). 

One additional note on the bright side: the statute does stipulate that the regulatory approach needs to allow for "licensed support staff" to conduct the database checks.  While I acknowledge that requiring PDMP checks for all narcotics scripts creates costs for the physician practice, I also believe it's in the best interest of patient safety to do so.  Allowing support staff to do that work will at least create some cost savings and efficiencies in doctors' offices throughout the state. 

Michael
On Twitter @PRIUM1

California UR: Constitutionality Aside, On the Right Track

Catching my breath after WCI last week.  Excellent conference.  Thanks to all those that took time to meet with our team or just swing by the booth. 

While digging through all of the news I missed from last week, I wasn't at all surprised to find a lot of back and forth on California work comp reform.  Of specific interest, however, was the proposal that would allow injured workers to appeal utilization review decisions only through an independent medical review process (and limiting the judiciary's ability to overturn such decisions of the independent review only to cases of fraud or conflict of interest). 

Much of the coverage on this topic has been dominated by questions of constitutionality, legal analysis, memos of such analysis that may or may not have been sent to certain people, etc. All good questions that need to be answered.

But let's look at the practical implications.  The CA UR system is fraught with gamesmanship.  If a UR request results in a non-certification, delivered in an accurate and timely fashion, the response on the part of the injured worker (and his attorney) is often predictable: Request it again... and again... and again... hoping each time that the carrier/employer screws up on a technicality (the decision is a day late or the correspondence isn't sent to all appropriate parties), thus creating an allowance for the care in question.  Obviously, we see this with medication therapy on a daily basis.

While the proposal to subject such cases to an independent medical review that has real teeth (i.e., the ability to truly shut down payment for clearly inappropriate care) is a breath of fresh air, even PRIUM's own internal counsel tells me this doesn't pass constitutional muster. 

Lawyers.

So let's amend the proposal to allow for slightly more expansive judicial review.  I'm not smart enough to figure out exactly what that means, but I do know that the guiding principle here is a good one: don't overburden the system and the WCAB with frequent and unnecessary review of obviously inappropriate care.

Michael
On Twitter @PRIUM1

Responsible Opioid Prescribing: Worth 5 Minutes of Your Time

As promised in a post several weeks ago, I'm providing additional information on how each of you will be able to support Physicians for Responsible Opioid Prescribing (PROP).  PROP has taken the lead on a petition to the FDA which seeks to change the labels on opioid painkillers to prohibit their use for moderate pain, add a max daily dose, and only allow patients to take the drugs for 90 days unless they're being treated for cancer-related pain.

It's time for you to take action.  Set aside 5 minutes of your day, click here, and make your voice heard at the FDA. 

Michael
On Twitter @PRIUM1

Pill Mill in Florida: Getting Off Easy

Given the nature of our work here at PRIUM, I'm often asked about "pill mills" and the impact they have on the epidemic of prescription drug addiction in this country.  My response is always the same: Yes, we occassionally see what looks like "pill mill" activity.  But those cases are few and far between and pale in comparison (with respect to volume, complexity, and duration) to the cases that follow the more typical, albeit ineffective, medical treatment pathway under the care of a licensed physician running a perfectly legal practice. 

That said, the pill mill phenomenon represents all that is wrong with prescription drug therapy and brings into specific relief the challenges associated with stemming the tide of addiction, dependence, diversion, and every other unethical and/or illegal practice associated with prescription drugs.  As far as I'm concerned, if local or federal authorities identify a pill mill, they should shut it down and prosecute the offenders to the greatest possible extent of the law.

A recent case in Florida is cause for both confusion and concern.  Dr. Riyaz Jummani allegedly wrote scripts for approximately 500,000 oxycodone pills... in three months.  Authorities called his operation one of the busiest pill mills in the state of Florida.  This is the sort of case where an example should be made, right?  Hit him hard and send a message - run a pill mill, and you're going to jail for a very long time. 

Jummani's probable sentence (based on a "deal" with the Attorney General)?  Six months.  And in a work-release program, too. 

How is this possible?  What, exactly, is Jummani giving authorities in return for this light weight sentence?  By all accounts, Jummani was the head of the operation - it's not as if he's the #2 guy offering to testify against #1. 

If we're going to make any progress, as a society, in reigning in the inappropriate use of prescription drugs, there is a lot we're going to have to do differently.  This is an easy one.  This guy should go away for a long, long time. 

Michael
On Twitter @PRIUM1

Kentucky's HB 1: Immediate Impact

Four "pain management clinics" in Kentucky have already folded up shop.  More than 9,000 providers have registered for PDMP access since April (115% increase since HB 1 passed).   And the law went into effect just a few days ago. 

That didn't take long...

Congratulations to Kentucky, which has clearly grown tired of serving as one of our nation's best examples of how NOT to stem the tide of prescription drug abuse.  HB 1 is working and that's not just great news for Kentucky - that's great news for all states looking for legislative and regulatory templates for how to deal with this crisis. 

Last week, I posted about the new Texas PDMP.  I was disappointed to learn that physicians in Texas object to any requirement that the database be consulted prior to writing a script for a controlled substance.  Such a requirement was referred to as an "unfunded mandate." 

In Kentucky, 90% of all KASPER (Kentucky's PDMP) reports are completed within 15 to 30 seconds.  That's 15 to 30 seconds to understand the types and amounts of controlled substances a patient might already be receiving prior to a new doctor writing additional prescriptions.  This is easy, fast, and clearly in the best interests of patient safety. 

HB 1 requires providers in Kentucky to run a KASPER report before prescribing a controlled substance.  Other states should do the same. 

Michael
On Twitter @PRIUM1

New PDMP in Texas: Right Direction, Still Work To Do

Texas has moved to the next phase of its implementatin of new PDMP technology and there is a lot to like about the new iteration. 

Up until now, prescribers in Texas had to manually request data from the PDMP that would arrive via mail days after the request.  The new system, now being rolled out to almost 90,000 practitioners in the state, is an online tool from which data can be accessed in minutes. 

Combine this with the reporting requirement that went into effect last September (pharmacies must report scripts to the database within 7 days), and this starts to look like a model PDMP program.  The full release is expected by month's end and will include pharmacists and other prescribers not included in this current phase of implementation. 

One weak point, however.  While reporting is mandatory, there is no requirement that physicians prescribing drugs must check the database at all.  This part of the program is voluntary.  Dr. Chris Schade, past President of the Texas Pain Society and a beta tester of the new PDMP, summed up the physicians' view: "What doctors don't want is an unfunded mandate requiring them to use the monitoring program." 

This is fundamentally about patient safety.  Are the pre-surgical verification steps outlined by JCAHO an "unfunded mandate"?  What about the commonly expected best practice of physicians washing their hands between patients?  These are things we do in the healthcare community to protect patients, physicians, and other stakeholders from the unintended consequences of case delivery.  I can't understand how that logic trail doesn't extend to prescribing opioids. 

Texas doctors, or appropriate physician-extenders, should be required (as they are in Kentucky, for example) to check the PDM database prior to writing a script for a schedule II narcotic. 

I know that will cost the docs money.  But if they don't do it, it might cost lives. 

Michael
On Twitter @PRIUM1

Ohio Drug Formulary: Encouraging Results

A new prescription drug formulary in Ohio, along with several other measures, appears to have reduced the dosage of narotics for work comp injuries by 12% in a year-over-year comparison conducted by Ohio Bureau of Workers' Compensation.  Costs were reduced by 15%, or $2.1 million.

Compare this to the early results from the Texas Closed Formulary - depending on the study you reference, the new rules have reduced initial opioid prescriptions for new injuries by anywhere from 50% to 67%.  And the rules don't apply to legacy claims until September of 2013. 

So, for those of you counting at home... that's two state-level formulary adoptions and two clearly favorable sets of early results. 

Michael
On Twitter @PRIUM1

Physicians for Responsible Opioid Prescribing: Get to Know This Organization

As we wage the daily battle against the over-utilization of opioids in workers' compensation, it's important to recognize an increasingly important ally in the physician community: Physicians for Responsible Opioid Prescribing (PROP). 

Just this week, PROP led the way on a petition to the FDA to change the labels on opioid painkillers to prohibit their use for moderate pain, add a max daily dose, and only allow patients to take the drugs for 90 days unless they're being treated for cancer-related pain.  This is a bold petition and an even bolder request, but PROP is as serious about this issue as they are credible. 

PRIUM relies on the PROP web site for training materials, both for internal staff as well as our network of physician reviewers.  The videos on the site are absolutely phenomenal and they help us to orient new employees and our physician partners to the seriousness of the issue, the complexities of dealing with the issue, and the dedication required to ensure positive clinical outcomes. 

Dr. Andrew Kolodny is the President of PROP.  He is working tirelessly to bring awareness and solutions to one of the great healthcare crises of our generation.  He speaks at conferences, he engages with physician groups, he speaks to payers, and he writes editorials published in the NY Times.  His message is consistent, credible, and critical.  I've met Dr. Kolodny a few times (he even bailed me out when I was speaking at a conference and had technical issues trying to show a PROP video - he kindly stood up and delivered the message himself!).  His passion for the appropriate use of prescription narcotics is powerful. 

Get to know PROP.  They're helping us in the payer/employer community every day.  Let's find some ways we can help them.   

Michael
On Twitter @PRIUM1

Courage in Illinois: Doing the Right Thing on Repackaging

Illinois is working through a regulatory change that would cap the price of repackaged drugs at AWP + a dispensing fee.  As I've previously argued, this is the right way to go about changing the practice of physician dispensing.  By eliminating the financial incentive to dispense medications, but maintaining the physician's right to do so for the rare cases where an injured worker may truly benefit from getting scripts in the office, the state leaves all stakeholders with the right mix of incentives. 

What's unique about Illinois, however, are the two votes that took place within the last few days.  The Illinois Workers' Compensation Commission voted 9-1 to move ahead with revisions to drug repackaging rules in the state, despite a 4-3 vote from the medical advisory board NOT to proceed.

At the risk of appearing dramatic, I view this relatively small procedural victory as a potential tipping point in the legislative/regulatory landscape around drug repackaging and physician dispensing.  Predictably, the insurance and employer community likes the new rule while the physician community is opposed.  But in this case, the physician community said "no" and the WCC moved forward anyway.  They did so because the evidence, data, and logic tells them this is the right thing to do. 

Progress.
Michael
On Twitter @PRIUM1

Drug Repackaging: WCRI and AHCS

From time to time, an important report is released that thoroughly covers a critical topic in our industry.  And sometimes, others provide such thorough analysis that I find it difficult to add to what's already been said.  Such is the case with WCRI's new report on physician dispensed repackaged drugs in work comp. 

David DePaolo's overview of the report is excellent and he provides a well balanced view of the controversy this report has sparked. 

Joe Paduda takes on the AHCS critique of the report.  His rebuttal is spot on and contains important insights for policy makers that will surely confront AHCS as the legislative/regulatory process evolves on a state by state basis to address this issue. 

Bottom line: The report is thorough, unbiased, data-driven, and eye-opening. The issue of physician dispensing of repackaged drugs is a major weak spot in many jurisdictions' work comp statutes and rules. A legislative/regulatory solution is needed and I think Connecticut's new rule provides an excellent template.

Michael
On Twitter @PRIUM1

Suboxone: Our View

I'm seeing and hearing a lot of advertising for www.turntohelp.com here in the Atlanta area.  I don't know if it's a nationwide push or unique to our market, but the ad buy here is significant. 

Of course, the site is sponsored by Reckitt Benckiser, makers of Suboxone - a drug "indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychological support."  

On the one hand, it's difficult to justify the suggestion that the solution to dependence on pills... is more pills.  Different pills, clearly, but still a pharmacological solution to a pharmacological (and psychological) problem.  Welcome to 21st century medicine.  Also troubling is how often we see Suboxone introduced without the weaning of the other opioid medications.  We see this on cases PRIUM reviews.  Sometimes, the doctor is choosing to prescribe Suboxone for chronic pain management (which represents off-label use, but is the doctor's right to do).  Sometimes, the doctor intends to wean the other medications, but finds the patient unable or unwilling to participate in the weaning process.  Why Suboxone isn't immediately discontinued in this scenario isn't clear, but we see if often enough that PRIUM's physician reviewers are clearly concerned about the appropriate use of this medication. 

On the flip side, we do see cases here at PRIUM where Suboxone is used appropriately and successfully.   And I personally know a few people that have been weaned off of very high dose narcotics successfully through the use of Suboxone.

Bottom line: If you see Suboxone on a claim, make absolutely sure that the physician is DATA 2000 certified and that the drug is being used appropriately.  Close monitoring is key to a successful outcome. 

Back to the web site for moment: www.turntohelp.com is actually a tremendous resource.  Clearly, RB put a lot of time, effort, and study into crafting an easy to navigate, informative, balanced approach to the treatment of opioid dependence.  Candidly, it took me about 10 minutes before I ended up on the Suboxone web site (I thought it would take less than a minute).  The information on the site emphasizes the need for counseling and psychological support and goes to great lengths to discuss all available treatment options.  RB is clearly not going for a direct sell of Suboxone, but rather counting on the fact that if more people seek treatment, some percentage may end up on Suboxone.  There are plenty of other sites you can leverage to get the same information, but I've not found any as well organized or easy to navigate.

Certainly open to recommendations, though...

Michael
On Twitter @PRIUM1

CMS, Part D, and Opioids: A Familiar Approach

CMS has asked for additional public comment on its plan to improve drug utilization review for Medicare Part D participants.  I'd provide a link to the memo, but it was emailed to me and I can't seem to locate the file on the CMS web site (go figure).  If you really want to get your hands on it, let me know and I can email it to you. 

Turns out, CMS has found that approximately 0.7% of the total Part D population (or about 225,000 beneficiaries) received more than 120 mg MED daily for at least 90 consecutive days in 2011.  Kudos to CMS - not only for recognizing the clinical value of the 120 mg MED threshold, but also for citing the State of Washington's Department of Health as a source. 

The current CMS approach has a lot going for it. (Candidly, it looks a lot like our process for addressing these claims, so no surprise that we're supportive).  In summary, it calls for the following:

1) The Part D plan should have a documented policy for addressing overutilization of opioids.

2) There should be clinical triggers, defined by the plan, to flag certain beneficiaries for review. 

3) Protocols should be developed to eliminate from review those beneficiaries with legitimate need for high dose opioid therapy (i.e., cancer diagnoses).

4) The plan should be prepared to communicate directly with prescribers of the opioid medications, both in writing and telephonically, to address patient safety concerns, medical appropriateness, and medical necessity.  Further, the CMS approach calls for the conversation to be "clinician-to-clinician" (we would suggest a slightly more specific definition of "peer-to-peer", but CMS leaves that to the discretion of the individual plan). 

5) The results of the intervention should be incorporated into future claims management decisions, most obviously via a beneficiary-level claim edit (what we would think of as a PBM prior auth or block on a particular medication). 

6) Should a prescriber not cooperate, the CMS approach gives the plan the power to put such beneficiary-level claim edits in place to protect the patient's safety. 

7) Some sort of case management activity is necessary to ensure future compliance.

Solid start. 
How does this compare with your organization's approach?

Michael
On Twitter @PRIUM1

FDA Plan on Opioids: Good News? Or Bad?

Today brought a tale of two headlines.  Business Insurance declared "FDA Approves Plan to Fight Growing Opioid Abuse" while the New York Times declared "FDA Won't Order Doctors to Get Pain-Drug Training."  Turns out, they're both right.

The FDA on Monday adopted the Risk Evaluation and Mitigation Strategy that has been debated, discussed, and deliberated for several years.   The plan requires manufacturers of prescription opioids to, among other things, create and distribute physician and patient educational materials.  That's not exactly a solution unto itself, but it does represent progress (and at least tacit acknowledgment on the part of the pharmaceutical industry that the misuse and abuse of prescription painkillers has become a national health crisis). 

The controversial nature of the FDA announcement is driven largely by what is absent from the plan - mandatory physician training on the topic of safe opioid prescribing.  In 2010, the FDA's own advisory panel rejected the notion that this plan should include "voluntary physician education," instead recommending that the such education should be mandatory.  But the FDA has chosen to punt to Congress on this issue.  The NY Times indicates that the FDA commissioner is "hopeful that Congress would eventually enact mandatory physician training." 

In principle, I think this position is dangerous and not in keeping with the severity of the issue we face as a society.  Pragmatically, however, I'm not certain the FDA has the authority (or perhaps more importantly, the enforcement capabilities) to create rules around mandatory physician education.

State medical boards and/or (I can't believe I'm writing this...) the US Congress need to step in and create both the mandate for physician training around opioid prescribing as well as the consequences for non-participation.  This is more complicated than it might seem, but certainly a policy step necessary to stem the tide of opioid misuse and abuse.

Michael
On Twitter @PRIUM1

Connecticut Gets Drug Repackaging Right: Removing the Financial Incentive

I just reviewed the proposed language for Connecticut's rule change on repackaged drugs.  Excellent piece of regulatory work, specifically because it includes all of the elements of an effective approach to mitigating the issue (and a road map for other states to follow):

1) The rule doesn't ban physician dispensing.  There are legitimate reasons a doctor may need to dispense medications to a patient and this rule allows for those limited circumstances.

2) The rule focuses on the financial remuneration tied to physician dispensing and fixes such fees at the Average Wholesale Price (AWP) of the medication plus a reasonable dispensing fee ($5 for brand and $8 for generics).

3) The rule clearly specifies the source for the AWP (Medi-Span).  Many states are silent to the AWP source and this creates a lot of noise in the system. 

4) The rule specifies that fees are determined by "a) the NDC for the underlying drug product from the original manufacturer, or b) the therapeutic equivalent drug product from the original manufacturer/labeler NDC."  This leaves no room for physicians or other agents to create new NDC codes as a result of repackaging.

5) If the underlying NDC isn't known or isn't shared, discretion rests with the payer to determine the most appropriate NDC code.  There is a dispute resolution process outlined if the provider disagrees. 

6) Perhaps most importantly, this is a regulatory change, not a statutory change.  The laws of the state of CT allow the Work Comp Commission Chairman John Mastropietro to enact this rule change without legislative approval.  This won't be possible in all states, but where it is, it's the way to go. 

These are the five (and six, where possible) central tenants of an effective regulatory approach to repackaged drugs.  Hopefully, we'll see this loophole closed state by state as soon as possible. 

Michael
On Twitter @PRIUM1

Purdue and GSK: Unintentional Irony in the Wall Street Journal

I'm still a little upset about the path Purdue Pharma is taking to extend patent exclusivity for Oxycontin for six additional months: testing in kids.  The same day this hit the news (Tuesday), it was also reported that GlaxoSmithKline had agreed to plead guilty to charges of illegally marketing drugs and intentionally withholding safety data from US regulators. 

Pages B2 and B3 of Tuesday's WSJ contain the two stories, virtually side by side.  Excerpts from both:

B3: "Purdue hopes to gain six extra months next year of patent protection for Oxycontin by testing whether the powerful painkiller is safe for children."

B2: "The Justice Department says GSK improperly promoted some of its drugs from 1999 through 2010 for off-label uses.  [One highlight from the government complaint]: Marketing Paxil, an antidepressant, as safe for children, despite trials that raised concerns about suicide.  Example: Gave free samples to child psychiatrists." 

Despite assurances from Purdue that the company doesn't promote the use of Oxycontin for children, I found the juxtaposition of these two stories both troubling and ironic.

Michael
On Twitter @PRIUM1

Purdue Crosses the Line: Leave the Kids Alone

Front page of the Wall Street Journal this morning: "Purdue Pharma hopes to gain six months of extra patent protection for OxyContin by testing whether the pain killer is safe for children."

As I flipped to the article, I thought "this must be for terminally ill kids... because as sad as that would be, there's no way, in good conscience, they could test this stuff on kids otherwise."

I was wrong. The study will include subjects ages 6 to 16 in "moderate to severe pain." Purdue is attempting to take advantage of an FDA rule that allows for the extension of patent exclusivity merely for conducting studies in pediatric populations. The goal of the incentive is to help pediatric specialists understand the effect of a wide range of medications on children (which sounds like a good idea). In this case, Purdue is exploiting the FDA reg in order to rack up another $1 billion before OxyContin goes generic. It's despicable.

The very nature of FDA trials are short-term. The real danger here is the long term effects on the children that participate in the study (about 150 children will be included). What impact might this have on the future risk of addiction to opioids or other addictive substances? How will Purdue know? Are there requirements to track these kids as they grow into adulthood? Is the risk here really worth the "benefit," which will largely accrue to a pharmaceutical company in the form of additional revenues?

True, pediatric specialists will have more data on the drug's safety and efficacy profile in children... but so what? While we grapple, as a society, with the unintended consequences of opioid misuse - a problem the CDC has rightly labeled an "epidemic" - let's leave the kids out of it. Please.

Michael
On Twitter @PRIUM1

MMI and Narcotics: Can't Get There From Here

For those of you with access to the American Medical Association's "Guides Newsletter", check out the March/April 2011 issue.  There's a great article entitled Prescription Narcotics: An Obstacle to Maximum Medical Improvement.  (I'm actually not that behind in my reading... I was just given a copy of this particular article recently). 

The article points out that there are "concerns that the obstables to MMI created by prescription narcotics will delay the resolution of claims (which could be harmful to the patient, as well as to other stakeholders).  There is also concern that evaluators will confuse the effects of narcotics with permanent impairment and will consequently create erroneous impairment ratings."

The basic premise here is that narcotics expand the nature of a patient's impairment beyond pain.  When one is on narcotics for a long period of time, MMI becomes nearly impossible to assess with any degree of accuracy. 

We're starting to see some physicians justify chronic opioid therapy and refuse to respond to the evidence because "the patient is at MMI."

Challenge this presumption.  It will benefit you and your claimant when you do. 

Michael
On Twitter @PRIUM1

Reducing Opioid Utilization: Feedback on IAIABC Model Legislation and Rules

[Submitted to IAIABC on June 28, 2012]

To Whom it May Concern:

On behalf of PRIUM, a URAC-accredited utilization review company based in Duluth, GA, I’d like to commend the IAIABC on its efforts to address the epidemic of prescription drug over-utilization in workers’ compensation systems throughout the country.  We have reviewed both the model statutory language as well as the model regulatory language IAIABC developed and would like to provide the following comments:

Regarding the model legislation, the critical components of any state effort to stem the tide of prescription drug misuse appear to be present.  Treatment guidelines, PDMPs, dosage and duration limitations, pre-authorization, appropriate billing for services, and dispute resolution are, in fact, the essential elements of an effective statutory strategy to address the issue.  We see room for improvement, however, in the model statutory language in two areas:

1)      [Section 2: Treatment guidelines]: The current language leaves far too much latitude for states to develop consensus-based guidelines (vs. evidence-based guidelines).  We recognize the use of the term “evidence based” in the model language, but left open to the whims of state politics, medical boards, and lobbying efforts from the pharmaceutical and medical device industries, a state might be left with relatively weak, ineffectual medical treatment guidelines that allow status quo prescribing patterns to continue unabated.  As an alternative, we suggest one of two approaches:

a.       Define the treatment guidelines to be adopted within the statutory language itself (as opposed to leaving it to the state agency to determine); or

b.      Provide a more thorough definition of appropriate medical treatment guidelines, perhaps through a series of criteria that must be met.  Such criteria might include requirements that the medical treatment guidelines:

                                                               i.      Rely on specified, comprehensive, systematic review of medical literature;

                                                             ii.      Include transparent criteria for rating the strength of evidence, including individual medical studies;

                                                            iii.      Remain current and incorporate contemporary studies;

                                                           iv.      Address frequency, duration, intensity, and appropriateness of treatment;

                                                             v.      Have been adopted by at least one other state.

2)      [Section 6: Prohibition]: The use of the word “may” in connection with preauthorization is troubling.  In some states, the preauthorization process is viewed by physicians as contentious and antagonistic.  PRIUM advocates the use of preauthorization procedures if, and only if, the treating physician refuses to engage in collegial discussion or respond to the medical evidence when it is presented to him/her by a peer.  Nevertheless, should a treating physician prove unresponsive to the evidence, we believe statutory language should provide more stringent protocols for addressing such issues.  We also find the limit in Section 6 to “specific forms of opioids” far too narrow to address the overarching issue the industry currently faces.  We suggest the following: “The Agency shall grant the insurance carrier the right to require preauthorization for any medications being prescribed that do not appear to meet the standard of care established by the medical treatment guidelines.” 

Regarding the model rules, the translation from statute to regulatory approach is well defined.  We found the “drafting notes” to be particularly helpful in guiding lawmakers in the development of these critical rules.  There are a few areas, however, that we believe require more nuanced thinking prior to launching the regulatory model:

1)      [Section 1, (3): Effective Date]: Our industry learned a valuable lesson from the creation, adoption, and implementation of the Texas Closed Formulary Rules.  Texas implemented these new rules in two stages: starting 9/1/11 for all new injuries as of that date, and starting 9/1/13 for all “legacy” claims, effectively providing a two year remediation period for the insurance carriers and treating physicians to address difficult cases in preparation for the 9/1/13 requirement for preauthorization of all N drugs.  This is smart public policy.  Contrast this with New York where adoption of medical treatment guidelines as of a single, “line in the sand” effective date has created a judicial and legislative battle that has yet to resolve itself.  On the one hand, a single effective date creates chaos as carriers and physicians try to figure out how to address legacy claims, which tend to be extremely complicated.  On the other hand, only applying new rules to new injuries creates two standards of care within a workers’ compensation system, where an injured worker’s treatment plan is driven entirely by the date on which they were injured (which makes no clinical sense).  We recommend model regulatory language that mirrors the Texas Closed Formulary approach – an initial implementation date for new injuries, followed by a remediation period for legacy claims, followed by a fully effective date for new rules and all claims. 

2)      [Section 7: Continuing Education]: We understand that there was a lively discussion on your most recent conference call regarding the mandated education component of the model rules.  Our view is that the absolute onslaught of marketing dollars spent by the pharmaceutical industry to “educate” doctors should, in fact must, be countered by mandated, unbiased continuing education focused on the risks associated with chronic opioid therapy.  In 2011, the pharmaceutical industry generated $11 billion from the sale of opioids, a full $3 billion just from Oxycontin.  The #1 source of information for physicians regarding these drugs remains the drug company sales representative.  This must change.  PRIUM is disappointed that state medical societies and the American Medical Association are opposed to such measures.  We strongly recommend that IAIABC remain committed to mandated continuing education.

3)      [Section 10, Preauthorization Required]: PRIUM believes that the best possible way to eliminate the over-utilization of prescription drugs in workers’ compensation is to engage the treating physician in the creation of a revised treatment plan.  Mandated preauthorization should not be the first step taken by an insurance carrier when a particular claim is brought under scrutiny due to the prescription medication regimen.  That being said, if the treating physician refuses to participate in the creation of a revised treatment plan and continues to prescribe, in some cases, dangerous levels of medications, mandated preauthorization can be a powerful tool to protect patient safety and ensure positive clinical outcomes. 

We appreciate the opportunity to provide this feedback and commend IAIABC for the transparency and collaboration that have been emblematic of this process thus far.

Respectfully submitted,

Michael Gavin

Chief Strategy Officer

PRIUM

Michael Gavin - Chief Strategy Officer

2805 Peachtree Industrial Blvd. Suite 112

Duluth, GA 30097

Direct Line: 678-735-7305

Toll Free: 888-588-4964 x104

Cell: 678-458-8216  Fax: 678-736-6585

Email: mgavin@prium.net

Website: www.prium.net

Blog: http://prium-evidencebased.blogspot.com/

Twitter: @PRIUM1

Joe Paduda Hosts Health Wonk Review

Thanks for including Evidence Based!
http://www.joepaduda.com/archives/002358.html

On Twitter @PRIUM1

The Medical/Legal Summit: Why Isn't Everyone Doing This?

I was privileged last week to spend a few days in Charlotte, NC with Arrowpoint Capital.  Julie Fortune, Chief Claims Officer, and her team put together a Medical/Legal Summit in hopes of educating, coordinating, and enhancing the medical management and litigation management of their claims.  They pulled together about 120 people including internal claims adjusters, litigation managers, outside vendors, outside legal counsel (from many different jurisdictions), medical experts, and even invited an Arrowpoint actuary (all joking aside, Rich gave a great presentation on the importance of historical cost data to actuaries). 

Topics focused on chronic pain management, appropriate use of prescription drug therapy, alternative treatment pathways, Medicare and secondary payment rules, case management, proper use of investigative services, changing rules and regulations at the state level, and how best to use clinical resources like doctors, nurses, and pharmacists. 

And this wasn't summer camp, folks.  This was an intense conference that started promptly at 8:00 am each morning and lasted well into the night as attendees worked on a rather complicated case study.  The Arrowpoint leadership team divided their employees and all of the outside attorneys into eight case teams and had each team present at the end of the conference, incorporating all that they had learned during the course of the conference.  And everyone had to present.  No free riders.  You had to pay attention and really show that you "got it". 

Arrowpoint is managing run-off claims, but every payer has a subset of claims that require high levels of coordination amongst many parties, internally and externally, in order to achieve positive outcomes (clinically and legally).  And one of my key take-aways from the Summit is how closely those two strategies - clinical and legal - need to be linked. 

Does your organization pull together an annual Medical/Legal Summit?  If not, why not?  This is the sort of education and coordination our industry needs. 

Let's get to work.
Michael
On Twitter @PRIUM1

PDMPs: NY Sets the Standard, MO Lags Behind

Prescription Drug Monitoring Programs (PDMPs) are an essential tool for combatting the inappropriate use of prescription drugs.  New York has put in place legislation that may serve as a model for how best to design and implement such a program.

The bill calls for mandatory electronic communication of prescriptions between doctors and pharmacies within three years, real time tracking of prescriptions, and required record checks before doctors write new scripts for certain medications, including opioids. 

Of course, state level efforts can only have so much impact.  Doctor shopping across borders is becoming increasingly common and right now, no single database contains sufficient information to help prevent inappropriate prescriptions on an interstate basis.   I understand there is some nascent movement toward establishing such a database, but my quick research didn't yield anything substantial. 

And congrats to New Hampshire for finally getting its act together.  NH is the 49th state to establish a PDMP program.  The "Live Free of Die" crowd certainly fought against it, even winning a provision that data would be deleted after 6 months (unless abuse is expected).  We'll take what we can get. 

The lone hold out?  Missouri.  The "Show Me" state needs to show us they're serious about prescription drug abuse.  Might be an uphill battle, though.  Here's a quote from Missouri State Senator Rob Shaaf (R-St. Joseph), a family physician, after the passage of a PDMP bill in March of this year (which appears to have stalled in committee back in May): "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... this is liberty versus safety."

Yeah... drug addicts should be free to doctor shop as much as they wish without fear of detection or consequence.  And drug seekers throughout the midwest should feel equally free to flood into Missouri seeking prescription drugs.  Not exactly enlightened public policy, but so what if the preservation of liberty makes Missouri the nation's capital for prescription drug abuse? 

Liberty has its bounds, Dr. Schaaf, and you're on the wrong side of this one. 

Michael
On Twitter @PRIUM1

The Battle Over Hydrocodone: Revisited

This blog, first and foremost, is intended to be informative and educational. My goal has always been to cast about with opinions and the allow others to offer feedback, guidance, and perspective.

Such has been the case since I advocated for moving hydrocodone-containing medications from schedule III to schedule II. On Monday, I wrote about the controversy regarding a provision drafted by Sen. Joe Manchin (D - WV) that would provide for such a reclassification.

In response to that post, I heard from several pharmacists that disagreed with my position.

First, it was pointed out that hydrocodone-acetaminophen is an acute medication and changing it to a schedule II drug may inhibit access to patients that need it quickly. I pointed out that data suggests the drug is often used for chronic pain management, too. That brought this response from a pharmacist: "Hydrocodone is often used chronically, although it is often for breakthrough pain and often with a long acting opioid. Hydrocodone/APAP would not be the sole pain medication. Data from a large carrier in Q4 2011 shows 14% of mature patients using hydrocodone (3 years or older) are using it with a long acting opioid."

Another issue, perhaps more relevant to the battle over abuse and addiction of prescription drugs: "Reclassifying hydrocodone/apap products as a CII does not address the inappropriate and over prescribing of this medication and opioids in general. All it will do is create undue burden on pharmacists and patients without addressing the real problem. Physicians generally do not care how much work or regulatory hoops pharmacists have to jump through to fill a prescription." Good point.

What we all decided to agree upon, though, is the fact that Zohydro (a single ingredient hydrocodone drug as a controlled release long acting opioid - currently pending FDA approval) should be a schedule II drug.

Thanks to all for the input.
Michael
On Twitter @PRIUM1

BCBS of Mass: Tough New Policy on Opioid Scripts

Blue Cross Blue Shield of Massachusetts is deploying a new policy regarding opioid scripts beginning on July 1. Physicians will be restricted from writing more than a 30 days supply of powerful painkillers without a mandatory review by BCBS.

This is a "first of its kind" policy in commercial/group health (as far as I can tell), though the concept isn't foreign to us in work comp. The issue of prescription drug abuse is pervasive and I'm pleased to see BCBS of MA take this bold step.

Yes, this is going to create some additional administrative burden and expense for physicians. Those concerns are legitimate. Unfortunately, the societal cost of abuse and addiction are sufficiently high that policies such as this are necessary.

Michael
On Twitter @PRIUM1

The Battle Over Hydrocodone: Pharmacists Take a Surprising Stand

US Senator Joe Manchin (D - WV) has authored a piece of legislation that would reschedule hydrocodone from schedule III to schedule II (via an amendment to the Prescription Drug User Fee Act).  This sounds simple enough and enjoys bipartisan support on the Hill. 

1) Most claims people (and even many clinical people) think hydrocodone is already a schedule II drug.
2) There's no doubt that hydrocone-containing products are dangerous, come with significant risk of addiction, and should be better controlled than they currently are. 
3) This represents an opportunity for politicians and regulators to show that they're at least willing to take some easy steps to stem the tide of prescription drug over-utilization and abuse in this country. 

You would think, at least. 

A letter was sent last week to all members of the House and Senate from five aligned groups that have two things in common: first, they are either made up of or represent pharmacists; and second, they don't want to see this bill pass.  The groups?  The American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists (really?), National Association of Chain Drug Stores, and National Pharmacists Association. 

The letter states, in part:
“We understand the concerns about diversion and abuse of these products and we share these concerns.  Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse.”

That is absolutely wrong headed. 

What are the practical implications of moving hydrocodone products to schedule II?
- They can't be prescribed as easily physicians and some states restrict NPs and PAs from precribing schedule II drugs at all.
- The drugs will become more costly for pharmacies to obtain and inventory will become more expensive to manage (given the stringent storage and inventory assessment requirements). 

Making hydrocodone harder to obtain WILL NOT impact patients that truly need the drugs.  The real issue here is that pharmacy margins, already thin, are going to take a hit.  I acknowledge this is a real economic issue and an unfortunate unintended consequence of doing the right thing.

Michael
On Twitter @PRIUM1

New Health Wonk Review

Check it out. Thanks to Maggie Mahar for including Evidence Based.

http://www.healthinsurance.org/blog/2012/06/07/health-wonk-review/

On Twitter @PRIUM1

NCCI Narcotics Report: The More You Get... The More You Get

Of all the interesting statistics contained in the new NCCI research brief, the one that stood out most to me was the section entitled "Early Narcotic Use Is Indicative of Prolonged Use."  Turns out, the earlier one gets narcotics and the higher the dose one receives... the longer one will likely be on the drugs and the higher the dose will likely be.

If ever there was an analysis that supported early intervention on claims where narcotics are being utilized, this is it.  Most of us have felt this intuitively, but this is the first analysis I've seen detailing the extent of the issue.   

Some highlights:

- Shockingly, about 10% of claimants receive > 825 mg MED in the first quarter following injury.  50% of all claims receive between 100 mg MED and 370 mg MED in the first quarter following injury.  Recall the 120 mg MED threshold from my post earlier this week.  That's a monthly metric, not quarterly... but I was still surprised at the prevalence of high doses of narcotics early in the claim life.

- 63% of claimants with MED > 825 mg in the initial quarter following injury continued to receive narcotics in the second quarter following injury.  Only 35% of claimants receiving between 370 mg and 825 mg MED in the first quarter post-injury continue to receive narcotics in the next quarter. 

- The graphics NCCI put together on this topic are compelling.  Check out Exhibits 8 and 9.  Once a claimant is on high doses of narcotics, that claimant is highly likely to remain on high doses of the drugs.  For the 10% of claimants that start out on > 825 mg MED, the average MED in the first quarter post-injury appears to be in the range of 2,000 mg MED (or approximately 650-700 mg MED per month).  By the 20th quarter post injury, this cohort averages around 7,000 mg MED (or over 2,000 mg MED per month). 

This is unfathomable.  And it begs the obvious question for further analysis: What is the death rate, by quarter, in the > 825 mg MED cohort? 

Michael
On Twitter @PRIUM1

Lousiana HB 126: Poor Guidelines and Covering Tracks

I've been tracking things in Louisiana over the last several weeks.  I'll be down in Baton Rouge in about 10 days to talk about prescription drug abuse and what can be done about it...
In the course of my preparation, however, I've come across a very disturbing confluence of events that deserves a bit more attention than its getting. 

Back in 2009, the Louisiana state legislature did an enlightened thing and instructed the Office of Workers' Compensation (OWC) to adopt medical treatment guidelines that met very specific criteria, including reliance on systematic medical literature review, published criteria for rating studies and strength of medical evidence, use of contemporary studies, and evidence of adoption by at least one other state - in short, evidence-based guidelines. 

Long story short - the OWC appointed a Medical Advisory Council to evaluate guidelines and recommend which should be chosen.  The OWC/MAC promptly ignored the statutory mandate and began a rather obvious and pronounced drift toward consensus-based guidelines.
I couldn't get anyone to go "on the record" for me regarding the the undue influence of outside stakeholders, but suffice it say that it appears likely that the pharmaceutical and/or medical device industry could have had significant input on the guidelines through the MAC.

And then it gets worse...

Herbert Dixon (D - Alexendria) and Chris Broadwater (R - District 86) of the Louisiana State House of Representatives have sheperded a bill through the legislature and onto the governor's desk (HB 126 can be found here) that completely absolves members of the Work Comp Advisory Committee and Medical Advisory Committee of any accountability whatsoever regarding their work.  Specifically, the bill states that members of these committees "shall not be subject to civil or administrative subpoena for his recommendations or exercise of judgment as a member of the council, including subpoena seeking his oral or written testimony at trial, discovery, or other proceeding, and a subpoena duces tecum seeking documents, inspections, things or information in electronic or any other form." 

Leaving aside the clear overstep of legislative authority (is this even constitutional?), let's just focus on the what this means:  A doctor in Louisiana can accept an appointment to the Medical Advisory Committee, do the bidding of the pharmaceutical and medical device industries, develop guidelines that absolutely do NOT adhere to the legislative mandate of SB303, leave the state work comp system in worse shape than it was already in... and all records, emails, transcripts, etc. connected to their work can be hidden from the light of day and they can never be called to testify in any forum to defend their judgment? 

I spoke to both Dixon and Broadwater.  Broadwater told me that the intent of HB 126 is to protect voluntary participation on the part of medical experts on such committees from inappropriate harassment.  Further, his position is that the rule-making process, public comment period, and ongoing opportunity to amend the medical treatment guidelines provide sufficient transparency in the system that knowing exactly who is influencing the MAC isn't relevant. 

I respectfully disagree.  If these people really are the "experts," I want assurances that their judgment, their expertise, and their counsel isn't being clouded by drug and device manufacturers.  Let's be realistic: the MAC may not have any rule making authority at all, but their advice (as experts) defines the default rules for public consideration.  How do we know we're starting off on the right foot? 

So, to sum up...

Dear Governor Jindal,
Don't sign this bill into law.
Sincerely,
All of us out here who think responsibility and accountability are fundamental tenets of government.

Michael
On Twitter @PRIUM1

Do You Know Your MEDs? A Powerful Metric for Opioid Management

MED stands for morphine equivalent dosage.  And you should immediately start using it (if you're not already) to identify and mitigate the potentially harmful effects of chronic opioid use. 

Different formulations of opioids can be compared to one another (and the real extent of opioid therapy can be established) by converting each drug to its morphine equivalent dosage.  Each opioid has an "MED conversion factor" and there are simple calculators available online (the State of Washington's is particularly useful: http://agencymeddirectors.wa.gov/mobile.html)

The Official Disability Guidelines chapter on pain has a helpful overview for how to interpret the data and keep claimants safe:

"Recommend that dosing not exceed 120 mg oral morphine equivalents per day. Opioids may be recommended as a 2^nd or 3^rd line treatment at doses ≤ 120 mg daily oral morphine equivalent dose (MED). Risk benefit of use should be evaluated, including that of substance abuse and death. An accurate diagnosis should be established and it is strongly recommended that a psychological evaluation occur before starting this class of drugs. Escalation of doses greater that 120 mg (MED) should be done with caution, and generally under the care of pain specialists, and in certain cases, addiction specialists, with the understanding that many patients who progress to chronic opioid therapy have underlying psychiatric disease and substance abuse issues."

Take a patient on 30 mg of oxycondone, twice a day (60 mg total) and Exalgo (hydromorphone ER) 16 mg twice a day (32 mg total).  The morphine equivalent of the oxycodone is 90 mg per day (MED conversion factor of 1.5) and the morphine equivalent of the hydromorphone is 128 mg per day (MED converstion factor of 4.0).  This leads to a total morphine equivalent dosage of 218 mg per day.  This is a major problem. 

There is significant evidence that suggests the 120 mg MED threshold should be taken very seriously.  One of the clearest pieces of evidence comes from a paper published last December by Gary Franklin and colleagues from Washington State Labor and Industries.  After the introduction of opioid dosing guidelines in 2007, Dr. Franklin and his team measured the impact: "Compared to before 2007, there has been a substantial decline in both the MED/day of long-acting DEA Schedule II opioids (by 27%) and the proportion of workers on doses ≥120 md/day MED (by 35%). There was a 50% decrease from 2009 to 2010 in the number of deaths."

Pay attention to MEDs and be prepared to identify and intervene on the claimant's behalf if the 120 mg threshold is breached.

Michael
On Twitter @PRIUM1

The Jury is In: Suffolk County, NY Shines a Light

A grand jury in Suffolk County, NY has issued a 100 page report that represents both a thorough historical analysis of the growth in opioid utilization as well as a stunningly broad solution set for addressing the problem.  You can find the full report here. 

The grand jury was empaneled as a consequence of a horrific crime committed in the county in June of 2011.  Four innocent people were murdered during a pharmacy robbery in which the gunman sought not cash, but Vicodin.  The grand jury's task was to "complete an investigation into the diversion and dissemination of controlled substances and issues related thereto."

What resulted, however, was a report that will prove itself useful to all of us fighting the problem of prescription drug over-utilization and, I would argue, a decent blue print for attacking the problem from a legislative and regulatory perspective. 

A few highlights (emphasis added):

"As previously noted, prescribers must obtain DEA authorization to issue prescriptions for controlled substances. However, there is no prerequisite of specialized training, board certification or continuing medical education required as a prerequisite at the federal or state level. Prescribers are authorized to issue prescriptions for analgesics, having the same addiction potential as heroin, without any specialized training or certification. This is unacceptable."

"Because, over time, chronic pain has become a commonly accepted diagnosis and condition, prescribers are fearful of malpractice suits and repercussions from professional organizations for under-treating pain; in turn, they have responded by overprescribing to ensure that the patient is satisfied with their treatment. As a result, prescribers are issuing more prescriptions for opioids and in higher doses."

"In essence, this highly addictive class of drugs has been readily prescribed for a condition that is poorly understood by practitioners.  The explosion of opioid treatment for a poorly defined medical condition lies with pharmaceutical companies whose aggresive marketing of these drugs has persuaded practitioners of their value."

Add this report to your reading list.  Great data, well researched, excellently articulated. 

Michael
On Twitter @PRIUM1