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

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Email: mgavin@prium.net

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