Tennessee and Opioids: Fumble at the Goal Line

(An update to this post is available here).

I was as excited as anyone this past summer when Tennessee’s legislature passed Senate Bill 3315.  SB 3315 amends the definition of Utilization Review to explicitly include Schedule II, III, and IV drugs being used for pain management.  Specifically, the bill states “it is the intent of the general assembly to ensure the availability of quality medical care services for injured and disabled employees and to manage medical costs in workers’ compensation matters by eradicating prescription drug abuse through the employment of the system established by subsection (a) to review any health care provider prescribing one (1) or more Schedule II, III, or IV controlled substances for pain management to an injured or disabled employee for a period of time exceeding ninety (90) days from the initial prescription of such controlled substances.”  Pretty clear legislative intent. 

Elsewhere in TN regs (specifically Chapter 0800-02-06.05 of the General Rules of the Workers’ Compensation Program), the circumstances under which mandatory UR can be invoked are clearly outlined: “The parties are required to participate in utilization review under this Chapter whenever a dispute arises as to the medical necessity of a recommended treatment.”

So, this should be simple.  Any opioid prescribed for pain management for more than 90 days should be subject to utilization review, allowing for a 3^rd party assessment of medical necessity and offering the payor community a statutorily recognized path to rein in opioid abuse.  Great news. 

If only that were the interpretation being offered by the Tennessee Department of Labor (TDOL)…   We’re hearing from several of our TN customers that SB 3315 is being misinterpreted by TDOL. 

There are several other components of SB 3315 among which is a section that states “If a treating physician determines that pain is persisting for an injured or disabled employee beyond an expected period for healing, the treating physician may either prescribe, if the physician is a qualified physician as defined… or refer, such injured or disabled employee for pain management encompassing pharmacological, non-pharmacological and other approaches to manage chronic pain.” 

Apparently, TDOL is unwilling to consider an otherwise valid UR determination unless:

1)      The treating physician has first documented that the pain has persisted “beyond an expected period for healing”; and

2)      The referral to a “qualified physician” has occurred and that physician has reached the same conclusion (that the pain has persisted “beyond an expected period for healing”); and

3)      An additional 90 days have elapsed.

I see several issues.

First, I’ve read SB 3315 over and over… and I have no idea how TDOL could stitch together these requirements, particularly based on the clearly stated legislative intent.

Second, the path outlined here relies entirely on a treating physician, who in many cases caused or at least contributed to the opioid dependence, to suddenly concede that his treatment might not be working after all… despite the increasing dosage of opioids and the addition of half a dozen companion drugs over the last 5 years.  Never.  Going.  To.  Happen.

Third, there are no statutorily recognized treatment guidelines in TN.  How is the “expected period of healing” to be determined by the physician?  On what should that determination be based? 

Fourth, this process has no chance of achieving the stated goal of SB 3315: to manage costs by eradicating (the bill actually uses the word “eradicate”!) prescription drug abuse.

SB 3315 had a chance of making a real impact.  Given the misinterpretation of the bill by TDOL, I fear Tennessee is coughing up the ball right at the goal line. 

If TDOL doesn’t straighten this out, we’ll be left with a court battle as TN payors fight for a proper regulatory interpretation of the legislative intent of SB 3315.  I hope it doesn’t come to that, but if it does, the real loser will be patients who continue to grow ever more dependent on opioid medications that have no hope of alleviating their chronic pain over the long term. 
On Twitter @PRIUM1

NWCDC: PRIUM Events

PRIUM has several events planned this week and wanted to let you know where to find us!

First and foremost, we're at booth 117.  Come by and see us. 

Second, we're sponsoring the Wednesday afternoon cocktail reception in the exhibit hall along with our friends at Health Care Solutions.  Grab a drink, a PRIUM koozie, and enjoy the networking opportunity in the exhibit hall before running out to the ten events you have to attend that night!

Third, PRIUM is excited to be participating in this year's "Opioid Solutions" track.  Mark Pew, PRIUM's SVP, is presenting on two panels this week:

On Thursday morning, Mark is co-presenting with Jim Andrews from Health Care Solutions.  You can catch their session, "Claim Cleanup: Review of Texas' Closed Formulary and National Implications" in LVCC N252 at 8:45 am Thursday.

On Friday morning, Mark is co-presenting with Jeff White and Paul Kauffman from Accident Fund.  Their presentation, "The Insurer's View: Developing a Narcotics Management Program" is at 9:00 am in LVCC N252. 

Busy week ahead.  Travel safely and enjoy the conference.

Michael
On Twitter @PRIUM1

Texas Closed Formulary: Still an Education Gap

The Texas Department of Workers' Compensation is hearing about some troubling, albeit isolated, incidents of adjusters denying medication therapy for legacy claims (i.e., claims with dates of injury prior to 9/1/11).  These claims are still subject to the "open formulary" - and even when the "closed formulary" kicks in on 9/1/13, these medications still must run through the established preauthorization process (unless, alternatively, the applicability of the closed formulary has been documented between the carrier/employer and the prescriber prior to 9/1/13). 

We spend a lot of time here at PRIUM thinking about, traveling to, and conducting business in Texas.  I am still uncomfortably surprised at how little is understood about the new closed formulary rules.  Granted, carriers, employers, and providers routinely express that they've heard about the rules and loosely understand them... but too often, they go on to completely and totally misinterpret the timeline, process, and rules associated with the closed formulary. 

I try very hard to ensure this blog isn't used as a direct marketing tool and I'm not going to start now. 
Whether you use PRIUM as your preferred URA or not, give us a call.  We'll deliver our certified continuing education unit to you, your team, your office, your company, etc. and we won't try to sell you anything (unless, of course, you ask).  We've worked hard to develop a deep understanding of the necessary approach to addressing the legacy claims and we're happy to help in any way we can - even if it's a simple webinar to walk through the rules and the associated process steps. 

If you don't take appropriate action now, legacy claim management is going to get tough come next September.  Let us know if we can help.

Michael
On Twitter @PRIUM1

Treatment Guidelines, Prospective Review, and Patient Safety

New Mexico is currently working through the process of adopting medical treatment guidelines.  Thankfully, they appear to be leaning toward nationally recognized, evidence-based guidelines like ODG and ACOEM (vs. the Medtronic-influenced, politically-driven brew of guidelines that states inevitably end up with when they try to develop their own guidelines).  Also encouraging is the presumption of correctness that the New Mexico rule contemplates.  Holding treating physicians accountable to the guidelines (even if that means ensuring clear, documented rationale for treating outside of said guidelines) is the only way to improve patient care and reduce state-to-state, practice-to-practice, and physician-to-physician variability in care.

Less encouraging is the proposed elimination of the requirement for providers to obtain prior authorization for medical services that are recommended by the guidelines.  While that sounds logical and efficient, there may be unintended consequences.

Prior authoriziation (or pre-authorization or pre-certification) comes in several shapes and sizes.  In many states, it's optional - something the provider will utilize only in circumstances where high cost care is being rendered and the provider wishes to ensure future payment (i.e., for a surgery).  In some states, pre-authorization is mandated - something the provider must do prior to delivering care.  There are pros and cons to both approaches.  Optional pre-authorization is administratively simpler and less onerous on providers.  Mandated pre-authorization is the opposite - more demanding administratively and on doctors.

But the clearest and most compelling argument for mandated pre-authorization is patient safety. New Mexico may allow for retrospective review if a physician performs a surgery or procedure outside of ODG or ACOEM.  But by then, the care has been rendered, potentially to the detriment of the patient. 

Texas serves as a bright spot in this regard.  Texas has adopted nationally recognized medical treatment guidelines and still maintains mandated pre-authorization, which now includes pre-authorization for certain pharmaceutical treatment as well.  Does anyone doubt that measures such as these have made Texas one of the most cost-effective work comp systems in the nation? 

High marks for New Mexico regarding treatment guidelines.  Low marks for trying to remove mandated prior authorization.  This strikes me as a quid pro quo with the physician community ("we're going to adopt these guidelines... but you don't have to ask permission anymore..."), but I don't think this bargain is in the best interest of patient safety.

Michael
On Twitter @PRIUM1

Thanks to LexisNexis

PRIUM's Evidence Based blog has been named a LexisNexis Top 25 Blog for Workers' Compensation and Workplace Issues for 2012.  We're grateful to LexisNexis for the honor and humbled to be in such good company.  I've had the opportunity to not only read the content generated by the other honorees on a daily or weekly basis, but also to interact and collaborate with many of them.  I like the feeling I'm often left with... that we're pulling in the same direction.   

Writing about important health care and public policy issues is energizing.  Writing about issues I care about is a blessing.  Getting to do both simultaneously is pure joy. 

We're just getting started.  Plenty of battles left to fight.  If a simple but thoughtful blog post can inform an important debate, change a single mind, or influence even one decision maker... then that post was worth writing. 

Thanks for reading.
Michael

On Twitter @PRIUM1

Prescription Drugs and Kids: This Will Make You Cringe

The New York Times published a piece last week that I find incredibly troubling.  While not directly impacting the workers' compensation system, the article sheds light on our cultural proclivity to rely on prescription medication for uses that were not intended and are not appropriate.  Further, it highlights the role of well-meaning medical practitioners who, in reality, are creating more harm than good. 

Dr. Michael Anderson, a pediatrician in Cherokee County, Georgia, noticed that some of his patients were performing poorly in school.  Unable to determine that anything was medically wrong with these children, Dr. Andersen assumed that the school itself was inadequate.  He may be right about that.  But his solution to the problem is shocking.

He prescribes Adderall. 

He admits, according to the NY Times, that the ADHD diagnosis that he makes is "made up" and "an excuse" to prescribe the drug for the express purpose of boosting academic performance (Adderall improves focus and impulse control).  Dr. Anderson goes on to say, "We've decided as a society that it's too expensive to modify the kid's environment.  So we have to modify the kid."

Wow.

Later in the article, we come to discover that one of the kids prescribed Adderall began hearing voices that were not there and admitting to suicidal thoughts.  Dr. Anderson's solution?  A week in a psych hospital and a switch from Adderall to Risperdal.  Problem solved.  For now. 

Gradually over the last half century, we have become far too comfortable with the idea that there is a pill to solve every problem, even when legitimate medical diagnoses don't exist.  Struggling in school?  Take a pill.  We see this every day in workers' comp.  Pain? Take a pill.  Still hurts?  Take a stronger pill.  And take more of them.  We have to focus on non-pharmacological solutions to social, environmental, and even biological problems. 

Dr. Anderson acknowledges that no one knows the long term effects of pharmacological solutions like Adderral for academically under performing kids.  But, he says, "I am the doctor for the patient, not for society."  In reality, he is doing a disservice to both.

Michael
On Twitter @PRIUM1

Connecticut: A Simple Suggestion to Help Control Costs

There's a great post today by Jon Coppelman over at Workers' Comp Insider that compares and contrasts the work comp systems of Massachusetts and Connecticut in light of the recently released Oregon Rate Study.  (Side note: see David DePaolo's post on the Oregon study here - good data, but certainly needs to be read in proper context).

After a thorough overview of each state's woes (which happen to be equally painful, but polar opposite sets of issues), Jon suggests the following for Connecticut: "... regulators must confront entrenched stake holders and begin to exert control over runaway costs." 

Well said.  And I have a suggestion for where the good people of Connecticut might start: Let us talk to the treating physicians.

The employer/insurer community in Connecticut is severely restricted with respect to being able to initiate a peer-to-peer conversation with a claimant's treating physician.  Communication between payor and the attending physician where such communication would involve unilateral disclosure or discussion of material information is not allowed.

Payors, however, may request the physician to complete the "Employee Medical & Work Status Form" or provide progress notes. Copies of this communication, as well as any responses from the physician, must be provided to the injured worker or his/her representative (Payor and Medical Provider Guidelines to Improve the Coordination of Medical Services, 2010).

But there is no allowance for the insurer to engage a peer physician to launch a call to the treating doctor and say, "Hey Dr. Smith... can we chat about why Joe has been on Oxycontin for three years? The evidence suggests that might not be good for him. Are there mitigating circumstances? Do you need help with weaning? How can we be of assistance?" In Connecticut, that conversation can't happen. And that's a shame. 

The goal of a peer-to-peer conversation is not to coerce or connive our way to a cheaper treatment plan.  That is a disservice to all stake holders and peer review companies that conduct clinical conversations that way have no place in our industry.  Yes, we will challenge the current treatment plan if it falls outside of the medical treatment guidelines.  But we do that with a specific end in mind.  The goal of a well conducted peer-to-peer conversation (which is admittedly harder than it might initially seem) is to engage, to understand, to educate, to guide... in a word, to help. 

These conversations play an important role in the dissemination and adoption of contemporary research and best practices.  Without them, treating physicians are often left with an unattractive and biased alternative information source: the local drug rep. 

Allowing for peer-to-peer conversation in Connecticut is not a magic bullet that will, by itself, lead to significant cost reduction.  But it's a start.

Michael
On Twitter @PRIUM1

The Repackagers Pivot to Drug Screening

Legislative and regulatory action across the country is likely to put a dent in the P&Ls of drug repackaging companies.  They'll fight every step of the way and spend lots of money on lobbyists, but the fundamental business model simply isn't sustainable.  They're not going away tomorrow, but the writing is on the wall.  Some of the more strategically adroit drug repackagers are beginning to explore new revenue sources to replace the waning dollars earned from helping physicians dispense medications.  Where are they looking?

One clear area is drug screening.  Random urine drug monitoring for chronic opioid users is indicated in several sets of medical treatment guidelines and PRIUM believes strongly in the practice.  In fact, this is one of the standard areas we explore on every review we conduct.  The importance of random drug screening cannot be overemphasized given its impact on patient safety.   But any virtue taken to an extreme can become a vice. 

The logic trail here is similar to drug repackaging.  Take a therapy or procedure that the doctor feels the patient needs... allow the doctor to administer the therapy or procedure directly in the office... bill the insurance company for services provided... increasing patient convenience and compliance.  Sounds rational, right?

The devil, as they say, is in the details. 

Drug repackagers routinely develop novel NDC codes, allowing them to create arbitrary average wholesale prices.  This practice allows doctors to bill insurance companies significantly more than the insurer would have paid had the drug been filled at a typical retail pharmacy.  And there is no evidence to suggest that the practice increases safety or compliance.  Additionally, restricting this activity entirely (as several states do) does not appear to impact access to needed medications on the part of injured workers.  Not so rational after all.

We see the same trend coming in drug screening.  Keep a look out for excessive utilization and/or obnoxiously high bills for urine drug screening performed in the treating physician's office.  The drug repackagers are going to start teaching docs how to game this system as well.  A couple of examples: http://thephysiciansrx.com/toxicology.html and http://physiciandispensingsolutions.com/services-view/drug-toxicology/

Be vigilant.  Understand the services you're buying.  Ensure that the screening is truly random and within the treatment guidelines.  Get another clinician to look at the test results - is the money you're paying actually telling you anything about the patient's adherence to the drug regimen? 

Michael
On Twitter @PRIUM1

Kentucky Revisited: Opioids and HB 1

Back in August, I wrote a post on the immediate impact of HB 1 in Kentucky.  I was a little surprised that most of the comments on that post (several of which I posted, some of which I didn't for reasons of either discretion or propriety) were negative in nature.  HB 1 was characterized as an overreach, dangerous to patients, and costly to the health care system in the state.  Further, the bill's basic constitutionality was brought into question (something along the lines of the KASPER database representing an invasion of privacy... shouldn't a citizen have a right to abuse drugs prescribed by multiple doctors without any consequences?)

This week, however, yields more data on the extent and severity of the opioid epidemic in Kentucky.  Turns out, Kentucky Medicaid patients are prescribed more narcotics than any other class of drug from 2000 to 2010.  According to this report from the University of Kentucky's Center for Business and Economic Research, the state spent $212 million on pain meds over this 10 year period for over 3.8 million prescriptions (just for Medicaid patients!). 

I understand HB 1 isn't perfect.  But I think the detractors owe us more than just a critique.  What's the specific set of alternative policies that could be implemented to help alleviate the epidemic of prescription drug use in Kentucky? 

HB 1 does inflict a greater burden on Kentucky medical providers and it does create a higher standard of care for chronic pain patients.  But I don't believe for one second that the increased cost to the state's health care system of these measures will not be easily overcome by the cost savings related to the mitigation of prescription drug misuse and abuse. 

Michael
On Twitter @PRIUM1

WCRI Report on Opioids: Only Part of the Story

WCRI published a very revealing report this week on long term opioid use and adherence to medical treatment guidelines.  The findings were disheartening, though not terribly surprising. 

The 21-state median percentage of long term opioid users receiving psychological evaluations was 7%.  For psychological treatment the number was 4% (vs. 6% is the prior period studied two years before).  Claims with indications of urine drug testing stood at 24%.  This means that more than 9 out of 10 long term opioid users aren't receiving any kind of psychological screening or treatment.  Only 1 in 4 is being tested to ensure the drugs are being taken properly. 

What's potentially more interesting is what WCRI didn't measure (or perhaps more appropriately, couldn't measure).  The component of the "medical treatment guidelines" for which WCRI was able to collect and analyze data was limited to urine drug monitoring, psychological evaluation, psychological treatment, and physical medicine.  These components of the the medical treatment guidelines all have one thing in common: each can be associated with one or more CPT codes, making data collection and analysis feasible. 

But what about other components of the medical treatment guidelines that doctors should consider in light of chronic opioid therapy?  I'm thinking mainly about functionality.  You can't measure that via a CPT code, but all too often long term opioid use leads to decreased functionality, not improved functionality. 

The WCRI study, along with this basic issue of functionality, begs a broad and important question:

If, theoretically, medical treatment guidelines were properly considered and adhered to for 100% of claims where opioids might have been prescribed... what percentage of opioid spend would disappear from work comp?  What's your best guess?

Michael
On Twitter @PRIUM1

Fighting Fire with Fire: Kudos to Florida Payers

Back in March, I wrote a post about a little known corner of the Florida work comp regs that allows carriers and employers to reduce the price they pay for repackaged drugs. 

Here's how this works: An injured worker gets hurt and sees a doctor. The doctor prescribes and dispenses a drug, then makes up an NDC code, marks it up 300%, and bills the insurer. However, if a retail pharmacy, under contract with the insurer, is "reasonably accessible" for the injured worker, the insurer can re-price the drug to the contracted rate it has with the retail pharmacy. I've talked to the Florida DWC about the definition of "reasonably accessible" - candidly, they're not really sure.  Perhaps they've clarified this for payers in the state, but I couldn't get a straight answer. 

I'm not the only one that pointed this out.  The folks at workcompcentral and several other bloggers pointed to Florida statute 440.13 (12) as a potential tool for payers in the fight against repackaged drug pricing. 

Today brings news from NCCI that this tactic appears to be working.  NCCI has cut its estimate of savings from a proposed repackaged drug bill by half (from about $62 million to about $27 million) due to employers and carriers re-pricing obnoxious bills on their own. 

Predictably, AHCS (a software firm specializing in drug repackaging) says this is further evidence that NCCI's numbers are a moving target.  On the contrary, NCCI's numbers reflect the market reality of payers taking control of the situation in Florida and using any and all available statutes and regulations to stem the tide of inappropriately priced drugs. 

Way to go Florida payers. 

Michael
On Twitter @PRIUM1

An Important Message from Physicians for Responsible Opioid Prescribing

I received the following note from Dr. Andrew Kolodny and with his permission, I'm passing it along to all of you.  Please take 5 minutes and do your part. 

Dear Friends and Colleagues,

As you may know, PROP filed a request to FDA for changes to opioid labels. Specifically, we asked them to add a suggested duration of use, a suggested upper dose and to limit (on-label) use to severe pain. You can read about this here:

http://supportprop.org/advocacy/index.html

If FDA implements our request, opioid manufacturers will be prohibited from advertising long-term use of opioids for chronic non-cancer pain and the medical community will be informed that this practice has not been proven safe and effective. (However, clinicians will still be permitted to prescribe long-term opioids). We believe that this will help reduce overprescribing of opioids. And since it’s overprescribing that’s harming pain patients and fueling the opioid addiction epidemic, the label change could help bring this unprecedented public health crisis under control.

FDA is seeking public comment about the Petition. Thus far, they have received about 200 comments supporting the petition and 130 opposed to the petition. Not surprisingly, industry-funded pain groups (and pain patients misled to believe that this is an effort to ban opioids) have weighed in against the Petition.

Submitting comments to FDA is easy... just click here:

http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001

A couple of sentences is all you need. Please make sure to state clearly in the first or second sentence that you support the petition.

For example, you can write: 

I support this petition. Drug companies should not be permitted to advertise long-term and high dose opioids for moderate chronic pain because this treatment has not been proven safe and effective. The medical community should be informed  by a revised label that risks may outweigh benefits when opioids are prescribed long-term. 

Please try to do this ASAP. As soon as FDA takes an action on the Petition (which could be very soon), they will close the comment period.

If you are interested in reading comments that have already been posted, you can do this here:

http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=fda-2012-p-0818

Thank you for your support!

Andrew

Andrew Kolodny, MD

President, Physicians for Responsible Opioid Prescribing

www.supportPROP.org

Chair, Department of Psychiatry
Maimonides Medical Center
920 48th St., Brooklyn, NY 11219
Tel: 718 283-7557; Fax: 718 283-6540
akolodny@maimonidesmed.org

On Twitter @PRIUM1

Louisiana: Will the Fix... Work?

I presented at the Louisiana Claims Association earlier this year to a room full of work comp adjusters, nurses, and executives.  We talked about the problem of opioid dependence and addiction and WCRI's analysis of Louisiana (not particularly good news for those assembled in that room). 
We talked about the new Medical Treatment Guidelines as well.  After sharing some uncomfortable laughs about the nature of Louisiana politics and how the development and adoption of the guidelines wasn't the most transparent of processes (I wrote about that here), we got into the specific area of the guidelines focused on prescription medications. 

In reality, the portion of the treatment guidelines dealing with drugs isn't bad.  Without going into the details, there's enough in the guidelines to, in theory, give Louisiana payers a way out of paying for medically unnecessary medication therapy. 

In theory.

I asked for a show of hands: How many payer organizations represented in the room were actively using utilization review, based on the treatment guidelines, to challenge inappropriate care?  A single hand went up.  And even that hand went up tentatively. 

What's the problem?  We all know.  Louisiana is like most state work comp systems.  Change isn't really change until the lawyers fight it out and the court says it's so.  And too often, the battle has been waged and lost by the payer community.  Thus, most payers take a "wait and see" approach to any level of reform that doesn't compel their action, but might cost them time and money. 

This week brings news that Louisiana is trying to clarify the appeals process for disputed medical treatment.  The goal is to edit form 1009 to make clear that the path to dispute resolution doesn't run immediately to the courts, but rather through the Office of Workers' Compensation Medical Director. 
A public hearing on the rule change is scheduled for tomorrow in Baton Rouge.

Louisiana readers: Will this make a difference?  Or is Louisiana creating a distinction in process without a difference in outcome?

Michael
On Twitter @PRIUM1

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