Thursday, June 28, 2012

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


Michael Gavin - Chief Strategy Officer

2805 Peachtree Industrial Blvd. Suite 112

Duluth, GA 30097

Direct Line: 678-735-7305

Toll Free: 888-588-4964 x104

Cell: 678-458-8216  Fax: 678-736-6585


Twitter: @PRIUM1

Friday, June 22, 2012

Joe Paduda Hosts Health Wonk Review

Thanks for including Evidence Based!

On Twitter @PRIUM1

Wednesday, June 20, 2012

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

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

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

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

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

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

Let's get to work.
On Twitter @PRIUM1

Monday, June 18, 2012

PDMPs: NY Sets the Standard, MO Lags Behind

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

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

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

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

The lone hold out?  Missouri.  The "Show Me" state needs to show us they're serious about prescription drug abuse.  Might be an uphill battle, though.  Here's a quote from Missouri State Senator Rob Shaaf (R-St. Joseph), a family physician, after the passage of a PDMP bill in March of this year (which appears to have stalled in committee back in May): "Letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives... this is liberty versus safety."

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

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

On Twitter @PRIUM1

Wednesday, June 13, 2012

The Battle Over Hydrocodone: Revisited

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

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

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

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

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

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

Thanks to all for the input.
On Twitter @PRIUM1

Tuesday, June 12, 2012

BCBS of Mass: Tough New Policy on Opioid Scripts

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

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

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

On Twitter @PRIUM1

Monday, June 11, 2012

The Battle Over Hydrocodone: Pharmacists Take a Surprising Stand

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

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

You would think, at least. 

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

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

That is absolutely wrong headed. 

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

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

On Twitter @PRIUM1

Wednesday, June 6, 2012

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

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

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

Some highlights:

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

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

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

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

On Twitter @PRIUM1

Tuesday, June 5, 2012

Lousiana HB 126: Poor Guidelines and Covering Tracks

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

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

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

And then it gets worse...

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

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

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

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

So, to sum up...

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

On Twitter @PRIUM1

Monday, June 4, 2012

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

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

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

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

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

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

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

On Twitter @PRIUM1

Friday, June 1, 2012

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

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

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

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

A few highlights (emphasis added):

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

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

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

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


On Twitter @PRIUM1