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

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