Monday, September 24, 2012

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

On Twitter @PRIUM1

No comments:

Post a Comment