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
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