Regulators and legislators have the very difficult job of developing and implementing public policy that preserves and protects the best interest of their constituents. For them,there are no easy answers.
Respective to medical care in workers’ compensation, evidence-based medicine (EBM) has been the center of discussion for the past decade. However, significant confusion about the term “evidence-based guidelines” remains. The same questions asked in 2008 are being asked today:
“Can you help me understand the term “evidence-based guidelines?” Various organizations are all saying they have them – and in fact seem to be competing over whose is the best. If they’re all evidence-based, why shouldn’t we just use the most user-friendly or cheapest one?
Evelyn in Evanston”(1)
I had the opportunity to participate in a discussion on drug formularies hosted by The Business Council of New York State last week. Similar to stakeholder sentiment in the state of California, New York regulators are aiming to adopt a drug formulary for workers’ compensation that works in harmony with the state’s Medical Treatment Guidelines (MTGs).
The purpose of having a drug formulary coincide with recommendations on pharmaceutical therapy in an existing MTG source, is the enforceability of formulary recommendations based on EBM – presuming the MTG source was developed according to EBM standards.
If there is now consensus that practice guidelines are the foundation for both treatment recommendations and drug formularies, then concerns about rigor, methodology and quality are of the utmost importance. Medical treatment decisions are being informed by this information. If the quality of the guidelines is in question, then every treatment or drug recommendation stemming from the guidelines must also be in question.
Most, if not all, states that have adopted and enacted EBM treatment guidelines and drug formularies have acted on the counsel of subcommittees comprised of medical providers, vendor representatives, and state representatives. All are well respected in their fields and are good-intentioned individuals. Although, a very visible gap in expertise exists in almost all cases – methodology (i.e., an expert who knows how to grade the quality of methodology).
The reliability of the technical aspects of the scientific method used to develop the guidelines is the most important issue to solve for. The underpinnings of the recommendations, both treatment protocols and drug recommendations, must stand up under scrutiny. If the recommendations themselves are a byproduct of the research process, they should be secondary in consideration to the quality of the methodology employed to develop them.
The question every regulator, legislator, and subcommittee should ask is not: What is the easiest and cheapest resource available? Rather, what is the most rigorous, transparent, reproducible, method used among the guidelines/drug formulary options?
If we can answer the question of quality correctly, all subsequent questions on appropriateness of care are also answered.
1. Christian, J. (2008, June). The Challenge of Evidence-based Guidelines [Web log post]. Retrieved from http://www.webility.md/pdfs/DrJ-column-2008-06.pdf