A Case for National Standards for State Workers’ Compensation

Would you be surprised to know that the definition of “Employee” and “Contractor” varies from one state to another? Would you be shocked if I told you that more state Workers’ Compensation agencies operate without a full-time, or part-time, Medical Director on staff than those that do?

Speaking with a prominent regulator, and Workers’ Compensation expert, at the #IAIABC103 conference in Portland, OR last week, rekindled my interest in determining what establishing national standards could do for a system where variances from one jurisdiction to the next seem endless.

The sources of variability in definitions and standards are numerous. Among the most prevalent, RESOURCES (expertise, budget, time etc.). Is it reasonable to suggest that the varying availability of resources from state-to-state present limitations for regulators in their pursuit to appropriately research prospective public policy that will improve system outcomes?

Take evidence-based medicine (EBM) for example…

Admittedly, EBM is a very complex concept that few people truly understand and appreciate (Note: This is particularly true, and ironic, in the Workers’ Compensation industry where misaligned incentives makes it nearly impossible for stakeholders to share a common goal). EBM goes beyond the review of literature and authoring of content. The path taken to form conclusions, interpreting scientific literature and answering defined clinical questions ultimately constitutes the content as evidence-based. Without an informed guide to point out technical deficiencies and/or important considerations, the outcome for the agency looking to adopt may result in the selection of a consensus-based resource, or worse, a resource with an undetermined basis.

Serving a Thanksgiving Meal on a Fast-food Budget

In Workers’ Compensation, state officials routinely struggle to serve a Thanksgiving meal given little more than a fast-food budget. This type of limitation in resources hinders small markets from properly researching and vetting EBM tools when considering a source for adoption.

In a best-case scenario, the adopted solution goes through uncontested for quality and trustworthiness, due to a lack of understanding, and provides a standard of care where there previously was none, albeit lesser in quality. Worst-case scenario, the inadequately vetted solution becomes a liability to patient health and is a source of significant system friction and cost due to errant research findings by the agency adopting it. With proper informed due diligence, which requires RESOURCES, both scenarios are entirely avoidable.

Stakeholders in the Workers’ Compensation system throughout the country are actively expanding the conversation on the necessary attributes in EBM treatment guidelines and drug formularies for state adoption. Increased scrutiny is placed on determining if guidelines and formularies are built atop a basis that aligns with public standards defined by the National Academies of Sciences, Engineering, Medicine (formerly the Institute of Medicine). Interestingly, these standards, and the non-profit entity that measures alignment among content sources (i.e., AHRQ’s National Guideline Clearinghouse), are deemphasized and lessened in value by small market states who do not have properly experienced personnel evaluating the standards’ merits. This should prompt action by every person with an interest in Workers’ Compensation – employees, employee attorneys, employers, physicians, carriers, et al.

Good Public Policy is Never Easy and Rarely Inexpensive

Select state agencies have expressed concerns with limited options for adopting EBM content and tools due to absent resources such as a Medical Director, Pharmacy and Therapeutics Committee, and staff with expertise in the area of scientific research. A state’s “limitations” supersedes its “needs” under these restrictive circumstances. The more limited the resources, the less available options for these agencies to consider for adoption.

It is my sincere belief that small market agencies, much like their large market counterparts, work extremely hard to educate themselves on evidence-based medicine treatment guidelines and drug formularies, as well any other area they seek to reform, and aim to make the right decisions. In the end, they are left to act using the resources they have at their disposal, whether plentiful or scarce.

Perhaps a national standard for the evaluation and adoption, better yet a definition of EBM for Workers’ Compensation, as an example, would help afford better options for small markets managing with modest resources.

AHRQ’s National Guideline Clearinghouse and its Relevance

This article was published on Louisiana Comp Blog. Click here to link to the article.

Still Relevant?

Medical practitioners face considerable uncertainty practicing the art of medicine. They rely on their knowledge, skills, experience, and patient preferences. They also rely on the scientific literature to inform their decisions on treatment planning and measuring patient restoration of function. Marketing-savvy device and drug manufacturers often cloud the picture and make identifying effective treatment protocols more difficult. The quality of life for many injured workers weighs in the balance, which is why it is necessary to have organizations such as the National Guidelines Clearinghouse separate trustworthy content from marketing speak.

Institute of Medicine Standards for Trustworthy Guidelines

As of 2011, there were over 3,700 published clinical practice guidelines from 39 countries available for use. Hundreds of these guidelines meet the definition of nationally recognized guidelines; a definition used in most legislative bills introduced and enacted by state legislatures to govern the standard of care for injured workers throughout the country. Being nationally recognized does not mean a guideline is safe and trustworthy to use as a standard of care for injured workers.

Because the term “evidence-based” has been thrown around quite readily, the U.S. Congress tasked the Institute of Medicine (IOM), now known as the National Academy of Medicine, through the Medicare Improvements for Patients and Providers Act of 2008 to initiate a study defining best practices used in developing rigorous, trustworthy clinical practice guidelines. The outcome of the request became the formation of an expert committee. The committee developed eight standards focused on developing guidelines using approaches that are objective, scientifically valid, consistent, transparent, and free of bias.

Evaluation of Guidelines’ Trustworthiness

The Agency for Healthcare Research and Quality (AHRQ) directs a portion of its research funding, through its National Guideline Clearinghouse (NGC), to evaluate guideline provider submissions against the Institute of Medicine’s eight standards. Assessments are made to determine the reliability, validity, and effects of these guidelines on health care quality and patient outcomes. As a result, the NGC is required to discontinue the inclusion of guidelines whose development does not meet the eight standards and whose development is insufficiently documented.

The standards used by National Guideline Clearinghouse to assess rigor and trustworthiness include:

Establishing transparency, management of conflict of interest, guideline development group composition, clinical practice guideline–systematic review intersection, establishing evidence foundations for and rating strength of recommendations, articulation of recommendations, external review, and updating.

NGC’s Applicability to Commercially Available Guidelines

NGC made national headlines in June of 2016 after announcing the removal of the Official Disability Guidelines (ODG), published by Work Loss Data Institute from its database of trustworthy clinical practice guidelines. According to NGC, the removal of ODG took place due to the following deficiencies:

  • Failure to explain how they selected studies for their evidence-based review;
  • Document did not include the number of studies identified or the number of studies evaluated;
  • No summary of inclusion and exclusion criteria; and
  • ODG did not provide synthesized detailed descriptions or evidence tables.

Phil Denniston, ODG’s former-President, went on the record commenting that the Clearinghouse “has moved in the direction of hosting academic guidelines, primarily guidelines produced by medical specialty societies who give the guidelines away to support the interests of their members.”

Mr. Denniston continued: “All of the leading commercial medical treatment guidelines, including Hearst, Milliman, MCG, Zynx, McKesson, Interqual, Dynamed, UpToDate, and others, now also decline to participate in NGC.”

Could it be that the pursuit of healthier margins are the reason commercial treatment guidelines publishers have declined to participate?

Meeting strict standards is not easy and it is not cheap, but the health of injured workers is too important and because of this importance, ReedGroup, owners of the ACOEM Practice Guidelines, have made the requisite commitment to meet the eight essential standards described earlier. As a result, NGC notified ReedGroup on March 2nd, 2017, that guidelines it submitted for evaluation were accepted for inclusion in the NGC. For the record, Reed Group’s ACOEM Practice Guidelines is the only other nationally recognized commercially available guideline for workers’ compensation.

The Importance of University-based Research

Reed Group’s approach to development using a university-based research team anchors the effort to produce trustworthy clinical practice guidelines. The team consults various databases for primary sources of original research. Also searched, are other databases likely to contain references to high quality literature:

  • National Library of Medicine’s National Institute of Health (PubMed)
  • CINAHL (nursing, biomedicine, health sciences librarianship, alternative/complementary medicine, consumer health and 17 allied health disciplines)
  • Cochrane Central Register of Controlled Trials
  • Scopus
  • Google Scholar

ODG’s methodology document, posted on its website, lists literature sources that include textbooks, conference proceedings/presentation slides, and case reports and descriptions. None of these sources meet the selection criteria for creating quality guidelines and rating literature set forth by the Institute of Medicine.

What does this mean to Louisiana and the rest of the country?

If the evidence underpinning the guidelines is in question, then every recommendation (conservative or invasive care, pharmacological, etc.) stemming from the guidelines must also be in question.

Discussions to adopt evidence-based drug formularies continue across the country. Will legislatures continue to perpetuate actions focused on fiscal benefits? Or, will a leader emerge in the south to recognize the relevance of the National Guideline Clearinghouse’s rigorous assessment of quality and trustworthiness among a sea of guidelines promoting physical benefits?

Meeting NGC criteria is not only relevant, it’s vital.

Inspiración en el Sistema de Compensación de Trabajadores Lesionados

La inspiración lleva a la gente a hacer cosas increíbles, a veces cosas atípicas. En raras ocasiones, la inspiración mueve a la gente en su núcleo y activa el comportamiento y la creencia, que no es característico para ellos. Cada cuatro años, la inspiración moviliza a millones de ciudadanos en esta nación para que se reúnan detrás de unas cuantas personas que ellos creen que los van a inspirar.

Las instituciones religiosas, organizaciones no comercial (educativas, basadas en las salud, políticas, etc.) y empresas de comercialización del sector privado con éxito usan como arma la influencia de la inspiración para reclutar el apoyo y la inversión necesarios para cumplir sus misiones definidas. Efectivamente, las organizaciones de ventas más exitosas construyen sus imperios sobre una base de inspiración, inyectando a sus representantes copiosas cantidades de la euforia adictiva.

Si la inspiración es de hecho un tan poderoso conducto de acción, ¿existe una parte constructiva que pueda desempeñar en el mundo de el sistema de compensación de los trabajadores lesionados? Un mundo sostenido por cuerpos rotos, muchas veces oscurados por la moral derrotada, y en casos raros, confiscados por un carácter en bancarrota.

Estudio tras estudio, pilas sobre pilas de datos científicos, se ha verificado la realidad de que los elementos no fisiológicos (psicosociales) tienen un impacto significativo en el retorno a la función de lesión / enfermedad fisiológica. Mientras que los pagadores, proveedores, reguladores, empleadores y abogados debaten sobre la conveniencia, y la necesidad médica de los protocolos de tratamiento diseñados para abordar los elementos fisiológicos, los psicosociales muchas veces no se observan mientras que conducen al paciente por un camino rico en sedación, pero pobre con mejoría funcional.

Sentado en un centro de convenciones lleno de gente, con 2,000 otros trajes, me inspiró recientemente un panel formado por un presidente americano de dos períodos, un proveedor / líder del cuidado de la salud de Baltimore, y dos adictos en recuperación de medicamentos recetados. Su peregrinación a la salud provocó una fuerte creencia de una realidad alternativa del systema de compensación de los trabajadores lesionados; una realidad donde los esfuerzos colectivos de las partes interesadas / accionistas en el sistema realmente podrían ayudar a las personas heridas o enfermas volver a la función severed y esfuerzo productivo y revertir una epidemia que demuestra ser más proficientes en matar que los accidentes de vehículos de motor y armas de fuego.

Me pregunto a mí mismo, ¿podría este mismo tipo de inspiración ayudar a impulsar al famélico de motivación, el quien esta roto en cuerpo y en la mente, regresar a una vida productiva después de una lesión o la enfermedad en el lugar de trabajo?

¿Cómo respondería a la inspiración el arduo ensamblador de gabinetes, padre de cuatro hijos, ganador primario de su hogar, con tres dedos cortados (el que experimenta dolor constante porque se niega a ingerir los narcóticos recetados)?

Tal vez estoy exageradamente sensacional; tal vez no…

Why Standards Matter

I had the privilege of attending the AASCIF conference for the first time, hosted in Oklahoma City this year. I was honored to have so many in the state compensation insurance fund community express support of our organization’s efforts to elevate evidence-based medicine (EBM) and advocate for the improvement of the quality of medical care to injured workers.

One conversation left a lasting impression. A well-known workers’ compensation veteran verbalized discomfort with some of my topical write-ups on EBM, trustworthy clinical guidelines, and my willingness to name certain commercial guidelines publishers in hopes of encouraging accountability. They echoed the conflict-free mantra, “There is enough room for all EBM treatment guidelines in workers’ compensation.”

A thought immediately consumed me:  My point of view is based on standards that are not defined by me, or my employer (also a commercial guidelines publisher), but standards that were developed independently by a non-interested not for profit entity at the request of the U.S. Congress looking to establish best methods used in developing clinical practice guidelines. The goal was to ensure such guidelines have information on approaches that are objective, transparent, scientifically valid, and consistent – the ideal basis of accountability for the clinical guidelines industry.

What is at Stake?

The statistics are sobering. Treating providers experience challenges in the clinic. A 10-year study conducted by a medical consultation firm found that nearly a fifth (~21%) of medical diagnoses in workers’ compensation claims involve errors costing the injured worker prolonged disability and household financial distress.

Workers’ compensation only covers a portion of the earned income and there is usually a ceiling, typically 66% of pre-tax earnings up to the state’s average weekly wage. Lost time from work for the injured worker due to injury or illness means loss of income. According to a study by the Washington State Department of Labor and Industries (2015), injured workers with less than 3 months of lost time lose an average of 3.5% of earning capacity over a 10-year period. Conversely, lost time of 3 to 12 months produces losses of income of approximately 11.6%; 28% loss in earnings is experienced after a 3-year absence due to workplace injury or illness.

Another study published in January 2017 looked at ~1.9 million short-term disability and workers’ compensation claims investigating for absences where prescribed opioids were contrary to a leading EBM drug formulary’s recommendations. The study estimated 57,000 (~3%) claims were found to have had an opioid prescribed that was either moderately or strongly not recommended in the formulary. The study also discovered approximately 133,000 (~7%) claims where prescribed opioids were contrary to the formulary recommendations for disorders of the peripheral nervous system including ulnar nerve lesions and carpal tunnel syndrome.

The challenges experienced in the care and claim continuum are plentiful and very difficult to navigate. Employees, employers, insurers, and medical providers deserve content measured and deemed trustworthy according to non-bias standards to guide injured workers through these challenges and on to recovery.

Thought-Leaders Stand Up

With the deep knowledge base and hands on experience of how quickly a workers’ compensation claim can go into free fall toward catastrophic health and recovery outcomes for the injured worker, why aren’t more “thought-leaders” taking a closer look at the status quo to identify inadvertent, or unintended, consequences and voice opportunities for improvement in their respective areas of expertise? Why is accountability viewed as a negative for industry report and the cost to the individual worker is almost intentionally ignored?

There may be enough room for all EBM treatment guidelines in workers’ compensation. However, there should never be room for vendors to profit from poorly constructed products that are dangerous to the well-being of injured workers and subsequently cost employers a lot more time and money.

Leading “comp-sters” have a duty to encourage accountability in the spirit of preserving the heart of the Grand Bargain, where the employee and the employer are center of the discussion. In cases where benefits and quality of medical care suffer from intendedshortcuts, or vendors falsely representing the basis of their products, accountability should not be viewed as bad for the industry rather it should be viewed through the eyes of an injured worker trusting they will get better.

The Truth Regarding Outcomes in Texas and the Guideline Never Discussed

The Texas workers’ compensation system is again the center of national discussion. Republican House Representatives in Louisiana are proposing the adoption of the binary drug list that Texas made popular resulting from the material reduction in cost and overall decrease of prescription drugs made available to injured workers in the state. However, employee and patient advocates struggle with correlating lower costs and medication prescriptions to a healthier workforce. Denying medical care, without the support of quality scientific evidence, does not guarantee better care and therefore may not result in overall health outcomes.

Texas Commissioner Ryan Brennan submitted a write up published by WorkCompCentral (subscription is required) encouraging the use of the Texas-model formulary by other jurisdictions. While the success of cost savings and reduced medication prescriptions to injured workers in the state is well documented, Commissioner Brennan’s claim that the drug list is responsible for the state’s improvements in return-to-work may not be as cut and dry. The dual adoption of individual commercial return-to-work and treatment guidelines in the state sets a stage worthy of scientific discourse and dramatic findings of deranged recommendations.

Texas’ Choice for Return-To-Work Standards

Texas’ legislated mandate to use return-to-work guidelines is an element of their workers’ compensation system that is usually discussed out of context, or is all together ignored. Leading up to the passage of House Bill 7, which includes the requirement that the Texas DWC adopt return-to-work guidelines in 2005, the state completed a thorough analysis of both ODG, providers of the Texas treatment guidelines and binary drug list, and Reed Group’s Medical Disability Advisor, now MDGuidelines. The state found the Medical Disability Advisor content to be more reliable and based on actual observed claims data wholly tagged by ICD codes and moved forward with adopting the content source to guide return-to-work decisions for injured workers in the state.

Commemorated in the Division of Workers’ Compensation Biennial Report to the 85th Texas Legislature, signed by Commissioner Brennan, Texas’ return-to-work outcomes are driven by the legislative reforms focusing on returning employees to work such as the return-to-work guidelines, return-to-work reimbursement program for employers, improvements in return-to-work outreach efforts, and other return-to-work specific programs. The report also correlates the rebound in return-to-work rates to the state’s economy in 2012 and 2013.

This information is critically important as state regulators and legislators reference the popular report Impact of a Texas-Like Formulary in other States by the Workers Compensation Research Institute and attempt to replicate outcomes experienced in the Texas system. The improvement in duration of disability and return-to-work is not the product of a binary drug list rather a result of a very comprehensive return-to-work effort mandated through legislative reform.

The following is an excerpt from the biennial report available online:

“Not only has the percentage of injured employees who returned to work and remained employed improved since the 2005 legislative reforms, but the amount of time the average injured employee who received TIBs [Temporary Income Benefits] is off work after an injury also decreased from a median of 28‐29 days in 2004‐2005 to 19 days in 2013. The reduction in the number of days off work per claim not only allows employers to quickly restore productivity levels after a work-related injury, it also allows injured employees to regain their wage-earning capacity quicker, helping them avoid severe economic losses as a result of a work-related injury.”

ODG Recommends Return-To-Work for SIDS & Other Pediatric Conditions

ODG claims to have a comprehensive data consortium undergirding its return-to-work guidelines data set as well. So why did Texas choose the Medical Disability Advisor over ODG? The publisher does not describe established standards for exclusion, fails to provide information about diversity with regard to industry or geographic location, and it cites the use of public databases (i.e., CDC NHIS and OSHA) where ICD codes are likely questionable or unavailable.

ODG also asserts its comprehensive guidelines cover every reportable condition and procedure, including over 10,000 ICD-9 codes, 65,000 ICD-10 codes, and 11,000 CPT procedure codes. Rather than screening these codes and providing information about conditions that affect working-age individuals, ODG’s website provides return-to-work summary guidelines for conditions not relevant to the working population:

  • Sudden Infant Death Syndrome (ICD-9 code 798.0)
  • Instantaneous Death (ICD-9 code 798.1)
  • Fussy Infant/Baby (ICD-9 code 780.91)
  • Infant Botulism (ICD-9 code 040.41).

Oddly, a search of ODG’s website using the term “infant” returns numerous conditions for which disability duration data does not exist and return-to-work guidelines are all together inappropriate. These recommendations call into question the source(s) of the numbers provided in the summary guidelines tables.

There is no doubt Texas made the right decision to adopt the Medical Disability Advisor, now MDGuidelines, as its standard for return-to-work over the ODG return-to-work content. The outcomes are irrefutable and a clear result of legislative reforms from 2005, not the savings-focused binary drug list made popular by the state.

However, the realization that the same entity that defines treatment standards for injured workers in Texas also publishes outlandish return-to-work guidance for deceased infants, should prompt severe concern for the quality of the science undergirding every recommendation stemming from the ODG library – treatment and return to work guidelines and drug formulary.

This prompts the question: Do the ODG treatment guidelines and drug formulary meet the definition of evidence-based medicine in the Texas Labor Code?

Texas Labor Code, Section 401.011 (18-a)

“Evidence-based medicine” [EBM] means the use of the current best quality scientific and medical evidence formulated from credible scientific studies, including peer reviewed medical literature and other currently scientifically based texts, and treatment and practice guidelines in making decisions about the care of individual patients.”

The labor code specifies “the use of current best quality scientific and medical evidence formulated from credible scientific studies.” While the State’s definition of EBM is not all together complete, the verbiage indicates the need for the content source to incorporate a transparent systematic review process.

Systematic review ensures the use of the “best” scientific evidence from “credible” sources; it is a core element of evidence-based medicine.

Good-working Systematic Review

As an example, the development of guidelines from the American College of Occupational and Environmental Medicine (ACOEM) utilizes Cochrane systematic reviews, in addition to other scientific systematic reviews that meet or exceed the Institute of Medicine’s (now known as the Academy of Medicine) Committee on Standards for Systematic Reviews of Comparative Effectiveness Research. The ACOEM Guidelines rely on systematic reviews conducted in accordance with the highest standards to provide current guidance on the relevant clinical questions.

Here is how it works: The Research Team conducts exhaustive systematic literature reviews for each guideline topic, and/or research question. In order to identify all high- and moderate-quality original research studies, the literature search is broad and comprehensive.

ACOEM searches PubMed, CINAHL, Cochrane Central Registry of Controlled Trials, and Scopus for primary sources of original research. ACOEM also conducts extensive supplementary searches using review articles, systematic reviews, and reference lists of the included and excluded studies. It searches other databases likely to contain references of high quality medical literature, including Google Scholar to identify potential quality, impactful literature that includes the grey literature.

Search strategies and methods are recorded in detail, including specific databases, search terms, number of studies found (e.g., regarding treatment efficacy searches including RCTs and crossover trials). A Search Results section, in paragraph form, is also included as a footnote for each evidence table.

  • The Search Results section includes:
  • Databases searched (that there were no limits on publication dates, limited to English language)
  • Search terms used
  • Number of studies found from all the databases searched
  • Total number of articles screened

– number meeting inclusion and exclusion criteria

– number critically appraised

  • Total number of studies included of high or moderate quality.

Also identified in tables, are studies of low quality.

In formulating the final recommendations, the numbers of studies and the strength of those studies, are all included in summary statements under the “Rationale for Recommendation” section.

The US Agency for Healthcare Research and Quality’s (AHRQ) Verdict on Texas’ Treatment Guidelines

In June of 2016, Mary Nix, AHRQ Health Science Administrator, stated in a WorkCompCentral interview, “Work Loss Data Institute [publisher of the Texas treatment guidelines a.k.a. Official Disability Guidelines/ODG] didn’t fully explain how it selected studies for its evidence-based review, including the number of studies identified, the number of studies evaluated, and a summary of inclusion and exclusion criteria. Another Requirement WLDI didn’t meet was to synthesize evidence from the selected studies in a detailed description or evidence table.”

In a separate interview with Business Insurance during the same month in 2016, Nix stated, “We were not able to … assure that the systematic evidence review was conducted for each of the topics that they cover in the ODGs”.

The following is a list of the types of evidence reviewed by ODG as documented in their methodology document available on line:

STUDIES:

  1. Systematic Review/Meta-Analysis
  2. Controlled Trial – Randomized (RCT) or Controlled
  3. Cohort Study – Prospective or Retrospective
  4. Case Control Series
  5. Unstructured Review

OTHER:

  1. Nationally Recognized Treatment Guideline (from guidelines.gov)
  2. State Treatment Guideline
  3. Other Treatment Guideline
  4. Textbook
  5. Conference Proceedings/Presentation Slides
  6. Case Reports and Descriptions

None of the “Other” materials reviewed and used by ODG meet the selection criteria for inclusion of any methodology literature-scoring model.

Recommendations for medical care should not be created based on single studies, or sources. Rather, recommendations should be based on the preponderance of evidence systemically gathered, reviewed, graded, summarized and evaluated. These steps are important to ensure the process is reproducible and the recommendations, when established, are valid and supported by the best quality scientific evidence meeting inclusion criteria from credible scientific studies.

The influence of Texas’ return to work standards on outcomes cannot be more apparent. While the evidence that the content underpinning their treatment standards do not meet their Labor Code’s definition of evidence-based medicine is overwhelming. It is a strange case indeed, when states such as Louisiana are specifically seeking to replicate the adoption of tools proven to have no scientific merit in hopes of achieving outcomes driven by sources and initiatives unique to Texas.

Why Details Matter for Louisiana in the Formulary Debate

An edited version of this article was published on Louisiana Comp Blog. Click here to link to view.

The Proverbial Broad Brush

Generalities plague the Workers’ Compensation industry. From indirectly typecasting opioid-using patients as drug addicts to characterizing physicians as narrow-minded profit-driven narcissists, and former State officials suggesting a single binary drug list can have similar cost-saving effects in multiple jurisdictions. The proverbial broad brush is a potent distraction from the specific issues needing attention in order to improve the quality of care to injured workers.

Louisiana’s Need of a Drug Formulary

Former Texas Workers’ Compensation Commissioner, Rod Bordelon, has represented Work Loss Data Institute and their ODG Treatment Guidelines and Drug Formulary in a number of jurisdictions. In November of 2016, he made a stop at the Louisiana Association of Self Insured Employers (LASIE) annual conference.

Armed with the usual workers’ compensation cost savings statistics from the State of Texas, Mr. Bordelon and LASIE made a case suggesting that Louisiana can experience similar savings if they adopted the same formulary as Texas – the ODG binary drug list. The presentation overlooked two critical differences between Louisiana and Texas that will have a significant impact on the formulary’s performance:

  • Louisiana recognizes the Colorado Treatment Guidelines as the presumptively correct standard of care and not the ODG Treatment Guidelines like Texas.
  • Louisiana does not have a legislative mandate to use Return-To-Work Guidelines to support the return to work process of its injured workers.

The Colorado Treatment Guidelines and ODG Treatment Guidelines have very different levels of rigor in their development methodology. As an indication of the differences in their scientific basis, the Colorado Guidelines are listed in AHRQ’s National Guideline Clearinghouse for being trustworthy clinical guidelines aligning with the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines. After it was determined that they did not meet critical standards of evidence-based medicine such as transparency, study inclusion/exclusion criteria, the ODG Treatment Guidelines were removed from the National Guideline Clearinghouse in June of 2016.  As a result, Louisiana stakeholders should expect to experience friction and disconnect resulting from using the ODG drug list, purportedly based on the ODG Treatment Guidelines, and the Colorado Guidelines in concert.

Perhaps the most underestimated component of the Texas Workers’ Compensation system that has supported their reduction in prescription drugs is their legislated mandate to use Return-To-Work guidelines to help injured workers return to productivity as soon and safely as possible. Texas’ efforts to keep workers employed while recovering from work-related injuries and illnesses has resulted in a drop in lost-time claims from 165,000 in 2000 to fewer than 90,000 in 2014. The success of the Return-To-Work program is preventing the pathogenic effects of job loss such as, decreased physical and mental health and higher treatment utilization, and thus driving down medication consumption.

The Basis of a Trustworthy Drug Formulary

On Monday, May 1st, the California Division of Workers Compensation (DWC) held a public hearing required by statute in order to collect feedback on its proposed regulation package for the enactment of the MTUS Drug Formulary/Preferred Drug List derived from the ACOEM-based Formulary. Their journey to adopting a trustworthy drug formulary has been long, detailed oriented, and started with a comprehensive independent report from the RAND Corporation, Implementing a Drug Formulary for California’s Workers’ Compensation Program.

Several assumptions regarding how California’s DWC would design and implement the drug formulary underpinned RAND’s methodological approach and policy analyses. Their first, and possibly most important, assumption was that the DWC intended to adopt a formulary designed to maximize quality-of-care, health, and work-related outcomes; this has also been a guiding principal behind Louisiana’s HB 592 according the bill’s sponsor, Representative Kirk Talbot and the Louisiana Association of Self Insured Employers. To accomplish these objectives in California, RAND recommended the formulary drug list and drug classification scheme to be evidence-based and as consistent with the California’s Medical Treatment Utilization Schedule (i.e., California’s Treatment Guidelines) as possible.

RAND reviewed five existing drug formulary models: Washington State Department of Labor and Industries, Reed Group’s ACOEM-based Formulary, Work Loss Data Institute’s ODG Formulary, Ohio Bureau of Workers’ Compensation, and California Department of Health Care Service (Medi-Cal, California’s Medicaid Program). The five models were compared across six criteria including, but not limited to: Reliance on evidence-based criteria, Transparency in process used to establish and maintain the formulary drug list and recommendation, Established process for regular updates to the formulary drugs and recommendations.

The RAND report identified that while the ODG formulary would be easier to implement, methods used to develop the guidelines used as the formulary’s basis have been less rigorous than its counterparts in the workers’ compensation arena (Nuckols et al., 2014), and the methodology used to derive California’s Prospective Review requirements when there are condition-specific variations in the guideline recommendations is not transparent. Based on these findings, the ODG Formulary may be easy to implement, but was not determined to be a trustworthy source to maximize quality-of-care, health, and work-related outcomes.

Due to fact that very little of California’s MTUS guidelines were based on ODG, the adoption of the ODG Formulary would represent a major departure from the current California Treatment Guidelines. Similar to California, a departure from Louisiana’s presumptively correct standards, the Colorado Treatment Guidelines, will create an environment governed by friction and disagreement.

Trends in State Adoptions of Commercial EBM Guidelines and Drug Formularies

A trend seems to be evolving throughout the country regarding proposals to adopt evidence-based treatment guidelines and drug formularies. In 2016, numerous stakeholders in more than a dozen States proposed the adoption of nationally recognized evidence-based medical treatment guidelines and drug formularies. A number of bills introduced during the 2016 legislative session specifically named the ODG treatment guidelines, drug formulary.

As education aimed at providing State lawmakers and stakeholders in workers’ compensation with important information to measure the quality and trustworthiness of EBM content sources becomes more popular, the interest in the ODG brand is waning. Of the two commercially available workers’ compensation guidelines and formularies, only Reed Group’s ACOEM Treatment Guidelines and Drug Formulary have been selected for adoption in the last 24 months (California and Nevada).

It is clear that AHRQ’s National Guideline Clearinghouse’s announcement of ODG’s removal from its database in June of 2016 was a major disruptor in the national workers’ compensation industry’s pursuit of the content source. According to Mary Nix (AHRQ’s Health Scientist Administrator), the removal was prompted after AHRQ’s clearinghouse was not able to assure that the systematic evidence review was conducted for the topics covered in ODG.

In addition to Louisiana, Montana, Nebraska, New York and Pennsylvania have ongoing legislative conversations pertaining to the adoption of a drug formulary. As with Louisiana, the Colorado Treatment Guidelines are adopted in part, or in whole, in Montana and New York providing the content source presumptive weight. The question of what formulary will work best in concert with the Colorado Treatment Guidelines will also need to be answered in these jurisdictions.

Time Will Tell

While most stakeholders in Louisiana feel an evidence-based drug formulary can be a useful tool to support other State measures to curb opioid prescriptions, not many believe the ODG binary drug list is the right fit for injured workers in the State. Louisiana Representative Chris Broadwater, author of this year’s HB 529 calling for the Louisiana Office of Workers’ Compensation Administration to create a drug formulary, pulled a similar bill introduced in 2016 requiring the use of the ODG binary drug list. What does Representative Broadwater know that Representative Kirk Talbot, Bordelon, and LASIE do not?

Comparing the Texas workers’ compensation system to Louisiana’s system is like comparing apples to oranges. The expectations for similar outcomes is a stretch, to say the least, at the expense of injured workers.

In an industry where complexity is normal and expected, it seems a broad-brush approach to anything would be unfamiliar and uncomfortable. Time will tell if the desire to save money will prevail over common sense, medical sensibility, and preserving the injured workers’ right to the appropriate medical care.

California Demonstrates Great Leadership

Major Overhaul Planned for MTUS

The California Department of Industrial Relations Division of Workers’ Compensation (DIR DWC) continues to demonstrate its commitment to improving the quality of medical care available to ill or injured workers in the state by announcing that all MTUS Guidelines will be updated to Reed Group’s ACOEM Practice Guidelines.

On February 23rd and 24th, then again on March 2nd and 3rd, the DIR DWC hosted several breakouts during the State’s Workers’ Compensation Education Conferences in Los Angeles and Oakland respectively. As expected, the team spent a considerable amount of time discussing updates to the enactment of California’s drug formulary. Dr. Raymond Meister (Medical Director, DIR DWC), Jackie Schauer (DIR DWC Legal Unit), and John Cortes (DIR Legal Counsel) also spent time discussing updates to MTUS via Senate Bill 1160’s expedited process.

Initial MTUS Guidelines Updates (As Discussed in Great Detail at Each Conference)

– ACOEM 2004 Neck and Upper Back Complaints (Updated to ACOEM 2016 Cervical and Thoracic Spine Disorder Guideline)

– ACOEM 2004 Shoulder Complaints Chapter (Updated to ACOEM 2016 Shoulder Disorders Guideline)

– ACOEM 2007 Elbow Disorder (Updated to ACOEM 2013 Elbow Disorders Chapter)

– ACOEM 2004 Forearm, Wrist, and Hand Complaints (Updated to ACOEM 2016 Hand, Wrist, and Forearm Disorders Guideline)

– ACOEM 2004 Low Back Complaints (Updated to ACOEM 2016 Low Back Disorders Guideline)

– ACOEM 2004 Knee Complaints (Updated to ACOEM 2015 Knee Disorders Guideline)

– ACOEM 2004 Ankle and Foot Complaints (Updated to ACOEM 2015 Ankle and Foot Disorder Guideline)

– ACOEM 2004 Eye (Updated to ACOEM 2017 Eye Disorders Chapter)

New Guidelines To Be Added

– ACOEM 2017 Hip and Groin Guideline

– ACOEM 2016 Occupational/Work Related Asthma Guideline

– ACOEM 2016 Occupational Interstitial Lung Disease Guideline

MTUS Updates Beginning Spring of 2017 via Expedited Process

– ODG 2015 Chronic Pain Medical Treatment Guidelines (Updated to ACOEM 2017 Chronic Pain Medical Treatment Guideline)

– CA MEEAC Opioids Treatment Guidelines (Updated to ACOEM 2014 Opioids Treatment Guideline)

– ACOEM 2004 General Approaches Guidelines (Updated to ACOEM 2016 General Approaches)

MTUS Updates To Be Made via Expedited Process Upon Completion of Guidelines by Reed Group/ACOEM

– ACOEM 2004 Stress Related Conditions (Updated to ACOEM 2017 Behavioral Health Guideline)

– ACOEM 2017 Traumatic Brain Injury Guideline

RAND Corporation and The National Academy of Medicine Measures of Quality EBM

The major updates to the MTUS coincide with the RAND Corporation’s report “Implementing a Drug Formulary for California’s Workers’ Compensation Program” and recommendations for the treatment guidelines and the formulary to incorporate the evidence-based standards of care that best meet the needs of California’s injured workers. The RAND report also recommended that there be consistency between the MTUS guidelines and the adopted ACOEM-based drug formulary. Perhaps the most important reason for California’s wholesale adoption of Reed Group’s ACOEM Practice guidelines is RAND’s determination that the ACOEM guidelines have a more rigorous, transparent development process. (Click HERE to view the complete PowerPoint presentation, Slide 4 provided below.)

The ACOEM Practice Guidelines are the only commercial nationally recognized content source that meticulously complies with all eight (8) Standards for Developing Trustworthy Clinical Practice Guidelines established by the National Academy of Medicine (NAM, formerly the Institute Of Medicine, IOM). The defined standards are:

  1. Establishing Transparency
    • The processes by which the clinical practice guideline is developed and funded should be detailed and explicitly and publicly accessible.
  2. Management of Conflict of Interest
    • Prior to selection of the guideline development group, individuals being considered for membership should declare all interests and activities potentially resulting in conflicts of interest with development group activity, by written disclosure to those convening the group activity.
  3. Guideline Development Group Composition
    • The guideline development group should be multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and populations expected to be affected by the clinical practice guideline.
  4. Clinical Practice Guideline-Systematic Review Intersection
    • Clinical practice guideline developers should use systematic reviews that meet standards set by the Institute of Medicine’s Committee on Standards for Systematic Reviews of Comparative Effectiveness Research.
  5. Establishing Evidence Foundations for and Rating Strength of Recommendations
    • For each recommendation, the following should be provided: An explanation of the reasoning underlying the recommendation, including:
      • A clear description of potential benefits and harms.
      • A summary of relevant available evidence (and evidentiary gaps), description of the quality (including applicability), – quantity (including completeness), and consistency of the aggregate available evidence.
      • An explanation of the part played by values, opinion, theory, and clinical experience in deriving the recommendation.
      • A rating of the level of confidence in (certainty regarding) the evidence underpinning the recommendation.
      • A rating of the strength of the recommendation in light of the preceding bullets.
      • A description and explanation of any differences of opinion regarding the recommendation.
  6. Articulation of Recommendations
    • Recommendations should be articulated in a standardized form detailing precisely what the recommended action is and under what circumstances it should be performed.
  7. External Review
    • External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations (e.g., health care, specialty societies), agencies (e.g., federal government), patients, and representatives of the public.
  8. Updating
    • The clinical practice guideline publication date, date of pertinent systematic evidence review and proposed date for future guideline review should be documented within the guideline.
    • Literature should be monitored regularly following the clinical practice guideline publication to identify the emergence of new, potentially relevant evidence and to evaluate the continued validity of the guideline.

ACOEM Practice Guidelines Meet The National Guideline Clearinghouse Inclusion Standards

The National Guideline Clearinghouse (a public agency for the AHRQ and public resource for summaries of evidence-based clinical practice guidelines) measures compliance to the above-mentioned standards. A prominent workers’ compensation news media outlet announced on Tuesday, March 7th, that the ACOEM Practice Guidelines were accepted by the clearinghouse, confirming they meet all of the newly updated inclusion criteria.

The National Guidelines Clearinghouse also made national workers’ compensation news in June of 2016 after announcing that the other commercial nationally recognized guidelines provider, ODG published by Work Loss Data Institute, had been removed from its database after it was determined that the ODG content and development process did not meet evidence-based medicine standards. Some examples provided of the unmet standards include:

– Explaining how ODG selected studies for their evidence-based review

– Including the number of studies identified

– Including the number of studies evaluated

– Providing a summary of inclusion and exclusion criteria

According to the NGC and AHRQ, evidence from the selected studies must also be synthesized in a detailed description or evidence table, which ODG did not provide for all of its treatment recommendations.

California’s patient-centric decision to replace all of its existing guidelines with the most current versions of the ACOEM Practice Guidelines is the first step in the much-needed direction towards patient advocacy. In addition to taking a position that places the doctor-patient relationship as paramount, the State also decided to take a leadership position with adopting a drug formulary model that differed from the news-mainstay and savings-focused Texas model. By moving away from the draconian yes/no drug list approach of yesteryear to a modern formulary model that eradicates assertions of a cookie-cutter, one-size fits all approach, the California ACOEM-based formulary elevates the importance of each individual patient’s medical condition and where they are in their respective treatment path, is not only the right thing to do, its smart medicine.

Will California’s innovative approach to improving medical care for injured workers pay off?

The sense is that while learnings will present themselves along the way, we are now much closer to making significant progress in workers’ compensation. The future will tell if other States follow California’s lead to put patients’ health and well-being at the center of their adopted standards for drug formularies and medical treatment guidelines.

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