Tag Archives: Recovery

Patient Engagement in Workers’ Compensation

This article was published on WorkCompCentral’s Work Comp World. Click here to link to the article.

The call to increase patient engagement to inform the development of standards and policies is gaining traction. The development of these standards ultimately helps improve health outcomes in workers’ compensation, and other health care influenced industries. Efforts to consistently collect and incorporate patient perspectives into the scientific process is becoming a priority for many. This is welcome news to all patients and patient advocates!

How important is patient input to ensuring the best possible health outcomes for ill or injured workers?

Understanding the importance of patient involvement in the composition of evidence-based Guideline Development Groups (GDG), The National Academies of Sciences, Engineering, Medicine (formerly the Institute of Medicine (IOM), included the requirement of patient input as one of its eight Standards for Developing Trustworthy Clinical Practice Guidelines in 2011. The standard directs guideline developers to incorporate patient involvement, at least, when formulating clinical questions and reviewing Clinical Practice Guideline (CPG) drafts. Former patients, patient advocates, or patient / consumer organization representatives qualify to participate in the GDGs under this requirement.

Accordingly, the requirement of patient involvement is included in AHRQ’s National Guideline Clearinghouse’s (NGC) assessment of submitted guidelines’ adherence to the academy’s standards of trustworthiness. Patient and public perspectives, along with multidisciplinary group participation and methodologist involvement, is measured by the NGC when grading the content developer’s GDG composition.

The newly energized push for patient engagement is prompting content developers aiming to align with National Academy standards to improve methods for soliciting, receiving, and incorporating patient and public input into the content development process. The American College of Occupational and Environment Medicine (ACOEM) accepts patient, and other stakeholder, input through an online portal to assist the development of its evidence-based medicine practice guidelines.

Patient Engagement beyond Content Development

Notable recent activity from the Food and Drug Administration (FDA) includes assembly of a Patient Engagement Advisory Committee (PEAC). A statement issued by the FDA explains the committee exists to support its efforts to broaden engagement with patients and deepen patient involvement in the administration’s regulatory activities.

More specifically, the initiative will seek patient perspectives for use across medical device design, clinical trial process, and post market evaluation. Additional guidance on patient preferences, such as tolerance of risk and patient point of view on benefits, will be used by the FDA to assess device benefit-risk profiles.

The administration can consider the systematically gathered patient preference information, in conjunction with its assessment of scientific evidence that demonstrates a device’s probable benefit outweighing its likely risks, to form its complete grouping of clinical and non-clinical testing.

Workers’ Compensation Continues its Efforts for Patient Engagement

Very few venues exist in workers’ compensation that facilitate direct engagement between industry vendors and patients. Perhaps the most visible platform today is WorkComp Central’s Comp Laude® Awards & Gala. Event participants advertise that Comp Laude’s most memorable moments typically occur when patients are involved in panel discussions. Event organizers have voiced their excitement about the overall positive impact patients have on the industry get-together.

Stemming from the mission and vision of the event’s late founder David DePaolo, Comp Laude® created a scholarship intended to create a path for direct engagement between the industry and its patients. The scholarship provides travel funds and covers lodging expenses along with conference registration for the patient and a guest. Several vendors, among them ReedGroup, are honored to have the opportunity to be sponsors of the scholarship fund.

Many have criticized the workers’ compensation industry for its numerous shortcomings, myself included. While it is important to acknowledge the industry has more work to do in the pursuit to increase patient engagement to improve health outcomes, it is equally important to acknowledge the progress gained by organizations whose corporate point of view regularly advocates for patients and their well-being. For this, the industry should be complimented.

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.

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.

The Problem with Treatment Guidelines and Drug Formularies

Participating in legislative discussions across the country on the efficacy of adopting evidence-based medicine (EBM) treatment guidelines and drug formularies has given me a front row seat into an area of significant concern. The issue to which I’m referring exists among several stakeholder groups and vendor verticals in the workers’ compensation industry – an unclear, off-center understanding of EBM.

This issue is particularly concerning due to the fact that a rudimentary level of understanding exists on the topic, but not enough to provide informed accurate guidance on the health benefits of state-wide adoptions of EBM. The term, “I know enough to be dangerous” is very apropos in this instance.

It is this high-level, broad-brush understanding of EBM that propels sentiments in the marketplace that the content and tools are designed simply for cost containment purposes used as mechanisms to say no to patients for justifiable needed care. The feeling in these circles is that EBM provides no real health benefit to the injured worker.

Admittedly, there are widely used sources that are designed as cost containment tools masquerading as EBM content. These tools are draconian and overly simplistic. Their claims of being evidence-based do not align with trusted public national criteria, such as the National Academy of Medicine (formerly the Institute of Medicine) that have defined Standards for Developing Trustworthy Clinical Practice Guidelines.

During a recent webinar on EBM treatment guidelines a panel comprised of workers’ compensation claims, managed care, medical, and state-agency professionals discussed the obstacles and opportunities of treatment guidelines. While the panelists agreed on the focus of EBM being patient safety, they had various interpretations of what constitutes EBM.

One panelist cited Texas Labor Code, Section 401.011 (18-a):

“Evidence-based medicine” 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.

In a 1996 editorial in the British Medical Journal, David Lawrence Sackett defined EBM as “…the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.”(100) It was further noted that the practice “…means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”(100) In 2005, EBM was defined as “… a set of principles and methods intended to ensure that to the greatest extent possible, medical decisions, guidelines, and other types of policies are based on and consistent with good evidence of effectiveness and benefit.”(101) Properly done, the use of EBM is a process which entails the identification of high-quality scientific evidence, as defined by rigorous criteria, and synthesis of the entire body of evidence applicable to a given condition to guide (not dictate) medical practice.

Texas’ definition, while partially correct, is incomplete. Missing from the labor code are cornerstone principles such as the need for a systematic research process, the identification of high-quality scientific evidence through defined rigorous criteria, and a synthesis of the entire body of evidence applicable to the given medical condition.

By nature, the systemic research and development process of EBM addresses the concerns most often raised by opponents of the content:

  • (Concern #1) The studies used in EBM are bias – A high quality EBM development process incorporates comprehensive review and the grading of literature by qualified researchers. This determines if the studies are reliable looking at study design, population sample, results, study sponsorship, and potential conflicts of interest. Additionally, a trustworthy EBM source will not only use literature that has been subject to peer review, as Texas’ definition requires, but their final developed guidelines will also go through an external peer review process conducted by uninterested parties such as a state medical association, or specialty medical society.
  • (Concern #2) EBM is one-size fits all, or cookie-cutter, medicine – The root definition of EMB defines it as the “conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients.” The evolution of the drug formulary concept is a great example of this. Today’s formularies provide drug recommendations appropriate to each patient’s condition and takes into account whether their condition is in the acute or chronic phase. Using the modern formulary concept ensures the right medication is prescribed for the right condition at the right time.
  • (Concern #3) EBM removes the authority to treat a patient from the provider and delegates medical care to a guideline – It is true that some stakeholder groups have used EBM as a blunt instrument. They treat EBM as a definitive authority rather than a guide. As defined by Sackett in 1996, and still applies today, EBM requires the integration of individual clinical expertise from a provider with the best available external clinical evidence for the care of the patient. When clinical expertise is disregarded, the practice is no longer considered EBM. As I’ve stated in previous blogs, the patient/doctor interaction in the clinic will play a key role in eradicating the great drug epidemic that this country is currently grappling with. Providers need high quality content and tools they can trust to educate and keep their patients safe.

The problem with treatment guidelines and drug formularies is not related to content as each content provider has clearly defined their methodologies, for better or worse. The problem is a lack of understanding on the subject by individuals who are tasked with making decisions that ultimately impact an injured workers’ wellbeing. The standards for developing trustworthy EBM are not subjective. Content that is labeled as EBM should be measured meticulously to the appropriate standards.

The webinar I referenced earlier concluded with one of the moderators politely criticizing education that has previously been disseminated, intended to parse fact from fiction, about EBM. The comments assumed that all guidelines are created equal and that there is no room for accountability in workers’ compensation. I politely disagree.

If there is a platform where accountability is needed, its workers’ compensation. Our organizations deal with human beings when many of them are in their most vulnerable state – emotionally, physiologically, and financially. We, who understand the complexities of the system and our respective industries, have a duty to be their advocates.

100.Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. Br Med J. 1996;312(7023):71-2.

101.Eddy DM. Evidence-based medicine: a unified approach. Health Aff 2005;24(1):9-17.

Fending Off the Feds

The Department of Labor’s report on Workers’ Compensation – Does the Workers’ Compensation System Fulfill Its Obligations to Injured Workers– is the subject of much discussion among stakeholders in the workers’ compensation industry. Does the key to much of what ails today’s workers’ compensation industry lie in the adoption of the value-based healthcare model?

Many media outlets have reported on the Department of Labor’s findings. Forum speakers touched on issues ranging from benefit and wage inadequacy to cost shifting.

For the most part, the panel ignored the real problem – the cause and treatment of disability.

The issue plaguing injured workers, and all workers’ compensation system stakeholders was almost entirely overlooked by the discussion’s organizers. The issue? Iatrogenesis– treatment by health professionals that does not support the recovery goals of the affected patient. This is a topic that demands great scrutiny if the workers’ compensation industry hopes to change the perception that its practices are negatively impacting social programs.

As one panelist stated, Gary Franklin, MD, PhD, long-time Medical Director of the Washington State Department of Labor and Industries, “workers’ comp medical care is about the worst in the country”. (1)

Enough said.

Concurrent with the over-prescription of narcotics, injured workers have been subject to the over-utilization of treatment (such as with lumbar fusion as referenced by Dr. Franklin on the call) and prolonged physician-approved absences from work. This has gone on for decades. These examples can be pointed to by many outside the workers’ compensation industry as the result of a lack of accountability and high quality healthcare in today’s system. As a result, injured workers become disabled workers,which adds additional stress to both SSDI and the healthcare industry.

Could moving to a value-based healthcare model in workers’ compensation establish shared accountability for all members in the care and claim continuum? Could the use of an evidence-based alternate payment model create a unified focus on returning injured workers to productivity at the soonest medically-appropriate time?

One key element of a value-based healthcare model is to eliminate unnecessary and expensive medical treatment. For example, rewards based on outcomes and productivity would curtail the rampant over-prescription of narcotics on new claims. As a result, disability duration, indemnity costs, and iatrogenic disease would materially decrease and be replaced by improved healthcare outcomes – a result the workers’ compensation industry could, and should, embrace.

A move to value-based healthcare may, or may not, dissuade the federal appetite to intervene in state workers’ compensation systems, but it will reduce the burden to social programs caused by prolonged disability and prescription drug addiction.

  1. Paduda, J. (2016, October). Takeaways from DOL’s State Workers’ Compensation Report [Web log post]. Retrieved fromhttp://www.joepaduda.com/2016/10/takeaways-dols-state-workers-compensation-report/