Tag Archives: Research

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.

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.

There Are No Easy Answers

Regulators and legislators have the very difficult job of developing and implementing public policy that preserves and protects the best interest of their constituents. For them,there are no easy answers.

Respective to medical care in workers’ compensation, evidence-based medicine (EBM) has been the center of discussion for the past decade. However, significant confusion about the term “evidence-based guidelines” remains. The same questions asked in 2008 are being asked today:

Can you help me understand the term “evidence-based guidelines?” Various organizations are all saying they have them – and in fact seem to be competing over whose is the best. If they’re all evidence-based, why shouldn’t we just use the most user-friendly or cheapest one?

                                                                                                                                             Evelyn in Evanston”(1)

I had the opportunity to participate in a discussion on drug formularies hosted by The Business Council of New York State last week. Similar to stakeholder sentiment in the state of California, New York regulators are aiming to adopt a drug formulary for workers’ compensation that works in harmony with the state’s Medical Treatment Guidelines (MTGs).

The purpose of having a drug formulary coincide with recommendations on pharmaceutical therapy in an existing MTG source, is the enforceability of formulary recommendations based on EBM – presuming the MTG source was developed according to EBM standards.

If there is now consensus that practice guidelines are the foundation for both treatment recommendations and drug formularies, then concerns about rigor, methodology and quality are of the utmost importance. Medical treatment decisions are being informed by this information. If the quality of the guidelines is in question, then every treatment or drug recommendation stemming from the guidelines must also be in question.

Most, if not all, states that have adopted and enacted EBM treatment guidelines and drug formularies have acted on the counsel of subcommittees comprised of medical providers, vendor representatives, and state representatives. All are well respected in their fields and are good-intentioned individuals. Although, a very visible gap in expertise exists in almost all cases – methodology (i.e., an expert who knows how to grade the quality of methodology).

The reliability of the technical aspects of the scientific method used to develop the guidelines is the most important issue to solve for. The underpinnings of the recommendations, both treatment protocols and drug recommendations, must stand up under scrutiny. If the recommendations themselves are a byproduct of the research process, they should be secondary in consideration to the quality of the methodology employed to develop them.

The question every regulator, legislator, and subcommittee should ask is not:  What is the easiest and cheapest resource available? Rather, what is the most rigorous, transparent, reproducible, method used among the guidelines/drug formulary options?

If we can answer the question of quality correctly, all subsequent questions on appropriateness of care are also answered.

 

1.     Christian, J. (2008, June). The Challenge of Evidence-based Guidelines [Web log post]. Retrieved from http://www.webility.md/pdfs/DrJ-column-2008-06.pdf

Caught in the Middle; Choosing Sides

Living and having my employer’s corporate headquarters based in the great State of Colorado provides a lot of benefits. Being presumed a pot expert, everywhere I go, isnot one of them.

The Drug Enforcement Agency’s denial of two petitions to reclassify marijuana last week maintained the topic’s position at the top of mind for Workers’ Compensation patients and professionals. Various articles, white papers, position papers, etc., have surfaced to add context to the discussion.

One piece struck a chord:  The article expressed, “While states generally involve physicians in the process by which patients obtain marijuana, national drug policies have traditionally had a chilling effect on these conversations.” Referencing the Journal of the American Medical Association (JAMA), the article also notes federal laws’ contradiction to state regulations as being the reason “many doctors say they feelcaught in the middle.” (1)

Many of the issues in Workers’ Compensation can be solved within the clinic-experience between the doctor and their patient. If we can get this part in care continuum correct, many (if not most) other facets will maintain a track for improved health outcomes.

The American Pain Society (APS), the Federation of State Medical Boards (FSMB), theAmerican College of Occupational and Environmental Medicine (ACOEM), have all publicly stated that irrespective of law inconsistencies, federal to state, providers must be adequately equipped to address medical marijuana’s place and use among the working population.

To paraphrase Mark Pew’s personal take – Medical marijuana is appropriate for somepeople for some conditions for some of the time.

While mixed feelings exist about the quality of available scientific evidence supporting the efficacy of medical marijuana, there is no disagreement about its continued and increased presence among the working population. Thus, the need to equip physicians with reliable information to educate employees of potential health risks and safety implications.

ACOEM’s “Marijuana in the Workplace: Guidance for Occupational Health Professionals and Employers” position paper, published in April 2015, has served as a great resource for Occupational Health Professionals and Employers whose workplaces are impacted by marijuana use for medical purposes. Since then, a number of other tools have emerged as valuable resources for front-line professionals who deal with the matter on an ongoing basis.

FSMB’s “Model Guidelines for the Recommendation of Marijuana in Patient Care” is an effective resource for “state medical boards in regulating physicians and physician assistants with full and unrestricted license participating in marijuana programs”. The guidelines are also “valuable in educating licensees as to the board’s expectations when recommending marijuana to a patient for a particular medical condition”. The precautions and steps provided for physicians considering recommending medical marijuana to a patient are similar to guidance provide for opioid prescription: patient evaluation, consulting the state Prescription Drug Monitoring Program (PDMP),documentation of a treatment plan, establishing goals of the treatment plan,ongoing assessment of patient’s response to the use of marijuana and overall health and level of function. (2)

Healthesystems’ Chief Medical Officer, Robert Goldberg, MD, FACOEM, published a white paper this month (August 2016), “Medically Speaking”, identifying “moderate level” evidence speaking to the benefits of marijuana to treat specific types of pain. As we learn more about the substance, the scientific evidence seems to be indicating some positive results from applications with appropriate, ongoing monitoring of functional improvement. Dr. Goldberg’s piece is optimistic about medical marijuana’s potential to reduce or eliminate opioid use for pain management. (3)

Contrasting the multiple medical societies (APS/FSMB/ACOEM), the Work Loss Data Institute’s (WLDI) data-driven Official Disability Guidelines (ODG), do not recommend the use of cannabinoids citing “no quality studies supporting cannabinoid use” and “serious risks”. Ken Eichler, from WLDI, went on record with WorkComp Central stating that the reimbursement for medical marijuana would “open the door” forheroin and ecstasy due to the drugs’ similar classification as Schedule 1 substances [meaning they have a high potential for dependency or addiction, with no accepted medical use according the Controlled Substance Act]. (4) However, when consideringmedical necessity, marijuana is significantly removed from the other two illicit drugs.

The need for alternative treatment options for pain is extremely evident. With the nation’s aggressive crackdown on the use of opioids, there is legitimate concern with the treatment pendulum swinging to another extreme (from over-prescription to non-prescription without trustworthy scientific basis). The answer lies somewhere in the middle, always supported by reliable, trustworthy, scientific evidence. In the absence of high quality studies, EBM standards call for the reliance of best practices and expert consensus for safe, medically-responsible treatment recommendations.

It would be of value for Workers’ Compensation as a whole to lean on the understanding of the medical societies mentioned above. The physician/patient relationship is a potent conduit for improved health and return to work outcomes. Equipping and empowering providers who feel they are caught in the middle of a legal struggle, between federal and state perspectives, will ensure patients have medically sound guidance should they inquire about medical marijuana as an alternative to treating their pain.

  1. Luthra, Shefali. “As States OK Medical Marijuana Laws, Doctors Struggle With Knowledge Gap.” KHN, Kaiser Health News, August 2016. Web. 15 August 2016 http://khn.org/news/as-states-ok-medical-marijuana-laws-doctors-struggle-with-knowledge-gap/
  1. “Model Guidelines for the Recommendation of Marijuana in Patient Care.” FSMB. April 2016. Web. 15 August 2016 http://www.fsmb.org/Media/Default/PDF/BRD_RPT_16-2_Marijuana_Model_Guidelines.pdf
  1. Goldberg, Robert. “Medically Speaking, Marijuana and Pain Management.”Healthesystems, August 2016. Web. 15 August. 2016. http://www.healthesystems.com/File%20Library/insights/06-1839_Whitepaper_Medical-Marijuana_VF.pdf
  1. Goodman, Elaine. “Guidance Begins to Emerge on Medical Marijuana Use.” WorkcompCentral, August 2016. Web. 15 August. 2016. https://www.workcompcentral.com/news/story/id/c620665e386963098f3c3d017a8f7d3caf88c7f2

Why would anyone want to keep injured workers from receiving the best care?

I was recently asked by a highly esteemed colleague, “Why would anyone want to keep injured workers from receiving the best care?”

After almost a decade of working with stakeholders and shareholders in and around Workers’ Compensation systems around the country, I’m still somewhat surprised each time I hear arguments opposing the implementation of standards that will encourage consistent care. The term “cookie-cutter” is almost always injected into the discussion attempting to peg consistent patient-centric care as inflexible and a “one size fits all” approach.

The truth of the matter is, obvious and significant variations in medical care for similar health conditions have been identified as signs of quality concerns in the medical process. I’ve yet to come across evidence, or even slightly compelling information, suggesting that this variability leads to improved patient care and better health outcomes. Variations in diagnostic considerations/interpretations and treatment approaches/methods occur in every medical specialty.

The State of Pennsylvania’s House Labor and Industry Committee will hear testimony today (March 17th, 2016) from various stakeholders on HB1800 that proposes the adoption of nationally recognized evidence-based medicine (EBM) treatment guidelines. WorkCompCentral published comments from the Pennsylvania Bar Association on March 9th stating, “The Pennsylvania Bar Association intends to just say no to proposed medical treatment guidelines it claims will shoehorn injured workers on workers’ compensation into a “one size fits all” treatment plan.”(1)

The original definitions of EBM focused on the care of individual patients, using scientific evidence to improve outcomes. Sackett defined EBM as “…the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients” in a 1996 editorial in the British Medical Journal.(2) It was further noted that the practice “…means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”(2) In other words, the sum of both individual (clinical) expertise combined with the best available (clinical) evidence equals EBM.

The California Workers’ Compensation Institute (CWCI) published a report on March 3rd, 2016 stating that California experienced a decrease in Workers’ Compensation inpatient hospitalizations by 22.8% from 2008 to 2014. The report also referenced that the number of Workers’ Compensation implant-eligible spinal surgeries declined by 8.4% in 2013 and 13.6% in 2014. CWCI cited that the decline “coincided with the continued development of evidence-based medicine…”(3)

The use of EBM treatment guidelines has been positively correlated with improved quality and patient safety and decreased costs in general medicine.(4) The same can be expected when properly applied in an occupational medicine scenario.

It is difficult to imagine the number of injured workers being subject to surgical intervention without the use of scientific evidence to confirm their eligibility for the procedure; or consulting the evidence to verify the procedure’s effectiveness.

Why would anyone want to keep injured workers from receiving the best/most effective care?

The inquiry left me without words…

References:

  1. “Bar Association Blasts Treatment Guidelines As ‘One Size Fits All’”. n.p. WorkCompCentral. March 9th, 2016. Web.
  2. 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.
  3. Goldberg, Stephanie. “Spinal surgery drop leads to fewer workers comp hospitalizations”. Business Insurance. March 4th, 2016. Web.
  4. Gochnour G, Ratcliffe S, Stone MB. The UTAH VBAC Study. Matern Child Health J. 2005;9(2):181-8.