Evidence-Based Medicine and the MSA

12.27.2018 Blog

Workers’ compensation and personal injury claims adjusters and attorneys spend a great deal of time analyzing medical records in connection with their cases. The most frequently scrutinized areas involve medical/legal causation, the reasonableness of medical treatment as well as the cost and likelihood of future injury related medical treatment. The workers’ compensation laws of several states also require that the workers’ compensation treatment be consistent with the state adopted Medical Treatment Guidelines or Medical Treatment Utilization Schedules. These treatment guidelines or schedules are often based on the treatment recommendations reflected in, or similar to those found in, the Official Disability Guidelines (ODG) or American College of Occupational and Environmental Medicine (ACOEM) guidelines. The principles of evidence-based medicine make up the foundation for the ODG and ACOEM types of guidelines.

The Centers for Medicare and Medicaid Services (CMS) purports to recognize the role that evidence-based medicine treatment guidelines play in the voluntary review process involving a Workers’ Compensation Medicare Set-Aside (WCMSA). The Workers’ Compensation Medicare Set-Aside Arrangement Reference Guide, Version 2.8 (Reference Guide) cites Milliman, MediRegs and PubMed as resources used by the Workers’ Compensation Review Contractor (WCRC) in determining whether a proposed WCMSA adequately considers Medicare’s interests in connection with the settlement. This article will examine the concept of evidence-based medicine treatment guidelines as well as their role in future medical treatment projections.

Evidence-Based Medicine

Although the legal definition of evidence is “any matter, verbal or physical, that can be used to support the existence of a factual proposition” (G. Lilly, An Introduction to the Law of Evidence), the concept of “evidence” in evidence-based medicine is a much more fluid concept. Dr. David Sackett is credited with the most common definition that was put forth in his article, “Evidence based medicine: what it is and what it isn’t” that was published in 1996 in the British Medical Journal. He wrote “evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” (Evidence based medicine: what it is and what it isn’t, (Sackett DL, Rosenberg WM, Gray JA, et al. BMJ. 1996 Jan 13:312 (7023):71-2) In this definition, clinical expertise refers to the physician’s skill set and experience, while the best research evidence must be clinically relevant and conducted using sound methodology.

An Evidence Based Practice (EBP) includes several components. The first involves the clinician’s “ask” of the appropriate clinical questions followed by the clinician’s need to then “acquire” relevant information by searching the available literature/ studies. The clinician must then “appraise” the evidence and customize the treatment plan for the patient.

In “appraising” the evidence, clinicians should consider the type of study used to support the author’s conclusions. Certain types of studies will provide more meaningful information than others. For example, a study based on the reported findings pertaining to several individual patients or one patient will have  limited statistical value, while randomized controlled clinical trial that are well designed may provide valuable information regarding the success of specific treatment on similar classes of patients. Other study types include cohort studies, systematic reviews, cross-sectional studies and case control studies. A meta-analysis review mathematically combines the results of numerous relevant valid studies and reports the results based on a statistical analysis of the data.

Medicare Set-Asides

By way of background, a Medicare Set-Aside (MSA) is a settlement tool that allocates a specific sum of settlement funds for future medical needs to prevent a cost shift of future injury related medical treatment to Medicare. CMS allows for a voluntary review of the adequacy of the MSA amount, provided that the total settlement meets CMS’ internal workload review threshold. If the parties elect to submit the MSA proposal to CMS for voluntary review, CMS requests that the parties comply with the guidance set forth in the WCMSA Reference Guide. The Reference Guide outlines the criteria used by the WCRC case reviewer in determining the adequacy of the proposed future medical care projection. Section 9.4.3 of the Reference Guide notes that the WCRC team:

“reviews all of the submitted records and attempts to determine the future care required for the individual claimant, taking into consideration the claimant’s specific condition, other comorbidities, and the claimant’s past use of healthcare services. Reviewers use evidence-based rationale for their determinations, taking into account both published guidelines and current peer-reviewed medical literature.”

A closer examination of the Reference Guide’s medical review guideline provisions however, shows that the provisions conflict with certain evidence-based medicine guidelines. For example, section 9.4.5 of the Reference Guide outlines the reviewers’ general inclusion of x-rays every 3 to 5 years for life, with yearly x-rays if there was or will be a major joint replacement. This formulaic frequency is applied regardless of whether the work related injury involves a healed fracture, a hip injury or a lumbar spine injury. An example is the lumbar spine: the ODG notes that researchers in a meta-analysis of randomized trials found no benefit to routine lumbar imaging (radiography, MRI, or CT) for low back pain absent an indication of a serious underlying conditions. The guidelines from the American College of Physicians similarly find that “routine imaging for low back pain is not beneficial and may even be harmful.”

Similarly, CMS’ drug projection methodology, which projects drugs on a monthly basis for life and is extrapolated from recent pharmacy history payment records, is contrary to evidence-based medicine guidelines for the majority of the drugs included in projections. Opioids that were at one time believed to be appropriate for the treatment of chronic non-cancer pain are no longer considered appropriate and are instead considered harmful to most patients. The American Pain Society, American College of Physicians and American Academy of Neurology all recommend against the use of opioids as first line therapy for chronic pain. If evidence-based medicine were truly being applied to the projections, CMS’ projection methodology would shift to accommodate the change.

Urine drug screen projections are another area where CMS’ projection methodology conflicts with evidence-based medicine guidelines. Over the past several months, our office and others involved in the MSP compliance industry have seen CMS routinely include four urine drug screens each year for life in determinations involving opioids regardless of actual treatment patterns. This is contrary to the ODG Guidelines that indicate that patients at “low risk” of addiction/aberrant behavior should undergo urine drug testing within six months of initiation of opioid therapy and on a yearly basis thereafter. No confirmatory testing is indicated unless the test is inappropriate or there are unexpected results. “Low risk” is defined by: identifiable pathology with objective and subjective symptoms to support a diagnosis and an absence of psychiatric comorbidity. “Aberrant drug behavior” for patients utilizing opioids is defined as behavior that suggests the presence of substance abuse or addiction and ODG recommends verbal screening regarding personal and family history of drug or alcohol abuse, previous drug-related behavior, dysfunctional coping strategies, co-morbid psychiatric conditions, cigarette smoking, and childhood sexual abuse. CMS’ formulaic inclusion of four urine drug screen projections in the absence of support in the treatment records or evidence-based medicine guidelines only serves to overinflate the WCMSA.

The disconnect between CMS’ projection methodology in the WCMSA review and actual treatment patterns has also been documented in several studies over the years. The California Workers’ Compensation Institute report on “Opioids in Workers’ Compensation Medicare Set-Asides” published in October 2017 compared two control groups of permanent disability claims involving similar primary diagnosis codes from accident years 2006 through 2009. One group had associated CMS reviewed WCMSAs while the other group did not. When it came to drug projections, the CMS reviewed WCMSA group had cumulative morphine milligram equivalent (MMEs) levels that were 36 times higher than the levels of the control group without the WCMSA. In addition, within the group of cases that were submitted to CMS for review, CMS increased the total WCMSA average medical allotment by 6.9 percent and the average pharmaceutical allotment by 3.6 percent.  Similar findings reflecting CMS’ tendency to increase submitted WCMSA were identified in the February 2018 and September 2014 NCCI Research Briefs on Medicare Set-Asides and Workers’ Compensation. The February 2018 report further noted an upward trend in the average submitted MSA since 2011 likely due to the submitter’s better understanding of CMS’ procedures.

Although it is clear that the purpose of the MSA is to avoid a cost shift of future injury related treatment to Medicare, CMS’ lip service to reliance on evidence-based medicine in determining future care projections is disingenuous. The conflicting medical review guideline provisions in the Reference Guide and CMS’ frequently overfunded determinations underscore CMS’ inherent bias and motivation to overproject future treatment allocations. This in turn has spurred the development of more robust non- submit programs. Data from professional WCMSA administration companies handling the post-settlement funds for such “non-submit programs” shows that claimants rarely exhaust CMS determined WCMSA funds. Actual treatment expenditures are usually significantly lower.

If CMS’ goal is to encourage more parties to submit allocations for review, CMS’ cookie cutter projection methodology must change and the WCRC team must provide detailed evidence-based medicine guideline support for any counter allocations. By returning more realistically projected determinations that are supported by evidence-based medicine and state law arguments, parties may be more willing to seek CMS review rather than run from it.

Although certain submitters may seek a high “match-up” rate between their submissions and CMS’ approvals, this may not necessarily be the most cost effective approach for your organization. Our Nyhan Bambrick Kinzie & Lowry MSP compliance team works with you in identifying the best Medicare Secondary Payer compliance strategy for your claim. Our customized approach to MSP compliance provides you with various options in your claim which may range from a traditional CMS-reviewed WCMSA to a non-submitted compromise MSA allocation. Should you choose to submit your WCMSA to CMS for review, we recommend submissions based on evidence-based medicine guidelines and state law arguments with a pre-submission discussion of the potential exposure. As attorneys, our role is to counsel you on the benefits and risks associated with the various options, strategize with you and work with you to implement your decision in the particular claim. Each claim is unique as is our approach. Contact Amy Bilton at abilton@nbkllaw.com to learn more.


The NBKL blog is provided for informational purposes; we are not giving legal advice or creating an attorney/client relationship by providing this information.  Before relying on any legal information of a general nature, you may consider consulting legal counsel as to your particular facts and applications of the law.