Evidence-Based Medicine Results in Optimal Clinical Outcomes: Why Potentially Lowering Your Medicare Set-Aside (MSA) is Just a Secondary Benefit
Evidence-based medicine (EBM) is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.”[1] The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management.
Generally, EBM in healthcare can be described as a systematic approach to medicine in which doctors and other health care professionals use the best available scientific evidence from clinical research to help make decisions about the care of individual patients. A physician’s clinical experience and the patient’s values and preferences are also important in the process of using the evidence to make decisions. The use of evidence-based medicine may help plan the best treatment and improve quality of care and patient outcomes.[2]
Evidence-based medicine (EBM) has been around for more than 40 years and is omni-present as ever. Over the last several decades, EBM has been utilized by The American Cancer Society to help determine screening practices, Group Health Plans (BCBS, etc.) to determine medical and prescription coverages, and by physicians and nurses in daily practices. Currently there are countless books, courses, programs, and even entire departments in medical schools dedicated to it, so why would this not apply to individuals receiving medical care in Workers’ Compensation cases? In some states it does. Let’s review some data.
Official Disability Guidelines (ODG) is a nationally accepted EBM guideline adopted by numerous states across the country. In fact, it is the most widely used guideline in the workers’ compensation industry. In addition to ODG, the American College of Occupational and Environmental Medicine (ACOEM) has also created nationally accepted EBM guidelines. Many states also have adopted or are considering adopting one of these two national guidelines, a combination of the two, or a unique, homegrown guideline that is state-specific to improve consensus around the definition of “necessary and appropriate” treatments for injured workers.[3]
In ODG’s case, decades of data demonstrates states adopting ODG treatment guidelines and formulary have substantially better clinical outcomes relative to other states. If we look simply just to 17 years of positive experience in Ohio, which adopted ODG treatment guidelines in 2003, we will see that treatment delays decreased by seventy-seven percent (77%), accompanied by a sixty percent (60%) reduction in medical costs and a sixty-six percent (66%) decrease in lost days per claim.[4]
These statistics demonstrate that EBM treatment is highly effective in creating optimal and improved clinical outcomes for injured workers, which allows for quicker recovery and the ability to return to work sooner than average. As mentioned prior, there is of course, much more to EBM as it relates to medical care outside of workers’ compensation claims, however, for our audience’s purpose we will focus on EBM in Medicare beneficiary settlements and how does/should EBM intersect with Medicare Set-Asides (MSAs) in workers’ compensation settlements. If EBM guidelines/principles apply during the pendency of the claim, there is no reasonable justification not to apply the same methodology when allocating medical treatment post settlement via an MSA allocation.
The Great Submission Debate
Regarding MSAs which are submitted to the Centers for Medicare & Medicaid Services (CMS), CMS’ contractor, the Workers’ Compensation Review Contractor (WCRC) performs the review/approval of the proposed MSA. CMS’ official policy guidance (WCMSA Reference Guide) confirms that “[t]he WCRC relies on evidence-based guidelines for prescription medications and medical treatment allocations.” – WCMSA Ref. Guide, Section 9.4.3 (WCRC Review Considerations). Unfortunately, while the WCMSA Reference Guide states that the WCRC relies on EBM to review of WCMSAs, in a practical sense, the WCRC does not apply EBM to the review and approval of WCMSAs. Instead, the WCRC tends to apply a “worst case scenario” possible treatment regimen when reviewing and allocating in a proposed WCMSA. It is well known in the workers’ compensation industry, particularly with WCMSAs involving an opioid regimen, that in many where cases where the CMS approved WCMSA allocation involves opioids/prescription drugs, if taken in the manner allocated, could in fact seriously further harm the already injured Medicare beneficiary employee.
On the other hand, since the mid-2010s, Evidence Based Medicare Set-Asides (EBMSAs), which are not submitted to CMS for review and approval, have gained significant popularity amongst workers’ compensation insurance carriers/payers. With the application of EBM to the MSA allocation, comes a more clinically appropriate and reasonable allocation of future medical treatment as it relates to the underlying workers’ compensation claim/settlement. Additionally, many clinical professionals that are preparing MSAs feel an ethical obligation to apply principles and methodologies that are designed to maximize positive outcomes and restore patient health safely and effectively. It should come as no surprise that EBMSAs have continued to gain popularity over time.
However, just a few months ago non-submit/EBMSAs gained even more buzz, but not necessarily for reasons related to their clinically effective outcomes. Earlier this year in January, we blogged about CMS updating their WCMSA Reference Guide to include a new section 4.3 which at the outset appeared to discredit non-approved EBMSAs. The new Section 4.3 seemed to threaten that any MSAs not approved by CMS may result in CMS denying benefits and seeking recovery of medical expenses up to the net settlement amount.
However, shortly after the update in January, CMS hosted a webinar in February and revised Section 4.3 in March to now make clear that EBMSAs that are not submitted to CMS will not automatically be deemed a burden shift to Medicare, and that CMS must prove that the EBMSA is not an adequate protection of Medicare’s interests for CMS to disregard the EBMSA and recover up to the net settlement amount. In other words, non-submitted EBMSAs are still legally valid as CMS submission is voluntary, supported by the Code of Federal Regulations, and a method in not only protecting Medicare’s interest, but also supports improved clinical outcomes for the beneficiary.
Arguably, the most important part of the current updated Section 4.3, is that CMS recognizes that a Non-Submit MSA will NOT automatically be deemed to be a burden shift to Medicare. CMS notes in the above that when the MSA fully exhausts, parties will have an opportunity to demonstrate that both the initial funding of the MSA was sufficient and utilization of MSA funds was also appropriate. Last but certainly not least, an MSA vendor that will stand behind their MSAs makes this a crucial point for settling parties.
Ultimately, to submit an MSA to CMS or not for review is a risk tolerance decision for the settling parties. However, at the heart of workers’ compensation is a promise to provide reasonable and necessary medical treatment that expedites recovery and return-to-work. Thus, it would seem counterintuitive to not fully support EBM in the MSA process, whether the MSA is submitted or not, as EBM has clearly been proven based upon scientific studies to provide improved clinical outcomes for Medicare beneficiaries. Improved clinical outcomes is a win-win and benefits ALL parties involved, including the beneficiary, the Medicare Trust Fund, and the workers’ compensation employer/carrier.
For questions on EBMSAs, or Sanderson Firm’s MSA services, please contact us.
[1] Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996). "Evidence based medicine: what it is and what it isn't". BMJ. 312 (7023): 71–72.
[2] https://www.cancer.gov/publications/dictionaries/cancer-terms/def/evidence-based-medicine
[3] https://riskandinsurance.com/study-supports-benefits-of-evidence-based-medicine/
[4] https://www.mcg.com/odg/blog/2020/10/17/a-case-for-evidence-based-medicine-in-workers-compensation/
