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Introduction1
The Social Security Act defines disability as
the inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment(s) which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months. (SSA, 2020)
As part of the overall disability determination process, the Social Security Administration (SSA) uses a step-by-step approach to understand how severe an individual’s condition is and whether it meets program criteria for disability. The use of various types of biomarkers has been suggested as a way to strengthen the amount and quality of objective evidence available to the review process.
Recognizing the practical value biomarkers may have in disability adjudication, SSA asked the National Academies of Sciences, Engineering, and Medicine’s (the National Academies’) Board on Health Care Services to organize a workshop titled The State of the Science of the Use of Biomarkers to Establish the Presence and Severity of Impairments. As
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1 The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
part of its charge, SSA asked the National Academies to organize general discussions around:
- The current use and potential uses for biomarkers in general;
- The current clinical use of biomarkers by health care professionals to determine function or impairment severity; and
- The legal and ethical implications associated with biomarker use in clinical decision making.
Furthermore, SSA asked the National Academies to focus on the use of non-genetic biomarkers as tools for the diagnosis or prognosis of the severity of six specific physical and mental impairments: fibromyalgia, arthritis, post-traumatic stress disorder (PTSD), major depression, schizophrenia, and chronic pain. The workshop was held virtually on July 21, 2020.
BACKGROUND
In the opening remarks at the workshop, Mark Warshawsky, deputy commissioner for retirement and disability policy at SSA, said, “SSA is always looking for ways to enhance our services to the public.” SSA is “committed to incorporating advances in medical sciences and technology” into the body of evidence, he explained, adding, “The use of biomarkers in identification and management of various health conditions is an emerging science with the potential to make a significant impact on the delivery of health care.”
In the process of understanding how these biomarkers would fit into the adjudication process, “we first require objective medical evidence to establish a medically determinable impairment,” Warshawsky continued. It is also necessary to consider the severity and duration of the impairment, or whether the individual has multiple impairments, he added. For its purposes, he said SSA “would like to know how biomarkers could serve as objective medical evidence to help make accurate, timely, and evidence-based decisions for claimants on a larger scale.” Essentially, he noted, SSA wants to know if it is possible to link biomarkers to function, as well as potential ethical and legal implications. He explained that SSA chose the six mental and physical conditions being presented at the workshop “because they appear frequently in applications for disability benefits and can be especially challenging to adjudicate.”
ORGANIZATION OF PROCEEDINGS
This proceedings document is organized into five chapters. Following the introduction with background on the charge from SSA, Chapter
2 presents an overview of how biomarkers are used and their potential for the diagnosis and prognosis of health and functionality. Chapter 3 reviews the state of the science for various biomarkers across several specific impairments, and Chapter 4 incorporates perspectives on legal and ethical implications for the use of biomarkers in clinical decision making. Chapter 5 provides final thoughts and suggestions for the use of biomarkers within SSA for disability determination. Appendix A includes the Statement of Task for the workshop. The workshop agenda is provided in Appendix B, and biographical sketches of the workshop speakers and planning committee members are found in Appendix C. Speakers’ presentations and the webcast have been archived online.2
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2 See https://www.nationalacademies.org/event/03-30-2020/the-use-of-biomarkers-to-establish-presence-and-severity-of-impairments-a-workshop (accessed September 3, 2020).
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