By:
Kelly Israel, Policy Analyst, Autistic Self Advocacy Network
Sara van Geertruyden, Executive Director, Partnership to Improve Patient Care
People with disabilities are consistently told they are too expensive to treat when compared to other groups. A metric of determining cost effectiveness of treatments and health services called the quality-adjusted life year (QALY) is yet another tool to make that argument on a larger scale. The QALY is often used to compare the benefits and costs of healthcare interventions. Cost effectiveness analyses based on the QALY are largely developed with intent for their use by insurers and payers to inform the treatments and services that may or may not be covered or subjected to utilization management practices. Advocates have long pushed for consideration of better metrics by payers that reflect the priorities of patients and people with disabilities, hoping to reduce hurdles to appropriate and timely care. As advocates work to understand how the concept of value is defined and used by states and health systems, it is imperative to understand why the QALY metric is discriminatory.
National Council on Disability Report on QALYs
The National Council on Disability (NCD), an independent federal agency advising Congress and the executive branch on disability policy issues, has recommended that Congress pass legislation prohibiting Medicare and Medicaid from using the QALY and that HHS release guidance on how best to utilize cost-effectiveness research without discriminating against people with disabilities. NCD even recommended that the U.S. Department of Justice and HHS Office for Civil Rights issue guidance clarifying that the Americans with Disabilities Act (ADA) applies to Medicaid programs and that payment decisions should not rely on “reports that are developed using QALYS.” NCD also described how QALYS had been used in the United Kingdom to restrict access to treatments for people with disabilities.
The Politics of QALYs
The QALY metric has long been opposed by disability advocates as a tool for determining the value of health care and how treatments will be covered by payers in both public and private insurance programs. In 1992, The U.S. Department of Health and Human Services rejected Oregon’s proposed Medicaid waiver application that would use QALYs to determine its prioritized list of services, stating, “Our principal concern is that Oregon’s plan in substantial part values the life of a person with a disability less than the life of a person without a disability. This premise is discriminatory and inconsistent with the Americans with Disabilities Act.” In 2010, the Affordable Care Act included provisions barring the use of QALYs by the Patient-Centered Outcomes Research Institute and by Medicare to determine coverage, reimbursement, and incentive programs. More recently, members of Congress have expressed opposition to the use of the metric in public programs. Yet, many states are advancing policies to incorporate its use particularly in restricting access to medications, and the Veterans Administration is openly referencing QALYs in its formulary development.
QALYs Defined and their Misuse
Part of the challenge is that academics are trained as students to construct cost effectiveness analyses based on QALYs and therefore may be hesitant to participate in efforts to advance more innovative methods. They would argue that QALYs are simply there to compare two treatments for the same condition. However, the QALY metric is inherently designed in a discriminatory manner.
To calculate a QALY, it is necessary to determine by how much not being in perfect health impacts a person’s quality of life. As described by disability experts, “QALYS do this by assigning a number between 0 and 1, called a health utility, to the various conditions a person’s health could be in (often called “health states”). A 0 would represent the lowest possible quality of life, while a 1 would represent the highest possible quality of life. Health states are represented by points on the scale of 0 to 1—for example, 0.2, 0.5, 0.8.” To determine this arbitrary number, researchers generally conduct surveys – primarily of nondisabled people – to determine how much they value (or even would dislike being in) each health state. Once this number is calculated, it is then applied to surveys of people with disabilities and studies of their health. There is nothing inherent to a QALY to prevent it being used in a discriminatory way, and plenty that makes it very attractive for those purposes as policymakers and payers seek to reduce their costs by restricting health coverage. If the goal is to solely compare treatments for the same condition, there are many comparison methods available for use that do not impose population-based judgements on the value of having that condition, and thereby the life lived with it. In fact, QALYs are not essential to that comparison. For example, PCORI, an independent research institute, was created by Congress to conduct comparative clinical effectiveness research. PCORI has succeeded in doing so without the need to incorporate the use of the QALY.
A researcher comparing two treatments for the same condition does not need to rely on this arbitrary metric to compare the treatments’ impact on ability to breathe, pain reduction, or some other primary endpoint for people living the condition being studied. In fact, using QALYs would only add additional steps to the calculation.
No one serious about studying how a treatment improves quality of life would use a generic questionnaire, like those used as an input to the QALY, to rate quality of life over a disease specific tool because the questionnaires use very broad categories to describe quality of life. In fact, the QALY’s bias emanates from the reality that people with disabilities are living with different conditions which have different impacts on their quality of life. The QALY metric, by effectively rating treatments by the degree to which they cause a person with a disability’s health and physicality to resemble that of a person without a disability, inherently favors people with some kinds of disabilities over people with other kinds of disabilities and treats life lived without a disability as “ideal.”
Additionally, people with disabilities, including those with serious and/or chronic illnesses, do not assign the same values to health gains as people without disabilities. Even if the health utility was a perfect measure of a person’s health-related quality of life (which as this article demonstrates, it is not), a person with a health utility of .4 would likely value a change in health from .4 to .5 more than a person that went from a .8 to .9, though on paper the improvement is the same (the increase would be .1. for both). Improvements to quality of life, even small ones, are incredibly valuable to people with disabilities whose disabilities do impact health, and that value is simply not captured by the QALY.
As states create boards and commissions to value treatments using cost effectiveness analyses, there is reason to be concerned about the use of the QALY. New York is openly referencing QALY-based value assessment studies from the Institute for Clinical and Economic Review (ICER), the Massachusetts Health Policy Commission contracted with ICER to develop a value framework, and the PBM CVS Caremark allowed some of its clients to use a $100,000 per QALY threshold for coverage during 2018. The last administration indicated willingness to allow states to restrict coverage of prescription drugs in their Medicaid programs, such as the proposed waiver submitted by the State of Tennessee last year. And despite the 1992 decision by HHS, the State of Oregon continues to use a QALY-based cost-effectiveness analysis as part of its formula for determining its prioritized list of services that will or will not be covered under its Medicaid and EPSDT waiver.
Other Examples of Discriminatory Metrics and Judgements in Policy
However, the use of discriminatory metrics to determine who is “worth it” to get care is increasingly being combated by disability rights and health care advocates in many different contexts. During the COVID-19 pandemic, other forms of discriminatory quality of life judgments were used to create Crisis Standards of Care that were intended to justify putting people with disabilities at the back of the line for a ventilator in a shortage, but these standards were successfully combated by a significant public outcry and advocacy movement against them. Similarly, a person’s eligibility for an organ transplant is often based upon discriminatory and entirely opaque decision-making by organ transplant centers. Nonetheless, disability rights advocates have combated this discrimination for twenty years and continue to advocate for state legislation prohibiting it in each state’s organ transplant centers, as well as federal legislation. There has been some degree of success even at the federal level. For example, recently two representatives of Congress introduced the Charlotte Woodward Organ Transplant Discrimination Prevention Act, named after a woman with Down Syndrome. It would prevent someone’s disability from being used as the only basis for denying them an organ transplant at the federal level.
Conclusion
Innovation should be encouraged to develop methods for assessing the value of treatments that better acknowledge the complexity of healthcare coverage decisions and that give people living with the condition the means to define the outcomes that are important to them in their care. Sustained advocacy is needed to remind states of their obligations under the ADA and other disability rights laws so that their policies do not devalue the lives of people with disabilities by relying on discriminatory metrics such as QALYs. We should not attempt to reduce the cost of health care by devaluing the lives of people with disabilities.
