The U.S. House of Representatives passed H.R. 485, the Protecting Health Care for All Patients Act, this week. The bill would prohibit federally-funded healthcare programs from using the Quality Adjusted Life Year to determine pricing and reimbursement of healthcare services and technologies, including prescription drugs. Effectively, this would extend the ban on the use of QALYs by government-funded healthcare programs to include Medicaid, the Veterans Affairs Administration and the Federal Employees Health Benefits Program.
According to the U.S.-based Institute for Clinical and Economic Review, the QALY measures how well different kinds of medical treatments extend lives or improve patients’ quality of life. As a composite measure of both quantity and quality of life it enables comparisons across disease states and treatments.
When combined with the costs associated with healthcare interventions, the QALY can be used to assess their relative worth from an economic perspective.
A main sponsor of the bill, Representative Cathy McMorris Rodgers (R-WA), has repeatedly warned of the potential for QALY-based approaches to evaluate medical technologies to discriminate and lead health insurers to deny care to persons with disabilities. In her view, QALYs inherently place a lower value on years of life gained by older people and those who live with disabling conditions. On her government website she writes: “All lives are worth living. It’s unconscionable that a healthcare bureaucracy would so callously determine that someone’s life is worth less. They deserve every chance to have hope and reach their full potential. The ‘quality-adjusted life years’ measurement is used to discriminate against people with chronic illnesses and disabilities, like cystic fibrosis, ALS, or Down syndrome, putting them at the back of the line for treatment.”
Other critics of the QALY maintain it is discriminatory and that there’s been bipartisan agreement on this for quite some time. So, while the vote to pass the Act in question was on (Republican) party lines, they point to the fact that the Democrat-led Affordable Care Act banned Medicare from using QALYs as a “threshold” measure to determine coverage and reimbursement. In addition, recent guidance published by the Centers for Medicare and Medicaid Services specifically acknowledges that the agency is subject to “nondiscrimination provisions in Medicare” through both the ACA and the Inflation Reduction Act, which was also passed on (Democratic) party lines.
The legislation which the House voted on has the support of top Republicans on the Senate Finance Committee. It stands a reasonable chance of passage in the Senate.
According to Harvard University researchers, however, the bill fundamentally misunderstands QALYs and how they’re used. Moreover, the broad language of the proposed law threatens the entire enterprise of comparative effectiveness research. Such research generates and synthesizes evidence to compare the benefits and harms of medical interventions to prevent, diagnose and treat a disease or condition. The QALY fits under the rubric of comparative effectiveness research and is in fact a widely prevalent measure of benefit used in cost-effectiveness analysis worldwide.
H.R. 485 aims to outlaw the use of QALYs and “similar measures.” It’s unclear what the latter phrase precisely means. But the QALY shares a lot in common with other measures that are in routine usage around the globe. In turn, this could imply that they, too, would be prohibited. This includes several Healthy Life Year Equivalent approaches to measure the loss of healthy life from disease and the gain from interventions.
Furthermore, contrary to how the law appears to be written, cost-effectiveness analysis, such as cost-per-QALY, is rarely the decisive factor in decision-making on coverage and pricing determinations. It’s merely one input. Policymakers, insurers and other interested parties also consider other criteria, including the availability of alternative therapies and benefits and risks of care that are not easily quantified.
Also, Cohen, Neumann and Ollendorf state that by placing greater value on life years with improved quality, the “QALY rewards healthcare that improves functioning, reduces pain, and helps people with serious and disabling conditions reengage in work and other activities.” They go on to reiterate that the QALY is a “measure of the health gains of treatments, not a measure of the value of people.”
As a concept the QALY can indeed accommodate some of the issues cited by critics, including being able to account for severity of disease. Alternatively, there are methods such as the equal value life-year gained, that can be employed to place the same value on additional years of life across diseases and populations.
This raises the question, would lawmakers interpreting the bill identify the evLYG approach as a “similar measure” and therefore reject its use out of hand.
The larger point is that in the face of scarce resources hard decisions must be made by healthcare policymakers. One can’t spend the same healthcare dollar twice, which means that policymakers must make each dollar go as far as it can in terms of producing health outcomes for the population as a whole.
Preferably their decisions on how to allocate such dollars are informed by robust evidence that lays out the benefits and harms of medical interventions.
Whether the bill gets enacted or not, policymakers will still need ways to measure the value of medical interventions under circumstances of finite resources. Otherwise, the system will revert to implicit ways of rationing, for instance, a person’s ability to pay or health insurance status. The problem is that implicit rationing, which is the default American way of allocating resources, is random, not evidence-based and invariably inequitable.