PIPC and more than 100 organizations representing patients, people with disabilities, and older adults submitted a letter to the Center for Medicare and Medicaid Innovation (CMMI) regarding the use of the GLOBE and GUARD models proposed as payment models for CMMI that would import QALYs and similar measures as used in other countries.
We are deeply disturbed that the Administration again seeks to model other countries that are so far behind the United States in access to drugs for serious and disabling conditions. We support the agency’s goal of lowering drug prices for all Americans, but it is critical that it is done in ways that work for all Americans. Policy making America like other countries that embrace the use of cost-effectiveness standards like the quality-adjusted life year (QALY) is the wrong approach. The statute creating the Center for Medicare and Medicaid Innovation (CMMI) was intended to center its work on patients and people with disabilities, valuing their lives and their lived experiences.
We are concerned that the model moves in the opposite direction, and would instead import standards for policymaking used in Organisation for Economic Co-operation and Development (OECD) countries that devalue many patients people with disabilities, ignore differences in the needs of individual patients and their families, and lead Americans to experience similar delays in access to innovation.
We are also concerned that this rule proposes to:
We urge CMMI to put in place safeguards to ensure that patients and people with disabilities are at the center of decision-making. We encourage the administration to work with our communities to develop patient-centered alternatives that recognize the inherent value of every person.
Note: The letters are identical with exception of one section in the GUARD letter that highlights the potential Part-D specific implications given how the model is constructed, emphasizing increased cost-sharing and utilization management acknowledged also in the rule. The letters will also be updated in the coming days to reflect additional signatures.
We are concerned that the model moves in the opposite direction, and would instead import standards for policymaking used in Organisation for Economic Co-operation and Development (OECD) countries that devalue many patients people with disabilities, ignore differences in the needs of individual patients and their families, and lead Americans to experience similar delays in access to innovation.
We are also concerned that this rule proposes to:
- Rely on cost-effectiveness assessment and the discriminatory QALY, which violates current statute that includes safeguards against the use of the QALY and similar metrics in Medicare.
- Lead to a health system devaluing disability that is in direct conflict with American civil rights and disability policy by importing policies that rely on the premise that people with disabilities and older adults are less valuable and less worth treating than “healthy” people.
- Make America more like the referenced countries where individual lives are assigned a numeric value, where treatments for people with disabilities and older adults have lower value and patients are forced to wait at length for their approval and access to them.
- Reference countries in which cost-effectiveness standards and health technology assessment processes routinely deprioritize patients with serious diseases and conditions by imposing long decision-making delays and ignoring outcomes that matter to patients such as improved quality of life and reduced burden on family caregivers.”
We urge CMMI to put in place safeguards to ensure that patients and people with disabilities are at the center of decision-making. We encourage the administration to work with our communities to develop patient-centered alternatives that recognize the inherent value of every person.
Note: The letters are identical with exception of one section in the GUARD letter that highlights the potential Part-D specific implications given how the model is constructed, emphasizing increased cost-sharing and utilization management acknowledged also in the rule. The letters will also be updated in the coming days to reflect additional signatures.
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