The drug price “negotiation” mechanism Democrats included in last year’s inaptly named Inflation Reduction Act will reduce innovation and the introduction of possible new cures. But a recently released document by the Centers for Medicare and Medicaid Services also suggests regulators may utilize the “negotiation” process to discriminate against people with disabilities.
As the mother of a child with cystic fibrosis and as a former member of the National Council on Disability, I find that the centers’ proposals raise more troubling questions about Democrats’ brave new drug pricing world.
BIDEN'S PROMISES ON DRUG PRICES SOUND HALLUCINOGENIC
In March, CMS released a 91-page guidance document providing the agency’s initial views of the drug “negotiation” process. The document indicated that when considering various factors to determine the “fair price” for the drug, regulators would exclude research that uses quality-adjusted life years, or QALYs, “in a manner that treats extending the life of an individual who is elderly, disabled, or terminally ill as of lower value than extending the life of an individual” without those characteristics.
This phrasing in CMS’s guidance echoed language included in the Inflation Reduction Act, and similar language is contained in a section of Obamacare that established a federal institute for comparative effectiveness research. But prohibiting the use of QALYs only “in a life-extension context,” as CMS suggests in the guidance, takes a constrained view of discrimination in ways that contradict past administrative actions and other federal laws.
Prohibiting the use of discriminatory cost-effectiveness metrics solely when it comes to valuing the quantity of life (i.e., life extension) would allow regulators to use such metrics to evaluate the quality of life. And on that front, the QALY metric, by definition, considers people with disabilities as of “lesser” value than the nondisabled. Moreover, other alternatives to the QALY that CMS could utilize, such as the equal value of life year gained, discriminate based upon age and contain similar flaws regarding quality-of-life improvements.
In my comments to CMS regarding its guidance, I noted that federal health regulators had previously not taken such a restrictive view about what constitutes discrimination against people with disabilities. In 1992, then-Secretary of Health and Human Services Louis Sullivan rejected a Medicaid waiver application from the state of Oregon because the waiver “in substantial part values the life of a person with a disability less than the life of a person without a disability.”
Sullivan and HHS based their decision not on the narrow “life-extension context” referred to in the Inflation Reduction Act and Obamacare but on a broader definition of discrimination laid out in the Americans with Disabilities Act. Specifically, sections of the Oregon proposal weighed “quality of life” heavily in determining what services Medicaid would cover, which HHS concluded constituted discrimination against people with disabilities. Only after Oregon officials deleted such language from their application did federal regulators approve the waiver.
The Oregon precedent demonstrates that discrimination against the disabled can occur regarding both quality and quantity of life. As such, CMS should take a more expansive view of the factors excluded from consideration during the “negotiation” process to ensure the agency complies with the Americans with Disabilities Act.
Yet some Democrats object. At a recent Energy and Commerce Committee markup of House legislation designed to ensure that federal programs do not use QALYs or similar discriminatory measures, ranking member Frank Pallone (D-NJ) raised concerns that the bill “could be used to delay or disrupt the implementation of the drug price negotiations in the Inflation Reduction Act.”
It speaks volumes that some Democrats apparently believe the federal government cannot “negotiate” drug prices without discriminating against the most vulnerable. Regardless, CMS should follow the example of federal regulators three decades ago and insist on excluding any discriminatory cost-effectiveness metrics from the “negotiation” process.
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Mary Vought is the founder of Vought Strategies and a senior fellow at the Independent Women's Forum. She's a former presidential appointee to the National Council on Disability.
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