PIPC shared concerns with the Connecticut legislature related to Section 6 of House Bill 5040 and its potential use of third-party comparative effectiveness reviews of prescription drugs in a manner that may allow for use of cost effectiveness analyses using quality-adjusted life years (QALYs) and similar measures from entities like the Institute for Clinical and Economic Review (ICER).
"Before advancing this legislation, it is important for the legislature to also be aware of the existing law and regulations that bar the use of QALYs and similar measures in decisions impacting reimbursement and coverage," wrote PIPC Chairman Tony Coelho. "We are very concerned that the legislation does not explicitly bar the use of QALYs and similar measures such as the equal value of life year gained (evLYG), consistent with federal law, and potentially allows for use of third-party studies that incorporate the use of QALYs and similar measures.”
March 2, 2026
Honorable Jillian Gilchrest
Representative
State of Connecticut
Legislative Office Building, Room 2002
Hartford, CT 06106-1591
Honorable Matt Lesser
Senator
State of Connecticut
Legislative Office Building, Room 2800
Hartford, CT 06106-1591
Dear Representative Gilchrest and Senator Lesser:
The Partnership to Improve Patient Care (PIPC) is writing to share the concerns of patients and
people with disabilities related to Section 6 of House Bill 5040 and its potential use of cost effectiveness analyses The legislation describes third party comparative effectiveness reviews of prescription drugs in a manner that may allow for use of cost effectiveness analyses using quality-adjusted life years (QALYs) and similar measures from entities like the Institute for Clinical and Economic Review (ICER).. Before advancing this legislation, it is important for the legislature to also be aware of the existing law and regulations that bar the use of QALYs and similar measures in decisions impacting reimbursement and coverage. We are very concerned that the legislation does not explicitly bar the use of QALYs and similar measures such as the equal value of life year gained (evLYG), consistent with federal law, and potentially allows for use of third-party studies that incorporate the use of QALYs and similar measures.
As the original author of the Americans with Disabilities Act (ADA), I feel strongly that QALYs and similar measures devaluing disabled lives have no place in our health care system. Over 100 organizations representing patients and people with disabilities agree.[1]
Federal Law Bars Use of QALYs and Similar Measures
After passage of the Americans with Disabilities Act (ADA), in 1992 the U.S. Department of Health and Human Services recognized that the use of QALYs in a Medicaid program would be a violation of the new law. Since then, in 2010, section 1182 of the Affordable Care Act (ACA) barred Medicare’s use of QALYs and similar measures that that discount the value of a life because of an individual’s disability. Despite these federal actions, the disability community has had to fight to clarify that disability nondiscrimination laws do not allow for the use of QALYs and similar measures in federal programs.
On May 9, 2024, the final new regulations governing Section 504 of the Rehabilitation Act were published, protecting the rights of people with disabilities in programs and activities receiving federal financial assistance.[2] PIPC joined 100 organizations and individuals on a letter supporting a rulemaking to bar the use of quality-adjusted life years and similar measures in decisions impacting access to care.[3] The final rule represents a critical step forward in protecting patients and people with disabilities against being devalued in health systems and sends a strong message that we need better solutions for U.S. decision-making that don’t rely on the biased, outdated standards historically used by payers. As described in the final rule, the new regulations would bar health care decisions made using measures that discount gains in life expectancy, which would include QALYs and evLYGs. The agency broadly interpreted what constitutes the discriminatory use of value assessment in its description of the rule, stating, “The Department interprets recipient obligations under the current language of § 84.57 to be broader than section 1182 of the Affordable Care Act, because it prohibits practices prohibited by section 1182 (where they are used to deny or afford an unequal opportunity to qualified individuals with disabilities with respect to the eligibility or referral for, or provision or withdrawal of an aid, benefit, or service) and prohibits other instances of discriminatory value assessment.” PIPC was pleased that the final rules governing Section 504 would be interpreted by the agency as broader than the section 1182 statute.[4] The language of the new rule reflects the shared bipartisan perspectives that were communicated widely early in the COVID-19 pandemic, consistent with enforcement of disability rights laws against state Crisis Standards of Care that would have put people with disabilities at the back of the line for care in a shortage.[5],[6]
The final rule referenced both § 84.56 and § 84.57 as relevant to entities receiving federal financial assistance, which includes state Medicaid programs. For example, the agency stated, “Methods of utility weight generation are subject to section 504 when they are used in a way that discriminates. They are subject to § 84.57 and other provisions within the rule, such as § 84.56’s prohibition of discrimination based on biases or stereotypes about a patient’s disability, among others.” Therefore, it will be critical for compliance with these rules that the state understand the methods for generating the utility weights in any clinical and cost effectiveness studies that it may be using to make decisions to ensure they do not devalue people with disabilities. As PIPC and others noted in comments to HHS, studies have confirmed inherent bias against people with disabilities in the general public, finding much of the public perceives that people with disabilities have a low quality of life.[7] Therefore, the potential for discrimination is significant when measures rely on public surveys, as does the QALY and the evLYG.
Bias Inherent Among Entities Supporting Use of QALYs and Similar Measures Undermines Trust and Credibility
Several entities, with support from Arnold Ventures – including the Program on Regulation, Therapeutics, and Law (PORTAL) and ICER – continue pushing for infusion of QALY-based cost effectiveness measures to inform Medicare and Medicaid coverage and payment decisions,[8] in direct conflict with the recommendations of the National Council on Disability (NCD), an independent federal agency advising Congress and the administration on disability policy. Regardless of the political party in charge, NCD’s position has always been that policymakers should avoid referencing QALYs, whether directly or indirectly from entities like ICER or from referencing other prices that were also established using QALYs.[9]
Therefore, the state should avoid reliance on entities that support use of one-size fits all metrics devaluing disabled lives, like the QALY or evLYG. We are very concerned that entities including PORTAL and ICER publicly view the QALY as the gold standard for measuring cost effectiveness – a fact that will undermine the trust of patients and people with disabilities if they are consulted in the state’s work.[10] We strongly urge the state to comply with the NCD recommendations against reference to QALYs.
Conclusion
Affordable access to health care is a significant priority. State policymakers must manage health costs in a manner centered on both affordability and access to meet the differing health care needs of people with disabilities and chronic conditions. In doing so, PIPC urges Connecticut to avoid policies that would potentially violate federal laws against devaluing people with disabilities and older adults, including new regulations governing Section 504 of the Rehabilitation Act, by relying on discriminatory metrics such as the QALY that have detrimental implications for access to needed care and treatment. The consequence of devaluing patients and people with disabilities is real, with implications for formulary placement, delayed or denied care, and increased out-of-pocket costs for patients choosing the care their doctors prescribe and that best meets their health needs even when it is not preferred by payers or health economists. We do not need more policies putting payers between decisions made by doctors and patients.
I hope that this information is useful to the state legislature as it moves forward in its deliberations. Thank you for your consideration.
[1]https://files.constantcontact.com/e7a90be4701/2e199106-a152-4598-838b-1b08dce510c2.pdf
[2]https://www.govinfo.gov/content/pkg/FR-2024-05-09/pdf/2024-09237.pdf?utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov
[3] https://www.pipcpatients.org/uploads/1/2/9/0/12902828/pipc_504_comment_final.pdf
[4] 89 FR 40066, “The Department interprets recipient obligations under the current language of § 84.57 to be broader than section 1182 of the Affordable Care Act, because it prohibits practices prohibited by section 1182 (where they are used to deny or afford an unequal opportunity to qualified individuals with disabilities with respect to the eligibility or referral for, or provision or withdrawal of an aid, benefit, or service) and prohibits other instances of discriminatory value assessment.”
[5] "We're concerned that crisis standards of care may start relying on value judgments as to the relative worth of one human being versus another, based on the presence or absence of disability," said Roger Severino, the director of the Office for Civil Rights. "We're concerned that stereotypes about what life is like living with a disability can be improperly used to exclude people from needed care." See https://www.npr.org/2020/03/28/823254597/hhs-warns-states-not-to-put-people-with-disabilities-at-the-back-of-the-line-for
[6] “Traditionally, American health care policy and treatment approaches have largely been driven by the concepts of cost-effectiveness analysis (CEA) and quality-adjusted life year (QALY). But these approaches are inherently discriminatory. They devalue the life of people with disabilities and older adults.” See
https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf
[7] Ne’eman et. al, “Identifying and Exploring Bias in Public Opinion on Scarce Resource Allocation During the COVID-19 Pandemic,” October 2022, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2022.00504.
[8] Authors supported by Arnold Ventures stated, “Congress should explicitly authorize, if not require, CMS to consider cost-effectiveness…” see https://www.healthaffairs.org/content/forefront/addressing-costs-through-pricing-and-coverage-policy
[9] National Council on Disability. (November 16, 2019). Quality-Adjusted Life Years and the Devaluation of Life with Disability. https://www.ncd.gov/report/quality-adjusted-life-years-and-the-devaluation-of-life-with-a-disability/
[10] https://www.pipcpatients.org/uploads/1/2/9/0/12902828/icer_2023_framework_final_comment.pdf
[2]https://www.govinfo.gov/content/pkg/FR-2024-05-09/pdf/2024-09237.pdf?utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov
[3] https://www.pipcpatients.org/uploads/1/2/9/0/12902828/pipc_504_comment_final.pdf
[4] 89 FR 40066, “The Department interprets recipient obligations under the current language of § 84.57 to be broader than section 1182 of the Affordable Care Act, because it prohibits practices prohibited by section 1182 (where they are used to deny or afford an unequal opportunity to qualified individuals with disabilities with respect to the eligibility or referral for, or provision or withdrawal of an aid, benefit, or service) and prohibits other instances of discriminatory value assessment.”
[5] "We're concerned that crisis standards of care may start relying on value judgments as to the relative worth of one human being versus another, based on the presence or absence of disability," said Roger Severino, the director of the Office for Civil Rights. "We're concerned that stereotypes about what life is like living with a disability can be improperly used to exclude people from needed care." See https://www.npr.org/2020/03/28/823254597/hhs-warns-states-not-to-put-people-with-disabilities-at-the-back-of-the-line-for
[6] “Traditionally, American health care policy and treatment approaches have largely been driven by the concepts of cost-effectiveness analysis (CEA) and quality-adjusted life year (QALY). But these approaches are inherently discriminatory. They devalue the life of people with disabilities and older adults.” See
https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf
[7] Ne’eman et. al, “Identifying and Exploring Bias in Public Opinion on Scarce Resource Allocation During the COVID-19 Pandemic,” October 2022, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2022.00504.
[8] Authors supported by Arnold Ventures stated, “Congress should explicitly authorize, if not require, CMS to consider cost-effectiveness…” see https://www.healthaffairs.org/content/forefront/addressing-costs-through-pricing-and-coverage-policy
[9] National Council on Disability. (November 16, 2019). Quality-Adjusted Life Years and the Devaluation of Life with Disability. https://www.ncd.gov/report/quality-adjusted-life-years-and-the-devaluation-of-life-with-a-disability/
[10] https://www.pipcpatients.org/uploads/1/2/9/0/12902828/icer_2023_framework_final_comment.pdf
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