NCD Letter to Congress recommending QALY ban in Build Back Better Act

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November 12, 2021

The Honorable Charles Schumer
Majority Leader
United States Senate
S-220, U.S. Capitol
Washington, D.C. 20510

The Honorable Nancy Pelosi
Speaker of the House
United States House of Representatives
H-232, U.S. Capitol
Washington, D.C. 20515

The Honorable Steny Hoyer
Majority Leader
United States House of Representatives
H-107, U.S. Capitol
Washington, DC 20515

RE:     Advising policymakers to include language a provision in the Build Back Better Act (H.R. 5367) that explicitly bans the use of QALYs

Dear Senate Majority Leader Schumer, Speaker Pelosi, and Majority Leader Hoyer:

I write on behalf of the National Council on Disability (NCD), as your federal disability policy advisor, to strongly encourage the inclusion of an unambiguous ban on the quality adjusted life year (QALY) within the text of the Build Back Better Act (H.R. 5367) and located within the bill text in such a way as to convey unequivocal application to the entire Sec. 1194. “Negotiation and Renegotiation Process,” by its addition to the end of the section. Consistent with our advice regarding the discriminatory nature of the QALY for people with disabilities and chronic illnesses, as documented in our 2019 report, Quality-Adjusted Life Years and the Devaluation of Life with a Disability,[i] I further encourage you to utilize the reconciliation package as an opportunity to expressly prohibit the use of the QALY by Medicaid and Medicare.

Since our initial advice to Congress in our 2019 report, NCD has consistently communicated our concerns with use of the QALY in letters to Committee leadership with jurisdiction over H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, as well as to the Congressional Budget Office regarding their assessment of H.R. 3, which dismissed concerns about the discriminatory design and impact of the QALY.[ii] In NCD’s Quality-Adjusted Life Years report, NCD documents sufficient evidence of the discriminatory design and impact of the QALY to warrant concern and recommend its prohibition. Our recommendation is based on issues raised by bioethicists, patient rights groups, and disability rights advocates; compelling arguments from prominent bioethicists condemning the use of the QALY; and the inability of patients with disabilities to access life-sustaining, lifesaving, and life-changing medications in countries where the QALY is used.[iii]

As we document in our 2019 report, it is both the QALY’s discriminatory design and impact that have resulted in its rejection in the U.S. in the past. When Oregon attempted to use the QALY in its Medicaid plan in the 1990s, CMS rejected the plan, finding it violated the Americans with Disabilities Act.[iv] The history of restricted access occurring in countries utilizing QALY-based cost effectiveness research raised concerns that its use in the U.S. would result in rationing care to seniors and people with disabilities, leading Congress in 2009 to prohibit its use under the Affordable Care Act of 2010 (ACA).[v] We encourage you to return to the language utilized in the ACA, which prohibited or severely limited certain federal agencies in their utilization of the QALY, within the text of the Build Back Better Act. That language stated that the Secretary of the U.S. Department of Health and Human Services “shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title XVIII in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill,” and instructed that the Patient-Centered Outcomes Research Institute (PCORI) “shall not develop or employ a dollars per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual’s disability) as a threshold to establish what type of health care is cost effective or recommended.”[vi]

We unequivocally agree that drug prices need to be lowered, as high drug prices can themselves be a source of health inequity for people with disabilities. However, their lowering should not be based on the use of a pricing methodology that devalues the lives of people with disabilities in its design and has been proven to be discriminatory in its impact in access to treatments for people with disabilities and chronic illnesses. Neither outright use of the QALY or acceptance of foreign drug prices set in reliance on the QALY method that effectively endorses the use of this discriminatory pricing methodology are acceptable for this reason.

NCD welcomes further opportunity to discuss our concerns and discuss our 2019 report with your staff. If this is of interest, please contact NCD’s Executive Director, Anne Sommers McIntosh (amcintosh@ncd.gov) and NCD’s General Counsel and Director of Policy, Joan Durocher (jdurocher@ncd.gov) to arrange a meeting.

Respectfully,

Andrés J. Gallegos
Chairman


[i] National Council on Disability, “Quality-Adjusted Life Years and the Devaluation of Life with a Disability” (2019), available at https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf.   

[ii] CBO’s Model of Drug Price Negotiations Under the Elijah E. Cummings Lower Drug Costs Now Act: Working Paper 2021-01, at 10 (February 4, 2021), available at https://www.cbo.gov/publication/56905 (referencing QALY as, “the best available to CBO and is consistent with the approach taken by many countries to negotiate drug prices.”)

[iii] See footnote 1, supra;  also see, NCD’s letter of January 15, 2021, to the Centers for Medicare and Medicaid Services regarding the Most Favored Nation Model Interim Final Rule, available at https://ncd.gov/publications/2021/ncd-letter-cms-most-favored-nation-rule (explaining the discriminatory nature and impact of the QALY and the danger of importing this metric through reliance on foreign drug prices).

[iv] Robert Pear, “White House Expected to Back Oregon’s Health-Care Rationing,” New York Times, March 18, 1993, pg. 00001, https://www.nytimes.com/1993/03/18/us/white-house-expected-to-back-orego....

[v] See, e.g., statements made during House and Senate debates on health care reform bills in October and November of 2009, expressing concern that U.S. use of cost-effectiveness research, like that utilized in the United Kingdom and Canada, would result in rationing care similar to that experienced by patients in those countries: Senator Kyl (AZ). Congressional Record 155:142 (October 5, 2009) p. S10081; Senator McConnell (KY). Congressional Record 155:19 (October 28, 2009) p. S25860; Senator Kyl (AZ). Congressional Record 155:161 (November 2, 2009) p. S10970; Representative Broun (GA). Congressional Record 155:162 (November 3, 2009) p. H12274; Representative Pitts (PA). Congressional Record 155:163 (November 4, 2009) p. H12293; Senator Roberts (KS). Congressional Record 155:173 (November 20, 2009) p. S11888.

[vi] 42 U.S. Code § 1320e–1 - Limitations on certain uses of comparative clinical effectiveness research.