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NCD letter to Centers for Medicare and Medicaid on QALYs, organ transplants Monday, February  3, 2020
 
 Seema Verma
Administrator, Centers for Medicare & Medicaid Services
U.S. Department of Health & Human Services
200 Independence Avenue, S.W., Mail Stop 314G
Washington, D.C. 20201 Brad Smith
Director, Center for Medicare & Medicaid Innovation
U.S. Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201 Dear Ms. Verma and Mr. Smith: I write on behalf of the National Council on Disability (NCD) - an independent, nonpartisan federal agency charged with advising the Administration, Congress, and federal agencies on disability policy - to inform you that we recently released two reports that make recommendations to the Centers for Medicare & Medicaid Services (CMS). *Organ Transplant Discrimination Against People with Disabilities*[[1]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn1) and *Quality Adjusted Life Years (QALYs) and the Devaluation of Life with Disability,*[[2]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn2) are part of a series of reports examining the ability of people with disabilities to access necessary healthcare and life-saving treatments an identifying actions that federal agencies can make to ensure nondiscrimination*.* This letter summarizes the reports and provides you with CMS specific recommendations. The second purpose of my correspondence is to commend you for describing federal disability nondiscrimination obligations of Organ Procurement Organizations in your recent proposed rule,[[3]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn3) and to make a recommendation on the proposed rule. In *Quality Adjusted Life Years (QALYs) and the Devaluation of Life with Disability*, NCD examined the design, application, and impact of QALYs - a way to measure cost-effectiveness of drugs which assigns a lesser life value to people with chronic illnesses and puts a lesser value on drugs/treatments that extend their lives - as well as the ethical implications of their use. NCD found sufficient evidence of the discriminatory effects of QALYs to warrant opposition to their use, including discriminatory design, the negative impact on patients in the United Kingdom where QALYs are used to inform coverage decisions, and the recent situation in New York, where Medicaid’s reliance on cost-effectiveness reports based on QALYs, created an impasse between pharmaceutical manufacturers and the state over pricing which, in turn, left people with cystic fibrosis without access to an effective, breakthrough medication. Despite its discriminatory design and effects, NCD found that public and private health insurance providers, pharmacy benefit managers, and some federal agencies are showing increased interest in using – or are currently using - cost-effectiveness reports, developed using QALYs, to determine what they will pay for prescription medicines and treatments. CMS has recently sought to reducing healthcare costs by modeling parts of national health insurance programs after those of other countries that use QALYs to make coverage decisions: CMS’s Advance Notice of Proposed Rulemaking (ANPRM) proposed an International Pricing Index (IPI) [[4]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn4) that would base the prices of certain drugs covered by Medicare Part B on prices from 16 other countries, like the United Kingdom, Ireland, and Canada – countries that use QALYs to make benefits and coverage decisions. There are alternatives to the use of QALYs. These alternatives range from well-established methods regularly used by United States federal agencies, such as Cost-Benefit Analysis, to unexplored but promising alternatives such as value frameworks that use patient preferences to determine the value of healthcare treatments. Based on our findings, NCD recommends that CMS: Utilize well-established alternatives to QALYs, such as MCDA, which is a method that better acknowledges the complexity of healthcare coverage decisions, or cost-benefit analysis, when the exact benefits and costs of a drug or treatment are known. CMS could utilize these methods in combination, such as using cost-benefit analysis as one component of a MCDA. If CMS does utilize cost-effectiveness analysis, it should consider utilizing it as one component of a condition-specific MCDA.
  Refrain from pursuing means of reducing Medicare and Medicaid prescription drug costs that attempt to model US pricing after the pricing in other countries, which may heavily rely on QALYs and often deny people with disabilities access to needed care.
  Rescind its Advanced Notice of Proposed Rulemaking, which proposed an IPI for Medicare Part B.
  Contribute to the development and use of value frameworks that utilize patient preferences to define which drugs and treatments are valuable, such as FasterCures’ PPVF. *Organ Transplant Discrimination* People with disabilities have long been prevented from equal opportunity in the organ transplant process - a type of healthcare discrimination that prevents access to life-saving organs by devaluing lives of people with disabilities based largely on stereotypes and assumptions about the quality of a life with a disability. NCD’s report, *Organ Transplant Discrimination Against People with Disabilities,*[[5]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn5) describes the organ transplant system, the organizations involved, and describes discrimination throughout the process. NCD’s examination found that disability-based discrimination is occurring in the organ procurement process: existing policies have not adequately protected individuals and families from being contacted and even pressured by organ procurement organizations prior to a decision that life support will be withdrawn, even in cases involving ICU patients who recovered and went home. The newly injured population is particularly vulnerable to abusive organ procurement policies because their recent trauma and uncertain future makes them susceptible to the message that their death would mean more to the people around them than their life. People with disabilities in intensive care units whose prognoses are uncertain are likewise vulnerable to abuse in organ procurement practices. In the initial phase of an injury or a serious exacerbation of a chronic or progressive condition, health care decision making that could lead to death may be under consideration. Conditions that involve ongoing interventions, such as a feeding tube or even ongoing critical medications, may also involve decisions that lead to death. These situations all create potential for organ donation and, thus, activities by organ procurement organizations. NCD commends you for explaining in your recent Proposed Rule[[6]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn6) that organ procurement organizations (OPOs) are required to follow the disability protections established by Section 504 of the Rehabilitation Act and Section 1557 of the Affordable Care Act, which protect qualified individuals with a disability, including prospective organ recipients with a disability and prospective organ donors with a disability, from unlawful discrimination in the administration of organ transplant programs. We appreciate your clarification that “under these laws, OPOs must ensure that qualified individuals with a disability are afforded opportunities to participate in or benefit from the organ transplant program that are equal to opportunities afforded others, and decisions to approve or deny organ transplants must be made based on objective facts related to the individual in question,”[[7]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn7) and that ‘‘Individuals with disabilities are also entitled to reasonable accommodations needed to participate in and benefit from a program, and auxiliary aids and services needed for effective communication.”[[8]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn8) NCD recommends that you maintain this nondiscrimination information in the final rule. NCD wants to ensure that people with disabilities and chronic illnesses in the United States continue to have access to the medications that they need as well as equal opportunity to access life-saving organs. Please note that NCD wrote a letter on September 25, 2019, to Thomas J. Engels, Acting Administrator of the Health Resources (HRSA); the Organ Procurement and Transplantation Network (OPTN); and the United Network for Organ Sharing (UNOS),[[9]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn9) with recommendations from our organ transplant discrimination report. Please also see our letter of the same date to Roger Severino, Director of HHS’s Office for Civil Rights, recommending the issuance of nondiscrimination guidance to entities involved in the transplantation and procurement of organs.[[10]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftn10) Thank you for your work to provide quality healthcare across the United States. NCD would like to meet with you to discuss the concerns and recommendations raised in this letter. Please contact Joan Durocher, General Counsel and Director of Policy, or Ana Torres-Davis, Attorney-Advisor, at jdurocher@ncd.gov or atorresdavis@ncd.gov, to schedule a meeting at your convenience. Respectfully, Neil Romano
Chairman  Cc:      Roger Severino, Director OCR
            Thomas J. Engels, Acting Administrator HRSA
            Maryl Johnson, President, Organ Procurement and Transplantation Network
            Brian Shepard, CEO, United Network for Organ Sharing [[1]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref1) </assets/uploads/docs/ncd-organ-transplant-508.pdf> [[2]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref2) </assets/uploads/docs/ncd-quality-adjusted-life-report-508.pdf> [[3]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref3) Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization, 84 Fed. Reg. 246, 70629 (Dec. 23, 2019). [[4]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref4) Medicare Program; International Pricing Index Model for Medicare Part B Drugs. Federal Register. 83 Fed. Reg. 54546 (proposed October 30, 2018) (to be codified at 42 CFR Chapter IV). [[5]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref5) *</assets/uploads/docs/ncd-organ-transplant-508.pdf>* [[6]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref6) Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization, 84 Fed. Reg. 246, 70629 (Dec. 23, 2019). [[7]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref7) Id. [[8]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref8) Id. [[9]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref9)*https://ncd.gov/publications/2019/ncd-letter-unos-optn-hrsa-regarding-organ-transplants* [[10]](https://ncd.gov/publications/2020/ncd-letter-centers-medicare-and-medicaid-qalys-organ-transplants#_ftnref10) https://ncd.gov/publications/2019/ncd-letter-hhs-and-doj-organ-transplants


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