In this week's edition...
— PIPC Response to Trump Administration’s Continued Push for MFN Pricing. Click here to view the statement.
— Engaging Medicaid Members and Community-Based Organizations Through Beneficiary Advisory Councils. Click here to learn more.
— PIPC Chairman Explains that the MFN is Exacting Too High a Price for Patients and People with Disabilities. Click here to read the statement.
— SFS Releases Survey Results Detailing Americans' Rejection of Foreign Drug Pricing Schemes. See details below.
— Bonnell Foundation in Detroit News: Critique of MFN as an Avenue for Drug Pricing Reform. Click here to read the article.
— Patient Organizations Send Letter to Washington PDAB. See details below.
— ICHOM Working Group: Kidney Stones Set Feedback Opportunity. See details below.
— PIPC Comment to CMS on ICR Emphasizes QALY Transparency. See details below.
— PIPC Urges Minnesota PDAB to Reject Discriminatory Value Assessments. Click here to read the letter.
— CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. See details below.
— EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. See details below.
— Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. See details below.
— Reps. Cammack and Hern Introduce QALY Ban Bill. See details below.
— Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— Update on the Texas v. Kennedy Lawsuit. See details below.
— Learn More About Alternative Measures for Value Assessment. Click here to learn more.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— PIPC Response to Trump Administration’s Continued Push for MFN Pricing. Click here to view the statement.
— Engaging Medicaid Members and Community-Based Organizations Through Beneficiary Advisory Councils. Click here to learn more.
— PIPC Chairman Explains that the MFN is Exacting Too High a Price for Patients and People with Disabilities. Click here to read the statement.
— SFS Releases Survey Results Detailing Americans' Rejection of Foreign Drug Pricing Schemes. See details below.
— Bonnell Foundation in Detroit News: Critique of MFN as an Avenue for Drug Pricing Reform. Click here to read the article.
— Patient Organizations Send Letter to Washington PDAB. See details below.
— ICHOM Working Group: Kidney Stones Set Feedback Opportunity. See details below.
— PIPC Comment to CMS on ICR Emphasizes QALY Transparency. See details below.
— PIPC Urges Minnesota PDAB to Reject Discriminatory Value Assessments. Click here to read the letter.
— CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. See details below.
— EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. See details below.
— Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. See details below.
— Reps. Cammack and Hern Introduce QALY Ban Bill. See details below.
— Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— Update on the Texas v. Kennedy Lawsuit. See details below.
— Learn More About Alternative Measures for Value Assessment. Click here to learn more.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
What We're Reading
PIPC welcomes new members to advance our efforts to assure patients and people with disabilities are at the center of research and policy! Please reach out to [email protected] for more information.
1. PIPC Response to Trump Administration’s Continued Push for MFN Pricing. In a statement released today, PIPC again warned against reliance on discriminatory measures like quality-adjusted life years (QALYs) and similar measures of cost effectiveness in decisions related to reimbursement and coverage of health care, including Most Favored Nation (MFN) pricing, that adopt other countries’ discriminatory QALY standards by referencing their reimbursement decisions. PIPC stated, "While we do not know the details of recent actions by the Administration or policies that are pending at the Office of Management and Budget, we remain very concerned that these efforts could open the door to reliance on QALYs and similar cost-effectiveness metrics in U.S. policy via reference to foreign prices...The United States must prioritize early access to innovations that optimize quality of life for all. We must protect against the kind of care rationing that is accepted elsewhere in the world. That means avoiding approaches that would modify U.S. coverage or pricing policy to factor in QALYs and similar measures, whether directly or by reference to other countries.” Stories like the Williams’ family illustrate why QALYs have no place in U.S. policy. Patients do not have the luxury of time. Click here to view the Williams’ struggle for access to care for Wilson disease. Click here to view the PIPC statement.
2. Engaging Medicaid Members and Community-Based Organizations Through Beneficiary Advisory Councils. In 2024, CMS issued a final rule requiring states to establish or strengthen Beneficiary Advisory Councils (BACs) — groups of Medicaid members, families, and caregivers that provide input on a range of topics, including covered services, care coordination, eligibility, enrollment, and cultural competency. Through the Building State Capacity for Community-Informed Policymaking Learning and Action Series, the Center for Health Care Strategies (CHCS) supported seven states in designing and implementing effective BACs, in partnership with CBOs. This webinar will share key lessons from the series, highlighting state experiences in developing BAC structures, recruitment strategies, charters and bylaws, and compensation policies. CHCS will lead a conversation with panelists from Maine and North Dakota who will share their insights. Click here to learn more and register.
3. PIPC Chairman Explains that the MFN is Exacting Too High a Price for Patients and People with Disabilities. In his latest "Chairman's Corner" blog, PIPC Chairman Tony Coelho explains why the "Most Favored Nation" (MFN) approach to drug pricing will devalue disabled lives. He explains the following: "Since it was first advanced by CMS in 2019, I’ve staunchly opposed proposals for so-called foreign reference pricing or Most Favored Nation pricing for drugs – not because I don’t want to see lower drug prices, but because this approach exacts too high a price on patients and people with disabilities."
Click here to read the statement. Learn more about how other countries devalue people with disabilities in the United Kingdom, Australia, South Korea, and Canada.
4. SFS Releases Survey Results Detailing Americans' Rejection of Foreign Drug Pricing Schemes. On September 17, Survivors for Solutions (SFS) released a new survey of over 1,200 individuals which found strong, bipartisan opposition to policies that import foreign drug pricing standards, such as the Most Favored Nation (MFN) proposal, which relies on discriminatory metrics like the Quality-Adjusted Life Year (QALY) to determine value. The data reveal deep concern about how the QALY metric is a tool used by European governments to undervalue the lives of older individuals, people with disabilities, and those living with chronic illness when determining the cost of treatments.
Key findings include: (1) 85% of respondents are concerned about policies that ration care based on cost formulas; (2) 84% are concerned that QALY-based policies discriminate against seniors and patients with disabilities; (3) 88% are concerned about “one-size-fits-all” government price-setting that limits doctor and patient choice; (4) over three-quarters of respondents prefer market-based reforms that lower prices by reining in middlemen and empowering patients. Additionally, they support safeguards against policies like the QALY.
Click here to read more.
5. Bonnell Foundation in Detroit News: Critique of MFN as an Avenue for Drug Pricing Reform. The Detroit News recently published an opinion piece criticizing President Trump's 'most favored nation' (MFN) policy. Laura Bonnell, President of the Bonnell Foundation and PIPC member, states, "It’s easy to say we should pay what other countries pay. But those countries operate under different healthcare systems— most have government-run models that dictate prices and often restrict access to newer treatments. Here in the U.S., we play a unique role: we are the engine of pharmaceutical innovation. The revenue generated here funds the next generation of breakthroughs. If we start importing prices from countries that don’t make the same investments, we risk shutting down that innovation pipeline, not just for Americans, but for people around the world.” Laura has been a vocal advocate against the use of QALYs and similar measures that devalue disabled lives in our nation’s health care system.
Click here to read the article.
6. Patient Organizations Send Letter to Washington PDAB. On September 11, a group of 28 community-based organizations and people living with challenging health conditions signed on to a letter to the Washington Prescription Drug Affordability Board (PDAB) which expressed over their process for engaging people with disabilities and chronic conditions in developing your surveys. As explained in the letter, "...the Board repeatedly referenced the Oregon PDAB as a model to be followed. Oregon’s engagement of patient and provider communities has been consistently concerning, and we have observed several critical issues that demonstrate why their approach should not serve as a model for Washington..."
Click here to read the letter.
7. ICHOM Working Group: Kidney Stones Set Feedback Opportunity. PIPC is pleased to share that the ICHOM Kidney Stones Working Group is now in the process of finalizing an adult & adolescent Kidney Stones Set, having identified a Set of minimum core outcomes most important to people who have experienced kidney stones and the outcome measures that should be used to assess them. They are now seeking feedback on the Working Group's recommendations from lived experience users to understand whether the outcomes identified by the Working Group are meaningful and reflect their priorities. A short survey provides an opportunity for feedback that the Working Group can use to improve their recommendations and thereby improve services for patients. You can find out more here. The link to the survey is here. Join PIPC and others at the ICHOM conference in Ireland September 30-October 1, 2025.
8. PIPC Comment to CMS on ICR Emphasizes QALY Transparency. Since passage of the Inflation Reduction Act, PIPC has worked collaboratively with organizations representing patients and people with disabilities to amplify the perspectives of those with lived experience in the implementation of the Medicare Drug Price Negotiation Program. In its ICR comment letter to the agency, PIPC reiterated the concerns outlined in an Open Letter signed by over 100 organizations representing patients and people with disabilities, cautioning against the agency’s use of data that devalues people with disabilities, individuals with serious chronic conditions, and older adults. The letter also highlights that the new IPAY 2028 guidance does not adequately reflect statutory limitations on the use of quality-adjusted life years (QALYs) and similar measures given the revised approach proposed for IPAY 2028 that would no longer require submitters to clarify whether such measures are included in their evidence. Disclosure of the use of QALYs and similar measures already barred from Medicare’s consideration is a necessary step to keep these value judgments out of Medicare decision-making as intended by the law. View PIPC's comments here.
9. PIPC Urges Minnesota PDAB to Reject Discriminatory Value Assessments. The Partnership to Improve Patient Care (PIPC) recently submitted a letter to the Minnesota Prescription Drug Affordability Board (PDAB) to share concerns of patients and people with disabilities related to the PDAB’s potential use of cost effectiveness analyses. The letter stresses the importance that the PDAB be aware of existing law and regulations that bar the use of QALYs and similar measures in decisions impacting reimbursement and coverage, as well as the inherent tradeoffs among different value assessment methods. PIPC is also concerned that the Minnesota PDAB is considering a policy alternative to automatically set Medicare’s “maximum fair price” as the upper payment limit (UPL) for drugs purchased in Minnesota whose price has been negotiated at the federal level.
Click here to read the letter.
10. CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of value assessments that rely on the quality-adjusted life year (QALY) and the equal value of life year gained (evLYG), measures that are contrary to the laws governing Medicare and barring disability discrimination. In the explanations released on December 20, 2024, CMS explicitly listed studies that included reference to QALYs. View a recently published study highlighting the extent to which QALYs were referenced in CMS’ explanations last December here.
11. EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. The Ensuring Access through Collaborative Health and Patient Inclusion Council (EACH/PIC) has released the findings of its new report, Patient Experience Survey: Prescription Drug Affordability and Unaffordability, which captures how patients and caregivers define and experience prescription drug affordability. The results challenge conventional cost-review frameworks by showing that focusing on the affordability of individual drugs often misses critical patient context about patients’ broader challenges. Policymakers risk overlooking the burdens that make medications inaccessible, including insurance design, cumulative healthcare costs, and complex personal circumstances. The report highlights that affordability, as defined by patients, is not limited to drug price or out-of-pocket (OOP) costs. Rather, it reflects broader personal experiences, evolving circumstances, and individual interpretations. Results of the study indicate that insurance design, financial assistance, and the overall burden of managing chronic illness play a significant role in patient considerations of affordability. The survey findings point to clear areas for policy reform to reduce financial stress, improve adherence, and better align affordability efforts with patient needs. A companion policy brief offers actionable recommendations. Click here to read more. Click here to SIGN a letter to Washington State PDAB emphasizing patient engagement in survey development.
12. Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. A new analysis by the Office of Health Economics (OHE) – the world’s oldest independent health economics research organization – sheds light on this crucial issue. To answer the question of how QALYs are used across countries to inform reimbursement and pricing decisions, OHE reviewed Health Technology Assessment (HTA) practices across Organisation for Economic Co-operation and Development (OECD) countries, with a goal of reporting on how QALYs are used in pricing and reimbursement decisions. OECD member countries have been the reference for prices included in proposed U.S. drug pricing policies such as “Most Favored Nation” pricing, a concept advanced by the current Trump administration, as well as Congressional legislative proposals. Click here to read more.
13. Reps. Cammack and Hern Introduce QALY Ban Bill. Representatives Kat Cammack (FL-03) and Kevin Hern (OK-01) introduced the Protecting Health Care for All Patients Act to ensure that Americans with disabilities, chronic illnesses, and rare conditions are not devalued in federal health care decisions. This legislation prohibits the use of Quality-Adjusted Life Years (QALYs)—a metric that assigns lower value to lives with disabilities— and similar measures in federal programs like Medicare, Medicaid, CHIP, and ACA exchanges. “The use of so-called cost-effective measures like QALYs threatens access to lifesaving care for the most vulnerable Americans,” said Congresswoman Cammack. “I am honored to lead this legislation alongside my colleague Rep. Kevin Hern to ensure that no patient is denied treatment simply because a mathematical formula decided their life is worth less. Every American—regardless of disability, chronic illness, or rare condition—deserves equal access to care.” View the press release here. View more information about the bill here. View PIPC's one pager here.
14. Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. In 2021, the Partnership to Improve Patient Care (PIPC), the American Association of People with Disabilities, and several organizations from the patient and disability communities partnered to publish an Open Letter that grounded our advocacy against policies that would reference QALYs and similar measures that devalue people with disabilities and older adults. Please join PIPC, ALS Association, Alliance for Aging Research, American Association of People with Disabilities, Epilepsy Foundation of America and Patients Rights Action Fund in signing a revised Open Letter! The threat for incorporating QALYs and similar measures into the American health system has grown with the last administration’s reference to QALY-based studies in the Medicare Drug Negotiation Program and in this administration's Executive Order seeking to model foreign countries that base drug prices on discriminatory value assessments. It is our goal to capitalize on the long history of robust, bipartisan opposition to QALY-based policies in Medicare and Medicaid that underscores America’s core belief that the lives of individuals with disabilities, older adults and infants are worth just as much as any other person.
The central theme of the updated letter is this: All lives are valuable, and our health care policy should adhere to this fundamental American belief. We strongly urge policymakers to reject policies that would devalue and ration care for any American whether modeled after foreign or domestic value assessment methodologies.
Click HERE to sign the updated Open Letter. Note we will add new signatories every few days to the updated letter which is available to share with policymakers here.
Click here to contact your Member of Congress.
15. National Minority Quality Forum Issue Brief Details MFN Consequences. The National Minority Quality Forum (NMQF) has released an issue brief examining the potential consequences of the Most Favored Nation (MFN) model recently introduced by President Trump in an executive order. The brief identifies five key concerns about MFN implementation: (1) creation of harmful timing mismatches between disease progression and bureaucratic processes; (2) disruption of innovation ecosystems for conditions affecting Americans; (3) the imposition of one-size-fits-all approaches that ignore unique biological needs; (4) importation of discriminatory evaluation tools that devalue vulnerable populations; and (5) legal and investment uncertainty that will immediately chill biomedical research.
Particularly concerning for NMQF is the model’s reliance on foreign pricing systems that often use quality-adjusted life year (QALY) metrics that systematically undervalue treatments for disabilities, rare diseases, and conditions disproportionately affecting communities of color.
Click here to read the issue brief.
16. Update on the Texas v. Kennedy Lawsuit. Texas v. Kennedy is a lawsuit brought by 17 states in federal court in the Northern District of Texas. The lawsuit challenges 2024 regulations from the U.S. Department of Health and Human Services (HHS), claiming that Section 504 of the Rehabilitation Act is unconstitutional.
As outlined by Bazelon, DREDF, The Arc, CPR and National Health Law Program, the Texas v. Kennedy case remains a significant threat to the rights of people with disabilities. The 17 states continue to challenge the updated Section 504 regulations, which include a ban on disability discrimination in medical treatment decisions including the use of discriminatory value assessments. On July 29, a Joint Status Report was filed by HHS and 17 states, requesting that the court continue the pause in the case.
Click here and scroll down to reach out to your State Attorney General.
17. Learn More About Alternative Measures for Value Assessment. PIPC has developed new resources about alternative methods and metrics for value assessment. It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. Click here to learn more.
Learn More About Emerging Threats in States for Use of Discriminatory Metrics
Several states are advancing policies that would reference quality-adjusted life years (QALYs) and similar measures known to discriminate and devalue people with disabilities and serious chronic conditions, despite laws barring their use. Contrary to the law, these measures are considered by some to be the “gold standard” for measuring cost effectiveness of treatments, including the Institute for Clinical and Economic Review (ICER) and by foreign countries. Their use as a reference for U.S. coverage and reimbursement decisions is concerning due to implications for access to care, as seen internationally where a focus on cost effectiveness disadvantages coverage of health care for people with conditions that are chronic or disabling. To keep track of state-based threats, several resources are available:
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
ICER's QALY-Based Study Topics
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines.
View PIPC value assessment resources on gene therapies here, on health equity here and an analysis on lack of patient-centered outcomes in value assessment here.
Upcoming Events and Webinars
Oregon PDAB Meeting
Oct. 15, 2025
Click here to view.
PCORI Annual Meeting
Oct. 21-22, 2025
Click here to view.
Washington PDAB Meeting
Nov. 19, 2025
Click here to view.
PIPC welcomes new members to advance our efforts to assure patients and people with disabilities are at the center of research and policy! Please reach out to [email protected] for more information.
1. PIPC Response to Trump Administration’s Continued Push for MFN Pricing. In a statement released today, PIPC again warned against reliance on discriminatory measures like quality-adjusted life years (QALYs) and similar measures of cost effectiveness in decisions related to reimbursement and coverage of health care, including Most Favored Nation (MFN) pricing, that adopt other countries’ discriminatory QALY standards by referencing their reimbursement decisions. PIPC stated, "While we do not know the details of recent actions by the Administration or policies that are pending at the Office of Management and Budget, we remain very concerned that these efforts could open the door to reliance on QALYs and similar cost-effectiveness metrics in U.S. policy via reference to foreign prices...The United States must prioritize early access to innovations that optimize quality of life for all. We must protect against the kind of care rationing that is accepted elsewhere in the world. That means avoiding approaches that would modify U.S. coverage or pricing policy to factor in QALYs and similar measures, whether directly or by reference to other countries.” Stories like the Williams’ family illustrate why QALYs have no place in U.S. policy. Patients do not have the luxury of time. Click here to view the Williams’ struggle for access to care for Wilson disease. Click here to view the PIPC statement.
2. Engaging Medicaid Members and Community-Based Organizations Through Beneficiary Advisory Councils. In 2024, CMS issued a final rule requiring states to establish or strengthen Beneficiary Advisory Councils (BACs) — groups of Medicaid members, families, and caregivers that provide input on a range of topics, including covered services, care coordination, eligibility, enrollment, and cultural competency. Through the Building State Capacity for Community-Informed Policymaking Learning and Action Series, the Center for Health Care Strategies (CHCS) supported seven states in designing and implementing effective BACs, in partnership with CBOs. This webinar will share key lessons from the series, highlighting state experiences in developing BAC structures, recruitment strategies, charters and bylaws, and compensation policies. CHCS will lead a conversation with panelists from Maine and North Dakota who will share their insights. Click here to learn more and register.
3. PIPC Chairman Explains that the MFN is Exacting Too High a Price for Patients and People with Disabilities. In his latest "Chairman's Corner" blog, PIPC Chairman Tony Coelho explains why the "Most Favored Nation" (MFN) approach to drug pricing will devalue disabled lives. He explains the following: "Since it was first advanced by CMS in 2019, I’ve staunchly opposed proposals for so-called foreign reference pricing or Most Favored Nation pricing for drugs – not because I don’t want to see lower drug prices, but because this approach exacts too high a price on patients and people with disabilities."
Click here to read the statement. Learn more about how other countries devalue people with disabilities in the United Kingdom, Australia, South Korea, and Canada.
4. SFS Releases Survey Results Detailing Americans' Rejection of Foreign Drug Pricing Schemes. On September 17, Survivors for Solutions (SFS) released a new survey of over 1,200 individuals which found strong, bipartisan opposition to policies that import foreign drug pricing standards, such as the Most Favored Nation (MFN) proposal, which relies on discriminatory metrics like the Quality-Adjusted Life Year (QALY) to determine value. The data reveal deep concern about how the QALY metric is a tool used by European governments to undervalue the lives of older individuals, people with disabilities, and those living with chronic illness when determining the cost of treatments.
Key findings include: (1) 85% of respondents are concerned about policies that ration care based on cost formulas; (2) 84% are concerned that QALY-based policies discriminate against seniors and patients with disabilities; (3) 88% are concerned about “one-size-fits-all” government price-setting that limits doctor and patient choice; (4) over three-quarters of respondents prefer market-based reforms that lower prices by reining in middlemen and empowering patients. Additionally, they support safeguards against policies like the QALY.
Click here to read more.
5. Bonnell Foundation in Detroit News: Critique of MFN as an Avenue for Drug Pricing Reform. The Detroit News recently published an opinion piece criticizing President Trump's 'most favored nation' (MFN) policy. Laura Bonnell, President of the Bonnell Foundation and PIPC member, states, "It’s easy to say we should pay what other countries pay. But those countries operate under different healthcare systems— most have government-run models that dictate prices and often restrict access to newer treatments. Here in the U.S., we play a unique role: we are the engine of pharmaceutical innovation. The revenue generated here funds the next generation of breakthroughs. If we start importing prices from countries that don’t make the same investments, we risk shutting down that innovation pipeline, not just for Americans, but for people around the world.” Laura has been a vocal advocate against the use of QALYs and similar measures that devalue disabled lives in our nation’s health care system.
Click here to read the article.
6. Patient Organizations Send Letter to Washington PDAB. On September 11, a group of 28 community-based organizations and people living with challenging health conditions signed on to a letter to the Washington Prescription Drug Affordability Board (PDAB) which expressed over their process for engaging people with disabilities and chronic conditions in developing your surveys. As explained in the letter, "...the Board repeatedly referenced the Oregon PDAB as a model to be followed. Oregon’s engagement of patient and provider communities has been consistently concerning, and we have observed several critical issues that demonstrate why their approach should not serve as a model for Washington..."
Click here to read the letter.
7. ICHOM Working Group: Kidney Stones Set Feedback Opportunity. PIPC is pleased to share that the ICHOM Kidney Stones Working Group is now in the process of finalizing an adult & adolescent Kidney Stones Set, having identified a Set of minimum core outcomes most important to people who have experienced kidney stones and the outcome measures that should be used to assess them. They are now seeking feedback on the Working Group's recommendations from lived experience users to understand whether the outcomes identified by the Working Group are meaningful and reflect their priorities. A short survey provides an opportunity for feedback that the Working Group can use to improve their recommendations and thereby improve services for patients. You can find out more here. The link to the survey is here. Join PIPC and others at the ICHOM conference in Ireland September 30-October 1, 2025.
8. PIPC Comment to CMS on ICR Emphasizes QALY Transparency. Since passage of the Inflation Reduction Act, PIPC has worked collaboratively with organizations representing patients and people with disabilities to amplify the perspectives of those with lived experience in the implementation of the Medicare Drug Price Negotiation Program. In its ICR comment letter to the agency, PIPC reiterated the concerns outlined in an Open Letter signed by over 100 organizations representing patients and people with disabilities, cautioning against the agency’s use of data that devalues people with disabilities, individuals with serious chronic conditions, and older adults. The letter also highlights that the new IPAY 2028 guidance does not adequately reflect statutory limitations on the use of quality-adjusted life years (QALYs) and similar measures given the revised approach proposed for IPAY 2028 that would no longer require submitters to clarify whether such measures are included in their evidence. Disclosure of the use of QALYs and similar measures already barred from Medicare’s consideration is a necessary step to keep these value judgments out of Medicare decision-making as intended by the law. View PIPC's comments here.
9. PIPC Urges Minnesota PDAB to Reject Discriminatory Value Assessments. The Partnership to Improve Patient Care (PIPC) recently submitted a letter to the Minnesota Prescription Drug Affordability Board (PDAB) to share concerns of patients and people with disabilities related to the PDAB’s potential use of cost effectiveness analyses. The letter stresses the importance that the PDAB be aware of existing law and regulations that bar the use of QALYs and similar measures in decisions impacting reimbursement and coverage, as well as the inherent tradeoffs among different value assessment methods. PIPC is also concerned that the Minnesota PDAB is considering a policy alternative to automatically set Medicare’s “maximum fair price” as the upper payment limit (UPL) for drugs purchased in Minnesota whose price has been negotiated at the federal level.
Click here to read the letter.
10. CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of value assessments that rely on the quality-adjusted life year (QALY) and the equal value of life year gained (evLYG), measures that are contrary to the laws governing Medicare and barring disability discrimination. In the explanations released on December 20, 2024, CMS explicitly listed studies that included reference to QALYs. View a recently published study highlighting the extent to which QALYs were referenced in CMS’ explanations last December here.
11. EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. The Ensuring Access through Collaborative Health and Patient Inclusion Council (EACH/PIC) has released the findings of its new report, Patient Experience Survey: Prescription Drug Affordability and Unaffordability, which captures how patients and caregivers define and experience prescription drug affordability. The results challenge conventional cost-review frameworks by showing that focusing on the affordability of individual drugs often misses critical patient context about patients’ broader challenges. Policymakers risk overlooking the burdens that make medications inaccessible, including insurance design, cumulative healthcare costs, and complex personal circumstances. The report highlights that affordability, as defined by patients, is not limited to drug price or out-of-pocket (OOP) costs. Rather, it reflects broader personal experiences, evolving circumstances, and individual interpretations. Results of the study indicate that insurance design, financial assistance, and the overall burden of managing chronic illness play a significant role in patient considerations of affordability. The survey findings point to clear areas for policy reform to reduce financial stress, improve adherence, and better align affordability efforts with patient needs. A companion policy brief offers actionable recommendations. Click here to read more. Click here to SIGN a letter to Washington State PDAB emphasizing patient engagement in survey development.
12. Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. A new analysis by the Office of Health Economics (OHE) – the world’s oldest independent health economics research organization – sheds light on this crucial issue. To answer the question of how QALYs are used across countries to inform reimbursement and pricing decisions, OHE reviewed Health Technology Assessment (HTA) practices across Organisation for Economic Co-operation and Development (OECD) countries, with a goal of reporting on how QALYs are used in pricing and reimbursement decisions. OECD member countries have been the reference for prices included in proposed U.S. drug pricing policies such as “Most Favored Nation” pricing, a concept advanced by the current Trump administration, as well as Congressional legislative proposals. Click here to read more.
13. Reps. Cammack and Hern Introduce QALY Ban Bill. Representatives Kat Cammack (FL-03) and Kevin Hern (OK-01) introduced the Protecting Health Care for All Patients Act to ensure that Americans with disabilities, chronic illnesses, and rare conditions are not devalued in federal health care decisions. This legislation prohibits the use of Quality-Adjusted Life Years (QALYs)—a metric that assigns lower value to lives with disabilities— and similar measures in federal programs like Medicare, Medicaid, CHIP, and ACA exchanges. “The use of so-called cost-effective measures like QALYs threatens access to lifesaving care for the most vulnerable Americans,” said Congresswoman Cammack. “I am honored to lead this legislation alongside my colleague Rep. Kevin Hern to ensure that no patient is denied treatment simply because a mathematical formula decided their life is worth less. Every American—regardless of disability, chronic illness, or rare condition—deserves equal access to care.” View the press release here. View more information about the bill here. View PIPC's one pager here.
14. Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. In 2021, the Partnership to Improve Patient Care (PIPC), the American Association of People with Disabilities, and several organizations from the patient and disability communities partnered to publish an Open Letter that grounded our advocacy against policies that would reference QALYs and similar measures that devalue people with disabilities and older adults. Please join PIPC, ALS Association, Alliance for Aging Research, American Association of People with Disabilities, Epilepsy Foundation of America and Patients Rights Action Fund in signing a revised Open Letter! The threat for incorporating QALYs and similar measures into the American health system has grown with the last administration’s reference to QALY-based studies in the Medicare Drug Negotiation Program and in this administration's Executive Order seeking to model foreign countries that base drug prices on discriminatory value assessments. It is our goal to capitalize on the long history of robust, bipartisan opposition to QALY-based policies in Medicare and Medicaid that underscores America’s core belief that the lives of individuals with disabilities, older adults and infants are worth just as much as any other person.
The central theme of the updated letter is this: All lives are valuable, and our health care policy should adhere to this fundamental American belief. We strongly urge policymakers to reject policies that would devalue and ration care for any American whether modeled after foreign or domestic value assessment methodologies.
Click HERE to sign the updated Open Letter. Note we will add new signatories every few days to the updated letter which is available to share with policymakers here.
Click here to contact your Member of Congress.
15. National Minority Quality Forum Issue Brief Details MFN Consequences. The National Minority Quality Forum (NMQF) has released an issue brief examining the potential consequences of the Most Favored Nation (MFN) model recently introduced by President Trump in an executive order. The brief identifies five key concerns about MFN implementation: (1) creation of harmful timing mismatches between disease progression and bureaucratic processes; (2) disruption of innovation ecosystems for conditions affecting Americans; (3) the imposition of one-size-fits-all approaches that ignore unique biological needs; (4) importation of discriminatory evaluation tools that devalue vulnerable populations; and (5) legal and investment uncertainty that will immediately chill biomedical research.
Particularly concerning for NMQF is the model’s reliance on foreign pricing systems that often use quality-adjusted life year (QALY) metrics that systematically undervalue treatments for disabilities, rare diseases, and conditions disproportionately affecting communities of color.
Click here to read the issue brief.
16. Update on the Texas v. Kennedy Lawsuit. Texas v. Kennedy is a lawsuit brought by 17 states in federal court in the Northern District of Texas. The lawsuit challenges 2024 regulations from the U.S. Department of Health and Human Services (HHS), claiming that Section 504 of the Rehabilitation Act is unconstitutional.
As outlined by Bazelon, DREDF, The Arc, CPR and National Health Law Program, the Texas v. Kennedy case remains a significant threat to the rights of people with disabilities. The 17 states continue to challenge the updated Section 504 regulations, which include a ban on disability discrimination in medical treatment decisions including the use of discriminatory value assessments. On July 29, a Joint Status Report was filed by HHS and 17 states, requesting that the court continue the pause in the case.
Click here and scroll down to reach out to your State Attorney General.
17. Learn More About Alternative Measures for Value Assessment. PIPC has developed new resources about alternative methods and metrics for value assessment. It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. Click here to learn more.
Learn More About Emerging Threats in States for Use of Discriminatory Metrics
Several states are advancing policies that would reference quality-adjusted life years (QALYs) and similar measures known to discriminate and devalue people with disabilities and serious chronic conditions, despite laws barring their use. Contrary to the law, these measures are considered by some to be the “gold standard” for measuring cost effectiveness of treatments, including the Institute for Clinical and Economic Review (ICER) and by foreign countries. Their use as a reference for U.S. coverage and reimbursement decisions is concerning due to implications for access to care, as seen internationally where a focus on cost effectiveness disadvantages coverage of health care for people with conditions that are chronic or disabling. To keep track of state-based threats, several resources are available:
- Patient Access Project State-by-state tracker of QALY-based policies and legislation, including Prescription Drug Affordability Boards, P&T Committees, and reference to discriminatory policies in foreign countries.
- Value Of Care Coalition advocacy tracker of state PDAB comment opportunities.
- AIMED Alliance resources and tracker of state PDAB activities.
- PIPC resources on use of QALYs and similar measures internationally.
- EACH/PIC Coalition resources.
- Value Our Health toolkit and resources on implications for disability discrimination.
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Canada. Patients with a rare form of brain cancer often need to turn to crowd fundraising in order to meet steep costs.
- France. The French National Authority for Health (HAS) rejected the request for early access to an emerging treatment for Alzheimer’s.
- New Zealand. Rare Disorders New Zealand Chairman James McGoram suffers with Fabry disease and is so desperate for life-saving medical treatment, he has been forced to move to Australia.
- New Zealand. Blood cancer patients and their families are calling for the government to fulfill a promise by the National government to close the medicine gap.
- New Zealand. The New Zealand government’s voluntary savings scheme is becoming less of a retirement fund, and more of a "life saver" for cancer patients forced to use it to pay for treatments not funded or available.
- United Kingdom. Barriers to access in the U.K. are shaping a “severe inequality” for patients who face a postcode lottery in order to access these drugs.
- Australia. Discriminatory “Most Favored Nations” benchmarks threatens patient access to new innovative treatment options — with decisions being made to slow new products launching.
- Australia. While Australia's medicines watchdog has approved a groundbreaking new Alzheimer's treatment, arbitrary restrictions have limited coverage to private insurance only, therefore raising costs and threatening access.
ICER's QALY-Based Study Topics
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines.
View PIPC value assessment resources on gene therapies here, on health equity here and an analysis on lack of patient-centered outcomes in value assessment here.
- IgA Nephropathy: Research Protocol available. Public meeting: February 2026.
- Launch Price and Access Report: Drug Approvals from 2023-2024: Protocol available.
- Smoking Cessation: Model Analysis Plan available. Public meeting: January 2026.
- Obesity Management: Draft Evidence Report available. Public comments due October 6, 2025 (TODAY). Public meeting: November 2025.
- Examining Strategies to Ensure Affordable Access for Obesity Medications: White Paper published on April 9, 2025.
- Non-Cystic Fibrosis Bronchiectasis: Evidence Report and Evidence Presentation available. Public meeting: September 2025.
- Spinal Muscular Atrophy: Final Evidence Report and Meeting Summary available.
- Multiple Sclerosis — SPMS: Final Evidence Report and Meeting Summary available.
- Retinitis Pigmentosa: Final Evidence Report and Meeting Summary available.
Upcoming Events and Webinars
Oregon PDAB Meeting
Oct. 15, 2025
Click here to view.
PCORI Annual Meeting
Oct. 21-22, 2025
Click here to view.
Washington PDAB Meeting
Nov. 19, 2025
Click here to view.
