In this week's edition...
— PIPC Responds to Medicare Negotiation Program’s Prices. View PIPC’s complete statement here.
— White House Issues RFI on Scientific Research & AI. See details below.
— Oregon Invites ICER to Hearing on Pricing Despite Statewide QALY Ban. More information is available here.
— Draft HEMA Report: USC Schaeffer Makes Case Against Accepting Individual Harms to Improve Population Averages. View USC Schaeffer’s response to the draft report here.
— PIPC Statement on GENEROUS Model, also known as “Most Favored Nation." View the statement here.
— Prasad and Makary Discuss Novel FDA Plausible Mechanism Pathway. Click here to read the NEJM publication.
— New PQA Patient Advisory Council Seeks Nominations. Individuals can submit their nominations via this form. Additional details are provided in a recent PQA blog.
— PCORI Discusses the Importance of Patient-Centered Comparative CER Research. Click here to read more.
— 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.
— Update on the Texas v. Kennedy Lawsuit. See details below.
— 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 Responds to Medicare Negotiation Program’s Prices. View PIPC’s complete statement here.
— White House Issues RFI on Scientific Research & AI. See details below.
— Oregon Invites ICER to Hearing on Pricing Despite Statewide QALY Ban. More information is available here.
— Draft HEMA Report: USC Schaeffer Makes Case Against Accepting Individual Harms to Improve Population Averages. View USC Schaeffer’s response to the draft report here.
— PIPC Statement on GENEROUS Model, also known as “Most Favored Nation." View the statement here.
— Prasad and Makary Discuss Novel FDA Plausible Mechanism Pathway. Click here to read the NEJM publication.
— New PQA Patient Advisory Council Seeks Nominations. Individuals can submit their nominations via this form. Additional details are provided in a recent PQA blog.
— PCORI Discusses the Importance of Patient-Centered Comparative CER Research. Click here to read more.
— 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.
— Update on the Texas v. Kennedy Lawsuit. See details below.
— 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 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 Responds to Medicare Negotiation Program’s Prices. PIPC published a statement highlighting its appreciation for the Trump Administration’s goal of lowering health care costs for patients awhile sharing continued concerns over the subjectivity and lack of transparency in the process for selecting a Maximum Fair Price (MFP), limited consideration of patient perspectives, and potential for continued reliance on value assessments conducted by the Institute for Clinical and Economic Review. As the Administration pursues greater transparency in health care, PIPC hopes this extends to the decision-making in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. We look forward to learning more from the Center for Medicare and Medicaid Services (CMS) about the evidence base for the recently announced MFP decisions when the explanations are made public by March 2026. View PIPC’s complete statement here.
2. White House Issues RFI on Scientific Research & AI. On November 24, President Trump signed an executive order (EO) to promote the growth and development artificial intelligence (AI) within the nation. In alignment with a previous administrative initiative, America's AI Action Plan, the announcement establishes "Mission Genesis," a national effort to propel AI innovation through the collection of U.S. resources and research. Built within a newly created infrastructure, the American Science and Security Platform, the EO seeks instill a sense of urgency in national AI development.
Of note, the White House Office of Science and Technology Policy (OSTP) released a request for information (RFI) pertaining to the recent EO. According to the notice, "... OSTP seeks input from academia; private sector organizations; industry groups; state, local, and tribal governments; and other stakeholders regarding priorities for strengthening the science and technology ecosystem to support both the expansion of scientific knowledge and the mechanisms to transition these discoveries into the marketplace." OSTP is looking for answers to various questions detailed in its notice, including: (1) The RFI specifies various questions it seeks information for including "What specific Federal statutes, regulations, or policies create unnecessary barriers to scientific research or the deployment of research outcomes? Please describe the barrier, its impact on scientific progress, and potential remedies that would preserve legitimate policy objectives while enabling innovation." and (2) "What policy mechanisms would ensure that the benefits of federally-funded research—including access to resulting technologies, economic opportunities, and improved quality of life—reach all Americans?"
Click here to read the EO. Click here to learn more about the RIF. Click here to submit comments.
3. Oregon Invites ICER to Hearing on Pricing Despite Statewide QALY Ban. Oregon’s Department of Consumer and Business Services will hold its annual public hearing on prescription drug pricing on December 4 at 1:30pm. ICER is scheduled to present during the hearing, an entity known to use quality-adjusted life years (QALYs) as measures of cost effectiveness in its studies. Yet, Oregon’s legislature barred the use of QALYs, including direct or indirect use of any quality of life in general measure, raising concerns about the state’s commitment to disability nondiscrimination.
The hearing will be held on Zoom, and pre-registration is not required. More information is available here. The Department is asking for public feedback ahead of the 2025 hearing through a short survey, created for consumers to share their experiences with rising prescription drug prices. The hearing will also include time for public comment. The public can provide live comments or submit written testimony. Questions can be sent to [email protected].
4. Draft HEMA Report: USC Schaeffer Makes Case Against Accepting Individual Harms to Improve Population Averages. The Institute for Clinical and Economic Review (ICER), Canada’s Drug Agency (CDA-AMC), and the National Institute for Health and Care Excellence (NICE - England) have convened the Health Economics Methods Advisory (HEMA) group on new methods and processes for economic evaluation. In response to HEMA's draft report, USC Schaeffer provided a counter-response that healthcare resource allocation should serve the needs of the individual people in a society who benefited from it and paid for it, not the needs of health technology assessment bodies or payers who are entrusted to manage those resources on individuals’ behalf. USC Schaeffer’s response advocates for patient-centered perspectives on value assessment that the HEMA report fails to consider. The HEMA report focuses value determinations on what HTA bodies view as beneficial, rather than on what individual patients view as beneficial. If the U.S. adopts HTA-based pricing from Europe as proposed by a Most Favored Nation pricing policy, innovators will be looking at HTA bodies for insights on where to prioritize investments as opposed to viewing innovation as serving the people that pay for health care. It is inherently discriminatory to view the lives of some patients to be less worthy than others in the name of improving population averages over individual health, which is why U.S. policymakers barred Medicare’s use of QALYs and similar measures in 2010 and again in the Inflation Reduction Act and in recent regulations governing disability nondiscrimination.
View USC Schaeffer’s response to the draft report here.
5. PIPC Statement on GENEROUS Model, also known as “Most Favored Nation." PIPC appreciates ongoing efforts to improve healthcare affordability, including prescription drugs, but we are concerned about the administration’s proposal called the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model that would import the worst of foreign health systems – their reliance on discriminatory value assessments.
HHS has provided limited details on this “Most Favored Nation” model for Medicaid that it announced on Nov. 6, but the proposal raises fundamental questions about the potential for government reliance on quality-adjusted life years (QALYs), and the degree to which decisions about treatment choice and access will be made by government agencies instead of doctors and patients. PIPC believes it is vital for these questions to be answered, and for the administration to advance policies that do not rely on cost-effectiveness thresholds and that protect patients and people with disabilities who may not fit an average QALY-based assessment.
While this new model does not provide for an opportunity to public comment, we urge the administration to provide added clarification in the future. We welcome additional information on the administration’s intentions to analyze the impact of this new model on patients, including the impact on efforts to address unmet needs of patients through innovation.
On behalf of patients and people with disabilities, PIPC for many years has opposed the codification of discriminatory cost-effectiveness standards, which are set to meet the priorities of payers and government agencies, not patients. Stories from outside the U.S., like that of the Williams’ family, illustrate why QALYs have no place in U.S. policy. Patients do not have the luxury of time. Government policy that relies on QALYs and similar measures, whether directly or through reliance on other countries’ decisions, centers health care decision-making on payer priorities instead of patient needs.
View the statement here.
Click here to read Chairman Coelho’s blog. Learn more here about how other countries devalue people with disabilities in the United Kingdom, Australia, South Korea, and Canada. Click here to read more about a new survey of over 1,200 individuals which found strong, bipartisan opposition to policies that import foreign drug pricing standards.
6. Prasad and Makary Discuss Novel FDA Plausible Mechanism Pathway. On November 12, Food and Drug Administration (FDA) Commissioner Marty Makary and Chief Medical and Scientific Officer Vinay Prasad published an essay in The New England Journal of Medicine (NEJM) discussing the FDA new “plausible mechanism pathway.” The new pathway intends to lay out an opportunity for therapies to gain approval when a randomized controlled trial is not feasible. This could be a helpful tool to get rare disease treatments to market if FDA is serious about its application.
Click here to read the NEJM publication.
7. New PQA Patient Advisory Council Seeks Nominations. PQA, the Pharmacy Quality Alliance, will launch a new Patient Advisory Council in 2026. This council will advise PQA on what matters most to patients, their families and caregivers as it relates to safe, effective and appropriate medication use. The council also will provide input on strategies to meaningfully incorporate patient perspectives throughout PQA’s work to improve the quality of medication use and patient outcomes. Self-nominations to participate on the council will be accepted through Friday, December 12. Individuals can submit their nominations via this form. Additional details are provided in a recent PQA blog.
8. PCORI Discusses the Importance of Patient-Centered Comparative CER Research. The Patient-Centered Outcomes Research Institute (PCORI) published a blog post highlighting the need to support PCORI-funded clinical effectiveness (CER) findings. The Institute explains that the patient-centered comparative CER research it funds "addresses the health and healthcare challenges Americans face every day. This research focuses on conditions such as diabetes, obesity, cancer, maternal morbidity and mortality, intellectual and developmental disabilities, rare diseases, and mental health, generating evidence that empowers patients, caregivers and the broader healthcare community with information to make better-informed healthcare decisions." Click here to read more.
9. 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.
10. 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.
11. 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. On October 27, another Joint Status Report was filed by the parties, requesting that the court continue the "stay" in the case. The parties have noted that they will file a new report on January 9, 2026.
Click here and scroll down to reach out to your State Attorney General.
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
Maryland PDAB Special Meeting
Dec. 8, 2025
Click here to view.
PCORI Board of Governors Meeting
Dec. 9, 2025
Click here to view.
Minnesota PDAB Meeting
Dec. 9, 2025
Click here to view.
Oregon PDAB Meeting
Dec. 17, 2025
Click here to view.
Washington State PDAB Meeting
March 18, 2026
Click here to view.
1. PIPC Responds to Medicare Negotiation Program’s Prices. PIPC published a statement highlighting its appreciation for the Trump Administration’s goal of lowering health care costs for patients awhile sharing continued concerns over the subjectivity and lack of transparency in the process for selecting a Maximum Fair Price (MFP), limited consideration of patient perspectives, and potential for continued reliance on value assessments conducted by the Institute for Clinical and Economic Review. As the Administration pursues greater transparency in health care, PIPC hopes this extends to the decision-making in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. We look forward to learning more from the Center for Medicare and Medicaid Services (CMS) about the evidence base for the recently announced MFP decisions when the explanations are made public by March 2026. View PIPC’s complete statement here.
2. White House Issues RFI on Scientific Research & AI. On November 24, President Trump signed an executive order (EO) to promote the growth and development artificial intelligence (AI) within the nation. In alignment with a previous administrative initiative, America's AI Action Plan, the announcement establishes "Mission Genesis," a national effort to propel AI innovation through the collection of U.S. resources and research. Built within a newly created infrastructure, the American Science and Security Platform, the EO seeks instill a sense of urgency in national AI development.
Of note, the White House Office of Science and Technology Policy (OSTP) released a request for information (RFI) pertaining to the recent EO. According to the notice, "... OSTP seeks input from academia; private sector organizations; industry groups; state, local, and tribal governments; and other stakeholders regarding priorities for strengthening the science and technology ecosystem to support both the expansion of scientific knowledge and the mechanisms to transition these discoveries into the marketplace." OSTP is looking for answers to various questions detailed in its notice, including: (1) The RFI specifies various questions it seeks information for including "What specific Federal statutes, regulations, or policies create unnecessary barriers to scientific research or the deployment of research outcomes? Please describe the barrier, its impact on scientific progress, and potential remedies that would preserve legitimate policy objectives while enabling innovation." and (2) "What policy mechanisms would ensure that the benefits of federally-funded research—including access to resulting technologies, economic opportunities, and improved quality of life—reach all Americans?"
Click here to read the EO. Click here to learn more about the RIF. Click here to submit comments.
3. Oregon Invites ICER to Hearing on Pricing Despite Statewide QALY Ban. Oregon’s Department of Consumer and Business Services will hold its annual public hearing on prescription drug pricing on December 4 at 1:30pm. ICER is scheduled to present during the hearing, an entity known to use quality-adjusted life years (QALYs) as measures of cost effectiveness in its studies. Yet, Oregon’s legislature barred the use of QALYs, including direct or indirect use of any quality of life in general measure, raising concerns about the state’s commitment to disability nondiscrimination.
The hearing will be held on Zoom, and pre-registration is not required. More information is available here. The Department is asking for public feedback ahead of the 2025 hearing through a short survey, created for consumers to share their experiences with rising prescription drug prices. The hearing will also include time for public comment. The public can provide live comments or submit written testimony. Questions can be sent to [email protected].
4. Draft HEMA Report: USC Schaeffer Makes Case Against Accepting Individual Harms to Improve Population Averages. The Institute for Clinical and Economic Review (ICER), Canada’s Drug Agency (CDA-AMC), and the National Institute for Health and Care Excellence (NICE - England) have convened the Health Economics Methods Advisory (HEMA) group on new methods and processes for economic evaluation. In response to HEMA's draft report, USC Schaeffer provided a counter-response that healthcare resource allocation should serve the needs of the individual people in a society who benefited from it and paid for it, not the needs of health technology assessment bodies or payers who are entrusted to manage those resources on individuals’ behalf. USC Schaeffer’s response advocates for patient-centered perspectives on value assessment that the HEMA report fails to consider. The HEMA report focuses value determinations on what HTA bodies view as beneficial, rather than on what individual patients view as beneficial. If the U.S. adopts HTA-based pricing from Europe as proposed by a Most Favored Nation pricing policy, innovators will be looking at HTA bodies for insights on where to prioritize investments as opposed to viewing innovation as serving the people that pay for health care. It is inherently discriminatory to view the lives of some patients to be less worthy than others in the name of improving population averages over individual health, which is why U.S. policymakers barred Medicare’s use of QALYs and similar measures in 2010 and again in the Inflation Reduction Act and in recent regulations governing disability nondiscrimination.
View USC Schaeffer’s response to the draft report here.
5. PIPC Statement on GENEROUS Model, also known as “Most Favored Nation." PIPC appreciates ongoing efforts to improve healthcare affordability, including prescription drugs, but we are concerned about the administration’s proposal called the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model that would import the worst of foreign health systems – their reliance on discriminatory value assessments.
HHS has provided limited details on this “Most Favored Nation” model for Medicaid that it announced on Nov. 6, but the proposal raises fundamental questions about the potential for government reliance on quality-adjusted life years (QALYs), and the degree to which decisions about treatment choice and access will be made by government agencies instead of doctors and patients. PIPC believes it is vital for these questions to be answered, and for the administration to advance policies that do not rely on cost-effectiveness thresholds and that protect patients and people with disabilities who may not fit an average QALY-based assessment.
While this new model does not provide for an opportunity to public comment, we urge the administration to provide added clarification in the future. We welcome additional information on the administration’s intentions to analyze the impact of this new model on patients, including the impact on efforts to address unmet needs of patients through innovation.
On behalf of patients and people with disabilities, PIPC for many years has opposed the codification of discriminatory cost-effectiveness standards, which are set to meet the priorities of payers and government agencies, not patients. Stories from outside the U.S., like that of the Williams’ family, illustrate why QALYs have no place in U.S. policy. Patients do not have the luxury of time. Government policy that relies on QALYs and similar measures, whether directly or through reliance on other countries’ decisions, centers health care decision-making on payer priorities instead of patient needs.
View the statement here.
Click here to read Chairman Coelho’s blog. Learn more here about how other countries devalue people with disabilities in the United Kingdom, Australia, South Korea, and Canada. Click here to read more about a new survey of over 1,200 individuals which found strong, bipartisan opposition to policies that import foreign drug pricing standards.
6. Prasad and Makary Discuss Novel FDA Plausible Mechanism Pathway. On November 12, Food and Drug Administration (FDA) Commissioner Marty Makary and Chief Medical and Scientific Officer Vinay Prasad published an essay in The New England Journal of Medicine (NEJM) discussing the FDA new “plausible mechanism pathway.” The new pathway intends to lay out an opportunity for therapies to gain approval when a randomized controlled trial is not feasible. This could be a helpful tool to get rare disease treatments to market if FDA is serious about its application.
Click here to read the NEJM publication.
7. New PQA Patient Advisory Council Seeks Nominations. PQA, the Pharmacy Quality Alliance, will launch a new Patient Advisory Council in 2026. This council will advise PQA on what matters most to patients, their families and caregivers as it relates to safe, effective and appropriate medication use. The council also will provide input on strategies to meaningfully incorporate patient perspectives throughout PQA’s work to improve the quality of medication use and patient outcomes. Self-nominations to participate on the council will be accepted through Friday, December 12. Individuals can submit their nominations via this form. Additional details are provided in a recent PQA blog.
8. PCORI Discusses the Importance of Patient-Centered Comparative CER Research. The Patient-Centered Outcomes Research Institute (PCORI) published a blog post highlighting the need to support PCORI-funded clinical effectiveness (CER) findings. The Institute explains that the patient-centered comparative CER research it funds "addresses the health and healthcare challenges Americans face every day. This research focuses on conditions such as diabetes, obesity, cancer, maternal morbidity and mortality, intellectual and developmental disabilities, rare diseases, and mental health, generating evidence that empowers patients, caregivers and the broader healthcare community with information to make better-informed healthcare decisions." Click here to read more.
9. 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.
10. 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.
11. 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. On October 27, another Joint Status Report was filed by the parties, requesting that the court continue the "stay" in the case. The parties have noted that they will file a new report on January 9, 2026.
Click here and scroll down to reach out to your State Attorney General.
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. The lack of easy access to rare disease treatments often leads patients, families, and their advocates petitioning the government to cover the costs, creating a significant mental toll.
- Canada. Legal action is forthcoming to try to force Quebec to add the only drug for a rare disease to the public drug plan.
- New Zealand. The government has denied funding for life-saving obesity medications, and the out of pocket costs present a significant barrier and equity problem for patients seeking access.
- New Zealand. A new op-ed points out the flaws of Pharmac’s decision to keep a “wish list” of treatments it funds instead of simply reprioritizing spending within the existing health care system.
- New Zealand. Arbitrary coverage decisions have created winners and losers among menopause patients who are trying to gain access to hormone replacement therapies that are readily available in other countries.
- United Kingdom. A man living with a rare genetic disorder says hope is being taken away because the drug he needs is not available.
- United Kingdom. Price negotiations on a “game changing” HIV drug has resulted in arbitrary restrictions that limit access to certain patients.
- United Kingdom. Parents of a boy with Duchenne muscular dystrophy are urging the NHS to provide access for a treatment they've been trying to access for more than a year.
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.
- COVID-19: Draft Scoping Document available. Public comments due December 2, 2025. Public meeting: June 2026.
- Narcolepsy: Revised Scoping Document available. Public meeting: May 2026.
- IgA Nephropathy: Model Analysis Plan available. Public meeting: February 2026.
- Launch Price and Access Report: Drug Approvals from 2023-2024: Final Report and Webinar Recording available.
- Smoking Cessation: Draft Evidence Report available. Public meeting: January 2026.
- Obesity Management: Evidence Report and Presentation available. Public meeting: November 2025.
- Examining Strategies to Ensure Affordable Access for Obesity Medications: White Paper published on April 9, 2025.
- Non-Cystic Fibrosis Bronchiectasis: Final Evidence Report and Meeting Summary available.
- 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
Maryland PDAB Special Meeting
Dec. 8, 2025
Click here to view.
PCORI Board of Governors Meeting
Dec. 9, 2025
Click here to view.
Minnesota PDAB Meeting
Dec. 9, 2025
Click here to view.
Oregon PDAB Meeting
Dec. 17, 2025
Click here to view.
Washington State PDAB Meeting
March 18, 2026
Click here to view.
