In this week's edition...
— 86 Organizations Comment to Senate Finance Committee, Oppose Importing QALYs, Urge Decisions Centered on Patients and People with Disabilities. View the RFI comments here.
— New Research Highlights Gaps in Use of CER and Patient Experience. View PIPC's Data Mine Blog analysis here and a recent Value in Health article here.
— PCORI Seeking Input on Research Priorities. Click here to submit your ideas by Nov. 2.
— PIPC Submits IPAY 2028 Comments to CMS. View the IPAY 2028 comments to CMS here.
— Washington Examiner: Review of Implications of Germany, Foreign Drug Prices. Read the Washington Examiner article here.
— As the ADA Turns 36, PIPC Highlights Work to be Done. Learn More About How the QALY Devalues Disabled Lives. View examples of QALY health utilities that assign a lower value to the lives of people with disabilities here.
— MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. We must not import access restrictions that devalue people living with rare diseases.
— 100 Members of Congress call on DOJ To Rescind Olmstead Memo. View the letter here. View a message from Senator Kirsten Gillibrand here.
— Join IVI for 2026 Whole Health Policy Summit in November. Learn more here. Register to attend in person here. Register to attend the livestream here.
— ICHOM Seeking Experts in Cataracts, Plus Annual Conference December 7-9. Register here!
— ICHOM Advances the Spinal Muscular Atrophy Patient Validation Survey. Complete the Patient Validation Survey here.
— PCORI Annual Meeting October 19-20. Click here to register.
— Senator Collins Speaks Up Against Importing QALYs to the U.S., Committee Advances Charlotte’s Bill. The video is available on LinkedIn here and on X here. We encourage others to share PIPC’s social media thanking the Senator on LinkedIn here and on X here. Hear Charlotte herself describe this terrific progress here.
— AMA Opposes Policies Setting Prices by Exclusive Reference to Other Countries or Averages. View the resolution here.
— Tell Congress to Oppose Most Favored Nation Policies Importing QALYs to the U.S. Learn more here. Reach out to your Member of Congress here.
— PIPC Report: The UK Health System, Lessons for the U.S. and the Risks of MFN Drug Pricing. Click here to read the full report.
— 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.
— 86 Organizations Comment to Senate Finance Committee, Oppose Importing QALYs, Urge Decisions Centered on Patients and People with Disabilities. View the RFI comments here.
— New Research Highlights Gaps in Use of CER and Patient Experience. View PIPC's Data Mine Blog analysis here and a recent Value in Health article here.
— PCORI Seeking Input on Research Priorities. Click here to submit your ideas by Nov. 2.
— PIPC Submits IPAY 2028 Comments to CMS. View the IPAY 2028 comments to CMS here.
— Washington Examiner: Review of Implications of Germany, Foreign Drug Prices. Read the Washington Examiner article here.
— As the ADA Turns 36, PIPC Highlights Work to be Done. Learn More About How the QALY Devalues Disabled Lives. View examples of QALY health utilities that assign a lower value to the lives of people with disabilities here.
— MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. We must not import access restrictions that devalue people living with rare diseases.
— 100 Members of Congress call on DOJ To Rescind Olmstead Memo. View the letter here. View a message from Senator Kirsten Gillibrand here.
— Join IVI for 2026 Whole Health Policy Summit in November. Learn more here. Register to attend in person here. Register to attend the livestream here.
— ICHOM Seeking Experts in Cataracts, Plus Annual Conference December 7-9. Register here!
— ICHOM Advances the Spinal Muscular Atrophy Patient Validation Survey. Complete the Patient Validation Survey here.
— PCORI Annual Meeting October 19-20. Click here to register.
— Senator Collins Speaks Up Against Importing QALYs to the U.S., Committee Advances Charlotte’s Bill. The video is available on LinkedIn here and on X here. We encourage others to share PIPC’s social media thanking the Senator on LinkedIn here and on X here. Hear Charlotte herself describe this terrific progress here.
— AMA Opposes Policies Setting Prices by Exclusive Reference to Other Countries or Averages. View the resolution here.
— Tell Congress to Oppose Most Favored Nation Policies Importing QALYs to the U.S. Learn more here. Reach out to your Member of Congress here.
— PIPC Report: The UK Health System, Lessons for the U.S. and the Risks of MFN Drug Pricing. Click here to read the full report.
— 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. 86 Organizations Comment to Senate Finance Committee, Oppose Importing QALYs, Urge Decisions Centered on Patients and People with Disabilities. On August 17, 2026, 86 organizations provided comments in response to the Senate Finance Committee minority staff’s request for information (RFI), Commonsense Policy Options to Lower Drug Prices for Patients. We urged the Committee to strengthen, rather than bypass, existing patient protections. That means addressing the patient engagement, evidentiary transparency, and QALY safeguard gaps in the current Medicare Drug Price Negotiation and rejecting international reference pricing as a mechanism for negotiation. We also urged a focus on policies that prevent payers from rejecting access to treatments that work best for individual patients and people with disabilities. As Chairman Coelho often says, "No patient is average.” View the final comment here.
2. New Research Highlights Gaps in Use of CER and Patient Experience. Recent research underscores the significant limitations inherent in use of comparative effectiveness research and evidence centered on patients in decisions being made across federal and state programs, including Prescription Drug Affordability Boards and the Medicare Drug Price Negotiation Program. For example, the law governing Medicare negotiation requires CMS to make judgments on factors that go to the heart of what matters to patients in their medical care – about therapeutic alternatives, comparative clinical benefit, therapeutic advances, and unmet medical need. A recent PIPC analysis looked at two key domains: first, how, if at all, was CMS considering patient input and patient-centered outcomes in its process; and second, to what degree was it citing studies that include cost-effectiveness analysis that employs the quality-adjusted life year (QALY). We found that evidence about patients’ priorities made up a small share of the literature, even when relevant patient-focused information was available. There are also still some instances where CMS cites research using QALYs and cost-effectiveness thresholds, without providing sufficient information to demonstrate how the research was considered within the context of legal constraints. View the Data Mine Blog analysis here.
A recent study published in Value in Health came to similar conclusions. A review of the gaps, challenges, and opportunities around the use of contemporary CER for federal and state drug pricing programs concluded: "Incorporating contemporary CER is crucial to informing drug pricing actions by federal (MDPNP) and state (PDAB) decision makers to best understand the current use and clinical benefit of a drug for the population being considered. We suggest that policymakers balance rigor, transparency, and feasibility. Evaluating evidence, answering policy questions, and inferring how evidence applies to different populations are core principles that should be applied rigorously and transparently in drug pricing programs.” View the article here.
3. PCORI Seeking Input on Research Priorities. PCORI is seeking input on high-priority evidence needs that could be addressed through patient-centered CER. PCORI wants to hear where important evidence gaps remain and what research could help people make more informed health and healthcare decisions. Through this Request for Information, PCORI is seeking perspectives on research questions that compare healthcare options, examine whether treatments may work differently across groups or communities, reflect current healthcare challenges, and are relevant to care delivered in a variety of settings. PCORI has shared that submissions will provide PCORI with a greater understanding of critical evidence needs and shape the continued evolution of PCORI’s Research Project Agenda and ensuing funding opportunities. Click here to submit your ideas by Nov. 2 at 5 p.m. (ET) and help inform future patient-centered CER.
4. PIPC Submits IPAY 2028 Comments to CMS. PIPC submitted comments to CMS making the following recommendations in response to its proposed rule governing the program.
View PIPC's comment letter to CMS here.
5. Washington Examiner: Review of Implications of Germany, Foreign Drug Prices. In a recent opinion, the author, whose mother died of colon cancer, highlights the implications of foreign pricing schemes that devalue medicines for patients with disabilities, cancer and other innovations. He stated, "For decades, Germany and other developed nations have underpaid for lifesaving medicines — and obtained low prices by delaying and rationing drug access. These access restrictions have had real impacts on patients...Even when the health systems in those developed countries decide to cover a new medicine, bureaucrats typically only allow the sickest patients to take cutting-edge drugs. Public insurance reimburses only 22% of new drugs for all approved uses. As a result, patients in those countries typically wait three years longer than Americans to access new medicines.” View the article here.
6. As the ADA Turns 36, PIPC Highlights Work to be Done. Learn More About How the QALY Devalues Disabled Lives. In many other countries, governments use the quality-adjusted life year (QALY) metric to assign a numeric value to patients’ lives and decide whether covering tests, treatments, services, and other forms of care is worth the cost. Decisions based on “cost effectiveness” which is typical in countries that ration care can delay or deny care to people with disabilities. Low QALY values and inaccurate measures of quality of life and health improvement can lead policymakers to determine that care is not cost effective or worth covering. These calculations may fail to reflect how people adapt to disability, the value of greater independence, or the benefits of accommodations and supportive services, yet are being considered for use in the U.S. through Most Favored Nation or international reference pricing schemes. View examples of QALY health utilities that assign a lower value to the lives of people with disabilities here.
7. MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. Devina, the mother of a child with cystic fibrosis shares her story of moving from Iowa to Canada only to learn that in Canada she is not able to access the medication her daughter needs. Devina’s daughter suffers from side effects from the medications currently available in Canada. Despite medications that work better for her existing, she cannot access them and is unable to fully manage her Cystic Fibrosis. We must not import access restrictions that devalue people living with rare diseases.
8. 100 Members of Congress call on DOJ To Rescind Olmstead Memo. 100 Members of Congress sent a letter to Acting Attorney General Todd Blanche calling on the Department of Justice (DOJ) to rescind its June 18 Office of Legal Counsel (OLC) opinion that undermines decades of protections for disability rights that have ensured people with disabilities are not arbitrarily placed in segregated, institutionalized settings and instead can access services in integrated settings within their communities. DOJ’s opinion, titled “Application of the Rehabilitation Act and Americans with Disabilities Act to State Institutionalization of Patients with Severe Mental Illness or Disabilities,” would undermine both the scope and enforcement of the integration mandate under Title II of the ADA and Section 504 of the Rehabilitation Act. Lawmakers stated, “We cannot return to a time when people with disabilities were denied basic civil rights, ripped away from their families, and institutionalized against their will… we urge the Department to honor both the letter and spirit of the ADA by rescinding this opinion.” View the letter here. View a message from Senator Kirsten Gillibrand here.
9. Join IVI for 2026 Whole Health Policy Summit. Join IVI on November 10, 2026, in Washington, DC, or via livestream, for the 2026 IVI Whole Health Policy Summit: Reframing What the U.S. Healthcare System Should Deliver. The Summit will bring together leaders across healthcare policy, patient advocacy, research, innovation, employer health, and care delivery to explore what the U.S. healthcare system should deliver for patients and families. Through keynote discussions and forward-looking policy sessions, participants will examine how policy, measurement, and incentives can better reflect real-world outcomes that matter most to patients and families, including health, emotional, social, time, and financial impacts.
Learn more here. Register to attend in person here. Register to attend the livestream here.
10. ICHOM Seeking Experts in Cataracts, Plus Annual Conference December 7-9. In 2012, ICHOM launched its very first Global Set of Patient-Centered Outcome Measures for Cataracts. More than a decade after its launch, the ICHOM Cataracts Set continues to support outcomes measurement worldwide. As cataract care evolves, we're updating the Set to reflect advances in ophthalmology, including refractive surgery-related outcomes, while ensuring it remains practical and accessible for global implementation. To support this work, ICHOM is assembling an international Steering Committee and are seeking: 1. Cataract specialists and ophthalmologists and 2. Patients and patient advocates with lived experience of cataracts. Steering Committee members will shape the future of outcomes measurement in cataract care, collaborate with an international network of healthcare leaders, and receive recognition in the published ICHOM Cataracts Set materials. Contact Christina Nielsen at [email protected] to express your interest or nominate a colleague.
ICHOM will hold its annual conference December 7-9 in Montreal, Canada. Register here!
11. ICHOM Advances the Spinal Muscular Atrophy Patient Validation Survey. The ICHOM Working Group for Spinal Muscular Atrophy (SMA) has proposed a minimum set of health outcomes that matter to people with lived experience of SMA. ICHOM is now inviting people with experience of SMA to take part in its Patient Validation Survey. Feedback will play an important role in shaping the Working Group's final recommendations and ensuring the outcomes selected genuinely reflect what matters most to people living with SMA. Please share this opportunity with your communities and networks and encourage eligible participants to take part. The survey is currently approved for dissemination in the UK, USA and New Zealand. Complete the Patient Validation Survey here.
12. PCORI Annual Meeting October 19-20. Registration is now open for the 2026 PCORI Annual Meeting, taking place Oct. 19-20, in Washington, D.C. Join patients, researchers and other healthcare decision makers from across the country for two days of learning, collaboration and connection at PCORI’s annual event highlighting patient-centered comparative clinical effectiveness research (CER). Topics include: (1) explore the latest findings from PCORI-funded patient-centered CER.; and (2) hear from healthcare leaders and experts through engaging sessions. Network with a national community committed to improving healthcare decision making and health outcomes. Click here to register.
13. Tell Congress to Oppose Most Favored Nation Policies Importing QALYs to the U.S. It continues to be important to remind both sides of the aisle that there is a long bipartisan history of opposition to QALYs and importing QALYs isn’t any better. Conversations about a Most Favored Nation model continue on the Hill and we are seeing a cultural shift toward modeling other countries where providing treatment to people who are older or have disabilities may not be considered “worth it.” If anything, Congress should be focused on protecting access to care. Even the National Council on Disability has consistently opposed referencing QALYs, including from other countries, to inform reimbursement/pricing and coverage knowing that QALYs were created to ration health care. Any amendment seeking to codify international reference pricing is inconsistent with policy accomplishments to ban use of QALYs on both sides of the aisle. The Inflation Reduction Act barred use of measures devaluing disabled lives in the Medicare Drug Price Negotiation Program, further making the use of QALYs in Medicare negotiation illegal. The House passed legislation in 2024 that would extend the existing ban on use of QALYs and similar measures across Medicare to other federal programs. Learn more here. Reach out to your Member of Congress here.
Additionally, you can sign an Open Letter to Congress HERE Note we will add new signatories every few days to the updated letter which is available to share with policymakers here.
14. PIPC Report: The UK Health System, Lessons for the U.S. and the Risks of MFN Drug Pricing. Debate over drug pricing and health care affordability in the U.S. has put a renewed spotlight on costs in other countries compared to the U.S., and on the tools used in other countries to control costs.
A number of leading stakeholders and researchers have noted that application of foreign reference pricing in the U.S. — for example, through the recent “Most Favored Nation” (MFN) proposals — would have the effect of importing the standards and values that those countries rely on in setting health care policy, and that these standards often do not reflect the values and preferences of U.S. patients and consumers. First and foremost among these is the quality-adjusted life year (QALY), a metric used by the UK and many other developed nations, including 18 of the 19 countries referenced in MFN proposals during the second Trump administration.
For several decades, the QALY has been widely recognized as being inappropriate for use in the U.S. In 1992, the Bush administration prevented use of QALYs to prioritize services available under a state Medicaid waiver. The Affordable Care Act (ACA) included a prohibition on use of QALYs or similar metrics in Medicare coverage and reimbursement decisions, reflecting concerns about the discriminatory implications of these approaches. These patient-focused safeguards are not present in many of the countries whose pricing systems are now being referenced in U.S. policy discussions. Further, the QALY is only one component of a broader set of health technology assessment (HTA) practices used internationally to evaluate treatments and determine access.
PIPC released a white paper examining how HTA processes in the UK diverge from the U.S.’ patient-centered principles, including key shortcomings such as: (1) failure to meaningfully capture the full range of outcomes (health and quality of life) that matter to patients and caregivers; (2) imposition of evidence standards that disadvantage patients with serious diseases and conditions; (3) lack of transparency and flexibility in HTA processes; and (4) failure of patient input to meaningfully shape decision outcomes.
Together, these features can result in patients in the UK encountering long delays in access to new tests and treatments and reduced flexibility for physicians to tailor care to the needs of different patients. As U.S. policymakers consider approaches such as MFN pricing, understanding how these underlying systems shape access and decision-making is critical to ensuring that efforts to lower costs do not come at the expense of patient-centered care.
Click here to read the full report.
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
Colorado PDAB Meeting
Sept. 25, 2026
Click here to view.
Maryland PDAB Meeting
Sept. 28, 2026
Click here to view.
Minnesota PDAB Meeting
Sept. 29, 2026
Click here to view.
PCORI Annual Meeting
Oct. 19-20, 2026
Click here to view.
Oregon PDAB Meeting
Oct. 21, 2026
Click here to view.
Maine PDAB Meeting
Oct. 26, 2026
Click here to view.
IVI Whole Health Policy Summit
Nov. 10, 2026
Click here to view.
Washington State PDAB Meeting
Nov. 18, 2026
Click here to view.
ICHOM Annual Conference
Dec. 7-9, 2026
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. 86 Organizations Comment to Senate Finance Committee, Oppose Importing QALYs, Urge Decisions Centered on Patients and People with Disabilities. On August 17, 2026, 86 organizations provided comments in response to the Senate Finance Committee minority staff’s request for information (RFI), Commonsense Policy Options to Lower Drug Prices for Patients. We urged the Committee to strengthen, rather than bypass, existing patient protections. That means addressing the patient engagement, evidentiary transparency, and QALY safeguard gaps in the current Medicare Drug Price Negotiation and rejecting international reference pricing as a mechanism for negotiation. We also urged a focus on policies that prevent payers from rejecting access to treatments that work best for individual patients and people with disabilities. As Chairman Coelho often says, "No patient is average.” View the final comment here.
2. New Research Highlights Gaps in Use of CER and Patient Experience. Recent research underscores the significant limitations inherent in use of comparative effectiveness research and evidence centered on patients in decisions being made across federal and state programs, including Prescription Drug Affordability Boards and the Medicare Drug Price Negotiation Program. For example, the law governing Medicare negotiation requires CMS to make judgments on factors that go to the heart of what matters to patients in their medical care – about therapeutic alternatives, comparative clinical benefit, therapeutic advances, and unmet medical need. A recent PIPC analysis looked at two key domains: first, how, if at all, was CMS considering patient input and patient-centered outcomes in its process; and second, to what degree was it citing studies that include cost-effectiveness analysis that employs the quality-adjusted life year (QALY). We found that evidence about patients’ priorities made up a small share of the literature, even when relevant patient-focused information was available. There are also still some instances where CMS cites research using QALYs and cost-effectiveness thresholds, without providing sufficient information to demonstrate how the research was considered within the context of legal constraints. View the Data Mine Blog analysis here.
A recent study published in Value in Health came to similar conclusions. A review of the gaps, challenges, and opportunities around the use of contemporary CER for federal and state drug pricing programs concluded: "Incorporating contemporary CER is crucial to informing drug pricing actions by federal (MDPNP) and state (PDAB) decision makers to best understand the current use and clinical benefit of a drug for the population being considered. We suggest that policymakers balance rigor, transparency, and feasibility. Evaluating evidence, answering policy questions, and inferring how evidence applies to different populations are core principles that should be applied rigorously and transparently in drug pricing programs.” View the article here.
3. PCORI Seeking Input on Research Priorities. PCORI is seeking input on high-priority evidence needs that could be addressed through patient-centered CER. PCORI wants to hear where important evidence gaps remain and what research could help people make more informed health and healthcare decisions. Through this Request for Information, PCORI is seeking perspectives on research questions that compare healthcare options, examine whether treatments may work differently across groups or communities, reflect current healthcare challenges, and are relevant to care delivered in a variety of settings. PCORI has shared that submissions will provide PCORI with a greater understanding of critical evidence needs and shape the continued evolution of PCORI’s Research Project Agenda and ensuing funding opportunities. Click here to submit your ideas by Nov. 2 at 5 p.m. (ET) and help inform future patient-centered CER.
4. PIPC Submits IPAY 2028 Comments to CMS. PIPC submitted comments to CMS making the following recommendations in response to its proposed rule governing the program.
- CMS should avoid one-size fits all value metrics such as the QALY.
- CMS should develop a formalized process to ensure continuous, robust engagement of patients and people with disabilities at multiple levels.
- Where high-quality patient data exists, like FDA Voice of the Patient Reports, CMS should use it.
- Using patient insights, CMS should clearly communicate how it intends to use the input it receives, and how that input is reflected in the final negotiated prices.
- CMS should solicit input from a variety of patients who rely on the treatments in question, including those in rural areas to ensure representation of the diversity of the patients and communities affected by the topic.
- CMS should ensure that opportunities for patient engagement are accessible.
- To gauge both successes and challenges, CMS should establish a structured process for continuous review and assessment of its engagement strategy and its holistic processes.
View PIPC's comment letter to CMS here.
5. Washington Examiner: Review of Implications of Germany, Foreign Drug Prices. In a recent opinion, the author, whose mother died of colon cancer, highlights the implications of foreign pricing schemes that devalue medicines for patients with disabilities, cancer and other innovations. He stated, "For decades, Germany and other developed nations have underpaid for lifesaving medicines — and obtained low prices by delaying and rationing drug access. These access restrictions have had real impacts on patients...Even when the health systems in those developed countries decide to cover a new medicine, bureaucrats typically only allow the sickest patients to take cutting-edge drugs. Public insurance reimburses only 22% of new drugs for all approved uses. As a result, patients in those countries typically wait three years longer than Americans to access new medicines.” View the article here.
6. As the ADA Turns 36, PIPC Highlights Work to be Done. Learn More About How the QALY Devalues Disabled Lives. In many other countries, governments use the quality-adjusted life year (QALY) metric to assign a numeric value to patients’ lives and decide whether covering tests, treatments, services, and other forms of care is worth the cost. Decisions based on “cost effectiveness” which is typical in countries that ration care can delay or deny care to people with disabilities. Low QALY values and inaccurate measures of quality of life and health improvement can lead policymakers to determine that care is not cost effective or worth covering. These calculations may fail to reflect how people adapt to disability, the value of greater independence, or the benefits of accommodations and supportive services, yet are being considered for use in the U.S. through Most Favored Nation or international reference pricing schemes. View examples of QALY health utilities that assign a lower value to the lives of people with disabilities here.
7. MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. Devina, the mother of a child with cystic fibrosis shares her story of moving from Iowa to Canada only to learn that in Canada she is not able to access the medication her daughter needs. Devina’s daughter suffers from side effects from the medications currently available in Canada. Despite medications that work better for her existing, she cannot access them and is unable to fully manage her Cystic Fibrosis. We must not import access restrictions that devalue people living with rare diseases.
8. 100 Members of Congress call on DOJ To Rescind Olmstead Memo. 100 Members of Congress sent a letter to Acting Attorney General Todd Blanche calling on the Department of Justice (DOJ) to rescind its June 18 Office of Legal Counsel (OLC) opinion that undermines decades of protections for disability rights that have ensured people with disabilities are not arbitrarily placed in segregated, institutionalized settings and instead can access services in integrated settings within their communities. DOJ’s opinion, titled “Application of the Rehabilitation Act and Americans with Disabilities Act to State Institutionalization of Patients with Severe Mental Illness or Disabilities,” would undermine both the scope and enforcement of the integration mandate under Title II of the ADA and Section 504 of the Rehabilitation Act. Lawmakers stated, “We cannot return to a time when people with disabilities were denied basic civil rights, ripped away from their families, and institutionalized against their will… we urge the Department to honor both the letter and spirit of the ADA by rescinding this opinion.” View the letter here. View a message from Senator Kirsten Gillibrand here.
9. Join IVI for 2026 Whole Health Policy Summit. Join IVI on November 10, 2026, in Washington, DC, or via livestream, for the 2026 IVI Whole Health Policy Summit: Reframing What the U.S. Healthcare System Should Deliver. The Summit will bring together leaders across healthcare policy, patient advocacy, research, innovation, employer health, and care delivery to explore what the U.S. healthcare system should deliver for patients and families. Through keynote discussions and forward-looking policy sessions, participants will examine how policy, measurement, and incentives can better reflect real-world outcomes that matter most to patients and families, including health, emotional, social, time, and financial impacts.
Learn more here. Register to attend in person here. Register to attend the livestream here.
10. ICHOM Seeking Experts in Cataracts, Plus Annual Conference December 7-9. In 2012, ICHOM launched its very first Global Set of Patient-Centered Outcome Measures for Cataracts. More than a decade after its launch, the ICHOM Cataracts Set continues to support outcomes measurement worldwide. As cataract care evolves, we're updating the Set to reflect advances in ophthalmology, including refractive surgery-related outcomes, while ensuring it remains practical and accessible for global implementation. To support this work, ICHOM is assembling an international Steering Committee and are seeking: 1. Cataract specialists and ophthalmologists and 2. Patients and patient advocates with lived experience of cataracts. Steering Committee members will shape the future of outcomes measurement in cataract care, collaborate with an international network of healthcare leaders, and receive recognition in the published ICHOM Cataracts Set materials. Contact Christina Nielsen at [email protected] to express your interest or nominate a colleague.
ICHOM will hold its annual conference December 7-9 in Montreal, Canada. Register here!
11. ICHOM Advances the Spinal Muscular Atrophy Patient Validation Survey. The ICHOM Working Group for Spinal Muscular Atrophy (SMA) has proposed a minimum set of health outcomes that matter to people with lived experience of SMA. ICHOM is now inviting people with experience of SMA to take part in its Patient Validation Survey. Feedback will play an important role in shaping the Working Group's final recommendations and ensuring the outcomes selected genuinely reflect what matters most to people living with SMA. Please share this opportunity with your communities and networks and encourage eligible participants to take part. The survey is currently approved for dissemination in the UK, USA and New Zealand. Complete the Patient Validation Survey here.
12. PCORI Annual Meeting October 19-20. Registration is now open for the 2026 PCORI Annual Meeting, taking place Oct. 19-20, in Washington, D.C. Join patients, researchers and other healthcare decision makers from across the country for two days of learning, collaboration and connection at PCORI’s annual event highlighting patient-centered comparative clinical effectiveness research (CER). Topics include: (1) explore the latest findings from PCORI-funded patient-centered CER.; and (2) hear from healthcare leaders and experts through engaging sessions. Network with a national community committed to improving healthcare decision making and health outcomes. Click here to register.
13. Tell Congress to Oppose Most Favored Nation Policies Importing QALYs to the U.S. It continues to be important to remind both sides of the aisle that there is a long bipartisan history of opposition to QALYs and importing QALYs isn’t any better. Conversations about a Most Favored Nation model continue on the Hill and we are seeing a cultural shift toward modeling other countries where providing treatment to people who are older or have disabilities may not be considered “worth it.” If anything, Congress should be focused on protecting access to care. Even the National Council on Disability has consistently opposed referencing QALYs, including from other countries, to inform reimbursement/pricing and coverage knowing that QALYs were created to ration health care. Any amendment seeking to codify international reference pricing is inconsistent with policy accomplishments to ban use of QALYs on both sides of the aisle. The Inflation Reduction Act barred use of measures devaluing disabled lives in the Medicare Drug Price Negotiation Program, further making the use of QALYs in Medicare negotiation illegal. The House passed legislation in 2024 that would extend the existing ban on use of QALYs and similar measures across Medicare to other federal programs. Learn more here. Reach out to your Member of Congress here.
Additionally, you can sign an Open Letter to Congress HERE Note we will add new signatories every few days to the updated letter which is available to share with policymakers here.
14. PIPC Report: The UK Health System, Lessons for the U.S. and the Risks of MFN Drug Pricing. Debate over drug pricing and health care affordability in the U.S. has put a renewed spotlight on costs in other countries compared to the U.S., and on the tools used in other countries to control costs.
A number of leading stakeholders and researchers have noted that application of foreign reference pricing in the U.S. — for example, through the recent “Most Favored Nation” (MFN) proposals — would have the effect of importing the standards and values that those countries rely on in setting health care policy, and that these standards often do not reflect the values and preferences of U.S. patients and consumers. First and foremost among these is the quality-adjusted life year (QALY), a metric used by the UK and many other developed nations, including 18 of the 19 countries referenced in MFN proposals during the second Trump administration.
For several decades, the QALY has been widely recognized as being inappropriate for use in the U.S. In 1992, the Bush administration prevented use of QALYs to prioritize services available under a state Medicaid waiver. The Affordable Care Act (ACA) included a prohibition on use of QALYs or similar metrics in Medicare coverage and reimbursement decisions, reflecting concerns about the discriminatory implications of these approaches. These patient-focused safeguards are not present in many of the countries whose pricing systems are now being referenced in U.S. policy discussions. Further, the QALY is only one component of a broader set of health technology assessment (HTA) practices used internationally to evaluate treatments and determine access.
PIPC released a white paper examining how HTA processes in the UK diverge from the U.S.’ patient-centered principles, including key shortcomings such as: (1) failure to meaningfully capture the full range of outcomes (health and quality of life) that matter to patients and caregivers; (2) imposition of evidence standards that disadvantage patients with serious diseases and conditions; (3) lack of transparency and flexibility in HTA processes; and (4) failure of patient input to meaningfully shape decision outcomes.
Together, these features can result in patients in the UK encountering long delays in access to new tests and treatments and reduced flexibility for physicians to tailor care to the needs of different patients. As U.S. policymakers consider approaches such as MFN pricing, understanding how these underlying systems shape access and decision-making is critical to ensuring that efforts to lower costs do not come at the expense of patient-centered care.
Click here to read the full report.
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.
- Australia. Australian MS patients nearly faced annual medicine costs of $33,000 after government pricing rules triggered demands for cuts of up to 50%. The U.S. should not import foreign pricing models that put continued access to essential medicines at risk.
- Australia. Australia temporarily preserved access to three MS treatments after manufacturers warned steep government-mandated price cuts could force them off the subsidy system. Foreign reference pricing can turn promised savings into uncertainty for patients
- Australia. Australians are paying more for medicines while restrictive pharmacy rules limit access to lower-cost options, according to a new report.
- Canada. Canada reversed its initial rejection of public coverage for lecanemab, but patients will still face strict eligibility and monitoring requirements. Foreign pricing systems often make regulatory approval only the beginning of another access battle.
- Canada. Canada is trying to accelerate drug approvals as rare-disease patients wait years longer than Americans for treatments, and many medicines never reach Canada at all. The U.S. should not tie its prices to systems struggling with delayed launches and limited availability.
- Canada. A Canadian woman with incurable breast cancer is considering draining her savings and retirement fund to pay $12,000 a month for a treatment her insurance will not cover. Government-centered systems do not guarantee access—and the U.S. should not import their restrictions.
- New Zealand. Foreign pricing models can shift costs from government budgets directly onto patients and families. A New Zealand man with stage 4 melanoma is relying on fundraising because some medicines recommended by his doctors are not publicly funded.
- United Kingdom. Foreign pricing models can lower government spending by leaving patients to bear the cost themselves. After discovering treatments available abroad were not routinely offered through the NHS, a UK brain cancer patient sold her house to fund care.
- United Kingdom. A British woman spent years suffering before paying £925 privately for a treatment unavailable through the NHS. Government-controlled systems can leave patients paying out of pocket when coverage rules fail to keep pace with medical need.
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.
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- COVID-19: Final Evidence Report and Meeting Summary available. Public meeting: June 2026.
- Narcolepsy: Final Evidence Report and Meeting Summary available. Public meeting: May 2026.
- Launch Price and Access Report: Drug Approvals from 2022-2025: Protocol available. Public Meeting: October 2026.
- Strengthening the FDA's Accelerated Approval Pathway: Progress and Unfinished Business: White Paper published on April 16, 2026.
- IgA Nephropathy: Final Evidence Report and Meeting Summary available.
- Launch Price and Access Report: Drug Approvals from 2023-2024: Final Report and Webinar Recording available.
- Smoking Cessation: Final Evidence Report and Meeting Summary available.
- Obesity Management: Final Evidence Report and Meeting Summary available.
- 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.
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