In this week's edition...
-- MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. As lawmakers continue to explore most favored nation pricing, they must listen to patients like Crystal.
-- USPSTF Changes Imply a Shift Toward Consideration of Cost Effectiveness. View the Inside Health Policy article here ($). View the AcademyHealth statement here.
-- Ruling Vacating Community Integration Provisions in 2024 Section 504 Rule. View the AAPD statement here. Learn more about the DCIC here.
-- Maryland Matters: The Danger of PDABs for Patients. Read a recent opinion piece, Gone from the shelf: The hidden danger of drug price caps, here.
-- Legacy HTA: Deconstructing the Impossible QALY. View the Class Notes here.
-- 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.
-- 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.
— 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.
-- MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. As lawmakers continue to explore most favored nation pricing, they must listen to patients like Crystal.
-- USPSTF Changes Imply a Shift Toward Consideration of Cost Effectiveness. View the Inside Health Policy article here ($). View the AcademyHealth statement here.
-- Ruling Vacating Community Integration Provisions in 2024 Section 504 Rule. View the AAPD statement here. Learn more about the DCIC here.
-- Maryland Matters: The Danger of PDABs for Patients. Read a recent opinion piece, Gone from the shelf: The hidden danger of drug price caps, here.
-- Legacy HTA: Deconstructing the Impossible QALY. View the Class Notes here.
-- 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.
-- 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.
— 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
1. MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. As lawmakers continue to explore most favored nation pricing, they must listen to patients like Crystal. Crystal, a patient living with a rare muscular dystrophy, shares her story about struggling to access the medications she needed in the Netherlands. Crystal enjoyed her life and job in the Netherlands but could not access the medications she needed to maintain her quality of life. She left the Netherlands and moved back to the United States due to inability to access quality care, fearing she would die without the ability to manage her condition.
2. USPSTF Changes Imply a Shift Toward Consideration of Cost Effectiveness. The U.S. Preventive Services Task Force recommendations shape preventive care for millions of Americans, and the backlog of topics waiting for a decision has only grown while the panel sat idle. Recently, according to STAT, HHS appointed "several specialists, a departure from the usual appointments of primary care doctors and other general practitioners, and a health care finance expert, raising questions about whether the panel, which has explicitly excluded cost effectiveness from its considerations in the past, will begin factoring in cost.” AcademyHealth stated, "HHS singled out one new member’s expertise in evaluating the cost and value of health care services. That's a notable thing to highlight, because the Task Force has never included cost in its recommendation grades. Those grades are based on benefits and harms. Nothing else. If the administration intends to change that, the public deserves to know, and any change should be transparent and grounded in law and evidence.”
View the Inside Health Policy article here (subscription required). View the AcademyHealth statement here.
3. Ruling Vacating Community Integration Provisions in 2024 Section 504 Rule. The federal judge in Texas v. Kennedy vacated the community integration requirements in the Department of Health and Human Services’ (HHS) Section 504 rule. The resolution approved by the judge was proposed by the Department of Justice (DOJ) on behalf of HHS and Texas, Florida, Alaska, Louisiana, and Montana. The case is now closed. The ruling affects only certain parts of the 2024 rule. Section 504, the Americans with Disabilities Act, and the Supreme Court’s Olmstead decision remain in place. Disability organizations have been critical of the decision. Maria Town, President and CEO of the American Association of People with Disabilities (AAPD) stated, "The judge’s decision to eliminate these requirements is a rollback of the right to community integration, but it is not a complete rollback of disability rights. Every disabled person deserves to receive care in the most integrated setting so that they maintain autonomy, agency, and self-direction.” The Defend Community Integration Coalition (DCIC) also condemned the federal government’s action resulting in this order and "urges renewed advocacy to protect our right to community integration.”
View the AAPD statement here. Learn more about the DCIC here.
4. Maryland Matters: The Danger of PDABs for Patients. A heartfelt opinion piece from patient Dominique Daniels from Maryland underscores the depth of concerns from patients and people with disabilities related to ongoing efforts in states with Prescription Drug Affordability Boards (PDABs) that may ultimately restrict access to care.
"I remember what my life looked like before I found the right medication. Crohn’s disease had stolen years from me, piece by piece. I spent more time managing my disease than with my family. I couldn’t trust my body to get me through a workday. After years of suffering, failed treatments, unwanted medication side effects and insurance denials, I worked with my doctor to find a treatment that was right for me. Within months, I was in remission. For the first time in years, I felt like myself again. This is what it means for a patient to finally find something that works, and what it would mean to lose access to it through no fault of their own...If the PDAB truly wants to help patients like me, it should pursue policies that lower costs at the pharmacy counter without dismantling the supply chain that gets the drugs there. It should demand transparency from pharmacy benefit managers, who collect enormous rebates from drug manufacturers that never make it to patients."
"I have no doubt that these are even harder problems to solve, but they are the right ones. The board has no guarantee that patients who need it will still be able to get it. 'Trust us.' is not a guarantee. The board has said it will monitor access after the fact, through quarterly reports on problems that emerge. But monitoring a crisis after it has harmed patients is not patient protection. It is failure. Trust us.”
View the entire opinion piece here.
5. Legacy HTA: Deconstructing the Impossible QALY.A University of Minnesota professor published “Class Notes” detailing the shortcomings of the quality-adjusted life years (QALYs) and why another generation of students should not be taught utilities, QALYs and cost-per-QALY analysis as legitimate quantitative science without first being given the measurement standards required to evaluate them. "The QALY has been a central feature of legacy HTA for more than 40 years, yet its status as a lawful measure of quality-adjusted time was never established before the arithmetic was adopted. There are two principal reasons for this failure. First, legacy HTA developed without adequate recognition of the requirements of representational measurement, particularly the requirements for ratio measurement and for constructing a dimensionless proportional adjustment factor. If time is to be adjusted proportionally, the adjustment factor must have an appropriate measurement foundation; it cannot acquire that status merely because a numerical value between 0 and 1 has been assigned to it. Second, legacy HTA focused on preferences or valuations attached to multidimensional health-state descriptions rather than beginning with the measurement of defined, unidimensional attributes.”
View the Class Notes here.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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!
14. 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.
15. 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.
16. 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.
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 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.
Colorado PDAB Meeting
Oct. 30, 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.
1. MFN Policies Limit Patients’ Ability to Access Treatments that Work Best for Them. As lawmakers continue to explore most favored nation pricing, they must listen to patients like Crystal. Crystal, a patient living with a rare muscular dystrophy, shares her story about struggling to access the medications she needed in the Netherlands. Crystal enjoyed her life and job in the Netherlands but could not access the medications she needed to maintain her quality of life. She left the Netherlands and moved back to the United States due to inability to access quality care, fearing she would die without the ability to manage her condition.
2. USPSTF Changes Imply a Shift Toward Consideration of Cost Effectiveness. The U.S. Preventive Services Task Force recommendations shape preventive care for millions of Americans, and the backlog of topics waiting for a decision has only grown while the panel sat idle. Recently, according to STAT, HHS appointed "several specialists, a departure from the usual appointments of primary care doctors and other general practitioners, and a health care finance expert, raising questions about whether the panel, which has explicitly excluded cost effectiveness from its considerations in the past, will begin factoring in cost.” AcademyHealth stated, "HHS singled out one new member’s expertise in evaluating the cost and value of health care services. That's a notable thing to highlight, because the Task Force has never included cost in its recommendation grades. Those grades are based on benefits and harms. Nothing else. If the administration intends to change that, the public deserves to know, and any change should be transparent and grounded in law and evidence.”
View the Inside Health Policy article here (subscription required). View the AcademyHealth statement here.
3. Ruling Vacating Community Integration Provisions in 2024 Section 504 Rule. The federal judge in Texas v. Kennedy vacated the community integration requirements in the Department of Health and Human Services’ (HHS) Section 504 rule. The resolution approved by the judge was proposed by the Department of Justice (DOJ) on behalf of HHS and Texas, Florida, Alaska, Louisiana, and Montana. The case is now closed. The ruling affects only certain parts of the 2024 rule. Section 504, the Americans with Disabilities Act, and the Supreme Court’s Olmstead decision remain in place. Disability organizations have been critical of the decision. Maria Town, President and CEO of the American Association of People with Disabilities (AAPD) stated, "The judge’s decision to eliminate these requirements is a rollback of the right to community integration, but it is not a complete rollback of disability rights. Every disabled person deserves to receive care in the most integrated setting so that they maintain autonomy, agency, and self-direction.” The Defend Community Integration Coalition (DCIC) also condemned the federal government’s action resulting in this order and "urges renewed advocacy to protect our right to community integration.”
View the AAPD statement here. Learn more about the DCIC here.
4. Maryland Matters: The Danger of PDABs for Patients. A heartfelt opinion piece from patient Dominique Daniels from Maryland underscores the depth of concerns from patients and people with disabilities related to ongoing efforts in states with Prescription Drug Affordability Boards (PDABs) that may ultimately restrict access to care.
"I remember what my life looked like before I found the right medication. Crohn’s disease had stolen years from me, piece by piece. I spent more time managing my disease than with my family. I couldn’t trust my body to get me through a workday. After years of suffering, failed treatments, unwanted medication side effects and insurance denials, I worked with my doctor to find a treatment that was right for me. Within months, I was in remission. For the first time in years, I felt like myself again. This is what it means for a patient to finally find something that works, and what it would mean to lose access to it through no fault of their own...If the PDAB truly wants to help patients like me, it should pursue policies that lower costs at the pharmacy counter without dismantling the supply chain that gets the drugs there. It should demand transparency from pharmacy benefit managers, who collect enormous rebates from drug manufacturers that never make it to patients."
"I have no doubt that these are even harder problems to solve, but they are the right ones. The board has no guarantee that patients who need it will still be able to get it. 'Trust us.' is not a guarantee. The board has said it will monitor access after the fact, through quarterly reports on problems that emerge. But monitoring a crisis after it has harmed patients is not patient protection. It is failure. Trust us.”
View the entire opinion piece here.
5. Legacy HTA: Deconstructing the Impossible QALY.A University of Minnesota professor published “Class Notes” detailing the shortcomings of the quality-adjusted life years (QALYs) and why another generation of students should not be taught utilities, QALYs and cost-per-QALY analysis as legitimate quantitative science without first being given the measurement standards required to evaluate them. "The QALY has been a central feature of legacy HTA for more than 40 years, yet its status as a lawful measure of quality-adjusted time was never established before the arithmetic was adopted. There are two principal reasons for this failure. First, legacy HTA developed without adequate recognition of the requirements of representational measurement, particularly the requirements for ratio measurement and for constructing a dimensionless proportional adjustment factor. If time is to be adjusted proportionally, the adjustment factor must have an appropriate measurement foundation; it cannot acquire that status merely because a numerical value between 0 and 1 has been assigned to it. Second, legacy HTA focused on preferences or valuations attached to multidimensional health-state descriptions rather than beginning with the measurement of defined, unidimensional attributes.”
View the Class Notes here.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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!
14. 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.
15. 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.
16. 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.
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.
- Friedreich's Ataxia: Research Protocol available. Public meeting: January 2027.
- Hypertension: Model Analysis Plan available. Public meeting: October 2026.
- Parkinson's Disease: Draft Evidence Report available. Public comments due August 25, 2026. Public meeting: October 2026.
- 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.
- Retinitis Pigmentosa: Final Evidence Report and Meeting Summary available.
Upcoming Events and Webinars
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.
Colorado PDAB Meeting
Oct. 30, 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.
