In this week's edition...
— CMS Collecting Written Information by March 1 and Holding Public Engagement Events for Medicare Drug Negotiation Program. See details below.
— Proposed Use of QALYs and Similar Measures from Foreign Countries. See details below.
— The Protecting Health Care for All Patients Act Has No Budget Impact. See details below.
— CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. See details below.
— Join PCORI's Advisory Panels: Applications, Nominations are Due March 7! Click here for additional details and to submit an application.
— PIPC Calls for Robust Engagement and Transparency as CMS Reviews 15 Additional Drugs under Medicare Drug Negotiation Program. See details below.
— Learn More About Alternative Measures for Value Assessment. Click here to learn more.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
— CMS Collecting Written Information by March 1 and Holding Public Engagement Events for Medicare Drug Negotiation Program. See details below.
— Proposed Use of QALYs and Similar Measures from Foreign Countries. See details below.
— The Protecting Health Care for All Patients Act Has No Budget Impact. See details below.
— CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. See details below.
— Join PCORI's Advisory Panels: Applications, Nominations are Due March 7! Click here for additional details and to submit an application.
— PIPC Calls for Robust Engagement and Transparency as CMS Reviews 15 Additional Drugs under Medicare Drug Negotiation Program. See details below.
— Learn More About Alternative Measures for Value Assessment. Click here to learn more.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
1. CMS Collecting Written Information by March 1 and Holding Public Engagement Events for Medicare Drug Negotiation Program. Information Collection Requests on each selected drug in the Program are due by March 1, with questions 36-42 tailored for patient input, providing an opportunity for patients to weigh in on their experience on drugs and what makes each uniquely tailored to their needs among "therapeutic alternatives" as patients push for CMS to ensure the Program does not undermine preferred coverage on payer formularies for any drugs in the classes under consideration. Provide written input by March 1 here. CMS will also host public engagement events for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties, such as clinicians and researchers to share input on drugs in second cycle of the Medicare Drug Negotiation Program. View details at the PIPC Action Center here. Registration information is here.
2. Proposed Use of QALYs and Similar Measures from Foreign Countries. As the 119th Congress works toward a budget resolution, importing QALYs from foreign countries is once again on the agenda. A Senate amendment allowing for legislation to import international policies and prices was considered and failed February 21, 2025, raising concerns for the disability community. PIPC is also monitoring closely the ongoing consideration of importing the use of QALYs and similar measures from foreign countries as part of state-based affordability reviews and setting reimbursement. PIPC has provided a series of comments to entities known as Prescription Drug Affordability Boards in states including Maryland, Oregon and Colorado to share and explain how discriminatory value assessments are used internationally to establish coverage and reimbursement policies. As background, the National Council on Disability, an independent federal agency advising Congress and the administration on disability policy, highlighted how foreign countries use QALYs and similar measures to discriminate as part of its Ethics Series in 2019 and in policy recommendations to Congress and the administration. Click here to view what the experts have said about policies importing QALYs and similar measures to the United States.
3. The Protecting Health Care for All Patients Act Has No Budget Impact. Last Congress, the Protecting Health Care for All Patients Act (H.R. 485) passed the House of Representatives on February 7, 2024. Since finalization of the Section 504 rules barring disability discrimination in May 2024, Congressional staff have been informed that the House-passed bill has no budget impact. When considered in the House, the Biden administration's concerns about the bill were limited to the use of a budget offset from the CDC, which is no longer needed. As highlighted by the White House, Democrats supported the original QALY ban in the Affordable Car Act and the nondiscrimination provisions in the IRA. Without the need for an offset, this bipartisan policy change has a stronger chance of consideration this year. People with disabilities and serious chronic conditions continue to support this legislation extending the law barring Medicare’s use of quality-adjusted life years (QALYs) and similar measures to other programs.
As CBO stated when the bill was introduced, current law already prohibits the Secretary from using QALYs and similar measures in Medicare, giving it no impact on the Medicare Drug Price Negotiation Program, which is subject to both the nondiscrimination provisions in the IRA and in the ACA. Entities receiving federal financial assistance (i.e. all the entities impacted by the bill) are also subject to the rules governing Section 504 of the Rehabilitation Act that similarly bar the use of use any measure, assessment, or tool that discounts the value of life extension on the basis of disability (i.e. QALYs) to deny or afford an unequal opportunity to qualified individuals with disabilities, with the agency also clarifying that methods of utility weight generation are also subject to Section 504 when they are used in a way that discriminates. The Protecting Health Care for All Patients Act would explicitly make the statute governing use of QALYs and similar measures also clear and consistent across federal programs.
We urge advocates to call on Congress to take action to pass The Protecting Health Care for All Patients Act this year. Click here to view a one-pager about the bill. The National Down Syndrome Society has updated their FAQ on the legislation here.
4. CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of ICER’s value assessments that rely on the quality-adjusted life year (QALY) and the equal value of life year gained (evLYG), measures that are contrary to the laws governing Medicare and barring disability discrimination. In the explanations released on December 20, 2024, CMS explicitly listed studies from the Institute for Clinical and Economic Review (ICER) in its explanations for the calculation of Maximum Fair Prices (MFPs) for the drugs Eliquis, Enbrel, Farxiga, and Xarelto. The explanation for Xarelto report also cites data from the National Institute for Health and Care Excellence (NICE) in the United Kingdom which is know for its explicit reliance on QALYs. In its public comments, ICER defends the use of the evLYG, calling it a nondiscriminatory alternative and highlighting its use by the Veterans Administration, Medicaid programs and private insurers. CMS did not acknowledge that the evLYG is a similar measure to the QALY that is barred under Section 1182 of the Affordable Care Act and under §84.56 of the rules governing Section 504 of the Rehabilitation Act barring disability discrimination. Click here to view the explanations from CMS.
5. Learn More About Alternative Measures for Value Assessment. PIPC has developed new resources about alternative methods and metrics for value assessment. It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. Click here to learn more.
6. Join PCORI's Advisory Panels: Applications, Nominations are Due March 7! PCORI is accepting applications and nominations for members on its multi-stakeholder advisory panels for the 2024-2025 cycle. These research advisory panels are an important way we bring voices from across the health care community into our work. The panels focus on clinical effectiveness and decision science, clinical trials, healthcare delivery and disparities research, patient engagement, and rare diseases. Click here for additional details and to submit an application.
7. PIPC Calls for Robust Engagement and Transparency as CMS Reviews 15 Additional Drugs under Medicare Drug Negotiation Program. On January 17, 2025, CMS released the second list of drugs that will be subject to Medicare negotiation under the Inflation Reduction Act (IRA). PIPC reiterated in a statement that many patients rely on these treatments for their health and quality of life. PIPC also highlighted concern that ICER and NICE were cited in the explanations for the most recent drugs reviewed by the program and urged CMS to avoid relying on outside research entities whose methods inherently devalue the lives of people with disabilities as they review the second list of drugs. It is not clear how the new administration may change the process to center on patients and people with disabilities.
PIPC stated, "It is imperative that they are consistently able to access the medications they need and that payers and government bureaucrats do not come between patients and their doctors...Unfortunately, CMS’ process over the past year did not provide a level of robust engagement and transparency that would allow patients and people with disabilities to trust that their voices were heard in the process and that different patients’ needs were considered. Therefore, we encourage the incoming administration to take the time necessary to revisit the processes for implementation of the program and address any shortcomings going forward.” View PIPC’s statement 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.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
March 18-19, 2025
Click here to view.
AHRQ Effective Program Updates
Systematic Review: Behavioral Interventions for Migraine Prevention. Click here to view.
Systematic Review: Healthcare Delivery of Clinical Preventive Services for People With Disabilities. Click here to view.
Systematic Review: Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents. Click here to view.
Research Protocol: Making Healthcare Safer IV: Programs for Responding to Harms Experienced by Patients during Clinical Care. Click here to view.
Research Protocol: Making Healthcare Safer IV: High Reliability Organization (HRO) as a Patient Safety Practice Click here to view.
Research Protocol: Making Healthcare Safer IV: Supply Chain Disruption Monitoring Programs Click here to view.
- Events will be held April 16-April 30;
- Deadline for registration is March 12, 2025.
- One event will be live-streamed for the public on April 30 on all selected drugs.
- 15 private patient-focused events for each drug will be held for patients, caregivers and patient organizations.
- Written input must be submitted here by March 1, 2025.
2. Proposed Use of QALYs and Similar Measures from Foreign Countries. As the 119th Congress works toward a budget resolution, importing QALYs from foreign countries is once again on the agenda. A Senate amendment allowing for legislation to import international policies and prices was considered and failed February 21, 2025, raising concerns for the disability community. PIPC is also monitoring closely the ongoing consideration of importing the use of QALYs and similar measures from foreign countries as part of state-based affordability reviews and setting reimbursement. PIPC has provided a series of comments to entities known as Prescription Drug Affordability Boards in states including Maryland, Oregon and Colorado to share and explain how discriminatory value assessments are used internationally to establish coverage and reimbursement policies. As background, the National Council on Disability, an independent federal agency advising Congress and the administration on disability policy, highlighted how foreign countries use QALYs and similar measures to discriminate as part of its Ethics Series in 2019 and in policy recommendations to Congress and the administration. Click here to view what the experts have said about policies importing QALYs and similar measures to the United States.
3. The Protecting Health Care for All Patients Act Has No Budget Impact. Last Congress, the Protecting Health Care for All Patients Act (H.R. 485) passed the House of Representatives on February 7, 2024. Since finalization of the Section 504 rules barring disability discrimination in May 2024, Congressional staff have been informed that the House-passed bill has no budget impact. When considered in the House, the Biden administration's concerns about the bill were limited to the use of a budget offset from the CDC, which is no longer needed. As highlighted by the White House, Democrats supported the original QALY ban in the Affordable Car Act and the nondiscrimination provisions in the IRA. Without the need for an offset, this bipartisan policy change has a stronger chance of consideration this year. People with disabilities and serious chronic conditions continue to support this legislation extending the law barring Medicare’s use of quality-adjusted life years (QALYs) and similar measures to other programs.
As CBO stated when the bill was introduced, current law already prohibits the Secretary from using QALYs and similar measures in Medicare, giving it no impact on the Medicare Drug Price Negotiation Program, which is subject to both the nondiscrimination provisions in the IRA and in the ACA. Entities receiving federal financial assistance (i.e. all the entities impacted by the bill) are also subject to the rules governing Section 504 of the Rehabilitation Act that similarly bar the use of use any measure, assessment, or tool that discounts the value of life extension on the basis of disability (i.e. QALYs) to deny or afford an unequal opportunity to qualified individuals with disabilities, with the agency also clarifying that methods of utility weight generation are also subject to Section 504 when they are used in a way that discriminates. The Protecting Health Care for All Patients Act would explicitly make the statute governing use of QALYs and similar measures also clear and consistent across federal programs.
We urge advocates to call on Congress to take action to pass The Protecting Health Care for All Patients Act this year. Click here to view a one-pager about the bill. The National Down Syndrome Society has updated their FAQ on the legislation here.
4. CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of ICER’s value assessments that rely on the quality-adjusted life year (QALY) and the equal value of life year gained (evLYG), measures that are contrary to the laws governing Medicare and barring disability discrimination. In the explanations released on December 20, 2024, CMS explicitly listed studies from the Institute for Clinical and Economic Review (ICER) in its explanations for the calculation of Maximum Fair Prices (MFPs) for the drugs Eliquis, Enbrel, Farxiga, and Xarelto. The explanation for Xarelto report also cites data from the National Institute for Health and Care Excellence (NICE) in the United Kingdom which is know for its explicit reliance on QALYs. In its public comments, ICER defends the use of the evLYG, calling it a nondiscriminatory alternative and highlighting its use by the Veterans Administration, Medicaid programs and private insurers. CMS did not acknowledge that the evLYG is a similar measure to the QALY that is barred under Section 1182 of the Affordable Care Act and under §84.56 of the rules governing Section 504 of the Rehabilitation Act barring disability discrimination. Click here to view the explanations from CMS.
5. Learn More About Alternative Measures for Value Assessment. PIPC has developed new resources about alternative methods and metrics for value assessment. It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. Click here to learn more.
6. Join PCORI's Advisory Panels: Applications, Nominations are Due March 7! PCORI is accepting applications and nominations for members on its multi-stakeholder advisory panels for the 2024-2025 cycle. These research advisory panels are an important way we bring voices from across the health care community into our work. The panels focus on clinical effectiveness and decision science, clinical trials, healthcare delivery and disparities research, patient engagement, and rare diseases. Click here for additional details and to submit an application.
7. PIPC Calls for Robust Engagement and Transparency as CMS Reviews 15 Additional Drugs under Medicare Drug Negotiation Program. On January 17, 2025, CMS released the second list of drugs that will be subject to Medicare negotiation under the Inflation Reduction Act (IRA). PIPC reiterated in a statement that many patients rely on these treatments for their health and quality of life. PIPC also highlighted concern that ICER and NICE were cited in the explanations for the most recent drugs reviewed by the program and urged CMS to avoid relying on outside research entities whose methods inherently devalue the lives of people with disabilities as they review the second list of drugs. It is not clear how the new administration may change the process to center on patients and people with disabilities.
PIPC stated, "It is imperative that they are consistently able to access the medications they need and that payers and government bureaucrats do not come between patients and their doctors...Unfortunately, CMS’ process over the past year did not provide a level of robust engagement and transparency that would allow patients and people with disabilities to trust that their voices were heard in the process and that different patients’ needs were considered. Therefore, we encourage the incoming administration to take the time necessary to revisit the processes for implementation of the program and address any shortcomings going forward.” View PIPC’s statement 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. “For far too long, menopausal women have had their experiences dismissed and faced barriers to accessing affordable treatment options.”
- Canada. Physicians are concerned about the lack of resources deployed by the government to treat epilepsy given widespread access in other countries.
- New Zealand. Patients with rare and aggressive forms of cancer often must pay out of pocket for treatments that help improve quality of life.
- United Kingdom. First drug proven to slow Alzheimer's disease won't be given to patients in Scotland due to arbitrary cost effectiveness assessments.
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.
- Spinal Muscular Atrophy: Revised Scoping Document, Research Protocol available. Public meeting: August 2025.
- Multiple Sclerosis — SPMS: Revised Scoping Document, Research Protocol available. Public meeting: June 2025.
- Special Assessment to Inform CMS Drug Price Negotiation: Research Protocol available. Final report due March 4, 2025.
- Retinitis Pigmentosa: Draft Evidence Report available. Comments due March 6, 2025. Public meeting: April 2025.
- Acute Pain: Draft Evidence Report available. Public meeting: Feb. 28, 2025.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
March 18-19, 2025
Click here to view.
AHRQ Effective Program Updates
Systematic Review: Behavioral Interventions for Migraine Prevention. Click here to view.
Systematic Review: Healthcare Delivery of Clinical Preventive Services for People With Disabilities. Click here to view.
Systematic Review: Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents. Click here to view.
Research Protocol: Making Healthcare Safer IV: Programs for Responding to Harms Experienced by Patients during Clinical Care. Click here to view.
Research Protocol: Making Healthcare Safer IV: High Reliability Organization (HRO) as a Patient Safety Practice Click here to view.
Research Protocol: Making Healthcare Safer IV: Supply Chain Disruption Monitoring Programs Click here to view.
