— Patient and Disability Advocates Support H.R. 485 Extending Medicare’s Ban on QALYs and Similar Measures. See details below.
— DOJ Enforces ADA to Ensure People with SUD Access Hepatitis C Medications. See details below.
— PIPC Responds to Cassidy RFI on Access to Cell and Gene Therapies. Click here to read the letter.
— PIPC Submits Comments on PCORI's Patient-Centered Economic Outcomes Landscape for Considering the Full Range of Outcomes. Click here to read the letter.
— AHRQ and PCORI Invest in Learning Health Systems Scientist Training. Click here to read the blog.
— PCORI Engagement Awards Now Open for LOI Submission. Click here for additional details on the upcoming engagement awards.
— Ban Quality-Adjusted Life-Years in Oregon. Click here to sign the petition.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
— 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.
— DOJ Enforces ADA to Ensure People with SUD Access Hepatitis C Medications. See details below.
— PIPC Responds to Cassidy RFI on Access to Cell and Gene Therapies. Click here to read the letter.
— PIPC Submits Comments on PCORI's Patient-Centered Economic Outcomes Landscape for Considering the Full Range of Outcomes. Click here to read the letter.
— AHRQ and PCORI Invest in Learning Health Systems Scientist Training. Click here to read the blog.
— PCORI Engagement Awards Now Open for LOI Submission. Click here for additional details on the upcoming engagement awards.
— Ban Quality-Adjusted Life-Years in Oregon. Click here to sign the petition.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
— 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.
What We're Reading
1. Patient and Disability Advocates Support H.R. 485 Extending Medicare’s Ban on QALYs and Similar Measures. Patient and disability advocates continue to support House efforts to advance H.R. 485, the Protecting Health Care for All Patients Act, legislation extending the existing protections in Medicare against the use of discriminatory measures to other programs. As passed from the House Committee on Energy and Commerce, the legislation does not change the existing protections in Medicare, which currently protects against the use of QALYs and similar measures to make decisions related to coverage, reimbursement and incentive programs. The legislation does extend those protections to other federal programs. Without weakening the existing Medicare law, the bill creates the consistent policy across federal programs recommended by the National Council on Disability.
PIPC Chairman Tony Coelho has raised concerns about misinformation related to the legislation, calling on Congress to act with bipartisanship to advance this important legislation and highlighting that the Medicare policy had strong support from Democrats when passed as part of the Affordable Care Act and the Inflation Reduction Act. The DNC Platform also opposes the use of QALYs. Click here to view the opinion from Chairman Coelho. Click here to view the letter supporting H.R. 485 from the Consortium of Constituents with Disabilities. Click here to view the 2019 report from the National Council on Disability. Click here to view the PIPC summary.
2. DOJ Enforces ADA to Ensure People with SUD Access Hepatitis C Medications. The Justice Department (DOJ) announced that it and the Department of Health and Human Services (HHS) issued a joint letter to state Medicaid administrators urging them to ensure, in accordance with the Americans with Disabilities Act (ADA), that their Medicaid programs allow people who have both Hepatitis C (HCV) and substance use disorder (SUD) to access life-saving HCV medications called direct-acting antivirals (DAAs). “Medicaid recipients with substance use disorders are entitled to the same access as others to a cure for Hepatitis C,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “This letter reminds state Medicaid administrators that they have an obligation to ensure their programs are in compliance with federal civil rights law. The Justice Department stands ready to enforce the ADA in order to eliminate unnecessary barriers that stand in the way of equal access to health care.” This action is consistent with comments from patient and disability organizations to the HHS Office for Civil Rights calling for updated regulations on Section 504 of the Rehabilitation Act to explicitly address that coverage and utilization management policies based on biased perceptions of quality-of-life lead to discriminatory judgments about a person’s worthiness of treatment are unlawful, citing hepatitis C restrictions as an example. Click here to view the DOJ press release. Click here to view the Harvard Center for Health Law and Policy Innovation press release. Click here to view the comments from advocates on Section 504.
3. PIPC Responds to Cassidy RFI on Access to Cell and Gene Therapies. PIPC submitted a response to Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy’s (R-LA) request for information (RFI) on ways to improve access to cell and gene therapies. PIPC recommendations included that considerations related to the value and effectiveness of cell and gene therapies should incorporate patient perspectives, avoid discriminatory and biased measures and health utilities; Congress should ban use of QALYs and similar measures consistently across federal programs; Congress should not adopt foreign government policies related to reimbursement and coverage of cell and gene therapies; coverage and utilization management policies should not be selectively based on a person’s level of disability or biased perceptions of quality-of-life, leading to discriminatory judgments about a person’s worthiness of treatment.
4. PIPC Submits Comments on PCORI's Patient-Centered Economic Outcomes Landscape for Considering the Full Range of Outcomes. PIPC recently submitted a comment letter on the Patient Centered Outcomes Research Institute's (PCORI) Patient-Centered Patient-Centered Economic Outcomes Landscape for Considering the Full Range of Outcomes in PCORI-funded research. The letter encourages PCORI's final published landscape to be cross referenced to the Patient Engagement Rubric so that PCORI-funded research is guided in determining burdens and economic impacts based on the experiences of patients and people with disabilities. PIPC also encourages PCORI to use the terminology patient-centered burdens and economic outcomes (PCBEOs) instead of patient-centered economic outcomes (PCEOs).
5. AHRQ and PCORI Invest in Learning Health Systems Scientist Training. Dr. Robert Otto Valdez and Dr. Nakela Cook —the heads of AHRQ and PCORI, respectively — penned a blog outlining their partnership to advance learning health system scientist training. “...In evolving our joint efforts, we have developed the Learning Health System Embedded Scientist Training and Research (LHS E-StaR) Centers, with an investment of up to $80 million over 5 years to support learning health systems, including patient-centered comparative clinical effectiveness research. We are pleased to announce that for this first year, $16 million has been awarded to fund 16 centers nationwide. Through this joint initiative, AHRQ and PCORI are following through on our mutual commitments to support learning health systems by training a new cadre of learning health system scientists. Awardees will create new models of learning health system infrastructure that will use evidence generated by these scientists' research to optimize care as quickly, broadly, and equitably as possible and ultimately improve health outcomes.”
6. PCORI Engagement Awards Now Open for LOI Submission. PCORI is now accepting Letters of Intent (LOIs) for the Eugene Washington PCORI Engagement Award Program. These awards are intended to bring more patients, caregivers, clinicians and other healthcare stakeholders into the patient-centered comparative clinical effectiveness research. Click here for additional details on the upcoming engagement awards.
7. Ban Quality-Adjusted Life-Years in Oregon. Disability Rights Oregon is circulating a petition to ban quality adjusted life years (QALYs) by payers in Oregon, a flawed scoring system economists use to determine cost-effectiveness of proposed medical treatments. Payers—including the Oregon Health Plan—use QALY scores to determine who is eligible for healthcare resources. The problem is the scores are calculated in inherently discriminatory ways. DRO states in their petition, "QALY violates both the Rehabilitation Act and the Americans with Disabilities Act. These types of scores have no place influencing what conditions and treatments the Oregon Health Plan will cover.” DRO hopes that the state legislature will act during a short legislative session. Click here to sign the petition.
8. PCORI Seeks Nominations for Advisory Panels. PCORI is currently seeking nominations for appointments to its advisory panels. These multi-stakeholder advisory panels must include patients, caregivers, or patient advocates. PCORI advisory panels do not serve in an official decision-making capacity, but their recommendations and advice will be taken into consideration by PCORI. PIPC encourages patients, caregivers, and patient advocates to apply or to submit nominations to serve on PCORI's five advisory panels on: Clinical Effectiveness and Decision Science, Clinical Trials, Healthcare Delivery & Disparities Research, Patient Engagement, and Rare Disease. The application is open through March 29, 2024. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
Colorado
Colorado passed legislation in 2021 creating a Prescription Drug Affordability Review Board. The legislation included language stating that the Upper Payment Limit for selected drugs "shall not consider research or methods that employ a dollars-per-quality adjusted life year, or similar measure, that discounts the value of a life because of an individual's disability or age.” However, this limitation did not clearly extend to the process for determining the selected drugs or the affordability review. Presentations to the Colorado Board from entities such as the Program on Regulation, Therapeutics, and Law (PORTAL) related to cost effectiveness analyses have referenced the merits of using of a cost-per-QALY or the equal value of life-year gained (evLYG) in estimating cost effectiveness of treatments, indicating that these discriminatory measures may have influenced how Colorado selected the drugs and may influence the affordability review. Concerns about the potential for discrimination were described in a letter to the Board from 16 patient and disability organizations. The PDAB offers several opportunities for patients to engage and ensure their voice is heard on these topics.
The next PDAB Meeting will be held Friday, February 16 from 1 -5 pm MT. Click here to register or provide comment. The PDACC has also noticed that it is currently accepting applications for new council members. Click here to apply.
Illinois
Legislation was introduced in the Illinois House (HB 4472) on January 17, 2024 creating a Health Care Availability and Access Board, using a model aligned with the NASHP template legislation for creation of Prescription Drug Affordability Boards. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Illinois. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)).
Massachusetts
The Massachusetts Senate’s Ways and Means Committees was referred the “PACT Act”, reported favorably on October 30, 2023 by the Joint Committee on Health Care Financing. The legislation includes a provision calling for the health policy commission not to base its determinations on measures such as QALYs. The Senate rejected an amendment (#19) pushed by Massachusetts advocates calling for transparency related to the use of cost effectiveness analyses by the commission, as well as increased requirements for stakeholder engagement. The Senate passed the bill on November 15, 2023. Massachusetts advocates will work with the House toward language that more clearly provides for public transparency of the evidence under consideration and opportunities for engagement from patients and people with disabilities.
Oregon
The Oregon legislature passed SB 844 in 2021 creating a Prescription Drug Affordability Board, which was updated based on the Board’s recommendations in 2023 by SB 192. While the legislation included language barring consideration of QALYs and similar formulas, the Board has engaged the Program on Regulation, Therapeutics, and Law (PORTAL), per their meeting agenda for November 15. PORTAL has a subcontract with the Institute for Clinical and Economic Review (ICER) for its work with the Massachusetts Health Policy Commission and has presented on the merits of the QALY and evLYG measures to the Colorado Prescription Drug Affordability Board. This raises concerns about the evidentiary basis for the Board’s decisions and the potential for reference to discriminatory measures of cost effectiveness.
The Oregon Board voted to advance an affordability review of 26 drugs at the October 18, 2023 meeting, with an ambitious plan to conduct the reviews by February. The Board’s rules for conducting an affordability review does not include a robust process for engaging patients and people with disabilities in their decisions. The Oregon PDAB held a meeting on January 17, 2023. In response, advocates sent a letter to the Board in advance of their December public meeting, available here. Guidance for providing public testimony is available here.
Click here to join Disability Rights Oregon in advocating for legislation banning use of QALYs.
Vermont
On January 4, 2024, the Vermont Senate Health and Welfare Committee raised S. 98, legislation that would direct the Green Mountain Care Board to conduct an affordability review using cost-effectiveness studies. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)). Advocates that want to weigh in may reach out to the committee assistant Kiki Carasi-Schwartz at [email protected].
Virginia
Legislation creating a Prescription Drug Affordability Board was reintroduced in the Virginia legislature (HB 570 and SB 274). The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Virginia. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)).
Washington State
At its December, 2023 meeting, the Washington State Prescription Drug Affordability Board acknowledged the limitation in its statute on using quality adjusted life years (QALYs) to establish an upper payment limit, yet also raised the possibility of contracting with the Institute for Clinical and Economic Review (ICER) as a consultant to the Board for its methodologies and analysis (1:03:25). At its October, 2023 meeting, the Board discussed partnering the Program on Regulation, Therapeutics, and Law (PORTAL), acknowledging its education of the Colorado Board and collaboration with the National Association of State Health Policy (NASHP) in development of the legislation creating Washington’s PDAB and supporting materials, further underscoring the potential influence of entities that view QALYs and evLYG measures as useful to the affordability review process (47:55). PIPC is following the PDAB’s implementation in Washington State closely for potential use of discriminatory measures of effectiveness. The next meeting is on January 31, 2024, though the registration and agenda is not yet posted.
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
February 13, 2024
Click here to view.
Medical Journal Articles
Comparative Effectiveness Research Using Claims Data: Meticulous Methods Don’t Solve Old Problems. Click here to read the article.
The Impact of The House Proposed IRA Expansion on the US Biopharma Ecosystem. Click here to view the report.
Using A Patient-Centered Value Assessment to Optimize Fair Prices for Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Click here to read the article.
Alternative approaches to measuring value: an update on innovative methods in the context of the United States Medicare drug price negotiation program. Click here to read the article.
Economic Outcomes in Patient-Centered Outcomes Research: A Paradigm Shift. Click here to read the article.
Visualization of Evidence for Shared Decision Making. Click here to read the article.
Avenues for Strengthening PCORnet’s Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research. Click here to read the article.
Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries. Click here to read the article.
Gene Therapies for Sickle Cell Disease: Effectiveness and Value. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
AHRQ Effective Program Updates
Systematic Review: Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
Technical Brief: Measuring Healthcare Organization Characteristics in Cancer Care Delivery Research. Click here to view.
Systematic Review: Postpartum Care up to 1 Year After Pregnancy: A Systematic Review and Meta-analysis. Click here to view.
Draft Report: Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
Systematic Review: Partian Breast Irradiation for Breast Cancer. Click here to view.
Systematic Review: Use of Telehealth During the COVID-19 Era. Click here to view.
Research Report: Analysis of Requirements for Coverage with Evidence Development (CED) - Topic Refinement. Click here to view.
Technical Brief: Infection Prevention and Control for the Emergency Medical Services and 911 Workforce. Click here to view.
Systematic Review: Management of Infantile Epilepsies. Click here to view.
1. Patient and Disability Advocates Support H.R. 485 Extending Medicare’s Ban on QALYs and Similar Measures. Patient and disability advocates continue to support House efforts to advance H.R. 485, the Protecting Health Care for All Patients Act, legislation extending the existing protections in Medicare against the use of discriminatory measures to other programs. As passed from the House Committee on Energy and Commerce, the legislation does not change the existing protections in Medicare, which currently protects against the use of QALYs and similar measures to make decisions related to coverage, reimbursement and incentive programs. The legislation does extend those protections to other federal programs. Without weakening the existing Medicare law, the bill creates the consistent policy across federal programs recommended by the National Council on Disability.
PIPC Chairman Tony Coelho has raised concerns about misinformation related to the legislation, calling on Congress to act with bipartisanship to advance this important legislation and highlighting that the Medicare policy had strong support from Democrats when passed as part of the Affordable Care Act and the Inflation Reduction Act. The DNC Platform also opposes the use of QALYs. Click here to view the opinion from Chairman Coelho. Click here to view the letter supporting H.R. 485 from the Consortium of Constituents with Disabilities. Click here to view the 2019 report from the National Council on Disability. Click here to view the PIPC summary.
2. DOJ Enforces ADA to Ensure People with SUD Access Hepatitis C Medications. The Justice Department (DOJ) announced that it and the Department of Health and Human Services (HHS) issued a joint letter to state Medicaid administrators urging them to ensure, in accordance with the Americans with Disabilities Act (ADA), that their Medicaid programs allow people who have both Hepatitis C (HCV) and substance use disorder (SUD) to access life-saving HCV medications called direct-acting antivirals (DAAs). “Medicaid recipients with substance use disorders are entitled to the same access as others to a cure for Hepatitis C,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “This letter reminds state Medicaid administrators that they have an obligation to ensure their programs are in compliance with federal civil rights law. The Justice Department stands ready to enforce the ADA in order to eliminate unnecessary barriers that stand in the way of equal access to health care.” This action is consistent with comments from patient and disability organizations to the HHS Office for Civil Rights calling for updated regulations on Section 504 of the Rehabilitation Act to explicitly address that coverage and utilization management policies based on biased perceptions of quality-of-life lead to discriminatory judgments about a person’s worthiness of treatment are unlawful, citing hepatitis C restrictions as an example. Click here to view the DOJ press release. Click here to view the Harvard Center for Health Law and Policy Innovation press release. Click here to view the comments from advocates on Section 504.
3. PIPC Responds to Cassidy RFI on Access to Cell and Gene Therapies. PIPC submitted a response to Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy’s (R-LA) request for information (RFI) on ways to improve access to cell and gene therapies. PIPC recommendations included that considerations related to the value and effectiveness of cell and gene therapies should incorporate patient perspectives, avoid discriminatory and biased measures and health utilities; Congress should ban use of QALYs and similar measures consistently across federal programs; Congress should not adopt foreign government policies related to reimbursement and coverage of cell and gene therapies; coverage and utilization management policies should not be selectively based on a person’s level of disability or biased perceptions of quality-of-life, leading to discriminatory judgments about a person’s worthiness of treatment.
4. PIPC Submits Comments on PCORI's Patient-Centered Economic Outcomes Landscape for Considering the Full Range of Outcomes. PIPC recently submitted a comment letter on the Patient Centered Outcomes Research Institute's (PCORI) Patient-Centered Patient-Centered Economic Outcomes Landscape for Considering the Full Range of Outcomes in PCORI-funded research. The letter encourages PCORI's final published landscape to be cross referenced to the Patient Engagement Rubric so that PCORI-funded research is guided in determining burdens and economic impacts based on the experiences of patients and people with disabilities. PIPC also encourages PCORI to use the terminology patient-centered burdens and economic outcomes (PCBEOs) instead of patient-centered economic outcomes (PCEOs).
5. AHRQ and PCORI Invest in Learning Health Systems Scientist Training. Dr. Robert Otto Valdez and Dr. Nakela Cook —the heads of AHRQ and PCORI, respectively — penned a blog outlining their partnership to advance learning health system scientist training. “...In evolving our joint efforts, we have developed the Learning Health System Embedded Scientist Training and Research (LHS E-StaR) Centers, with an investment of up to $80 million over 5 years to support learning health systems, including patient-centered comparative clinical effectiveness research. We are pleased to announce that for this first year, $16 million has been awarded to fund 16 centers nationwide. Through this joint initiative, AHRQ and PCORI are following through on our mutual commitments to support learning health systems by training a new cadre of learning health system scientists. Awardees will create new models of learning health system infrastructure that will use evidence generated by these scientists' research to optimize care as quickly, broadly, and equitably as possible and ultimately improve health outcomes.”
6. PCORI Engagement Awards Now Open for LOI Submission. PCORI is now accepting Letters of Intent (LOIs) for the Eugene Washington PCORI Engagement Award Program. These awards are intended to bring more patients, caregivers, clinicians and other healthcare stakeholders into the patient-centered comparative clinical effectiveness research. Click here for additional details on the upcoming engagement awards.
7. Ban Quality-Adjusted Life-Years in Oregon. Disability Rights Oregon is circulating a petition to ban quality adjusted life years (QALYs) by payers in Oregon, a flawed scoring system economists use to determine cost-effectiveness of proposed medical treatments. Payers—including the Oregon Health Plan—use QALY scores to determine who is eligible for healthcare resources. The problem is the scores are calculated in inherently discriminatory ways. DRO states in their petition, "QALY violates both the Rehabilitation Act and the Americans with Disabilities Act. These types of scores have no place influencing what conditions and treatments the Oregon Health Plan will cover.” DRO hopes that the state legislature will act during a short legislative session. Click here to sign the petition.
8. PCORI Seeks Nominations for Advisory Panels. PCORI is currently seeking nominations for appointments to its advisory panels. These multi-stakeholder advisory panels must include patients, caregivers, or patient advocates. PCORI advisory panels do not serve in an official decision-making capacity, but their recommendations and advice will be taken into consideration by PCORI. PIPC encourages patients, caregivers, and patient advocates to apply or to submit nominations to serve on PCORI's five advisory panels on: Clinical Effectiveness and Decision Science, Clinical Trials, Healthcare Delivery & Disparities Research, Patient Engagement, and Rare Disease. The application is open through March 29, 2024. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
- Click here to learn more about the potential for Prescription Drug Affordability Boards to discriminate by incorporating the use of QALYS.
- Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
- Click here to view a one pager about the flaws in ICER’s methodology.
- Click here to view information from experts on the downside of referencing foreign countries.
- Click here to learn about statutory protections against use of QALYs.
Colorado
Colorado passed legislation in 2021 creating a Prescription Drug Affordability Review Board. The legislation included language stating that the Upper Payment Limit for selected drugs "shall not consider research or methods that employ a dollars-per-quality adjusted life year, or similar measure, that discounts the value of a life because of an individual's disability or age.” However, this limitation did not clearly extend to the process for determining the selected drugs or the affordability review. Presentations to the Colorado Board from entities such as the Program on Regulation, Therapeutics, and Law (PORTAL) related to cost effectiveness analyses have referenced the merits of using of a cost-per-QALY or the equal value of life-year gained (evLYG) in estimating cost effectiveness of treatments, indicating that these discriminatory measures may have influenced how Colorado selected the drugs and may influence the affordability review. Concerns about the potential for discrimination were described in a letter to the Board from 16 patient and disability organizations. The PDAB offers several opportunities for patients to engage and ensure their voice is heard on these topics.
The next PDAB Meeting will be held Friday, February 16 from 1 -5 pm MT. Click here to register or provide comment. The PDACC has also noticed that it is currently accepting applications for new council members. Click here to apply.
Illinois
Legislation was introduced in the Illinois House (HB 4472) on January 17, 2024 creating a Health Care Availability and Access Board, using a model aligned with the NASHP template legislation for creation of Prescription Drug Affordability Boards. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Illinois. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)).
Massachusetts
The Massachusetts Senate’s Ways and Means Committees was referred the “PACT Act”, reported favorably on October 30, 2023 by the Joint Committee on Health Care Financing. The legislation includes a provision calling for the health policy commission not to base its determinations on measures such as QALYs. The Senate rejected an amendment (#19) pushed by Massachusetts advocates calling for transparency related to the use of cost effectiveness analyses by the commission, as well as increased requirements for stakeholder engagement. The Senate passed the bill on November 15, 2023. Massachusetts advocates will work with the House toward language that more clearly provides for public transparency of the evidence under consideration and opportunities for engagement from patients and people with disabilities.
Oregon
The Oregon legislature passed SB 844 in 2021 creating a Prescription Drug Affordability Board, which was updated based on the Board’s recommendations in 2023 by SB 192. While the legislation included language barring consideration of QALYs and similar formulas, the Board has engaged the Program on Regulation, Therapeutics, and Law (PORTAL), per their meeting agenda for November 15. PORTAL has a subcontract with the Institute for Clinical and Economic Review (ICER) for its work with the Massachusetts Health Policy Commission and has presented on the merits of the QALY and evLYG measures to the Colorado Prescription Drug Affordability Board. This raises concerns about the evidentiary basis for the Board’s decisions and the potential for reference to discriminatory measures of cost effectiveness.
The Oregon Board voted to advance an affordability review of 26 drugs at the October 18, 2023 meeting, with an ambitious plan to conduct the reviews by February. The Board’s rules for conducting an affordability review does not include a robust process for engaging patients and people with disabilities in their decisions. The Oregon PDAB held a meeting on January 17, 2023. In response, advocates sent a letter to the Board in advance of their December public meeting, available here. Guidance for providing public testimony is available here.
Click here to join Disability Rights Oregon in advocating for legislation banning use of QALYs.
Vermont
On January 4, 2024, the Vermont Senate Health and Welfare Committee raised S. 98, legislation that would direct the Green Mountain Care Board to conduct an affordability review using cost-effectiveness studies. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)). Advocates that want to weigh in may reach out to the committee assistant Kiki Carasi-Schwartz at [email protected].
Virginia
Legislation creating a Prescription Drug Affordability Board was reintroduced in the Virginia legislature (HB 570 and SB 274). The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Virginia. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)).
Washington State
At its December, 2023 meeting, the Washington State Prescription Drug Affordability Board acknowledged the limitation in its statute on using quality adjusted life years (QALYs) to establish an upper payment limit, yet also raised the possibility of contracting with the Institute for Clinical and Economic Review (ICER) as a consultant to the Board for its methodologies and analysis (1:03:25). At its October, 2023 meeting, the Board discussed partnering the Program on Regulation, Therapeutics, and Law (PORTAL), acknowledging its education of the Colorado Board and collaboration with the National Association of State Health Policy (NASHP) in development of the legislation creating Washington’s PDAB and supporting materials, further underscoring the potential influence of entities that view QALYs and evLYG measures as useful to the affordability review process (47:55). PIPC is following the PDAB’s implementation in Washington State closely for potential use of discriminatory measures of effectiveness. The next meeting is on January 31, 2024, though the registration and agenda is not yet posted.
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.
- New Zealand: Cancer patients are turning to crowdfunding to gain access to a drug that has a 60 percent success rate in various forms of the disease.
- United Kingdom: A family is pushing for access to a cystic fibrosis drug for their five-month old baby, but right now it is still considered too expensive to be covered by the NHS.
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.
- Myelodysplastic Syndrome: Revised Scoping Document available. Public meeting: July 2024.
- Chronic Obstructive Pulmonary Disease: Revised Scoping Document available. Public meeting: June 2024
- Post-Traumatic Stress Disorder: Revised Scoping Document available. Main review: May 30, 2024.
- Paroxysmal Nocturnal Hemoglobinuria: Draft Evidence Report available.
- Schizophrenia: Evidence Report available. Public meeting: February 9, 2024.
- Pulmonary Arterial Hypertension: Final Evidence Report and Meeting Summary available.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
February 13, 2024
Click here to view.
Medical Journal Articles
Comparative Effectiveness Research Using Claims Data: Meticulous Methods Don’t Solve Old Problems. Click here to read the article.
The Impact of The House Proposed IRA Expansion on the US Biopharma Ecosystem. Click here to view the report.
Using A Patient-Centered Value Assessment to Optimize Fair Prices for Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Click here to read the article.
Alternative approaches to measuring value: an update on innovative methods in the context of the United States Medicare drug price negotiation program. Click here to read the article.
Economic Outcomes in Patient-Centered Outcomes Research: A Paradigm Shift. Click here to read the article.
Visualization of Evidence for Shared Decision Making. Click here to read the article.
Avenues for Strengthening PCORnet’s Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research. Click here to read the article.
Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries. Click here to read the article.
Gene Therapies for Sickle Cell Disease: Effectiveness and Value. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
AHRQ Effective Program Updates
Systematic Review: Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
Technical Brief: Measuring Healthcare Organization Characteristics in Cancer Care Delivery Research. Click here to view.
Systematic Review: Postpartum Care up to 1 Year After Pregnancy: A Systematic Review and Meta-analysis. Click here to view.
Draft Report: Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
Systematic Review: Partian Breast Irradiation for Breast Cancer. Click here to view.
Systematic Review: Use of Telehealth During the COVID-19 Era. Click here to view.
Research Report: Analysis of Requirements for Coverage with Evidence Development (CED) - Topic Refinement. Click here to view.
Technical Brief: Infection Prevention and Control for the Emergency Medical Services and 911 Workforce. Click here to view.
Systematic Review: Management of Infantile Epilepsies. Click here to view.
