— PCORI Board of Governors Discusses Health Equity and Value. See below for details.
— Advocacy Organizations Comment to AHRQ Opposing Use of QALYs in Coverage with Evidence Development Requirements. Click here to view the letter.
— Patient-Centered Care Takes Center Stage in New Report from AHRQ’s Digital Healthcare Research Program. Click here to read the blog post.
— Experts Discuss Innovations in Care Delivery, Technology Driving Integration of Patient-Centric Value Frameworks. Click here to read the article.
— PIPC Chairman Coelho Testifies to Oregon HERC that QALYs are Contrary to the ADA, Advocates Weigh In. Click here to read Coelho's full remarks.
— PIPC Joins Over 80 Organizations Urging HHS Civil Rights Office to Ban QALYs Across Federal Programs. Click here to read the letter.
— PIPC Submits Feedback to E&C GOP on Disability Policies for the 21st Century. Click here to read the letter.
— PCORI to Release Funding Opportunity on Health Equity Research Partnerships. See below for details.
— Senate Republicans Urge HHS to Ban the Use of QALYs and Other Discriminatory Comparative Effectiveness Research. Click here to read the letter.
— CDER Official Reflects on a Decade of Patient-Focused Drug Development. Click here to read the article.
— 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. PCORI Board of Governors Discusses Health Equity and Value. The PCORI Board of Governors held a meeting on September 20, 2022 during which the Board emphasized its ongoing work toward health equity. The Board discussed its Partnering Research and Community Organizations for Novel Health Equity Research or the Partner Initiative. PCORI intends to release a funding announcement related to its Health Equity Initiative soon. Dr. Kara Ayers emphasized the potential of PCORnet as a driver of data equity. It is a goal of PCORnet to accelerate participation of diverse, underrepresented, and underserved populations, both in governance and research. PCORI also discussed the work of the Healthcare Cost and Value Work Group, including a published landscape review of patient and stakeholder perspectives on value in health and healthcare. Click here to view the transcript. Click here to view information about the Partner Initiative. Click here to view information about PCORnet. Click here to review the landscape review on value.
2. Advocacy Organizations Comment to AHRQ Opposing Use of QALYs in Coverage with Evidence Development Requirements. On September 7, 2022, the Agency for Healthcare Research and Quality (AHRQ) released proposed updated study requirements for Medicare’s coverage with evidence development (CED) program. CED is utilized by the Centers for Medicare and Medicaid Services (CMS) when the agency believes additional clinical information is necessary before providing broad access to a procedure, medical device, diagnostic, or prescription drug in the Medicare program. Among their concerns, advocates pointed out AHRQ’a improper reliance on cost-effectiveness studies, including the use of quality-adjusted life years. The letter states, "More specifically, the ACA disallows the HHS Secretary (and AHRQ, as an agency within HHS) to use QALY as “a threshold to determine coverage, [or] reimbursement,” in the Medicare program. Despite this clear parameter, AHRQ, for purposes of a study that will directly impact the CMS CED process which will determine both coverage and reimbursement, is using such studies. We believe AHRQ’s use and reliance upon these studies is in direct violation of law.” Click here to view the letter. Click here to view the article in Inside Health Policy (subscription required).
3. Patient-Centered Care Takes Center Stage in New Report from AHRQ’s Digital Healthcare Research Program. As detailed in a blog from the Agency for Healthcare Research and Quality (AHRQ), "the goal of patient-centered care supported by digital healthcare tools is being realized today at an ever-faster pace. And as recent projects supported by AHRQ’s Digital Healthcare Research Program show, their benefits are extending to patients whose needs have often fallen through the cracks of our healthcare delivery system." Through their 2021 annual report, AHRQ highlights projects that speak to the role that digital healthcare technology plays in improving patient care. The report describes 21 completed and 25 ongoing AHRQ-funded research projects, such as digital tools to better manage attention deficit-hyperactivity disorder (ADHD) among others. Additionally, the report highlights emerging research in AHRQ’s priority areas, notably the role of social determinants of health (SDOH) in access and outcomes. Click here to read the blog post.
4. Experts Discuss Innovations in Care Delivery, Technology Driving Integration of Patient-Centric Value Frameworks. On October 12, 2022, two expert stakeholders from Avalere Health discussed the utility of patient-centric value frameworks for equitable health care delivery, in additional to challenges and strategies regarding its implementation at the Academy of Managed Care Pharmacy (AMCP) Nexus 2022 meeting. Notably, the experts note that "patient preferences and consideration of SDOH and other external factors are key to achieving value-based care delivery, but the lack of data on these variables or even a mechanism to define their impact remains a major limitation to the integration of these frameworks." Click here to read the article.
5. PIPC Chairman Coelho Testifies to Oregon HERC that QALYs are Contrary to the ADA, Advocates Weigh In. Chairman Coelho testified in response to the Oregon Health Evidence Review Committee’s (HERC) proposed options for continuing its use of the quality-adjusted life year or QALY te determine its prioritized list of services. Chairman Coelho urged the HERC to stop using QALYs altogether and referenced his work authoring the Americans with Disabilities Act (ADA) as intended to drive equal access to health care. HHS referenced the ADA in rejecting Oregon’s use of QALYs in 1992, giving Oregon 30 years to find alternative strategies for covering health care services. Chairman Coelho said, "Being part of the solution – instead of the problem – means ending use of evidence that feeds bias and inequity in health care.” At the HERC meeting, the Oregon Health Authority expressed their intent to continue use of a prioritized list as part of its State Plan Amendment after 2027. The HERC will move forward with public comment on options to continue its use of QALYs. Click here to read Coelho's full remarks. Click here to view the letter from almost 50 advocates in Oregon. Click here to view the options under consideration - comments due November 1, 2022. Scroll down to state updates for more information.
6. PIPC Joins Over 80 Organizations Urging HHS Civil Rights Office to Ban QALYs Across Federal Programs. PIPC joined over 80 organizations in signing a letter to the HHS Office for Civil Rights commenting on the proposed rule implementing Section 1557 of the Affordable Care Act. The groups support a comprehensive proposed rule seeking to strengthen civil rights protections in federally funded health programs and HHS programs and agreed that the ability to access needed health care fully and free from discrimination is critical and requires action to support and strengthen existing nondiscrimination laws. Their comments focused on the agency’s request for comments on the extent, scope and nature of value assessment methods that discriminate on the basis of race, color, national origin, sex, age, or disability; the use of clinical algorithms in health care decision-making; and nondiscrimination requirements and enforcement.
Among the recommendations, the groups urged the Office for Civil Rights to advance a rulemaking that codifies a ban on the use of methods for calculating value that penalize individuals or groups of individuals on the basis of race, color, national origin, sex, age, or disability as part of utilization management, formulary design, price negotiations, alternative payment models and other incentive-based programs impacting access to care and affordability of care. The letter also urged HHS to learn from the pandemic and codify regulations that health care providers may not rely on clinical algorithms that function to discriminate against providing care to people based on race, color, national origin, sex, age, and disability and to ensure state Medicaid programs are meeting the ADA’s requirements for accessibility to the information on which they make decisions and communicating that information in a manner that does not disadvantage people with disabilities or people with limited access to technology. Click here to view the letter.
7. PIPC Submits Feedback to E&C GOP on Disability Policies for the 21st Century. In a letter to House Energy and Commerce (E&C) Committee Ranking Member Cathy McMorris Rodgers (R-WA), the Partnership to Improve Patient Care (PIPC) provided feedback on the Republicans' request for information (RFI) entitled "Disability Policies for the 21st Century: Building Opportunities for Work and Inclusion." The letter applauds the E&C GOP for prioritizing legislation that will ban the use of the quality-adjusted-life-years (QALY) metric across federal health care programs, including Medicaid. PIPC also encourages the committee to strengthen oversight requirements at the Department of Health and Human Services (HHS) and Department of Justice to ensure that people with disabilities are able to access health care without discrimination. "We are grateful that you are aware of and prioritize advancing legislation that will bar the use of the QALY across Federal programs, the Protecting Health Care for All Patients Act," wrote PIPC Chair Tony Coelho.
8. PCORI to Release Funding Opportunity on Health Equity Research Partnerships. In January 2023, the Patient-Centered Outcomes Research Institute (PCORI) will release a new Targeted PCORI Funding Announcement (PFA). This new Targeted PFA not only focuses on improving maternal outcomes by simultaneously addressing health conditions and social determinants of health, it also uniquely positions community organizations to be a full partner and co-lead the project alongside research organizations. Click here for details about this new Targeted PFA, entitled Partnering Research and Community Organizations for Novel Health Equity Research: Addressing Social and Clinical Determinants of Maternal Health. Register for the October applicant town hall to find out more about this new funding opportunity.
9. Senate Republicans Urge HHS to Ban the Use of QALYs and Other Discriminatory Comparative Effectiveness Research. On September 14 a group of Senate Republicans sent a letter to Secretary Becerra and Administrator Brooks LaSure about the implementation of the Medicare negotiation provision in the Inflation Reduction Act expressing concerns about the potential implications to patient access. The letter specifically noted the fact that the CBO used the QALY when modeling the bill, made clear the QALY is a discriminatory metric, and requested HHS commit to excluding any research including the QALY and lay out a concrete plan to enforce the legislation’s ban on the use of discriminatory comparative effectiveness research. The letter also called for HHS to lay out a plan for robust engagement with affected stakeholders – including patients, people with disabilities, and caregivers – throughout the process noting that, “the exclusion of patient voices from policymaking poses potentially catastrophic consequences, particularly for individuals living with rare diseases or with disabilities.”
10. CDER Official Reflects on a Decade of Patient-Focused Drug Development. Dr. Theresa Mullin, Ph.D., associate director for strategic initiatives within the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), said that patient-focused drug development is "a systematic approach to help ensure that patients' experiences and their perspectives and needs and priorities are captured and meaningfully incorporated into drug development and benefit-risk assessment." Using the patient-focused allows FDA staff and industry to involve patients and their caregivers in drug development, clinical trials, and regulatory decisions and identify what outcomes are important to them, according to Dr. Mullin. Click here to read the article.
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.
On August 31, 2022, California Attorney General Rob Bonta sent letters to hospital CEOs across the state requesting information about how healthcare facilities and other providers are identifying and addressing racial and ethnic disparities in commercial decision-making tools. The request for information is the first step in a DOJ inquiry into whether commercial healthcare algorithms – types of software used by healthcare providers to make decisions that affect access to healthcare for California patients – have discriminatory impacts based on race and ethnicity. Click here to view the Attorney General’s letter. In March, 2022, ICER received a grant from the California Health Care Foundation to develop annual unsupported price increase reports as well as a policymaker guide for using its research to determine “fair” access and pricing to drugs. Advocates are concerned of the implications of this grant given ICER’s reliance on QALYs. Click here to view the letter to CHCF from advocates.
On September 22, 2022, the Nevada Patient Protection Committee received a presentation highlighting efforts have been undertaken in other states with the goal of lower drug prices including establishing a Prescription Drug Affordability Board, relying on ICER’s unsupported price increase report, and referencing the prices of Canadian drugs, risking reliance on metrics that discriminate with potential implications for access to care, similar to the experience of patients and people with disabilities in Canada. The Committee meeting did not include participation from patients and people with disabilities, and the Committee did not discuss the discriminatory implications of the QALY. The next meeting is on October 19, 2022. Click here for more information and to register to participate the week prior to the meeting. The PPC allows testimony to be submitted and opportunities to comment during the meeting
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) Value based Benefits Subcommittee discussed a proposed plan for using QALYs, including proposals to redact the word QALY from the HERC’s deliberations without barring the use of the metric in making decisions. The meeting followed CMS approval of Oregon’s waiver application, which does not bar the use of QALYs in the interim. Click here to read comments submitted by PIPC along with 62 other groups asking CMS to reject the waiver. Click here to view the CMS-approved waiver. At the HERC meeting, the Oregon Health Authority expressed its intent to continue using a prioritized list, shifting it from use under a waiver to use as part of the State Plan Amendment after the waiver expires in 2027. The HERC decided to accept comments on options to either adjust their use of QALYs or to cease mentioning QALYs at meetings and redact their mention from published articles, despite vehement opposition from advocates based on the implications for discrimination and health equity, as well as the potential lack of transparency related to their use to make decisions if simply redacted from studies considered by the HERC. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs, to support Oregon’s health equity goals and to lead in developing alternative coverage strategies that do not discriminate. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act and the implications of QALYs for violating existing federal civil and disability rights laws. Click here to view the options that continue to be under consideration by the HERC to continue using QALYs - comments due on November 1, 2022. The HERC will meet again on November 17, 2022 to vote on the options under consideration. Click here to join the meeting on November 17.
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: An MS patient is taking a chance on an intensive treatment option, an Autologous Hematopoietic Stem Cell Transplant (AHSCT), but AHSCT is only available in her country through a medical trial which she is not eligible for.
- Canada: A CF patient, who recently committed suicide, started an equitable drug access campaign in 2017 for the government to cover the cost of a life-saving CF drug for all patients in need, until the government finally gave in last year.
- New Zealand: Lung cancer patient advocate is pleading with Pharmac to cover treatments for patients with Stage 4 lung cancer, as many countries are covered, causing patients unprecedented financial hardship.
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.
- Amyotrophic Lateral Sclerosis (ALS): Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- Non Alcoholic Steatohepatitis: 11/3/2022: Revised Scoping Document. Draft Scoping Document available. Public comments open until 10/26/2022.
- Menopause: Vasomotor Symptoms: Draft Evidence Report available. Public Comments open until 11/7/2022. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available. Draft Scoping Document available. 12/1/2022: Evidence Report.
- Alzheimer's Disease: 11/10/2022: Model Analysis Plan Research Protocol available. Revised Scoping Document available.
- Beta Thalassemia: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- COVID-19: Final Evidence Report and Meeting Summary available. Evidence Presentation and Report available. Draft Evidence Report Available. Public comments closed. Model Analysis Plan available. Draft Scoping Document and Research Protocol available.
- Obesity Management: Evidence Report available. Evidence Presentation available. 10/17/2022: Final Evidence Report and Meeting Summary. Draft Evidence Report available. Model Analysis Plan available. Research Protocol available.
- Multiple Sclerosis: CIS, RRMS, and SPMS: Draft Evidence Report. Public comments open until 11/11/2022.Model Analysis Plan. Research Protocol available. Revised Scoping Document available. Draft Scoping Document available.
- Gene Therapies for Hemophilia A and B: 11/2/2022: Evidence Report. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Revised Scoping Document available. Draft Scoping Document available.
- Unsupported Price Increases Occurring in 2020 in California: Protocol available. 10/13/2022: Final Report.
- Type 2 Diabetes: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available. Draft Scoping Document and Research Protocol available.
- Hypertrophic Cardiomyopathy: Final Evidence Report and Meeting Summary available. Evidence Report Available. Evidence Presentation available.
- Asthma: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available.
Upcoming Events and Webinars
PCORI Methodology Committee Meeting
October 17, 2022
Click here to view.
PCORI Annual Meeting
October 26-27, 2022
Click here to view.
Board of Governors Meeting
December 13, 2022
Click here to view.
Medical Journal Articles
Identifying And Exploring Bias In Public Opinion On Scarce Resource Allocation During The COVID-19 Pandemic. Click here to view.
Machine Learning Applied to Patient-Reported Outcomes to Classify Physician-Derived Measures of Rheumatoid Arthritis Disease Activity. Click here to view.
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Click here to view.
The Use of Generic Patient-Reported Outcome Measures in Emergency Department Surveys: Discriminant Validity Evidence for the Veterans RAND 12-Item Health Survey and the EQ-5D. Click here to view.
Challenges and Opportunities for Advancing Patient-Centered Clinical Decision Support: Findings from a Horizontal Scan, click here to view.
Can Alternative Payment Models and Value-Based Insurance Design Alter the Course of Diabetes in the United States? Click here to view.
A Pragmatic Guide to Assessing Real Option Value for Medical Technologies, click here to view.
Stakeholder Engagement Infrastructure to Support Multicenter Research Networks: Advances from the Clinical Research Networks Participating in PCORnet, click here to view.
Use of Pragmatic and Explanatory Trial Designs in Acute Care Research: Lessons from COVID-19, click here to view.
Impact of the COVID-19 Pandemic on Healthcare Resource Utilization Across Selected Disease Areas in the USA, click here to view.
Total Cost of Care Differences in National Comprehensive Cancer Center (NCCN) Concordant and Non-Concordant Breast Cancer Patients, click here to view.
The Role Of Prices In Excess US Health Spending, click here to view.
Application of Quantitative Bias Analysis for Unmeasured Confounding in Cost–Effectiveness Modelling, click here to view.
Seriously Ill Individuals—A Canary in the Coal Mine for Medicare’s Transition to Accountable Health Care, click here to view.
Perceptions and Use of Telehealth Among Mental Health, Primary, and Specialty Care Clinicians During the COVID-19 Pandemic, click here to view.
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial, click here to view.
AHRQ Effective Program Updates
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Research Report: Health System Panel to Inform and Encourage Use of Evidence Reports. Click here to view.
Systematic Review: Schedule of Visits and Televisits for Routine Antenatal Care. Click here to view.
Systematic Review: Telehealth for Women's Preventive Services. Click here to view.
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Systematic Review: Maternal and Child Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Click here to view.
Research Report: Research Gaps in Women’s Health: 2022. Click here to view.
Systematic Review: Treatments for Acute Pain. Click here to view.
Systematic Review: Models of Care That Include Primary Care for Adult Survivors of Childhood Cancer: A Realist Review. Click here to view.
Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms. Click here to view.