1. PIPC Annual Forum: December 14 at 12pm! See details below.
2. PCORI Hires Deputy Executive Director for Patient-Centered Programs. Click here to read the full article.
3. NCD Calls for Build Back Better to Bar QALYs Throughout Medicare and Medicaid. Click here to view the letter.
4. PIPC and Morning Consult Publish Poll Showing Strong Support for NCD Recommendations to Ban QALYs. Click here to view the poll results.
5. Patient Advocates Push to Overhaul Oregon Medicaid's 'Prioritized List' for Care. Click here to read the article.
6. PCORI Seeks Nominations for Advisory Panels. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
7. Health Affairs Submits Request for Abstracts - Disability and Health. Click here to view the full release.
8. Effective Treatments for People with Chronic Diseases and Disabilities are Being Denied Based on the Discriminatory Quality-Adjusted Life Year. Click here to read the full article.
9. DREDF Releases Report Responding to a Flawed ICER Analyses, Instead Finds that QALY Violates Disability Nondiscrimination Law. Click here to view the report.
10. Upcoming opportunity within the Center for Evidence and Practice Improvement at AHRQ, see details below.
11. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
12. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
13. ICER's QALY-Based Study Topics: Beta Thalassemia, Chemotherapy-Induced Neutropenia, COVID-19, Type 2 Diabetes, Hypertrophic Cardiomyopathy, Asthma, Unsupported Price Increase, Fair Access: Coverage Policies. Click here to provide patient input.
14. Upcoming Events and Webinars, see details below.
15. Medical Journal Articles, see details below.
16. AHRQ Effective Program Updates, see details below.
Please join the Partnership to Improve Patient Care (PIPC) for our 12th Annual Forum TOMORROW, Tuesday, December 14. This year's forum discussion will focus on the recommendation of the National Council on Disability (NCD) for an unambiguous ban on the quality adjusted life year (QALY) within the text of the Build Back Better Act (H.R. 5367) and the increasing reference to comparative and cost effectiveness assessments in determining reimbursement, coverage, and programs at the state and federal level. We are excited to hear from NCD Chairman Andres Gallegos to learn more about the NCD’s recommendation. We are also excited to hear from Meaghan Moyer with Disability Rights Oregon and Jenn McNary, the parent of sons with Duchenne Muscular Dystrophy, as well as Caitlin McCormick with PCORI, Dr. Richard Xie with the Innovation and Value Initiative and Dr. Elisabeth Oehrlein with National Health Council. This year’s forum will be virtual. RSVP's accepted here or to firstname.lastname@example.org.
2. PCORI Hires Deputy Executive Director for Patient-Centered Programs
Politico published an article highlighting that the Patient-Centered Outcomes Research Institute hired University of Pennsylvania scholar Harold Feldman to be its first deputy executive director for patient-centered research programs. His duties include “engagement of the healthcare community in PCORI’s work and management of stakeholder partnerships and initiatives to advance dissemination and implementation of research findings,” the institute says. According to Politico, he starts on July 1. Click here to read the full article.
3. NCD Calls for Build Back Better to Bar QALYs Throughout Medicare and Medicaid
The Chair of the National Council on Disability sent a letter to Congress "to strongly encourage the inclusion of an unambiguous ban on the quality adjusted life year (QALY) within the text of the Build Back Better Act (H.R. 5367) and located within the bill text in such a way as to convey unequivocal application to the entire Sec. 1194.” He stated, "Consistent with our advice regarding the discriminatory nature of the QALY for people with disabilities and chronic illnesses, as documented in our 2019 report, Quality-Adjusted Life Years and the Devaluation of Life with a Disability, I further encourage you to utilize the reconciliation package as an opportunity to expressly prohibit the use of the QALY by Medicaid and Medicare.” Click here to view the letter.
4. PIPC and Morning Consult Publish Poll Showing Strong Support for NCD Recommendations to Ban QALYs
Morning Consult ran a poll on behalf of Partnership to Improve Patient Care focusing on the use of cost-effectiveness assessments to determine the value of coverage and treatment costs. The survey found that Americans want patients and their doctors in charge of health care decision making and are opposed to the use of cost assessments such as Quality-Adjusted Life Year (QALY).
PIPC Chairman Tony Coelho published an opinion piece in Morning Consult about the poll, stating, "Ten years after the Partnership to Improve Patient Care (PIPC) released its first public opinion survey, our latest poll released today underscores how vitally important it is for lawmakers to maintain and strengthen safeguards for patients and people with disabilities in all health care policies.” Chairman Coelho was heartened to see the National Council on Disability — an independent federal agency that advises Congress and the administration on disability policy — recently come out with targeted recommendations to strengthen BBBA by including meaningful protections against government use of discriminatory cost-effectiveness thresholds based on the quality-adjusted life year (QALY). He emphasized that this recommendation represents an important step in protecting patients and patients with disabilities. Despite the long history in the United States acknowledging that metrics like QALYs discriminate in violation of disability and civil rights laws, their use is rising —not falling. He concluded that it is time to finally end the ambiguity and prohibit QALYs altogether.
5. Patient Advocates Push to Overhaul Oregon Medicaid's 'Prioritized List' for Care
The Portland Business Journal published an article on how patient advocates are pushing to overhaul Oregon Medicaid's drug list to ensure people with disabilities are not denied care. She writes that, "Disability rights advocates are pushing Oregon’s Medicaid program to change how it decides which treatments to cover in order to ensure that people with disabilities are not discriminated against and denied services. Disability Rights Oregon’s request comes as the state prepares its application to the federal government to renew its Medicaid waiver for another five years. The application, to be submitted to the Centers for Medicare and Medicaid Services in February, includes changes to advance health equity, while maintaining the coordinated care model Oregon created nearly a decade ago. But Disability Rights Oregon would like the program to use a different methodology for deciding what rises 'above the line' on Oregon’s Prioritized List of health services and is fully covered, and what falls below. 'There are medically necessary treatments not being covered by Oregon’s Medicaid program that a state not operating under a waiver is required to provide,' said Meghan Moyer, the organization’s public policy director." Click here to read the full article.
6. PCORI Seeks Nominations for Advisory Panels.
PCORI is currently seeking nominations for appointments to its advisory panels. The advisory panels must include patients or patient advocates. PCORI's staff, board, and methodology committee take advisory panels' recommendations into account when making decisions and determinations. PIPC encourages patients and patient advocates to submit nominations to serve on PCORI's advisory panels, including on the Advisory Panel on Clinical Effectiveness and Decision Science, Advisory Panel on Patient Engagement, and Advisory Panel on Rare Disease. Nominations are open through March 31, 2022. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
7. Requests for Abstracts - Disability and Health
Health Affairs is planning a theme issue on disability and health, to be published in October 2022. They plan to publish peer-reviewed articles from leading researchers, scholars, analysts, and health care stakeholders. Content will include original research, analyses, and commentaries to provide a multidimensional perspective on disability and health. They primarily seek papers presenting empirical evidence and analyses that contribute to our knowledge. Health Affairs encourages papers that represent cross-disciplinary efforts that bridge health and non-health sectors. They also welcome contributions that use a variety of methods, including qualitative work, case studies, ethnographic studies, and community-based participatory research. Papers should have a strong policy orientation, and they will put a premium on work that supports future planning and decision making.
Health Affairs invites all interested authors to submit abstracts for consideration for this issue. Editors will review the abstracts and, for those that best fit the vision and goals for the issue, invite authors to submit full papers for consideration for the issue. In order to be considered, abstracts must be submitted no later than 11:59PM Eastern time, December 20, 2021. Abstracts submitted after that date will not be considered. Abstracts must be submitted via our abstract submission portal — abstracts submitted via other channels will not be considered. Click here to view the full release and requirements.
8. Effective Treatments for People with Chronic Diseases and Disabilities are Being Denied Based on the Discriminatory Quality-Adjusted Life Year
Jenn McNary, patient advocate and mother of two children with Duchenne Muscular Dystrophy published an opinion piece in the Boston Globe supporting the passage of a bill before the Massachusetts Legislature, An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, which would codify patient protections, including a ban on the use of the Quality-Adjusted Life Year. Ms. McNary shares her real-life experience of having ICER’s QALY-based assessment cited as a reason her son could not access a treatment that had previously been effective for him and cautions about Massachusetts’ continued partnership with ICER. Click here to read the full article.
9. DREDF Releases Report Responding to a Flawed ICER Analyses, Instead Finds that QALY Violates Disability Nondiscrimination Law
The Disability Rights Education and Defense Fund ("DREDF") responded directly to a report commissioned for the Institute for Clinical and Economic Review (“ICER”), an organization specializing in clinical cost-effectiveness analyses relying on the QALY, in which its hired legal consultants posit that the use of QALY as a measure of the cost-effectiveness of specific drugs and therapies “poses absolutely no risk of discrimination against any patient group.” DREDF strongly disagrees with this conclusion. In its response, DREDF challenges the factual and legal assumptions of ICER's report and explains how the use of the QALY, even in tandem with alternative measures such as the Equal Value of Life Years Gained (“evLYG”), violates disability nondiscrimination law.
DREDF will join Familia Unida to celebrate National Disabilities Awareness Month and share information about its new report and the ongoing work of the disability community against disability discrimination in healthcare. Click here to view the DREDF report. Click here to view the one-pager. Click here to find summaries in both English and Spanish.
10. Upcoming Opportunity Within the Center for Evidence and Practice Improvement at AHRQ
AHRQ will soon be hiring a Senior Staff Service Fellow in CEPI’s Office of the Director to support activities funded by the Patient-Centered Outcomes Research Trust Fund (PCOR TF) under the National Center for Excellence in Primary Care Research (NCEPCR). The Senior Staff Service Fellow will support AHRQ’s mandated roles under the PCOR TF in evidence dissemination and implementation in primary care as well as of training and capacity building for comparative effectiveness research in primary care settings.
The Senior Staff Service Fellow designs, executes and evaluates projects funded by the PCOR TF to increase the uptake of evidence in primary care including by using new models of primary/ambulatory care delivery, advancing health equity and engaging learning health systems. AHRQ is looking for a team player to lead a multidisciplinary team to design, that leads national initiatives to disseminate and implement PCOR findings related to transforming primary/ambulatory care delivery to make care more equitable and patient-centered including a focus on people living with multiple chronic conditions and other at risk populations.
This Senior Staff Service Fellow will also advise other members of CEPI and AHRQ on dissemination and implementation activities related to the PCOR TF; supports and aligns ongoing primary care projects across all divisions within the Center as well as across AHRQ. Serves as a recognized expert within the areas of primary care, primary care research and implementation science.
11. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Australia: Cancer patient is undergoing further surgery and treatment, for which she will have to pay for herself because it isn't listed on the PBS.
- New Zealand: A review of Pharmac is showing that its strategy disadvantages disabled people as it has an 'excessive focus on costs.' The interim report found that Pharmac is 'too focused on saving money' and is not patient-centric.
- United Kingdom: After IFPR refused to fund her procedure, cancer patient is condemning the panel for not dealing with her court case like a human being.
12. 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. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. We encourage sharing resources for advocates in key states mentioned below to ensure protections against discrimination!
- 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.
Other states to watch: Rhode Island, Minnesota and Washington State are also potential targets for future legislation that could trigger the use of discriminatory QALYs.
Efforts are underway to advance legislation that would create a Prescription Drug Affordability Board in the State of Virginia, triggering concerns about potential discrimination, according to recent news. It is not clear that these efforts will include provisions to bar discrimination and protect patient access to medications, such as achieved by disability advocates in other states such as Oregon where the legislature barred the use of QALYs in similar Board deliberations.
Renewed efforts are anticipated in New Mexico to advance legislation creating a Prescription Drug Affordability Board, triggering concerns about potential discrimination. It is not clear that these efforts will include provisions to bar discrimination and protect patient access to medications, such as achieved by disability advocates in other states. The news about the effort has not mentioned including a ban on the use of discriminatory QALYs nor including patient and disability representation or other patient protections from restricted access to care.
The Maryland legislature passed legislation earlier this year creating a Prescription Drug Affordability Board. The legislation did not include protections for patients and people with disabilities such as barring the use of discriminatory QALYs. The Board has begun meeting to hear from stakeholders, including hearing a presentation from the Institute for Clinical and Economic Review which relies on QALYs to assess treatment value. Legislation was introduced this year to bar the use of QALYs and implement patient protections that has not advanced in the legislature. On August 3, organizations representing patients and people with disabilities sent a letter urging the Board to avoid policies that would potentially discriminate by relying on discriminatory metrics such as QALYs.
The Governor of Colorado has signed into law SB 21-175, which creates a prescription drug affordability review board. SB 21-75 did include an amendment that prohibits the use of QALYs in the section of the bill that determines an upper payment limit. In some states these types of boards and commissions have referenced value assessments based on QALYs from the Institute for Clinical and Economic Review (ICER). In Massachusetts, the Health Policy Commission went so far as to contract with ICER. In order to mitigate this, it is important that the Board has representation from patients and people with disabilities. The Governors office is accepting applications for both the Colorado Prescription Drug Affordability Review Board and the Colorado Prescription Drug Affordability Advisory Council. It is essential that the Board and Advisory Committee include representation from patients and people with disabilities to ensure that that the Board’s deliberations do not include consideration of QALYs and other metrics that may discriminate or lead to restricted access for people with disabilities and chronic conditions or older adults.
The Massachusetts House and Senate have each taken the positive step of introducing An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, H.201 and S.753. This bill would enshrine essential patient protections including a ban on the use of the QALY, a requirement for research to meet patient-centeredness criteria, and robust engagement of the patient and disability communities in health care decision making. H. 201 was heard before the Joint Committee on Health Care Financing on November 9. Written testimony is being accepted until tomorrow, November 16. It is important the Committee hear about the discriminatory implications of QALYs from the patient and disability communities. Details on submitting testimony may be found here.
Oregon is applying to the Centers for Medicare & Medicaid Services (CMS) for a new five-year Medicaid waiver known as the 1115 Demonstration. The purpose of the waiver is to reform the state’s Medicaid program. Advocates have expressed concern about the state’s ongoing use of quality-adjusted life years (QALYs) in determining the prioritized list of services under Oregon’s existing waiver. Click here to view the timeline for providing input.
13. ICER's QALY-Based Study Topics: Beta Thalassemia, Chemotherapy-Induced Neutropenia, COVID-19, Type 2 Diabetes, Hypertrophic Cardiomyopathy, Asthma, Unsupported Price Increase, Fair Access: Coverage Policies
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.
- Beta Thalassemia: Draft Scoping Document available. Public Comments open through 12/16/2021. 12/23/2021: Revised Scoping Document. 1/7/2022: Research Protocol. 2/28/2022: Model Analysis Plan. 4/13/2022: Draft Evidence Report.
- Chemotherapy-Induced Neutropenia: Model Analysis Plan available. Draft Scoping Document and Research Protocol available. 1/25/2022: Draft Evidence Report.
- COVID-19: Model Analysis Plan available. Draft Scoping Document and Research Protocol available. 2/3/2022: Draft Evidence Report.
- Type 2 Diabetes: Draft Evidence Report available. Public Comments closed. Draft Scoping Document and Research Protocol available. Meeting 1/20/2022: Deliberation and vote on evidence presented in ICER's report on therapies for Type 2 Diabetes.
- Hypertrophic Cardiomyopathy: Final Evidence Report and Meeting Summary available. Evidence Report Available. Evidence Presentation available.
- Unsupported Price Increase: Final Report available.
- Asthma: Evidence Presentation available. Evidence Report Available. Model Analysis Plan available. 12/16/2021: Final Evidence Report and Meeting Summary.
- Fair Access: Coverage Policies in 2020: Protocol Available. Final Report available.
14. Upcoming Events and Webinars
Advisory Panel on Rare Disease Winter 2021 Meeting
December 13, 2021
Click here for details.
Enhancing Data Infrastructure for Collection and Integration of Patient-Reported Outcomes and other Patient-Generated Health Data within PCORnet
December 14, 2021
Click here to details.
MDD Model Draft Model Protocol: Public Comment Period Presentation
December 15, 2021
Click here for details.
15. Medical Journal Articles
“It’s Time to Represent”: Shifting the Paradigm to Improve the Quality of Inputs into Value Assessment Frameworks, click here to view.
Evaluation of Financial Outcomes Under a Value-Based Payment Program for Community Pharmacies, click here to view.
Limited Role of Patient Input in Specialty Drug Coverage Policies, click here to view.
The Importance of Collaboration in Pursuit of Patient-Centered Value Assessment, click here to view.
Toward Better Data Dashboards for US Drug Value Assessments, click here to view.
Prevalence of Avoidable and Bias-Inflicting Methodological Pitfalls in Real-World Studies of Medication Safety and Effectiveness, click here to view.
Association of Co-Pay Elimination With Medication Adherence and Total Cost, click here to view.
The Utility of Patient Engagement in Drug Research and Development, click here to view.
Patient-Powered Research Networks of the Autoimmune Research Collaborative: Rationale, Capacity, and Future Directions, click here to view.
Enhancing Patient Research Partner Engagement: Research in Psoriatic Arthritis, click here to view.
Patient Voices in Value-Based Cancer Care: Priorities for the Biden Administration, click here to view.
The Dollar or Disease Burden: Caps on Healthcare Spending May Save Money, but at What “Cost” to Patients?, click here to view.
16. AHRQ Effective Program Updates
Systematic Review: Prehabilitation and Rehabilitation for Major Joint Replacement. Click here to view.
Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms. Click here to view.
Systematic Review: Management of High-Need, High-Cost Patients: A “Best Fit” Framework Synthesis, Realist Review, and Systematic Review. Click here to view.
Research Protocol: Partial Breast Irradiation for Breast Cancer. Click here to view.
Systematic Review: Physical Activity and the Health of Wheelchair Users: A Systematic Review in Multiple Sclerosis, Cerebral Palsy, and Spinal Cord Injury. Click here to view.
Research Report: Developing and Piloting a Tool to Create Dot Plots to Summarize Pooled Data for Multiple Outcomes in Systematic Reviews. Click here to view.
Systematic Review: Malnutrition in Hospitalized Adults. Click here to view.
Research Protocol: Nutrition as Prevention for Improved Cancer Outcomes. Click here to view.
Research Protocol: Telehealth During COVID-19. Click here to view.
Research Protocol: Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD Repository Evidence Base. Click here to view.
Systematic Review: Transitions of Care From Pediatric to Adult Services For Children With Special Healthcare Needs. Click here to view.
Systematic Review: Interventional Treatments for Acute and Chronic Pain. Click here to view.