1. NCD Calls on HHS to Strengthen Rights and Protections for People with Disabilities in Letter, click here to read the letter.
2. PIPC Joins 30 Leading Disability and Civil Rights Stakeholders in Letter Asking HHS to Step Up Nondiscrimination Efforts, click here to read the letter.
3. Chairman's Corner: CBO Confirms Use of Discriminatory Metrics in H.R. 3, see details below.
4. PCORI Virtual Briefing on COVID-19 & Telehealth, click here to learn more and register.
5. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
6. 2021 AUCD Virtual Gala, click here to learn more and register.
7. EveryLife Foundation for Rare Diseases Report on the Economic Burden of Rare Diseases in America and the Rare on the Road Leadership Tour, see details below.
8. Vaccination Equity and Communication, see details below.
9. PCORI Seeks Nominations for Advisory Panels, click here to learn more, submit a nomination, or apply to be on an advisory panel.
10. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
11. ICER's QALY-Based Study Topics: Atopic Dermatitis, Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease, click here to provide patient input.
12. Upcoming Events and Webinars, see details below.
13. Medical Journal Articles, see details below.
14. AHRQ Effective Program Updates, see details below.
The National Council on Disability (NCD), an independent federal agency charged with providing advice and recommendations regarding disability policy to the President, Congress, and other federal agencies, wrote to HHS calling for it to move ahead with a Request for Information (RFI) on “Discrimination on the Basis of Disability in Critical Health and Human Service Programs or Activities."
"A strong evidence base, shared principles, and strong coalitions make for effective policy, and it is clear that there is such coalescence surrounding this RFI," NCD Chairman Andrés J. Gallegos wrote. "We believe strengthening Section 504 would align with both HHS’s mission, as well as the focus of NCD’s bipartisan membership during my tenure as Chairman: to provide equality of access and care for all individuals with disabilities."
The letter also referenced a letter from 30 leading disability and civil rights stakeholders, including PIPC, also calling for the RFI to be issued. Read more about that letter below.
Click here to read the NCD letter.
2. PIPC Joins 30 Leading Disability and Civil Rights Stakeholders in Letter Asking HHS to Step Up Nondiscrimination Efforts
The Partnership to Improve Patient Care (PIPC) proudly joined 30 leading disability rights and racial justice organizations in a letter to the Department of Health and Human Services' Office of Civil Rights that calls for additional regulatory action aimed at preventing discrimination in health care. In particular, the letter calls on HHS to formally issue its Request for Information (RFI) on “Discrimination on the Basis of Disability in Critical Health and Human Service Programs or Activities."
The RFI addresses disability non-discrimination in a number of key health care areas. This includes life-sustaining care, organ transplants, Crisis Standards of Care, suicide prevention programs and services, the child welfare system, health care value assessment methodologies, and auxiliary aids and accessible medical equipment in the health care system.
“…As recent reports from the National Council on Disability show, people with disabilities still face significant disparities and obstacles to access in healthcare,” the letter states.” “The issues addressed in this RFI look to root out the common thread they all share: too many medical professionals see life with a disability as less worth living and less worthy of care, sometimes so much less so that they view death as the correct course.” Click here to read the letter.
3. Chairman's Corner: CBO Confirms Use of Discriminatory Metrics in H.R. 3
In response to a Congressional Budget Office (CBO) working paper acknowledging that it used quality-adjusted life years (QALY) and data from ICER in its work scoring drug pricing legislation, PIPC Chairman Tony Coelho wrote that it is time to lay discriminatory metrics to rest and invest in better solutions. "I am relieved that we are now seeing bipartisan opposition to the use of QALYs, whether from domestic entities such as ICER or foreign countries," he wrote. "Experts such as the National Council on Disability, an independent federal agency, share our concerns. NCD published a long report on how QALYs discriminate and provided recommendations against their use by policymakers, including opposition to importing QALYS from foreign countries. The DNC Platform now includes a statement against the use of QALYs. Senators on both sides of the aisle opposed the use of cost effectiveness based on metrics such as QALYs when creating the Patient-Centered Outcomes Research Institute (PCORI) and barred their use by PCORI and in Medicare in 2010....We don’t need to further entrench the stigma of disability especially during a pandemic." Click here to read Chairman Coelho's blog post.
4. PCORI Virtual Briefing on COVID-19 & Telehealth
Join PCORI for important funding updates on telehealth and COVID-19 as well as key takeaways and themes from PCORI’s telehealth portfolio that can inform ongoing conversations on the current and post-COVID landscape of telehealth policy. Hear about the lessons, opportunities, and challenges of the application of telehealth during the pandemic from the provider perspective, along with telehealth policy insights from a state health expert that may be useful to policy makers and Congress. This event is being held virtually on Tuesday, March 23 – 2:30 pm to 3:30 pm Eastern. Click here to learn more and register.
5. 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 or are considering policies to import QALY-based decisions from other countries. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. 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.
North Dakota is currently considering a piece of legislation, SB 2170, which would import QALYs from Canada. The bill directly references the prices paid for drugs in five Canadian provinces. Before applying for coverage by the provinces, all drugs must complete a Common Drug Review by CADTH, which uses QALYs. The result of this is that in Canada is that many individuals living with disabilities are unable to receive the treatments and care they need. The National Council on Disability (NCD) warned in its 2019 report that similar coverage denials and loss of access to care could also be the outcome if the United States if we reference other countries. The NCD also highlighted in its report that Section 504 of the Rehab Act and Section 1557 of the ACA also apply to Medicaid programs because they receive federal financial assistance. Click here to view S.B. 734. Click here to view the NCD report. Click here to view the NCD's recent letter to CMS against importing QALYs. SB 2170 narrowly passed by vote in the Senate on February, 19, 2021. It has not yet been heard in the House.
It appears now that advocates were successful in communicating their concerns about Washington State bill SB 5020. The legislation had stated, "In order to determine whether a price increase for a prescription drug is unsupported by new clinical evidence, the state must utilize and rely upon the analyses of prescription drugs prepared annually by the institute for clinical and economic review and published in its annual unsupported price increase report.” Treatments identified by ICER would then be subject to the penalties outlined in the legislation despite ICER’s reliance on quality-adjusted life years (QALYs) which is known to be a discriminatory metric. Federal policymakers on both sides of the aisle have expressed concern that measures that would unlawfully discriminate on the basis of disability or age are subject to section 504 of the Rehabilitation Act, the Americans with Disabilities Act, the Age Discrimination Act, and section 1557 of the Affordable Care Act - including state Medicaid agencies. PIPC, Epilepsy Foundation, AAPD, and AUCD all submitted written testimony. The Senate Ways & Means Committee adjourned on Monday February 22 and did not hear SB 5020. The bill therefore did not meet the crossover deadline, so, barring any special procedural maneuvers, the bill will not be taken up for the remainder of the session. The robust feedback from patients and people with disabilities highlighting the discriminatory implications of the bill greatly influenced members of the committee.
Last year, advocates applauded the State of Oklahoma for being the first state to pass legislation explicitly barring the use of quality-adjusted life years (QALYs) or any other metric that would devalue lives lived with a disability, whether from within its agency or a third party. Oklahoma's Health and Human Services Committee passed separate legislation that would import QALYs from Canada, where the Patented Medicine Prices Review Board relies on a cost-utility analysis model in which health outcomes are expressed as QALYs. The National Council on Disability (NCD) warned in its 2019 report that similar coverage denials and loss of access to care could also be the outcome in the United States if we reference other countries. The NCD also highlighted in its report that Section 504 of the Rehab Act and Section 1557 of the ACA also apply to Medicaid programs because they receive federal financial assistance. Click here to view S.B. 734. Click here to view the NCD report. Click here to view the NCD's recent letter to CMS against importing QALYs. The bill will heard by the Appropriations committee today, Monday March 1 in a 10am hearing. Reach out to committee members to express concern that S.B. 734 would import QALYS from Canada and violate the QALY ban in the Nondiscrimination in Health Care Coverage Act passed in 2020.
The legislature in the State of New Mexico has introduced HOUSE BILL 154 which would create a prescription drug affordability board. The proposed law would authorize the board to review the cost of prescription drugs and vote on whether to impose an upper payment limit on purchases and payer reimbursements of prescription drug products in the state, similar to the State of New York. Similar to New York, the bill explicitly authorizes the board to enter into contracts with qualified, independent third parties (such as the Institute for clinical and Economic Review) for services necessary to carry out the powers and duties of the board. New York explicitly references ICER which is known to refer to the quality-adjusted life year (QALY) as the “gold standard” for value assessment. To mitigate states from this kind of discrimination, organizations supporting Value Our Health developed a template for state 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. To provide input advocating for the inclusion of protections for people with disabilities and chronic conditions modeled on the bar on use of QALYs in Medicare included in the Affordable Care Act, send an email to SPAC@nmlegis.gov with Name, Entity Representing, Bill Number, and For or Against.
In the past, we have reported that Pennsylvania is considering the establishment of a Health Policy Committee, modeled after Massachusetts. The Pennsylvania State Treasurer is proposing to create a Drug Affordability Review Board and to institute “value-based purchasing” of pharmaceuticals. Interestingly, the Treasurer specifically references VBP arrangements in Oklahoma but does not mention that the Oklahoma state legislature subsequently barred the use of QALYs. We will follow these developments closely to see if Pennsylvania similarly seeks to bar QALYs as part of their considerations.
6. 2021 AUCD Virtual Gala
Join AUCD on April 14, 2021 for its AUCD for All Virtual Gala. This year’s Gala is free for everyone to attend and in a virtual, accessible format. This year’s theme is Celebrating 50 Years of Leadership: Looking Back, Moving Forward in recognition of AUCD’s 50th Anniversary. During the Gala, AUCD will reflect on its past accomplishments while amplifying the voices of current and future leaders in the disability community. Click here to learn more and register.
7. EveryLife Foundation for Rare Diseases Report on the Economic Burden of Rare Diseases in America and the Rare on the Road Leadership Tour
The Rare on the Road Leadership Tour mobilizes grassroots advocates by bringing the combined expertise of the EveryLife Foundation for Rare Diseases and Global Genes to areas not tapped by other rare disease events, as we work to identify and activate new patients and to ensure the patient voice is larger and louder than ever before. This year, due to the circumstances surrounding COVID-19, the 2021 RARE on the Road Leadership Tour is going virtual with an updated format, which will consist of one interactive webinar and three virtual, state-specific meetings geared toward uniting and activating the rare disease community at the local level. To make this year’s RARE on the Road Leadership Tour as accessible as possible, English language closed caption, in addition to real-time Spanish translation, will be made available in all virtual spaces. Register here.
8. Vaccination Equity and Communication
There is critical ongoing work to assure equity in the prioritization of vaccinations, as well as communication to address reluctance and ensure access to information and systems. PIPC Steering member the Association of University Centers on Disabilities (AUCD) aggregated the following resources that we wanted to share:
- Elevated COVID-19 Mortality Risk Among Recipients of Home and Community-Based Services: A Case for Prioritizing Vaccination for This Population
- National Council on Disability letter to Governors Association
- COVID-19 Vaccine Prioritization Dashboard
- Measuring the impact of COVID-19 vaccine misinformation on vaccination intent in the UK and USA
- COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination — United States, September and December 2020
- KFF COVID-19 Vaccine Monitor: What Do We Know About Those Who Want to “Wait and See” Before Getting a COVID-19 Vaccine?
9. 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, 2020. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
10. 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: Lifesaving cystic fibrosis drug stuck in approval process limbo.
- Canada: Cystic fibrosis patients continue to wait for access to "game-changing" drug.
- New Zealand: New Zealanders go into debt to access drugs that other countries fund. Bowel cancer patient "desperate" to raise funds for cancer drug that government refuses to fund. Pharmac will not pay for cystic fibrosis drug for patient who will die without it.
- United Kingdom: Family of child with spinal muscular atrophy looking for options abroad as NHS will not fund lifesaving treatment. Thousands of men with prostate cancer will be denied life-extending drug after health experts ruled it was not cost effective.
11. ICER's QALY-Based Study Topics: Atopic Dermatitis, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease
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.
- Atopic Dermatitis: Research Protocol available. 3/22/2021: Model Analysis Plan.
- High Cholesterol: Meeting 2/5/2021: The Midwest CEPAC convened to review treatments for high cholesterol. 3/2/2021: Final Evidence Report.
- Anemia in Chronic Kidney Disease: Meeting 2/11/2021: CTAF deliberated and voted on evidence presented in ICER’s report on therapies for anemia in chronic kidney disease. 3/5/2021: Final Evidence Report.
- Lupus Nephritis: Draft Evidence Report available. 3/12/2021: Evidence Report. Meeting 3/26/2021: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for lupus nephritis.
- Multiple Myeloma: Draft Evidence Report AVAILABLE, Comment Period OPEN through 3/11/2021. Meeting 4/16/2021.
- Alzheimer's Disease: Model Analysis Plan available. 5/5/2021: Draft Evidence Report.
12. Upcoming Events and Webinars
Cycle 1 2021 PCORnet Phase 3 Applicant Town Hall
March 2, 2021
Click here to view.
Engagement Awards 2021 Special Cycle -- Applicant Office Hours
March 8, 2021
Click here to view.
National Health Council Webinar: Case Examples of Patient-Centered Real-World Evidence
March 12, 2021
Click here to view.
PCORI Workshop on Methodologic Challenges in Intellectual and Developmental Disabilities Research
March 15, 2021
Click here to view.
PCORI Board of Governors Meeting
March 16, 2021
Click here to view.
13. Medical Journal Articles
Approval and Coverage of Cancer Drugs in England, Canada, and the US, click here to view.
Experiences of an HCV Patient Engagement Group: A Seven-Year Journey, click here to view.
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research, click here to view.
Health Technology Assessment With Diminishing Returns to Health: The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) Approach, click here to view.
Comparative Effectiveness Research Needs to Consider Optimal Dosing and Scheduling, click here to view.
Are Patients More Adherent to Newer Drugs?, click here to view.
Improving the Quality of Person-Centred Healthcare from the Patient Perspective: Development of Person-Centred Quality Indicators, click here to view.
Six Ways to Foster Community-Engaged Research During Times of Societal Crises, click here to view.
Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI), click here to view.
Improving Access and Quality of Health Care in the United States: Shared Goals Among Patient Advocates, click here to view.
Using Electronic Health Record Data to Identify Comparator Populations for Comparative Effectiveness Research, click here to view.
Pharmaceutical Pricing Benchmarks: Governmental Versus Private Sector, click here to view.
14. AHRQ Effective Program Updates
REQUEST FOR INFORMATION OPEN UNTIL APRIL 16, 2021: Use of Clinical Algorithms That Have the Potential To Introduce Racial/Ethnic Bias Into Healthcare Delivery. Click here to view.
Systematic Review: Integrating Palliative Care in Ambulatory Care of Noncancer Serious Chronic Illness. Click here to view.
Research Protocol: Management of Infantile Epilepsy. Click here to view.
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Research Protocol: Improving Rural Health Through Telehealth-Guided Provider-to-Provider Communication. Click here to view.
Systematic Review: Treatments for Acute Pain. Click here to view.
Systematic Review: Acute Treatments for Episodic Migraine. Click here to view.
Research Protocol: Interventional Treatments for Acute and Chronic Pain: Systematic Review. Click here to view.
Research Protocol: Diagnostic Errors in the Emergency Department. Click here to view.
Research Protocol: Maternal and Childhood Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Click here to view.
White Paper: Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression. Click here to view.