In this week's edition...
— PIPC Submits Comments on CMS Proposed Guidance for Coverage with Evidence Development. Click here to read the article.
— ICHOM Seeks Input on Patient Charter. See details below.
— New ASPE Report Assesses Relevant Outcomes for Patient-Centered Outcomes Research. See details below.
— Patient Engagement Is Key to the Success of Value-Based Care Programs. Click here to read the column.
— AAPD: What Health Equity Means to the Disability Community. Click here to read the blog.
— Drugs Extending My Life, but Boston Institute Disagrees. Click here to read the op-ed.
— 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.
— Job Openings. See details below.
— PIPC Submits Comments on CMS Proposed Guidance for Coverage with Evidence Development. Click here to read the article.
— ICHOM Seeks Input on Patient Charter. See details below.
— New ASPE Report Assesses Relevant Outcomes for Patient-Centered Outcomes Research. See details below.
— Patient Engagement Is Key to the Success of Value-Based Care Programs. Click here to read the column.
— AAPD: What Health Equity Means to the Disability Community. Click here to read the blog.
— Drugs Extending My Life, but Boston Institute Disagrees. Click here to read the op-ed.
— 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.
— Job Openings. See details below.
What We're Reading
1. PIPC Submits Comments on CMS Proposed Guidance for Coverage with Evidence Development. In a comment letter to the Centers for Medicare and Medicaid Services (CMS), the Partnership to Improve Patient Care (PIPC) offered feedback on CMS's Proposed Guidance Document for Coverage with Evidence Development (CED). The letter stresses that PIPC shares CMS's concerns that a framework is needed for more predictable and transparent evidence development. To that end, Our comments focus on the following concerns and recommendations:
Click here to read the article.
2. ICHOM Seeks Input on Patient Charter. The International Consortium for Health Outcomes Measurement (ICHOM) is a non-profit organization working to define the health outcomes that matter most to patients and is currently seeking input from patients and people with disabilities about its Patient Charter. Jennifer Bright recently joined the ICHOM team as its President. The ICHOM Patient Charter "articulates ICHOM's commitments to the patient community and the rights and empowerment actions that patient representatives are entitled to when co-leading research and other initiatives with ICHOM. It will serve as a framework for fair partnerships to ensure the expertise of patient representatives is acknowledged and integrated at all stages of ICHOM initiatives, and is a step in our journey towards being a stronger ally for the patient community going forward.” To find out more about the Patient Charter, click here. To participate in the survey please click here.
3. New ASPE Report Assesses Relevant Outcomes for Patient-Centered Outcomes Research. A new report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) identifies individual-level measures for conducting patient-centered outcomes research (PCOR) relevant to adults with disabilities, aged 18–64 years. The work identifies six broad outcome domains relevant to PCOR for this population from prior research, including: (1) social and community engagement; (2) choice and control; (3) employment and self-sufficiency; (4) privacy, rights, and human security; (5) health-related social needs; and (6) health and wellbeing. Additionally, it identifies 32 sources of measures across the domains that include standardized tools/instruments, routinely fielded surveys, and administrative datasets. Click here for additional details.
4. Patient Engagement Is Key to the Success of Value-Based Care Programs. In a column for MedCity News, Rahul Sharma and Lynn Carroll emphasize the importance of patient engagement in value-based care.“...An engaged patient is an empowered patient, so it is crucial that providers and payers share with patients their personal medical histories as well as educational materials that help patients take a more proactive and effective role in their care management. Patients shouldn’t have to struggle to obtain their health data; it should be as easy as a handful of clicks on a computer screen or mobile app. The challenge for providers and payers is that not all the data standards necessary to support robust patient engagement initiatives exist.” Click here to read the column.
5. AAPD: What Health Equity Means to the Disability Community. American Association of People With Disabilities (AAPD) CEO Maria Town explains why health equity is vital for the disability community and how QALYs impact access to care. "One glaring example of this ableism in the healthcare system is the use of Quality-Adjusted Life Years (QALY). QALYs are used when making medical decisions and allocating resources. QALYs literally devalue a person’s quality of life when disability is taken into account. Because of this, people with disabilities or complex health issues are at a high risk of being denied coverage because according to the QALY metric, they are not worth spending time, effort, or resources on. This explicitly places a higher value of life on people without disabilities. People with disabilities should never be denied coverage based on the use of QALY metrics or similar metrics that so clearly discriminate against people based on their disability status, life expectancy, or age. Thus, many in the disability community, including AAPD, have come together to urge Congress to pass the Protecting Healthcare for All Patients Act, which would prohibit the use of QALYs in federally funded healthcare programs." Click here to read the blog.
6. Drugs Extending My Life, but Boston Institute Disagrees. Steve Kowalski details how ICER's assessment of ALS medicines has restricted his accesses to much needed therapies. "I recently testified at an ICER meeting regarding the medicines I’m on. ICER’s final report regarding one of my medicines found that the results from one trial aren’t enough, despite approval by the Federal Drug Administration (FDA). To add insult to injury, ICER made its decision by comparing treatment of a rare, rapidly progressing terminal illness to other livable diseases with more treatment options. It’s simply not a valid comparison and the repercussions are drastic. Already the insurer CIGNA has said it will stop covering that one treatment." Click here to read the op-ed.
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.
Pennsylvania
In the last legislative session, the legislature introduced, HB 1722, a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a third party that could include ICER. The bill has not been reintroduced in 2023. The Pennsylvania legislature held an informational meeting on Prescription Drug Boards in the House Health Committee on April 12 at 10am. Click here to learn more about Prescription Drug Affordability Boards and the implications of discriminatory measures of cost effectiveness. Click here to learn more about the committee chair, Rep. Dan Frankel.
Massachusetts
An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with disabilities, SD. 2117 and HD. 3356 has been introduced in both the House and Senate. This bill includes important patient protections including a ban on the discriminatory Quality-Adjusted Life Year (QALY).
California
California Attorney General Rob Bonta has solicited information from hospital CEOs across the state about how healthcare facilities and other providers are identifying and addressing racial and ethnic disparities in commercial decision-making tools. In response to this letter, advocates urged Attorney General Bonta to include QALYs and similar metrics in his investigation. Click here to view the Attorney General’s letter. Click here to view a response from advocates.
Oregon
The Oregon legislature held a hearing on March 27, 2023 on SB 492, legislation that would address the use of biased measures of quality of life, such as quality-adjusted life years or QALYs. PIPC Chairman Tony Coelho submitted testimony stating, "This legislation reflects decades of work to advance disability rights and to end the use of discriminatory measures of the effectiveness of health care that too often drive barriers to care for people with disabilities. In the past this may have been considered just a disability issue, but today we recognize the implications of these biased algorithms for health equity more broadly.” Click here to view testimony from PIPC Chairman Tony Coelho. Click here to view testimony submitted by the Caring Ambassadors Program. Click here to view the list of organizations in Oregon supporting the bill.
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) discussed a proposed plan for using QALYs. 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 their use of QALYs but has not made a decision as to whether they will adjust their methodology. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act. Click here to view the options that continue to be under consideration by the HERC to continue using QALYs. Click here to view all of the comments shared with PIPC.
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
September 11, 2023
Click here to view.
2023 PCORI Annual Meeting
October 4-5, 2023
Click here to view.
Medical Journal Articles
Comparative Effectiveness of Treatments for Rheumatoid Arthritis in Clinical Practice: A Systematic Review. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials. Click here to view.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes. Click here to view.
Patient-Reported Outcomes for People with Diabetes: What and How to Measure? A Narrative Review. Click here to view.
Patient Engagement in Research; Benefits, Challenges, Importance, and Implications. Click here to view.
The Opportunity for Greater Patient and Public Involvement and Engagement in Drug Development and Regulation. Click here to view.
AHRQ Effective Program Updates
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. PIPC Submits Comments on CMS Proposed Guidance for Coverage with Evidence Development. In a comment letter to the Centers for Medicare and Medicaid Services (CMS), the Partnership to Improve Patient Care (PIPC) offered feedback on CMS's Proposed Guidance Document for Coverage with Evidence Development (CED). The letter stresses that PIPC shares CMS's concerns that a framework is needed for more predictable and transparent evidence development. To that end, Our comments focus on the following concerns and recommendations:
- CED guidance should promote early and consistent engagement of patients and people with disabilities.
- Patient safeguards should promote health equity, not restrict access to care.
- CED should focus on real world data collection.
- CMS should establish standards for meeting evidence generation requirements.
- CED should clearly acknowledge and abide by the laws barring use of QALYs and similar measures.
Click here to read the article.
2. ICHOM Seeks Input on Patient Charter. The International Consortium for Health Outcomes Measurement (ICHOM) is a non-profit organization working to define the health outcomes that matter most to patients and is currently seeking input from patients and people with disabilities about its Patient Charter. Jennifer Bright recently joined the ICHOM team as its President. The ICHOM Patient Charter "articulates ICHOM's commitments to the patient community and the rights and empowerment actions that patient representatives are entitled to when co-leading research and other initiatives with ICHOM. It will serve as a framework for fair partnerships to ensure the expertise of patient representatives is acknowledged and integrated at all stages of ICHOM initiatives, and is a step in our journey towards being a stronger ally for the patient community going forward.” To find out more about the Patient Charter, click here. To participate in the survey please click here.
3. New ASPE Report Assesses Relevant Outcomes for Patient-Centered Outcomes Research. A new report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) identifies individual-level measures for conducting patient-centered outcomes research (PCOR) relevant to adults with disabilities, aged 18–64 years. The work identifies six broad outcome domains relevant to PCOR for this population from prior research, including: (1) social and community engagement; (2) choice and control; (3) employment and self-sufficiency; (4) privacy, rights, and human security; (5) health-related social needs; and (6) health and wellbeing. Additionally, it identifies 32 sources of measures across the domains that include standardized tools/instruments, routinely fielded surveys, and administrative datasets. Click here for additional details.
4. Patient Engagement Is Key to the Success of Value-Based Care Programs. In a column for MedCity News, Rahul Sharma and Lynn Carroll emphasize the importance of patient engagement in value-based care.“...An engaged patient is an empowered patient, so it is crucial that providers and payers share with patients their personal medical histories as well as educational materials that help patients take a more proactive and effective role in their care management. Patients shouldn’t have to struggle to obtain their health data; it should be as easy as a handful of clicks on a computer screen or mobile app. The challenge for providers and payers is that not all the data standards necessary to support robust patient engagement initiatives exist.” Click here to read the column.
5. AAPD: What Health Equity Means to the Disability Community. American Association of People With Disabilities (AAPD) CEO Maria Town explains why health equity is vital for the disability community and how QALYs impact access to care. "One glaring example of this ableism in the healthcare system is the use of Quality-Adjusted Life Years (QALY). QALYs are used when making medical decisions and allocating resources. QALYs literally devalue a person’s quality of life when disability is taken into account. Because of this, people with disabilities or complex health issues are at a high risk of being denied coverage because according to the QALY metric, they are not worth spending time, effort, or resources on. This explicitly places a higher value of life on people without disabilities. People with disabilities should never be denied coverage based on the use of QALY metrics or similar metrics that so clearly discriminate against people based on their disability status, life expectancy, or age. Thus, many in the disability community, including AAPD, have come together to urge Congress to pass the Protecting Healthcare for All Patients Act, which would prohibit the use of QALYs in federally funded healthcare programs." Click here to read the blog.
6. Drugs Extending My Life, but Boston Institute Disagrees. Steve Kowalski details how ICER's assessment of ALS medicines has restricted his accesses to much needed therapies. "I recently testified at an ICER meeting regarding the medicines I’m on. ICER’s final report regarding one of my medicines found that the results from one trial aren’t enough, despite approval by the Federal Drug Administration (FDA). To add insult to injury, ICER made its decision by comparing treatment of a rare, rapidly progressing terminal illness to other livable diseases with more treatment options. It’s simply not a valid comparison and the repercussions are drastic. Already the insurer CIGNA has said it will stop covering that one treatment." Click here to read the op-ed.
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.
Pennsylvania
In the last legislative session, the legislature introduced, HB 1722, a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a third party that could include ICER. The bill has not been reintroduced in 2023. The Pennsylvania legislature held an informational meeting on Prescription Drug Boards in the House Health Committee on April 12 at 10am. Click here to learn more about Prescription Drug Affordability Boards and the implications of discriminatory measures of cost effectiveness. Click here to learn more about the committee chair, Rep. Dan Frankel.
Massachusetts
An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with disabilities, SD. 2117 and HD. 3356 has been introduced in both the House and Senate. This bill includes important patient protections including a ban on the discriminatory Quality-Adjusted Life Year (QALY).
California
California Attorney General Rob Bonta has solicited information from hospital CEOs across the state about how healthcare facilities and other providers are identifying and addressing racial and ethnic disparities in commercial decision-making tools. In response to this letter, advocates urged Attorney General Bonta to include QALYs and similar metrics in his investigation. Click here to view the Attorney General’s letter. Click here to view a response from advocates.
Oregon
The Oregon legislature held a hearing on March 27, 2023 on SB 492, legislation that would address the use of biased measures of quality of life, such as quality-adjusted life years or QALYs. PIPC Chairman Tony Coelho submitted testimony stating, "This legislation reflects decades of work to advance disability rights and to end the use of discriminatory measures of the effectiveness of health care that too often drive barriers to care for people with disabilities. In the past this may have been considered just a disability issue, but today we recognize the implications of these biased algorithms for health equity more broadly.” Click here to view testimony from PIPC Chairman Tony Coelho. Click here to view testimony submitted by the Caring Ambassadors Program. Click here to view the list of organizations in Oregon supporting the bill.
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) discussed a proposed plan for using QALYs. 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 their use of QALYs but has not made a decision as to whether they will adjust their methodology. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act. Click here to view the options that continue to be under consideration by the HERC to continue using QALYs. Click here to view all of the comments shared with PIPC.
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: MS patients in Australia face limited choices with respect to effective treatments covered, and some are forced to raise money for treatment overseas.
- U.K: The family of a patient with MS has had to turn to crowdfunding for treatment that is not funded through 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.
- Paroxysmal Nocturnal Hemoglobinuria: Draft Scoping Document Available. Comments due August 14, 2023.
- Schizophrenia: Draft Scoping Document available. Comments due on July 26, 2023.
- Metachromatic Leukodystrophy: Draft Evidence Report now available.
- Pulmonary Arterial Hypertension: Draft Scoping Document available. Open for comments until June 5, 2023.
- Sickle Cell Disease: Evidence Report Available. California Technology Assessment Forum (CTAF) to meet on July 27, 2023, to review.
- Non-Alcoholic Steatohepatitis: Final Evidence Report now available.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
September 11, 2023
Click here to view.
2023 PCORI Annual Meeting
October 4-5, 2023
Click here to view.
Medical Journal Articles
Comparative Effectiveness of Treatments for Rheumatoid Arthritis in Clinical Practice: A Systematic Review. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials. Click here to view.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes. Click here to view.
Patient-Reported Outcomes for People with Diabetes: What and How to Measure? A Narrative Review. Click here to view.
Patient Engagement in Research; Benefits, Challenges, Importance, and Implications. Click here to view.
The Opportunity for Greater Patient and Public Involvement and Engagement in Drug Development and Regulation. Click here to view.
AHRQ Effective Program Updates
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.
