1. PIPC, Other Disability and Patient Organizations Call for Further Guidance on COVID-19 Patient Non-Discrimination, click here to read the letter.
2. Lung Cancer Advocates Call for Protections for Individuals with Pre-Existing Conditions, Disabilities During COVID-19 Crisis, click here to read the letter.
3. New PCORI Executive Director: Our Shared Journey to Enduring Success, click here to read the blog post.
4. Evaluation Framework for Crisis Standard of Care Plans, see details below.
5. Health Care Rationing is Already Happening, click here to read the article.
6. Members of Congress Speak Out on Discrimination Against People with Disabilities During Pandemic, see details below.
7. Cystic Fibrosis Foundation: Expand Paid Sick Leave to Protect Vulnerable Populations, click here to read the letter.
8. Request for Nominations for the Board of Governors of the Patient-Centered Outcomes Research Institute, click here to read the notice and to submit a nomination.
9. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
10. ICER's QALY-Based Study Topics: Hemophilia A, Acute Migraine, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, click here to provide patient input.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.
Over 400 aging, disability, and patient organizations sent a letter urging the Department of Health and Human Services (HHS) to issue further guidance addressing the application of federal non-discrimination laws to plans to ration scarce health care resources during the COVID-19 pandemic.
While HHS has previously issued a bulletin on this topic, advocates say additional guidance is necessary. In a letter to Health and Human Services Secretary Alex Azar and Office for Civil Rights Director Roger Severino, the coalition of organizations, led by the American Association of People with Disabilities, the Bazelon Center for Mental Health Law, the Center for Public Representation, and the Disability Rights, Education and Defense Fund called upon the HHS Office of Civil Rights to provide guidance clarifying, among other things, that federal law prohibits states and health care providers from making treatment allocation decisions based on assumptions that an individual’s disability or age will lessen the possibility of survival beyond the short-term or require the use of greater treatment resources. Click here to read the letter.
To track nondiscrimination and civil rights activities related to COVID-19, click here to view information on the Center for Public Representation website.
2. Lung Cancer Advocates Call for Protections for Individuals with Pre-Existing Conditions, Disabilities During COVID-19 Crisis
GO2 Foundation for Lung Cancer sent a letter to Congressional Leaders with a copy to HHS Secretary Alex Azar to recommend specific actions in response to the growing concerns about pre-existing conditions and disability discrimination in access to treatment during the COVID-19 crisis. "In light of continued media reports suggesting that rationing of care may be inevitable in state hospitals, we request that further federal guidance to states include explicit language about protection for preexisting, severe chronic disease or individuals with immunosuppressed conditions, in addition to disabilities, be spelled out to give assurance to all affected communities," the letter read. Click here to read the letter.
3. New PCORI Executive Director: Our Shared Journey to Enduring Success
On April 15, Dr. Nakela Cook joined PCORI as its new Executive Director. She penned a blog post to mark the occasion. "In the months ahead, I look forward to collaborating with the Board, staff, patients, caregivers, clinicians, and healthcare stakeholders—all valued members of the diverse PCORI community. I will treasure their advice and support on our shared journey to continued success. Together, we will build on PCORI’s strong foundation to generate evidence most meaningful to patients and conduct patient-centered outcomes research that has significant health and healthcare impact. With a decade of accomplishment behind us, and a 10-year reauthorization sustaining our future, now is the time for audacious, innovative, and courageous action; the opportunities are ours to seize," she wrote. Click here to read the full blog post.
4. Evaluation Framework for Crisis Standard of Care Plans
A team of disability rights groups created a new evaluation framework for crisis standard of care plans that states use to make medical resource allocation and re-allocation decisions during an emergency such as the COVID-19 pandemic. The framework asks five broad questions: (1) Does the plan include categorical exclusions on the basis of diagnosis or functional impairment? (2) Does the plan include implicit or explicit quality of life assessments as an allocation criteria? (3) Does the plan include long-term survival beyond the acute care episode as an allocation criteria? (4) Does the plan permit allocation or re-allocation on the basis of anticipated or documented duration of need? (5) Where the plan incorporates short-term survival probabilities, does it do so in an individualized fashion consistent with available standards of evidence? It also makes special considerations for chronic ventilator users. Click here to see the framework.
Framework co-author Ari Ne'eman also wrote a blog post for the Hastings Center exploring the framework and the ethical considerations it raises. Click here to read the blog post.
5. Health Care Rationing is Already Happening
Health care providers are instituting health care rationing in light of the COVID-19 outbreak, writes the Alliance for Aging Research's Sue Peschin. For instance, Washington State's Department of Health suggests transferring patients out of the hospital or to palliative care if their baseline functioning is marked by “loss of reserves in energy, physical ability, cognition and general health.” But rationing has been going on for years, she continues. "Most people have never heard of the Institute for Clinical and Economic Review (ICER), but it plays a central role in deciding access to doctor-prescribed treatments....The basis for ICER analyses is a discriminatory algorithm called a Quality-Adjusted Life Year, or QALY. QALY is based on the premise that an older person living with a disease or a person of any age living with a disability is economically worth less than a younger or healthier patient. In just one example, a study using QALYs found that a miscarriage had a higher 'utility' (i.e., value) than a child born with moderate to severe Down syndrome," writes Ms. Peschin. Click here to read the full article.
6. Members of Congress Speak Out on Discrimination Against People with Disabilities During Pandemic
A group of senators led by Sens. Elizabeth Warren (D-MA) and Bob Casey (D-PA) called on U.S. Department of Health and Human Services leadership to protect people with disabilities as the country tackles the COVID-19 epidemic. They wrote that the Americans with Disabilities Act makes it clear that discrimination based on disabilities is illegal. "Traditionally, American health care policy and treatment approaches have largely been driven by the concepts of cost-effectiveness analysis (CEA) and quality-adjusted life year (QALY). But these approaches are inherently discriminatory. They devalue the life of people with disabilities and older adults," they said. Click here to read the letter.
U.S. Representative Jim Langevin (D-RI) and Ruderman Foundation President Jay Ruderman penned an op-ed in The Hill raising the alarm that some places are discriminating against people with disabilities amidst the COVID-19 crisis and calling for nondiscrimination in treatment. "While some may feel that the treatment of younger, abled-bodied individuals should be prioritized over people with disabilities and compromised immune system, we cannot make judgments on who lives and who dies. We cannot cast aside any human because of their age or disability. We can and must do better," they wrote. "This complex ethical conundrum will not be resolved overnight. But even for Americans who do not work in health care and its associated regulatory bodies, or those who do not hold elected office in state legislatures and on Capitol Hill, there are modest steps that can be taken immediately to support the most vulnerable among us — from seniors to people with disabilities to other at-risk individuals." Click here to read the op-ed.
7. Cystic Fibrosis Foundation: Expand Paid Sick Leave to Protect Vulnerable Populations
The Cystic Fibrosis Foundation, along with 157 other organizations, called on Congress to expand its new paid sick leave policies to help individuals with cystic fibrosis and other diseases that place people at greater risk from COVID-19 stay home and out of harm's way. "In this extremely uncertain time for our country, we believe Congress can come together to provide some certainty for Americans who are afraid that their health or the health of a loved one will be placed at risk should they continue to work," the letter reads. Click here to read the letter.
8. Request for Nominations for the Board of Governors of the Patient-Centered Outcomes Research Institute
The Government Accountability Office (GAO) is seeking nominations for PCORI's Board of Governors. Among several categories, GAO is looking to add a patient advocate to the Board of Governors. Letters of nomination should be submitted no later than May 13, 2020. Click here to read the notice and to submit a nomination.
9. 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.
- Canada: Canadian government's refusal to provide lifesaving cystic fibrosis increases the risks that cystic fibrosis patients face during the COVID-19 pandemic. Access to new cystic fibrosis drugs would "change everything" for patients.
- New Zealand: Access to a cancer drug is life-changing for patients with multiple myeloma.
10. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments
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. Please note the following upcoming formal ICER deadlines per their website:
- Ulcerative Colitis: Model Analysis Plan available. 5/15/2020: Draft Evidence Report and Draft Voting Questions. Meeting 9/24/2020: CTAF will convene to deliberate and vote on evidence presented in ICER's report on ulcerative colitis therapies.
- Cystic Fibrosis: Draft Evidence Report and Draft Voting Questions available. 4/23/2020: Evidence Report and Response to Comments. Meeting POSTPONED: CTAF will convene to deliberate and vote on evidence presented in ICER's report on treatments for cystic fibrosis.
- Sickle Cell Disease: Evidence Report and Responses to Comments AVAILABLE. Meeting POSTPONED: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for sickle cell disease.
- Non-Alcoholic Steatohepatitis: MARCH 2020: DEADLINES PUSHED BACK 2-3 MONTHS. Draft Evidence Report and Voting Questions AVAILABLE, Comment Period OPEN through 6/24/2020. Meeting 8/13/2020: The Midwest CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for NASH.
- Hemophilia A: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Revised Scoping Document available. 6/15/2020: Research Protocol. Meeting 11/5/2020: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for hemophilia.
- Bladder Cancer: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Draft Scoping Document available, comment period open through 6/1/2020.
- Opioids: Digital Apps: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Draft Scoping Document available, Comment Period open through 6/1/2020.
- Opioids: Supervised Injection Centers: Open input period, no end date specified.
11. Upcoming Events and Webinars
PCORI: Nurse Staffing Amid COVID-19
April 21, 2020
Click here for details.
Webinar: Unlocking Health Data to Improve Oncology Outcomes
April 28, 2020
Click here for details.
PCORI Board of Governors Meeting
May 5, 2020
Click here for details.
FT US Pharma and Biotech Summit 2020
May 14, 2020
Click here for details.
Advancing Value-Based Care
May 14, 2020
Click here for details.
12. Medical Journal Articles
How Are Incremental Cost-Effectiveness, Contextual Considerations, and Other Benefits Viewed in Health Technology Assessment Recommendations in the United States?, click here to view.
The Implementation of Health Technology Assessment Principles in Public Decisions Concerning Orphan Drugs, click here to view.
Decision-Making under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the US and Europe, click here to view.
What Types of Real-World Evidence Studies Do U.S. Commercial Health Plans Cite in Their Specialty Drug Coverage Decisions?, click here to view.
Defining the Role of the Public in Health Technology Assessment (HTA) and HTA-Informed Decision-Making Processes, click here to view.
When Guidelines Recommend Shared Decision-Making, click here to view.
Upholding Trust in Therapeutic Trials and Evidence-Based Medicine: Need for Full Disclosure of Data, Crowdsourcing Data Analysis and Independent Review?, click here to view.
Physician and Patient Adjustment to Reference Pricing for Drugs, click here to view.
Patient-Centered Outcomes Research and the Injured Patient: A Summary of Application, click here to view.
Does the Use of Health Technology Assessment Have an Impact on the Utilisation of Health Care Resources? Evidence from Two European Countries, click here to view.
Patients, Clinicians and Researchers Working Together to Improve Cardiovascular Health: A Qualitative Study of Barriers and Priorities for Patient-Oriented Research, click here to view.
13. AHRQ Effective Program Updates
Systematic Review: Opioid Treatments for Chronic Pain. Click here to view.
Systematic Review: Nonopioid Pharmacologic Treatments for Chronic Pain. Click here to view.
Systematic Review: Noninvasive Nonpharmacologic Treatments for Chronic Pain. Click here to view.
OPEN FOR COMMENT THROUGH APRIL 21: Systematic Review: Care Interventions for People With Dementia (PWD) and Their Caregivers. Click here to view.
OPEN FOR COMMENT THROUGH MAY 4: Systematic Review: Interventions for Dyspnea in Patients with Advanced Cancer. Click here to view.
Research Protocol: Safety of Vaccines Used for Routine Immunization in the United States. Click here to view.
Systematic Review: Treatment of Depression in Children and Adolescents. Click here to view.
Research Report: Integrating Health System Data With Systematic Reviews. Click here to view.
Technical Brief: Impact of Community Health Worker Certification on Workforce and Service Delivery for Asthma and Other Selected Chronic Diseases. Click here to view.
EPC Program Concludes Series on Improving Health Systems Use of Evidence Reviews. Click here to view.