1. Evaluation Framework for Crisis Standard of Care Plans, see details below.
2. Health Care Rationing is Already Happening, click here to read the article.
3. Members of Congress Speak Out on Discrimination Against People with Disabilities During Pandemic, see details below.
4. Cystic Fibrosis Foundation: Expand Paid Sick Leave to Protect Vulnerable Populations, click here to read the letter.
5. 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.
6. Gunnar Esiason: Rationing-of-Care Debate Must Include Those Most at Risk, click here to read the article.
7. Advocates Call for Nondiscrimination in the Face of the Coronavirus Crisis, see details below.
8. Pioneer Institute Report: Quality Adjusted Life Years (QALY) – The Threat to Older Americans, see details below.
9. Planetree: Family Visitation Policies During Pandemics Must Account for Adverse Effects, click here to read the statement.
10. Caravanserai: What Nonprofits Need to Do to Survive Coronavirus, see details below.
11. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
12. 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.
13. Upcoming Events and Webinars, see details below.
14. Medical Journal Articles, see details below.
15. AHRQ Effective Program Updates, see details below.
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.
2. 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.
3. 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. "People with disabilities and older adults should not face discrimination in the allocation of life-sustaining treatment from which they are able to clinically benefit. Given the challenges anticipated in the coming weeks and months, we ask you to continue to protect the rights of people with disabilities," 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.
4. 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.
5. 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.
6. Gunnar Esiason: Rationing-of-Care Debate Must Include Those Most at Risk
Gunnar Esiason writes in Real Clear Politics that current conversations about rationing care must not discriminate against individuals with chronic disease, including cystic fibrosis. "Government and hospital leaders are working to establish regional or statewide triage guidance for front-line care providers based on various patient attributes such as underlying health issues or expected “life years” remaining. This is a scary topic for people who may fall outside that guidance because of chronic conditions or advanced age. If we are not heard now, who will speak up for us when it is too late? Those of us who stand to lose the most must be given equity in the decision-making process that will ultimately result in triage guidelines for doctors," he writes. Click here to read the article.
7. Advocates Call for Nondiscrimination in the Face of the Coronavirus Crisis
The HHS Office of Civil Rights (OCR) issued a bulletin to ensure that entities covered by civil rights authorities keep in mind their obligations under laws and regulations that prohibit discrimination on the basis of race, color, national origin, disability, age, sex, and exercise of conscience and religion in HHS-funded programs, including in the provision of health care services during COVID-19. OCR enforces the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, the Age Discrimination Act, and Section 1557 of the Affordable Care Act which prohibits discrimination in HHS funded health programs or activities. OCR made it clear that these laws, like other civil rights statutes OCR enforces, remain in effect. As such, persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities or age. As noted by Ari Ne’eman in the New York Times, “The bulletin 'represents an important first step in protecting the rights of people with disabilities in the current crisis,'” Click here to view the OCR bulletin. Click here to view the New York Times article.
As the COVID-19 crisis escalates, people with disabilities have communicated a clear message against perpetuating discrimination in violation of the Americans with Disabilities Act (ADA). The New York Times published a response from PIPC Chairman Tony Coelho to a troubling opinion piece stating, "I did not fight for the Americans With Disabilities Act to let this country count people with disabilities as having less value than others. Those with underlying conditions should not allow self-appointed ‘experts' to instill fear.” The New York Daily News published a more expansive opinion by Chairman Coelho stating, "Right now, we need leadership directing resources to the most vulnerable populations, not away from them. Health officials in the administration are taking aggressive steps to ensure anyone with COVID-19 can access the care they need. Similarly, leaders in Congress like my friend Sen. Bob Casey and many of his Senate colleagues are getting this right by calling for steps to protect people in nursing homes, older adults and people with disabilities...People with disabilities understand very clearly what is at stake in this crisis. Will we as a nation rise above fear and reaffirm our value for every person, regardless of their age or abilities? Or give way to fear and retreat to self-preservation?” Click here to view Chairman Coelho’s Letter to the Editor and here to view his opinion.
The National Kidney Foundation sent a letter calling for the nation's hospitals to not implement rationing policies that discriminate against patients with chronic disease. "we call on all health systems to recognize that ESRD patients have the same inherent worth as any other patient and should be afforded the same level of care," NKF wrote. Click here to read the letter.
The Consortium for Citizens with Disabilities had called for OCR to "ensure that decisions regarding the possibility of benefit, the prospect of survival, and the use of treatment resources are free from bias or stereotype." CCD continued, saying, "the bias against individuals with disabilities and older adults by medical professionals has been well documented, and it often expresses itself in exaggerated fears about the cost, burden, or futility of treatment of such individuals." Click here to read the CCD letter.
The National Council on Disability had requested that the OCR quickly issue a notice to physicians and hospitals specifying the applicability of non-discrimination requirements of the ADA, Section 504 of the Rehabilitation Act, and Section 1557 of the Affordable Care Act in making treatment decisions. Click here to view the NCD letter.
To track nondiscrimination and civil rights activities related to COVID-19, click here to view information on the Center for Public Representation website.
8. Pioneer Institute Report: Quality Adjusted Life Years (QALY) – The Threat to Older Americans
With the recent growth in medicine spending, state and federal policymakers are exploring the use of cost-effectiveness reviews to determine treatment value and access. ICER uses a controversial cost-effectiveness methodology that utilizes a QALY standard to assess the cost-effectiveness of a drug based on a monetary value of the drug’s potential ability to improve a patient’s quality of life and extend it.
A new Pioneer Institute report examines how the QALY methodology to determine drug treatment value and access threatens to discriminate against older adults by placing a lower value on treatments that would extend or improve the quality of life for older patients. Pioneer Institute’s report warns that proposals such as “Medicare for All,” that encourage the use of QALYs to make treatment access decisions, could have disastrous consequences for American seniors. Click here to read the report. Click here to read a one-page handout. Click here to watch a video on the topic.
9. Planetree: Family Visitation Policies During Pandemics Must Account for Adverse Effects
Planetree, an organization dedicated to patient-centered care, wrote that care facilities' policies on family visitation must stay patient-centered during pandemics. "When weighing the need to limit visitation – particularly in complex family presence scenarios – healthcare leaders and state health departments are advised to consider not only the risk that visitation my cause to the staff, patients and loved ones, but also the risk that these visitation restrictions may create for the emotional and psychological health of these same individuals both in the short and long term. Particularly in cases of pediatric care, childbirth and patients at the end-of-life, eliminating the ability of patients to have a familiar support person by their side may have devastating long-term emotional, psychological and other health effects. Similarly, restricting the presence of chaplains and other spiritual caregivers can be extremely distressing to some ethnic and religious groups," the group wrote. Click here to read the full statement.
10. Caravanserai: What Nonprofits Need to Do to Survive Coronavirus
Nonprofit organizations face unique challenges during the pandemic. Caravanserai wrote a pair of articles on how nonprofits can weather the storm. One provides an "emergency intervention" guide on how social impact groups should approach the crisis and what steps they should consider to ensure their survival. Click here to read the article. The second expanded upon the emergency intervention guide, and added additional resources related to Congressional action and the financial assistance that may be available to nonprofits. Click here to read the article.
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: Blood cancer patients in Australia will now have access to a lifesaving treatment after having it denied for years.
- New Zealand: Patients will die unless Pharmac expands access to treatments for individuals with compromised immune systems.
- United Kingdom: Mother with cancer needs to raise funds to get treatment in Germany because the therapy she needs is unavailable on the NHS.
12. 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. 4/15/2020: 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.
Elective and Urgent Surgeries Amid COVID-19
April 14, 2020
Click here for details.
Market Access USA at eyeforpharma Philadelphia
April 15, 2020
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Online Training: Introduction to Real-World Evidence & Real-World Data
April 15-17, 2020
Click here for details.
Webinar: Unlocking Health Data to Improve Oncology Outcomes
April 28, 2020
Click here for details.
FT US Pharma and Biotech Summit 2020
May 14, 2020
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Advancing Value-Based Care
May 14, 2020
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14. Medical Journal Articles
A Proposed Framework for Patient Engagement Throughout the Broader Research Enterprise, click here to view.
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.
15. AHRQ Effective Program Updates
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.
Research Protocol: Prehospital Airway Management: A Systematic Review. Click here to view.
Technical Brief: Strategies for Patient, Family, and Caregiver Engagement. Click here to view.
Research Protocol: Pharmacologic and Nonpharmacologic Treatments of Posttraumatic Stress Disorder, click here to view.