1. 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.
2. Gunnar Esiason: Rationing-of-Care Debate Must Include Those Most at Risk, click here to read the article.
3. Advocates Call for Nondiscrimination in the Face of the Coronavirus Crisis, see details below.
4. Pioneer Institute Report: Quality Adjusted Life Years (QALY) – The Threat to Older Americans, see details below.
5. Planetree: Family Visitation Policies During Pandemics Must Account for Adverse Effects, click here to read the statement.
6. People with Disabilities Are Among Most Vulnerable During the COVID-19 Crisis, click here to read the article.
7. Caravanserai: What Nonprofits Need to Do to Survive Coronavirus, see details below.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
9. 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.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
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. Click here to read the notice and to submit a nomination.
2. 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.
3. Advocates Call for Nondiscrimination in the Face of the Coronavirus Crisis
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 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 last week 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 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.
4. 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.
5. 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.
6. People with Disabilities Are Among Most Vulnerable During the COVID-19 Crisis
With "social distancing" policies going into effect and workers increasingly staying home, people with disabilities are at risk of not receiving the care they need. A USA Today report examines the human cost of having health care workers unavailable to care for people who need it. "One of the voiced concerns was that health care providers were not going to be able to continue making home visits as the outbreak deepened....With no home care, states could turn to grouping those with severe disabilities in state-run facilities -- a trend advocates have worked hard to reverse over the past three decades. There's also fear that hospitals will classify people with disabilities and chronic illnesses as a lower priority for healthcare," the article says. Click here to read the article.
7. 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.
8. 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: Patient who drained his savings to survive prostate cancer says Australia should do more to help people who are struggling.
- Canada: Health Canada's refusal to provide access to cystic fibrosis medicaitons is making the COVID-19 crisis worse for Canadians with CF.
- United Kingdom: Mother with cancer needs to raise funds to get treatment in Germany because the therapy she needs is unavailable on the NHS.
9. 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.
10. Upcoming Events and Webinars
Webinar: Adding Depth to Observational Research through Data Linkage
April 8, 2020
Click here for details.
PCORI: Dealing with the Emergency Department Amid COVID-19
April 9, 2020
Click here for details.
Market Access USA at eyeforpharma Philadelphia
April 15, 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
Click here for details.
Advancing Value-Based Care
May 14, 2020
Click here for details.
11. Medical Journal Articles
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.
HTA Around the World: Broadening Our Understanding of Cross-Country Differences, click here to view.
12. AHRQ Effective Program Updates
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.
OPEN FOR COMMENT THROUGH MARCH 2: 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.
2019 Year in Review—Accomplishments From the Evidence-based Practice Center Program, click here to view.
Research Protocol: Radiation Therapy for Brain Metastases: A Systematic Review, click here to view.
Research Protocol: Cervical Ripening in the Outpatient Setting, click here to view.
Research Protocol: Treatments for Acute Episodic Migraine, click here to view.