1. HHS Office of Civil Rights Issues Nondiscrimination Guidance in the COVID-19 Crisis, see details below.
2. Patients Should Fear an FDA-ICER Partnership, click here to read the op-ed.
3. Disability Groups File Complaints on COVID-19 Guidance that Discriminates Against People with Disabilities, see details below.
4. People with Disabilities Are Among Most Vulnerable During the COVID-19 Crisis, click here to read the article.
5. Rationing Care Violates Civil Rights of People with Disabilities, click here to read the article.
6. Cancer Patient Speaks Out About Seeking Treatment During Coronavirus, click here to read the article.
7. Don't Let Bureaucrats Deny Care for Kids with Cystic Fibrosis, click here to read the op-ed.
8. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Cystic Fibrosis, click here to read the letter.
9. COVID-19 Has Highlighted the Need for Good Hygiene, and Cystic Fibrosis Patients Hope This Awareness Continues, click here to read the article.
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: Hemophilia A, Acute Migraine, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, 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 HHS Office of Civil Rights 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, 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 National Council on Disability had requested that the Office for Civil Rights (OCR) quickly issue a notice to physicians and hospitals specifying the applicability of non-discrimination requirements of the Americans with Disabilities Act (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.
2. Patients Should Fear an FDA-ICER Partnership
A potential partnership between the Food and Drug Administration (FDA) and ICER should give patients chills, writes Emory University's Kenneth Thorpe. "ICER insists it wants to help patients and the FDA make more-informed decisions. The group has proposed hosting debriefing sessions with patient groups at the end of each cost-effectiveness review. Then, ICER and the patients would co-write a letter to the FDA with tips for gathering more effective data in future clinical trials. But ICER has spent years devaluing the lives of people living with chronic illnesses and disabilities. Patients would be wise to think twice before trusting the organization to have their best interests at heart," he writes. Click here to read the op-ed.
3. Disability Groups File Complaints on COVID-19 Guidance that Discriminates Against People with Disabilities
As cases of COVID-19 rise and states become concerned about their ability to treat all patients impacted, many are issuing guidance on whom to give care in the case of a shortage. Leading disability groups have now filed complaints in Alabama, Tennessee and Washington State, since these guidelines discriminate against people with disabilities explicitly saying that care should be prioritized for younger, healthier people.
4. 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.
5. Rationing Care Violates Civil Rights of People with Disabilities
In the face of the COVID-19 crisis, the Washington State Department of Health issued guidelines for doctors who may be faced with the decision of to whom to give care if there is a shortage. Disability groups and people living with disabilities filed a complaint, saying that the guidelines tell doctors to give care to younger and healthier people. "People with disabilities are terrified," said Ari Ne'eman. "They are terrified that when it comes to scarce resources like ventilators they will being sent to the back of the line. And they are right to be terrified because many states are saying this quite explicitly in their allocation criteria." Click here to read the article.
6. Cancer Patient Speaks Out About Seeking Treatment During Coronavirus
Having a life-threatening disease in the time of COVID-19 is terrifying and leads to unmet needs, writes the University of Washington's Morhaf Al Ackhar. "It's like being in prison inside a prison. Having advanced cancer while being wary of the COVID-19 virus really sucks. I am speaking both as a doctor and as a person with cancer – since 2016, I have lived with stage 4 lung cancer. The threat of cancer hangs in the air like a gun to your head. It makes you think about risks and survival odds. It forces you to confront the fact that you may die sooner than you'd imagined. It's a terror that the coronavirus is only making more palpable. COVID-19 is another reminder of the fragility of our lives. And even if a person with cancer manages to look away from the idea of mortality, the virus will bring it back into view," he writes. Click here to read the article.
7. Don't Let Bureaucrats Deny Care for Kids with Cystic Fibrosis
When the Affordable Care Act passed ten years ago, lawmakers made it clear that the government should not ration health care, wrote Boomer Esiason and Mary Vought in the New York Post. "Despite these clear prohibitions on rationing of care within Medicare, other government programs have taken it upon themselves to outsource their coverage decisions to an outside body—the Institute for Clinical and Economic Review (ICER). As parents of cystic fibrosis patients, we see obvious problems with the ICER approach. First, its QALY formula discounts the value, and the inherent worth, of individuals with disabilities. Our children deserve the right to a future just as much as other Americans—yet the QALY measure values their well being less than 'healthy' Americans. In fact, the National Council on Disability released a report last fall, noting that, 'QALY-based programs have been found to violate the Americans with Disabilities Act.' Second, ICER represents an unelected, unaccountable group of officials making decisions that influence the health coverage decisions—and thus the lives—of millions of Americans. ICER recently released draft recommendations regarding cystic fibrosis treatments. Despite finding 'substantial' evidence of net health benefits in several instances, the ICER draft branded treatments like the miracle drug, Trikafta, too expensive to justify coverage by insurers. But as parents who have seen the way that new medications like Orkambi and Symdeko have changed the lives of many with cystic fibrosis, we believe the entire ICER process undermines the value of not only our children, but also all Americans," they said. Click here to read the op-ed.
8. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Cystic Fibrosis
In a letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) offered feedback on ICER’s draft evidence report for Cystic Fibrosis treatments. PIPC Chairman Tony Coelho was critical of ICER’s QALY-based approach in its assessment, noting that the QALY disservices those with chronic and disabling conditions such as CF. Chairman Coelho also took issue with ICER’s willingness to prioritize financial savings over patient life and well-being. “ICER needs to reconsider its use of the QALY and model construction to ensure it is capturing an accurate picture of the value of treatments to patients,” wrote Chairman Coelho. “We disagree, as do the patients and families impacted by your analysis, that ICER should have the authority to determine the value of a patient with cystic fibrosis. Click here to read the letter.
9. COVID-19 Has Highlighted the Need for Good Hygiene, and Cystic Fibrosis Patients Hope This Awareness Continues
Individuals living with cystic fibrosis and their families, among others with compromised immune systems, have been practicing the good hygiene needed to combat the novel coronavirus, COVID-19, for years. In USA Today, Boomer Esiason and Mary Vought, two parents of cystic fibrosis patients write that it is important for their children that people continue to practice good hygiene after the pandemic ends. "We know there is an eventual end in sight for the coronavirus pandemic, but vulnerable populations will continue to be just that: vulnerable. That means proper health hygiene should not disappear with the virus. Continuing to take the necessary steps to protect those around you is the considerate course of action. Please keep washing those hands and covering those coughs. It will not only help you, it helps protect the people we love, those who can’t protect themselves," they wrote. Click here to read the article.
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: Drug finally made available by the government gives cancer patients hope.
- Canada: Cystic fibrosis patient calls for access to life-changing treatment.
- United Kingdom: Cystic fibrosis patient criticizes "lottery" that prevents her from accessing treatment. Another cystic fibrosis patient accesses treatment only through a public outcry.
11. 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 6/30/2020: 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: FOLLOWING CURRENT COMMENT PERIOD, DEADLINES PUSHED BACK 2-3 MONTHS. Draft Evidence Report and Voting Questions AVAILABLE, Comment Period OPEN through 4/15/2020. Meeting 5/28/2020: 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. 3/30/2020: Research Protocol. Meeting 8/3/2020: 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.
- Opioids: Digital Apps: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Draft Scoping Document available, Comment Period open through 4/2/2020. 4/10/2020: Revised Scoping Document.
- Opioids: Supervised Injection Centers: Open input period, no end date specified.
12. Upcoming Events and Webinars
PCORI Board of Governors Meeting
April 1, 2020
Click here for details.
Part 1 Follow-Up Q&A Session - Report from the Field: How PCORI Is Managing Incident Command
April 2, 2020
Click here for details.
Webinar: Adding Depth to Observational Research through Data Linkage
April 8, 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.
13. Medical Journal Articles
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.
Early Returns From the Era of Precision Medicine, click here to view.
Who Assigns Value in Value-Based Insurance Design?, click here to view.
Does the Institute for Clinical and Economic Review Revise Its Findings in Response to Industry Comments?, click here to view.
14. AHRQ Effective Program Updates
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.
Research Protocol: Mixed Methods Review: Integrating Palliative Care With Chronic Disease Management in Ambulatory Care, click here to view.
Online Training for SRDR+ Now Available at the Evidence Synthesis Academy, click here to read more.