1. WEBINAR TOMORROW: Public Comment on PCORI Proposed National Priorities for Health, see details below.
2. TOMORROW: AUCD Webinar on Strategies for COVID-19 Vaccine Access and Confidence for People with Disabilities, click here to register.
3. PIPC Submits Comments to CMS on National Coverage Decision for Screening Lung Cancer with LDCT, click here to read the letter.
4. Health Affairs: Medicare Beneficiaries with Disabilities More Likely to Have Preventable Emergency Room Visits, click here to view the paper.
5. RECORDING AVAILABLE -- Discrimination and Health Care: How it Impacts You, click here to view the webinar.
6. New CDC Guidance on COVID-19 Vaccines for People with Underlying Medical Conditions, click here to read more.
7. States Rely on Template Legislation that References ICER and Discriminatory Metrics, see details below.
8. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
9. IVI to Hold Second Methods Summit, click here to learn more.
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: Hypertrophic Cardiomyopathy, Myasthenia Gravis, Atopic Dermatitis, Lupus Nephritis, Alzheimer's Disease, Asthma, 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.
In 2020, PCORI started an initiative to identify new priorities to direct its work in the coming years. PCORI's Board of Governors approved posting for public comment of five proposed National Priorities for Health developed in consultation with stakeholders, advisors, and experts. Public comment on the priorities will begin TODAY, June 28, and will run through August 27. The five priorities are:
- Increase Evidence for Existing Interventions and Emerging Innovations in Health
- Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research
- Advance the Science of Dissemination, Implementation, and Health Communication
- Achieve Health Equity
- Accelerate Progress Toward an Integrated Learning Health System
Click here to read more and to submit comments.
In addition, PCORI will hold a webinar overviewing the priorities TOMORROW, June 29 at 2:30 pm Eastern. Click here to sign up for the webinar.
2. TOMORROW: AUCD Webinar on Strategies for COVID-19 Vaccine Access and Confidence for People with Disabilities
Tomorrow, June 29 at 3:00 p.m. Eastern, the Association of University Centers on Disabilities (AUCD) will hold a webinar discussing outreach strategies, lessons learned, and continuing barriers in the goal of vaccinating all eligible persons with disabilities by the 31st Anniversary of the Americans with Disabilities Act on July 26th. Presenters will discuss real-world examples of vaccination efforts to include people with disabilities. The webinar will also speak to how we can better include people with disabilities, including those from racial and ethnic minorities, in future public health emergency planning. ASL and CART captioning will be provided. Click here to register.
3. PIPC Submits Comments to CMS on National Coverage Decision for Screening Lung Cancer with LDCT
In a comment letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho offered feedback on CMS’ National Coverage Determination (NCD) for Lung Cancer with Low Dose Computed Tomography (LDCT). Chairman Coelho reiterated the importance of clear guidance at CMS to facilitate shared decision-making. With respect to the NCD, the letter expresses concerns that the rigid SDM requirements and criteria for lung cancer screening coverage could have the unintended effect of hindering screening access and uptake. “Consistent with this recommendation, CMS has an opportunity to act on the broader recommendations of organizations representing patients and people with disabilities articulated in prior communications to the agency related to SDM,” wrote Chairman Coelho. “A patient-centered approach is beneficial and appropriate across cancer screenings.” Click here to read the letter.
4. Health Affairs: Medicare Beneficiaries with Disabilities More Likely to Have Preventable Emergency Room Visits
In a new study published in Health Affairs, researchers found that among Medicare beneficiaries, people with disabilities had less access to care and were more likely to seek emergency services. "Medicare beneficiaries (ages 21–64) with disabilities were 119 percent more likely to report difficulty accessing care and were 33 percent and 49 percent more likely to lack annual clinician evaluation and management visits for primary and specialty care, respectively, than those without disabilities," the study reads. "Beneficiaries (ages 21–64) with disabilities also had 42 percent, 67 percent, and 77 percent higher likelihood of having all-cause, nonemergent, and preventable emergency department (ED) visits. Furthermore, people with both a disability and a lack of specialist evaluation and management visits also had 21 percent, 48 percent, and 64 percent increased likelihood of all-cause, nonemergent, and preventable ED visits. Barriers to accessing ambulatory care may be a key contributor to the reliance of Americans with disabilities on ED services."
Click here to view the paper.
5. RECORDING AVAILABLE -- Discrimination and Health Care: How it Impacts You
The Bonnell Foundation: Living with Cystic Fibrosis held a webinar discussing the ways that policymakers and payers make decisions about whether or to cover a given treatment. The system being proposed to state and federal policymakers was put forth by a self-appointed group that uses Quality Adjusted Life Years (QALY). The process for valuing treatments using QALYs puts a lower value on lives lived with a disability or chronic disease. The webinar also covered the existing civil and disability rights laws that have created precedent against using QALYs in public health programs, as well as threats at the state and federal level for incorporating the use of QALYs. Click here to view the webinar.
6. New CDC Guidance on COVID-19 Vaccines for People with Underlying Medical Conditions
The Centers for Disease Control and Prevention (CDC) recently updated its guidance on COVID-19 vaccines for individuals with underlying medical conditions. CDC says that people living with HIV, those with weakened immune systems, or those taking medications that weaken the immune systems may not be fully protected even if fully vaccinated. The agency suggests that such individuals talk to their health care providers and continue taking precautions such as masking and social distancing, even after vaccination. Click here to read more.
7. States Rely on Template Legislation that References ICER and Discriminatory Metrics
We are seeing many states reference pieces of template legislation put forward by the National Association of Health Policy (NASHP). Though the intent of these bills is to lower healthcare costs, several implicate the discriminatory Quality-Adjusted Life Year (QALY) and others rely on the Institute for Clinical and Economic Review (ICER) as the sole source for evidence. The three primary bills are:
- Canadian Reference Pricing -- This piece of template legislation directly references the prices paid for drugs in five Canadian provinces. Before applying for coverage by the provinces, all drugs must complete a Common Drug Review by CADTH, which uses QALYs. The result of this is that in Canada is that many individuals living with disabilities are unable to receive the treatments and care they need. The National Council on Disability (NCD) warned in its 2019 report that similar coverage denials and loss of access to care could also be the outcome if the United States if we reference other countries.
- Unsupported Price Increase -- This piece of template legislation relies on one report by ICER to determine whether a price increase on certain therapies were supported by additional evidence. This is concerning as it codifies reference to an independent entity lacking oversight and accountability as a sole source of information. ICER is the sole arbiter as to what evidence it uses to develop this report, and patients have consistently expressed concern with ICER’s lack of transparency and omission of real-world evidence. ICER also has the ability to change the inputs and methodology of the report without oversight. Though the 2020 report does not use the QALY, it is possible that future reports will.
- Drug Pricing Review Board -- This piece of template legislation establishes a drug review board or commission. The goal of the board is to allow the state to review and evaluate the reimbursement rate and/or coverage for pharmaceuticals. Most have fairly broad parameters of how they can assess a drug’s value, and specifically permit the state to rely on third-party research or contract directly with a third-party for the purpose of fulfilling its duties. As has happened in other states such as New York and Massachusetts, without patient protections, these bills allow the new state board or commission to reference value assessments that rely on QALY and similar metrics. It is imperative that these boards has patient and disability representation and that a QALY ban is included in the legislation.
8. 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 or are considering policies to import QALY-based decisions from other countries. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. 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. Other states are taking positive steps to ban the use of the QALY and other discriminatory metrics.
The Maryland legislature passed legislation earlier this year creating a Prescription Drug Affordability Board. The legislation did not include protections for patients and people with disabilities such as barring the use of discriminatory QALYs. The Board has begun meeting to hear from stakeholders, including hearing a presentation from the Institute for Clinical and Economic Review which relies on QALYs to assess treatment value. Legislation was introduced this year to bar the use of QALYs and implement patient protections that has not advanced in the legislature. Click here to view the Board meeting agenda and here to view reference to the discussion on how to leverage ICER studies. Click here to view HB 1167 which would bar the use of QALYs in Maryland.
The Governor of Colorado has signed into law SB 21-175, which creates a prescription drug affordability review board. SB 21-75 did include an amendment that prohibits the use of QALYs in the section of the bill that determines an upper payment limit, but it does not include similar protections in the sections establishing the commission’s authority to perform value assessments for treatments would prevent QALYs from being used to target treatments for people with disabilities and older adults. In some states these types of boards and commissions have led to referencing value assessments based on QALYs from the Institute for Clinical and Economic Review (ICER). In Massachusetts, the Health Policy Commission went so far as to contract with ICER. In order to mitigate this, it is important that the Board has representation from patients and people with disabilities. The Governors office is currently accepting applications for both the Colorado Prescription Drug Affordability Review Board and the Colorado Prescription Drug Affordability Advisory Council.
The Massachusetts House and Senate have each taken the positive step of introducing An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, H.201 and S.753. This bill would enshrine essential patient protections including a ban on the use of the QALY, a requirement for research to meet patient-centeredness criteria, and robust engagement of the patient and disability communities in health care decision making.
CA AB 1130, the California Health Care Quality and Affordability Act, is being considered in California to create an Office of Health Care Affordability. Similar to the Massachusetts Health Policy Commission, the legislation would authorize reviewing health costs and "require the office to set priority standards for various health care metrics.” In Massachusetts, the Health Policy Commission went so far as to contract with ICER. We understand the legislation is likely to pass the Appropriations Committee this session, and amendments to protect patients from discrimination has not been considered. It was originally proposed by Governor Gavin Newsom in the California Budget for 2021-22 which included a proposal for a new Office of Health Care Affordability to be housed within the Office of Statewide Health Planning and Development (OSHPD) that would seek to promote “cost efficient” care. It is anticipated that this office could advance as an independent bill, or as part of the California budget in mid-June. The Value Our Health template language has not been introduced or passed in California to protect patients from the use of QALYs and discriminatory considerations of cost effectiveness.
9. IVI to Hold Second Methods Summit
The Innovation and Value Initiative (IVI) announced that it will hold a second methods summit to drive patient-centered value assessment. The multi-stakeholder event is intended to drive consensus on priority patient inputs, methods, and research that more fully represent the patient perspective in comparative effectiveness research and economic evaluations of health care interventions. The three-part series will take place in Fall 2021. Overall, the goal of IVI’s summit is to define an action agenda for patient-centered outcomes research and cost-effectiveness research by exploring patient outcomes, beyond traditional clinical factors, that represent important impacts to patients and must be accounted for in economic analyses. Click here to learn more.
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.
- Canada: "Time is a scary thing:" mother seeking access to lifesaving cystic fibrosis for her daughter. ALS patient pulls all-night walk in race for better treatments.
- United Kingdom: Woman with idiopathic pulmonary fibrosis waiting for a lengthy review to see if the government will grant her access to lifesaving drugs.
11. ICER's QALY-Based Study Topics: Hypertrophic Myocardiopathy, Myasthenia Gravis, Atopic Dermatitis, Lupus Nephritis, Alzheimer's Disease, Asthma
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.
- Hypertrophic Cardiomyopathy: 5/14/2021: Research Protocol available. 7/2/2021: Model Analysis Plan. Meeting 10/22/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on therapies for obstructive hypertrophic cardiomyopathy.
- Myasthenia Gravis: Model Analysis Plan available. 7/22/2021: Draft Evidence Report. Meeting 9/24/2021: New England CEPAC will deliberate and vote on evidence presented in ICER’s report on therapies for myasthenia gravis.
- Atopic Dermatitis: Draft Evidence Report available. 7/9/2021: Evidence Report Meeting 7/23/2021: An assessment of treatments for atopic dermatitis by the New England CEPAC.
- Hereditary Angioedema: 7/27/2021: Final Updated Assessment with RWE Update.
- Unsupported Price Increase: 11/16/2021: Final Report.
- Asthma: Research Protocol available. 8/2/2021: Model Analysis Plan. Meeting 11/19/2021: New England CEPAC will deliberate and vote on evidence presented in ICER’s report on therapies for severe asthma.
- Alzheimer's Disease: Draft Evidence Report available. 6/30/2021: Evidence Report. Meeting 7/15/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on Alzheimer’s disease.
- Fair Access: Coverage Policies in 2020: Protocol Available. 10/20/2021: Final Report.
12. Upcoming Events and Webinars
AHRQ Webinar: COVID-19’s Impact on Digital Healthcare
July 1, 2021
Click here to view.
PCORI Advisory Panel on Patient Engagement Summer 2021 Meeting
July 15-16, 2021
Click here to view.
Whistleblowers of America: Workplace Promise Institute 2021 Conference
September 9-10, 2021
Click here to view.
13. Medical Journal Articles
Association of Co-Pay Elimination With Medication Adherence and Total Cost, click here to view.
The Utility of Patient Engagement in Drug Research and Development, click here to view.
Patient-Powered Research Networks of the Autoimmune Research Collaborative: Rationale, Capacity, and Future Directions, click here to view.
Enhancing Patient Research Partner Engagement: Research in Psoriatic Arthritis, click here to view.
Patient Voices in Value-Based Cancer Care: Priorities for the Biden Administration, click here to view.
The Dollar or Disease Burden: Caps on Healthcare Spending May Save Money, but at What “Cost” to Patients?, click here to view.
Embedding Clinical Trials Within Routine Health-Care Delivery: Challenges and Opportunities, click here to view.
Approval and Coverage of Cancer Drugs in England, Canada, and the US, click here to view.
Experiences of an HCV Patient Engagement Group: A Seven-Year Journey, click here to view.
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research, click here to view.
14. AHRQ Effective Program Updates
Surveillance Report: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
OPEN FOR COMMENT THROUGH JULY 8, 2021: Key Questions: Telehealth During COVID-19. Click here to view.
Systematic Review: Prehospital Airway Management. Click here to view.
Systematic Review: Radiation Therapy for Brain Metastases. Click here to view.
OPEN FOR COMMENT THROUGH JULY 1, 2021: Systematic Review: Malnutrition in Hospitalized Adults. Click here to view.
Systematic Review: Safety of Vaccines Used for Routine Immunization in the United States: An Update. Click here to view.
Research Protocol: Evaluation of Mental Health Applications. Click here to view.
Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacologic Interventions. Click here to view.
Rapid Evidence Product: Improving Pain Management in the Context of America's Opioid and Substance Use Disorders Crisis. Click here to view.
Systematic Review: Cervical Ripening in the Outpatient Setting. Click here to view.