The world is getting safer
…well, at least fewer people are dying from natural disasters. This is from a recent New York Times article.
Category: Data
Key obstacle to reducing health disparities: measurement
One of President Biden’s top priorities is reducing health disparities. In fact, President Biden created a Health Equity Task Force to address the issue; the Centers for Medicare and Medicaid Services (CMS) have created their own Framework for Health Equity 2022–2032. The 5 priories in this CMS Framework are: Expand the collection, reporting, and analysis…
Building Data Capacity for Patient-Centered Outcomes Research
What types of data capacity does the National Academies believe are needed to improve patient-centered outcomes research (PCOR), particularly with respect to health disparities. A report out this month (highlights) highlights some of the data capacity needs and also describes how U.S. Department of Health and Human Services (HHS)’s Office of the Assistant Secretary for…
How to map HCPCS codes to meaningful procedure categories
In order for health care providers to be reimbursed for the services they provide, they need to input a variety of information into health insurance claims systems including what type of services were performed. The codes used to define the services provided are Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes.…
Guidance on use of real-world evidence for devices and diagnostics
Real-world evidence is often used to assess the safety of devices and diagnostics. For instance, the FDA’s , Postmarketing Surveillance Program includes the FDA Adverse Event Reporting System (FAERS); FDA may also require some MedTech companies to conduct Post-Approval Studies. However, as new legislation (e.g., 21st Century Cures Act) has passed and new technology has…
Use of real-world evidence for regulatory decision-making
How do you evaluate treatment efficacy and safety outside of the clinical trial setting? This is not just a question of academic interest. In last week’s JAMA, Rubin 2021 writes about some of the challenges of evaluating COVID-19 vaccines outside of a clinical trial setting. In an interesting, two-day workshop last week, the Duke Margolis…
Dual Eligibles’ Medicaid Policy Database
Poor, elderly individuals who may qualify for both Medicaid (for being poor) and Medicare (for being elderly, blind, disabled or have ESRD). In these cases, Medicaid serves as a supplemental insurer, covering Medicare coinsurance and deductibles. The generosity of this supplemental coverage for so-called ‘dual-eligibles’ varies across states. These differences in Medicaid payments arise from…
Improving the transparency of healthcare database study design
Healthcare database studies can be complicated. The data itself can be complex. Raw data needs to be transformed into useful variables. Then this analytic file needs to evaluated in an appropriate manner. Plus, the results need to be communicated clearly. What are the key aspects for describing this approach both among members of the research…
What evidence do health plans use to determine coverage for specialty drugs?
According to Chambers et al. (2019), the answer varies widely depending on the health plan. The authors use a data from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database. 203 specialty drugs issued by 17 of the 20 largest US commercial health plans are included in the database. This study examines nearly…
Why use real-world evidence for clinical trials?
Clinical trials are the hallmark of the drug development process. In most cases, life sciences firms are required to conduct randomized controlled trials (RCTs) to examine their treatment’s safety and efficacy relative to standard of care. While RCTs do a great job at measuring causal inference, there as a number of limitations. First of all,…