Unbiased Analysis of Today's Healthcare Issues
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.…
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…
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…
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…
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…
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…
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,…
The 21st Century Cures Act, enacted December 2016, mandated that the FDA consider how to use real-world evidence (RWE) to bring innovative treatments to market faster. To meet this statutory requirement, the FDA has provided guidance outlining its policies for using RWE to support the approval of a new drug indication. What is real-world evidence?…
Patients and providers should be able to securely access a patient’s medical record wherever they are. Not having a patient’s full record could result in poor treatment choices and suboptimal patient outcomes. The dream of a seamless, cloud-based electronic medical record (EMR), however, is years away. Consider the example shared by CMS administrator Seema Verma…
The Robert Wood Johnson Foundation has a publicly available data source you can use to find this information. Known as HIX Compare, the data contain descriptions of plans in the individual and small group markets across all 50 states. HIX Compare is the only dataset with information on nearly every individual and small group marketplace plan…