Utilizing Medicare claims data for real‐time drug safety evaluations: is it feasible?^,

Abstract

Claims delay is consistent across time and is minimal. Claims adjudication does not substantially impact the content of clinical information in the Medicare claims database. Therefore, the Medicare claims database provides consistent information regarding health services and prescription drugs in a manner that is prompt enough to facilitate medical product safety evaluations in real time.

Assessing the Comparative Effectiveness of Newly Marketed Medications: Methodological Challenges and Implications for Drug Development

“…Claims data need to go through an adjudication process by insurance companies before they become useful for research. This process may take from 3 months (commercial) to a year or longer (some aspects of Medicare/Medicaid) 40 Granularity of information : In some situations, specific information with a high degree of granularity is required.…”

“…Claims data need to go through an adjudication process by insurance companies before they become useful for research. This process may take from 3 months (commercial) to a year or longer (some aspects of Medicare/Medicaid) 40 …”

Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near‐Real‐Time Monitoring Program in Italy

“…In this pilot monitoring program the sequential accrual of the data was simulated to conduct sequential analyses. As new medications enter the market, this monitoring framework will promptly provide Italian prescribers with relevant clinical information on the safety and effectiveness of new agents in “near”‐real‐time, which comes from the fact that there is generally a lag between when the drug is delivered to a patient and when the data become available for analysis . This occurs in temporal updates, which we refer to as “monitoring periods” in the current article.…”

Near real‐time adverse drug reaction surveillance within population‐based health networks: methodology considerations for data accrual

“…This approach relies on frequent extracts of medical utilization and medical product exposure data, with emphasis on using the most current data possible, that is, near real‐time. However, real‐time data collection is susceptible to delayed, incomplete, and erroneous data capture caused by omissions during documentation at the time of service delivery or delays in the processing of claims within health insurers related to the adjudication process . The impact of data capture issues on prospective safety surveillance systems is not fully understood.…”