LMI understands that companies with regulated products or services are required to track and report specific information or events to applicable regulatory agencies, such as the U.S. Food and Drug Administration (FDA). Members of LMI’s Operations Support team have significant experience assisting these companies in meeting their governmental obligations.
LMI has the ability to produce data and/or supporting documentation in either paper or electronic format and we are able to create electronic files with searchable text. LMI is also able to create and distribute Client Score Card reports, which track internal and government-mandated timelines, enabling clients and counsel to best manage their reporting responsibilities.
LMI is able to assist clients with mandatory reporting requirements under Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA) by allowing for increased efficiencies and cost-effective reporting of settlement awards, judgment awards and/or other payments (such as workers’ compensation) to the Centers for Medicare & Medicaid Services (CMS). We customize our services to best meet the specific needs of each client.
LMI is able to serve as the RRE reporting agent, or prepare files for submission by RRE or other existing agent (e.g., settlement administration or lien resolution company). LMI is able to conduct eligibility and settlement reporting, as well as process return files and submit data augmentation as needed.
Product Safety Reporting
LMI has significant experience assisting companies in meeting product safety tracking and reporting obligations, such as the reporting of Adverse Events (AEs) to the U.S. Food and Drug Administration. LMI's clients benefit from our in-depth understanding of duties and how best to manage companies' reporting responsibilities, as well as the following:
- AE documentation produced in either paper or electronic format.
- Electronic files with searchable OCR text.
- AE documents produced to a company well in advance of associated reporting deadlines so that the company has ample time to cull pertinent pages from new documents.
- LMI performance score cards that detail turn-around times to demonstrate regulatory deadlines are consistently met.
LMI is able to serve as an authorized agent to insurers who may be required to report medical malpractice payments to the National Practitioner Data Bank (NPDB) and, where applicable, appropriate state licensing boards, in accordance with Title IV (and/or other applicable regulations). In this role, LMI completes and submits the necessary reports on behalf of the insurer. Reporting is typically done directly through the NPDB website. Reports can also be forwarded to applicable state boards through the NPDB website or via a separate reporting process as required.
LMI is registered with the NPDB and meets the appropriate requirements to serve as an authorized agent on behalf of eligible reporting entities.