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Medicare Advantage Regulatory Scrutiny Keeps Pace with Growth: OIG Report Examines Prior Authorization and Payment Denial Errors

On April 28, 2022, the United States Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a report finding that 15 of the largest Medicare Advantage Organizations (“MAOs”) in the United States have at times denied or delayed beneficiary access to care and provider payment requests for services that met Medicare coverage and MAO billing rules (the “Report”).

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA

Practices: Health Care

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The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, national authorities have issued guidance for sponsors, investigators and institutional review boards (IRBs)/research ethics committees (RECs) regarding the conduct of clinical trials. The chart below summarizes guidance from the U.S. Food and Drug Administration (“FDA”) (updated March 27, 2020), the European Medicines Agency (“EMA”) (dated March 27, 2020), the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) (updated March 24, 2020), and Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) (dated March 27, 2020).

View the PDF to read the guidance.

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