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CMS Issues Final Rule Redefining Medicare Part D “Negotiated Price” As Pharmacy’s Lowest Possible Reimbursement

On April 29, 2022, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule revising the way Medicare determines the “negotiated price” (i.e., the price upon which beneficiary cost-sharing is based at the pharmacy counter) under Medicare Part D.

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by Key European National Regulatory Authorities, the Australian Department of Health, Brazil’s ANVISA, Health Canada and Singapore’s HSA

Practices: Health Care

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Coronavirus Landing Site

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. Following up on an earlier alert that was released on April 2, 2020, available here summarizing guidance from FDA, EMA, MHRA and PMDA, the below chart summarizes guidance related to COVID-19 and clinical trials released by additional national regulatory authorities. The chart below summarizes guidance from the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”), Switzerland's Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”), Health Canada, and Singapore Health Sciences Authority (“HSA”).

View the PDF to read the guidance.

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