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FDA Guidance on Diversity Plans in Clinical Trials: What You Need to Know

The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more

New Year Brings Significant Changes to Medicare Physician Fee Schedule

The Medicare Physician Fee Schedule Final Rule for Calendar Year 2021 (the Final Rule) issued by the Centers for Medicare & Medicaid Services (CMS) on December 1, 2020, and published in the Federal Register on December 28,...more

Penalties for COVID-19 Reporting Failures and Other New CMS Rules on Mandatory Testing and Ordering Limits

Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more

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