False Claims Act Diagnostic Company Reaches False Claims Act Settlement Thomas Sullivan Mar 18, 2022 0 In mid-February 2022, American Health Associates, Inc. (AHA) reached an agreement with the United States Department of Justice…
DTC OPDP Sends “Bad Ad” Warning Letter over PARAGARD Video Thomas Sullivan Mar 17, 2022 0 On February 12, 2021, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a…
Anti Kickback California Court Rules that FMV Payments Can Qualify as Illegal Kickbacks Thomas Sullivan Mar 16, 2022 0 On February 23, 2022, the United States District Court for the Central District of California denied Medtronic’s motion to dismiss…
Anti Kickback Mallinckrodt Reaches $260 Million Anti-Kickback Settlement Thomas Sullivan Mar 15, 2022 0 Recently, Mallinckrodt ARD LLC reached a $260 million settlement to resolve allegations that Mallinckrodt violated the False…
Drug Prices Connecticut Governor Proposes Price Restrictions on Prescription Drugs Thomas Sullivan Mar 14, 2022 0 Earlier this year, Connecticut Governor Ned Lamont proposed to set a maximum price on prescription drugs, drawing criticism from…
CME CME Webinar Series Guides Clinicians on Individualizing HER2-Positive… Thomas Sullivan Mar 13, 2022 0 Despite significant improvement in the treatment of HER2-positive metastatic breast cancer in recent years, breast cancer remains…
Life Science Compliance Update Policy and Medicine Compliance Update March 2022 Issue Features: Global… Thomas Sullivan Mar 12, 2022 0 Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…
FDA OPDP Sends Warning Letter to CytoDyn Over Promotional Video for Its IND… Thomas Sullivan Mar 11, 2022 0 On February 11, 2022, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a…
HHS District of Delaware Rules HRSA Exceeded Its Authority in Issuing 340B… Thomas Sullivan Mar 10, 2022 0 We have written several times on the December 2020 letter issued by the United States Department of Health and Human Services…
CMS CMS Announces New Flexibilities to QPP and MIPS Thomas Sullivan Mar 9, 2022 0 In light of the Coronavirus (COVID-19) pandemic, the Centers for Medicare and Medicaid Services (CMS) has been implementing…