Tag Archives: Compliance

cGMPs for Combination Products – FDA’s Proposal for Streamlined Mechanisms of Compliance

By Mark I. Schwartz — On January 22, 2013, FDA published its final rule on cGMP requirements for combination products under 21 CFR Part 4. Specifically Part 4.4 provides two mechanisms for combination product manufacturers to comply with the cGMP … Continue reading

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Professional Administration: The Last Piece of the MSP Compliance Puzzle

It has been nearly one year since the Centers for Medicare & Medicaid Services (CMS) first released a revised Workers’ Compensation Medicare Set-Aside (WCMSA) Reference Guide,[1] which addressed one of the lesser discussed topics in Medicare Secondary Payer (MSP) compliance: … Continue reading

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EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions

By Timothy D. Backstrom and Lisa M. Campbell On June 19, 2018, sixteen federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the … Continue reading

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Philadelphia Personal Injury Law Firm Agrees to Start Compliance Program and Reimburse the United States for Clients’ Medicare Debts

Medicare is watching personal injury settlements and seeking to hold personal injury lawyers responsible for Medicare liens on settlements or judgment proceeds. On June 18, 2018, a Philadelphia personal injury law firm, Rosenbaum and its Associates, and its principal  entered into a … Continue reading

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U.S. Attorney’s Office Settles Conditional Payments Debts with Personal Injury Law Firm and Requires Attorney to Institute Best Internal Compliance Practices

On Monday, the U.S. Department of Justice’s Attorney’s Office for the Eastern District of Pennsylvania issued a press release concerning a settlement arrangement involving the repayment of conditional payments.  U.S. Attorney William M. McSwain announced that the Philadelphia personal injury … Continue reading

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