Category Archives: FDA

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CMS Finalizes Transitional Coverage for Emerging Technologies (TCET) Pathway: A New...

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. A Health Law Defense and Compliance Firm CMS has announced the finalization of its Transitional Coverage for Emerging Technologies (TCET) ...

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Court Rejects Former Relator’s Recovery Attempt for Share of Amgen Whistleblower...

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. A Health Law Defense and Compliance Firm The False Claims Act (FCA) is an essential weapon in combating fraud against the government, but ...

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Boston’s Magellan Diagnostics Pleads Guilty to Criminal Charges Over Faulty Testing...

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. A Health Law Defense and Compliance Firm Magellan Diagnostics, a Massachusetts-based medical device company, has pleaded guilty to criminal...

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Supreme Court Decision Limits Regulatory Authority: Implications for Healthcare Providers

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. A Health Law Defense and Compliance Firm In a landmark decision, the Supreme Court significantly restricted federal agencies' authority to...

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Magellan Diagnostics Settles $42 Million for Concealing Lead Test Malfunction

By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. A Health Law Defense and Compliance Firm Magellan Diagnostics, Inc., a medical device company based in Billerica, Massachusetts, has agreed to pay $42...

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