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CMS Delays and Reopens Comment Opportunity for Breakthrough Device Coverage Rule and Regulatory Definition of “Reasonable and Necessary”

USA - March 24 2021 On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule1 delaying the effective date of the final rule…

Donielle McCutcheon, Meenakshi Datta, Stephanie P. Hales, Trevor L. Wear, William A. Sarraille.

CMS Finalizes Medicaid Drug Rebate Changes Addressing PBM Accumulators, VBP Arrangements and Line Extensions

USA - December 29 2020 On December 21, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing significant manufacturer price…

Corbin T. Santo, Meenakshi Datta, Trevor L. Wear, William A. Sarraille.

HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule

USA - December 15 2020 On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed…

Colleen Theresa Brown, Meenakshi Datta, Megan Svedman, Rina Mady.

HRSA Releases 340B Administrative Dispute Resolution Final Rule

USA - December 14 2020 On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a final…

Meenakshi Datta, Stephanie P. Hales, William A. Sarraille.

HHS-OIG Special Fraud Alert Addresses Speaker Program Suspect Factors

USA - November 17 2020 In a Special Fraud Alert1 published on November 16, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) cautions…

Jaime L.M. Jones, Mark B. Langdon, Meenakshi Datta, Whitney Nebolisa.