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In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute

On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more

The Wait is Over . . . Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced proposed permanent rules around prescribing controlled substances via telemedicine that expand the circumstances under which practitioners can prescribe...more

Finalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge

On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

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