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HHS-OIG Issues FAQ Guidance Related to Pharmacy Benefit Manager Arrangements

The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more

Newly Proposed AKS and Stark Law Protections For Value-Based Care Models

The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more

Proposed Revisions to Stark Law and AKS Protections for Electronic Health Records Donations

The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more

OIG Proposes Modifications to Personal Services Safe Harbor Under the AKS

The Situation: The Office of Inspector General ("OIG") proposes modifications to the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand shelter to...more

Newly Proposed Protections for Cybersecurity Technology Under the AKS and Stark Law

The Situation: Despite the ongoing evolution of cybersecurity technology and services, patients' health information and other confidential data remain vulnerable to cyberattacks because such technology and services are often...more

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