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Focus on Regulation

Tag Archives: OIG

New HHS OIG Work Plan Indicates Focus on Subrecipient Monitoring

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently released its Work Plan for Fiscal Year 2016. The Work Plan discusses OIG’s anticipated reviews and audits of HHS programs and operations over the coming year. As is typical, the FY 2016 Work Plan includes many items of interest to recipients

OIG Issues Supplemental Special Advisory Bulletin Expanding Guidance on Independent Charity Patient Assistance Programs

Likely in response to recent controversy and public scrutiny, on 21 May 2014, the Office of Inspector General issued a supplemental Special Advisory Bulletin regarding independent charitable organizations that provide cost-sharing assistance for prescription drugs, including to federal healthcare program beneficiaries. Read More: OIG Issues Supplemental Special Advisory Bulletin Expanding Guidance on Independent Charity Patient

HHS OIG Releases Proposed Rule Regarding Exclusion from Federal Health Care Programs

On May 9, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services released a proposed rule amending regulations regarding OIG’s exclusion authorities. The Affordable Care Act (ACA) expanded OIG’s authority to protect Federal health care programs from fraud and abuse through exclusions. The proposed rule would codify changes adopted

HHS-OIG updates Special Advisory Bulletin on effect of exclusion from federal healthcare programs

On May 8, 2013, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published an updated Special Advisory Bulletin (SAB) on the scope and effect of federal healthcare program exclusion. OIG is the agency with the authority to exclude from participation in Medicare, Medicaid, and other federal healthcare programs

Protecting EHR Donations 2.0

In today’s Federal Register, OIG and CMS propose three discrete revisions to existing regulations protecting the donation of electronic health records and solicit comments for potentially more far-reaching changes.  The current safe harbor to the federal Anti-Kickback Statute (AKS), 42 C.F.R. § 1001.952(y), and the exception to the Physician Self-Referral Law (Stark), 42 C.F.R. §

Updates from FDLI’s Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress

Recently, industry leaders, members of the FDA bar, and government officials convened at the Food & Drug Law Institute’s (FDLI’s) Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress. Topics included policy updates and enforcement priorities from FDA’s centers, Office of Inspector General (OIG) and Department of Justice (DOJ) current and future enforcement