Tag: enforcement

HHS To Launch New HIPAA Audits in Early 2016 in Response to OIG Reports

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports  yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and Accountability Act (HIPAA) enforcement efforts.   In response to these reports, HHS announced that it […]

BEWARE: DOJ Announces New Policy to Increase Prosecutions of Individuals Involved in Corporate Fraud

Earlier this week, Deputy Attorney General (AG) Sally Quillian Yates issued a memorandum to Department of Justice (DOJ) attorneys discussing the need to hold individuals accountable for corporate wrongdoing in both civil and criminal enforcement actions. Deputy AG Yates further discussed the memo in a speech yesterday at the New York […]

CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law.  In addition to summarizing the process and outcome of the 2014 reporting period, the recently released annual report includes a few key takeaways for pharmaceutical and medical device manufacturers […]

On a Roll . . . Vermont Attorney General Posts Two More Enforcement Actions for Gift Ban & Disclosure Law

The Vermont Attorney General (VT AG) posted its third round of enforcement actions of 2015 against a manufacturer of surgical microscopes and a dental products company.  You can read Cooley’s posts about the first two 2015 enforcement actions here and here. The Assurance of Discontinuance for Premier Dental Products Company states that it provided allowable expenditures […]

Vermont AG Posts Second Enforcement Action of 2015 Related to State Disclosure Law

Last week, the Vermont Attorney General (VT AG) posted its second enforcement action of 2015, this time against a dental products manufacturer.  You can read about the first 2015 enforcement action here.  According to the Assurance of Discontinuance, Heraeus Kulzer, LLC provided allowable expenditures and/or permitted gifts to Vermont health care professionals in […]

Vermont AG Announces Another Disclosure Law Enforcement Action

As discussed here and here, the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s Prescribed Products Gift Ban and Disclosure Law, 18 V.S.A. §§ 4631a, 4632.  Last week, the VT AG posted another enforcement action […]

HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain […]