Category: Government Enforcement

Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the laboratories and physicians involved in kickback schemes. The U.S. Department of Justice (DOJ) announced in late March and early April […]

The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? If you answered yes to both questions, then you need to understand the Trade Agreements Act […]

HIPAA FAQ Series: Are Covered Entities Liable for Business Associates’ HIPAA Violations?

This post marks the beginning of a new series on this blog covering various frequently asked questions regarding the Health Insurance Portability and Accountability Act (HIPAA).  There are many questions regarding HIPAA applicability, implementation, and liability that come up repeatedly.  We plan to use this series to discuss and analyze […]

Resource Launch: Key Considerations for Health Care Fraud Government Investigations/Inquiries

Cooley is excited to release a new resource for health care and life sciences companies: Key Considerations for Health Care Fraud Government Investigations/Inquiries. This quick reference documents provides a list of steps that companies should consider taking before a government investigation/inquiry occurs, and key steps to take if a becomes aware of a […]

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 […]

Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental agencies to pay a supplemental amount, based on revenue, that would provide an additional funding source for the U.S. Food and Drug […]

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 Releases Annual Solicitation for New and Modified Anti-Kickback Safe Harbors and for New Special Fraud Alerts

On December 29, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released its annual solicitation (the “Solicitation”) for proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal Health Care Program Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”), as well […]

Alaska Provider Reaches HIPAA Settlement with OCR for Security Deficiencies

On December 8, 2014, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that Anchorage Community Mental Health Services (“ACMHS”) has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  ACMHS will pay a $150,000 penalty and also enter […]