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Fraud and Abuse Manufacturers

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned Device Companies

After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more

The Volkov Law Group

Drug and Medical Device Fraud Risks Increase in Pandemic Era

The Volkov Law Group on

The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in...more

Hogan Lovells

DEA launches new ARCOS enhancement to help manufacturers and distributors "know your customer" and detect suspicious orders

Hogan Lovells on

The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that "will allow DEA-registered...more

K&L Gates LLP

K&L Gates Triage: 340B Update: State Medicaid 340B Billing Requirements

K&L Gates LLP on

In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These...more

Ballard Spahr LLP

USCIS: Are Your Signatures Valid?

Ballard Spahr LLP on

Starting March 18, the U.S. Citizenship and Immigration Services (USCIS) will require individuals who are submitting an application, petition, request, or other documents to provide a "valid" signature on forms filed with the...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

Baker Donelson on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

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