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OIG Approves Manufacturer’s Offer of Free Genetic Testing

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

OIG Advisory Opinion Permits a Pharmaceutical Manufacturer to Provide Financial Assistance to Needy Patients Receiving Risky Cell...

The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more

Compounding Pharmacy and Private Equity Firm Owner Agree to $21 Million Settlement to Resolve FCA Allegations

The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden...more

OIG Advisory Opinion Allows Smartphone Loan for Needy Patients Taking Digital Drug

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more

Provisions of Interest to Labs in the Protecting Access to Medicare Act of 2014

The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more

GlaxoSmithKline Announces Further Limits on Payments to Physicians and on Sales Compensation

GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more

CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions

Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013. The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

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