Theresa C. Carnegie

Theresa C. Carnegie

Mintz Levin

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Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more

11/5/2014 - Affordable Care Act CMS Healthcare Healthcare Reform HHS Medicare Medicare Part D OIG

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

10/21/2014 - Affordable Care Act Ambulance Providers Anti-Kickback Statute CMP Law Gainsharing Hospitals OIG Pharmacies Physicians Proposed Regulation Safe Harbors

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more

10/10/2014 - Ambulance Providers Anti-Kickback Statute Cost-Sharing Medicare Part D OIG Proposed Regulation Safe Harbors

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

8/13/2014 - Drug Manufacturers Generic Drugs Marketing OIG Pharmaceutical Prescription Drugs

New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...more

8/8/2013 - Ancillary Agreements Civil Monetary Penalty GAO HHS Medicare OIG Stark Law

OIG Issues Favorable Advisory Opinion Regarding Tiered Rebate Program

Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the “Requestor”) tiered rebate program (the “Proposed Arrangement”)....more

7/2/2013 - Healthcare Medical Devices OIG Rebates Safe Harbors

OIG Report Critical of P&T Committee Oversight

In a newly issued Report, the OIG has expressed concern regarding CMS’s lack of oversight of P&T Committee conflicts of interest. As the entities responsible for making Medicare Part D formulary decisions, P&T Committees...more

3/12/2013 - CMS Conflicts of Interest Medicare OIG P&T Committees

OIG Approves Gift Cards to Encourage Clinical Visits to Health Center

In Advisory Opinion 12-21, the OIG concluded that a Federally qualified health center’s offer of grocery store gift cards to capitated managed care patients would not constitute grounds for the imposition of sanctions under...more

1/10/2013 - Anti-Kickback Statute Gift-Cards Medicaid Medicare OIG

OIG Approves Hospital’s Electronic Interface Arrangement

In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback...more

12/21/2012 - Anti-Kickback Statute Hospitals OIG Safe Harbors Sanctions

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes...more

12/13/2012 - OIG Pharmacies Software

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