When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more
On December 16, 2021, OIG issued an advisory opinion (Advisory Opinion No. 21-20) to a requestor (Requestor) regarding a proposal to create an online search platform for users to find and contact home-based health care...more
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
On January 15, 2020, OIG issued Advisory Opinion No. 20-02 analyzing an arrangement between a pharmaceutical manufacturer and certain drug recipients whereby the manufacturer provides certain drug recipients with financial...more
On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care...more
As the industry eagerly awaits the outcome of the “Regulatory Sprint to Coordinated Care”—the multi-pronged, inter-agency initiative within the Department of Health and Human Services (HHS) to identify and remove barriers to...more
The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a new advisory opinion finding that free introductory visits (the “Introductory Visits”) for patients offered by a home health...more
Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial...more
The HHS OIG recently issued a brief fraud alert (Fraud Alert) reminding physicians that inappropriate compensation arrangements may lead to enforcement actions under the federal anti-kickback statute and Civil Monetary...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 15-03 and concluded that a licensed provider (the Requestor) of Medicare Supplemental Health Insurance (Medigap) would not be sanctioned under the civil...more
Each year brings significant changes and challenges in the laws governing the health care industry, and 2014 proved to be no exception. What the year may have lacked in the high drama that accompanies comprehensive health...more
On October 21, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 14-10, approving a Medigap insurer’s proposed contract with a preferred hospital network. Similar to...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 14-09 [PDF] and concluded that a town that uses tax revenues to cover out-of-pocket expenses owed for basic life support (BLS) emergency ambulance...more
On October 17, 2014 the Centers for Medicare and Medicaid (CMS) and Office of Inspector General (OIG) within the Department of Health and Human Services published a continuation notice in the Federal Register extending the...more
The Centers for Medicare and Medicaid Services (CMS) began sending reminders last week that open enrollment begins on November 15; CMS’s Marketplace CEO, Kevin Counihan, said that end-to-end testing of HealthCare.gov was...more
On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability...more
On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more
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
On October 3, 2014, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to add new safe harbors to the federal health care program anti-kickback statute...more
On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”) that would amend certain rules under the Civil...more
On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more
On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,...more
On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a long-awaited proposed rule for implementing amendments to safe harbors under the Anti-kickback Statute and...more