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
On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more
On June 27, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule amending OIG’s civil money penalty (CMP) regulations implementing the 21st Century Cures Act...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 CFTC Division of Enforcement (Division) of the U.S. Commodity Futures Trading Commission (CFTC) issued new guidance (Guidance) on May 20, 2020, that reflects the considerations of the Division when recommending civil...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
The Government Contracts Quarterly Update is published by BakerHostetler’s Government Contracts Practice team to inform our clients and friends of the latest developments in federal government contracting. ...more
The Office of Inspector General (OIG) announced this week that it will launch a special litigation team devoted solely to Civil Money Penalty (CMP) and Exclusion cases. The announcement was made by representatives of the...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
President Obama recently signed into law Public Law No. 114-10, the “Medicare Access and CHIP Reauthorization Act of 2015” (P.L. 114-10), which overhauls Medicare physician reimbursements by eliminating the use of the...more
On April 22, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-05 [PDF], approving a Medigap insurer’s proposed contract with a preferred hospital network. The...more
The legislation repealing the Medicare sustainable growth rate formula (SGR), signed by President Obama on April 16, 2015, contained several anti-fraud related provisions that affect the health care industry. The provision...more
On April 16, 2015, President Obama signed into law H.R.2, the Medicare Access and CHIP Reauthorization Act of 2015 (the "Act"), which provides for sweeping changes to how Medicare pays doctors. Specifically, the Act seeks to...more
On April 16, 2015, the President signed the Medicare Access and CHIP Reauthorization Act of 2015, commonly known as the “Doc Fix.” As has been extensively reported, the Act repeals the Sustainable Growth Rate or (SGR)...more
On April 16, President Barack Obama signed into law the “Medicare Access and CHIP Reauthorization Act of 2015,” ending a perennial struggle over the Medicare reimbursement formula for physicians. Although the law is most...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
The Centers for Medicare and Medicaid Services (“CMS”) recently released the civil money penalty (“CMP”) analytic tool used by CMS Regional Offices (“RO”) to review, approve or modify the proposed fines for nursing facilities...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