Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
A recent Advisory Opinion (No. 23-15) from the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that a healthcare consulting company’s plan to offer gift cards to physician practices...more
In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more
On June 29, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 22-14 regarding an ophthalmology practice’s proposed options to fund continuing education (CE)...more
A recent settlement involving a Medicare Advantage plan should serve as a reminder that the federal Anti-Kickback Statute (AKS) is broad and far-reaching, both on its face and in practice. On July 1, 2022, the U.S. Department...more
OIG has a long history of scrutinizing laboratory arrangements because of the agency’s view that these arrangements are particularly susceptible to fraud and abuse. Much of OIG’s past guidance focused on laboratory...more
The Anti-Kickback Statute (AKS) protects healthcare beneficiaries from the influence of money in their medical decision-making. Overall, the AKS criminalizes renumeration “intended to induce patient referrals or influence the...more
In many ways, the COVID-19 pandemic increased the business opportunities available to clinical labs, including molecular and respiratory labs. As the nation—and the world—struggled to develop adequate testing infrastructure,...more
The U.S. Department of Justice (DOJ) announced that Flower Mound Hospital Partners LLC, a partially physician-owned hospital in Flower Mound, Texas, agreed to pay $18.2 million to settle its alleged violations of the False...more
On April 26, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) issued favorable Advisory Opinion No. 21-02 regarding a proposed investment in an ambulatory surgery center (“ASC”) by a...more
On October 9, 2019, the Department of Health and Human Services' Centers for Medicare and Medicaid ("CMS") and Office of Inspector General ("OIG"), respectively, published proposed rules updating the long-standing physician...more
This is an uncomfortable summer for health care providers in Florida! The legal landscape changed dramatically over the 4th of July holiday. Buried in Florida’s HB 369 regarding substance abuse services was a dramatic...more
• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more
Ambulatory surgery center (ASC) development and ownership has made a comeback after a number of years of stagnation due to an oversupply of centers and poor income growth. However, with significant changes in payment...more
The Department of Justice (DOJ) recently announced that Montana’s Kalispell Regional Healthcare System (KRH) and six subsidiaries and related entities agreed to pay $24 million to resolve allegations that they violated the...more
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
After a prolonged period of stagnant growth primarily due to a glut of capacity coupled with flat or declining revenue growth, we’re beginning to see a resurgence of Ambulatory Surgery Centers (ASCs). In fact, experts are...more
Federal scrutiny of charities that assist patients with accessing prescription drugs has increased with rising prescription drug prices. Some prescription drug charities receive funding from medical providers or drug...more
Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 15-15 and concluded that an arrangement under which a hospital proposed to provide transcription services to a radiology practice in exchange for fair...more
In an alert published October 6, 2015, the OIG reminded the public that “information blocking”—generally described as individuals or entities knowingly and unreasonably interfering with the exchange or use of electronic...more
After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more
In a recent case Hebrew Homes Health Network, Inc. and its former president and executive Director agreed to pay $17 million to settle allegations that Hebrew Homes violated the federal anti-kickback statute. According to the...more
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...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