Recently, pharmaceutical companies are gaining increased notoriety for violations of the False Claims Act, the Anti-Kickback Statute, and general fraudulent practices directed toward physicians and medical care providers with the intent to increase profits. In 2019, Avanir Pharmaceuticals settled with the Department of Justice to pay more than $108 million of criminal penalties and civil damages for engaging in kickbacks with physicians, and misleading marketing of their drug Nudexta for unapproved purposes. Then, in May of 2021, Incyte Corp., a Delaware-based pharmaceutical manufacturer agreed to pay $12.6 million for unspecified damages arising under a violation of the Federal False Claims Act for improperly using an independent foundation to cover copays of individuals consuming Incyte’s cancer drug, Jakafi. Despite widespread prosecutions against pharmaceutical drug manufacturers, and the fraud deterrent provisions of the False Claims Act, the risk of fraud and remuneration still runs high in relationships between healthcare professionals and pharmaceutical companies.
Vertical Healthcare Companies Merging Compliance Programs Perri Nena Smith Senior Editor Loyola University Chicago School of Law, JD 2021 In 2020, The Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) released guidelines for vertical mergers to give clarity to companies so they can avoid harmful mergers. Healthcare companies are an industry that has been …
The Federal Bureau of Investigation (“FBI”), the Department of Health and Human Services (“HHS”), and the Department of Homeland Security Cybersecurity and Infrastructure Security Agency (“CISA”) recently announced that hackers have been and will continue to target the United States hospitals and health-care providers. These attacks are cyber in nature and often lead to ransomware attacks, data left, and inevitable disruption of health care services when patient information is locked until the ransom can be paid.
On March 3, 2020, the Department of Justice (“DOJ”) launched a National Nursing Home Initiative to “coordinate and enhance civil and criminal efforts to pursue nursing homes and long-term care facilities that provide grossly substandard care to their residents.” The DOJ’s new initiative adds to its extensive efforts to combat elder abuse and financial fraud targeted at American seniors. The initiative will start with a focus on some of the worst nursing homes and enhance all civil and criminal efforts to pursue the nursing homes that provide grossly substandard care to their residents.
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.
In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).
In the graphic novel and film “The Watchmen,” there is a reoccurring phrase: “Who watches the watchmen?” In context, it’s an indictment of the comic book world’s broken justice system. However, in a compliance context, the concept can be just as important. In a recent discussion with a hospital system’s compliance officer, he raised the point that a company’s compliance department is seen as the ultimate authority and expertise in laws and regulations, monitoring compliance and noncompliance, and implementing corrective and disciplinary actions. Yet while many compliance professionals may assume that their actions are always compliant, who oversees those who are overseeing systems and organizations? Who ensures that compliance is compliant?
After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.
Landlords have a duty to know the laws applicable to their properties, in all matters great and small. While security deposits may seem on the “smaller” end of a landlord’s duties, he or she must remain compliant with all state and local municipal laws—even when handling security deposits. Whether a large or small residential unit landlord in the City of Chicago, a violation of the state and municipal security deposit laws can have a catastrophic domino effect, resulting in lost revenue, penalties, and lawsuits. In fact, some landlords have had to shell out six-figure settlements and file for bankruptcy as a result of violating the laws surrounding security deposits.
In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.