I recently authored an article for the American Bar Association (ABA) Health Law Section detailing the growing need for private equity firms to consider the increased risk of False Claims Act (FCA) liability.
Continue Reading Increased False Claims Act Exposure for Private Equity Firms Investing in Healthcare
PPP Enforcement Actions Gather Steam
The Paycheck Protection Program (PPP) was intended to provide a fast influx of assistance to small businesses during the economic shock created by the COVID-19 pandemic. The speed with which loans were distributed to businesses nationwide was striking, and so was the speed with which the Department of Justice (DOJ) began prosecuting those abusing the program. Reports of corporations and individuals seeking to take advantage of the PPP prompted a vigorous law enforcement response that has broadened its scope in recent months. As we highlighted last year, the DOJ has taken aggressive action to pursue those who engaged in misconduct involving the PPP and other CARES Act stimulus programs.
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DOJ’s Civil Cyber-Fraud Initiative Impact on Healthcare Organizations
I was recently interviewed on the Healthcare Strategies podcast about how the Department of Justice (DOJ) is enforcing the Civil Cyber-Fraud Initiative to hold healthcare organizations accountable for cybersecurity matters. The Initiative, launched by DOJ in October 2021, utilizes the False Claims Act (FCA) to take action against entities that knowingly provide insufficient data security measures.
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[REGISTER NOW] Healthcare How-To Instructional Webinar Series: How to Conduct an Effective Internal Investigation
Healthcare is one of the most highly regulated industries in the country and providers of all types will eventually be called to action, whether it be responding to an investigation, conducting a compliance review, or proceeding with a self-disclosure. Bass, Berry & Sims has designed the Healthcare How-To Instructional Webinar Series to provide simple step-by-step instructions and best practices for responding accurately and efficiently while avoiding bad tactics, questionable strategies, and unnecessary risk, which can create problems and less than ideal outcomes.
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The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute
Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention Act (IFPA).
Continue Reading The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute
DOJ Expands False Claims Act Reach into Cybersecurity
There is a new weapon in the Department of Justice’s (DOJ’s) already powerful False Claims Act (FCA) arsenal. In October 2021, the DOJ announced a new Civil Cyber-Fraud Initiative, under which it will pursue FCA liability against government contractors in the cybersecurity space. According to the announcement from Deputy Attorney General Lisa O. Monaco, the initiative seeks to “hold accountable entities or individuals that put U.S. information or systems at risk by knowingly providing deficient cybersecurity products or services, knowingly misrepresenting their cybersecurity protocols, or knowingly violating obligations to monitor and report cybersecurity incidents and breaches.”
Overview of the Civil Cyber-Fraud Initiative
The Civil Cyber-Fraud Initiative follows several significant cyberattacks, which are only becoming more prevalent. The new initiative is the first formal step DOJ has taken in combatting them by focusing on the preventative cybersecurity efforts of government contractors.
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[WEBINAR] Pfizer v. OIG – A Showdown: Prosecutions Involving Patient Assistance Programs
Pfizer lost a legal battle focused on the company’s financial assistance program against the Department of Health and Human Services Office of Inspector General (OIG) in the U.S. District Court for the Southern District of New York. The agency denied the pharmaceutical company’s request to vacate an OIG advisory opinion that effectively precludes the manufacturer
False Claims Act Cases in Home Health Sector
I recently discussed the trends related to False Claims Act (FCA) settlements in the home health sector, as revealed in the Healthcare Fraud & Abuse Settlements Database which we launched earlier this year. The database was part of the comprehensive Healthcare Fraud & Abuse Resource Center that provides an overview of FCA enforcement settlements, court decisions, updates involving the Stark Law and Anti-Kickback Statute, and other developments affecting the healthcare industry.
“We wanted to create a database of False Claims Act settlements to allow providers to have easy access to information, to see the cases that the government or regulators have resolved in the health care fraud space,” I told Home Health Care News. “This is the first publicly available database of this type.”
According to the information in the database, home health providers have paid at least $422.6 million since 2012 to settle FCA allegations. This represents 51 different cases over the time period from 2012-2020.
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Telehealth Scrutiny Following COVID-19 Pandemic
During the COVID-19 pandemic, many healthcare providers have relied on telehealth options to provide patients access to care. But, as I discussed in a recent article for Physicians Practice, “As long as utilization of telehealth services remains high, corresponding scrutiny and government enforcement efforts will remain focused on this area.”
In the article, I recommend ways that physicians and other providers can prepare for this additional scrutiny:
Continue Reading Telehealth Scrutiny Following COVID-19 Pandemic
How Health Care Companies Can Protect Against Government Scrutiny of COVID-19 Relief Funding
In our previous article, we outlined steps companies can take now to protect themselves during later government investigations and enforcement actions related to COVID-19 relief funding. These steps include: leverage compliance resources, document the application/funding process, document how money is used, schedule an interim internal review, and respond to employee complaints. In this article we focus specifically on the health care industry and how companies can protect against inevitable government scrutiny after receiving COVID-19 relief funding.
The health care industry must be particularly vigilant about protecting against future enforcement risks because it is a highly regulated industry facing an enforcement perfect storm—fast cash, poor guidance and retrospective review. Congress allocated $175 billion to the U.S. Department of Health and Human Services (HHS) through the Coronavirus Aid, Relief and Economic Security Act Provider Relief Fund (Relief Fund). To support an industry hurt by COVID-19-related patient surges, stay-at-home driven closures and elective procedure treatment delays, HHS adopted a strategy to release relief funds quickly and perform reconciliation on the back end. As a result, HHS released what it touted as “no strings attached” relief funds through a series of general and targeted allocations each with a list of somewhat vague terms and conditions. The only other guidance available were application instructions, where applicable, and a continuously evolving set of frequently asked questions.
Of course, no government funding comes with “no strings attached.” The government inevitably will review whether recipients of HHS relief funds met the eligibility requirements and complied with the terms and conditions for using relief funds. Given that any deliberate omission, misrepresentation or falsification of information related to the HHS relief funds comes with potentially severe consequences—including but not limited to revocation of Medicare billing privileges; exclusion from federal health care programs; and/or the imposition of fines, civil damages and/or imprisonment—health care companies should consider the following steps to support their acceptance and use of the funds: