Courts around the country continue to disagree on the causation standard to be applied in False Claims Act cases based on alleged Anti-Kickback Statute violations. Two recent federal district court decisions out of the District of Massachusetts, United States v. Regeneron Pharms., Inc., No. 20-11217-FDS, 2023 WL 7016900 (D. Mass. Oct. 25, 2023) and United … Continue Reading
In August, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) introduced a new “Strategic Plan for Oversight of Managed Care for Medicare and Medicaid” (the “Strategic Plan”). The introduction of the Strategic Plan is in response to the continued growth of managed care in government sponsored health … Continue Reading
The Department of Justice (“DOJ”) recently announced its largest ever health care fraud and opioid enforcement action. In a coordinated effort, DOJ charged 345 defendants with more than $6 billion in fraud losses for submitting false and fraudulent claims to federal health care programs and private insurers. The nationwide enforcement operation has been in motion since April … Continue Reading
The CARES Act requires Medicare providers to attest to multiple certifications. Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.… Continue Reading
On May 29, and June 2, the Department of Health and Human Services (HHS) updated its “Provider Relief Fund FAQs” on disbursements made to providers from the $175 billion Provider Relief Fund initially established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, for expenses and lost revenues attributable to the coronavirus pandemic. HHS’s … Continue Reading
With their insider access to business operations, whistleblowers will follow stimulus money to learn whether the business abides by the strings attached to that money. Whistleblowers look for an opportunity to cash in on what they consider fraudulent conduct. What’s a business to do? See our discussion here on the Anticorruption blog. … Continue Reading
The government incentivizes whistleblowers in order to increase healthcare recoveries under the False Claims Act. See our analysis here of how the Act’s qui tam provisions work by Colin Jennings, Marisa Darden, and Ayako Hobbs. … Continue Reading
Once again, healthcare leads other industries for recoveries by the government and whistleblowers under the False Claims Act. Enforcement actions span the entire health care supply chain. See our report here in the Anticorruption blog.… Continue Reading
Suspicious of the practices of one of its cardiologists, a hospital hired an independent expert to investigate. The expert examined records of 12 patients but “could not find support in any of the twelve cases” to implant pacemakers. The hospital terminated the doctor, and the government indicted him for health care fraud. During trial the government deployed an … Continue Reading
On October 9, the Department of Health and Human Services (HHS) released proposed rules (the Proposed Rules) aiming to update the Anti-Kickback Statute (the AKS), Stark Law and Civil Monetary Penalties Law (CMPL) to address today’s value-based and coordinated healthcare environment. The proposals reflect a recognition on HHS’s part that the healthcare landscape of today … Continue Reading
By selecting a more severe Secondary Diagnosis Code for a patient, a physician may increase the reimbursement due from Medicare. If a hospital intentionally changes codes across its patient population, the increased revenue can be substantial. Is that legal? A federal district court in Texas faced this question when a relator filed suit under the … Continue Reading
In 2019 the Department of Justice took off its gloves in the opioid fight. For the second time, DOJ has acted to hold opioid distributors and manufacturers criminally liable for contributing to the drug crisis. Read my analysis here in the Anticorruption blog.… Continue Reading
The Department of Justice intervened in a False Claims Act lawsuit involving “so-called charitable patient assistance funds” used for prescription drug copays. The DOJ wants to make “clear that the Department will hold accountable drug companies that pay illegal kickbacks to facilitate increased drug prices.” See a report at the Anticorruption blog here.… Continue Reading
The Department of Justice just released new guidance how to obtain credit for cooperation under the False Claims Act (FCA). The guidance stresses the importance of cooperation but mentions other actions as well. The FCA greatly impacts the health care sector, with settlements and judgments reaching to billions of dollars. Please see the post on the Anticorruption blog … Continue Reading
On February 6, 2019, the Department of Health and Human Services (HHS) published a Proposed Rule modifying the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for (primarily Medicare Part D and Medicaid Managed Care Plan) consumers. With the Proposed Rule, HHS hopes to encourage medication … Continue Reading
Policy Shifts at the Department of Justice – 2018 in Review provides an easily navigated yet detailed summary of significant developments at the Department of Justice (DOJ) focusing on fraud and abuse. This Alert sheds light on how the policy shifts may affect the health care industry in the coming year. Among the topics of interest … Continue Reading
The federal government’s civil recoveries for false claims during FY2018 topped $2.8 billion. Health care fraud claims lead the collection. Government Rakes in Billions The Department of Justice (DOJ) recently released statistics for its civil False Claims Act (“FCA”) recoveries during FY2018. Although that total is lower than in some previous years, the trajectory of recoveries … Continue Reading
Deputy Attorney General Rod J. Rosenstein announced a revision of the “Yates Memo” concerning credit a company will receive for cooperating with an investigation. Instead of an “all or nothing” approach, the new policy permits a company to “identify all individuals substantially involved in or responsible for the misconduct at issue.” More about this change … Continue Reading
Many may view a C plea to mean a Corporate Plea. Used infrequently, a C plea restricts discretion of a federal district judge to sentence a criminal defendant. When one federal judge expressed his concerns about a proposed C plea for a pharmaceutical company, he changed the result. In an article published by the American … Continue Reading
Late last month, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking input regarding the Medicare physician self-referral law and its implementing regulations (“Stark Law”) and how it may prevent or inhibit care coordination amongst healthcare providers. As part of CMS’s broader “Regulatory Sprint to Coordinated Care” initiative, the … Continue Reading
The Government executed a record nationwide healthcare takedown according to multiple measurements. The enforcement action charged hundreds of medical professionals, across the country, for a variety of frauds that totaled approximately $2 billion.… Continue Reading
CMS has recently signaled its intention to review the Stark Law and its impact on providers. During a January, 2018 American Hospital Association webinar, CMS Administrator Seema Verma announced the development of an inter-agency group to review the Stark Law in light of provider complaints that the law acts as a barrier to their ability to … Continue Reading
The 2017 Year in Review of the Department of Justice reveals a Data Analytics Team (the “Team”) for tracking healthcare fraud. The Healthcare Fraud Unit launched the Team in order to provide data mining expertise that efficiently detects healthcare fraud.… Continue Reading
A recent blog post summarized an opinion in which a district court catalogued his reasons for rejecting a corporate “C” plea involving a pharmaceutical company. Several developments have occurred since the court’s opinion including a plea and sentencing hearing scheduled for January 30, 2018. Please see the Anticorruption blog here for an update on this matter.… Continue Reading