Donna S. Clark

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Former Tuomey CEO Settles with DOJ for $1 Million

By Donna S. Clark and Banee Pachuca on Posted in Uncategorized
The U.S. Department of Justice (DOJ) recently reached a $1 million settlement with Ralph J. Cox III, the former CEO for Tuomey Health System, Inc. (Tuomey), in connection with his involvement in the notable Stark Law case. After protracted litigation, Tuomey agreed to pay $72.4 million in October 2015 to settle allegations that the system had violated the … Continue Reading

The Deeper Dive: Senate Finance Committee Examining Modernization of the Stark Law

By Darby C. Allen and Donna S. Clark on Posted in Uncategorized
The Committee’s interest in the Stark Law and receptiveness to feedback from industry leaders may indicate that significant changes to the law are in the pipeline. As the healthcare industry moves from a fee-for-service (FFS) reimbursement system for physicians to a value-based payment system, industry insiders are questioning whether the federal physician self-referral law and … Continue Reading

CMS Finalizes Revisions to Stark to Ease Burden on Providers, Refines “Incident to” Requirements

Photo of Kristen McDermott WoodrumBy Kristen McDermott Woodrum, Darby C. Allen and Donna S. Clark on Posted in Uncategorized
In its calendar year 2016 Physician Fee Schedule Final Rule published in the Federal Register on November 16, 2015 (Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized amendments to the federal physician self-referral (Stark) regulations proposed in the Physician Fee Schedule proposed rule released in July. Among the significant provisions contained in the Final Rule are … Continue Reading

Health System Free Transportation Program Does Not Warrant Sanctions, Says OIG

Photo of Joel D. GottesmanBy Donna S. Clark and Joel D. Gottesman on Posted in Uncategorized
The Office of Inspector General (OIG) recently issued Advisory Opinion 15-13, addressing whether an integrated health system (Health System) was at risk for administrative sanctions under the federal anti-kickback statute or civil monetary penalty law for offering free shuttle services to patients. The OIG concluded that the proposed transportation arrangement presents minimal risk of fraud … Continue Reading

Tuomey Judgment Upheld in Novel Stark Law and False Claims Act Case

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
The U.S. Court of Appeals for the Fourth Circuit recently upheld the judgment against Tuomey Healthcare System, Inc. (Tuomey), in a qui tam False Claims Act case predicated on Stark Law violations. The district court in the case had previously upheld a jury verdict finding that Tuomey, a community hospital in South Carolina, violated the … Continue Reading

Providers Get Rare Win in New Texas Law Protecting Out-of-Network Referrals

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
On June 1, 2015, Texas Governor Greg Abbott signed House Bill 574 into law protecting physicians and other providers from having their participating provider agreements terminated by an insurer solely because the provider’s patients use out-of-network providers. The law aims to address aggressive tactics employed by many insurers in recent years to curb physicians’ referrals … Continue Reading

OIG Fraud Alert Cautions Against Sham Medical Director Arrangements

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
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 Penalties Law. Although not mentioned in the Fraud Alert, improper compensation arrangements also raise issues under the federal self-referral law known as the Stark Law. … Continue Reading

OIG Advisory Opinion Sheds Light on Preventive Care Exception

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued an advisory opinion approving an arrangement whereby a licensed entity providing services under a state program for at-risk mothers and children (State Program) would provide diapers and play yards to program participants who are Medicaid beneficiaries. The advisory opinion … Continue Reading

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors, protect additional conduct from enforcement under the civil monetary penalties (CMP) law related to beneficiary inducements and create a new gainsharing … Continue Reading

Summer Fraud and Abuse Roundup

By Darby C. Allen, Donna S. Clark and B. Scott McBride on Posted in Uncategorized
The federal government was busy over the summer when it came to decisions and settlements under the Stark Law, anti-kickback law and federal False Claims Act. This article revisits recent developments with respect to healthcare fraud and abuse. Group Practice Pays Over $1 Million for Improper Compensation Formula The New York Heart Center, a cardiology … Continue Reading

Stark Law Update: All Children’s Settles False Claims Act Allegations

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
All Children’s Health System (ACHS) will pay the federal government and state of Florida $7 million to settle allegations that it violated the federal and Florida False Claims Act statutes by submitting claims to Medicaid that were illegal under the Stark Law. The whistleblower in the case was the Director of Operations of Pediatric Physician … Continue Reading

Halifax Reportedly Settles Landmark Stark Case

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
According to minutes filed in the U.S. District Court for the Middle District of Florida, Halifax Hospital Medical Center (Halifax) and the U.S. Department of Justice (DOJ) have reached a settlement in the pending False Claims Act case in which Halifax is accused of entering into financial relationships with medical oncologists and neurosurgeons in violation … Continue Reading

OIG and CMS Extend Expiration Date for EHR Donations

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
As the final days of 2013 passed and the sunset of the Stark Law exception and anti-kickback law safe harbor for electronic health record (EHR) donations loomed nearer, the U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) issued last-minute final regulations to … Continue Reading

Federal Judge Dismisses All Anti-Kickback Claims in Halifax Hospital Medical Center Case

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
On January 8, 2014, the U.S. district judge in the Halifax Hospital Medical Center (Hospital) case pending in the Middle District of Florida granted the Hospital’s motion to dismiss all of the relator’s anti-kickback law claims. This False Claims Act case is partially predicated on alleged violations of the Stark Law and the anti-kickback law … Continue Reading

Feds Win Crucial Motions in Two High-Stakes Stark Cases

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
On the heels of the landmark Tuomey case (see the October 3, 2013 issue of the Health Law Update), the federal government recently has seen success in two more False Claims Act cases predicated on alleged Stark Law violations. Halifax Hospital Medical Center In November, a federal district court judge in Florida granted partial summary judgment … Continue Reading

Two for Me; Many Times More for the Government in the Largest Whistleblower Award Against a Community Hospital

Photo of Robert M. WolinBy Donna S. Clark, Robert M. Wolin and Darby C. Allen on Posted in Uncategorized
A U.S. district judge in South Carolina approved the government’s request for a civil penalty award and ordered Tuomey Healthcare System, Inc. (Tuomey) to pay more than $237 million in damages and fines in a whistleblower case that accused Tuomey of paying doctors pursuant to compensation arrangements that violated the Stark Law. The penalty was … Continue Reading

Hospital Ordered to Produce Privileged Documents Under the Crime-Fraud Exception

By Donna S. Clark and Darby C. Allen on Posted in Uncategorized
A magistrate judge in the U.S. District Court for the Middle District of Florida recently ordered a hospital defendant in a False Claims Act (FCA) case to turn over two prime documents to the U.S. Department of Justice and the whistleblower that would seem to fall within the traditional confines of the attorney-client privilege. The … Continue Reading
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