Darby C. Allen

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Providers Breathe Sigh of Relief with New Anti-Kickback Safe Harbors and CMP Exceptions

By Darby C. Allen on Posted in Uncategorized
On December 7, 2016, the HHS Office of Inspector General (OIG) finalized a set of rules first proposed in 2014 adding new anti-kickback law safe harbors and protecting additional conduct from enforcement under the civil monetary penalties (CMP) law related to beneficiary inducements. The OIG’s stated purpose in adopting the rule is to allow greater … Continue Reading

Summer Fraud and Abuse Roundup

By Banee Pachuca and Darby C. Allen on Posted in Uncategorized
Now that the kids are back in school and summer vacations are in the rearview mirror, it’s time to catch up on recent fraud and abuse developments. The federal government was busy this summer negotiating a pair of settlements under the Stark Law and anti-kickback statute, drafting changes to the Self-Referral Disclosure Protocol (SRDP), and … 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

Caution: False Claims Act Penalties Poised to Double

By Darby C. Allen and B. Scott McBride on Posted in Uncategorized
A preview of the effects that a provision in the Bipartisan Budget Act of 2015 will have on healthcare providers came to light this week when the Railroad Retirement Board (Board) published an interim final rule implementing the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Act). The Act requires federal agencies to … Continue Reading

The Deeper Dive: The Final Overpayment Rule

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
The Centers for Medicare and Medicaid Services (CMS) recently issued its final rule for Reporting and Returning of Overpayments (Final Rule). The Final Rule implements section 1128J(d) of the Social Security Act, which requires Medicare providers and suppliers to report and return overpayments within 60 days after the overpayment was identified in most instances. Failure to report … Continue Reading

Breaking News: 60-Day Overpayment Rule Finalized

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
The Centers for Medicare and Medicaid Services (CMS) released its final rule implementing Section 6402(a) of the Affordable Care Act that requires Medicare providers and suppliers to report and return overpayments within 60 days after the date on which the overpayment was identified in most instances. Failure to report and return overpayments in accordance with … 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

DOJ Takes Aim at Responsible Individuals in Corporate Investigations

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
U.S. Deputy Attorney General Sally Quillian Yates recently announced new instructions for attorneys at the U.S. Department of Justice (DOJ), outlining in a memorandum the DOJ’s policies with respect to civil and criminal enforcement actions against responsible individuals in corporate investigations. The policy announcement underscores that the federal government is increasingly focused on deterring responsible … Continue Reading

Texas Hospital Strikes Back at Aetna

By B. Scott McBride, Darby C. Allen and John W. Petrelli on Posted in Uncategorized
On February 23, 2015, Aetna filed suit in Texas federal court against Robert A. Behar, M.D. and North Cypress Medical Center (North Cypress), alleging that Dr. Behar, the CEO of North Cypress, offered impermissible ownership stakes in the 139-bed community hospital in exchange for patient referrals and designed an out-of-network business strategy that gave rise … Continue Reading

Proposed Rule Aims to Refine Stark Regulations and Clarify “Incident To”

Photo of Kristen McDermott WoodrumBy Kristen McDermott Woodrum and Darby C. Allen on Posted in Uncategorized
On July 15, 2015, the Centers for Medicare and Medicaid Services (CMS) published the calendar year (CY) 2016 Physician Fee Schedule Proposed Rule. In addition to updating several traditional Part B payment policies, the proposed rule contains significant changes to the physician self-referral regulations (Stark regulations) and the Medicare “incident to” coverage rule. The comment … 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

Supreme Court Decision Has Good News and Bad News for Those Facing False Claims Act Litigation

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
On May 26, 2015, the Supreme Court of the United States (SCOTUS) issued an opinion in a federal False Claims Act (FCA) case that resolves two important procedural points litigants face: the tolling of the six-year statute of limitations period under the Wartime Suspension of Limitations Act (WSLA) and the application of the “first-to-file” rule. … Continue Reading

Aetna Out of Patience With Hospital’s Alleged Out-of-Network Billing Scheme

By B. Scott McBride, Darby C. Allen and John W. Petrelli on Posted in Uncategorized
Aetna Life Insurance Company (Aetna) is going on the offensive against a Northwest Houston hospital with an out-of-network strategy. On February 23, 2015, Aetna filed suit in Texas federal court against Robert A. Behar, M.D. and North Cypress Medical Center (North Cypress), alleging that Dr. Behar, the CEO of North Cypress, offered impermissible ownership stakes … 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

Breaking News: CMS Delays Final Overpayment Rule

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
Today, the Centers for Medicare and Medicaid Services (CMS) announced that it is extending the deadline to finalize the rule implementing the Affordable Care Act provision that requires providers to timely report and return overpayments to the Medicare program. The proposed rule was issued in February 2012, and CMS is required to provide notice to … 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

OIG Revamps Regulations Concerning CMPs and Exclusion

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
In a pair of proposed rules published in May, the HHS OIG unveiled changes to the regulations concerning OIG’s authority to impose civil monetary penalties (CMPs) and exclude individuals and entities from participation in federal healthcare programs. The changes are largely driven by provisions in the Affordable Care Act (ACA) and illustrate OIG’s expansion of … 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
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