News & Analysis as of

Physicians Anti-Kickback Statute

Criminal Prosecutions of Individuals Outside the FCPA

by Michael Volkov on

When you look outside the FCPA arena and examine DOJ criminal prosecutions in healthcare, antitrust, tax, fraud, and other white-collar areas, there is no shortage of cases against individual violators. I am perplexed, to say...more

Avoiding Risks with Referring Physician Compensation Arrangements

by Hinshaw & Culbertson LLP on

The settlement described below highlights the importance of carefully structuring compensation arrangements with referring physicians, and the risk involved in trying to work backwards to achieve a desired level of...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

Court Puts the Brakes on Whistleblower's FCA Parking Claims

by Baker Ober Health Law on

The Department of Justice (DOJ) reports that, in fiscal year 2016 ending September 30, it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims. More than half of this...more

Proceed with Caution in Using New Process to Self-Report Stark Law Violations

by Barley Snyder on

Effective June 1, health care providers must use standardized forms for reporting Stark Law violations to the Centers for Medicare & Medicaid Services (CMS). These forms are part of a self-referral disclosure protocol (SRDP)...more

FCA Issues to Watch: Intersection of the FCA and the Anti-Kickback Statute

by Bass, Berry & Sims PLC on

In the recent past, the government has racked up a number of FCA settlements based on alleged violations of the Anti-Kickback Statute (AKS). This focus undoubtedly will remain a high enforcement priority....more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

Health System Defeats FCA Suit Based on Alleged Provision of Free Parking Benefits and Tax Exemptions

by King & Spalding on

On April 18, 2017, the United States District Court for the Middle District of Florida adopted the magistrate judge’s report and recommendation and granted BayCare Health System’s (BayCare’s) motion for summary judgment. The...more

FCA Issues to Watch: FCA Claims Concerning Physician Compensation

by Bass, Berry & Sims PLC on

Physician employment arrangements with hospitals have remained a significant area of regulatory scrutiny in recent months with the announcement of several high profile settlements and decisions in key FCA cases involving...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Leasing to Health Care Tenants: What You Need to Know

by Pepper Hamilton LLP on

Commercial office building landlords frequently find themselves leasing to health care provider tenants. A landlord may not consider doctor’s offices or diagnostic labs as specialty uses, but there are several lease...more

New Safe Harbor Permits Some Free Transportation to Patients

by Ruder Ware on

A new safe harbor was recently issued by the Health and Human Services (HHS) Office of Inspector General (OIG) that permits eligible health care providers to offer free or discounted transportation to established patients....more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Ambulatory Surgery Center Physician Exclusions - Reducing Risk of Forced Redemption of ASC Investment Interests

by Ruder Ware on

Many surgery centers are eventually faced with decisions about how to treat investing physicians who do not perform as many procedures in the surgery center as others. Under performing physicians can create political issues...more

Health Law Insights: January Newsletter

by Roetzel & Andress on

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

Managing the Transition to Transformation: Alternative Payment Systems: Evolving Compliance Challenges

by McDermott Will & Emery on

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

by Sherman & Howard L.L.C. on

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

2017 Physician Fee Schedule Includes Clarification of Space and Equipment Rental Exception Under Stark Law

by Roetzel & Andress on

The Department of Health and Human Services Center for Medicaid and Medicaid Services (“CMS”) recently finalized the Calendar Year 2017 Physician Fee Schedule (“2017 Fee Schedule”), which includes a restatement of a provision...more

Managing the Transition to Transformation: Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform

by McDermott Will & Emery on

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

Health Law Insights Newsletter - Issue 13

by McCarter & English, LLP on

McCarter & English, LLP’s Health Care Group presents Issue 13 of the Health Law Insights, which discusses the latest legal issues in the health care industry. - Failure to Update Business Associate Agreement Results in...more

OIG Approves Free Vaccine Refrigeration Systems in Physician Offices

by Baker Ober Health Law on

On September 16, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) released Advisory Opinion 16-09, approving a refrigerator manufacturer’s proposal to install a vaccine storage and...more

When a Discount May be a Kickback

Healthcare providers of all kinds, as well as medical equipment suppliers, have traditionally relied upon discounts as a legitimate means of attracting patients and commercial clients without running afoul of the federal...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

by Thomas Fox on

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

by Michael Volkov on

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Healthcare Compliance: Juggling Risk Mitigation Strategies

by Michael Volkov on

Healthcare organizations – ranging from physician practice groups to large, multi-state hospital systems – face a variety of risks, including fraud and abuse, as well as HIPAA privacy issues. Starting from a baseline risk...more

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