Stark Law

News & Analysis as of

Recent DOJ and OIG Actions Show Growing Federal Scrutiny of Physician Financial Arrangements

Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial...more

Court Upholds CMS' Prohibition on 'Under-Arrangements' Transactions, Strikes Down CMS' Prohibition on 'Per-Click' Equipment Rental...

A 2008 rule change from the Centers for Medicare and Medicaid (CMS)—which effectively prohibited referring physician-owned companies from furnishing hospital services “under arrangements”—has withstood a challenge by a...more

OIG Fraud Alert Cautions Against Sham Medical Director Arrangements

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...more

OIG Fraud Alert Targets Physician Compensation Arrangements

It bears repeating so much that even the Office of Inspector General of the Department of Health and Human Services just issued a Fraud Alert on it – physician compensation arrangements are fraught with potential violations...more

DC Circuit calls into question legality of Stark Law ban on per-click equipment leases

On June 12, 2015, the US Court of Appeals for the District of Columbia Circuit issued a lengthy decision calling into question the regulatory prohibition on per-click equipment leases under the federal physician self-referral...more

Physician Estopped From Alleging FCA Violations in Contract He Previously Approved

Cooper v. Pottstown Hospital is another case where a dissatisfied party is attempting to use the federal Anti-Kickback Statute or the Stark Law in litigation arising out of the contracts to which they were willing parties at...more

Texas Hospital Settles Stark Statute and False Claims Act Allegations for $21.75 Million

According to a press release from the Department of Justice, Citizens Medical Center (“CMC”), a county-owned hospital in Victoria, Texas, will pay $21,750,000 to the federal government to settle allegations that it entered...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases

Trends & Analysis - ..We have identified 67 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of those cases, 29 were filed before January 1, 2014, with seven...more

ABA Antitrust Spring Meeting Highlight: “Antitrust & Health Care: Square Peg in a Round Hole?”

In this month’s American Bar Association (ABA) Section of Antitrust Law Spring Meeting, the program “Antitrust & Health Care: Square Peg in a Round Hole?” featured debate and discussion about antitrust law treatment of health...more

The Enemy of My Enemy Is My Friend

We don’t normally think of American Hospital Association and the Federation of American Hospitals as friends. After all, the AHA represents nonprofits, while the FAH represents for-profits. ...more

The Three “Hows” Of Physician Compensation

New care delivery models and healthcare reimbursement trends are heating up the market for hospital employment of physicians yet again, but does a productivity-based compensation model still work in this environment?...more

Anti-Kickback and Stark Law: Pitfalls and Problems

When you think your life is tough in the FCPA compliance arena, just remember you could be head of compliance for a pharmaceutical company or hospital responsible for domestic anti-kickback and Stark law compliance....more

Catching Up on the False Claims Act

From a corporate risk perspective, if your company is in the financial industry, healthcare, or defense industry, your greatest legal and compliance risk has to be the False Claims Act....more

Paperwork Burden Eased in CMS Voluntary Self-Referral Disclosure Protocol Filings

In late December 2014, CMS made a small change to its voluntary Self-Referral Disclosure Protocol (SRDP) to help reduce some of the paperwork burden associated with filing under the SRDP. Section 6409 of the Affordable...more

2014 – The Health Law Year in Review

Each year brings significant changes and challenges in the laws governing the health care industry, and 2014 proved to be no exception. What the year may have lacked in the high drama that accompanies comprehensive health...more

Recent Changes to Stark Law's Whole Hospital Exception

The federal physician self-referral law, or Stark Law, provides a number of exceptions to the law's prohibition of physician referrals of designated health services to an entity in which the physician has an ownership or...more

11th Circuit Brings Back Part of Whistleblower Suit

According to the ruling of the 11th U.S. Circuit Court of Appeals, a former health care executive that exposed a kickback and illegal referral scheme by his employer will be allowed to proceed with certain allegations listed...more

CMS Grants First Waiver of Stark Law Expansion Restrictions—Are More Ahead?

Are changes to the landscape of physician hospital ownership ahead? The Affordable Care Act amended the federal Stark Law to eliminate the “whole hospital exception” that permitted self-referrals provided the referring...more

ACO Fraud and Abuse Waivers Extended Through November 2, 2015

On October 17, 2014 the Centers for Medicare and Medicaid (CMS) and Office of Inspector General (OIG) within the Department of Health and Human Services published a continuation notice in the Federal Register extending the...more

Uncertain Privilege: Implied Waiver of the Attorney-Client Privilege in False Claims Act Litigation

In a pending False Claims Act (“FCA”) case stemming from alleged violations of the physician self-referral law (the “Stark Law”), 42 U.S.C. § 1395nn, and the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. §1320a-7b, the...more

SRDP No Longer New Wine

More than four years after the Centers for Medicare & Medicaid Services' (CMS) issuance of the Stark Self-Referral Disclosure Protocol (SRDP), it's time to assess the results. The SRDP was designed by Congress to resolve...more

Texas Hospital Qualifies for Exception to Limitation on Exception to Elimination of Exception to Stark Law

Lake Pointe Medical Center has become the first hospital in America to qualify for (i) an exception to (ii) the limitation on the (iii) grandfather exception to the (iv) elimination of the (v) whole-hospital exception to the...more

Health Care Reform Implementation Update

The Centers for Medicare and Medicaid Services (CMS) began sending reminders last week that open enrollment begins on November 15; CMS’s Marketplace CEO, Kevin Counihan, said that end-to-end testing of HealthCare.gov was...more

Words can come back to haunt you: Boilerplate pleading could lead to inadvertent waiver of attorney-client privilege

Recently, a federal district court in Georgia ruled that a defendant waived the attorney-client privilege in communications with counsel about the lawfulness of its conduct under the False Claims Act simply by pleading good...more

CMS and OIG Extend Interim Final Rule Regarding Waivers of Fraud and Abuse Laws For ACOs

On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability...more

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