Stark Law Anti-Kickback Statute Healthcare

News & Analysis as of

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

On July 9, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that seeks to implement a mandatory episode-based payment model for lower extremity joint replacement (and reattachment) care in...more

CMS Stark Proposals Allow “Holdover” Arrangements and Signature Window

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available below....more

Health Law Pulse - August 2015

The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a nonprofit health system (System) and a nonprofit psychiatric hospital (Center) regarding a proposal whereby the...more

CMS Proposes New Stark Exceptions: Timeshare Lease

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comment on what I consider the most significant new...more

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

Mintz Levin Health Care Qui Tam Update - July 2015

Trends & Analysis - ..We have identified 36 health care–related qui tam cases that have been unsealed since the cases covered in our last Qui Tam Update. Of these cases, eight were filed within the last year. A number...more

Tuomey’s Appeal of $237M False Claims Act Judgment Denied by the Fourth Circuit

In This Issue: - Background - Tuomey’s Second Appeal to the Fourth Circuit - The Trial Court’s Grant of a New Trial - Tuomey’s Request for Judgement as a Matter of Law on the Stark Law and FCA...more

Healthcare Law Update

Governing boards of health care organizations can greatly benefit from reading a recently released educational document that presents practical tips for board members responsible for overseeing their organizations’ compliance...more

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

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

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

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

Summer Fraud and Abuse Roundup

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...more

What’s Scarier than a Compliance Officer Turned Whistleblower? A Whole Association of Them

In U.S. ex rel. Corporate Compliance Assocs. v. N.Y. Society for the Relief of the Ruptured & Crippled the court ruled that the whistleblower failed to meet the False Claims Act’s requirement that allegations be described...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Driving Health Care Efficiencies through Consolidation: Despite Reforms, The Usual Rules Apply

With almost 18 percent of U.S. GDP spent on health care, experts see consolidation as fundamental to reducing costs—by integrating care coordination and delivery, and by increasing scale to drive efficiencies, including with...more

Healthcare Law: What Every Provider Should Know

Healthcare is an incredibly broad, diverse and dynamic industry. Because of the breadth in the field, providers are surrounded by a wide array of legal issues relating to: employment contracts, taxes, business structure,...more

There is No Such Thing as a “Free” Urine Test

On May 5, 2014, in Ameritox, Ltd. v. Millennium Labs., Inc., [No. 8:11-cv-775-T-24-TBM], 2014 WL 1779267 (M.D. Fla. May 5, 2014), the U.S. District Court for the Middle District of Florida granted in part and denied in part a...more

There is No Such Thing as a "Free" Urine Test

On May 5, 2014, in Ameritox, Ltd. v. Millennium Labs., Inc., [No. 8:11-cv-775-T-24-TBM], 2014 WL 1779267 (M.D. Fla. May 5, 2014), the U.S. District Court for the Middle District of Florida granted in part and denied in part a...more

CMS and the OIG Extend Protections for Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) each published, in the Federal Register, a final rule that amends regulations under the Anti-Kickback...more

CMS and OIG Issue Final Regulations to Extend the Stark Exception and Anti-Kickback Statute Safe Harbor for EHR Donations

On December 27, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and...more

U.S. District Court Grants in Part, Denies in Part Halifax Hospital’s Summary Judgment for Relator’s Non-Intervened FCA Claims

On January 8th, a United States District Court in the Middle District of Florida granted in part, denied in part summary judgment in favor of Halifax Hospital Medical Center and certain other defendants (collectively, Halifax...more

Federal Government Extends Donated EHR Technology Protections under Stark and AKS through 2021

Some of the most important protections under the federal Stark Law (“Stark”) and the federal Anti-Kickback Statute (“AKS”) have been those that permit hospitals and other organizations to donate electronic health records...more

CMS and OIG Issue Final Rules Extending EHR Stark Law Exception and AKS Safeharbor to December 31, 2021

On December 27, 2013, CMS published a final rule in the Federal Register revising the previously enacted exception to the Stark law that permits certain arrangements involving the donation of electronic health records (EHR)...more

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