News & Analysis as of

Stark Law Anti-Kickback Statute Office of the Inspector General

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

When to Use the OIG’s Self Disclosure Protocols

by Ruder Ware on

The HHS Office of Inspector General offers providers an opportunity to self-disclose certain violations in exchange for avoiding some of the more draconian penalties that may otherwise apply under applicable regulations. ...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

CMS and OIG Issue Notice of Amended Waivers for Next Generation ACO Model

by King & Spalding on

On December 29, 2016, CMS and OIG issued a Notice of Amended Waivers of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model (the 2016 Notice). The 2016 Notice does not change or limit arrangements...more

Health Care Institutions

by K&L Gates LLP on

Originally published in Haig, Business and Commercial Litigation in Federal Courts, Fourth Edition §§ 87:1 et seq. © 2016 American Bar Association. This chapter discusses federal court litigation relating to health care...more

Summer Fraud and Abuse Roundup

by BakerHostetler on

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...more

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

by Foley & Lardner LLP on

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

Physician-Owned Distributor (POD) Update

by Reed Smith on

For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors ("PODs"). From the Department of Health and Human Services Office of Inspector General’s ("OIG") issuance...more

OIG Issues New Exclusion and CIA Guidance

by McDermott Will & Emery on

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

[Webinar] 2016 OIG Work Plan: Focus on Compliance - Dec. 10th, 12:00pm ET

by LeClairRyan on

This webinar will include an overview of OIG’s new and ongoing areas of focus related to hospitals and physicians. The focus of the discussion will be the practical impact of these key enforcement priorities on planning and...more

Advisory Opinion: Free van shuttle services to medical facilities

by Tucker Arensberg, P.C. on

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle...more

Limited Modifications in Final ACO Fraud and Abuse Waivers Most Notably Include Cut of Gainsharing CMP Waiver

by Baker Ober Health Law on

Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more

CMS and OIG Issue Final ACO Waivers

by Saul Ewing LLP on

On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more

Millennium Health to Pay $256 million in False Claims Act Settlement

by Polsinelli on

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

CMS/OIG Finalize Fraud Authority Waivers for Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program...

by Reed Smith on

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized a rule designed to “remove legal and regulatory barriers that can impede care coordination in furtherance of the...more

Giving Your Physician Agreements a Check-Up

by Buchalter on

On June 9, 2015, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a fraud alert regarding physician compensation relationships and potential liability for illegal kickbacks under the...more

Health Care and Life Sciences Practice Newsletter

by Buchalter on

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Healthcare Legal News: Volume 5, Number 3

by Dickinson Wright on

RESPONDING TO SUBPOENAS AND OTHER REQUESTS FOR PERSONAL HEALTH INFORMATION: TAKE THEM AT FACE VALUE - Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from...more

OIG Issues Two Favorable Advisory Opinions

by King & Spalding on

OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

Health Law Pulse - August 2015

by Robinson & Cole LLP on

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

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

by McDermott Will & Emery on

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

by BakerHostetler on

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

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

ACO Fraud and Abuse Waivers Extended Through November 2, 2015

by Baker Ober Health Law on

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

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