News & Analysis as of

Stark Law Office of the Inspector General

Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated...

Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an...more

Stark Law: What Providers Should Know About New CMS Form

by Polsinelli on

The Centers for Medicare and Medicaid Services (CMS) has finalized Form CMS-10328 (the SRDP Form), a new OMB-approved information collection instrument that must be used by providers and suppliers utilizing the Stark Law...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

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

by McDermott Will & Emery on

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...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

CMS Re-proposes Ban on Per-Click Fees for Space and Equipment Leases under Stark

by Baker Ober Health Law on

In the CY 2017 Medicare Physician Fee Schedule (CY 2017 MPFS), the Centers for Medicare & Medicaid Services (CMS) issued proposed updates to the physician self-referral law (Stark law). The primary Stark law update focused on...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

Health Update - December 2015

Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal - Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more

2015 Health Care Year in Review

by Burr & Forman on

In 2015, ICD-10 finally became a reality, and the dire predictions of problems seem to be wrong. Providers now have codes to describe just about every conceivable (and a few simply bizarre) medical occurrences. If a patient...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

Beware the Feds: Emerging Risks to Health Care Executives Under the Yates Memo

by Reed Smith on

Last month’s “Yates Memo” from the Department of Justice (DOJ) promises to be a game-changer in the world of government investigations and enforcement activity. While several U.S. Attorney Offices had been applying many of...more

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases: October 2015

by Mintz Levin on

Trends & Analysis: ..We have identified 15 health care–related qui tam cases that were unsealed since our last Qui Tam Update. Of those, 12 were filed from 2012 to the present. All but two cases had been pending more...more

Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post-Tuomey?

by McDermott Will & Emery on

After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...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

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