News & Analysis as of

Stark Law Civil Monetary Penalty

Brave New World: Compliance and the Transition to Value-Based Care

by Ropes & Gray LLP on

The U.S. health care system is in the midst of a fundamental shift, away from traditional “fee-for-service” models that reward providers for the quantity of services provided to patients, toward value-based models designed to...more

Provider Beware: MACRA Implementation Fraught with Fraud and Abuse Implications

by Carlton Fields on

Although the fate of the Center for Medicare and Medicaid Innovation (CMMI) and the mandatory alternative payment models thereunder face threat of repeal under Republican leadership, the Medicare Access and Chip...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

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

Federal Agencies Forced to Implement Huge Increases in Civil Monetary Penalties for Health Care Fraud

by Baker Ober Health Law on

Thanks to section 701 of the Bipartisan Budget Act of 2015, Public Law 114–74, federal agencies have been forced to implement huge increases in penalties intended to deter health care fraud. The Federal Civil Penalties...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Senate Finance Committee Examines Repeal of the Stark Law

by Morgan Lewis on

A new report suggests that the Stark law is obsolete in new payment models. On June 30, the US Senate Committee on Finance (the Committee) released the report Why Stark, Why Now? Suggestions to Improve the Stark Law to...more

CMS Issues Final Rule for Waivers in Connection With the Shared Savings Program

by King & Spalding on

On October 29, 2015, CMS issued its Final Rule setting forth waivers of the application of the physician self-referral law (the Stark law), the Federal anti-kickback statute (AKS), and the civil monetary penalties (CMP) law...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

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

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

Toumey Healthcare Settles False Claims Act Suit for $72 Million

by Arnall Golden Gregory LLP on

In a long-running False Claims Act case with significant implications for hospitals, Toumey Healthcare System last week agreed to settle its case by paying $72.4 million to the government. While this sum is significant, it is...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

Corporate Investigations & White Collar Defense - August 2015

Are the Circuits A-Splitting? The Ninth Circuit Declines to Follow the Second Circuit's Insider Trading Decision in U.S. v. Newman - Why it matters: On July 6, 2015, the Ninth Circuit in U.S. v. Salman declined to...more

SRDP No Longer New Wine

by Faegre Baker Daniels on

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

New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...more

OIG Unveils Updated Self-Disclosure Protocol

by Epstein Becker & Green on

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

OIG Advisory Opinion Sheds Light On Pay-For-Performance Relationships Between Hospitals And Physicians

by BakerHostetler on

On January 7, 2013, the HHS OIG released Advisory Opinion 12-22 concerning a rural hospital's (Hospital) proposal to pay a cardiology group (Group) a performance bonus for achieving certain patient service, quality and cost...more

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