News & Analysis as of

Stark Law Anti-Kickback Statute Civil Monetary Penalty

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

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A new report suggests that the Stark law is obsolete in new payment models.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

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

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

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

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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