Amy H. Kearbey Amy H. Kearbey

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Amy Hooper Kearbey advises clients on health care fraud and abuse laws and digital health strategy.  She represents a broad range of health industry stakeholders, including hospital systems, medical societies, pharmaceutical and medical device companies, clinical laboratories, and data informatics companies. Read Amy Hooper Kearbey's full bio.

Remuneration? Not If It’s Fair Market Value, Says Eleventh Circuit


By and on Sep 27, 2019
Posted In Anti-Kickback Statute / Stark Law

Bingham v. HCA, Inc., a recent Eleventh Circuit case, highlights the centrality of fair market value to Anti-Kickback Statute (AKS) analyses. This decision is significant for several reasons and we expect to see Bingham cited by many defendants in future False Claims Act cases. The case is also a reminder that the current regulatory and...

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Health Care Enforcement Quarterly Roundup | Q3 | September 2018


By , , , , , , , , , , , and on Oct 8, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions

In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months. In this issue, we report on: Practical applications of recent guidance from the US Department of Justice (DOJ) A recent blow to DOJ’s effort to use...

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OIG Seeks Comments on Anti-Kickback Statute and Beneficiary Inducements as Part of its Regulatory Sprint to Coordinated Care


By , , , , , and on Aug 27, 2018
Posted In Anti-Kickback Statute / Stark Law, Compliance Developments

On August 24, 2018, the Office of Inspector General (OIG), Department of Health and Human Services (HHS) published a request for information, seeking input from the public on potential new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement prohibition in the Civil Monetary Penalty (CMP) Law to remove impediments to care...

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CMS Seeks Comments on Stark Law Reforms Needed to Reduce Obstacles to Innovation


By , , , , , and on Jul 3, 2018
Posted In Stark

On June 25, 2018, the Centers for Medicare and Medicaid Services (CMS) published a request for information, seeking input from the public on how to address any undue regulatory impact and burden of the physician self-referral law (Stark Law) on value-based and other coordinated care arrangements designed to improve quality and lower cost. While the...

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Update: Judge Denies Relator’s Attempt to Freeze Nursing Home’s Assets Pending Appeal


By and on Jan 30, 2018
Posted In Damages and Penalties, Materiality, Sampling/Extrapolation

On January 23, 2018, the same judge who two weeks ago set aside a $350 million jury verdict against a nursing home operator denied a new emergency motion by relator to freeze the defendant’s assets pending the relator’s appeal of the court’s order granting judgment as a matter of law. The relator argued that the...

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DOJ Settlement with Home Health Providers Underscores Strategic Considerations for Self-Disclosure


By on Oct 23, 2017
Posted In Anti-Kickback Statute / Stark Law, Corporate Integrity Agreements, Damages and Penalties, Reverse False Claims, Stark

Eventually, any health care organization with an effective compliance program is very likely to discover an issue that raises potential liability and requires disclosure to a government entity. While we largely discuss False Claims Act (FCA) litigation and defense issues on this blog, a complementary issue is how to address matters that raise potential liability...

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Physician Compensation Scrutiny Continues in Recent FCA Settlement


By and on Jun 16, 2017
Posted In Anti-Kickback Statute / Stark Law, Corporate Integrity Agreements, Damages and Penalties, Stark

A hospital system in Missouri recently agreed to settle with the US Department of Justice (DOJ) for $34 million to resolve claims related to alleged violations of the Stark Law. On May 18, 2017, DOJ announced a settlement agreement with Mercy Hospital Springfield (Hospital) and its affiliate, Mercy Clinic Springfield Communities (Clinic). The Hospital and...

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CMS Proposes Stark Law Amendments, Requests Comments on Whether Stark Law Is Barrier to Health Care Reform


By , , , , , and on Jul 22, 2015
Posted In Stark

The Centers for Medicare & Medicaid Services (CMS) recently published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law. CMS also used this proposed rule to state its positions on certain questions of Stark Law interpretation and application, and to solicit comments from the industry on whether the Stark...

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