The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of...more
Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here...more
In our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” we discussed the advanced...more
On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more
11/30/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Cybersecurity ,
Electronic Medical Records ,
Exceptions ,
Health Care Providers ,
New Guidance ,
OIG ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants. In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice...more
12/5/2019
/ Anti-Kickback Statute ,
Appeals ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Mortgage Fraud ,
Pharmaceutical Industry ,
Qui Tam ,
Relators ,
Shell Corporations ,
The Granston Memo
As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...more
On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory...more
10/11/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On July 31, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s decision to grant summary judgment to hospital operator HCA and dismiss relator Thomas Bingham’s allegations. Bingham v. HCA (S.D....more
8/19/2019
/ Anti-Kickback Statute ,
Discovery ,
False Claims Act (FCA) ,
Federal Pleading Requirements ,
Health Care Providers ,
Healthcare Fraud ,
Motion To Strike ,
Physician Compensation Arrangements ,
Relators ,
Rule 9(b) ,
Stark Law
On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge...more
I. Introduction -
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, seeks to prohibit...more
1/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Kickbacks ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse