This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the...more
10/23/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare Reform ,
OIG ,
Personal Services ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care ,
Warranties
On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more
10/11/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
OIG ,
Physicians ,
Proposed Rules ,
Public Comment ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the “Final Rule”) that is designed to increase CMS’s ability to identify and prevent bad actors from participating in...more
9/13/2019
/ Affiliates ,
Bad Actors ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
Medicare
On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator’s qui tam suit because of the defendant’s burdensome discovery demands, in Polansky v. Executive...more
8/24/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Discovery ,
Dismissals ,
EHR ,
False Claims Act (FCA) ,
Health Care Providers ,
Qui Tam ,
Relators ,
The Granston Memo ,
Two-Midnight Rule
The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in...more
2/22/2019
/ Department of Justice (DOJ) ,
Failure to Comply ,
False Claims Act (FCA) ,
Health Care Providers ,
Local Coverage Determination (LCD) ,
Medical Necessity ,
Medicare ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators
Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...more
2/14/2019
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
Health Care Providers ,
Meaningful Use ,
Medicaid ,
Medicare ,
OIG ,
Settlement Agreements ,
Software ,
Third-Party Service Provider
Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more
2/7/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Civil Monetary Penalty ,
Digital Health ,
Health Care Providers ,
Low-Income Issues ,
Manufacturers ,
Medical Devices ,
New Guidance ,
OIG ,
Patient Assistance Programs ,
Patient Safety ,
Pharmaceutical Industry ,
Smartphones
As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators,...more
1/16/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Petition for Writ of Certiorari ,
Solicitor General ,
Universal Health Services Inc v United States ex rel Escobar
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
Regulatory Requirements ,
Remuneration ,
Safe Harbors ,
Secretary of HHS
Thousands of laboratories nationwide will be happy to hear that Florida, which licenses in-state as well as out-of-state laboratories, has repealed its laboratory licensure requirements. As of July 1, 2018, laboratories...more
The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days...more
With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more
10/29/2015
/ 60-Day Rule ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fair Market Value ,
False Claims Act (FCA) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Overpayment ,
Physician Compensation Arrangements ,
Qui Tam ,
Relators ,
Safe Harbors ,
Settlement ,
Stark Law ,
Suppliers ,
Third-Party ,
Training
GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more