The Sixth Circuit expanded the existing circuit split regarding when a kickback causes a federal health care claim to be false or fraudulent under the False Claims Act (FCA) and set out a new analysis for what constitutes...more
The emerging circuit split on the causation standard used to identify claims “resulting from” violations of the Anti-Kickback Statute (AKS) for purposes of the False Claims Act (FCA) raises proof problems for relators and the...more
The Eighth Circuit released an opinion Tuesday in U.S. ex rel. Cairns v. D.S. Medical LLC that creates a new circuit split on the interpretation of the causation standard for establishing that a claim “resulting from” a...more
Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final rules intended to “modernize and clarify” the physician self-referral (Stark)...more
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) adopted additional revisions to the Stark Law regulations (the final...more
12/1/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Patient Referrals ,
Physicians ,
Stark Law ,
Value-Based Care
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more
10/21/2019
/ Anti-Kickback Statute ,
Carve Out Provisions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Life Sciences ,
Patient Referrals ,
Proposed Regulation ,
Regulatory Agenda ,
Stark Law ,
Value-Based Care
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
2/11/2019
/ Anti-Kickback Statute ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Incentives ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda ,
Safe Harbors ,
Trump Administration
On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more
10/9/2018
/ Anti-Kickback Statute ,
Health Care Providers ,
Healthcare Fraud ,
Legislative Agendas ,
Opioid ,
Pain Management ,
Pending Legislation ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Remuneration
On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more
8/29/2018
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Medicare Shared Savings Program ,
OIG ,
Request For Information ,
Safe Harbors ,
Stark Law