Boards and management should make use of recent expanded guidance from the US Department of Justice to ensure that their compliance programs are considered “effective” if and when an investigation arises. Companies should...more
Introduction -
In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in...more
4/26/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
OIG ,
Opioid ,
Prescription Drugs ,
Qui Tam ,
Statute of Limitations ,
Telemedicine ,
The Granston Memo
In its first update in a decade and effective January 1, 2020, the revised Advanced Medical Technology Association (AdvaMed) Code of Ethics in Interactions with Health Care Professionals (Code) in the United States contains...more
On February 6, 2019, the DOJ announced a settlement agreement with Greenway Health, a vendor of EHR software, under which Greenway agreed to pay approximately $57 million to resolve allegations that it caused its health care...more
2/26/2019
/ Anti-Kickback Statute ,
CEHRT ,
Department of Justice (DOJ) ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
False Statements ,
Health Care Providers ,
Health Information Technologies ,
OIG ,
Settlement Agreements ,
Vendors
On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing...more
2/14/2019
/ Controlled Substances ,
Controlled Substances Act ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Federal Agency Taskforce ,
Government Investigations ,
Medicare ,
Opioid ,
Permanent Injunctions ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Substance Abuse ,
TRO
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of...more
1/29/2019
/ Anti-Kickback Statute ,
Corporate Investigations ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Individual Accountability ,
Materiality ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
REMS ,
RICO ,
Settlement ,
Universal Health Services Inc v United States ex rel Escobar ,
Yates Memorandum
On December 21, just before the government shutdown began, the Civil Division of the US Department of Justice (DOJ) announced its fiscal 2018 False Claims Act (FCA) statistics. According to DOJ, FCA judgments and settlements...more
The Office of Inspector General, Department of Health and Human Services posted an unusual negative Advisory Opinion (AO 18-14) on a drug company’s proposal to provide free drugs to hospitals for use with pediatric patients...more
A massive bill intended to address the nation’s opioid crisis is about to become law—the House overwhelmingly voted in favor of the SUPPORT for Patients and Communities Act (H.R. 6) on Friday, September 28, 2018, and the...more
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 the practical...more
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...more
Following our inaugural installment of the Health Care Enforcement Quarterly Roundup, we are pleased to be back this quarter with another overview of key enforcement trends in the health care industry. In this issue, we...more
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...more
On May 31, 2018, the Centers for Medicare and Medicaid Services (CMS) published a proposing to reinstate a controversial claim review demonstration project whereby CMS would review 100 percent of home health agency (HHA)...more
Over the past 18 months, we have closely monitored the Trump administration’s approach to health care enforcement issues, with a particular focus on whether prosecution of the False Claims Act (FCA) remains a priority under...more
In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more
2/16/2018
/ Administrative Procedure Act ,
Attorney General ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Branch ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Memorandum of Guidance ,
Rulemaking Process
The government’s focus on the US opioid crisis has been consistently expanding over the past year beyond manufacturers to reach prescribers and health care providers who submit claims to federal health care programs for...more
Earlier this year, DOJ and OIG independently issued guides focused on evaluating compliance program effectiveness. The guides approach the topic from different perspectives but cover overlapping themes and work well in...more
On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate...more
With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more
The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more
3/3/2017
/ Affirmative Action ,
Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Health Care Providers ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OIG ,
Permissive Exclusion Authority ,
Reinstatement ,
Safe Harbors ,
Social Security Act
In a burst of rulemaking in December 2016, the US Department of Health and Human Services, Office of Inspector General, issued two new final rules containing significant changes to OIG’s Civil Monetary Penalty authorities....more
On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more
9/29/2016
/ CEOs ,
Civil Monetary Penalty ,
Corporate Executives ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare ,
Medicare Part A ,
OIG ,
Qui Tam ,
Service Agreements ,
Settlement ,
Skilled Nursing Facility ,
Stark Law ,
Yates Memorandum
On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more
4/29/2016
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Medicare ,
New Guidance ,
OIG ,
Permissive Exclusion Authority ,
Stark Law
On February 11, 2016, the Center for Medicare and Medicaid Services (CMS) issued the much-anticipated final rule concerning Section 6402(a) of the Affordable Care Act, the so-called "60 Day Rule". This section requires...more