The US Court of Appeals for the Third Circuit endorsed two controversial interpretations of the Stark Law’s “volume or value” standard, known as the correlation theory and the practice “loss” theory in U.S. ex rel. J. William...more
10/3/2019
/ Appeals ,
Compensation Agreements ,
Dismissal With Prejudice ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medical Centers ,
Motion to Dismiss ,
Patient Referrals ,
Petition For Rehearing ,
Physician Compensation Arrangements ,
Physician Medicare Reimbursements ,
Physicians ,
Pleading Standards ,
Relators ,
Reversal ,
Rule 9(b) ,
Stark Law ,
Statutory Interpretation ,
Statutory Violations
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...more
9/18/2019
/ Amended Complaints ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Motion to Dismiss ,
Physicians ,
Qui Tam ,
Relators ,
Remuneration ,
Rule 9(b) ,
Stark Law
In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts...more
8/16/2019
/ Acquisitions ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Home Health Agencies ,
Mergers ,
New Guidance ,
New Rules ,
OCR ,
OIG ,
Opioid ,
Pharmaceutical Industry
Frequent regulatory and policy changes, increasing government scrutiny and private whistleblower activity pose greater risks to health care organizations more than ever before. McDermott’s Q2 Health Care Enforcement Roundup...more
7/30/2019
/ Compliance ,
Continuing Legal Education ,
Cooperation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Freedom of Religion ,
Health Care Providers ,
Home Health Agencies ,
Home Health Care ,
Hospitals ,
Opioid ,
Opt-Outs ,
Physicians ,
Stark Law ,
Statute of Limitations ,
Telemedicine ,
Webinars ,
Whistleblowers
DOJ recently announced the release of formal guidance on how civil attorneys can award “cooperation credit” to defendants who cooperate with DOJ during a False Claims Act investigation. This formal policy provides some new...more
6/21/2019
/ Chief Compliance Officers ,
Cooperation ,
Corporate Misconduct ,
Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Good Faith ,
Government Investigations ,
New Guidance ,
Scienter ,
Self-Disclosure Requirements
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
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
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
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
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
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
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
After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more
9/28/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Fair Market Value ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Individual Accountability ,
OIG ,
Patient Referrals ,
Physician Compensation Arrangements ,
Physicians ,
Qui Tam ,
Relators ,
Self-Referral Disclosure Protocol ,
Settlement ,
Stark Law ,
Tuomey ,
Yates Memorandum
In This Issue:
- Background
- Tuomey’s Second Appeal to the Fourth Circuit
- The Trial Court’s Grant of a New Trial
- Tuomey’s Request for Judgement as a Matter of Law on the Stark Law and FCA...more
7/13/2015
/ Anti-Kickback Statute ,
Appeals ,
Employment Contract ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Hospitals ,
Jury Instructions ,
Medicare ,
New Trial ,
Non-Compete Agreements ,
Patient Referrals ,
Physicians ,
Stark Law ,
Treble Damages
The federal government’s health care fraud enforcement efforts expanded this week with an announcement by the Office of the Inspector General (OIG), of the U.S. Department of Health and Human Services, that it has created a...more
Over the last month the Office of Inspector General (OIG) of the Department of Health and Human Services and the Department of Justice (DOJ) have each taken actions that suggest an increasing appetite to examine the financial...more
7/2/2015
/ Anti-Kickback Statute ,
CMP Law ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud Alerts ,
Healthcare ,
Medical Directors ,
OIG ,
Physician Compensation Arrangements ,
Physicians ,
Stark Law