The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...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 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
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
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 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
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
On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law (the Proposed Rule). 80 Fed. Reg. 41,686,...more
7/28/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
FQHC ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
Patient Referrals ,
Physician Compensation Arrangements ,
Physician-Owned Hospitals ,
Physicians ,
Proposed Regulation ,
Rural Health Care Providers ,
Stark Law
On July 13, 2015, the Centers for Medicare & Medicaid (CMS) issued a long-awaited proposed rule (Proposed Rule) that would revise the requirements that long-term care (LTC) facilities must meet to participate in the Medicare...more
7/16/2015
/ Affordable Care Act ,
Binding Arbitration ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Elder Abuse ,
Employee Training ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Long Term Care Facilities ,
Long-Term Care ,
Medicaid ,
Medicare ,
Neglect ,
Nurse Practitioners ,
Nurses ,
Physicians ,
Prescription Drugs ,
Proposed Regulation ,
Quality Assurance Programs ,
Training Requirements
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
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
A 2008 rule change from the Centers for Medicare and Medicaid (CMS)—which effectively prohibited referring physician-owned companies from furnishing hospital services “under arrangements”—has withstood a challenge by a...more
The legislation repealing the Medicare sustainable growth rate formula (SGR), signed by President Obama on April 16, 2015, contained several anti-fraud related provisions that affect the health care industry. The provision...more