The Centers for Medicare & Medicaid Services and the Office of Inspector General recently released notices of proposed rulemaking relating to the Stark Law and the Anti-Kickback Statute. We break down the new proposed...more
12/10/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Proposed Regulation ,
Proposed Rules ,
Remuneration ,
Safe Harbors ,
Stark Law ,
Value-Based Care
A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more
12/6/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Local Coverage Determination (LCD) ,
Medicare ,
Medicare Part C ,
New Guidance ,
Notice and Comment ,
OGC ,
Overpayment ,
Provider Payments ,
Rulemaking Process ,
SCOTUS ,
Social Security Act
To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more
11/13/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Healthcare Reform ,
Incentives ,
Patients ,
Physicians ,
Proposed Rules ,
Regulatory Burden ,
Reimbursements ,
Safe Harbors ,
Self-Referral ,
Stark Law ,
Value-Based Care ,
Webinars
On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more
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
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
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 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
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
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
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
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
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) annual release of a new Work Plan both summarizes the results achieved last year and highlights new areas for examination in the next....more
The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report on September 30, 2015, that calls for the Centers for Medicare and Medicaid Services (CMS) to reform payment for...more
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