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
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
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 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
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
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
On November 16, 2015, the Centers for Medicare and Medicaid Services (CMS) published the 2016 Medicare Physician Fee Schedule final rule with comment period in the Federal Register at 80 Fed. Reg. 70,886, which includes a...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
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
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