Massachusetts has expanded regulatory oversight of health care transactions by imposing False Claims Act liability on health care owners and investors for changes including failure to disclose violations. On January 8, 2025,...more
Under a new 2025 law, Massachusetts is one of the first in the nation to broaden its state False Claims Act (FCA) to require disclosures by investors and owners of health care entities. On January 8, 2025, Governor Maura...more
As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the...more
On March 12, 2024, the U.S. Court of Appeals for the Second Circuit issued an important decision interpreting the “willfulness” standard necessary to find a violation of the federal Anti-Kickback Statute (AKS). The decision...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the...more
1/4/2023
/ 60-Day Rule ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare ,
Overpayment ,
Overpayment Recovery Time Limits ,
Proposed Rules ,
Regulatory Agenda
On October 14, 2021, the Massachusetts Attorney General (MA AG) announced a $25 million settlement with South Bay Mental Health Center, Inc.’s (SBMHC) private equity owner and two former executives for allegedly causing false...more
12/20/2021
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Pharmaceutical Industry ,
Pharmacies ,
Private Equity Firms ,
Qui Tam ,
Whistleblowers
The Robinson+Cole Health Law Group is committed to examining and reporting on issues important to the health care and life sciences industries. Below are excerpts from our Health Law Diagnosis blog, where we post on fraud and...more
On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations,...more
9/25/2019
/ Department of Justice (DOJ) ,
Drug Compounding ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Investment ,
Kickbacks ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Private Equity Firms ,
Settlement Agreements ,
TRICARE
In a 3-0 decision issued September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a three-year-old district court ruling in United States v. AseraCare, Inc. that a Medicare claim for hospice services...more
9/17/2019
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraudulent Charges ,
Health Care Providers ,
Healthcare Facilities ,
Hospice ,
Medicare ,
Medicare Beneficiaries ,
Objective Falsity ,
Reversal
A recent complaint filed by the United States against a private equity firm regarding an alleged kickback further illustrates new concerns private equity should be aware of in the healthcare arena and working with counsel to...more
DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE -
On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more
9/7/2016
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Physician Assistants ,
Settlement ,
Vaccinations
On June 14, 2016, a federal district court in the Northern District of Illinois denied a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger of Advocate Health Care...more
7/19/2016
/ Antitrust Investigations ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Hospital Mergers ,
Hospitals ,
Mergers ,
Penalties ,
Preliminary Injunctions ,
Stark Law
On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Final Rule) interpreting the application of Section 1128J(d) of the Social Security Act (the 60-Day Rule) to over payments...more
CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN
FEE SCHEDULE -
The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more
In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
10/8/2015
/ 60-Day Rule ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Fee-for-Service ,
GPOs ,
Healthcare ,
HIV ,
HRSA ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Overpayment Recovery Time Limits ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Whistleblowers
The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more
9/9/2015
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Generic Drugs ,
Healthcare ,
HEAT ,
Kickbacks ,
Kmart ,
Medicare ,
Pharmacies ,
Prescription Drugs
On August 3, 2015, the United States District Court in the Southern District of New York issued a long-awaited opinion and order rejecting a motion to dismiss filed by the defendants in U.S. ex rel. Kane v. Continuum Health...more
8/21/2015
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Whistleblowers
The Centers for Medicare and Medicaid Services (CMS) announced on February 13, 2015, that it will delay publishing final regulations concerning the “60-Day Rule.” The final rule will be published on or before February 17,...more
In This Issue:
- Connecticut Supreme Court: HIPAA Does Not Preempt Negligence Claims
- CMS Removes Continuing Education Exemption to Physician Payments Sunshine Act
- Federal Government and New York...more
11/24/2014
/ Centers for Medicare & Medicaid Services (CMS) ,
Continuing Medical Education ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medicaid ,
Negligence ,
PHI ,
Sunshine Act
On September 22, 2014, Mount Sinai Health System (Mount Sinai) filed a motion to dismiss a groundbreaking lawsuit filed against it in a New York federal district court. The suit is the first publicly unsealed whistleblower...more