The Centers for Medicare and Medicaid Services (CMS) published its final rule regarding the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program in early February 2023. Among other matters, the final rule...more
In recent days, the federal government has taken two significant steps to increase healthcare funding to assist providers in responding to the medical and economic consequences of the novel coronavirus pandemic.
$100 Billion...more
4/30/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Families First Coronavirus Response Act (FFCRA) ,
Federal Funding ,
Fee-for-Service ,
Health Care Providers ,
Healthcare Provider Corporations ,
Indian Health Service (IHS) ,
Medicare ,
Paycheck Protection Program and Health Care Enhancement Act ,
Public Health ,
Relief Measures ,
Rural Health Care Providers ,
Uninsured Patients ,
Virus Testing
The Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” became law on March 27, 2020. The CARES Act implements wide-ranging changes to law and funding designed to ameliorate the coronavirus...more
03.16.2020 | Updates By a vote of 363-40 the U.S. House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act, on March 14, 2020. The bill now proceeds to the U.S. Senate, and the White House has...more
The U.S. Department of Justice (DOJ) has reached a settlement with hospice company AseraCare, closing a 12-year-old saga that carries substantial implications for False Claims Act (FCA) enforcement in cases involving a...more
3/10/2020
/ Department of Justice (DOJ) ,
Evidence ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Jury Instructions ,
Medical Necessity ,
Medicare ,
Motion For New Trial ,
Objective Falsity ,
Remand
The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more
12/19/2018
/ Amicus Briefs ,
Department of Justice (DOJ) ,
Discovery ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Manufacturers ,
Materiality ,
Misrepresentation ,
Motion to Dismiss ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qui Tam ,
Reimbursements ,
Relators ,
Remand ,
Solicitor General
The U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers...more
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
9/23/2015
/ Amarin ,
Commercial Speech ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs
In a ruling with significant implications for state professional licensing boards and their members, on February 25, 2015, the United States Supreme Court found that practitioner-controlled state boards do not have inherent...more