In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A. The appellate court affirmed the district court’s imposition of damages and...more
2/2/2022
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Certification Requirements ,
CLIA ,
Clinical Laboratory Testing ,
Damages ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Penalties ,
Reimbursements ,
Statutory Violations
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
2/1/2022
/ Advertising ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Workers ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
National Federation of Independent Business v Department of Labor and OSHA ,
OPDP ,
Opioid ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
Vaccinations
On September 3, 2020, Special Agents of the Federal Bureau of Investigation, Department of Health and Human Services Office of Inspector General, and the Internal Revenue Service, along with investigators from the...more
On February 12, 2018, a second judge in the Central District of California, Judge Michael W. Fitzgerald, dismissed, with leave to amend by February 26, 2018, counts in a False Claims Act (FCA) case alleging that UnitedHealth...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
4/22/2016
/ Abbott Laboratories ,
All Natural ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Investors ,
Medicare Part B ,
Misleading Impressions ,
Natural Products ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Fraud
On March 31, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report on hospice billing for general inpatient care (GIP). According to the OIG, hospices billed Medicare for...more
The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently released its 2016 Work Plan. The Work Plan may offer evidence of a growing shift in the agency’s priorities, particularly with regard...more
On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more
10/27/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Testing ,
False Claims Act (FCA) ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG ,
Qui Tam
On September 30, 2015, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its fifth report in five years on billings for therapy services in SNFs. The Medicare Payment System For...more
On August 27, 2015, following notification by the government that it had decided not to intervene, the United States District Court for the Middle District of North Carolina, ordered that a qui tam complaint charging...more
9/15/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Declination ,
Department of Labor (DOL) ,
Employee Retirement Income Security Act (ERISA) ,
False Claims Act (FCA) ,
Hospitals ,
Medicare ,
OIG ,
PPOs ,
Qui Tam ,
Relators ,
Self-Funded Health Plans ,
Self-Insurance ,
Wage Index
On June 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) released another study in its continuing scrutiny of skilled nursing facilities (SNFs) and therapy services: Skilled Nursing...more