Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
11/3/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
Fraud and Abuse ,
Generic Drugs ,
Health Care Providers ,
Medicare ,
Medicare Part D ,
OIG ,
Out-of-Pocket Expenses ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Subsidies
New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
10/18/2021
/ Abuse of Discretion ,
Anti-Kickback Statute ,
Appeals ,
Attorney-Client Privilege ,
Comment Period ,
Criminal Investigations ,
Discovery ,
Draft Guidance ,
Evidence ,
Failure To State A Claim ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
10/2/2018
/ Comment Period ,
Deadlines ,
Draft Guidance ,
Drug Compounding ,
Drug Distribution ,
DSCSA ,
Food and Drug Administration (FDA) ,
Grandfathering Rules ,
Manufacturers ,
New Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Product Identifiers ,
Product Packaging ,
Public Comment ,
Regulatory Requirements ,
Suppliers ,
Supply Chain ,
Wholesale
Medicaid -
Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law -
By Eddie Williams -
In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
6/7/2017
/ Anti-Kickback Statute ,
Antitrust Violations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DSM ,
Enforcement Actions ,
Failure To Warn ,
False Claims Act (FCA) ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicaid Act ,
Misrepresentation ,
Noerr-Pennington Doctrine ,
OCR ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Prescription Drugs ,
Sherman Act ,
Stark Law ,
Third-Party Liability ,
Unfair or Deceptive Trade Practices ,
Warning Labels
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
9/29/2015
/ Audits ,
Compliance ,
Covered Entities ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
Healthcare ,
Hospice ,
Hospitals ,
HRSA ,
MCOs ,
Medicaid ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Skilled Nursing Facility
Pharmaceutical wholesalers typically focus on getting drugs from Point A to Point B in a secure and efficient manner. Reputable wholesalers have detailed policies and procedures relating to recordkeeping, pedigrees, drug...more
Florida boasts the most stringent pharmaceutical distribution regulations in the United States. When they do business in Florida, some of the most sophisticated drug companies in the world discover the hard way that their...more