In a move that could reshape the regulatory landscape for pharmacies servicing Massachusetts residents, the Massachusetts Board of Pharmacy has announced that it will soon begin licensing nonresident pharmacies and requiring...more
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
For years, patients and healthcare companies have been wrestling with privacy issues relating to cookies, pixels and other tracking technologies. The U.S. Department of Health and Human Services' (HHS) Office of Civil Rights...more
12/5/2022
/ Data Breach ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
New Guidance ,
OCR ,
Personally Identifiable Information ,
PHI ,
Popular ,
Tracking Systems ,
Web Tracking
A recent settlement involving a Medicare Advantage plan should serve as a reminder that the federal Anti-Kickback Statute (AKS) is broad and far-reaching, both on its face and in practice. On July 1, 2022, the U.S. Department...more
7/12/2022
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Incentives ,
Medicare ,
Medicare Advantage ,
OIG ,
Patient Referrals ,
Settlement
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more
• The U.S. Department of Justice (DOJ) recently updated its guidance to Criminal Division prosecutors in evaluating a corporation's compliance program when making charging decisions (Guidance).
• The Guidance directs...more
5/9/2019
/ Best Practices ,
Chief Compliance Officers ,
Criminal Prosecution ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Federal Sentencing Guidelines ,
Foreign Corrupt Practices Act (FCPA) ,
Government Investigations ,
Health Care Providers ,
New Guidance ,
OIG ,
Policies and Procedures ,
Risk Assessment
• A recent federal jury verdict in Dallas affirms the U.S. Department of Justice's determination to extend federal prosecutions to healthcare arrangements involving commercial payers by utilizing the federal Travel Act, which...more
4/26/2019
/ Aiding and Abetting ,
Anti-Kickback Statute ,
Bribery ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
Federal Health Care Programs (FHCP) ,
Federal Prosecutors ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Hospitals ,
Indictments ,
Interstate Commerce ,
Jury Verdicts ,
Kickbacks ,
Medical Centers ,
Money Laundering ,
Out of Network Provider ,
Patient Referrals ,
Physicians ,
Travel Act
• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals.
• The proposed structure, called the International Pricing Index (IPI)...more
11/15/2018
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Section 340B ,
Vendors
Enforcement -
OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals -
On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more
3/27/2017
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Free Health-Related Services ,
Health Care Providers ,
Health Insurance ,
Hospital Mergers ,
Hospitals ,
Market Allocation Scheme ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors ,
Sherman Act ,
Unfair or Deceptive Trade Practices ,
Value-Based Purchasing
The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more
On November 21, 2012, the Massachusetts Public Health Council (PHC) approved the final regulatory amendments implementing the Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N, which was amended by Gov....more
Governor Deval Patrick signed into law Massachusetts’ fiscal year 2013 budget on July 8, 2012. The budget includes amendments to the state’s Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N. The...more