On April 20, 2022, the Department of Justice (“DOJ”) announced twenty-one (21) defendants were charged in nine (9) different districts related to $149 million in COVID-19-related false billing issues. $8 million in cash and...more
4/26/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Confidential Information ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement ,
False Billing ,
Fraud ,
Healthcare Fraud ,
Personal Protective Equipment ,
Provider Relief Fund
On November 4, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (the Proposed Rule) outlining proposals for the coverage and payment for durable medical equipment, prosthetics, orthotics, and...more
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule -
On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
6/24/2020
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
MDRP ,
Medicaid ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Reimbursements ,
Value-Based Purchasing
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
1/7/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Enhanced Penalties ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory History ,
Regulatory Requirements ,
Supply Chain
HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers -
In today’s Federal Register, the...more
10/17/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Rules ,
Safe Harbors ,
Value-Based Care
The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements -
On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more
5/14/2019
/ Administrative Authority ,
Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
Drug Pricing ,
Final Rules ,
First Amendment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency
President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more
4/22/2019
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Life Sciences ,
Manufacturers ,
MDRP ,
Medicaid ,
OIG ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Trump Administration
On July 11, 2018, CMS announced that the process for recompeting contracts with suppliers currently in effect under the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) Competitive Bidding Program (CBP)...more
State Budget Includes Medicaid Drug Expenditure Cap -
On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...more