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McDermott Will & Emery

This Week in 340B: August 2023

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This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Faegre Drinker Biddle & Reath LLP

OIG Issues Favorable Advisory Opinion for Free Genetic Testing and Counseling Program Offered by a Pharmaceutical Company

Faegre Drinker Biddle & Reath LLP on

On April 11, 2022, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion No. 22-06 (AO 22-06), which approved a biopharmaceutical company’s proposed arrangement to...more

Mintz - Health Care Viewpoints

OIG Approves Manufacturer’s Offer of Free Genetic Testing

Mintz - Health Care Viewpoints on

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more

Bricker Graydon LLP

EHR vendor Practice Fusion agrees to $145 million settlement to resolve criminal and civil kickback violations

Bricker Graydon LLP on

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

K2 Integrity on

When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...more

Thomas Fox - Compliance Evangelist

Bribery Schemes from 2019 FCPA Enforcement Actions

Thomas Fox - Compliance Evangelist on

In today’s blog post, I want to look at some of the more unusual bribery schemes from Foreign Corrupt Practices Act (FCPA) enforcement actions in 2019. Some of these schemes were not unusual but they were accomplished with...more

Goodwin

Coherus Enters into Prime Vendor Agreement with Apexus that Includes Udenyca™

Goodwin on

Last week, Coherus BioSciences, Inc. announced that it had entered into a 340B prime vendor program contract agreement with Apexus, LLC. This agreement includes Udenyca™, which, as we reported last month, is the second...more

Robinson+Cole Health Law Diagnosis

OIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory Opinion

Robinson+Cole Health Law Diagnosis on

On November 16, 2018, the Office of the Inspector General of the Department of Health and Human Services (OIG) posted an unfavorable Advisory Opinion No. 18-14 regarding an arrangement where a vendor (Requestor) of a commonly...more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

Holland & Knight LLP on

• 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

Sheppard Mullin Richter & Hampton LLP

VA Streamlines MSPV-NG Acquisition through Distribution and Supply Agreements

Sheppard Mullin Richter & Hampton LLP on

The Department of Veterans Affairs issued a Justification and Approval (J&A) for Other than Full and Open Competition on April 12, 2018, to allow prime vendors currently performing “distribution” contracts under the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care Investigation Trends: Corporate Integrity Agreements No Longer a Given

Skadden, Arps, Slate, Meagher & Flom LLP on

2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more

Mintz - Health Care Viewpoints

HIPAA Lessons from the Warner Chilcott Settlement

Mintz - Health Care Viewpoints on

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

The Volkov Law Group

Doctors, Enforcement Risks And Compliance Programs

The Volkov Law Group on

Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

Holland & Knight LLP on

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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