News & Analysis as of

Medical Devices Pharmaceutical Industry Anti-Kickback Statute

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Healthcare Law Update: December 2016

by Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"

On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

by Thomas Fox on

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

by Holland & Knight LLP on

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Update on the Provider Self-Disclosure Protocol

Since we last reported on the Provider Self-Disclosure Protocol (“Protocol”) issued by the Department of Health and Human Services, Office of the Inspector General (“OIG”), the entire Protocol has been revamped. Rather than...more

Let The Sunshine In – The Risks To Pharmaceutical And Medical Device Companies From Open Payment Transparency

by Michael Volkov on

Pharmaceutical and medical device manufacturers (as well as group purchasing organizations “GPOs”) have a major compliance challenge ahead — the Physician Payment Sunshine Act regulations. ...more

Doctors, Enforcement Risks And Compliance Programs

by Michael Volkov on

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

Pharmaceutical And Medical Device Compliance: Domestic And Foreign Bribery

by Michael Volkov on

Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more

Health Care Reform: Key Legislative Changes Impacting the Pharmaceutical, Biotechnology, and Medical Device Industries

by Ropes & Gray LLP on

Last week, Congress adopted comprehensive health care reform through the passage of the Patient Protection and Affordable Health Care Act (H.R. 3590) (signed into law on March 23) and the Health Care and Education...more

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