News & Analysis as of October 12, 2024

Sunshine Act

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on 4/2/2024

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

California Passes New Law Requiring Physicians and their Employers to Notify Patients about the Open Payments Database

Mintz - Health Care Viewpoints on 10/11/2022

A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more

Italy Becomes Latest Country to Pass Sunshine Act

Pietragallo Gordon Alfano Bosick & Raspanti,... on 7/21/2022

Takeaway: Although the enactment of the Italian Sunshine Act furthers the global expansion of healthcare transparency, the implied consent provision may not comply with the GDPR....more

Compensating Physician Advisors with Equity: Considerations for Life Sciences Companies

Fenwick & West LLP on 7/13/2022

Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more

OIG Approves Physician-Owned Medical Device Company

Mintz - Health Care Viewpoints on 4/28/2022

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

Physician Group Monitoring of “Open Payments”

Williams Mullen on 4/27/2022

Is your physician group monitoring the Open Payments database? Each June, the Centers for Medicare and Medicaid Services (CMS) releases data showcasing the payments made by reporting entities to physician groups and other...more

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on 11/5/2021

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on 7/9/2021

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Pharmaceutical and Medical Device Manufacturers Be Advised: Sunshine Act / Open Payments Enforcement is on the Rise

Mintz - Health Care Viewpoints on 5/28/2021

Pharmaceutical and medical device manufacturers should be advised that the government is using its enforcement authority under the Open Payments Program (otherwise known as the Sunshine Act) in conjunction with the...more

DOJ Puts Teeth in Sunshine Act Reporting Requirements

Skadden, Arps, Slate, Meagher & Flom LLP on 5/26/2021

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers About the Enforcement in Life Sciences Series Recent settlements between the U.S. Department of...more

Do You Have The COVID-19 Blues? Don’t Forget About Sunshine!

MoFo Life Sciences on 3/1/2021

While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more

DOJ Announces the First Open Payments Program / Sunshine Act Enforcement Action

Mintz - Health Care Viewpoints on 11/3/2020

On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million...more

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

Bond Schoeneck & King PLLC on 7/28/2014

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

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

The Volkov Law Group on 7/12/2013

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

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Anti-Kickback Statute › Centers for Medicare & Medicaid Services (CMS) › Sunshine Act

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