News & Analysis as of

Anti-Kickback Statute › Sunshine Act

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... more +
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 -
Gardner Law

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

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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

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

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When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Pietragallo Gordon Alfano Bosick & Raspanti,...

Italy Becomes Latest Country to Pass Sunshine Act

Pietragallo Gordon Alfano Bosick & Raspanti,... on

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

Fenwick & West LLP

Compensating Physician Advisors with Equity: Considerations for Life Sciences Companies

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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

Mintz - Health Care Viewpoints

OIG Approves Physician-Owned Medical Device Company

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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

Williams Mullen

Physician Group Monitoring of “Open Payments”

Williams Mullen on

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

Health Care Compliance Association (HCCA)

[Event] 26th Annual Compliance Institute - March 28th - 31st, Phoenix, AZ

Health Care Compliance Association (HCCA) on

The primary educational and networking event for healthcare compliance professionals - As our flagship healthcare compliance conference, HCCA’s Compliance Institute (CI) has been providing educational resources and...more

Goodwin

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on

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

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Puts Teeth in Sunshine Act Reporting Requirements

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Skadden, Arps, Slate, Meagher & Flom LLP on

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....more

MoFo Life Sciences

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

MoFo Life Sciences on

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

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 25th Annual Compliance Institute - April 19th - 22nd, 9:30 am - 4:35 pm CDT

Health Care Compliance Association (HCCA) on

The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...more

Arnall Golden Gregory LLP

Ain’t No Sunshine When the Government Comes: The DOJ and OIG Enforce the Sunshine Act

Arnall Golden Gregory LLP on

Recently, the United States Department of Justice and the Department of Health and Human Services’ Office of Inspector General entered into a Settlement Agreement with a medical drug company that caught our eye because of the...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Due Diligence: A Reference Guide for Your Life Sciences Corporate Transactions

Akin Gump Strauss Hauer & Feld LLP on

• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Foley & Lardner LLP

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Foley & Lardner LLP on

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

Bond Schoeneck & King PLLC

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

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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

The Volkov Law Group

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

The Volkov Law Group 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

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

Morgan Lewis

Hospitals and Doctors Beware: OIG Issues Special Fraud Alert on Physician-Owned Entities

Morgan Lewis on

Alert notes attributes and practices that produce substantial fraud and abuse risk. On March 26, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its "Special Fraud...more

Saul Ewing Arnstein & Lehr LLP

OIG Places Fraud and Abuse Spotlight on Physician-Owned Entities

Saul Ewing Arnstein & Lehr LLP on

Physician-owned distributorships continue to attract federal scrutiny. A new OIG Alert highlights health care transactions that make these distributorships vulnerable to enforcement activity. ...more

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