News & Analysis as of

Sunshine Act Health Care Providers

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

Wilson Sonsini Goodrich & Rosati

New California Law Turns Up the Heat on the Sunshine Act: California Physicians and Surgeons Must Provide Notice to Patients About...

Effective January 1, 2023, California Assembly Bill 1278 requires California-licensed physicians and surgeons, including physicians and surgeons licensed under the Medical Practice Act or the Osteopathic Act (but excluding...more

Arnall Golden Gregory LLP

New California Law Requires Physicians to Provide Patients with Notice of the Federal Open Payments Program

A new California law – Assembly Bill 1278, which was signed by the Governor on September 29, 2022 – requires physicians to provide patients with notice of the federal Open Payments database. The federal Open Payments program...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Italy Becomes Latest Country to Pass Sunshine Act

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

Williams Mullen

Physician Group Monitoring of “Open Payments”

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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

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

Goodwin

Patient Stakeholder Group Zeroes in on Medical Device Industry

Goodwin on

In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices. Each report articulates the stakeholder group’s concerns over...more

Goodwin

CMS Proposes Important New Updates to the Sunshine Act’s Open Payments Program

Goodwin on

The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

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

Mintz - Health Care Viewpoints

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

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

Baker Donelson

Medicare Spreads Sunshine Act Coverage to New Categories of Payments, Recipients

Baker Donelson on

On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more

Mintz - Health Care Viewpoints

CMS Finalizes Changes Expanding the Scope of the Open Payments Program

On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. The Open Payments reporting requirements,...more

McGuireWoods LLP

CMS Proposes Revising Physician Payments Sunshine Act Reporting Requirements

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On July 29, 2019, the Centers for Medicare and Medicaid Services (CMS) released the Medicare CY 2020 Physician Fee Schedule proposed rule (the Proposed Rule), including proposed changes to regulations implementing the...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Akin Gump Strauss Hauer & Feld LLP

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

• 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

Arnall Golden Gregory LLP

U.S. Senate Finance Committee Chairman and Ranking Member Write to HHS-OIG Regarding Physician-Owned Distributorships' Potential...

In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services (HHS) Office of Inspector General...more

Akin Gump Strauss Hauer & Feld LLP

Analyzing the Revised AdvaMed Code: Suggested Evaluation Checklist

• Review the AdvaMed Code revisions with an eye towards other key fraud and abuse, transparency and compliance issues on the horizon: the expansion of the Sunshine Act and anticipated regulatory changes to address value-based...more

Dorsey & Whitney LLP

Getting Ready for Open Payments

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Today, the Centers for Medicare and Medicaid Services (“CMS”) released additional tips regarding submitting Open Payments data. A quick refresher: Submitting data through CMS’s application, Open Payments, is the means to...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Jones Day

Sunshine Act Reporting Requirements Expanded to Physician Assistants and Advance Practice Nurses

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Applicable manufacturers will need to update their methods of documenting payments and transfers of value to include the newly expanded list of providers. A bill recently signed into law expands the reporting requirements...more

Cooley LLP

Blog: Federal Sunshine Act Reporting Requirements Expanded to Other Prescribers

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Currently, the federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the...more

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