The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
• 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
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
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
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
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 better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more
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
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