The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
The Commonwealth Court’s decision in Coleman v. Parkland Sch. Dist., 305 A.3d 238 (Pa. Commw. Ct. 2023) has significant implications for boroughs in Pennsylvania. The Court ruled that Section 712.1(e) of the Sunshine Act is...more
In a spate of executive orders and other actions over the last several weeks, the new administration has moved to exert unprecedented control over independent regulatory agencies, including the Federal Energy Regulatory...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
For some companies that make and distribute medical devices and drugs, and for group purchasing organizations (GPOs), reporting financial information to the U.S. government has become a regular part of doing business. The...more
Every day, the Freedom of Information Act illuminates government practices by ensuring public access to federal records. It is the quintessential Sunshine Act and has been a key tool for ensuring government transparency since...more
Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more
Below are brief summaries of the agenda items for the Federal Energy Regulatory Commission’s (FERC or the Commission) open meeting to be held on May 13th, at 11:00 a.m. ET. The summaries below are based on publicly available...more
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
The SEC's five commissioners on March 6, 2024, will vote on whether to adopt long-awaited public company climate disclosure rules that would require registrants to report climate-related risks and metrics. In a Feb. 28, 2024,...more
The Securities & Exchange Commission has announced that it will be voting on “whether to adopt rules to require registrants to provide certain climate-related information in their registration statements and annual...more
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more
The Federal Energy Regulatory Commission (“FERC”) will host its January Open Meeting on Thursday, January 18, 2024. The Sunshine Act Meeting Notice (“Notice”) issued January 11, 2024, indicates that FERC intends to take...more
The Federal Energy Regulatory Commission (“FERC”) will host its December Open Meeting on Tuesday, December 19, 2023 (originally scheduled for Thursday, December 21, 2023). The Sunshine Act Meeting Notice (“Notice”) issued...more
In Coleman v. Parkland Sch. Dist., 2023 Pa. Commw. LEXIS 187, at *10 (Commw. Ct. Nov. 8, 2023), a divided Commonwealth Court concluded that the recently enacted Section 712.1 of the Sunshine Act does not permit local...more
On September 21, 2023, during the Federal Energy Regulatory Commission’s (FERC) September open meeting, Acting FERC Chairman Willie Phillips committed to scheduling a vote on pending rehearing petitions related to two...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
Bipartisan legislative activity related to pharmacy benefit manager (PBM) oversight is at an all-time high in both the House and Senate. As we noted last week, several bills that address PBM activities are moving through the...more
Sunshine Act reporting for Program Year 2022 (January 1, 2022 – December 31, 2022) must be submitted to CMS via the Open Payments System by March 31, 2023. What is the Sunshine Act? - The Physician Payments Sunshine...more
To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1,...more
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
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
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