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
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
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
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
The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more
On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more
CMS announced today that in acknowledgment of the extreme circumstances posed by COVID-19, it will exercise enforcement discretion with respect to any Physician Payments Sunshine Act Open Payments reporting that is submitted...more
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and...more
The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report...more
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
The Centers for Medicare and Medicaid Services (CMS) recently released the CY 2020 Proposed Physician Fee Schedule....more
• 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
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
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
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more
On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more
On June 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published detailed information regarding payments made by pharmaceutical and medical device manufacturers to physicians and teaching hospitals during 2014...more
The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more
The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more
The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more
The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more
As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when...more