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Ready or Not – Sunshine Act Data Collection Starts August 1, 2013

Today pharmaceutical and medical device manufacturers and group purchasing organizations (“GPOs”)  start to collect data on their financial arrangements with physicians and teaching hospitals to comply with the Physician Payments Sunshine Act (‘‘Sunshine Act’’).  In February the Centers for Medicare & Medicaid Services (‘‘CMS’’) published the final rule implementing the Sunshine Act, which was passed as part of the Affordable Care Act.  The Sunshine Act requires manufacturers of drugs, devices, biologics, or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments and other transfers of value to physicians and teaching hospitals. The Sunshine Act also requires manufacturers and GPOs to disclose ownership or investment interests held by physicians or their immediate family members.  The Final Rule specified August 1st as the start date by which manufacturers and GPOs must begin collecting the required data, and they must report data for the remainder of 2013 to CMS by March 31, 2014.

The Final Rule set off a frenzy of compliance activity among manufacturers and GPOs to be ready for today’s start date, including securing final software changes from vendors, testing these new systems, assuring payments meet legal requirements, integrating internal computer systems, developing internal reporting systems and protocols, and training marketing and sales representatives.  Despite these herculean efforts, manufacturers and GPOs will almost certainly encounter glitches and flaws during the first year or two of data collection.  Some errors may be spotted quickly if companies invest in early warning compliance reviews while others may not be discovered until much later when companies start to complete their reports and when the required dispute period starts, when physicians may review and question the data.

Manufacturers, GPOs, and other affected parties interested in hearing the latest guidance from CMS should consider participating in an upcoming national provider call on August 8th at 1:30 p.m. Eastern.

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume III, Number 213
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About this Author

Thomas Crane, Health Care Attorney, Mintz Levin, Anti-Kickback Lawyer, FLSA,Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Medicare, Medicaid & Commercial Coverage & Reimbursement Health Care Enforcement & Investigations White Collar Defense & Government Investigations
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Tom is nationally recognized for his work defending health care clients against anti-kickback, Stark Law, false claims, and whistleblower allegations. His work includes litigation, internal investigations, corporate integrity agreements, and self-disclosures. Tom also counsels clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Additionally, Tom has worked with several academic medical center clients in restructuring arrangements among medical school, teaching hospital, and faculty physicians. Tom gained national...

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