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Signed into law in 2010 as part of the Affordable Care Act, the Physician Payments Sunshine Act (the “Sunshine Law”) requires manufacturers, including certain distributors, of medical devices, drugs, biologicals, and medical supplies to track and report certain payments made to and transfers of value provided to physicians and teaching hospitals.
The Sunshine Law also requires manufacturers and Group Purchasing Organizations (GPOs) to report certain ownership and investment interests held by physicians and their immediate family members.
The main purpose of the Sunshine Law is to provide patients with enhanced transparency into the relationships their health care providers have with life science manufacturers, including medical technology companies. It’s important to note that the Sunshine Law does not restrict industry-physician collaboration or interactions, or prohibit payments or transfers of value. Rather, it requires tracking and reporting of payments and transfers of value that result from these interactions.
The Official CMS Website for the Sunshine Law, also referred to as the National Physician Payment Transparency Program:
Information from the AMA:
Information from AdvaMed:
Payments and Transfers of Value made by Manufacturers to “Physicians” and “Teaching Hospitals” must be reported. Payments made to physicians and teaching hospitals through a third party or those made to a third party at the request of or on behalf of a physician or teaching hospital are reported and include the name of the third party.
Payments, Transfers of Value, and Ownership/Investment interests.
Payments and Transfers of Value: must be reported when an item is worth $10 or more and if items are worth less than $10, when the sum of all items given to a particular recipient over a year exceeds $100.
Manufacturers are required to report:
(a) Direct payments and transfers of value
(b) Indirect payments and transfers of value; and
(c) Payments and transfers of value that are made to a third party at the request of or on behalf of a physician.
Ownership and Investment Interests held by Physicians or their Immediate Family Members, in GPOs and Manufacturers—
Payments related to research must be reported separately and submitted the year the payment occurs stating the name of the institution & principal investigators. Some of these details may qualify for delayed publication to the public CMS website.
The Payment/Transfer of Value must be categorized as one of the following:
Payments /Transfers of Value that are:
Before information is publicly posted, a Physician will have 45 days to Review submitted data and Initiate Disputes once access to his/her own data is made available by CMS on a secure online portal. If the dispute is not resolved during this 45 day period, an additional 15 days are provided to come to a resolution.
If the dispute continues, the data will still be posted to the public webpage but will be flagged as Disputed.
Physicians are also able to seek correction or contest reports for two years after access has been provided to a report with disputed information.
Reporting incomplete or inaccurate information has the potential to mislead patients and other stakeholders and damage the reputation of manufacturers, physicians and teaching hospitals.
Depending on the circumstances, non-compliance with the Sunshine Law’s reporting requirements could subject a manufacturer to financial penalties ranging from:
(a) $1,000 to $10,000 for each payment or transfer of value not reported; and
(b) $10,000 to $100,000 for “knowingly” failing to report a payment or transfer of value.
The total maximum penalties which may be imposed against a Manufacturer or GPO is $1,150,000 per year.
Most of what is provided in the Transparency Reports will be published annually on a public website that is searchable. 2013 data will be published on Sept. 30, 2014. In subsequent years, information made public on June 30.
The Secretary of HHS will also be required to submit a report to Congress on an annual basis.