CMS finally sets start date for reporting physician gifts under Sunshine Act
Starting Aug. 1, drug and device manufacturers that receive government reimbursements must begin collecting data on gifts and payments they provide to physicians and teaching hospitals, according to the long-delayed final rule of the Physician Payment Sunshine Act, known officially as the National Physician Payment Transparency Program: Open Payments.
The final rule requires companies to submit 2013 data to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014. Physicians will have 45 days to review and dispute their data before it becomes public, no later than Sept. 30, 2014.
The rule also requires manufacturers and group-purchasing organizations to disclose physician ownership or investment interests. Companies that fail to do so could face fines of up to $1 million.
Passed as part of the Affordable Care Act, the Sunshine Act is intended to increase transparency and reduce conflicts of interest that could influence clinical research, education, and decision making, such as prescribing behavior.
Numerous items are exempt from the Sunshine Act reporting requirements, including the following:
- Over-the-counter drugs and class I and II medical devices, such as elastic bandages and suture materials.
- Gifts or payments valued at less than $10 (unless the aggregate amount paid to the physician exceeds $100 annually).
- Incidental items worth less than $10 (e.g., pens and note pads) as well as general food and drinks offered offered to all participants at conferences or large-scale events.
- Educational materials and items intended for use by or with patients.
- Discounts and rebates from a manufacturer.
- Samples intended for patient use, including coupons and vouchers for obtaining samples.
- Payments for speaking at accredited or certified CME programs, which are already governed by rules designed to reduce industry influence, as long as the manufacturer does not select the speaker or pay him or her directly.
- Certain indirect payments transferred by a third party if the manufacturer does not know the identity of the recipient.
- Payments or other transfers of value to residents.
The Sunshine Act's final rule was supposed to have been issued by the end of 2012 but was delayed, in part because CMS received more than 300 responses during the comment period. The AAFP was among them, warning that the reporting requirements would create "significant complexities."
CMS has estimated the rule will cost health care companies and providers $224 million in the first year and over $163 million annually thereafter to comply.
Additional reading: Physician Payment Sunshine Act: Final Rule Top 50 Things to Know.
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