"However, if the practice group includes five physicians, then the per-covered recipient cost is $5 (regardless of whether all five physicians actually consumed any of the food provided), so the payment would not need to be reported."
Group purchasing organizations covered by the proposed rule are broadly defined as any entity that purchases and arranges for, or negotiates the purchase of covered drugs, devices, biologicals or medical supplies in the U.S. whether they purchase them directly or for resale or distribution.
The reporting requirements also are proposed to exclude:
- Transfers of value less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient exceeds $100 in a calendar year.
- Product samples that are not intended to be sold and are intended for patient use.
- Educational materials that directly benefit patients or are intended for patient use.
- The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
- Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
- A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a covered recipient.
- Discounts, including rebates.
CMS says it will accept comments on the proposed rule until Feb. 17.