124 STAT. 696 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(B) EXCLUSIONS.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following: ‘‘(i) A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100. For calendar years after 2012, the dollar amounts specified in the preceding sentence shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers (all items; U.S. city average) for the 12-month period ending with June of the pre- vious year. ‘‘(ii) Product samples that are not intended to be sold and are intended for patient use. ‘‘(iii) Educational materials that directly benefit patients or are intended for patient use. ‘‘(iv) 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. ‘‘(v) 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. ‘‘(vi) 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. ‘‘(vii) Discounts (including rebates). ‘‘(viii) In-kind items used for the provision of charity care. ‘‘(ix) A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund (as described in sec- tion 1877(c)). ‘‘(x) In the case of an applicable manufacturer who offers a self-insured plan, payments for the provi- sion of health care to employees under the plan. ‘‘(xi) In the case of a covered recipient who is a licensed non-medical professional, a transfer of any- thing of value to the covered recipient if the transfer is payment solely for the non-medical professional serv- ices of such licensed non-medical professional. ‘‘(xii) In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the covered recipient with respect to a civil or criminal action or an administrative pro- ceeding. ‘‘(11) PHYSICIAN.—The term ‘physician’ has the meaning given that term in section 1861(r).’’.
