Electronic health records items and services
(w) Electronic health records items and services. Nonmonetary remuneration (consisting of items and services in the form of software or information technology and training services, including cybersecurity software and services) necessary and used predominantly to create, maintain, transmit, receive, or protect electronic health records, if all of the following conditions are met: (1) The items and services are provided to a physician by an entity (as defined at 411.351) that is not a laboratory company. (2) The software is interoperable (as defined at 411.351) at the time it is provided to the physician. For purposes of this paragraph (w), software is deemed to be interoperable if, on the date it is provided to the physician, it is certified by a certifying body authorized by the National Coordinator for Health Information Technology to certification criteria identified in the then-applicable version of 45 CFR part 170. (3) [Reserved] (4) (i) Before receipt of the initial donation of items and services or the donation of replacement items and services, the physician pays 15 percent of the donor's cost for the items and services. (ii) Except as provided in paragraph (w)(4)(i) of this section, with respect to items and services received from the donor after the initial donation of items and services or the donation of replacement items and services, the physician pays 15 percent of the donor's cost for the items and services at reasonable intervals. (iii) The donor (or any party related to the donor) does not finance the physician's payment or loan funds to be used by the physician to pay for the items and services. (5) Neither the physician nor the physician's practice (including employees and staff members) makes the receipt of items or services, or the amount or nature of the items or services, a condition of doing business with the donor. (6) Neither the eligibility of a physician for the items or services, nor the amount or nature of the items or services, is determined in any manner that directly takes into account the volume or value of referrals or other business generated between the parties. For purposes of this paragraph (w), the determination is deemed not to directly take into account the volume or value of referrals or other business generated between the parties if any one of the following conditions is met: (i) The determination is based on the total number of prescriptions written by the physician (but not the volume or value of prescriptions dispensed or paid by the donor or billed to the program); (ii) The determination is based on the size of the physician's medical practice (for example, total patients, total patient encounters, or total relative value units); (iii) The determination is based on the total number of hours that the physician practices medicine; (iv) The determination is based on the physician's overall use of automated technology in his or her medical practice (without specific reference to the use of technology in connection with referrals made to the donor); (v) The determination is based on whether the physician is a member of the donor's medical staff, if the donor has a formal medical staff; (vi) The determination is based on the level of uncompensated care provided by the physician; or (vii) The determination is made in any reasonable and verifiable manner that does not directly take into account the volume or value of referrals or other business generated between the parties. (7) The arrangement is set forth in a written agreement that (i) Is signed by the parties; (ii) Specifies the items and services being provided, the donor's cost of the items and services, and the amount of the physician's contribution; and (iii) Covers all of the electronic health records items and services to be provided by the donor. This requirement is met if all separate agreements between the donor and the physician (and the donor and any family members of the physician) incorporate each other by reference or if they cross-reference a master list of agreements that is maintained and updated centrally and is available for review by the Secretary upon request. The master list must be maintained in a manner that preserves the historical record of agreements. (8) [Reserved] (9) For items or services that are of the type that can be used for any patient without regard to payer status, the donor does not restrict, or take any action to limit, the physician's right or ability to use the items or services for any patient. (10) The items and services do not include staffing of physician offices and are not used primarily to conduct personal business or business unrelated to the physician's medical practice. (x) Assistance to compensate a nonphysician practitioner. (1) Remuneration provided by a hospital to a physician to compensate a nonphysician practitioner to provide NPP patient care services, if all of the following conditions are met: (i) The arrangement (A) Is set out in writing and signed by the hospital, the physician, and the nonphysician practitioner; and (B) Commences before the physician (or the physician organization in whose shoes the physician stands under 411.354(c)) enters into the compensation arrangement described in paragraph (x)(1)(vi)(A) of this section. (ii) The arrangement is not conditioned on (A) The physician's referrals to the hospital; or (B) The nonphysician practitioner's NPP referrals to the hospital. (iii) The remuneration from the hospital (A) Does not exceed 50 percent of the actual compensation, signing bonus, and benefits paid by the physician to the nonphysician practitioner during a period not to exceed the first 2 consecutive years of the compensation arrangement between the nonphysician practitioner and the physician (or the physician organization in whose shoes the physician stands); and (B) Is not determined in any manner that takes into account the volume or value of actual or anticipated referrals by