Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Electronic Health Records Items and Services

Stark
Stark exception related to compensation arrangements for electronic health records items and services 42 CFR 411.357(w)

Anti-Kickback
Safe harbor for payments made for electronic health records  42 CFR 1001.952(y)

The remuneration is nonmonetary and consists 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.

The remuneration is nonmonetary and consists 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.

The items and services are provided to a physician by an entity that is not a laboratory company.

The items and services are provided to (i) an individual or entity, other than a laboratory company, that provides services covered by a Federal health care program and submits claims or requests for payment, either directly or through reassignment, to the Federal health care program or is comprised of the types of individuals and entities that provide services covered by a Federal health care program and submits claims or requests for payment, either directly or through reassignment, to the Federal health care program; or (ii) a health plan.

The software is interoperable at the time it is provided to the physician. Software is deemed to be interoperable if, on the date it is provided to the physician, it is certified by a certifying body recognized by the National Coordinator for Health Information Technology. 

The software is interoperable at the time it is provided to the recipient. For purposes of this subparagraph, software is deemed to be interoperable if, on the date it is provided to the recipient, it is certified by a certifying body authorized by the National Coordinator for Health Information Technology certification criteria identified in the then-applicable version of 45 CFR part 170.

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. For items and services received after the initial donation (other than replacement items and services) the physician pays 15 percent of the donor’s cost for the items and services at reasonable intervals. 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.

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.

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 exception, 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.

Neither the eligibility of a recipient for the items or services, nor the amount or nature of the items or services, is determined in a manner that directly takes into account the volume or value of referrals or other business generated between the parties. For the purposes of this paragraph, 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 recipient (but not the volume or value of prescriptions dispensed or paid by the donor or billed to a Federal health care program); (ii) the determination is based on the size of the recipient'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 recipient practices medicine; (iv) the determination is based on the recipient'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 recipient 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 recipient; 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.

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 will be 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 of HHS upon request. The master list should be maintained in a manner that preserves the historical record of agreements.

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 those items and services, and the amount of the recipient's contribution; and (iii) covers all of the electronic health records items and services to be provided by the donor (or any affiliate). This requirement will be met if all separate agreements between the donor (and affiliated parties) and the recipient 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 of HHS upon request. The master list should be maintained in a manner that preserves the historical record of agreements.

For items or services that are of the type that can be used for any patient without regard to payor 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.

For items or services that are of the type that can be used for any patient without regard to payor status, the donor does not restrict, or take any action to limit, the recipient's right or ability to use the items or services for any patient.

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.

The items and services do not include staffing of the recipient's office and are not used primarily to conduct personal business or business unrelated to the recipient's clinical practice or clinical operations.

The donor does not shift the costs of the items or services to any Federal health care program.