Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Electronic Prescribing Items and Services
Electronic Prescribing Items and Services – Current as of March 2021
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Stark |
Anti-Kickback |
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The remuneration is nonmonetary and consists of items and services in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription information. |
The remuneration is nonmonetary and consists of items and services in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription information. |
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The items and services are provided by a (i) a hospital to a physician who is a member of its medical staff; (ii) a group practice to a physician who is a member of the group; or (iii) a PDP sponsor or MA organization to a prescribing physician. |
The items and services are provided by a (i) hospital to a physician who is a member of its medical staff; (ii) group practice to a prescribing health care professional who is a member of the group practice; and (iii) PDP sponsor or MA organization to pharmacists and pharmacies participating in the network of such sponsor or organization and to prescribing health care professionals. |
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The items and services are provided as part of, or are used to access, an electronic prescription drug program that meets the applicable standards under Medicare Part D at the time the items and services are provided. |
The items and services are provided as part of, or are used to access, an electronic prescription drug program that meets the applicable standards under Medicare Part D at the time the items and services are provided. |
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The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use or compatibility of the items or services with other electronic prescribing or electronic health records systems. |
The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use or compatibility of the items or services with other electronic prescribing or electronic health records systems. |
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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 physician's right or ability to use the items or services for any patient. |
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Neither the physician nor the physician's practice (including employees and staff members) makes the receipt of the items or services, or the amount or nature of the items or services, a condition of doing business with the donor. |
Neither the recipient nor the recipient's practice (or any affiliated individual or entity) 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. |
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Neither the eligibility of a physician for the items or services, nor the amount or nature of the items or services, is determined in a manner that takes into account the volume or value of referrals or other business generated between the parties. |
Neither the eligibility of a physician for the items or services, nor the amount or nature of the items or services, is determined in a manner that takes into account the volume or value of referrals or other business generated between the parties. |
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The arrangement is set forth in a written agreement that (i) is signed by the parties; (ii) specifies the items and services being provided and the donor's cost of the items and services; and (iii) covers all of the electronic prescribing 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 and the donor's cost of the items and services; and (iii) covers all of the electronic prescribing items and services to be provided by the donor (or affiliated parties). 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. |
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The donor does not have actual knowledge of, and does not act in reckless disregard or deliberate ignorance of, the fact that the physician possesses or has obtained items or services equivalent to those provided by the donor. |
The donor does not have actual knowledge of, and does not act in reckless disregard or deliberate ignorance of, the fact that the recipient possesses or has obtained items or services equivalent to those provided by the donor. |