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Electronic prescribing items and services

One of the new safe harbors adopted in 2006 at 42 C.F.R. § 1001.952(x) allows certain health care entities to give nonmonetary remuneration (consisting of items and services in the form of hardware, software, or information technology and training services) where it is necessary and used solely to receive and transmit electronic prescription information [prescription information hyperlink], if all of the following conditions are met:

For purposes of this safe harbor, prescription information shall mean information about prescriptions for drugs or for any other item or service normally accomplished through a written prescription.
  • The items and services are provided by:
    • (i) A hospital to a physician who is a member of its medical staff;
    • (ii) A group practice to a prescribing health care professional who is a member of the group practice; and
    • (iii) A PDP sponsor or MA organization to pharmacists and pharmacies participating in the network of such sponsor or organization and to prescribing health care professionals.
  • The items and services must be provided as part of, or 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 donor (or any person on the donor's behalf) may 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.
  • For items or services that are of the type that can be used for any patient without regard to payor status, the donor may not restrict, or take any action to limit, the recipient's right or ability to use the items or services for any patient.
  • Neither the recipient nor the recipient's practice (or any affiliated individual or entity) may make 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 recipient 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.
  • The arrangement must be 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 the Department of Health & Human Services upon request. The master list should be maintained in a manner that preserves the historical record of agreements.
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
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