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HIPAA ORGAN PROCUREMENT TRANSPLANTATION PROVISIONS

Hospital | Read Sarah's StoryEarly Referral | JCAHO Standards | Medicare | HIPPA

Nationwide, hospitals are updating their agreements to comply with the privacy regulations contained in the Health Insurance Portability and Accountability Act (HIPAA).

The core functions of New Mexico Donor Services as an Organ Procurement Organization (OPO) are subject to two regulatory exemptions in the final HIPPA privacy regulations.

  • A health care provider may use or disclose information if and as required by law. This exemption allows OPOs and hospitals to comply with the Medicare Conditions of Participation, 42 CFR subsection 482.45 which specifically authorize referrals and record audits.
  • Subsection 164.512(h) allows information to be released to OPOs or other entities involved in the procurement, banking or transplantation of cadaveric organs, eyes, or tissue for the purposes of facilitating organ, eye or tissue donation and transplantation. This allows the release of information by and to, donor hospitals, transplant hospitals, UNOs, tissue banks and laboratories.

Pursuant to these two exemptions, hospitals do not need to obtain patient consent for OPOs to do their core jobs; the coordination of donation and transplant, and the review of records. Furthermore, the Centers for Medicare and Medicaid Services' (CMS) responses to comments on the regulations clarify that OPOs are not 'business parners' of hospitals. The response states, in pertinent part, "...organ procurement organizations and tissue banks are generally not business associates of hospitals."

Finally, in the preamble to the final rule, CMS states that OPOs are not "health care providers" when they are engaged in the procurement or banking of organs, blood or tissues. Thus, with regard to hospital affiliations, OPOs are neither covered entities, nor business partners, and are specifically permitted to perform their core function, with stringent confidentiality, but outside the ambit of HIPAA.

 

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