Upcoming Webinars

  • No upcoming events

Disclaimer

The analysis of any legal or medical billing is dependent on numerous specific facts — including the factual situations present related to the patients, the practice, the professionals and the medical services and advice. Additionally, laws and regulations and insurance and payer policies are subject to change. The information that has been accurate previously can be particularly dependent on changes in time or circumstances. The information contained in this web site is intended as general information only. It is not intended to serve as medical, health, legal or financial advice or as a substitute for professional advice of a medical coding professional, healthcare consultant, physician or medical professional, legal counsel, accountant or financial advisor. If you have a question about a specific matter, you should contact a professional advisor directly. CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.


Menu
Log in

Organizational Requirements

Standard: Healthcare Component 

If a covered entity is a hybrid entity, the requirements of this part apply only to the health care component(s) of the entity.

Implementation Specifications:

Application of other provisions

 In applying a provision of this part, other than the requirements of this section, §§164.314, and 164.504, to a hybrid entity:

    • A reference in such provision to a “covered entity” refers to a health care component of the covered entity;
    • A reference in such provision to a “health plan,” “covered health care provider,” or “health care clearinghouse,” refers to a health care component of the covered entity if such health care component performs the functions of a health plan, health care provider, or health care clearinghouse, as applicable;
    • A reference in such provision to “protected health information” refers to protected health information that is created or received by or on behalf of the health care component of the covered entity; and
    • A reference in such provision to “electronic protected health information” refers to electronic protected health information that is created, received, maintained, or transmitted by or on behalf of the health care component of the covered entity.

Safeguard requirements

The covered entity that is a hybrid entity must ensure that a health care component of the entity complies with the applicable requirements of this part. In particular, and without limiting this requirement, such covered entity must ensure that:

    • Its health care component does not disclose protected health information to another component of the covered entity in circumstances that would prohibit such disclosure if the health care component and the other component were separate and distinct legal entities;
    • Its health care component protects electronic protected health information with respect to another component of the covered entity to the same extent that it would be required protect such information if the health care component and the other component were separate and distinct legal entities;
    • If a person performs duties for both the health care component in the capacity of a member of the workforce of such component and for another component of the entity in the same capacity with respect to that component, such workforce member must not use or disclose protected health information created or received in the course of or incident to the member's work for the health care component in a way prohibited.

Responsibilities of the covered entity

A covered entity that is a hybrid entity has the following responsibilities:

    • Pertaining to compliance and enforcement, the covered entity has the responsibility of complying with this part.
    • The covered entity is responsible for the implementation of policies and procedures to ensure compliance with applicable requirements of this part, including the safeguard requirements.
    • The covered entity is responsible for business associate arrangements and other organizational requirements.
    • The covered entity is responsible for designating the components that are part of one or more health care components of the covered entity and documenting the designation in accordance with paragraph (c) of this section, provided that, if the covered entity designates one or more health care components, it must include any component that would meet the definition of a covered entity or business associate if it were a separate legal entity. Health care component(s) also may include a component only to the extent that it performs covered functions.

Standard: Affiliated Covered Entities

Legally separate covered entities that are affiliated may designate themselves as a single covered entity for purposes of this part.

Implementation Specifications:

Requirements for designation of an affiliated covered entity

    • Legally separate covered entities may designate themselves (including any health care component of such covered entity) as a single affiliated covered entity, for purposes of this part, if all of the covered entities designated are under common ownership or control.
    • The designation of an affiliated covered entity must be documented and the documentation maintained as required.

Safeguard requirements. 

An affiliated covered entity must ensure that it complies with the applicable requirements of this part, including, if the affiliated covered entity combines the functions of a health plan, health care provider, or health care clearinghouse.

Standard: Documentation

A covered entity must maintain a written or electronic record of a designation.

Implementation specification: Retention period

A covered entity must retain the documentation as required for six (6) years from the date of its creation or the date when it last was in effect, whichever is later.

Citation

45 CFR § 164.105


Copyright Med Comply LLC 2020

Med Comply does not claim copyright over US Federal and State materials

CPT codes are copyright 1995-2020 American Medical Association. All rights reserved.


Powered by Wild Apricot Membership Software