Are Laboratories Covered Entities Under HIPAA?

Modified on Tue, 13 Aug at 4:59 PM

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Not all labs are covered entities under HIPAA.

For a laboratory (lab) to be a covered entity under HIPAA, two factors must be present:

1. The laboratory must be furnishing healthcare

2. The laboratory must engage in one or more of eight "covered transactions."

What is Healthcare?
Under the HIPAA regulations, healthcare is:

Care, services, or supplies related to the health of an individual. Health care includes, but is not limited to, the following:

(1) Preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual or that affects the structure or function of the body; and

(2) Sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.

What is a Covered Transaction?
A transaction is an electronic exchange of information (transmission) between two parties to carry out financial or administrative activities related to health care. For example, a healthcare send a claim to a health plan to request payment for medical services.

If a healthcare provider conducts any of these transactions electronically, the general rule is that the provider is a covered entity under HIPAA.

1. A Health care claims or equivalent encounter information transaction is either of the following: (a) A request to obtain payment, and necessary accompanying information, from a health care provider to a health plan, for health care. (b) If there is no direct claim, because the reimbursement contract is based on a mechanism other than charges or reimbursement rates for specific services, the transaction is the transmission of encounter information for the purpose of reporting health care.

2. The eligibility for a health plan transaction is the transmission of either of the following:(a) An inquiry from a health care provider to a health plan or from one health plan to another health plan, to obtain any of the following information about a benefit plan for an enrollee:1) Eligibility to receive health care under the health plan. (2) Coverage of health care under the health plan. (3) Benefits associated with the benefit plan.(b) A response from a health plan to a health care provider’s (or another health plan’s) inquiry described in paragraph (a), above.

3. The referral certification and authorization transaction is any of the following transmissions: (a) A request for the review of health care to obtain an authorization for the health care. (b) A request to obtain authorization for referring an individual to another health care provider. (c) A response to a request described in (a) or (b).

4. The healthcare claim status transaction is the transmission of either of the following:(a) An inquiry to determine the status of a health care claim, or (b) A response about the status of a health care claim.

5. The "enrollment and disenrollment in a health plan" transaction is the transmission of subscriber enrollment information to a health plan to establish or terminate insurance coverage.

6. The healthcare payment and remittance advice transaction is the transmission of either of the following for health care: (a) The transmission of any of the following from a health plan to a healthcare provider’s financial institution: (1) Payment. (2) Information about the transfer of funds. (3) Payment processing information.(b) The transmission of either of the following from a health plan to a health care provider: (1) Explanation of benefits. (2) Remittance advice.

7. The health plan premium payment transaction is the transmission of any of the following from the entity that is arranging for the provision of health care or is providing health care coverage payments for an individual to a health plan:
(a) Payment.
(b) Information about the transfer of funds.
(c) Detailed remittance information about individuals for whom premiums are being paid.
(d) Payment processing information to transmit health care premium payments including any of the following:
(1) Payroll deductions.
(2) Other group premium payments.
(3) Associated group premium payment information.

8. The coordination of benefits transaction is the transmission from any entity to a health plan for the purpose of determining the relative payment responsibilities of the health plan, of either of the following for health care: (a) Claims. (b) Payment information.