02-031-490 Me. Code R. § 5

Current through 2024-46, November 13, 2024

Section 031-490-5 - Informed consent to AIDS testing

A. Title 5 M.R.S.A. §19203-A requires that an HIV test be voluntary and undertaken only with a patient's knowledge and understanding that an HIV test is planned. A written informed consent of the person to be tested must be obtained prior to testing. Informed Consent forms as required by 5 M.R.S.A. §19203-A shall be filed with the Superintendent of Insurance consistent with 24-A M.R.S.A. §2412 and subject to 24-A § 601 filing fee requirements.

B. The Informed Consent forms may be in the standardized format provided by Attachment A. The form may be filed in a different format if the basis for each divergence from the standardized form is explained by the insurer or nonprofit entity and the Superintendent finds that the proposed form includes all the information contained in the standard form and is not inaccurate, misleading, or inconsistent with any applicable law or rule.

C. When an Informed Consent form is filed by the insurer or nonprofit entity with the Superintendent for approval, the following disclosures shall be included in that filing:

1. HIV testing protocol employed;

2. Manner of reporting HIV test results to the Medical Information Bureau (MIB);

3. Nature of written AIDS informational materials provided to the applicant, including copies of material if not widely available; and

4. Manner of providing post-test counseling.

At least 30 days prior to implementing any change in the procedures or material disclosed in Paragraphs 1 through 4, the insurer or nonprofit entity shall file any proposed changes with the Superintendent.

D. The Informed Consent form shall not be approved if the disclosure provided pursuant to Subsection C, Paragraphs 1 through 4 indicates that the insurer or nonprofit entity has not complied with relevant provisions of Maine law or this Rule.

E. Each insurer or nonprofit entity utilizing a written form as proof of the process of obtaining the informed consent of applicants for insurance to take an HIV test shall read that form aloud to the applicant prior to his or her signing of the form.

F. If an applicant is required to submit a second sample for testing, notification of this requirement shall be in writing, and shall include notification of the continued availability of post-test counseling.

02-031 C.M.R. ch. 490, § 5