211 CMR 36.04 - Informed Consent

Current through Register 1466, April 1, 2022

(1) Before a carrier may conduct an HIV test, the individual to be tested must give prior written informed consent to such testing to the carrier, laboratories and blood testing centers or agents in compliance with the requirements of 211 CMR 36.04. Such consent shall be based on an understanding by the individual to be tested that the test is being performed, of the nature of the test, of the persons or entities which will or may have access to the test results or to which the results of that test may be disclosed, of the purpose for which the test results may be used, and of any reasonably foreseeable risks and benefits resulting from the test.
(2) Such informed consent shall include, at a minimum, the following disclosures:
(a) The carrier shall provide to the individual the following information in writing:
1.notification of the purpose(s) of the HIV test(s), including whether the test is required as a condition of obtaining an insurance benefit;
2.information concerning the effect(s) of the test result(s) on the approval of the application, or the risk classification of the individual;
3.information explaining HIV and AIDS, including without limitation, the following:
a.the nature of the HIV test(s), including the name(s) of the test(s) to be performed, and the degree of reliability of each of the tests, including the risks of false negative results and false positive results;
b.the meaning of the results of the test(s), including the implication of a positive HIV test result for developing AIDS, a description of HIV and AIDS, its major risk groups, symptoms, and the potential for adverse psychological effects to the individual upon being tested and upon learning of a positive test result;
4.a description of the carrier's confidentiality standards and procedures, including full disclosure of any potential use that may be made of the test results or HIV-related information about the individual, and the extent to which the carrier restricts access to such results and information;
5.a complete description of the persons or entities which may reasonably be expected to have access to the test results or any other HIV-related information about the individual as permitted under 211 CMR 36.00 and the purposes for which such results or information would be provided to such persons or entities;
6.a statement concerning the availability of free, anonymous or confidential HIV testing, with the opportunity for both pre-test and post-test counseling;
7.a statement that the individual may wish to obtain counseling before undergoing the HIV test because of the serious nature of HIV and AIDS, and that if an individual waits to sign the consent form for up to 21 days from the date the test was requested by the carrier or insurance producer, absent changes in underwriting factors, that delay will not prejudice the application for insurance benefits;
8.a statement that HIV-related information concerning the individual maintained by the carrier will be available to the individual directly, or indirectly through a designated physician if preferred by the individual, upon his or her written request, and at no more than the reasonable cost of photocopying; and
9.a statement that if the individual believes that his or her rights concerning the confidentiality of HIV-related information have been violated he or she may contact the Division of Insurance.
(b) The carrier shall furnish the individual with a copy of the notice of HIV testing and authorization for testing and disclosure, including the signed and dated authorization in conformity with the requirements of 211 CMR 36.04.
(3) Content of the Authorization. An authorization form must contain the following minimum information:
(a) that the authorization to conduct an HIV test is valid for a period of not longer than 90 days after the date on which the informed consent form is signed, or for such lesser period as the carrier may select;
(b) a description of the test protocol, including the name(s) of the test(s) to be performed, the laboratory or laboratories which will conduct the test or which customarily conduct such tests for the carrier, the carrier which will receive the test results, and the purpose(s) of the test(s);
(c) a statement that the test results will not be released to any person or entity other than those described in the consent form (which persons and entities shall consist only of those persons or entities to which release of such confidential medical information is lawful), unless the carrier obtains the specific prior written consent of the individual, which consent may not be sought in this consent form; further, any statement that information will be shared with the MIB or any other insurance support organization must describe that organization, its policy of disclosure to other carriers, its policy concerning consumer access to information and the process by which consumers can correct inaccurate information, and include that organization's address and telephone number;
(d) a statement that HIV-related information will be disclosed only to persons and entities for which prior written informed consent to the release has been given, and that in the event of such a release of HIV-related information concerning the individual to any person or entity other than the carrier, its employees, reinsurers, attorneys, and contractors solely on a need to know bases for use for underwriting, claims or another business purpose in connection with the insurance transaction, or any insurance support organization, the carrier will notify the individual in writing of the name and address of such person or entity, and subject to 211 CMR 36.04(3)(e), upon the request of the individual, will promptly provide to the individual a copy of the information released at no more than the reasonable cost of photocopying; and
(e) a description of the methods by which the carrier shall notify the individual of a positive HIV test result, and the time period, which shall be as expeditiously as possible, but in no event later than 45 days after the individual's blood sample is taken, by which such test results will be conveyed in accordance with 211 CMR 36.05. The description shall offer the individual the option to receive the information from a physician he or she designates on the form, or directly from the carrier, and shall inform the individual that such information sent to the physician may become part of the physician's permanent medical record concerning that individual. The individual may change his or her election by so informing the carrier in writing.
(4) A carrier shall use a notice of HIV testing and authorization for testing and disclosure form that contains at a minimum the information specified in 211 CMR 36.04(2) and (3). Copies of all such forms shall be retained on file by the carrier and shall be available to the Division upon its request.


211 CMR 36.04
Amended by Mass Register Issue 1268, eff. 8/29/2014.

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