Md. Code Regs. 31.10.06.26

Current through Register Vol. 51, No. 22, November 1, 2024

Section 31.10.06.26 - Prohibition Against Use of Genetic Information and Requests for Genetic Testing

A. This regulation applies to all policies with policy years beginning on or after July 1, 2009.

B. Definitions.

(1) In this regulation, the following terms have the meanings indicated.

(2) Terms Defined.

(a) "Family member" means, with respect to an individual, any other individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of the individual.

(b) Genetic Information.

(i) "Genetic information" means, with respect to an individual, information about the individual's genetic tests, the genetic tests of a family member of the individual, and the manifestation of a disease or disorder in a family member of the individual.

(ii) "Genetic information" includes, with respect to an individual, a request for, or receipt of, genetic services, or participation in clinical research that includes genetic services, by the individual or a family member of the individual.

(iii) "Genetic information" includes, with respect to a pregnant woman, genetic information of a fetus carried by the pregnant woman,

(iv) "Genetic information" includes, with respect to an individual or family member utilizing reproductive technology, genetic information of an embryo legally held by the individual or family member.

(v) "Genetic information" does not include information about the sex or age of an individual.

(c) "Genetic services" means:

(i) A genetic test;

(ii) Genetic counseling, including obtaining, interpreting, or assessing genetic information; or

(iii) Genetic education.

(d) Genetic Test.

(i) "Genetic test" means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.

(ii) "Genetic test" does not mean an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes.

(iii) "Genetic test" does not mean an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.

(e) Issuer of a Medicare Supplement Policy or Certificate.

(i) "Issuer of a Medicare supplement policy or certificate" means an insurance company, fraternal benefit society, nonprofit health service plan, health maintenance organization, or any other entity delivering or issuing for delivery in this State Medicare supplement policies or certificates.

(ii) "Issuer of a Medicare supplement policy or certificate" includes a third-party administrator or other person acting for or on behalf of an entity described in §B(2)(e)(i) of this regulation.

(f) "Underwriting purposes" means:

(i) Rules for, or determination of, eligibility, including enrollment and continued eligibility, for benefits under the policy;

(ii) The computation of premium or contribution amounts under the policy;

(iii) The application of a preexisting condition exclusion under the policy; and

(iv) Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.

C. An issuer of a Medicare supplement policy or certificate may not:

(1) Deny or condition the issuance or effectiveness of the policy or certificate, including the imposition of an exclusion of benefits under the policy or certificate because of a preexisting condition, based on the genetic information with respect to an individual;

(2) Discriminate in the pricing of the policy or certificate, including the adjustment of premium rates, of an individual based on the genetic information with respect to the individual;

(3) Request or require an individual or a family member of the individual to undergo a genetic test;

(4) Request, require, or purchase genetic information for underwriting purposes; or

(5) Request, require, or purchase, in connection with an enrollment, genetic information with respect to an individual before the individual's enrollment under the policy.

D. The prohibitions described in §C(1) and (2) of this regulation do not limit the ability of an issuer of a Medicare supplement policy or certificate, to the extent otherwise permitted by law, from:

(1) Denying or conditioning the issuance or effectiveness of the policy or certificate or increasing the premium for a group based on the manifestation of a disease or disorder of an insured or applicant; or

(2) Increasing the premium for a policy issued to an individual based on the manifestation of a disease or disorder of an individual who is covered under the policy, but the manifestation of a disease or disorder in one individual may not also be used as genetic information about other group members and to further increase the premium for the group.

E. The prohibition described in §C(3) of this regulation does not preclude an issuer of a Medicare supplement policy or certificate from obtaining and using the results of a genetic test in making a determination regarding payment, as defined for the purposes of applying the regulations promulgated under Part C of Title XI and Section 264 of the Health Insurance Portability and Accountability Act of 1996, and consistent with §C(1) and (2) of this regulation.

F. For purposes of carrying out §E of this regulation, an issuer of a Medicare supplement policy or certificate may request only the minimum amount of information necessary to accomplish the intended purpose.

G. Notwithstanding §C(3) of this regulation, an issuer of a Medicare supplement policy or certificate may request, but not require, that an individual or a family member of the individual undergo a genetic test if all of the following conditions are met:

(1) The request is made pursuant to research that complies with Part 46 of Title 45, Code of Federal Regulations, or equivalent federal regulations, and any applicable State or local law or regulations for the protection of human subjects in research;

(2) The issuer clearly indicates to the individual, or in the case of a minor child, to the legal guardian of the child, to whom the request is made that:

(a) Compliance with the request is voluntary, and

(b) Noncompliance with the request will have no effect on enrollment status or premium or contribution amounts;

(3) The issuer does not use genetic information collected or acquired under §G of this regulation to underwrite, determine eligibility to enroll or maintain enrollment status, set premium rates, or determine whether to issue, renew, or replace a policy or certificate;

(4) The issuer notifies the Secretary in writing that the issuer is conducting activities under the exception provided by §G of this regulation, and includes a description of the activities conducted; and

(5) The issuer complies with all other conditions for activities conducted under §G of this regulation, as the Secretary may require by regulation.

H. If an issuer of a Medicare supplement policy or certificate obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning an individual, the request, requirement, or purchase will not be considered a violation of §C(5) of this regulation if the request, requirement, or purchase does not violate §C(4) of this regulation.

Md. Code Regs. 31.10.06.26

Regulation .26 adopted effective June 29, 2009 (36:13 Md. R. 901)