Current through Register Vol. 54, No. 49, December 7, 2024
Section 89.791 - Prohibition against use of genetic information and requests for genetic testing(a) This section applies to all Medicare supplement policies with policy years beginning on or after May 21, 2009.(b) For purposes of this section, the following words and terms have the following meanings, unless the context clearly indicates otherwise: Issuer-The issuer of a Medicare supplement policy or certificate as defined in § 89.772. This term includes a third party administrator, or other person acting for or on behalf of the issuer.
Family member-A first-degree, second-degree, third-degree or fourth-degree relative of an individual.
Genetic counseling-Obtaining, interpreting, or assessing genetic information.
Genetic information-Except for the sex or age of an individual, information regarding:
(i) Genetic tests of an individual or individual's family member.(ii) The manifestation of a disease or disorder in an individual's family member.(iii) An individual's request for, or receipt of, genetic services.(iv) Participation in clinical research involving genetic services by an individual or an individual's family member.(v) When an individual or family member is a pregnant woman, any reference to information of any fetus carried by the woman.(vi) Information of any embryo legally held by an individual or family member utilizing reproductive technology.Genetic services-A genetic test, genetic counseling or genetic education.Genetic test-An analysis of human DNA, RNA, chromosomes, proteins or metabolites, that detect genotypes, mutations or chromosomal changes. The term does not include an analysis of proteins or metabolites that does not detect genotypes, mutations or chromosomal changes or an analysis of proteins or metabolites directly related to a manifested disease, disorder, or pathological condition that may reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved.(c) An issuer of a Medicare supplement policy or certificate may not:(1) Use an individual's genetic information to deny or condition the issuance or effectiveness of a policy or certificate to that individual, including the imposition of an exclusion of benefits based on a preexisting condition.(2) Use an individual's genetic information to discriminate in the pricing of the policy or certificate, including the adjustment of premium rates.(3) Request or require an individual or an individual's family member to undergo a genetic test, except the issuer may: (i) Obtain and use the results of a genetic test in making a determination regarding payment, as defined for the purposes of applying regulations promulgated under Title XI Part C of the Social Security Act ( 42 U.S.C.A. §§ 1320d-1320d-9 ) and section 264 of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C.A. § 1320d-2 note 2), consistent with paragraphs (1) and (2) if the issuer requests only the minimum amount of information necessary to accomplish the intended purpose.(ii) Request, but not require, an individual or individual's family member to undergo a genetic test if the following conditions are met:(A) The request is made under research that complies with 45 CFR Part 46 (relating to protection of human subjects), or equivalent Federal regulations, and any applicable State or local law or regulations for the protection of human subjects in research.(B) The issuer clearly indicates to the individual, or the legal guardian of a minor child, to whom the request is made, that compliance with the request is voluntary and that noncompliance will have no effect on enrollment status or premium or contribution amounts.(C) The issuer does not use genetic information collected or acquired under this clause for underwriting, determination of eligibility to enroll or maintain enrollment status, premium rates, or the issuance, renewal, or replacement of a policy or certificate.(D) The issuer notifies the HHS Secretary in writing that the issuer is conducting activities under the exception provided for under this subsection, including a description of the activities conducted.(E) The issuer complies with other conditions as the HHS Secretary may, by regulation, require for activities conducted under this subparagraph.(4) Request, require, or purchase genetic information for underwriting purposes to: (i) Determine enrollment, eligibility or continued eligibility for benefits under a policy.(ii) Compute premium contribution amounts under a policy.(iii) Apply any preexisting condition exclusion under a policy.(iv) Conduct any activity related to the creation, renewal or replacement of a contract of health insurance or health benefits.(5) Request, require or purchase an individual's genetic information prior to that individual's enrollment under the policy in connection with enrollment. If an issuer obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning an individual, the request, requirement, or purchase is not a violation of this paragraph if the request, requirement or purpose does not violate paragraph (4).(d) Nothing in subsection (c)(1) or (2) shall be construed to limit the ability of an issuer, 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.(2) Increasing the premium for any policy issued to an individual based on the manifestation of a disease or disorder of an individual who is covered under a group policy; provided that 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.The provisions of this § 89.791 adopted April 24, 2009, effective 4/25/2009, 39 Pa.B. 2086.The provision of this § 89.791 issued under sections 206, 506, 1501 and 1502 of The Administrative Code of 1929 (71 P. S. §§ 66, 186, 411 and 412), the Medicare Improvements for Patients and Providers Act of 2008, Pub. L. No. 100-275, 122 Stat. 2494 and the Genetic Information Nondiscrimination Act of 2008, Pub. L. No. 110-233, 122 Stat. 881.