§ 164.502(a)(5)(i) Use and disclosure of genetic information for underwriting purposes: Notwithstanding any other provision of this subpart, a health plan, excluding an issuer of a long-term care policy falling within paragraph (1)(viii) of the definition of health plan, shall not use or disclose protected health information that is genetic information for underwriting purposes. For purposes of paragraph (a)(5)(i) of this section, underwriting purposes means, with respect to a health plan: (A) Except as provided in paragraph (a)(5)(i)(B) of this section: (1) Rules for, or determination of, eligibility (including enrollment and continued eligibility) for, or determination of, benefits under the plan, coverage, or policy (including changes in deductibles or other cost-sharing mechanisms in return for activities such as completing a health risk assessment or participating in a wellness program); (2) The computation of premium or contribution amounts under the plan, coverage, or policy (including discounts, rebates, payments in kind, or other premium differential mechanisms in return for activities such as completing a health risk assessment or participating in a wellness program); (3) The application of any pre-existing condition exclusion under the plan, coverage, or policy; and (4) Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
(B) Underwriting purposes does not include determinations of medical appropriateness where an individual seeks a benefit under the plan, coverage, or policy.
From § 160.103 Definitions.
Genetic information means: (1) Subject to paragraphs (2) and (3) of this definition, with respect to an individual, information about: (i) The individual’s genetic tests; (ii) The genetic tests of family members of the individual; (iii) The manifestation of a disease or disorder in family members of such individual; or (iv) Any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by the individual or any family member of the individual. (2) Any reference in this subchapter to genetic information concerning an individual or family member of an individual shall include the genetic information of:
(i) A fetus carried by the individual or family member who is a pregnant woman; and (ii) Any embryo legally held by an individual or family member utilizing an assisted reproductive technology. (3) Genetic information excludes information about the sex or age of any individual. (ii) Genetic services means: (1) A genetic test; (2) Genetic counseling (including obtaining, interpreting, or assessing genetic information); or (3) Genetic education. Genetic test means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if the analysis detects genotypes, mutations, or chromosomal changes. Genetic test does not include an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition.
Audit Inquiry
Does the health plan use or disclose for underwriting purposes, “Genetic Information” as defined at § 160.103, including family history? Inquire of management.
Obtain and review all underwriting policies and procedures (for example, published and unpublished underwriting guidelines currently used by underwriting staff, including manuals and training materials). Evaluate whether the underwriting policies are consistent with the established performance criterion.