Current through Register Vol. XLI, No. 38, September 20, 2024
22.1. This section
applies to all policies with policy years beginning on or after May 21,
2009.
22.2. An issuer of a Medicare
supplement policy or certificate;
22.2.a. Shall
not deny or condition the issuance or effectiveness of the policy or certificate
(including the imposition of any exclusion of benefits under the policy based on a
pre-existing condition) on the basis of the genetic information with respect to the
individual; and
22.2.b. Shall not
discriminate in the pricing of the policy or certificate (including the adjustment
of premium rates) of an individual on the basis of the genetic information with
respect to the individual.
22.3. Nothing in subsection 22.2 of this section
shall be construed to limit the ability of an issuer, to the extent otherwise
permitted by law, from:
22.3.a. 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
22.3.b. 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 the policy (in such case, the manifestation of a
disease or disorder in one individual cannot also be used as genetic information
about other group members and to further increase the premium for the
group).
22.4. An issuer of a
Medicare supplement policy or certificate shall not request or require an individual
or a family member of the individual to undergo a genetic test.
22.5. Subsection 22.4 of this section shall not be
construed to 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, as may be revised from time to time) and
consistent with subsection 22.2 of this section.
22.6. For purposes of carrying out subsection 22.5
of this section, an issuer of a Medicare supplement policy or certificate may
request only the minimum amount of information necessary to accomplish the intended
purpose.
22.7. Notwithstanding
subsection 22.4 of this section, an issuer of a Medicare supplement policy may
request, but not require, that an individual or a family member of the individual
undergo a genetic test if each of the following conditions is met:
22.7.a. 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.
22.7.b. The issuer clearly indicates to each
individual, or in the case of a minor child, to the legal guardian of the child, to
whom the request is made that:
22.7.b.1.
Compliance with the request is voluntary; and
22.7.b.2. Non-compliance will have no effect on
enrollment status or premium or contribution amounts.
22.7.c. No genetic information collected or
acquired under this subsection shall be used for underwriting, determination of
eligibility to enroll or maintain enrollment status, premium rates, or the issuance,
renewal, or replacement of a policy or certificate.
22.7.d. The issuer notifies the Secretary in
writing that the issuer is conducting activities pursuant to the exception provided
for under this subsection, including a description of the activities
conducted.
22.7.e. The issuer complies
with other conditions as the Secretary may by regulation require for activities
conducted under this subsection.
22.8. An issuer of a Medicare supplement policy or
certificate shall not request, require, or purchase genetic information for
underwriting purposes.
22.9. An issuer
of a Medicare supplement policy or certificate shall not request, require, or
purchase genetic information with respect to any individual prior to the
individual's enrollment under the policy in connection with the enrollment.
22.10. If an issuer of a Medicare
supplement policy or certificate obtains genetic information incidental to the
requesting, requiring, or purchasing of other information concerning any individual,
the request, requirement, or purchase shall not be considered a violation of
subsection 22.9 of this section if the request, requirement, or purchase is not in
violation of subsection 22.8 of this section.
22.11. For the purposes of this section only:
22.11.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.
22.11.b. "Genetic information" means, with respect
to any individual, information about the individual's genetic tests, the genetic
tests of family members of the individual and the manifestation of a disease or
disorder in family members of the individual. The term includes, with respect to any
individual, 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. Any reference to genetic information concerning an
individual or family member of an individual who is a pregnant woman, includes
genetic information of any fetus carried by a pregnant woman, or with respect to an
individual or family member utilizing reproductive technology, includes genetic
information of any embryo legally held by an individual or family member. The term
"genetic information" does not include information about the sex or age of any
individual.
22.11.c. "Genetic services"
means a genetic test, genetic counseling (including obtaining, interpreting, or
assessing genetic information), or genetic education.
22.11.d. "Genetic test" means an analysis of human
DNA, RNA, chromosomes, proteins, or metabolites, that detect genotypes, mutations,
or chromosomal changes. The term "genetic test" does not mean an analysis of
proteins or metabolites that does not detect genotypes, mutations, or chromosomal
changes; or 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.
22.11.e.
"Issuer of a Medicare supplement policy or certificate" includes third-party
administrator or other person acting for or on behalf of the issuer.
22.11.f. "Underwriting purposes" means,
22.11.f.1. Rules for, or determination of,
eligibility (including enrollment and continued eligibility) for benefits under the
policy;
22.11.f.2. The computation of
premium or contribution amounts under the policy;
22.11.f.3. The application of any pre-existing
condition exclusion under the policy; and
22.11.f.4. Other activities related to the
creation, renewal or replacement of a contract of health insurance or health
benefits.
