Current through Reg. 50, No. 13; March 28, 2025
This section applies to all Medicare supplement policies
and certificates with policy years beginning on or after July 1, 2009.
(1) The definitions in subparagraphs (A) -
(F) of this paragraph apply to this section only.
(A) "Issuer of a Medicare supplement policy
or certificate" includes a third-party administrator, or other person acting
for or on behalf of such issuer.
(B) "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 such individual.
(C) "Genetic information" means, with respect
to any individual, information about such individual's genetic tests, the
genetic tests of family members of such individual, and the manifestation of a
disease or disorder in family members of such individual. Such 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 such individual or any family member of such 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 such 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.
(D) "Genetic services"
means a genetic test, genetic counseling (including obtaining, interpreting, or
assessing genetic information), or genetic education.
(E) "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.
(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 any pre-existing
condition exclusion under the policy; and
(iv) other activities related to the
issuance, renewal, or replacement of a contract of health insurance or health
benefits.
(2)
An issuer of a Medicare supplement policy or certificate must comply with
subparagraphs (A) and (B) of this paragraph.
(A) The issuer 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
such individual; and
(B) The issuer
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 such individual.
(3) Nothing in paragraph (2) of this section
shall be construed to limit the ability of an issuer, to the extent otherwise
permitted by law, from:
(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
(B) increasing the premium for any policy
issued or issued for delivery 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.
(4) An issuer of a Medicare supplement policy
or certificate shall not request or require an individual or a family member of
such individual to undergo a genetic test.
(5) Paragraph (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. The payment must be consistent with paragraph (2) of this
section.
(6) In implementing
paragraph (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.
(7) Notwithstanding paragraph (4) of this
section, an issuer of a Medicare supplement policy may request, but not
require, that an individual or a family member of such individual undergo a
genetic test if each of the conditions specified in subparagraphs (A) - (E) of
this paragraph is met:
(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;
(B) the issuer clearly
indicates to each individual, or in the case of a minor child, to the legal
guardian of such child, to whom the request is made that:
(i) compliance with the request is voluntary;
and
(ii) non-compliance will have
no effect on enrollment status or premium or contribution amounts;
(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;
(D) the issuer
notifies the commissioner in writing that the issuer is conducting activities
pursuant to the exception provided for under this paragraph, including a
description of the activities conducted; and
(E) the issuer complies with such other
conditions as the commissioner may by rule require for activities conducted
under this paragraph.
(8) An issuer of a Medicare supplement policy
or certificate shall not request, require, or purchase genetic information for
underwriting purposes.
(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 such individual's enrollment under the policy in connection with such
enrollment.
(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, such request, requirement, or purchase shall not be
considered a violation of paragraph (9) of this section if such request,
requirement, or purchase is not in violation of paragraph (8) of this
section.
