NDAC 45-06-01.1-20.1
Prohibition against use of genetic information and requests for genetic testing
Cite as N.D. Admin. Code ยง 45-06-01.1-20.1
This section applies to all policies with policy years beginning on or after May 21, 2009.
1.
An issuer of a Medicare supplement policy or certificate shall not:
a.
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 preexisting condition,
on the basis of the genetic information with respect to such individual; and
b.
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.
2.
Nothing in subsection a 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 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.
3.
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.
4.
Subsection 3 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 1.
5.
For purposes of carrying out subsection 4, an issuer of a Medicare supplement policy or
certificate may request only the minimum amount of information necessary to accomplish the
intended purpose.
6.
Notwithstanding subsection 3, 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 following conditions 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:
(1)
Compliance with the request is voluntary; and
(2)
Noncompliance 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 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.
e.
The issuer complies with such other conditions as the secretary may by regulation
require for activities conducted under this subsection.
7.
An issuer of a Medicare supplement policy or certificate shall not request, require, or purchase
genetic information for underwriting purposes.
8.
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.
9.
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
subsection 8 if such request, requirement, or purchase is not in violation of subsection 7.
10.
For the purposes of this section only:
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 such individual.
b.
"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.
c.
"Genetic services" means a genetic test, genetic counseling (including obtaining,
interpreting, or assessing genetic information), or genetic education.
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.
e.
"Issuer of a Medicare supplement policy or certificate" includes third-party administrator,
or other person acting for or on behalf of such issuer.
f.
"Underwriting purposes" means:
(1)
Rules for, or determination of, eligibility (including enrollment and continued
eligibility) for benefits under the policy;
(2)
The computation of premium or contribution amounts under the policy;
(3)
The application of any preexisting condition exclusion under the policy; and
(4)
Other activities related to the creation, renewal, or replacement of a contract of
health insurance or health benefits.