Regl. 7747, art. L-24
Prohibition Against Use of Genetic Information and Requests for
Length: 1,060 wordsOfficial source
Cite as Reglamento Núm. 7747, Art. L-24
Genetic Testing
This Section applies to all policies with policy years beginning on or after May 21, 2009.
A.
An issuer of a Medicare supplements policy or certificate;
1.
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
2.
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.
104
B.
Nothing in Subsection A 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; or
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 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).
C.
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.
D.
Subsection C 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 A.
E.
For purposes of carrying out Subsection D, an issuer of a Medicare
supplement policy or certificate may request only the minimum amount
of information necessary to accomplish the intended purpose.
F.
Notwithstanding Subsection C, 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:
(1)
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.
(2)
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 -
(a)
compliance with the request is voluntary; and
(b)
non-compliance will have no effect on enrollment status or
premium or contribution amounts.
(3)
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.
(4)
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.
105
(5)
The issuer complies with such other conditions as the Secretary
may by regulation require for activities conducted under this
Subsection.
G.
An issuer of a Medicare supplement policy or certificate shall not request,
require, or purchase genetic information for underwriting purposes.
H.
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.
I.
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 H if such
request, requirement, or purchase is not in violation of Subsection G.
J.
For the purposes of this Section only:
(1)
"Issuer of a Medicare supplement policy or certificate" includes
third-party administrator, or other person acting for or on behalf of
such issuer.
(2)
"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.
(3)
"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.
(4)
"Genetic services" means a genetic test, genetic counseling
(including obtaining, interpreting, or assessing genetic
information), or genetic education.
(5)
"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.
(6)
"Underwriting purposes" means,
106
(a)
rules for, or determination of, eligibility (including
enrollment and continued eligibility) for benefits under the
policy;
(b)
the computation of premium or contribution amounts under
the policy;
(c)
the application of any pre-existing condition exclusion under
the policy; and
(d)
other activities related to the creation, renewal, or
replacement of a contract of health insurance or health
benefits.