This rule applies to all Medicare supplement policies or
certificates with policy years beginning on or after May 21, 2009.
(1)
Definitions. For the
purposes of this rule, the following definitions shall apply:
"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.
"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. "Genetic information"
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.
"Genetic services" means a genetic test,
genetic counseling (including obtaining, interpreting, or assessing genetic
information), or genetic education.
"Genetic test" means an analysis of human
DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes,
mutations, or chromosomal changes. The term "genetic test" does not
mean:
1. An analysis of proteins or
metabolites that does not detect genotypes, mutations, or chromosomal changes;
or
2. 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.
"Issuer of a Medicare supplement policy or
certificate" means the same as "issuer" as defined in rule
191-37.3(514D) and includes a third-party administrator, or other person acting
for or on behalf of such issuer.
"Underwriting purposes" means:
1. Rules for or determination of eligibility
(including enrollment and continued eligibility) for benefits under the
Medicare supplement policy or certificate;
2. The computation of premium or contribution
amounts under the Medicare supplement policy or certificate;
3. The application of any preexisting
condition exclusion under the Medicare supplement policy or certificate;
and
4. Other activities related to
the creation, renewal, or replacement of a contract of health insurance or
health benefits.
(2)
Use of genetic information by issuer prohibited. An issuer of
a Medicare supplement policy or certificate:
a. Shall not deny or condition the issuance
or effectiveness of the Medicare supplement policy or certificate (including
the imposition of any exclusion of benefits under the policy based on a
preexisting condition) of an individual on the basis of the genetic information
with respect to such individual; and
b. Shall not discriminate in the pricing of
the Medicare supplement 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)
What prohibition does not
include. Nothing in subrule 37.34(2) shall be construed to limit the
ability of an issuer of a Medicare supplement policy or certificate, to the
extent otherwise permitted by law, from:
a.
Denying or conditioning the issuance or effectiveness of the Medicare
supplement policy or certificate or increasing the premium for a group plan
based on the manifestation of a disease or disorder of a covered individual or
applicant; or
b. Increasing the
premium for any Medicare supplement policy or certificate issued to an
individual based on the manifestation of a disease or disorder of another
individual who is covered under the Medicare supplement 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 insured group.
(4)
Issuer prohibited from requiring
genetic testing. 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)
Obtaining and using test results
to determine payment. Subrule 37.34(4) 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 Medicare 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 subrule 37.34(2). However, for purposes of
carrying out this subrule, an issuer of a Medicare supplement policy or
certificate may request only the minimum amount of information necessary to
accomplish the intended purpose.
(6)
Conditions when issuer may
request a genetic test. Notwithstanding subrule 37.34(4), an issuer of
a Medicare supplement policy or certificate 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
of a Medicare supplement policy or certificate 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 subrule shall be used for underwriting, determination of
eligibility to enroll or maintain enrollment status, premium rates, or the
issuance, renewal, or replacement of a Medicare supplement policy or
certificate.
d. The issuer of a
Medicare supplement policy or certificate notifies the Secretary in writing
that the issuer of a Medicare supplement policy or certificate is conducting
activities pursuant to the exception provided for under this subrule, including
a description of the activities conducted.
e. The issuer of a Medicare supplement policy
or certificate complies with such other conditions as the Secretary may by
regulation require for activities conducted under this subrule.
(7)
Issuer prohibited from
actively obtaining genetic information for underwriting. An issuer of
a Medicare supplement policy or certificate shall not request, require, or
purchase genetic information for underwriting purposes.
(8)
Issuer prohibited from actively
obtaining genetic information for enrollment. 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)
Obtaining information
incidentally not a violation. 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
subrule 37.34(8) if such request, requirement, or purchase is not in violation
of subrule 37.34(7).