Preproposal statement of inquiry was filed as WSR 08-15-157.
Title of Rule and Other Identifying Information: Prohibitions on use of genetic information in medicare supplemental insurance.
Hearing Location(s): Insurance Commissioner's Office, Room TR 120, 5000 Capitol Boulevard, Tumwater, WA 98504-0255, on January 27, 2009, at 10:00 a.m.
Date of Intended Adoption: February 3, 2009.
Submit Written Comments to: Kacy Scott, P.O. Box 40258, Olympia, WA 98504-0258, e-mail KacyS@oic.wa.gov, fax (360) 586-3109, by January 26, 2009.
Assistance for Persons with Disabilities: Contact Lorie Villaflores by January 26, 2009, TTY (306) 586-0241 or (360) 725-7087.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The federal Genetic Information Nondiscrimination Act (GINA) prohibits employers and insurers from using genetic information when making employment or coverage decisions. Section 104 of GINA prohibits denial, conditioning, or discrimination in the pricing of a medicare supplemental policy on the basis of genetic information and limits the ability of medicare supplement issuers to request or require genetic testing. It also prohibits the collection of genetic information for underwriting or other purposes prior to enrollment in medicare supplement insurance.
Reasons Supporting Proposal: The NAIC adopted an amendment to its Medicare Supplement Model Regulation which, in turn, will be adopted by Washington. GINA gives states until July 1, 2009 to adopt the new nondiscrimination section of the NAIC model regulation.
Statutory Authority for Adoption: RCW 48.66.165.
Statute Being Implemented: Chapter 48.66 RCW.
Rule is necessary because of federal law, 110 P.L. 275.
Name of Proponent: Mike Kreidler, insurance commissioner, governmental.
Name of Agency Personnel Responsible for Drafting: Melodie Bankers, P.O. Box 40258, Olympia, WA 98504-0258, (360) 725-7039; Implementation: Beth Berendt, P.O. Box 40255, Olympia, WA 98504-0255, (360) 725-7117; and Enforcement: Carol Sureau, P.O. Box 40255, Olympia, WA 98504-0255, (360) 725-7050.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under provisions of H.R. 493 (the Genetic Information Nondiscrimination Act of 2008) Washington state and the office of the insurance commissioner would lose authority to accept and approve rate and form filings for Medigap policies if these rules are not adopted by July 1, 2009, as written in the law. This would result in this authority reverting to the federal government, which would apply the same standards as are being proposed in these rules. Either result will be the same for small businesses; therefore the proposed rules will have nothing more than a minor impact for small businesses.
A cost-benefit analysis is not required under RCW 34.05.328. These proposed rules use almost exactly the same language as is found both in the NAIC Model Act language (adopted in October 2008) and language expressly required by H.R. 493 (the Genetic Information Nondiscrimination Act of 2008). Any changes in language from these two documents are not substantive in nature. Therefore, under provisions of RCW 34.05.328 (5)(b)(iii), a cost-benefit analysis is not required.
December 22, 2008
WAC 284-66-068 Prohibition against use of genetic information and requests for genetic testing. Except as provided in subsection (3) of this section:
(1) An issuer of a medicare supplement insurance policy or certificate must not deny or condition the issuance of effectiveness of the policy or certificate and must not discriminate in the pricing of the policy or certificate of an individual on the basis of the genetic information with respect to any individual. This includes the imposition of any exclusion of benefits under the policy based on a preexisting condition or adjustment of premium rates based on genetic information. This subsection shall not 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 based on the manifestation of a disease or disorder of the 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. The manifestation of a disease or disorder in one individual must not be used as genetic information about other group members or to increase the premium for the group.
(2) An issuer of a medicare supplement insurance policy or certificate must not request or require an individual or a family member of the individual to undergo a genetic test. This subsection shall not be construed to preclude an issuer from obtaining and using the results of a genetic test in making a determination regarding payment consistent with subsection (1) of this section. For purposes of this section, "payment" has the meaning set forth in 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. An issuer may request only the minimum information necessary to accomplish the intended purpose.
(3) An issuer may request, but must not require, that an individual or a family member of the individual undergo a genetic test only if all of the following conditions are met:
(a) The request is made for research that complies with Part 46 of Title 45, Code of Federal Regulations, or its equivalent, or any other applicable state or local law or rule 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 the child, to whom the request is made that:
(i) Compliance with the request is voluntary; and
(ii) Noncompliance will have no effect on enrollment status or premium or contribution amounts;
(c) Genetic information collected or acquired under this subsection must not 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 of the United States Department of Health and Human Services 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 all other conditions required by regulation by the secretary of the United States Department of Health and Human Services for activities conducted under this subsection;
(4) An issuer must not request, require, or purchase genetic information for underwriting purposes;
(5) An issuer 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; and
(6) If an issuer obtains genetic information incidental to the requesting, requiring, or purchasing of other information concerning any individual, the request, requirement, or purchase will not be considered a violation of subsection (5) of this section only if the request, requirement, or purchase is not in violation of subsection (4) of this section.
(7) For purposes of this section:
(a) "Issuer" has the meaning set forth in WAC 284-66-030(4) and includes any third-party administrator or other person acting for or on behalf of the issuer.
(b) "Family member" means any individual who is a first-degree, second-degree, third-degree, or fourth-degree relative of the individual.
(c) "Genetic information" means 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. The term includes any requests for or receipt of genetic services or participation in clinical research which includes genetic services by the individual or a family member. Any reference to genetic information concerning an individual or family member who is a pregnant woman includes genetic information of any fetus carried by the 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. Genetic information does not include information about the gender 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 termination 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 preexisting condition exclusion under the policy; and
(iv) Other activities related to the creation, renewal, or replacement of a policy of health insurance or health benefits.