In the Matter of: |
The Amendment of Insurance | Docket Number:
Department Regulation No. 56. | 99-20
ORDER
COMES NOW, the Insurance Commissioner of the State of Delaware and in accordance with 18 Delaware Code § 311 and 29 Delaware Code Chapter 101 Orders as follows:
WHEREAS, the permissible acquired immunodeficiency syndrome test as established by the test protocol set forth in “Attachment No. 1” to Regulation 56 restricts such testing to fluids of blood and oral origin; and
WHEREAS, the Food and Drug Administration authorizes the use of acquired immunodeficiency syndrome tests on bodily fluids other than blood and saliva; and
WHEREAS, the Delaware Department of Public Health supports a revision to the test protocol allowing for the use of FDA approved HIV tests regardless of the bodily fluid on which they are conducted.
NOW THEREFORE, I Order that Regulation No. 56 be amended to strike the restriction against testing fluids other than those of blood and oral origin as reflected in the attached AIDS test protocol, effective August 15, 1999.
SO ORDERED this 7th day of July, 1999.
DONNA LEE WILLIAMS
Insurance Commissioner, State of Delaware
NOTICE OF AMENDED REGULATION
INSURANCE COMMISSIONER, DONNA LEE WILLIAMS hereby gives notice that the testing protocols for Human Immunodeficiency Virus (“HIV”) and Acquired Immunodeficiency Syndrome (“AIDS”) set forth in Insurance Department Regulation 56 have been amended to conform with revised federal testing guidelines. The sole revision appears in the first paragraph of text of “Attachment No. 1” where the last line containing a restriction on the bodily fluids that may be tested is stricken. Regulation 56 and Attachment No. 1 are attached hereto.
This regulation has been amended in accordance with 18 Delaware Code § 311 and 29 Delaware Code Chapter 101.
Regulation 56, Life and Health Submissions Regarding Acquired Immunodeficiency Syndrome (Aids)
Table of Contents
Section
1. Authority
2. Purpose
3. Testing and Filings Allowed
4. Effective Date
Section 1. Authority
This regulation is promulgated in accordance with 18 Delaware Code Sections 311 and 2714 and 29 Delaware Code Chapter 101.
Section 2. Purpose
The purpose of this regulation is to establish guidelines to prevent discrimination against prospective insureds by life and health insurers when phrasing policy questions or requiring tests relating to Acquired Immunodeficiency Syndrome (“AIDS”) or Human Immunodeficiency Virus (“HIV”).
Section 3. Testing and Filings Allowed
A. Whenever an applicant is requested to take an AIDS-related test in connection with an application for insurance, the use of such a test must be revealed to the applicant and his or her written consent obtained. The administration of the test must meet the test protocol as established by the Delaware Division of Public Health. (Attachment 1) The results of testing must be maintained in confidentiality between the insured and insurer. The insurer may ask the applicant to designate whether the applicant wants the results forwarded to (1) applicant only, (2) applicant’s personal physician, (3) other (list) or (4) no one.
B. Insurers are permitted to ask diagnostic questions. The Department will permit diagnostic questions such as, but not limited to, the following examples:
“Have you ever been treated for or diagnosed as having Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (“HIV”)?
“Have you ever been told you have Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)?“
Insurers are also permitted to ask predictive questions (i.e., have you tested positive on an AIDS-related blood test) but only if predictive questions are asked by the insurer pertaining to other major life threatening diseases.
Questions which are vague, subjective, unfairly discriminatory, overly technical or ask for the applicant’s opinion are prohibited.
C. Any underwriting use of AIDS-related test information or results, whether acquired by questioning the applicant or by tests administered in accordance with this Regulation, must be strictly limited to the test’s predictive value, and used in a balanced way relative to predictive information relating to other life threatening diseases.
D. The Commissioner will disapprove a policy form filing which he determines violates the standards set forth in Section 3.A., B. and C.
Willful disregard of Delaware Insurance Law may subject an insurer to all administrative remedies provided in accordance with 18 Delaware Code Sections 106 and 334.
Section 4. Effective Date
This regulation shall become effective February 1, 1998.
(ATTACHMENT NO. 1)
TEST PROTOCOL AS ESTABLISHED BY THE DELAWARE DEPARTMENT OF PUBLIC HEALTH
A medically significant and sufficiently reliable test or series of tests for the presence of HIV, antigen or nonantigenic products of HIV or an antibody to HIV includes one of more of the following. Such tests may be performed on bodily fluids of blood or oral origin.
a. A single specimen which is repeatedly reactive using any Food and Drug Administration (FDA) licensed enzyme immunoassay (EIA) HIV antibody test and confirmed positive using an FDA licensed HIV antibody confirmatory test (e.g., Western blot, immunofluorescence assay).
b. A single specimen which is repeatedly reactive using an FDA licensed HIV antigen test and an FDA licensed EIA HIV antibody test. Specimens which are repeatedly reactive to an FDA licensed HIV antigen test shall be confirmed through a neutraliza-tion assay. Specimens which are repeatedly reactive to an FDA licensed EIA HIV antibody test shall be tested with an FDA licensed HIV antibody confirmatory test.
c. A single specimen which is tested for the presence of HIV using a molecular amplification method for the detection of HIV nucleic acids (e.g., polymerase chain reaction, RNA viral load) consistent with the National Committee for Clinical Laboratory Standards.
d. A single specimen which is tested for the presence of HIV using viral culture methods.