II

106TH CONGRESS

1ST SESSION S. 543

To prohibit discrimination on the basis of genetic information with respect

to health insurance.

IN THE SENATE OF THE UNITED STATES

MARCH 4, 1999

Ms. SNOWE (for herself, Mr. FRIST, Mr. JEFFORDS Mr. HAGEL, Ms. COLLINS, and Mr. ENZI) introduced the following bill; which was read twice

and referred to the Committee on Health Education, Labor, and Pensions

A BILL

To prohibit discrimination on the basis of genetic information

with respect to health insurance.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Genetic Information

5 Nondiscrimination in Health Insurance Act of 1999’’.

6 SEC. 2. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME

7 SECURITY ACT OF 1974.

8 (a) PROHIBITION OF HEALTH DISCRIMINATION ON

9 THE BASIS OF GENETIC INFORMATION OR GENETIC

10 SERVICES.—
2

•S 543 IS

1 (1) NO ENROLLMENT RESTRICTION FOR GE2 NETIC SERVICES.—Section 702(a)(1)(F) of the Em3 ployee Retirement Income Security Act of 1974 (29

4 U.S.C. 1182(a)(1)(F)) is amended by inserting be5 fore the period the following: ‘‘(including informa6 tion about a request for or receipt of genetic serv7 ices)’’.

8 (2) NO DISCRIMINATION IN GROUP PREMIUMS

9 BASED ON PREDICTIVE GENETIC INFORMATION.—

10 Subpart B of part 7 of subtitle B of title I of the

11 Employee Retirement Income Security Act of 1974,

12 as amended by the Omnibus Consolidated and

13 Emergency Supplemental Appropriations Act, 1999

14 (Public Law 105–277), is amended by adding at the

15 end the following:

16 ‘‘SEC. 714. PROHIBITING PREMIUM DISCRIMINATION

17 AGAINST GROUPS ON THE BASIS OF PRE18 DICTIVE GENETIC INFORMATION.

19 ‘‘A group health plan, or a health insurance issuer

20 offering group health insurance coverage in connection

21 with a group health plan, shall not adjust premium or con22 tribution amounts for a group on the basis of predictive

23 genetic information concerning an individual in the group

24 or a family member of the individual (including informa25 tion about a request for or receipt of genetic services).’’.
3

•S 543 IS

1 (3) CONFORMING AMENDMENTS.—

2 (A) IN GENERAL.—Section 702(b) of the

3 Employee Retirement Income Security Act of

4 1974 (29 U.S.C. 1182(b)) is amended by add5 ing at the end the following:

6 ‘‘(3) REFERENCE TO RELATED PROVISION.—

7 For a provision prohibiting the adjustment of pre8 mium or contribution amounts for a group under a

9 group health plan on the basis of predictive genetic

10 information (including information about a request

11 for or receipt of genetic services), see section 714.’’.

12 (B) TABLE OF CONTENTS.—The table of

13 contents in section 1 of the Employee Retire14 ment Income Security Act of 1974 is amended

15 by inserting after the item relating to section

16 713 the following new item:

‘‘Sec. 714. Prohibiting premium discrimination against groups on the basis of

predictive genetic information.’’.

17 (b) LIMITATION ON COLLECTION OF PREDICTIVE

18 GENETIC INFORMATION.—Section 702 of the Employee

19 Retirement Income Security Act of 1974 (29 U.S.C. 1182)

20 is amended by adding at the end the following:

21 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFOR22 MATION.—

23 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR24 ING PREDICTIVE GENETIC INFORMATION.—Except
4

•S 543 IS

1 as provided in paragraph (2), a group health plan,

2 or a health insurance issuer offering health insur3 ance coverage in connection with a group health

4 plan, shall not request or require predictive genetic

5 information concerning an individual or a family

6 member of the individual (including information

7 about a request for or receipt of genetic services).

8 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

9 TREATMENT, OR PAYMENT.—

10 ‘‘(A) IN GENERAL.—Notwithstanding para11 graph (1), a group health plan, or a health in12 surance issuer offering health insurance cov13 erage in connection with a group health plan,

14 that provides health care items and services to

15 an individual or dependent may request (but

16 may not require) that such individual or de17 pendent disclose, or authorize the collection or

18 disclosure of, predictive genetic information for

19 purposes of diagnosis, treatment, or payment

20 relating to the provision of health care items

21 and services to such individual or dependent.

22 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC23 TICES AND DESCRIPTION OF SAFEGUARDS.—As

24 a part of a request under subparagraph (A),

25 the group health plan, or a health insurance
5

•S 543 IS

1 issuer offering health insurance coverage in

2 connection with a group health plan, shall pro3 vide to the individual or dependent a descrip4 tion of the procedures in place to safeguard the

5 confidentiality, as described in subsection (d),

6 of such predictive genetic information.

7 ‘‘(d) CONFIDENTIALITY WITH RESPECT TO PRE8 DICTIVE GENETIC INFORMATION.—

9 ‘‘(1) NOTICE OF CONFIDENTIALITY PRAC10 TICES.—

11 ‘‘(A) PREPARATION OF WRITTEN NO12 TICE.—A group health plan, or a health insur13 ance issuer offering health insurance coverage

14 in connection with a group health plan, shall

15 post or provide, in writing and in a clear and

16 conspicuous manner, notice of the plan or

17 issuer’s confidentiality practices, that shall

18 include—

19 ‘‘(i) a description of an individual’s

20 rights with respect to predictive genetic in21 formation;

22 ‘‘(ii) the procedures established by the

23 plan or issuer for the exercise of the indi24 vidual’s rights; and
6

•S 543 IS

1 ‘‘(iii) the right to obtain a copy of the

2 notice of the confidentiality practices re3 quired under this subsection.

4 ‘‘(B) MODEL NOTICE.—The Secretary, in

5 consultation with the National Committee on

6 Vital and Health Statistics and the National

7 Association of Insurance Commissioners, and

8 after notice and opportunity for public com9 ment, shall develop and disseminate model no10 tices of confidentiality practices. Use of the

11 model notice shall serve as a defense against

12 claims of receiving inappropriate notice.

13 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

14 group health plan, or a health insurance issuer offer15 ing health insurance coverage in connection with a

16 group health plan, shall establish and maintain ap17 propriate administrative, technical, and physical

18 safeguards to protect the confidentiality, security,

19 accuracy, and integrity of predictive genetic informa20 tion created, received, obtained, maintained, used,

21 transmitted, or disposed of by such plan or issuer.’’.

22 (c) DEFINITIONS.—Section 733(d) of the Employee

23 Retirement Income Security Act of 1974 (29 U.S.C.

24 1191b(d)) is amended by adding at the end the following:
7

•S 543 IS

1 ‘‘(5) FAMILY MEMBER.—The term ‘family

2 member’ means with respect to an individual—

3 ‘‘(A) the spouse of the individual;

4 ‘‘(B) a dependent child of the individual,

5 including a child who is born to or placed for

6 adoption with the individual; and

7 ‘‘(C) all other individuals related by blood

8 to the individual or the spouse or child de9 scribed in subparagraph (A) or (B).

10 ‘‘(6) GENETIC INFORMATION.—The term ‘ge11 netic information’ means information about genes,

12 gene products, or inherited characteristics that may

13 derive from an individual or a family member (in14 cluding information about a request for or receipt of

15 genetic services).

16 ‘‘(7) GENETIC SERVICES.—The term ‘genetic

17 services’ means health services provided to obtain,

18 assess, or interpret genetic information for diag19 nostic and therapeutic purposes, and for genetic

20 education and counseling.

21 ‘‘(8) PREDICTIVE GENETIC INFORMATION.—

22 ‘‘(A) IN GENERAL.—The term ‘predictive

23 genetic information’ means, in the absence of

24 symptoms, clinical signs, or a diagnosis of the

25 condition related to such information—
8

•S 543 IS

1 ‘‘(i) information about an individual’s

2 genetic tests;

3 ‘‘(ii) information about genetic tests

4 of family members of the individual; or

5 ‘‘(iii) information about the occur6 rence of a disease or disorder in family

7 members.

8 ‘‘(B) EXCEPTIONS.—The term ‘predictive

9 genetic information’ shall not include—

10 ‘‘(i) information about the sex or age

11 of the individual;

12 ‘‘(ii) information derived from phys13 ical tests, such as the chemical, blood, or

14 urine analyses of the individual including

15 cholesterol tests; and

16 ‘‘(iii) information about physical

17 exams of the individual.

18 ‘‘(9) GENETIC TEST.—The term ‘genetic test’

19 means the analysis of human DNA, RNA, chro20 mosomes, proteins, and certain metabolites, includ21 ing analysis of genotypes, mutations, phenotypes, or

22 karyotypes, for the purpose of predicting risk of dis23 ease in asymptomatic or undiagnosed individuals.’’.

24 (d) EFFECTIVE DATE.—Except as provided in this

25 section, this section and the amendments made by this
9

•S 543 IS

1 section shall apply with respect to group health plans for

2 plan years beginning 1 year after the date of the enact3 ment of this Act.

4 SEC. 3. AMENDMENTS TO THE PUBLIC HEALTH SERVICE

5 ACT.

6 (a) AMENDMENTS RELATING TO THE GROUP MAR7 KET.—

8 (1) PROHIBITION OF HEALTH DISCRIMINATION

9 ON THE BASIS OF GENETIC INFORMATION IN THE

10 GROUP MARKET.—

11 (A) NO ENROLLMENT RESTRICTION FOR

12 GENETIC SERVICES.—Section 2702(a)(1)(F) of

13 the Public Health Service Act (42 U.S.C.

14 300gg–1(a)(1)(F)) is amended by inserting be15 fore the period the following: ‘‘(including infor16 mation about a request for or receipt of genetic

17 services)’’.

18 (B) NO DISCRIMINATION IN PREMIUMS

19 BASED ON PREDICTIVE GENETIC INFORMA20 TION.—Subpart 2 of part A of title XXVII of

21 the Public Health Service Act, as amended by

22 the Omnibus Consolidated and Emergency Sup23 plemental Appropriations Act, 1999 (Public

24 Law 105–277), is amended by adding at the

25 end the following new section:
10

•S 543 IS

1 ‘‘SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION

2 AGAINST GROUPS ON THE BASIS OF PRE3 DICTIVE GENETIC INFORMATION IN THE

4 GROUP MARKET.

5 ‘‘A group health plan, or a health insurance issuer

6 offering group health insurance coverage in connection

7 with a group health plan shall not adjust premium or con8 tribution amounts for a group on the basis of predictive

9 genetic information concerning an individual in the group

10 or a family member of the individual (including informa11 tion about a request for or receipt of genetic services).’’.

12 (C) CONFORMING AMENDMENT.—Section

13 2702(b) of the Public Health Service Act (42

14 U.S.C. 300gg–1(b)) is amended by adding at

15 the end the following:

16 ‘‘(3) REFERENCE TO RELATED PROVISION.—

17 For a provision prohibiting the adjustment of pre18 mium or contribution amounts for a group under a

19 group health plan on the basis of predictive genetic

20 information (including information about a request

21 for or receipt of genetic services), see section 2707.’’.

22 (D) LIMITATION ON COLLECTION AND DIS23 CLOSURE OF PREDICTIVE GENETIC INFORMA24 TION.—Section 2702 of the Public Health Serv25 ice Act (42 U.S.C. 300gg–1) is amended by

26 adding at the end the following:
11

•S 543 IS

1 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFOR2 MATION.—

3 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR4 ING PREDICTIVE GENETIC INFORMATION.—Except

5 as provided in paragraph (2), a group health plan,

6 or a health insurance issuer offering health insur7 ance coverage in connection with a group health

8 plan, shall not request or require predictive genetic

9 information concerning an individual or a family

10 member of the individual (including information

11 about a request for or receipt of genetic services).

12 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

13 TREATMENT, OR PAYMENT.—

14 ‘‘(A) IN GENERAL.—Notwithstanding para15 graph (1), a group health plan, or a health in16 surance issuer offering health insurance cov17 erage in connection with a group health plan,

18 that provides health care items and services to

19 an individual or dependent may request (but

20 may not require) that such individual or de21 pendent disclose, or authorize the collection or

22 disclosure of, predictive genetic information for

23 purposes of diagnosis, treatment, or payment

24 relating to the provision of health care items

25 and services to such individual or dependent.
12

•S 543 IS

1 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC2 TICES AND DESCRIPTION OF SAFEGUARDS.—As

3 a part of a request under subparagraph (A),

4 the group health plan, or a health insurance

5 issuer offering health insurance coverage in

6 connection with a group health plan, shall pro7 vide to the individual or dependent a descrip8 tion of the procedures in place to safeguard the

9 confidentiality, as described in subsection (d),

10 of such predictive genetic information.

11 ‘‘(d) CONFIDENTIALITY WITH RESPECT TO PRE12 DICTIVE GENETIC INFORMATION.—

13 ‘‘(1) NOTICE OF CONFIDENTIALITY PRAC14 TICES.—

15 ‘‘(A) PREPARATION OF WRITTEN NO16 TICE.—A group health plan, or a health insur17 ance issuer offering health insurance coverage

18 in connection with a group health plan, shall

19 post or provide, in writing and in a clear and

20 conspicuous manner, notice of the plan or

21 issuer’s confidentiality practices, that shall

22 include—

23 ‘‘(i) a description of an individual’s

24 rights with respect to predictive genetic in25 formation;
13

•S 543 IS

1 ‘‘(ii) the procedures established by the

2 plan or issuer for the exercise of the indi3 vidual’s rights; and

4 ‘‘(iii) the right to obtain a copy of the

5 notice of the confidentiality practices re6 quired under this subsection.

7 ‘‘(B) MODEL NOTICE.—The Secretary, in

8 consultation with the National Committee on

9 Vital and Health Statistics and the National

10 Association of Insurance Commissioners, and

11 after notice and opportunity for public com12 ment, shall develop and disseminate model no13 tices of confidentiality practices. Use of the

14 model notice shall serve as a defense against

15 claims of receiving inappropriate notice.

16 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

17 group health plan, or a health insurance issuer offer18 ing health insurance coverage in connection with a

19 group health plan, shall establish and maintain ap20 propriate administrative, technical, and physical

21 safeguards to protect the confidentiality, security,

22 accuracy, and integrity of predictive genetic informa23 tion created, received, obtained, maintained, used,

24 transmitted, or disposed of by such plan or issuer.’’.
14

•S 543 IS

1 (2) DEFINITIONS.—Section 2791(d) of the Pub2 lic Health Service Act (42 U.S.C. 300gg–91(d)) is

3 amended by adding at the end the following:

4 ‘‘(15) FAMILY MEMBER.—The term ‘family

5 member’ means, with respect to an individual—

6 ‘‘(A) the spouse of the individual;

7 ‘‘(B) a dependent child of the individual,

8 including a child who is born to or placed for

9 adoption with the individual; and

10 ‘‘(C) all other individuals related by blood

11 to the individual or the spouse or child de12 scribed in subparagraph (A) or (B).

13 ‘‘(16) GENETIC INFORMATION.—The term ‘ge14 netic information’ means information about genes,

15 gene products, or inherited characteristics that may

16 derive from an individual or a family member (in17 cluding information about a request for or receipt of

18 genetic services).

19 ‘‘(17) GENETIC SERVICES.—The term ‘genetic

20 services’ means health services provided to obtain,

21 assess, or interpret genetic information for diag22 nostic and therapeutic purposes, and for genetic

23 education and counseling.

24 ‘‘(18) PREDICTIVE GENETIC INFORMATION.—
15

•S 543 IS

1 ‘‘(A) IN GENERAL.—The term ‘predictive

2 genetic information’ means, in the absence of

3 symptoms, clinical signs, or a diagnosis of the

4 condition related to such information—

5 ‘‘(i) information about an individual’s

6 genetic tests;

7 ‘‘(ii) information about genetic tests

8 of family members of the individual; or

9 ‘‘(iii) information about the occur10 rence of a disease or disorder in family

11 members.

12 ‘‘(B) EXCEPTIONS.—The term ‘predictive

13 genetic information’ shall not include—

14 ‘‘(i) information about the sex or age

15 of the individual;

16 ‘‘(ii) information derived from phys17 ical tests, such as the chemical, blood, or

18 urine analyses of the individual including

19 cholesterol tests; and

20 ‘‘(iii) information about physical

21 exams of the individual.

22 ‘‘(19) GENETIC TEST.—The term ‘genetic test’

23 means the analysis of human DNA, RNA, chro24 mosomes, proteins, and certain metabolites, includ25 ing analysis of genotypes, mutations, phenotypes, or
16

•S 543 IS

1 karyotypes, for the purpose of predicting risk of dis2 ease in asymptomatic or undiagnosed individuals.’’.

3 (b) AMENDMENT RELATING TO THE INDIVIDUAL

4 MARKET.—The first subpart 3 of part B of title XXVII

5 of the Public Health Service Act (42 U.S.C. 300gg–51 et

6 seq.) (relating to other requirements), as amended by the

7 Omnibus Consolidated and Emergency Supplemental Ap8 propriations Act, 1999 (Public Law 105–277) is

9 amended—

10 (1) by redesignating such subpart as subpart 2;

11 and

12 (2) by adding at the end the following:

13 ‘‘SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON

14 THE BASIS OF PREDICTIVE GENETIC INFOR15 MATION.

16 ‘‘(a) PROHIBITION ON PREDICTIVE GENETIC INFOR17 MATION AS A CONDITION OF ELIGIBILITY.—A health in18 surance issuer offering health insurance coverage in the

19 individual market may not use predictive genetic informa20 tion as a condition of eligibility of an individual to enroll

21 in individual health insurance coverage (including infor22 mation about a request for or receipt of genetic services).

23 ‘‘(b) PROHIBITION ON PREDICTIVE GENETIC INFOR24 MATION IN SETTING PREMIUM RATES.—A health insur25 ance issuer offering health insurance coverage in the indi-
17

•S 543 IS

1 vidual market shall not adjust premium rates for individ2 uals on the basis of predictive genetic information concern3 ing such an enrollee or a family member of the enrollee

4 (including information about a request for or receipt of

5 genetic services).

6 ‘‘(c) COLLECTION OF PREDICTIVE GENETIC INFOR7 MATION.—

8 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR9 ING PREDICTIVE GENETIC INFORMATION.—Except

10 as provided in paragraph (2), a health insurance

11 issuer offering health insurance coverage in the indi12 vidual market shall not request or require predictive

13 genetic information concerning an individual or a

14 family member of the individual (including informa15 tion about a request for or receipt of genetic serv16 ices).

17 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

18 TREATMENT, OR PAYMENT.—

19 ‘‘(A) IN GENERAL.—Notwithstanding para20 graph (1), a health insurance issuer offering

21 health insurance coverage in the individual mar22 ket that provides health care items and services

23 to an individual or dependent may request (but

24 may not require) that such individual or de25 pendent disclose, or authorize the collection or
18

•S 543 IS

1 disclosure of, predictive genetic information for

2 purposes of diagnosis, treatment, or payment

3 relating to the provision of health care items

4 and services to such individual or dependent.

5 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC6 TICES AND DESCRIPTION OF SAFEGUARDS.—As

7 a part of a request under subparagraph (A),

8 the health insurance issuer offering health in9 surance coverage in the individual market shall

10 provide to the individual or dependent a de11 scription of the procedures in place to safe12 guard the confidentiality, as described in sub13 section (d), of such predictive genetic informa14 tion.

15 ‘‘(d) CONFIDENTIALITY WITH RESPECT TO PRE16 DICTIVE GENETIC INFORMATION.—

17 ‘‘(1) NOTICE OF CONFIDENTIALITY PRAC18 TICES.—

19 ‘‘(A) PREPARATION OF WRITTEN NO20 TICE.—A health insurance issuer offering

21 health insurance coverage in the individual mar22 ket shall post or provide, in writing and in a

23 clear and conspicuous manner, notice of the

24 issuer’s confidentiality practices, that shall

25 include—
19

•S 543 IS

1 ‘‘(i) a description of an individual’s

2 rights with respect to predictive genetic in3 formation;

4 ‘‘(ii) the procedures established by the

5 issuer for the exercise of the individual’s

6 rights; and

7 ‘‘(iii) the right to obtain a copy of the

8 notice of the confidentiality practices re9 quired under this subsection.

10 ‘‘(B) MODEL NOTICE.—The Secretary, in

11 consultation with the National Committee on

12 Vital and Health Statistics and the National

13 Association of Insurance Commissioners, and

14 after notice and opportunity for public com15 ment, shall develop and disseminate model no16 tices of confidentiality practices. Use of the

17 model notice shall serve as a defense against

18 claims of receiving inappropriate notice.

19 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

20 health insurance issuer offering health insurance

21 coverage in the individual market shall establish and

22 maintain appropriate administrative, technical, and

23 physical safeguards to protect the confidentiality, se24 curity, accuracy, and integrity of predictive genetic
20

•S 543 IS

1 information created, received, obtained, maintained,

2 used, transmitted, or disposed of by such issuer.’’.

3 (c) EFFECTIVE DATE.—The amendments made by

4 this section shall apply with respect to—

5 (1) group health plans, and health insurance

6 coverage offered in connection with group health

7 plans, for plan years beginning after 1 year after the

8 date of enactment of this Act; and

9 (2) health insurance coverage offered, sold,

10 issued, renewed, in effect, or operated in the individ11 ual market after 1 year after the date of enactment

12 of this Act.

13 SEC. 4. AMENDMENTS TO THE INTERNAL REVENUE CODE

14 OF 1986.

15 (a) PROHIBITION OF HEALTH DISCRIMINATION ON

16 THE BASIS OF GENETIC INFORMATION OR GENETIC

17 SERVICES.—

18 (1) NO ENROLLMENT RESTRICTION FOR GE19 NETIC SERVICES.—Section 9802(a)(1)(F) of the In20 ternal Revenue Code of 1986 is amended by insert21 ing before the period the following: ‘‘(including in22 formation about a request for or receipt of genetic

23 services)’’.

24 (2) NO DISCRIMINATION IN GROUP PREMIUMS

25 BASED ON PREDICTIVE GENETIC INFORMATION.—
21

•S 543 IS

1 (A) IN GENERAL.—Subchapter B of chap2 ter 100 of the Internal Revenue Code of 1986

3 is amended by adding at the end the following:

4 ‘‘SEC. 9813. PROHIBITING PREMIUM DISCRIMINATION

5 AGAINST GROUPS ON THE BASIS OF PRE6 DICTIVE GENETIC INFORMATION.

7 ‘‘A group health plan shall not adjust premium or

8 contribution amounts for a group on the basis of predictive

9 genetic information concerning an individual in the group

10 or a family member of the individual (including informa11 tion about a request for or receipt of genetic services).’’.

12 (B) CONFORMING AMENDMENT.—Section

13 9802(b) of the Internal Revenue Code of 1986

14 is amended by adding at the end the following:

15 ‘‘(3) REFERENCE TO RELATED PROVISION.—

16 For a provision prohibiting the adjustment of pre17 mium or contribution amounts for a group under a

18 group health plan on the basis of predictive genetic

19 information (including information about a request

20 for or the receipt of genetic services), see section

21 9813.’’.

22 (C) AMENDMENT TO TABLE OF SEC23 TIONS.—The table of sections for subchapter B

24 of chapter 100 of the Internal Revenue Code of
22

•S 543 IS

1 1986 is amended by adding at the end the fol2 lowing:

‘‘Sec. 9813. Prohibiting premium discrimination against groups on the basis of

predictive genetic information.’’.

3 (b) LIMITATION ON COLLECTION OF PREDICTIVE

4 GENETIC INFORMATION.—Section 9802 of the Internal

5 Revenue Code of 1986 is amended by adding at the end

6 the following:

7 ‘‘(d) COLLECTION OF PREDICTIVE GENETIC INFOR8 MATION.—

9 ‘‘(1) LIMITATION ON REQUESTING OR REQUIR10 ING PREDICTIVE GENETIC INFORMATION.—Except

11 as provided in paragraph (2), a group health plan

12 shall not request or require predictive genetic infor13 mation concerning an individual or a family member

14 of the individual (including information about a re15 quest for or receipt of genetic services).

16 ‘‘(2) INFORMATION NEEDED FOR DIAGNOSIS,

17 TREATMENT, OR PAYMENT.—

18 ‘‘(A) IN GENERAL.—Notwithstanding para19 graph (1), a group health plan that provides

20 health care items and services to an individual

21 or dependent may request (but may not re22 quire) that such individual or dependent dis23 close, or authorize the collection or disclosure

24 of, predictive genetic information for purposes
23

•S 543 IS

1 of diagnosis, treatment, or payment relating to

2 the provision of health care items and services

3 to such individual or dependent.

4 ‘‘(B) NOTICE OF CONFIDENTIALITY PRAC5 TICES; DESCRIPTION OF SAFEGUARDS.—As a

6 part of a request under subparagraph (A), the

7 group health plan shall provide to the individual

8 or dependent a description of the procedures in

9 place to safeguard the confidentiality, as de10 scribed in subsection (e), of such predictive ge11 netic information.

12 ‘‘(e) CONFIDENTIALITY WITH RESPECT TO PRE13 DICTIVE GENETIC INFORMATION.—

14 ‘‘(1) NOTICE OF CONFIDENTIALITY PRAC15 TICES.—

16 ‘‘(A) PREPARATION OF WRITTEN NO17 TICE.—A group health plan shall post or pro18 vide, in writing and in a clear and conspicuous

19 manner, notice of the plan’s confidentiality

20 practices, that shall include—

21 ‘‘(i) a description of an individual’s

22 rights with respect to predictive genetic in23 formation;
24

•S 543 IS

1 ‘‘(ii) the procedures established by the

2 plan for the exercise of the individual’s

3 rights; and

4 ‘‘(iii) the right to obtain a copy of the

5 notice of the confidentiality practices re6 quired under this subsection.

7 ‘‘(B) MODEL NOTICE.—The Secretary, in

8 consultation with the National Committee on

9 Vital and Health Statistics and the National

10 Association of Insurance Commissioners, and

11 after notice and opportunity for public com12 ment, shall develop and disseminate model no13 tices of confidentiality practices. Use of the

14 model notice shall serve as a defense against

15 claims of receiving inappropriate notice.

16 ‘‘(2) ESTABLISHMENT OF SAFEGUARDS.—A

17 group health plan shall establish and maintain ap18 propriate administrative, technical, and physical

19 safeguards to protect the confidentiality, security,

20 accuracy, and integrity of predictive genetic informa21 tion created, received, obtained, maintained, used,

22 transmitted, or disposed of by such plan.’’.

23 (c) DEFINITIONS.—Section 9832(d) of the Internal

24 Revenue Code of 1986 is amended by adding at the end

25 the following:
25

•S 543 IS

1 ‘‘(6) FAMILY MEMBER.—The term ‘family

2 member’ means, with respect to an individual—

3 ‘‘(A) the spouse of the individual;

4 ‘‘(B) a dependent child of the individual,

5 including a child who is born to or placed for

6 adoption with the individual; and

7 ‘‘(C) all other individuals related by blood

8 to the individual or the spouse or child de9 scribed in subparagraph (A) or (B).

10 ‘‘(7) GENETIC INFORMATION.—The term ‘ge11 netic information’ means information about genes,

12 gene products, or inherited characteristics that may

13 derive from an individual or a family member (in14 cluding information about a request for or receipt of

15 genetic services).

16 ‘‘(8) GENETIC SERVICES.—The term ‘genetic

17 services’ means health services provided to obtain,

18 assess, or interpret genetic information for diag19 nostic and therapeutic purposes, and for genetic

20 education and counseling.

21 ‘‘(9) PREDICTIVE GENETIC INFORMATION.—

22 ‘‘(A) IN GENERAL.—The term ‘predictive

23 genetic information’ means, in the absence of

24 symptoms, clinical signs, or a diagnosis of the

25 condition related to such information—
26

•S 543 IS

1 ‘‘(i) information about an individual’s

2 genetic tests;

3 ‘‘(ii) information about genetic tests

4 of family members of the individual; or

5 ‘‘(iii) information about the occur6 rence of a disease or disorder in family

7 members.

8 ‘‘(B) EXCEPTIONS.—The term ‘predictive

9 genetic information’ shall not include—

10 ‘‘(i) information about the sex or age

11 of the individual;

12 ‘‘(ii) information derived from phys13 ical tests, such as the chemical, blood, or

14 urine analyses of the individual including

15 cholesterol tests; and

16 ‘‘(iii) information about physical

17 exams of the individual.

18 ‘‘(10) GENETIC TEST.—The term ‘genetic test’

19 means the analysis of human DNA, RNA, chro20 mosomes, proteins, and certain metabolites, includ21 ing analysis of genotypes, mutations, phenotypes, or

22 karyotypes, for the purpose of predicting risk of dis23 ease in asymptomatic or undiagnosed individuals.’’.

24 (d) EFFECTIVE DATE.—Except as provided in this

25 section, this section and the amendments made by this
27

•S 543 IS

1 section shall apply with respect to group health plans for

2 plan years beginning after 1 year after the date of the

3 enactment of this Act.

Æ