II

106TH CONGRESS

1ST SESSION S. 117

To permit individuals to continue health plan coverage of services while

participating in approved clinical studies.

IN THE SENATE OF THE UNITED STATES

JANUARY 19, 1999

Ms. SNOWE introduced the following bill; which was read twice and referred

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

A BILL

To permit individuals to continue health plan coverage of

services while participating in approved clinical studies.

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 ‘‘Improved Patient Ac5 cess to Clinical Studies Act of 1999’’.

6 SEC. 2. COVERAGE FOR INDIVIDUALS PARTICIPATING IN

7 APPROVED CLINICAL STUDIES.

8 (a) AMENDMENTS TO ERISA.—

9 (1) IN GENERAL.—Subpart B of part 7 of sub10 title B of title I of the Employee Retirement Income
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1 Security Act of 1974 (29 U.S.C. 1185 et seq.) (as

2 amended by the Women’s Health and Cancer Rights

3 Act of 1998) is further amended by adding at the

4 end the following new section:

5 ‘‘SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN

6 APPROVED CLINICAL STUDIES.

7 ‘‘(a) PERMITTING PARTICIPATION IN APPROVED

8 CLINICAL STUDIES.—A group health plan, and a health

9 insurance issuer offering health insurance coverage in con10 nection with a group health plan, may not deny (or limit

11 or impose additional conditions on) the coverage of items

12 and services furnished to an enrollee if—

13 ‘‘(1) the enrollee is participating in an approved

14 clinical study;

15 ‘‘(2) the items and services are furnished ac16 cording to the design of the study or to treat condi17 tions resulting from participation in the study; and

18 ‘‘(3) the items and services would otherwise be

19 covered under the plan except for the fact that the

20 items and services are provided in connection with

21 participation in such a study.

22 Such a plan or issuer may not discriminate against an

23 enrollee on the basis of the enrollee’s participation in such

24 a study.
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1 ‘‘(b) CONSTRUCTION.—Nothing in subsection (a)

2 shall be construed as requiring a group health plan, or

3 a health insurance issuer offering health insurance cov4 erage in connection with a group health plan, to provide

5 for payment for items and services normally paid for as

6 part of an approved clinical study.

7 ‘‘(c) APPROVED CLINICAL STUDY DEFINED.—In this

8 section, the term ‘approved clinical study’ means—

9 ‘‘(1) a research study approved by the Sec10 retary of Health and Human Services, the Director

11 of the National Institutes of Health, the Commis12 sioner of Food and Drugs, the Secretary of Veterans

13 Affairs, the Secretary of Defense, or a qualified non14 governmental research entity (as defined in guide15 lines of the National Institutes of Health); or

16 ‘‘(2) a peer-reviewed and approved research

17 program, as defined by the Secretary of Health and

18 Human Services, conducted for the primary purpose

19 of determining whether or not a treatment is safe,

20 is efficacious, or has any other characteristic of a

21 treatment that must be demonstrated in order for

22 the treatment to be medically necessary or appro23 priate.’’.

24 (2) TABLE OF CONTENTS.—The table of con25 tents in section 1 of the Employee Retirement In-
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1 come Security Act of 1974 (29 U.S.C. prec. 1001)

2 is amended by inserting after the item relating to

3 section 713 the following:

‘‘Sec. 714. Coverage for individuals participating in approved clinical studies.’’.

4 (b) AMENDMENTS TO PHSA.—

5 (1) GROUP MARKET.—Subpart 2 of part A of

6 title XXVII of the Public Health Service Act (29

7 U.S.C. 300gg–4 et seq.) (as amended by the Wom8 en’s Health and Cancer Rights Act of 1998) is fur9 ther amended by adding at the end the following

10 new section:

11 ‘‘SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING

12 IN APPROVED CLINICAL STUDIES.

13 ‘‘(a) PERMITTING PARTICIPATION IN APPROVED

14 CLINICAL STUDIES.—A group health plan, and a health

15 insurance issuer offering health insurance coverage in con16 nection with a group health plan, may not deny (or limit

17 or impose additional conditions on) the coverage of items

18 and services furnished to an enrollee if—

19 ‘‘(1) the enrollee is participating in an approved

20 clinical study;

21 ‘‘(2) the items and services are furnished ac22 cording to the design of the study or to treat condi23 tions resulting from participation in the study; and

24 ‘‘(3) the items and services would otherwise be

25 covered under the plan except for the fact that the
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1 items and services are provided in connection with

2 participation in such a study.

3 Such a plan or issuer may not discriminate against an

4 enrollee on the basis of the enrollee’s participation in such

5 a study.

6 ‘‘(b) CONSTRUCTION.—Nothing in subsection (a)

7 shall be construed as requiring a group health plan, or

8 a health insurance issuer offering health insurance cov9 erage in connection with a group health plan, to provide

10 for payment for items and services normally paid for as

11 part of an approved clinical study.

12 ‘‘(c) APPROVED CLINICAL STUDY DEFINED.—In this

13 section, the term ‘approved clinical study’ means—

14 ‘‘(1) a research study approved by the Sec15 retary of Health and Human Services, the Director

16 of the National Institutes of Health, the Commis17 sioner of Food and Drugs, the Secretary of Veterans

18 Affairs, the Secretary of Defense, or a qualified non19 governmental research entity (as defined in guide20 lines of the National Institutes of Health); or

21 ‘‘(2) a peer-reviewed and approved research

22 program, as defined by the Secretary of Health and

23 Human Services, conducted for the primary purpose

24 of determining whether or not a treatment is safe,

25 is efficacious, or has any other characteristic of a
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1 treatment that must be demonstrated in order for

2 the treatment to be medically necessary or appro3 priate.’’.

4 (2) INDIVIDUAL MARKET.—Subpart 3 of part B

5 of title XXVII of the Public Health Service Act (29

6 U.S.C. 300gg–51 et seq.) (as added by section

7 605(a) of the Newborn’s and Mother’s Health Pro8 tection Act of 1996 and amended by the Women’s

9 Health and Cancer Rights Act of 1998) is further

10 amended by adding at the end the following new sec11 tion:

12 ‘‘SEC. 2753. COVERAGE FOR INDIVIDUALS PARTICIPATING

13 IN APPROVED CLINICAL STUDIES.

14 ‘‘The provisions of section 2707 shall apply to health

15 insurance coverage offered by a health insurance issuer

16 in the individual market in the same manner as the provi17 sions apply to health insurance coverage offered by a

18 health insurance issuer in connection with a group health

19 plan in the small or large group market.’’.

20 SEC. 3. EFFECTIVE DATE.

21 The amendments made by this Act shall apply—

22 (1) with respect to group health plans for plan

23 years beginning on or after January 1, 2000; and

24 (2) with respect to health insurance coverage

25 offered, sold, issued, renewed, in effect, or operated
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1 in the individual market on or after January 1,

2 2000.

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