II

106TH CONGRESS

1ST SESSION S. 1267

To require that health care providers inform their patients of certain referral

fees upon the referral of the patients to clinical trials.

IN THE SENATE OF THE UNITED STATES

JUNE 23, 1999

Mr. SCHUMER introduced the following bill; which was read twice and referred

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

A BILL

To require that health care providers inform their patients

of certain referral fees upon the referral of the patients

to clinical trials.

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 ‘‘Clinical Trials Disclo5 sure Act of 1999’’.

6 SEC. 2. REQUIRED DISCLOSURE OF REFERRAL FEES.

7 (a) THROUGH CONTRACTS WITH INSURERS.—

8 (1) AMENDMENT TO ERISA.—

9 (A) IN GENERAL.—Subpart B of part 7 of

10 subtitle B of title I of the Employee Retirement
2

•S 1267 IS

1 Income Security Act of 1974 (29 U.S.C. 1185

2 et seq.) is amended by adding at the end the

3 following new section:

4 ‘‘SEC. 714. REQUIRED DISCLOSURE OF REFERRAL FEES.

5 ‘‘The provisions of any contract or agreement, or the

6 operation of any contract or agreement, between a group

7 health plan or health insurance issuer in relation to health

8 insurance coverage (including any partnership, associa9 tion, or other organization that enters into or administers

10 such a contract or agreement) and a health care provider

11 (or group of providers) shall require that, if the provider

12 refers a patient to a clinical trial, the provider shall dis13 close (orally and in writing) to the patient (at the time

14 of such referral) any payments or other compensation that

15 the provider receives (or expects to receive) from any enti16 ty in connection with such referral.’’.

17 (B) CLERICAL AMENDMENT.—The table of

18 contents in section 1 of the Employee Retire19 ment Income Security Act of 1974 (29 U.S.C.

20 1001 note) is amended by inserting after the

21 item relating to section 713 the following new

22 item:

‘‘Sec. 714. Required disclosure of referral fees.’’.

23 (2) AMENDMENTS TO PHSA.—

24 (A) GROUP MARKET.—Subpart 2 of part A

25 of title XXVII of the Public Health Service Act
3

•S 1267 IS

1 (42 U.S.C. 300gg–4 et seq.) is amended by

2 adding at the end the following new section:

3 ‘‘SEC. 2707. REQUIRED DISCLOSURE OF REFERRAL FEES.

4 ‘‘The provisions of any contract or agreement, or the

5 operation of any contract or agreement, between a group

6 health plan or health insurance issuer in relation to health

7 insurance coverage (including any partnership, associa8 tion, or other organization that enters into or administers

9 such a contract or agreement) and a health care provider

10 (or group of providers) shall require that, if the provider

11 refers a patient to a clinical trial, the provider shall dis12 close (orally and in writing) to the patient (at the time

13 of such referral) any payments or other compensation that

14 the provider receives (or expects to receive) from any enti15 ty in connection with such referral.’’.

16 (B) INDIVIDUAL MARKET.—Part B of title

17 XXVII of the Public Health Service Act (42

18 U.S.C. 300gg–41 et seq.) is amended—

19 (1) by redesignating the first subpart 3 (relat20 ing to other requirements) as subpart 2; and

21 (2) by adding at the end of subpart 2 the fol22 lowing new section:

23 ‘‘SEC. 2753. REQUIRED DISCLOSURE OF REFERRAL FEES.

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

25 insurance coverage offered by a health insurance issuer
4

•S 1267 IS

1 in the individual market in the same manner as they apply

2 to health insurance coverage offered by a health insurance

3 issuer in connection with a group health plan in the small

4 or large group market.’’.

5 (b) OTHER PROVIDERS.—A health care provider who

6 provides services to beneficiaries under the medicare pro7 gram under title XVIII of the Social Security Act (42

8 U.S.C. 1395 et seq.) shall, with respect to any patient that

9 such provider refers to a clinical trial, disclose (orally and

10 in writing) to the patient (at the time of such referral)

11 any payments or other compensation that the provider re12 ceives (or expects to receive) from any entity in connection

13 with such referral.

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