[Congressional Record Volume 145, Number 90 (Wednesday, June 23, 1999)]
[Senate]
[Page S7527]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SCHUMER:
  S. 1267. A bill to require that health care providers inform their 
patients of certain referral fees upon the referral of the patients to 
clinical trials; to the Committee on Health, Education, Labor, and 
Pensions.


                 clinical trials disclosure act of 1999

  Mr. SCHUMER. Mr. President, I rise today to introduce the Clinical 
Trials Disclosure Act of 1999. As the Senate debates important health 
care issues such as Medicare, prescription drug access, and managed 
care reform, I want to call our attention to another important health 
care matter: doctors and other health care providers accepting payments 
from drug companies and their contractors to refer patients to clinical 
trials. Each of us understands that by providing a forum for medical 
research, clinical trials play a vital role in our health care system. 
Unfortunately, some providers are violating the patient-doctor 
relationship by not informing patients of the fees they receive for 
referrals to the clinical trials.
  Recent media reports have highlighted this growing trend that 
threatens the important relationship between doctor and patient. In one 
case in California, a doctor received over $1,600 to refer a patient to 
a prostate cancer drug trial despite the fact that the patient's 
prostate was healthy. Other drug companies offer bonuses to physicians 
who refer numbers over and above a certain quota. Providers benefit in 
other ways, too. A cooperative doctor may get his or her name attached 
to an academic study authored by a ghost writer based on the drug 
company's data. No matter how the doctor benefits, however, he or she 
is not compelled to inform the patient of his or her relationship with 
the drug company. This is why today I introduce the Clinical Trials 
Disclosure Act of 1999.
  This bill simply requires that if a health care provider receives 
payments or other compensation for referring a patient to a clinical 
trial, the provider must inform the patient both orally and in writing. 
The measure is not intended to discourage patient participation in 
important medical research. Instead, it will strengthen the 
relationship between doctor and patient and help ensure that clinical 
trials attract patients who will benefit from their important work.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1267

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Clinical Trials Disclosure 
     Act of 1999''.

     SEC. 2. REQUIRED DISCLOSURE OF REFERRAL FEES.

       (a) Through Contracts with Insurers.--
       (1) Amendment to erisa.--
       (A) In general.--Subpart B of part 7 of subtitle B of title 
     I of the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1185 et seq.) is amended by adding at the end the 
     following new section:

     ``SEC. 714. REQUIRED DISCLOSURE OF REFERRAL FEES.

       ``The provisions of any contract or agreement, or the 
     operation of any contract or agreement, between a group 
     health plan or health insurance issuer in relation to health 
     insurance coverage (including any partnership, association, 
     or other organization that enters into or administers such a 
     contract or agreement) and a health care provider (or group 
     of providers) shall require that, if the provider refers a 
     patient to a clinical trial, the provider shall disclose 
     (orally and in writing) to the patient (at the time of such 
     referral) any payments or other compensation that the 
     provider receives (or expects to receive) from any entity in 
     connection with such referral.''.
       (B) Clerical amendment.--The table of contents in section 1 
     of the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1001 note) is amended by inserting after the item 
     relating to section 713 the following new item:

``Sec. 714. Required disclosure of referral fees.''.

       (2) Amendments to phsa.--
       (A) Group market.--Subpart 2 of part A of title XXVII of 
     the Public Health Service Act (42 U.S.C. 300gg-4 et seq.) is 
     amended by adding at the end the following new section:

     ``SEC. 2707. REQUIRED DISCLOSURE OF REFERRAL FEES.

       ``The provisions of any contract or agreement, or the 
     operation of any contract or agreement, between a group 
     health plan or health insurance issuer in relation to health 
     insurance coverage (including any partnership, association, 
     or other organization that enters into or administers such a 
     contract or agreement) and a health care provider (or group 
     of providers) shall require that, if the provider refers a 
     patient to a clinical trial, the provider shall disclose 
     (orally and in writing) to the patient (at the time of such 
     referral) any payments or other compensation that the 
     provider receives (or expects to receive) from any entity in 
     connection with such referral.''.
       (B) Individual market.--Part B of title XXVII of the Public 
     Health Service Act (42 U.S.C. 300gg-41 et seq.) is amended--
       (1) by redesignating the first subpart 3 (relating to other 
     requirements) as subpart 2; and
       (2) by adding at the end of subpart 2 the following new 
     section:

     ``SEC. 2753. REQUIRED DISCLOSURE OF REFERRAL FEES.

       ``The provisions of section 2707 shall apply to health 
     insurance coverage offered by a health insurance issuer in 
     the individual market in the same manner as they apply to 
     health insurance coverage offered by a health insurance 
     issuer in connection with a group health plan in the small or 
     large group market.''.
       (b) Other Providers.--A health care provider who provides 
     services to beneficiaries under the medicare program under 
     title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.) shall, with respect to any patient that such provider 
     refers to a clinical trial, disclose (orally and in writing) 
     to the patient (at the time of such referral) any payments or 
     other compensation that the provider receives (or expects to 
     receive) from any entity in connection with such referral.
                                 ______