[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3283 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 3283

To amend title XVIII of the Social Security Act to provide for Medicare 
      reimbursement of routine patient care costs for individuals 
 participating in federally approved clinical trials and to require a 
report on costs of requiring coverage of these costs under group health 
                  plans and health insurance coverage.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 26, 1998

 Mr. Bentsen introduced the following bill; which was referred to the 
   Committee on Ways and Means, and in addition to the Committee on 
Commerce, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide for Medicare 
      reimbursement of routine patient care costs for individuals 
 participating in federally approved clinical trials and to require a 
report on costs of requiring coverage of these costs under group health 
                  plans and health insurance coverage.

    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 ``Medicare Clinical Trial Coverage Act 
of 1998''.

SEC. 2. MEDICARE REIMBURSEMENT FOR INDIVIDUALS PARTICIPATING IN 
              CLINICAL TRIALS.

    (a) In General.--Section 1862 of the Social Security Act (42 U.S.C. 
1395y) is amended--
            (1) in subsection (a)(1)--
                    (A) by striking ``and'' at the end of subparagraph 
                (H);
                    (B) by striking the semicolon at the end of 
                subparagraph (I) and inserting ``, and''; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(J) in the case of expenses incurred in connection with 
        any phase of a Federally approved clinical trial (as defined in 
        subsection (h)(1)), unless such expenses are for routine 
        patient care costs (as defined in subsection (h)(2));''; and
            (2) by inserting after subsection (g) the following new 
        subsection:
    ``(h)(1) For purposes of subsection (a)(1)(J), the term `Federally 
approved clinical trial' means a clinical trial which is approved by 
any of the following:
            ``(A) The Secretary.
            ``(B) The Director of the the National Institutes of 
        Health.
            ``(C) The Commissioner of the Food and Drug Administration.
            ``(D) The Secretary of Veterans Affairs.
            ``(E) The Secretary of Defense.
            ``(F) The Secretary of Energy.
            ``(G) A nongovernmental research entity (as defined in the 
        guidelines of the National Institutes of Health) or a peer-
        review and approved research program (as defined by the 
        Secretary).
    ``(2)(A) Subject to subparagraph (B), for purposes of subsection 
(a)(1)(J), the term `routine patient care costs' includes the costs 
associated with the provision of items and services that--
            ``(i) would otherwise be covered under this title if such 
        items and services were not provided in connection with a 
        Federally approved clinical trial; and
            ``(ii) are furnished according to the design of a Federally 
        approved clinical trial.
    ``(B) Such term does not include the costs associated with the 
provision of--
            ``(i) an investigational drug or device, unless the 
        Secretary has authorized the manufacturer of such drug or 
        device to charge for such drug or device; or
            ``(ii) any item or service supplied without charge by the 
        sponsor of the Federally approved clinical trial.''.
    (b) Assuring Coverage Under Medicare+Choice Plans.--Section 
1852(d)(2) of such Act (42 U.S.C. 1395w-22(d)(2)) is amended--
            (1) by striking ``and'' at the end of subparagraph (D);
            (2) by striking the period at the end of subparagraph (E) 
        and inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(F) coverage is provided under the plan for 
                routine patient care costs of Federally approved 
                clinical trials (as such terms are defined in section 
                1862(h)).''.
    (c) Effective Date.--The amendments made by this section apply to 
items and services furnished on or after January 1, 1999.

SEC. 3. REPORT ON COSTS OF COVERAGE OF BENEFITS FOR FEDERALLY APPROVED 
              CLINICAL TRIALS UNDER GROUP HEALTH PLANS AND HEALTH 
              INSURANCE COVERAGE.

    The Secretaries of Health and Human Services and Labor shall 
jointly prepare and submit to Congress a report on the costs associated 
with requiring that group health plans and health insurance coverage do 
not deny payment of routine patient care costs for services furnished 
in connection with Federally approved clinical trials (as those terms 
are defined in section 1862(h) of the Social Security Act).
                                 <all>