[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3959 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3959

 To establish a demonstration project to study and provide coverage of 
 routine patient care costs for Medicare beneficiaries with cancer who 
          are enrolled in an approved clinical trial program.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             August 2, 1996

 Mrs. Johnson of Connecticut 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 establish a demonstration project to study and provide coverage of 
 routine patient care costs for Medicare beneficiaries with cancer who 
          are enrolled in an approved clinical trial program.

    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 Cancer Clinical Trial 
Program Coverage Act of 1996''.

SEC. 2. MEDICARE CANCER PATIENT DEMONSTRATION PROJECT.

    (a) Establishment.--Not later than January 1, 1997, the Secretary 
of Health and Human Services (in this Act referred to as the 
``Secretary'') shall establish a demonstration project which provides 
for payment under the Medicare Program under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.) of routine patient care costs--
            (1) which are provided to an individual diagnosed with 
        cancer and enrolled in the Medicare Program under such title as 
        part of the individual's participating in an approved clinical 
        trial program; and
            (2) which are not otherwise eligible for payment under such 
        title for individuals who are entitled to benefits under such 
        title.
    (b) Application.--The beneficiary cost sharing provisions under the 
Medicare Program, such as deductibles, coinsurance, and copayment 
amounts, shall apply to any individual participating in a demonstration 
project conducted under this Act.
    (c) Approved Clinical Trial Program.--For purposes of this Act, the 
term ``approved clinical trial program'' means a clinical trial program 
which is approved by--
            (1) the National Institutes of Health;
            (2) a National Institutes of Health cooperative group or a 
        National Institutes of Health center;
            (3) the Food and Drug Administration (in the form of an 
        investigational new drug or device exemption);
            (4) the Department of Veterans Affairs;
            (5) the Department of Defense; or
            (6) a qualified nongovernmental research entity identified 
        in the guidelines issued by the National Institutes of Health 
        for center support grants.
    (d) Routine Patient Care Costs.--
            (1) In General.--For purposes of this Act, ``routine 
        patient care costs'' shall include the costs associated with 
        the provision of items and services that--
                    (A) would otherwise be covered under the Medicare 
                Program if such items and services were not provided in 
                connection with an approved clinical trial program; and
                    (B) are furnished according to the design of an 
                approved clinical trial program.
            (2) Exclusion.--For purposes of this Act, ``routine patient 
        care costs'' shall not include the costs associated with the 
        provision of--
                    (A) 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
                    (B) any item or service supplied without charge by 
                the sponsor of the approved clinical trial program.

SEC. 3. STUDY, REPORT, AND TERMINATION.

    (A) Study.--The Secretary shall study the impact on the Medicare 
Program under title XVIII of the Social Security Act of covering 
routine patient care costs of individuals with a diagnosis of cancer 
and other diagnoses, who are entitled to benefits under such title and 
who are enrolled in an approved clinical trial program.
    (b) Report to Congress.--Not later than January 1, 2001, the 
Secretary shall submit a report to Congress that contains a statement 
regarding--
            (1) any incremental cost to the Medicare Program under 
        title XVIII of the Social Security Act resulting from the 
        provisions of this Act; and
            (2) a projection of expenditures under the Medicare Program 
        if coverage of routine patient care costs in an approved 
        clinical trial program were extended to individuals entitled to 
        benefits under the Medicare Program who have a diagnosis other 
        than cancer.
    (c) Termination.--The provisions of this Act shall not apply after 
June 30, 2001.
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