[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1758 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 1758

To amend title XVIII of the Social Security Act to provide for coverage 
 under part B of the Medicare Program of certain beta interferons and 
       other biologicals and drugs approved by the Food and Drug 
          Administration for treatment of multiple sclerosis.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 8, 2001

 Mr. LaFalce introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, 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 coverage 
 under part B of the Medicare Program of certain beta interferons and 
       other biologicals and drugs approved by the Food and Drug 
          Administration for treatment of multiple sclerosis.

    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 ``Multiple Sclerosis Treatment Act of 
2001''.

SEC. 2. MEDICARE COVERAGE OF CERTAIN SELF-ADMINISTERED BETA INTERFERONS 
              AND OTHER DRUGS AND BIOLOGICALS FOR PATIENTS WITH 
              MULTIPLE SCLEROSIS.

    (a) In General.--Section 1861(s)(2) of the Social Security Act (42 
U.S.C. 1395x(s)(2)), as amended by the Medicare, Medicaid, and SCHIP 
Benefits Improvement and Protection Act of 2000, is amended--
            (1) by striking ``and'' at the end of subparagraph (U);
            (2) by inserting ``and'' at the end of subparagraph (V); 
        and
            (3) by adding at the end the following new subparagraph:
            ``(W) the following biologicals or drugs approved by the 
        Food and Drug Administration for self-administration by 
        patients with multiple sclerosis, subject to methods and 
        standards established by the Secretary by regulation for the 
        safe and effective use of such biological or drug:
                    ``(i) interferon beta 1-a,
                    ``(ii) interferon beta 1-b,
                    ``(iii) glatiramer acetate, and
                    ``(iv) any other biological or drug found in a 
                review and approved by the Food and Drug Administration 
                to change the underlying course of multiple sclerosis 
                by such mechanisms as, for example, slowing the 
                progression or the relapse rate of the disease;''
    (b) Regulations.--The Secretary of Health and Human Services shall 
issue final regulations setting forth methods and standards for the 
safe and effective use of biologicals and drugs described in section 
1861(s)(2)(W) of the Social Security Act (as added by subsection 
(a)(3)) for purposes of carrying out such section. The Secretary shall 
first issue such regulations--
            (1) for biologicals and drugs described in clauses (i) 
        through (iii) of such section, by not later than January 1, 
        2002; and
            (2) for any biological or drug described in clause (iv) of 
        such section, by not later than (A) 60 days after the date of 
        approval of the biological or drug by the Food and Drug 
        Administration, or (B) January 1, 2002, whichever is later.
    (c) Effective Date.--The amendments made by subsection (a) shall 
apply to payments for items and services furnished on or after January 
1, 2002.
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