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.
END