I
106TH CONGRESS
1ST SESSION
H. R. 2338
To require the Secretary of Health and Human Services to provide an
individual who seeks to have a particular type of item or service to
be covered benefit under the Medicare Program the option to meet
with the Secretary in advance to develop a written agreement specifying
the information necessary for the Secretary to make a national coverage
determination under the Medicare Program.
IN THE HOUSE OF REPRESENTATIVES
JUNE 24, 1999
Mr. RAMSTAD introduced the following bill; which was referred to the Com-
mittee on Ways and Means, and in addition to the Committee on Com-
merce, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned
A BILL
To require the Secretary of Health and Human Services
to provide an individual who seeks to have a particular
type of item or service to be covered benefit under the
Medicare Program the option to meet with the Secretary
in advance to develop a written agreement specifying
the information necessary for the Secretary to make a
national coverage determination under the Medicare Pro-
gram.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Medicare Coverage In-
formation Decision Act of 1999’’.
SEC. 2. MEETINGS REGARDING COVERAGE DECISIONS.
(a) MEETINGS WITH THE SECRETARY.—
(1) IN GENERAL.—
(A) DEADLINE
FOR
MEETING.—In the
case of a person who submits to the Secretary
of Health and Human Services written notice
that the person intends to seek a national cov-
erage determination by the Secretary with re-
spect to whether a particular type or class of
items or services shall be covered under the
medicare program under title XVIII of the So-
cial Security Act (42 U.S.C. 1395 et seq.), the
Secretary shall meet with such person not later
than 30 days after receiving the request.
(B) PURPOSE
OF
MEETING.—Subject to
paragraph (3), the purpose of any meeting pur-
suant to paragraph (1) shall be to enter into a
written agreement that describes the specific in-
formation the Secretary requires in order to
make a national coverage determination with
respect to the particular type or class of items
or services under such title.
(2) CONTENT
OF
NOTICE.—A notice under
paragraph (1) shall include the following descrip-
tions:
(A) A description of the particular type or
class of items or services proposed to be covered
under such title.
(B) A description of the conditions for the
use of the particular type or class of items or
services.
(C) A description of the benefit categories
for which the particular type or class of items
or services is intended to be used.
(3) EXCEPTION.—If the Secretary determines
that a national coverage policy determination is not
appropriate or is premature for the particular class
of items or services that is the subject of the meet-
ing, the Secretary may decline to enter into an
agreement.
(b) PROVISIONS REGARDING AGREEMENTS.—
(1) IN GENERAL.—In the case of an agreement
entered into by the Secretary and such person under
subsection (a), not later than 30 days after the date
the agreement is entered into, the Secretary shall
transmit the written agreement to such person. The
written agreement shall be part of the administrative
record with respect to the national coverage deter-
mination of the particular type or class of items or
services proposed by such person to be covered
under such title.
(2) MODIFICATIONS.—
(A) IN
GENERAL.—Subject to subpara-
graphs (B) and (C), any agreement entered into
under subsection (a) may not be modified.
(B) EXCEPTIONS.—Any such agreement
may be modified in any of the follow manners:
(i) In the case of a proposed modifica-
tion to the person by the Secretary, other
than a determination under clause (ii), the
person submits to the Secretary written
notice that the person agrees to the modi-
fication.
(ii) Subject to subparagraph (C), the
Secretary determines that a substantial
scientific issue essential to determining
whether the particular type of class of
items or services is reasonable and nec-
essary has been identified.
(C) SUBSTANTIAL
SCIENTIFIC
ISSUE.—A
modification to an agreement by reason of a de-
termination under subparagraph (B)(ii) shall be
in writing, and may only be made after the Sec-
retary has provided to such person an oppor-
tunity to meet with the Secretary to discuss the
scientific issue involved.
(c) TRADE SECRETS.—Subject to paragraph (2), any
information reported to or otherwise obtained by the Sec-
retary pursuant to this section which is exempt from dis-
closure pursuant to subsection (a) of section 552 of title
5, United States Code, by reason of subsection (b)(4) of
such section, shall be considered confidential and may not
be disclosed, except that such information may be dis-
closed to officers or employees of the Department of
Health and Human Services in their capacity as employees
in administering the medicare program under title XVIII
of the Social Security Act.
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