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 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 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Medicare Coverage In3 formation Decision Act of 1999’’.

4 SEC. 2. MEETINGS REGARDING COVERAGE DECISIONS.

5 (a) MEETINGS WITH THE SECRETARY.—

6 (1) IN GENERAL.—

7 (A) DEADLINE FOR MEETING.—In the

8 case of a person who submits to the Secretary

9 of Health and Human Services written notice

10 that the person intends to seek a national cov11 erage determination by the Secretary with re12 spect to whether a particular type or class of

13 items or services shall be covered under the

14 medicare program under title XVIII of the So15 cial Security Act (42 U.S.C. 1395 et seq.), the

16 Secretary shall meet with such person not later

17 than 30 days after receiving the request.

18 (B) PURPOSE OF MEETING.—Subject to

19 paragraph (3), the purpose of any meeting pur20 suant to paragraph (1) shall be to enter into a

21 written agreement that describes the specific in22 formation the Secretary requires in order to

23 make a national coverage determination with

24 respect to the particular type or class of items

25 or services under such title.
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1 (2) CONTENT OF NOTICE.—A notice under

2 paragraph (1) shall include the following descrip3 tions:

4 (A) A description of the particular type or

5 class of items or services proposed to be covered

6 under such title.

7 (B) A description of the conditions for the

8 use of the particular type or class of items or

9 services.

10 (C) A description of the benefit categories

11 for which the particular type or class of items

12 or services is intended to be used.

13 (3) EXCEPTION.—If the Secretary determines

14 that a national coverage policy determination is not

15 appropriate or is premature for the particular class

16 of items or services that is the subject of the meet17 ing, the Secretary may decline to enter into an

18 agreement.

19 (b) PROVISIONS REGARDING AGREEMENTS.—

20 (1) IN GENERAL.—In the case of an agreement

21 entered into by the Secretary and such person under

22 subsection (a), not later than 30 days after the date

23 the agreement is entered into, the Secretary shall

24 transmit the written agreement to such person. The

25 written agreement shall be part of the administrative
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1 record with respect to the national coverage deter2 mination of the particular type or class of items or

3 services proposed by such person to be covered

4 under such title.

5 (2) MODIFICATIONS.—

6 (A) IN GENERAL.—Subject to subpara7 graphs (B) and (C), any agreement entered into

8 under subsection (a) may not be modified.

9 (B) EXCEPTIONS.—Any such agreement

10 may be modified in any of the follow manners:

11 (i) In the case of a proposed modifica12 tion to the person by the Secretary, other

13 than a determination under clause (ii), the

14 person submits to the Secretary written

15 notice that the person agrees to the modi16 fication.

17 (ii) Subject to subparagraph (C), the

18 Secretary determines that a substantial

19 scientific issue essential to determining

20 whether the particular type of class of

21 items or services is reasonable and nec22 essary has been identified.

23 (C) SUBSTANTIAL SCIENTIFIC ISSUE.—A

24 modification to an agreement by reason of a de25 termination under subparagraph (B)(ii) shall be
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1 in writing, and may only be made after the Sec2 retary has provided to such person an oppor3 tunity to meet with the Secretary to discuss the

4 scientific issue involved.

5 (c) TRADE SECRETS.—Subject to paragraph (2), any

6 information reported to or otherwise obtained by the Sec7 retary pursuant to this section which is exempt from dis8 closure pursuant to subsection (a) of section 552 of title

9 5, United States Code, by reason of subsection (b)(4) of

10 such section, shall be considered confidential and may not

11 be disclosed, except that such information may be dis12 closed to officers or employees of the Department of

13 Health and Human Services in their capacity as employees

14 in administering the medicare program under title XVIII

15 of the Social Security Act.

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