[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2338 Introduced in House (IH)]







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.

    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 Coverage Information 
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 coverage determination by the Secretary with 
                respect to whether a particular type or class of items 
                or services shall be covered under the medicare program 
                under title XVIII of the Social 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 pursuant to paragraph (1) 
                shall be to enter into a written agreement that 
                describes the specific information 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 descriptions:
                    (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 meeting, 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 
        determination 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 subparagraphs (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 modification 
                        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 modification.
                            (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 necessary has 
                        been identified.
                    (C) Substantial scientific issue.--A modification 
                to an agreement by reason of a determination under 
                subparagraph (B)(ii) shall be in writing, and may only 
                be made after the Secretary has provided to such person 
                an opportunity 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 Secretary pursuant to this 
section which is exempt from disclosure 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 disclosed 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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