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[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 955 Introduced in Senate (IS)]

104th CONGRESS
  1st Session
                                 S. 955

   To clarify the scope of coverage and amount of payment under the 
 medicare program of items and services associated with the use in the 
 furnishing of inpatient hospital services of certain medical devices 
                   approved for investigational use.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                June 22 (legislative day, June 19), 1995

    Mr. Hatch (for himself, Mr. Gregg, Mr. Frist, Mr. Kennedy, Mrs. 
 Kassebaum, Mr. Grams, Mr. Wellstone, Mr. Chafee, Mrs. Hutchison, and 
 Mr. D'Amato) introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL

 
   To clarify the scope of coverage and amount of payment under the 
 medicare program of items and services associated with the use in the 
 furnishing of inpatient hospital services of certain medical devices 
                   approved for investigational use.
    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 ``Advanced Medical Devices Access 
Assurance Act of 1995''.

SEC. 2. CLARIFICATION OF MEDICARE COVERAGE OF ITEMS AND SERVICES 
              ASSOCIATED WITH CERTAIN MEDICAL DEVICES APPROVED FOR 
              INVESTIGATIONAL USE.

    (a) Coverage.--Nothing in title XVIII of the Social Security Act 
may be construed to prohibit coverage under part A or part B of the 
medicare program of items and services associated with the use of a 
medical device in the furnishing of inpatient hospital services (as 
defined for purposes of part A of the medicare program) solely on the 
grounds that the device is not an approved device, if--
            (1) the device is an investigational device; and
            (2) the device is used instead of either an approved device 
        or a covered procedure.
    (b) Clarification of Payment Amount.--Notwithstanding any other 
provision of title XVIII of the Social Security Act, the amount of 
payment made under the medicare program for any item or service 
associated with the use of an investigational device in the furnishing 
of inpatient hospital services (as defined for purposes of part A of 
the medicare program) may not exceed the amount of the payment which 
would have been made under the program for the item or service if the 
item or service were associated with the use of an approved device or a 
covered procedure.

SEC. 3. DEFINITIONS.

    In this Act--
            (1) the term ``approved device'' means a medical device 
        which has been approved for marketing under pre-market approval 
        under the Federal Food, Drug, and Cosmetic Act or cleared for 
        marketing under a 510(k) notice under such Act; and
            (2) the term ``investigational device'' means a medical 
        device (other than a device described in paragraph (1)) which 
        is approved for investigational use under section 520(g) of the 
        Federal Food, Drug, and Cosmetic Act.
                                 <all>
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