[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3681 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 3681

To amend title XVIII of the Social Security Act to promote health care 
 technology innovation and access to medical devices and services for 
 which patients choose to self-pay under the Medicare program, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            December 9, 2013

Mr. Paulsen (for himself, Mr. Matheson, Mr. Shimkus, and Mr. Barrow of 
   Georgia) introduced the following bill; which was referred to the 
Committee on Ways and Means, and in addition to the Committee on Energy 
    and 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 amend title XVIII of the Social Security Act to promote health care 
 technology innovation and access to medical devices and services for 
 which patients choose to self-pay under the Medicare program, and for 
                            other purposes.

    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 ``Accelerating Innovation in Medicine 
Act of 2013'' or the ``AIM Act of 2013''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Innovation in health care technology is necessary to 
        improve health outcomes and depends in part on the ability of 
        medical technology developers, including scientists, 
        physicians, engineers, and patient advocates, to introduce 
        medical devices into the marketplace.
            (2) Even after meeting requirements for marketing set by 
        the Food and Drug Administration, there may be uncertainties 
        about patient access through government health care programs, 
        causing significant delays in bringing innovative medical 
        devices to patients or causing medical technology developers to 
        abandon potential health care solutions.
            (3) Patients covered by the Medicare program are often 
        willing to enter into self-pay arrangements with physicians and 
        other providers to purchase items or services, yet under 
        current laws restricting such freedom of choice, the self-pay 
        arrangements may be associated with regulatory impediments or a 
        risk of civil penalties.
            (4) Enabling health care technology manufacturers to 
        designate products to be directly available to self-pay 
        patients and excluded from government health program payments 
        at an early stage of product development will promote 
        innovation and result in increased patient access to desired 
        products and services, save taxpayer dollars, and reduce 
        administrative burdens on physicians and the government.
            (5) Enabling health care technology manufacturers to 
        designate their devices as available to self-pay patients would 
        permit a window of time during which additional data may be 
        obtained on outcomes, comparative clinical effectiveness or 
        other data elements for possible future coverage by the 
        Medicare program.

SEC. 3. ESTABLISHMENT OF MANUFACTURER OPT-OUT PROGRAM FOR MEDICAL 
              DEVICES.

    (a) In General.--Section 1862 of the Social Security Act (42 U.S.C. 
1395y) is amended adding at the end the following new subsection:
    ``(p) Establishment of Accelerating Innovation in Medicine (AIM) 
List of Medical Devices Voluntarily Excluded From Coverage.--
            ``(1) In general.--Not later than 90 days after the date of 
        the enactment of this subsection, the Secretary shall develop 
        and maintain a listing (in this section referred to as the `AIM 
        list') of medical devices for which, because of their inclusion 
        in such listing, no insurance benefit and no payment may be 
        made for such a device under this title either directly or on a 
        capitated basis such that no claim for payment may be submitted 
        under this title for such a device and an individual who 
        consents to receive such a device is responsible for payment 
        for the device and services related to furnishing the device.
            ``(2) Procedures for inclusion in aim list.--
                    ``(A) Requirement for written consent of 
                manufacturer.--No medical device may be included in the 
                AIM list without the written consent of the 
                manufacturer of the device.
                    ``(B) Submission process.--A manufacturer seeking 
                to have a medical device included in the AIM list shall 
                submit to the Secretary a request for inclusion of the 
                device in the AIM list. In the case of such a device 
                for which--
                            ``(i) there is a request for approval or 
                        clearance for marketing and sale of the device 
                        by the Food and Drug Administration pursuant to 
                        authority granted by the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 301 et seq.), 
                        including pursuant to section 510(k) or 515(c) 
                        of such Act (21 U.S.C. 360(k), 360e(c)), the 
                        request for inclusion of the device in the AIM 
                        list may not be submitted earlier than the date 
                        of the request for such approval or clearance 
                        and no later than the first business day of the 
                        month beginning at least 30 days after the date 
                        of such approval or clearance; or
                            ``(ii) the device is exempt from such 
                        approval and clearance requirements, the 
                        request may be submitted at a time that is not 
                        later than the first business day of the month 
                        beginning at least 30 days after the date of 
                        the first sale of the device by its 
                        manufacturer.
            ``(3) Listing periods; removal from list.--
                    ``(A) 3-year listing periods.--A medical device 
                included in the AIM list shall be initially listed for 
                a period of 3 years and shall remain so listed for 
                subsequent 3-year periods subject to subparagraphs (B) 
                and (C).
                    ``(B) Removal at request of manufacturer.--At any 
                time a device of a manufacturer included in the AIM 
                list shall be removed from the AIM list upon the 
                written request of the manufacturer. Subject to 
                subparagraph (C), such a device of a manufacturer may 
                not be removed from the AIM list except upon the 
                written request of the manufacturer.
                    ``(C) Provision of data on clinical studies as a 
                condition for continued listing.--As a condition for 
                the continued inclusion of the device of a manufacturer 
                in the AIM list for a subsequent 3-year listing period 
                under subparagraph (A), the manufacturer shall provide 
                the Secretary with published or publicly available data 
                on clinical studies completed for the device at the end 
                of the previous 3-year listing period. If the Secretary 
                determines that a manufacturer of a device has 
                materially failed to provide such data for the device, 
                the Secretary may remove the device from the AIM list 
                or not renew the listing for the device or both.
            ``(4) Medical device defined.--In this subsection, the term 
        `medical device' has the meaning given the term `device' in 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h)).
            ``(5) Posting of listed devices on website.--The Secretary 
        shall post on a public website of the Department of Health and 
        Human Services or other publicly accessible manner a list of 
        the medical devices included in the AIM list and shall provide 
        for updating the website on a real-time basis (but no less 
        frequently than monthly) to reflect changes in the medical 
        devices in the AIM list.
            ``(6) Regulations not required.--Nothing in this subsection 
        shall be construed as requiring the Secretary to promulgate 
        regulations to carry out this subsection.
            ``(7) Requirement for informed consent in order for 
        provider to charge for device.--If a physician or other entity 
        furnishes a medical device included in the AIM list to an 
        individual under this title and failed to obtain, before 
        furnishing the device, an appropriate informed consent under 
        which the individual is informed of and accepts liability under 
        paragraph (1) for payment for the device (and related 
        services), the physician or other entity is deemed to have 
        agreed not to impose any charge under this title for such 
        device (and for services related to furnishing the device).''.
    (b) Conforming Amendment.--Section 1862(a) of the Social Security 
Act (42 U.S.C. 1395y(a)) is amended--
            (1) in paragraph (24), by striking ``or'' at the end;
            (2) in paragraph (25), by striking the period at the end 
        and inserting ``; or''; and
            (3) by inserting after paragraph (25) the following new 
        paragraph:
            ``(26) where such expenses are for a medical device 
        included in the AIM list under section 1862(p) or for items and 
        services related to furnishing such device.''.
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