Accelerating Innovation in Medicine Act of 2013 or AIM Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to develop an AIM list of medical devices for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual who consents to receive such a device is responsible for paying for it and for any related services.
Directs the Secretary to post on a public HHS website or other publicly accessible media an updated list of the medical devices on the AIM list.
[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.''.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
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