uct development will promote innovation and result 
in increased patient access to desired products and 
services, save taxpayer dollars, and reduce adminis-
trative burdens on physicians and the Government. 
(5) Enabling health care technology manufac-
turers 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 ele-
ments 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 Secu-
rity Act (42 U.S.C. 1395y) is amended adding at the end 
the following new subsection: 
‘‘(p) ESTABLISHMENT OF ACCELERATING INNOVA-
TION 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 med-
ical devices for which, because of their inclusion in 
such listing, no insurance benefit and no payment 
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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 re-
ceive such a device is responsible for payment for 
the device and services related to furnishing the de-
vice. 
‘‘(2) PROCEDURES
FOR
INCLUSION
IN
AIM 
LIST.— 
‘‘(A) REQUIREMENT
FOR
WRITTEN
CON-
SENT OF MANUFACTURER.—No medical device 
may be included in the AIM list without the 
written consent of the manufacturer of the de-
vice. 
‘‘(B) SUBMISSION PROCESS.—A manufac-
turer 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 de-
vice by the Food and Drug Administration 
pursuant to authority granted by the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), including pursuant to 
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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 med-
ical device included in the AIM list shall be ini-
tially listed for a period of 3 years and shall re-
main so listed for subsequent 3-year periods 
subject to subparagraphs (B) and (C). 
‘‘(B) REMOVAL AT REQUEST OF MANUFAC-
TURER.—At any time a device of a manufac-
turer included in the AIM list shall be removed 
from the AIM list upon the written request of 
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the manufacturer. Subject to subparagraph (C), 
such a device of a manufacturer may not be re-
moved from the AIM list except upon the writ-
ten request of the manufacturer. 
‘‘(C) PROVISION
OF
DATA
ON
CLINICAL 
STUDIES
AS
A
CONDITION
FOR
CONTINUED 
LISTING.—As a condition for the continued in-
clusion 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 com-
pleted for the device at the end of the previous 
3-year listing period. If the Secretary deter-
mines that a manufacturer of a device has ma-
terially failed to provide such data for the de-
vice, the Secretary may remove the device from 
the AIM list or not renew the listing for the de-
vice or both. 
‘‘(4) MEDICAL DEVICE DEFINED.—In this sub-
section, the term ‘medical device’ has the meaning 
given the term ‘device’ in section 201(h) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
321(h)). 
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‘‘(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
DE-
VICE.—If a physician or other entity furnishes a 
medical device included in the AIM list to an indi-
vidual under this title and failed to obtain, before 
furnishing the device, an appropriate informed con-
sent 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).’’. 
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