I 

114TH CONGRESS 

1ST SESSION H. R. 2597 

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 

JUNE 1, 2015 

Mr. PAULSEN (for himself, Mr. KIND, Mr. SHIMKUS, and Mrs. MIMI WALTERS of California) 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 selfpay under the Medicare program, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accelerating Innova5 tion in Medicine Act of 2015’’ or the ‘‘AIM Act of 2015’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) Innovation in health care technology is nec4 essary to improve health outcomes and depends in 

5 part on the ability of medical technology developers, 

6 including scientists, physicians, engineers, and pa7 tient advocates, to introduce medical devices into the 

8 marketplace. 

9 (2) Even after meeting requirements for mar10 keting set by the Food and Drug Administration, 

11 there may be uncertainties about patient access 

12 through Government health care programs, causing 

13 significant delays in bringing innovative medical de14 vices to patients or causing medical technology de15 velopers to abandon potential health care solutions. 

16 (3) Patients covered by the Medicare program 

17 are often willing to enter into self-pay arrangements 

18 with physicians and other providers to purchase 

19 items or services, yet under current laws restricting 

20 such freedom of choice, the self-pay arrangements 

21 may be associated with regulatory impediments or a 

22 risk of civil penalties. 

23 (4) Enabling health care technology manufac24 turers to designate products to be directly available 

25 to self-pay patients and excluded from Government 

26 health program payments at an early stage of prodVerDate Sep 11 2014 04:15 Jun 02, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2597.IH H2597

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1 uct development will promote innovation and result 

2 in increased patient access to desired products and 

3 services, save taxpayer dollars, and reduce adminis4 trative burdens on physicians and the Government. 

5 (5) Enabling health care technology manufac6 turers to designate their devices as available to self7 pay patients would permit a window of time during 

8 which additional data may be obtained on outcomes, 

9 comparative clinical effectiveness or other data ele10 ments for possible future coverage by the Medicare 

11 program. 

12 SEC. 3. ESTABLISHMENT OF MANUFACTURER OPT-OUT 

13 PROGRAM FOR MEDICAL DEVICES. 

14 (a) IN GENERAL.—Section 1862 of the Social Secu15 rity Act (42 U.S.C. 1395y) is amended adding at the end 

16 the following new subsection: 

17 ‘‘(p) ESTABLISHMENT OF ACCELERATING INNOVA18 TION IN MEDICINE (AIM) LIST OF MEDICAL DEVICES

19 VOLUNTARILY EXCLUDED FROM COVERAGE.— 

20 ‘‘(1) IN GENERAL.—Not later than 90 days 

21 after the date of the enactment of this subsection, 

22 the Secretary shall develop and maintain a listing 

23 (in this section referred to as the ‘AIM list’) of med24 ical devices for which, because of their inclusion in 

25 such listing, no insurance benefit and no payment 


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1 may be made for such a device under this title either 

2 directly or on a capitated basis such that no claim 

3 for payment may be submitted under this title for 

4 such a device and an individual who consents to re5 ceive such a device is responsible for payment for 

6 the device and services related to furnishing the de7 vice. 

8 ‘‘(2) PROCEDURES FOR INCLUSION IN AIM

9 LIST.— 

10 ‘‘(A) REQUIREMENT FOR WRITTEN CON11 SENT OF MANUFACTURER.—No medical device 

12 may be included in the AIM list without the 

13 written consent of the manufacturer of the de14 vice. 

15 ‘‘(B) SUBMISSION PROCESS.—A manufac16 turer seeking to have a medical device included 

17 in the AIM list shall submit to the Secretary a 

18 request for inclusion of the device in the AIM 

19 list. In the case of such a device for which— 

20 ‘‘(i) there is a request for approval or 

21 clearance for marketing and sale of the de22 vice by the Food and Drug Administration 

23 pursuant to authority granted by the Fed24 eral Food, Drug, and Cosmetic Act (21 

25 U.S.C. 301 et seq.), including pursuant to 


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1 section 510(k) or 515(c) of such Act (21 

2 U.S.C. 360(k), 360e(c)), the request for 

3 inclusion of the device in the AIM list may 

4 not be submitted earlier than the date of 

5 the request for such approval or clearance 

6 and no later than the first business day of 

7 the month beginning at least 30 days after 

8 the date of such approval or clearance; or 

9 ‘‘(ii) the device is exempt from such 

10 approval and clearance requirements, the 

11 request may be submitted at a time that is 

12 not later than the first business day of the 

13 month beginning at least 30 days after the 

14 date of the first sale of the device by its 

15 manufacturer. 

16 ‘‘(3) LISTING PERIODS; REMOVAL FROM LIST.— 

17 ‘‘(A) 3-YEAR LISTING PERIODS.—A med18 ical device included in the AIM list shall be ini19 tially listed for a period of 3 years and shall re20 main so listed for subsequent 3-year periods 

21 subject to subparagraphs (B) and (C). 

22 ‘‘(B) REMOVAL AT REQUEST OF MANUFAC23 TURER.—At any time a device of a manufac24 turer included in the AIM list shall be removed 

25 from the AIM list upon the written request of 


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1 the manufacturer. Subject to subparagraph (C), 

2 such a device of a manufacturer may not be re3 moved from the AIM list except upon the writ4 ten request of the manufacturer. 

5 ‘‘(C) PROVISION OF DATA ON CLINICAL

6 STUDIES AS A CONDITION FOR CONTINUED

7 LISTING.—As a condition for the continued in8 clusion of the device of a manufacturer in the 

9 AIM list for a subsequent 3-year listing period 

10 under subparagraph (A), the manufacturer 

11 shall provide the Secretary with published or 

12 publicly available data on clinical studies com13 pleted for the device at the end of the previous 

14 3-year listing period. If the Secretary deter15 mines that a manufacturer of a device has ma16 terially failed to provide such data for the de17 vice, the Secretary may remove the device from 

18 the AIM list or not renew the listing for the de19 vice or both. 

20 ‘‘(4) MEDICAL DEVICE DEFINED.—In this sub21 section, the term ‘medical device’ has the meaning 

22 given the term ‘device’ in section 201(h) of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

24 321(h)). 


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1 ‘‘(5) POSTING OF LISTED DEVICES ON

2 WEBSITE.—The Secretary shall post on a public 

3 website of the Department of Health and Human 

4 Services or other publicly accessible manner a list of 

5 the medical devices included in the AIM list and 

6 shall provide for updating the website on a real-time 

7 basis (but no less frequently than monthly) to reflect 

8 changes in the medical devices in the AIM list. 

9 ‘‘(6) REGULATIONS NOT REQUIRED.—Nothing 

10 in this subsection shall be construed as requiring the 

11 Secretary to promulgate regulations to carry out this 

12 subsection. 

13 ‘‘(7) REQUIREMENT FOR INFORMED CONSENT

14 IN ORDER FOR PROVIDER TO CHARGE FOR DE15 VICE.—If a physician or other entity furnishes a 

16 medical device included in the AIM list to an indi17 vidual under this title and failed to obtain, before 

18 furnishing the device, an appropriate informed con19 sent under which the individual is informed of and 

20 accepts liability under paragraph (1) for payment 

21 for the device (and related services), the physician or 

22 other entity is deemed to have agreed not to impose 

23 any charge under this title for such device (and for 

24 services related to furnishing the device).’’. 


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1 (b) CONFORMING AMENDMENT.—Section 1862(a) of 

2 the Social Security Act (42 U.S.C. 1395y(a)) is amend3 ed— 

4 (1) in paragraph (24), by striking ‘‘or’’ at the 

5 end; 

6 (2) in paragraph (25), by striking the period at 

7 the end and inserting ‘‘; or’’; and 

8 (3) by inserting after paragraph (25) the fol9 lowing new paragraph: 

10 ‘‘(26) where such expenses are for a medical de11 vice included in the AIM list under section 1862(p) 

12 or for items and services related to furnishing such 

13 device.’’. 

Æ 


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