II 

114TH CONGRESS 

1ST SESSION S. 1757 

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 SENATE OF THE UNITED STATES 

JULY 14, 2015 

Mr. PORTMAN (for himself, Mr. HEINRICH, Mr. THUNE, and Mr. BENNET) 

introduced the following bill; which was read twice and referred to the 

Committee on Finance 

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’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 


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1 (1) Innovation in health care technology is nec2 essary to improve health outcomes and depends in 

3 part on the ability of medical technology developers, 

4 including scientists, physicians, engineers, and pa5 tient advocates, to introduce medical devices into the 

6 marketplace. 

7 (2) Even after meeting requirements for mar8 keting set by the Food and Drug Administration, 

9 there may be uncertainties about patient access 

10 through government health care programs, causing 

11 significant delays in bringing innovative medical de12 vices to patients or causing medical technology de13 velopers to abandon potential health care solutions. 

14 (3) Patients covered by the Medicare program 

15 are often willing to enter into self-pay arrangements 

16 with physicians and other providers to purchase 

17 items or services, yet under current laws restricting 

18 such freedom of choice, the self-pay arrangements 

19 may be associated with regulatory impediments or a 

20 risk of civil penalties. 

21 (4) Enabling health care technology manufac22 turers to designate products to be directly available 

23 to self-pay patients and excluded from government 

24 health program payments at an early stage of prod25 uct development will promote innovation and result 


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1 in increased patient access to desired products and 

2 services, save taxpayer dollars, and reduce adminis3 trative burdens on physicians and the government. 

4 (5) Enabling health care technology manufac5 turers to designate their devices as available to self6 pay patients would permit a window of time during 

7 which additional data may be obtained on outcomes, 

8 comparative clinical effectiveness or other data ele9 ments for possible future coverage by the Medicare 

10 program. 

11 SEC. 3. ESTABLISHMENT OF MANUFACTURER OPT-OUT 

12 PROGRAM FOR MEDICAL DEVICES. 

13 (a) IN GENERAL.—Section 1862 of the Social Secu14 rity Act (42 U.S.C. 1395y) is amended adding at the end 

15 the following new subsection: 

16 ‘‘(p) ESTABLISHMENT OF ACCELERATING INNOVA17 TION IN MEDICINE (AIM) LIST OF MEDICAL DEVICES

18 VOLUNTARILY EXCLUDED FROM COVERAGE.— 

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

20 after the date of the enactment of this subsection, 

21 the Secretary shall develop and maintain a listing 

22 (in this section referred to as the ‘AIM list’) of med23 ical devices for which, because of their inclusion in 

24 such listing, no insurance benefit and no payment 

25 may be made for such a device (or for any items or 


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1 services related to furnishing such device) under this 

2 title either directly or on a capitated basis such that 

3 no claim for payment may be submitted under this 

4 title for such a device (or for any items or services 

5 related to furnishing such device) and an individual 

6 who consents to receive such a device is responsible 

7 for payment for the device (and for any items and 

8 services related to furnishing such device). 

9 ‘‘(2) PROCEDURES FOR INCLUSION IN AIM

10 LIST.— 

11 ‘‘(A) REQUIREMENT FOR WRITTEN CON12 SENT OF MANUFACTURER.—No medical device 

13 may be included in the AIM list without the 

14 written consent of the manufacturer of the de15 vice. 

16 ‘‘(B) SUBMISSION PROCESS.—A manufac17 turer seeking to have a medical device included 

18 in the AIM list shall submit to the Secretary a 

19 request for inclusion of the device in the AIM 

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

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

22 clearance for marketing and sale of the de23 vice by the Food and Drug Administration 

24 pursuant to authority granted by the Fed25 eral Food, Drug, and Cosmetic Act (21 


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

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

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

4 inclusion of the device in the AIM list may 

5 not be submitted earlier than the date of 

6 the request for such approval or clearance 

7 and no later than the first business day of 

8 the month beginning at least 30 days after 

9 the date of such approval or clearance; or 

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

11 approval and clearance requirements, the 

12 request may be submitted at a time that is 

13 not later than the first business day of the 

14 month beginning at least 30 days after the 

15 date of the first sale of the device by its 

16 manufacturer. 

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

18 ‘‘(A) 3-YEAR LISTING PERIODS.—A med19 ical device included in the AIM list shall be ini20 tially listed for a period of 3 years and shall re21 main so listed for subsequent 3-year periods 

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

23 ‘‘(B) REMOVAL AT REQUEST OF MANUFAC24 TURER.—At any time a device of a manufac25 turer included in the AIM list shall be removed 


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1 from the AIM list upon the written request of 

2 the manufacturer. Subject to subparagraph (C), 

3 such a device of a manufacturer may not be re4 moved from the AIM list except upon the writ5 ten request of the manufacturer. 

6 ‘‘(C) PROVISION OF DATA ON CLINICAL

7 STUDIES AS A CONDITION FOR CONTINUED

8 LISTING.—As a condition for the continued in9 clusion of the device of a manufacturer in the 

10 AIM list for a subsequent 3-year listing period 

11 under subparagraph (A), the manufacturer 

12 shall provide the Secretary with published or 

13 publicly available data on clinical studies com14 pleted for the device at the end of the previous 

15 3-year listing period. If the Secretary deter16 mines that a manufacturer of a device has ma17 terially failed to provide such data for the de18 vice, the Secretary may remove the device from 

19 the AIM list or not renew the listing for the de20 vice or both. 

21 ‘‘(4) MEDICAL DEVICE DEFINED.—In this sub22 section, the term ‘medical device’ has the meaning 

23 given the term ‘device’ in section 201(h) of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

25 321(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 for items and services related to 

22 furnishing such device), the physician or other entity 

23 is deemed to have agreed not to impose any charge 

24 under this title for such device (and for items and 

25 services related to furnishing such 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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