II 

116TH CONGRESS 

2D SESSION S. 3914 

To amend title XVIII of the Social Security Act to ensure prompt coverage 

of breakthrough devices under the Medicare program, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 8, 2020 

Ms. MCSALLY 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 ensure 

prompt coverage of breakthrough devices 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 ‘‘Ensuring Patient Ac5 cess to Critical Breakthrough Products Act of 2020’’. 

6 SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH 

7 DEVICES UNDER THE MEDICARE PROGRAM. 

8 (a) IN GENERAL.—Part E of title XVIII of the Social 

9 Security Act (42 U.S.C. 1395x et seq.) is amended by add10 ing at the end the following new section: 


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1 ‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES. 

2 ‘‘(a) BREAKTHROUGH DEVICES.— 

3 ‘‘(1) IN GENERAL.—For purposes of this sec4 tion, the term ‘breakthrough device’ means a med5 ical device that is a device (as defined in section 201 

6 of the Federal Food, Drug, and Cosmetic Act) and 

7 that is— 

8 ‘‘(A) provided with review priority by the 

9 Secretary under subsection (d)(5) of section 

10 515 of such Act; and 

11 ‘‘(B) approved or cleared pursuant to sec12 tion 510(k), 513(f), or 515 of such Act for use 

13 in treating an indication on or after July 1, 

14 2019. 

15 Such term also includes a breakthrough device that 

16 is a specified breakthrough device (as defined in sub17 section (e)(1)(B)) approved or cleared pursuant to 

18 section 510(k), 513(f), or 515 of such Act for use 

19 in treating an indication on or after December 1, 

20 2018. 

21 ‘‘(2) LIMITATION ON NUMBER OF 510(k) DE22 VICES.—With respect to a 5-year period, in no case 

23 may more than five medical devices described in 

24 paragraph (1) that are classified under section 

25 510(k) of the Federal Food, Drug, and Cosmetic 


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1 Act be covered and paid for under this title by rea2 son of this section during each such 5-year period. 

3 ‘‘(b) COVERAGE.— 

4 ‘‘(1) TRANSITIONAL COVERAGE.— 

5 ‘‘(A) IN GENERAL.—During the transi6 tional coverage period (as defined in subpara7 graph (B)) a breakthrough device shall be— 

8 ‘‘(i) deemed to be reasonable and nec9 essary for purposes of section 

10 1862(a)(1)(A); 

11 ‘‘(ii) deemed to be a medical or other 

12 health service for purposes of section 

13 1861(s); 

14 ‘‘(iii) deemed to be approved for an 

15 additional payment under section 

16 1886(d)(5)(K) (other than with respect to 

17 the cost criterion under clause (ii)(I) of 

18 such section); 

19 ‘‘(iv) deemed to be approved for pass20 through payment under section 1833(t)(6) 

21 and section 1833(i) (other than with re22 spect to the cost criterion under section 

23 1833(t)(6)(A)(iv)); and 

24 ‘‘(v) insofar as such breakthrough de25 vice may be furnished in a setting for 


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1 which payment is made under an applica2 ble payment system described in subpara3 graphs (D) through (L) of subsection 

4 (c)(4), deemed eligible for an additional 

5 payment or payment adjustment, as the 

6 case may be, pursuant to subsection (d)(3) 

7 when furnished in a setting for which pay8 ment is made under such an applicable 

9 payment system during such transitional 

10 coverage period. 

11 ‘‘(B) TRANSITIONAL COVERAGE PERIOD

12 DEFINED.—As used in this section, the term 

13 ‘transitional coverage period’ means, with re14 spect to a breakthrough device, the period 

15 that— 

16 ‘‘(i) begins on the date of the approval 

17 under section 515 of the Federal Food, 

18 Drug, and Cosmetic Act or of the clear19 ance under section 510(k) of such Act, as 

20 applicable, of such device by the Secretary 

21 for the indication described in subsection 

22 (a)(1); and 

23 ‘‘(ii) ends on the last day of the 3- 

24 year period that begins on the date that 

25 the Secretary, pursuant to subsection 


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1 (c)(2), updates the relevant applicable pay2 ment system (as defined in subsection 

3 (c)(4)) to recognize the unique temporary 

4 or permanent code or codes assigned under 

5 subsection (c)(1) to such breakthrough de6 vice, except as provided in subsections 

7 (d)(1)(B) and (d)(2)(B). 

8 ‘‘(C) DATA USED TO MEET THE NTAP AND

9 PASS-THROUGH COST CRITERIA.—In deter10 mining whether a breakthrough device qualifies 

11 for an additional payment under section 

12 1886(d)(5)(K) or for pass-through payment 

13 under section 1833(t)(6) or section 1833(i), the 

14 Secretary shall use the most recently available 

15 data and information on the costs of such 

16 breakthrough device, which may include list 

17 prices and invoice prices charged for such 

18 breakthrough device. 

19 ‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 

20 purposes of the application of section 1862(a)(1)(A) 

21 to a breakthrough device furnished after the transi22 tional coverage period (as defined in paragraph 

23 (1)(B)) for such device, the Secretary shall establish 

24 a process for the coverage of such breakthrough de25 vices under this title after such period as follows: 


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1 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI2 DENCE.— 

3 ‘‘(i) IN GENERAL.—With respect to a 

4 breakthrough device, not later than 1 year 

5 after the date of the approval of such de6 vice under section 515 of the Federal 

7 Food, Drug, and Cosmetic Act or of the 

8 clearance of such device under section 

9 510(k) of such Act, as applicable, the Sec10 retary shall identify whether any additional 

11 data or evidence is required with respect to 

12 any indications for such device for pur13 poses of the application of such section 

14 1862(a)(1)(A) to such device for such indi15 cations. 

16 ‘‘(ii) NON-DUPLICATION OF DATA RE17 QUESTS.—In carrying out clause (i) with 

18 respect to a breakthrough device, the Sec19 retary shall ensure that data or evidence 

20 identified— 

21 ‘‘(I) does not duplicate data re22 quired to be collected by the Food and 

23 Drug Administration with respect to 

24 such breakthrough device; 


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1 ‘‘(II) minimizes the administra2 tive burdens of data collection and re3 porting on providers of services, sup4 pliers, and manufacturers of break5 through devices; and 

6 ‘‘(III) is not otherwise unneces7 sary or redundant. 

8 ‘‘(B) PROPOSAL FOR COVERAGE AFTER

9 THE TRANSITIONAL COVERAGE PERIOD.—Not 

10 later than 2 years after the date of the approval 

11 or clearance of a breakthrough device by the 

12 Food and Drug Administration, the Secretary 

13 shall develop a proposal for coverage under this 

14 title of such breakthrough device for such indi15 cations as the Secretary determines to be ap16 propriate, based on the data and evidence col17 lected under subparagraph (A), for such devices 

18 furnished after the transitional coverage period 

19 under paragraph (1) for such device. If the Sec20 retary does not, on a date that is before the end 

21 of such 2-year period, take action to modify the 

22 indications for which coverage of a break23 through device may be provided under this title 

24 after such period, for purposes of section 

25 1862(a)(1)(A) coverage under this title of such 


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1 breakthrough device shall be made for all indi2 cations for which such device is approved under 

3 section 515 of the Federal Food, Drug, and 

4 Cosmetic Act or cleared under section 510(k) of 

5 such Act. 

6 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 

7 this section shall be construed to— 

8 ‘‘(A) affect the ability of the manufacturer 

9 of a breakthrough device to seek approval for 

10 pass-through payment status under section 

11 1833(t)(6) or to seek approval for an additional 

12 payment under section 1886(d)(5)(K) insofar 

13 as such breakthrough device does not qualify 

14 for transitional coverage under paragraph (1); 

15 or 

16 ‘‘(B) affect the application and approval 

17 process for pass-through payment status under 

18 section 1833(t)(6) or for an additional payment 

19 under section 1886(d)(5)(K) in the case of a 

20 medical device that is not approved by the Food 

21 and Drug Administration as a breakthrough de22 vice. 

23 ‘‘(c) CODING.— 

24 ‘‘(1) PROMPT ASSIGNMENT.—Not later than 

25 three months after the date of approval or clearance 


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1 of a breakthrough device by the Food and Drug Ad2 ministration, subject to subsection (b)(1)(B), the 

3 Secretary shall assign a unique temporary or perma4 nent code or codes for purposes of coverage and pay5 ment for such breakthrough device under the appli6 cable payment systems (described in paragraph (4)). 

7 ‘‘(2) UPDATES.— 

8 ‘‘(A) IPPS.—The Secretary shall provide 

9 for semiannual updates under the applicable 

10 payment system described in paragraph (4)(A) 

11 (relating to the inpatient hospital prospective 

12 payment system) to recognize the code or codes 

13 assigned under paragraph (1). 

14 ‘‘(B) OPPS.—The Secretary shall provide 

15 for quarterly updates under the applicable pay16 ment system described in paragraph (4)(B) (re17 lating to the outpatient hospital prospective 

18 payment system) to recognize the code or codes 

19 assigned under paragraph (1). 

20 ‘‘(C) OTHER PAYMENT SYSTEMS.—The 

21 Secretary shall provide for semiannual or quar22 terly updates, as the case may be, under the ap23 plicable payment systems described in subpara24 graphs (C) through (L) of paragraph (4) to recVerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914

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1 ognize the code or codes assigned under para2 graph (1). 

3 ‘‘(3) TRANSPARENCY.—The process for the as4 signment of a code or codes under this subsection 

5 shall provide for public notice and a meaningful op6 portunity for public comment from affected parties. 

7 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE8 SCRIBED.—For purposes of this subsection, the term 

9 ‘applicable payment systems’ means— 

10 ‘‘(A) with respect to inpatient hospital 

11 services, the prospective payment system for in12 patient hospital services established under sec13 tion 1886(d); 

14 ‘‘(B) with respect to outpatient hospital 

15 services, the prospective payment system for 

16 covered OPD services established under section 

17 1833(t); 

18 ‘‘(C) with respect to ambulatory surgical 

19 center services, the fee schedule for such serv20 ices established under section 1833(i); 

21 ‘‘(D) with respect to physicians’ services, 

22 the physician fee schedules established under 

23 section 1848; 


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1 ‘‘(E) with respect to covered items of dura2 ble medical equipment, the applicable fee sched3 ules established under section 1834; 

4 ‘‘(F) with respect to diagnostic laboratory 

5 tests, the payment amounts under section 

6 1834A and the fee schedules establish under 

7 section 1848, as the case may be; 

8 ‘‘(G) with respect to renal dialysis services 

9 furnished by a provider of services or a renal 

10 dialysis facility, the single payment system es11 tablished under section 1881(b)(14); 

12 ‘‘(H) with respect to inpatient hospital 

13 services furnished by rehabilitation facilities, 

14 the prospective payment system established 

15 under section 1886(j); 

16 ‘‘(I) with respect to inpatient hospital serv17 ices furnished by long-term care hospitals, the 

18 prospective payment system under section 

19 1886(m); 

20 ‘‘(J) with respect to inpatient hospital 

21 services furnished by psychiatric hospitals and 

22 psychiatric units, the prospective payment sys23 tem under section 1886(s); 


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1 ‘‘(K) with respect to home health services, 

2 the prospective payment system under section 

3 1895; and 

4 ‘‘(L) with respect to items and services, or 

5 a provider of services or supplier, not described 

6 in subparagraphs (A) through (K), the payment 

7 system established under this title for such 

8 items and services when furnished by such pro9 vider of services or supplier. 

10 ‘‘(d) PAYMENT.— 

11 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY12 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK13 THROUGH PAYMENT.—The Secretary shall deem 

14 each breakthrough device as approved for an addi15 tional payment under section 1886(d)(5)(K) for the 

16 3-year period that begins— 

17 ‘‘(A) except as provided in subparagraph 

18 (B), on the date that the Secretary, pursuant to 

19 subsection (c)(2)(A), updates the payment sys20 tem under section 1886(d) to recognize the 

21 unique temporary or permanent code or codes 

22 assigned under subsection (c)(1) to such break23 through device; or 

24 ‘‘(B) in the case of a device that has not 

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1 through device by the Food and Drug Adminis2 tration before such payment system is updated 

3 under subsection (c)(2)(A) to recognize the 

4 unique temporary or permanent code or codes 

5 assigned under subsection (c)(1) to such device, 

6 on the date of such approval or clearance. 

7 Nothing in this paragraph shall be construed to af8 fect the authority of the Secretary to use claims 

9 data to establish new diagnosis or procedure codes 

10 for breakthrough devices or to identify appropriate 

11 diagnosis-related groups for the assignment of 

12 breakthrough devices under annual rulemaking to 

13 carry out section 1886(d)(5)(K). 

14 ‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS15 TEM: DEEMED ELIGIBILITY FOR PASS-THROUGH

16 PAYMENT.—The Secretary shall deem each break17 through device as approved for pass-through pay18 ment under section 1833(t)(6) (including for pur19 poses of section 1833(i)(2)(D)) during the 3-year pe20 riod that begins— 

21 ‘‘(A) except as provided in subparagraph 

22 (B), on the date that the Secretary, pursuant to 

23 subsection (c)(2)(B), updates the payment sys24 tem under section 1833(t) to recognize the 

25 unique temporary or permanent code or codes 


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1 assigned under subsection (c)(1) to such break2 through device; or 

3 ‘‘(B) in the case of a device that has not 

4 received approval or clearance as a break5 through device by the Food and Drug Adminis6 tration before such payment system is updated 

7 under subsection (c)(2)(B) to recognize the 

8 unique temporary or permanent code or codes 

9 assigned under subsection (c)(1) to such device, 

10 on the date of such approval or clearance. 

11 Nothing in this paragraph shall be construed to af12 fect the authority of the Secretary to use claims 

13 data to establish new ambulatory payment classifica14 tion groups for breakthrough devices or to revise 

15 such groups to take into account breakthrough de16 vices under annual rulemaking to carry out section 

17 1833(t). 

18 ‘‘(3) OTHER PAYMENT SYSTEMS.— 

19 ‘‘(A) IN GENERAL.—In the case of a 

20 breakthrough device that is furnished and for 

21 which payment may be made under the pay22 ment system established under section 1834, 

23 1834A, 1848, 1881(b)(14), 1886(j), 1886(m), 

24 1886(s), or 1895, or any other provision of this 

25 title (other than sections 1833(i), 1833(t), and 


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1 1886(d)), the Secretary shall provide for an ad2 ditional payment for such breakthrough device 

3 under such applicable payment system or an 

4 adjustment to such applicable payment system, 

5 as the case may be. The payment basis for such 

6 additional payment or adjustment, as the case 

7 may be, shall equal an amount that the Sec8 retary determines covers the costs of such 

9 breakthrough device. 

10 ‘‘(B) COST INFORMATION.—In determining 

11 the costs of a breakthrough device for purposes 

12 of determining an additional payment or pay13 ment adjustment under subparagraph (A), the 

14 Secretary shall use the most recently available 

15 data and information on the costs of such 

16 breakthrough device, which may include list 

17 prices and invoice prices charged for such 

18 breakthrough device. 

19 ‘‘(C) RULE OF CONSTRUCTION.—Nothing 

20 in this paragraph shall be construed to affect 

21 the authority of the Secretary to use claims 

22 data to establish new or modify existing ambu23 latory payment classification groups, diagnosis24 related groups, level II HCPCS codes, or such 

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1 tablish under the annual rulemaking authority 

2 under the provisions referred to in subpara3 graph (A). 

4 ‘‘(D) CLINICAL DIAGNOSTIC LABORATORY

5 TESTS.—An additional payment or payment ad6 justment under subparagraph (A) for a break7 through device under the applicable payment 

8 system established in section 1834A may be in 

9 the form of an increase to the amount deter10 mined for the breakthrough device using cross11 walking under section 1834A(c)(1)(A), an ex12 tension of the initial period of payment applica13 ble to advance diagnostic laboratory tests under 

14 section 1834A(d)(1)(A), and in such other form 

15 or manner as the Secretary determines reflects 

16 the costs for such breakthrough device under 

17 the relevant provisions of section 1834A. 

18 ‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES

19 AFTER THE TRANSITIONAL COVERAGE PERIOD.— 

20 Payment for a breakthrough device that is furnished 

21 after the conclusion of the transitional coverage pe22 riod under subsection (b)(1) for such device shall be 

23 made pursuant to the applicable payment system in24 volved, taking into account the additional evidence 

25 and data collected under subsection (b)(2). 


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1 ‘‘(e) SPECIAL RULES FOR CERTAIN BREAKTHROUGH

2 DEVICES.— 

3 ‘‘(1) COVERAGE OF SPECIFIED BREAKTHROUGH

4 DEVICES.— 

5 ‘‘(A) IN GENERAL.—Subject to the suc6 ceeding provisions of this subsection and not7 withstanding any other provision of law, the 

8 Secretary shall provide for coverage and pay9 ment pursuant to this section of a specified 

10 breakthrough device (as defined in subpara11 graph (B)). 

12 ‘‘(B) SPECIFIED BREAKTHROUGH DEVICE

13 DEFINED.—In this section, the term ‘specified 

14 breakthrough device’ means a breakthrough de15 vice with respect to which no Medicare benefit 

16 category exists. 

17 ‘‘(2) PERIOD OF TRANSITIONAL COVERAGE.— 

18 ‘‘(A) IN GENERAL.—Subject to subpara19 graph (C), the provisions of subsection (b)(1) 

20 (relating to the transitional coverage period and 

21 payment for breakthrough devices, including the 

22 use of the most recently available data and in23 formation on costs) shall apply to a specified 

24 breakthrough device in the same manner as 

25 such provisions apply to a breakthrough device. 


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1 The Secretary may use methodologies under ex2 isting payment systems established under this 

3 title, may provide for appropriate adjustments 

4 to such methodologies, or may establish a new 

5 payment methodology under this title, to pro6 vide for payment for a specified breakthrough 

7 device to ensure the payment basis for such 

8 payment covers costs of the specified break9 through device. 

10 ‘‘(B) REPORT.— 

11 ‘‘(i) IN GENERAL.—With respect to 

12 each specified breakthrough device, the 

13 Secretary shall submit to Congress a re14 port on the coverage of and payment for 

15 such specified breakthrough device under 

16 this section that includes the following in17 formation: 

18 ‘‘(I) The manner in which cov19 erage is provided and payment is 

20 made for the specified breakthrough 

21 device, including how such device was 

22 classified (such as an item of durable 

23 medical equipment or otherwise) and 

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1 retary applied with respect to such de2 vice. 

3 ‘‘(II) The impact of the avail4 ability of the specified breakthrough 

5 device to Medicare beneficiaries, in6 cluding impacts on the quality of pa7 tient care, patient outcomes, and pa8 tient experience. 

9 ‘‘(III) The impact of the avail10 ability of the specified breakthrough 

11 device to Medicare beneficiaries on 

12 program expenditures under this title. 

13 ‘‘(IV) Such other information as 

14 the Secretary determines to be appro15 priate. 

16 ‘‘(ii) DEADLINE.— 

17 ‘‘(I) IN GENERAL.—Except as 

18 provided in subclause (II), the Sec19 retary shall submit a report required 

20 under this subparagraph no later than 

21 the end of the transitional period of 

22 coverage and payment applicable to 

23 such specified breakthrough device. 

24 ‘‘(II) EXTENSION TO GENERATE

25 ADDITIONAL DATA.—If the Secretary 


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1 determines that additional data or evi2 dence is required to complete a report 

3 required under this subparagraph 

4 with respect to a specified break5 through device, the deadline under 

6 this clause may be extended for an 

7 additional two years. 

8 ‘‘(C) ADDITIONAL PERIOD OF TRANSI9 TIONAL COVERAGE TO DEVELOP ADDITIONAL

10 DATA.—Insofar as the Secretary determines 

11 that additional data or evidence is required to 

12 complete a report required under subparagraph 

13 (B) with respect to a specified breakthrough de14 vice, the transitional coverage period of cov15 erage and payment for such device shall be ex16 tended by the lesser of— 

17 ‘‘(i) two years; or 

18 ‘‘(ii) the amount of additional time re19 quired for the submission of the report 

20 with respect to such device. 

21 ‘‘(3) COVERAGE AND PAYMENT AFTER THE

22 TRANSITIONAL PERIOD.—The Secretary may con23 tinue to provide for coverage of and payment for a 

24 specified breakthrough device after the end of the 

25 transitional period of coverage and payment for 


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1 breakthrough devices through the national coverage 

2 determination process if the Secretary determines 

3 that the specified breakthrough device— 

4 ‘‘(A) improves the quality of care and pa5 tient outcomes; 

6 ‘‘(B) improves the delivery of care; or 

7 ‘‘(C) reduces spending under this title 

8 without reducing the quality of care.’’. 

9 (b) STUDY OF LIMIT ON 510(k) BREAKTHROUGH

10 DEVICES.— 

11 (1) STUDY.—The Secretary of Health and 

12 Human Services shall conduct a study on the effect 

13 of the limit under section 1899C(a)(2) of the Social 

14 Security Act, as added by subsection (a), on the 

15 number of devices cleared under section 510(k) of 

16 the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 360(k)) that are breakthrough devices for 

18 purposes of such section 1899C. 

19 (2) MATTERS EXAMINED.—In conducting the 

20 study described in paragraph (1), the Secretary 

21 shall— 

22 (A) determine the number of medical de23 vices cleared under such section 510(k) during 

24 the 5-year period beginning on the date of the 

25 enactment of this Act; 


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1 (B) determine the number of such devices 

2 that were not included as breakthrough devices 

3 for purposes of such section 1899C by reason 

4 of the limitation under subsection (a)(2) of such 

5 section; and 

6 (C) examine the impact of such limitation 

7 on access to such devices for individuals entitled 

8 to benefits under part A or enrolled in part B 

9 of title XVIII of the Social Security Act (42 

10 U.S.C. 1395 et seq.) or both. 

11 (3) REPORT.—Not later than 6 years after the 

12 date of the enactment of this Act, the Secretary 

13 shall submit to Congress a report on the study con14 ducted under this subsection and shall include such 

15 recommendations for legislative or administrative 

16 changes as the Secretary determines to be appro17 priate. 

18 (c) CLARIFICATION REGARDING CERTAIN PAY19 MENTS.— 

20 (1) IPPS NEW TECHNOLOGY PAYMENT.—Sec21 tion 1886(d)(5)(K) of the Social Security Act (42 

22 U.S.C. 1395ww(d)(5)(K)) is amended by adding at 

23 the end the following new clause: 

24 ‘‘(x) During the period with respect to which a new 

25 medical service or technology is eligible for an additional 


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1 payment under this subsection by reason of this subpara2 graph, any local coverage determination (as defined in sec3 tion 1869(f)(2)(B)) that would affect the coverage of, or 

4 the additional payment under this subsection for, such 

5 new medical service or technology shall have no force or 

6 effect in law or regulation.’’. 

7 (2) OPPS PASS-THROUGH PAYMENT.—Section 

8 1833(t)(6) of the Social Security Act (42 U.S.C. 

9 1395l(t)(6)) is amended by adding at the end the 

10 following new subparagraph: 

11 ‘‘(K) PROHIBITION ON USE OF LOCAL COV12 ERAGE DETERMINATIONS TO AFFECT COV13 ERAGE OF AND PAYMENT FOR PASS-THROUGH

14 PRODUCTS.—During the period with respect to 

15 which a drug, biological, or medical device is eli16 gible for an additional payment under this 

17 paragraph, any local coverage determination (as 

18 defined in section 1869(f)(2)(B)) that would af19 fect the coverage of, or the additional payment 

20 under this paragraph for, such drug, biological, 

21 or medical device shall have no force or effect 

22 in law or regulation.’’. 

23 (3) EFFECTIVE DATE.—This subsection, and 

24 the amendments made by this subsection, shall apply 

25 with respect to items and services furnished on or 


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1 after the date of the enactment of this Act, including 

2 any such item or service that is eligible on such date 

3 for an additional payment under section 1886(d) of 

4 the Social Security Act (42 U.S.C. 1395ww(d)) by 

5 reason of paragraph (5)(K) of such section or under 

6 section 1833(t)(6) of such Act (42 U.S.C. 

7 1395ww(t)(6)), or that would have been so eligible 

8 on such date but for a local coverage determination 

9 that limits or denies coverage of and such additional 

10 payment for the item or service. 

11 (d) CONFORMING AMENDMENTS.— 

12 (1) INPATIENT PROSPECTIVE PAYMENT SYS13 TEM.—Section 1886(d)(5)(K) of the Social Security 

14 Act (42 U.S.C. 1395ww(d)(5)(K)), as amended by 

15 subsection (c)(1), is amended by adding at the end 

16 the following new clause: 

17 ‘‘(xi) Effective for discharges occurring on or after 

18 October 1, 2020, in the case of a new medical service or 

19 technology that is a breakthrough device (as defined in 

20 section 1899C(a)), the additional payment established for 

21 such breakthrough device under this subparagraph shall 

22 be made for the 3-year period applicable to such break23 through device under section 1899C(d)(1). In determining 

24 the amount of the additional payment for a breakthrough 

25 device under this subparagraph during such 3-year period, 


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1 the Secretary shall apply section 412.88(b) of title 42, 

2 Code of Federal Regulations (or any successor regulation), 

3 as if the reference to ‘50 percent’ in such section were 

4 a reference to ‘80 percent’.’’. 

5 (2) OUTPATIENT PROSPECTIVE PAYMENT SYS6 TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 

7 1395l(t)(6)(C)) is amended by adding at the end the 

8 following new clause: 

9 ‘‘(iii) SPECIAL RULE FOR BREAK10 THROUGH DEVICES.—Notwithstanding 

11 clause (i) or (ii), or any other provision of 

12 this paragraph to the contrary, in the case 

13 of a breakthrough device (as defined in 

14 section 1899C(a)) that is furnished on or 

15 after January 1, 2021, payment under this 

16 paragraph for such breakthrough device 

17 shall be made for the 3-year period appli18 cable to such breakthrough device under 

19 section 1899C(d)(2). The provisions of this 

20 clause shall also apply for purposes of 

21 transitional pass-through payment under 

22 section 1833(i)(2)(D).’’. 

23 (3) COMPETITIVE BIDDING PROGRAM.—Section 

24 1847(a) of such Act (42 U.S.C. 1395w–3(a)) is 

25 amended— 


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•S 3914 IS

1 (A) in paragraph (2)(A)— 

2 (i) by striking ‘‘and excluding drugs’’ 

3 and inserting ‘‘excluding drugs’’; and 

4 (ii) by inserting before the period at 

5 the end the following: ‘‘, and excluding 

6 breakthrough devices (as defined in section 

7 1899C(a))’’; and 

8 (B) in paragraph (7), by adding at the end 

9 the following new subparagraph: 

10 ‘‘(C) BREAKTHROUGH DEVICES.—A break11 through device described in paragraph (2)(A) 

12 that is furnished during the transitional cov13 erage period (as defined in section 

14 1899C(b)(1)(B)) applicable to such device 

15 under section 1899C.’’. 

16 (e) EFFECTIVE DATE.—This section, and the amend17 ments made by this section, shall take effect on the date 

18 of the enactment of this Act and, unless otherwise speci19 fied in this section (or in an amendment made by this sec20 tion), shall apply to breakthrough devices (as defined in 

21 section 1899C(a) of the Social Security Act, as added by 

22 subsection (a)), approved or cleared on or after July 1, 

23 2019, or, in the case of a specified breakthrough device 


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1 (as defined in such section as so added), approved or 

2 cleared on or after December 1, 2018. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS