I 

116TH CONGRESS 

1ST SESSION H. R. 5333 

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 HOUSE OF REPRESENTATIVES 

DECEMBER 6, 2019 

Ms. DELBENE (for herself, Mrs. WALORSKI, Mr. CA ́RDENAS, Mr. BILIRAKIS, 

Ms. SEWELL of Alabama, and Mr. MARSHALL) 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 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 2019’’. 


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1 SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH 

2 DEVICES UNDER THE MEDICARE PROGRAM. 

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

4 Security Act (42 U.S.C. 1395x et seq.) is amended by add5 ing at the end the following new section: 

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

7 ‘‘(a) BREAKTHROUGH DEVICES.— 

8 ‘‘(1) IN GENERAL.—For purposes of this sec9 tion, the term ‘breakthrough device’ means a med10 ical device that is a device (as defined in section 201 

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

12 that is— 

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

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

15 515 of such Act; and 

16 ‘‘(B) approved or cleared pursuant to sec17 tion 510(k), 513(f), or 515 of such Act for use 

18 in treating an indication on or after July 1, 

19 2019. 

20 Such term also includes a breakthrough device that 

21 is a specified breakthrough device (as defined in sub22 section (e)(1)(B)) approved or cleared pursuant to 

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

24 in treating an indication on or after December 1, 

25 2018. 


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1 ‘‘(2) LIMITATION ON NUMBER OF 510(K) DE2 VICES.—With respect to a 5-year period, in no case 

3 may more than five medical devices described in 

4 paragraph (1) that are classified under section 

5 510(k) of the Federal Food, Drug, and Cosmetic 

6 Act be covered and paid for under this title by rea7 son of this section during each such 5-year period. 

8 ‘‘(b) COVERAGE.— 

9 ‘‘(1) TRANSITIONAL COVERAGE.— 

10 ‘‘(A) IN GENERAL.—During the transi11 tional coverage period (as defined in subpara12 graph (B)) a breakthrough device shall be— 

13 ‘‘(i) deemed to be reasonable and nec14 essary for purposes of section 

15 1862(a)(1)(A); 

16 ‘‘(ii) deemed to be approved for an ad17 ditional payment under section 

18 1886(d)(5)(K) (other than with respect to 

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

20 such section); 

21 ‘‘(iii) deemed to be approved for pass22 through payment under section 1833(t)(6) 

23 and section 1833(i) (other than with re24 spect to the cost criterion under section 

25 1833(t)(6)(A)(iv)); and 


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1 ‘‘(iv) insofar as such breakthrough de2 vice may be furnished in a setting for 

3 which payment is made under an applica4 ble payment system described in subpara5 graphs (D) through (I) of subsection 

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

7 payment or payment adjustment, as the 

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

9 when furnished in a setting for which pay10 ment is made under such an applicable 

11 payment system during such transitional 

12 coverage period. 

13 ‘‘(B) TRANSITIONAL COVERAGE PERIOD

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

15 ‘transitional coverage period’ means, with re16 spect to a breakthrough device, the period 

17 that— 

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

19 under section 515 of the Federal Food, 

20 Drug, and Cosmetic Act or of the clear21 ance under section 510(k) of such Act, as 

22 applicable, of such device by the Secretary 

23 for the indication described in subsection 

24 (a)(1); and 


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

2 year period that begins on the date that 

3 the Secretary, pursuant to subsection 

4 (c)(2), updates the relevant applicable pay5 ment system (as defined in subsection 

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

7 or permanent code or codes assigned under 

8 subsection (c)(1) to such breakthrough de9 vice, except as provided in subsections 

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

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

12 PASS-THROUGH COST CRITERIA.—In deter13 mining whether a breakthrough device qualifies 

14 for an additional payment under section 

15 1886(d)(5)(K) or for pass-through payment 

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

17 Secretary shall use the most recently available 

18 data and information on the costs of such 

19 breakthrough device, which may include list 

20 prices and invoice prices charged for such 

21 breakthrough device. 

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

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

24 to a breakthrough device furnished after the transi25 tional coverage period (as defined in paragraph 


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

2 a process for the coverage of such breakthrough de3 vices under this title after such period as follows: 

4 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI5 DENCE.— 

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

7 breakthrough device, not later than 1 year 

8 after the date of the approval of such de9 vice under section 515 of the Federal 

10 Food, Drug, and Cosmetic Act or of the 

11 clearance of such device under section 

12 510(k) of such Act, as applicable, the Sec13 retary shall identify whether any additional 

14 data or evidence is required with respect to 

15 any indications for such device for pur16 poses of the application of such section 

17 1862(a)(1)(A) to such device for such indi18 cations. 

19 ‘‘(ii) NON-DUPLICATION OF DATA RE20 QUESTS.—In carrying out clause (i) with 

21 respect to a breakthrough device, the Sec22 retary shall ensure that data or evidence 

23 identified— 

24 ‘‘(I) does not duplicate data re25 quired to be collected by the Food and 


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1 Drug Administration with respect to 

2 such breakthrough device; 

3 ‘‘(II) minimizes the administra4 tive burdens of data collection and re5 porting on providers of services, sup6 pliers, and manufacturers of break7 through devices; and 

8 ‘‘(III) is not otherwise unneces9 sary or redundant. 

10 ‘‘(B) PROPOSAL FOR COVERAGE AFTER

11 THE TRANSITIONAL COVERAGE PERIOD.—Not 

12 later than 2 years after the date of the approval 

13 or clearance of a breakthrough device by the 

14 Food and Drug Administration, the Secretary 

15 shall develop a proposal for coverage under this 

16 title of such breakthrough device for such indi17 cations as the Secretary determines to be ap18 propriate, based on the data and evidence col19 lected under subparagraph (A), for such devices 

20 furnished after the transitional coverage period 

21 under paragraph (1) for such device. If the Sec22 retary does not, on a date that is before the end 

23 of such two-year period, take action to modify 

24 the indications for which coverage of a break25 through device may be provided under this title 


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1 after such period, for purposes of section 

2 1862(a)(1)(A) coverage under this title of such 

3 breakthrough device shall be made for all indi4 cations for which such device is approved under 

5 section 515 of the Federal Food, Drug, and 

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

7 such Act. 

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

9 this section shall be construed to— 

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

11 of a breakthrough device to seek approval for 

12 pass-through payment status under section 

13 1833(t)(6) or to seek approval for an additional 

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

15 as such breakthrough device does not qualify 

16 for transitional coverage under paragraph (1); 

17 or 

18 ‘‘(B) affect the application and approval 

19 process for pass-through payment status under 

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

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

22 medical device that is not approved by the Food 

23 and Drug Administration as a breakthrough de24 vice. 

25 ‘‘(c) CODING.— 


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

2 three months after the date of approval or clearance 

3 of a breakthrough device by the Food and Drug Ad4 ministration, subject to subparagraph (B), the Sec5 retary shall assign a unique temporary or permanent 

6 code or codes for purposes of coverage and payment 

7 for such breakthrough device under the applicable 

8 payment systems (described in paragraph (4)). 

9 ‘‘(2) UPDATES.— 

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

11 for semiannual updates under the applicable 

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

13 (relating to the inpatient hospital prospective 

14 payment system) to recognize the code or codes 

15 assigned under paragraph (1). 

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

17 for quarterly updates under the applicable pay18 ment system described in paragraph (4)(B) (re19 lating to the outpatient hospital prospective 

20 payment system) to recognize the code or codes 

21 assigned under paragraph (1). 

22 ‘‘(C) OTHER PAYMENT SYSTEMS.—The 

23 Secretary shall provide for semiannual or quar24 terly updates, as the case may be, under the ap25 plicable payment systems described in subparaVerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 graphs (C) through (L) of paragraph (4) to rec2 ognize the code or codes assigned under para3 graph (1). 

4 ‘‘(3) TRANSPARENCY.—The process for the as5 signment of a code or codes under this subsection 

6 shall provide for public notice and a meaningful op7 portunity for public comment from affected parties. 

8 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE9 SCRIBED.—For purposes of this subsection, the term 

10 ‘applicable payment systems’ means— 

11 ‘‘(A) with respect to inpatient hospital 

12 services, the prospective payment system for in13 patient hospital services established under sec14 tion 1886(d); 

15 ‘‘(B) with respect to outpatient hospital 

16 services, the prospective payment system for 

17 covered OPD services established under section 

18 1833(t); 

19 ‘‘(C) with respect to ambulatory surgical 

20 center services, the fee schedule for such serv21 ices established under 1833(i); 

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

23 the physician fee schedules established under 

24 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 inpatient hospital 

9 services furnished by rehabilitation facilities, 

10 the prospective payment system established 

11 under section 1886(j); 

12 ‘‘(H) with respect to inpatient hospital 

13 services furnished by long-term care hospitals, 

14 the prospective payment system under section 

15 1886(m); 

16 ‘‘(I) with respect to inpatient hospital serv17 ices furnished by psychiatric hospitals and psy18 chiatric units, the prospective payment system 

19 under section 1886(s); 

20 ‘‘(J) with respect to home health services, 

21 the prospective payment system under section 

22 1895; and 

23 ‘‘(K) with respect to items and services, or 

24 a provider of services or supplier, not described 

25 in subparagraphs (A) through (I), the payment 


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1 system established under this title for such 

2 items and services when furnished by such pro3 vider of services or supplier. 

4 ‘‘(d) PAYMENT.— 

5 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY6 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK7 THROUGH PAYMENT.—The Secretary shall deem 

8 each breakthrough device as approved for an addi9 tional payment under section 1886(d)(5)(K) for the 

10 3-year period that begins— 

11 ‘‘(A) except as provided in subparagraph 

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

13 subsection (c)(2)(A), updates the payment sys14 tem under section 1886(d) to recognize the 

15 unique temporary or permanent code or codes 

16 assigned under subsection (c)(1) to such break17 through device; or 

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

19 received approval or clearance as a break20 through device by the Food and Drug Adminis21 tration before such payment system is updated 

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

23 unique temporary or permanent code or codes 

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

25 on the date of such approval or clearance. 


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1 Nothing in this paragraph shall be construed to af2 fect the authority of the Secretary to use claims 

3 data to establish new diagnosis or procedure codes 

4 for breakthrough devices or to identify appropriate 

5 diagnosis-related groups for the assignment of 

6 breakthrough devices under annual rulemaking to 

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

8 ‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS9 TEM: DEEMED ELIGIBILITY FOR PASS-THROUGH

10 PAYMENT.—The Secretary shall deem each break11 through device as approved for pass-through pay12 ment under section 1833(t)(6) (including for pur13 poses of section 1833(i)(2)(D)) during the 3-year pe14 riod that begins— 

15 ‘‘(A) except as provided in subparagraph 

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

17 subsection (c)(2)(B), updates the payment sys18 tem under section 1833(t) to recognize the 

19 unique temporary or permanent code or codes 

20 assigned under subsection (c)(1) to such break21 through device; or 

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

23 received approval or clearance as a break24 through device by the Food and Drug Adminis25 tration before such payment system is updated 


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

2 unique temporary or permanent code or codes 

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

4 on the date of such approval or clearance. 

5 Nothing in this paragraph shall be construed to af6 fect the authority of the Secretary to use claims 

7 data to establish new ambulatory payment classifica8 tion groups for breakthrough devices or to revise 

9 such groups to take into account breakthrough de10 vices under annual rulemaking to carry out section 

11 1833(t). 

12 ‘‘(3) OTHER PAYMENT SYSTEMS.— 

13 ‘‘(A) IN GENERAL.—In the case of break14 through device that is furnished and for which 

15 payment may be made under the payment sys16 tem established under section 1834, 1834A, 

17 1848, 1886(j), 1886(m), 1886(s), or 1895 or 

18 any other provision of this title (other than sec19 tions 1833(i), 1833(t), and 1886(d)), the Sec20 retary shall provide for an additional payment 

21 for such breakthrough device under such appli22 cable payment system or an adjustment to such 

23 applicable payment system, as the case may be. 

24 The payment basis for such additional payment 

25 or adjustment, as the case may be, shall equal 


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1 an amount that the Secretary determines covers 

2 the costs of such breakthrough device. 

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

4 the costs of a breakthrough device for purposes 

5 of determining an additional payment or pay6 ment adjustment under subparagraph (A), the 

7 Secretary shall use the most recently available 

8 data and information on the costs of such 

9 breakthrough device, which may include list 

10 prices and invoice prices charged for such 

11 breakthrough device. 

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

13 in this paragraph shall be construed to affect 

14 the authority of the Secretary to use claims 

15 data to establish new or modify existing ambu16 latory payment classification groups, diagnosis17 related groups, level II HCPCS codes or such 

18 other groups or codes as the Secretary may es19 tablish under the annual rulemaking authority 

20 under the provisions referred to in subpara21 graph (A). 

22 ‘‘(D) CLINICAL DIAGNOSTIC LABORATORY

23 TESTS.—An additional payment or payment ad24 justment under subparagraph (A) for a break25 through device under the applicable payment 


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1 system established in section 1834A may be in 

2 the form of an increase to the amount deter3 mined for the breakthrough device using cross4 walking under section 1834A(c)(1)(A), an ex5 tension of the initial period of payment applica6 ble to advance diagnostic laboratory tests under 

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

8 or manner as the Secretary determines reflects 

9 the costs for such breakthrough device under 

10 the relevant provisions of section 1834A. 

11 ‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES

12 AFTER THE TRANSITIONAL COVERAGE PERIOD.— 

13 Payment for a breakthrough device that is furnished 

14 after the conclusion of the transitional coverage pe15 riod under subsection (b)(1) for such device shall be 

16 made pursuant to the applicable payment system in17 volved, taking into account the additional evidence 

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

19 ‘‘(e) SPECIAL RULES FOR CERTAIN BREAKTHROUGH

20 DEVICES.— 

21 ‘‘(1) COVERAGE OF SPECIFIED BREAKTHROUGH

22 DEVICES.— 

23 ‘‘(A) IN GENERAL.—Subject to the suc24 ceeding provisions of this subsection and not25 withstanding any other provision of law, the 


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1 Secretary shall provide for coverage and pay2 ment pursuant to this section of a specified 

3 breakthrough device (as defined in subpara4 graph (B)). 

5 ‘‘(B) SPECIFIED BREAKTHROUGH DEVICE

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

7 breakthrough device’ means a breakthrough de8 vice with respect to which no Medicare benefit 

9 category exists. 

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

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (C), the provisions of subsection (b)(1) 

13 (relating to the transitional coverage period and 

14 payment for breakthrough devices, including the 

15 use of the most recently available data and in16 formation on costs) shall apply to a specified 

17 breakthrough device in the same manner as 

18 such provisions apply to a breakthrough device. 

19 The Secretary may use methodologies under ex20 isting payment systems established under this 

21 title, may provide for appropriate adjustments 

22 to such methodologies, or may establish a new 

23 payment methodology under this title, to pro24 vide for payment for a specified breakthrough 

25 device to ensure the payment basis for such 


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1 payment covers costs of the specified break2 through device are covered by such payment. 

3 ‘‘(B) REPORT.— 

4 ‘‘(i) IN GENERAL.—With respect to 

5 each specified breakthrough device, the 

6 Secretary shall submit to Congress a re7 port on the coverage of and payment for 

8 such specified breakthrough device under 

9 this section that includes the following in10 formation: 

11 ‘‘(I) The manner in which cov12 erage is provided and payment is 

13 made for the specified breakthrough 

14 device, including how such device was 

15 classified (such as an item of durable 

16 medical equipment or otherwise) and 

17 the payment methodology the Sec18 retary applied with respect to such de19 vice. 

20 ‘‘(II) The impact of the avail21 ability of the specified breakthrough 

22 device to Medicare beneficiaries, in23 cluding impacts on the quality of pa24 tient care, patient outcomes, and pa25 tient experience. 


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1 ‘‘(III) The impact of the avail2 ability of the specified breakthrough 

3 device to Medicare beneficiaries on 

4 program expenditures under this title. 

5 ‘‘(IV) Such other information as 

6 the Secretary determines to be appro7 priate. 

8 ‘‘(ii) DEADLINE.— 

9 ‘‘(I) IN GENERAL.—Except as 

10 provided in subclause (II), the Sec11 retary shall submit a report required 

12 under this subparagraph no later than 

13 the end of the transitional period of 

14 coverage and payment applicable to 

15 such specified breakthrough device. 

16 ‘‘(II) EXTENSION TO GENERATE

17 ADDITIONAL DATA.—If the Secretary 

18 determines that additional data or evi19 dence is required to complete a report 

20 required under this subparagraph 

21 with respect to a specified break22 through device, the deadline under 

23 this clause may be extended for an 

24 additional two years. 


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1 ‘‘(C) ADDITIONAL PERIOD OF TRANSI2 TIONAL COVERAGE TO DEVELOP ADDITIONAL

3 DATA.—Insofar as the Secretary determines 

4 that additional data or evidence is required to 

5 complete a report required under subparagraph 

6 (B) with respect to a specified breakthrough de7 vice, the transitional coverage period of cov8 erage and payment for such device shall be ex9 tended by the lesser of— 

10 ‘‘(i) two years; or 

11 ‘‘(ii) the amount of additional time re12 quired for the submission of the report 

13 with respect to such device. 

14 ‘‘(3) COVERAGE AND PAYMENT AFTER THE

15 TRANSITIONAL PERIOD.—The Secretary may con16 tinue to provide for coverage of and payment for a 

17 specified breakthrough device after the end of the 

18 transitional period of coverage and payment for 

19 breakthrough devices through the national coverage 

20 determination process if the Secretary determines 

21 that the specified breakthrough device— 

22 ‘‘(A) improves the quality of care and pa23 tient outcomes; 

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


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1 ‘‘(C) reduces spending under this title 

2 without reducing the quality of care.’’. 

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

4 DEVICES.— 

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

6 Human Services shall conduct a study on the effect 

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

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

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

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

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

12 purposes of such section 1899C. 

13 (2) MATTERS EXAMINED.—In conducting the 

14 study described in paragraph (1), the Secretary 

15 shall— 

16 (A) determine the number of medical de17 vices cleared under such section 510(k) during 

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

19 enactment of this Act; 

20 (B) determine the number of such devices 

21 that were not included as breakthrough devices 

22 for purposes of such section 1899C by reason 

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

24 section; and 


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1 (C) examine the impact of such limitation 

2 on access to such devices for individuals entitled 

3 to benefits under part A or enrolled in part B 

4 of title XVIII of the Social Security Act (42 

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

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

7 date of the enactment of this Act, the Secretary 

8 shall submit to Congress a report on the study con9 ducted under this subsection and shall include such 

10 recommendations for legislative or administrative 

11 changes as the Secretary determines to be appro12 priate. 

13 (c) CONFORMING AMENDMENTS.— 

14 (1) INPATIENT PROSPECTIVE PAYMENT SYS15 TEM.—Section 1886(d)(5)(K) of the Social Security 

16 Act (42 U.S.C. 1395ww(d)(5)(K)) is amended by 

17 adding at the end the following new clause: 

18 ‘‘(x) Effective for discharges occurring on 

19 or after October 1, 2019, in the case of a new 

20 medical service or technology that is a break21 through device (as defined in section 

22 1899C(a)), the additional payment established 

23 for such breakthrough device under this sub24 paragraph shall be made for the 3-year period 

25 applicable to such breakthrough device under 


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1 section 1899C(d)(1). In determining the 

2 amount of the additional payment for a break3 through device under this subparagraph during 

4 such 3-year period, the Secretary shall apply 

5 section 412.88(b) of title 42, Code of Federal 

6 Regulations (or any successor regulation), as if 

7 the reference to ‘50 percent’ in such section 

8 were a reference to ‘80 percent’.’’. 

9 (2) OUTPATIENT PROSPECTIVE PAYMENT SYS10 TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 

11 1395l(t)(6)(C)) is amended by adding at the end the 

12 following new clause: 

13 ‘‘(iii) SPECIAL RULE FOR BREAK14 THROUGH DEVICES.—Notwithstanding 

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

16 this paragraph to the contrary, in the case 

17 of a breakthrough device (as defined in 

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

19 after January 1, 2020, payment under this 

20 paragraph for such breakthrough device 

21 shall be made for the 3-year period appli22 cable to such breakthrough device under 

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

24 clause shall also apply for purposes of 


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1 transitional pass-through payment under 

2 section 1833(i)(2)(D).’’. 

3 (3) COMPETITIVE BIDDING PROGRAM.—Section 

4 1847(a) of such Act (42 U.S.C. 1395w-3(a)) is 

5 amended— 

6 (A) in paragraph (2)(A)— 

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

8 and inserting ‘‘excluding drugs’’; and 

9 (ii) by inserting before the period at 

10 the end the following: ‘‘and excluding 

11 breakthrough devices (as defined in section 

12 1899C(a))’’; and 

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

14 the following new subparagraph: 

15 ‘‘(C) BREAKTHROUGH DEVICES.—A break16 through device described in paragraph (2)(A) 

17 that is furnished during the transitional cov18 erage period (as defined in section 

19 1899C(b)(1)(B)) applicable to such device 

20 under section 1899C.’’. 

21 (d) EFFECTIVE DATE.—This section, and the amend22 ments made by this section, shall take effect on the date 

23 of the enactment of this Act and, unless otherwise speci24 fied in this section (or in an amendment made by this sec25 tion), shall apply to breakthrough devices (as defined in 


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

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

3 2019, or, in the case of a specified breakthrough device 

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

5 cleared on or after December 1, 2018. 

Æ 


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