I 

118TH CONGRESS 

1ST SESSION H. R. 1691 

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 

MARCH 22, 2023 

Mr. WENSTRUP (for himself, Ms. DELBENE, Mr. BILIRAKIS, Mr. CA ́RDENAS, 

Mr. MOORE of Utah, Ms. SEWELL, Mr. GUTHRIE, and Ms. ESHOO) 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 2023’’. 


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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.—For purposes of 

8 this section, the term ‘breakthrough device’ means a med9 ical device that is a device (as defined in section 201 of 

10 the Federal Food, Drug, and Cosmetic Act) and that is— 

11 ‘‘(1) provided with review priority by the Sec12 retary under subsection (d)(5) of section 515 of such 

13 Act; and 

14 ‘‘(2) approved or cleared pursuant to section 

15 510(k), 513(f), or 515 of such Act for use in treat16 ing an indication on or after March 15, 2021. 

17 Such term also includes a breakthrough device that is a 

18 specified breakthrough device (as defined in subsection 

19 (e)(1)(B)) approved or cleared pursuant to section 510(k), 

20 513(f), or 515 of such Act for use in treating an indication 

21 on or after March 15, 2021. 

22 ‘‘(b) COVERAGE.— 

23 ‘‘(1) TRANSITIONAL COVERAGE.— 

24 ‘‘(A) IN GENERAL.—During the transi25 tional coverage period (as defined in subpara26 graph (B)) a breakthrough device shall be— 


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1 ‘‘(i) deemed to be reasonable and nec2 essary for purposes of section 

3 1862(a)(1)(A); 

4 ‘‘(ii) deemed to be approved for an ad5 ditional payment under section 

6 1886(d)(5)(K) (other than with respect to 

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

8 such section); 

9 ‘‘(iii) deemed to be approved for pass10 through payment under section 1833(t)(6) 

11 and section 1833(i) (other than with re12 spect to the cost criterion under section 

13 1833(t)(6)(A)(iv)); and 

14 ‘‘(iv) insofar as such breakthrough de15 vice may be furnished in a setting for 

16 which payment is made under an applica17 ble payment system described in subpara18 graphs (D) through (I) of subsection 

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

20 payment or payment adjustment, as the 

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

22 when furnished in a setting for which pay23 ment is made under such an applicable 

24 payment system during such transitional 

25 coverage period. 


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1 ‘‘(B) TRANSITIONAL COVERAGE PERIOD

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

3 ‘transitional coverage period’ means, with re4 spect to a breakthrough device, the period 

5 that— 

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

7 under section 515 of the Federal Food, 

8 Drug, and Cosmetic Act or of the clear9 ance under section 510(k) of such Act, as 

10 applicable, of such device by the Secretary 

11 for the indication described in subsection 

12 (a)(1); and 

13 ‘‘(ii) ends on the last day of the 4- 

14 year period that begins on the date that 

15 the Secretary, pursuant to subsection 

16 (c)(2), updates the relevant applicable pay17 ment system (as defined in subsection 

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

19 or permanent code or codes assigned under 

20 subsection (c)(1) to such breakthrough de21 vice, except as provided in subsections 

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

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

24 PASS-THROUGH COST CRITERIA.—In deter25 mining whether a breakthrough device qualifies 


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1 for an additional payment under section 

2 1886(d)(5)(K) or for pass-through payment 

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

4 Secretary shall use the most recently available 

5 data and information on the costs of such 

6 breakthrough device, which may include list 

7 prices and invoice prices charged for such 

8 breakthrough device. 

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

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

11 to a breakthrough device furnished after the transi12 tional coverage period (as defined in paragraph 

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

14 a process for the coverage of such breakthrough de15 vices under this title after such period as follows: 

16 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI17 DENCE.— 

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

19 breakthrough device, not later than 1 year 

20 after the date of the approval of such de21 vice under section 515 of the Federal 

22 Food, Drug, and Cosmetic Act or of the 

23 clearance of such device under section 

24 510(k) of such Act, as applicable, the Sec25 retary shall identify whether any additional 


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1 data or evidence is required with respect to 

2 any indications for such device for pur3 poses of the application of such section 

4 1862(a)(1)(A) to such device for such indi5 cations. 

6 ‘‘(ii) NON-DUPLICATION OF DATA RE7 QUESTS.—In carrying out clause (i) with 

8 respect to a breakthrough device, the Sec9 retary shall ensure that data or evidence 

10 identified— 

11 ‘‘(I) does not duplicate data re12 quired to be collected by the Food and 

13 Drug Administration with respect to 

14 such breakthrough device; 

15 ‘‘(II) minimizes the administra16 tive burdens of data collection and re17 porting on providers of services, sup18 pliers, and manufacturers of break19 through devices; and 

20 ‘‘(III) is not otherwise unneces21 sary or redundant. 

22 ‘‘(B) PROPOSAL FOR COVERAGE AFTER

23 THE TRANSITIONAL COVERAGE PERIOD.—Not 

24 later than 2 years after the date of the approval 

25 or clearance of a breakthrough device by the 


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1 Food and Drug Administration, the Secretary 

2 shall develop a proposal for coverage under this 

3 title of such breakthrough device for such indi4 cations as the Secretary determines to be ap5 propriate, based on the data and evidence col6 lected under subparagraph (A), for such devices 

7 furnished after the transitional coverage period 

8 under paragraph (1) for such device. If the Sec9 retary does not, on a date that is before the end 

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

11 the indications for which coverage of a break12 through device may be provided under this title 

13 after such period, for purposes of section 

14 1862(a)(1)(A) coverage under this title of such 

15 breakthrough device shall be made for all indi16 cations for which such device is approved under 

17 section 515 of the Federal Food, Drug, and 

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

19 such Act. 

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

21 this section shall be construed to— 

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

23 of a breakthrough device to seek approval for 

24 pass-through payment status under section 

25 1833(t)(6) or to seek approval for an additional 


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

2 as such breakthrough device does not qualify 

3 for transitional coverage under paragraph (1); 

4 ‘‘(B) affect the application and approval 

5 process for pass-through payment status under 

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

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

8 medical device that is not approved by the Food 

9 and Drug Administration as a breakthrough de10 vice; or 

11 ‘‘(C) prohibit the Secretary from using ex12 isting authority under this title to suspend or 

13 terminate coverage of a breakthrough device if 

14 the Secretary, based on clinical evidence, deter15 mines that— 

16 ‘‘(i) such breakthrough device offers 

17 no clinical benefit to Medicare bene18 ficiaries; or 

19 ‘‘(ii) furnishing such breakthrough de20 vice to Medicare beneficiaries causes, or 

21 may cause, serious harm to Medicare bene22 ficiaries. 

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, the Secretary shall assign a unique 

3 temporary or permanent code or codes for purposes 

4 of coverage and payment for such breakthrough de5 vice under the applicable payment systems (de6 scribed 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 21:01 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1691.IH H1691

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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 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 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 4-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 4-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 a 

14 breakthrough device that is furnished and for 

15 which payment may be made under the pay16 ment system established under section 1834, 

17 1834A, 1848, 1886(j), 1886(m), 1886(s), or 

18 1895 or any other provision of this title (other 

19 than sections 1833(i), 1833(t), and 1886(d)), 

20 the Secretary shall provide for an additional 

21 payment for such breakthrough device under 

22 such applicable payment system or an adjust23 ment to such applicable payment system, as the 

24 case may be. The payment basis for such addi25 tional payment or adjustment, as the case may 


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1 be, shall equal an amount that the Secretary 

2 determines covers the costs of such break3 through device. 

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

5 the costs of a breakthrough device for purposes 

6 of determining an additional payment or pay7 ment adjustment under subparagraph (A), the 

8 Secretary shall use the most recently available 

9 data and information on the costs of such 

10 breakthrough device, which may include list 

11 prices and invoice prices charged for such 

12 breakthrough device. 

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

14 in this paragraph shall be construed to affect 

15 the authority of the Secretary to use claims 

16 data to establish new or modify existing ambu17 latory payment classification groups, diagnosis18 related groups, level II HCPCS codes or such 

19 other groups or codes as the Secretary may es20 tablish under the annual rulemaking authority 

21 under the provisions referred to in subpara22 graph (A). 

23 ‘‘(D) CLINICAL DIAGNOSTIC LABORATORY

24 TESTS.—An additional payment or payment ad25 justment under subparagraph (A) for a breakVerDate Sep 11 2014 21:01 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H1691.IH H1691

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1 through device under the applicable payment 

2 system established in section 1834A may be in 

3 the form of an increase to the amount deter4 mined for the breakthrough device using cross5 walking under section 1834A(c)(1)(A), an ex6 tension of the initial period of payment applica7 ble to advance diagnostic laboratory tests under 

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

9 or manner as the Secretary determines reflects 

10 the costs for such breakthrough device under 

11 the relevant provisions of section 1834A. 

12 ‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES

13 AFTER THE TRANSITIONAL COVERAGE PERIOD.— 

14 Payment for a breakthrough device that is furnished 

15 after the conclusion of the transitional coverage pe16 riod under subsection (b)(1) for such device shall be 

17 made pursuant to the applicable payment system in18 volved, taking into account the additional evidence 

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

20 ‘‘(e) SPECIAL RULES FOR CERTAIN BREAKTHROUGH

21 DEVICES.— 

22 ‘‘(1) COVERAGE OF SPECIFIED BREAKTHROUGH

23 DEVICES.— 

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1 withstanding any other provision of law, the 

2 Secretary shall provide for coverage and pay3 ment pursuant to this section of a specified 

4 breakthrough device (as defined in subpara5 graph (B)). 

6 ‘‘(B) SPECIFIED BREAKTHROUGH DEVICE

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

8 breakthrough device’ means a breakthrough de9 vice with respect to which no Medicare benefit 

10 category exists. 

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

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (C), the provisions of subsection (b)(1) 

14 (relating to the transitional coverage period and 

15 payment for breakthrough devices, including the 

16 use of the most recently available data and in17 formation on costs) shall apply to a specified 

18 breakthrough device in the same manner as 

19 such provisions apply to a breakthrough device. 

20 The Secretary may use methodologies under ex21 isting payment systems established under this 

22 title, may provide for appropriate adjustments 

23 to such methodologies, or may establish a new 

24 payment methodology under this title, to pro25 vide for payment for a specified breakthrough 


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1 device to ensure the payment basis for such 

2 payment covers costs of the specified break3 through device are covered by such payment. 

4 ‘‘(B) REPORT.— 

5 ‘‘(i) IN GENERAL.—With respect to 

6 each specified breakthrough device, the 

7 Secretary shall submit to Congress a re8 port on the coverage of and payment for 

9 such specified breakthrough device under 

10 this section that includes the following in11 formation: 

12 ‘‘(I) The manner in which cov13 erage is provided and payment is 

14 made for the specified breakthrough 

15 device, including how such device was 

16 classified (such as an item of durable 

17 medical equipment or otherwise) and 

18 the payment methodology the Sec19 retary applied with respect to such de20 vice. 

21 ‘‘(II) The impact of the avail22 ability of the specified breakthrough 

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1 tient care, patient outcomes, and pa2 tient experience. 

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

5 device to Medicare beneficiaries on 

6 program expenditures under this title. 

7 ‘‘(IV) Such other information as 

8 the Secretary determines to be appro9 priate. 

10 ‘‘(ii) DEADLINE.— 

11 ‘‘(I) IN GENERAL.—Except as 

12 provided in subclause (II), the Sec13 retary shall submit a report required 

14 under this subparagraph no later than 

15 the end of the transitional period of 

16 coverage and payment applicable to 

17 such specified breakthrough device. 

18 ‘‘(II) EXTENSION TO GENERATE

19 ADDITIONAL DATA.—If the Secretary 

20 determines that additional data or evi21 dence is required to complete a report 

22 required under this subparagraph 

23 with respect to a specified break24 through device, the deadline under 


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1 this clause may be extended for an 

2 additional two years. 

3 ‘‘(C) ADDITIONAL PERIOD OF TRANSI4 TIONAL COVERAGE TO DEVELOP ADDITIONAL

5 DATA.—Insofar as the Secretary determines 

6 that additional data or evidence is required to 

7 complete a report required under subparagraph 

8 (B) with respect to a specified breakthrough de9 vice, the transitional coverage period of cov10 erage and payment for such device shall be ex11 tended by the lesser of— 

12 ‘‘(i) two years; or 

13 ‘‘(ii) the amount of additional time re14 quired for the submission of the report 

15 with respect to such device. 

16 ‘‘(3) COVERAGE AND PAYMENT AFTER THE

17 TRANSITIONAL PERIOD.—The Secretary may con18 tinue to provide for coverage of and payment for a 

19 specified breakthrough device after the end of the 

20 transitional period of coverage and payment for 

21 breakthrough devices through the national coverage 

22 determination process if the Secretary determines 

23 that the specified breakthrough device— 

24 ‘‘(A) improves the quality of care and pa25 tient outcomes; 


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

2 ‘‘(C) reduces spending under this title 

3 without reducing the quality of care.’’. 

4 (b) CONFORMING AMENDMENTS.— 

5 (1) INPATIENT PROSPECTIVE PAYMENT SYS6 TEM.—Section 1886(d)(5)(K) of the Social Security 

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

8 adding at the end the following new clause: 

9 ‘‘(x) Effective for discharges occurring on 

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

11 medical service or technology that is a break12 through device (as defined in section 

13 1899C(a)), the additional payment established 

14 for such breakthrough device under this sub15 paragraph shall be made for the 4-year period 

16 applicable to such breakthrough device under 

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

18 amount of the additional payment for a break19 through device under this subparagraph during 

20 such 4-year period, the Secretary shall apply 

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

22 Regulations, as in effect on the date of the en23 actment of this clause, except as if the ref24 erence in such section to ‘65 percent’ were a 


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1 reference to ‘65 percent (or such greater per2 cent specified by the Secretary)’.’’. 

3 (2) OUTPATIENT PROSPECTIVE PAYMENT SYS4 TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 

5 1395l(t)(6)(C)) is amended by adding at the end the 

6 following new clause: 

7 ‘‘(iii) SPECIAL RULE FOR BREAK8 THROUGH DEVICES.—Notwithstanding 

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

10 this paragraph to the contrary, in the case 

11 of a breakthrough device (as defined in 

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

13 after January 1, 2020, payment under this 

14 paragraph for such breakthrough device 

15 shall be made for the 4-year period appli16 cable to such breakthrough device under 

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

18 clause shall also apply for purposes of 

19 transitional pass-through payment under 

20 section 1833(i)(2)(D).’’. 

21 (c) 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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