I 

114TH CONGRESS 

2D SESSION H. R. 5009 

To amend titles XVIII and XIX of the Social Security Act to ensure prompt 

coverage of breakthrough devices under the Medicare and Medicaid programs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 20, 2016 

Mr. BOUSTANY (for himself, Mr. NEAL, Mr. BILIRAKIS, and Mr. CA ́RDENAS) 

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 titles XVIII and XIX of the Social Security Act 

to ensure prompt coverage of breakthrough devices under 

the Medicare and Medicaid programs, 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 2016’’. 


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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 either— 

13 ‘‘(A) is— 

14 ‘‘(i) provided with review priority by 

15 the Secretary under subsection (d)(5) of 

16 section 515 of such Act; and 

17 ‘‘(ii) approved under such section for 

18 use in treating an indication; or 

19 ‘‘(B) subject to paragraph (2), is cleared 

20 under section 510(k) of such Act for use in 

21 treating an indication. 

22 ‘‘(2) LIMITATION ON NUMBER OF 510(k) DE23 VICES.—With respect to a 5-year period, in no case 

24 may more than five medical devices described in 

25 paragraph (1)(B) be covered and paid for under this 


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1 title by reason of this section during each such 5- 

2 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 approved for an ad12 ditional payment under section 

13 1886(d)(5)(K); 

14 ‘‘(iii) deemed to be approved for pass15 through payment under section 1833(t)(6) 

16 and section 1833(i); and 

17 ‘‘(iv) insofar as such breakthrough de18 vice may be furnished in a setting for 

19 which payment is made under an applica20 ble payment system described in subpara21 graphs (D) through (I) of subsection 

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

23 payment pursuant to subsection (d)(3) 

24 when furnished in a setting for which pay25 ment is made under such an applicable 


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1 payment system during such transitional 

2 coverage period. 

3 ‘‘(B) TRANSITIONAL COVERAGE PERIOD

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

5 ‘transitional coverage period’ means, with re6 spect to a breakthrough device, the period 

7 that— 

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

9 under section 515 of the Federal Food, 

10 Drug, and Cosmetic Act or of the clear11 ance under section 510(k) of such Act, as 

12 applicable, of such device by the Secretary 

13 for the indication described in subpara14 graph (A)(ii) or (B) of subsection (a)(1), 

15 respectively; and 

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

17 year period that begins on the date that 

18 the Secretary, pursuant to subsection 

19 (c)(2), updates the relevant applicable pay20 ment system (as defined in subsection 

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

22 or permanent code or codes assigned under 

23 subsection (c)(1) to such breakthrough de24 vice, except as provided in subsections 

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


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

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

3 to a breakthrough device furnished after the transi4 tional coverage period (as defined in paragraph 

5 (1)(B)) for such device, the Secretary, acting 

6 through the Council for Technology and Innovation 

7 (established under section 1868(b)) in conjunction 

8 with the Coverage and Analysis Group of the Cen9 ters for Medicare & Medicaid Services, shall estab10 lish a process for the coverage of such breakthrough 

11 devices under this title after such period as follows: 

12 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI13 DENCE.— 

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

15 breakthrough device, not later than 1 year 

16 after the date of the approval of such de17 vice under section 515 of the Federal 

18 Food, Drug, and Cosmetic Act or of the 

19 clearance of such device under section 

20 510(k) of such Act, as applicable, the Sec21 retary shall identify whether any additional 

22 data or evidence is required with respect to 

23 any indications for such device for pur24 poses of the application of such section 


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1 1862(a)(1)(A) to such device for such indi2 cations. 

3 ‘‘(ii) NON-DUPLICATION OF DATA RE4 QUESTS.—In carrying out clause (i) with 

5 respect to a breakthrough device, the Sec6 retary shall ensure that data or evidence 

7 identified— 

8 ‘‘(I) does not duplicate data re9 quired to be collected by the Food and 

10 Drug Administration with respect to 

11 such breakthrough device; 

12 ‘‘(II) minimizes the administra13 tive burdens of data collection and re14 porting on providers of services, sup15 pliers, and manufacturers of break16 through devices; and 

17 ‘‘(III) is not otherwise unneces18 sary or redundant. 

19 ‘‘(B) PROPOSAL FOR COVERAGE AFTER

20 THE TRANSITIONAL COVERAGE PERIOD.—Not 

21 later than 2 years after the date of the approval 

22 or clearance of a breakthrough device by the 

23 Food and Drug Administration, the Secretary 

24 shall develop a proposal for coverage under this 

25 title of such breakthrough device for such indiVerDate Sep 11 2014 02:55 Apr 30, 2016 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5009.IH H5009

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1 cations as the Secretary determines to be ap2 propriate, based on the data and evidence col3 lected under subparagraph (A), for such devices 

4 furnished after the transitional coverage period 

5 under paragraph (1) for such device. If the Sec6 retary does not, on a date that is before the end 

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

8 the indications for which coverage of a break9 through device may be provided under this title 

10 after such period, for purposes of section 

11 1862(a)(1)(A) coverage under this title of such 

12 breakthrough device shall be made for all indi13 cations for which such device is approved under 

14 section 515 of the Federal Food, Drug, and 

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

16 such Act. 

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

18 this section shall be construed to— 

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

20 of a breakthrough device to seek approval for 

21 pass-through payment status under section 

22 1833(t)(6) or to seek approval for an additional 

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

24 as such breakthrough device does not qualify 


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1 for transitional coverage under paragraph (1); 

2 or 

3 ‘‘(B) affect the application and approval 

4 process for pass-through payment status under 

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

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

7 medical device that is not approved by the Food 

8 and Drug Administration as a breakthrough de9 vice. 

10 ‘‘(c) CODING.— 

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

12 three months after the date of approval or clearance 

13 of a breakthrough device by the Food and Drug Ad14 ministration, subject to subparagraph (B), the Sec15 retary shall assign a unique temporary or permanent 

16 code or codes for purposes of coverage and payment 

17 for such breakthrough device under the applicable 

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

19 ‘‘(2) UPDATES.— 

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

21 for semiannual updates under the applicable 

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

23 (relating to the inpatient hospital prospective 

24 payment system) to recognize the code or codes 

25 assigned under paragraph (1). 


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

2 for quarterly updates under the applicable pay3 ment system described in paragraph (4)(B) (re4 lating to the outpatient hospital prospective 

5 payment system) to recognize the code or codes 

6 assigned under paragraph (1). 

7 ‘‘(3) TRANSPARENCY.—The process for the as8 signment of a code or codes under this subsection 

9 shall provide for public notice and a meaningful op10 portunity for public comment from affected parties. 

11 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE12 SCRIBED.—For purposes of this subsection, the term 

13 ‘applicable payment systems’ means— 

14 ‘‘(A) with respect to inpatient hospital 

15 services, the prospective payment system for in16 patient hospital services established under sec17 tion 1886(d); 

18 ‘‘(B) with respect to outpatient hospital 

19 services, the prospective payment system for 

20 covered OPD services established under section 

21 1833(t); 

22 ‘‘(C) with respect to ambulatory surgical 

23 center services, the fee schedule for such serv24 ices established under 1833(i); 


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

2 the physician fee schedules established under 

3 section 1848; 

4 ‘‘(E) with respect to covered items of dura5 ble medical equipment, the applicable fee sched6 ules established under section 1834; 

7 ‘‘(F) with respect to diagnostic laboratory 

8 tests, the fee schedule established under section 

9 1834(h), the payment amounts under section 

10 1834A, and the fee schedules establish under 

11 section 1848, as the case may be; 

12 ‘‘(G) with respect to inpatient hospital 

13 services furnished by rehabilitation facilities, 

14 the prospective payment system established 

15 under section 1886(j); 

16 ‘‘(H) with respect to inpatient hospital 

17 services furnished by long-term care hospitals, 

18 the prospective payment system under section 

19 1886(m); and 

20 ‘‘(I) with respect to inpatient hospital serv21 ices furnished by psychiatric hospitals and psy22 chiatric units, the prospective payment system 

23 under section 1886(s). 

24 ‘‘(d) PAYMENT.— 


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1 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY2 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK3 THROUGH PAYMENT.—The Secretary shall deem 

4 each breakthrough device as approved for an addi5 tional payment under section 1886(d)(5)(K) for the 

6 3-year period that begins— 

7 ‘‘(A) except as provided in subparagraph 

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

9 subsection (c)(2)(A), updates the payment sys10 tem under section 1886(d) to recognize the 

11 unique temporary or permanent code or codes 

12 assigned under subsection (c)(1) to such break13 through device; or 

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

15 received approval or clearance as a break16 through device by the Food and Drug Adminis17 tration before such payment system is updated 

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

19 unique temporary or permanent code or codes 

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

21 on the date of such approval or clearance. 

22 Nothing in this paragraph shall be construed to af23 fect the authority of the Secretary to use claims 

24 data to establish new diagnosis or procedure codes 

25 for breakthrough devices or to identify appropriate 


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1 diagnosis-related groups for the assignment of 

2 breakthrough devices under annual rulemaking to 

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

4 ‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS5 TEM: DEEMED ELIGIBILITY FOR PASS-THROUGH

6 PAYMENT.—The Secretary shall deem each break7 through device as approved for pass-through pay8 ment under section 1833(t)(6) (including for pur9 poses of section 1833(i)(2)(D)) during the 3-year pe10 riod that begins— 

11 ‘‘(A) except as provided in subparagraph 

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

13 subsection (c)(2)(B), updates the payment sys14 tem under section 1833(t) 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)(B) 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 ambulatory payment classifica4 tion groups for breakthrough devices or to revise 

5 such groups to take into account breakthrough de6 vices under annual rulemaking to carry out section 

7 1833(t). 

8 ‘‘(3) OTHER PAYMENT SYSTEMS.— 

9 ‘‘(A) IN GENERAL.—In the case of break10 through device that is furnished and for which 

11 payment may be made under the payment sys12 tem established under sections 1834, 1834A, 

13 1848, 1886(j), 1886(m), 1886(s), or any other 

14 relevant provision of this title (other than sec15 tions 1833(i), 1833(t), and 1886(d)), the Sec16 retary shall provide for an additional payment 

17 for such breakthrough device under such pay18 ment systems in an amount equal to 80 percent 

19 of the costs of such breakthrough device. 

20 ‘‘(B) RULE OF CONSTRUCTION.—Nothing 

21 in this paragraph shall be construed to affect 

22 the authority of the Secretary to use claims 

23 data to establish new or modify existing ambu24 latory payment classification groups, diagnosis25 related groups, level II HCPCS codes or such 


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1 other groups or codes as the Secretary may es2 tablish under the annual rulemaking authority 

3 under the provisions referred to in subpara4 graph (A). 

5 ‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES

6 AFTER THE TRANSITIONAL COVERAGE PERIOD.— 

7 Payment for a breakthrough device that is furnished 

8 after the conclusion of the transitional coverage pe9 riod under subsection (b)(1) for such device shall be 

10 made pursuant to the applicable payment system in11 volved, taking into account the additional evidence 

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

13 ‘‘(e) TREATMENT OF BREAKTHROUGH DEVICES

14 UNDER PAY-FOR-PERFORMANCE PROGRAMS.— 

15 ‘‘(1) PAY-FOR-PERFORMANCE PROGRAMS DE16 FINED.—In this subsection, the term ‘pay-for-per17 formance programs’ means, with respect to items 

18 and services for which payment is made under the 

19 applicable payment systems under this title, pay20 ment initiatives designed to improve the quality, effi21 ciency, and overall value of health care furnished to 

22 individuals entitled to benefits under part A or en23 rolled under part B through financial incentives to 

24 providers of services and suppliers for meeting or ex25 ceeding certain quality or performance measures or 


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1 through financial penalties on providers that fail to 

2 achieve specified goals or cost savings, or both. Such 

3 term includes— 

4 ‘‘(A) the Medicare shared savings program 

5 under established section 1899; 

6 ‘‘(B) shared savings programs tested by 

7 the Center for Medicare and Medicaid Innova8 tion under section 1115A, including the Pioneer 

9 ACO program; 

10 ‘‘(C) the National Pilot Program on Pay11 ment Bundling under section 1866D; 

12 ‘‘(D) bundled payment programs tested by 

13 the Center for Medicare and Medicaid Innova14 tion under section 1115A; and 

15 ‘‘(E) any other similar program conducted 

16 under this title or under applicable authorities 

17 under title XI. 

18 ‘‘(2) EXCLUSION OF ADDITIONAL COSTS OF

19 BREAKTHROUGH DEVICES.—Insofar as the amount 

20 of payment for a breakthrough device exceeds the 

21 amount of payment that the item or service would 

22 otherwise receive under a pay-for-performance pro23 gram for which shared savings or shared losses are 

24 calculated, the Secretary shall exclude from the cal25 culation of such shared savings or losses under such 


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1 program for such period the amount by which the 

2 payment for the breakthrough device involved ex3 ceeds the payment amount for such other item or 

4 service that would have been made but for the use 

5 of the breakthrough device. 

6 ‘‘(3) ADJUSTMENT TO QUALITY PROCESS MEAS7 URES FOR BREAKTHROUGH DEVICES.— 

8 ‘‘(A) IN GENERAL.—In the case that the 

9 furnishing by a provider of services or supplier 

10 participating in a pay-for-performance program 

11 of a breakthrough device to an individual enti12 tled to benefits under part A or enrolled under 

13 part B and participating in such program would 

14 result in such provider or supplier, with respect 

15 to the condition and episode of care for which 

16 such device is furnished, receiving a poor or 

17 failing score for a quality measure under such 

18 program that measures whether such provider 

19 or supplier gave the treatment known to give 

20 the best results for most patients with a par21 ticular condition (commonly known as a ‘clinical 

22 process of care’ measure), the Secretary shall 

23 exclude such quality measure from any deter24 mination of whether such provider or supplier 

25 met applicable quality performance thresholds 


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1 under such program with respect to such condi2 tion and episode of care of such individual. 

3 ‘‘(B) INAPPLICABILITY TO CLINICAL OUT4 COMES MEASURES.—Nothing in subparagraph 

5 (A) may be construed to allow for the exclusion, 

6 with respect to a breakthrough device furnished 

7 to an individual by a provider or supplier under 

8 a pay-for-performance program, of any quality 

9 measure designed to reflect the results of care 

10 furnished to such individual by such provider or 

11 supplier (commonly known as a ‘clinical out12 come’ measure) from a determination described 

13 in such subparagraph.’’. 

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

15 DEVICES.— 

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

17 Human Services shall conduct a study on the effect 

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

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

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

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

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

23 purposes of such section 1899C. 


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1 (2) MATTERS EXAMINED.—In conducting the 

2 study described in paragraph (1), the Secretary 

3 shall— 

4 (A) determine the number of medical de5 vices cleared under such section 510(k) during 

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

7 enactment of this Act; 

8 (B) determine the number of such devices 

9 that were not breakthrough devices for pur10 poses of such section 1899C by reason of the 

11 limitation under subsection (a)(2) of such sec12 tion; and 

13 (C) examine the impact of such limitation 

14 on access to such devices for individuals entitled 

15 to benefits under part A or enrolled in part B 

16 of title XVIII of the Social Security Act (42 

17 U.S.C. 1395 et seq.). 

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

19 date of the enactment of this Act, the Secretary 

20 shall submit to Congress a report on the study con21 ducted under this subsection and shall include such 

22 recommendations for legislative or administrative 

23 changes as the Secretary determines to be appro24 priate. 


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1 (c) MODIFICATIONS TO THE COUNCIL FOR TECH2 NOLOGY AND INNOVATION.— 

3 (1) EXPANSION OF DUTIES.—Paragraph (3) of 

4 section 1868(b) of the Social Security Act (42 

5 U.S.C. 1395ee(b)) is amended by adding at the end 

6 the following: ‘‘The Council shall also coordinate ac7 tivities of the Secretary for the implementation of 

8 section 1899C (relating to breakthrough devices), es9 pecially with respect to timely coverage, coding, evi10 dence-gathering, and payment for such devices.’’. 

11 (2) REORGANIZATION WITHIN THE CMMI.— 

12 Such section is further amended— 

13 (A) in paragraph (1), by striking ‘‘within 

14 the Centers’’ and all that follows through the 

15 end and inserting ‘‘within the Center for Medi16 care and Medicaid Innovation established under 

17 section 1115A (in this subsection referred to as 

18 ‘CMMI’).’’; and 

19 (B) in paragraph (4), by striking ‘‘the Ad20 ministrator of CMS’’ and inserting ‘‘the Direc21 tor of the CMMI’’. 

22 (d) IMPROVEMENTS TO NTAP PAYMENT ADJUST23 MENT UNDER THE INPATIENT PROSPECTIVE PAYMENT

24 SYSTEM.— 


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1 (1) PAYMENT FOR COSTS OF NEW TECH2 NOLOGIES.—With respect to hospital discharges for 

3 which payment is made under section 1886(d) of the 

4 Social Security Act (42 U.S.C. 1395ww(d)) occur5 ring on or after October 1, 2016, in calculating the 

6 amount of the additional payment for a new medical 

7 service or technology under paragraph (5)(K) of 

8 such section with respect to such a discharge, the 

9 Secretary of Health and Human Services shall apply 

10 section 412.88 of title 42, Code of Federal Regula11 tions, as if the reference to ‘‘50 percent’’ each place 

12 it appears in such section were a reference to ‘‘80 

13 percent’’. 

14 (2) CLARIFICATION REGARDING PAYMENTS FOR

15 NEW TECHNOLOGIES.— 

16 (A) IPPS NEW TECHNOLOGY PAYMENT.— 

17 Section 1886(d)(5)(K) of the Social Security 

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

19 by adding at the end the following new clause: 

20 ‘‘(x) During the period with respect to 

21 which a new medical service or technology 

22 is eligible for an additional payment under 

23 this subsection by reason of this subpara24 graph, any local coverage determination 

25 (as defined in section 1869(f)(2)(B)) that 


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1 would affect the coverage of, or the addi2 tional payment under this subsection for, 

3 such new medical service or technology 

4 shall have no force or effect in law or regu5 lation.’’. 

6 (B) CONFORMING AMENDMENT FOR OPPS

7 PASS-THROUGH PAYMENT.—Section 1833(t)(6) 

8 of the Social Security Act (42 U.S.C. 

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

10 the following new subparagraph: 

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

14 DEVICES.—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 (C) EFFECTIVE DATE.—This paragraph, 

24 and the amendments made by this paragraph, 

25 shall apply with respect to items and services 


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1 furnished on or after the date of the enactment 

2 of this Act, including any such item or service 

3 that is eligible on such date for an additional 

4 payment under section 1833(t)(6) of the Social 

5 Security Act (42 U.S.C. 1395l(t)(6)) or under 

6 section 1886(d) of such Act (42 U.S.C. 

7 1395ww(d)) by reason of paragraph (5)(K) of 

8 such section, or that would have been so eligible 

9 on such date but for a local coverage deter10 mination that limits or denies coverage of and 

11 such additional payment for the item or service. 

12 (3) REVISION TO THE COST THRESHOLD.— 

13 (A) IN GENERAL.—Section 

14 1886(d)(5)(K)(ii)(I) of the Social Security Act 

15 (42 U.S.C. 1395ww(d)(5)(K)(ii)(I)) is amended 

16 by striking ‘‘75 percent’’ each place it appears 

17 and inserting ‘‘50 percent’’. 

18 (B) EFFECTIVE DATE.—The amendment 

19 made by subparagraph (A) shall take effect on 

20 the date of the enactment of this Act. 

21 (4) USE OF BEST AVAILABLE COST DATA FOR

22 MS–DRG CLASSIFICATION.— 

23 (A) IN GENERAL.—Section 1886(d)(5)(K) 

24 of the Social Security Act (42 U.S.C. 

25 1395ww(d)(5)(K)), as amended by paragraph 


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1 (2)(A)), is further amended by adding at the 

2 end the following new clause: 

3 ‘‘(xi) In carrying out the requirement 

4 under clause (ii)(IV) for classification of a 

5 new medical service or technology to a new 

6 or existing diagnosis-related group after 

7 the close of the period under clause (ii)(II), 

8 the Secretary shall use the most recently 

9 available data and information on the costs 

10 of such service or technology in making 

11 such a classification for the service or tech12 nology, including data and information 

13 from surveys of providers of services and 

14 suppliers conducted by the Secretary, pri15 vate payers, health plans, physician spe16 cialty societies, or manufacturers as well as 

17 commercial price data and data from man18 ufacturer invoices.’’. 

19 (B) EFFECTIVE DATE.—The amendment 

20 made by subparagraph (A) shall take effect on 

21 the date of the enactment of this Act. 

22 (5) CRITERIA APPLIED IN MAKING SUBSTAN23 TIAL IMPROVEMENT DETERMINATIONS.— 

24 (A) IN GENERAL.—Section 1886(d)(5)(K) 

25 of the Social Security Act (42 U.S.C. 


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1 1395ww(d)(5)(K)), as amended by paragraphs 

2 (2)(A) and (4)(A), is further amended by add3 ing at the end the following new clause: 

4 ‘‘(xii)(I) In making a determination 

5 under this subparagraph whether a new 

6 medical service or technology represents an 

7 advance in medical technology that sub8 stantially improves the diagnosis or treat9 ment of Medicare beneficiaries relative to a 

10 medical service or technology that was pre11 viously available, the Secretary shall also 

12 consider whether such new medical service 

13 or technology meets one or more of the fol14 lowing criteria: 

15 ‘‘(aa) The use of the new medical 

16 service or technology can result in a 

17 reduction of the length of a hospital 

18 stay. 

19 ‘‘(bb) The use of the new medical 

20 service or technology can improve pa21 tient quality of life. 

22 ‘‘(cc) The use of the new medical 

23 service or technology can create long24 term clinical efficiencies in treatment. 


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1 ‘‘(dd) The use of the new medical 

2 service or technology can address pa3 tient-centered objectives (as defined 

4 by the Secretary). 

5 ‘‘(ee) The use of the new medical 

6 service or technology can meet such 

7 other criteria as the Secretary may 

8 specify. 

9 ‘‘(II) In considering whether a new 

10 medical service or technology potentially 

11 meets the criteria under subclause (I), the 

12 Secretary shall consider the following 

13 forms of evidence: 

14 ‘‘(aa) Evidence described in well15 documented case histories, including 

16 registry data. 

17 ‘‘(bb) Studies published in peer18 reviewed journals. 

19 ‘‘(cc) Data collected in countries 

20 other than the United States so long 

21 as such data otherwise meet the cri22 teria specified in this clause.’’. 

23 (B) EFFECTIVE DATE.—The amendment 

24 made by subparagraph (A) shall take effect on 

25 the date of the enactment of this Act. 


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1 (6) REVISION TO THE NEWNESS CRITERION.— 

2 (A) IN GENERAL.—Section 

3 1886(d)(5)(K)(vi) of the Social Security Act 

4 (42 U.S.C. 1395ww(d)(5)(K)(vi)) is amended— 

5 (i) by inserting ‘‘(I)’’ after ‘‘(vi)’’; and 

6 (ii) by adding at the end the following 

7 new subclauses: 

8 ‘‘(II) Under the criteria estab9 lished under this clause with respect 

10 to the determination of whether a 

11 medical service or technology is con12 sidered new for purposes of this sub13 paragraph and subparagraph (L), the 

14 Secretary shall include devices that in15 volve a significant technological 

16 change that do not raise different 

17 questions of safety and effectiveness 

18 (in a comparison to the predicate de19 vice) and result in enhanced clinical 

20 advantages or reduced cost, even 

21 though they use the same or similar 

22 mechanism of action or are assigned 

23 to the same diagnosis-related group. 

24 ‘‘(III) Under the criteria estab25 lished under this clause with respect 


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1 to the determination of whether a 

2 medical service or technology is con3 sidered new for purposes of this sub4 paragraph and subparagraph (L), the 

5 Secretary shall not disqualify a new 

6 medical service or technology as not 

7 meeting the newness criterion solely 

8 on the basis of a finding of a de mini9 mis number of claims for such med10 ical service or technology in Medicare 

11 claims data. For purposes of this sub12 clause, the term ‘de minimis’ means, 

13 with respect to claims, an amount 

14 that is fewer than 50.’’. 

15 (B) EFFECTIVE DATE.—The amendment 

16 made by subparagraph (A) shall take effect on 

17 the date of the enactment of this Act. 

18 (7) REVISION TO THE COMMENCEMENT OF THE

19 PERIOD FOR COLLECTION OF COST DATA FOR NEW

20 TECHNOLOGIES.— 

21 (A) IN GENERAL.—Section 

22 1886(d)(5)(K)(ii)(II) of the Social Security Act 

23 (42 U.S.C. 1395ww(d)(5)(K)(ii)(II)) is amend24 ed by inserting ‘‘the later of the date that is the 

25 date of the clearance or approval by the ComVerDate Sep 11 2014 02:55 Apr 30, 2016 Jkt 059200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H5009.IH H5009

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1 missioner of Food and Drugs of the service or 

2 technology or’’ after ‘‘beginning on’’. 

3 (B) EFFECTIVE DATE.—The amendment 

4 made by subparagraph (A) shall take effect on 

5 the date of the enactment of this Act, and shall 

6 apply with respect to hospital discharges for in7 patient hospital services for which payment is 

8 made under section 1886(d) of the Social Secu9 rity Act (42 U.S.C. 1395ww) occurring on or 

10 after October 1, 2016. 

11 (8) PERMITTING APPEALS OF NTAP DETER12 MINATIONS.— 

13 (A) IN GENERAL.—Section 1886(d)(5)(K) 

14 of the Social Security Act (42 U.S.C. 

15 1395ww(d)(5)(K)), as amended by paragraphs 

16 (2)(A), (4)(A), and (5)(A), is further amended 

17 by adding at the end the following new clause: 

18 ‘‘(xiii)(I) An individual or entity that 

19 submits an application for additional pay20 ment under this subparagraph for a new 

21 technology shall be entitled to administra22 tive review of an adverse determination by 

23 the Secretary with respect to such applica24 tion. 


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1 ‘‘(II) The Secretary shall establish a 

2 process for administrative review for pur3 poses of subclause (I). Under such process, 

4 administrative review shall be conducted by 

5 an official of the Department of Health 

6 and Human Services (other than an offi7 cial of the Centers for Medicare & Med8 icaid Services). Under such process, the 

9 Department official involved shall complete 

10 administrative review within 90 days of re11 ceipt of a request for such review. 

12 ‘‘(III) In the case of an application 

13 for additional payment under this subpara14 graph for a new technology that is ap15 proved under administrative review, the 

16 Secretary shall provide for such additional 

17 payment for such new technology during 

18 the period that— 

19 ‘‘(aa) begins on the date that is 

20 the first day of the first calendar 

21 quarter that begins after the date of 

22 the completion of such administrative 

23 review; and 

24 ‘‘(bb) ends on the date that is 

25 not less than 2 years and not more 


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1 than 3 years after the date referred to 

2 in item (aa).’’. 

3 (B) CONFORMING AMENDMENT.—Section 

4 1886(d)(7)(B) of such Act (42 U.S.C. 

5 1395ww(d)(7)(B)) is amended by inserting ‘‘but 

6 not including a denial by the Secretary of an 

7 application for additional payment under para8 graph (5)(K) with respect to a discharge occur9 ring on or after the date of the date of the en10 actment of the Ensuring Patient Access to Crit11 ical Breakthrough Products Act of 2016’’ after 

12 ‘‘paragraph (4)(D)’’. 

13 (C) EFFECTIVE DATE.—The amendments 

14 made by this paragraph shall take effect on the 

15 date of the enactment of this Act, and shall 

16 apply with respect to hospital discharges for in17 patient hospital services for which payment is 

18 made under section 1886(d) of the Social Secu19 rity Act (42 U.S.C. 1395ww) occurring on or 

20 after October 1, 2016. 

21 (e) CONFORMING AMENDMENTS.— 

22 (1) INPATIENT PROSPECTIVE PAYMENT SYS23 TEM.—Section 1886(d)(5)(K)(i) of the Social Secu24 rity Act (42 U.S.C. 1395ww(d)(5)(K)(i)) is amended 

25 by adding at the end the following new sentence: 


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1 ‘‘Effective for discharges occurring on or after Octo2 ber 1, 2016, in the case of a new medical service or 

3 technology that is a breakthrough device (as defined 

4 in section 1899C(a)) payment for such breakthrough 

5 device shall be made for the 3-year period applicable 

6 to such breakthrough device under section 

7 1899C(d)(1).’’. 

8 (2) OUTPATIENT PROSPECTIVE PAYMENT SYS9 TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 

10 1395l(t)(6)(C)) is amended by adding at the end the 

11 following new clause: 

12 ‘‘(iii) SPECIAL RULE FOR BREAK13 THROUGH DEVICES.—Notwithstanding 

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

15 this paragraph to the contrary, in the case 

16 of a breakthrough device (as defined in 

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

18 after January 1, 2017, payment under this 

19 paragraph for such breakthrough device 

20 shall be made for the 3-year period appli21 cable to such breakthrough device under 

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

23 clause shall also apply for purposes of 

24 transitional pass-through payment under 

25 section 1833(i)(2)(D).’’. 


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1 (f) EFFECTIVE DATE.—This section and the amend2 ments made by this section shall take effect on the date 

3 of the enactment of this Act and, unless otherwise speci4 fied in this section (or in an amendment made by this sec5 tion), shall apply to breakthrough devices (as defined in 

6 section 1899C(a), as added by subsection (a)) approved 

7 on or after January 1, 2017. 

Æ 


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