Ensuring Patient Access to Critical Breakthrough Products Act of 2019

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 con- cerned A BILL To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medi- care program, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Ensuring Patient Ac- 4 cess to Critical Breakthrough Products Act of 2019’’. 5 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 2 •HR 5333 IH SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH 1 DEVICES UNDER THE MEDICARE PROGRAM. 2 (a) IN GENERAL.—Part E of title XVIII of the Social 3 Security Act (42 U.S.C. 1395x et seq.) is amended by add- 4 ing at the end the following new section: 5 ‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES. 6 ‘‘(a) BREAKTHROUGH DEVICES.— 7 ‘‘(1) IN GENERAL.—For purposes of this sec- 8 tion, the term ‘breakthrough device’ means a med- 9 ical device that is a device (as defined in section 201 10 of the Federal Food, Drug, and Cosmetic Act) and 11 that is— 12 ‘‘(A) provided with review priority by the 13 Secretary under subsection (d)(5) of section 14 515 of such Act; and 15 ‘‘(B) approved or cleared pursuant to sec- 16 tion 510(k), 513(f), or 515 of such Act for use 17 in treating an indication on or after July 1, 18 2019. 19 Such term also includes a breakthrough device that 20 is a specified breakthrough device (as defined in sub- 21 section (e)(1)(B)) approved or cleared pursuant to 22 section 510(k), 513(f), or 515 of such Act for use 23 in treating an indication on or after December 1, 24 2018. 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 3 •HR 5333 IH ‘‘(2) LIMITATION ON NUMBER OF 510(K) DE- 1 VICES.—With respect to a 5-year period, in no case 2 may more than five medical devices described in 3 paragraph (1) that are classified under section 4 510(k) of the Federal Food, Drug, and Cosmetic 5 Act be covered and paid for under this title by rea- 6 son of this section during each such 5-year period. 7 ‘‘(b) COVERAGE.— 8 ‘‘(1) TRANSITIONAL COVERAGE.— 9 ‘‘(A) IN GENERAL.—During the transi- 10 tional coverage period (as defined in subpara- 11 graph (B)) a breakthrough device shall be— 12 ‘‘(i) deemed to be reasonable and nec- 13 essary for purposes of section 14 1862(a)(1)(A); 15 ‘‘(ii) deemed to be approved for an ad- 16 ditional payment under section 17 1886(d)(5)(K) (other than with respect to 18 the cost criterion under clause (ii)(I) of 19 such section); 20 ‘‘(iii) deemed to be approved for pass- 21 through payment under section 1833(t)(6) 22 and section 1833(i) (other than with re- 23 spect to the cost criterion under section 24 1833(t)(6)(A)(iv)); and 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 4 •HR 5333 IH ‘‘(iv) insofar as such breakthrough de- 1 vice may be furnished in a setting for 2 which payment is made under an applica- 3 ble payment system described in subpara- 4 graphs (D) through (I) of subsection 5 (c)(4), deemed eligible for an additional 6 payment or payment adjustment, as the 7 case may be, pursuant to subsection (d)(3) 8 when furnished in a setting for which pay- 9 ment is made under such an applicable 10 payment system during such transitional 11 coverage period. 12 ‘‘(B) TRANSITIONAL COVERAGE PERIOD 13 DEFINED.—As used in this section, the term 14 ‘transitional coverage period’ means, with re- 15 spect to a breakthrough device, the period 16 that— 17 ‘‘(i) begins on the date of the approval 18 under section 515 of the Federal Food, 19 Drug, and Cosmetic Act or of the clear- 20 ance under section 510(k) of such Act, as 21 applicable, of such device by the Secretary 22 for the indication described in subsection 23 (a)(1); and 24 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 5 •HR 5333 IH ‘‘(ii) ends on the last day of the 3- 1 year period that begins on the date that 2 the Secretary, pursuant to subsection 3 (c)(2), updates the relevant applicable pay- 4 ment system (as defined in subsection 5 (c)(4)) to recognize the unique temporary 6 or permanent code or codes assigned under 7 subsection (c)(1) to such breakthrough de- 8 vice, except as provided in subsections 9 (d)(1)(B) and (d)(2)(B). 10 ‘‘(C) DATA USED TO MEET THE NTAP AND 11 PASS-THROUGH COST CRITERIA.—In deter- 12 mining whether a breakthrough device qualifies 13 for an additional payment under section 14 1886(d)(5)(K) or for pass-through payment 15 under section 1833(t)(6) or section 1833(i), the 16 Secretary shall use the most recently available 17 data and information on the costs of such 18 breakthrough device, which may include list 19 prices and invoice prices charged for such 20 breakthrough device. 21 ‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 22 purposes of the application of section 1862(a)(1)(A) 23 to a breakthrough device furnished after the transi- 24 tional coverage period (as defined in paragraph 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 6 •HR 5333 IH (1)(B)) for such device, the Secretary shall establish 1 a process for the coverage of such breakthrough de- 2 vices under this title after such period as follows: 3 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI- 4 DENCE.— 5 ‘‘(i) IN GENERAL.—With respect to a 6 breakthrough device, not later than 1 year 7 after the date of the approval of such de- 8 vice under section 515 of the Federal 9 Food, Drug, and Cosmetic Act or of the 10 clearance of such device under section 11 510(k) of such Act, as applicable, the Sec- 12 retary shall identify whether any additional 13 data or evidence is required with respect to 14 any indications for such device for pur- 15 poses of the application of such section 16 1862(a)(1)(A) to such device for such indi- 17 cations. 18 ‘‘(ii) NON-DUPLICATION OF DATA RE- 19 QUESTS.—In carrying out clause (i) with 20 respect to a breakthrough device, the Sec- 21 retary shall ensure that data or evidence 22 identified— 23 ‘‘(I) does not duplicate data re- 24 quired to be collected by the Food and 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 7 •HR 5333 IH Drug Administration with respect to 1 such breakthrough device; 2 ‘‘(II) minimizes the administra- 3 tive burdens of data collection and re- 4 porting on providers of services, sup- 5 pliers, and manufacturers of break- 6 through devices; and 7 ‘‘(III) is not otherwise unneces- 8 sary or redundant. 9 ‘‘(B) PROPOSAL FOR COVERAGE AFTER 10 THE TRANSITIONAL COVERAGE PERIOD.—Not 11 later than 2 years after the date of the approval 12 or clearance of a breakthrough device by the 13 Food and Drug Administration, the Secretary 14 shall develop a proposal for coverage under this 15 title of such breakthrough device for such indi- 16 cations as the Secretary determines to be ap- 17 propriate, based on the data and evidence col- 18 lected under subparagraph (A), for such devices 19 furnished after the transitional coverage period 20 under paragraph (1) for such device. If the Sec- 21 retary does not, on a date that is before the end 22 of such two-year period, take action to modify 23 the indications for which coverage of a break- 24 through device may be provided under this title 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 8 •HR 5333 IH after such period, for purposes of section 1 1862(a)(1)(A) coverage under this title of such 2 breakthrough device shall be made for all indi- 3 cations for which such device is approved under 4 section 515 of the Federal Food, Drug, and 5 Cosmetic Act or cleared under section 510(k) of 6 such Act. 7 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 8 this section shall be construed to— 9 ‘‘(A) affect the ability of the manufacturer 10 of a breakthrough device to seek approval for 11 pass-through payment status under section 12 1833(t)(6) or to seek approval for an additional 13 payment under section 1886(d)(5)(K) insofar 14 as such breakthrough device does not qualify 15 for transitional coverage under paragraph (1); 16 or 17 ‘‘(B) affect the application and approval 18 process for pass-through payment status under 19 section 1833(t)(6) or for an additional payment 20 under section 1886(d)(5)(K) in the case of a 21 medical device that is not approved by the Food 22 and Drug Administration as a breakthrough de- 23 vice. 24 ‘‘(c) CODING.— 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 9 •HR 5333 IH ‘‘(1) PROMPT ASSIGNMENT.—Not later than 1 three months after the date of approval or clearance 2 of a breakthrough device by the Food and Drug Ad- 3 ministration, subject to subparagraph (B), the Sec- 4 retary shall assign a unique temporary or permanent 5 code or codes for purposes of coverage and payment 6 for such breakthrough device under the applicable 7 payment systems (described in paragraph (4)). 8 ‘‘(2) UPDATES.— 9 ‘‘(A) IPPS.—The Secretary shall provide 10 for semiannual updates under the applicable 11 payment system described in paragraph (4)(A) 12 (relating to the inpatient hospital prospective 13 payment system) to recognize the code or codes 14 assigned under paragraph (1). 15 ‘‘(B) OPPS.—The Secretary shall provide 16 for quarterly updates under the applicable pay- 17 ment system described in paragraph (4)(B) (re- 18 lating to the outpatient hospital prospective 19 payment system) to recognize the code or codes 20 assigned under paragraph (1). 21 ‘‘(C) OTHER PAYMENT SYSTEMS.—The 22 Secretary shall provide for semiannual or quar- 23 terly updates, as the case may be, under the ap- 24 plicable payment systems described in subpara- 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 10 •HR 5333 IH graphs (C) through (L) of paragraph (4) to rec- 1 ognize the code or codes assigned under para- 2 graph (1). 3 ‘‘(3) TRANSPARENCY.—The process for the as- 4 signment of a code or codes under this subsection 5 shall provide for public notice and a meaningful op- 6 portunity for public comment from affected parties. 7 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE- 8 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 in- 12 patient hospital services established under sec- 13 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 serv- 20 ices established under 1833(i); 21 ‘‘(D) with respect to physicians’ services, 22 the physician fee schedules established under 23 section 1848; 24 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 11 •HR 5333 IH ‘‘(E) with respect to covered items of dura- 1 ble medical equipment, the applicable fee sched- 2 ules established under section 1834; 3 ‘‘(F) with respect to diagnostic laboratory 4 tests, the payment amounts under section 5 1834A and the fee schedules establish under 6 section 1848, as the case may be; 7 ‘‘(G) with respect to inpatient hospital 8 services furnished by rehabilitation facilities, 9 the prospective payment system established 10 under section 1886(j); 11 ‘‘(H) with respect to inpatient hospital 12 services furnished by long-term care hospitals, 13 the prospective payment system under section 14 1886(m); 15 ‘‘(I) with respect to inpatient hospital serv- 16 ices furnished by psychiatric hospitals and psy- 17 chiatric units, the prospective payment system 18 under section 1886(s); 19 ‘‘(J) with respect to home health services, 20 the prospective payment system under section 21 1895; and 22 ‘‘(K) with respect to items and services, or 23 a provider of services or supplier, not described 24 in subparagraphs (A) through (I), the payment 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 12 •HR 5333 IH system established under this title for such 1 items and services when furnished by such pro- 2 vider of services or supplier. 3 ‘‘(d) PAYMENT.— 4 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY- 5 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK- 6 THROUGH PAYMENT.—The Secretary shall deem 7 each breakthrough device as approved for an addi- 8 tional payment under section 1886(d)(5)(K) for the 9 3-year period that begins— 10 ‘‘(A) except as provided in subparagraph 11 (B), on the date that the Secretary, pursuant to 12 subsection (c)(2)(A), updates the payment sys- 13 tem under section 1886(d) to recognize the 14 unique temporary or permanent code or codes 15 assigned under subsection (c)(1) to such break- 16 through device; or 17 ‘‘(B) in the case of a device that has not 18 received approval or clearance as a break- 19 through device by the Food and Drug Adminis- 20 tration before such payment system is updated 21 under subsection (c)(2)(A) to recognize the 22 unique temporary or permanent code or codes 23 assigned under subsection (c)(1) to such device, 24 on the date of such approval or clearance. 25 VerDate Sep 11 2014 05:09 Dec 13, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333 kjohnson on DSK79L0C42 with BILLS 13 •HR 5333 IH Nothing in this paragraph shall be construed t [Text truncated for display. Full text available on Congress.gov.]