Ensuring Patient Access to Critical Breakthrough Products Act of 2020

II 116TH CONGRESS 2D SESSION S. 3914 To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes. IN THE SENATE OF THE UNITED STATES JUNE 8, 2020 Ms. MCSALLY introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the 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 2020’’. 5 SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH 6 DEVICES UNDER THE MEDICARE PROGRAM. 7 (a) IN GENERAL.—Part E of title XVIII of the Social 8 Security Act (42 U.S.C. 1395x et seq.) is amended by add- 9 ing at the end the following new section: 10 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3914 IS ‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES. 1 ‘‘(a) BREAKTHROUGH DEVICES.— 2 ‘‘(1) IN GENERAL.—For purposes of this sec- 3 tion, the term ‘breakthrough device’ means a med- 4 ical device that is a device (as defined in section 201 5 of the Federal Food, Drug, and Cosmetic Act) and 6 that is— 7 ‘‘(A) provided with review priority by the 8 Secretary under subsection (d)(5) of section 9 515 of such Act; and 10 ‘‘(B) approved or cleared pursuant to sec- 11 tion 510(k), 513(f), or 515 of such Act for use 12 in treating an indication on or after July 1, 13 2019. 14 Such term also includes a breakthrough device that 15 is a specified breakthrough device (as defined in sub- 16 section (e)(1)(B)) approved or cleared pursuant to 17 section 510(k), 513(f), or 515 of such Act for use 18 in treating an indication on or after December 1, 19 2018. 20 ‘‘(2) LIMITATION ON NUMBER OF 510(k) DE- 21 VICES.—With respect to a 5-year period, in no case 22 may more than five medical devices described in 23 paragraph (1) that are classified under section 24 510(k) of the Federal Food, Drug, and Cosmetic 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3914 IS Act be covered and paid for under this title by rea- 1 son of this section during each such 5-year period. 2 ‘‘(b) COVERAGE.— 3 ‘‘(1) TRANSITIONAL COVERAGE.— 4 ‘‘(A) IN GENERAL.—During the transi- 5 tional coverage period (as defined in subpara- 6 graph (B)) a breakthrough device shall be— 7 ‘‘(i) deemed to be reasonable and nec- 8 essary for purposes of section 9 1862(a)(1)(A); 10 ‘‘(ii) deemed to be a medical or other 11 health service for purposes of section 12 1861(s); 13 ‘‘(iii) deemed to be approved for an 14 additional payment under section 15 1886(d)(5)(K) (other than with respect to 16 the cost criterion under clause (ii)(I) of 17 such section); 18 ‘‘(iv) deemed to be approved for pass- 19 through payment under section 1833(t)(6) 20 and section 1833(i) (other than with re- 21 spect to the cost criterion under section 22 1833(t)(6)(A)(iv)); and 23 ‘‘(v) insofar as such breakthrough de- 24 vice may be furnished in a setting for 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3914 IS which payment is made under an applica- 1 ble payment system described in subpara- 2 graphs (D) through (L) of subsection 3 (c)(4), deemed eligible for an additional 4 payment or payment adjustment, as the 5 case may be, pursuant to subsection (d)(3) 6 when furnished in a setting for which pay- 7 ment is made under such an applicable 8 payment system during such transitional 9 coverage period. 10 ‘‘(B) TRANSITIONAL COVERAGE PERIOD 11 DEFINED.—As used in this section, the term 12 ‘transitional coverage period’ means, with re- 13 spect to a breakthrough device, the period 14 that— 15 ‘‘(i) begins on the date of the approval 16 under section 515 of the Federal Food, 17 Drug, and Cosmetic Act or of the clear- 18 ance under section 510(k) of such Act, as 19 applicable, of such device by the Secretary 20 for the indication described in subsection 21 (a)(1); and 22 ‘‘(ii) ends on the last day of the 3- 23 year period that begins on the date that 24 the Secretary, pursuant to subsection 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3914 IS (c)(2), updates the relevant applicable pay- 1 ment system (as defined in subsection 2 (c)(4)) to recognize the unique temporary 3 or permanent code or codes assigned under 4 subsection (c)(1) to such breakthrough de- 5 vice, except as provided in subsections 6 (d)(1)(B) and (d)(2)(B). 7 ‘‘(C) DATA USED TO MEET THE NTAP AND 8 PASS-THROUGH COST CRITERIA.—In deter- 9 mining whether a breakthrough device qualifies 10 for an additional payment under section 11 1886(d)(5)(K) or for pass-through payment 12 under section 1833(t)(6) or section 1833(i), the 13 Secretary shall use the most recently available 14 data and information on the costs of such 15 breakthrough device, which may include list 16 prices and invoice prices charged for such 17 breakthrough device. 18 ‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 19 purposes of the application of section 1862(a)(1)(A) 20 to a breakthrough device furnished after the transi- 21 tional coverage period (as defined in paragraph 22 (1)(B)) for such device, the Secretary shall establish 23 a process for the coverage of such breakthrough de- 24 vices under this title after such period as follows: 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 6 •S 3914 IS ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI- 1 DENCE.— 2 ‘‘(i) IN GENERAL.—With respect to a 3 breakthrough device, not later than 1 year 4 after the date of the approval of such de- 5 vice under section 515 of the Federal 6 Food, Drug, and Cosmetic Act or of the 7 clearance of such device under section 8 510(k) of such Act, as applicable, the Sec- 9 retary shall identify whether any additional 10 data or evidence is required with respect to 11 any indications for such device for pur- 12 poses of the application of such section 13 1862(a)(1)(A) to such device for such indi- 14 cations. 15 ‘‘(ii) NON-DUPLICATION OF DATA RE- 16 QUESTS.—In carrying out clause (i) with 17 respect to a breakthrough device, the Sec- 18 retary shall ensure that data or evidence 19 identified— 20 ‘‘(I) does not duplicate data re- 21 quired to be collected by the Food and 22 Drug Administration with respect to 23 such breakthrough device; 24 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 7 •S 3914 IS ‘‘(II) minimizes the administra- 1 tive burdens of data collection and re- 2 porting on providers of services, sup- 3 pliers, and manufacturers of break- 4 through devices; and 5 ‘‘(III) is not otherwise unneces- 6 sary or redundant. 7 ‘‘(B) PROPOSAL FOR COVERAGE AFTER 8 THE TRANSITIONAL COVERAGE PERIOD.—Not 9 later than 2 years after the date of the approval 10 or clearance of a breakthrough device by the 11 Food and Drug Administration, the Secretary 12 shall develop a proposal for coverage under this 13 title of such breakthrough device for such indi- 14 cations as the Secretary determines to be ap- 15 propriate, based on the data and evidence col- 16 lected under subparagraph (A), for such devices 17 furnished after the transitional coverage period 18 under paragraph (1) for such device. If the Sec- 19 retary does not, on a date that is before the end 20 of such 2-year period, take action to modify the 21 indications for which coverage of a break- 22 through device may be provided under this title 23 after such period, for purposes of section 24 1862(a)(1)(A) coverage under this title of such 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 8 •S 3914 IS breakthrough device shall be made for all indi- 1 cations for which such device is approved under 2 section 515 of the Federal Food, Drug, and 3 Cosmetic Act or cleared under section 510(k) of 4 such Act. 5 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 6 this section shall be construed to— 7 ‘‘(A) affect the ability of the manufacturer 8 of a breakthrough device to seek approval for 9 pass-through payment status under section 10 1833(t)(6) or to seek approval for an additional 11 payment under section 1886(d)(5)(K) insofar 12 as such breakthrough device does not qualify 13 for transitional coverage under paragraph (1); 14 or 15 ‘‘(B) affect the application and approval 16 process for pass-through payment status under 17 section 1833(t)(6) or for an additional payment 18 under section 1886(d)(5)(K) in the case of a 19 medical device that is not approved by the Food 20 and Drug Administration as a breakthrough de- 21 vice. 22 ‘‘(c) CODING.— 23 ‘‘(1) PROMPT ASSIGNMENT.—Not later than 24 three months after the date of approval or clearance 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 9 •S 3914 IS of a breakthrough device by the Food and Drug Ad- 1 ministration, subject to subsection (b)(1)(B), the 2 Secretary shall assign a unique temporary or perma- 3 nent code or codes for purposes of coverage and pay- 4 ment for such breakthrough device under the appli- 5 cable payment systems (described in paragraph (4)). 6 ‘‘(2) UPDATES.— 7 ‘‘(A) IPPS.—The Secretary shall provide 8 for semiannual updates under the applicable 9 payment system described in paragraph (4)(A) 10 (relating to the inpatient hospital prospective 11 payment system) to recognize the code or codes 12 assigned under paragraph (1). 13 ‘‘(B) OPPS.—The Secretary shall provide 14 for quarterly updates under the applicable pay- 15 ment system described in paragraph (4)(B) (re- 16 lating to the outpatient hospital prospective 17 payment system) to recognize the code or codes 18 assigned under paragraph (1). 19 ‘‘(C) OTHER PAYMENT SYSTEMS.—The 20 Secretary shall provide for semiannual or quar- 21 terly updates, as the case may be, under the ap- 22 plicable payment systems described in subpara- 23 graphs (C) through (L) of paragraph (4) to rec- 24 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 10 •S 3914 IS ognize the code or codes assigned under para- 1 graph (1). 2 ‘‘(3) TRANSPARENCY.—The process for the as- 3 signment of a code or codes under this subsection 4 shall provide for public notice and a meaningful op- 5 portunity for public comment from affected parties. 6 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE- 7 SCRIBED.—For purposes of this subsection, the term 8 ‘applicable payment systems’ means— 9 ‘‘(A) with respect to inpatient hospital 10 services, the prospective payment system for in- 11 patient hospital services established under sec- 12 tion 1886(d); 13 ‘‘(B) with respect to outpatient hospital 14 services, the prospective payment system for 15 covered OPD services established under section 16 1833(t); 17 ‘‘(C) with respect to ambulatory surgical 18 center services, the fee schedule for such serv- 19 ices established under section 1833(i); 20 ‘‘(D) with respect to physicians’ services, 21 the physician fee schedules established under 22 section 1848; 23 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 11 •S 3914 IS ‘‘(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 renal dialysis services 8 furnished by a provider of services or a renal 9 dialysis facility, the single payment system es- 10 tablished under section 1881(b)(14); 11 ‘‘(H) with respect to inpatient hospital 12 services furnished by rehabilitation facilities, 13 the prospective payment system established 14 under section 1886(j); 15 ‘‘(I) with respect to inpatient hospital serv- 16 ices furnished by long-term care hospitals, the 17 prospective payment system under section 18 1886(m); 19 ‘‘(J) with respect to inpatient hospital 20 services furnished by psychiatric hospitals and 21 psychiatric units, the prospective payment sys- 22 tem under section 1886(s); 23 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 12 •S 3914 IS ‘‘(K) with respect to home health services, 1 the prospective payment system under section 2 1895; and 3 ‘‘(L) with respect to items and services, or 4 a provider of services or supplier, not described 5 in subparagraphs (A) through (K), the payment 6 system established under this title for such 7 items and services when furnished by such pro- 8 vider of services or supplier. 9 ‘‘(d) PAYMENT.— 10 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY- 11 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK- 12 THROUGH PAYMENT.—The Secretary shall deem 13 each breakthrough device as approved for an addi- 14 tional payment under section 1886(d)(5)(K) for the 15 3-year period that begins— 16 ‘‘(A) except as provided in subparagraph 17 (B), on the date that the Secretary, pursuant to 18 subsection (c)(2)(A), updates the payment sys- 19 tem under section 1886(d) to recognize the 20 unique temporary or permanent code or codes 21 assigned under subsection (c)(1) to such break- 22 through device; or 23 ‘‘(B) in the case of a device that has not 24 received approval or clearance as a break- 25 VerDate Sep 11 2014 03:57 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S3914.IS S3914 kjohnson on DSK79L0C42PROD with BILLS 13 •S 3914 IS through device by the Food and Drug Adminis- 1 tration before such payment system is updated 2 under subsection (c)(2)(A) to recognize the 3 unique temporary or permanent code or codes 4 assigned under subsection (c)(1) to such device, 5 on the date of such approval or clearance. 6 Nothing in this paragraph shall be construed [Text truncated for display. 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