Ensuring Patient Access to Critical Breakthrough Products Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 4043 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 JUNE 22, 2021 Ms. DELBENE (for herself, Mrs. WALORSKI, Mr. CA´RDENAS, Mr. BILIRAKIS, Ms. SEWELL, and Mr. UPTON) 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 de- termined 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 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 2021’’. 5 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 4043 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.—For purposes of 7 this section, the term ‘breakthrough device’ means a med- 8 ical device that is a device (as defined in section 201 of 9 the Federal Food, Drug, and Cosmetic Act) and that is— 10 ‘‘(1) provided with review priority by the Sec- 11 retary under subsection (d)(5) of section 515 of such 12 Act; and 13 ‘‘(2) approved or cleared pursuant to section 14 510(k), 513(f), or 515 of such Act for use in treat- 15 ing an indication on or after March 15, 2019. 16 Such term also includes a breakthrough device that is a 17 specified breakthrough device (as defined in subsection 18 (e)(1)(B)) approved or cleared pursuant to section 510(k), 19 513(f), or 515 of such Act for use in treating an indication 20 on or after March 15, 2019. 21 ‘‘(b) COVERAGE.— 22 ‘‘(1) TRANSITIONAL COVERAGE.— 23 ‘‘(A) IN GENERAL.—During the transi- 24 tional coverage period (as defined in subpara- 25 graph (B)) a breakthrough device shall be— 26 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 4043 IH ‘‘(i) deemed to be reasonable and nec- 1 essary for purposes of section 2 1862(a)(1)(A); 3 ‘‘(ii) deemed to be approved for an ad- 4 ditional payment under section 5 1886(d)(5)(K) (other than with respect to 6 the cost criterion under clause (ii)(I) of 7 such section); 8 ‘‘(iii) deemed to be approved for pass- 9 through payment under section 1833(t)(6) 10 and section 1833(i) (other than with re- 11 spect to the cost criterion under section 12 1833(t)(6)(A)(iv)); and 13 ‘‘(iv) insofar as such breakthrough de- 14 vice may be furnished in a setting for 15 which payment is made under an applica- 16 ble payment system described in subpara- 17 graphs (D) through (I) of subsection 18 (c)(4), deemed eligible for an additional 19 payment or payment adjustment, as the 20 case may be, pursuant to subsection (d)(3) 21 when furnished in a setting for which pay- 22 ment is made under such an applicable 23 payment system during such transitional 24 coverage period. 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 4043 IH ‘‘(B) TRANSITIONAL COVERAGE PERIOD 1 DEFINED.—As used in this section, the term 2 ‘transitional coverage period’ means, with re- 3 spect to a breakthrough device, the period 4 that— 5 ‘‘(i) begins on the date of the approval 6 under section 515 of the Federal Food, 7 Drug, and Cosmetic Act or of the clear- 8 ance under section 510(k) of such Act, as 9 applicable, of such device by the Secretary 10 for the indication described in subsection 11 (a)(1); and 12 ‘‘(ii) ends on the last day of the 4- 13 year period that begins on the date that 14 the Secretary, pursuant to subsection 15 (c)(2), updates the relevant applicable pay- 16 ment system (as defined in subsection 17 (c)(4)) to recognize the unique temporary 18 or permanent code or codes assigned under 19 subsection (c)(1) to such breakthrough de- 20 vice, except as provided in subsections 21 (d)(1)(B) and (d)(2)(B). 22 ‘‘(C) DATA USED TO MEET THE NTAP AND 23 PASS-THROUGH COST CRITERIA.—In deter- 24 mining whether a breakthrough device qualifies 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 4043 IH for an additional payment under section 1 1886(d)(5)(K) or for pass-through payment 2 under section 1833(t)(6) or section 1833(i), the 3 Secretary shall use the most recently available 4 data and information on the costs of such 5 breakthrough device, which may include list 6 prices and invoice prices charged for such 7 breakthrough device. 8 ‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 9 purposes of the application of section 1862(a)(1)(A) 10 to a breakthrough device furnished after the transi- 11 tional coverage period (as defined in paragraph 12 (1)(B)) for such device, the Secretary shall establish 13 a process for the coverage of such breakthrough de- 14 vices under this title after such period as follows: 15 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI- 16 DENCE.— 17 ‘‘(i) IN GENERAL.—With respect to a 18 breakthrough device, not later than 1 year 19 after the date of the approval of such de- 20 vice under section 515 of the Federal 21 Food, Drug, and Cosmetic Act or of the 22 clearance of such device under section 23 510(k) of such Act, as applicable, the Sec- 24 retary shall identify whether any additional 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 4043 IH data or evidence is required with respect to 1 any indications for such device for pur- 2 poses of the application of such section 3 1862(a)(1)(A) to such device for such indi- 4 cations. 5 ‘‘(ii) NON-DUPLICATION OF DATA RE- 6 QUESTS.—In carrying out clause (i) with 7 respect to a breakthrough device, the Sec- 8 retary shall ensure that data or evidence 9 identified— 10 ‘‘(I) does not duplicate data re- 11 quired to be collected by the Food and 12 Drug Administration with respect to 13 such breakthrough device; 14 ‘‘(II) minimizes the administra- 15 tive burdens of data collection and re- 16 porting on providers of services, sup- 17 pliers, and manufacturers of break- 18 through devices; and 19 ‘‘(III) is not otherwise unneces- 20 sary or redundant. 21 ‘‘(B) PROPOSAL FOR COVERAGE AFTER 22 THE TRANSITIONAL COVERAGE PERIOD.—Not 23 later than 2 years after the date of the approval 24 or clearance of a breakthrough device by the 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 4043 IH Food and Drug Administration, the Secretary 1 shall develop a proposal for coverage under this 2 title of such breakthrough device for such indi- 3 cations as the Secretary determines to be ap- 4 propriate, based on the data and evidence col- 5 lected under subparagraph (A), for such devices 6 furnished after the transitional coverage period 7 under paragraph (1) for such device. If the Sec- 8 retary does not, on a date that is before the end 9 of such two-year period, take action to modify 10 the indications for which coverage of a break- 11 through device may be provided under this title 12 after such period, for purposes of section 13 1862(a)(1)(A) coverage under this title of such 14 breakthrough device shall be made for all indi- 15 cations for which such device is approved under 16 section 515 of the Federal Food, Drug, and 17 Cosmetic Act or cleared under section 510(k) of 18 such Act. 19 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 20 this section shall be construed to— 21 ‘‘(A) affect the ability of the manufacturer 22 of a breakthrough device to seek approval for 23 pass-through payment status under section 24 1833(t)(6) or to seek approval for an additional 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 4043 IH payment under section 1886(d)(5)(K) insofar 1 as such breakthrough device does not qualify 2 for transitional coverage under paragraph (1); 3 or 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 de- 10 vice. 11 ‘‘(c) CODING.— 12 ‘‘(1) PROMPT ASSIGNMENT.—Not later than 13 three months after the date of approval or clearance 14 of a breakthrough device by the Food and Drug Ad- 15 ministration, the Secretary shall assign a unique 16 temporary or permanent code or codes for purposes 17 of coverage and payment for such breakthrough de- 18 vice under the applicable payment systems (de- 19 scribed in paragraph (4)). 20 ‘‘(2) UPDATES.— 21 ‘‘(A) IPPS.—The Secretary shall provide 22 for semiannual updates under the applicable 23 payment system described in paragraph (4)(A) 24 (relating to the inpatient hospital prospective 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 4043 IH payment system) to recognize the code or codes 1 assigned under paragraph (1). 2 ‘‘(B) OPPS.—The Secretary shall provide 3 for quarterly updates under the applicable pay- 4 ment system described in paragraph (4)(B) (re- 5 lating to the outpatient hospital prospective 6 payment system) to recognize the code or codes 7 assigned under paragraph (1). 8 ‘‘(C) OTHER PAYMENT SYSTEMS.—The 9 Secretary shall provide for semiannual or quar- 10 terly updates, as the case may be, under the ap- 11 plicable payment systems described in subpara- 12 graphs (C) through (K) of paragraph (4) to 13 recognize the code or codes assigned under 14 paragraph (1). 15 ‘‘(3) TRANSPARENCY.—The process for the as- 16 signment of a code or codes under this subsection 17 shall provide for public notice and a meaningful op- 18 portunity for public comment from affected parties. 19 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE- 20 SCRIBED.—For purposes of this subsection, the term 21 ‘applicable payment systems’ means— 22 ‘‘(A) with respect to inpatient hospital 23 services, the prospective payment system for in- 24 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 4043 IH patient hospital services established under sec- 1 tion 1886(d); 2 ‘‘(B) with respect to outpatient hospital 3 services, the prospective payment system for 4 covered OPD services established under section 5 1833(t); 6 ‘‘(C) with respect to ambulatory surgical 7 center services, the fee schedule for such serv- 8 ices established under 1833(i); 9 ‘‘(D) with respect to physicians’ services, 10 the physician fee schedules established under 11 section 1848; 12 ‘‘(E) with respect to covered items of dura- 13 ble medical equipment, the applicable fee sched- 14 ules established under section 1834; 15 ‘‘(F) with respect to diagnostic laboratory 16 tests, the payment amounts under section 17 1834A and the fee schedules establish under 18 section 1848, as the case may be; 19 ‘‘(G) with respect to inpatient hospital 20 services furnished by rehabilitation facilities, 21 the prospective payment system established 22 under section 1886(j); 23 ‘‘(H) with respect to inpatient hospital 24 services furnished by long-term care hospitals, 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 4043 IH the prospective payment system under section 1 1886(m); 2 ‘‘(I) with respect to inpatient hospital serv- 3 ices furnished by psychiatric hospitals and psy- 4 chiatric units, the prospective payment system 5 under section 1886(s); 6 ‘‘(J) with respect to home health services, 7 the prospective payment system under section 8 1895; and 9 ‘‘(K) with respect to items and services, or 10 a provider of services or supplier, not described 11 in subparagraphs (A) through (K), the payment 12 system established under this title for such 13 items and services when furnished by such pro- 14 vider of services or supplier. 15 ‘‘(d) PAYMENT.— 16 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY- 17 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK- 18 THROUGH PAYMENT.—The Secretary shall deem 19 each breakthrough device as approved for an addi- 20 tional payment under section 1886(d)(5)(K) for the 21 4-year period that begins— 22 ‘‘(A) except as provided in subparagraph 23 (B), on the date that the Secretary, pursuant to 24 subsection (c)(2)(A), updates the payment sys- 25 VerDate Sep 11 2014 17:34 Aug 03, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4043.IH H4043 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 4043 IH tem under section 1886(d) to recognize the 1 unique temporary or permanent code or codes 2 assigned under subsection (c)(1) to such break- 3 through device; or 4 ‘‘(B) in the case of a device that has not 5 received approval or clearance as a break- 6 through device by the Food and Drug Adminis- 7 tration before such payment system is updated 8 under subsection (c)(2)(A) to recognize the 9 unique temporary or permanent code or codes 10 assigned under subsection (c)(1) to such device, 11 on the date of such approval or clearance. 12 Nothing in this paragraph shall be construed to af- 13 fect the authority of the Secretary to use claims 14 data to establish new diagnosis or procedure codes 15 for breakthrough devices or to identify appropriate 16 diagnosis-related groups for the assignment of 17 breakthrough devices under annual rulemaking to 18 carry out section 1886(d)(5)(K). 19 ‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS- 20 TEM: DEEMED ELIGIBILITY FOR PASS-THROUGH 21 PAYMENT.—The Secretary shall deem each break- 22 through device as approved for pass-through pay- 23 ment under section 1833(t)(6) (including for pur- 24 VerDate Sep [Text truncated for display. 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