Removing Barriers to Colorectal Cancer Screening Act of 2020

IIB 116TH CONGRESS 2D SESSION H. R. 1570 IN THE SENATE OF THE UNITED STATES DECEMBER 10, 2020 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend title XVIII of the Social Security Act to waive coinsurance under Medicare for colorectal cancer screen- ing tests, regardless of whether therapeutic intervention is required during the screening, 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 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 2 HR 1570 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Removing Barriers to 2 Colorectal Cancer Screening Act of 2020’’. 3 SEC. 2. WAIVING MEDICARE COINSURANCE FOR CERTAIN 4 COLORECTAL CANCER SCREENING TESTS. 5 (a) IN GENERAL.—Section 1833(a) of the Social Se- 6 curity Act (42 U.S.C. 1395l(a)) is amended— 7 (1) in the second sentence, by striking ‘‘section 8 1834(0)’’ and inserting ‘‘section 1834(o)’’; 9 (2) by moving such second sentence 2 ems to 10 the left; and 11 (3) by inserting the following third sentence fol- 12 lowing such second sentence: ‘‘For services furnished 13 on or after January 1, 2022, paragraph (1)(Y) shall 14 apply with respect to a colorectal cancer screening 15 test regardless of the code that is billed for the es- 16 tablishment of a diagnosis as a result of the test, or 17 for the removal of tissue or other matter or other 18 procedure that is furnished in connection with, as a 19 result of, and in the same clinical encounter as the 20 screening test.’’. 21 (b) SPECIAL COINSURANCE RULE FOR CERTAIN 22 TESTS.—Section 1833 of the Social Security Act (42 23 U.S.C. 1395l) is amended— 24 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 3 HR 1570 RFS (1) in subsection (a)(1)(Y), by inserting ‘‘sub- 1 ject to subsection (dd),’’ before ‘‘with respect to’’; 2 and 3 (2) by adding at the end the following new sub- 4 section: 5 ‘‘(dd) SPECIAL COINSURANCE RULE FOR CERTAIN 6 COLORECTAL CANCER SCREENING TESTS.— 7 ‘‘(1) IN GENERAL.—In the case of a colorectal 8 cancer screening test to which paragraph (1)(Y) of 9 subsection (a) would not apply but for the third sen- 10 tence of such subsection that is furnished during a 11 year beginning on or after January 1, 2022, and be- 12 fore January 1, 2030, the amount paid shall be 13 equal to the specified percent (as defined in para- 14 graph (2)) for such year of the lesser of the actual 15 charge for the service or the amount determined 16 under the fee schedule that applies to such test 17 under this part (or, in the case such test is a cov- 18 ered OPD service (as defined in subsection 19 (t)(1)(B)), the amount determined under subsection 20 (t)). 21 ‘‘(2) SPECIFIED PERCENT DEFINED.—For pur- 22 poses of paragraph (1), the term ‘specified percent’ 23 means— 24 ‘‘(A) for 2022 and 2023, 80 percent; 25 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 4 HR 1570 RFS ‘‘(B) for 2024 and 2025, 85 percent; 1 ‘‘(C) for 2026 and 2027, 90 percent; and 2 ‘‘(D) for 2028 and 2029, 95 percent.’’. 3 (c) CONFORMING AMENDMENTS.—Paragraphs (2) 4 and (3) of section 1834(d) of the Social Security Act (42 5 U.S.C. 1395m(d)) are each amended— 6 (1) in subparagraph (C)(ii), in the matter pre- 7 ceding subclause (I), by striking ‘‘Notwithstanding’’ 8 and inserting ‘‘Subject to section 1833(a)(1)(Y), but 9 notwithstanding’’; and 10 (2) in subparagraph (D), by striking ‘‘If dur- 11 ing’’ and inserting ‘‘Subject to section 12 1833(a)(1)(Y), if during’’. 13 SEC. 3. REQUIRING CERTAIN MANUFACTURERS TO REPORT 14 DRUG PRICING INFORMATION WITH RE- 15 SPECT TO DRUGS UNDER THE MEDICARE 16 PROGRAM. 17 (a) IN GENERAL.—Section 1847A of the Social Secu- 18 rity Act (42 U.S.C. 1395w–3a) is amended— 19 (1) in subsection (b)— 20 (A) in paragraph (2)(A), by inserting ‘‘or 21 subsection (f)(2), as applicable’’ before the pe- 22 riod at the end; 23 (B) in paragraph (3), in the matter pre- 24 ceding subparagraph (A), by inserting ‘‘or sub- 25 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 5 HR 1570 RFS section (f)(2), as applicable,’’ before ‘‘deter- 1 mined by’’; and 2 (C) in paragraph (6)(A), in the matter 3 preceding clause (i), by inserting ‘‘or subsection 4 (f)(2), as applicable,’’ before ‘‘determined by’’; 5 and 6 (2) in subsection (f)— 7 (A) by striking ‘‘For requirements’’ and 8 inserting the following: 9 ‘‘(1) IN GENERAL.—For requirements’’; and 10 (B) by adding at the end the following new 11 paragraph: 12 ‘‘(2) MANUFACTURERS WITHOUT A REBATE 13 AGREEMENT UNDER TITLE XIX.— 14 ‘‘(A) IN GENERAL.—If the manufacturer 15 of a drug or biological described in subpara- 16 graph (C), (E), or (G) of section 1842(o)(1) or 17 in section 1881(b)(14)(B) that is payable under 18 this part has not entered into and does not 19 have in effect a rebate agreement described in 20 subsection (b) of section 1927, for calendar 21 quarters beginning with the second calendar 22 quarter beginning on or after the date of the 23 enactment of this paragraph, such manufac- 24 turer shall report to the Secretary the informa- 25 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 6 HR 1570 RFS tion described in subsection (b)(3)(A)(iii) of 1 such section 1927 with respect to such drug or 2 biological in a time and manner specified by the 3 Secretary. For purposes of applying this para- 4 graph, a drug or biological described in the pre- 5 vious sentence includes items, services, supplies, 6 and products that are payable under this part 7 as a drug or biological. 8 ‘‘(B) AUDIT.—Information reported under 9 subparagraph (A) is subject to audit by the In- 10 spector General of the Department of Health 11 and Human Services. 12 ‘‘(C) VERIFICATION.—The Secretary may 13 survey wholesalers and manufacturers that di- 14 rectly distribute drugs described in subpara- 15 graph (A), when necessary, to verify manufac- 16 turer prices and manufacturer’s average sales 17 prices (including wholesale acquisition cost) if 18 required to make payment reported under sub- 19 paragraph (A). The Secretary may impose a 20 civil monetary penalty in an amount not to ex- 21 ceed $100,000 on a wholesaler, manufacturer, 22 or direct seller, if the wholesaler, manufacturer, 23 or direct seller of such a drug refuses a request 24 for information about charges or prices by the 25 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 7 HR 1570 RFS Secretary in connection with a survey under 1 this subparagraph or knowingly provides false 2 information. The provisions of section 1128A 3 (other than subsections (a) (with respect to 4 amounts of penalties or additional assessments) 5 and (b)) shall apply to a civil money penalty 6 under this subparagraph in the same manner as 7 such provisions apply to a penalty or proceeding 8 under section 1128A(a). 9 ‘‘(D) CONFIDENTIALITY.—Notwith- 10 standing any other provision of law, information 11 disclosed by manufacturers or wholesalers 12 under this paragraph (other than the wholesale 13 acquisition cost for purposes of carrying out 14 this section) is confidential and shall not be dis- 15 closed by the Secretary in a form which dis- 16 closes the identity of a specific manufacturer or 17 wholesaler or prices charged for drugs by such 18 manufacturer or wholesaler, except— 19 ‘‘(i) as the Secretary determines to be 20 necessary to carry out this section (includ- 21 ing the determination and implementation 22 of the payment amount), or to carry out 23 section 1847B; 24 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 8 HR 1570 RFS ‘‘(ii) to permit the Comptroller Gen- 1 eral of the United States to review the in- 2 formation provided; and 3 ‘‘(iii) to permit the Director of the 4 Congressional Budget Office to review the 5 information provided.’’. 6 (b) ENFORCEMENT.—Section 1847A of such Act (42 7 U.S.C. 1395w–3a) is further amended— 8 (1) in subsection (d)(4)— 9 (A) in subparagraph (A), by striking ‘‘IN 10 GENERAL’’ and inserting ‘‘MISREPRESENTA- 11 TION’’; 12 (B) in subparagraph (B), by striking ‘‘sub- 13 paragraph (B)’’ and inserting ‘‘subparagraph 14 (A), (B), or (C)’’; 15 (C) by redesignating subparagraph (B) as 16 subparagraph (D); and 17 (D) by inserting after subparagraph (A) 18 the following new subparagraphs: 19 ‘‘(B) FAILURE TO PROVIDE TIMELY INFOR- 20 MATION.—If the Secretary determines that a 21 manufacturer described in subsection (f)(2) has 22 failed to report on information described in sec- 23 tion 1927(b)(3)(A)(iii) with respect to a drug or 24 biological in accordance with such subsection, 25 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 9 HR 1570 RFS the Secretary shall apply a civil money penalty 1 in an amount of $10,000 for each day the man- 2 ufacturer has failed to report such information 3 and such amount shall be paid to the Treasury. 4 ‘‘(C) FALSE INFORMATION.—Any manu- 5 facturer required to submit information under 6 subsection (f)(2) that knowingly provides false 7 information is subject to a civil money penalty 8 in an amount not to exceed $100,000 for each 9 item of false information. Such civil money pen- 10 alties are in addition to other penalties as may 11 be prescribed by law.’’; and 12 (2) in subsection (c)(6)(A), by striking the pe- 13 riod at the end and inserting ‘‘, except that, for pur- 14 poses of subsection (f)(2), the Secretary may, if the 15 Secretary determines appropriate, exclude repack- 16 agers of a drug or biological from such term.’’. 17 (c) MANUFACTURERS WITH A REBATE AGREE- 18 MENT.— 19 (1) IN GENERAL.—Section 1927(b)(3)(A) of the 20 Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is 21 amended by adding at the end the following new 22 sentence: ‘‘For purposes of applying clause (iii), a 23 drug or biological described in the flush matter fol- 24 lowing such clause includes items, services, supplies, 25 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 10 HR 1570 RFS and products that are payable under this part as a 1 drug or biological.’’. 2 (2) TECHNICAL AMENDMENT.—Section 3 1927(b)(3)(A)(iii) of the Social Security Act (42 4 U.S.C. 1396r-8(b)(3)(A)(iii)) is amended by striking 5 ‘‘section 1881(b)(13)(A)(ii)’’ and inserting ‘‘section 6 1881(b)(14)(B)’’. 7 (d) REPORT.—Not later than January 1, 2023, the 8 Inspector General of the Department of Health and 9 Human Services shall assess and submit to Congress a 10 report on the accuracy of average sales price information 11 submitted by manufacturers under section 1847A of the 12 Social Security Act (42 U.S.C. 1395w–3a). Such report 13 shall include any recommendations on how to improve the 14 accuracy of such information. 15 SEC. 4. DETERMINATION OF BUDGETARY EFFECTS. 16 The budgetary effects of this Act, for the purpose of 17 complying with the Statutory Pay-As-You-Go Act of 2010, 18 shall be determined by reference to the latest statement 19 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 20 Act, submitted for printing in the Congressional Record 21 by the Chairman of the House Budget Committee, pro- 22 VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS 11 HR 1570 RFS vided that such statement has been submitted prior to the 1 vote on passage. 2 Passed the House of Representatives December 9, 2020. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570 pbinns on DSKJLVW7X2PROD with BILLS