Lower Costs, More Cures Act of 2019

II 116TH CONGRESS 1ST SESSION S. 3129 To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 19, 2019 Mr. CRAPO (for himself, Mr. ENZI, Mr. BURR, Mr. BARRASSO, Mr. TILLIS, and Mr. RISCH) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, 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 ‘‘Lower Costs, More 4 Cures Act of 2019’’. 5 SEC. 2. TABLE OF CONTENTS. 6 The table of contents for this Act is as follows: 7 Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—MEDICARE PARTS B AND D VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 3129 IS Subtitle A—Medicare Part B Provisions Sec. 101. Improvements to Medicare site-of-service transparency. Sec. 102. Requiring manufacturers of certain single-dose container or single-use package drugs payable under part B of the Medicare program to provide refunds with respect to discarded amounts of such drugs. Sec. 103. Providing for variation in payment for certain drugs covered under part B of the Medicare program. Sec. 104. Establishment of maximum add-on payment for drugs and biologicals. Sec. 105. Treatment of drug administration services furnished by certain ex- cepted off-campus outpatient departments of a provider. Sec. 106. Payment for biosimilar biological products during initial period. Sec. 107. Education on biological and biosimilar products. Sec. 108. GAO study and report on average sales price. Subtitle B—Medicare Part D Provisions Sec. 111. Medicare part D benefit redesign. Sec. 112. Transitional coverage and retroactive Medicare part D coverage for certain low-income beneficiaries. Sec. 113. Allowing the offering of additional prescription drug plans under Medicare part D. Sec. 114. Allowing certain enrollees of prescription drug plans and MA–PD plans under the Medicare program to spread out cost-sharing under certain circumstances. Sec. 115. Establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or MA– PD plan. Sec. 116. Growth rate of Medicare part D out-of-pocket cost threshold. Sec. 117. Requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor’s electronic prescription program under the Medicare program. Sec. 118. Requiring prescription drug plans and MA–PD plans to report poten- tial fraud, waste, and abuse to the Secretary of HHS. Sec. 119. Establishment of pharmacy quality measures under Medicare part D. TITLE II—DRUG PRICE TRANSPARENCY Sec. 201. Reporting on explanation for drug price increases. Sec. 202. Public disclosure of drug discounts. Sec. 203. Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program. Sec. 204. Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities. Sec. 205. Providing the Medicare Payment Advisory Commission and Medicaid and CHIP Payment and Access Commission with access to cer- tain drug payment information, including certain rebate infor- mation. Sec. 206. Sense of the Senate regarding the need to expand commercially avail- able drug pricing comparison platforms. TITLE III—REVENUE PROVISIONS Sec. 301. Permanent extension of reduction in medical expense deduction floor. VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 3129 IS Sec. 302. Safe harbor for high deductible health plans without deductible for insulin. Sec. 303. Inclusion of certain over-the-counter medical products as qualified medical expenses. TITLE IV—MISCELLANEOUS Sec. 401. Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services. Sec. 402. Patient consultation in Medicare national and local coverage deter- minations in order to mitigate barriers to inclusion of such per- spectives. Sec. 403. MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D. Sec. 404. Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-mis- leading pricing information. Sec. 405. Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative. TITLE I—MEDICARE PARTS B 1 AND D 2 Subtitle A—Medicare Part B 3 Provisions 4 SEC. 101. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE 5 TRANSPARENCY. 6 Section 1834(t) of the Social Security Act (42 U.S.C. 7 1395m(t)) is amended— 8 (1) in paragraph (1)— 9 (A) in the heading, by striking ‘‘IN GEN- 10 ERAL’’ and inserting ‘‘SITE PAYMENT’’; 11 (B) in the matter preceding subparagraph 12 (A)— 13 (i) by striking ‘‘or to’’ and inserting ‘‘, 14 to’’; 15 (ii) by inserting ‘‘, or to a physician 16 for services furnished in a physician’s of- 17 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 3129 IS fice’’ after ‘‘surgical center under this 1 title’’; and 2 (iii) by inserting ‘‘(or 2021 with re- 3 spect to a physician for services furnished 4 in a physician’s office)’’ after ‘‘2018’’; and 5 (C) in subparagraph (A)— 6 (i) by striking ‘‘and the’’ and insert- 7 ing ‘‘, the’’; and 8 (ii) by inserting ‘‘, and the physician 9 fee schedule under section 1848 (with re- 10 spect to the practice expense component of 11 such payment amount)’’ after ‘‘such sec- 12 tion’’; 13 (2) by redesignating paragraphs (2) through 14 (4) as paragraphs (3) through (5), respectively; and 15 (3) by inserting after paragraph (1) the fol- 16 lowing new paragraph: 17 ‘‘(2) PHYSICIAN PAYMENT.—Beginning in 18 2021, the Secretary shall expand the information in- 19 cluded on the Internet website described in para- 20 graph (1) to include— 21 ‘‘(A) the amount paid to a physician under 22 section 1848 for an item or service for the set- 23 tings described in paragraph (1); and 24 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 3129 IS ‘‘(B) the estimated amount of beneficiary 1 liability applicable to the item or service.’’. 2 SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SIN- 3 GLE-DOSE CONTAINER OR SINGLE-USE PACK- 4 AGE DRUGS PAYABLE UNDER PART B OF THE 5 MEDICARE PROGRAM TO PROVIDE REFUNDS 6 WITH RESPECT TO DISCARDED AMOUNTS OF 7 SUCH DRUGS. 8 Section 1847A of the Social Security Act (42 U.S.C. 9 1395–3a) is amended by adding at the end the following 10 new subsection: 11 ‘‘(h) REFUND FOR CERTAIN DISCARDED SINGLE- 12 DOSE CONTAINER OR SINGLE-USE PACKAGE DRUGS.— 13 ‘‘(1) SECRETARIAL PROVISION OF INFORMA- 14 TION.— 15 ‘‘(A) IN GENERAL.—For each calendar 16 quarter beginning on or after July 1, 2021, the 17 Secretary shall, with respect to a refundable 18 single-dose container or single-use package drug 19 (as defined in paragraph (8)), report to each 20 manufacturer (as defined in subsection 21 (c)(6)(A)) of such refundable single-dose con- 22 tainer or single-use package drug the following 23 for the calendar quarter: 24 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 3129 IS ‘‘(i) Subject to subparagraph (C), in- 1 formation on the total number of units of 2 the billing and payment code of such drug, 3 if any, that were discarded during such 4 quarter, as determined using a mechanism 5 such as the JW modifier used as of the 6 date of enactment of this subsection (or 7 any such successor modifier that includes 8 such data as determined appropriate by 9 the Secretary). 10 ‘‘(ii) The refund amount that the 11 manufacturer is liable for pursuant to 12 paragraph (3). 13 ‘‘(B) DETERMINATION OF DISCARDED 14 AMOUNTS.—For purposes of subparagraph 15 (A)(i), with respect to a refundable single-dose 16 container or single-use package drug furnished 17 during a quarter, the amount of such drug that 18 was discarded shall be determined based on the 19 amount of such drug that was unused and dis- 20 carded for each drug on the date of service. 21 ‘‘(C) EXCLUSION OF UNITS OF PACKAGED 22 DRUGS.—The total number of units of the bill- 23 ing and payment code of a refundable single- 24 dose container or single-use package drug of a 25 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 3129 IS manufacturer furnished during a calendar quar- 1 ter for purposes of subparagraph (A)(i), and 2 the determination of the estimated total allowed 3 charges for the drug in the quarter for purposes 4 of paragraph (3)(A)(ii), shall not include such 5 units that are packaged into the payment 6 amount for an item or service and are not sepa- 7 rately payable. 8 ‘‘(2) MANUFACTURER REQUIREMENT.—For 9 each calendar quarter beginning on or after July 1, 10 2021, the manufacturer of a refundable single-dose 11 container or single-use package drug shall, for such 12 drug, provide to the Secretary a refund that is equal 13 to the amount specified in paragraph (3) for such 14 drug for such quarter. 15 ‘‘(3) REFUND AMOUNT.— 16 ‘‘(A) IN GENERAL.—The amount of the re- 17 fund specified in this paragraph is, with respect 18 to a refundable single-dose container or single- 19 use package drug of a manufacturer assigned to 20 a billing and payment code for a calendar quar- 21 ter beginning on or after July 1, 2021, an 22 amount equal to the estimated amount (if any) 23 by which— 24 ‘‘(i) the product of— 25 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 3129 IS ‘‘(I) the total number of units of 1 the billing and payment code for such 2 drug that were discarded during such 3 quarter (as determined under para- 4 graph (1)); and 5 ‘‘(II)(aa) in the case of a refund- 6 able single-dose container or single- 7 use package drug that is a single 8 source drug or biological, the amount 9 determined for such drug under sub- 10 section (b)(4); or 11 ‘‘(bb) in the case of a refundable 12 single-dose container or single-use 13 package drug that is a biosimilar bio- 14 logical product, the average sales price 15 determined under subsection 16 (b)(8)(A); exceeds 17 ‘‘(ii) an amount equal to the applica- 18 ble percentage (as defined in subparagraph 19 (B)) of the estimated total allowed charges 20 for such drug during the quarter. 21 ‘‘(B) APPLICABLE PERCENTAGE DE- 22 FINED.— 23 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 3129 IS ‘‘(i) IN GENERAL.—For purposes of 1 subparagraph (A)(ii), the term ‘applicable 2 percentage’ means— 3 ‘‘(I) subject to subclause (II), 10 4 percent; and 5 ‘‘(II) if applicable, in the case of 6 a refundable single-dose container or 7 single-use package drug described in 8 clause (ii), a percentage specified by 9 the Secretary pursuant to such clause. 10 ‘‘(ii) TREATMENT OF DRUGS THAT 11 HAVE UNIQUE CIRCUMSTANCES.—In the 12 case of a refundable single-dose container 13 or single-use package drug that has unique 14 circumstances involving similar loss of 15 product as that described in paragraph 16 (8)(B), the Secretary, through notice and 17 comment rulemaking, may increase the ap- 18 plicable percentage otherwise applicable 19 under clause (i)(I) as determined appro- 20 priate by the Secretary. 21 ‘‘(4) FREQUENCY.—Amounts required to be re- 22 funded pursuant to paragraph (2) shall be paid in 23 regular intervals (as determined appropriate by the 24 Secretary). 25 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 3129 IS ‘‘(5) REFUND DEPOSITS.—Amounts paid as re- 1 funds pursuant to paragraph (2) shall be deposited 2 into the Federal Supplementary Medical Insurance 3 Trust Fund established under section 1841. 4 ‘‘(6) ENFORCEMENT.— 5 ‘‘(A) AUDITS.— 6 ‘‘(i) MANUFACTURER AUDITS.—Each 7 manufacturer of a refundable single-dose 8 container or single-use package drug that 9 is required to provide a refund under this 10 subsection shall be subject to periodic 11 audit with respect to such drug and such 12 refunds by the Secretary. 13 ‘‘(ii) PROVIDER AUDITS.—The Sec- 14 retary shall conduct periodic audits of 15 claims submitted under this part with re- 16 spect to refundable single-dose container or 17 single-use package drugs in accordance 18 with the authority under section 1833(e) to 19 ensure compliance with the requirements 20 applicable under this subsection. 21 ‘‘(B) CIVIL MONEY PENALTY.— 22 ‘‘(i) IN GENERAL.—The Secretary 23 shall impose a civil money penalty on a 24 manufacturer of a refundable single-dose 25 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 3129 IS container or single-use package drug who 1 has failed to comply with the requirement 2 under paragraph (2) for such drug for a 3 calendar quarter in an amount equal to the 4 sum of— 5 ‘‘(I) the amount that the manu- 6 facturer would have paid under such 7 paragraph with respect to such drug 8 for such quarter; and 9 ‘‘(II) 25 percent of such amount. 10 ‘‘(ii) APPLICATION.—The provisions 11 of section 1128A (other than subsections 12 (a) and (b)) shall apply to a civil money 13 penalty under this subparagraph in the 14 same manner as such provisions apply to a 15 penalty or proceeding under section 16 1128A(a). 17 ‘‘(7) IMPLEMENTATION.—The Secretary shall 18 implement this subsection through notice and com- 19 ment rulemaking. 20 ‘‘(8) DEFINITION OF REFUNDABLE SINGLE- 21 DOSE CONTAINER OR SINGLE-USE PACKAGE DRUG.— 22 ‘‘(A) IN GENERAL.—Except as provided in 23 subparagraph (B), in this subsection, the term 24 ‘refundable single-dose container or single-use 25 VerDate Sep 11 2014 20:20 Dec 30, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3129.IS S3129 pamtmann on D [Text truncated for display. 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