Lower Costs, More Cures Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 19 To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration, and for other purposes. IN THE HOUSE OF REPRESENTATIVES APRIL 21, 2021 Mrs. RODGERS of Washington (for herself, Mr. BRADY, Ms. FOXX, Mr. GUTH- RIE, Mr. NUNES, and Mr. ALLEN) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consider- ation of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration, 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 2021’’. 5 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 19 IH SEC. 2. TABLE OF CONTENTS. 1 The table of contents for this Act is as follows: 2 Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—MEDICARE PARTS B AND D 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. Subtitle B—Drug Price Transparency Sec. 111. Reporting on explanation for drug price increases. Sec. 112. Public disclosure of drug discounts. Sec. 113. Study of pharmaceutical supply chain intermediaries and merger ac- tivity. Sec. 114. Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities. Sec. 115. Sense of Congress regarding the need to expand commercially avail- able drug pricing comparison platforms. Subtitle C—Medicare Part D Benefit Redesign Sec. 121. Medicare part D benefit redesign. Subtitle D—Other Medicare Part D Provisions Sec. 131. Allowing the offering of additional prescription drug plans under Medicare part D. Sec. 132. Allowing certain enrollees of prescription drug plans and MA–PD plans under Medicare program to spread out cost-sharing under certain circumstances. Sec. 133. Establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or MA– PD plan. Sec. 134. Growth rate of Medicare part D out-of-pocket cost threshold. TITLE II—MEDICAID Sec. 201. Medicaid pharmacy and therapeutics committee improvements. Sec. 202. GAO report on conflicts of interest in State Medicaid program drug use review boards and pharmacy and therapeutics (P&T) com- mittees. Sec. 203. Ensuring the accuracy of manufacturer price and drug product infor- mation under the Medicaid drug rebate program. VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 19 IH Sec. 204. Improving transparency and preventing the use of abusive spread pricing and related practices in Medicaid. Sec. 205. T–MSIS drug data analytics reports. Sec. 206. Risk-sharing value-based payment agreements for covered outpatient drugs under Medicaid. Sec. 207. Applying Medicaid drug rebate requirement to drugs provided as part of outpatient hospital services. TITLE III—FOOD AND DRUG ADMINISTRATION Subtitle A—Pay-for-Delay Sec. 301. Unlawful agreements. Sec. 302. Notice and certification of agreements. Sec. 303. Forfeiture of 180-day exclusivity period. Sec. 304. Commission litigation authority. Sec. 305. Statute of limitations. Subtitle B—Advancing Education on Biosimilars Sec. 321. Education on biological products. Subtitle C—Other Provisions Sec. 331. Clarifying the meaning of new chemical entity. TITLE IV—REVENUE PROVISION Sec. 401. Safe harbor for high deductible health plans without deductible for insulin. TITLE V—MISCELLANEOUS Sec. 501. Payment for biosimilar biological products during initial period. Sec. 502. GAO study and report on average sales price. Sec. 503. Requiring prescription drug plans and MA–PD plans to report poten- tial fraud, waste, and abuse to the Secretary of HHS. Sec. 504. Establishment of pharmacy quality measures under Medicare part D. Sec. 505. Improving coordination between the Food and Drug Administration and the Centers for Medicare & Medicaid Services. Sec. 506. Patient consultation in Medicare national and local coverage deter- minations in order to mitigate barriers to inclusion of such per- spectives. Sec. 507. MedPAC report on shifting coverage of certain Medicare part B drugs to Medicare part D. Sec. 508. Requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-mis- leading pricing information. Sec. 509. Chief Pharmaceutical Negotiator at the Office of the United States Trade Representative. VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6211 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 19 IH 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 fice’’ after ‘‘surgical center’’; and 18 (iii) by inserting ‘‘(or 2022 with re- 19 spect to a physician for services furnished 20 in a physician’s office)’’ after ‘‘2018’’; and 21 (C) in subparagraph (A)— 22 (i) by striking ‘‘and the’’ and insert- 23 ing ‘‘, the’’; and 24 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 19 IH (ii) by inserting ‘‘, and the physician 1 fee schedule under section 1848 (with re- 2 spect to the practice expense component of 3 such payment amount)’’ after ‘‘such sec- 4 tion’’; 5 (2) by redesignating paragraphs (2) through 6 (4) as paragraphs (3) through (5), respectively; and 7 (3) by inserting after paragraph (1) the fol- 8 lowing new paragraph: 9 ‘‘(2) PHYSICIAN PAYMENT.—Beginning in 10 2022, the Secretary shall expand the information in- 11 cluded on the Internet website described in para- 12 graph (1) to include— 13 ‘‘(A) the amount paid to a physician under 14 section 1848 for an item or service for the set- 15 tings described in paragraph (1); and 16 ‘‘(B) the estimated amount of beneficiary 17 liability applicable to the item or service.’’. 18 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 19 IH SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SIN- 1 GLE-DOSE CONTAINER OR SINGLE-USE PACK- 2 AGE DRUGS PAYABLE UNDER PART B OF THE 3 MEDICARE PROGRAM TO PROVIDE REFUNDS 4 WITH RESPECT TO DISCARDED AMOUNTS OF 5 SUCH DRUGS. 6 Section 1847A of the Social Security Act (42 U.S.C. 7 1395w–3a) is amended by adding at the end the following 8 new subsection: 9 ‘‘(i) REFUND FOR CERTAIN DISCARDED SINGLE- 10 DOSE CONTAINER OR SINGLE-USE PACKAGE DRUGS.— 11 ‘‘(1) SECRETARIAL PROVISION OF INFORMA- 12 TION.— 13 ‘‘(A) IN GENERAL.—For each calendar 14 quarter beginning on or after January 1, 2022, 15 the Secretary shall, with respect to a refundable 16 single-dose container or single-use package drug 17 (as defined in paragraph (8)), report to each 18 manufacturer (as defined in subsection 19 (c)(6)(A)) of such refundable single-dose con- 20 tainer or single-use package drug the following 21 for the calendar quarter: 22 ‘‘(i) Subject to subparagraph (C), in- 23 formation on the total number of units of 24 the billing and payment code of such drug, 25 if any, that were discarded during such 26 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 19 IH quarter, as determined using a mechanism 1 such as the JW modifier used as of the 2 date of enactment of this subsection (or 3 any such successor modifier that includes 4 such data as determined appropriate by 5 the Secretary). 6 ‘‘(ii) The refund amount that the 7 manufacturer is liable for pursuant to 8 paragraph (3). 9 ‘‘(B) DETERMINATION OF DISCARDED 10 AMOUNTS.—For purposes of subparagraph 11 (A)(i), with respect to a refundable single-dose 12 container or single-use package drug furnished 13 during a quarter, the amount of such drug that 14 was discarded shall be determined based on the 15 amount of such drug that was unused and dis- 16 carded for each drug on the date of service. 17 ‘‘(C) EXCLUSION OF UNITS OF PACKAGED 18 DRUGS.—The total number of units of the bill- 19 ing and payment code of a refundable single- 20 dose container or single-use package drug of a 21 manufacturer furnished during a calendar quar- 22 ter for purposes of subparagraph (A)(i), and 23 the determination of the estimated total allowed 24 charges for the drug in the quarter for purposes 25 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 19 IH of paragraph (3)(A)(ii), shall not include such 1 units that are packaged into the payment 2 amount for an item or service and are not sepa- 3 rately payable. 4 ‘‘(2) MANUFACTURER REQUIREMENT.—For 5 each calendar quarter beginning on or after January 6 1, 2022, the manufacturer of a refundable single- 7 dose container or single-use package drug shall, for 8 such drug, provide to the Secretary a refund that is 9 equal to the amount specified in paragraph (3) for 10 such drug for such quarter. 11 ‘‘(3) REFUND AMOUNT.— 12 ‘‘(A) IN GENERAL.—The amount of the re- 13 fund specified in this paragraph is, with respect 14 to a refundable single-dose container or single- 15 use package drug of a manufacturer assigned to 16 a billing and payment code for a calendar quar- 17 ter beginning on or after January 1, 2022, an 18 amount equal to the estimated amount (if any) 19 by which— 20 ‘‘(i) the product of— 21 ‘‘(I) the total number of units of 22 the billing and payment code for such 23 drug that were discarded during such 24 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 19 IH quarter (as determined under para- 1 graph (1)); and 2 ‘‘(II)(aa) in the case of a refund- 3 able single-dose container or single- 4 use package drug that is a single 5 source drug or biological, the amount 6 of payment determined for such drug 7 or biological under subsection 8 (b)(1)(B) for such quarter; or 9 ‘‘(bb) in the case of a refundable 10 single-dose container or single-use 11 package drug that is a biosimilar bio- 12 logical product, the amount of pay- 13 ment determined for such product 14 under subsection (b)(1)(C) for such 15 quarter; exceeds 16 ‘‘(ii) an amount equal to the applica- 17 ble percentage (as defined in subparagraph 18 (B)) of the estimated total allowed charges 19 for such drug under this part during the 20 quarter. 21 ‘‘(B) APPLICABLE PERCENTAGE DE- 22 FINED.— 23 VerDate Sep 11 2014 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 19 IH ‘‘(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)(ii), the Secretary, through notice 17 and comment rulemaking, may increase 18 the applicable percentage otherwise appli- 19 cable under clause (i)(I) as determined ap- 20 propriate 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 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 19 IH ‘‘(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 00:26 Apr 24, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 19 IH container or single-use p [Text truncated for display. 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