Lower Costs, More Cures Act of 2019

I 116TH 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 DECEMBER 9, 2019 Mr. WALDEN (for himself, Mr. BRADY, Ms. FOXX of North Carolina, Mr. COLLINS of Georgia, Mr. BURGESS, Mr. NUNES, Mr. WALBERG, Mr. SENSENBRENNER, Mr. SCALISE, Ms. CHENEY, Mr. UPTON, Mr. SHIM- KUS, Mr. LATTA, Mr. GUTHRIE, Mrs. RODGERS of Washington, Mr. OLSON, Mr. MCKINLEY, Mr. KINZINGER, Mr. GRIFFITH, Mr. BILIRAKIS, Mr. JOHNSON of Ohio, Mr. LONG, Mr. BUCSHON, Mr. FLORES, Mrs. BROOKS of Indiana, Mr. MULLIN, Mr. HUDSON, Mr. CARTER of Georgia, Mr. GIANFORTE, Mr. PALMER, Mr. COLE, Mr. WILLIAMS, Mr. ABRAHAM, Mr. KELLER, Mr. RUTHERFORD, Mr. FERGUSON, Mr. KUSTOFF of Ten- nessee, Mr. RIGGLEMAN, Mr. WESTERMAN, Mr. GRAVES of Louisiana, Mr. LAMALFA, Mr. BAIRD, Mr. HUIZENGA, Mr. MURPHY of North Caro- lina, Mr. CONAWAY, Mr. ALLEN, Mr. WEBER of Texas, Mr. NEWHOUSE, Mr. BABIN, Mr. HAGEDORN, Mr. ROUZER, Mr. RICE of South Carolina, Mr. WILSON of South Carolina, Mr. PENCE, Mr. HILL of Arkansas, Mr. MARSHALL, Mr. BALDERSON, Mr. ADERHOLT, Mr. RODNEY DAVIS of Il- linois, Mr. MITCHELL, Mr. CRENSHAW, Mr. JOYCE of Pennsylvania, Mr. JOHNSON of South Dakota, Mr. GREEN of Tennessee, Mrs. MILLER, Ms. STEFANIK, Mr. BANKS, Mr. COMER, Mr. MCCAUL, Mr. DIAZ-BALART, Mr. AMODEI, Mr. NORMAN, Mr. DAVID P. ROE of Tennessee, Mr. BUDD, Mr. COOK, Mr. KEVIN HERN of Oklahoma, Mr. CHABOT, Mr. STEUBE, Mr. CURTIS, Mr. GROTHMAN, Mr. STEIL, Mr. JOYCE of Ohio, Mr. SMITH of New Jersey, Mr. GONZALEZ of Ohio, Mr. STAUBER, Mr. BUCHANAN, Mr. SMITH of Nebraska, Mr. ARRINGTON, Mr. MARCHANT, Mrs. WALORSKI, Mr. KELLY of Pennsylvania, Mr. SMITH of Missouri, Mr. LAHOOD, Mr. HOLDING, Mr. ESTES, Mr. REED, Mr. SCHWEIKERT, Mr. WENSTRUP, Mrs. ROBY, Mr. RESCHENTHALER, Mr. HURD of Texas, Mr. WATKINS, Mr. LUETKEMEYER, Mr. TURNER, Mr. THOMPSON of Pennsyl- vania, Ms. HERRERA BEUTLER, Mr. GUEST, Mrs. HARTZLER, Mrs. WAG- NER, Mr. WALTZ, Mr. WRIGHT, and Mr. GIBBS) 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, VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 19 IH for a period to be subsequently determined by the Speaker, in each case for consideration 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 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 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. VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 19 IH Sec. 113. Study of pharmaceutical supply chain intermediaries and merger ac- tivity. Sec. 114. Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program. Sec. 115. Making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities. Sec. 116. 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. 117. Sense of Congress regarding the need to expand commercially avail- able drug pricing comparison platforms. Sec. 118. Technical corrections. Subtitle C—Medicare Part D Benefit Redesign Sec. 121. Medicare part D benefit redesign. Subtitle D—Other Medicare Part D Provisions Sec. 131. Transitional coverage and retroactive Medicare part D coverage for certain low-income beneficiaries. Sec. 132. Allowing the offering of additional prescription drug plans under Medicare part D. Sec. 133. Allowing certain enrollees of prescription drugs plans and MA–PD plans under Medicare program to spread out cost-sharing under certain circumstances. Sec. 134. Establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or MA– PD plan. Sec. 135. Growth rate of Medicare part D out-of-pocket cost threshold. Subtitle E—MedPAC Sec. 141. 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. TITLE II—MEDICAID Sec. 201. Sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs. Sec. 202. Medicaid pharmacy and therapeutics committee improvements. Sec. 203. GAO report on conflicts of interest in State Medicaid program drug use review boards and pharmacy and therapeutics (P&T) com- mittees. Sec. 204. Ensuring the accuracy of manufacturer price and drug product infor- mation under the Medicaid drug rebate program. Sec. 205. Improving transparency and preventing the use of abusive spread pricing and related practices in Medicaid. Sec. 206. T–MSIS drug data analytics reports. Sec. 207. Risk-sharing value-based payment agreements for covered outpatient drugs under Medicaid. Sec. 208. Applying Medicaid drug rebate requirement to drugs provided as part of outpatient hospital services. TITLE III—FOOD AND DRUG ADMINISTRATION VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6211 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 19 IH Subtitle A—CREATES Act Sec. 301. Actions for delays of generic drugs and biosimilar biological products. Sec. 302. REMS approval process for subsequent filers. Sec. 303. Rule of construction. Subtitle B—Pay-for-Delay Sec. 311. Unlawful agreements. Sec. 312. Notice and certification of agreements. Sec. 313. Forfeiture of 180-day exclusivity period. Sec. 314. Commission litigation authority. Sec. 315. Statute of limitations. Subtitle C—BLOCKING Act Sec. 321. Change conditions of first generic exclusivity to spur access and com- petition. Subtitle D—Purple Book Sec. 331. Public listing. Sec. 332. Review and report on types of information to be listed. Subtitle E—Orange Book Sec. 341. Orange Book. Sec. 342. GAO report to Congress. Subtitle F—Advancing Education on Biosimilars Sec. 351. Education on biological products. Subtitle G—Streamlining Transition of Biological Products Sec. 361. Streamlining the transition of biological products. Subtitle H—Over-the-Counter Monograph Safety, Innovation, and Reform Sec. 370. Short title; references in subtitle. PART 1—OTC DRUG REVIEW Sec. 371. Regulation of certain nonprescription drugs that are marketed with- out an approved drug application. Sec. 372. Misbranding. Sec. 373. Drugs excluded from the over-the-counter drug review. Sec. 374. Treatment of Sunscreen Innovation Act. Sec. 375. Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs. Sec. 376. Technical corrections. PART 2—USER FEES Sec. 381. Short title; finding. Sec. 382. Fees relating to over-the-counter drugs. Subtitle I—Other Provisions Sec. 391. Protecting access to biological products. VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6211 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 19 IH Sec. 392. Orphan drug clarification. Sec. 393. Conditions of use for biosimilar biological products. Sec. 394. Clarifying the meaning of new chemical entity. TITLE IV—REVENUE PROVISIONS Sec. 401. Permanent extension of reduction in medical expense deduction floor. Sec. 402. Safe harbor for high deductible health plans without deductible for insulin. Sec. 403. Inclusion of certain over-the-counter medical products as qualified medical expenses. 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. Sec. 510. Waiving Medicare coinsurance for colorectal cancer screening tests. 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 VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 19 IH (B) in the matter preceding subparagraph 1 (A)— 2 (i) by striking ‘‘or to’’ and inserting ‘‘, 3 to’’; 4 (ii) by inserting ‘‘, or to a physician 5 for services furnished in a physician’s of- 6 fice’’ after ‘‘surgical center’’; and 7 (iii) by inserting ‘‘(or 2021 with re- 8 spect to a physician for services furnished 9 in a physician’s office)’’ after ‘‘2018’’; and 10 (C) in subparagraph (A)— 11 (i) by striking ‘‘and the’’ and insert- 12 ing ‘‘, the’’; and 13 (ii) by inserting ‘‘, and the physician 14 fee schedule under section 1848 (with re- 15 spect to the practice expense component of 16 such payment amount)’’ after ‘‘such sec- 17 tion’’; 18 (2) by redesignating paragraphs (2) through 19 (4) as paragraphs (3) through (5), respectively; and 20 (3) by inserting after paragraph (1) the fol- 21 lowing new paragraph: 22 ‘‘(2) PHYSICIAN PAYMENT.—Beginning in 23 2021, the Secretary shall expand the information in- 24 VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 19 IH cluded on the Internet website described in para- 1 graph (1) to include— 2 ‘‘(A) the amount paid to a physician under 3 section 1848 for an item or service for the set- 4 tings described in paragraph (1); and 5 ‘‘(B) the estimated amount of beneficiary 6 liability applicable to the item or service.’’. 7 SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SIN- 8 GLE-DOSE CONTAINER OR SINGLE-USE PACK- 9 AGE DRUGS PAYABLE UNDER PART B OF THE 10 MEDICARE PROGRAM TO PROVIDE REFUNDS 11 WITH RESPECT TO DISCARDED AMOUNTS OF 12 SUCH DRUGS. 13 Section 1847A of the Social Security Act (42 U.S.C. 14 1395–3a) is amended by adding at the end the following 15 new subsection: 16 ‘‘(h) REFUND FOR CERTAIN DISCARDED SINGLE- 17 DOSE CONTAINER OR SINGLE-USE PACKAGE DRUGS.— 18 ‘‘(1) SECRETARIAL PROVISION OF INFORMA- 19 TION.— 20 ‘‘(A) IN GENERAL.—For each calendar 21 quarter beginning on or after July 1, 2021, the 22 Secretary shall, with respect to a refundable 23 single-dose container or single-use package drug 24 (as defined in paragraph (8)), report to each 25 VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 19 IH manufacturer (as defined in subsection 1 (c)(6)(A)) of such refundable single-dose con- 2 tainer or single-use package drug the following 3 for the calendar quarter: 4 ‘‘(i) Subject to subparagraph (C), in- 5 formation on the total number of units of 6 the billing and payment code of such drug, 7 if any, that were discarded during such 8 quarter, as determined using a mechanism 9 such as the JW modifier used as of the 10 date of enactment of this subsection (or 11 any such successor modifier that includes 12 such data as determined appropriate by 13 the Secretary). 14 ‘‘(ii) The refund amount that the 15 manufacturer is liable for pursuant to 16 paragraph (3). 17 ‘‘(B) DETERMINATION OF DISCARDED 18 AMOUNTS.—For purposes of subparagraph 19 (A)(i), with respect to a refundable single-dose 20 container or single-use package drug furnished 21 during a quarter, the amount of such drug that 22 was discarded shall be determined based on the 23 amount of such drug that was unused and dis- 24 carded for each drug on the date of service. 25 VerDate Sep 11 2014 04:12 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H19.IH H19 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 19 IH ‘‘(C) EXCLUSION OF UNITS OF PACKAGED 1 DRUGS.—The total number of units of the bill- 2 ing and payment code of a refundable single- 3 dose container or single-use package drug of a 4 manufacturer furnished during a calendar quar- 5 ter for purposes of subparagraph (A)(i), and 6 the determination of the estimated total allowed 7 charges for the drug in the quarter for purposes 8 of paragraph (3)(A)(ii), shall not include such 9 units that are packaged into the payment 10 amount for an item or service and are not sepa- 11 rately payable. 12 ‘‘(2) MANUFACTURER REQUIREMENT. 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