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Titles (7)

Short Titles

Short Titles - House of Representatives

Short Titles as Passed House

Elijah E. Cummings Lower Drug Costs Now Act

Short Titles as Passed House for portions of this bill
  • Home Visiting to Reduce Maternal Mortality and Morbidity Act
  • Pathways to Health Careers Act

Short Title(s) as Reported to House

Elijah E. Cummings Lower Drug Costs Now Act
Lower Drug Costs Now Act of 2019

Short Title(s) as Introduced

Lower Drug Costs Now Act of 2019

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes.


Actions Overview (5)

Date Actions Overview
12/12/2019Passed/agreed to in House: On passage Passed by the Yeas and Nays: 230 - 192 (Roll no. 682).
12/09/2019Reported (Amended) by the Committee on Education and Labor. H. Rept. 116-324, Part III.
12/06/2019Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-324, Part II.
12/06/2019Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-324, Part I.
09/19/2019Introduced in House

All Actions (85)

Date Chamber All Actions
09/08/2020SenateRead the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
08/13/2020SenateRead the first time. Placed on Senate Legislative Calendar under Read the First Time.
12/16/2019SenateReceived in the Senate.
12/12/2019-2:09pmHouseMotion to reconsider laid on the table Agreed to without objection.
12/12/2019-2:09pmHouseOn passage Passed by the Yeas and Nays: 230 - 192 (Roll no. 682).
12/12/2019-2:03pmHouseOn motion to recommit with instructions Failed by the Yeas and Nays: 196 - 226 (Roll no. 681).
12/12/2019-1:56pmHouseThe previous question on the motion to recommit with instructions was ordered without objection.
12/12/2019-1:44pmHouseDEBATE - The House proceeded with 10 minutes of debate on the Upton motion to recommit with instructions. The instructions contained in the motion seek to require the bill to be reported back to the House with an amendment to change the effective date of the Act until the Secretary of Health and Human Services certifies that the implementation of the provisions in the bill are not projected to result in fewer new drug applications with respect to unmet medical needs and life saving cures.
12/12/2019-1:43pmHouseMr. Upton moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H10223)
12/12/2019-1:43pmHouseThe House adopted the amendments en gross as agreed to by the Committee of the Whole House on the state of the Union.
12/12/2019-1:42pmHouseThe previous question was ordered pursuant to the rule.
12/12/2019-1:41pmHouseThe House rose from the Committee of the Whole House on the state of the Union to report H.R. 3.
12/12/2019-1:41pmHouseH.Amdt.721 On agreeing to the Cunningham amendment (A011) Agreed to by recorded vote: 234 - 192 (Roll no. 680).
12/12/2019-1:35pmHouseH.Amdt.720 On agreeing to the Luria amendment (A010) Agreed to by recorded vote: 231 - 192 (Roll no. 679).
12/12/2019-1:30pmHouseH.Amdt.717 On agreeing to the Gottheimer amendment (A007) Agreed to by recorded vote: 380 - 45 (Roll no. 678).
12/12/2019-1:26pmHouseH.Amdt.715 On agreeing to the O'Halleran amendment (A005) Agreed to by recorded vote: 351 - 73 (Roll no. 677).
12/12/2019-1:20pmHouseH.Amdt.711 On agreeing to the Walden amendment (A001) Failed by recorded vote: 201 - 223 (Roll no. 676).
12/12/2019-12:46pmHouseUNFINISHED BUSINESS - The Chair announced that the unfinished business was on adoption of amendments, which were debated earlier and on which further proceedings had been postponed.
12/12/2019-12:46pmHouseH.Amdt.722 On agreeing to the Houlahan amendment (A012) Agreed to by voice vote.
12/12/2019-12:36pmHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Houlahan amendment No. 12.
12/12/2019-12:36pmHouseH.Amdt.722 Amendment (A012) offered by Ms. Houlahan. (consideration: CR H10217-10219; text: CR H10217-10218)
12/12/2019-12:36pmHousePOSTPONED PROCEEDINGS - At the conclusion of debate on the Cunningham amendment the Chair put the question on adoption of the amendment and by voice vote, announced that the ayes had prevailed. Mr. Roe (TN) demanded a recorded vote and the Chair postponed further proceedings until a time to be announced.
12/12/2019-12:28pmHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Cunningham amendment No. 11.
12/12/2019-12:28pmHouseH.Amdt.721 Amendment (A011) offered by Mr. Cunningham. (consideration: CR H10216-10217, H10222; text: CR H10216)
12/12/2019-12:27pmHousePOSTPONED PROCEEDINGS - At the conclusion of debate on the Luria amendment the Chair put the question on adoption of the amendment and by voice vote, announced that the ayes had prevailed. Mr. Walden demanded a recorded vote and the Chair postponed further proceedings until a time to be announced.
12/12/2019-12:21pmHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Luria amendment No. 10.
12/12/2019-12:21pmHouseH.Amdt.720 Amendment (A010) offered by Mrs. Luria. (consideration: CR H10215-10216, H10221-10222; text: CR H10215)
12/12/2019-12:21pmHouseH.Amdt.719 On agreeing to the Finkenauer amendment (A009) Agreed to by voice vote.
12/12/2019-12:13pmHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Finkenauer amendment No. 9.
12/12/2019-12:13pmHouseH.Amdt.719 Amendment (A009) offered by Ms. Finkenauer. (consideration: CR H10214-10215; text: CR H10214)
12/12/2019-12:12pmHouseH.Amdt.718 On agreeing to the Axne amendment (A008) Agreed to by voice vote.
12/12/2019-12:05pmHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Axne amendment No. 8.
12/12/2019-12:05pmHouseH.Amdt.718 Amendment (A008) offered by Mrs. Axne. (consideration: CR H10211-10214; text: CR H10211-10213)
12/12/2019-12:04pmHousePOSTPONED PROCEEDINGS - At the conclusion of debate on the Gottheimer amendment the Chair put the question on adoption of the amendment and by voice vote, announced that the ayes had prevailed. Mr. Gottheimer demanded a recorded vote and the Chair postponed further proceedings until a time to be announced.
12/12/2019-11:54amHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Gottheimer amendment No. 7.
12/12/2019-11:54amHouseH.Amdt.717 Amendment (A007) offered by Mr. Gottheimer. (consideration: CR H10210-10211, H10221; text: CR H10210)
12/12/2019-11:53amHouseH.Amdt.716 On agreeing to the Kennedy amendment (A006) Agreed to by voice vote.
12/12/2019-11:45amHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Kennedy amendment No. 6.
12/12/2019-11:45amHouseH.Amdt.716 Amendment (A006) offered by Mr. Kennedy. (consideration: CR H10208-10210; text: CR H10208)
12/12/2019-11:45amHousePOSTPONED PROCEEDINGS - At the conclusion of debate on the O'Halleran amendment the Chair put the question on adoption of the amendment and by voice vote, announced that the ayes had prevailed. Mr. O'Halleran demanded a recorded vote and the Chair postponed further proceedings until a time to be announced.
12/12/2019-11:34amHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the O'Halleran amendment No. 5.
12/12/2019-11:34amHouseH.Amdt.715 Amendment (A005) offered by Mr. O'Halleran. (consideration: CR H10206-10208, H10220-10221; text: CR H10207)
12/12/2019-11:34amHouseH.Amdt.714 On agreeing to the Kennedy amendment (A004) Agreed to by voice vote.
12/12/2019-11:25amHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Kennedy amendment No. 4.
12/12/2019-11:25amHouseH.Amdt.714 Amendment (A004) offered by Mr. Kennedy. (consideration: CR H10205-10206; text: CR H10205)
12/12/2019-11:24amHouseH.Amdt.713 On agreeing to the Peters amendment (A003) Agreed to by voice vote.
12/12/2019-11:15amHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Peters amendment No. 3.
12/12/2019-11:15amHouseH.Amdt.713 Amendment (A003) offered by Mr. Peters. (consideration: CR H10204-10205; text: CR H10204)
12/12/2019-11:14amHouseH.Amdt.712 On agreeing to the Tonko amendment (A002) Agreed to by voice vote.
12/12/2019-11:03amHouseDEBATE - Pursuant to the provisions of H. Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Tonko amendment No. 2.
12/12/2019-11:03amHouseH.Amdt.712 Amendment (A002) offered by Mr. Tonko. (consideration: CR H10202-10204; text: CR H10202-10203)
12/12/2019-11:02amHousePOSTPONED PROCEEDINGS - At the conclusion of debate on the Walden amendment the Chair put the question on adoption of the amendment and by voice vote, announced that the noes had prevailed. Mr. Walden demanded a recorded vote and the Chair postponed further proceedings until a time to be announced.
12/12/2019-10:49amHouseDEBATE - Pursuant to the provisions of H.Res. 758, the Committee of the Whole proceeded with 10 minutes of debate on the Walden amendment No. 1.
12/12/2019-10:49amHouseH.Amdt.711 Amendment (A001) offered by Mr. Walden. (consideration: CR H10167-10202, H10219-10220; text: CR H10167-10201)
12/12/2019-9:15amHouseGENERAL DEBATE - The Committee of the Whole proceeded with one hour of further debate on H.R. 3.
12/12/2019-9:15amHouseThe House resolved into Committee of the Whole House on the state of the Union for further consideration.
12/12/2019-9:14amHouseConsidered as unfinished business. (consideration: CR H10129-10225; text: CR H10141-10167)
12/11/2019-9:20pmHouseCommittee of the Whole House on the state of the Union rises leaving H.R. 3 as unfinished business.
12/11/2019-9:20pmHouseOn motion that the Committee rise Agreed to by voice vote.
12/11/2019-9:19pmHouseMr. Scott (VA) moved that the Committee rise.
12/11/2019-6:19pmHouseGENERAL DEBATE - The Committee of the Whole proceeded with four hours of general debate on H.R. 3.
12/11/2019-6:18pmHouseThe Speaker designated the Honorable Donald M. Payne, Jr. to act as Chairman of the Committee.
12/11/2019-6:18pmHouseHouse resolved itself into the Committee of the Whole House on the state of the Union pursuant to H. Res. 758 and Rule XVIII.
12/11/2019-6:18pmHouseThe rule provides for consideration of H.R. 3, under a structured rule, with 4 hours of general debate. The rule provides for consideration of H.R. 5038 under a closed rule, with 1 hour of general debate. The rule provides for consideration of the conference report to accompany S. 1790 with 1 hour of debate.
12/11/2019-6:18pmHouseConsidered under the provisions of rule H. Res. 758. (consideration: CR H10096-10117)
12/10/2019-9:16pmHouseRules Committee Resolution H. Res. 758 Reported to House. The rule provides for consideration of H.R. 3, under a structured rule, with 4 hours of general debate. The rule provides for consideration of H.R. 5038 under a closed rule, with 1 hour of general debate. The rule provides for consideration of the conference report to accompany S. 1790 with 1 hour of debate.
12/09/2019HousePlaced on the Union Calendar, Calendar No. 264.
12/09/2019HouseReported (Amended) by the Committee on Education and Labor. H. Rept. 116-324, Part III.
12/06/2019HouseHouse Committee on Education and Labor Granted an extension for further consideration ending not later than Dec. 9, 2019.
12/06/2019HouseReported (Amended) by the Committee on Ways and Means. H. Rept. 116-324, Part II.
12/06/2019HouseReported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-324, Part I.
10/22/2019HouseOrdered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 24 - 17.
Action By: Committee on Ways and Means
10/22/2019HouseCommittee Consideration and Mark-up Session Held.
Action By: Committee on Ways and Means
10/17/2019HouseOrdered to be Reported (Amended) by the Yeas and Nays: 27 - 21.
Action By: Committee on Education and Labor
10/17/2019HouseCommittee Consideration and Mark-up Session Held.
Action By: Committee on Education and Labor
10/17/2019HouseSubcommittee on Health Discharged.
10/17/2019HouseOrdered to be Reported by the Yeas and Nays: 30 - 22.
Action By: Committee on Energy and Commerce
10/17/2019HouseCommittee Consideration and Mark-up Session Held.
Action By: Committee on Energy and Commerce
09/25/2019HouseSubcommittee Hearings Held.
Action By: House Energy and Commerce Subcommittee on Health
09/20/2019HouseReferred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
09/19/2019HouseReferred to the Subcommittee on Health.
Action By: Committee on Ways and Means
09/19/2019HouseReferred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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.
09/19/2019HouseReferred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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.
09/19/2019HouseReferred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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.
09/19/2019HouseIntroduced in House

Cosponsors (106)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Neal, Richard E. [D-MA-1]* 09/19/2019
Rep. Scott, Robert C. "Bobby" [D-VA-3]* 09/19/2019
Rep. Larson, John B. [D-CT-1] 09/20/2019
Rep. Kuster, Ann M. [D-NH-2] 09/24/2019
Rep. DeGette, Diana [D-CO-1] 09/24/2019
Rep. Rush, Bobby L. [D-IL-1] 09/24/2019
Rep. Shalala, Donna E. [D-FL-27] 09/24/2019
Rep. Ryan, Tim [D-OH-13] 09/24/2019
Rep. Morelle, Joseph D. [D-NY-25] 09/24/2019
Del. Sablan, Gregorio Kilili Camacho [D-MP-At Large] 09/24/2019
Rep. Case, Ed [D-HI-1] 09/24/2019
Rep. Engel, Eliot L. [D-NY-16] 09/25/2019
Rep. Castor, Kathy [D-FL-14] 09/25/2019
Rep. Frankel, Lois [D-FL-21] 09/25/2019
Rep. Evans, Dwight [D-PA-3] 09/25/2019
Rep. Courtney, Joe [D-CT-2] 09/25/2019
Rep. Norcross, Donald [D-NJ-1] 09/25/2019
Rep. Moore, Gwen [D-WI-4] 09/25/2019
Rep. Kildee, Daniel T. [D-MI-5] 09/25/2019
Del. Norton, Eleanor Holmes [D-DC-At Large] 09/25/2019
Rep. McGovern, James P. [D-MA-2] 09/25/2019
Rep. Visclosky, Peter J. [D-IN-1] 09/26/2019
Rep. Carbajal, Salud O. [D-CA-24] 09/26/2019
Rep. Pappas, Chris [D-NH-1] 09/26/2019
Rep. Bonamici, Suzanne [D-OR-1] 09/26/2019
Rep. Hill, Katie [D-CA-25] 09/26/2019
Rep. Hayes, Jahana [D-CT-5] 10/01/2019
Rep. Cartwright, Matt [D-PA-8] 10/01/2019
Rep. McNerney, Jerry [D-CA-9] 10/01/2019
Rep. Blunt Rochester, Lisa [D-DE-At Large] 10/01/2019
Rep. Kim, Andy [D-NJ-3] 10/01/2019
Rep. Trone, David J. [D-MD-6] 10/01/2019
Rep. Allred, Colin Z. [D-TX-32] 10/01/2019
Rep. Rose, Max [D-NY-11] 10/01/2019
Rep. Thompson, Mike [D-CA-5] 10/01/2019
Rep. Meng, Grace [D-NY-6] 10/01/2019
Rep. Cohen, Steve [D-TN-9] 10/01/2019
Rep. Suozzi, Thomas R. [D-NY-3] 10/08/2019
Rep. Wild, Susan [D-PA-7] 10/08/2019
Rep. Eshoo, Anna G. [D-CA-18] 10/08/2019
Rep. Soto, Darren [D-FL-9] 10/08/2019
Rep. Horsford, Steven [D-NV-4] 10/08/2019
Rep. Vela, Filemon [D-TX-34] 10/08/2019
Rep. Beatty, Joyce [D-OH-3] 10/08/2019
Rep. Wasserman Schultz, Debbie [D-FL-23] 10/11/2019
Rep. Keating, William R. [D-MA-9] 10/11/2019
Rep. Golden, Jared F. [D-ME-2] 10/11/2019
Rep. Schiff, Adam B. [D-CA-28] 10/11/2019
Rep. Craig, Angie [D-MN-2] 10/11/2019
Rep. Welch, Peter [D-VT-At Large] 10/16/2019
Rep. Doyle, Michael F. [D-PA-18] 10/16/2019
Rep. Garcia, Sylvia R. [D-TX-29] 10/16/2019
Rep. Davis, Danny K. [D-IL-7] 10/16/2019
Rep. Ruiz, Raul [D-CA-36] 10/16/2019
Rep. Matsui, Doris O. [D-CA-6] 10/16/2019
Rep. Slotkin, Elissa [D-MI-8] 10/16/2019
Rep. Wilson, Frederica S. [D-FL-24] 10/16/2019
Rep. Loebsack, David [D-IA-2] 10/21/2019
Rep. Crist, Charlie [D-FL-13] 10/21/2019
Rep. Bustos, Cheri [D-IL-17] 10/21/2019
Rep. Mucarsel-Powell, Debbie [D-FL-26] 10/21/2019
Rep. Casten, Sean [D-IL-6] 10/21/2019
Rep. Schrier, Kim [D-WA-8] 10/21/2019
Rep. Cuellar, Henry [D-TX-28] 10/21/2019
Rep. Wexton, Jennifer [D-VA-10] 10/22/2019
Rep. Cleaver, Emanuel [D-MO-5] 10/22/2019
Rep. Schakowsky, Janice D. [D-IL-9] 10/22/2019
Rep. Sarbanes, John P. [D-MD-3] 10/22/2019
Rep. Maloney, Sean Patrick [D-NY-18] 10/28/2019
Rep. Lawson, Al, Jr. [D-FL-5] 10/28/2019
Rep. Phillips, Dean [D-MN-3] 10/28/2019
Rep. Schneider, Bradley Scott [D-IL-10] 10/28/2019
Rep. Meeks, Gregory W. [D-NY-5] 10/29/2019
Rep. Espaillat, Adriano [D-NY-13] 10/29/2019
Rep. Lynch, Stephen F. [D-MA-8] 10/29/2019
Rep. Higgins, Brian [D-NY-26] 10/30/2019
Rep. Langevin, James R. [D-RI-2] 10/30/2019
Rep. Chu, Judy [D-CA-27] 10/31/2019
Rep. Stevens, Haley M. [D-MI-11] 10/31/2019
Rep. Perlmutter, Ed [D-CO-7] 10/31/2019
Rep. Davids, Sharice [D-KS-3] 10/31/2019
Rep. Axne, Cynthia [D-IA-3] 11/01/2019
Rep. Hastings, Alcee L. [D-FL-20] 11/01/2019
Rep. Beyer, Donald S., Jr. [D-VA-8] 11/01/2019
Rep. Lowey, Nita M. [D-NY-17] 11/01/2019
Rep. McEachin, A. Donald [D-VA-4] 11/05/2019
Rep. Torres, Norma J. [D-CA-35] 11/08/2019
Rep. Payne, Donald M., Jr. [D-NJ-10] 11/08/2019
Rep. Scanlon, Mary Gay [D-PA-5] 11/08/2019
Rep. Deutch, Theodore E. [D-FL-22] 11/08/2019
Rep. Yarmuth, John A. [D-KY-3] 11/08/2019
Rep. Spanberger, Abigail Davis [D-VA-7] 11/08/2019
Rep. Jeffries, Hakeem S. [D-NY-8] 11/08/2019
Rep. McBath, Lucy [D-GA-6] 11/08/2019
Rep. Dingell, Debbie [D-MI-12] 11/12/2019
Rep. Finkenauer, Abby [D-IA-1] 11/12/2019
Rep. Garamendi, John [D-CA-3] 11/13/2019
Rep. McCollum, Betty [D-MN-4] 11/13/2019
Rep. Veasey, Marc A. [D-TX-33] 11/13/2019
Rep. Castro, Joaquin [D-TX-20] 11/21/2019
Rep. Gonzalez, Vicente [D-TX-15] 11/21/2019
Rep. Bass, Karen [D-CA-37] 11/21/2019
Rep. Bishop, Sanford D., Jr. [D-GA-2] 11/26/2019
Rep. Smith, Adam [D-WA-9] 12/03/2019
Rep. Lowenthal, Alan S. [D-CA-47] 12/05/2019
Rep. Fletcher, Lizzie [D-TX-7] 12/06/2019

Committees (3)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Related Documents
House Energy and Commerce09/19/2019 Referred to
10/17/2019 Markup by
12/06/2019 Reported by H. Rept. 116-324,Part 1
House Energy and Commerce Subcommittee on Health09/20/2019 Referred to
09/25/2019 Hearings by
10/17/2019 Discharged from
House Ways and Means09/19/2019 Referred to
10/22/2019 Markup by
12/06/2019 Reported by H. Rept. 116-324,Part 2
House Ways and Means Subcommittee on Health09/19/2019 Referred to
House Education and Labor09/19/2019 Referred to
10/17/2019 Markup by
12/09/2019 Reported by H. Rept. 116-324,Part 3

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.


Subjects (58)


Latest Summary (2)

There are 2 summaries for H.R.3. View summaries

Shown Here:
Passed House (12/12/2019)

Elijah E. Cummings Lower Drug Costs Now Act

This bill establishes several programs and requirements relating to the prices of prescription drugs, health care coverage and costs, and public health.

TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION

The bill requires the Department of Health and Human Services (HHS) to negotiate prices for certain drugs. (Under current law, HHS may not negotiate the prices of covered drugs under the Medicare prescription drug benefit.)

Specifically, HHS must negotiate maximum prices for (1) insulin products; (2) with respect to 2023, at least 25 single-source, brand-name drugs that do not have generic competition and that are among either the 125 drugs that account for the greatest national spending or the 125 drugs that account for the greatest spending under the Medicare prescription drug benefit and Medicare Advantage (MA); (3) beginning in 2024, at least 50 such single-source, brand-name drugs; and (4) newly approved single-source, brand-name drugs that meet or exceed a specified price threshold and that HHS determines are likely to meet the spending criteria. The negotiated prices must be offered under Medicare and MA and may also be offered under private health insurance unless the insurer opts out.

The negotiated maximum price may not exceed (1) 120% of the average price in Australia, Canada, France, Germany, Japan, and the United Kingdom; or (2) if such information is not available, 85% of the U.S. average manufacturer price. Drug manufacturers that fail to comply with the bill's negotiation requirements are subject to civil and tax penalties.

TITLE II--MEDICARE PARTS B AND D PRESCRIPTION DRUG INFLATION REBATES

The bill also requires drug manufacturers, subject to civil penalties, to issue rebates to the Centers for Medicare & Medicaid Services (CMS) for covered drugs under Medicare that cost $100 or more and for which the average manufacturer price increases faster than inflation.

TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR MEDICARE BENEFICIARIES

The bill reduces the annual out-of-pocket spending threshold, and eliminates beneficiary cost-sharing above this threshold, under the Medicare prescription drug benefit. Additionally, prescription drug plan sponsors must allow certain beneficiaries to make coinsurance payments in periodic installments, in accordance with CMS requirements.

TITLE IV--DRUG PRICE TRANSPARENCY

Drug manufacturers must report, subject to civil penalties, specified information for certain drugs that cost $100 or more and that are covered under Medicare or Medicaid, based on the rate of price or spending increases. Among other things, manufacturers must report a qualifying price increase at least 30 days before the effective date of the increase; HHS must publish the information on its website the day the increase takes effect.

TITLE V--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES

The bill expands eligibility for certain premium and cost-sharing subsidies for low-income beneficiaries under the Medicare prescription drug benefit. For example, the bill (1) raises the maximum allowable income for beneficiaries to qualify, and (2) allows certain residents of U.S. territories to automatically qualify.

TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE MEDICARE PROGRAM

The bill also expands Medicare coverage to include (1) dentures and dental and oral health services, including basic and major treatments (as determined by the CMS) as well as specified preventive and screening services; (2) hearing aids and hearing rehabilitation and treatment services; and (3) eyeglasses, contact lenses, and vision services, including routine eye examinations and contact lens fittings.

TITLE VII--NIH, FDA, AND OPIOIDS FUNDING

The bill provides additional funds for several public health programs. Among other things, the bill (1) provides specified funds for innovation projects at the National Institutes of Health through FY2030 and for innovation projects at the Food and Drug Administration through FY2029; and (2) establishes the Opioid Epidemic Response Fund to support HHS programs and initiatives, including the State Opioid Response Grant Program.

Additionally, HHS must take a series of actions relating to health care administrative costs. Specifically, HHS must develop a strategy and take associated action to reduce unnecessary costs and administrative burdens in the health care system, including Medicare, Medicaid, and the private health-insurance market, by at least half over a period of 10 years. HHS must also award grants so that states may establish commissions targeting such costs.

TITLE VIII--MISCELLANEOUS

The bill also establishes and revises several other health care programs and requirements.

For example, the bill (1) expands guaranteed issue rights with respect to Medigap policies (Medicare supplemental health-insurance policies); (2) provides specified funds for the Community Health Centers Fund through FY2025; (3) establishes grant programs to support mental health and trauma services in schools, as well as career development programs for health professionals; and (4) requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with pharmacy benefit managers under Medicaid.

Additionally, the CMS must issue regulations that require direct-to-consumer television advertisements for all covered drugs and biologics under Medicare and Medicaid to include the list price of a 30-day supply or for a typical course of treatment. (On May 10, 2019, the CMS issued a final rule titled Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency. The rule requires direct-to-consumer television advertisements for covered drugs and biologics under Medicare and Medicaid to include the list price of a 30-day supply or for a typical course of treatment, if the list price is at least $35 per month. The rule was scheduled to take effect July 9, 2019; however, a federal court blocked implementation, citing a lack of statutory authority.)