Elijah E. Cummings Lower Drug Costs Now Act

Bill: 116-hr-3
Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6]
Introduced: 2019-09-19 in the House
Policy area: Health
Subjects: Accounting and auditing
Administrative law and regulatory procedures
Adult education and literacy
Cancer
Centers for Disease Control and Prevention (CDC)
Child care and development
Child health
Civil actions and liability
Congressional oversight
Criminal justice information and records
Dental care
Department of Health and Human Services
Digestive and metabolic diseases
Drug safety, medical device, and laboratory regulation
Drug trafficking and controlled substances
Education of the disadvantaged
Education programs funding
Elementary and secondary education
Employee hiring
Employment and training programs
Executive agency funding and structure
Food and Drug Administration (FDA)
Government information and archives
Government studies and investigations
Health care costs and insurance
Health care coverage and access
Health care quality
Health facilities and institutions
Health information and medical records
Health personnel
Health programs administration and funding
Health promotion and preventive care
Health technology, devices, supplies
Hearing, speech, and vision care
Indian social and development programs
Inflation and prices
Manufacturing
Marketing and advertising
Medicaid
Medical education
Medical tests and diagnostic methods
Medicare
Mental health
Minority health
National Institutes of Health (NIH)
Performance measurement
Prescription drugs
Public contracts and procurement
Public-private cooperation
Research administration and funding
Rural conditions and development
Sales and excise taxes
Sex and reproductive health
State and local government operations
U.S. territories and protectorates
Veterans' education, employment, rehabilitation
Women's health

Summary:
action_date: 2019-09-19
text: 

Lower Drug Costs Now Act of 2019

 
This bill establishes several programs and requirements relating to the prices of prescription drugs. 
 
In particular, the bill requires the Department of Health and Human Services (HHS) to negotiate prices for certain drugs (current law prohibits HHS from doing so). Specifically, HHS must negotiate maximum prices for (1) insulin products; and (2) at least 25 single source, brand-name drugs that do not have generic competition and that are among 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). 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.
 
The bill also makes a series of additional changes to Medicare prescription drug coverage and pricing. Among other things, the bill (1) requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for covered drugs that cost $100 or more and for which the average manufacturer price increases faster than inflation; and (2) reduces the annual out-of-pocket spending threshold, and eliminates beneficiary cost-sharing above this threshold, under the Medicare prescription drug benefit.

action_date: 2019-12-12
text: 

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.)


Legislative actions:
action_date: 2020-09-08
text: Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
action_date: 2020-08-13
text: Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
action_date: 2019-12-16
text: Received in the Senate.
action_date: 2019-12-12
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2019-12-12
text: On passage Passed by the Yeas and Nays: 230 - 192 (Roll no. 682).
action_date: 2019-12-12
text: Passed/agreed to in House: On passage Passed by the Yeas and Nays: 230 - 192 (Roll no. 682).
action_date: 2019-12-12
text: On motion to recommit with instructions Failed by the Yeas and Nays: 196 - 226 (Roll no. 681).
action_date: 2019-12-12
text: The previous question on the motion to recommit with instructions was ordered without objection.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: Mr. Upton moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H10223)
action_date: 2019-12-12
text: The House adopted the amendments en gross as agreed to by the Committee of the Whole House on the state of the Union.
action_date: 2019-12-12
text: The previous question was ordered pursuant to the rule.
action_date: 2019-12-12
text: The House rose from the Committee of the Whole House on the state of the Union to report H.R. 3.
action_date: 2019-12-12
text: UNFINISHED 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: POSTPONED 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: POSTPONED 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: POSTPONED 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: POSTPONED 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: POSTPONED 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.
action_date: 2019-12-12
text: DEBATE - 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.
action_date: 2019-12-12
text: GENERAL DEBATE - The Committee of the Whole proceeded with one hour of further debate on H.R. 3.
action_date: 2019-12-12
text: The House resolved into Committee of the Whole House on the state of the Union for further consideration.
action_date: 2019-12-12
text: Considered as unfinished business. (consideration: CR H10129-10225; text: CR H10141-10167)
action_date: 2019-12-11
text: Committee of the Whole House on the state of the Union rises leaving H.R. 3 as unfinished business.
action_date: 2019-12-11
text: On motion that the Committee rise Agreed to by voice vote.
action_date: 2019-12-11
text: Mr. Scott (VA) moved that the Committee rise.
action_date: 2019-12-11
text: GENERAL DEBATE - The Committee of the Whole proceeded with four hours of general debate on H.R. 3.
action_date: 2019-12-11
text: The Speaker designated the Honorable Donald M. Payne, Jr. to act as Chairman of the Committee.
action_date: 2019-12-11
text: House resolved itself into the Committee of the Whole House on the state of the Union pursuant to H. Res. 758 and Rule XVIII.
action_date: 2019-12-11
text: 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.
action_date: 2019-12-11
text: Considered under the provisions of rule H. Res. 758. (consideration: CR H10096-10117)
action_date: 2019-12-10
text: Rules 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.
action_date: 2019-12-09
text: Placed on the Union Calendar, Calendar No. 264.
action_date: 2019-12-09
text: Reported (Amended) by the Committee on Education and Labor. H. Rept. 116-324, Part III.
action_date: 2019-12-09
text: Reported (Amended) by the Committee on Education and Labor. H. Rept. 116-324, Part III.
action_date: 2019-12-06
text: House Committee on Education and Labor Granted an extension for further consideration ending not later than Dec. 9, 2019.
action_date: 2019-12-06
text: Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-324, Part II.
action_date: 2019-12-06
text: Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-324, Part II.
action_date: 2019-12-06
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-324, Part I.
action_date: 2019-12-06
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-324, Part I.
action_date: 2019-10-22
text: Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 24 - 17.
action_date: 2019-10-22
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-10-17
text: Ordered to be Reported (Amended) by the Yeas and Nays: 27 - 21.
action_date: 2019-10-17
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-10-17
text: Subcommittee on Health Discharged.
action_date: 2019-10-17
text: Ordered to be Reported by the Yeas and Nays: 30 - 22.
action_date: 2019-10-17
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-09-25
text: Subcommittee Hearings Held.
action_date: 2019-09-20
text: Referred to the Subcommittee on Health.
action_date: 2019-09-19
text: Referred to the Subcommittee on Health.
action_date: 2019-09-19
text: Referred 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.
action_date: 2019-09-19
text: Referred 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.
action_date: 2019-09-19
text: Referred 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.
action_date: 2019-09-19
text: Introduced in House
action_date: 2019-09-19
text: Introduced in House