Federal - HR 3

Drug Price Negotiation Bill (official title to be confirmed).

Introduced

September 10, 2019

Description

Drug Price Negotiation Bill (official title to be confirmed).

Our Position

Oppose

Original Sponsor 1

Co-Sponsors 106

Latest Actions See More/Less

  • Sept. 8, 2020 — Placed on the Senate Legislative Calendar under the provisions of Rule XIV. Congressional Record p. S5430, S5441

  • Aug. 13, 2020 — Taken from the desk and read the first time. Congressional Record p. S5407, S5413

  • Jan. 9, 2020John Lewis, D-Ga., House speech: Personal explanation for roll call vote no.682, and would have voted yea if present. Congressional Record p. E20

  • Jan. 9, 2020John Lewis, D-Ga., House speech: Personal explanation for roll call vote no.680, and would have voted yea if present. Congressional Record p. E20

  • Jan. 9, 2020John Lewis, D-Ga., House speech: Personal explanation for roll call vote no.679, and would have voted yea if present. Congressional Record p. E20

  • Jan. 9, 2020John Lewis, D-Ga., House speech: Personal explanation for roll call vote no.678, and would have voted yea if present. Congressional Record p. E20

  • Jan. 9, 2020John Lewis, D-Ga., House speech: Personal explanation for roll call vote no.677, and would have voted yea if present. Congressional Record p. E20

  • Jan. 9, 2020John Lewis, D-Ga., House speech: Personal explanation for roll call vote no.676, and would have voted nay if present. Congressional Record p. E20

  • Dec. 19, 2019Wenstrup, R-Ohio, House speech: Personal explanation for roll call vote no.671, and would have voted nay if present. Congressional Record p. E1635

  • Dec. 18, 2019Norman, R-S.C., House speech: Personal explanation for roll call vote no.671, and would have voted nay if present. Congressional Record p. E1609

  • Dec. 18, 2019Norman, R-S.C., House speech: Personal explanation for roll call vote no.669, and would have voted nay if present. Congressional Record p. E1609

  • Dec. 18, 2019Norman, R-S.C., House speech: Personal explanation for roll call vote no.668, and would have voted nay if present. Congressional Record p. E1609

  • Dec. 16, 2019 — Received in the Senate and held at the desk. Congressional Record p. S7048

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.682, and would have voted nay if present. Congressional Record p. E1589

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.681, and would have voted yea if present. Congressional Record p. E1589

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.680, and would have voted nay if present. Congressional Record p. E1589

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.679, and would have voted nay if present. Congressional Record p. E1589

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.678, and would have voted nay if present. Congressional Record p. E1589

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.677, and would have voted nay if present. Congressional Record p. E1589

  • Dec. 15, 2019Burchett, R-Tenn., House speech: Personal explanation for roll call vote no.676, and would have voted yea if present. Congressional Record p. E1589

  • Dec. 12, 2019House Vote 682 Drug Price Negotiation — Passage
    Passage of the bill, as amended, that would allow the Health and Human Services Department to negotiate prices for certain drugs under Medicare programs and would make a number of modifications to Medicare programs related to drug costs and plan benefits. Specifically, the bill would establish a fair price negotiation program in which HHS would enter into agreements with drug manufacturers to negotiate maximum fair prices for certain drugs. It would allow the department to negotiate a "maximum fair price" for insulin and up to 250 other Medicare-eligible, brand-name drugs that do not have generic competition, including 125 drugs that account for the greatest national spending and 125 drugs that account for the greatest spending under Medicare parts C and D. The bill would require the department to negotiate the maximum price of at least 25 drugs for 2023 and at least 50 drugs in each subsequent year. It would require that such maximum prices would not exceed 120% of a drug's average international price or 85% of the average manufacturer price for drugs for a year. The bill would subject drug manufacturers who do not reach a negotiated agreement for a drug to excise taxes based on gross sales of that drug. It would require manufacturers to offer negotiated prices to private health insurers. The bill would also make adjustments to payments, pricing structures, and programs related to Medicare parts B and D. Among other provisions, it would place a $2,000 annual out-of-pocket cap on costs for Medicare Part D beneficiaries, expand eligibility for a Part D low-income subsidy program, and add comprehensive vision, dental, and hearing coverage under Medicare Part B. Finally, it would authorize funding for HHS programs to address opioid and substance use disorders and authorize funding for National Institutes of Health and Food and Drug Administration activities related to the development of new drugs and medical treatments. Passed 230-192. Note: A "nay" was a vote in support of the president's position. Congressional Record p. H10224-H10225

  • Dec. 12, 2019House Vote 681 Drug Price Negotiation — Recommit
    Upton, R-Mich., motion to recommit the Elijah E. Cummings Lower Drug Costs Now Act (HR 3) to the House Energy and Commerce Committee with instructions to report it back immediately with an amendment that would prohibit the provisions of the bill from going into effect unless the Health and Human Services Department certifies that the implementation of such provisions is not projected to result in fewer new drug applications in relation to unmet medical needs and potential cures. Motion rejected 196-226. Congressional Record p. H10223-H10224

  • Dec. 12, 2019 — Houlahan, D-Pa. for Scanlon, D-Pa., amendment no. 12 that would increase by $180 million funds transferred from the Treasury general fund for a National Institutes of Health clinical trial grant program. Among other provisions, it would require contracts between states and certain health benefit managers to use a pass-through pricing model limiting payment amounts to such managers for administrative services. It would modify a Health and Human Services Department retail drug price survey to require certain retail community pharmacies to respond to the survey and authorize $5 million annually to carry out the survey, adopted by voice vote. Amendment text. Congressional Record p. H10217-H10219

  • Dec. 12, 2019House Vote 680 Drug Price Negotiation — VA Drug Procurement
    Cunningham, D-S.C., amendment no. 11 that would require drug manufacturers contracting with the Veterans Affairs Department to comply with maximum prices set for any drug under the bill's provisions, if the VA determines that such maximum prices are less than those determined under existing law regarding VA drug procurement. Adopted in Committee of the Whole 234-192. Congressional Record p. H10216-H10217, H10222

  • Dec. 12, 2019House Vote 679 Drug Price Negotiation — Federal Health Plan Contracts
    Luria, D-Va., amendment no. 10 that would prohibit the federal office of personnel management from contracting with a health benefits plan if the plan carrier has elected not to participate in the fair price negotiation program established by the bill. Adopted in Committee of the Whole 231-192. Congressional Record p. H10215-H10216, H10221-H10222

  • Dec. 12, 2019 — Finkenauer, D-Iowa, amendment no. 9 that would require the Health and Human Services Department to implement regulations requiring direct-to-consumer television advertisements for Medicare- or Medicaid-eligible prescription drugs or biological products to include truthful information indicating the list price of the drug or product advertised, adopted by voice vote. Amendment text. Congressional Record p. H10214-H10215

  • Dec. 12, 2019 — Axne, D-Iowa, amendment no. 8 that would authorize $250 million for a five-year fiscal period starting in fiscal 2020 for the Health and Human Services Department to award grants to at least 15 states to establish and administer multi-stakeholder commissions to reduce health care administrative costs within and across states, including by developing infrastructure to support electronic administrative data sharing and by conducting pilot projects to test the use of electronic health care transactions. It would require HHS to establish strategies and make recommendations to reduce administrative costs and burdens across the health care system, adopted by voice vote. Amendment text. Congressional Record p. H10211-H10214

  • Dec. 12, 2019House Vote 678 Drug Price Negotiation — New Medical Treatments Study
    Gottheimer, D-N.J., amendment no. 7 that would require the Health and Human Services Department to conduct a study to identify diseases or conditions that lack treatments approved by the Food and Drug Administration and instances in which development of such treatments could fill unmet medical needs for serious, life-threatening, or rare diseases and conditions. The amendment would also require the study to identify incentives that would lead to the development, approval, and marketing of such treatments. Adopted in Committee of the Whole 380-45. Congressional Record p. H10210-H10211, H10221

  • Dec. 12, 2019 — Kennedy, D-Mass., for Jackson Lee, D-Texas, amendment no. 6 that would express the sense of Congress that the bill should positively impact communities of color and individuals living in rural or sparsely populated areas of the United States. It would express that prescription drug prices are a barrier to proper disease treatment, especially for such communities and individuals, and it would note that 55% of medically uninsured individuals under the age of 65 are individuals of color, adopted by voice vote. Amendment text. Congressional Record p. H10208-H10210

  • Dec. 12, 2019House Vote 677 Drug Price Negotiation — Rural Hospital Residency Program Grants
    O'Halleran, D-Ariz., amendment no. 5 that would require the Health and Human Services Department to establish grant programs to award grants of no more than $250,000 to encourage hospitals in rural and medically underserved areas, including critical access hospitals, to establish medical residency training programs or to establish partnerships with other hospitals to host residents under such a program. It would authorize such sums as may be necessary for such grants through fiscal 2029. Adopted in Committee of the Whole 351-73. Congressional Record p. H10206-H10208, H10220

  • Dec. 12, 2019 — Kennedy, D-Mass., amendment no. 4 that would require the highest-ranking Health and Human Services official determined by the HHS general counsel not to have a financial conflict of interest to carry out the bill's provisions related to selection and publication of a list of negotiation-eligible prescription drugs, adopted by voice vote. Amendment text. Congressional Record p. H10205-H10206

  • Dec. 12, 2019 — Peters, D-Calif., amendment no. 3 that would authorize $100 million annually from fiscal 2021 through 2025 for the National Institutes of Health to award grants or contracts to entities to develop, expand, and enhance the commercialization of biomedical products. It would decrease by the same amount funding authorized by the bill for an NIH pilot grant program for clinical trials, adopted by voice vote. Amendment text. Congressional Record p. H10204-H10205

  • Dec. 12, 2019 — Tonko, D-N.Y., amendment no. 2 that would require the Health and Human Services Department to add a new set of measures to its rating system evaluating the performance of Medicare Advantage and Medicare Part D plans, based on enrollees' ability to access to certain biosimilar biological products, adopted by voice vote. Amendment text. Congressional Record p. H10202-H10204

  • Dec. 12, 2019House Vote 676 Drug Price Negotiation — Drug Price and Manufacturing Substitute
    Walden, R-Ore., substitute amendment no. 1 that consists of the provisions of the Lower Costs, More Cures Act (HR 19). The substitute amendment would make a number of modifications to payments and pricing structures under Medicare Parts B and D and Medicaid, including to place a $3,100 annual out-of-pocket cap on costs for Medicare Part D beneficiaries and to require insurance companies to establish a monthly post-deductible cap of $50 on insulin for Part D beneficiaries, starting in 2022. It would establish or modify a number of requirements related to availability of drug pricing information, payment systems, and availability of refunds from drug manufacturers. It would make a number of modifications to FDA regulations related to biosimilar drug products and generic drug exclusivity. It would expedite or simplify certain procedures for the approval and market entry of generic drugs, and it would prohibit generic and brand-name drug manufacturers from entering into agreements in which brand-name manufacturers pay to delay entry of a generic drug into the market. It would require Health and Human Services Department to establish a requirement that direct-to-consumer television advertisements for Medicare- or Medicaid-eligible prescription drugs or biological products include truthful information indicating the list price of the drug or product advertised. It would also reduce from 10% to 7.5% the threshold for medical expense tax deductions to allow taxpayers to deduct medical expenses exceeding 7.5% of their adjusted gross income. Rejected in Committee of the Whole 201-223. Congressional Record p. H10167-H10202, H10219-H10220

  • Dec. 12, 2019 — Considered by the House. Congressional Record p. H10129-H10225

  • Dec. 11, 2019Estes, R-Kan., House speech: Personal explanation for roll call vote no.671, and would have voted nay if present. Congressional Record p. H10044

  • Dec. 11, 2019Gomez, D-Calif., House speech: Personal explanation for roll call vote no.671, and would have voted yea if present. Congressional Record p. H10044

  • Dec. 11, 2019Conaway, R-Texas, House speech: Personal explanation for roll call vote no.671, and would have voted yea if present. Congressional Record p. H10044

  • Dec. 11, 2019Pascrell, D-N.J., House speech: Personal explanation for roll call vote no.671, and would have voted yea if present. Congressional Record p. H10044

  • Dec. 11, 2019Barragan, D-Calif., House speech: Personal explanation for roll call vote no.671, and would have voted yea if present. Congressional Record p. H10095

  • Dec. 11, 2019Joyce, R-Pa., House speech: Personal explanation for roll call vote no.669, and would have voted nay if present. Congressional Record p. 10043

  • Dec. 11, 2019Cheney, R-Wyo., House speech: Personal explanation for roll call vote no.669, and would have voted nay if present. Congressional Record p. H10043

  • Dec. 11, 2019Barragan, D-Calif., House speech: Personal explanation for roll call vote no.669, and would have voted yea if present. Congressional Record p. H10044

  • Dec. 11, 2019Barragan, D-Calif., House speech: Personal explanation for roll call vote no.668, and would have voted yea if present. Congressional Record p. H10044

  • Dec. 11, 2019 — Considered by the House. Congressional Record p. H10096-H10117

  • Dec. 11, 2019House Vote 671 Agricultural Workers; Fiscal 2020 Defense Authorization; Drug Price Negotiation — Motion to Table
    Nadler, D-N.Y., motion to table (kill) the McGovern, D-Mass., motion to reconsider the vote by which the House adopted, 222-190, the rule (H Res 758) on Wednesday, Dec. 11, 2019. Motion agreed to 196-170. Congressional Record p. H10044

  • Dec. 11, 2019House Vote 669 Agricultural Workers; Fiscal 2020 Defense Authorization; Drug Price Negotiation — Rule
    Adoption of the rule (H Res 758) that would provide for consideration of the Farm Workforce Modernization Act (HR 5038); the conference report to accompany the fiscal 2020 National Defense Authorization Act (S 1790); and the Elijah E. Cummings Lower Drug Costs Now Act (HR 3). The rule would provide for automatic adoption of a Nadler, D-N.Y., manager's amendment to HR 5038 that would decrease from 2,500 to 500 the number of H-2A nonimmigrant visas available for sheep and goat herding per fiscal year. The rule would also provide for floor consideration of 12 amendments to HR 3 and provide for automatic adoption of the Pallone, D-N.J., manager's amendment to the bill. The Pallone manager's amendment to HR 3 would require the Labor Department, in consultation with the Health and Human Services and Treasury departments, to issue regulations to implement models related to agreement processes and enforcement mechanisms for inflation rebates by prescription drug manufacturers, if the department determines that a sufficient number of prescription drug prices have increased and that such models are feasible, not later than Dec. 31, 2022. The amendment would also make technical corrections and adjust effective dates for several provisions in the bill. Adopted 222-190. Congressional Record p. H10042-H10043

  • Dec. 11, 2019House Vote 668 Agricultural Workers; Fiscal 2020 Defense Authorization; Drug Price Negotiation — Previous Question
    Shalala, D-Fla., motion to order the previous question (thus ending debate and possibility of amendment) on the rule (H Res 758) that would provide for consideration of the Farm Workforce Modernization Act (HR 5038); the conference report to accompany the fiscal 2020 National Defense Authorization Act (S 1790); and the Elijah E. Cummings Lower Drug Costs Now Act (HR 3). The rule would provide for automatic adoption of a Nadler, D-N.Y., manager's amendment to HR 5038 that would decrease from 2,500 to 500 the number of H-2A nonimmigrant visas available for sheep and goat herding per fiscal year. The rule would also provide for floor consideration of 12 amendments to HR 3 and provide for automatic adoption of the Pallone, D-N.J., manager's amendment to the bill. The Pallone manager's amendment to HR 3 would require the Labor Department, in consultation with the Health and Human Services and Treasury departments, to issue regulations to implement models related to agreement processes and enforcement mechanisms for inflation rebates by prescription drug manufacturers, if the department determines that a sufficient number of prescription drug prices have increased and that such models are feasible, not later than Dec. 31, 2022. The amendment would also make technical corrections and adjust effective dates for several provisions in the bill. Motion agreed to 227-189. Congressional Record p. H10042

  • Dec. 10, 2019 — Rules Committee resolution, H Res 758, reported to the House as a rule for HR 3.

  • Dec. 10, 2019Statement of Administration Policy issued by Office of Management and Budget.

  • Dec. 10, 2019Cost Estimate issued by Congressional Budget Office.

  • Dec. 10, 2019 — House Rules Committee granted a structured rule providing for consideration of the bill. Congressional Record p. H10014, H10015

  • Dec. 10, 2019 — Full committee proceeding held by the House Rules Committee.

  • Dec. 9, 2019 — Reported to the House amended by the House Education and Labor Committee and placed on the Union Calendar. H Rept 116-324, Pt. 3Congressional Record p. H9386

  • Dec. 6, 2019 — Reported to the House amended by the House Energy and Commerce Committee and ordered printed. H Rept 116-324, Pt. 1Congressional Record p. H9345

  • Dec. 6, 2019 — Reported to the House amended by the House Ways and Means Committee and ordered printed. H Rept 116-324, Pt. 2Congressional Record p. H9345

  • Dec. 6, 2019 — Additional cosponsor(s): 1

    Fletcher, (D-Texas)
  • Dec. 5, 2019 — Additional cosponsor(s): 1

    Lowenthal, (D-Calif.)
  • Dec. 3, 2019 — Additional cosponsor(s): 1

    Smith, Adam (D-Wash.)
  • Nov. 26, 2019 — Additional cosponsor(s): 1

    Bishop, S. (D-Ga.)
  • Nov. 21, 2019 — Additional cosponsor(s): 3

    Bass, (D-Calif.)Castro, (D-Texas)Gonzalez, (D-Texas)
  • Nov. 13, 2019 — Additional cosponsor(s): 3

    Garamendi, (D-Calif.)McCollum, (D-Minn.)Veasey, (D-Texas)
  • Nov. 12, 2019 — Additional cosponsor(s): 2

    Dingell, (D-Mich.)Finkenauer, (D-Iowa)
  • Nov. 8, 2019 — Additional cosponsor(s): 8

    Deutch, (D-Fla.)Payne (D-N.J.)Torres, (D-Calif.)
    Jeffries, (D-N.Y.)Scanlon, (D-Pa.)Yarmuth, (D-Ky.)
    McBath, (D-Ga.)Spanberger, (D-Va.)
  • Nov. 5, 2019 — Additional cosponsor(s): 1

    McEachin, (D-Va.)
  • Nov. 1, 2019 — Additional cosponsor(s): 4

    Axne, (D-Iowa)Hastings, (D-Fla.)
    Beyer (D-Va.)Lowey, (D-N.Y.)
  • Oct. 31, 2019 — Additional cosponsor(s): 4

    Chu, (D-Calif.)Perlmutter, (D-Colo.)
    Davids, (D-Kan.)Stevens, (D-Mich.)
  • Oct. 30, 2019 — Additional cosponsor(s): 2

    Higgins, B. (D-N.Y.)Langevin, (D-R.I.)
  • Oct. 29, 2019 — Additional cosponsor(s): 3

    Espaillat, (D-N.Y.)Lynch, (D-Mass.)Meeks, (D-N.Y.)
  • Oct. 28, 2019 — Additional cosponsor(s): 4

    Lawson, (D-Fla.)Phillips, (D-Minn.)
    Maloney, S.P. (D-N.Y.)Schneider, (D-Ill.)
  • Oct. 22, 2019 — Full committee consideration and markup held by the House Ways and Means Committee.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Bill Short Title
      Pascrell, D-N.J. —

    Amendment to the Neal, D-Mass., substitute amendment that would designate the bill's short title as the "Elijah E. Cummings Lower Drug Costs Now Act."

    Amendment to the Neal, D-Mass., substitute amendment that would designate the bill's short title as the "Elijah E. Cummings Lower Drug Costs Now Act."

    Adopted by voice vote.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Alternative Plan for Reducing Drug Costs
      K. Brady, R-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would replace the provisions of the substitute amendment with language to address the cost of prescription drugs.

    The amendment would require Medicare to make public the payments to physicians based on services provided.

    It also would incorporate provisions that would redesign the structure of Medicare Part D, including language that would allow beneficiaries to spread out paying their cost-sharing obligations in certain circumstances.

    It also would require the secretary of Health and Human Services to implement a program to provide transitional Medicare Part D coverage to low-income individuals enrolling for the first time.

    It also would require pharmacy benefit managers to pass through negotiated drug discounts to Part D plan sponsors, as well as to Medicaid programs or managed care programs operating under Medicaid.

    The amendment also would require the negotiated prices of Part D drugs to be provided at the point of sale.

    It also would require hospitals participating in the 340B drug discount program to pass through savings to qualifying patients.

    It also would require insurers to calculate cost-sharing obligations considering discounts provided under 340B.

    It also would express the sense of Congress that the 340B program is to lower drug costs for low-income and uninsured individuals.

    It also would update requirements for committees that update state Medicaid formularies, and require a report from the Government Accountability Office on potential conflicts of interest on those committees.

    It also would require the secretary to conduct audits of manufacturer prices being charged to Medicaid programs and issue reports on prescribing patterns under Medicaid.

    It also would alow state Medicaid programs to negotiate payment deals with drug manufacturers that would allow for payments over time contingent on the effectiveness of the medications.

    It also would remove exchange health plans and child health plans from the calculation of Medicaid's best price for drugs.

    It also would require Medicare Part D Plans and Medicare Advantage plans to report fraud, waste and abuse to HHS.

    It also would establish pharmacy quality measures under Medicare Part D.

    It also would require the Food and Drug Administration and the Centers for Medicare and Medicaid Services to convene meetings and issue a report on improving coordination between the two agencies.

    It also would require that direct-to-consumer advertisements for prescription drugs covered by Medicare and Medicaid include a disclosure of truthful and non-misleading pricing information.

    It also would allow independent advisory commissions on Medicare and Medicaid to access certain drug payment information including rebate information.

    The amendment also would prohibit drug manufacturers from denying from denying samples of products to potential generic competitors.

    The amendment also would prohibit so-called "pay-for-delay" settlement agreements which allow name-brand drug manufacturers to pay a generic manufacturer to postpone seeking approval of their lower cost alternative.

    It also would revise requirements for awarding a 180-day exclusivity period for generic drugs and update requirements for public posting of patent information for biologic drugs.

    Amendment to the Neal, D-Mass., substitute amendment that would replace the provisions of the substitute amendment with language to address the cost of prescription drugs.

    The amendment would require Medicare to make public the payments to physicians based on services provided.

    It also would incorporate provisions that would redesign the structure of Medicare Part D, including language that would allow beneficiaries to spread out paying their cost-sharing obligations in certain circumstances.

    It also would require the secretary of Health and Human Services to implement a program to provide transitional Medicare Part D coverage to low-income individuals enrolling for the first time.

    It also would require pharmacy benefit managers to pass through negotiated drug discounts to Part D plan sponsors, as well as to Medicaid programs or managed care programs operating under Medicaid.

    The amendment also would require the negotiated prices of Part D drugs to be provided at the point of sale.

    It also would require hospitals participating in the 340B drug discount program to pass through savings to qualifying patients.

    It also would require insurers to calculate cost-sharing obligations considering discounts provided under 340B.

    It also would express the sense of Congress that the 340B program is to lower drug costs for low-income and uninsured individuals.

    It also would update requirements for committees that update state Medicaid formularies, and require a report from the Government Accountability Office on potential conflicts of interest on those committees.

    It also would require the secretary to conduct audits of manufacturer prices being charged to Medicaid programs and issue reports on prescribing patterns under Medicaid.

    It also would alow state Medicaid programs to negotiate payment deals with drug manufacturers that would allow for payments over time contingent on the effectiveness of the medications.

    It also would remove exchange health plans and child health plans from the calculation of Medicaid's best price for drugs.

    It also would require Medicare Part D Plans and Medicare Advantage plans to report fraud, waste and abuse to HHS.

    It also would establish pharmacy quality measures under Medicare Part D.

    It also would require the Food and Drug Administration and the Centers for Medicare and Medicaid Services to convene meetings and issue a report on improving coordination between the two agencies.

    It also would require that direct-to-consumer advertisements for prescription drugs covered by Medicare and Medicaid include a disclosure of truthful and non-misleading pricing information.

    It also would allow independent advisory commissions on Medicare and Medicaid to access certain drug payment information including rebate information.

    The amendment also would prohibit drug manufacturers from denying from denying samples of products to potential generic competitors.

    The amendment also would prohibit so-called "pay-for-delay" settlement agreements which allow name-brand drug manufacturers to pay a generic manufacturer to postpone seeking approval of their lower cost alternative.

    It also would revise requirements for awarding a 180-day exclusivity period for generic drugs and update requirements for public posting of patent information for biologic drugs.

    Ruled not germane. Note: <p>Thompson, D-Calif., raised a point of order that the amendment was not germane.</p>

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Restructure Medicare Part D
      K. Brady, R-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would impose an out-of-pocket spending limit of $3,100 for Medicare Part D beneficiaries.

    The amendment also would reduce, beginning in 2022, the Medicare Part D share of the liability after the out-of-pocket maximum from the current 80 percent to 20 percent or 30 percent depending upon the classification of the drug.

    It also would require that manufacturer discounts on drugs be provided to beneficiaries at the point of sale.

    It also would allow Medicare Part D beneficiaries who reach the out-of-pocket maximum with one prescription to pay in installments over time.

    Amendment to the Neal, D-Mass., substitute amendment that would impose an out-of-pocket spending limit of $3,100 for Medicare Part D beneficiaries.

    The amendment also would reduce, beginning in 2022, the Medicare Part D share of the liability after the out-of-pocket maximum from the current 80 percent to 20 percent or 30 percent depending upon the classification of the drug.

    It also would require that manufacturer discounts on drugs be provided to beneficiaries at the point of sale.

    It also would allow Medicare Part D beneficiaries who reach the out-of-pocket maximum with one prescription to pay in installments over time.

    Rejected 16-24.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Medicare Part B Add-On
      Adrian Smith, R-Neb. —

    Amendment to the Neal, D-Mass., substitute amendment that would establish a new variable add-on payment for the current average sales price reimbursement methodology under Medicare Part B.

    The amendment would provide that the new reimbursement would allow an add-on payment of 4 percent for higher priced drugs and up to 10 percent for lower cost drugs, compared to the current 6 percent add-on reimbursed for Part B drugs.

    It also would cap the increased add-on amount to $1,000 during the 2021-2028 period with an inflation adjustment in subsequent years.

    Amendment to the Neal, D-Mass., substitute amendment that would establish a new variable add-on payment for the current average sales price reimbursement methodology under Medicare Part B.

    The amendment would provide that the new reimbursement would allow an add-on payment of 4 percent for higher priced drugs and up to 10 percent for lower cost drugs, compared to the current 6 percent add-on reimbursed for Part B drugs.

    It also would cap the increased add-on amount to $1,000 during the 2021-2028 period with an inflation adjustment in subsequent years.

    Rejected 17-24.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Site-neutral Medicare Payments
      Wenstrup, R-Ohio —

    Amendment to the Neal, D-Mass., substitute amendment that would add new disclosure requirements to the information the secretary of Health and Human Services must currently make available on the department website regarding Medicare Part B payments made to hospitals and outpatient surgical centers. The amendment would require the secretary to disclose the amount paid to physicians for an item or service under the Part B program. It also would require that hospital-owned doctors practices and independent doctor practices receive the same reimbursement rates for drugs administered under Medicare Part B.

    Amendment to the Neal, D-Mass., substitute amendment that would add new disclosure requirements to the information the secretary of Health and Human Services must currently make available on the department website regarding Medicare Part B payments made to hospitals and outpatient surgical centers. The amendment would require the secretary to disclose the amount paid to physicians for an item or service under the Part B program. It also would require that hospital-owned doctors practices and independent doctor practices receive the same reimbursement rates for drugs administered under Medicare Part B.

    Rejected 19-23.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Point-of-Sale Rebates
      Arrington, R-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would require pharmacy benefit managers to pass through 100 percent of discounts negotiated with drug manufacturers to Medicare Part D plan sponsors or Medicare Advantage organizations.

    The amendment also would require beginning on Jan 1, 2022, a portion of the negotiated price savings or discounts to be provided to beneficiaries at the point of sale, starting at 10 percent and rising by 10 percent each year until it reaches 60 percent.

    Amendment to the Neal, D-Mass., substitute amendment that would require pharmacy benefit managers to pass through 100 percent of discounts negotiated with drug manufacturers to Medicare Part D plan sponsors or Medicare Advantage organizations.

    The amendment also would require beginning on Jan 1, 2022, a portion of the negotiated price savings or discounts to be provided to beneficiaries at the point of sale, starting at 10 percent and rising by 10 percent each year until it reaches 60 percent.

    Rejected by voice vote.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Medicare Part D Plan Offerings
      T. Reed, R-N.Y. —

    Amendment to the Neal, D-Mass., substitute amendment that would allow Medicare Part D plan sponsors to offer more than one plan. It would allow plans to offer up to four in a region and up to six if the plans provided at least 25 percent of manufacturer rebates to the beneficiary at the point of sale or use the rebates to reduce beneficiary cost-sharing.

    Amendment to the Neal, D-Mass., substitute amendment that would allow Medicare Part D plan sponsors to offer more than one plan. It would allow plans to offer up to four in a region and up to six if the plans provided at least 25 percent of manufacturer rebates to the beneficiary at the point of sale or use the rebates to reduce beneficiary cost-sharing.

    Rejected 17-23.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Insulin Savings
      T. Reed, R-N.Y. —

    Amendment to the Neal, D-Mass., substitute amendment that would require 100 percent of price concessions negotiated by Medicare Part D plans for the purchase of insulin to be passed on to patients at the point of sale.

    Amendment to the Neal, D-Mass., substitute amendment that would require 100 percent of price concessions negotiated by Medicare Part D plans for the purchase of insulin to be passed on to patients at the point of sale.

    Rejected 17-24.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — 340B Drug Discount Program
      Wenstrup, R-Ohio —

    Amendment to the Neal, D-Mass., substitute amendment that would require that co-payments for drugs covered by the 340B drug discount program reflect the discounted rate at which the hospital acquired the drug.

    The amendment also would express the sense of Congress that the intent of the 340B program is to lower-out-of-pocket drug costs for low-income and uninsured individuals.

    Amendment to the Neal, D-Mass., substitute amendment that would require that co-payments for drugs covered by the 340B drug discount program reflect the discounted rate at which the hospital acquired the drug.

    The amendment also would express the sense of Congress that the intent of the 340B program is to lower-out-of-pocket drug costs for low-income and uninsured individuals.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Increased Competition of Lower Cost Drugs
      Ferguson, R-Ga. —

    Amendment to the Neal, D-Mass., substitute amendment that would add language to the bill that would provide drug manufacturer rebate information to independent advisory commissions on Medicare and Medicaid.

    The amendment also would deter drug manufacturers from denying samples of products to potential generic competitors.

    It also would prohibit so-called "pay-for-delay" settlement agreements between name brand and generic drug manufacturers.

    The amendment also would deter a first generic drug applicant from using the 180-day exclusivity period to delay the approval of other generic versions of a drug by allowing the Food and Drug Administration to approve a subsequent generic drug application before the expiration of the 180-day exclusivity period for the first generic drug application.

    It also would require the FDA to more proactively update patent and exclusivity information in its public databases of approved drugs and biologic drugs.

    Amendment to the Neal, D-Mass., substitute amendment that would add language to the bill that would provide drug manufacturer rebate information to independent advisory commissions on Medicare and Medicaid.

    The amendment also would deter drug manufacturers from denying samples of products to potential generic competitors.

    It also would prohibit so-called "pay-for-delay" settlement agreements between name brand and generic drug manufacturers.

    The amendment also would deter a first generic drug applicant from using the 180-day exclusivity period to delay the approval of other generic versions of a drug by allowing the Food and Drug Administration to approve a subsequent generic drug application before the expiration of the 180-day exclusivity period for the first generic drug application.

    It also would require the FDA to more proactively update patent and exclusivity information in its public databases of approved drugs and biologic drugs.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Tax Penalties and Medical Device Tax
      Walorski, R-Ind. —

    Amendment to the Neal, D-Mass., substitute amendment that would remove language from the bill that would impose a tax penalties on drug manufacturers who do not participate in the price negotiation system, established by the legislation.

    The amendment also would repeal the 2.3 percent tax on medical devices imposed by the 2010 health care law (PL 111-148, PL 111-152).

    It also would permanently extend the income threshold for the medical expense deduction at 7.5 percent of adjusted gross income.

    Amendment to the Neal, D-Mass., substitute amendment that would remove language from the bill that would impose a tax penalties on drug manufacturers who do not participate in the price negotiation system, established by the legislation.

    The amendment also would repeal the 2.3 percent tax on medical devices imposed by the 2010 health care law (PL 111-148, PL 111-152).

    It also would permanently extend the income threshold for the medical expense deduction at 7.5 percent of adjusted gross income.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Drug Price Negotiation Program
      Nunes, R-Calif. —

    Amendment to the Neal, D-Mass., substitute amendment that would remove language that would require the secretary of Health and Human Services to establish a drug price negotiation program and impose financial penalties on drug manufacturers that do not participate in the program.

    Amendment to the Neal, D-Mass., substitute amendment that would remove language that would require the secretary of Health and Human Services to establish a drug price negotiation program and impose financial penalties on drug manufacturers that do not participate in the program.

    Rejected 17-24.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — International Price Provisions
      Holding, R-N.C. —

    Amendment to the Neal, D-Mass., substitute amendment that would remove language that would direct the secretary of Health and Human Services to use data relating to the average international market price that it requests from manufacturers on an ongoing basis.

    It also would remove language that would require manufacturers to provide to HHS the average international price.

    It also would remove language that would establish the maximum fair price for a drug as 120 percent of the average price of the drug in Australia, Canada, France, Germany, Japan and the United Kingdom.

    Amendment to the Neal, D-Mass., substitute amendment that would remove language that would direct the secretary of Health and Human Services to use data relating to the average international market price that it requests from manufacturers on an ongoing basis.

    It also would remove language that would require manufacturers to provide to HHS the average international price.

    It also would remove language that would establish the maximum fair price for a drug as 120 percent of the average price of the drug in Australia, Canada, France, Germany, Japan and the United Kingdom.

    Rejected 17-25.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Alzheimer's Drugs
      LaHood, R-Ill. —

    Amendment to the Neal, D-Mass., substitute amendment that would exempt from the Fair Price Negotiation Program any treatments for Alzheimer's disease.

    Amendment to the Neal, D-Mass., substitute amendment that would exempt from the Fair Price Negotiation Program any treatments for Alzheimer's disease.

    Rejected 14-23.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Cancer Drugs
      Walorski, R-Ind. —

    Amendment to the Neal, D-Mass., substitute amendment that would exempt from the Fair Price Negotiation Program any treatments for cancer.

    Amendment to the Neal, D-Mass., substitute amendment that would exempt from the Fair Price Negotiation Program any treatments for cancer.

    Rejected 16-24.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Drugs to Treat Rare Disease
      Adrian Smith, R-Neb. —

    Amendment to the Neal, D-Mass., substitute amendment that would exempt from the Fair Price Negotiation Program any drug used to treat or cure rare diseases or any other disease "most prevalent to seniors."

    Amendment to the Neal, D-Mass., substitute amendment that would exempt from the Fair Price Negotiation Program any drug used to treat or cure rare diseases or any other disease "most prevalent to seniors."

    Rejected by voice vote.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Effective Date
      M. Kelly, R-Pa. —

    Amendment to the Neal, D-Mass., substitute amendment that would prevent the bill from going into effect unless the secretary of Health and Human Services could certify that implementing the bill wouldn't result in fewer new drug applications for products that would be used for treating unmet needs among Medicare beneficiaries.

    Amendment to the Neal, D-Mass., substitute amendment that would prevent the bill from going into effect unless the secretary of Health and Human Services could certify that implementing the bill wouldn't result in fewer new drug applications for products that would be used for treating unmet needs among Medicare beneficiaries.

    Rejected by voice vote.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Prevent Investment and Job Loss
      LaHood, R-Ill. —

    Amendment to the Neal, D-Mass., substitute amendment that would add language to prevent the provisions in the bill from going into effect until the secretary of Health and Human Services certifies that implementation would not shift pharmaceutical investment or drug manufacturing jobs away from the United States.

    Amendment to the Neal, D-Mass., substitute amendment that would add language to prevent the provisions in the bill from going into effect until the secretary of Health and Human Services certifies that implementation would not shift pharmaceutical investment or drug manufacturing jobs away from the United States.

    Ruled not germane. Note: <p>Thompson, D-Calif., raised a point of order that the LaHood amendment was not germane.</p>

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Motion to Table
    M. Thompson, D-Calif. —

    Motion to table the LaHood, R-Ill., motion to appeal the ruling of the chairman that the LaHood amendment to the Neal, D-Mass., substitute amendment was not germane. The LaHood amendment would prevent the provisions in the bill from going into effect unless the administration certifies that implementing them would not shift pharmaceutical investment or drug manufacturing jobs away from the United States.

    Motion to table the LaHood, R-Ill., motion to appeal the ruling of the chairman that the LaHood amendment to the Neal, D-Mass., substitute amendment was not germane. The LaHood amendment would prevent the provisions in the bill from going into effect unless the administration certifies that implementing them would not shift pharmaceutical investment or drug manufacturing jobs away from the United States.

    Agreed to 24-16.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Rural Hospital Protection
      J. Smith, R-Mo. —

    Amendment to the Neal, D-Mass., substitute amendment that would add language to prevent the provisions in the bill from going into effect until the secretary of Health and Human Services certifies that there would be no reduction in access to life-saving medications by individuals in rural areas.

    Amendment to the Neal, D-Mass., substitute amendment that would add language to prevent the provisions in the bill from going into effect until the secretary of Health and Human Services certifies that there would be no reduction in access to life-saving medications by individuals in rural areas.

    Rejected 17-25.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Rural Physicians
      Ferguson, R-Ga. —

    Amendment to the Neal, D-Mass., substitute amendment that would add language to prevent any of the bill's provisions from going into effect unless the secretary of Health and Human Services certifies that implementation of the bill will not reduce patient access to physicians, including oncologists, in rural areas.

    Amendment to the Neal, D-Mass., substitute amendment that would add language to prevent any of the bill's provisions from going into effect unless the secretary of Health and Human Services certifies that implementation of the bill will not reduce patient access to physicians, including oncologists, in rural areas.

    Ruled not germane. Note: <p>Thompson, D-Calif., raised a point of order that the Ferguson amendment was not germane.</p>

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Motion to Table
    M. Thompson, D-Calif. —

    Motion to table (kill) the Ferguson, R-Ga., motion to appeal the ruling of the chairman that the Ferguson amendment to the Neal, D-Mass., substitute amendment was not germane. The Ferguson amendment would add language to prevent any of the bill's provisions from going into effect unless the secretary of Health and Human Services certifies that implementation of the bill would not reduce patient access to physicians, including oncologists, in rural areas.

    Motion to table (kill) the Ferguson, R-Ga., motion to appeal the ruling of the chairman that the Ferguson amendment to the Neal, D-Mass., substitute amendment was not germane. The Ferguson amendment would add language to prevent any of the bill's provisions from going into effect unless the secretary of Health and Human Services certifies that implementation of the bill would not reduce patient access to physicians, including oncologists, in rural areas.

    Agreed to 25-17.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Pharmaceutical Trade Negotiator
      Arrington, R-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would create a chief pharmaceutical negotiator, within the Office of the United States Trade Representative, to negotiate and enforce trade agreements related to pharmaceutical products and be a "vigorous advocate" for U.S. pharmaceutical interests.

    Amendment to the Neal, D-Mass., substitute amendment that would create a chief pharmaceutical negotiator, within the Office of the United States Trade Representative, to negotiate and enforce trade agreements related to pharmaceutical products and be a "vigorous advocate" for U.S. pharmaceutical interests.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Payment Models Panel
      Schweikert, R-Ariz. —

    Amendment to the Neal, D-Mass., substitute amendment that would require the secretary of Health and Human Services, within 180 days of the bill's enactment, to convene a technical expert panel to provide recommendations to Congress on implementing alternative Medicare payment methods to encourage the development of effective treatments, including immunotherapies.

    Amendment to the Neal, D-Mass., substitute amendment that would require the secretary of Health and Human Services, within 180 days of the bill's enactment, to convene a technical expert panel to provide recommendations to Congress on implementing alternative Medicare payment methods to encourage the development of effective treatments, including immunotherapies.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Medication Adherence Devices
      Schweikert, R-Ariz. —

    Amendment to the Neal, D-Mass., substitute amendment that would require the secretary of Health and Human Services to establish a medication adherence task force to evaluate the use of medication adherence devices and the impact of their use on adherence rates.

    The amendment also would require that the task force include a representative from the Food and Drug Administration, the National Institutes of Health, Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, a self-insured group health plan and 10 other expert representatives.

    It also would require the secretary to establish a medical device innovation pilot program to monitor drug treatment adherence. It also would authorize the secretary to award grants for monitoring the effectiveness of the adherence devices in the pilot program.

    Amendment to the Neal, D-Mass., substitute amendment that would require the secretary of Health and Human Services to establish a medication adherence task force to evaluate the use of medication adherence devices and the impact of their use on adherence rates.

    The amendment also would require that the task force include a representative from the Food and Drug Administration, the National Institutes of Health, Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, a self-insured group health plan and 10 other expert representatives.

    It also would require the secretary to establish a medical device innovation pilot program to monitor drug treatment adherence. It also would authorize the secretary to award grants for monitoring the effectiveness of the adherence devices in the pilot program.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Generic Insulin
      M. Kelly, R-Pa. —

    Amendment to the Neal, D-Mass., substitute amendment that would allow chemically synthesized insulin to go through the traditional generic drug approval process at the Food and Drug Administration, rather than the pathway for biosimilar versions of biologic drugs, in order to expedite the availability of a potentially lower cost insulin.

    Amendment to the Neal, D-Mass., substitute amendment that would allow chemically synthesized insulin to go through the traditional generic drug approval process at the Food and Drug Administration, rather than the pathway for biosimilar versions of biologic drugs, in order to expedite the availability of a potentially lower cost insulin.

    Ruled not germane. Note: <p>Thompson, D-Calif., raised a point of order that the Kelly amendment was not germane.</p>

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Motion to Table
    M. Thompson, D-Calif. —

    Motion to table (kill) the Kelly, R-Pa., motion to appeal the ruling of the chairman that the Kelly amendment to the Neal, D-Mass., substitute amendment was not germane. The Kelly amendment would allow chemically synthesized insulin to go through the traditional generic drug approval process at the Food and Drug Administration, rather than the pathway for biosimilar versions of biologic drugs.

    Motion to table (kill) the Kelly, R-Pa., motion to appeal the ruling of the chairman that the Kelly amendment to the Neal, D-Mass., substitute amendment was not germane. The Kelly amendment would allow chemically synthesized insulin to go through the traditional generic drug approval process at the Food and Drug Administration, rather than the pathway for biosimilar versions of biologic drugs.

    Agreed to 25-17.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Federal Hospital Insurance Trust Fund
      Estes, R-Kan. —

    Amendment to the Neal, D-Mass., substitute amendment that would require any reduction in federal spending that results from implementation of the bill's provisions, be deposited to the Federal Hospital Insurance Trust Fund for Medicare Part A.

    Amendment to the Neal, D-Mass., substitute amendment that would require any reduction in federal spending that results from implementation of the bill's provisions, be deposited to the Federal Hospital Insurance Trust Fund for Medicare Part A.

    Ruled not germane. Note: <p>Thompson, D-Calif., raised a point of order that the Estes amendment was not germane.</p>

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Motion to Table
    M. Thompson, D-Calif. —

    Motion to table (kill) the Estes, R-Kan., motion to appeal the ruling of the chairman that the Estes amendment to the Neal, D-Mass., substitute amendment was not germane. The Estes amendment would require any reduction in federal spending that results from implementation of the bill's provisions, be deposited to the Federal Hospital Insurance Trust Fund for Medicare Part A.

    Motion to table (kill) the Estes, R-Kan., motion to appeal the ruling of the chairman that the Estes amendment to the Neal, D-Mass., substitute amendment was not germane. The Estes amendment would require any reduction in federal spending that results from implementation of the bill's provisions, be deposited to the Federal Hospital Insurance Trust Fund for Medicare Part A.

    Agreed to 25-16.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Branded Prescription Drugs
      T. Rice, R-S.C. —

    Amendment to the Neal, D-Mass., substitute amendment that would repeal the branded prescription drug fee enacted as part of the 2010 health law (PL 111-148 and PL 111-152) which imposes an annual fee on pharmaceutical manufacturers and importers based on the value of branded prescription drug sales to federal health care programs.

    Amendment to the Neal, D-Mass., substitute amendment that would repeal the branded prescription drug fee enacted as part of the 2010 health law (PL 111-148 and PL 111-152) which imposes an annual fee on pharmaceutical manufacturers and importers based on the value of branded prescription drug sales to federal health care programs.

    Rejected 17-25.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Lower Prices for Uninsured
      Doggett, D-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would make individuals who are not enrolled in a health plan eligible to receive the negotiated price of a drug.

    Amendment to the Neal, D-Mass., substitute amendment that would make individuals who are not enrolled in a health plan eligible to receive the negotiated price of a drug.

    Rejected 4-20.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Negotiated Drugs
      Doggett, D-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would increase the minimum number of drugs subject to price negotiation from 30 after five years to 50 after five years, and from 35 after 10 years to 100 after 10 years.

    Amendment to the Neal, D-Mass., substitute amendment that would increase the minimum number of drugs subject to price negotiation from 30 after five years to 50 after five years, and from 35 after 10 years to 100 after 10 years.

    Rejected 3-39.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Non-Interference Clause
      Doggett, D-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would sunset by April 15, 2021, a provision in current law that prevents the secretary of health and Human Services from directly negotiating with drug companies over the price of their products.

    Amendment to the Neal, D-Mass., substitute amendment that would sunset by April 15, 2021, a provision in current law that prevents the secretary of health and Human Services from directly negotiating with drug companies over the price of their products.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Negotiate New Drugs
      Doggett, D-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would require the secretary of Health and Human Services to negotiate the price for any drug launched with a price that is equal to or greater than the U.S. median household income.

    Amendment to the Neal, D-Mass., substitute amendment that would require the secretary of Health and Human Services to negotiate the price for any drug launched with a price that is equal to or greater than the U.S. median household income.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Tax on Price Spikes
      Doggett, D-Texas —

    Amendment to the Neal, D-Mass., substitute amendment that would impose a tax penalty on drug manufacturers who institute increases in the cost of their drugs at a rate higher than the rate of inflation.

    Amendment to the Neal, D-Mass., substitute amendment that would impose a tax penalty on drug manufacturers who institute increases in the cost of their drugs at a rate higher than the rate of inflation.

    Withdrawn.

    Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Substitute Amendment
      Neal, D-Mass. —

    Substitute amendment that would incrementally increase the minimum number of drugs subject to negotiation starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

    The amendment also would direct the secretary of Health and Human Services to determine a maximum fair price for new single-source drugs that launch at a price that is at least the U.S. median household income if the drug is likely to be included as a negotiation-eligible drug.

    It also would add language to require the inclusion of payment codes in the information the HHS secretary is required to report to drug manufacturers of Medicare Part B drugs that qualify for inflation rebates.

    It also would adjust for inflation the rebate calculation included in the bill, from the first quarter of the previous year to the previous 12 months.

    It also would reduce rebate penalties for multiple source drugs to 20 percent of the difference between the price and the inflation-adjusted price.

    It also would allow the HHS secretary to exempt Medicare Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

    It also would shorten the time period for the secretary to terminate information agreements with manufacturers from 60 days after notification to 30 days.

    The amendment also would require Medicare Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It also would require that such beneficiaries be given the opportunity to make the payment in installments over the course of one year.

    It also would allow Medicare Part D plans to develop quality standards for pharmacies in order to provide incentive payments for meeting or exceeding the standards and extract price concessions for failure to meet the standards.

    It also would specify that beneficiaries who participate in the low-income subsidy program in Medicare Part D would no longer have any copay requirements for generic drugs.

    It also would require the Medicare program to provide those eligible for low-income subsidies with information that helps them compare their costs under different drug plan options. It also would require the Medicare program to develop a system for automatically enrolling low-income subsidy eligible individuals to Medicare Part D plans that best meet their prescription drug needs.

    It also would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current law level of 135 percent of the poverty level. It also would expand eligibility for the partial subsidy to include people at 200 percent of the poverty level.

    It also would make residents of U.S. territories who are enrolled in their local Medicaid programs eligible for a low-income subsidy for Medicare Part D.

    It also would make residents of U.S. states who are enrolled in Medicaid automatically eligible for a Medicare Part D low-income subsidy upon turning 65 years of age.

    It also would include distributions and withdrawals from retirement savings plans in the income verification calculation for determining eligibility for Medicare Part D subsidies, except for distributions from eligible annuity plans or deferred compensation plans.

    It also would require drug manufacturers who raise the price by 10 percent over a 12-month period or 25 percent over a 36-month period for drugs that cost more than $100 for a month's supply, to submit a report to the HHS secretary, within 30 days of implementing the increase, which would include a justification for the price increase. It also would specify that the requirements also apply to drugs that launch at a price of $26,000 or more per year.

    It also would require the reports to include:

    • The amount of the price increase and its effective date.
    • An explanation for the price increase.
    • A description of the history of price increases.
    • The current cost of the drug.
    • Expenditures on manufacturing the drug, acquiring patents, purchasing the drug.
    • The percentage of total expenditures on research and development that was derived from federal funds.
    • The total research and development expenditures that were necessary for Food and Drug Administration approval.
    • The total expenditures on research for new or expanded indications.
    • Expenditures on carrying out post-market requirements.
    • Revenue and net profit generated from the drug for each year since approval.
    • Costs associated with marketing and advertising.
    • The total revenue and net profit for the manufacturer.
    • The stock-based performance metrics used to determine executive compensation.

    It also would require the report to be truthful, non-misleading and accurate.

    It also would subject drug manufacturers who fail to submit a report to a penalty of $75,000 for each day of the violation. Manufacturers who include false information would be fined $100,000 for each item of false information.

    It also would require the HHS secretary to post the report publicly on the day the department receives notification of the price increase. It also would require the enforcement of laws to protect confidential commercial information and trade secrets.

    It also would require HHS to submit annual reports to Congress summarizing the price increase reports submitted.

    Substitute amendment that would incrementally increase the minimum number of drugs subject to negotiation starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

    The amendment also would direct the secretary of Health and Human Services to determine a maximum fair price for new single-source drugs that launch at a price that is at least the U.S. median household income if the drug is likely to be included as a negotiation-eligible drug.

    It also would add language to require the inclusion of payment codes in the information the HHS secretary is required to report to drug manufacturers of Medicare Part B drugs that qualify for inflation rebates.

    It also would adjust for inflation the rebate calculation included in the bill, from the first quarter of the previous year to the previous 12 months.

    It also would reduce rebate penalties for multiple source drugs to 20 percent of the difference between the price and the inflation-adjusted price.

    It also would allow the HHS secretary to exempt Medicare Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

    It also would shorten the time period for the secretary to terminate information agreements with manufacturers from 60 days after notification to 30 days.

    The amendment also would require Medicare Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It also would require that such beneficiaries be given the opportunity to make the payment in installments over the course of one year.

    It also would allow Medicare Part D plans to develop quality standards for pharmacies in order to provide incentive payments for meeting or exceeding the standards and extract price concessions for failure to meet the standards.

    It also would specify that beneficiaries who participate in the low-income subsidy program in Medicare Part D would no longer have any copay requirements for generic drugs.

    It also would require the Medicare program to provide those eligible for low-income subsidies with information that helps them compare their costs under different drug plan options. It also would require the Medicare program to develop a system for automatically enrolling low-income subsidy eligible individuals to Medicare Part D plans that best meet their prescription drug needs.

    It also would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current law level of 135 percent of the poverty level. It also would expand eligibility for the partial subsidy to include people at 200 percent of the poverty level.

    It also would make residents of U.S. territories who are enrolled in their local Medicaid programs eligible for a low-income subsidy for Medicare Part D.

    It also would make residents of U.S. states who are enrolled in Medicaid automatically eligible for a Medicare Part D low-income subsidy upon turning 65 years of age.

    It also would include distributions and withdrawals from retirement savings plans in the income verification calculation for determining eligibility for Medicare Part D subsidies, except for distributions from eligible annuity plans or deferred compensation plans.

    It also would require drug manufacturers who raise the price by 10 percent over a 12-month period or 25 percent over a 36-month period for drugs that cost more than $100 for a month's supply, to submit a report to the HHS secretary, within 30 days of implementing the increase, which would include a justification for the price increase. It also would specify that the requirements also apply to drugs that launch at a price of $26,000 or more per year.

    It also would require the reports to include:

    • The amount of the price increase and its effective date.
    • An explanation for the price increase.
    • A description of the history of price increases.
    • The current cost of the drug.
    • Expenditures on manufacturing the drug, acquiring patents, purchasing the drug.
    • The percentage of total expenditures on research and development that was derived from federal funds.
    • The total research and development expenditures that were necessary for Food and Drug Administration approval.
    • The total expenditures on research for new or expanded indications.
    • Expenditures on carrying out post-market requirements.
    • Revenue and net profit generated from the drug for each year since approval.
    • Costs associated with marketing and advertising.
    • The total revenue and net profit for the manufacturer.
    • The stock-based performance metrics used to determine executive compensation.
    • It also would require the report to be truthful, non-misleading and accurate.

      It also would subject drug manufacturers who fail to submit a report to a penalty of $75,000 for each day of the violation. Manufacturers who include false information would be fined $100,000 for each item of false information.

      It also would require the HHS secretary to post the report publicly on the day the department receives notification of the price increase. It also would require the enforcement of laws to protect confidential commercial information and trade secrets.

      It also would require HHS to submit annual reports to Congress summarizing the price increase reports submitted.

      Adopted (as amended) by voice vote.

      Oct. 22, 2019 — Committee Vote: Prescription Drug Price Negotiations — Vote to Report

      Amend current law to make changes to Medicare reimbursement policies for prescription drugs.

      The bill would require the secretary of Health and Human Services to identify the 250 most expensive sole-source drugs to Medicare and the U.S. health system, and post the list of eligible drugs in the Federal Register.

      It also would require HHS to negotiate drug prices for at least 25 drugs, as well as insulin, beginning in 2023. It also would require the secretary to achieve the lowest maximum fir price for each selected drug while appropriately rewarding innovation. The price agreement would remain in effect until the drug no longer meets eligibility requirements.

      As amended, the bill also would incrementally increase the minimum number of drugs subject to negotiation starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

      It also would require the secretary to submit an annual report to Congress on how each negotiated price was reached and post the negotiated prices in the Federal Register. It also would require the secretary to prioritize certain factors when negotiating, including the cost of research and development; federal research investment into the discovery and development of the drug; market, sales and patent data; clinical trials data; unit costs of production and distribution; comparisons to existing bio-equivalent alternatives when negotiating; and cost/benefit information from affected parties.

      It also would set the target price as the lowest average price that exists in any of the reference countries, and 80 percent of the average manufacturer price for drugs without an international reference price.

      It also would establish a ceiling price of 1.2 times the average international price paid in Australia, Canada, France, Germany, Japan and the United Kingdom. It also would establish a ceiling price of 85 percent of the average manufacturer price for drugs without an international reference price. Drugs without an international reference price will rebate the difference between the average manufacturer price and 200 percent of the international price, once one becomes available, within one year.

      As amended, it also would direct the HHS secretary to determine a maximum fair price for new single-source drugs that launch at a price that is at least the U.S. median household income if the drug is likely to be included as a negotiation-eligible drug.

      The bill also would require drug manufacturers to submit pricing information for reference countries, and require the HHS secretary to verify those prices. It also would limit proprietary pricing information to the HHS secretary, the comptroller general and the Medicare Payment Advisory Commission.

      It also would exclude drugs with the new negotiated prices from the current 340b drug discount program.

      It also would require the Labor and Treasury secretaries to publish a list of health plans that opt out of using prices negotiated by the HHS secretary.

      The bill also would impose a penalty for drug manufacturers worth 10 times the difference between the negotiated price and the list price if the manufacturer fails to offer the negotiated price to individuals, providers or suppliers.

      It also would establish a maximum $1 million penalty for each violation of the manufacturer's agreement with HHS. It also would establish a 65 percent excise tax on manufacturers who refuse to negotiate. Under the bill the tax would increase 10 percent every quarter to a maximum of 95 percent.

      It also would require the National Academy of Medicine to submit a report to Congress on potential improvements to the negotiation program by Dec. 31, 2025. It also would require the Medicare Payment Advisory Commission to submit a study to Congress on the program's effects by Dec. 31, 2025.

      It also would exclude from judicial review which drugs are eligible for negotiation, the negotiated price, the publication of a list of those drugs and how many units are considered in the calculation of the ceiling price.

      It also would allow commercial health plans access to the government-negotiated prices and requires public disclosure if they opt not to use them.

      It also would require, starting in July 2021, drug manufacturers participating in Medicare Part B, who raise the price of their drug faster than the rate of inflation to rebate Medicare for the excess costs above inflation. It also would require Medicare to assess price changes each quarter. It also would set the rebate as the product of the price increase and the number of units reimbursed under Medicare Part B.

      The bill also would specify that the rebate would only apply to Part B drugs that are single-source products. It would not apply to drugs that have annual charge of less than $100, or vaccines. It also would specify that the total number of units would not include drugs packaged into a bundled payment for a procedure, drugs under single payment for renal dialysis services, or units that were sold under a discount for the 340B program.

      It also would allow the secretary to waive the rebate for drugs that are in short supply.

      It also would require that the coinsurance paid by beneficiaries for Medicare Part B drugs be based on the inflation-adjusted price, and be set at 20 percent of that price.

      It also would require that rebates collected be credited to the Medicare Part B trust fund.

      The bill also would subject to a civil monetary penalty, equal to 125 percent of the total rebate amount that they owe, drug manufacturers who do not comply with the requirements.

      It also would require HHS to study the feasibility of requiring multiple-source drugs in the rebate system, including drugs paid for under Medicare Advantage plans, and including other drugs or units of drugs excluded from the rebates.

      The bill also would require manufacturers, starting in 2022, to reach an agreement with HHS that it will provide a rebate to Medicare if it increases the price of their drug faster than the rate of inflation in order to participate in the Medicare Part D program. It would set the rebate as the product of the amount above the inflation-adjusted price and the amount of the drug dispensed in Part D.

      It also would require HHS to establish a formula for follow-on products for single-source drugs or innovator drugs that have multiple sources. It would require that the rebate be paid into the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance Trust Fund.

      It also would require drug manufacturers who do not comply with their rebate agreement to pay 125 percent of the rebate that they owe. Under the bill, drugs that cost less than $100 per person per year would not be subject to the rebate. It would apply rebates retroactively for price increases that took effect starting in January 2016.

      The bill also would redesign the structure of Medicare Part D to impose a $2,000 out-of-pocket spending limit for beneficiaries starting in 2022. The limit would be subjected to increases over time. When the spending for a beneficiary surpasses the out-of-pocket spending limit, the Medicare program would be responsible for covering 20 percent of the expenses above the limit, as opposed to the 80 percent it pays under current law.

      It also would require drug manufacturers to enter into agreements with Medicare to provide discounts for certain drugs with beneficiaries at the point of sale. It also would require HHS to periodically audit drug manufacturers for compliance and companies that fail to provide the discounts would be subject to civil monetary penalties equal to the amount of the discount plus 25 percent.

      It also would require that drug prices be discounted by 10 percent when a beneficiary has exceeded their annual deductible currently $415, but before they reach the annual limit. After the annual limit is reached, it would require the manufacturer to provide a 30 percent discount to Medicare.

      It also would phase out the coverage gap in the Medicare Part D program starting in 2022 for generic drugs.

      It also would require the private insurers that administer Medicare Part D plans to consider the drug manufacturers discounts when making their annual bids for coverage. It also would make plans liable for 50 percent of the costs above the out-of-pocket limit.

      As amended, it also would adjust the inflation rebate calculation included in the bill, from the first quarter of the previous year to the previous 12 months.

      As amended, it also would allow the HHS secretary to exempt Medicare Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

      As amended, it also would require Medicare Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It also would require that such beneficiaries be given the opportunity to make the payment in installments over the course of one year.

      As amended, it also would allow Medicare Part D plans to develop quality standards for pharmacies in order to provide incentive payments for meeting or exceeding the standards and extract price concessions for failure to meet the standards.

      As amended, the bill also would specify that beneficiaries who participate in the low-income subsidy program in Medicare Part D would no longer have any copay requirements for generic drugs.

      As amended, it also would require the Medicare program to provide those eligible for low-income subsidies with information that helps them compare their costs under different drug plan options. It also would require the Medicare program to develop a system for automatically enrolling low-income subsidy eligible individuals to Medicare Part D plans that best meet their prescription drug needs.

      As amended, it also would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current law level of 135 percent of the poverty level. It also would expand eligibility for the partial subsidy to include people at 200 percent of the poverty level.

      As amended, it also would make residents of United States territories who are enrolled in their local Medicaid programs eligible for a low-income subsidy for Medicare Part D.

      As amended, the bill also would make residents of U.S. states who are enrolled in Medicaid automatically eligible for a Medicare Part D low-income subsidy upon turning 65 years of age.

      As amended, it also would include distributions and withdrawals from retirement savings plans in the income verification calculation for determining eligibility for Medicare Part D subsidies, except for distributions from eligible annuity plans or deferred compensation plans.

      Amend current law to make changes to Medicare reimbursement policies for prescription drugs.

      The bill would require the secretary of Health and Human Services to identify the 250 most expensive sole-source drugs to Medicare and the U.S. health system, and post the list of eligible drugs in the Federal Register.

      It also would require HHS to negotiate drug prices for at least 25 drugs, as well as insulin, beginning in 2023. It also would require the secretary to achieve the lowest maximum fir price for each selected drug while appropriately rewarding innovation. The price agreement would remain in effect until the drug no longer meets eligibility requirements.

      As amended, the bill also would incrementally increase the minimum number of drugs subject to negotiation starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

      It also would require the secretary to submit an annual report to Congress on how each negotiated price was reached and post the negotiated prices in the Federal Register. It also would require the secretary to prioritize certain factors when negotiating, including the cost of research and development; federal research investment into the discovery and development of the drug; market, sales and patent data; clinical trials data; unit costs of production and distribution; comparisons to existing bio-equivalent alternatives when negotiating; and cost/benefit information from affected parties.

      It also would set the target price as the lowest average price that exists in any of the reference countries, and 80 percent of the average manufacturer price for drugs without an international reference price.

      It also would establish a ceiling price of 1.2 times the average international price paid in Australia, Canada, France, Germany, Japan and the United Kingdom. It also would establish a ceiling price of 85 percent of the average manufacturer price for drugs without an international reference price. Drugs without an international reference price will rebate the difference between the average manufacturer price and 200 percent of the international price, once one becomes available, within one year.

      As amended, it also would direct the HHS secretary to determine a maximum fair price for new single-source drugs that launch at a price that is at least the U.S. median household income if the drug is likely to be included as a negotiation-eligible drug.

      The bill also would require drug manufacturers to submit pricing information for reference countries, and require the HHS secretary to verify those prices. It also would limit proprietary pricing information to the HHS secretary, the comptroller general and the Medicare Payment Advisory Commission.

      It also would exclude drugs with the new negotiated prices from the current 340b drug discount program.

      It also would require the Labor and Treasury secretaries to publish a list of health plans that opt out of using prices negotiated by the HHS secretary.

      The bill also would impose a penalty for drug manufacturers worth 10 times the difference between the negotiated price and the list price if the manufacturer fails to offer the negotiated price to individuals, providers or suppliers.

      It also would establish a maximum $1 million penalty for each violation of the manufacturer's agreement with HHS. It also would establish a 65 percent excise tax on manufacturers who refuse to negotiate. Under the bill the tax would increase 10 percent every quarter to a maximum of 95 percent.

      It also would require the National Academy of Medicine to submit a report to Congress on potential improvements to the negotiation program by Dec. 31, 2025. It also would require the Medicare Payment Advisory Commission to submit a study to Congress on the program's effects by Dec. 31, 2025.

      It also would exclude from judicial review which drugs are eligible for negotiation, the negotiated price, the publication of a list of those drugs and how many units are considered in the calculation of the ceiling price.

      It also would allow commercial health plans access to the government-negotiated prices and requires public disclosure if they opt not to use them.

      It also would require, starting in July 2021, drug manufacturers participating in Medicare Part B, who raise the price of their drug faster than the rate of inflation to rebate Medicare for the excess costs above inflation. It also would require Medicare to assess price changes each quarter. It also would set the rebate as the product of the price increase and the number of units reimbursed under Medicare Part B.

      The bill also would specify that the rebate would only apply to Part B drugs that are single-source products. It would not apply to drugs that have annual charge of less than $100, or vaccines. It also would specify that the total number of units would not include drugs packaged into a bundled payment for a procedure, drugs under single payment for renal dialysis services, or units that were sold under a discount for the 340B program.

      It also would allow the secretary to waive the rebate for drugs that are in short supply.

      It also would require that the coinsurance paid by beneficiaries for Medicare Part B drugs be based on the inflation-adjusted price, and be set at 20 percent of that price.

      It also would require that rebates collected be credited to the Medicare Part B trust fund.

      The bill also would subject to a civil monetary penalty, equal to 125 percent of the total rebate amount that they owe, drug manufacturers who do not comply with the requirements.

      It also would require HHS to study the feasibility of requiring multiple-source drugs in the rebate system, including drugs paid for under Medicare Advantage plans, and including other drugs or units of drugs excluded from the rebates.

      The bill also would require manufacturers, starting in 2022, to reach an agreement with HHS that it will provide a rebate to Medicare if it increases the price of their drug faster than the rate of inflation in order to participate in the Medicare Part D program. It would set the rebate as the product of the amount above the inflation-adjusted price and the amount of the drug dispensed in Part D.

      It also would require HHS to establish a formula for follow-on products for single-source drugs or innovator drugs that have multiple sources. It would require that the rebate be paid into the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance Trust Fund.

      It also would require drug manufacturers who do not comply with their rebate agreement to pay 125 percent of the rebate that they owe. Under the bill, drugs that cost less than $100 per person per year would not be subject to the rebate. It would apply rebates retroactively for price increases that took effect starting in January 2016.

      The bill also would redesign the structure of Medicare Part D to impose a $2,000 out-of-pocket spending limit for beneficiaries starting in 2022. The limit would be subjected to increases over time. When the spending for a beneficiary surpasses the out-of-pocket spending limit, the Medicare program would be responsible for covering 20 percent of the expenses above the limit, as opposed to the 80 percent it pays under current law.

      It also would require drug manufacturers to enter into agreements with Medicare to provide discounts for certain drugs with beneficiaries at the point of sale. It also would require HHS to periodically audit drug manufacturers for compliance and companies that fail to provide the discounts would be subject to civil monetary penalties equal to the amount of the discount plus 25 percent.

      It also would require that drug prices be discounted by 10 percent when a beneficiary has exceeded their annual deductible currently $415, but before they reach the annual limit. After the annual limit is reached, it would require the manufacturer to provide a 30 percent discount to Medicare.

      It also would phase out the coverage gap in the Medicare Part D program starting in 2022 for generic drugs.

      It also would require the private insurers that administer Medicare Part D plans to consider the drug manufacturers discounts when making their annual bids for coverage. It also would make plans liable for 50 percent of the costs above the out-of-pocket limit.

      As amended, it also would adjust the inflation rebate calculation included in the bill, from the first quarter of the previous year to the previous 12 months.

      As amended, it also would allow the HHS secretary to exempt Medicare Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

      As amended, it also would require Medicare Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It also would require that such beneficiaries be given the opportunity to make the payment in installments over the course of one year.

      As amended, it also would allow Medicare Part D plans to develop quality standards for pharmacies in order to provide incentive payments for meeting or exceeding the standards and extract price concessions for failure to meet the standards.

      As amended, the bill also would specify that beneficiaries who participate in the low-income subsidy program in Medicare Part D would no longer have any copay requirements for generic drugs.

      As amended, it also would require the Medicare program to provide those eligible for low-income subsidies with information that helps them compare their costs under different drug plan options. It also would require the Medicare program to develop a system for automatically enrolling low-income subsidy eligible individuals to Medicare Part D plans that best meet their prescription drug needs.

      As amended, it also would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current law level of 135 percent of the poverty level. It also would expand eligibility for the partial subsidy to include people at 200 percent of the poverty level.

      As amended, it also would make residents of United States territories who are enrolled in their local Medicaid programs eligible for a low-income subsidy for Medicare Part D.

      As amended, the bill also would make residents of U.S. states who are enrolled in Medicaid automatically eligible for a Medicare Part D low-income subsidy upon turning 65 years of age.

      As amended, it also would include distributions and withdrawals from retirement savings plans in the income verification calculation for determining eligibility for Medicare Part D subsidies, except for distributions from eligible annuity plans or deferred compensation plans.

      Ordered reported favorably to the full House (as amended) 24-17.

  • Oct. 22, 2019 — Additional cosponsor(s): 4

    Cleaver (D-Mo.)Schakowsky, (D-Ill.)
    Sarbanes, (D-Md.)Wexton, (D-Va.)
  • Oct. 21, 2019 — Additional cosponsor(s): 7

    Bustos, (D-Ill.)Cuellar, (D-Texas)Schrier, (D-Wash.)
    Casten, (D-Ill.)Loebsack, (D-Iowa)
    Crist, (D-Fla.)Mucarsel-Powell, (D-Fla.)
  • Oct. 17, 2019 — Full committee consideration and markup held by the House Education and Labor Committee.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Cost-sharing
      Norcross, D-N.J. —

    Amendment to the Scott, D-Va., substitute amendment that would limit to the government-negotiated price the group health plan cost-sharing for eligible drugs.

    Amendment to the Scott, D-Va., substitute amendment that would limit to the government-negotiated price the group health plan cost-sharing for eligible drugs.

    Adopted by voice vote.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — GAO Drug Negotiation Study
      Trahan, D-Mass. —

    Amendment to the Scott, D-Va., substitute amendment that would require the Government Accountability Office to conduct, and submit to Congress, a study on the effects of the Fair Price Negotiation Program by Dec. 31, 2025.

    Amendment to the Scott, D-Va., substitute amendment that would require the Government Accountability Office to conduct, and submit to Congress, a study on the effects of the Fair Price Negotiation Program by Dec. 31, 2025.

    Adopted by voice vote.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Inflation Rebate Study
      Jayapal, D-Wash. —

    Amendment to the Scott, D-Va., substitute amendment that would require the secretary of Labor, in consultation with the secretaries of Health and Human Services and Treasury, to conduct and submit to Congress a study on the feasibility of extending inflation rebates to group health plans by Dec. 31, 2021. The amendment also would require the Labor secretary to implement an inflation rebate if the secretary determines the process is feasible and that a "sufficient" number of drug prices exceeded the urban consumer price index for a determined period of time.

    Amendment to the Scott, D-Va., substitute amendment that would require the secretary of Labor, in consultation with the secretaries of Health and Human Services and Treasury, to conduct and submit to Congress a study on the feasibility of extending inflation rebates to group health plans by Dec. 31, 2021. The amendment also would require the Labor secretary to implement an inflation rebate if the secretary determines the process is feasible and that a "sufficient" number of drug prices exceeded the urban consumer price index for a determined period of time.

    Adopted by voice vote.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Duplicative Data Collection
      Harder, D-Calif. —

    Amendment to the Scott, D-Va., substitute amendment that would require the secretary of Health and Human Services, to ensure that the data collection from prescription drug plans required by the bill does not duplicate other data collection efforts.

    Amendment to the Scott, D-Va., substitute amendment that would require the secretary of Health and Human Services, to ensure that the data collection from prescription drug plans required by the bill does not duplicate other data collection efforts.

    Adopted by voice vote.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Pass-through Rebates
      Roe, R-Tenn. —

    Amendment to the Scott, D-Va., substitute amendment that would exempt commercial group health plans from the bill and require pharmacy benefit managers (PBMs) to pass full drug rebates back to employer sponsors within 90 days. The amendment also would require PBM payments to be a flat service fee, rather than based on the price of a drug. It also would subject non-compliant PBMs to a daily penalty of $10,000.

    Amendment to the Scott, D-Va., substitute amendment that would exempt commercial group health plans from the bill and require pharmacy benefit managers (PBMs) to pass full drug rebates back to employer sponsors within 90 days. The amendment also would require PBM payments to be a flat service fee, rather than based on the price of a drug. It also would subject non-compliant PBMs to a daily penalty of $10,000.

    Ruled not germane.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Alzheimer's Drugs
      Walberg, R-Mich. —

    Amendment to the Scott, D-Va., substitute amendment that would exclude from the Fair Price Negotiation Program drugs to treat or cure Alzheimer's disease.

    Amendment to the Scott, D-Va., substitute amendment that would exclude from the Fair Price Negotiation Program drugs to treat or cure Alzheimer's disease.

    Rejected by voice vote.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Investments in China
      Allen, R-Ga. —

    Amendment to the Scott, D-Va., substitute amendment that would prevent the bill from taking effect unless the Department of Labor certifies it would not result in investments in biotechnology or manufacturing jobs in the U.S. moving to China.

    Amendment to the Scott, D-Va., substitute amendment that would prevent the bill from taking effect unless the Department of Labor certifies it would not result in investments in biotechnology or manufacturing jobs in the U.S. moving to China.

    Rejected 20-26.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Health Plan Fiduciaries
      Johnson, R-S.D. —

    Amendment to the Scott, D-Va., substitute amendment that would clarify that the bill would not interfere with group health plan employees' fiduciary obligations.

    Amendment to the Scott, D-Va., substitute amendment that would clarify that the bill would not interfere with group health plan employees' fiduciary obligations.

    Rejected 20-26.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Non-participation List
      Foxx, R-N.C. —

    Amendment to the Scott, D-Va., substitute amendment that would clarify that group health plans are exempt from inclusion on a public list of plans that opt not to accept the government-negotiated price for a drug if the commercial price is lower than the government price.

    Amendment to the Scott, D-Va., substitute amendment that would clarify that group health plans are exempt from inclusion on a public list of plans that opt not to accept the government-negotiated price for a drug if the commercial price is lower than the government price.

    Rejected 21-26.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Job Losses
      Foxx, R-N.C. —

    Amendment to the Scott, D-Va., substitute amendment that would block the bill from taking effect unless the comptroller general certifies that fewer than 50,000 manufacturing, construction, research and development and scientist jobs would be lost.

    Amendment to the Scott, D-Va., substitute amendment that would block the bill from taking effect unless the comptroller general certifies that fewer than 50,000 manufacturing, construction, research and development and scientist jobs would be lost.

    Rejected 21-26.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Research and Development Investments
      Walker, R-N.C. —

    Amendment to the Scott, D-Va., substitute amendment that would block the bill from taking effect unless the comptroller general determines that investments in research and development would not decrease by $10 billion per year or more.

    Amendment to the Scott, D-Va., substitute amendment that would block the bill from taking effect unless the comptroller general determines that investments in research and development would not decrease by $10 billion per year or more.

    Rejected 21-27.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Access to Prescription Drugs
      Roe, R-Tenn. —

    Amendment to the Scott, D-Va., substitute amendment that would prevent the bill's provisions from taking effect unless the secretary of Labor certifies that implementing the provisions would not decrease access to prescription drugs in commercial group health plans or group health coverage.

    Amendment to the Scott, D-Va., substitute amendment that would prevent the bill's provisions from taking effect unless the secretary of Labor certifies that implementing the provisions would not decrease access to prescription drugs in commercial group health plans or group health coverage.

    Rejected 21-27.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Substitute Amendment
      R. Scott, D-Va. —

    Substitute amendment that would increase the minimum number of drugs subject to negotiation over time, starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

    For new single-source drugs that launch at a price that is at least the U.S. median household income, if the drug is likely to be included as a negotiation-eligible drug, it would require the Department of Health and Human Services to determine a maximum fair price for the drug.

    It would add payment codes to the information that the HHS secretary is required to report to drug manufacturers of Medicare Part B drugs that qualify for inflation rebates.

    It would extend the inflation rebate calculation from the first quarter of the previous year to the previous 12 months.

    It would authorize a rebate penalty for multiple source drugs set at 20 percent of the difference between the price and the inflation-adjusted price.

    It would allow the HHS secretary to exempt Medicare Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

    It would shorten the time period for the secretary to terminate information agreements with manufacturers from 60 days after notification to 30 days. It also would change the dates from when manufacturers can terminate agreements from the year occurring at least 60 days after notification to HHS to the day after the year if the notice occurs before Jan. 30, or the day after the following year if the notice occurs on or after Jan. 30.

    It would define the calculation used to determine the annual price and the benchmark price of a Medicare Part D drug subject to inflation rebates.

    It would require Medicare Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It would require the policy to give those beneficiaries the opportunity to make the payment in installments over the course of one year.

    It would allow Medicare Part D plans to develop quality standards for pharmacies to provide incentive payments or extract price concessions.

    Beneficiaries who participate in the Medicare Part D low-income subsidy program would no longer have any copay requirements for generic drugs.

    It would require Medicare to provide those eligible for low-income subsidies with information that helps them compare their costs under different plan options.

    It also would require Medicare to develop a system for automatically enrolling low-income subsidy eligible individuals to Medicare Part D plans that best meet their prescription drug needs.

    It would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current level of 135 percent of poverty. It also would expand the partial subsidy to make people at 200 percent of the poverty level eligible for the subsidy.

    It would make residents of United States territories who are enrolled in their local Medicaid programs automatically eligible for a low-income subsidy for Medicare Part D. It also would specify that residents of U.S. states who are enrolled in Medicaid would automatically qualify for a Medicare Part D low-income subsidy upon turning 65 years of age.

    It would require drugmakers who raise their prices by 10 percent over a 12-month period or 25 percent over a 36-month period to submit a report to the Department of Health and Human Services explaining the reasons for the price increase. The requirements also would apply to drugs that launch at a price of $26,000 or more per year. The requirements would only apply to drugs that cost more than $100 for a months supply. It also would specify that the reports be due within 30 days of the price increase.

    It also would require the reports to include:

    • The amount of the price increase and its effective date.
    • An explanation for the price increase.
    • A description of the history of price increases.
    • The current cost of the drug.
    • Expenditures on manufacturing the drug, acquiring patents, and purchasing the drug.
    • The percentage of total expenditures on research and development that was derived from federal funds.
    • The total research and development expenditures that were necessary for Food and Drug Administration approval.
    • The total expenditures on research for new or expanded indications.
    • Expenditures on carrying out post-market requirements.
    • Revenue and net profit generated from the drug for each year since approval.
    • Costs associated with marketing and advertising.
    • The total revenue and net profit for the manufacturer.
    • Stock-based performance metrics used to determine executive compensation.
    • Any other information the drugmaker would like to provide.

    It also would require that the report be truthful, non-misleading and accurate.

    It would subject drugmakers who fail to submit a report to a penalty of $75,000 for each day of the violation. It also would specify that drugmakers who include false information would be fined $100,000 for each item of false information.

    It also would require the HHS secretary to post the report publicly on the day of the price increase. It also would require enforcement of laws to protect confidential commercial information and trade secrets.

    It also would require HHS to submit annual reports to Congress summarizing the price increase reports submitted.

    Substitute amendment that would increase the minimum number of drugs subject to negotiation over time, starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

    For new single-source drugs that launch at a price that is at least the U.S. median household income, if the drug is likely to be included as a negotiation-eligible drug, it would require the Department of Health and Human Services to determine a maximum fair price for the drug.

    It would add payment codes to the information that the HHS secretary is required to report to drug manufacturers of Medicare Part B drugs that qualify for inflation rebates.

    It would extend the inflation rebate calculation from the first quarter of the previous year to the previous 12 months.

    It would authorize a rebate penalty for multiple source drugs set at 20 percent of the difference between the price and the inflation-adjusted price.

    It would allow the HHS secretary to exempt Medicare Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

    It would shorten the time period for the secretary to terminate information agreements with manufacturers from 60 days after notification to 30 days. It also would change the dates from when manufacturers can terminate agreements from the year occurring at least 60 days after notification to HHS to the day after the year if the notice occurs before Jan. 30, or the day after the following year if the notice occurs on or after Jan. 30.

    It would define the calculation used to determine the annual price and the benchmark price of a Medicare Part D drug subject to inflation rebates.

    It would require Medicare Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It would require the policy to give those beneficiaries the opportunity to make the payment in installments over the course of one year.

    It would allow Medicare Part D plans to develop quality standards for pharmacies to provide incentive payments or extract price concessions.

    Beneficiaries who participate in the Medicare Part D low-income subsidy program would no longer have any copay requirements for generic drugs.

    It would require Medicare to provide those eligible for low-income subsidies with information that helps them compare their costs under different plan options.

    It also would require Medicare to develop a system for automatically enrolling low-income subsidy eligible individuals to Medicare Part D plans that best meet their prescription drug needs.

    It would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current level of 135 percent of poverty. It also would expand the partial subsidy to make people at 200 percent of the poverty level eligible for the subsidy.

    It would make residents of United States territories who are enrolled in their local Medicaid programs automatically eligible for a low-income subsidy for Medicare Part D. It also would specify that residents of U.S. states who are enrolled in Medicaid would automatically qualify for a Medicare Part D low-income subsidy upon turning 65 years of age.

    It would require drugmakers who raise their prices by 10 percent over a 12-month period or 25 percent over a 36-month period to submit a report to the Department of Health and Human Services explaining the reasons for the price increase. The requirements also would apply to drugs that launch at a price of $26,000 or more per year. The requirements would only apply to drugs that cost more than $100 for a months supply. It also would specify that the reports be due within 30 days of the price increase.

    It also would require the reports to include:

    • The amount of the price increase and its effective date.
    • An explanation for the price increase.
    • A description of the history of price increases.
    • The current cost of the drug.
    • Expenditures on manufacturing the drug, acquiring patents, and purchasing the drug.
    • The percentage of total expenditures on research and development that was derived from federal funds.
    • The total research and development expenditures that were necessary for Food and Drug Administration approval.
    • The total expenditures on research for new or expanded indications.
    • Expenditures on carrying out post-market requirements.
    • Revenue and net profit generated from the drug for each year since approval.
    • Costs associated with marketing and advertising.
    • The total revenue and net profit for the manufacturer.
    • Stock-based performance metrics used to determine executive compensation.
    • Any other information the drugmaker would like to provide.
    • It also would require that the report be truthful, non-misleading and accurate.

      It would subject drugmakers who fail to submit a report to a penalty of $75,000 for each day of the violation. It also would specify that drugmakers who include false information would be fined $100,000 for each item of false information.

      It also would require the HHS secretary to post the report publicly on the day of the price increase. It also would require enforcement of laws to protect confidential commercial information and trade secrets.

      It also would require HHS to submit annual reports to Congress summarizing the price increase reports submitted.

      Adopted (as amended) by voice vote.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Pricing Negotiations — Vote to Report

      Require the secretary of Health and Human Services to identify the 250 most expensive sole-source drugs to Medicare and the U.S. health system, and post a list of eligible drugs in the Federal Register. The bill also would require HHS to negotiate drug prices for at least 25 drugs, as well as insulin, beginning in 2023. It would specify that the price agreement would remain in effect until the drug no longer meets eligibility requirements. It would require the secretary to achieve the lowest maximum fair price for each selected drug while appropriately rewarding innovation.

      The bill would require the secretary to submit an annual report on how each negotiated price was reached and post the prices in the Federal Register.

      It also would require the secretary to prioritize certain factors when negotiating, including research and development; federal research investment; market, sales and patent data; clinical trials data; unit costs of production and distribution; comparisons to existing alternatives when negotiating; and information from affected parties.

      It would establish a ceiling price of 1.2 times the average international price paid in Australia, Canada, France, Germany, Japan and the United Kingdom.

      It would set the target price as the lowest average price that exists in any of the reference countries, and 80 percent of the average manufacturer price for drugs without an international reference price.

      It would establish a ceiling price of 85 percent of the average manufacturer price for drugs without an international reference price. It would require that drugs without an international reference price rebate the difference between the average manufacturer price and 200 percent of the international price, once one becomes available, within one year.

      It would require drug manufacturers to submit pricing information for reference countries, and require the HHS secretary to verify those prices. It would limit proprietary pricing information to the HHS secretary, comptroller general and the Medicare Payment Advisory Commission.

      It would exclude drugs with negotiated prices from the 340b drug discount program.

      It would require the Labor and Treasury secretaries to publish a list of health plans that opt out of using prices negotiated by HHS.

      It would implement a penalty for drug manufacturers worth 10 times the difference between the negotiated price and the list price if the drugmaker does not offer the price to individuals, providers or suppliers.

      It would establish a maximum $1 million penalty for each violation of the manufacturers agreement with HHS.

      It would implement a 65 percent excise tax on manufacturers who refuse to negotiate. The tax increases 10 percent every quarter to a maximum of 95 percent.

      It would require the National Academy of Medicine to submit a report to Congress on potential improvements to the negotiation program by Dec. 31, 2025. It also would require the Medicare Payment Advisory Commission to submit a study on the program's effects by Dec. 31, 2025.

      It would exclude from judicial review which drugs are eligible for negotiation, the negotiated price, the publication of a list of those drugs and how many units are considered in the calculation of the ceiling price.

      It would allow commercial health plans access to the government-negotiated prices and requires public disclosure if they opt not to use them.

      In Medicare Part B, starting in July 2021, the bill would require drugmakers who raise the prices faster than the rate of inflation to rebate Medicare for the excess costs above inflation. It would direct Medicare to assess price changes each quarter. It also would set the rebate as the product of the price increase and the number of units reimbursed under Medicare Part B.

      It would specify that the rebate would only apply to Medicare Part B drugs that are single-source products. It would not apply to drugs if the average total annual charges for an individual is less than $100, or to vaccines.

      It would specify that the total number of units would not include drugs packaged into a bundled payment for a procedure, drugs under single payment for renal dialysis services, or units that were sold under a discount for the 340B program.

      It would allow for the waiver of rebates for drugs that are in shortage.

      It would require that the coinsurance paid by beneficiaries for Part B drugs be based on the inflation-adjusted price, and would be set at 20 percent of the price.

      It would require that rebates be paid to the Medicare Part B trust fund.

      It would subject to a civil monetary penalty equal to 125 percent of the total rebate amount that they owe drugmakers who do not comply with the rebate requirements.

      It would require HHS to study the feasibility of requiring multiple-source drugs in the rebate system, including drugs paid for under Medicare Advantage plans, and including other drugs or units of drugs excluded from the rebates.

      In Medicare Part D, starting in 2022, in order for a drug to qualify for coverage, it would require manufacturers to reach an agreement with HHS that it provide a rebate if it increases the price of the drug faster than the rate of inflation. It would require that the rebate be a product of the amount above the inflation-adjusted price and the amount of the drug dispensed in Part D.

      It would allow the rebate penalty to be waived in the event of a drug shortage.

      It would require HHS to establish a formula for follow-on products for single-source drugs or innovator drugs that have multiple sources.

      It would require drugmakers who don't comply with their rebate agreement to pay 125 percent of the rebate that they owe.

      It would specify that drugs that cost less than $100 per person per year would not be subject to the rebate.

      It would stipulate that rebates would be applied retroactively for price increases that took effect starting in January 2016.

      The bill would redesign the structure of Medicare Part D to impose a $2,000 out-of-pocket spending limit for beneficiaries starting in 2022. The limit would be subjected to increases over time.

      When the spending for a beneficiary surpasses the out-of-pocket spending limit, it would require the Medicare program to cover 20 percent of the expenses above the limit, as opposed to the 80 percent it pays under current law.

      It would require drug manufacturers to enter into agreements with Medicare to provide discounts for certain drugs with beneficiaries at the point of sale. It would direct HHS to periodically audit drugmakers for compliance and drugmakers who fail to provide the discounts would be subject to civil monetary penalties equal to the amount of the discount plus 25 percent. It would allow the price to be discounted by 10 percent when a beneficiary has exceeded their annual deductible but before they reach the annual limit. After the annual limit is reached, it would require the manufacturer to provide a 30 percent discount to Medicare.

      It would phase out the coverage gap in the Medicare Part D program starting in 2022.

      It also would require the private insurers that administer Medicare Part D plans to consider the drugmaker discounts when making their annual bids for coverage. It would specify that plans would be liable for 50 percent of the costs above the out-of-pocket limit.

      Require the secretary of Health and Human Services to identify the 250 most expensive sole-source drugs to Medicare and the U.S. health system, and post a list of eligible drugs in the Federal Register. The bill also would require HHS to negotiate drug prices for at least 25 drugs, as well as insulin, beginning in 2023. It would specify that the price agreement would remain in effect until the drug no longer meets eligibility requirements. It would require the secretary to achieve the lowest maximum fair price for each selected drug while appropriately rewarding innovation.

      The bill would require the secretary to submit an annual report on how each negotiated price was reached and post the prices in the Federal Register.

      It also would require the secretary to prioritize certain factors when negotiating, including research and development; federal research investment; market, sales and patent data; clinical trials data; unit costs of production and distribution; comparisons to existing alternatives when negotiating; and information from affected parties.

      It would establish a ceiling price of 1.2 times the average international price paid in Australia, Canada, France, Germany, Japan and the United Kingdom.

      It would set the target price as the lowest average price that exists in any of the reference countries, and 80 percent of the average manufacturer price for drugs without an international reference price.

      It would establish a ceiling price of 85 percent of the average manufacturer price for drugs without an international reference price. It would require that drugs without an international reference price rebate the difference between the average manufacturer price and 200 percent of the international price, once one becomes available, within one year.

      It would require drug manufacturers to submit pricing information for reference countries, and require the HHS secretary to verify those prices. It would limit proprietary pricing information to the HHS secretary, comptroller general and the Medicare Payment Advisory Commission.

      It would exclude drugs with negotiated prices from the 340b drug discount program.

      It would require the Labor and Treasury secretaries to publish a list of health plans that opt out of using prices negotiated by HHS.

      It would implement a penalty for drug manufacturers worth 10 times the difference between the negotiated price and the list price if the drugmaker does not offer the price to individuals, providers or suppliers.

      It would establish a maximum $1 million penalty for each violation of the manufacturers agreement with HHS.

      It would implement a 65 percent excise tax on manufacturers who refuse to negotiate. The tax increases 10 percent every quarter to a maximum of 95 percent.

      It would require the National Academy of Medicine to submit a report to Congress on potential improvements to the negotiation program by Dec. 31, 2025. It also would require the Medicare Payment Advisory Commission to submit a study on the program's effects by Dec. 31, 2025.

      It would exclude from judicial review which drugs are eligible for negotiation, the negotiated price, the publication of a list of those drugs and how many units are considered in the calculation of the ceiling price.

      It would allow commercial health plans access to the government-negotiated prices and requires public disclosure if they opt not to use them.

      In Medicare Part B, starting in July 2021, the bill would require drugmakers who raise the prices faster than the rate of inflation to rebate Medicare for the excess costs above inflation. It would direct Medicare to assess price changes each quarter. It also would set the rebate as the product of the price increase and the number of units reimbursed under Medicare Part B.

      It would specify that the rebate would only apply to Medicare Part B drugs that are single-source products. It would not apply to drugs if the average total annual charges for an individual is less than $100, or to vaccines.

      It would specify that the total number of units would not include drugs packaged into a bundled payment for a procedure, drugs under single payment for renal dialysis services, or units that were sold under a discount for the 340B program.

      It would allow for the waiver of rebates for drugs that are in shortage.

      It would require that the coinsurance paid by beneficiaries for Part B drugs be based on the inflation-adjusted price, and would be set at 20 percent of the price.

      It would require that rebates be paid to the Medicare Part B trust fund.

      It would subject to a civil monetary penalty equal to 125 percent of the total rebate amount that they owe drugmakers who do not comply with the rebate requirements.

      It would require HHS to study the feasibility of requiring multiple-source drugs in the rebate system, including drugs paid for under Medicare Advantage plans, and including other drugs or units of drugs excluded from the rebates.

      In Medicare Part D, starting in 2022, in order for a drug to qualify for coverage, it would require manufacturers to reach an agreement with HHS that it provide a rebate if it increases the price of the drug faster than the rate of inflation. It would require that the rebate be a product of the amount above the inflation-adjusted price and the amount of the drug dispensed in Part D.

      It would allow the rebate penalty to be waived in the event of a drug shortage.

      It would require HHS to establish a formula for follow-on products for single-source drugs or innovator drugs that have multiple sources.

      It would require drugmakers who don't comply with their rebate agreement to pay 125 percent of the rebate that they owe.

      It would specify that drugs that cost less than $100 per person per year would not be subject to the rebate.

      It would stipulate that rebates would be applied retroactively for price increases that took effect starting in January 2016.

      The bill would redesign the structure of Medicare Part D to impose a $2,000 out-of-pocket spending limit for beneficiaries starting in 2022. The limit would be subjected to increases over time.

      When the spending for a beneficiary surpasses the out-of-pocket spending limit, it would require the Medicare program to cover 20 percent of the expenses above the limit, as opposed to the 80 percent it pays under current law.

      It would require drug manufacturers to enter into agreements with Medicare to provide discounts for certain drugs with beneficiaries at the point of sale. It would direct HHS to periodically audit drugmakers for compliance and drugmakers who fail to provide the discounts would be subject to civil monetary penalties equal to the amount of the discount plus 25 percent. It would allow the price to be discounted by 10 percent when a beneficiary has exceeded their annual deductible but before they reach the annual limit. After the annual limit is reached, it would require the manufacturer to provide a 30 percent discount to Medicare.

      It would phase out the coverage gap in the Medicare Part D program starting in 2022.

      It also would require the private insurers that administer Medicare Part D plans to consider the drugmaker discounts when making their annual bids for coverage. It would specify that plans would be liable for 50 percent of the costs above the out-of-pocket limit.

      Ordered reported favorably to the full House (as amended) 27-21.

  • Oct. 17, 2019 — Full committee consideration and markup held by the House Energy and Commerce Committee.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiations — Insulin Rebates
    Burgess, R-Texas —

    Amendment to the Pallone, D-N.J., substitute amendment that would require Medicare Part D plans to provide 100 percent of negotiated price concessions for insulin to beneficiaries at the point of sale. It also would require the Government Accountability Office to report to Congress, within two years of the bill's enactment, on trends in list and net prices of insulin, savings for enrollees and trends in out-of-pocket costs.

    Amendment to the Pallone, D-N.J., substitute amendment that would require Medicare Part D plans to provide 100 percent of negotiated price concessions for insulin to beneficiaries at the point of sale. It also would require the Government Accountability Office to report to Congress, within two years of the bill's enactment, on trends in list and net prices of insulin, savings for enrollees and trends in out-of-pocket costs.

    Rejected 23-30.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiations — Biosimilar Reimbursements
      Schrader, D-Ore. —

    Amendment to the Pallone, D-N.J., substitute amendment that would, for a five-year period, reimburse biosimilar drugs in Medicare Part B at a rate of the product's average sales price plus 8 percent.

    Amendment to the Pallone, D-N.J., substitute amendment that would, for a five-year period, reimburse biosimilar drugs in Medicare Part B at a rate of the product's average sales price plus 8 percent.

    Adopted by voice vote.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiations — Alzheimer's Exception
      E.L. Carter, R-Ga. —

    Amendment to the Pallone, D-N.J., substitute amendment that would exempt from the Fair Price Negotiation Program any treatments for Alzheimer's disease.

    Amendment to the Pallone, D-N.J., substitute amendment that would exempt from the Fair Price Negotiation Program any treatments for Alzheimer's disease.

    Rejected 24-27.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiations — Biosimilar Coverage Quality Measures
      Tonko, D-N.Y. —

    Amendment to the Pallone, D-N.J., substitute amendment that would direct the secretary of Health and Human Services to add a new set of measures to the 5-star rating system for Medicare Advantage plans, which would assess the plan's structure on how enrollees can access biosimilar drugs. It would require the new measures to assess coverage of biosimilars, tier placement for cost-sharing, use of utilization management tools and how many beneficiaries are using biosimilars.

    Amendment to the Pallone, D-N.J., substitute amendment that would direct the secretary of Health and Human Services to add a new set of measures to the 5-star rating system for Medicare Advantage plans, which would assess the plan's structure on how enrollees can access biosimilar drugs. It would require the new measures to assess coverage of biosimilars, tier placement for cost-sharing, use of utilization management tools and how many beneficiaries are using biosimilars.

    Withdrawn.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Pharmacy Fees
      Welch, D-Vt. —

    Amendment to the Pallone, D-N.J., substitute amendment that would prohibit pharmacy benefit managers from retroactively reducing payments to pharmacies, unless it is determined that the claim is not "clean," including if it lacks required substantiating documentation. It would specify that the prohibition would apply to contracts that started on or after Jan. 1, 2020. It also would specify that retroactive payment increases would be allowed.

    Amendment to the Pallone, D-N.J., substitute amendment that would prohibit pharmacy benefit managers from retroactively reducing payments to pharmacies, unless it is determined that the claim is not "clean," including if it lacks required substantiating documentation. It would specify that the prohibition would apply to contracts that started on or after Jan. 1, 2020. It also would specify that retroactive payment increases would be allowed.

    Withdrawn.

    Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Drug Selection Committee
      Schrader, D-Ore. —

    Amendment to the Pallone, D-N.J., substitute amendment that would require the secretary of Health and Human Services, within one year of the bill's enactment, to establish an advisory committee to make recommendations for the selection of negotiation-eligible drugs.

    It would require the committee to include:

    • One practicing physician and pharmacist with expertise in care for specific populations.
    • One representative from a group health plan or insurance issuer;.
    • A representative from a manufacturer of a single-source drug, a generic drug, a biological product, a biosimilar product.
    • Any other individual determined appropriate by the secretary.

    It also would require the secretary to establish a conflict-of-interest policy that would involve publicly posting the conflicts, posting annual disclosures and establishing processes for recusing from voting or discussion.

    Amendment to the Pallone, D-N.J., substitute amendment that would require the secretary of Health and Human Services, within one year of the bill's enactment, to establish an advisory committee to make recommendations for the selection of negotiation-eligible drugs.

    It would require the committee to include:

    • One practicing physician and pharmacist with expertise in care for specific populations.
    • One representative from a group health plan or insurance issuer;.
    • A representative from a manufacturer of a single-source drug, a generic drug, a biological product, a biosimilar product.
    • Any other individual determined appropriate by the secretary.
    • It also would require the secretary to establish a conflict-of-interest policy that would involve publicly posting the conflicts, posting annual disclosures and establishing processes for recusing from voting or discussion.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Maternal Mental Health Benefits
        Joseph P. Kennedy, D-Mass. —

      Amendment to the Pallone, D-N.J., substitute amendment that would clarify that essential health benefits included as part of the 2010 health care law (PL 111-148, PL 111-152) include drugs prescribed to a mother to treat postpartum mental illness for one year after the date of a child's birth. It would prohibit plans from applying cost-sharing for these drugs.

      Amendment to the Pallone, D-N.J., substitute amendment that would clarify that essential health benefits included as part of the 2010 health care law (PL 111-148, PL 111-152) include drugs prescribed to a mother to treat postpartum mental illness for one year after the date of a child's birth. It would prohibit plans from applying cost-sharing for these drugs.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Rural Medical Education
        O'Halleran, D-Ariz. —

      Amendment to the Pallone, D-N.J., substitute amendment that would require the secretary of Health and Human Services, within one year of the bill's enactment, to establish a graduate medical education grant program specific to rural and underserved communities. It would allow the secretary to award grants to such communities that don't have their own medical residency training programs.

      It also would direct the HHS secretary, within one year of the bill's enactment, to establish a grant program to link critical access hospitals without residency programs to host residents from approved programs.

      It also would require the Government Accountability Office to report to Congress, within 10 years of the bill's enactment, with an analysis of the number of residents who trained at a hospital or critical access hospital that received funding under the graduate medical education grant program or the critical access hospital grant program.

      Amendment to the Pallone, D-N.J., substitute amendment that would require the secretary of Health and Human Services, within one year of the bill's enactment, to establish a graduate medical education grant program specific to rural and underserved communities. It would allow the secretary to award grants to such communities that don't have their own medical residency training programs.

      It also would direct the HHS secretary, within one year of the bill's enactment, to establish a grant program to link critical access hospitals without residency programs to host residents from approved programs.

      It also would require the Government Accountability Office to report to Congress, within 10 years of the bill's enactment, with an analysis of the number of residents who trained at a hospital or critical access hospital that received funding under the graduate medical education grant program or the critical access hospital grant program.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Negotiation on Selected Services
        Walden, R-Ore. —

      Amendment to the Pallone, D-N.J., substitute amendment that would direct the secretary of Health and Human Services, within one year of the bill's enactment, to expand the Fair Price Negotiation Program to determine a maximum fair prices for other health care services selected by the secretary.

      Amendment to the Pallone, D-N.J., substitute amendment that would direct the secretary of Health and Human Services, within one year of the bill's enactment, to expand the Fair Price Negotiation Program to determine a maximum fair prices for other health care services selected by the secretary.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Medicare Part D
        E.L. Carter, R-Ga. —

      Amendment to the Pallone, D-N.J., substitute amendment that would revise language to overhaul the structure of the Medicare Part D program. It would set the out-of-pocket spending maximum at $3,100, instead of $2,000 as called for in the substitute amendment. It also would require drugmakers to provide 10 percent discounts in both the initial coverage phase and after the out-of-pocket limit is reached.

      Amendment to the Pallone, D-N.J., substitute amendment that would revise language to overhaul the structure of the Medicare Part D program. It would set the out-of-pocket spending maximum at $3,100, instead of $2,000 as called for in the substitute amendment. It also would require drugmakers to provide 10 percent discounts in both the initial coverage phase and after the out-of-pocket limit is reached.

      Rejected 24-29.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Bipartisan Alternative
        Walden, R-Ore. —

      Amendment to the Pallone, D-N.J., substitute amendment that would replace the text of the amendment with language that would:

      • Require Medicare to make public the payments to physicians based on site of services provided.
      • Incorporates language that would redesign the structure of Medicare Part D, including language that would allow beneficiaries to spread out paying their cost-sharing obligations in certain circumstances.
      • Require the secretary of Health and Human Services to implement a program to provide transitional Medicare Part D coverage to low-income individuals enrolling for the first time.
      • Require pharmacy benefit managers to pass through negotiated drug discounts to Part D plan sponsors, as well as to Medicaid programs or managed care programs operating under Medicaid.
      • Require the negotiated prices of Part D drugs to be provided at the point of sale.
      • Require hospitals participating in the 340B drug discount program to pass through savings to qualifying patients. It would require insurers to calculate cost-sharing obligations considering discounts provided under 340B. It also would express the sense of Congress that the 340B program is to lower drug costs for low-income and uninsured individuals.
      • Update requirements for committees that update state Medicaid formularies, and require a report from the Government Accountability Office on potential conflicts of interest on those committees.
      • Require the HHS secretary to conduct audits of manufacturer prices being charged to Medicaid programs and issue reports on prescribing patterns under Medicaid.
      • Allow state Medicaid programs to negotiate payment deals with drugmakers that would allow for payments over time contingent on whether the drug works.
      • Exchange health plans and child health plans would no longer be included in the calculation of Medicaids best price for drugs.
      • Require Medicare Part D Plans and Medicare Advantage plans to report fraud, waste and abuse to HHS.
      • Establish pharmacy quality measures under Medicare Part D.

      It also would require the Food and Drug Administration and the Centers for Medicare and Medicaid Services to convene meetings and issue a report on improving coordination between the two agencies.

      Amendment to the Pallone, D-N.J., substitute amendment that would replace the text of the amendment with language that would:

    • Require Medicare to make public the payments to physicians based on site of services provided.
    • Incorporates language that would redesign the structure of Medicare Part D, including language that would allow beneficiaries to spread out paying their cost-sharing obligations in certain circumstances.
    • Require the secretary of Health and Human Services to implement a program to provide transitional Medicare Part D coverage to low-income individuals enrolling for the first time.
    • Require pharmacy benefit managers to pass through negotiated drug discounts to Part D plan sponsors, as well as to Medicaid programs or managed care programs operating under Medicaid.
    • Require the negotiated prices of Part D drugs to be provided at the point of sale.
    • Require hospitals participating in the 340B drug discount program to pass through savings to qualifying patients. It would require insurers to calculate cost-sharing obligations considering discounts provided under 340B. It also would express the sense of Congress that the 340B program is to lower drug costs for low-income and uninsured individuals.
    • Update requirements for committees that update state Medicaid formularies, and require a report from the Government Accountability Office on potential conflicts of interest on those committees.
    • Require the HHS secretary to conduct audits of manufacturer prices being charged to Medicaid programs and issue reports on prescribing patterns under Medicaid.
    • Allow state Medicaid programs to negotiate payment deals with drugmakers that would allow for payments over time contingent on whether the drug works.
    • Exchange health plans and child health plans would no longer be included in the calculation of Medicaids best price for drugs.
    • Require Medicare Part D Plans and Medicare Advantage plans to report fraud, waste and abuse to HHS.
    • Establish pharmacy quality measures under Medicare Part D.
    • It also would require the Food and Drug Administration and the Centers for Medicare and Medicaid Services to convene meetings and issue a report on improving coordination between the two agencies.

      Rejected 22-30.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Orphan Drugs Exclusion
        Walberg, R-Mich. —

      Amendment to the Pallone, D-N.J., substitute amendment that would exclude from the Fair Drug Price Negotiation Program drugs used to treat rare diseases or a diffuse intrinsic pontine glioma.

      Amendment to the Pallone, D-N.J., substitute amendment that would exclude from the Fair Drug Price Negotiation Program drugs used to treat rare diseases or a diffuse intrinsic pontine glioma.

      Rejected 24-29.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Mental Illness Treatments
        Latta, R-Ohio —

      Amendment to the Pallone, D-N.J., substitute amendment that would require the secretary of Health and Human Services to certify that the bill's provisions to create a Fair Drug Price Negotiation Program, make changes to Medicare prescription drug inflation rebates, and to redesign the Medicare Part D benefit program would not negatively impact the development of treatments for serious mental illness and addiction, or access to those treatments before the provisions could take effect.

      Amendment to the Pallone, D-N.J., substitute amendment that would require the secretary of Health and Human Services to certify that the bill's provisions to create a Fair Drug Price Negotiation Program, make changes to Medicare prescription drug inflation rebates, and to redesign the Medicare Part D benefit program would not negatively impact the development of treatments for serious mental illness and addiction, or access to those treatments before the provisions could take effect.

      Rejected 24-29.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — International Reference Pricing
        Bucshon, R-Ind. —

      Amendment to the Pallone, D-N.J., substitute amendment that would strike provisions that would:

      • Define the average international market price.
      • Instruct the secretary of Health and Human Services to use data relating to the average international market price that it requests from manufacturers on an ongoing basis.
      • Require manufacturers to provide the average international price.
      • Establish rules for drugs without an average international price.
      • Require HHS to accept a maximum fair price offered for a drug.
      • Establish the maximum fair price for a drug as 120 percent of the average price of the drug in Australia, Canada, France, Germany, Japan and the United Kingdom.
      • Specify that establishing the average international price for a drug as an administrative function of the Department of Health and Human Services.

      Amendment to the Pallone, D-N.J., substitute amendment that would strike provisions that would:

    • Define the average international market price.
    • Instruct the secretary of Health and Human Services to use data relating to the average international market price that it requests from manufacturers on an ongoing basis.
    • Require manufacturers to provide the average international price.
    • Establish rules for drugs without an average international price.
    • Require HHS to accept a maximum fair price offered for a drug.
    • Establish the maximum fair price for a drug as 120 percent of the average price of the drug in Australia, Canada, France, Germany, Japan and the United Kingdom.
    • Specify that establishing the average international price for a drug as an administrative function of the Department of Health and Human Services.
    • Rejected 24-29.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Compression Therapy Coverage
        Schakowsky, D-Ill. —

      Amendment to the Pallone, D-N.J., substitute amendment that would provide Medicare coverage of lymphedema compression treatment items, including compression garments, devices, bandaging systems, components and supplies prescribed by a health provider that wouldn't normally be covered under Medicare. It would specify that the coverage would apply to such treatment items provided on or after Jan. 1, 2021.

      Amendment to the Pallone, D-N.J., substitute amendment that would provide Medicare coverage of lymphedema compression treatment items, including compression garments, devices, bandaging systems, components and supplies prescribed by a health provider that wouldn't normally be covered under Medicare. It would specify that the coverage would apply to such treatment items provided on or after Jan. 1, 2021.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Outpatient Drug Savings
        Burgess, R-Texas —

      Amendment to the Pallone, D-N.J., substitute amendment that would require hospitals participating in the 340B drug discount program for outpatient drugs to pass along 75 percent of their drug savings to the patient receiving the drug. It also would require insurers to base their cost-sharing requirements on the discounted price for a drug covered under the program.

      Amendment to the Pallone, D-N.J., substitute amendment that would require hospitals participating in the 340B drug discount program for outpatient drugs to pass along 75 percent of their drug savings to the patient receiving the drug. It also would require insurers to base their cost-sharing requirements on the discounted price for a drug covered under the program.

      Rejected by voice vote.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Generic Drug Coverage
        Kuster, D-N.H. —

      Amendment to the Pallone, D-N.J., substitute amendment that would require Medicare Part D plans to cover generic and biosimilar drugs, and require plans to have specific cost-sharing tiers for generic drugs to make them cost less than branded products. It would clarify that generic products that cost more than their reference brand product would not have to be included on the lower-cost tier.

      Amendment to the Pallone, D-N.J., substitute amendment that would require Medicare Part D plans to cover generic and biosimilar drugs, and require plans to have specific cost-sharing tiers for generic drugs to make them cost less than branded products. It would clarify that generic products that cost more than their reference brand product would not have to be included on the lower-cost tier.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Sickle-Cell Treatments
        Burgess, R-Texas —

      Amendment to the Pallone, D-N.J., substitute amendment that would exclude treatments for sickle cell disease from the Fair Price Negotiation Program.

      Amendment to the Pallone, D-N.J., substitute amendment that would exclude treatments for sickle cell disease from the Fair Price Negotiation Program.

      Rejected 22-28.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Non-Severability Clause
        Griffith, R-Va. —

      Amendment to the Pallone, D-N.J., substitute amendment that would insert a non-severability clause to clarify that the bill would be invalid if any provision of the bill is found to be invalid or unconstitutional.

      Amendment to the Pallone, D-N.J., substitute amendment that would insert a non-severability clause to clarify that the bill would be invalid if any provision of the bill is found to be invalid or unconstitutional.

      Rejected by voice vote.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Payment Model Approval
        Shimkus, R-Ill. —

      Amendment to the Pallone, D-N.J., substitute amendment that would require congressional approval for expansions of payment models being tested by the Centers for Medicare and Medicaid Innovation.

      Amendment to the Pallone, D-N.J., substitute amendment that would require congressional approval for expansions of payment models being tested by the Centers for Medicare and Medicaid Innovation.

      Ruled not germane. Note: <p>Clarke, D-N.Y., raised a point of order that the amendment was not germane because it contained provisions that are in the jurisdiction of the House Rules Committee.</p>

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Value-based Payments
        Mullin, R-Okla. —

      Amendment to the Pallone, D-N.J., substitute amendment that would allow state Medicaid programs, beginning Jan. 1, 2022, to negotiate deals with drugmakers for long-term payments of expensive drugs. It would specify that the deals could allow states to pay in installments. It also would specify that such payments would only be required if the drug works as intended. It also would specify that the price for such drugs would not be factored into the "best price" that drugmakers must offer to all state Medicaid programs.

      Amendment to the Pallone, D-N.J., substitute amendment that would allow state Medicaid programs, beginning Jan. 1, 2022, to negotiate deals with drugmakers for long-term payments of expensive drugs. It would specify that the deals could allow states to pay in installments. It also would specify that such payments would only be required if the drug works as intended. It also would specify that the price for such drugs would not be factored into the "best price" that drugmakers must offer to all state Medicaid programs.

      Withdrawn.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Overseas drug manufacturing
        Flores, R-Texas —

      Amendment to the Pallone, D-N.J., substitute amendment that would prevent the bill from taking effect unless the secretary of Health and Human Services certifies that implementing the provisions wouldn't result in a shift in investment in biotech in the United States, or U.S. manufacturing jobs moving to China.

      Amendment to the Pallone, D-N.J., substitute amendment that would prevent the bill from taking effect unless the secretary of Health and Human Services certifies that implementing the provisions wouldn't result in a shift in investment in biotech in the United States, or U.S. manufacturing jobs moving to China.

      Rejected 22-30.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Substitute Amendment
        Pallone, D-N.J. —

      Substitute amendment that would incrementally increase the minimum number of drugs subject to negotiation starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

      As amended, it would increase the Medicare Part B reimbursement for biosimilar drugs.

      It would direct the secretary of Health and Human Services to determine a maximum fair price for new single-source drugs that launch at a price that is at least the U.S. median household income if the drug is likely to be included as a negotiation-eligible drug.

      It would add language to require the inclusion of payment codes in the information the HHS secretary is required to report to drug manufacturers of Part B drugs that qualify for inflation rebates.

      It also would adjust the inflation rebate calculation from the first quarter of the previous year to the previous 12 months.

      It would reduces rebate penalty for multiple source drugs to 20 percent of the difference between the price and the inflation-adjusted price.

      It would allow the HHS secretary to exempt Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

      It would shorten the time period for the secretary to terminate information agreements with manufacturers from 60 days after notification to 30 days.

      The amendment would require Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It would require that such beneficiaries be given the opportunity to make the payment in installments over the course of one year.

      It would allow Part D plans to develop quality standards for pharmacies to provide incentive payments or extract price concessions.

      It would specify that beneficiaries who participate in the low-income subsidy program in Part D would no longer have any copay requirements for generic drugs.

      It would require the Medicare program to provide those eligible for low-income subsidies with information that helps them compare their costs under different plan options. It also would require the Medicare program to develop a system for automatically enrolling low-income subsidy eligible individuals to Part D plans that best meet their prescription drug needs.

      It would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current level of 135 percent of the poverty level. It also would expand eligibility for the partial subsidy to include people at 200 percent of the poverty level.

      It would make residents of United States territories who are enrolled in their local Medicaid programs would eligible for a low-income subsidy for Medicare Part D.

      It also would make residents of U.S. states who are enrolled in Medicaid eligible for a Part D low-income subsidy upon turning 65 years of age.

      It would require drugmakers who raise their prices by 10 percent over a 12-month period or 25 percent over a 36-month period to submit a report to the administration explaining the reasons for the price increase, within 30 dys of the price increase. It would specify that the requirements also apply to drugs that launch at a price of $26,000 or more per year. The requirements would only apply to drugs that cost more than $100 for a months supply.

      It would require the reports to include:

      • The amount of the price increase and its effective date.
      • An explanation for the price increase.
      • A description of the history of price increases.
      • The current cost of the drug.
      • Expenditures on manufacturing the drug, acquiring patents, purchasing the drug.
      • The percentage of total expenditures on research and development that was derived from federal funds.
      • The total research and development expenditures that were necessary for Food and Drug Administration approval.
      • The total expenditures on research for new or expanded indications.
      • Expenditures on carrying out post-market requirements.
      • Revenue and net profit generated from the drug for each year since approval.
      • Costs associated with marketing and advertising.
      • The total revenue and net profit for the manufacturer.
      • The stock-based performance metrics used to determine executive compensation.

      It also would require the report to be truthful, non-misleading and accurate.

      It would subject drugmakers who fail to submit a report to a penalty of $75,000 for each day of the violation. Drugmakers who include false information would be fined $100,000 for each item of false information.

      It would require the HHS secretary to post the report publicly on the day of the price increase. It also would require the enforcement of laws to protect confidential commercial information and trade secrets.

      It also would require HHS to submit annual reports to Congress summarizing the price increase reports submitted.

      Substitute amendment that would incrementally increase the minimum number of drugs subject to negotiation starting with 25 during the first five years of the program, 30 during the next five years, and 35 after that.

      As amended, it would increase the Medicare Part B reimbursement for biosimilar drugs.

      It would direct the secretary of Health and Human Services to determine a maximum fair price for new single-source drugs that launch at a price that is at least the U.S. median household income if the drug is likely to be included as a negotiation-eligible drug.

      It would add language to require the inclusion of payment codes in the information the HHS secretary is required to report to drug manufacturers of Part B drugs that qualify for inflation rebates.

      It also would adjust the inflation rebate calculation from the first quarter of the previous year to the previous 12 months.

      It would reduces rebate penalty for multiple source drugs to 20 percent of the difference between the price and the inflation-adjusted price.

      It would allow the HHS secretary to exempt Part D drugs from the inflation penalty if the secretary determines the product is essential to the health of beneficiaries or if there are extenuating circumstances.

      It would shorten the time period for the secretary to terminate information agreements with manufacturers from 60 days after notification to 30 days.

      The amendment would require Part D plans to establish a policy for beneficiaries who reach the out-of-pocket maximum upon their first fill of a prescription. It would require that such beneficiaries be given the opportunity to make the payment in installments over the course of one year.

      It would allow Part D plans to develop quality standards for pharmacies to provide incentive payments or extract price concessions.

      It would specify that beneficiaries who participate in the low-income subsidy program in Part D would no longer have any copay requirements for generic drugs.

      It would require the Medicare program to provide those eligible for low-income subsidies with information that helps them compare their costs under different plan options. It also would require the Medicare program to develop a system for automatically enrolling low-income subsidy eligible individuals to Part D plans that best meet their prescription drug needs.

      It would expand eligibility for the full low-income subsidy to those whose incomes are at 150 percent of the poverty level, compared to the current level of 135 percent of the poverty level. It also would expand eligibility for the partial subsidy to include people at 200 percent of the poverty level.

      It would make residents of United States territories who are enrolled in their local Medicaid programs would eligible for a low-income subsidy for Medicare Part D.

      It also would make residents of U.S. states who are enrolled in Medicaid eligible for a Part D low-income subsidy upon turning 65 years of age.

      It would require drugmakers who raise their prices by 10 percent over a 12-month period or 25 percent over a 36-month period to submit a report to the administration explaining the reasons for the price increase, within 30 dys of the price increase. It would specify that the requirements also apply to drugs that launch at a price of $26,000 or more per year. The requirements would only apply to drugs that cost more than $100 for a months supply.

      It would require the reports to include:

    • The amount of the price increase and its effective date.
    • An explanation for the price increase.
    • A description of the history of price increases.
    • The current cost of the drug.
    • Expenditures on manufacturing the drug, acquiring patents, purchasing the drug.
    • The percentage of total expenditures on research and development that was derived from federal funds.
    • The total research and development expenditures that were necessary for Food and Drug Administration approval.
    • The total expenditures on research for new or expanded indications.
    • Expenditures on carrying out post-market requirements.
    • Revenue and net profit generated from the drug for each year since approval.
    • Costs associated with marketing and advertising.
    • The total revenue and net profit for the manufacturer.
    • The stock-based performance metrics used to determine executive compensation.
    • It also would require the report to be truthful, non-misleading and accurate.

      It would subject drugmakers who fail to submit a report to a penalty of $75,000 for each day of the violation. Drugmakers who include false information would be fined $100,000 for each item of false information.

      It would require the HHS secretary to post the report publicly on the day of the price increase. It also would require the enforcement of laws to protect confidential commercial information and trade secrets.

      It also would require HHS to submit annual reports to Congress summarizing the price increase reports submitted.

      Adopted by voice vote.

      Oct. 17, 2019 — Committee Vote: Prescription Drug Price Negotiation — Vote to Report

      Make changes to how Medicare pays for prescription drugs.

      The bill would require the secretary of Health and Human Services to identify the 250 most expensive sole-source drugs to Medicare and the U.S. health system, and post a list of eligible drugs in the Federal Register.

      It would require HHS to negotiate drug prices for at least 25 drugs, as well as insulin, beginning in 2023. The price agreement would remain in effect until the drug no longer meets eligibility requirements and requires the secretary to achieve the lowest maximum fair price for each selected drug while appropriately rewarding innovation.

      It would require the secretary to submit an annual report on how each negotiated price was reached and post the negotiated prices in the Federal Register. It also would require the secretary to prioritize certain factors when negotiating, including research and development; federal research investment; market, sales and patent data; clinical trials data; unit costs of production and distribution; comparisons to existing alternatives when negotiating; and information from affected parties.

      It would set the target price as the lowest average price that exists in any of the reference countries, and 80 percent of the average manufacturer price for drugs without an international reference price.

      It would establish a ceiling price of 1.2 times the average international price paid in Australia, Canada, France, Germany, Japan and the United Kingdom. It also would establish a ceiling price of 85 percent of the average manufacturer price for drugs without an international reference price. Drugs without an international reference price will rebate the difference between the average manufacturer price and 200 percent of the international price, once one becomes available, within one year.

      The bill would require drug manufacturers to submit pricing information for reference countries, and requires HHS secretary to verify those prices. It would limit proprietary pricing information to the HHS secretary, the comptroller general and the Medicare Payment Advisory Commission.

      It would excludes drugs with negotiated prices from the 340b drug discount program.

      It would require the Labor and Treasury secretaries to publish a list of health plans that opt out of using prices negotiated by HHS.

      It would impose a penalty for drug manufacturers worth 10 times the difference between the negotiated price and the list price if the drugmaker does not offer the price to individuals, providers or suppliers.

      It would establish a maximum $1 million penalty for each violation of the manufacturers agreement with HHS. It also would establish a 65 percent excise tax on manufacturers who refuse to negotiate. The tax would increase 10 percent every quarter to a maximum of 95 percent.

      It would require the National Academy of Medicine to submit a report to Congress on potential improvements to the negotiation program by Dec. 31, 2025. It also would require the Medicare Payment Advisory Commission to submit a study on the program's effects by Dec. 31, 2025.

      It would exclude from judicial review which drugs are eligible for negotiation, the negotiated price, the publication of a list of those drugs and how many units are considered in the calculation of the ceiling price.

      It would allow commercial health plans access to the government-negotiated prices and requires public disclosure if they opt not to use them.

      In Medicare Part B, starting in July 2021, it would require drugmakers who raise the prices faster than the rate of inflation to rebate Medicare for the excess costs above inflation. It would require Medicare to assess price changes each quarter. It would set the rebate as the product of the price increase and the number of units reimbursed under Part B.

      It would specify that the rebate would only apply to Part B drugs that are single-source products. It would not apply to drugs if the average total annual charges for an individual is less than $100, or to vaccines.
      The total number of units would not include drugs packaged into a bundled payment for a procedure, drugs under single payment for renal dialysis services, or units that were sold under a discount for the 340B program.

      It would allow the rebate to be waived for drugs that are in shortage.

      It would require that the coinsurance paid by beneficiaries for Part B drugs be based on the inflation-adjusted price, and be set at 20 percent of the price.

      It would require that rebates would be paid to the Medicare Part B trust fund.

      The bill would subject to a civil monetary penalty, equal to 125 percent of the total rebate amount that they owe, drugmakers who do not comply with the requirements.

      It would require HHS to study the feasibility of requiring multiple-source drugs in the rebate system, including drugs paid for under Medicare Advantage plans, and including other drugs or units of drugs excluded from the rebates.

      In Medicare Part D, starting in 2022, in order for a drug to qualify for coverage, it would require manufacturers to reach an agreement with the administration that it provide a rebate if it increases the price of the drug faster than the rate of inflation. The rebate would be a product of the amount above the inflation-adjusted price and the amount of the drug dispensed in Part D.

      It would require HHS to establish a formula for follow-on products for single-source drugs or innovator drugs that have multiple sources. The rebate would be paid into the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance trust fund.

      It would require drugmakers who do not comply with their rebate agreement to pay 125 percent of the rebate that they owe. Under the bill, drugs that cost less than $100 per person per year would not be subject to the rebate. It would apply rebates retroactively for price increases that took effect starting in January 2016.

      The bill also would redesigns the structure of Medicare Part D to impose a $2,000 out-of-pocket spending limit for beneficiaries starting in 2022. The limit would be subjected to increases over time
      When the spending for a beneficiary surpasses the out-of-pocket spending limit, the Medicare program would be responsible for covering 20 percent of the expenses above the limit, as opposed to the 80 percent it pays under current law.

      It would require drug manufacturers to enter into agreements with Medicare to provide discounts for certain drugs with beneficiaries at the point of sale. It would require HHS to periodically audit drugmakers for compliance and drugmakers who fail to provide the discounts would be subject to civil monetary penalties equal to the amount of the discount plus 25 percent.

      It would require that drug prices be discounted by 10 percent when a beneficiary has exceeded their annual deductible but before they reach the annual limit. After the annual limit is reached, it would require the manufacturer to provide a 30 percent discount to Medicare.

      It would phase out the coverage gap in the Part D program starting in 2022.

      It also would require the private insurers that administer part D plans to consider the drugmaker discounts when making their annual bids for coverage. It also would make plans liable for 50 percent of the costs above the out-of-pocket limit.

      Make changes to how Medicare pays for prescription drugs.

      The bill would require the secretary of Health and Human Services to identify the 250 most expensive sole-source drugs to Medicare and the U.S. health system, and post a list of eligible drugs in the Federal Register.

      It would require HHS to negotiate drug prices for at least 25 drugs, as well as insulin, beginning in 2023. The price agreement would remain in effect until the drug no longer meets eligibility requirements and requires the secretary to achieve the lowest maximum fair price for each selected drug while appropriately rewarding innovation.

      It would require the secretary to submit an annual report on how each negotiated price was reached and post the negotiated prices in the Federal Register. It also would require the secretary to prioritize certain factors when negotiating, including research and development; federal research investment; market, sales and patent data; clinical trials data; unit costs of production and distribution; comparisons to existing alternatives when negotiating; and information from affected parties.

      It would set the target price as the lowest average price that exists in any of the reference countries, and 80 percent of the average manufacturer price for drugs without an international reference price.

      It would establish a ceiling price of 1.2 times the average international price paid in Australia, Canada, France, Germany, Japan and the United Kingdom. It also would establish a ceiling price of 85 percent of the average manufacturer price for drugs without an international reference price. Drugs without an international reference price will rebate the difference between the average manufacturer price and 200 percent of the international price, once one becomes available, within one year.

      The bill would require drug manufacturers to submit pricing information for reference countries, and requires HHS secretary to verify those prices. It would limit proprietary pricing information to the HHS secretary, the comptroller general and the Medicare Payment Advisory Commission.

      It would excludes drugs with negotiated prices from the 340b drug discount program.

      It would require the Labor and Treasury secretaries to publish a list of health plans that opt out of using prices negotiated by HHS.

      It would impose a penalty for drug manufacturers worth 10 times the difference between the negotiated price and the list price if the drugmaker does not offer the price to individuals, providers or suppliers.

      It would establish a maximum $1 million penalty for each violation of the manufacturers agreement with HHS. It also would establish a 65 percent excise tax on manufacturers who refuse to negotiate. The tax would increase 10 percent every quarter to a maximum of 95 percent.

      It would require the National Academy of Medicine to submit a report to Congress on potential improvements to the negotiation program by Dec. 31, 2025. It also would require the Medicare Payment Advisory Commission to submit a study on the program's effects by Dec. 31, 2025.

      It would exclude from judicial review which drugs are eligible for negotiation, the negotiated price, the publication of a list of those drugs and how many units are considered in the calculation of the ceiling price.

      It would allow commercial health plans access to the government-negotiated prices and requires public disclosure if they opt not to use them.

      In Medicare Part B, starting in July 2021, it would require drugmakers who raise the prices faster than the rate of inflation to rebate Medicare for the excess costs above inflation. It would require Medicare to assess price changes each quarter. It would set the rebate as the product of the price increase and the number of units reimbursed under Part B.

      It would specify that the rebate would only apply to Part B drugs that are single-source products. It would not apply to drugs if the average total annual charges for an individual is less than $100, or to vaccines. The total number of units would not include drugs packaged into a bundled payment for a procedure, drugs under single payment for renal dialysis services, or units that were sold under a discount for the 340B program.

      It would allow the rebate to be waived for drugs that are in shortage.

      It would require that the coinsurance paid by beneficiaries for Part B drugs be based on the inflation-adjusted price, and be set at 20 percent of the price.

      It would require that rebates would be paid to the Medicare Part B trust fund.

      The bill would subject to a civil monetary penalty, equal to 125 percent of the total rebate amount that they owe, drugmakers who do not comply with the requirements.

      It would require HHS to study the feasibility of requiring multiple-source drugs in the rebate system, including drugs paid for under Medicare Advantage plans, and including other drugs or units of drugs excluded from the rebates.

      In Medicare Part D, starting in 2022, in order for a drug to qualify for coverage, it would require manufacturers to reach an agreement with the administration that it provide a rebate if it increases the price of the drug faster than the rate of inflation. The rebate would be a product of the amount above the inflation-adjusted price and the amount of the drug dispensed in Part D.

      It would require HHS to establish a formula for follow-on products for single-source drugs or innovator drugs that have multiple sources. The rebate would be paid into the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance trust fund.

      It would require drugmakers who do not comply with their rebate agreement to pay 125 percent of the rebate that they owe. Under the bill, drugs that cost less than $100 per person per year would not be subject to the rebate. It would apply rebates retroactively for price increases that took effect starting in January 2016.

      The bill also would redesigns the structure of Medicare Part D to impose a $2,000 out-of-pocket spending limit for beneficiaries starting in 2022. The limit would be subjected to increases over time When the spending for a beneficiary surpasses the out-of-pocket spending limit, the Medicare program would be responsible for covering 20 percent of the expenses above the limit, as opposed to the 80 percent it pays under current law.

      It would require drug manufacturers to enter into agreements with Medicare to provide discounts for certain drugs with beneficiaries at the point of sale. It would require HHS to periodically audit drugmakers for compliance and drugmakers who fail to provide the discounts would be subject to civil monetary penalties equal to the amount of the discount plus 25 percent.

      It would require that drug prices be discounted by 10 percent when a beneficiary has exceeded their annual deductible but before they reach the annual limit. After the annual limit is reached, it would require the manufacturer to provide a 30 percent discount to Medicare.

      It would phase out the coverage gap in the Part D program starting in 2022.

      It also would require the private insurers that administer part D plans to consider the drugmaker discounts when making their annual bids for coverage. It also would make plans liable for 50 percent of the costs above the out-of-pocket limit.

      Ordered reported favorably to the full House (as amended) 30-22. Note: <p>The committee voted 30-22 to approve the bill.</p>

  • Oct. 16, 2019 — Additional cosponsor(s): 8

    Davis, D. (D-Ill.)Matsui, (D-Calif.)Welch, (D-Vt.)
    Doyle, (D-Pa.)Ruiz, (D-Calif.)Wilson, F. (D-Fla.)
    Garcia, (D-Texas)Slotkin, (D-Mich.)
  • Oct. 11, 2019Cost Estimate issued by Congressional Budget Office.

  • Oct. 11, 2019 — Additional cosponsor(s): 5

    Craig, (D-Minn.)Keating, (D-Mass.)Wasserman Schultz, (D-Fla.)
    Golden, (D-Maine)Schiff, (D-Calif.)
  • Oct. 8, 2019 — Additional cosponsor(s): 7

    Beatty, (D-Ohio)Soto, (D-Fla.)Wild, (D-Pa.)
    Eshoo, (D-Calif.)Suozzi, (D-N.Y.)
    Horsford, (D-Nev.)Vela, (D-Texas)
  • Oct. 1, 2019 — Additional cosponsor(s): 11

    Allred, (D-Texas)Hayes, (D-Conn.)Rose, (D-N.Y.)
    Blunt Rochester, (D-Del.)Kim, (D-N.J.)Thompson, M. (D-Calif.)
    Cartwright, (D-Pa.)McNerney, (D-Calif.)Trone, (D-Md.)
    Cohen, (D-Tenn.)Meng, (D-N.Y.)
  • Sept. 26, 2019 — Additional cosponsor(s): 5

    Bonamici, (D-Ore.)Hill, (D-Calif.)Visclosky, (D-Ind.)
    Carbajal, (D-Calif.)Pappas, (D-N.H.)
  • Sept. 25, 2019 — Subcommittee hearing held by the House Energy and Commerce Committee, Subcommittee on Health.

  • Sept. 25, 2019 — Additional cosponsor(s): 10

    Castor, (D-Fla.)Frankel, (D-Fla.)Norcross, (D-N.J.)
    Courtney, (D-Conn.)Kildee, (D-Mich.)Norton, (D-D.C.)
    Engel, (D-N.Y.)McGovern, (D-Mass.)
    Evans, (D-Pa.)Moore, (D-Wis.)
  • Sept. 24, 2019 — Additional cosponsor(s): 8

    Case, (D-Hawaii)Morelle, (D-N.Y.)Sablan, (I-N. Marianas)
    DeGette, (D-Colo.)Rush, (D-Ill.)Shalala, (D-Fla.)
    Kuster, (D-N.H.)Ryan, T. (D-Ohio)
  • Sept. 20, 2019 — Additional cosponsor(s): 1

    Larson, J. (D-Conn.)
  • Sept. 19, 2019Draft bill text released by Rep. Pallone, D-N.J.

  • Sept. 19, 2019 — Original cosponsor(s): 2

    Neal, (D-Mass.)Scott, R. (D-Va.)
  • Sept. 19, 2019 — Read twice and referred to: House Education and Labor, House Energy and Commerce, House Ways and Means.Congressional Record p. H7834

  • Feb. 28, 2019 — Provisions of the bill are included in HR 1425, the Patient Protection and Affordable Care Enhancement Act. Please see HR 1425 for further action on that bill.