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Prescription Drug STAR Act

USA116th CongressHR-2113| House 
| Updated: 12/24/2020
Richard E. Neal

Richard E. Neal

Democratic Representative

Massachusetts

Cosponsors (11)
Ben McAdams (Democratic)Chrissy Houlahan (Democratic)Jefferson Van Drew (Republican)Kevin Brady (Republican)Daniel Lipinski (Democratic)Abby Finkenauer (Democratic)Jamie Raskin (Democratic)Mark E. Amodei (Republican)Elissa Slotkin (Democratic)Zoe Lofgren (Democratic)Lauren Underwood (Democratic)

Ways and Means Committee, Health Subcommittee, Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Prescription Drug Sunshine, Transparency, Accountability and Reporting Act or the Prescription Drug STAR Act This bill establishes requirements for prescription drug manufacturers to provide certain information about pricing, discounts, and product samples of applicable drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to annually determine whether there are price increases of a certain threshold for outpatient prescription drugs covered under Medicare, excluding low-cost drugs. Manufacturers must provide HHS with an explanation for drug prices that (1) cumulatively increase by at least 10% or $10,000 over one year; (2) cumulatively increase by at least 25% or $25,000 over three years; or (3) are at least $26,000 annually, per individual, if first covered by Medicare during the applicable year. The manufacturer must explain the role of the factors contributing to such prices and other relevant information, including manufacturing costs, marketing costs, and revenue. Additionally, drug manufacturers must provide HHS with aggregate data related to product samples of drugs, devices, biologic products, and medical supplies given to hospitals, physicians, or other medical professionals during the previous calendar year, beginning in 2023. The bill further requires HHS to make publicly available the information related to drug discounts, rebates, and price concessions that is provided annually to HHS by group health plans. Drug manufacturers also must report to HHS certain sales information for drugs available under Medicare for which the manufacturer does not have a rebate agreement in place. The bill requires HHS to study and report on trends concerning inpatient hospital drug costs.

Bill Text Versions

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Timeline
Apr 8, 2019
Introduced in House
Apr 8, 2019
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Apr 8, 2019
Referred to the Subcommittee on Health.
Apr 9, 2019
Referred to the Subcommittee on Health.
Apr 9, 2019
Committee Consideration and Mark-up Session Held.
Apr 9, 2019
Ordered to be Reported by Voice Vote.
Dec 24, 2020
Placed on the Union Calendar, Calendar No. 571.
Dec 24, 2020
Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-688, Part I.
Dec 24, 2020
Committee on Energy and Commerce discharged.
  • April 8, 2019
    Introduced in House


  • April 8, 2019
    Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.


  • April 8, 2019
    Referred to the Subcommittee on Health.


  • April 9, 2019
    Referred to the Subcommittee on Health.


  • April 9, 2019
    Committee Consideration and Mark-up Session Held.


  • April 9, 2019
    Ordered to be Reported by Voice Vote.


  • December 24, 2020
    Placed on the Union Calendar, Calendar No. 571.


  • December 24, 2020
    Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-688, Part I.


  • December 24, 2020
    Committee on Energy and Commerce discharged.

Health

Related Bills

  • HR 116-2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes.
  • HR 116-2069: SPIKE Act
  • S 116-2051: Strengthening Average Sales Price Reporting Act of 2019
  • HR 116-2087: Drug Price Transparency Act
  • HR 116-2115: Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act
Business recordsCivil actions and liabilityCongressional oversightCorporate finance and managementGovernment information and archivesHealth care costs and insuranceInflation and pricesManufacturingMedicarePrescription drugs

Prescription Drug STAR Act

USA116th CongressHR-2113| House 
| Updated: 12/24/2020
Prescription Drug Sunshine, Transparency, Accountability and Reporting Act or the Prescription Drug STAR Act This bill establishes requirements for prescription drug manufacturers to provide certain information about pricing, discounts, and product samples of applicable drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to annually determine whether there are price increases of a certain threshold for outpatient prescription drugs covered under Medicare, excluding low-cost drugs. Manufacturers must provide HHS with an explanation for drug prices that (1) cumulatively increase by at least 10% or $10,000 over one year; (2) cumulatively increase by at least 25% or $25,000 over three years; or (3) are at least $26,000 annually, per individual, if first covered by Medicare during the applicable year. The manufacturer must explain the role of the factors contributing to such prices and other relevant information, including manufacturing costs, marketing costs, and revenue. Additionally, drug manufacturers must provide HHS with aggregate data related to product samples of drugs, devices, biologic products, and medical supplies given to hospitals, physicians, or other medical professionals during the previous calendar year, beginning in 2023. The bill further requires HHS to make publicly available the information related to drug discounts, rebates, and price concessions that is provided annually to HHS by group health plans. Drug manufacturers also must report to HHS certain sales information for drugs available under Medicare for which the manufacturer does not have a rebate agreement in place. The bill requires HHS to study and report on trends concerning inpatient hospital drug costs.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Apr 8, 2019
Introduced in House
Apr 8, 2019
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Apr 8, 2019
Referred to the Subcommittee on Health.
Apr 9, 2019
Referred to the Subcommittee on Health.
Apr 9, 2019
Committee Consideration and Mark-up Session Held.
Apr 9, 2019
Ordered to be Reported by Voice Vote.
Dec 24, 2020
Placed on the Union Calendar, Calendar No. 571.
Dec 24, 2020
Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-688, Part I.
Dec 24, 2020
Committee on Energy and Commerce discharged.
  • April 8, 2019
    Introduced in House


  • April 8, 2019
    Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.


  • April 8, 2019
    Referred to the Subcommittee on Health.


  • April 9, 2019
    Referred to the Subcommittee on Health.


  • April 9, 2019
    Committee Consideration and Mark-up Session Held.


  • April 9, 2019
    Ordered to be Reported by Voice Vote.


  • December 24, 2020
    Placed on the Union Calendar, Calendar No. 571.


  • December 24, 2020
    Reported (Amended) by the Committee on Ways and Means. H. Rept. 116-688, Part I.


  • December 24, 2020
    Committee on Energy and Commerce discharged.
Richard E. Neal

Richard E. Neal

Democratic Representative

Massachusetts

Cosponsors (11)
Ben McAdams (Democratic)Chrissy Houlahan (Democratic)Jefferson Van Drew (Republican)Kevin Brady (Republican)Daniel Lipinski (Democratic)Abby Finkenauer (Democratic)Jamie Raskin (Democratic)Mark E. Amodei (Republican)Elissa Slotkin (Democratic)Zoe Lofgren (Democratic)Lauren Underwood (Democratic)

Ways and Means Committee, Health Subcommittee, Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes.
  • HR 116-2069: SPIKE Act
  • S 116-2051: Strengthening Average Sales Price Reporting Act of 2019
  • HR 116-2087: Drug Price Transparency Act
  • HR 116-2115: Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Business recordsCivil actions and liabilityCongressional oversightCorporate finance and managementGovernment information and archivesHealth care costs and insuranceInflation and pricesManufacturingMedicarePrescription drugs