Prescription Drug STAR Act

Summary

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.

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Timeline

1. 8 April 2019

   Introduced

   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.

   Source: IntroReferral

2. 8 April 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

3. 8 April 2019

   Introduced

   Introduced in House

   Source: IntroReferral

4. 8 April 2019

   Introduced

   Introduced in House

   Source: IntroReferral

5. 9 April 2019

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

6. 9 April 2019

   Reported

   Ordered to be Reported by Voice Vote.

   Source: Committee

7. 9 April 2019

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

8. 24 December 2020

   Calendars

   Placed on the Union Calendar, Calendar No. 571.

   Source: Calendars

9. 24 December 2020

   Discharge

   Committee on Energy and Commerce discharged.

   Source: Discharge

10. 24 December 2020

    Committee

    Committee on Energy and Commerce discharged.

    Source: Committee

11. 24 December 2020

    Reported

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

    Source: Committee

12. 24 December 2020

    Reported

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

    Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported in House · 24 December 2020 · Download file
• Introduced in House · 8 April 2019 · Download file

Documents

6 official files

• Reported in House (text)

  Reported in House · EN · 24 December 2020

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 24 December 2020

  ViewDownloadOpen at official source

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• Reported to House, Part I

  summary · EN · 24 December 2020

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  Vertaal document

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• Introduced in House (text)

  Introduced in House · EN · 8 April 2019

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House (PDF)

  Introduced in House · EN · 8 April 2019

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  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House

  summary · EN · 8 April 2019

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Neal, Richard E. [D-MA-1] · D · Sponsor
• Rep. Brady, Kevin [R-TX-8] · R · Sponsor
• Rep. Van Drew, Jefferson [R-NJ-2] · D · Cosponsor
• Rep. Finkenauer, Abby [D-IA-1] · D · Cosponsor
• Rep. Houlahan, Chrissy [D-PA-6] · D · Cosponsor
• Rep. Raskin, Jamie [D-MD-8] · D · Cosponsor
• Rep. McAdams, Ben [D-UT-4] · D · Cosponsor
• Rep. Underwood, Lauren [D-IL-14] · D · Cosponsor
• Sen. Slotkin, Elissa [D-MI] · D · Cosponsor
• Rep. Lipinski, Daniel [D-IL-3] · D · Cosponsor
• Rep. Lofgren, Zoe [D-CA-18] · D · Cosponsor
• Rep. Amodei, Mark E. [R-NV-2] · R · Cosponsor
• · hsif00 · Standing
• · hswm00 · Standing

Related records

• related to → Drug Price Transparency Act
• related to → Public Disclosure of Drug Discounts and Real-Time Beneficiary Drug Cost Act
• related to → 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.
• related to → SPIKE Act
• related to ← Strengthening Average Sales Price Reporting Act of 2019