11 April 2019

Ways and Means advances bipartisan Prescription Drug Transparency Bill

On April 10, the House Ways and Means Committee unanimously advanced bipartisan prescription drug transparency legislation aimed at shining a light on the pharmaceutical supply chain. In a joint statement, Chairman Richie Neal (D-MA) and Ranking Member Kevin Brady (R-TX) said, "our committee put aside our ideological differences and passed the bipartisan Prescription Drug STAR Act, a first step in addressing the high cost of prescription drugs affecting consumers in Massachusetts, Texas, and across the country by improving transparency for patients." Chairman of the health subcommittee Rep. Lloyd Doggett (D-TX), however, cautioned that Democrats need to take stronger steps to address the rising cost of prescription drugs and avoid watering down legislation to appease Republicans, despite supporting the legislation. In his criticism of the bill, he noted that drugmakers could easily sidestep certain provisions designed to promote transparency and said the committee will fail "if we merely hold hands and settle for whatever is acceptable to the member of the committee that is most-protective of big pharma."

The STAR Act would:

  • Require drug manufacturers to publicly justify large price increases for existing drugs and high launch prices for new drugs (increases of more than 10% or $10,000 over one year, or 25% or $25,000 over three years, or if the manufacturer launches a new drug at or above $26,000), and require the Secretary of Health and Human Services (HHS) to publicly post a summary of the justification;
  • Require applicable manufacturers of certain drugs, devices, biologics, or medical supplies to annually report to the Secretary the total aggregate monetary value and quantity of samples provided to covered entities;
  • Require the Secretary to conduct a study on inpatient (Medicare Part A) drug costs, spending, and volume, including trends in the use of inpatient drugs by hospital type and the impact of drug shortages;
  • Require the Secretary to publicly disclose the aggregate rebates, discounts, and other price concessions achieved by pharmaceutical benefits managers (PBMs) on a public website, so consumers, employers, and other payers can understand and compare the discounts PBMs receive; and
  • Require all drug manufacturers to submit information to the Secretary on the average sales price (ASP) for physician-administered drugs covered under Medicare Part B and authorized the Secretary to fine a manufacturer a civil monetary penalty of $10,000 for each day the manufacturer fails to report the information and up to $100,000 for each item of false information.

The House Energy and Commerce Committee has a rival drug pricing measure, the FAIR Drug Pricing Act (HR 2439), which they plan to take up later this year. Lead sponsor Rep. Jan Schakowsky (D-IL) said she prefers her bill over the STAR Act and will pursue it through the committee process. The STAR Act is supported by the AARP, American Hospital Association, ERISA Industry Committee, National Community Pharmacists Association, and Federation of American Hospitals, among others.

For additional information, see:Ways and Means Press Release; Markup landing page; Legislative text; Section-by-section summary (attached below).

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Contact Information
For additional information concerning this Alert, please contact:
 
Washington Council Ernst & Young
   • Any member of the group, at (202) 293-7474.

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ATTACHMENT

STAR Act

Document ID: 2019-0750