TAPP Submits Comments Supporting the 340B Rebate Model Pilot Program

In response to a Health Resources and Services Administration Request for Information in the Federal Register, the Trade Alliance to Promote Prosperity today submitted comments supporting a proposed 340B rebate model pilot program.

Here is an executive summary of the comments that TAPP submitted:

Executive Summary

The proposed rebate model:

  • Is consistent with Section 340B of the Public Health Service Act (PHSA) (42 U.S.C. § 256b).

  • Is necessary to prevent unlawful duplicate discounts in light of the Medicare Drug Price Negotiation Program established under the Inflation Reduction Act (IRA) (42 U.S.C. § 1320f et seq.).

  • Imposes negligible financing costs on covered entities based on independent analysis.

  • Enhances program integrity and transparency.

  • Protects taxpayers from potentially billions of dollars in duplicate discounts.

A claims-level rebate reconciliation mechanism is not only permissible under federal statute—it is increasingly necessary to harmonize overlapping federal drug pricing obligations.

By preventing unlawful duplicate discounts and ensuring that manufacturers provide only the single discount required under law, the 340B rebate pilot protects funding for high-risk biomedical research and U.S. drug innovation, thereby maintaining U.S. leadership globally.

By reducing billions in cost-shifting to the commercial market, it also helps stabilize premiums, limit upward pressure on list prices, and create a more predictable, accountable system that protects consumers and American global competitiveness.

Therefore, HRSA should continue advancing the rebate model pilot and establish clear operational standards.

Read the full comments here.

TAPP encourages like-minded individuals and organizations to submit comments, too, at https://www.federalregister.gov/documents/2026/02/17/2026-03042/request-for-information-340b-rebate-model-pilot-program#open-comment.

Ainsley Shea