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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
BIO Comments to HHS's Centers for Medicare &…
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
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BIO Comments to the Department of Justice on…
In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…
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Biotech Companies Express Concern With Proposed…
We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…
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BIO Comments to HHS's Centers for Medicare & Medicaid Services in response to their Information Collection Request (ICR) on the Part C and Part D Medicare Prescription Payment Plan
April 19, 2024
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
BIO Comments to the Department of Justice on proposed regulations “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.”
April 19, 2024
In response to their advance notice of proposed rulemaking (ANPRM), BIO submitted comments to the DOJ's National Security Division on implementing the White House Executive Order of February 28, 2024, “Preventing Access to Americans’ Bulk Sensitive…
Biotech Companies Express Concern With Proposed Changes to the Medicaid Drug Rebate Program (MDRP)
April 11, 2024
We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…
BIO Statement to the Senate 340B Bipartisan Working Group on Safeguarding and Strengthening 340B
April 1, 2024
In response to the 340B Request for Information issued by the Senate 340B Bipartisan Working Group, BIO submits detailed comments.
BIO Comments to HHS on Medicare Prescription Payment Plan: Draft Part Two Guidance on Implementation of Section 1860D-2 of the Social Security Act for 2025
March 16, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS’s/the Agency’s) Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics,…
BIO Request for Information to U.S. House Committee on Education and the Workforce on ERISA’s 50th Anniversary: Reforms to Increase Affordability and Quality in Employer-Sponsored Health Coverage
March 15, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Committee on Education and the Workforce’s (Committee’s) Request for Information on Reforms to Increase Affordability and Quality in Employer…
BIO Comments to FDA on their Advanced Manufacturing Technologies Designation Program
March 12, 2024
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
BIO Comments to FDA on their Draft Report and Plan on Best Practices for Guidance
March 4, 2024
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
BIO Comments to HHS Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions
March 1, 2024
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions.
BIO Comments to HHS on Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Docket CMS-2024-0006)
March 1, 2024
CMS proposes updates to the RxHCC to reflect the impact of the new 2025 Part D benefit structure per the Inflation Reduction Act (IRA).