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Biotechnology Innovation Organization (BIO)

Trade or professional group Pharma & Medical Devices

Biotechnology Innovation Organization (BIO) is listed as a trade or professional group in Pharma & Medical Devices. It has filed 10 comment letters on 9 proposed federal rules between 2022 and 2026, most often with the Centers for Medicare & Medicaid Services. Of those rules, 1 rule became final.

Type
Trade or professional group
Industry
Pharma & Medical Devices
Comment letters
10
Rules commented on
9
First letter
2022-06-22
Latest letter
2026-09-08
Agencies most often
Centers for Medicare & Medicaid Services (6); Health and Human Services Department (2); Office of the Secretary (1)

Activity by year

20221
20269

Letters

2026

Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

CMS-2026-2080Health and Human Services Department, Centers for Medicare & Medicaid Services · filed 2026-09-08 · filed as “Biotechnology Innovation Organization”

Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program

CMS-2026-2245Health and Human Services Department, Centers for Medicare & Medicaid Services · filed 2026-08-25 · filed as “BIO”

Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection

CMS-2026-2212Health and Human Services Department, Centers for Medicare & Medicaid Services · filed 2026-07-24 · filed as “BIO”

Request for Information; Comprehensive Review of the Essential Health Benefits Framework and Typical Employer Plan Standard

CMS-2026-2081Health and Human Services Department · filed 2026-07-17 · filed as “Biotechnology Innovation Organization”

Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges

CMS-2026-1255Health and Human Services Department, Centers for Medicare & Medicaid Services, Office of the Secretary · filed 2026-06-29

Global Benchmark for Efficient Drug Pricing (GLOBE) Model

CMS-2025-1889Health and Human Services Department, Centers for Medicare & Medicaid Services · filed 2026-02-25 · filed as “Biotechnology Innovation Organization”

Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

CMS-2025-1888Health and Human Services Department, Centers for Medicare & Medicaid Services · filed 2026-02-25 · filed as “Biotechnology Innovation Organization”

Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

CMS-2025-1888Health and Human Services Department, Centers for Medicare & Medicaid Services · filed 2026-02-25 · filed as “Biotechnology Innovation Organization”

Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts

HHSIG-2025-0001Health and Human Services Department · filed 2026-02-10

2022

Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure

S7-09-22Securities and Exchange Commission · filed 2022-06-22 Final rule 2023