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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2025  Centers for Medicare & Medicaid Services (CMS) Final
Updates to Chapter 1 of the Medicare Claims Processing Manual (Publication (Pub.) 100-04) to Include Newly Created and Utilized Payer Only Codes  Centers for Medicare & Medicaid Services (CMS) Final
Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
July 2025 Integrated Outpatient Code Editor (I/OCE) Specifications Version 26.2  Centers for Medicare & Medicaid Services (CMS) Final
July 2025 Update of the Hospital Outpatient Prospective Payment System (OPPS)  Centers for Medicare & Medicaid Services (CMS) Final
April Quarterly Update for 2025 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule  Centers for Medicare & Medicaid Services (CMS) Final
Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
MA CY2026 AIP D SNP HPMS release memo G  Centers for Medicare & Medicaid Services (CMS) Final
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