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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Implementation of Editing for Programs of All-Inclusive Care for the Elderly (PACE) Inpatient Claims Submitted for Indirect Medical Education (IME) Payment  Centers for Medicare & Medicaid Services (CMS) Final
Health Insurance Portability and Accountability Act (HIPAA) Electronic Data Interchange (EDI) Front End Updates for October 2026  Centers for Medicare & Medicaid Services (CMS) Final
Certain Postapproval Requirements and Resources for ANDAs  Food and Drug Administration (FDA) Final
Update to the Internet Only Manual (IOM) Publication 100-04, Chapters 3, 13, 17, 18 and 32 for Coding Revisions to National Coverage Determination (NCDs) - January 2026 Change Requests (CRs) 14194 and 14197  Centers for Medicare & Medicaid Services (CMS) Final
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing  Food and Drug Administration (FDA) Proposed
MM14464 - ICD-10 & Other Coding Revisions to National Coverage Determinations: October 2026 Update  Centers for Medicare & Medicaid Services (CMS) Final
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Final
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Interim Final Rule with Comment Period: Medicaid Program; Community Engagement Requirement for Certain Individuals (CMS-2454-IFC)  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 5570 documents.