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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions  Food and Drug Administration (FDA) Final
Instructions for Downloading the Medicare ZIP Code File for October 2025 Files  Centers for Medicare & Medicaid Services (CMS) Final
Quarterly Update to the End Stage Renal Disease Prospective Payment System (ESRD PPS)  Centers for Medicare & Medicaid Services (CMS) Final
Updates to Medicare Claims Processing Manual for Rural Health Clinics (RHC) and Federally Qualified Health Centers (FQHC) Chapter 9  Centers for Medicare & Medicaid Services (CMS) Final
Quarterly Update to the End Stage Renal Disease Prospective Payment System (ESRD PPS)  Centers for Medicare & Medicaid Services (CMS) Final
Updates to the Medicare Carrier System (MCS), the Viable Information Processing Systems Medicare Systems (VMS) and the Common Working File (CWF) Processes to Capture and Further Automate the Medicare Secondary Payer (MSP) Processes  Centers for Medicare & Medicaid Services (CMS) Final
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol  Food and Drug Administration (FDA) Proposed
July Quarterly Update for 2025 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule  Centers for Medicare & Medicaid Services (CMS) Final
Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes   Centers for Medicare & Medicaid Services (CMS) Final
Internet-Only Manual (IOM) Update: Addition of Section 70.2 to Publication 100-04, Chapter 17 –Billing Zero Charges for Drug Line Items Provided at No Cost  Centers for Medicare & Medicaid Services (CMS) Final
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