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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Omnibus Change Request (CR) Covering Updates for the Medicare Physician Fee Schedule (MPFS) Rule 2025: (1) Updates to Colorectal Cancer Screening and Hepatitis B Vaccine Policies  Centers for Medicare & Medicaid Services (CMS) Final
Omnibus Change Request (CR) Covering Updates for the Medicare Physician Fee Schedule (MPFS) Rule 2025: (1) Updates to Colorectal Cancer Screening and Hepatitis B Vaccine Policies  Centers for Medicare & Medicaid Services (CMS) Final
October 2025 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder  Centers for Medicare & Medicaid Services (CMS) Final
Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2025  Centers for Medicare & Medicaid Services (CMS) Final
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Data Reporting Compliance for the Transformed-Medicaid Statistical Information System (T-MSIS)  Centers for Medicare & Medicaid Services (CMS) Final
Updated 2025 SSI and Spousal Impoverishment Standards  Centers for Medicare & Medicaid Services (CMS) Final
CY2023 Medicare Quality Withhold Repayment for MMPs HPMS Memo G  Centers for Medicare & Medicaid Services (CMS) Final
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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