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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Fiscal Intermediary Shared System (FISS) Changes to Automate the Application of Condition Code ZC for Chimeric Antigen Receptor (CAR) T-Cell and Other Immunotherapy Cases Involving a Clinical Trial of a Different Product  Centers for Medicare & Medicaid Services (CMS) Final
January 2025 Update of the Ambulatory Surgical Center [ASC] Payment System  Centers for Medicare & Medicaid Services (CMS) Final
Updates to Billing for Care Coordination Services for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)  Centers for Medicare & Medicaid Services (CMS) Final
MIUpdattedMarketingModelsMemoCY202501032025_G  Centers for Medicare & Medicaid Services (CMS) Final
Extensions of Certain Temporary Changes to the Low-Volume Hospital Payment Adjustment and the Medicare-Dependent Hospital (MDH) Program under the Inpatient Prospective Payment System (IPPS) provided by the American Relief Act, 2025  Centers for Medicare & Medicaid Services (CMS) Final
MM13918: Billing Instructions: Expedited Determinations Based on Medicare Change of Status Notifications  Centers for Medicare & Medicaid Services (CMS) Final
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
Developing Drugs for Optical Imaging  Food and Drug Administration (FDA) Proposed
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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