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Why do we have a Guidance Portal?

On December 3, 2020, HHS released a Final Rule governing the agency's release and maintenance of guidance documents. See Good Guidance Practices Final Rule. These regulations will help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.


HHS Good Guidance Rule

Additional HHS guidance is incorporated throughout the preambles to proposed and final rules. These preambles are available at Department of Health and Human Services Federal Register entries, then performing a keyword search.

As explained in the Good Guidance Practices Final Rule, guidance documents issued by the Food and Drug Administration (“FDA”) will be subject to the requirements of the Final Rule until the Secretary amends FDA’s existing good guidance practices regulation. FDA has obtained two exemptions from the Director of the Office of Management and Budget that exempt the following types of guidance documents from the requirement that they be posted to the guidance repository: (1) Product-Specific Guidances for Generic Drug Development, and (2) Mammography Quality Standards Act (MQSA) Policy Guidance Help System (PGHS). These exemptions will be incorporated into the FDA’s amendments to its good guidance practices regulation. In the meantime, copies of these guidance documents can be found here:

Product-Specific Guidances for Generic Drug Development.
	Mammography Quality Standards Act Policy Guidance Help System
	FDA Guidance Documents Search PageDISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.


Announcements

Guidance Document Rescinded For Non-Compliance With Allina and the Administrative Procedure Act (Dec. 3, 2020)
	OGC Advisory Opinion 20-05
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  Title
                                                            OpDiv/StaffDiv
                                                            Guidance Status
                                                            Issue DateMedicare Provider Reimbursement Manual Part 2, Provider Cost Reporting Forms and Instructions, Chapter 48, Form CMS-287-22
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/29/2024How to Resolve Income Data Matching Inconsistencies (DMIs)
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year (FY) 2022 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTCHs)
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) – July 2024
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024July 2024 Quarterly Update to Healthcare Common Procedure Coding System (HCPCS) Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024April 2024 Update of the Ambulatory Surgical Center [ASC] Payment System
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024Outlier Reconciliation and Cost-to-Charge Ratio (CCR) Updates for the Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024Updates to Pub. 100-04 Claims Processing Manual, Chapter 20, Section 181.1 Payment for Lymphedema Compression Treatment Items
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/28/2024MM13568 - Hospital Outpatient Prospective Payment System: April 2024 Update
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/25/2024Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties (Revised)
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        12/15/2023

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            4993This Guidance Portal contains 49930 documents.
Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

Petition Responses

CDC

Petition Response to RB with Exhibit A*CMS

Good Guidance Petition Response No. 21-01** This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties. Return to top



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