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HHS Guidance Submissions

On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 55235). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS's guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more.

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.

DISCLAIMER: 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

HHS Guidance

Title OpDiv/StaffDiv Guidance Status Issue Date
Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees Office of Inspector General (OIG) Final
Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements Office of Inspector General (OIG) Final
MMP High Level Systems Diagrams- Alternate Flow Centers for Medicare & Medicaid Services (CMS) Final
MMP NCPDP Companion Guide Centers for Medicare & Medicaid Services (CMS) Final
Summary Notes Industry Update - March 16, 2011 Centers for Medicare & Medicaid Services (CMS) Final
Summary Notes Industry Update - January 19, 2011 Centers for Medicare & Medicaid Services (CMS) Final
Submitter/Receiver ID Application Centers for Medicare & Medicaid Services (CMS) Final
Session 4 Encounter Data System Reports Centers for Medicare & Medicaid Services (CMS) Final
Session 3 Encounter Data Centers for Medicare & Medicaid Services (CMS) Final
Session 2 Risk Score Calculation Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 17249 documents.
This is archived HHS content.