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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 August 20, 2020, HHS published a Notice of Proposed Rulemaking that proposes to issue regulations governing the agency's release and maintenance of guidance documents. See 85 FR 51396. These regulations should, if finalized, 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 has issued a Request for Information soliciting comments relating to the Department's current compliance with Executive Order 13891, and in particular, seeks specific feedback about potential opportunities to improve and ensure the Department's compliance with, and best practices relating to, the legal obligations governing the appropriate issuance of guidance. Comments are due on October 30, 2020 and should be submitted electronically to GuidanceRFI@hhs.gov.

HHS Extension Request for EO 13891

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.

HHS Guidance

Title OpDiv/StaffDiv Guidance Status Issue Date
Termination Procedures State Agency Documentation Requirements Centers for Medicare & Medicaid Services (CMS) Final
Nursing Home Enforcement - Frequently Asked Questions Centers for Medicare & Medicaid Services (CMS) Final
Microsoft Word - TMVR CMS NCD Reconsideration Final 042919 Centers for Medicare & Medicaid Services (CMS) Final
Actinic Keratoses Final report Centers for Medicare & Medicaid Services (CMS) Final
A Proposed Framework to Evaluate Home Tests for Use in the Management of Chronic Diseases. Final Report. Centers for Medicare & Medicaid Services (CMS) Final
Formal Request for a National Coverage Determination (NCO) for Epi proColon, a blood-based
screening test for Colorectal Cancer as a covered Colorectal Cancer Screening test (210.3) under the
Soc Sec Act§ 1861 (pp)l
Centers for Medicare & Medicaid Services (CMS) Final
Centers for Medicare and Medicaide Services (CMS) posted a decision memorandum on January 14, 2000 that concluded “that a suff Centers for Medicare & Medicaid Services (CMS) Final
Statement on Positron Emission Tomography Centers for Medicare & Medicaid Services (CMS) Final
Formal Request for Reconsideration of Artificial Heart National Coverage Determination Centers for Medicare & Medicaid Services (CMS) Final
FORMAL REQUEST BY AN EXTERNAL PARTY FOR RECONSIDERATION OF AN EXISTING NCD Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 30362 documents.