CMS Requirements for Informed Consent


The Centers for Medicare & Medicaid Services (CMS) Hospital Interpretive Guidelines for Informed Consent Forms are summarized in the table below.  Use of the iMedConsent™ application can ensure full compliance with all CMS requirements.

Consent Form Element

Interpretive Guidelines

Disposition
Name of hospital

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
Name of procedure(s) or treatment(s)

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
Name of practitioner performing the procedure

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
Name of practitioner who conducted the informed consent discussion

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application
Statement that procedure, risks, benefits and alternatives were explained to the patient

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
 .
Listing of the risks associated with the procedure or treatment

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application
Statement, if applicable, that other physicians (including residents) may perform some of the surgical tasks

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application
 .
Statement, if applicable, that non-physician practitioners may perform some of the surgical tasks or administration of anesthesia

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application
 .
Signature of patient or legal representative

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
Date of patient signature

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
Time of day of patient signature

§482.24(c)(4)(v) – minimum required element

Fully addressed by the iMedConsent™ application
Signature of witness

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application
Date of witness signature

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application
Time of day of witness signature

§482.24(c)(4)(v) – element of a well-designed form

Fully addressed by the iMedConsent™ application

 

Note:  Many of the descriptions of the consent form elements listed above are abbreviated – please review the complete CMS Hospital Interpretive Guidelines (Centers for Medicare & Medicaid Services, State Operations Manual, Regulations and Interpretive Guidelines for Hospitals, §482.24(c)(4)(v), Rev. 151, 11-20-15.) for the sections indicated.

See: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf

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