In
May 2004, CMS adopted new guidelines regarding informed consent.
Those guidelines, published in the State Operations
Manual (which is used by surveyors to determine a hospital's
compliance with the Medicare Conditions of Participation),
expanded the information that had to be provided to patients
and documented on the consent form.
Hospitals were most concerned about
the requirement that patients be informed if a practitioner
other than the primary surgeon (another physician or a non-physician
practitioner) will perform important parts of the proposed
surgical procedure and that those additional practitioners
be specifically listed on the consent form. This requirement
applied even when the additional practitioner was working under
the supervision of the primary surgeon.
Hospitals raised their concerns with
CMS which has now responded by significantly changing three
Medicare CoPs concerning patients' rights, surgical services
and medical records. Gone is the requirement to list those
practitioners other than the primary surgeon. In its place
are rules that focus on a proper informed consent process and
policy.
These new Guidelines are now in
effect. Learn what you need to know to be in compliance with
them.
Alan
and Monica discuss:
The new emphasis on process
and policies to address all parts of the patient's informed
consent.
The elements of a well-designed
informed consent process.
The elements that must be
in the consent form and what additional information might be
included.
The survey procedures to be used
to determine hospital compliance, including the medical records
to be reviewed and individuals to be interviewed.
Supplementary materials include all
of the revised Guidelines and a consent form that complies
with those Guidelines.
