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CMS Finally Issues Informed Guidance
on Informed Consent: 2004 Interpretive Guidelines Revised
By Clark
Stanton
[May 2007]
Last month,
the Centers for Medicare and Medicaid Services (CMS) revised
guidance issued in 2004 for the application of informed consent
requirements under the Medicare Conditions of Participation
for hospitals. The new guidance comes as a relief to hospitals
and physicians alike, as it reverses burdensome requirements
CMS had previously attempted to impose on the informed consent
process.
Background
The Medicare Conditions of Participation require patient records
to contain properly executed informed consent forms for those
procedures and treatments that require written patient consent,
and they specifically require that there be a properly executed
informed consent form in the patient’s chart before surgery,
except in emergencies. See 42 CFR § 482.51(b)(2), 42 CFR
§ 482.24(c)(2)(v). However, the Conditions of Participation
leave the specific content of informed consent forms to be defined
by hospitals or applicable law.
In May 2004, CMS issued Interpretive Guidelines for the Medicare
Conditions of Participation, including detailed requirements
for the content of informed consent forms. These Interpretive
Guidelines created a considerable stir at the time as they imposed
requirements on the informed consent process that exceeded the
standard practice for documentation of consent. Under these
guidelines, consent forms were to include, among other elements,
the following information:
- The risks and consequences of the procedure and the risks
and consequences if no treatment is rendered.
- Any alternative procedures and treatments.
- The names of all practitioners performing the procedure
or important aspects of the procedure, including the names
and specific significant surgical tasks to be conducted by
practitioners other than the primary surgeon/practitioner.
Significant surgical tasks were said to include opening and
closing, harvesting grafts, dissecting tissue, removing tissue,
implanting devices, altering tissues.
- The signature of the person witnessing the consent, who
must be a “professional.”
- The name and signature of the person who explained the
procedure to the patient.
The standard practice for most hospitals has been to rely on
treating physicians to determine how best to provide information
to their patients regarding the procedures they are to undergo.
In many cases this information is provided orally and over time,
often in the physician’s office. As a consequence, hospital
consent forms are typically used to confirm that the exchange
of information about the procedure has taken place rather than
to contain all of that information. Hospital consent forms also
do not typically contain the names of all the persons who would
be involved in a procedure. The identities of those persons
might not be known at the time the form is executed or might
change. Such a requirement would be especially problematic for
hospitals with resident training programs.
After the issuance of the 2004 Interpretive Guidelines, numerous
hospital and physician organizations complained to CMS about
the new requirements – not just that they were burdensome
but that they failed to support or reflect actual and best practices
in the consent process. Despite these protests, preliminary
feedback from CMS had indicated that only minor adjustments
in the Interpretive Guidelines could be expected.
The April 2007 Guidance
Given this background, there was considerable relief in the
hospital and medical community when CMS released its latest
guidance to state survey agency directors on April 13, 2007.1
This new guidance revises the 2004 Guidelines as they apply
to informed consent to make several significant changes:
- The Guidelines no longer require that hospital consent forms
list the risks and consequences of the procedure and the risks
and consequences if no treatment is rendered.
- The Guidelines no longer require that hospital consent
forms list any alternative procedures and treatments.
- The Guidelines no longer require that hospital consent
forms include the names of all practitioners performing the
procedure or important aspects of the procedure, or the names
and specific significant surgical tasks that will be conducted
by practitioners other than the primary surgeon/practitioner.
- The Guidelines no longer require that a “professional”
witness the consent.
Focus on policies, not forms
Instead of focusing on hospital consent forms, the new Guidelines
focus on the need for hospital policies to support the informed
consent process – to assure that patients receive adequate
information, provided in a manner they can understand, so that
they can effectively exercise the right to make informed decisions
concerning treatment. The new Guidelines describe appropriate
informed consent policies and “well designed” consent
processes and forms.
With respect to consent forms themselves, the new Guidelines
list the following minimum requirements for procedures or other
types of medical treatment requiring informed consent:
- Name of the hospital where the procedure is to take place.
- Name of the specific procedure for which consent is being
given.
- Name of the responsible practitioner who is performing
the procedure.
- Statement that the procedure, including the anticipated
benefits, material risks, and alternative therapies, was explained
to the patient or the patient’s legal representative.
(Material risks could include risks with a high degree of
likelihood but a low degree of severity, as well as those
with a very low degree of likelihood but high degree of severity.
Hospitals are free to delegate to the responsible practitioner,
who uses the available clinical evidence as informed by the
practitioner’s professional judgment, the determination
of which material risks, benefits and alternatives will be
discussed with the patient.)
- Signature of the patient or the patient’s legal representative.
- If there is applicable state law governing the content
of the informed consent form, then the hospital’s form
must also comply with those requirements.
The new Guidelines go on to state that a well-designed informed
consent form might also include the following additional information:
- Name of the practitioner who conducted the informed consent
discussion with the patient or the patient’s representative.
- Date, time, and signature of the person witnessing the patient
or the patient’s legal representative signing the consent
form.
- Indication or listing of the material risks of the procedure
or treatment that were discussed with the patient or the patient’s
representative.
- Statement, if applicable, that physicians other than the
operating practitioner, including but not limited to residents,
will be performing important tasks related to the surgery,
in accordance with the hospital’s policies and, in the
case of residents, based on their skill set and under the
supervision of the responsible practitioner.
- Statement, if applicable, that qualified medical practitioners
who are not physicians who will perform important parts of
the surgery or administration of anesthesia will be performing
only tasks that are within their scope of practice, as determined
under state law, and for which they have been granted privileges
by the hospital.
Recommended documentation
It is recommended that the physician carefully document in
the hospital medical record that a discussion was held with
the patient and that informed consent was obtained. This documentation
can be accomplished in a variety of ways – through a chart
note in the progress notes of the patient’s record, through
a note in the patient’s history and physical, through
a certification provision on the consent form itself (if the
form contains one), or through documentation provided from the
physician’s office (e.g., an informed consent form signed
by both the patient and the physician).
Finally, CMS states in the new Guidelines that the medical
staff at each health care facility “should” specify
in the medical staff bylaws those procedures and treatments
that require informed consent. In our view, the medical staff
bylaws would not seem to be the best place for this information;
the medical staff rules and regulations or a policy and procedure
would seem to be better choices. However it is done, the description
of those procedures requiring informed consent should be appropriately
documented and approved by the medical staff’s executive
committee.
Footnote
1
See CMS memorandum dated April
13, 2007, “Revisions to the Hospital Interpretive Guidelines
for Informed Consent,” available at: http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf.
For more information, please contact:
This advisory
is a publication of the Health Law Group of Davis Wright Tremaine
LLP. Our purpose in publishing this advisory is to inform our
clients and friends of recent legal developments. It is not
intended, nor should it be used, as a substitute for specific
legal advice as legal counsel may only be given in response
to inquiries regarding particular situations.
Copyright 2007, Davis Wright Tremaine
LLP.
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