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Health Law Advisory Bulletin
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. Attorney
Advertising. Prior results do not guarantee a similar outcome. Thank
you.
Copyright 2007, Davis Wright Tremaine LLP.
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