BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 303|
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THIRD READING
Bill No: SB 303
Author: Alquist (D), et al
Amended: 4/27/09
Vote: 21
SENATE JUDICIARY COMMITTEE : 3-2, 4/28/09
AYES: Corbett, Florez, Leno
NOES: Harman, Walters
SENATE HEALTH COMMITTEE : 8-3, 4/1/09
AYES: Alquist, Cedillo, DeSaulnier, Leno, Maldonado,
Negrete McLeod, Pavley, Wolk
NOES: Strickland, Aanestad, Cox
SENATE APPROPRIATIONS COMMITTEE : 7-5, 5/28/09
AYES: Kehoe, Corbett, DeSaulnier, Hancock, Leno, Oropeza,
Yee
NOES: Cox, Denham, Runner, Walters, Wyland
NO VOTE RECORDED: Wolk
SUBJECT : Nursing facility residents: informed consent
SOURCE : California Advocates for Nursing Home Reform
California Alliance for Retired Americans
DIGEST : This bill codifies certain regulations
promulgated by the Department of Public Health relative to
the right of a skilled nursing or intermediate care
facility resident to information that is material to the
resident's decision to accept or refuse a proposed
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treatment or procedure, and makes the resident's attending
physician or the proscribing physician responsible for
disclosing the material information and for obtaining the
resident's informed consent, as defined, prior to
prescribing, ordering, or increasing an order for an
antipsychotic medication for the resident.
ANALYSIS : Under existing law, long-term health care
facilities include skilled nursing facility (SNFs),
intermediate care facilities, congregate living facilities,
nursing facilities, and pediatric day health and respite
facilities. Existing law defines a SNF as a health
facility that provides skilled nursing care and supportive
care to patients whose primary need is for the availability
of skilled nursing care on an extended basis.
Existing law requires SNFs to be licensed and certified by
the Department of Public Health (DPH). Existing law also
requires DPH to conduct periodic inspections of SNFs, to
ensure compliance with statutory and regulatory
requirements, and authorizes DPH to assess penalties,
including citations which may result in monetary fines,
against SNFs that have violated federal or state law.
Existing law requires an attending physician of a SNF
resident, who has the capacity to make decisions concerning
his or her own health care, to obtain the informed consent
of the resident when prescribing, ordering, or increasing
an order for an antipsychotic medication. Existing law
also requires the attending physician to, with the
resident's consent, notify the resident's family member, as
designated within the resident's medical record, within 48
hours of the prescription, order, or increase of an order
of an antipsychotic medication, as specified.
Existing law establishes various rights that SNF residents
are entitled to, including rights to good personal hygiene,
quality food in sufficient quantities, activity programs,
and readmission to the SNF after they have been discharged
from a hospital, as specified. Existing law states that
the rights of a resident judicially determined to be
incompetent, determined by a physician to be medically
incapable of understanding his or her rights, or who
exhibits a communication barrier, shall devolve to the
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patient's guardian, conservator, next of kin, sponsoring
agency, or representative payer, as specified.
Existing regulations:
1. Set forth various resident rights, in addition to what
is set forth in statute, including the right to receive
all information that is material to a resident's
decision concerning whether to accept or refuse any
proposed treatment or procedure. Existing regulations
require SNFs to ensure that these rights are not
violated.
2. State that it is the responsibility of the physician to
determine what information the resident would consider
material to a decision to accept or refuse a proposed
treatment or procedure, and that the disclosure of
material information, and obtaining informed consent, is
the responsibility of the physician. Existing
regulations also specify that the material information
relating to the administration of psychotherapeutic
drugs, physical restraints, or other devices that impede
the body's normal function, that shall be disclosed,
shall include:
A. The reason for the treatment and the nature and
seriousness of the patient's illness.
B. The nature of the procedures to be used in the
proposed treatment, as specified.
C. The degree and duration of improvement or
remission expected with or without the proposed
treatment.
D. The associated side effects and significant risks
of the proposed treatment, as specified.
E. Why the proposed treatment is recommended, as well
as possible alternative treatments and risks.
F. The patient has the right to accept or refuse the
proposed treatment, and upon consent of the
treatment, to revoke his or her consent at any time
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for any reason.
3. Require SNFs, before the administration of
psychotherapeutic drugs, physical restraints, or other
devices that impede the body's normal function, to
verify that the patient's health record contains
documentation that the patient has given informed
consent, and also to ensure that all decisions regarding
the withdrawal or withholding of life sustaining
treatments are documented in the resident's health
record.
4. Require SNFs to specify, in the resident's rights
policies and procedures, how the facility will verify
that the resident provided informed consent or refused
treatment pertaining to the administration of
psychotherapeutic drugs, physical restraints, or other
devices that impede the body's normal function.
5. Grant the rights of a resident that has been determined
by a court, or a physician, as specified, to lack
capacity to understand his or her rights or proposed
treatments, to the resident's representative, such as a
conservator, next of kin, or other legally recognized
health care decision maker.
This bill:
1. Requires an attending physician of a SNF resident, who
has the capacity to make decisions concerning his/her
own health care, to obtain the informed consent of the
resident when prescribing, ordering, or increasing an
order for an antipsychotic medication.
2. Provides that a resident shall have the right to receive
all information that is material to an individual's
decision concerning whether to accept or refuse any
proposed treatment or procedure, and requires certain
disclosures for administration of psychotherapeutic
drugs.
3. Defines "informed consent" for this purpose to mean the
voluntary agreement of a resident or resident's
representative to accept a treatment or procedure after
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receiving information, as further specified.
4. Specifies that the information required for "informed
consent" is all information that is material to the
individual's decision concerning whether to accept or
refuse any proposed treatment or procedure, and shall
include, but not be limited to, the following:
A. The reason for the treatment and the nature and
seriousness of the resident's illness.
B. The nature of the procedure to be used in the
proposed treatment, including probable frequency
and duration.
C. The probable degree and duration, whether
temporary or permanent, of improvement or remission
expected with or without the proposed treatment.
D. The nature, degree, duration and probability of
side effects and significant risks associate with
the medication.
E. The reasonable alternative treatments and risks,
and why a particular treatment is recommended.
F. That the resident has the right to accept or
refuse the proposed treatment, and, if the resident
consents, that he/she has the right top revoke the
consent for any reason at any time.
5. Makes the attending physician responsible for
determining what information a reasonable person n the
resident's condition and circumstances considers
material to a decision to accept or refuse a proposed
treatment or procedure, and provides that information
that is commonly appreciated need not be disclosed.
6. Requires the facility staff, prior to administration of
psychotherapeutic drugs ordered by an attending
physician, to inspect the resident's medical record and
verify that the record contains a notation by the
attending physician that he/she has obtained the
informed consent of the resident for the proposed
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treatment or procedure.
7. Requires the facility staff to then verify with the
resident or the resident's representative that the
resident has voluntarily agreed to accept the proposed
treatment or procedure after receiving information from
the attending physician, and to document this
verification in the resident's health record.
8. Requires the facility staff to ensure that all decisions
concerning the withdrawal or withholding of life
sustaining treatment are documented in the resident's
health record.
9. Provides that obtain informed consent each time a
treatment or procedure is administered is not required,
unless material circumstances or risks change.
10.Provides that nothing in the bill shall be construed to
impair or otherwise alter other non-conflicting
statutory or regulatory requirements related to
requirements for informed consent for the administration
of psychotherapeutic drugs.
11.Requires DPH to inspect a facility for compliance with
these informed consent requirements during prescribed
inspections.
Background
Psychotherapeutic drugs are defined in existing state
regulations as medications meant to control behavior or to
treat thought disorder process. Psychotherapeutic drugs,
such as anti-depressants, are widely used in nursing
facilities to treat residents for various conditions.
According to data provided by the Centers for Medicare and
Medicaid Services (CMS) On-Line Survey, Certification, and
Reporting system, approximately 58 percent of California
nursing facility residents were administered
psychotherapeutic drugs in 2007.
Antipsychotic drugs are a group of psychotherapeutic drugs
that are primarily designed to treat severe conditions such
as schizophrenia. Studies show that the use of
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antipsychotic drugs in nursing homes throughout California
and the nation has increased during recent years, as more
and more physicians prescribe these drugs, for "off-label"
use, to patients with Alzheimer's disease and other forms
of dementia. According to a 2008 CMS report, approximately
20 percent of California nursing facility residents were
administered antipsychotic drugs.
Antipsychotic drugs are known to have major side effects
and risks, including increased risk of heart attack,
stroke, and death among elderly patients, thereby prompting
the federal FDA to require black box warnings on their
labels, informing patients of the health risks associated
with their use.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2009-10 2010-11
2011-12 Fund
Medi-Cal SNF nurse $40-$80 General/
training reimbursement $61-$126 Federal
SUPPORT : (Verified 5/29/09)
California Advocates for Nursing Home Reform (co-source)
California Alliance for Retired Americans (co-source)
Advocacy, Inc.
Alameda County Network of Mental Health
American Association of Retired Persons
Bet Tzedek Legal Services
California Senior Legislature
Congress of California Seniors
Dayle McIntosh Center
Disability Rights CA
Foundation Aiding the Elderly
Gray Panthers Sacramento
Kings Tulare Area Agency on Aging
Long-Term Care Services of Ventura County, Inc.
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Ombudsman Services of Northern California
Pathways
OPPOSITION : (Verified 5/29/09)
California Association of Health Facilities
California Medical Association
ARGUMENTS IN SUPPORT : The California Advocates for
Nursing Home Reform (CANHR) states that nursing homes have
increasingly turned to psychotherapeutic drugs to sedate
and control residents, especially those who display
confused or agitated behaviors caused by dementia. CANHR
states that while these drugs are sometimes appropriately
prescribed to treat mental health conditions, many of the
psychotherapeutic drugs being used in nursing homes,
particularly antipsychotic drugs designed to treat serious
psychiatric disorders, are dangerous and used without
medical justification. CANHR states that this bill
addresses these concerns by codifying existing regulations
that establish a nursing home resident's right to informed
consent concerning the use of psychoactive drugs,
strengthening requirements for informed consent
verification, and clarifying that DPH shall inspect for
compliance with informed consent requirements. CANHR
states that this bill also removes a problematic conflict
between the statute and the regulation by replacing an
existing statute regarding the residents' rights devolving
to their representatives, with existing regulatory language
that contains an updated, more complete and accurate list
of persons who can exercise a resident's rights. CANHR
states that this bill will not create any new costs as
physicians are already required to obtain informed consent,
SNFs are already required to verify consent, and DPH is
already required and funded to inspect for compliance with
these requirements. CANHR asserts that this bill will help
ensure that these existing duties are carried out in an
appropriate manner.
ARGUMENTS IN OPPOSITION : The California Association of
Health Facilities (CAHF) opposes the bill unless amended,
and states that this bill would make a SNF liable for
citations and penalties for the acts and/or omissions of an
attending physician for whom a facility has no control.
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CAHF states that this bill adds a new right to informed
consent, which is the physician's responsibility to obtain,
in the section of the code that sets forth facility
requirements, and suggests amending the bill to instead
place this requirement in the section of the law dealing
with existing informed consent requirements. CAHF states
that this bill place additional, prescriptive requirements
on the physician, with a new procedure for informed
consent, but would hold SNFs liable for citations and fines
if the attending physician does not carry out his/her
obligations to seek informed consent. CAHF states that
this bill will require nursing staff to have a conversation
with residents to verify that the patient was fully
informed about his/her proposed treatment, which creates
the risk that nursing staff will talk to the patient about
the proposed treatment which would violate their scope of
practice. CAHF also states that this bill will delete the
current law related to the rights of a resident who has
been judicially determined to be incompetent, and replaces
it with broader language concerning the rights of residents
who lack capacity. CAHF states that it is concerned about
the impact of placing the rights of these residents with
the residents' representatives, which will lead to greater
confusion about to whom a resident's rights are granted,
and thus, more litigation. CAHF proposes that this
language be stricken from the bill.
CTW:do:m 5/29/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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