BILL ANALYSIS
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VETO
Bill No: SB 303
Author: Alquist (D), et al
Amended: 9/2/09
Vote: 21
SENATE HEALTH COMMITTEE : 8-3, 4/1/09
AYES: Alquist, Cedillo, DeSaulnier, Leno, Maldonado,
Negrete McLeod, Pavley, Wolk
NOES: Strickland, Aanestad, Cox
SENATE JUDICIARY COMMITTEE : 3-2, 4/28/09
AYES: Corbett, Florez, Leno
NOES: Harman, Walters
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
SENATE FLOOR : 25-13, 6/2/09
AYES: Alquist, Calderon, Cedillo, Corbett, Correa,
DeSaulnier, Ducheny, Florez, Hancock, Kehoe, Leno, Liu,
Lowenthal, Maldonado, Negrete McLeod, Oropeza, Padilla,
Pavley, Romero, Simitian, Steinberg, Wiggins, Wolk,
Wright, Yee
NOES: Aanestad, Ashburn, Benoit, Cogdill, Cox, Denham,
Dutton, Hollingsworth, Huff, Runner, Strickland, Walters,
Wyland
NO VOTE RECORDED: Harman, Vacancy
SENATE FLOOR : 22-13, 9/10/09
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AYES: Alquist, Calderon, Cedillo, Corbett, DeSaulnier,
Ducheny, Florez, Hancock, Leno, Liu, Lowenthal,
Maldonado, Negrete McLeod, Pavley, Price, Romero,
Simitian, Steinberg, Wiggins, Wolk, Wright, Yee
NOES: Aanestad, Benoit, Cogdill, Correa, Cox, Denham,
Dutton, Harman, Hollingsworth, Huff, Runner, Strickland,
Walters
NO VOTE RECORDED: Ashburn, Kehoe, Oropeza, Padilla, Wyland
ASSEMBLY FLOOR : 50-26, 9/8/09 - See last page for vote
SUBJECT : Nursing facility residents: informed consent
SOURCE : California Advocates for Nursing Home Reform
California Alliance for Retired Americans
DIGEST : This bill enacts the Nursing Facility Resident
Informed Consent Protection Act of 2009, which establishes
the right of a resident of a skilled nursing or
intermediate care facility (nursing facility) to receive
information material to the decision to accept or refuse
any treatment or procedure, including the administration of
psychotherapeutic drugs, and codifies existing regulations
requiring attending physicians to obtain informed consent
after providing specified material information.
Assembly Amendments require treatment to be withheld if the
resident did not voluntarily agree or is now refusing
treatment, and requires facility staff, if the resident or
the resident's representative has questions or concerns
about treatment risks, benefits or alternatives, to
immediately refer the questions or concerns to the
attending or prescribing physician and surgeon.
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.
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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
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
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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
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
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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.Codifies a regulatory requirement that the attending
physician be the responsible party to determine what
information a reasonable person in the resident's
condition and circumstances would consider material to a
decision to accept or refuse a proposed treatment or
procedure. Specifies that information that is commonly
appreciated need not be disclosed. Codifies current
related regulatory definitions.
2.Requires the physician to disclose the material
information and obtain informed consent.
3.Requires information material to a decision concerning
the administration of a psychotherapeutic drug to
include:
A. The reason for the treatment and the nature and
seriousness of the resident's illness, as specified
in existing regulations.
B. The nature of the procedure to be used in the
proposed treatment, including the procedure's
probable frequency and duration, as specified in
existing regulations.
C. The probable degree and duration, whether
temporary or permanent, of improvement or remission
expected with or without the proposed treatment, as
specified in existing regulations.
D. The nature, degree, duration, and probability of
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the side effects and significant risks that are
commonly known by the health professions, as
specified in existing regulations.
E. The reasonable alternative treatments and risks,
and why the health professional is recommending a
particular treatment, as specified in existing
regulations.
F. That the resident has the right to accept or
refuse the proposed treatment, and, if he or she
consents, the right to revoke his or her consent
for any reason at any time, as specified in
existing regulations.
4.Adds, to the information on risks associated with
psychotherapeutic drugs from the existing regulations in
3) d) above, the following:
A. Whether a proposed medication is being
prescribed for a purpose or medical condition other
than the purpose or medical condition for which the
United States Food and Drug Administration (FDA)
has specifically approved that medication.
B. In writing, any current boxed warning labels and
accompanying detailed information regarding
contradictions, warnings, and precautions required
by the FDA.
5.Codifies a regulatory requirement that nursing facility
staff, before initiating the administration of
psychotherapeutic drugs, verify that the resident's
health record contains a notation by the attending or
prescribing physician and surgeon that the physician and
surgeon has obtained the informed consent of the
resident to the proposed treatment or procedure.
6.Requires health facility staff to verify with the
resident or resident's representative that the resident
has voluntarily agreed to accept the proposed treatment
or procedure after receiving information from the
attending physician and surgeon and to document this
verification in the resident's health record. If the
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resident did not voluntarily agree or is now refusing
treatment, requires the treatment to be withheld.
7.If the resident or the resident's representative has
questions or concerns about treatment risks, benefits or
alternatives, requires facility staff to immediately
refer the questions or concerns to the attending or
prescribing physician and surgeon.
8.Requires facilities to ensure that all decisions
concerning the withdrawal or withholding of life
sustaining treatment are documented in the resident's
health record.
9.Requires facility residents' rights policies and
procedures governing consent, informed consent and
refusal of treatment, to specify how the facility will
verify that the resident provided informed consent or
refused treatment or procedures regarding the
administration of psychotherapeutic drugs.
10.Codifies a regulatory provision that nothing in this
bill shall be construed to require a facility to obtain
informed consent each time a treatment or procedure is
administered unless material circumstances or risks
change.
11.Requires the California Department of Public Health
(DPH) to inspect nursing facilities for compliance with
this bill during DPH's periodic inspections or complaint
investigations.
12.Specifies that a violation of the informed consent
rights provided in this bill constitutes a class "B",
"A," or "AA" violation pursuant to existing law.
13.Clarifies nothing in this bill impairs or otherwise
alters other non-conflicting statutory or regulatory
requirements, including, but not limited to,
requirements contained in DPH's regulations or otherwise
related requirements for informed consent for the
administration of psychotherapeutic drugs.
14.States legislative findings and declarations related to
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the risks associated with the prescription of
psychotherapeutic drugs, the lack of information
provided to nursing facility residents, and the lack of
enforcement of current regulations on informed consent
for nursing facility residents.
15.States legislative intent to codify and enhance current
regulatory provisions related to nursing facility
patient rights to informed consent on any proposed
treatment or procedure, including the administration of
psychotherapeutic drugs.
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
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
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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 9/9/09)
California Advocates for Nursing Home Reform (co-source)
California Alliance for Retired Americans (co-source)
Advocacy, Inc.
Alameda County Network of Mental Health
Alzheimer's Association
American Association of Retired Persons
Bet Tzedek Legal Services
California Senior Legislature
Congress of California Seniors
Consumer Attorney's of California
Contra Costa County Advisory Council of Aging
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.
Older Women's League of California
Ombudsman Services of Northern California
Pathways
Source Employees International Union
OPPOSITION : (Verified 9/9/09)
Association of California Healthcare Districts
California Association of Health Facilities
California Hospital Association
California Medical Association
Crestwood Behavioral Health, Inc.
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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.
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
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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.
GOVERNOR'S VETO MESSAGE:
"I am returning Senate Bill 303 without my signature.
My Administration is concerned about the
inappropriate use of psychotherapeutic medications,
especially antipsychotics, in skilled nursing
facilities. One recent study concluded that over
half of the residents receiving antipsychotic therapy
were being treated outside the current Center for
Medicare and Medicaid Service guidelines.
I have instructed my Department of Public Health to
identify providers that may be inappropriately
prescribing these medications and thereby posing a
threat to the health and safety of residents in
skilled nursing facilities. If the department's
analysis indicates that such inappropriate
prescribing behavior is occurring and recommends
statutory changes in this area, I ask the Legislature
to immediately seek changes to correct it.
I thank the author for bringing this issue to my
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Administration's attention and will continue to
monitor this closely."
ASSEMBLY FLOOR :
AYES: Ammiano, Arambula, Beall, Block, Blumenfield,
Brownley, Caballero, Charles Calderon, Carter, Chesbro,
Coto, Davis, De La Torre, De Leon, Evans, Feuer, Fong,
Fuentes, Furutani, Gilmore, Hall, Harkey, Hayashi,
Hernandez, Hill, Huffman, Jeffries, Jones, Krekorian,
Lieu, Bonnie Lowenthal, Ma, Mendoza, Monning, Nava, John
A. Perez, V. Manuel Perez, Portantino, Ruskin, Salas,
Saldana, Skinner, Smyth, Solorio, Swanson, Torlakson,
Torres, Torrico, Yamada, Bass
NOES: Adams, Anderson, Bill Berryhill, Tom Berryhill,
Blakeslee, Conway, Cook, DeVore, Duvall, Emmerson,
Fletcher, Fuller, Gaines, Garrick, Hagman, Huber, Knight,
Logue, Miller, Nestande, Niello, Nielsen, Silva, Audra
Strickland, Tran, Villines
NO VOTE RECORDED: Buchanan, Eng, Galgiani, Vacancy
JJA:do 1/7/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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