BILL ANALYSIS
SB 303
Page 1
SENATE THIRD READING
SB 303 (Alquist)
As Amended August 17, 2009
Majority vote
SENATE VOTE :25-13
HEALTH 13-3 JUDICIARY 7-3
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|Ayes:|Jones, Ammiano, Block, |Ayes:|Feuer, Brownley, Evans, |
| |Carter, Hill, De Leon, | |Jones, Krekorian, Lieu, |
| |Hall, Hayashi, Hernandez, | |Monning |
| |Bonnie Lowenthal, Nava, | | |
| |V. Manuel Perez, Salas | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Emmerson, Gaines, Audra |Nays:|Tran, Knight, Silva |
| |Strickland | | |
| | | | |
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APPROPRIATIONS 12-5
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|Ayes:|De Leon, Ammiano, |
| |Charles Calderon, Coto, |
| |Davis, Fuentes, Hall, |
| |John A. Perez, Skinner, |
| |Solorio, Torlakson, Hill |
| | |
|-----+--------------------------|
|Nays:|Conway, Duvall, Harkey, |
| |Miller, Audra Strickland |
| | |
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SUMMARY : 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. Specifically, this bill :
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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 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; and,
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)
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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; and,
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 contain 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 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.
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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 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.
EXISTING LAW :
1)Requires nursing facilities to be licensed by DPH, which is
required to conduct periodic inspections of nursing facilities
to ensure compliance with statutory and regulatory
requirements, and authorized to assess penalties, including
citations which may result in monetary fines, against nursing
facilities that have violated the law.
2)Requires an attending physician to obtain informed consent
from a nursing facility resident who has the capacity to make
decisions concerning his or her own health care, when
prescribing, ordering, or increasing an order for an
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antipsychotic medication.
3)Requires the attending physician to, with the nursing home
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.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, absorbable workload to DPH to continue oversight of
patient safety and facility compliance with health and safety
standards at nursing facilities.
COMMENTS : According to the author, the use of antipsychotic
drugs in nursing facilities throughout California and the nation
has significantly 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,
in order to quiet their symptoms. The author cites data from
the federal Center for Medicare and Medicaid Services (CMS),
indicating that approximately 60% of nursing facility residents
are prescribed psychotherapeutic drugs, and asserts that a
significant number of those residents are not adequately
informed of the side effects and risks of the medications.
Although DPH is responsible for the enforcement of existing
informed consent requirements, the author states that existing
regulations pertaining to informed consent are rarely enforced,
resulting in little evaluation and oversight of nursing facility
compliance. The author states that this bill is needed to
ensure that nursing facility residents, or their
representatives, give informed consent before nursing facility
staff administer psychotherapeutic drugs to their residents.
Psychotherapeutic drugs are medications meant to control
behavior or to treat thought disorder processes.
Psychotherapeutic drugs, such as anti-depressants, are widely
used in nursing facilities to treat residents for various
conditions. According to CMS data, approximately 58% 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. Antipsychotic
drugs are known to have major side effects and risks, including
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increased risk of heart attack, stroke, and death among elderly
patients, thereby prompting FDA to require black box warnings on
their labels, informing patients of the health risks associated
with their use.
In 2006, in an effort to ensure proper management, monitoring
and use of drugs by nursing facility residents, CMS issued
guidelines for facility surveyors regarding the prescription and
administration of antipsychotic medication to nursing facility
residents. An analysis of antipsychotic drug use by 693,000
Medicare nursing home residents revealed that 28.5% of doses
received were excessive and 32.2% lacked appropriate indications
for use. The guidelines state that facilities must ensure that
residents who have not used antipsychotic drugs are not given
these drugs unless such therapy is necessary to treat a specific
diagnosed condition and is documented in the resident's health
record, and that residents who use antipsychotic drugs receive
gradual dose reductions, unless clinically contraindicated, and
behavioral interventions. The guidelines also set forth the
conditions and diagnoses for which antipsychotic drugs should be
used, as well as conditions or behaviors exhibited by residents
for which antipsychotic drugs should not be used, including mild
anxiety, restlessness, nervousness, or uncooperativeness.
The California Advocates for Nursing Home Reform (CANHR), the
sponsor of this measure, 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 will not create any
new costs as physicians are already required to obtain informed
consent, nursing facilities are already required to verify
consent, and DPH is already required and funded to inspect for
compliance with these requirements.
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The California Association of Health Facilities (CAHF) and the
California Hospital Association (CHA) are both opposed to this
bill. CAHF states that this bill only codifies a portion of
existing regulations, broadens the requirement for informed
consent in a way that infringes on scope of practice issues for
nurses and on the physician's professional judgment, and
requires facilities to develop new policies and procedures to
implement these new requirements. CHA argues that this bill
does not provide meaningful improvement in patient care in
skilled nursing facilities. CHA also states that the provisions
of this bill require that nursing personnel initiate an inquiry
with patients regarding informed consent for the administration
of psychoactive drugs. According to CHA, such an inquiry will
undoubtedly lead to discussions regarding treatment and
treatment options that are outside the nursing scope of
practice.
Analysis Prepared by : Joyce Iseri / HEALTH / (916) 319-2097
FN: 0002379