BILL ANALYSIS
SB 303
Page 1
Date of Hearing: June 23, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 303 (Alquist) - As Amended: April 27, 2009
SENATE VOTE : 25-13
SUBJECT : Nursing facility residents: informed consent.
SUMMARY : Enacts the Nursing Facility Resident Informed Consent
Protection Act of 2009 which establishes the right of a resident
of a skilled nursing or immediate care facility (nursing
facility) to receive information material to the decision to
accept or refuse any treatment, including the administration of
psychotherapeutic drugs, and codifies existing regulations
requiring physicians to obtain informed consent and to provide
specified information material to the decision to refuse any
treatment or procedure. Specifically, this bill :
1)Codifies from existing regulations the following definitions:
a) "Attending physician" means the physician chosen by the
resident or the resident's representative to be responsible
for the medical treatment of the resident in the facility;
b) "Informed consent" means the voluntary agreement of a
patient or a resident's representative to accept a
treatment or procedure after receiving information in
accordance with: i) Information that is material to an
individual patient's decision concerning whether to accept
or refuse any proposed treatment or procedure; and, ii)
Number 4) below of the existing regulations; and,
c) "Psychotherapeutic drug" means a medication to control
behavior or to treat thought disorder processes.
2)Requires as in existing regulations the attending physician to
be the responsible party and 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.
SB 303
Page 2
3)Requires the physician to disclose the material information
and obtain informed consent.
4)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.
5)Adds, to the information on risks associated with
psychotherapeutic drugs from the existing regulations in 4) 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; and,
b) In writing, any current boxed warning labels and
accompanying detailed information regarding contradictions,
SB 303
Page 3
warnings, and precautions required by the FDA.
6)Codifies from existing regulations the 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.
7)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.
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 resident's 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 from existing regulations that nothing in this bill
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 DPH to inspect nursing facilities for compliance
with the provisions in this bill during DPH's periodic
inspections or complaint investigations already required under
existing law.
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
SB 303
Page 4
consent for the administration of psychotherapeutic drugs.
14)States the following legislative findings and declarations
related to the risks associated with the prescription of
psychotherapeutic drugs and the lack of information provided
to nursing facility residents:
a) Almost 60% of California nursing facility residents are
prescribed psychoactive drugs, many of which have dangerous
side effects;
b) Nearly 20% of California nursing facility residents are
receiving powerful antipsychotic drugs that are not
intended or approved for the resident's underlying medical
condition;
c) The United States Food and Drug Administration (FDA) has
issued black box warnings for the antipsychotic drugs most
commonly provided to nursing facility residents. The
warnings state that these antipsychotic drugs greatly
increase the risk of death for seniors with dementia;
d) Nursing facility residents and resident's
representatives rarely see the medication inserts that
provide the black box warnings and often do not receive
sufficient information about the side effects of
medications;
e) Nursing facility residents and resident's
representatives must be well-informed in advance about the
risks of proposed antipsychotic drugs and their consent
must be obtained before medications are used; and,
f) California's existing regulations on informed consent
for nursing facility residents are rarely enforced.
15)States the legislative intent in this bill to do all of the
following:
a) Codify provisions that establish a resident's right to
informed consent concerning the use of psychotherapeutic
drugs;
b) Specify that residents and their representatives must be
informed in writing about the content of black box warnings
SB 303
Page 5
for proposed drugs and whether the drug's proposed use has
been approved by the FDA; and,
c) Adds to the patient rights afforded to nursing facility
residents 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,
including decisions related to the administration of
psychotherapeutic drugs.
EXISTING LAW :
1)Requires nursing facilities to be licensed by DPH and requires
DPH to conduct periodic inspections of nursing facilities to
ensure compliance with statutory and regulatory requirements,
and authorizes DPH 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
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 Senate Appropriations
Committee analysis, this bill would have likely one-time costs
for fiscal year 2009-10 to the Medi-Cal Program of about $75,000
to $180,000 total funds ($30,000 to $70,000 General Fund and
$45,000 to $110,000 federal fund). These figures assume that
approximately 65% of nursing facility stays are paid by Medi-Cal
and current information indicates approximately 20% to 50% of
all facilities would not need to train their nursing staff on
these policies since many nursing facilities currently have
informed consent policies that meet or exceed the requirements
in this bill.
COMMENTS :
SB 303
Page 6
1)PURPOSE OF THIS BILL . 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 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.
The author also states that DPH is responsible for the
enforcement of existing informed consent requirements, but
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 administers psychotherapeutic drugs to their
residents.
2)BACKGROUND . 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 data provided by CMS' On-Line
Survey, Certification, and Reporting system, 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 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 February 2009, the Attorney General arrested a nurse,
physician, and pharmacist who worked for a nursing facility in
Kern County, for forcibly administering high doses of
antipsychotic drugs to patients with Alzheimer's disease and
dementia who were noisy, uncooperative, or otherwise
SB 303
Page 7
disruptive. As a result of the forced administration of these
drugs, three residents died and one resident suffered great
bodily injury. When the case was discovered, DPH immediately
sent an investigative team to the facility, where the team
discovered 22 residents had been given high doses of
antipsychotic drugs to control and quiet their behavior. DPH
issued a "certificate of immediate jeopardy" to the facility
and turned the case over to the Department of Justice.
3)CMS GUIDELINES REGARDING PSYCHOTHERAPEUTIC DRUGS . In 2006, in
an effort to ensure nursing facility residents' drug regimes
are properly managed and monitored, and to prevent unnecessary
and excessive 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.
In the guidelines, CMS cited an analysis of antipsychotic drug
use by 693,000 Medicare nursing home residents which revealed
that 28.5% of doses received were excessive and 32.2% lacked
appropriate indications for use. CMS guidelines state that
facilities must ensure that residents who have not used
antipsychotic drugs are not given these drugs unless
antipsychotic drug therapy is necessary to treat a specific
condition as diagnosed, and is documented in the resident's
health record, and that residents who use antipsychotic drugs
receive gradual dose reductions, unless clinically
contraindicated, as well as behavioral interventions, in an
effort to discontinue the use of the drugs. 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.
4)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
SB 303
Page 8
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, nursing facilities 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.
5)OPPOSITION . 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. CHA further argues
that obtaining informed consent from the patient or the
patient's representative is the responsibility of the
attending physician.
6)PRIOR LEGISLATION . AB 894 (Alquist), Chapter 46, Statutes of
2000, requires an attending physician of a SNF resident to
obtain the informed consent of that resident for purposes of
prescribing, ordering, or increasing an order for psychoactive
medication, and to, with resident consent, notify the
SB 303
Page 9
resident's designated family member within 48 hours of the
prescription, order, or increase of an order of antipsychotic
medication.
7)DOUBLE REFERRAL . This bill is double referred. Should it
pass out of this committee it will be referred to the
Committee on Judiciary.
8)DRAFTING ISSUES .
a) Terminology . This bill uses several different terms in
referencing the medications subject to its provisions,
including antipsychotic, psychotic and psychotherapeutic.
Staff recommends that the author amend this bill to use
consistent and accurate terminology throughout.
b) Facility Type . Just prior to completion of this
analysis, the committee received a letter communicating
that DPH is neutral with amendments. DPH is requesting
that this bill be amended with technical amendments to
clarify that it would apply to skilled nursing and
intermediate care facilities. Staff recommends that the
author amend this bill to make the technical clarifications
needed.
REGISTERED SUPPORT / OPPOSITION :
Support
California Advocates for Nursing Home Reform (sponsor)
AARP
Area Agency on Aging of Lake & Mendocino Counties
Bet Tzedek Legal Services
California Alliance for Retired Americans
California Senior Legislature
Consumer Attorneys of California
Contra Costa County Advisory Council on Aging
Disability Rights California
Gray Panthers Sacramento
Long-Term Care Ombudsman for Santa Cruz and San Benito Counties
Older Women's League of California
Service Employees International Union
Opposition
SB 303
Page 10
California Association of Health Facilities
California Hospital Association
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097