BILL ANALYSIS
SB 303
Page 1
Date of Hearing: June 30, 2009
ASSEMBLY COMMITTEE ON JUDICIARY
Mike Feuer, Chair
SB 303 (Alquist) - As Amended: April 27, 2009
As Proposed to be Amended
SENATE VOTE : 25-13
SUBJECT : Nursing facility residents: informed consent
KEY ISSUE : IN ORDER TO BETTER PROTECT RESIDENTS OF NURSING
HOMES, SHOULD THEIR RIGHT TO MAKE INFORMED DECISIONS REGARDING
TREATMENTS, INCLUDING THE ADMINISTRATION OF PSYCHOTHERAPEUTIC
DRUGS, BE MADE EXPLICIT IN LEGISLATION?
FISCAL EFFECT : As currently in print this bill is keyed fiscal.
SYNOPSIS
Sponsored by California Advocates for Nursing Home Reform
(CANHR), this bill enacts the Nursing Facility Resident Informed
Consent Protection Act of 2009 which codifies existing
regulations regarding informed consent and establishes the right
of residents of nursing facilities to receive information
material to the decision to accept or refuse any treatment,
including the administration of psychotherapeutic drugs.
According to the author, the use of psychotherapeutic drugs in
nursing facilities 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
is concerned that such usage is dangerous and that a significant
number of those residents are not adequately informed of the
side effects and risks of the medications. 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. The bill is supported by numerous
senior and consumer groups.
Groups representing health facilities oppose the bill, arguing
that it broadens the requirement for informed consent in a way
that infringes on scope of practice issues for nurses and on the
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physician's professional judgment; requires facilities to
develop new policies and procedures to implement these new
requirements; and it does not provide meaningful improvement in
patient care in skilled nursing facilities.
The bill passed out of the Assembly Health Committee last week
on a 13-3 vote, with the agreement that the author would take
some technical amendments, discussed below in the analysis, in
this Committee.
SUMMARY : Enacts the Nursing Facility Resident Informed Consent
Protection Act of 2009. Specifically, this bill :
1)Codifies, from existing regulations, definitions for
"attending physician," "informed consent," and
"psychotherapeutic drug."
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. 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
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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, 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,
warnings, and precautions required by the FDA.
5)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 that the physician 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 to
document this verification in the resident's health record.
Requires facilities to ensure that all decisions concerning
the withdrawal or withholding of life sustaining treatment are
documented in the resident's health record.
7)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.
8)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.
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9)Requires the Department of Public Health (DPH) to inspect
skilled nursing facilities and intermediate care facilities
for compliance with the provisions in this bill during DPH's
periodic inspections or complaint investigations already
required under existing law. 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.
10)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.
11)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 percent of California nursing facility
residents are prescribed psychotherapeutic drugs, many of
which have dangerous side effects;
b) Nearly 20 percent of California nursing facility
residents are receiving powerful antipsychotic drugs, which
are a subclass of psychotherapeutic drugs, that are not
intended or approved for the residents' underlying medical
condition;
c) The 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 residents'
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 residents'
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.
EXISTING LAW :
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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. (Health and Safety Code Sections
1250 et seq. and 1417 et seq. Unless stated otherwise, all
further references are to that code.)
2)Sets forth the bill of rights for residents of nursing
facilities. (Section 1599 et seq.)
3)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. (Section 1418.9.)
4)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. (Id.)
COMMENTS : This bill, sponsored by CANHR, enacts the Nursing
Facility Resident Informed Consent Protection Act of 2009 which
codifies existing regulations requiring physicians to obtain
informed consent and establishes the right of residents of
nursing facilities to receive information material to the
decision to accept or refuse any treatment, including the
administration of psychotherapeutic drugs.
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 percent 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.
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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.
Psychotherapeutic Drugs : 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 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. 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 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.
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
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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 percent of doses received were excessive and 32.2
percent 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.
Amendments Agreed to in Assembly Health Committee : This bill
passed out of the Assembly Health Committee on June 23, 2009, on
a vote of 13 to 3. At the hearing, the author agreed to accept
technical amendments that, because of timing, need to be taken
in this Committee. The amendments simply (1) make consistent
use of medication terminology throughout the bill; and (2)
clarify, as requested by DPH, that the bill applies only to
skilled nursing and intermediate care facilities.
ARGUMENTS IN SUPPORT : CANHR and supporters, including AARP, Bet
Tzedek Legal Services, California Alliance for Retired Americans
and California Senior Legislature, state 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. They state 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. They state 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
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that DPH shall inspect for compliance with informed consent
requirements. They state 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. They assert that this bill
will help ensure that these existing duties are carried out in
an appropriate manner.
ARGUMENTS IN OPPOSITION : The bill is opposed by, among others,
the California Association of Health Facilities (CAHF),
California Association of Long Term Medicine (CALTM) and the
California Hospital Association (CHA). 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.
The CALTM opposes the bill arguing that "there are no approved
alternative medications for the problems of psychosis due to
dementia" and that the bill is duplicative of existing
requirements, unworkable, confusing and seeks to tell physicians
how to practice medicine.
The sponsor counters that the bill "is in complete conformance
with California's law and guiding principles regarding informed
consent" and that it simply reinforces and clarifies existing
laws and regulations to ensure that nursing home residents "will
be able to more meaningfully participate in their treatment
decisions and protect their health and well-being."
Prior Legislation : AB 894 (Alquist), Chap. 46, Stats. 2000,
requires an attending physician of a nursing facility resident
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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 resident's
designated family member within 48 hours of the prescription,
order, or increase of an order of antipsychotic medication.
REGISTERED SUPPORT / OPPOSITION :
Support
California Advocates for Nursing Home Reform (sponsor)
AARP
Alameda County Network of Mental Health Clients
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
Older Women's League of California
Service Employees International Union
Opposition
Aging Services of California
Association of California Health Care Districts
California Association of Health Facilities
California Association of Long Term Medicine
California Hospital Association
Crestwood Behavioral Health, Inc. (unless amended)
Analysis Prepared by : Leora Gershenzon / JUD. / (916)
319-2334