BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 303
S
AUTHOR: Alquist
B
AMENDED: As Introduced
HEARING DATE: April 1, 2009
3
REFERRAL: Judiciary
0
CONSULTANT:
3
Green/
SUBJECT
Nursing facility residents: informed consent
SUMMARY
Codifies existing regulations that establish a skilled
nursing facility (SNF) resident's right to informed consent
concerning the use of psychotherapeutic drugs. Specifies
the type of information residents shall receive in order to
make informed consent, and requires nursing home staff to
verify informed consent prior to the administration of a
psychotherapeutic drug.
CHANGES TO EXISTING LAW
Existing law:
Under existing law, long-term health care facilities
include 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
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STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 2
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:
Existing regulations 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.
Existing regulations 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
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 3
restraints, or other devices that impede the body's normal
function, that shall be disclosed, shall include:
the reason for the treatment and the nature and
seriousness of the patient's illness;
the nature of the procedures to be used in the proposed
treatment, as specified;
the degree and duration of improvement or remission
expected with or without the proposed treatment;
the associated side effects and significant risks of the
proposed treatment, as specified;
why the proposed treatment is recommended, as well as
possible alternative treatments and risks; and,
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.
Existing regulations 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.
Existing regulations 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.
Existing regulations also 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:
This bill would codify existing regulations relating to a
SNF resident's right to receive all material information
relating to a proposed treatment or procedure. With regard
to the administration of psychotherapeutic drugs, physical
restraints, or other devices that impede the body's normal
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 4
function, the bill would codify existing regulations
relating to the physician's responsibility to obtain a
resident's informed consent, the type of material
information to be disclosed when obtaining informed
consent, and SNF policies and procedures for facility staff
verification of informed consent.
This bill would require that information on risks
associated with psychotherapeutic drugs, including whether
the drug is being prescribed for off-label use, current
boxed warning labels on the drug packaging, and information
regarding contraindications, warnings, and precautions
required by the federal Food and Drug Administration (FDA),
be included in the material information.
This bill would, prior to the administration of
psychotherapeutic drugs, physical restraints, or other
devices that impede the body's normal function, require
facility staff to verify with the resident, or the
resident's representative, that the resident has been fully
informed about, and given consent for, the proposed
treatment, and to document that verification in the
resident's health record.
The bill would clarify that, during periodic inspections,
DPH shall inspect SNFs for compliance with the informed
consent requirements, and that a violation of the informed
consent requirements may result in a citation, as
specified. The bill would also repeal the existing statute
relating to the rights of a resident determined to be
incompetent, and replace it with related existing
regulatory provisions.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
According to the author, the use of antipsychotic drugs in
nursing homes 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
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 5
Services (CMS), indicating that approximately 60 percent of
nursing home 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 home compliance. The author states
that this bill is needed to ensure that nursing facility
residents, or their representatives, give informed consent
before nursing home staff administers psychotherapeutic
drugs to their residents.
Psychotherapeutic drugs in nursing facilities
Pscyhotherapeutic 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 (OSCAR) 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 Food and Drug Administration (FDA) to require
black box warnings on their labels, informing patients of
the health risks associated with their use.
Recent CMS guidelines
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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, the Centers of Medicare and Medicaid
Services (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 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.
Other federal and state actions
In February 2009, the California Attorney General arrested
a nurse, physician, and pharmacist who worked for a SNF 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,
three residents died, and one resident suffered great
bodily injury. Upon discovery of the case, DPH immediately
sent an investigative team to the facility, and discovered
that a total of 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's Bureau of Medi-Cal Fraud and Elder Abuse.
In response to reports of increased off-label marketing and
prescription of anti-psychotic medications to nursing
facility residents, the federal government, and other
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 7
states have taken steps to attempt to investigate marketing
practices, and to increase enforcement.
In January 2009, Eli Lilly, manufacturer of an
antipsychotic drug called Zyprexa, agreed to a federal
court settlement under which it agreed to pay $1.4 billion
in civil and criminal penalties to the federal government,
and various states, including California, for illegally
marketing Zyprexa for off-label use, and encouraging
doctors to prescribe the drug to dementia patients. As a
result of the settlement, California's Medi-Cal program
will receive $112 million from the settlement.
In 2007, U.S. Senator Chuck Grassley (R-Iowa), asked the
U.S. Inspector General to investigate the growing use of
antipsychotic medications in nursing homes, and also
launched an inquiry of three leading antipsychotic drug
manufacturers to examine their practices of marketing the
drugs for use by nursing home residents.
In 2007, in response to a growing number of complaints of
excessive and inappropriate administration of antipsychotic
drugs to nursing home residents, the Minnesota Department
of Health Services increased enforcement of the misuse of
antipsychotic medications in nursing homes. Of the state's
398 nursing homes, 38 percent were cited for misuse, an
increase of 11 percent from the year before.
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 resident's designated family member within 48
hours of the prescription, order, or increase of an order
of antipsychotic medication.
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
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 8
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.
Advocacy, Inc., which operates the Long-Term Care Ombudsman
Program for Santa Cruz and San Benito Counties, states that
the inappropriate and excessive use of psychoactive drugs
in SNF settings, and their effect on facility residents,
are frequently reported to its program, and that in
2008-09, ombudsman staff responded to 31 psychoactive
medication cases dealing with a lack of informed consent,
and inappropriate and/or excessive use. The Long-Term Care
Services of Ventura County, and the Ombudsman Services of
Northern California state that ombudsman staff visit SNFs
regularly and are keenly aware of the misuse of
psychotherapeutic drugs, which are often used for the
convenience of facility staff. The Long-Term Care Services
of Ventura County states that it currently has a number of
complaints under investigation regarding this matter, and
that this bill will help ensure that SNF residents or their
representatives give informed consent after having been
warned of the risks of these drugs.
AARP states that residents or their representatives are
often not aware of the warning labels on the medications
administered to them and, therefore are not aware of the
associated health risks. The California Alliance of
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 9
Retired Americans (CARA) and the Gray Panthers state that
the FDA has never approved use of antipsychotic drugs to
treat dementia, yet the use of these medications in nursing
homes is rampant, even though they sometimes worsen the
agitation in residents that they are prescribed to treat.
These supporters state that this bill will provide
residents and family members the opportunity to make
choices that help them manage their long-term care.
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 would 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 or 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 or 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.
Taking an oppose unless amended position, the California
Medical Association (CMA) states that this bill goes well
beyond existing law and could create burdensome
requirements that will inhibit communication with patients.
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CMA states that physicians worry that the new requirements
are onerous and unworkable, and will have a chilling effect
on getting physicians to work in long-term care settings,
which is already very challenging. CMA states that the
bill also appears to inject the court, without physician
input, into decision making about the capacity of patients
to make medical decisions, which could erect barriers and
delays to appropriate care. CMA states that, if
enforcement of existing informed consent law is lacking, it
is unclear how adding more to the law will help.
Concerns
The California Hospital Association (CHA), which represents
over 120 hospital-based SNFs, states that SB 303 makes
unnecessary changes to current law, and does not provide
for meaningful improvement in SNF resident care. CHA
states that SB 303 largely restates requirements that
already exist in state regulations, that current law
regarding informed consent are sufficient to patient rights
and safety, and additional legislation is not necessary.
COMMENTS
1. Bill should codify existing regulations regarding
facility staff verification of consent. Existing
regulations require facility staff to verify that the
resident's health record contains documentation that the
resident has given informed consent, prior to the
administration of a psychotherapeutic drug. This bill does
not codify this requirement, but does impose additional
requirements for staff to verify with the resident that he
or she has been informed about the proposed treatment, and
to document such verification. The author may wish to
codify the existing regulatory staff verification
requirement so that all pertinent facility staff
verification requirements are set forth together in the
statute, rather than separately in statute and regulations.
POSITIONS
Support: California Advocates for Nursing Home Reform
(sponsor)
AARP
Advocacy, Inc.
Bet Tzedek Legal Services
California Alliance for Retired Americans
STAFF ANALYSIS OF SENATE BILL SB 303 (Alquist)Page 11
California Senior Legislature
Dayle McIntosh Center
Gray Panthers
Kings Tulare Area Agency on Aging
Legal Services for Prisoners with Chidren
Long-Term Care Services of Ventura County, Inc.
Ombudsman Services of Northern California
Numerous individuals
Oppose: California Association of Health Facilities
(unless amended)
California Medical Association (unless amended)
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