Existing law provides for the licensure and regulation of health facilities, including skilled nursing facilities and intermediate care facilities, by the State Department of Public Health. Existing law requires skilled nursing facilities and intermediate care facilities to have written policies regarding the rights of patients.

This bill would add to these rights the right of every resident to receive the information that is material to an individuals informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs, as specified. This bill would also add the right to be free from psychotherapeutic drugs used for the purpose of resident discipline or convenience, or from psychotherapeutic drugs used as a chemical restraint except in an emergency, as specified. Under the bill, all residents of skilled nursing facilities, intermediate care facilities, and hospice facilities would have the right to appeal an involuntary transfer or discharge through the appeal process, as specified, regardless of a residents payment source or the Medi-Cal or Medicare certification status of the facility in which the resident resides.

The bill would make the prescriber responsible for disclosing the material information relating to psychotherapeutic drugs to the resident and obtaining their informed consent, as defined. The bill would require facility staff to verify that a residents health record contains a signed, written consent form before initiating treatment with psychotherapeutic drugs, except as specified. The bill would require the facility, within 6 months after the consent form is signed, and every 6 months thereafter, to provide a written notice to the resident and their representative of any recommended dosage adjustments and the residents right to revoke consent, as specified. The bill would permit the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent.

The bill would declare the willful or repeated violation of these provisions to be punishable as a misdemeanor. By creating a new crime, the bill would impose a state-mandated local program.

The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form. The bill would require the informed consent form to be available to skilled nursing facilities and intermediate care facilities by December 31, 2025, and would exempt the facilities from including the written consent form in the residents health record until the informed consent form is available. Under the bill, the above-described provisions would be inapplicable to an individual under the care of the State Department of State Hospitals.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure and regulation of health facilities, including skilled nursing facilities and intermediate care facilities, by the State Department of Public Health. Existing law requires skilled nursing facilities and intermediate care facilities to have written policies regarding the rights of patients.

This bill would add to these rights the right of every resident to receive the information that is material to an individuals informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs, as specified. This bill would also add the right to be free from psychotherapeutic drugs used for the purpose of resident discipline or convenience, or from psychotherapeutic drugs used as a chemical restraint except in an emergency, as specified. Under the bill, all residents of skilled nursing facilities, intermediate care facilities, and hospice facilities would have the right to appeal an involuntary transfer or discharge through the appeal process, as specified, regardless of a residents payment source or the Medi-Cal or Medicare certification status of the facility in which the resident resides.

The bill would make the prescriber responsible for disclosing the material information relating to psychotherapeutic drugs to the resident and obtaining their informed consent, as defined. The bill would require facility staff to verify that a residents health record contains a signed, written consent form before initiating treatment with psychotherapeutic drugs, except as specified. The bill would require the facility, within 6 months after the consent form is signed, and every 6 months thereafter, to provide a written notice to the resident and their representative of any recommended dosage adjustments and the residents right to revoke consent, as specified. The bill would permit the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent.

The bill would declare the willful or repeated violation of these provisions to be punishable as a misdemeanor. By creating a new crime, the bill would impose a state-mandated local program.

The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form. The bill would require the informed consent form to be available to skilled nursing facilities and intermediate care facilities by December 31, 2025, and would exempt the facilities from including the written consent form in the residents health record until the informed consent form is available. Under the bill, the above-described provisions would be inapplicable to an individual under the care of the State Department of State Hospitals.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure and regulation of health facilities, including skilled nursing facilities and intermediate care facilities, by the State Department of Public Health. Existing law requires skilled nursing facilities and intermediate care facilities to have written policies regarding the rights of patients.

This bill would add to these rights the right of every resident to receive the information that is material to an individuals informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs, as specified. This bill would also add the right to be free from psychotherapeutic drugs used for the purpose of resident discipline, convenience, or chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. This discipline or convenience, or from psychotherapeutic drugs used as a chemical restraint except in an emergency, as specified. Under the bill, all residents of skilled nursing facilities, intermediate care facilities, and hospice facilities would have the right to appeal an involuntary transfer or discharge through the appeal process, as specified, regardless of a residents payment source or the Medi-Cal or Medicare certification status of the facility in which the resident resides.

The bill would make the prescriber responsible for disclosing the material information relating to psychotherapeutic drugs to the resident and obtaining their informed consent, as defined. The bill would require facility staff to verify that a residents health record contains a signed, written consent form before initiating treatment with psychotherapeutic drugs. drugs, except as specified. The bill would require the facility, within 6 months after the consent form is signed, and every 6 months thereafter, to provide a written notice to the resident and their representative of any recommended dosage adjustments and the residents right to revoke consent, as specified. The bill would permit the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent. The

The bill would declare the willful or repeated violation of these provisions to be punishable as a misdemeanor. By establishing creating a new crime, the bill would create impose a state-mandated local program.

The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form. The bill would require the informed consent form to be available to skilled nursing facilities and intermediate care facilities by December 31, 2024, 2025, and would exempt the skilled nursing facilities from this requirement facilities from including the written consent form in the residents health record until the informed consent form is available. Under the bill, the above-described provisions would be inapplicable to an individual under the care of the State Department of State Hospitals.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure and regulation of health facilities, including skilled nursing facilities and intermediate care facilities, by the State Department of Public Health. Existing law requires skilled nursing facilities and intermediate care facilities to have written policies regarding the rights of patients.

This bill would add to these rights the right of every resident to receive the information that is material to an individuals informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs, as specified. This bill would also add the right to be free from psychotherapeutic drugs used for the purpose of resident discipline, convenience, or chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. This bill would make the prescriber responsible for disclosing the material information relating to psychotherapeutic drugs to the resident and obtaining their informed consent, as defined. The bill would require facility staff to verify that a residents health record contains a signed, written consent form before initiating treatment with psychotherapeutic drugs. The bill would require the facility, within 6 months after the consent form is signed, and every 6 months thereafter, to provide a written notice to the resident and their representative of any recommended dosage adjustments and the residents right to revoke consent, as specified. The bill would permit the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent. The bill would declare the willful or repeated violation of these provisions to be punishable as a misdemeanor. By establishing a new crime, the bill would create a state-mandated local program.

The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form. The bill would require the informed consent form to be available to skilled nursing facilities and intermediate care facilities by December 31, 2024, and would exempt the skilled nursing facilities from this requirement until the informed consent form is available.

This bill would also require the State Department of Public Health to inspect for compliance with the informed consent requirements described above during prescribed inspections.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure and regulation of health facilities, including skilled nursing facilities and intermediate care facilities, by the State Department of Public Health. Existing law requires skilled nursing facilities and intermediate care facilities to have written policies regarding the rights of patients.

This bill would add to these rights the right of every resident to receive the information that is material to an individuals informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs, as specified. This bill would also add the right to be free from psychotherapeutic drugs used for the purpose of resident discipline, convenience, or chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. This bill would make the prescriber responsible for disclosing the material information relating to psychotherapeutic drugs to the resident and obtaining their informed consent, as defined. The bill would require facility staff to verify that a residents health record contains a signed, written consent form before initiating treatment with psychotherapeutic drugs. The bill would require the facility, within 6 months after the consent form is signed, and every 6 months thereafter, to provide a written notice to the resident and their representative of any recommended dosage adjustments and the residents right to revoke consent, as specified. The bill would permit the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent. The bill would declare the willful or repeated violation of these provisions to be punishable as a misdemeanor. By establishing a new crime, the bill would create a state-mandated local program.

The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form. The bill would require the informed consent form to be available to skilled nursing facilities and intermediate care facilities by December 31, 2024, and would exempt the skilled nursing facilities from this requirement until the informed consent form is available.

This bill would also require the State Department of Public Health to inspect for compliance with the informed consent requirements described above during prescribed inspections.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the licensure and regulation of health facilities, including skilled nursing facilities and intermediate care facilities, by the State Department of Public Health. Existing law requires skilled nursing facilities and intermediate care facilities to have written policies regarding the rights of patients.

This bill would add to these rights the right of every resident to receive the information that is material to an individuals informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs, as specified. This bill would also add the right to be free from psychotherapeutic drugs used for the purpose of resident discipline, convenience, or chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. This bill would make the prescriber responsible for disclosing the material information relating to psychotherapeutic drugs to the resident and obtaining their informed consent, as defined. The bill would require facility staff to verify that a residents health record contains a signed, written consent form before initiating treatment with psychotherapeutic drugs. The bill would require the facility, within 6 months after the consent form is signed, and every 6 months thereafter, to provide a written notice to the resident and their representative of any recommended dosage adjustments and the residents right to revoke consent, as specified. The bill would permit the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent. The bill would declare the willful or repeated violation of these provisions to be punishable as a misdemeanor. By establishing a new crime, the bill would create a state-mandated local program.

The bill would require the State Department of Public Health, in consultation with interested stakeholders, to develop a standardized informed consent form. The bill would require the informed consent form to be available to skilled nursing facilities and intermediate care facilities by December 31, 2024, and would exempt the skilled nursing facilities from this requirement until the informed consent form is available.

This bill would also require the State Department of Public Health to inspect for compliance with the informed consent requirements described above during prescribed inspections.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 48

Author:(Aguiar-Curry)

As Amended Ver:September 8, 2023

Majority vote

SUMMARY

Creates the Nursing Facility Resident Informed Consent Protection Act of 2023 which requires a prescriber, prior to prescribing a psychotherapeutic drug for a resident of a skilled nursing facility (SNF) or intermediate care facility (ICF) to personally examine and obtain the informed written consent of the resident or the resident’s representative.

Senate Amendments

1. Require a prescriber, when obtaining informed consent from a resident or their representatives, to disclose whether a proposed drug being prescribed has or has not been approved by the Food and Drug Administration (FDA);
2. Delete the requirement that the Department of Public Health (DPH) evaluate compliance with the provisions of this bill during state licensing inspections;
3. Add language clarifying all residents of SNFS, ICFs, and hospice facilities have the right to appeal an involuntary transfer or discharge regardless of the resident's payment source, or the Medi-Cal or Medicare certification status of the facility in which the resident resides;
4. Require, if written translation services are not available, the consent form may be provided in English with oral interpretation in a language that the resident understands;
5. Exempt facilities from including the written consent form in the resident's health record until the informed consent form is made available by DPH;
6. Create a presumption that a violation of these provisions will be presumed to have caused the affected resident harm, which can be rebutted, and will be classified according to the nature of the violation and cited by DPH; and,
7. Clarify that the provisions of this bill do not apply to and individual under the care of the Department of State Hospitals, and makes other technical and clarifying changes.

COMMENTS

1. Current informed consent requirements at SNFs and ICFs. Under existing regulations for both SNFs and ICFs, there are a number of requirements governing informed consent, including specific requirements governing the administration of a psychotherapeutic drug or physical restraint. The regulations state that it is the responsibility of the attending physician to determine what information a reasonable person in the patient's condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure, and that the disclosure of the material information and obtaining informed consent is the responsibility of the licensed healthcare practitioner, acting within their scope of practice, who orders the treatment for which informed consent is required. For the administration of a psychotherapeutic drug or a physical restraint, or the prolonged use of a device that may lead to the inability of a patient to regain use of a normal bodily function, the material information required to be disclosed in order for the patient or the patient's representative to provide informed consent includes the following:
   1. The reason for the treatment and the nature and seriousness of the patient's illness;
   2. The nature of the procedures to be used in the proposed treatment, including their probable frequency and duration;
   3. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
   4. The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions;
   5. The reasonable alternative treatment and risks, and why the health professional is recommending this particular treatment; and,
   6. That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.

Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff is required to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The regulations permit the initiation of treatment without informed consent if there is documentation within the patient's record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for the preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impractical to obtain the required consent. The regulations also permit the disclosure of risks of a proposed treatment or procedure to be withheld if there is documentation that the patient or patient's representative specifically requested that they not be informed of the risks, or when the licensed health care practitioner relied upon objective facts that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient's representative gave informed consent. A general consent form in a contract for admission can only encompass consent for routine nursing care or emergency care.

The requirements in this bill build off the requirements in regulations as described by, among other things, requiring the informed consent for psychotherapeutic drugs to be written and signed by both the prescriber and the patient or the patient's representative, requiring the prescriber to personally examine and obtain the written informed consent, and adding additional required disclosures such as whether a drug is being prescribed for a purpose that has not been approved by the FDA, and information related to black box warnings.

1. Black box warnings. A "Black Box Warning" exists on the label of all antipsychotic drugs reading: "Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. Antipsychotics are not approved for the treatment of patients with dementia related psychosis."

However, antipsychotic drugs have been used for some time for "off label" use for patients with dementia. To use a drug "off label" means the prescription of a medication to treat a condition that has not been officially approved by the FDA for that purpose. Prescribing a drug for an "off label" reason is not illegal, and providers must use current research and standards to determine if such a use is beneficial.

1. Changing diagnosis. According to New York Times investigative reports published in October and November of 2021, the share of nursing home residents who are recorded as having schizophrenia has soared over the past decade. The 2012 Centers for Medicare & Medicaid Services effort to reduce unnecessary antipsychotic drug use in nursing homes included an exemption for residents with schizophrenia. Since then, the diagnoses have grown by 70%. The impact of this has been more severe on Black residents. A September 2021 study in the Journal of the American Geriatrics Society, "Disproportionate increases in schizophrenia diagnoses among Black nursing home residents with Alzheimer's and related dementia" found that since the new rules went into place, Black Americans with dementia have been 1.7 times as likely as their white nursing home neighbors to be diagnosed with schizophrenia.

According to the Author

Nursing facilities such as SNFs and ICFs have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. The author notes that while these drugs are sometimes appropriately prescribed to treat mental health conditions, many of the psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. The author states that this bill gives nursing home residents and their families' tools to decide if a medication is right for them.

Arguments in Support

California Advocates for Nursing Home Reform (CANHR) is the sponsor of this bill and states that antipsychotics and other psychotropic drugs are not only unsafe for elderly people with dementia, they often cause side effects that actually decrease a patient's cognitive abilities. The leading prescriber/pharmacy guide for reducing inappropriate drugging and adverse drug effects in elderly patients, the "Beers Criteria," lists nearly all psychotropic drugs in the "avoid" category, citing sedation, cognitive impairment, and increased risk of death.

Arguments in Opposition

The Department of Finance is opposed to this bill because it creates additional cost pressures on the Licensing and Certification Fund and may potentially compromise the health of residents at ICFs and SNFs. DPH notes that allowing prescribers of psychotherapeutic drugs to examine and obtain consent remotely may reduce the safety and quality of care for residents of long-term health care facilities and that the bill’s definition of psychotherapeutic drugs would narrow the scope of drugs subject to informed consent requirements.

FISCAL COMMENTS

According to the Senate Appropriations Committee:

1. The California Department of Public Health (CDPH) estimates one-time costs of $166,000 (Licensing and Certification Program Fund) for state administration.
2. Unknown, potentially significant court workload cost pressures resulting from additional misdemeanor prosecutions that are brought under the provisions of this bill (Trial Court Trust Fund, General Fund).

VOTES:

ASM HEALTH: 13-0-2

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner Horvath, Lackey, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ABS, ABST OR NV: Wendy Carrillo, Flora

ASM JUDICIARY: 9-0-2

YES: Maienschein, Essayli, Connolly, Haney, Pacheco, Papan, Reyes, Robert Rivas, Sanchez

ABS, ABST OR NV: Dixon, Kalra

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Weber, Ortega

ABS, ABST OR NV: Robert Rivas

ASSEMBLY FLOOR: 77-0-3

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

ABS, ABST OR NV: Chen, Lackey, Quirk-Silva

UPDATED

VERSION: September 8, 2023

CONSULTANT: Lara Flynn / HEALTH / (916) 319-2097 FN: 0002195

 THIRD READING  

Bill No: AB 48

Author: Aguiar-Curry (D), et al.

Amended: 9/8/23 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 12-0, 6/14/23

AYES: Eggman, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

SENATE JUDICIARY COMMITTEE: 11-0, 6/27/23

AYES: Umberg, Wilk, Allen, Ashby, Caballero, Durazo, Laird, Min, Niello, Stern, Wiener

SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/23

AYES: Portantino, Jones, Ashby, Bradford, Seyarto, Wahab, Wiener

ASSEMBLY FLOOR: 77-0, 5/22/23 - See last page for vote

SUBJECT: Nursing Facility Resident Informed Consent Protection Act of 2023

SOURCE: California Advocates for Nursing Home Reform

DIGEST:

This bill requires a prescriber, prior to prescribing a psychotherapeutic drug for a nursing home resident, to personally examine and obtain the informed written consent of the resident or their representative, and requires specified information to be disclosed when obtaining informed written consent.

Senate Floor Amendments of 9/8/23 incorporated technical assistance from the California Department of Public Health, including requiring residents of long term care facilities to have the right to appeal an involuntary transfer or discharge regardless of the resident’s payment source or whether the facility is Medi-Cal or Medicare certified, exempting the provisions of this bill from applying to an individual under the care of the Department of State Hospitals, deleting a number of findings and declarations, and making other minor and conforming changes.

ANALYSIS:

Existing law:

1. Licenses and regulates skilled nursing facilities (SNFs) and intermediate care facilities (ICFs) by the California Department of Public Health (CDPH). SNFs are defined as health facilities that provide skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis, and ICFs are defined as facilities that provide inpatient care to ambulatory or non-ambulatory patients who have recurring need for skilled nursing supervision and supportive care, but who do not require the availability of continuous skilled nursing care. [HSC §1250 (c) and (d)]
2. Permits an attending physician and a SNF or ICF to initiate a medical intervention for a resident of a SNF or ICF that requires informed consent, when the physician has determined the resident lacks the capacity to make health care decisions and there is no person with legal authority to makes those decisions on behalf of the resident, in accordance with acceptable standards of practice. [HSC §1418.8 (d)]

Existing state regulations:

1. Specifies, for purposes of obtaining informed consent in SNFs and ICFs, that it is the responsibility of the attending licensed healthcare practitioner acting within the scope of his or her professional practice to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure. [22 CCR §72528(a)]
2. Requires, for purposes of informed consent in SNFs and ICFs, that information material to a decision concerning the administration of a psychotherapeutic drug or physical restraint, or the prolonged use of a device that may lead to the inability of the patient to regain use of a normal bodily function, to include specified information, including the nature, degree, duration, and probability of side effects and significant risks, and reasonable alternative treatments and risks. [22 CCR §72528(b)]
3. Requires, prior to initiating the administration of psychotherapeutic drugs, SNF or ICF staff to verify that the patient’s health record has documentation that the patient gave informed consent to the proposed treatment. [22 CCR §72528(c)]
4. Defines “psychotherapeutic drug,” for purposes of requirements pertaining to SNFs and ICFs, as a medication to control behavior or to treat though disorder processes. [22 CCR §72092]

This bill:

1. Requires a prescriber, prior to prescribing a psychotherapeutic drug for a resident of a SNF or ICF, to personally examine and obtain the informed written consent of the resident or the resident’s representative.
2. Defines terms for purposes of this bill, including that “psychotherapeutic drug” means a drug to control behavior or to treat thought disorder processes but excludes antidepressants; and, “representative” means an individual who has authority to act on behalf of the resident, including a conservator, guardian, person authorized as agent in the resident’s advanced health care directive, the resident’s spouse, registered domestic partner, or family member, a person designated by the resident, or other legally designated individual.
3. Requires the prescriber, for purposes of the requirement in 1) above, to communicate, and the written consent form to contain, in a language the resident understands, the information a reasonable person in the resident’s condition and circumstances would consider material to a decision to accept or refuse the drug. If written translations services are not timely available, permits the written consent form to be provided in English with oral interpretation, and if the resident is hearing impaired or vision impaired, requires the material information and written consent form to be provided in an accessible format.
4. Requires the written consent form to be signed by the resident or their representative, and to also be signed by a health care professional who declares the resident or resident representative has been provided the material information. Permits, if the signature of the resident or resident’s representative cannot be obtain, a licensed nursing to sign the form and verify that they confirmed informed consistent with the resident or resident’s representative and state the name of the person with whom they verified consent. Requires copies of the signed consent form to be given to the resident and their representative.
5. Requires the SNF or ICF, within six months after the consent form is signed, and every six months thereafter during which the resident receives a psychotherapeutic drug, to provide a written notice to the resident and the resident’s representative of any recommended dosage adjustments and the resident’s right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
6. Permits the use of remote technology, including telehealth, to allow a prescriber to examine and obtain informed written consent, and permits the prescriber, the resident, or the resident’s representative to use electronic signatures.
7. Requires the prescriber to provide, in addition to the information required in specified regulations governing informed consent in SNFs and ICFs, the following additional information material to an informed consent decision concerning the administration of a psychotherapeutic drug:
   1. Possible nonpharmacologic approaches that could address their needs;
   2. Whether the drug has a boxed warning label along with a summary and information on how to find the contraindications and warnings required by the United States Food and Drug Administration (FDA);
   3. Whether a proposed drug is being prescribed for a purpose that has or has not been approved by the FDA;
   4. Possible interactions with other drugs the resident is receiving; and,
   5. How the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.
8. Requires facility staff, before initiating treatment with psychotherapeutic drugs, to verify that the resident’s health record contains a written consent form with the required signatures. Requires facility staff, for a prescription written prior to the admission and encompassing the admission of the resident, to verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
9. Requires residents’ rights policies and procedures established pursuant to this bill concerning informed consent to specify how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
10. Prohibits this bill from being construed to require a SNF or ICF to obtain informed consent each time a drug is administered unless material circumstances or risks change.
11. Requires a violation of the requirement for facility staff to verify that a resident has a signed written consent form prior to the administration of psychotherapeutic drugs to be presumed to have caused the affected residents harm, which may be rebutted, and to be classified as a “B,” “A,” or “AA” violation pursuant to the standards under existing law for these violations.
12. Specifies that in addition to any other penalties, the willful or repeated violation of this bill is punishable as a misdemeanor unless there is an emergency as described in specified regulations.
13. Requires CDPH, in consultation with interested stakeholders, to develop a standardized informed consent form.
14. Specifies that SNFs and ICFs are not required to include the written consent form in the resident’s health record until the informed consent form is available as developed by CDPH. Requires CDPH to have a final informed consent form available to SNFs and ICFs by December 31, 2025. Specifies that nothing in this bill negates existing informed consent requirements in law or regulations.
15. Exempts an individual under the care of the Department of State Hospitals from the provisions of this bill.
16. Permits CDPH, without taking any regulatory actions, to implement, interpret, or make specific this bill by means of an All Facilities Letter.
17. Requires all residents of SNFs, ICFs, and hospice facilities to have the right to appeal an involuntary transfer or discharge through the appeal process established under federal regulations applicable to Medi-Cal and Medicare services, regardless of a resident’s payment source or the Medi-Cal or Medicare certification status of the SNF, ICF, or hospice facility.
18. Adds requirements to the Skilled Nursing and Intermediate Care Facility Patient’s Bill of Rights related to the right to receive information material to a decision about whether to accept or refuse a proposed treatment, and related to the right to be free from psychotherapeutic drugs.
19. Makes various legislative findings and declarations, including that in 2022, the Office of the Inspector General for the United States Department of Health and Human Services found that approximately 80% of long-stay nursing home residents are receiving psychotherapeutic drugs, and that it is the intent of the Legislature to codify and expand rules that establish a resident’s right to provide or withhold written informed consent concerning the use of psychotherapeutic drugs and the right to be free from chemical restraint.

Comments

1. Author’s statement. According to the author, nursing facilities have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. While these drugs are sometimes appropriately prescribed to treat mental health conditions, many psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. This bill gives nursing home residents and their families tools to decide if a medication is right for them. This bill codifies 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 CDPH must inspect for compliance with informed consent requirements.
2. Current informed consent requirements at SNFs and ICFs. Under existing regulations for both SNFs and ICFs, there are a number of requirements governing informed consent, including specific requirements governing the administration of a psychotherapeutic drug or physical restraint. First, the regulations state that it is the responsibility of the attending physician to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure, and that the disclosure of the material information and obtaining informed consent is the responsibility of the licensed healthcare practitioner, acting within their scope of practice, orders the treatment for which informed consent is required. For the administration of a psychotherapeutic drug or a physical restraint, or the prolonged use of a device that may lead to the inability to regain use of a normal bodily function, the material information required to be disclosed in order for the patient or the patient’s representative to provide informed consent includes the following:
   1. The reason for the treatment and the seriousness of the patient’s illness;
   2. The nature of the procedures to be used in the proposed treatment, including their probable frequency and duration;
   3. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
   4. The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions;
   5. The reasonable alternative treatment and risks, and why the health professional is recommending this particular treatment; and,
   6. That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.

Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff is required to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The regulations permit the initiation of treatment without informed consent if there is documentation within the patient’s record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for the preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impractical to obtain the required consent. The regulations also permit the disclosure of risks of a proposed treatment or procedure to be withheld if there is documentation that the patient or patient’s representative specifically requested that they not be informed of the risks, or when the licensed health care practitioner relied upon objective facts that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient’s representative gave informed consent. A general consent form in a contract for admission can only encompass consent for routine nursing care or emergency care.

The requirements in this bill build off the requirements in regulations as described here by, among other things, requiring the informed consent for psychotherapeutic drugs to be written and signed by both the prescriber and the patient or the patient’s representative, requiring the prescriber to personally examine and obtain the written informed consent, and adding additional required disclosures such as if a drug is being prescribed for a purpose that has not been approved by the FDA, and information on black box warnings.

1. Drug labeling and black box warnings. Under FDA drug labeling requirements, certain drug interactions, adverse reactions, and other potential safety hazards that are considered serious or are otherwise clinically significant are required to be included in a “warning and precautions” section of a drug label. This could involve lengthy and detailed information about adverse reactions, laboratory test interference, and is typically included in a package insert. Also on the insert is a section on “contraindications,” where there are known hazards that in some clinical situation indicate the risk from use outweighs any therapeutic benefit. A “boxed warning,” also known as a black box warning, is the strongest form of warning required by the FDA for prescription drug labeling. It is presented in a box surrounded by a black border and is placed on the drug label and any package inserts. A boxed warning is ordinarily used to highlight for prescribers when there is an adverse reaction so serious in proportion to the potential benefit, such as a life-threatening reaction, that it is essential that it be considered in assessing the risks and benefits of using the drug. A boxed warning is also used when there is a serious adverse reaction that can be prevented or reduced in frequency by appropriate use of the drug (patient selection, monitoring, addition of another drug, etc.), or when FDA approved the drug with restrictions to ensure safe use. According to FDA guidance, a boxed warning provides a brief, concise summary of the information that is critical for a prescriber to consider, including any restriction on distribution or use. There is typically a more detailed discussion of the risk elsewhere in the labeling, such as in the “warnings and precautions” or “contraindications” section, that must be identified by cross-reference.
2. Psychotherapeutics, antipsychotics, and black box warning on the use of antipsychotics in the elderly. This bill imposes enhanced informed consent procedures when a proposed treatment involves “psychotherapeutic drugs,” which is defined to mean a drug to control behavior or to treat thought disorder processes, excluding antidepressants. Psychotherapeutic drug is a general term that can encompass a number of medications that affect brain chemistry. It can include antidepressants (which are specifically excluded from this bill), anti-anxiety medications such as benzodiazepines, stimulants such as medication to treat attention-deficit/hyperactivity disorder, and antipsychotic medicines, which are used to manage psychosis. Antipsychotic drugs are used to treat conditions such as schizophrenia and bipolar disorder. There are older, first generation antipsychotics, also called “typical” antipsychotics, which include chlorpromazine and haloperidol, and newer “atypical” antipsychotics such as risperidone, olanzapine, and quetiapine. Going back to 2003, the FDA began warning about increased risk of “cerebrovascular adverse events including stroke” in dementia patients treated with the atypical antipsychotic drug risperidone. Following a meta-analysis, the FDA issued a black-box warning citing an increased risk of mortality for patients receiving atypical antipsychotics versus placebo, which was applied to all atypical antipsychotics as a class. In 2008, the FDA updated this black box warning to apply to conventional first generation, or typical, antipsychotics as well. The warning states that conventional or atypical antipsychotic drugs are not FDA-approved for the treatment of dementia-related psychosis. The warning states that use of conventional or atypical antipsychotic drugs in elderly patients with dementia-related psychosis is associated with an increased risk of death, and that prescribers who institute antipsychotic drug use in the regimen of an elderly patient with dementia-related psychosis should discuss the increased risk of mortality with the patient, caregivers, and family members.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee:

• CDPH estimates one-time costs of $166,000 (Licensing and Certification Program Fund) for state administration.
• Unknown, potentially significant court workload cost pressures resulting from additional misdemeanor prosecutions that are brought under the provisions of this bill (Trial Court Trust Fund, General Fund).

SUPPORT: (Verified 9/8/23)

California Advocates for Nursing Home Reform (source)

A Voice for Choice Advocacy

AARP

Alzheimer's Greater Los Angeles

Alzheimer's Orange County

Alzheimer's San Diego

Berkeley City Council District 4, Office of Vice Mayor Kate Harrison

California Alliance for Retired Americans

California Commission on Aging

California Health Coalition Advocacy

California Long-Term Care Ombudsman Association

California Office of the State Long-term Care Ombudsman

California Retired Teachers Association

Consumer Attorneys of California

Educate. Advocate.

Elder Law & Advocacy

Essential Caregivers Coalition

Gray Panthers of San Francisco

Justice in Aging

Long Term Care Services of Ventura County

National Association of Social Workers, California Chapter

Oakland Privacy

Retired Public Employees Association

The Geriatric Circle

OPPOSITION: (Verified 9/8/23)

Department of Finance

ARGUMENTS IN SUPPORT: This bill is sponsored by California Advocates for Nursing Home Reform (CANHR), which states that for decades, regulations that ensure the rights of nursing home residents to give informed consent before being administered psychotropic drugs have become less meaningful as enforcement and compliance have diminished. Today, over-drugging is once again at crisis levels for nursing home residents, and refreshing and codifying informed consent protections for residents would ameliorate this problem. According to CANHR, following a number of studies showing severe side effects, including death, the FDA issued public health advisories that the treatment of dementia with antipsychotic medications was contra-indicated. Antipsychotics are associated with increased stroke, heart attack, pneumonia, extrapyramidal side effects and a host of other serious conditions. According to CANHR, the FDA now requires that all antipsychotics be accompanies by a black box warning label, cautioning the user that the drugs nearly double the risk of death for elderly patients with dementia. CANHR states that expert guidance in the care of people with dementia mandates that psychotropic drugs be used only as a last resort and only after non-pharmacological options have been exhausted. A number of organizations support this bill. The Office of the State Long-Term Care Ombudsman states that their representatives continue to handle hundreds of complaints from residents or their representatives that relate to chemical restraints, in addition to side effects that are caused by these drugs. The California Alliance of Retired Americans states that information and choice are nursing home residents’ best protection against inappropriate psychotropic drug use.

ARGUMENTS IN OPPOSITION: The California Department of Finance (DOF) states it opposes this bill because it creates additional cost pressures on the Licensing and Certification Fund and may potentially compromise the health of residents at intermediate care and skilled nursing facilities. According to DOF, allowing prescribers of psychotherapeutic drugs to examine and obtain consent remotely may reduce the safety and quality of care for residents of facilities and that the bill’s definition of psychotherapeutic drugs would narrow the scope of drugs subject to informed consent requirements. Finally, because the provisions would not take effect until December 31, 2024, it would simultaneously codify and delay existing consent requirements, which could create conduction among facilities and their residents.

ASSEMBLY FLOOR: 77-0, 5/22/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Chen, Lackey, Quirk-Silva

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

9/11/23 12:47:45

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 48 (Aguiar-Curry) - Nursing Facility Resident Informed Consent Protection Act of 2023

Bill Summary:

AB 48 would require a prescriber, prior to prescribing a psychotherapeutic drug for a nursing home resident, to personally examine and obtain the informed written consent of the resident or their representative, and would require specified information to be disclosed when obtaining informed written consent.

*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********

The following information is revised to reflect amendments

adopted by the committee on September 1, 2023

Fiscal Impact:

• The California Department of Public Health (CDPH) estimates one-time costs of $166,000 (Licensing and Certification Program Fund) for state administration.
• Unknown, potentially significant court workload cost pressures resulting from additional misdemeanor prosecutions that are brought under the provisions of this bill (Trial Court Trust Fund, General Fund).

Author Amendments:

Author amendments specify that the prescriber must also provide informational material to an informed consent decision regarding whether a proposed drug is being prescribed for a purpose that has been approved by the U.S. Food and Drug Administration.

-- END --

SENATE COMMITTEE ON

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 48 (Aguiar-Curry) - Nursing Facility Resident Informed Consent Protection Act of 2023

Bill Summary:

AB 48 would require a prescriber, prior to prescribing a psychotherapeutic drug for a nursing home resident, to personally examine and obtain the informed written consent of the resident or their representative, and would require specified information to be disclosed when obtaining informed written consent.

Fiscal Impact:

• The California Department of Public Health (CDPH) estimates one-time costs of $166,000 (Licensing and Certification Program Fund) for state administration.
• Unknown, potentially significant court workload cost pressures resulting from additional misdemeanor prosecutions that are brought under the provisions of this bill (Trial Court Trust Fund, General Fund). Misdemeanor prosecutions carry the potential for incarceration and therefore certain defendants’ rights are attached to the proceedings. These include the right to a jury trial and the right to appointed counsel at public expense if the defendant cannot afford to hire an attorney. Invocation of these rights can lead to lengthier and more complex court proceedings. It generally costs about $1,000 to operate a courtroom for one hour. Although courts are not funded on the basis of workload, increased pressure on staff time and resources may create a need for increased funding for courts from the General Fund to perform existing duties. Numerous trial court operations are funded through the imposition and collection of criminal fines and fees. However, the Legislature has reduced and eliminated criminal fines and fees over the past decade. As a result, the 2023-24 May Revision proposed an ongoing annual allocation of $105.1 million from the General Fund to backfill declining revenue to the Trial Court Trust Fund.

Background:

The CDPH licenses and regulates skilled nursing facilities (SNFs) and intermediate care facilities (ICFs). Under existing regulations for SNFs and ICFs, there are a number of requirements governing informed consent, including specific requirements governing the administration of a psychotherapeutic drug or physical restraint.

The regulations state that it is the responsibility of the attending physician to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure, and that the disclosure of the material information and obtaining informed consent is the responsibility of the licensed healthcare practitioner. Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff is required to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure.

The regulations permit the initiation of treatment without informed consent if there is documentation within the patient’s record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for the preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impractical to obtain the required consent.

The regulations also permit the disclosure of risks of a proposed treatment or procedure to be withheld if there is documentation that the patient or patient’s representative specifically requested that they not be informed of the risks, or when the licensed health care practitioner relied upon objective facts that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient’s representative gave informed consent. A general consent form in a contract for admission can only encompass consent for routine nursing care or emergency care.

Proposed Law:

Specific provisions of the bill would:

• Require a prescriber, prior to prescribing a psychotherapeutic drug for a SNF or ICF resident, to personally examine and obtain the informed written consent of the resident or their representative, and require specified information to be disclosed when obtaining informed written consent.
• Require CDPH to inspect facilities for compliance, as specified.
• State that the willful or repeated violation of these provisions is punishable as a misdemeanor, as specified.
• Require CDPH, in consultation with interested stakeholders, to develop a standardized informed consent form and require CDPH to have a final informed consent form available by December 31, 2024.
• Permit CDPH, without taking any regulatory actions, to implement these provisions by means of an All-Facilities Letter or similar instruction.

Related Legislation:

AB 1809 (Aguiar-Curry, 2022) was similar to this bill. The bill was vetoed by the Governor.

-- END --

SENATE JUDICIARY COMMITTEE

Senator Thomas Umberg, Chair

2023-2024 Regular Session

Bill No: AB 48 (Author:Aguiar-Curry)

Version: March 16, 2023

Hearing Date: June 27, 2023

Fiscal: Yes

Urgency: No

Consultant: ID

SUBJECT

Nursing Facility Resident Informed Consent Protection Act of 2023

DIGEST

In order to protect the dignity of nursing home residents and decrease the misuse of psychotherapeutic drugs, this bill establishes new rights and processes for obtaining informed consent for psychotherapeutic drugs for nursing home patients. The bill also establishes mechanisms to enforce the new rights and processes.

EXECUTIVE SUMMARY

AB 48 attempts to address the issue of the overuse of psychotherapeutic drugs in California nursing homes. Psychotherapeutic drugs are meant to control behavior and thought disorder processes. Psychotherapeutic drugs, specifically antipsychotics, can increase the risk of death for elderly patients with dementia, yet are still widely used for residents with dementia in nursing homes. AB 48 aims to reduce the use of antipsychotics in nursing homes for elderly patients with dementia by requiring that nursing home facilities obtain the informed written consent of a resident or their representative before using or prescribing antipsychotics. It also requires that nursing home facilities provide residents with specific information about antipsychotics, their risks, and alternative options. The bill requires the Department of Public Health (DPH) to develop an informed written consent form for use by nursing homes under these provisions, and requires that nursing homes keep the signed form in the resident’s medical file, provide certain notices every six months after obtaining the consent, and affirm that informed written consent has been obtained before administering any antipsychotics. Lastly, the bill requires that the DPH conduct regular inspections of nursing home facilities for compliance, and makes the willful or repeated violation of the bill’s sections punishable as a misdemeanor. AB 48 is a reintroduction of a bill that passed the Legislature last year but was vetoed by the Governor, AB 1809 (Aguiar-Curry, 2022). This bill is sponsored by the California Advocates for Nursing Home Reform, and supported by 21 other organizations and individuals. There is no known opposition.

PROPOSED CHANGES TO THE LAW

Existing law:

1. Sets forth the bill of rights for patients in a skilled nursing, intermediate care, or hospice facility. (Health & Saf. Code § 1599 et seq.)
2. Defines “skilled nursing facility” as a health facility that provides skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis, including a small house skilled nursing facility. (Health & Saf. Code § 1250 (b).)
3. Defines “intermediate care facility” as a health facility that provides inpatient care to ambulatory or nonambulatory patients who have a recurring need for skilled nursing supervision and need supportive care, but who do not require availability of continuous skilled nursing care. (Health & Saf. Code § 1250 (d).)
4. Requires DPH to conduct periodic inspections of long-term health 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 & Saf. Code § 1420 et seq.)
5. Requires an attending physician at a skilled nursing facility to obtain informed consent from a nursing facility resident when prescribing, ordering, or increasing an order for an antipsychotic medication. (Health & Saf. Code § 1418.9.)
6. 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. (Ibid.)
7. Establishes a process whereby an attending physician and surgeon of a resident in a skilled nursing facility or intermediate care facility may prescribe or order a medical intervention requiring informed consent when they are unable to obtain informed consent because a resident lacks the capacity to provide informed consent. (Health & Saf. Code § 1418.8.)
8. Establishes that it is the responsibility of the attending licensed healthcare practitioner to determine what information a reasonable person in the patient's condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure. (22 Cal. Code of Regs. § 72528(a).)
9. Establishes that information material to a decision concerning the administration of a psychotherapeutic drug or other specified treatments must include the following:
   1. the reason for the treatment and the nature and seriousness of the patient's illness;
   2. the nature of the procedures to be used in the proposed treatment including their probable frequency and duration;
   3. the probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
   4. the nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions; and
   5. alternative treatments and risks, and why the health professional is recommending this particular treatment. (22 Cal. Code of Regs. § 72528(b).)
10. States that the patient has the right to accept or refuse the proposed treatment, and has the right to revoke his or her consent for any reason at any time. Id.
11. Before initiating psychotherapeutic drugs or other specified procedures, facility staff must verify that the patient's health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. (22 Cal. Code of Regs. § 72528(c).)
12. Establishes certain procedures for how a nursing facility may initiate a proposed treatment without the resident’s informed consent in certain circumstances, including when an emergency exists. (22 Cal. Code Regs., §§ 72528 (a)-(f).)

This bill:

1. Makes various legislative findings and declarations, including that as of 2021, 22% of California nursing facility residents are given powerful antipsychotic drugs, which are a subset of psychotherapeutic drugs; that the FDA has issued black box warnings stating that antipsychotic drugs greatly increase the risk of death for seniors with dementia; and, that it is the intent of the Legislature to codify and expand rules that establish a resident’s right to provide or withhold written informed consent concerning the use of psychotherapeutic drugs and the right to be free from chemical restraint.
2. Requires a prescriber, prior to prescribing a psychotherapeutic drug to the resident of a Skilled Nursing Facility (SNF) or Intermediate Care Facility (ICF) to personally examine and obtain the informed written consent of the resident or the resident’s representative.
3. Defines the following terms for the purposes of this bill:
   1. “Informed consent” means the voluntary agreement of a resident or a resident’s representative to accept a treatment or procedure after receiving specified information;
   2. “Psychotherapeutic drug” means a drug to control behavior or to treat thought disorder processes, excluding antidepressants; and,
   3. “Representative” means an individual who has authority to act on behalf of the resident, including, but not limited to, a conservator, guardian, person authorized as agent in the resident’s advanced health care directive, the resident’s spouse, registered domestic partner, or family member, a person designated by the resident, or other legally designated individual.
4. Requires the prescriber to communicate, and the written consent form to contain, in a language the resident understands, the information a reasonable person in the resident’s condition and circumstances would consider material to a decision to accept or refuse the drug. Permits the written consent form to be provided in English if written translation services are not timely available. Requires the information and written consent form to be provided in an accessible format if the resident is hearing or vision impaired.
5. Requires the written consent form, for purposes of the requirement in 3) above, to be signed by the resident or the resident’s representative, and to be signed by a health care professional who declares the resident or resident representative has been provided the material information. Requires copies of the signed consent form to be given to the resident and their representative.
6. Requires, if the signature of the resident or resident’s representative cannot be obtained, a licensed nurse to sign the form and verify that they confirmed informed consent with the resident or resident’s representative and to state the name of the person with whom they verified consent and the date.
7. Requires the nursing facility, within six months after the consent form is signed and every six months thereafter during which the resident receives a psychotherapeutic drug, to provide a written notice to the resident and the resident’s representative of any recommended dosage adjustments and the resident’s right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
8. Authorizes the use of remote technology, including, but not limited to, telehealth, to allow a prescriber to examine and obtain informed written consent.
9. Requires the prescriber to provide, in addition to the information required in specified regulations governing informed consent in SNFs and ICFs, the following additional information material to an informed consent decision concerning the administration of a psychotherapeutic drug:
   1. possible non-pharmacologic approaches that could address the resident’s needs;
   2. any current boxed warning labels and accompanying detailed information regarding contraindications, warning, and precautions required by the United States Food and Drug Administration (FDA);
   3. whether a proposed drug is being prescribed for a purpose that has not been approved by the FDA;
   4. possible interactions with other drugs the resident is receiving; and,
   5. how the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.
10. Requires facility staff, before initiating treatment with psychotherapeutic drugs, to verify that the resident’s health record contains a written consent form with the required signatures. Requires facility staff, for a prescription written prior to the admission and encompassing the admission of the resident, to verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
11. Requires residents’ rights policies and procedures established pursuant to this bill concerning informed consent to specify how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
12. Prohibits this bill from being construed to require a facility to obtain informed consent each time a drug is administered unless material circumstances or risks change.
13. Requires the DPH to inspect nursing facilities for compliance with this bill during required periodic inspections and, as appropriate, during complaint investigations. Prohibits this inspection requirement from limiting DPH’s authority in other circumstances to cite for violations or to inspect for compliance with this bill.
14. Deems a violation of the requirement above for facility staff to verify that a resident has a signed written consent form prior to the administration of psychotherapeutic drugs to have caused the affected residents harm and to constitute a class “B,” “A,” or “AA” violation pursuant to the standards under existing law for these violations.
15. Specifies that in addition to any other penalties, the willful or repeated violation of this bill is punishable as a misdemeanor unless there is an emergency as described in specified regulations.
16. Specifies that nothing in this bill impairs or otherwise alters other non-conflicting statutory or regulatory requirements, including but not limited to, requirements contained in specified regulations pertaining to initiating treatment without informed consent if an emergency exists in which immediate action is necessary for the prevention of serious bodily harm or to alleviate severe physical pain.
17. Requires DPH to develop a standardized informed consent form in consultation with specified stakeholders.
18. Specifies that nursing facilities are not required to comply with this bill until the informed consent form is available as developed by DPH, and requires DPH to have a final informed consent form available by December 31, 2024.
19. Authorizes DPH to implement the provisions of this bill by means of an All Facilities Letter, or similar instruction, and specifies that nothing in this bill negates existing informed consent requirements in law or regulations.
20. Adds the following two requirements to the Skilled Nursing and Intermediate Care Facility Patient’s Bill of Rights:
    1. requires a resident of a nursing home facility to have the right to receive the information that is material to an individual’s decision concerning whether to accept or refuse a proposed treatment or procedure, pursuant to specified regulations governing informed consent. Requires the disclosure of material information for administration of psychotherapeutic drugs to also include the disclosures required by this bill in 9) above; and,
    2. requires a resident of a nursing home facility to have the right to be free from psychotherapeutic drugs used for the purpose of resident discipline or convenience, and to have the right to be free from psychotherapeutic drugs used as a chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. Requires, if a chemical restraint is administered during an emergency, the chemical restraint to only be a drug that is required to treat the emergency condition, after being deemed the least intrusive treatment alternative for the resident, and used only for a specified and limited period of time. Defines “chemical restraint,” for purposes of this provision, as a drug used to control behavior and used in a manner not required to treat the resident’s medical symptoms.

COMMENTS

1. The Purpose of AB 48 according to the author

According to the author, AB 48 is necessary because:

Nursing facilities have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. While these drugs are sometimes appropriately prescribed to treat mental health conditions, many psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. This bill gives nursing home residents and their families tools to decide if a medication is right for them. This bill codifies 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 must inspect for compliance with informed consent requirements.

1. Dementia and the Best Practices for Managing the Disease

Dementia is a general term referring to for a variety of diseases that are caused by abnormal changes in the brain. Dementia impairs a person’s memory, cognition, attention, ability to communicate, reasoning and judgement, ability to complete daily tasks, and sometimes personality and behavior. Some types of dementia may cause difficulty with sleeping at night and hallucinations, while others can cause difficulty with walking or eating and irritability and personality changes. It is sometimes associated with particularly challenging behaviors like agitation, anger, disrobing, eating abnormalities, inappropriate sexual behavior, paranoia, and physical and verbal aggression.^[1] Dementia occurs due to changes in the brain that result in the death of brain cells and prevents brain cells from communicating with each other. Certain factors also increase the risk of dementia, such as age, family history, poor cardiovascular health, and past or repeated traumatic brain injuries.^[2] Additionally, race and ethnicity affect the likelihood of dementia – African Americans are twice as likely, and Latinos 1.5 times as likely, as Caucasians to have dementia. Behavioral and environmental interventions, such as increased structured activities, multisensory stimulation, music therapy, and reminiscence and problem-solving therapies, are the most effective interventions to manage dementia, but such therapies require investments in human resources and customization to each patient.^[3] On the other hand, evidence shows that pharmacological interventions, particularly antipsychotic drugs, have only mixed results at best and pose significant risks to patients.^[4]

1. The state of nursing facilities that care for patients with dementia and other illnesses

Nationally, it has been estimated that about 49% of all nursing home residents and 45.5% of all long-term care hospital patients have been diagnosed with some form of dementia.^[5] About 400,000 Californians are cared for in long-term care facilities every year.^[6]

Despite the extensive scholarship on best practices for managing dementia and the risks and limited efficacy of pharmacological treatments, a 2022 report from the United States Office of Inspector General (OIG) found that 80% of residents of nursing homes who resided at the home for at least 100 days were routinely given psychotropic drugs.^[7] Other reports, such as by Human Rights Watch and the Long Term Care Community Coalition, support these findings as well.^[8] Proponents of this bill also assert that nursing homes underreport psychotropic drug use by using psychotropic drugs not counted by the federal government or by misdiagnosing schizophrenia to hide the utilization of psychotropic drugs. A report by the New York Times supports this assertion as well.^[9] These reports suggest that many nursing homes are turning to antipsychotic drugs for their residents with dementia despite the risks due to staffing shortages and insufficient training to adequately provide the care and treatment experts say is most effective. A number of reports have shown a correlation between lower ratios of registered nurse staff to residents and between higher percentages of residents with low-income subsidies with a high use of psychotropic drugs.^[10] Reports indicate that nursing homes are using antipsychotics as a way of sedating residents with dementia instead, and they may even be hiding the true numbers through misdiagnosing schizophrenia or other illnesses to avoid having to report antipsychotic use to the federal government.

1. The risks of psychotherapeutic drugs to nursing facilities residents

The proponents of AB 48 assert nursing homes use of antipsychotic drugs have dire consequences, and the research supports the claim. Antipsychotics are not recommended as treatment options for dementia; rather, they are meant to treat schizophrenia or mania. Clinical studies have shown that using antipsychotics for dementia, an off-label use (a use other than their intended or described use), leads to a mortality rate 1.6 to 1.7 times higher for older patients with dementia given antipsychotics than those not given antipsychotics.^[11] Death from antipsychotics most often occurs from cardiovascular illnesses or from infection. Because of these serious risks, the FDA requires pharmaceutical companies to “black-label” antipsychotics, the highest safety-related warning that medications can be assigned by the FDA. Their labels must state on the label must state atypical use of antipsychotics are dangerous to older patients with dementia.

1. The History of nursing home reform and campaigns to reduce the use of antipsychotics:

One of the earliest reports on the over-use of antipsychotics in nursing homes was published by the United States Senate Special Committee on Aging in 1975. The report stated that “the flow of drugs through most of America’s 23,000 nursing homes is almost totally without controls; it is haphazard, inefficient, costly, and, most of all, dangerous to the patients who must trust others for their protection.”^[12] That report also noted that the elderly are particularly susceptible to the side effects of antipsychotic drugs, such that good medical practice requires that their use be strictly time-limited, episodic, and only supplementary to addressing the cause of a dementia patient’s agitation. Another report of the Institute of Medicine again highlighted the issue of the misuse of antipsychotics in 1986.^[13] In response, the United States Congress passed the Nursing Home Reform Law of 1987, which created a Resident’s Bill of Rights and banned the use of drugs that serve the interest of the nursing home or staff rather than the patient. The Bill of Rights at that time included the right to participate in the review of one’s own patient care plan and be informed of changes to the plan, including the risks and benefits of any medication, the right to refuse a medication, and included the right to be free from chemical restraints.

In 2005, the FDA published a public health advisory on the dangers of antipsychotics for elderly nursing home residents with dementia.^[14] That report resulted in the FDA announcing that manufacturers of certain antipsychotics must include the “black-label” warnings for atypical antipsychotics warning of these increased dangers of death. Three years later, this black-label warning requirement was extended to all antipsychotics. Research later suggested that the FDA’s black-label warnings, while decreasing the usage of antipsychotics, resulted in nursing homes simply shifting drugs, from antipsychotics to antiepileptics and opioids.^[15] Another report from the Office of Inspector General in 2011 highlighted the continued rampant use of antipsychotics in nursing homes.^[16] That report found that elderly patients with dementia accounted for 88 percent of antipsychotic prescriptions in nursing homes.

Following the 2011 OIG report, resident advocates and the United States Center for Medicare and Medicaid Services (CMS) created the National Partnership to Improve Dementia Care. That partnership aimed to reduce the use of antipsychotics in nursing homes through training for nursing home staff, emphasizing non-pharmacological alternatives to manage dementia patients, and through the collecting and publishing of data on each nursing home’s antipsychotic drug use. As part of this last strategy, CMS began requiring that nursing homes disclose how many of their residents are taking antipsychotics; however, there is an exception for instances in which the resident is taking the antipsychotics because of a schizophrenia, Huntington’s Disease, or a Tourette’s Syndrome diagnosis. Reporting, such as that by the New York Times previously mentioned, suggest that nursing homes may be undercounting the number of their residents taking antipsychotics by simply over diagnosing or misdiagnosing residents with schizophrenia.^[17] Therefore, the reporting and studies have suggested that the modest decrease in overall antipsychotic usage is misleading, and overuse of antipsychotics continues to pose serious risks to elderly residents in nursing homes. All of this evidence suggests that the nursing home patients can benefit from additional protections under the law.

1. Current informed consent obligations

Currently, attending physicians are required to obtain informed consent from nursing home residents when prescribing, ordering, or increasing an order for antipsychotics. (Health & Saf. Code § 1418.9(a)(1).) They also are required to seek the resident’s consent to notify the resident’s interested family member that is designated in the resident’s medical record, and to attempt to notify that family member within 48 hours of a prescription, order, or increase of any antipsychotic medication if the resident consents. (Health & Saf. Code § 1418.9(a)(2).) The attending physician is not required to attempt to notify a family member if no interested family members have been designated in the resident’s medical record, if the resident has been diagnosed with a terminal illness and is in hospice care, or if the resident does not consent to the notification. (Health & Saf. Code § 1418.9(b).) Before administering antipsychotics or physical restraints, nursing home staff is required to verify that the resident’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure.

However, the law allows for some medical intervention without the resident’s informed consent. If medical staff determine that consent cannot be obtained, the medical staff may initiate treatment without the resident’s informed consent if it is determined that the resident lacks the capacity to make a decision regarding their healthcare, is unable to understand the nature and consequences of the proposed intervention, or is unable to express a preference, and the nursing home follows additional procedures for documenting the lack of capacity, attempting to locate a suitable legal decision-maker, or conducting an interdisciplinary team review. (Health & Saf. Code § 1418.8.) In the case of an emergency where immediate action is needed for the preservation of life, for the prevention of serious bodily harm to the patient or others, or to alleviate severe physical pain, medical staff may initiate a medical invention without the resident’s informed consent even if that informed consent would otherwise be required.

Existing regulations further define what constitutes informed consent. California Code of Regulations mandates that the attending licensed healthcare practitioner at the skilled nursing facility “determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure.” (22 Cal. Code Regs. § 72528(a).) For the administration of a psychotherapeutic drug or a physical restraint, or the prolonged use of a device that could prevent the resident from regaining normal bodily function, the information considered material and required for disclosure includes:

1. the reason for the treatment and the nature and seriousness of the patient’s illness;
2. the nature of the procedures to be used in the proposed treatment, including their probable frequency and duration;
3. the probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
4. the nature, degree, duration and probability of the side effects and significant risks, commonly known by health professions;
5. the reasonable alternative treatment and risks, and why the health professional is recommending this particular treatment; and
6. that the patient has the right to accept or refuse the proposed treatment, and if they consent, has the right to revoke their consent for any reason at any time. (22 Cal. Code of Regs. § 72528(b).)
7. What AB 48 does to address the issue of overprescribing of psychotherapeutics:

Proponents of this bill assert that strong informed consent requirements are essential to ameliorating the problem of the overuse of antipsychotics in nursing homes. They propose codifying the regulations in section 72528 of the California Code of Regulations, and strengthening the existing rules and procedures on informed consent.

First, AB 48 establishes a new right that residents receive all “information that is material to an individual’s informed consent decision concerning whether to accept or refuse the administration of psychotherapeutic drugs.” The bill specifically states that the information required under this rule should be pursuant to the material information listed in section 722528 of the California Code of Regulations, and adds the following to the list of material information:

1. possible nonpharmacologic approaches that could address the resident’s needs;
2. whether the drug has a current boxed warning label along with a summary of, and information about how to find, the contraindications, warnings, and precautions required by the FDA;
3. whether a proposed drug is being prescribed for a purpose that has not been approved by the FDA;
4. possible interactions with other drugs the resident is receiving; and
5. how the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.

A health care professional at the nursing home facility must sign a form attesting to the fact that the resident received this material information, and keep this record in the resident’s file. AB 48 states that a violation of these provisions for the providing of material information shall be deemed to have caused the affected resident’s harm.

AB 48 also adds to the code the right for a resident to be free from the use of psychotherapeutic drugs for the “purposes of resident discipline or convenience.” It adds to the emergency exception for the use of a psychotherapeutic drug as a “chemical restraint” the requirements that the psychotherapeutic only be a drug that is required to treat the emergency condition, after being deemed the least intrusive treatment alternative, and that the drug only be used for a specified and limited period of time.

Lastly, AB 48 establishes a written informed consent procedure and requires that the California Department of Public Health create an informed consent form that must be signed by a resident before a nursing home can prescribe and administer a psychotherapeutic drug to a resident. The written consent must be in language the resident understands, and must be kept in the resident’s medical file. It must be provided in an accessible format if the resident is hearing or vision impaired. Copies of this form must be given to the resident or their representative, and must be kept in the resident’s medical file. AB 48 requires that every six months after such written informed consent is provided, the facility provide a written notice to the resident or their representative of any recommended dosage adjustments and the resident’s right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.

To enforce these provisions requiring obtaining written informed consent, this bill requires the California Department of Public Health to inspect nursing facilities for compliance during periodic inspections and complaint investigations. The willful or repeated violation of the requirements created by AB 48 will be punishable as a misdemeanor.

1. How AB 48 addresses concerns with AB 1807 that was vetoed in 2022

AB 48 is very similar to AB 1809 that was passed by the Legislature in 2022 but vetoed by Governor Newsom. The Governor’s veto message stated:

This bill would establish new rights and procedures for obtaining informed consent from nursing home residents before administering treatments or procedures and provides residents with the right to refuse psychotherapeutic drugs used as a chemical restraint, except in an emergency. The bill would also require the California Department of Public Health (CDPH) to develop an informed consent form for long-term care residents that includes a model disclosure statement for providing material information on the use of psychotherapeutic medications and the resident's right to withdraw informed consent.

I support the author's goal of improving informed consent requirements and protecting long-term care residents from inappropriate uses of psychotherapeutic medications. However, this bill creates ambiguity as to whether long-standing informed consent requirements will continue to be required until a new standardized form is developed, which could put the health of long-term care residents in jeopardy. Furthermore, the State Health Facilities Citation Penalties Account is not an appropriate funding source for the development of this form because the funds in the account are by law reserved for the protection of health or property of residents of long-term health care facilities. I encourage the author to work with CDPH to resolve these concerns in the next legislative session.

To address the Governor’s concerns regarding AB 1809’s ambiguity regarding the informed consent requirements while the Department of Public Health develops the informed consent form, AB 48 makes clear that nursing facilities are not required to comply with the provisions of AB 48 until the informed consent form is available. It also sets a deadline for the department to have the informed consent form available at December 31, 2024. AB 48 also includes a provision stating that nothing in the bill negates existing informed consent requirements.

To address the Governor’s other concern with AB 1809, that the fund designated for funding the development of the informed consent form was not an appropriate funding source, AB 48 does not specify a funding source for the development of the form by the Department of Public Health.

1. Arguments in support

According to the California Advocates for Nursing Home Reform, who sponsored this bill:

There are many routes to reducing the misuse of psychotropic drugs in nursing homes: prescribers, pharmacists, frontline nursing staff, and regulators. Perhaps the best assurance against misuse, though, is to provide each resident and, if applicable, their representative, with robust information about the proposed drug’s risks, benefits, and alternatives. An informed resident or their representative is best situated to decide whether a proposed drug is truly in their best interests: no prescriber, pharmacist, or nurse cares more about the well-being of the resident than the resident or their representative.

Informed consent is built on a rich tradition of centuries’ old common law and constitutional precepts. Courts throughout the country have fiercely guarded patient autonomy and self-determination, finding that, despite the expertise of prescribers, patients have the ultimate say regarding the treatment they receive. Physicians must provide information that would be material to the patient, including the nature and purpose of the proposed treatment, risks and benefits, and alternative treatments (including doing nothing). The decision, however, is left to the patient.

Despite the deep foundation of informed consent laws and protections that are specific in nursing homes, the process of obtaining informed consent is often meaningless. In 2011, the Department of Public Health (DPH) conducted an Antipsychotic Drugs Collaborative to evaluate the use of antipsychotics in nursing homes.10 The results were stunning. DPH found 147 violations involving 41 different regulations in just 24 facilities, an average of 6.1 deficiencies per facility. …

AB 48 enhances the current nursing home informed consent requirements in two critical ways. First, it requires doctors to provide pertinent information, like Black Box warnings and notifications of off-label use. Black Box warnings are the FDA’s sternest warning label, telling consumers when a prescribed drug will increase their risk of death. Nursing home residents never see Black Box warnings. Their drugs are received by nursing home staff who discard the packaging, leaving residents ignorant of the important message it conveys. Sharing Black Box information, off label use, and other important information about risks, benefits, and alternatives with residents or their representatives assures that consent for antipsychotic drugs is truly informed.

Second, AB 48 requires the prescriber to use a written consent form, documenting that material information is delivered and consent is obtained. In addition, the bill requires nursing home staff to verify when a consent form is signed and make it part of the resident’s medical record. This simple process for written informed consent is already routine at many nursing homes in California.

SUPPORT

California Advocates for Nursing Home Reform (CANHR) (Sponsor)

California Long-Term Care Ombudsman Association (CLTCOA)

National Association of Social Workers – California (NASW)

California Health Coalition Advocacy

Office of the State Long-Term Care Ombudsman

AARP California

A Voice for Choice Advocacy

Alzheimer’s Los Angeles

Alzheimer’s Orange County

Alzheimer’s San Diego

California Alliance for Retired Americans (CARA)

California Commission on Aging

California Retired Teachers Association (CalRTA)

Consumer Attorneys of California

Educate. Advocate.

Elder Law & Advocacy

Essential Caregivers Coalition California

California Geriatric Circle

Gray Panthers of San Francisco

Justice in Aging

Office of Vice Mayor Kate Harrison, Berkeley City Council District 4

Long Term Care Services of Ventura County, Inc.

Oakland Privacy

Retired Public Employees Association (RPEA)

California Continuing Care Residents Association (CALCRA)

OPPOSITION

None known

RELATED LEGISLATION

Pending Legislation: None known.

Prior Legislation:

AB 1809 (Aguiar-Curry, 2022) would have enacted the Nursing Facility Resident Informed Consent Protection Act of 2022 which establishes the rights of skilled nursing facility (SNF) and intermediate care facility (ICF) residents to receive information that is material to the individual's decision whether to accept or refuse a proposed treatment or procedure and provides residents with the right to be free from psychotherapeutic drugs used as a chemical restraint, except in the case of an emergency, as specified. This bill was vetoed by the Governor. See Comment 8 for a description of the Governor’s veto.

SB 303 (Alquist, 2009) would have enacted 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.

PRIOR VOTES:

Senate Health Committee (Ayes 12, Noes 0)

Assembly Floor (Ayes 77, Noes 0)

Assembly Appropriations Committee (Ayes 15, Noes 0)

Assembly Judiciary Committee (Ayes 9, Noes 0)

Assembly Health Committee (Ayes 13, Noes 0)

**************

1. Zwijsen, et al., Coming to grips with challenging behavior: a cluster randomized controlled trial on the effects of a multidisciplinary care program for challenging behaviors in dementia, Journal of the American Medical Directors Association (May 28, 2014), available at https://pubmed.ncbi.nlm.nih.gov/24878214/. ↑

2. Cal. Center for Disease Control, “About Dementia” (Apr. 5, 2019), available at https://www.cdc.gov/aging/dementia/index.html. ↑

3. Art Walaszek, “Best Practices In the Care of Patients with Behavioral and Psychological Symptoms of Dementia,” Alzheimer’s Disease Research Center, University of Wisconsin-Madison (Sept. 6, 2019), available at https://www.adrc.wisc.edu/news/best-practices-care-patients-behavioral-and-psychological-symptoms-dementia. ↑

4. Id. ↑

5. Christine Caffrey et al, “Post-acute and Long-term Care Providers and Services Users in the United States, 2017-2018,” U.S. Dept. of Human Services (May 2022), available at https://www.cdc.gov/nchs/fastats/alzheimers.htm. ↑

6. “Facts and Statistics: Long-Term Care Providers,” California Association of Health Facilities (Mar. 2021), available at https://www.cahf.org/About/Consumer-Help/Facts-and-Statistics. ↑

7. Office of the Inspector General, Long-Term Trends of Psychotropic Drug Use in Nursing Homes, U.S. Dept. of Health & Human Svcs. OEI-07-20-00500 (Nov. 2022). ↑

8. See, Human Rights Watch, “‘They Want Docile’: How Nursing Homes in the United States Overmedicate People with Dementia,” (February 2018); Long Term Care Community Coalition, “A Decade of Drugging: Sedation of Nursing Home Residents with Dangerous Antipsychotic Drugs Persists Despite Federal Partnership,” (2022). ↑

9. Katie Thomas, et al, “Phony Diagnoses Hide High Rates of Drugging at Nursing Homes,” The New York Times (Sept. 11, 2021), available at https://www.nytimes.com/2021/09/11/health/nursing-homes-schizophrenia-antipsychotics.html. ↑

10. Office of Inspector General, supra note 7. ↑

11. Karen Dagerman, “Risk of Death With Atypical Antipsychotic Drug Treatment for Dementia,” JAMA 294(15):1934-1943 (2005), available at https://jamanetwork.com/journals/jama/article-abstract/201714. ↑

12. Drugs in Nursing Homes: Misuse, High Costs, and Kickbacks, Sen.Doc. No. 41-557, 94th Cong., 1st Sess. (1975). ↑

13. Institute of Medicine, Improving the Quality of Care in Nursing Homes, (1986). ↑

14. Food & Drug Adm., Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances, U.S. Dept. Health & Hum. Svcs. (Apr. 11, 2005). ↑

15. Michael Ganz et al., “Association of the US Food and Drug Administration Antipsychotic Drug Boxed Warning with Medication Use and Health Outcomes in Elderly Patients with Dementia,” JAMA Network Open (Apr. 28, 2020), available at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2765053#:~:text=Meaning%20The%202005%20FDA%20boxed,patients%20to%20new%20health%20risks. ↑

16. Office of the Inspector General, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents, U.S. Dept. of Health & Hum. Svcs., OEI-07-08-00150 (May 2011). ↑

17. Thomas, supra note 9; Long Term Care Community Coalition, supra note 8 at 8. ↑

SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: AB 48

SUBJECT: Nursing Facility Resident Informed Consent Protection Act of 2023

SUMMARY:

Requires a prescriber, prior to prescribing a psychotherapeutic drug for a nursing home resident, to personally examine and obtain the informed written consent of the resident or their representative, and requires specified information to be disclosed when obtaining informed written consent.

Existing statute:

1. Licenses and regulates skilled nursing facilities (SNFs) and intermediate care facilities (ICFs) by the California Department of Public Health (CDPH). SNFs are defined as health facilities that provide skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis, and ICFs are defined as health facilities that provide inpatient care to ambulatory or non-ambulatory patients who have recurring need for skilled nursing supervision and need supportive care, but who do not require the availability of continuous skilled nursing care. [HSC §1250 (c) and (d)]
2. Permits an attending physician and a SNF or ICF to initiate a medical intervention for a resident of a SNF or ICF that requires informed consent, when the physician has determined the resident lacks the capacity to make health care decisions and there is no person with legal authority to makes those decisions on behalf of the resident, in accordance with acceptable standards of practice. [HSC §1418.8 (d)]
3. Specifies that a resident lacks capacity to make a decision regarding his or her health care if the resident is unable to understand the nature and consequences of the proposed medical intervention, or is unable to express a preference regarding the intervention. Requires the physician, in making this determination regarding capacity, to interview the resident, review the resident’s medical records, and consult with SNF or ICF staff, and family members and friends of the resident, if any have been identified. [HSC §1418.8 (b)]
4. Specifies that a person with legal authority to make medical decisions on behalf of a resident is a person designated under a valid Durable Power of Attorney for Health Care, a guardian, a conservator, or next of kin. Requires a physician to interview the resident, review medical records, and consult with SNF or ICF staff, and with family members and friends, if identified, in order to determine the existence of a person with legal authority. [HSC §1418.8 (c)]

Existing regulations:

1. Specifies, for purposes of obtaining informed consent in SNFs and ICFs, that it is the responsibility of the attending licensed healthcare practitioner acting within the scope of his or her professional practice to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure. [22 CCR §72528(a)]
2. Requires, for purposes of informed consent in SNFs and ICFs, that information material to a decision concerning the administration of a psychotherapeutic drug or physical restraint, or the prolonged use of a device that may lead to the inability of the patient to regain use of a normal bodily function, to include specified information, including the nature, degree, duration, and probability of side effects and significant risks, and reasonable alternative treatments and risks. [22 CCR §72528(b)]
3. Requires, prior to initiating the administration of psychotherapeutic drugs, SNF or ICF staff to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment. [22 CCR §72528(c)]
4. Defines “psychotherapeutic drug,” for purposes of requirements pertaining to SNFs and ICFs, as a medication to control behavior or to treat though disorder processes. [22 CCR §72092]

This bill:

1. Requires a prescriber, prior to prescribing a psychotherapeutic drug for a resident of a SNF or ICF, to personally examine and obtain the informed written consent of the resident or the resident’s representative.
2. Defines terms for purposes of this bill, including that “psychotherapeutic drug” means a drug to control behavior or to treat thought disorder processes but excludes antidepressants; and, “representative” means an individual who has authority to act on behalf of the resident, including a conservator, guardian, person authorized as agent in the resident’s advanced health care directive, the resident’s spouse, registered domestic partner, or family member, a person designated by the resident, or other legally designated individual.
3. Requires the prescriber, for purposes of the requirement in 1) above, to communicate, and the written consent form to contain, in a language the resident understands, the information a reasonable person in the resident’s condition and circumstances would consider material to a decision to accept or refuse the drug. If written translations services are not timely available, permits the written consent form to be provided in English, and if the resident is hearing impaired or vision impaired, requires the material information and written consent form to be provided in an accessible format.
4. Requires the written consent form to be signed by the resident or their representative, and to also be signed by a health care professional who declares the resident or resident representative has been provided the material information. Permits, if the signature of the resident or resident’s representative cannot be obtain, a licensed nursing to sign the form and verify that they confirmed informed consistent with the resident or resident’s representative and state the name of the person with whom they verified informed consent. Requires copies of the signed consent form to be given to the resident and their representative.
5. Requires the SNF or ICF, within six months after the consent form is signed, and every six months thereafter during which the resident receives a psychotherapeutic drug, to provide a written notice to the resident and the resident’s representative of any recommended dosage adjustments and the resident’s right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
6. Permits the use of remote technology, including, but not limited to, telehealth, to allow a prescriber to examine and obtain informed written consent, and permits the prescriber, the resident, or the resident’s representative to use electronic signatures.
7. Requires the prescriber to provide, in addition to the information required in specified regulations governing informed consent in SNFs and ICFs, the following additional information material to an informed consent decision concerning the administration of a psychotherapeutic drug:
   1. Possible nonpharmacologic approaches that could address their needs;
   2. Whether the drug has a boxed warning label along with a summary and information on how to find the contraindications and warnings required by the United States Food and Drug Administration (FDA);
   3. Whether a proposed drug is being prescribed for a purpose that has not been approved by the FDA;
   4. Possible interactions with other drugs the resident is receiving; and,
   5. How the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.
8. Requires facility staff, before initiating treatment with psychotherapeutic drugs, to verify that the resident’s health record contains a written consent form with the required signatures. Requires facility staff, for a prescription written prior to the admission and encompassing the admission of the resident, to verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
9. Requires residents’ rights policies and procedures established pursuant to this bill concerning informed consent to specify how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
10. Prohibits this bill from being construed to require a SNF or ICF to obtain informed consent each time a drug is administered unless material circumstances or risks change.
11. Requires CDPH to inspect SNFs and ICFs for compliance with this bill during required periodic inspections and, as appropriate, during complaint investigations. Prohibits this inspection requirement from limiting CDPH’s authority in other circumstances to cite for violations or to inspect for compliance with this bill.
12. Deems a violation of the requirement for facility staff to verify that a resident has a signed written consent form prior to the administration of psychotherapeutic drugs to have caused the affected residents harm and to constitute a class “B,” “A,” or “AA” violation pursuant to the standards under existing law for these violations.
13. Specifies that in addition to any other penalties, the willful or repeated violation of this bill is punishable as a misdemeanor unless there is an emergency as described in specified regulations.
14. Requires CDPH, in consultation with interested stakeholders, to develop a standardized informed consent form.
15. Specifies that SNFs and ICFs are not required to comply with this bill until the informed consent form is available as developed by CDPH. Requires CDPH to have a final informed consent form available to SNFs and ICFs by December 31, 2024. Specifies that nothing in this bill negates existing informed consent requirements in law or regulations.
16. Permits CDPH, without taking any regulatory actions, to implement, interpret, or make specific this bill by means of an All Facilities Letter or similar instruction.
17. Adds requirements to the Skilled Nursing and Intermediate Care Facility Patient’s Bill of Rights related to the right to receive information material to a decision about whether to accept or refuse a proposed treatment, and related to the right to be free from psychotherapeutic drugs.
18. Makes various legislative findings and declarations, including that as of 2021, 22% of California nursing facility residents are given powerful antipsychotic drugs, which are a subset of psychotherapeutic drugs, that the FDA has issued black box warnings stating that antipsychotic drugs greatly increase the risk of death for seniors with dementia, and that it is the intent of the Legislature to codify and expand rules that establish a resident’s right to provide or withhold written informed consent concerning the use of psychotherapeutic drugs and the right to be free from chemical restraint.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, CDPH estimates implementing this bill will require one additional full-time associate governmental program analyst for one year, at a cost of $166,000 (Licensing and Certification Fund).

Cost pressure may result from this bill’s creation of a new misdemeanor. If this bill results in five new misdemeanor trials annually, requiring an average two eight-hour court days each, the annual costs to the courts would be approximately $83,000 (Trial Court Trust Fund). Local costs of implementing this bill are potentially reimbursable by the state, subject to a determination by the Commission on State Mandates.

COMMENTS:

1. Author’s statement. According to the author, nursing facilities have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. While these drugs are sometimes appropriately prescribed to treat mental health conditions, many psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. This bill gives nursing home residents and their families tools to decide if a medication is right for them. This bill codifies 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 CDPH must inspect for compliance with informed consent requirements.
2. Current informed consent requirements at SNFs and ICFs. Under existing regulations for both SNFs and ICFs, there are a number of requirements governing informed consent, including specific requirements governing the administration of a psychotherapeutic drug or physical restraint. First, the regulations state that it is the responsibility of the attending physician to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure, and that the disclosure of the material information and obtaining informed consent is the responsibility of the licensed healthcare practitioner, acting within their scope of practice, orders the treatment for which informed consent is required. For the administration of a psychotherapeutic drug or a physical restraint, or the prolonged use of a device that may lead to the inability of a patient to regain use of a normal bodily function, the material information required to be disclosed in order for the patient or the patient’s representative to provide informed consent includes the following:
   1. The reason for the treatment and the nature and seriousness of the patient’s illness;
   2. The nature of the procedures to be used in the proposed treatment, including their probable frequency and duration;
   3. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
   4. The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions;
   5. The reasonable alternative treatment and risks, and why the health professional is recommending this particular treatment; and,
   6. That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.

Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff is required to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The regulations permit the initiation of treatment without informed consent if there is documentation within the patient’s record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for the preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impractical to obtain the required consent. The regulations also permit the disclosure of risks of a proposed treatment or procedure to be withheld if there is documentation that the patient or patient’s representative specifically requested that they not be informed of the risks, or when the licensed health care practitioner relied upon objective facts that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient’s representative gave informed consent. A general consent form in a contract for admission can only encompass consent for routine nursing care or emergency care.

The requirements in this bill build off the requirements in regulations as described here by, among other things, requiring the informed consent for psychotherapeutic drugs to be written and signed by both the prescriber and the patient or the patient’s representative, requiring the prescriber to personally examine and obtain the written informed consent, and adding additional required disclosures such as whether a drug is being prescribed for a purpose that has not been approved by the FDA, and information related to black box warnings.

1. Background on informed consent. With the exception of a medical emergency, all medical procedures require the consent of the patient. If the medical treatment is more involved, or if there are some risks involved, the patient needs to be informed of those risks or potential complications, and this “informed consent” must be documented in the patient’s record. A patient must be capable of understanding those risks to be able to provide consent to the treatment. While a court can adjudicate a person to be incompetent to make medical decisions, even if this has not happened, a physician can still make a determination that a person lacks capacity to make health care decisions. Sometimes this is temporary, such as when a patient is unconscious, or it can be more permanent if caused by something like dementia. In most cases, the resident of the nursing home has a surviving spouse or child or other next of kin, or someone else previously designated as a surrogate decision maker, whether through a Durable Power of Attorney for Health Care, or some other mechanism. The problem is when the nursing home patient does not have anyone available to represent them. The Probate Code allows a physician or a health facility, among others, to file a petition in court to determine that a patient lacks capacity and to have the court authorize recommended medical treatment, or to appoint someone to make decisions on the patient’s behalf.
2. Drug labeling and black box warnings. Under FDA drug labeling requirements, certain drug interactions, adverse reactions, and other potential safety hazards that are considered serious or are otherwise clinically significant are required to be included in a “warning and precautions” section of a drug label. This could involve lengthy and detailed information about adverse reactions, laboratory test interference, and is typically included in a package insert. Also on the insert is a section on “contraindications,” where there are known hazards that in some clinical situation indicate the risk from use outweighs any therapeutic benefit. A “boxed warning,” also known as a black box warning, is the strongest form of warning required by the FDA for prescription drug labeling. It is presented in a box surrounded by a black border and is placed on the drug label and any package inserts. A boxed warning is ordinarily used to highlight for prescribers when there is an adverse reaction so serious in proportion to the potential benefit, such as a life-threatening reaction, that it is essential that it be considered in assessing the risks and benefits of using the drug. A boxed warning is also used when there is a serious adverse reaction that can be prevented or reduced in frequency by appropriate use of the drug (patient selection, monitoring, addition of another drug, etc.), or when FDA approved the drug with restrictions to ensure safe use. According to FDA guidance, a boxed warning provides a brief, concise summary of the information that is critical for a prescriber to consider, including any restriction on distribution or use. There is typically a more detailed discussion of the risk elsewhere in the labeling, such as in the “warnings and precautions” or “contraindications” section, that must be identified by cross-reference.
3. Psychotherapeutics, antipsychotics, and black box warning on the use of antipsychotics in the elderly. This bill imposes enhanced informed consent procedures when a proposed treatment involves “psychotherapeutic drugs,” which is defined to mean a drug to control behavior or to treat thought disorder processes, excluding antidepressants. Psychotherapeutic drug is a general term that can encompass a number of medications that affect brain chemistry. It can include antidepressants (which are specifically excluded from this bill), anti-anxiety medications such as benzodiazepines, stimulants such as medication to treat attention-deficit/hyperactivity disorder, and antipsychotic medicines, which are used to manage psychosis. Antipsychotic drugs are used to treat conditions such as schizophrenia and bipolar disorder. There are older, first generation antipsychotics, also called “typical” antipsychotics, which include chlorpromazine and haloperidol, and newer “atypical” antipsychotics such as risperidone, olanzapine, and quetiapine.
   
   Going back to 2003, the FDA began warning about increased risk of “cerebrovascular adverse events including stroke” in dementia patients treated with the atypical antipsychotic drug risperidone. Following a meta-analysis, the FDA issued a black-box warning citing an increased risk of mortality for patients receiving atypical antipsychotics versus placebo, which was applied to all atypical antipsychotics as a class. In 2008, the FDA updated this black box warning to apply to conventional first generation, or typical, antipsychotics as well. The warning states that conventional or atypical antipsychotic drugs are not FDA-approved for the treatment of dementia-related psychosis. The warning states that use of conventional or atypical antipsychotic drugs in elderly patients with dementia-related psychosis is associated with an increased risk of death, and that prescribers who institute antipsychotic drug use in the regimen of an elderly patient with dementia-related psychosis should discuss the increased risk of mortality with the patient, caregivers, and family members. Since there is no FDA-approved medication for the treatment of dementia-related psychosis, other management options should be considered by health care providers.
4. Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Judiciary Committee.
5. Prior legislation. AB 1809 (Aguiar-Curry) of 2022 was substantially similar to this bill. AB 1809 was vetoed by the Governor, who stated that while he supported the goal of the author, the bill created ambiguity as to whether long-standing informed consent requirements will continue to be required until a new standardized form is developed, which could put the health of long-term care residents in jeopardy. Furthermore, the Governor stated that the State Health Facilities Citation Penalties Account is not an appropriate funding source for the development of this form because the funds in the account are by law reserved for the protection of health or property of residents of long-term health care facilities, and the Governor encouraged the author to work with CDPH to resolve these concerns in the next legislative session. While this bill is substantially similar to AB 1809, this bill does not specify a funding source for CDPH to develop an informed consent form, and it clarifies that this bill does not negate existing informed consent requirements in law or regulations.

SB 460 (Pan of 2021) proposed to establish an Office of Patient Representative within California Department of Aging (CDA) to provide residents of nursing homes, who have been determined to lack capacity to provide informed consent for proposed medical interventions and do not have anyone to provide representation on their behalf, with someone to represent their interests on the interdisciplinary team that reviews proposed medical interventions for these residents. Additionally, it made changes to the process for administering medical interventions for incapacitated and unrepresented nursing home residents, including by requiring residents to receive written notice of the determination of incapacity, and by requiring a patient representative at all interdisciplinary team meetings to review proposed medical interventions. SB 460 was not taken up on the Senate Floor; substantially similar provisions were included in the health budget trailer bill, described below.

AB 135 (Committee on Budget, Chapter 85, Statutes of 2021) was the health budget trailer bill, and among other provisions, it established the Long-Term Care Patient Representative Program within CDA to provide public patient representatives for residents of SNFs and ICFs to participate in interdisciplinary team reviews held pursuant to specified provisions of law governing proposed medical interventions for patients who lack capacity to provide informed consent and do not have anyone to represent their interests.

SB 481 (Pan of 2017) would have required that a resident of a long term care facility who has been determined to lack capacity to make health care decisions and there is no person with legal authority to make those decisions on the resident’s behalf, to be notified prior to implementing a medical intervention, of this lack of capacity determination, of the medical intervention that has been prescribed, and of the right of the resident to challenge these determinations in a judicial proceeding. These provisions were amended out of SB 481.

1. Support. This bill is sponsored by California Advocates for Nursing Home Reform (CANHR), which states that for decades, regulations that ensure the rights of nursing home residents to give informed consent before being administered psychotropic drugs have become less meaningful as enforcement and compliance have diminished. Today, over-drugging is once again at crisis levels for nursing home residents, and refreshing and codifying informed consent protections for residents would ameliorate this problem. According to CANHR, following a number of studies showing severe side effects, including death, the FDA issued public health advisories that the treatment of dementia with antipsychotic medications was contra-indicated. Antipsychotics are associated with increased stroke, heart attack, pneumonia, extrapyramidal side effects and a host of other serious conditions. According to CANHR, the FDA now requires that all antipsychotics be accompanies by a black box warning label, cautioning the user that the drugs nearly double the risk of death for elderly patients with dementia. CANHR states that expert guidance in the care of people with dementia mandates that psychotropic drugs be used only as a last resort and only after non-pharmacological options have been exhausted.
   
   A number of organizations support this bill. The Office of the State Long-Term Care Ombudsman states that their representatives continue to handle hundreds of complaints from residents or their representatives that relate to chemical restraints, in addition to side effects that are caused by these drugs. The California Alliance of Retired Americans states that information and choice are nursing home residents’ best protection against inappropriate psychotropic drug use.

SUPPORT AND OPPOSITION:

Support: California Advocates for Nursing Home Reform (sponsor)

A Voice for Choice Advocacy
AARP
Alzheimer's Greater Los Angeles
Alzheimer's Orange County
Alzheimer's San Diego
Berkeley City Council District 4, Office of Vice Mayor Kate Harrison
California Alliance for Retired Americans
California Commission on Aging
California Health Coalition Advocacy

California Long-Term Care Ombudsman Association
California Office of The State Long-term Care Ombudsman
California Retired Teachers Association
Educate. Advocate.
Elder Law & Advocacy
Justice in Aging
Long Term Care Services of Ventura County
National Association of Social Workers, California Chapter
Oakland Privacy
Retired Public Employees Association

Oppose: None received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 48

Author:(Aguiar-Curry)

As Amended Ver:March 16, 2023

Majority vote

SUMMARY

Creates the Nursing Facility Resident Informed Consent Protection Act of 2023 which requires a prescriber, prior to prescribing a psychotherapeutic drug for a resident of a skilled nursing facility (SNF) or intermediate care facility (ICF) to personally examine and obtain the informed written consent of the resident or the resident’s representative.

Major Provisions

COMMENTS

1. Current informed consent requirements at SNFs and ICFs. Under existing regulations for both SNFs and ICFs, there are a number of requirements governing informed consent, including specific requirements governing the administration of a psychotherapeutic drug or physical restraint. The regulations state that it is the responsibility of the attending physician to determine what information a reasonable person in the patient's condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure, and that the disclosure of the material information and obtaining informed consent is the responsibility of the licensed healthcare practitioner, acting within their scope of practice, who orders the treatment for which informed consent is required. For the administration of a psychotherapeutic drug or a physical restraint, or the prolonged use of a device that may lead to the inability of a patient to regain use of a normal bodily function, the material information required to be disclosed in order for the patient or the patient’s representative to provide informed consent includes the following:
   1. The reason for the treatment and the nature and seriousness of the patient's illness;
   2. The nature of the procedures to be used in the proposed treatment, including their probable frequency and duration;
   3. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
   4. The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions;
   5. The reasonable alternative treatment and risks, and why the health professional is recommending this particular treatment; and,
   6. That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.

Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff is required to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The regulations permit the initiation of treatment without informed consent if there is documentation within the patient's record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for the preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impractical to obtain the required consent. The regulations also permit the disclosure of risks of a proposed treatment or procedure to be withheld if there is documentation that the patient or patient's representative specifically requested that they not be informed of the risks, or when the licensed health care practitioner relied upon objective facts that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient's representative gave informed consent. A general consent form in a contract for admission can only encompass consent for routine nursing care or emergency care.

The requirements in this bill build off the requirements in regulations as described by, among other things, requiring the informed consent for psychotherapeutic drugs to be written and signed by both the prescriber and the patient or the patient's representative, requiring the prescriber to personally examine and obtain the written informed consent, and adding additional required disclosures such as whether a drug is being prescribed for a purpose that has not been approved by the Food and Drug Administration (FDA), and information related to black box warnings.

1. Black box warnings. A "Black Box Warning" exists on the label of all antipsychotic drugs reading: "Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. Antipsychotics are not approved for the treatment of patients with dementia related psychosis."

Psychotherapeutic agents are drugs that are used to treat problems in thought processes of individuals with both perceptual and behavioral disorders. These agents do not provide cure for psychoses but they help both adult and pediatric patients perform activities of daily living. Antipsychotic drugs are dopamine-receptor blockers used to treat disorders associated with problems in thought processes. These drugs are also referred to as neuroleptic agents because of their known neurological adverse effects. Previously, they were called major tranquilizers but later this was changed because their primary action is not sedation. Two classifications of antipsychotic drugs are: a) typical antipsychotics; and, b) atypical antipsychotics. Typical antipsychotics are indicated for schizophrenia and manifestations of other psychotic disorders including hyperactivity, combative behavior, and severe behavioral problems.

However, antipsychotic drugs have been used for some time for "off label" use for patients with dementia. To use a drug "off label" means the prescription of a medication to treat a condition that has not been officially approved by the FDA for that purpose. Prescribing a drug for an "off label" reason is not illegal, and providers must use current research and standards to determine if such a use is beneficial.

1. Changing diagnosis. According to New York Times investigative reports published in October and November of 2021, the share of nursing home residents who are recorded as having schizophrenia has soared over the past decade. The 2012 Centers for Medicare & Medicaid Services effort to reduce unnecessary antipsychotic drug use in nursing homes included an exemption for residents with schizophrenia. Since then, the diagnoses have grown by 70%. The impact of this has been more severe on Black residents. A September 2021 study in the Journal of the American Geriatrics Society, "Disproportionate increases in schizophrenia diagnoses among Black nursing home residents with Alzheimer's and related dementia" found that since the new rules went into place, Black Americans with dementia have been 1.7 times as likely as their white nursing home neighbors to be diagnosed with schizophrenia.

According to the Author

Nursing facilities such as SNFs and ICFs have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. The author notes that while these drugs are sometimes appropriately prescribed to treat mental health conditions, many of the psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. The author states that this bill gives nursing home residents and their families' tools to decide if a medication is right for them. The author concludes that this bill codifies existing regulations that establish a nursing home resident's right to informed consent concerning the use of psychoactive drugs, strengthens requirements for informed consent verification, and clarifies that the Department of Public Health (DPH) must inspect for compliance with informed consent requirements.

Arguments in Support

California Advocates for Nursing Home Reform (CANHR) is the sponsor of this bill and states that antipsychotics and other psychotropic drugs are not only unsafe for elderly people with dementia, they often cause side effects that actually decrease a patient's cognitive abilities. The leading prescriber/pharmacy guide for reducing inappropriate drugging and adverse drug effects in elderly patients, the "Beers Criteria," lists nearly all psychotropic drugs in the "avoid" category, citing sedation, cognitive impairment, and increased risk of death. CANHR notes that significant amounts of research demonstrate that antipsychotics have minimal benefit, often outperformed by placebos or simple pain medications like Tylenol. The only benefits of antipsychotics for dementia patients – if they can be called benefits – are sedation and submission which increase fatigue and decrease activity. The resident's subsequent incapacity increases the patient's susceptibility to devastating falls, pressure sores, weight loss, and infection. These outcomes are what give antipsychotics, and other psychotropic drugs, their lethality for elderly people with dementia.

CANHR contends that despite the deep foundation of informed consent laws and protections that are specific in nursing homes, the process of obtaining informed consent is often meaningless. In 2011, DPH conducted an Antipsychotic Drugs Collaborative (the Collaborative) to evaluate the use of antipsychotics in nursing homes. DPH found 147 violations involving 41 different regulations in just 24 facilities, an average of 6.1 deficiencies per facility. Most of the violations involved the use of unnecessary drugs or drugs in excessive dosage and the failure to obtain informed consent. The Collaborative investigations determined the majority of the sampled nursing homes had violated at least one rule regarding informed consent. The most common violation was the total failure to obtain the consent of the resident or a surrogate before administering a psychotropic drug while another common violation was the absence of the physician in the informed consent process. CANHR states that the use of mind-altering drugs without consent violates some of our most precious and fundamental human rights: the right to control what goes into our bodies, the right to our thoughts and expression, and the freedom to make our own decisions. CANHR concludes that informed consent lies at the heart of residents’ ability to ultimately direct the course of their health care treatment and this bill ensures that their choices will be appropriately honored.

Arguments in Opposition

There is no known opposition.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, DPH estimates implementing this bill will require one additional full-time associate governmental program analyst for one year, at a cost of $166,000 (Licensing and Certification Fund). Cost pressure may result from this bill's creation of a new misdemeanor. If this bill results in five new misdemeanor trials annually, requiring an average two eight-hour court days each, the annual costs to the courts would be approximately $83,000 (Trial Court Trust Fund). Local costs of implementing this bill are potentially reimbursable by the state, subject to a determination by the Commission on State Mandates.

VOTES

ASM HEALTH: 13-0-2

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner Horvath, Lackey, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ABS, ABST OR NV: Wendy Carrillo, Flora

ASM JUDICIARY: 9-0-2

YES: Maienschein, Essayli, Connolly, Haney, Pacheco, Papan, Reyes, Robert Rivas, Sanchez

ABS, ABST OR NV: Dixon, Kalra

ASM APPROPRIATIONS: 15-0-1

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Weber, Ortega

ABS, ABST OR NV: Robert Rivas

UPDATED

VERSION: March 16, 2023

CONSULTANT: Lara Flynn / HEALTH / (916) 319-2097 FN: 0000486

Date of Hearing: April 19, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 48

Author:(Aguiar-Curry) – As Amended Ver:March 16, 2023

Urgency: No State Mandated Local Program: Yes Reimbursable: Yes

SUMMARY:

This bill requires prescribers of psychotherapeutics drugs to verify a resident of a skilled nursing facility or intermediate care facility (collectively, “nursing facilities”) has provided informed consent to be treated with psychotherapeutic drugs, and establishes rights of residents of skilled nursing facilities and to be free from psychotherapeutic drugs and to be informed about treatments. This bill also requires the Department of Public Health (DPH) to develop a standardized informed consent form and to evaluate compliance during periodic licensing inspections. This bill makes the willful or repeated violation of the above provisions, except in an emergency, punishable as a misdemeanor.

FISCAL EFFECT:

DPH estimates implementing this bill will require one additional full-time associate governmental program analyst for one year, at a cost of $166,000 (Licensing and Certification Fund).

Cost pressure may result from this bill’s creation of a new misdemeanor. If this bill results in five new misdemeanor trials annually, requiring an average two eight-hour court days each, the annual costs to the courts would be approximately $83,000 (Trial Court Trust Fund).

Local costs of implementing this bill are potentially reimbursable by the state, subject to a determination by the Commission on State Mandates.

COMMENTS:

1. Purpose. According to the author:

Nursing facilities have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. While these drugs are sometimes appropriately prescribed to treat mental health conditions, many of the psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. This bill gives nursing home residents and their families tools to decide if a medication is right for them. This bill codifies 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 must inspect for compliance with informed consent requirements.

1. Use of Antipsychotic Drugs in Nursing Facilities. Antipsychotic drugs, one of four classes of psychotherapeutic drugs, are primarily intended to treat psychotic conditions such as schizophrenia and are not intended to be used to treat dementia. Off-label use of these drugs can be particularly dangerous for older patients. A review of 25 studies on the use of antipsychotic medications in nursing homes found considerable evidence that off-label use of antipsychotic medications has dangerous consequences, including mortality, hip fractures, thrombotic events, cardiovascular events, and hospitalizations. A randomized trial of patients with Alzheimer’s disease found that the three-year survival rate of patients receiving antipsychotic drugs was approximately one-half that of patients receiving the placebo.
   
   In 2020, an estimated 100,000 California residents lived in nursing facilities. Nationally, approximately 50% of nursing facility patients have been diagnosed with dementia. An estimated 80% of patients with dementia exhibit challenging behaviors, such as agitation, anger, disrobing, eating abnormalities, inappropriate sexual behavior, paranoia, and physical and verbal aggression, which can make caring for dementia patients difficult. Best practices for addressing these challenging behaviors are behavior modification techniques; however, these techniques require adequate staff, training, and time.
   
   During the COVID-19 pandemic, staffing levels at nursing facilities plunged to their lowest levels since 1994. In many facilities, especially those short on skilled staff, antipsychotic drugs were used off-label as “chemical restraints” – that is, as shortcuts to sedate patients. Studies have shown a link between staffing shortages and the off-label use of antipsychotics in nursing facilities. According to California Advocates for Nursing Home Reform (CANHR), sponsor of this bill, nursing homes have underreported psychotropic drug use by turning to psychotropic drugs that are not counted by the federal government or by using questionable schizophrenia diagnoses to hide inappropriate psychotropic drug use.
2. Informed Consent in Nursing Facilities. State regulations require the attending physician at a skilled nursing facility to obtain informed consent from a nursing home resident and notify the resident’s family member within 48 hours when prescribing, ordering, or increasing an order for antipsychotic drugs. However, investigations by Human Rights Watch and DPH have documented numerous gaps in compliance with existing laws and regulations pertaining to informed consent.
   
3. Related Legislation.
   
   1. AB 486 (Kalra) removes the ability of a long term care (LTC) facility to adjudicate the validity of a citation issued by DPH in a county superior court, and instead requires all citation appeals to be made through an administrative law judge. AB 486 is pending in Assembly Health Committee.
      
   2. AB 1537 (Wood) establishes a direct patient-related services spending, reporting, and rebate requirement for skilled nursing facilities (SNFs), and requires a minimum of 85% of a facility’s total non-Medicare health revenues from all payers be expended on residents’ direct patient-related services.
4. Prior Legislation.
   1. AB 135 (Committee on Budget), Chapter 85, Statutes of 2021, creates, among other provisions, the Long-Term Care Patient Representative Program (program) and the Office of the Long-Term Care Patient Representative in the Department of Aging to provide patient representatives to protect the rights of nursing home residents. The bill requires the program to assign a public patient representative if no family member or friend is available to serve in that capacity.
   2. AB 323 (Kalra), Chapter 458, Statutes of 2021, changes, from “direct proximate cause” to “substantial factor,” the standard DPH uses when issuing penalties against LTC facilities for violations that result in the death of a resident and the death was a result of the violation. The bill also increases the amount of civil penalties that may be assessed against LTC facilities.
      
   3. AB 849 (Reyes), Chapter 471, Statutes of 2021, clarifies that an LTC facility licensee is liable for up to $500 per violation when a current or former resident, patient representative, or successor in interest of a current or former resident or patient of an LTC facility brings a civil action against the facility for violation of any rights of the resident or patient.
   4. AB 1809 (Aguiar-Curry), of the 2021-22 Legislative Session, was substantially similar to this bill. AB 1809 was vetoed by Governor Newsom, who stated, in part:

[T]his bill creates ambiguity as to whether long-standing informed consent requirements will continue to be required until a new standardized form is developed, which could put the health of long-term care residents in jeopardy. Furthermore, the State Health Facilities Citation Penalties Account is not an appropriate funding source for the development of this form because the funds in the account are by law reserved for the protection of health or property of residents of long-term health care facilities. I encourage the author to work with DPH to resolve these concerns in the next legislative session.

• 1. SB 460 (Pan), of the 2021-22 Legislative Session, would have created the Office of the Patient Representative within Department of Aging to train, certify, provide, and oversee patient representatives to protect the rights of SNF and intermediate care facility (ICF) residents when a medical intervention is prescribed for a resident who cannot provide informed consent, as specified. SB 460 would also have refined procedures for determining that a resident of a SNFs or an ICF lacks capacity to provide informed consent for a medical intervention. SB 460 was not taken up for a vote on the Senate Floor.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: March 28, 2023

ASSEMBLY COMMITTEE ON JUDICIARY

Brian Maienschein, Chair

ABPCA Bill Id:AB 48

Author:(Aguiar-Curry) – As Amended Ver:March 16, 2023

PROPOSED CONSENT

SUBJECT: Nursing Facility Resident Informed Consent Protection Act

KEY ISSUES:

1. should nursing home residents have the right to receive information about their treatment and to be free from the use of psychotherApeutic drugs that are administered for discipline or convenience?
2. should nursing home facilities be required to obtain written consent and provide material information to residents before administering psychotherApeutic drugs?

SYNOPSIS

Psychotherapeutic drugs are medications meant to control behavior or to treat thought disorder processes. One class of these drugs, antipsychotics, are primarily designed to treat psychotic disorders, such as schizophrenia. They are not intended to be used to treat dementia. In fact, off-label use of antipsychotics to treat dementia poses considerable risk to a patient, including a substantial increase in the risk of mortality.

But in many nursing home facilities, especially those short on skilled staff, antipsychotic drugs are used off-label as dangerous shortcuts to sedate patients, leading some to term them “chemical restraints.” Despite decades of investigations and regulations aimed at curbing this practice, it continues. As of 2021, 22 percent of nursing home residents in California received antipsychotic drugs. Recent pandemic-related staffing shortages have likely only increased reliance on this practice.

This bill, the Nursing Facility Resident Informed Consent Protection Act of 2023, establishes new rights and procedures for obtaining informed consent from nursing home residents before administering treatments and procedures. First, it establishes the rights for nursing home residents to receive “all information material to an individual’s decision concerning whether to accept or refuse a proposed treatment or procedure” and to refuse the use of psychotherapeutic drugs, except in the case of an emergency. Second, it expands existing law by establishing a process whereby prescribers in nursing facilities must obtain written informed consent before prescribing psychotherapeutic drugs. This consent expires after six months. Third, it establishes oversight and accountability mechanisms, including requiring the Department of Public Health to investigate compliance with the informed consent process.

The bill, which recently was approved by the Assembly Health Committee by a vote of 13- 0, is sponsored by California Advocates for Nursing Home Reform and supported by advocacy groups that point to the potential for the bill to curb the dangerous practice of antipsychotic abuse in nursing homes. There is no opposition to the bill on file.

SUMMARY: In order to protect the dignity of nursing home residents and avoid the misuse of psychotherapeutic drugs, establishes new rights, processes, and enforcement mechanisms for obtaining informed consent for psychotherapeutic drugs from nursing home patients. Specifically, this bill:

1. Requires a prescriber, prior to prescribing a psychotherapeutic drug to the resident of a Skilled Nursing Facility (SNF) or Intermediate Care Facility (ICF) to personally examine and obtain the informed written consent of the resident or the resident’s representative.
2. Defines the following terms for the purposes of this bill:
   1. “Informed consent” means the voluntary agreement of a resident or a resident’s representative to accept a treatment or procedure after receiving specified information;
   2. “Psychotherapeutic drug” means a drug to control behavior or to treat thought disorder processes, excluding antidepressants; and,
   3. “Representative” means an individual who has authority to act on behalf of the resident, including, but not limited to, a conservator, guardian, person authorized as agent in the resident’s advanced health care directive, the resident’s spouse, registered domestic partner, or family member, a person designated by the resident, or other legally designated individual.
3. Requires the prescriber, for purposes of the requirement in 1) above, to communicate, and the written consent form to contain, in a language the resident understands, the information a reasonable person in the resident’s condition and circumstances would consider material to a decision to accept or refuse the drug. Permits the written consent form to be provided in English if written translation services are not timely available. Requires the information and written consent form to be provided in an accessible format if the resident is hearing or vision impaired.
4. Requires the written consent form, for purposes of the requirement in 3) above, to be signed by the resident or the resident’s representative, and to be signed by a health care professional who declares the resident or resident representative has been provided the material information. Requires copies of the signed consent form to be given to the resident and their representative.
5. Requires, if the signature of the resident or resident’s representative cannot be obtained, a licensed nurse to sign the form and verify that they confirmed informed consent with the resident or resident’s representative and to state the name of the person with whom they verified consent and the date.
6. Requires the SNF or ICF, within six months after the consent form is signed and every six months thereafter during which the resident receives a psychotherapeutic drug, to provide a written notice to the resident and the resident’s representative, of any recommended dosage adjustments and the resident’s right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
7. Authorizes the use of remote technology, including, but not limited to, telehealth, to allow a prescriber to examine and obtain informed written consent.
8. Requires the prescriber to provide, in addition to the information required in specified regulations governing informed consent in SNFs and ICFs, the following additional information material to an informed consent decision concerning the administration of a psychotherapeutic drug:
   1. Possible non-pharmacologic approaches that could address the resident’s needs;
   2. Any current boxed warning labels and accompanying detailed information regarding contraindications, warning, and precautions required by the United States Food and Drug Administration (FDA);
   3. Whether a proposed drug is being prescribed for a purpose that has not been approved by the FDA;
   4. Possible interactions with other drugs the resident is receiving; and,
   5. How the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.
9. Requires facility staff, before initiating treatment with psychotherapeutic drugs, to verify that the resident’s health record contains a written consent form with the required signatures. Requires facility staff, for a prescription written prior to the admission and encompassing the admission of the resident, to verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
10. Requires residents’ rights policies and procedures established pursuant to this bill concerning informed consent to specify how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
11. Prohibits this bill from being construed to require a facility to obtain informed consent each time a drug is administered unless material circumstances or risks change.
12. Requires the Department of Public Health (DPH) to inspect SNFs and ICFs for compliance with this bill during required periodic inspections and, as appropriate, during complaint investigations. Prohibits this inspection requirement from limiting DPH’s authority in other circumstances to cite for violations or to inspect for compliance with this bill.
13. Deems a violation of the requirement in 9), above, for facility staff to verify that a resident has a signed written consent form prior to the administration of psychotherapeutic drugs to have caused the affected residents harm and to constitute a class “B,” “A,” or “AA” violation pursuant to the standards under existing law for these violations.
14. Specifies that in addition to any other penalties, the willful or repeated violation of this bill is punishable as a misdemeanor unless there is an emergency as described in specified regulations.
15. Specifies that nothing in this bill impairs or otherwise alters other non-conflicting statutory or regulatory requirements, including but not limited to, requirements contained in specified regulations pertaining to initiating treatment without informed consent if an emergency exists in which immediate action is necessary for the prevention of serious bodily harm or to alleviate severe physical pain.
16. Requires DPH to develop a standardized informed consent form in consultation with interested stakeholders.
17. Specifies that SNFs and ICFs are not required to comply with this bill until the informed consent form is available as developed by DPH and requires DPH to have a final informed consent form available to SNFs and ICFs by December 31, 2024.
18. Authorizes DPH to implement the provisions of this bill by means of an All Facilities Letter, or similar instruction and specifies that nothing in this bill negates existing informed consent requirements in law or regulations.
19. Adds the following two requirements to the Skilled Nursing and Intermediate Care Facility Patient’s Bill of Rights:
    1. Requires a resident of a SNF or ICF to have the right to receive the information that is material to an individual’s decision concerning whether to accept or refuse a proposed treatment or procedure, pursuant to specified regulations governing informed consent in SNFs. Requires the disclosure of material information for administration of psychotherapeutic drugs to also include the disclosures required by this bill in 8) above; and,
    2. Requires a resident of a SNF or ICF to have the right to be free from psychotherapeutic drugs used for the purpose of resident discipline or convenience, and to have the right to be free from psychotherapeutic drugs used as a chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. Requires, if a chemical restraint is administered during an emergency, the chemical restraint to only be a drug that is required to treat the emergency condition, after being deemed the least intrusive treatment alternative for the resident, and used only for a specified and limited period of time. Defines “chemical restraint,” for purposes of this provision, as a drug used to control behavior and used in a manner not required to treat the resident’s medical symptoms.
20. Makes various legislative findings and declarations, including that as of 2021, 22% of California nursing facility residents are given powerful antipsychotic drugs, which are a subset of psychotherapeutic drugs; that the FDA has issued black box warnings stating that antipsychotic drugs greatly increase the risk of death for seniors with dementia; and, that it is the intent of the Legislature to codify and expand rules that establish a resident’s right to provide or withhold written informed consent concerning the use of psychotherapeutic drugs and the right to be free from chemical restraint.

EXISTING LAW:

1. Sets forth the bill of rights for patients in a skilled nursing, intermediate care, or hospice facility. (Health and Safety Code Section 1599 et seq. All further statutory references are to this code, unless otherwise indicated.)
2. Defines “skilled nursing facility” as a health facility that provides skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis, including a small house skilled nursing facility. (Section 1250 (b).)
3. Defines “intermediate care facility” as a health facility that provides inpatient care to ambulatory or nonambulatory patients who have recurring need for skilled nursing supervision and need supportive care, but who do not require availability of continuous skilled nursing care. (Section 1250 (d).)
4. Establishes a centralized consumer response unit with the California Department of Public Health (DPH) to respond to consumer inquiries and complaints of long-term health facilities. Establishes a process for inspecting complaints of long-term health facilities. (Section 1419 et seq.)
5. Requires DPH to conduct periodic inspections of long-term health 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. (Section 1420 et seq.)
6. Establishes a classification of potential violations of long-term health facilities, specifying that:
   1. Class “AA” violations (the most severe), are those that meet the criteria for a class “A” violation and that were a substantial factor in the death of a resident;
   2. Class “A” violations present either imminent danger of death or serious harm to residents, or a substantial probability that death or serious harm to residents would result;
   3. Class “B” violations are those that DPH determines have a direct or immediate relationship to the health, safety, or security of residents. (Section 1424.)
7. Requires an attending physician at a skilled nursing facility to obtain informed consent from a nursing facility resident when prescribing, ordering, or increasing an order for an antipsychotic medication. (Section 1418.9.)
8. 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. (Ibid.)
9. Establishes a process whereby an attending physician and surgeon of a resident in a skilled nursing facility or intermediate care facility may prescribe or order a medical intervention requiring informed consent when they are unable to obtain informed consent because a resident lacks capacity to provide informed consent. (Section 1418.8.)
10. Establishes informed consent requirements within skilled nursing facilities. These requirements provide that:
    1. It is the responsibility of the attending licensed healthcare practitioner to determine what information a reasonable person in the patient's condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure.
    2. The disclosure of material information and obtaining informed consent shall be the responsibility of the licensed healthcare practitioner who performs or orders the procedure or treatment for which informed consent is required.
    3. Information material to a decision concerning the administration of a psychotherapeutic drug or other specified treatments must include the following:
       1. The reason for the treatment and the nature and seriousness of the patient's illness.
       2. The nature of the procedures to be used in the proposed treatment including their probable frequency and duration.
       3. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment.
       4. The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions.
       5. Alternative treatments and risks, and why the health professional is recommending this particular treatment.
       6. That the patient has the right to accept or refuse the proposed treatment, and has the right to revoke his or her consent for any reason at any time.
    4. Before initiating psychotherapeutic drugs or other specified procedures, facility staff must verify that the patient's health record contains documentation that the patient has given informed consent to the proposed treatment or procedure.
    5. The informed consent requirements enumerated above should not be construed as requiring obtaining informed consent each time a treatment or procedure is administrated unless material circumstances change.
    6. It is not a violation of initiating treatment without informed consent if the patient’s health record documents that a specified emergency exists, is impractical to obtain consent, and the action taken is within the customary practice of licensed health care practitioners of good standing in similar circumstances. (Cal. Code Regs., title 22, section 72528 (a)-(f).)

FISCAL EFFECT: As currently in print this bill is keyed fiscal.

COMMENTS: This bill, sponsored by California Advocates for Nursing Home Reform (CANHR), enacts the Nursing Facility Resident Informed Consent Protection Act of 2023. It establishes rights for residents of skilled nursing facilities (SNFs) and intermediate care facilities (ICFs), collectively referred to in the analysis as nursing homes, to receive material information about treatments and procedures and to be free from psychotherapeutic drugs, except in an emergency. The bill also strengthens and expands existing law and regulations concerning informed consent by establishing a written consent process for psychotherapeutic drugs and oversight and enforcement mechanisms through Department of Public Health inspections. Finally, it makes the willful or repeated violation of the above provisions punishable as a misdemeanor unless there is an emergency. The author states the following regarding the purpose and necessity of the bill:

Nursing facilities have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. While these drugs are sometimes appropriately prescribed to treat mental health conditions, many of the psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs were designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification.

This bill gives nursing home residents and their families tools to decide if a medication is right for them. This bill codifies 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 must inspect for compliance with informed consent requirements.

Psychotherapeutic Drugs: Psychotherapeutic drugs are medications meant to control behavior or to treat thought disorder processes. There are 4 classes of psychotherapeutic drugs: anti-anxiety agents, anti-depressants, sedatives/hypnotics, and antipsychotics. Antipsychotic drugs are primarily designed to treat psychotic conditions such as schizophrenia. They are not intended to be used to treat dementia. In fact, off-label use of these drugs can be particularly dangerous for older patients. A review of twenty-five studies on the use of antipsychotic medications in nursing homes found considerable evidence that off-label use of antipsychotic medications has dangerous consequences, including mortality, hip fractures, thrombotic events, cardiovascular events, and hospitalizations. (Chiu et al., A literature review of clinical outcomes associated with antipsychotic medication use in North American nursing home residents (Feb. 2015) Health Policy.) Consistent with this review, a randomized control trial of patients with Alzheimer’s Disease found that the 3-year survival rate of patients receiving antipsychotic drugs was nearly half (30%) the 3-year survival rate of patients receiving the placebo (59%). (Ballard, et al., The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial (2009), The Lancet Neurology.)

The use of antipsychotic drugs in nursing homes. Estimates vary, but, as of 2020, California was home to 101,030 residents in nursing home facilities, the second largest population in the country. (U.S. House of Representatives, Under-Enforced and Over-Prescribed: The Antipsychotic Drug Epidemic Ravaging America’s Nursing Homes (July 2020).) Nationally, about 50% of nursing home patients have been diagnosed with dementia. (National Center for Health Statistics, Vital and Health Statistics (Feb. 2019).) Dementia is often associated with especially challenging behaviors that can make caring for dementia patients difficult. It is estimated that 80 percent of patients with dementia exhibit challenging behaviors, which include agitation, anger, disrobing, eating abnormalities, inappropriate sexual behavior, paranoia, and physical and verbal aggression. (Zwijsen, et al., Coming to grips with challenging behavior: a cluster randomized controlled trial on the effects of a multidisciplinary care program for challenging behaviors in dementia (2014) Journal of the American Medical Directors Association.) Though best practices for addressing these challenging behaviors are behavioral modification techniques, these techniques require adequate staff, training, and time.

Following the onset of the COVID-19 pandemic, staffing levels at nursing homes plunged to their lowest levels since 1994. (U.S. Bureau of Labor Statistics, All Employees, Nursing Care Facilities (March 2022), available here.) In many facilities, especially those short on skilled staff, antipsychotic drugs were used off-label as dangerous shortcuts to sedate patients, leading some to term them “chemical restraints.” In fact, numerous studies have demonstrated a persistent empirical correlation between staffing shortages and the off-label use of antipsychotics in nursing homes. (Mattingly, A Review Exploring the Relationship Between Nursing Home Staffing and Antipsychotic Medication Use (2015) Neurology and Therapy.) A 2022 report from the federal Office of Inspector General found that an astounding 80% of people who have resided in a nursing home for at least 100 days are routinely given psychotropic drugs. According to CANHR, nursing homes have underreported their psychotropic drug use by turning to psychotropic drugs that are not counted by the federal government or by using questionable schizophrenia diagnoses to hide psychotropic drug use that would otherwise be counted. (U.S. Department of Health and Human Services, Office of Inspector General Report in Brief November 2022, OEI-07-20-00500, available at https://oig.hhs.gov/oei/reports/OEI-07-20-00500.pdf.)

Policy responses to the use of antipsychotics in nursing homes. For decades, investigations have revealed the use of off-label antipsychotic drugs in nursing homes, and policy officials have responded with regulations aimed at curbing the practice. One of the earliest reforms occurred after a 1986 study by the Institute of Medicine revealed widespread neglect and abuse in nursing homes. This resulted in the 1987 Nursing Home Reform Act, which established a Resident’s Bill of Rights, including the right to participate in the review of one’s plan and to be fully informed of changes to one’s plan. It also banned the use of drugs that serve the interest of the nursing home or its staff, rather than the patient. Antipsychotic use due to a lack of skilled staff is a violation of this right.

In the early 2000s, numerous clinical trials demonstrated the risks of antipsychotic drugs, including the near doubling of the risk of death for dementia patients on antipsychotics. In 2005, the FDA responded by requiring drug manufacturers to include a warning label on antipsychotic drugs about the risks of using these drugs among elderly patients with dementia. Nursing homes today are required to report how many of its residents are receiving psychotherapeutics off-label to the Centers for Medicare and Medicaid Services. Despite this requirement, overprescribing of antipsychotics remains a widespread problem. A New York Times investigation revealed widespread, deliberate misdiagnosis of nursing home residents with schizophrenia in order to skirt off-label reporting requirements. (Thomas et al., Phony Diagnoses Hide High Rates of Drugging at Nursing Homes (Sep. 2021).) Given the historically low staffing levels at nursing homes, abuse of antipsychotic drug prescriptions is likely growing today.

Informed consent in nursing facilities today. As underscored by supporters of this bill, a robust informed consent process is a crucial component to reducing the overuse of psychotropic drugs in nursing facilities. However, investigations by Human Rights Watch and the Department of Public Health have documented numerous gaps in compliance with existing laws and regulations pertaining to obtaining meaningful informed consent. The California Code of Regulations establishes that it is the responsibility of the attending licensed healthcare practitioner at a skilled nursing facility to “determine what information a reasonable person in the patient's condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure.” (Cal. Code Regs., title 22, section 72528 (a).) These regulations also enumerate minimal standards of what constitutes “information material to a decision” with regard to psychotherapeutic drugs and other procedures. With regard to antipsychotics specifically, when prescribing, ordering, or increasing an order for antipsychotics, attending physicians are required to obtain informed consent from nursing home residents. (Section 1418.9 (a)(1).) They must also notify the resident’s family member within 48 hours of the prescription, order, or any increase of an antipsychotic medication. (Section 1418.9 (a)(2).)

This bill establishes new rights and processes for receiving informed consent from nursing home residents before administering psychotherapeutics. This bill, the Nursing Facility Resident Informed Consent Protection Act of 2023, establishes new rights and procedures for obtaining informed consent from nursing home patients before administering treatments and procedures. First, it establishes a new right for residents to receive “all information that is material to an individual’s decision concerning whether to accept or refuse a proposed treatment or procedure.” This includes information pertaining to psychotherapeutic drugs and, presumably, the black box warning labels for psychotherapeutic drugs. Second, it provides that a resident has the right to be free from the use of psychotherapeutic drug use for the “purposes of resident discipline or convenience” except in the case of an emergency. As described above, the off-label use of psychotherapeutic drugs, especially antipsychotics, poses significant danger and risks. Third, it establishes a written consent procedure that must be followed before an attending physician at a nursing home can prescribe a psychotherapeutic drug to a resident and before facility staff may administer psychotherapeutic drugs. This procedure includes providing specified material information to the resident or resident’s representative, such as the reason the drug is being prescribed and the risks associated with the drug, and receiving the signature of a health care professional attesting that the person received this information. This written consent expires after six months.

This bill establishes new oversight and accountability mechanisms for violating informed consent. This bill establishes oversight and accountability over the written informed consent process through several mechanisms. First, it requires the State Department of Public Health to inspect for compliance with the written informed consent process, specifying that violations of this process “shall be deemed to have caused the affected residents harm.” Second, this bill establishes criminal penalties for individuals who violate the written informed consent process. Specifically, it classifies the willful and repeated violation of process outlined in this bill as a misdemeanor, except in the case of a declared public health emergency.

This bill applies to all psychotherapeutic drugs and uses. Though the prevalence of antipsychotic drug abuse is well-documented and a key motivation for this bill, it is important to note that the bill addresses all classes of psychotherapeutics, not just antipsychotics. This would appear to include common anti-depressants and anti-anxiety medications, such as Zoloft, Lexapro, and Xanax. Also, this bill does not distinguish between regulating drugs when used for their primary indications or their off-label uses. However, the bill does require a prescriber to provide information to a nursing home resident about whether it is being prescribed off-label by defining “informed consent” to include disclosure about “[w]hether a proposed drug is being prescribed for a purpose that has not been approved by the United States Food and Drug Administration.” Given the strength and potential side effects of psychotherapeutic drugs, it appears prudent for prescribers to obtain written informed consent for both types of use cases.

Informed consent only partly addresses the crisis in nursing home facilities. Though this bill is a critical step towards protecting patients from the dangers of off-label antipsychotic drug use, as described above, data suggest that the lack of skilled staff is one driver resulting in overprescribing these drugs. The author may wish to consider future legislation to fund training programs for health care practitioners in nursing home facilities and to incentivize individuals to enter the health care field. Such efforts may reduce the abuse of antipsychotics and elevate the general level of care in nursing homes.

Veto of Last Year’s AB 1809. AB 1809, by the author of this bill, would have enacted the Nursing Facility Resident Informed Consent Protection Act of 2022, by establishing new rights, processes, and enforcement mechanisms for obtaining informed consent for psychotherapeutic drugs from nursing home patients virtually identical to this bill. AB 1809 was vetoed by Governor Newsom, with the following veto message.

To the Members of the California State Assembly: 

I am returning Assembly Bill 1809 without my signature.

This bill would establish new rights and procedures for obtaining informed consent from nursing home residents before administering treatments or procedures and provides residents with the right to refuse psychotherapeutic drugs used as a chemical restraint, except in an emergency. The bill would also require the California Department of Public Health (CDPH) to develop an informed consent form for long-term care residents that includes a model disclosure statement for providing material information on the use of psychotherapeutic medications and the resident's right to withdraw informed consent.

I support the author's goal of improving informed consent requirements and protecting long-term care residents from inappropriate uses of psychotherapeutic medications. However, this bill creates ambiguity as to whether long-standing informed consent requirements will continue to be required until a new standardized form is developed, which could put the health of long-term care residents in jeopardy. Furthermore, the State Health Facilities Citation Penalties Account is not an appropriate funding source for the development of this form because the funds in the account are by law reserved for the protection of health or property of residents of long-term health care facilities. I encourage the author to work with CDPH to resolve these concerns in the next legislative session.

Differences between this bill and AB 1809. This bill is very similar to last year’s AB 1809. However, this bill differs in a number of significant ways. In addition to minor differences in effective dates (to account for this bill being introduced after AB 1809) and corrected cross-references, this bill’s key differences do the following:

• Correct dates when current federal regulations became effective and enforceable vis-à-vis nursing homes.
• Delete the condition that the requirement for DPH to develop a number of forms, including an informed consent form would take effect “upon appropriation by the Legislature for the express purpose” of DPH doing so. Instead, DPH is simply required, “in consultation with interested stakeholders, [to] develop a standardized informed consent form.”
• Clarify that the bill does not negate “existing informed consent requirements in law or regulations.”

It is unclear whether the governor’s concerns with the form, and the funding source for development of the form, have been resolved by these differences. However, CANHR states the following about how this bill seeks to address them:

The Governor’s veto message cited two problems with AB 1809: one, the bill did not state that long-standing informed consent requirements would continue until a written informed consent form was developed and two, the State Health Facilities Citation Penalties Account should not be used to pay for the development of the form. AB 48 addresses both of those concerns by stating that the new law shall not negate existing requirements and removing the reference to the Citation Penalties Account.

Also, it is noteworthy that this bill, like the version of AB 1809 sent to Governor Newsom, does not include a new civil cause of action for violations of the bill’s requirements as AB 1809 did when it was heard and passed by the Committee last year.

ARGUMENTS IN SUPPORT: CANHR writes the following about the importance of the bill:

The use of mind-altering drugs without consent violates some of our most precious and fundamental human rights: the right to control what goes into our bodies, the right to our thoughts and expression, and the freedom to make our own decisions. Informed consent lies at the heart of residents’ ability to ultimately direct the course of their health care treatment and AB 48 ensures that their choices will be appropriately honored. AB 48 sends a strong message that California will not tolerate the rampant drugging of nursing home residents and helps secure their rights to be treated with dignity, respect, and to direct their treatment.

Other related and previous legislation. AB 1907 (Bauer-Kahan), Chap. 277, Stats. 2022, extended the maximum amount of time allowed between inspections of a long-term health care facility from two years to 30 months.

SR 67 (Archuleta, 2022) proclaims the week of May 1, 2022, as Tardive Dyskinesia Awareness Week, and encourages everyone in the United States to become better informed about the disorder. Proclaims that antipsychotics are one cause of Tardive Dyskinesia, among other proclamations.

AB 323 (Kalra), Chap. 458, Stats. 2021, changed the standard DPH uses when issuing penalties against long term care facilities for violations that result in the death of a resident from “direct proximate cause” to “substantial factor” and the death was a result of the violation. Increases the amount of civil penalties assessed against long-term care facilities for all classes of violations.

AB 849 (Reyes), Chap. 471, Stats. 2021, clarified that the licensee of a long term care facility is liable for up to $500 per violation when a current or former resident, or patient, or the legal representative, personal representative, or successor in interest of a current or former resident or patient brings a civil action against the facility for violation of any rights of the resident or patient as set forth in the Patient's Bill of Rights or any other right provided for by federal or state law or regulation.

SB 303 (Alquist, 2009), vetoed, would have enacted the Nursing Facility Resident Informed Consent Protection Act of 2009, which would have established the right of a resident of a nursing facility to receive information material to the decision to accept or refuse any treatment or procedure, including the administration of psychotherapeutic drugs. It also would have codified existing regulations requiring attending physicians to obtain informed consent after providing specified material information.

REGISTERED SUPPORT / OPPOSITION:

Support

California Advocates for Nursing Home Reform (sponsor)
A Voice for Choice Advocacy
AARP
Alzheimer's Greater Los Angeles
Alzheimer's Orange County
Alzheimer's San Diego
Berkeley City Council District 4, Office of Vice Mayor Kate Harrison
California Alliance for Retired Americans
California Health Coalition Advocacy
California Retired Teachers Association
Consumer Attorneys of California
Educate. Advocate.
Elder Law & Advocacy
Essential Caregivers Coalition
Gray Panthers of San Francisco
Justice in Aging
Oakland Privacy
The Geriatric Circle

Opposition

None on file

Analysis Prepared by: Alison Merrilees / JUD. / (916) 319-2334

Date of Hearing: March 14, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 48

Author:(Aguiar-Curry) – As Introduced: Ver:December 5, 2022

SUBJECT: Nursing Facility Resident Informed Consent Protection Act of 2023.

SUMMARY: Creates the Nursing Facility Resident Informed Consent Protection Act of 2023 which requires a prescriber, prior to prescribing a psychotherapeutic drug for a resident of a skilled nursing facility (SNF) or intermediate care facility (ICF) to personally examine and obtain the informed written consent of the resident or the resident’s representative. Specifically, this bill:

1. Requires a prescriber, prior to prescribing a psychotherapeutic drug for a SNF or ICF resident, to personally examine and obtain the informed written consent of the resident or the resident’s representative.
   
2. Defines the following terms for the purposes of this bill:
   1. “Informed consent” means the voluntary agreement of a resident or a resident’s representative to accept a treatment or procedure after receiving specified information;
   2. “Psychotherapeutic drug” means a drug to control behavior or to treat thought disorder processes, excluding antidepressants; and,
   3. “Representative” means an individual who has authority to act on behalf of the resident, including, but not limited to, a conservator, guardian, person authorized as agent in the resident’s advanced health care directive, the resident’s spouse, registered domestic partner, or family member, a person designated by the resident, or other legally designated individual.
3. Requires the prescriber, for purposes of the requirement in 1) above, to communicate, and the written consent form to contain, in a language the resident understands, the information a reasonable person in the resident’s condition and circumstances would consider material to a decision to accept or refuse the drug. Permits the written consent form to be provided in English if written translation services are not timely available. Requires the information and written consent form to be provided in an accessible format if the resident is hearing or vision impaired.
4. Requires the written consent form, for purposes of the requirement in 3) above, to be signed by the resident or the resident’s representative, and to be signed by a health care professional who declares the resident or resident representative has been provided the material information. Requires copies of the signed consent form to be given to the resident and their representative.
5. Requires, if the signature of the resident or resident’s representative cannot be obtained, a licensed nurse to sign the form and verify that they confirmed informed consent with the resident or resident’s representative and to state the name of the person with whom they verified consent and the date.
6. Requires the SNF or ICF, within six months after the consent form is signed and every six months thereafter during which the resident receives a psychotherapeutic drug, to provide a written notice to the resident and the resident’s representative, of any recommended dosage adjustments and the resident’s right to revoke consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
7. Authorizes the use of remote technology, including, but not limited to, telehealth, to allow a prescriber to examine and obtain informed written consent.
   
8. Requires the prescriber to provide, in addition to the information required in specified regulations governing informed consent in SNFs and ICFs, the following additional information material to an informed consent decision concerning the administration of a psychotherapeutic drug:
   1. Possible non-pharmacologic approaches that could address the resident’s needs;
   2. Any current boxed warning labels and accompanying detailed information regarding contraindications, warning, and precautions required by the United States Food and Drug Administration (FDA);
   3. Whether a proposed drug is being prescribed for a purpose that has not been approved by the FDA;
   4. Possible interactions with other drugs the resident is receiving; and,
   5. How the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.
      
9. Requires facility staff, before initiating treatment with psychotherapeutic drugs, to verify that the resident’s health record contains a written consent form with the required signatures. Requires facility staff, for a prescription written prior to the admission and encompassing the admission of the resident, to verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
   
10. Requires residents’ rights policies and procedures established pursuant to this bill concerning informed consent to specify how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
11. Prohibits this bill from being construed to require a facility to obtain informed consent each time a drug is administered unless material circumstances or risks change.
12. Requires the Department of Public Health (DPH) to inspect SNFs and ICFs for compliance with this bill during required periodic inspections and, as appropriate, during complaint investigations. Prohibits this inspection requirement from limiting DPH’s authority in other circumstances to cite for violations or to inspect for compliance with this bill.
13. Deems a violation of the requirement in 9) above for facility staff to verify that a resident has a signed written consent form prior to the administration of psychotherapeutic drugs to have caused the affected residents harm and to constitute a class “B,” “A,” or “AA” violation pursuant to the standards under existing law for these violations.
14. Specifies that in addition to any other penalties, the willful or repeated violation of this bill is punishable as a misdemeanor unless there is an emergency as described in specified regulations.
15. Specifies that nothing in this bill impairs or otherwise alters other non-conflicting statutory or regulatory requirements, including but not limited to, requirements contained in specified regulations pertaining to initiating treatment without informed consent if an emergency exists in which immediate action is necessary for the prevention of serious bodily harm or to alleviate severe physical pain.
    
16. Requires DPH to develop a standardized informed consent form in consultation with interested stakeholders.
17. Specifies that SNFs and ICFs are not required to comply with this bill until the informed consent form is available as developed by DPH and requires DPH to have a final informed consent form available by December 31, 2024.
    
18. Authorizes DPH to implement the provisions of this bill by means of an All Facilities Letter, or similar instruction and specifies that nothing in this bill negates existing informed consent requirements in law or regulations.
19. Adds the following two requirements to the Skilled Nursing and Intermediate Care Facility Patient’s Bill of Rights:
    1. Requires a resident of a SNF or ICF to have the right to receive the information that is material to an individual’s decision concerning whether to accept or refuse a proposed treatment or procedure, pursuant to specified regulations governing informed consent in SNFs. Requires the disclosure of material information for administration of psychotherapeutic drugs to also include the disclosures required by this bill in 8) above; and,
    2. Requires a resident of a SNF or ICF to have the right to be free from psychotherapeutic drugs used for the purpose of resident discipline or convenience, and to have the right to be free from psychotherapeutic drugs used as a chemical restraint, except in an emergency that threatens to cause immediate injury to the resident or others. Requires, if a chemical restraint is administered during an emergency, the chemical restraint to only be a drug that is required to treat the emergency condition, after being deemed the least intrusive treatment alternative for the resident, and used only for a specified and limited period of time. Defines “chemical restraint,” for purposes of this provision, as a drug used to control behavior and used in a manner not required to treat the resident’s medical symptoms.
20. Makes various legislative findings and declarations, including that as of 2021, 22% of California nursing facility residents are given powerful antipsychotic drugs, which are a subset of psychotherapeutic drugs; that the FDA has issued black box warnings stating that antipsychotic drugs greatly increase the risk of death for seniors with dementia; and, that it is the intent of the Legislature to codify and expand rules that establish a resident’s right to provide or withhold written informed consent concerning the use of psychotherapeutic drugs and the right to be free from chemical restraint.
    

EXISTING LAW:

1. Establishes DPH, which, among other functions, licenses and regulates SNFs and ICFs. Defines SNFs as health facilities that provide skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis, and ICFs as health facilities that provide inpatient care to ambulatory or non-ambulatory patients who have recurring need for skilled nursing supervision and need supportive care, but who do not require the availability of continuous skilled nursing care. [Health and Safety Code (HSC) §1250 (c) and (d)]
   
2. Permits an attending physician and a SNF or ICF to initiate a medical intervention for a resident of a SNF or ICF that requires informed consent, when the physician has determined the resident lacks the capacity to make health care decisions and there is no person with legal authority to makes those decisions on behalf of the resident, in accordance with acceptable standards of practice. [HSC §1418.8 (b)]
3. Specifies that a resident lacks capacity to make a decision regarding their health care if the resident is unable to understand the nature and consequences of the proposed medical intervention, or is unable to express a preference regarding the intervention. Requires the physician, in making a determination regarding capacity, to interview the resident, review the resident’s medical records, and consult with SNF or ICF staff, and family members and friends of the resident, if any have been identified.[Id.]
   
4. Specifies that a person with legal authority to make medical decisions on behalf of a resident is a person designated under a valid Durable Power of Attorney for Health Care, a guardian, a conservator, or next of kin. Requires a physician to interview the resident, review medical records, and consult with SNF or ICF staff, and with family members and friends, if identified, in order to determine the existence of a person with legal authority. [HSC §1418.8 (c)]
   
5. Requires a SNF or ICF to contact the Long-Term Care Patient Representative Program (PR Program) within 72 hours of a physician’s determination pursuant to 3) above, if no family or friend is identified to serve as the patient representative. [Id.]
   
6. Requires a facility to conduct an interdisciplinary team review of the prescribed medical treatment prior to the administration of the medical intervention when a resident of a SNF or ICF has been prescribed a medical intervention that requires informed consent, and the physician determined that the resident lacked capacity to make decisions, and there is no legal decision-maker. Requires a notice to be provided to the resident and the patient representative. [HSC §1418.8 (d) and (e)]
   
7. Authorizes a SNF or ICF, in the case of an emergency and after obtaining a physician’s order, to administer a medical intervention that requires informed consent prior to the facility issuing the notice described in 6) above, and prior to conducting an interdisciplinary team review. Requires the emergency to be documented in the resident’s records, and for the facility to conduct the interdisciplinary team review within one week of the emergency. [HSC §1418.8 (h)]
   
8. Establishes a civil penalty structure for long term care (LTC) facilities, including SNFs and ICFs, categorized into “AA,” “A,” and “B” violations:
   1. “A” violations are those which DPH determines the violation presents either imminent danger of death or serious harm, or a substantial probability that death or serious harm to residents would result;
   2. “AA” violations (the most severe) are those that meet the criteria for a class “A” violation that DPH determines was a substantial factor (as defined) in the death of a resident of an LTC facility; and;
   3. “B” violations are those that DPH determines have a direct or immediate relationship to the health, safety, or security of LTC facility residents. [HSC §1424]
      

Existing regulations:

1. Specify, for purposes of obtaining informed consent in SNFs and ICFs, that it is the responsibility of the attending licensed healthcare practitioner acting within the scope of their professional practice to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure. [Title 22, California Code of Regulations (CCR) §72528(a)]
   
2. Require, for purposes of informed consent in SNFs and ICFs, that information material to a decision concerning the administration of a psychotherapeutic drug or physical restraint, or the prolonged use of a device that may lead to the inability of the patient to regain use of a normal bodily function, to include specified information, including the nature, degree, duration, and probability of side effects and significant risks, and reasonable alternative treatments and risks. [22 CCR §72528(b)]
3. Require, prior to initiating the administration of psychotherapeutic drugs, SNF or ICF staff to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment. [22 CCR §72528(c)]
4. Define “psychotherapeutic drug,” for purposes of requirements pertaining to SNFs and ICFs, as a medication to control behavior or to treat thought disorder processes. [22 CCR §72092]
   

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, nursing facilities such as SNFs and ICFs have increasingly turned to psychotherapeutic drugs to sedate and control residents, especially those who display confused or agitated behaviors caused by dementia. The author notes that while these drugs are sometimes appropriately prescribed to treat mental health conditions, many of the psychotherapeutic drugs are being misused in nursing facilities. For example, antipsychotic drugs are designed to treat serious psychiatric disorders like schizophrenia, but are instead prescribed to residents with dementia, which can increase the risks of dangerous side effects and death without medical justification. The author states that this bill gives nursing home residents and their families’ tools to decide if a medication is right for them. The author concludes that this bill codifies existing regulations that establish a nursing home resident's right to informed consent concerning the use of psychoactive drugs, strengthens requirements for informed consent verification, and clarifies that DPH must inspect for compliance with informed consent requirements.
   
2. BACKGROUND.
   1. Current informed consent requirements at SNFs and ICFs. Under existing regulations for both SNFs and ICFs, there are a number of requirements governing informed consent, including specific requirements governing the administration of a psychotherapeutic drug or physical restraint. The regulations state that it is the responsibility of the attending physician to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure, and that the disclosure of the material information and obtaining informed consent is the responsibility of the licensed healthcare practitioner, acting within their scope of practice, who orders the treatment for which informed consent is required. For the administration of a psychotherapeutic drug or a physical restraint, or the prolonged use of a device that may lead to the inability of a patient to regain use of a normal bodily function, the material information required to be disclosed in order for the patient or the patient’s representative to provide informed consent includes the following:
      1. The reason for the treatment and the nature and seriousness of the patient’s illness;
      2. The nature of the procedures to be used in the proposed treatment, including their probable frequency and duration;
      3. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment;
      4. The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions;
      5. The reasonable alternative treatment and risks, and why the health professional is recommending this particular treatment; and,
      6. That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.
         

Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff is required to verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The regulations permit the initiation of treatment without informed consent if there is documentation within the patient’s record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for the preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impractical to obtain the required consent. The regulations also permit the disclosure of risks of a proposed treatment or procedure to be withheld if there is documentation that the patient or patient’s representative specifically requested that they not be informed of the risks, or when the licensed health care practitioner relied upon objective facts that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient’s representative gave informed consent. A general consent form in a contract for admission can only encompass consent for routine nursing care or emergency care.

The requirements in this bill build off the requirements in regulations as described by, among other things, requiring the informed consent for psychotherapeutic drugs to be written and signed by both the prescriber and the patient or the patient’s representative, requiring the prescriber to personally examine and obtain the written informed consent, and adding additional required disclosures such as whether a drug is being prescribed for a purpose that has not been approved by the FDA, and information related to black box warnings.

• 1. Background on informed consent. With the exception of a medical emergency, all medical procedures require the consent of the patient. If the medical treatment is more involved, or if there are some risks involved, the patient needs to be informed of those risks or potential complications, and this “informed consent” must be documented in the patient’s record. A patient must be capable of understanding those risks to be able to provide consent to the treatment. While a court can adjudicate a person to be incompetent to make medical decisions, even if this has not happened, a physician can still make a determination that a person lacks capacity to make health care decisions. Sometimes this is temporary, such as when a patient is unconscious, or it can be more permanent if caused by something like dementia. In most cases, the resident of the nursing home has a surviving spouse or child or other next of kin, or someone else previously designated as a surrogate decision maker, whether through a Durable Power of Attorney for Health Care, or some other mechanism. The problem is when the nursing home patient does not have anyone available to represent them. The Probate Code allows a physician or a health facility, among others, to file a petition in court to determine that a patient lacks capacity and to have the court authorize recommended medical treatment, or to appoint someone to make decisions on the patient’s behalf.
     
  2. The PR Program. The PR Program is a new program within the California Department of Aging (DoA), which provides trained representatives for specified long-term care residents who may need medical treatment but lack the capacity to make health care decisions and have no legal surrogate authorized to make decisions on their behalf.
     
     Under existing law, SNFs and ICFs may convene an interdisciplinary team to make medical decisions for residents who lack capacity and have no legal surrogate. These teams include the resident’s physician, a registered nurse responsible for the resident’s care, and other appropriate staff. In the past, the teams also sometimes included patient representatives, but this was not required. As the result of a court case, SNFs and ICFs will be required to include a patient representative when they convene an interdisciplinary team. This new requirement became effective January 27, 2023. The Office of the Long-Term Patient Representative began accepting referrals on January 27, 2023. As of March 1, 2023, the DoA has the following data available:
     1. The PR Program has received 136 referrals. These referrals are received directly from SNFs and ICFs via the California Patient Representative Information System database. These referrals are requests to have a public patient representative attend an interdisciplinary team (IDT) meeting. Of those referrals:
        1. One hundred and seven did not meet criteria (as defined in WIC § 9270) for an IDT meeting; and,
        2. Twelve were for emergency interventions.
     2. Public patient representatives have attended 19 IDT meetings:
        1. Two of the 19 were an IDT for an emergency referral; and,
        2. There are 16 IDTs pending further review.

DoA is currently working out technical details associated with collection and reporting of the data. DoA is also providing technical assistance to facilities regarding their data submission requirements. The collected data will be made available to the public without any personally identifiable information.

If a facility makes a case an “emergency” they are still required to notify the PR Program Office of these interventions within 24 hours and an IDT is to be held within a week of the emergency notice. DPH has indicated that they will evaluate the compliance with these requirements through their survey and compliance process. DoA defers to DPH regarding any penalties if a resident does not receive the benefit of and IDT.

• 1. Black box warnings. A “Black Box Warning” exists on the label of all antipsychotic drugs reading: “Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. Antipsychotics are not approved for the treatment of patients with dementia related psychosis.”
     
     Psychotherapeutic agents are drugs that are used to treat problems in thought processes of individuals with both perceptual and behavioral disorders. These agents do not provide cure for psychoses but they help both adult and pediatric patients perform activities of daily living. Antipsychotic drugs are dopamine-receptor blockers used to treat disorders associated with problems in thought processes. These drugs are also referred to as neuroleptic agents because of their known neurological adverse effects. Previously, they were called major tranquilizers but later this was changed because their primary action is not sedation. Two classifications of antipsychotic drugs are: i) typical antipsychotics; and, ii) atypical antipsychotics. Typical antipsychotics are indicated for schizophrenia and manifestations of other psychotic disorders including hyperactivity, combative behavior, and severe behavioral problems.
     
     However, antipsychotic drugs have been used for some time for “off label” use for patients with dementia. To use a drug “off label” means the prescription of a medication to treat a condition that has not been officially approved by the FDA for that purpose. Prescribing a drug for an “off label” reason is not illegal, and providers must use current research and standards to determine if such a use is beneficial.
     
  2. 2011 Office of Inspector General (OIG) Report, “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents.” In 2011, the OIG evaluated the extent to which elderly nursing home residents receive atypical antipsychotic drugs and the associated cost to Medicare due to concerns about atypical antipsychotic drugs prescribed for elderly nursing home residents with dementia. Side effects associated with these drugs include increased risk of death in elderly persons with dementia. Medicare requires that drugs be used for medically accepted indications supported by one or more of three compendia to be eligible for reimbursement. For the period January 1 through June 30, 2007, the OIG determined using medical record review that 51% of Medicare claims for atypical antipsychotic drugs were erroneous, amounting to $116 million in costs. OIG also found that 14% of the 2.1 million elderly (i.e., age 65 and older) nursing home residents had at least one claim for these drugs. OIG determined using medical record review that 83% of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88% were associated with dementia.
     
     In 2012, the Centers for Medicare & Medicaid Services (CMS) created the Partnership to Improve Dementia Care in Nursing Homes (the Partnership), in recognition of the unacceptably high prevalence of antipsychotic drug use in nursing homes. CMS tracks the progress of the Partnership by reviewing publicly reported measures. The official measure of the Partnership is the percentage of long-stay nursing home residents who are receiving an antipsychotic medication, excluding those residents diagnosed with schizophrenia, Huntington's disease, or Tourette’s syndrome. In 2011Q4, 23.9% of long-stay nursing home residents were receiving an antipsychotic medication; since then there has been a decrease of 39.6% to a national prevalence of 14.4% in 2021Q2.
     
     On January 18, 2023 CMS announced that it will start conducting targeted, off-site audits to determine whether nursing homes are accurately assessing and coding individuals with a schizophrenia diagnosis.
     
  3. Changing diagnosis. According to New York Times investigative reports published in October and November of 2021, the share of nursing home residents who are recorded as having schizophrenia has soared over the past decade. The 2012 CMS effort to reduce unnecessary antipsychotic drug use in nursing homes included an exemption for residents with schizophrenia. Since then, the diagnoses have grown by 70%. The impact of this has been more severe on Black residents. A September 2021 study in the Journal of the American Geriatrics Society, “Disproportionate increases in schizophrenia diagnoses among Black nursing home residents with Alzheimer’s and related dementia” found that since the new rules went into place, Black Americans with dementia have been 1.7 times as likely as their white nursing home neighbors to be diagnosed with schizophrenia.

1. SUPPORT. California Advocates for Nursing Home Reform (CANHR) is the sponsor of this bill and states that antipsychotics and other psychotropic drugs are not only unsafe for elderly people with dementia, they often cause side effects that actually decrease a patient’s cognitive abilities. The leading prescriber/pharmacy guide for reducing inappropriate drugging and adverse drug effects in elderly patients, the “Beers Criteria,” lists nearly all psychotropic drugs in the “avoid” category, citing sedation, cognitive impairment, and increased risk of death. CANHR notes that significant amounts of research demonstrate that antipsychotics have minimal benefit, often outperformed by placebos or simple pain medications like Tylenol. The only benefits of antipsychotics for dementia patients – if they can be called benefits – are sedation and submission which increase fatigue and decrease activity. The resident’s subsequent incapacity increases the patient’s susceptibility to devastating falls, pressure sores, weight loss, and infection. These outcomes are what give antipsychotics, and other psychotropic drugs, their lethality for elderly people with dementia.
   
   CANHR contends that despite the deep foundation of informed consent laws and protections that are specific in nursing homes, the process of obtaining informed consent is often meaningless. In 2011, DPH conducted an Antipsychotic Drugs Collaborative (the Collaborative) to evaluate the use of antipsychotics in nursing homes. DPH found 147 violations involving 41 different regulations in just 24 facilities, an average of 6.1 deficiencies per facility. Most of the violations involved the use of unnecessary drugs or drugs in excessive dosage and the failure to obtain informed consent. The Collaborative investigations determined the majority of the sampled nursing homes had violated at least one rule regarding informed consent. The most common violation was the total failure to obtain the consent of the resident or a surrogate before administering a psychotropic drug while another common violation was the absence of the physician in the informed consent

process. CANHR states that the use of mind-altering drugs without consent violates some of our most precious and fundamental human rights: the right to control what goes into our bodies, the right to our thoughts and expression, and the freedom to make our own decisions. CANHR concludes that informed consent lies at the heart of residents’ ability to ultimately direct the course of their health care treatment and this bill ensures that their choices will be appropriately honored.

1. RELATED LEGISLATION.
   1. AB 486 (Kalra) removes the ability of a LTC facility to adjudicate the validity of a citation issued by DPH in a county superior court, and instead requires all citation appeals to be made through an administrative law judge. AB 486 is pending in the Assembly Health Committee.
   2. AB 1537 (Wood) requires, no later than July 1, 2024, the establishment of a direct patient-related services spending, reporting, and rebate requirement for skilled nursing facilities (SNFs), with certain exceptions. Requires that a minimum of 85% of a facility’s total non-Medicare health revenues from all payer sources in each fiscal year be expended on residents’ direct patient-related services, as defined.
2. PREVIOUS LEGISLATION.
   1. AB 1809 (Aguiar-Curry) of 2022 was substantially similar to this bill. AB 1809 was vetoed by Governor Newsom, who stated: “I support the author's goal of improving informed consent requirements and protecting long-term care residents from inappropriate uses of psychotherapeutic medications. However, this bill creates ambiguity as to whether long-standing informed consent requirements will continue to be required until a new standardized form is developed, which could put the health of long-term care residents in jeopardy. Furthermore, the State Health Facilities Citation Penalties Account is not an appropriate funding source for the development of this form because the funds in the account are by law reserved for the protection of health or property of residents of long-term health care facilities. I encourage the author to work with DPH to resolve these concerns in the next legislative session.”
   2. AB 135 (Budget Committee), Chapter 85, Statutes of 2021, creates, among other provisions, the Long-Term Care Patient Representative Program (program) and the Office of the Long-Term Care Patient Representative in the Department of Aging to provide patient representatives to protect the rights of nursing home residents. Requires the program to assign a public patient representative if no family member or friend is available to serve in that capacity.
   3. AB 323 (Kalra), Chapter 458, Statutes of 2021, changes the standard DPH uses when issuing penalties against LTC facilities for violations that result in the death of a resident from “direct proximate cause” to “substantial factor” and the death was a result of the violation. Increases the amount of civil penalties assessed against LTC facilities.
   4. AB 849 (Reyes), Chapter 471, Statutes of 2021, clarifies that a LTC facility licensee is liable for up to $500 per violation when a current or former resident, or patient, or the legal representative, personal representative, or successor in interest of a current or former resident or patient, of a LTC facility brings a civil action against the facility for violation of any rights of the resident or patient as set forth in the Patient's Bill of Rights or any other right provided for by federal or state law or regulation. Provides that the above per violation penalty applies to violations that occur on or after March 1, 2021.
   5. SB 460 (Pan) of 2021 would have created the Office of the Patient Representative within DoA to train, certify, provide, and oversee patient representatives to protect the rights of SNF and ICF residents when a medical intervention is prescribed for residents who cannot provide informed consent, as specified. SB 460 would also have refined procedures for determining that residents of SNFs and ICFs lack capacity to provide informed consent for a medical intervention. SB 460 was not taken up for a vote on the Senate Floor.
   6. SB 503 (Ed Hernandez) of 2016 would have made changes to the process for the prescribing or ordering of a medical intervention for a resident of a SNF or ICF who lacks capacity to make decisions involving their health care; modified the existing IDT review process required for such medical interventions; and established a new process for the administration of antipsychotic medication to residents of SNFs and ICFs. SB 503 was subsequently amended to address a different subject matter.
3. DOUBLE REFERRAL. This bill is double referred; upon passage in this Committee, this bill will be referred to the Assembly Judiciary Committee.
4. TECHNICAL AMENDMENT. The Committee recommends amending this bill to clarify that DPH will provide the final consent form to skilled nursing facilities, and intermediate care facilities, by December 31, 2024.

REGISTERED SUPPORT / OPPOSITION:

Support

California Advocates for Nursing Home Reform (sponsor)
A Voice for Choice Advocacy
AARP
Alzheimer's Greater Los Angeles
Alzheimer's Orange County
Alzheimer's San Diego
Berkeley City Council District 4, Office of Vice Mayor Kate Harrison
California Advocates for Nursing Home Reform
California Alliance for Retired Americans
California Commission on Aging
California Health Coalition Advocacy
Consumer Attorneys of California
Educate. Advocate.
Elder Law & Advocacy
Gray Panthers of San Francisco
Justice in Aging
Long Term Care Services of Ventura Co, Ombudsman
Oakland Privacy
The Geriatric Circle

Opposition

None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097