The Passing of AB-48 - Nursing Facility Resident Informed Consent Protection Act of 2023 - Elder Abuse Prevention

California Governor Gavin Newsom signs bills into laws.

California Assembly Bill 48 or Nursing Facility Resident Informed Consent Protection Act of 2023 was recently signed into law by Governor Gavin Newsom. Among the changes made by this law is the resident shall have the right to be free from 'psychotherapeutic' drugs used for the purpose of resident discipline or convenience. It also provides for informed consent for a class of drugs called psychotropics and soft restraints.

What does this mean for the 97,749 California nursing home residents it is meant to protect?

What are psychotherapeutic medications?

Psychotherapeutic means relating to psychotherapy. Psychotherapy is an approach for treating mental health issues by talking with a mental health provider. Psychotropic drug, is what must have been meant in the overall language of the law. A psychotropic drug is a chemical substance that changes the function of the nervous system and results in alterations of perception, mood, cognition, and behavior.

What the law does

• Amends §1599.1 of, and adds §1599.15 to the Health and Safety Code relating to skilled nursing facilities (SNF) and intermediate care facilities (ICF).
• Establishes 'Residents’ rights policies and procedures' pursuant to 1599.1 concerning informed consent and specifies how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of 'psychotherapeutic' drugs.
• Within six months after the consent form is signed, and every six months thereafter during which the resident receives a psychotherapeutic drug, the facility shall provide a written notice to the resident and, if applicable, 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.
• Residents are informed about FDA boxed warnings that apply to certain medications that carry serious risks for the person taking them.

Problems with the AB-48

With the exception of a medical emergency, all medical procedures already 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.

The Alzheimer's Association 2020 Alzheimer's Disease Facts and Figures report states, 48% percent of nursing home residents are living with Alzheimer's or other dementias. Among older adults in residential facilities, including assisted living, 42% or more have some form of Alzheimer's or other dementias. If the patient’s diagnosis is correct, they would likely be unable to comprehend drug information and much less consent. Given the broad definition of 'psychotherapeutic' drugs, would the state be interfering with the physician’s ability to care for this vulnerable and large nursing and intermediate care facility population? Yes.

AB-48 states, 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. This makes no sense. In a psychotic state the resident could present a danger to themselves and others. If the patient is suffering from dementia or other impaired state when placed in the SNF or ICF, waiting until the patient is out of control is dangerous to the staff and the patient. The method of waiting for a psychotic incident would deter health care employees from working in nursing facilities and exacerbate existing staff shortages.

The Alzheimer's Association 2023 Alzheimer's Disease Facts and Figures report states the long-term care field is already struggling to fill existing direct care positions. Turnover* rates are high in this workforce estimated at 64%  for direct care workers providing home care and 99% for nursing assistants in nursing homes.

* The ratio of the number of workers that had to be replaced in a given time period to the average number of workers annually.

Problems with the data it is based on

Cited in the law was a 2022 Office of Inspector General for the United States Department of Health and Human Services report that found that approximately 80% of long-stay nursing home residents were receiving 'psychotherapeutic' drugs from 2011 through 2019. Unfortunately, the report doesn't detail 'psychotherapeutic' drugs but psychotropics. Psychotropics even excluding anti-seizure medications and hormones that affect neural activity such as melatonin have a place in the care of nursing home residents. Secondary uses for psychotropic drugs include:

• Allergies/Antihistamine (Hydroxyzine)
• Alzheimer's disease (Levetiracetam)
• Chronic pain (Gabapentin)
• Drug withdrawal (Clonidine)
• Focal seizures (Oxcarbazepine)
• Fibromyalgia (Tiagabine)
• Hypertension (Inderal, Clonodine, etc.)
• Insomnia (Mirtazapine, Imipramine, Doxepin, Quetiapine, etc.)
• Migraine headaches (Topiramate)
• Nausea (Trifluoperazine)
• Nerve/Neuropathic pain from diabetes, etc. (Depakote, Doxepin, Protriptyline, etc.)
• Obesity (Contrave or Naltrexone with Bupropion, Desoxyn,  etc.)
• Parkinson's disease (Pimavanserin)
• Skeletal muscle relaxant (Clorazepate, Estazolam, etc.)
• Spasticity (Clonidine)

The report states, "Our review did not assess the administration of or medical necessity of psychotropic drugs for nursing home residents." It also states, "We used Minimum Data Set (MDS) assessment data from calendar years 2011 through 2019 to identify long-stay nursing home residents aged 65 and older and reviewed Medicare Part D psychotropic drug claims data for these residents. From these data, we identified the number of residents who received a prescription for any of these drugs."

Medicare Part D claims data include information about the drugs dispensed but do not include diagnosis information because Centers for Medicare & Medicaid Services (CMS) does not require or collect diagnoses (i.e., the reasons for the drugs) for these items. Because of this a conclusion that 80% of residents take psychotropics doesn't necessarily mean chemical restraint abuse.

In further reading of the report states, "In 2019, the unsupported reporting of schizophrenia was concentrated in 99 nursing homes in which 20 percent or more of the residents had a report of schizophrenia in the MDS that was not found in the Medicare claims history."

The report continues, "By not collecting diagnoses on Medicare Part D claims, CMS is limited in its ability to effectively conduct oversight of psychotropic drugs. First, not having diagnoses on claims limits CMS’s ability to detect patient risk and patterns of potentially inappropriate drug use. Second, the lack of diagnoses makes it difficult for CMS to systematically determine whether claims meet the payment requirement that drugs be used for medically accepted purposes."

The Smoking Gun, or drug

The caveat of 'without diagnostic information' regarding the psychotropic drugs leaving a hole in the data is false. If one is to accuse the nursing home of chemical restraint abuse, you'd have to know who prescribed the medication. SNF and ICF have limited interest in the prescribing of medication. It is left to the attending physician that typically is still the resident's primary doctor. If the physician employed with the nursing home doesn't even prescribe the medicine, where is the chemical restraint abuse? 

He/She would be a disinterested party in prescribing unnecessary drugs as the doctor wouldn't be profiting from it at all. The way it might work would be the facility lying about the patient's signs and symptoms. However, this is best investigated by the the local Sheriff, Adult Protective Services, the Public Health Department or a long-term-care ombudsman, an agent who investigates complaints.

In reality, other uses and secondary or tertiary diagnoses, would make it difficult to glean results from the CMS drug data alone. For example, a patient with Parkinson's over time develops psychosis. His doctor prescribes an antipsychotic for him. Just because he didn't come into residential care as a schizophrenic, doesn't mean the prescription is shady. However, even without a diagnosis, anti-psychotic medication might not be the smoking gun of chemical restraint they seem to believe it is. The report ignores who is prescribing the medication is essential to discovering abuse as well as the circumstances under which it was prescribed.

California Laws Governing Chemical Restraint

Welfare and Institutions Code §4436.5, §4900, §14126.022 & §15610.63
Health and Safety Code §1257.8, §1267.75 & §1418.8

California laws governing Elder Abuse

Penal Code §166 (c)(1)(C), §186.12, §288, §368, §13750, & §11160
Evidence Code §1109

Hugs are important to resident care. Residents may feel socially isolated, leading to increased risk for depression, anxiety, and expressions of distress.

Legitimate use of anti-psychotics in over age 60 populations

Parkinson's disease PD is a chronic degenerative disorder of the central nervous system that affects both the motor system and non-motor systems. The symptoms usually develop slowly, and as the disease worsens, non-motor symptoms become more common. Early symptoms are tremor, rigidity, slowness of movement, and difficulty with walking. Problems may also arise with cognition, behavior, sleep, and sensory systems. Parkinson's disease dementia becomes common in advanced stages of the disease.The primary risk factor for PD is age. According to the World Health Organization, 8.5 million individuals live with PD worldwide with 1.2 million in the US.

Hallucinations or delusions occur in about 50% of people with PD over the course of the illness, and may herald the emergence of dementia. These range from minor hallucinations to full blown vivid, formed visual hallucinations and paranoid ideation. Psychosis is believed to be an integral part of the disease. A psychosis with delusions and associated delirium is a recognized complication of anti-Parkinson drug treatment. Urinary tract infections (frequent in the elderly) and underlying brain pathology or changes in neurotransmitters or their receptors (e.g., acetylcholine, serotonin) are thought to play a role in psychosis in PD.

Other similar illnesses such as Alzheimers, Multiple Sclerosis, Huntington's disease, Lou Gehrig's disease, etc. have symptoms that include problems with mood or mental/psychiatric health as well as onsets that occur or worsen later in life, especially while living in a nursing home due to physical and/or mental degeneration.

According to the 2023  Alzheimer's Fact and Figures Report, at age 80, approximately 75% of people with Alzheimer’s dementia live in a nursing home compared with only 4% of the general population aged 80. In all, an estimated two-thirds of those who die of dementia do so in nursing homes, compared with 20% of people with cancer and 28% of people dying from all other conditions. With these sorts of diagnoses, use of anti-psychotics might ease the suffering of someone with psychosis caused by degenerative disease.

A possible better approach to over-medication, bribery and fraud...Jail

Criminal Prosecution

In a recent case, California Attorney General Rob Bonta, in partnership with the U.S. Department of Justice agreed to a  $3.8 million settlement with a Riverside skilled nursing facility, Alta Vista Healthcare & Wellness Center, and its management company, Rockport Healthcare Services, to resolve allegations of Medi-Cal fraud. 

The defendants are accused of violating the federal Anti-Kickback Statute and False Claims Act, as well as the California False Claims Act, by paying illegal kickbacks to doctors to encourage them to refer Medicaid and Medi-Cal patients to Alta Vista. As part of this settlement, the United States will receive $2.8 million and California will receive $596,700, based on the proportion of losses to state and federal funds. According to the allegations, nearly $60,000 a year was misappropriated from the state, and $280,000 from Medicare.

This is not the first time Rechnitz-owned facilities have settled a case involving illegal resident referral kickbacks. In 2017, four Rechnitz-owned San Diego nursing homes settled a similar case for $6.9 million. Despite the settlement, the state Department of Public Health nonetheless approved Rechnitz’s application to oversee 24 more nursing homes. The license applications had been pending for nine years and several of them had previously been denied but the Department went ahead and agreed to approve them in a recently executed “settlement agreement.” The state’s approval, with only very modest conditions, is wildly disappointing for nursing home residents, sending a message that poor performing nursing home operators have a safe haven in California.

Given the purely monetary and arguably lackadaisical response, perhaps criminal penalties should be enacted in confirmed cases of fraud, bribes and chemical restraint abuse. This would serve as a better deterrent than fines and settlements.

If you suspect abuse or have witnessed abuse please contact...

• Adult Protective Services programs help protect vulnerable adults from abuse, neglect, and exploitation. The National Adult Protective Services Association provides phone numbers for programs in each state on its website or by calling 202-370-6292.
  
  
• The National Center on Elder Abuse provides guidance on how to report abuse, where to get help, and state laws that deal with abuse and neglect. Visit the Center online or call 855-500-3537 for more information.
  
  
• Long-term care ombudsmen advocate for the needs of people who live in assisted living facilities, board and care homes, and nursing homes. They are trained to help resolve problems. Find a long-term care ombudsman in your state online or by calling 202-332-2275.

If you think someone is in urgent danger, call 911.