Amid Pandemic, A Pharma-Backed Effort to Ease Oversight on Psych Meds

mental health
Illustration by Christine Ongjoco

As the California Assembly struggles to begin creating new laws on Monday amid the ravages of the coronavirus pandemic, lawmakers are being urged to select only the most vital-to-the-times bills. To contain infections that have topped 43,000 in the state, there will be masks and gloves, and people seated far from each other in cavernous hearing rooms. Virtual testimony is expected.

Against that backdrop, the Assembly Health Committee is set to hear bill number 3285, which is being pitched as “more crucial than ever.” The legislation aims to scale back oversight on the most powerful and expensive type of psychiatric drugs prescribed to Californians reliant on the state’s Medicaid plan for mental health services. 

Democratic state Assembly Member Jacqui Irwin’s bill, sponsored by a special interest group with close ties to the pharmaceutical industry, seeks a change in state law so that quality-of-care and cost reviews of antipsychotic drug prescriptions paid for by Medi-Cal take place annually, instead of every month. The legislation is described as necessary to more quickly deliver antipsychotics – one of several classes of psychotropic drugs – to those suffering from poor access to health care, particularly the homeless.

In an April 17 letter seeking support for AB 3285 to be considered by the Assembly Health Committee, the bill’s sponsor highlights the need for “uninterrupted access to prescribed medication” for those with severe mental illness. The letter calls the issue “more crucial than ever as the state attempts to address homelessness amid the COVID-19 pandemic.” Le Ondra Harvey, executive director of the California Access Coalition, describes the bill as seeking “modest, but very impactful changes to the Medi-Cal system.”

State Assembly Member Jacqui Irwin’s (D) bill would dramatically cut down the frequency of reviews for prescriptions of powerful mental health drugs to people enrolled in Medicaid.

 But it doesn’t appear that way to Tisha Ortiz. She’s a former foster youth living in the Bay Area who bounced from group homes to motels and cramped apartments, before finding some emotional and residential stability in recent years. Four Aprils ago, then 23-year-old Ortiz braved media glare, the formality of a packed Senate hearing room and speaking into a microphone, to describe personal pain few would have the courage to publicly disclose.

Dressed smartly in a black blazer, her hair pulled in a tight bun, she stoically faced the panel of senators and described being a child in a group home, prescribed four different classifications of psychotropic medications – antipsychotics, antidepressants, anti-anxiety drugs and mood stabilizers. At one point in her childhood, Ortiz testified, she took 12 pills a day.

“I had a swollen tongue, tics all over my body, and I couldn’t stay awake in class,” she testified. “I was normally an A and B student, and all of a sudden I’m failing. I had tunnel vision and I felt like a zombie. I also developed an irregular heartbeat because of these medications.” Ortiz said she tried to talk to the doctor in her group home, but she felt dismissed: “They were all about upping or adding more medication, and not what was really going on with my mental health.”

In 2016, within five months of her testimony, former Gov. Jerry Brown (D) signed into law a bill that barred “excessive prescribing, furnishing, or administering psychotropic medications to a minor.” The Medical Board of California was directed to “prioritize its investigative and prosecutorial resources to ensure that physicians and surgeons representing the greatest threat of harm are identified and disciplined expeditiously.”

The package of bills grew to six new laws, making California a national leader on curbing out-of-control prescribing of mental health drugs to some of Medi-Cal’s most vulnerable patients – children and teens in foster care suffering from trauma and displacement.

It has long been widely acknowledged that foster youth are particularly vulnerable to the over prescribing of psychotropics – in their mildest form, drugs to treat attention-deficits, and in their most extreme, antipsychotics, which are only scientifically proven effective for adults with serious mental illnesses such as schizophrenia and bipolar disorder. For foster youth with histories of abuse and neglect, behaviors that can be hard for caregivers to safely manage, and no parents to pay close attention, the drugs have silently left many overmedicated and suffering the lasting consequences. They include obesity, diabetes and irreversible tics.

The problem had been called out by child welfare advocates across the country for years. And beginning in 2011, the federal government took notice, with reports and recommendations from the General Accounting Office and the Obama administration. 

California’s reforms included new rules requiring juvenile court judges to sign off on psychotropics, accountability from group homes, and stepped-up reviews of prescriptions, required every month. The result was dramatic. According to state health care data, antipsychotic prescriptions for foster youth plunged 50 percent in less than three years. Children on multiple antipsychotics declined by almost three-fourths.

But this month, four years to the date from Ortiz’s testimony, it looked like all those efforts were about to be wiped away.

mental health
Tisha Ortiz and State Sen. Jim Beall (D), in 2016, testifying in support of measures to increase state oversight on the use of psych meds on youth in foster care.

Assembly Bill 3285, introduced Feb. 21, is described by the California Access Coalition sponsor as aiming to “improve access to crucial antipsychotic drugs for Medi-Cal patients with Severe Mental Illnesses (SMI) by removing unnecessary barriers.”

The bill, which would amend sections of the Welfare and Institutions Code relating to Medi-Cal, proposes four changes that focus on easier dispensing of antipsychotic drugs. For those drugs, it seeks to eliminate the monthly “prior authorization” reviews conducted by specially trained board-certified psychiatric pharmacists before the high-cost Medi-Cal prescriptions can be filled. Instead, the legislation proposes that after initial prescriptions of drugs that can cost up to $1,000 a month are filled, state reviews be conducted only once a year. 

The bill would also exempt antipsychotic medications from the current six-prescription per-month limit for Medi-Cal patients, and allow for 90-day supplies to be dispensed for certain patients.

A summary of the need for the bill does not highlight, specifically, how many patients in California have been affected by the current system. It focuses more broadly on patients with severe mental illness who can’t access prescriptions, leaving them more likely to end up in the hospital, homeless, jailed or suicidal.

Karie Portillo Guerra, Assembly Member Irwin’s communications director, responded by email to interview requests last week, stating that “due to the Assemblymember’s overbooked schedule, she is unavailable.”

Irwin’s legislative staffer, Lucia Saldivar, also did not respond to followup questions. Among them: Why does Irwin, who leads committees managing veterans affairs and cybersecurity, feel this legislation is needed? How many people are impacted by the problem this bill describes? What about the current system is not working, and based on what evidence? No answers were given about how the bill would affect children on Medi-Cal or in foster care, and why, regardless of the age of the Medi-Cal patient, it was necessary to relax the system of monthly quality control and cost reviews.

The author of the bill’s office also did not answer why, given all the priorities of the global coronavirus pandemic, this bill was a top priority for the state Legislature to consider.

The bill’s sponsor, the California Access Coalition – a nonprofit network of organizations working to eliminate barriers to accessing medication and mental health treatment – and its lobbyist, who works for the California Psychiatric Association, also declined to comment. Both directed a reporter’s questions to Irwin’s office, which also did not answer follow-up questions.

The California Access Coalition lists nine “corporate partners” on its website, all of which are drug companies, among them pharmaceutical giants Eli Lilly, Johnson & Johnson, Pfizer and PhRMA. Executive Director Harvey is among those crossing over from the public to private sectors, working previously as chief consultant for the Assembly’s Committee on Business and Professions. 

James Gross is a lobbyist working the bill on behalf of California psychiatrists. His lobbying firm, Neilsen Merksamer, is one of the state’s most powerful, and includes among its clients the pharmaceutical companies Merck & Co., Johnson & Johnson and Novo Nordisk. 

After weeks of emails and conversations with child welfare advocates concerned about AB 3285, late Friday, Gross sent them a set of draft amendments that would exempt foster youth ages 21 and younger.

Those amendments, which have yet to be formally introduced, would not cover thousands of former foster youth who remain on Medi-Cal, automatically, until at least age 26, and thereafter if they remain qualified.

Few bills, urgent needs

New bills being heard in the California Legislature land amid virtually unprecedented desperation among state residents.

The numbers of residents infected with coronavirus grows daily, now scaling 41,000, with more than 1,600 dead. Shelter-in-place orders – while credited with saving lives – have devastated huge swaths of the economy. Newly unemployed heads of households are now relying on their children’s shuttered schools to feed them, or lining up at food banks for the first time. The most recent statewide unemployment data shows residents here are losing jobs at a rate that dwarfs job loss during the Great Depression, according to the Public Policy Institute of California.

Amid the seemingly unending tragedy, the California Assembly is scheduled to take up new bills on May 4. No committee hearings have been finalized yet and many of the details remain undecided, legislative staffers said, including where committees will meet and how. 

Elected leaders have advised committee chairs that bills are to be pared down from the usual quantity, and prioritized. Top issues must be how to address the coronavirus pandemic, the homeless crisis and – California’s other recent tragedy –  the wildfires that have ravaged the state in recent years. 

Only the most vital bills to be considered

The chair of the health committee that will hear AB 3285, Assembly Member Jim Wood (D-Santa Rosa), said through a staffer that his office is not aware of the bill’s status, or any discussion surrounding it. Cathy Mudge, Wood’s communications director, did confirm, however, that the health committee chair, a dentist and the former mayor of Healdsburg, had been given some direction about picking the most important bills amid the ongoing public health catastrophe.

Leadership has asked all legislators to think about prioritizing their bills,” Mudge stated in an email Friday. But she added that much is still in flux, and “nothing is finalized.” 

For weeks – in an escalating series of emails and phone calls – Bay Area health policy expert and advocate for foster youth Anna Johnson has challenged the bill’s premise. Johnson, who now works for the John Burton Advocates for Youth, previously led a yearslong campaign with the National Center for Youth Law to limit the excessive prescribing of psychotropics to foster youth. 

“So many people have spent years and years in work groups, expert panels and oversight hearings trying to curb the dangerous practices we knew were impacting children in our state,” Johnson said. “And if this law were to go forward it would undo the core principles of all of those efforts.”

It appears the efforts of Johnson – a respected expert in California mental health policy – paid off late Friday, when the draft amendments to the bill were proposed on email threads among those working on the bill. The amendments have not yet been publicly posted. And, Johnson notes, they also do not address the larger patient protection issues for adults, even if current foster youth are exempted.

An investigative series published by the San Jose Mercury News beginning in 2014, described lifelong health hazards for young people treated with too many psychotropic drugs, particularly the antipsychotic class. The heavy hand of the pharmaceutical industry was also a key finding of the Drugging Our Kids story and video series. Drugmakers, anxious to expand the taxpayer-funded drug market for some of their most profitable products, spent more than double the amount wooing foster care prescribers than what they gave to the typical California physician. In turn, doctors who received the most money for gifts, meals, travel and speeches were the heaviest Medi-Cal prescribers.

The series, and advocacy by the National Center for Youth Law, led to legislative and court reforms, as well as enhanced statewide prescribing policies that afforded patients greater protections. In combination, the efforts had a dramatic effect: Between late 2014 and 2017, the number of California foster youth prescribed antipsychotic drugs plunged by almost half, state data showed, from 5,076 to 2,778 patients, and the number of foster children prescribed multiple antipsychotics dropped by 73 percent.

Given California’s efforts to combat overprescribing of antipsychotics – involving juvenile court judges, public health nurses and social workers, Ortiz said the bill introduced this month shocked her.

It’s kind of upsetting how it potentially pushes back the protections that were put in place for youth in foster care on psychotropic medications,” she said. “Prescribing a lot of medications isn’t the best practice.”

Retired Bay Area child psychiatrist Stuart Bair also said the bill’s original language concerned him, if children were to be included, because “the vast majority” of youth placed on antipsychotics are prescribed not because they suffer from psychosis, but because they are acting out in foster and group homes in ways that are difficult for caregivers to manage. 

But even with adults, less review is also problematic, Bair said. For people experiencing mental health crises, their situation is typically not static. Symptoms wax and wane, Bair said, “so a more frequent, rather than less frequent re-evaluation always seems to be in order as far as I am concerned.”

Bair said that in his experience working in county mental health programs, frequent psychiatrist turnover resulted in a tendency “to not rock the boat and continue whatever the patient was on again and again.” Thus, delaying a medication’s review from one month to a year, he said, “makes it really easy to pass the buck.”

Waiting a year for review ‘is ridiculous’

Mental health and child welfare experts consulted about AB 3285 speculated that the problem the bill attempts to address is related to paperwork delays and a sluggish bureaucracy that can’t move nimbly enough in a crisis. Some Californian physicians have complained that approvals from the state’s pharmacy benefit claims office for Treatment Authorization Requests, known as TARs, can get bogged down. Lawyers for children say the problem can also be physicians who fail to properly complete forms or leave off key details such as whether a child is being offered non-drug therapies as well as medications.

Regardless, under state guidelines, California doctors can prescribe on an emergency basis without a treatment authorization for three days, and then extend that window if the state has not approved the prescription.

Child psychiatrist Thomas Tarshis, the executive director of Bay Area Clinical Associates, said the prior-authorization process can be a hassle “because often there are denials that don’t make sense or things that need to be submitted multiple times.” Patients with acute psychiatric symptoms such as psychosis, he added, “should be able to walk right to the pharmacy and get started on medication.”

But Tarshis said the solution is to use technology and better communication to streamline approvals – such as online portals, software that flags applications filled out improperly, or the ability for the state’s pharmacy reviewers to call a doctor’s office more quickly when problems arise.

Waiting 365 days for review, “is ridiculous,” Tarshis said. “Even with how poor the current system is, a 15-day window would be sufficient.” 

Johnson, the foster youth advocate, said AB 3285 sets up Medi-Cal patients for “second-class status” in terms of legal protection. Also troubling, she said, is the bill’s proposal that no treatment authorization be required if one of the six drugs a Medi-Cal patient is prescribed is an antipsychotic. The drugs can have serious harmful effects without regular lab tests and when mixed with other medications.

“Why would you waive an entire quality-of-care measure just because someone has a serious mental illness?” Johnson said. “This is a population that needs that oversight even more.”

Karen de Sá is the Safety Net Reporting Fellow for The Chronicle, and a former investigative reporter for the San Francisco Chronicle and the San Jose Mercury News. She can be reached at kdesa@chronicleofsocialchange.org.

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Karen de Sa, Safety Net Fellow, The Chronicle of Social Change
About Karen de Sa, Safety Net Fellow, The Chronicle of Social Change 3 Articles
Karen is the 2020 Safety Net Fellow for The Chronicle of Social Change. Reach her at kdesa@chronicleofsocialchange.org.