by Art Levine
Yet as The New York Times and other media outlets have reported, building on the research of the Center for Medicare Advocacy (CMA), most nursing homes have gamed the Medicare system. According to the Times, Rosewood Post-Acute Rehab in Carmichael, California, was in the elite tier of five-star facilities in the country, even though it had as many as 165 complaints filed against it with the state health department in four years—and had even been fined $100,000 after a woman died following an overdose of a blood-thinning drug. As CMA attorney Toby Edelman points out, these government data sets are “fraudulent and based mostly on self-reports.”
Stung by the criticism, CMS vowed to improve the star rating system in 2014 by adding additional government audits of nursing home quality claims and including the use of antipsychotics as a measurement of quality. But the nursing home industry still runs the show by apparently undermining state and federal assessments, inspections and surveys. In October 2015, roughly a year after those CMS “reforms” were announced, Al Jazeera’s America Tonight reported that over forty nursing homes with five-star ratings openly admitted that they were drugging their patients at well more than twice the rate of CMS’s estimated 17 percent usage rate; in some cases, up to 50 percent of patients at these top-rated facilities were being pummeled with antipsychotics.
One of the nursing homes that says it’s doing better than the national average is the Roseville facility where Conover’s mom died after receiving antipsychotic injections; it has reported that a mere 14.6 percent of patients get antipsychotics.
But all you really need to know about enforcement and the government data that consumers use to evaluate nursing homes can be found in the state health department’s response to the death of Zizzo. The FATE group filed a complaint on her behalf in June 2013, alleging that the two injections of Haldol in one night left her “completely comatose in a vegetative state,” and that she had been a victim of “elder abuse, dehydration, undiagnosed fracture of the spine, physical and verbal abuse.” A few days after FATE complained, Conover received a call from a state health department investigator indicating the agency had no intention of seriously investigating any of the allegations.
For instance, Conover offered to send the medical records from Kaiser confirming dehydration, a urinary infection and a fractured spine, among other major problems. She also wanted to provide a letter—written by an experienced home health aide who visited the nursing home—that described the relatively few scattered dark stains on Rizzo’s soiled diaper indicating dehydration, especially because it seemingly wasn’t changed for days.
“Don’t bother to send that,” the state health official callously sniffed. “I won’t be looking at it.” This sort of indifferent official attitude towards Conover’s concerns, as she recounts it, is one of the points raised in the nearly four-year-old appeal that wasn’t answered until April 2017.
By August 2013, following this “investigation,” the licensing and certification program of the California Department of Public Health (CDPH) found all the FATE allegations “unsubstantiated” and didn’t find any other violations. The state agency also didn’t substantiate a later complaint filed by Conover directly alleging Roseville’s mishandling of her mother’s urinary infection. The department didn’t reply to specific allegations that it mishandled the Zizzo inquiry, but said in a statement, “CDPH takes complaints seriously and investigates thoroughly,” while claiming it was working “diligently” to improve the timeliness of its inquiries. (That assertion was undermined by a January 2017 report by Disability Rights California that found that the state was “low-balling” penalties in death cases.)
This critique was reinforced by the state’s final response to the appeal in the Zizzo case: It issued a “Class B” citation of $600 to Roseville for giving Marisa Conover’s mother the Haldol injections without informed consent. “It’s an insult,” says Carole Herman. “It’s better than the original finding as ‘unsubstantiated complaint,’ but high-level officials in California are protecting the operator in my opinion.”
At least in the case of Zizzo, the state pretended to conduct an investigation. A scathing state audit in 2014 found that the department ignored a backlog of 11,000 mostly high-priority complaints against nursing homes, including nearly four hundred cases where patients were in “immediate jeopardy” of death or injury. The audit was spurred in large part by the wide-ranging lawsuit filed by FATE in 2013 targeting the department for failing to pursue complaints against nursing homes. At the end of 2014, the director of the department and his two top associates resigned after a public outcry. (Rather than being drummed out of the health-care field, though, they’ve all landed plum new jobs, some with higher pay.)
The lawsuit filed by FATE was finally settled in October 2016, when a state court ordered CDPH to perform timely investigations and appeals, supplemented by a law that aimed to force the state agency in 2016 to complete new investigations within ninety days. But with numerous loopholes and a stubborn bureaucracy, long delays are still commonplace.
“There’s no enforcement anywhere in the United States,” says Carol Herman, the founder of FATE. “They don’t really care.” That indifference is also reflected in CMS’s questionable five-star rating system and, as cited earlier, its highly touted “partnership” with the industry that has purportedly brought down antipsychotic prescribing in nursing homes to 17.4 percent—a figure that few, if any, nursing home reform organizations believe.
Further questions about the validity of these glowing Medicare assessments and claimed antipsychotic downturns emerged in 2014 and 2015 when a handful of the sister facilities in the same chain that owns Roseville faced new public scrutiny and criminal investigations. In addition, the federal government decertified three of that chain’s nursing homes over safety questions and some deaths, barring them from receiving Medicare and Medicaid funds. Much of this new attention from federal and state agencies was spurred by a Sacramento Bee investigative series in 2014 looking into the chain’s head, Shlomo Rechnitz, a Los Angeles entrepreneur who has become the owner of approximately eighty facilities, including the South Pasadena Convalescent Hospital, which was decertified in January 2015, three months after a mentally ill patient died by wandering off and setting herself on fire.
In response to Conover’s original accusations about the alleged maltreatment of Rizzo, the Bee reported that Rechnitz’s legal team cited the state’s closing of the case, and “declined to comment further due to privacy laws protecting patients.”
According to the Bee, Rechnitz is the largest operator of nursing homes in California. He has defended the quality of care in his facilities and noted his willingness at some sites to take in mentally ill patients whom he claims local governments don’t help; his homes still serve seniors. Yet by the fall of 2015, Rechnitz’s Riverside, California, facility was raided for undisclosed reasons by FBI agents with search warrants; four former staffers at two other facilities were also charged with crimes ranging from tolerating resident-on-resident sexual abuse to the death of a burn victim in a Montrose nursing home due to alleged neglect in August 2014. In August 2015, the state attorney general also charged the home itself with involuntary manslaughter. Until that criminal charge, the state government—including the health department—found no cause to cite the Montrose facility for any deficiencies or incidents for three straight years. Rechnitz and his spokesperson have traditionally cited high marks from the state for most of their facilities as a sign of their quality. (In response to an interview request in May 2016 from a Los Angeles CBS affiliate reporting on another facility death in Inglewood, a spokesperson issued this overview statement: “Mr. Rechnitz has for years been an integral part of providing quality nursing home services to Californians … [and] provides life-aiding services to thousands of Californians.”)
The lack of any meaningful sanctions for nursing homes, especially for overdrugging, is commonplace. Indeed, in fiscal year 2012, during the first year of the vaunted “partne
rship” with the nursing home industry to reduce overprescribing, only twenty-five or so individual incidents of “harmful drugging” in the nation’s nearly 16,000 nursing homes were cited by government agencies.
It is a common practice for regulators across a range of industries to remain on good terms with—or even advance the interests of—those they “regulate.” For example, a key architect of Medicare’s dubious five-star rating system, Kerry Weems, a former acting director of CMS, joined forces with one of the occasional beneficiaries of those rankings: Rechnitz. Weems signed up in early January 2014 as chief executive of a medical supply and services company, TwinMed (co-owned by Rechnitz with his twin brother Steven), that contracts, in part, with the Rechnitz nursing home chain.
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THE BALEFUL CORPORATE INFLUENCE ON PATIENT SAFETY AND QUALITY of care has never been made clearer than by the drug companies’ promotion of the overuse of antipsychotics in nursing facilities. That’s been well documented in major federal civil and criminal settlements costing the drug firms billions over their illegal marketing, and in the very rare prosecution of a corrupt doctor for fraudulently prescribing psychotropic drugs in nursing homes.
Sometimes, despite the free rein given doctors to prescribe practically any drug for any reason, a physician can go too far and get in trouble, especially if he’s been singled out by ProPublica, The Chicago Tribune and the Department of Justice. In February 2015, Dr. Michael Reinstein pled guilty to one felony charge of taking $600,000 in kickbacks from both the original maker and then the generic manufacturer to prescribe an especially risky antipsychotic drug, Clozaril, to thousands of nursing home patients in his care. It is a drug of last resort meant only for people with schizophrenia who haven’t responded to other drugs, and it poses risks of fatality because it lowers the white blood cell count and causes seizures. He also agreed to pay $3.5 million as part of a federal civil lawsuit filed in 2012 for submitting 140,000 false claims for his antipsychotic prescriptions, which included Seroquel, Zyprexa and Clozaril, based not on patient evaluations, but on drug company payoffs, according to the lawsuit.
Some patients died from his overprescribing, and he has faced over a dozen malpractice and wrongful death lawsuits since 2005. Yet even as he prescribed more Clozaril than all of the Medicaid doctors combined in three states—Texas, Florida and North Carolina—he continued to be reimbursed by Medicare and Medicaid for nearly two decades after he was first exposed by The Chicago Tribune in 1993 for massive prescribing. Ultimately, over a five-year period, he raked in $55 million from Medicaid alone. Despite his guilty plea, Reinstein has remained unapologetic about his wide use of Clozaril and other antipsychotics.
Before he became a prescribing workhorse for Clozaril, AstraZeneca had already fallen in love with Reinstein, paying him nearly $500,000 for a decade starting in the 1990s to spread the good news about Seroquel’s safety in over five hundred talks. He was valued by executives as potentially bringing in a half-billion dollars in drug revenues because of his heavy prescribing and salesmanship. They continued to fund his Seroquel research and pay him to promote the drug despite internal documents showing that company executives had grave doubts early on about his dubious research. One of his studies’ results showed zero adverse effects from patients taking high dosages of Seroquel, while another improbably proved that Seroquel could reverse diabetes and help people lose weight. These prompted one executive to call them “suspect” and “hard to believe,” as first reported by ProPublica and The Chicago Tribune.
Reinstein may have pushed the envelope further than most industry shills, but his eagerness reflects the aggressive marketing of the drug companies pushing antipsychotics on elderly people who don’t need them. Perhaps no company has used so many corrupting methods so widely to spread its antipsychotic drug, Risperdal, as Johnson & Johnson’s Janssen division. As part of a wide-ranging $2.2 billion criminal and civil settlement in 2013 for illegally marketing three drugs, primarily Risperdal, Johnson & Johnson (the creators of TMAP) admitted to the various schemes, including paying kickbacks, they used to reach nursing homes. But the company only formally accepted guilt on one criminal count.
Johnson & Johnson had an even more staggeringly ambitious plan to get Risperdal into nursing homes: paying kickbacks to Omnicare, the nation’s largest provider of drugs to nursing homes. The FDA required a warning on the drug’s label stating that it wasn’t safe for the elderly and told the company it shouldn’t market the drug as such, but J&J didn’t care with so many billions at stake. As early as 1997, as noted in Steve Brill’s lengthy Huffington Post series, lawsuits against the company revealed Johnson & Johnson had signed an “active intervention agreement” to pay Omnicare to favor Risperdal.
Risperdal was among the first of the new antipsychotics approved by the FDA in the 1990s, and succeeding brands, especially Zyprexa and Seroquel, had to make their mark by also expanding into the lucrative seniors and nursing home market. Eli Lilly was the first company to have its fraudulent antipsychotic marketing schemes—in this case, for Zyprexa—exposed in 2006 when The New York Times reported on leaked internal documents. This exposé was followed by damaging whistleblower evidence included in a $1.4 billion settlement in 2009 with the Justice Department for off-label promotion; it showed just how much unapproved drugging of the elderly for such conditions as dementia was essential to its marketing game plans, including “Viva Zyprexa” for primary care doctors (borrowed from Pfizer’s “Viva Viagra” campaign). For instance, for nursing home pharmacies and staff, Eli Lilly came up with a catchy slogan: a “5 at 5” campaign that urged nursing homes to administer 5 mg of Zyprexa at 5 p.m. to induce sleep in patients.
Before Eli Lilly was exposed, AstraZeneca officials had been working on cracking the primary care and nursing home market since 2001 by pushing Seroquel for dementia, according to the $520 million settlement the company reached with DOJ in 2010. They added academic polish to their marketing plans by giving doctors payoffs for putting their names on journal articles ghostwritten by the company, federal investigators found. A 2014 lawsuit filed by the Texas Attorney General charges comparable off-label misconduct in pushing the new time-released version of Seroquel, Seroquel XR, but with a greater emphasis, allegedly, on marketing to children’s doctors and psychiatrists.
Whistleblower James Wetta, a former salesman at AstraZeneca, revealed in his earlier unsealed 2010 lawsuit a host of sleazy tricks used to push Seroquel on the elderly. Controlling patients by sedating them with Seroquel was a major theme of the company’s invitation-only seminars for doctors, which had titles such as “Comprehensive Management of Behavioral Disturbances in Dementia.” Despite the health risk, Wetta pointed out, “AstraZeneca made a marketing decision to aggressively promote its drug to physicians to ‘higher functioning patients,’” as opposed to schizophrenics, including the elderly and children.
In a reply to my queries about the legal criticisms of AstraZeneca, the company’s media relations director, Abigail Bozarth, said in a statement, “AstraZeneca is committed to acting responsibly and sharing information about the safety and efficacy of its medicines. AstraZeneca’s policy is to promote its medicines in accordance with FDA-approved labeling and FDA regulations. Our employees are required to follow our compliance policies.” She declined to comment on the pending 2014 fraud lawsuit aimed at AstraZeneca.
Even as the Justice Department plays catch-up with fraudulent marketing by drug companies, HHS and its CMS division remain adamant about continuing payments for off-label and fraudulent prescribing to seniors—just as the agency does for children. In response to an HHS Inspector General’s report in 2011 decrying overmedication in nursing homes, CMS officials insisted, “Prevention of [improper] payment [is] beyond our statutory authority.”
The Obama-era Department of Justice, however, showed a way forward in new fraud litigation directly against a nursing home company that could serve as a template for HHS and Medicare to finally stop paying for off-la
bel uses of antipsychotics for unapproved uses. In May 2015, the US Attorney’s office in San Francisco announced that the owners and operators of two Watsonville, California, nursing homes agreed to pay $3.8 million to settle charges that they submitted false claims for “substandard and worthless services”: over-drugging the elderly. Ironies abound in this case, with a circular loop of failed enforcement. The HHS Inspector General office is charged with enforcing a five-year Corporate Integrity Agreement requiring the Watsonville nursing homes to comply with statutes that forbid fraudulent spending, including payment for off-label drugs. At the same time, the sister agency in HHS that pays for those services, CMS, has said that such fraud statutes don’t apply to medications and that it has no authority to enforce such laws. Meanwhile, this same HHS Inspector General’s office has conspicuously failed to enforce previous corporate integrity agreements with drug companies following multibillion-dollar settlements for illegal marketing. These failures are worsened because the drug companies apparently didn’t honestly report their marketing practices to the see-no-evil officials at HHS’s Inspector General office, as outlined in new anti-fraud lawsuits against the manufacturers of Geodon and Seroquel.
But if the federal government’s indifferent enforcement and its unquestioning reimbursement for fraudulent overmedication continue, as seems likely in a Trump administration, don’t expect any real change that could save lives.