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Kaiser Health News

Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice

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Arthur Allen
Tue, 19 Sep 2023 09:00:00 +0000

Tennessee last year spent $48 million on a single drug, Humira — about $62,000 for each of the 775 who were covered by its employee insurance program and receiving the treatment. So when nine Humira knockoffs, known as biosimilars, hit the market for as little as $995 a month, the for savings appeared ample and immediate.

But it isn't here yet. Makers of biosimilars must still work within a system in which basic economics rarely seems to hold sway.

For real competition to take hold, the big pharmacy benefit managers, or PBMs, the companies that negotiate prices and set the prescription drug menu for 80% of insured patients in the United States, would have to position the new drugs favorably in health plans.

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They haven't, though the logic for doing so seems plain.

Humira has enjoyed high-priced U.S. exclusivity for 20 years. Its challengers could save the health care system $9 billion and herald savings from the whole class of drugs called biosimilars — a windfall akin to the hundreds of billions saved each year through the purchase of generic drugs.

The biosimilars work the same way as Humira, an injectable treatment for rheumatoid arthritis and other autoimmune diseases. And countries such as the United Kingdom, Denmark, and Poland have moved more than 90% of their Humira patients to the rival drugs since they launched in Europe in 2018. Kaiser Permanente, which oversees medical care for 12 million people in eight U.S. states, switched most of its patients to a biosimilar in February and expects to save $300 million this year alone.

Biologics — both the brand-name drugs and their imitators, or biosimilars — are made with living cells, such as yeast or bacteria. With dozens of biologics nearing the end of their patent protection in the next two decades, biosimilars could generate much higher savings than generics, said Paul Holmes, a partner at Williams Barber Morel who works with self-insured health plans. That's because biologics are much more expensive than pills and other formulations made through simpler chemical processes.

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For example, after the first generics for the blockbuster anti-reflux drug Nexium hit the market in 2015, they cost around $10 a month, with Nexium's $100 price tag. Coherus BioSciences launched its Humira biosimilar, Yusimry, in July at $995 per two-syringe carton, compared with Humira's $6,600 list price for a nearly identical product.

“The percentage savings might be similar, but the total dollar savings are much bigger,” Holmes said, “as long as the plan sponsors, the employers, realize the opportunity.”

That's a big if.

While a manufacturer may need to spend a few million dollars to get a generic pill ready to market, makers of biosimilars say their development can require up to eight years and $200 million. The business won't work unless they gain significant market share, they say.

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The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.

“We're not seeing a lot of takeup of the biosimilar,” said Keith Athow, pharmacy director for Tennessee's group insurance program, which covers 292,000 state and local employees and their dependents.

The ongoing saga of Humira — its peculiar appeal to drug middlemen and insurers, the patients who've benefited, the patients who've suffered as its list price jumped sixfold since 2003 — exemplifies the convoluted U.S. health care system, whose prescription drug coverage can be spotty and expenditures far more unequal than in other advanced economies.

Biologics like Humira occupy a growing share of U.S. health care spending, with their costs increasing 12.5% annually over the past five years. The drugs are increasingly important in treating cancers and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease, that afflict about 1 in 10 Americans.

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Humira's $200 billion in global sales make it the best-selling drug in history. Its manufacturer, AbbVie, has aggressively defended the drug, filing more than 240 patents and deploying legal threats and tweaks to the product to keep patent protections and competitors at bay.

The company's fight for Humira didn't stop when the biosimilars finally appeared. The drugmaker has told investors it doesn't expect to lose much market share through 2024. “We are competing very effectively with the various biosimilar offerings,” AbbVie CEO Richard Gonzalez said during an earnings call.

How AbbVie Maintains Market Share

One of AbbVie's strategies was to warn health plans that if they recommended biosimilars over Humira they would lose rebates on purchases of Skyrizi and Rinvoq, two drugs with no generic imitators that are each listed at about $120,000 a year, according to PBM . In other words, dropping one AbbVie drug would to higher costs for others.

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Industry sources also say the PBMs persuaded AbbVie to increase its Humira rebates — the end-of-the-year payments, based on total use of the drug, which are mostly passed along by the PBMs to the health plan sponsors. Although rebate numbers are kept secret and vary widely, some reportedly jumped this year by 40% to 60% of the drug's list price.

The leading PBMs — Express Scripts, Optum, and CVS Caremark — are powerful players, each part of a giant health conglomerate that includes a leading insurer, specialty pharmacies, doctors' offices, and other businesses, some of them based overseas for tax advantages.

Yet challenges to PBM practices are mounting. The Federal Trade Commission began a major probe of the companies last year. Kroger canceled its pharmacy contract with Express Scripts last fall, saying it had no bargaining power in the arrangement, and, on Aug. 17, the insurer Blue Shield of California announced it was severing most of its business with CVS Caremark for similar reasons.

Critics of the top PBMs see the Humira biosimilars as a potential turning point for the secretive business processes that have contributed to stunningly high drug prices.

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Although list prices for Humira are many times higher than those of the new biosimilars, discounts and rebates offered by AbbVie make its drug more competitive. But even if health plans were paying only, say, half of the net amount they pay for Humira now — and if several biosimilar makers charged as little as a sixth of the gross price — the costs could fall by around $30,000 a year per patient, said Greg Baker, CEO of AffirmedRx, a smaller PBM that is challenging the big companies.

Multiplied by the 313,000 patients currently prescribed Humira, that to about $9 billion in annual savings — a not inconsequential 1.4% of total national spending on pharmaceuticals in 2022.

The launch of the biosimilar Yusimry, which is being sold through Mark Cuban's Cost Plus Drugs pharmacy and elsewhere, “should send off alarms to the employers,” said Juliana Reed, executive director of the Biosimilars Forum, an industry group. “They are going to ask, ‘Time out, why are you charging me 85% more, Mr. PBM, than what Mark Cuban is offering? What is going on in this system?'”

Cheaper drugs could make it easier for patients to pay for their drugs and presumably make them healthier. A KFF survey in 2022 found that nearly a fifth of adults reported not filling a prescription because of the cost. Reports of Humira patients quitting the drug for its cost are rife.

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Convenience, Inertia, and Fear

When Sue Lee of suburban Louisville, Kentucky, retired as an insurance claims reviewer and went on Medicare in 2017, she learned that her monthly copay for Humira, which she took to treat painful plaque psoriasis, was rising from $60 to $8,000 a year.

It was a particularly bitter experience for Lee, now 81, because AbbVie had paid her for the previous three years to proselytize for the drug by chatting up dermatology nurses at fancy AbbVie-sponsored dinners. Casting about for a way to stay on the drug, Lee asked the company for , but her income at the time was too high to qualify her for its assistance program.

“They were done with me,” she said. Lee went off the drug, and within a few weeks the psoriasis came back with a vengeance. Sores covered her calves, torso, and even the tips of her ears. Months later she got relief by entering a clinical trial for another drug.

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Health plans are motivated to keep Humira as a preferred choice out of convenience, inertia, and fear. While such data is secret, one Midwestern firm with 2,500 employees told KFF Health News that AbbVie had effectively lowered Humira's net cost to the company by 40% after July 1, the day most of the biosimilars launched.

One of the top three PBMs, CVS Caremark, announced in August that it was creating a partnership with drugmaker Sandoz to market its own cut-rate version of Humira, called Hyrimoz, in 2024. But Caremark didn't appear to be fully embracing even its own biosimilar. Officials from the PBM notified customers that Hyrimoz will be on the same tier as Humira to “maximize rebates” from AbbVie, Tennessee's Athow said.

Most of the rebates are passed along to health plans, the PBMs say. But if the state of Tennessee received a check for, say, $20 million at the end of last year, it was merely getting back some of the $48 million it already spent.

“It's a devil's bargain,” said Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions. “The happiest day of a benefit executive's year is walking into the CFO's office with a several-million-dollar check and saying, ‘Look what I got you!'”

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Executives from the leading PBMs have said their clients prefer high-priced, high-rebate drugs, but that's not the whole story. Some of the fees and other payments that PBMs, distributors, consultants, and wholesalers earn are calculated based on a drug's price, which gives them equally misplaced incentives, said Antonio Ciaccia, CEO of 46Brooklyn, a nonprofit that researches the drug supply chain.

“The large intermediaries are wedded to inflated sticker prices,” said Ciaccia.

AbbVie has warned some PBMs that if Humira isn't offered on the same tier as biosimilars it will stop paying rebates for the drug, according to Alex Jung, a forensic accountant who consults with the Midwest Business Group on Health.

AbbVie did not respond to requests for comment.

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One of the low-cost Humira biosimilars, Organon's Hadlima, has made it onto several formularies, the ranked lists of drugs that health plans offer patients, since launching in February, but “access alone does not guarantee success” and doesn't mean patients will get the product, Kevin Ali, Organon's CEO, said in an earnings call in August.

If the biosimilars are priced no lower than Humira on health plan formularies, rheumatologists will lack an incentive to prescribe them. When PBMs put drugs on the same “tier” on a formulary, the patient's copay is generally the same.

In an emailed statement, Optum Rx said that by adding several biosimilars to its formularies at the same price as Humira, “we are fostering competition while ensuring the broadest possible choice and access for those we serve.”

Switching a patient involves administrative costs for the patient, health plan, pharmacy, and doctor, said Marcus Snow, chair of the American College of Rheumatology's Committee on Rheumatologic Care.

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Doctors' Inertia Is Powerful

Doctors seem reluctant to move patients off Humira. After years of struggling with insurance, the biggest concern of the patient and the rheumatologist, Snow said, is “forced switching by the insurer. If the patient is doing well, any change is concerning to them.” Still, the American College of Rheumatology recently distributed a video informing patients of the availability of biosimilars, and “the data is there that there's virtually no difference,” Snow said. “We know the cost of health care is exploding. But at the same time, my job is to make my patient better. That trumps everything.”

“All things being equal, I like to keep the patient on the same drug,” said Madelaine Feldman, a New Orleans rheumatologist.

Gastrointestinal specialists, who often prescribe Humira for inflammatory bowel disease, seem similarly conflicted. American Gastroenterological Association spokesperson Rachel Shubert said the group's policy guidance “opposes nonmedical switching” by an insurer, unless the is shared by provider and patient. But Siddharth Singh, chair of the group's clinical guidelines committee, said he would not hesitate to switch a new patient to a biosimilar, although “these decisions are largely insurance-driven.”

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HealthTrust, a company that procures drugs for about 2 million people, has had only five patients switch from Humira this year, said Cora Opsahl, director of the Service Employees International Union's 32BJ Health Fund, a New York state plan that procures drugs through HealthTrust.

But the biosimilar companies hope to slowly gain market footholds. Companies like Coherus will have a niche and “they might be on the front end of a wave,” said Ciaccia, given employers' growing demands for change in the system.

The $2,000 out-of-pocket cap on Medicare drug spending that goes into effect in 2025 under the Inflation Reduction Act could spur more interest in biosimilars. With insurers on the hook for more of a drug's cost, they should be looking for cheaper options.

For Kaiser Permanente, the move to biosimilars was obvious once the company determined they were safe and effective, said Mary Beth Lang, KP's chief pharmacy officer. The first Humira biosimilar, Amjevita, was 55% cheaper than the original drug, and she indicated that KP was paying even less since more drastically discounted biosimilars launched. Switched patients pay less for their medication than before, she said, and very few have tried to get back on Humira.

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Prescryptive, a small PBM that promises transparent policies, switched 100% of its patients after most of the other biosimilars entered the market July 1 “with absolutely no interruption of therapy, no complaints, and no changes,” said Rich Lieblich, the company's vice president for clinical services and industry relations.

AbbVie declined to respond to him with a competitive price, he said.

——————————
By: Arthur Allen
Title: Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice
Sourced From: kffhealthnews.org/news/article/humira-abbvie-biosimilar-biologic-savings-pbm-rebates/
Published Date: Tue, 19 Sep 2023 09:00:00 +0000

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Kaiser Health News

Medicaid ‘Unwinding’ Decried as Biased Against Disabled People

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Daniel Chang
Tue, 14 May 2024 09:00:00 +0000

Jacqueline Saa has a genetic condition that leaves her unable to stand and walk on her own or hold a job. Every weekday for four years, Saa, 43, has relied on a home health aide to help her cook, bathe and dress, go to the doctor, pick up medications, and accomplish other tasks.


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She received coverage through Florida's Medicaid program until it abruptly stopped at the end of March, she said.

“Every day the anxiety builds,” said Saa, who lost her home health aide for 11 days, starting April 1, despite being eligible. The state has since restored Saa's home health aide service, but during the gap she leaned on her mother and her 23- and 15-year-old daughters, while struggling to regain her Medicaid benefits.

“It's just so much to worry about,” she said. “This is a system that's supposed to help.”

Medicaid's home and community-based services are designed to help people like Saa, who have disabilities and need help with everyday activities, stay out of a nursing facility. But people are losing benefits with little or no notice, getting bad advice when they call for information, and facing major disruptions in care while they wait for the issue to get sorted out, according to attorneys and advocates who are hearing from patients.

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In Colorado, Texas, and Washington, D.C., the National Health Law Program, a nonprofit that advocates for low-income and underserved people, has filed complaints with two federal agencies alleging discrimination against people with disabilities. The group has not filed a in Florida, though its attorneys say they've heard of many of the same problems there.

Attorneys nationwide say the special needs of disabled people were not prioritized as states began to review eligibility for Medicaid enrollees after a pandemic-era mandate for coverage expired in March 2023.

“Instead of monitoring and ensuring that people with disabilities could make their way through the , they sort of treated them like everyone else with Medicaid,” said Elizabeth Edwards, a senior attorney for the National Health Law Program. Federal law puts an “obligation on states to make sure people with disabilities don't get missed.”

At least 21 million people nationwide have been disenrolled from Medicaid since states began eligibility redeterminations in spring 2023, according to a KFF analysis.

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The unwinding, as it's known, is an immense undertaking, Edwards said, and some states did not take extra steps to set up a special telephone line for those with disabilities, for example, so people could renew their coverage or contact a case manager.

As states prepared for the unwinding, the Centers for Medicare & Medicaid Services, the federal agency that regulates Medicaid, advised states that they must give people with disabilities the help they need to benefit from the program, including specialized communications for people who are deaf or blind.

The Florida Department of and Families, which verifies eligibility for the state's Medicaid program, has a specialized team that processes applications for home health services, said Mallory McManus, the department's communications director.

People with disabilities disenrolled from Medicaid services were “properly noticed and either did not respond timely or no longer met financial eligibility requirements,” McManus said, noting that people “would have been contacted by us up to 13 times via phone, mail, email, and text before processing their disenrollment.”

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Allison Pellegrin of Ormond Beach, Florida, who lives with her sister Rhea Whitaker, who is blind and cognitively disabled, said that never happened for her .

“They just cut off the benefits without a call, without a letter or anything stating that the benefits would be terminating,” Pellegrin said. Her sister's home health aide, whom she had used every day for nearly eight years, stopped service for 12 days. “If I'm getting everything else in the mail,” she said, “it seems weird that after 13 times I wouldn't have received one of them.”

Pellegrin, 58, a sales manager who gets health insurance through her employer, took time off from work to care for Whitaker, 56, who was disabled by a severe brain injury in 2006.

Medicaid reviews have been complicated, in part, by the fact that eligibility works differently for home health services than for general coverage, based on federal regulations that give states more flexibility to determine financial eligibility. Income limits for home health services are higher, for instance, and assets are counted differently.

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In Texas, a parent in a household of three would be limited to earning no more than $344 a month to qualify for Medicaid. And most adults with a disability can qualify without a dependent child and be eligible for Medicaid home health services with an income of up to $2,800 a month.

The state was not taking that into consideration, said Terry Anstee, a supervising attorney for community integration at Disability Rights Texas, a nonprofit advocacy group.

Even a brief lapse in Medicaid home health services can fracture relationships that took years to build.

“It may be very difficult for that person who lost that attendant to find another attendant,” Anstee said, because of workforce shortages for attendants and nurses and high demand.

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Nearly all states have a waiting list for home health services. About 700,000 people were on waiting lists in 2023, most of them with intellectual and developmental disabilities, according to KFF data.

Daniel Tsai, a deputy administrator at CMS, said the agency is committed to ensuring that people with disabilities receiving home health services “can renew their Medicaid coverage with as little red tape as possible.”

CMS finalized a rule this year for states to monitor Medicaid home health services. For example, CMS will now track how long it takes for people who need home health care to receive the services and will require states to track how long people are on waitlists.

Staff turnover and vacancies at local Medicaid agencies have contributed to backlogs, according to complaints filed with two federal agencies focused on civil rights.

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The District of Columbia's Medicaid agency requires that case managers help people with disabilities complete renewals. However, a complaint says, case managers are the only ones who can help enrollees complete eligibility reviews and, sometimes, they don't do their jobs.

Advocates for Medicaid enrollees have also complained to the Federal Trade Commission about faulty eligibility systems developed by Deloitte, a global consulting firm that contracts with about two dozen states to design, implement, or operate automated benefits .

KFF Health News found that multiple audits of Colorado's eligibility system, managed by Deloitte, uncovered errors in notices sent to enrollees. A 2023 review by the Colorado Office of the State Auditor found that 90% of sampled notices contained problems, some of which violate the state's Medicaid rules. The audit blamed “flaws in system design” for populating notices with incorrect dates.

Deloitte declined to comment on specific state issues.

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In March, Colorado paused disenrollment for people on Medicaid who received home health services, which includes people with disabilities, after a “system update” led to wrongful terminations in February.

Another common problem is people being told to reapply, which immediately cuts off their benefits, instead of appealing the cancellation, which would ensure their coverage while the claim is investigated, said attorney Miriam Harmatz, founder of the Florida Health Justice Project.

“What they're being advised to do is not appropriate. The best way to protect their legal rights,” Harmatz said, “is to file an appeal.”

But some disabled people are worried about having to repay the cost of their care.

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Saa, who lives in Davie, Florida, received a letter shortly before her benefits were cut that said she “may be responsible to repay any benefits” if she lost her appeal.

The state should presume such people are still eligible and preserve their coverage, Harmatz said, because income and assets for most beneficiaries are not going to increase significantly and their conditions are not likely to improve.

The Florida Department of Children and Families would not say how many people with disabilities had lost Medicaid home health services.

But in Miami-Dade, Florida's most populous county, the Alliance for Aging, a nonprofit that helps older and disabled people apply for Medicaid, saw requests for help jump from 58 in March to 146 in April, said Lisa Mele, the organization's director of its Aging and Disability Resources Center.

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“So many people are calling us,” she said.

States are not tracking the numbers, so “the impact is not clear,” Edwards said. “It's a really complicated struggle.”

Saa filed an appeal March 29 after learning from her social worker that her benefits would expire at the end of the month. She went to the agency but couldn't stand in a line that was 100 people deep. Calls to the state's Medicaid eligibility review agency were fruitless, she said.

“When they finally connected me to a customer service representative, she was literally just reading the same explanation letter that I've read,” Saa said. “I did everything in my power.”

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Saa canceled her home health aide. She lives on limited Social Security disability income and said she could not afford to pay for the care.

On April 10, she received a letter from the state saying her Medicaid had been reinstated, but she later learned that her plan did not home health care.

The following day, Saa said, advocates put her in touch with a point person at Florida's Medicaid agency who restored her benefits. A home health aide showed up April 12. Saa said she's thankful but feels anxious about the future.

“The toughest part of that period is knowing that that can happen at any time,” she said, “and not because of anything I did wrong.”

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Have you or someone you know with disabilities unexpectedly lost Medicaid benefits since April 2023? Tell KFF Health News about it here.

KFF Health News correspondents Samantha Liss and Rachana Pradhan contributed to this report.

——————————
By: Daniel Chang
Title: Medicaid ‘Unwinding' Decried as Biased Against Disabled People
Sourced From: kffhealthnews.org/news/article/medicaid-unwinding-people-with-disabilities-home-health-benefits/
Published Date: Tue, 14 May 2024 09:00:00 +0000

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Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits

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Fred Schulte, KFF Health News
Tue, 14 May 2024 09:00:00 +0000

In early 2020, with reports of covid-19 outbreaks making dire headlines, Trever Schapers worried about her father's safety in a nursing home in Queens.

She had delighted in watching her dad, John Schapers, blow out the candles on his 90th birthday cake that February at the Lawrence Care Center in the New York City borough. Then the home went into lockdown.

Soon her father was dead. The former union painter spiked a fever and was transferred to a hospital, where he tested positive for covid, his daughter said, and after two weeks on a ventilator, he died in May 2020.

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But when Trever Schapers sued the nursing home for negligence and wrongful in 2022, a judge dismissed the case, citing a New York law hastily passed early in the pandemic. It granted immunity to medical providers for “harm or damages” from an “act or omission” in treating or arranging care for covid. She is appealing the decision.

“I feel that families are being ignored by judges and courts not recognizing that something needs to be done and changed,” said Schapers, 48, who works in the medical field. “There needs to be accountability.”

The nursing home did not return calls seeking comment. In a court filing, the home argued that Schapers offered no evidence that the home was “grossly negligent” in treating her father.

More than four years after covid first raged through many U.S. nursing homes, hundreds of lawsuits blaming patient deaths on negligent care have been tossed out or languished in the courts amid contentious legal battles.

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Even some nursing homes that were shut down by health officials for violating safety standards have claimed immunity against such suits, court records show. And some families that allege homes kept them in the dark about the health of their loved ones, even denying there were cases of covid in the building, have had their cases dismissed.

Schapers alleged in a complaint to state health officials that the nursing home failed to advise her that it had admitted covid-positive from a nearby hospital in March 2020. In early April, she received a call telling her the facility had some covid-positive residents.

“The call I received was very alarming, and they refused to answer any of my questions,” she said.

About two weeks later, a social worker called to say that her father had a fever, but the staff did not test him to confirm covid, according to Schapers' complaint.

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The industry says federal health officials and lawmakers in most states granted medical providers broad protection from lawsuits for good faith actions during the health emergency. Rachel Reeves, a senior vice president with the American Health Care Association, an industry trade group, called covid “an unprecedented public health crisis brought on by a vicious virus that uniquely targeted our population.”

In scores of lawsuits, however, family members allege that nursing homes failed to secure enough protective gear or tests for staffers or residents, haphazardly mixed covid-positive patients with other residents, failed to follow strict infection control protocols, and brazenly misled frightened families about the severity of covid outbreaks among patients and staff.

“They trusted these facilities to take care of loved ones, and that trust was betrayed,” said Florida attorney Lindsey Gale, who has represented several families suing over covid-related deaths.

“The grieving people had to go through was horrible,” Gale said.

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A Deadly Toll

KFF Health News found that more than 1,100 covid-related lawsuits, most alleging wrongful death or other negligent care, were filed against nursing homes from March 2020 through March of this year.

While there's no full accounting of the outcomes, court filings show that judges have dismissed some suits outright, citing state or federal immunity provisions, while other cases have been settled under confidential terms. And many cases have stalled due to lengthy and costly arguments and appeals to hash out limits, if any, of immunity protection.

In their defense, nursing homes initially cited the federal Public Readiness and Emergency Preparedness Act, which Congress passed in December 2005. The law grants liability protection from claims for deaths or injuries tied to vaccines or “medical countermeasures” taken to prevent or treat a disease during national emergencies.

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The PREP Act steps in once the secretary of Health and Human Services declares a “public health emergency,” which happened with covid on March 17, 2020. The emergency order expired on May 11, 2023.

The law carved out an exception for “willful misconduct,” but proving it occurred can be daunting for families — even when nursing homes have long histories of violating safety standards, including infection controls.

Governors of at least 38 states issued covid executive orders, or their legislatures passed laws, granting medical providers at least some degree of immunity, according to one consumer group's tally. Just how much legal protection was intended is at the crux of the skirmishes.

Nursing homes answered many negligence lawsuits by getting them removed from state courts into the federal judicial system and asking for dismissal under the PREP Act.

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For the most part, that didn't work because federal judges declined to hear the cases. Some judges ruled that the PREP Act was not intended to shield medical providers from negligence caused by inaction, such as failing to protect patients from the coronavirus. These rulings and appeals sent cases back to state courts, often after long delays that left families in legal limbo.

“These delays have been devastating,” said Jeffrey Guzman, a New York City attorney who represents Schapers and other families. He said the industry has fought “tooth and nail” trying to “fight these people getting their day in court.”

Empire State Epicenter

New York, where covid hit early and hard, is ground zero for court battles over nursing home immunity.

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Relatives of residents have filed more than 750 negligence or wrongful death cases in New York counties since the start of the pandemic, according to court data KFF Health News compiled using the judicial service Courthouse News Service. No other area close. Chicago's Cook County, a jurisdiction where private lawyers for years have aggressively sued nursing homes alleging poor infection control, recorded 121 covid-related cases.

Plaintiffs in hundreds of New York cases argue that nursing homes knew early in 2020 that covid would pose a deadly threat but largely failed to gird for its impact. Many suits cite inspection reports detailing chronic violations of infection control standards in the years preceding the pandemic, court records show. Responses to this strategy vary.

“Different judges take different views,” said Joseph Ciaccio, a New York lawyer who has filed hundreds of such cases. “It's been very mixed.”

Lawyers for nursing homes counter that most lawsuits rely on vague allegations of wrongdoing and “boilerplate” claims that, even if true, don't demonstrate the kind of gross negligence that would override an immunity claim.

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New York lawmakers added another wrinkle by repealing the immunity statute in April 2021 after Letitia James noted the law could give nursing homes a free pass to make “financially motivated decisions” to cut costs and put patients at risk.

So far, appeals courts have ruled lawmakers didn't specify that the repeal should be made retroactive, thus stymying many negligence cases.

“So these cases are all wasting the courts' time and preventing cases that aren't barred by immunity statutes from being resolved sooner and clogging up the court system that was already backlogged from COVID,” said attorney Anna Borea, who represents nursing homes.

Troubled Homes Deflect Suits

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Some nursing homes that paid hefty fines or were ordered by health officials to shut down at least temporarily because of their inadequate response to covid have claimed immunity against suits, court records show.

Among them is Andover Subacute and Rehabilitation nursing home in New Jersey, which made national headlines when authorities found 17 bodies stacked in a makeshift morgue in April 2020.

Federal health officials fined the facility $220,235 after issuing a critical 36-page on covid violations and other deficiencies, and the state halted admissions in February 2022.

Yet the home has won court pauses in at least three negligence lawsuits as it appeals lower court rulings denying immunity under the federal PREP Act, court records show. The operators of the home could not be reached for comment. In court filings, they denied any wrongdoing.

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In Oregon, health officials suspended operations at Healthcare at Foster Creek, calling the Portland nursing home “a serious danger to the public health and safety.” The May 2020 order cited the home's “consistent inability to adhere to basic infection control standards.”

Bonnie Richardson, a Portland lawyer, sued the facility on behalf of the family of Judith Jones, 75, who had dementia and died in April 2020. Jones' was among dozens of covid-related deaths at that home.

“It was a very hard-fought battle,” said Richardson, who has since settled the case under confidential terms. Although the nursing home claimed immunity, her clients “wanted to know what happened and to understand why.” The owners of the nursing home provided no comment.

No Covid Here

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Many families believe nursing homes misled them about covid's relentless spread. They often had to settle for window visits to connect with their loved ones.

Relatives of five patients who died in 2020 at the Sapphire Center for Rehabilitation and Nursing in the Flushing neighborhood in Queens filed lawsuits accusing the home's operators of keeping them in the dark.

When they phoned to check on elderly parents, they either couldn't get through or were told there was “no COVID-19 in the building,” according to one court affidavit.

One woman grew alarmed after visiting in February 2020 and seeing nurses wearing masks “below their noses or under their chin,” according to a court affidavit.

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The woman was shocked when the home relayed that her mother had died in April 2020 from unknown causes, perhaps “from depression and not eating,” according to her affidavit.

A short time later, news media reported that dozens of Sapphire Center residents had died from the virus — her 85-year-old mother among them, she argued in a lawsuit.

The nursing home denied liability and won dismissal of all five lawsuits after citing the New York immunity law. Several families are appealing. The nursing home's administrator declined to comment.

Broadening Immunity

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Nursing home operators also have cited immunity to foil negligence lawsuits based on falls or other allegations of substandard care, such as bedsores, with little obvious connection to the pandemic, court records show.

The family of Marilyn Kearney, an 89-year-old with a “history of dementia and falls,” sued the Watrous Nursing Center in Madison, Connecticut, for negligence. Days after she was admitted in June 2020, she fell in her room, fracturing her right hip and requiring surgery, according to court filings.

She died at a local hospital on Sept. 16, 2020, from sepsis attributed to dehydration and malnutrition, according to the suit.

Her family argued that the 45-bed nursing home failed to assess her risk of falling and develop a plan to prevent that. But Watrous fired back by citing an April 2020 declaration by Connecticut Gov. Ned Lamont, a Democrat, granting health care professionals or facilities immunity from “any injury or death alleged to have been sustained because of the individual's or health care facility's acts or omissions undertaken in good faith while providing health care services in of the state's COVID-19 response.”

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Watrous denied liability and, in a motion to dismiss the case, cited Lamont's executive order and affidavits that argued the home did its best in the throes of a “public health crisis, the likes of which had never been seen before.” The operators of the nursing home, which closed in July 2021 because of covid, did not respond to a request for comment. The case is pending.

Attorney Wendi Kowarik, who represents Kearney's family, said courts are wrestling with how much protection to afford nursing homes.

“We're just beginning to get some guidelines,” she said.

One pending Connecticut case alleges that an 88-year-old man died in October 2020 after experiencing multiple falls, sustaining bedsores, and dropping more than 30 pounds in the two months he lived at a nursing home, court records state. The nursing home denied liability and contends it is entitled to immunity.

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So do the owners of a Connecticut facility that cared for a 75-year-old woman with obesity who required a lift to get out of bed. She fell on April 26, 2020, smashing several teeth and fracturing bones. She later died from her injuries, according to the suit, which is pending.

“I think it is really repugnant that providers are arguing that they should not be held accountable for falls, pressure sores, and other outcomes of gross neglect,” said Richard Mollot, executive director of the Long Term Care Community Coalition, which advocates for patients.

“The government did not declare open season on nursing home residents when it implemented COVID policies,” he said.

Protecting the Vulnerable

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Since early 2020, U.S. nursing homes have reported more than 172,000 residents' deaths, according to Centers for Medicare & Medicaid Services data. That's about 1 in 7 of all recorded U.S. covid deaths.

As it battles covid lawsuits, the nursing home industry says it is “struggling to recover due to ongoing labor shortages, inflation, and chronic government underfunding,” according to Reeves, the trade association executive.

She said the American Health Care Association has advocated for “reasonable, limited liability protections that defend staff and providers for their good faith efforts” during the pandemic.

“Caregivers were doing everything they could,” Reeves said, “often with limited resources and ever-changing information, in an effort to protect and care for residents.”

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But patients' advocates remain wary of policies that might bar the courthouse door against grieving families.

“I don't think we want to continue to enact laws that reward nursing homes for bad care,” said Sam Brooks, of the Coalition for the Protection of Residents of Long-Term Care Facilities, a patient advocacy group.

“We need to keep that in mind if, God forbid, we have another pandemic,” Brooks said.

Bill Hammond, a senior fellow at the Empire Center for Public Policy, a nonpartisan New York think tank, said policymakers should focus on better strategies to protect patients from infectious outbreaks, rather than leaving it up to the courts to sort out liability years later.

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“There is no serious effort to have that conversation,” Hammond said. “I think that's crazy.”

——————————
By: Fred Schulte, KFF Health News
Title: Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits
Sourced From: kffhealthnews.org/news/article/nursing-home-pandemic-immunity-wrongful-death-lawsuits/
Published Date: Tue, 14 May 2024 09:00:00 +0000

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First Responders, Veterans Hail Benefits of Psychedelic Drugs as California Debates Legalization

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Bernard J. Wolfson
Mon, 13 May 2024 09:00:00 +0000

Wade Trammell recalls the time he and his fellow firefighters responded to a highway crash in which a beer truck rammed into a pole, propelling the truck's engine through the cab and into the driver's abdomen.

“The guy was up there screaming and squirming. Then the cab caught on fire,” Trammell says. “I couldn't move him. He burned to death right there in my arms.”

Memories of that gruesome death and other traumatic incidents he had witnessed as a firefighter in Mountain View, California, didn't seem to bother Trammell for the first seven years after he retired in 2015. But then he started crying a lot, drinking heavily, and losing sleep. At first, he didn't understand why, but he would later to he was suffering from post-traumatic stress disorder.

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After therapy failed to improve his mental well-being, he heard about the potential benefits of psychedelic drugs to help first responders with PTSD.

Last July, Trammell went on a retreat in Puerto Vallarta, Mexico, organized by The S.I.R.E.N. Project, a nonprofit that advocates the use of psychedelics and other alternative medicines to help first responders. He took psilocybin mushrooms and, the next day, another psychedelic derived from the toxic secretions of the Sonoran Desert toad. The experience, he says, produced an existential shift in the way he thinks of the terrible things he saw as a firefighter.

“All that trauma and all that crap I saw and dealt with, it's all very temporary and everything goes back into the universe as energy,” Trammell says.

Abundant research has shown that psychedelics have the potential to produce lasting relief from depression, anxiety, PTSD, addiction, and other mental conditions. Many universities around the United States have programs researching psychedelics. But experts warn that these powerful drugs are not for everybody, especially those with a history of psychosis or cardiovascular problems.

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Most psychedelic drugs are prohibited under federal , but California may soon join a growing number of local and state governments allowing their use.

A bill working its way through the California Legislature, would allow the therapeutic use of psilocybin; mescaline; MDMA, the active ingredient in ecstasy; and dimethyltryptamine, the active ingredient in ayahuasca, a plant-based psychoactive tea. The drugs could be purchased and ingested in approved locations under the supervision of facilitators, who would undergo and be licensed by a new state board. The facilitators would need a professional health credential to qualify.

The bill, co-sponsored by Sen. Scott Wiener (D-San Francisco), Assembly member Marie Waldron (R-San Diego), and several other lawmakers, follows last year's unsuccessful effort to decriminalize certain psychedelics for personal use. Gov. Gavin Newsom, a Democrat, vetoed that bill, though he extolled psychedelics as “an exciting frontier” and asked for new legislation with “regulated treatment guidelines.”

Wiener says the new bill was drafted with Newsom's request in mind. It is supported by some and first responder groups and opposed by numerous law enforcement agencies.

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One potential roadblock is the state's budget deficit, pegged at between $38 billion and $73 billion. Newsom and legislative may choose not to launch a new initiative when they are cutting existing programs. “That is something we'll certainly grapple with,” Wiener says.

The legislation, which is making its way through committees, would require the new board to begin accepting facilitator license applications in April 2026. The system would look somewhat like the one in Oregon, which allows the use of psilocybin mushrooms under the guidance of state-licensed facilitators at psilocybin service centers. And like Oregon, California would not allow for the personal use or possession of psychedelics; the drugs would have to be purchased and consumed at the authorized locations.

Colorado, following the passage of a ballot initiative in 2022, is creating a system of regulated “healing centers,” where people will be able to legally consume psilocybin mushrooms and some other psychedelics under the supervision of licensed facilitators. Colorado's law allows for the personal use and possession of a handful of psychedelics.

In California, the cities of Oakland, San Francisco, Berkeley, Santa Cruz, and Arcata have effectively decriminalized many psychedelics, as have other cities around the United States, Ann Arbor, Michigan; Cambridge, ; Detroit; Minneapolis; Seattle; and Washington, D.C.

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Psychedelics such as psilocybin, ayahuasca, and peyote have been used for thousands of years by Indigenous populations in Latin America and the current-day United States. And some non-Indigenous groups use these substances in a spiritual way.

The Church of Ambrosia, with locations in San Francisco and Oakland, considers psilocybin mushrooms, also known as magic mushrooms, a sacrament. “Mushrooms affect the border between this world and the next, and allow people to connect to their soul,” says Dave Hodges, founder and pastor of the church.

Hodges was behind an unsuccessful attempt to get an initiative on the California ballot this year that would have decriminalized the possession and use of mushrooms. He hopes it will qualify for the 2026 ballot.

The pending California legislation is rooted in studies showing psychedelics can be powerful agents in mental health treatment.

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Charles Grob, a psychiatry professor at the University of California-Los Angeles School of Medicine who has researched psychedelics for nearly 40 years, led a study that found synthetic psilocybin could help reduce end-of-life anxiety in patients with advanced-stage cancer.

Grob says MDMA is good for couples counseling because it facilitates communication and puts people in touch with their feelings. And he conducted research in Brazil that showed ayahuasca used in a religious context helped people overcome alcoholism.

But Grob warns that the unsupervised use of psychedelics can be dangerous and says people should undergo mental and medical health screenings before ingesting them. “There are cases of people going off the rails. It's a small minority, but it can happen, and when it does happen it can be very frightening,” Grob says.

Ken Finn, past president of the American Board of Pain Medicine, says that psychedelics have a number of side effects, including elevated blood pressure, high heart rate, and vomiting, and that they can trigger “persistent psychosis” in a small minority of users. Legal drugs also pose risks, he says, “but we have much better guardrails on things like prescriptions and over-the-counter medications.” He also worries about product contamination and says manufacturers would need to be tightly regulated.

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Another potential problem is health equity. Since insurance would not cover these sessions, at least initially, they would likely attract people with disposable income. A supervised psilocybin journey in Oregon, for example, can cost more than $2,500.

Many people who have experienced psychedelics corroborate the research results. Ben Kramer, a former Marine who served in Afghanistan and now works as a psilocybin facilitator in Beaverton, Oregon, says a high-dose mushroom altered his worldview.

“I relived the first time I was ever shot at in Afghanistan,” he says. “I was there. I had this overwhelming love and compassion for the guy who was shooting at me, who was fighting for what he believed in, just like I was.”

Another characteristic of psychedelic therapy is that just a few sessions can potentially produce lasting results.

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Trammell, the retired firefighter, hasn't taken psychedelics since that retreat in Mexico 10 months ago. “I just felt like I kind of got what I needed,” he says. “I've been fine ever since.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

——————————
By: Bernard J. Wolfson
Title: First Responders, Veterans Hail Benefits of Psychedelic Drugs as California Debates Legalization
Sourced From: kffhealthnews.org/news/article/first-responders-veterans-psychedelic-drugs-california-legalization/
Published Date: Mon, 13 May 2024 09:00:00 +0000

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