When Greg and Sugar Bull were ready to start a family, health challenges necessitated that they work with a gestational surrogate. The woman who carried and gave birth to their twins lived two states away.
The pregnancy went well until the surrogate experienced high blood pressure and other symptoms of preeclampsia, which could have harmed her and the babies. Doctors ordered an emergency delivery at 34 weeks' gestation. Both infants had to spend more than a week in the neonatal intensive care unit.
It was April 2020, early in the pandemic. Unable to take a plane, the Bulls drove from their home in Huntington Beach, California, to the hospital in Provo, Utah. They had to quarantine in Utah before they could see the children in the hospital.
A couple of weeks later, after the babies could eat and breathe on their own, the Bulls took them home to California.
Then the bills came.
The Patients: Scarlett and Redford Bull, newborn twins covered by a Cigna policy sponsored by Greg Bull's employer. The gestational surrogate had her own insurance, which covered her care.
Medical Service: Neonatal intensive care when the babies were born prematurely after emergency induced labor. Scarlett spent 16 days in the NICU; Redford, 10.
Total Bill: $117,084. The hospital was out of network for the infants. Cigna paid for some of Scarlett's care, for reasons the Bulls couldn't figure out. The Bulls were left on the hook for about $80,000, for both babies. Their account was ultimately sent to collections.
Service Provider: Utah Valley Hospital in Provo, Utah, one of 24 hospitals run by Intermountain Healthcare, a nonprofit with about $8 billion in revenue.
What Gives: The Bulls' ordeal points up a loophole in coverage for emergency care — even under the No Surprises Act, which took effect Jan. 1 and outlaws many kinds of surprise medical bills.
Patients who need prompt, lifesaving treatment often don't have time to find an in-network hospital. In the past, health plans sometimes have said they would pay for emergency care even if it's out of network. The No Surprises Act now makes this a legal requirement in every state. The provider and insurer are supposed to negotiate a reasonable payment, leaving the patient out of the equation.
But what if the insurance company denies that the care is for an emergency? Or the hospital doesn't supply the paperwork to prove it?
That's what happened to the Bulls. Cigna said it lacked documentation that the NICU care for the twins qualified as an emergency.
So the Bulls began receiving insurance explanations showing huge balances owed to Utah Valley. The family had expected to owe its out-of-network, out-of-pocket maximum of $10,000 for the twins' care. They assumed most of the bills would be paid by Cigna soon. They weren't.
"I was, like, there is no way this can be real," said Sugar Bull, an interior designer.
"Dear Scarlett Bull," began one of Cigna's letters, addressed to a 6-month-old baby. "We found the service requested is not medically necessary."
How could NICU care not qualify? The gestational surrogate was admitted to obstetrics by her doctor without going through the emergency department, which prompted Cigna to initially conclude there was no emergency, said Dylan Kirksey of Resolve Medical Bills, a consultancy that eventually worked with the Bulls to resolve the claims.
To establish that there was, Cigna asked for daily progress notes and other medical records on the infants. The Bulls tried to get the hospital to comply. Cigna kept saying it hadn't received the necessary documentation.
The Bulls appealed. Sugar spent hours with insurance paperwork and hold music. But almost a year later, about $80,000 in bills remained. Utah Valley sent the accounts to collections, Sugar Bull said. It was the last thing she had time for.
"I own a company, and I am super busy, and we had twins," she said. "Every two weeks or so, I would feel a panic and righteous anger about it. And I would keep pushing and calling, and it would take like five hours every time."
Though they disputed what they were being charged, the Bulls agreed to pay the hospital $500 a month for five years to settle just one of the babies' bills, in an attempt to keep their good credit.
Resolution: With seemingly nowhere else to turn, the family hired Resolve, which beats a path through the claims jungle in return for a portion of the money it saves clients.
"It was a lot of prodding" to get Utah Valley to give Cigna the information it needed to pay the hospital, said Kirksey, a senior advocate with Resolve, which was founded in 2019 and has 16 employees. He said he had to give the hospital a detailed list of steps to take and then follow up with multiple calls and emails per week.
In the end, most of the errors causing the Bulls' nightmare were on the hospital's side, Kirksey said. But instead of supplying what Cigna needed, Utah Valley went after the Bulls.
"The hospital repeatedly failed to provide a detailed list of services and important clinical information, despite our continuous efforts to secure the information," said Cigna spokesperson Meaghan MacDonald.
"There were no errors on the hospital's part," said Utah Valley spokesperson Daron Cowley. "Utah Valley Hospital properly billed for services provided to the twins and provided the requested information to Cigna in a timely manner."
The hospital didn't bill the Bulls for outstanding balances until nine months after the twins were born and didn't send the accounts to collections until six months after that, "after the family did not return the legally required paperwork to set up a payment plan," he said.
Finally, in fall 2021, the bills were settled. The twins were 1½ years old. To compensate Resolve for curing the balance, the Bulls paid the company about 10% — $8,000.
The fee, though substantial and unrelated to medical care, was worth it to avoid the much larger debt, said Greg Bull, who works in finance. "At the end of the day, it was such a relief for it to be a smaller amount," he said. Still, many families could not have afforded it.
The Takeaway: About 1 in 5 emergency room visits are at facilities that are out of network for the patient's insurance, research has shown. The No Surprises Act requires insurers to cover non-network emergency treatment with the same patient cost sharing as in-network care. It also prohibits hospitals from billing patients extra.
But if the insurer denies that the care was for an emergency or doesn't obtain documentation to prove it, the claim can still be rejected and the patient left on the hook.
"That's a coding issue we see a lot," said Kirksey, especially "if the person didn't literally check in through the emergency room."
If this happens, insurance experts urge patients to immediately appeal the decision to the insurance company, a process the law requires to be available. Unfortunately, that usually requires more phone calls, paperwork, and waiting. (If the appeal with the insurer fails, patients can then turn to an independent reviewer, like their state insurance board, state attorney general's office, or the No Surprises Help Desk.)
"It would be a critical step for the consumer to leverage their appeal rights … and get the determination that it was an emergency service from the get-go," said Kevin Lucia, co-director of the Center on Health Insurance Reforms at Georgetown University.
Once it's established that the visit was for an emergency, he said, protections from the No Surprises Act clearly apply.
The No Surprises Act is a step in the right direction. But it is clear that loopholes and minefields remain.
Stephanie O'Neill contributed the audio portrait with this story.
Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
HANFORD, Calif. — On May 13 of last year, the cellphones of thousands of California residents undergoing treatment for chronic pain lit up with a terse text message: "Due to unforeseen circumstances, Lags Medical Centers will be closing effective May 19, 2021."
In a matter of days, Lags Medical, a sprawling network of privately owned pain clinics serving more than 20,000 patients throughout the state's Central Valley and Central Coast, would shut its doors. Its patients, most of them working-class people reliant on government-funded insurance, were left without ready access to their medical records or handoffs to other physicians. Many patients were dependent on opioids to manage the pain caused by a debilitating disease or injury, according to alerts about the closures that state health officials emailed to area physicians. They were sent off with one final 30-day prescription, and no clear path for how to handle the agony — whether from their underlying conditions or the physical dependency that accompanies long-term use of painkillers — once that prescription ran out.
The closures came on the same day that the California Department of Healthcare Services suspended state Medi-Cal reimbursements to 17 of Lags Medical's 28 locations, citing without detail "potential harm to patients" and an ongoing investigation by the state Department of Justice into "credible allegations of fraud." In the months since, the state has declined to elaborate on the concerns that prompted its investigation. Patients are still in the dark about what happened with their care and to their bodies.
Even as the government remains largely silent about its investigation, interviews with former Lags Medical patients and employees, as well as KHN analyses of reams of Medicare and Medi-Cal billing data and other court and government documents, suggest the clinics operated based on a markedly high-volume and unorthodox approach to pain management. This includes regularly performing skin biopsies that industry experts describe as out of the norm for pain specialists, as well as notably high rates of other sometimes painful procedures, including nerve ablations and high-end urine tests that screen for an extensive list of drugs.
Those procedures generated millions of dollars in insurer payments in recent years for Lags Medical Centers, an affiliated network of clinics under the ownership of Dr. Francis P. Lagattuta. The clinics' patients primarily were insured by Medicare, the federally funded program for seniors and people with disabilities, or Medi-Cal, California's Medicaid program for low-income residents.
Taken individually, the fees for each procedure are not eye-popping. But when performed at high volume, they add up to millions of dollars.
Take, for example, the punch biopsy, a medical procedure in which a circular blade is used to extract a sample of deep skin tissue the size of a pencil eraser. The technique is commonly used in dermatology to diagnose skin cancer but has limited use in pain management medicine, usually involving a referral to a neurologist, according to multiple experts interviewed. These experts said it would be unusual to use the procedure as part of routine pain management.
In Lagattuta's specialty — physical medicine and rehabilitation, a common pain management field — just six of the nearly 8,000 U.S. physicians treating Medicare patients billed for punch biopsies on more than 10 patients in 2019, the most recent year for which data was available. Four, including Lagattuta, were affiliated with Lags Medical.
Medicare and Medi-Cal data are organized differently, and each provides distinct insights into Lags Medical's billing practices. For Medicare, KHN's findings reflect the number of procedures and actual reimbursements billed through Lagattuta's provider number. But the Medicare figures do not encompass services and billing amounts for other providers across the chain, nor reimbursements for patients enrolled in private Medicare Advantage plans.
KHN used Medi-Cal records to assess the volume of services performed across the entire chain. But the state could not provide totals for how much Lags Medical was reimbursed because of California's extensive use of managed-care plans, which do not make their reimbursement rates public. Where possible, KHN estimated the worth of Medi-Cal procedures based on the set rates Medi-Cal pays traditional fee-for-service plans, which are public.
Lags Medical clinics performed more than 22,000 punch biopsies on Medi-Cal patients from 2016 through 2019, according to state data. Medi-Cal reimbursement rates for punch biopsies changed over time. In 2019 the state's reimbursement rate was more than $200 for a set of three biopsies performed on patients in fee-for-service plans.
Laboratory analysis of punch biopsies was worth far more. Lags Medical clinics sent biopsies to a Lags-affiliated lab co-located at a clinic in Santa Maria, according to medical records and employee interviews. From 2016 through 2019, Lags Medical clinics and providers performed tens of thousands of pathology services associated with the preparation and examination of tissue samples from Medi-Cal patients, according to state records. The services would have been worth an estimated $3.9 million using Medi-Cal's average fee-for-service rates during that period.
In that same period, Medicare reimbursed Lagattuta at least $5.7 million for pathology activities using those same billing codes, federal data shows.
Much of the work at Lags Medical was performed by a relatively small number of nurse practitioners and physician assistants, each juggling dozens of patients a day with sporadic, often remote supervision by the medical doctors affiliated with the clinics, according to interviews with former employees. Lagattuta himself lived in Florida for more than a year while serving as medical director, according to testimony he provided as part of an ongoing malpractice lawsuit that names Lagattuta, Lags Medical, and a former employee as defendants.
Former employees said they were given bonuses if they treated more than 32 patients in a day, a strategy Lagattuta confirmed in his deposition in the malpractice lawsuit. "If they saw over, like, 32 patients, they would get, like, $10 a patient," Lagattuta testified.
The lawsuit, filed in Fresno County Superior Court, accuses a Lags Medical provider in Fresno of puncturing a patient's lung during a botched injection for back pain. Lagattuta and the other named defendants have denied the incident was due to negligent treatment, saying, in part, the patient consented to the procedure knowing it carried risks.
Hector Sanchez, the nurse practitioner who performed the injection and is named in the lawsuit, testified in his own deposition that providers at the Lags Medical clinic in Fresno each treated from 30 to 40 patients on a typical workday.
According to Sanchez's testimony and interviews with two additional former employees, Lags Medical clinics also offered financial bonuses to encourage providers to perform certain medical procedures, including punch biopsies and various injections. "We were incentivized initially to do these things with cash bonuses," said one former employee, who asked not to be named for fear of retribution. "There was a lot of pressure to get those done, to talk patients into getting these done."
In his own deposition in the Fresno case, Lagattuta denied paying bonuses for specific medical procedures.
Interviews with 17 former patients revealed common observations at Lags Medical clinics, such as crowded waiting rooms and an assembly-line environment. Many reported feeling pressure to consent to injections and other procedures or risk having their opioid supplies cut off.
Audrey Audelo Ramirez said she had worried for years that the care she was receiving at a Lags Medical clinic in Fresno was subpar. In the past couple of years, she said, there were sometimes so many patients waiting that the line wrapped around the building.
Ramirez, 52, suffers from trigeminal neuralgia, a rare nerve disease that sends shocks of pain across the face so severe it's known as the "suicide disease." Over the years, Lags Medical had taken over prescribing almost all her medications. This included not only the opioids and gabapentin she relies on to endure excruciating pain, but also drugs to treat depression, anxiety, and sleep issues.
Ramirez said she often felt pressured to get procedures she didn't want. "They were always just pushing injections, injections, injections," she said. She said staffers performed painful punch biopsies on her that resulted in an additional diagnosis of small fiber neuropathy, a nerve disorder that can cause stabbing pain.
She was among numerous patients who said they felt they needed to undergo the recommended procedures if they wanted continued prescriptions for their pain medications. "If you refuse any treatment they say they're going to give you, you're considered noncompliant and they stop your medication," Ramirez said.
She said she eventually agreed to an injection in her face, which she said was administered without adequate sedation. "It was horrible, horrible," she said. Still, she said, she kept going to the office because there weren't many other options in her town.
Lagattuta, through his lawyer, declined a request from KHN to respond to questions about the care provided at his clinics, citing the state investigation. "Since there is an active investigation, Dr. Lagattuta cannot comment on it until it is completed," attorney Matthew Brinegar wrote in an email. Lagattuta's license remains in good standing, and he said in his deposition in the Fresno lawsuit that he is still seeing patients in California.
Experts interviewed by KHN noted that medical procedures such as injections can have a legitimate role in comprehensive pain management. But they also spoke in general terms about the emergence of a troubling pattern at U.S. pain clinics involving the overuse of procedures. In the 1990s and early 2000s, problematic pain clinics hooked patients on opioids, then demanded cash to continue prescriptions, said Dr. Theodore Parran, who is a professor of medicine at Case Western Reserve University and has served as an expert witness in federal investigations into pain clinics.
"What has replaced them are troubled pain clinics that hook patients with the meds and accept insurance, but overuse procedures which really pay well," he said. For patients, he added, the consequences are not benign.
"I mean they are painful," he said. "You're putting needles into people."
'Knee Injections, Hip Injections, Foot Injections'
Before moving to California in 1998, Dr. Francis Lagattuta lived in Illinois and worked as a team doctor for the Chicago Bulls during its 1995-96 championship season. Out West, he opened a clinic in Santa Maria, a Latino-majority city along California's Central Coast known for its strawberry fields, vineyards, and barbecue. From 2015 to 2020, the chain grew from a couple of clinics in Santa Barbara County to dozens throughout California, largely in rural areas, as well as far-flung locations in Washington state, Delaware, and Florida.
The California portion of the chain is organized as more than two dozen corporations and limited liability corporations owned by Lagattuta. His son, Francis P. Lagattuta II, was a manager for the company.
On the Lags Medical website and in conversation with employees, the elder Lagattuta claimed he was on the vanguard of diagnosing and treating small fiber neuropathy. Much of the website has now been taken down. But pages available via an archival site claim he had pioneered a three-pronged approach to pain management that made minimal use of opioids and surgeries, instead emphasizing testing, injections, mental health, diet, and exercise. "In keeping with his social justice values, Dr. Lagattuta plans to share these findings to the rest of the world, hopefully to help solve the opioid crisis, and end suffering for millions of people struggling with pain," touted a biography once highlighted on the website.
Numerous Lags Medical patients interviewed by KHN said that even when they were given punch biopsies and a subsequent diagnosis of neuropathy, their treatment plan continued to involve high doses of opioid medications.
Dr. Victor C. Wang, chief of the division of pain neurology at Brigham and Women's Hospital in Boston, said punch biopsies are occasionally used in research but are not a standard part of pain medicine. Instead, small fiber neuropathy is usually diagnosed with a simple clinical exam.
"The treatment is going to be the same whether you have a biopsy or not," said Wang. "I always tell the fellows, you can do this test or that one, but is it really going to change the management of the patient?"
Ruby Avila, a mother of three in Visalia, remembers having the punch biopsies done at least three times during her four years as a Lags Medical patient. "I have scars down my leg," she said. Each time, she said, providers removed a set of three skin specimens that were used to diagnose her with small fiber neuropathy.
Avila, 37, who has lived with pain since childhood, had found it validating to finally have a diagnosis. But after learning more about how common the biopsies were at Lags Medical, she was shaken. "It's overwhelming to hear that they were doing it on a lot of people," she said.
Sanchez, the nurse practitioner named in the Fresno lawsuit, spoke of other procedures that garnered bonuses: "Trigger point injections, knee injections, hip injections, foot injections for plantar fasciitis and elbow injections" all qualified for $10 bonuses, he said in his testimony.
Two former employees, who asked not to be named, echoed Sanchez, saying they were incentivized to do certain procedures, including injections and punch biopsies.
In his testimony in the Fresno case, Lagattuta denied paying bonuses for procedures. "It was only for the patients," he said. "We never did it based on procedures."
Incentive systems for a specific procedure are "completely unethical," said Dr. Michael Barnett, an assistant professor of health policy at Harvard. "It's like giving police officers a quota for speeding tickets. What do you think they're going to do? I can't think of any justification."
Dr. Carl Johnson, 77, is a pathologist who directed Lags Medical's Santa Maria lab from 2018 to 2021. Johnson said the only specimens he looked at came from punch biopsies, the first time in his long career as a pathologist that he had been asked to run such an analysis. On an average day, he said, he examined the slides of about 40 patients, searching for signs of small fiber neuropathy. Lagattuta gave him papers to read on peripheral neuropathy and assured him they were on the cutting edge of care for pain patients. Johnson said he "never thought there was anything untoward going on" until he arrived on his last day and was told to pack up his belongings because the entire operation was shutting down.
Lags Medical performed other procedures at rates that also set them apart. From 2015 through 2020 — the span for which KHN had state data — Lags Medical performed more than 24,000 nerve ablations, a procedure in which part of a nerve is destroyed to reduce pain, on Medi-Cal patients. That's more than 1 in 6 of all nerve ablations billed through Medi-Cal during that period.
An analysis of federal data also shows Lagattuta was an outlier. For example, in 2018 he billed Medicare for nerve ablations more often than 88% of the doctors in his field who performed the procedure.
Lags Medical also used the in-house lab to run drug tests on patients' urine samples. From 2017 through 2019, Lags Medical facilities often ordered the most extensive — and expensive — set of drug tests, which check for the presence of at least 22 drugs, according to state and federal data.
For perspective, in 2019, more than 23,000 of the most extensive drug tests were ordered on Medi-Cal patients under Lagattuta's provider number, more than double the number tied to the next highest biller. The next five top billers were all lab companies.
Overall, from 2017 through 2019, nearly 60,000 of the most extensive drug tests were billed to Medicare and Medi-Cal under Lagattuta's provider number. Medicare reimbursed Lagattuta $5.4 million for these tests during that period. Using state fee-for-service rates, the testing billed to Medi-Cal would have been worth an estimated $6.3 million. That doesn't include less extensive drug screens or those billed under other providers' numbers.
Pain management experts described the use of extensive screening as unnecessary in routine pain treatment; the overuse of such tests has been the subject of numerous Medicare investigations in recent years.
Private pain clinics like Lags Medical are only loosely regulated and generally are not required to hold a special license from the state. But the physicians who work there are regulated by the Medical Board of California.
In December 2019, a patient who'd visited clinics in both Visalia and the Central Coast filed a complaint against Lagattuta with the medical board claiming, among other things, that she received biopsies that were not properly performed, that she underwent excessive testing, and that positive drug tests had been falsified. The medical board had another pain management doctor review more than 300 pages of documents and found "no deviations from the standard of care" and "did not find any over testing, or improperly performed biopsies."
He did, however, find some record-keeping problems, including numerous procedures in which patient consent was not documented. He also found instances in which procedures were performed and repeated without documentation that they were effective. The patient who filed the complaint was given a medial branch nerve block in November 2014, followed by a radiofrequency ablation in December, and another in February. No improvements for the patient were ever noted in the charts, the investigating doctor found.
The medical board chalked it up to a record-keeping error and fined Lagattuta $350.
A Halfway-Normal Life
On a warm evening in late July, Leah Munoz drove her power wheelchair around the long plastic tables at the Veterans Memorial Building in Hanford, a dusty farm town in California's Central Valley. Senior bingo night was crowded with gray-haired players waiting for the game to begin. She found an empty spot and carefully set out $50 worth of bingo cards, alongside her collection of 14 brightly colored daubers.
Munoz, 55 and a mother of six, said she has suffered from a litany of illnesses — thyroid cancer, breast cancer, lupus, osteoarthritis — that leave her in near-constant pain. She's been playing bingo since she was a little girl, and said it helps distract from the pain and calm her mind. She looks forward to this event all week.
Munoz was a Lags Medical patient for about four years and, while her pain never disappeared, the opioids prescribed provided enough relief for her to continue doing the things she loved. "There's a difference between addiction and dependence. I need it to live a halfway-normal life," Munoz said.
After Lags Medical closed in May, her primary care doctor initially refused to refill her opioid prescriptions. She said she called the Lags Medical offices to try to get a copy of her medical records to prove her need, and even showed up in person. But she said she was unable to get them. As the pills dwindled and the pain surged, Munoz said, it became hard to leave her home. "I missed a lot of bingo, a lot of grocery shopping, a lot of going to my grandkids' birthday parties. You miss out on life," she said. Ultimately, she said, her primary care doctor referred her to another pain clinic, and she was able to resume her prescription.
Even with pain medications, Munoz said, she never received true relief during her time as a patient at Lags Medical. She said she felt coerced to get several injections, none of which seemed to help. "If I didn't get the procedures, I didn't get the pain medication," she said. Her husband, Ramon, a landscaper who was also a patient, received an injection there that he said left him with permanent stiffness in his neck.
Munoz knows at least five other people at bingo night who were former patients at Lags Medical. One of them, Rick Freeman, came over to her table to chat. He swayed back and forth as he walked, his knees, he explained, swollen after 35 years living with HIV. At Lags Medical, Freeman said, he felt pressured by staff to receive injections if he wanted to continue receiving his opioid prescriptions. "If you don't cooperate with them, they would reduce your meds down," he said.
At the front of the room, Gail Soto, who ran the event, sold bingo cards to the latecomers. Soto, 72, said she injured her back while working an administrative job at a construction company years ago and suffers from spinal stenosis, rheumatoid arthritis, and fibromyalgia. She, too, was a patient at Lags Medical for years. In addition to her opioid prescription, Soto said, she received repeated injections and three nerve ablations. At first, the ablations helped, but what staff members didn't tell her, she said, was that the nerves they destroyed could grow back. Ultimately, she said, the procedures left her in worse pain.
Soto's biggest concern is the spinal stimulator that she said Lags Medical surgically inserted into her back five years ago. She said the doctors told her the device would work so well that she would no longer need her pain pills. She said they didn't explain that the device would work only two hours a day, and on one side of her body. She remained in too much pain to give up her meds, she said, and, five years later, the battery is failing.
Soto sleeps in a recliner chair in her three-bedroom mobile home in Lemoore, another small city near Hanford. It's well kept but humble, and she and her husband keep a collection of wind chimes on the front porch that create a wave of gentle music when a breeze passes by. The couple take good care of each other and their two beloved Chihuahuas, but life has become increasingly difficult for Soto.
As the battery on her spinal stimulator has started to fail, she said, she has sudden electrical pulses that shoot up her body. "My husband says sometimes when I sleep that my body will just jump up in the air," she said. But now that Lags Medical is closed, she said, she can't find a doctor willing to remove the device. "Most doctors are telling me right now, 'We can't, because we didn't [put it in]. We don't want nothing to do with that.'"
Ramon Soto and his wife, Gail, are devoted to their two beloved Chihuahuas. Their mobile home in Lemoore, California, is well kept but humble. (Anna Maria Barry-Jester / KHN)
Waitlists and Withdrawal
Audrey Audelo Ramirez said she picked up her final refill from Lags Medical on June 4 and by July 4 had no meds left to treat her pain. Ramirez said she called every pain management clinic in Fresno, but none were taking new patients.
"They left us all high and dry," she said. "Everybody."
In the weeks that followed the closures, county officials throughout the Central Valley saw a flood of patients on high doses of opioids in search of new providers, they said. Patients couldn't access their medical records, so other providers had no idea what their treatments had been.
"We had to create a crisis response to it because there was no organized response at that time," said Dr. Rais Vohra, the interim health officer for Fresno County.
Fresno County's health system is already lean, Vohra said. Toss in this abrupt closure and you end up in the kind of crisis rarely seen in other fields of medicine: "You'd never do this with a cancer clinic," he said. "You'd never abruptly stop chemo."
The state asked Dr. Phillip Coffin, director of substance abuse research for the San Francisco Department of Public Health, to run provider training and persuade doctors to take on new patients. Many practices have rules against taking new patients on opioids, or will refuse to prescribe doses above certain thresholds.
"We know that when you stop prescribing opioids, some people end up with death from suicide, overdose, increased illicit opioid use, pain exacerbations. It's really important to have a continuity, and that is not really possible in the current opioid-prescribing culture," Coffin said. The threat to patients is so severe that the FDA issued a warning in 2019 against cutting patients off from prescription opioids.
Gina, a retired nurse who asked to be identified by only her first name for fear she'd be discriminated against by other doctors, had been a Lags Medical patient for six years. She said she called every practice she could find in her Central Coast town, and was put on a waiting list at one. Suffering from a severe case of scoliosis, she started rationing the pain pills she had come to rely on.
When she finally secured an appointment, she said, she was told by the doctor she was on "some very strong meds" and he would fill only one of her two prescriptions. "You're like a criminal," she said. "You're branded as 'we don't trust you.'"
She started experiencing withdrawal symptoms — sweating, lost appetite, sleeplessness, anxiety. Worst of all, her pain "came back with a vengeance," she said.
"I think about this, what I'd have been like if I'd never gone through pain management. I sometimes wonder if I'd be better off."
As for Ramirez, her primary care doctor finally secured an appointment for her at another pain clinic, she said. It was in the same space as the old Lags Medical clinic, and she said she recognized many of the staff members. But now there was a new name: Central California Pain Management. From her perspective, it was as if nothing had changed. And she still doesn't know whether she needs to worry about the care she received during more than four years at Lags Medical.
The new clinic's owner, Dr. Ashok Parmar, said that he is leasing the space and that Lagattuta is his landlord. Parmar said he doesn't do punch biopsies, nor does he diagnose small fiber neuropathy. After all, he said, he would treat the pain the same way, with or without the diagnosis.
How We Did This
KHN evaluated the billing practices of physicians and clinics associated with Lags Medical Centers using data from both Medicare and Medi-Cal.
KHN did multiple analyses using Medicare Part B records that show, for each medical practitioner or lab, every procedure or service billed to the federal government, along with the number of times a procedure was performed, the number of Medicare beneficiaries who received specific services, and how much Medicare reimbursed. The Part B records include billings from 2015 through 2019, the most recent years available. The records are limited to beneficiaries who have traditional fee-for-service Medicare rather than private Medicare Advantage plans. Medicare suppressed data in cases in which a provider performed a procedure on 10 or fewer beneficiaries in a year.
KHN analyzed Medicare billing records for a range of specific procedures, comparing Dr. Francis P. Lagattuta's billings with those of other practitioners who also identified themselves in the records as Physical Medicine and Rehabilitation specialists.
Through a public records request, KHN also obtained data from the California Department of Healthcare Services for a range of specific medical procedures performed on state Medi-Cal recipients by all California providers from 2015 through 2020, as well as every service rendered through Medi-Cal under Lagattuta's provider number during that time. The Medi-Cal data is organized to show both the rendering and billing provider for a procedure, allowing KHN to look across the network of Lags Medical clinics. To calculate services provided at Lags Medical Centers, KHN included services performed under Lagattuta's provider number, as well as active provider numbers of organizations with a mailing address associated with Lags Medical clinics that listed Dr. Francis P. Lagattuta or another Lags employee as their authorized official. DHCS suppressed data for instances in which a provider performed a procedure fewer than 11 times on Medi-Cal patients in a year.
The Medi-Cal data did not include reimbursement amounts for procedures, so KHN obtained historical reimbursement amounts from DHCS to calculate the value of the services based on the fee-for-service reimbursement rate in July of each year. Care received by patients with Medi-Cal is generally reimbursed by the state in one of two ways: a fee-for-service model, in which physicians are reimbursed for services according to a set fee schedule that is public; or a managed-care model, in which the state pays insurers a monthly fee per patient, and the insurers reimburse providers amounts that are not public. Only a small percentage of Lags Medical services were reimbursed through fee-for-service plans during the years reviewed. As a result, the values of procedures calculated by KHN are meant to convey a general estimate of their worth. All estimates are calculated using the Basic Rate.
KHN senior correspondent Jordan Rau and Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.
People who are at high risk — and the loved ones who fear passing along the virus to them — are speaking out about being left behind as society drops pandemic safeguards.
This article was published on Tuesday, February 22, 2022 in Kaiser Health News.
Iesha White is so fed up with the U.S. response to COVID-19 that she's seriously considering moving to Europe.
"I'm that disgusted. The lack of care for each other, to me, it's too much," said White, 30, of Los Angeles. She has multiple sclerosis and takes a medicine that suppresses her immune system. "As a Black disabled person, I feel like nobody gives a [expletive] about me or my safety."
The Centers for Disease Control and Prevention has a strict definition of who is considered moderately or severely immunocompromised, such as cancer patients undergoing active treatment and organ transplant recipients. Still, millions of other people are living with chronic illnesses or disabilities that also make them especially susceptible to the disease. Though vulnerability differs based on each person and their health condition — and can depend on circumstances — catching COVID is a risk they cannot take.
As a result, these Americans who are at high risk — and the loved ones who fear passing along the virus to them — are speaking out about being left behind as the rest of society drops pandemic safeguards such as masking and physical distancing.
Their fears were amplified this month as several Democratic governors, including the leaders of California and New York — places that were out front in implementing mask mandates early on — moved to lift such safety requirements. To many people, the step signaled that "normal" life was returning. But for people considered immunocompromised or who face high risks from COVID because of other conditions, it upped the level of anxiety.
"I know my normal is never going to be normal," said Chris Neblett, 44, of Indiana, Pennsylvania, a kidney transplant recipient who takes immunosuppressive drugs to prevent his body from rejecting his transplanted organ. "I'm still going to be wearing a mask in public. I'm still probably going to go to the grocery store late at night or early in the morning to avoid other people."
He is especially concerned because his wife and young daughter recently tested positive for COVID.
Even though he's fully vaccinated, he's not sure he is protected from the virus's worst outcomes. Neblett participates in a Johns Hopkins University School of Medicine study tracking transplant recipients' immune response to the vaccine, so he knows his body produced only a low amount of antibodies after the third dose and is waiting on the results of the fourth. For now, he's isolating himself from his wife and two kids for 10 days by staying in his second garage.
"I told my wife when COVID first happened, 'I have to make it to the vaccine,'" he said. But learning the vaccine hasn't triggered an adequate immune-system response so far is crushing. "Your world really changes. You start wondering, 'Am I going to be a statistic? Am I going to be a number to people that don't seem to care?'"
Scientists estimate that almost 3% of Americans meet the strict definition of having weakened immune systems, but researchers acknowledge that many more chronically ill and disabled Americans could be severely affected if they catch COVID.
By summer 2021, scientific evidence indicated that immunocompromised people would likely benefit from a third shot, but it took federal agencies time to update their guidance. Even then, only certain groups of immunocompromised people were eligible, leaving others out.
In October, the CDC again quietly revised its vaccine guidance to allow immunocompromised people to receive a fourth COVID vaccine dose, though a recent KHN story revealed that pharmacists unaware of this change were still turning away eligible people in January.
People with weakened immune systems or other high-risk conditions argue that now is the time, as the omicron surge subsides, to double down on policies that protect vulnerable Americans like them.
"The pandemic isn't over," said Matthew Cortland, a senior fellow working on disability and healthcare for Data for Progress, who is chronically ill and immunocompromised. "There is no reason to believe that another variant won't emerge. … Now is the time, as this omicron wave begins to recede, to pursue policies and interventions that protect chronically ill, disabled, and immunocompromised people so that we aren't left behind."
Several people interviewed by KHN who are part of this community said that, instead, the opposite is taking place, pointing to a January comment by CDC Director Dr. Rochelle Walensky that implied it was "encouraging news" that the majority of people dying of COVID were already sick.
"The overwhelming number of deaths, over 75%, occurred in people who had at least four comorbidities, so really these are people who were unwell to begin with," said Walensky, when discussing a study during a television interview that showed the level of protection vaccinated people had against severe illness from COVID. "And yes, really encouraging news in the context of omicron."
Although the CDC later said Walensky's remarks were taken out of context, Kendall Ciesemier, a 29-year-old multimedia producer living in Brooklyn, New York, said she was disturbed by the comments.
Walensky's statement "sent shock waves through the disability community and the chronic illness community," said Ciesemier, who has had two liver transplants.
"It was saying the quiet part out loud," she added, noting that though it was likely a gaffe, the strong reaction to it "stemmed from this holistic feeling that these communities have not been prioritized during the pandemic and it feels like our lives are acceptable losses."
When asked by a KHN reporter at the Feb. 9 White House COVID press briefing what she wanted to convey to people who feel they are being left behind, Walensky didn't offer a clear answer.
"We, of course, have to make recommendations that are, you know, relevant for New York City and rural Montana," she said, adding that they have to be "relevant for the public, but also for the public who is immunocompromised and disabled. And so, that — all of those considerations are taken into account as we work on our guidance."
Although the CDC currently recommends that vaccinated people continue to wear masks indoors if they are in a place with high or substantial COVID transmission — which includes most of the U.S. — federal officials have indicated this guidance may be updated soon.
"We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen," said Walensky during a Feb. 16 White House COVID briefing, when discussing whether CDC's COVID prevention policies would be altered soon.
But there's no mask break in sight for Dennis Boen, a 67-year-old retiree who has had three kidney transplants. Because his community of Wooster, Ohio, already lacks a mask mandate and few residents voluntarily wear masks, he hasn't felt comfortable returning to many of the social events that he enjoys.
"I quit going to my Rotary Club that I've been a part of for decades," Boen said. "I went once in the summer to a picnic outside and it was like the people who didn't believe [in COVID] or didn't care weren't wearing masks and they weren't giving me any space. Therefore, it was just easier to not go."
Charis Hill, a 35-year-old disability activist in Sacramento, California, has postponed two surgeries, a hysterectomy, and an umbilical hernia repair for over a year because Hill didn't feel safe. Delaying has meant Hill has had to take additional medications and eat only certain foods. The surgeries are scheduled for March 21, but now that California's mask mandate has lifted, Hill is thinking about delaying the procedures again.
"I feel disposable. As if my life doesn't have value," said Hill, who is living with axial spondyloarthritis, a chronic inflammatory disease, and takes immune-suppressing medication. "I am tired of constantly being told that I should just stay home and let the rest of the world move on."
Late one night in January, Jonathan Coffino, 78, turned to his wife as they sat in bed. "I don't know how much longer I can do this," he said, glumly.
Navigating Aging focuses on medical issues and advice associated with aging and end-of-life care, helping America's 45 million seniors and their families navigate the healthcare system.
Coffino was referring to the caution that's come to define his life during the COVID-19 pandemic. After two years of mostly staying at home and avoiding people, his patience is frayed and his distress is growing.
"There's a terrible fear that I'll never get back my normal life," Coffino told me, describing feelings he tries to keep at bay. "And there's an awful sense of purposelessness."
Despite recent signals that COVID's grip on the country may be easing, many older adults are struggling with persistent malaise, heightened by the spread of the highly contagious omicron variant. Even those who adapted well initially are saying their fortitude is waning or wearing thin.
Like younger people, they're beset by uncertainty about what the future may bring. But added to that is an especially painful feeling that opportunities that will never come again are being squandered, time is running out, and death is drawing ever nearer.
"Folks are becoming more anxious and angry and stressed and agitated because this has gone on for so long," said Katherine Cook, chief operating officer of Monadnock Family Services in Keene, New Hampshire, which operates a community mental health center that serves older adults.
"I've never seen so many people who say they're hopeless and have nothing to look forward to," said Henry Kimmel, a clinical psychologist in Sherman Oaks, California, who focuses on older adults.
Older adults have suffered more illness and death from COVID-19 than any other group. How are they faring as the pandemic enters its third year? KHN and The John A. Hartford Foundation will explore that question in depth in a 90-minute interactive web event beginning at Noon ET on Wednesday, Feb. 23.
To be sure, older adults have cause for concern. Throughout the pandemic, they've been at much higher risk of becoming seriously ill and dying than other age groups. Even seniors who are fully vaccinated and boosted remain vulnerable: More than two-thirds of vaccinated people hospitalized from June through September with breakthrough infections were 65 or older.
The constant stress of wondering "Am I going to be OK?" and "What's the future going to look like?" has been hard for Kathleen Tate, 74, a retired nurse in Mount Vernon, Washington. She has late-onset post-polio syndrome and severe osteoarthritis.
"I guess I had the expectation that once we were vaccinated the world would open up again," said Tate, who lives alone. Although that happened for a while last summer, she largely stopped going out as first the delta and then the omicron variants swept through her area. Now, she said she feels "a quiet desperation."
This isn't something that Tate talks about with friends, though she's hungry for human connection. "I see everybody dealing with extraordinary stresses in their lives, and I don't want to add to that by complaining or asking to be comforted," she said.
Tate described a feeling of "flatness" and "being worn out" that saps her motivation. "It's almost too much effort to reach out to people and try to pull myself out of that place," she said, admitting she's watching too much TV and drinking too much alcohol. "It's just like I want to mellow out and go numb, instead of bucking up and trying to pull myself together."
Beth Spencer, 73, a recently retired social worker who lives in Ann Arbor, Michigan, with her 90-year-old husband, is grappling with similar feelings during this typically challenging Midwestern winter. "The weather here is gray, the sky is gray, and my psyche is gray," she told me. "I typically am an upbeat person, but I'm struggling to stay motivated."
"I can't sort out whether what I'm going through is due to retirement or caregiver stress or COVID," Spencer said, explaining that her husband was recently diagnosed with congestive heart failure. "I find myself asking 'What's the meaning of my life right now?' and I don't have an answer."
Bonnie Olsen, a clinical psychologist at the University of Southern California's Keck School of Medicine, works extensively with older adults. "At the beginning of the pandemic, many older adults hunkered down and used a lifetime of coping skills to get through this," she said. "Now, as people face this current surge, it's as if their well of emotional reserves is being depleted."
Most at risk are older adults who are isolated and frail, who were vulnerable to depression and anxiety even before the pandemic, or who have suffered serious losses and acute grief. Watch for signs that they are withdrawing from social contact or shutting down emotionally, Olsen said. "When people start to avoid being in touch, then I become more worried," she said.
Fred Axelrod, 66, of Los Angeles, who's disabled by ankylosing spondylitis, a serious form of arthritis, lost three close friends during the pandemic: Two died of cancer and one of complications related to diabetes. "You can't go out and replace friends like that at my age," he told me.
Now, the only person Axelrod talks to on a regular basis is Kimmel, his therapist. "I don't do anything. There's nothing to do, nowhere to go," he complained. "There's a lot of times I feel I'm just letting the clock run out. You start thinking, 'How much more time do I have left?'"
"Older adults are thinking about mortality more than ever and asking, 'How will we ever get out of this nightmare,'" Kimmel said. "I tell them we all have to stay in the present moment and do our best to keep ourselves occupied and connect with other people."
Loss has also been a defining feature of the pandemic for Bud Carraway, 79, of Midvale, Utah, whose wife, Virginia, died a year ago. She was a stroke survivor who had chronic obstructive pulmonary disease and atrial fibrillation, an abnormal heartbeat. The couple, who met in the Marines, had been married 55 years.
"I became depressed. Anxiety kept me awake at night. I couldn't turn my mind off," Carraway told me. Those feelings and a sense of being trapped throughout the pandemic "brought me pretty far down," he said.
Help came from an eight-week grief support program offered online through the University of Utah. One of the assignments was to come up with a list of strategies for cultivating well-being, which Carraway keeps on his front door. Among the items listed: "Walk the mall. Eat with friends. Do some volunteer work. Join a bowling league. Go to a movie. Check out senior centers."
"I'd circle them as I accomplished each one of them. I knew I had to get up and get out and live again," Carraway said. "This program, it just made a world of difference."
Kathie Supiano, an associate professor at the University of Utah College of Nursing who oversees the COVID grief groups, said older adults' ability to bounce back from setbacks shouldn't be discounted. "This isn't their first rodeo. Many people remember polio and the AIDs epidemic. They've been through a lot and know how to put things in perspective."
Alissa Ballot, 66, realized recently she can trust herself to find a way forward. After becoming extremely isolated early in the pandemic, Ballot moved last November from Chicago to New York City. There, she found a community of new friends online at Central Synagogue in Manhattan and her loneliness evaporated as she began attending events in person.
With omicron's rise in December, Ballot briefly became fearful that she'd end up alone again. But, this time, something clicked as she pondered some of her rabbi's spiritual teachings.
"I felt paused on a precipice looking into the unknown and suddenly I thought, 'So, we don't know what's going to happen next, stop worrying.' And I relaxed. Now I'm like, this is a blip, and I'll get through it."
We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the healthcare system. Visit khn.org/columnists to submit your requests or tips.
For a national look at Medicare penalties, read Jordan Rau's "Healthcare Paradox: Medicare Penalizes Dozens of Hospitals It Also Gives Five Stars"
This broadcast was released on Saturday, February 19, 2022 in Kaiser Health News.
Samantha Young, a political correspondent for California Healthline, on Feb. 15 discussed how Medi-Cal patients struggle to get their prescription drugs on KCRW's "Press Play."
Interim Southern bureau editor Andy Miller discussed Medicare penalties for hospitals in Georgia on Georgia Public Broadcasting's "Lawmakers" on Feb. 10.
For some counties and cities that share a public health agency with other local governments, differences over mask mandates, business restrictions, and other COVID preventive measures have strained those partnerships. At least two have been pushed past the breaking point.
A county in Colorado and a small city in Southern California are splitting from their longtime public health agencies to set up their own local departments. Both Douglas County, Colorado, and West Covina, California, plan to contract some of their health services to private entities.
In Douglas County, Colorado, which is just south of Denver and has one of the nation's highest median household incomes, many residents had opposed mask mandate guidance from the Tri-County Health Department, a partnership among Adams, Arapahoe, and Douglas counties. Tri-County issued a mask order for the counties' school districts in September 2021 and, within days, conservative Douglas County announced its commissioners had voted unanimously to form its own health department.
Douglas County, which in 1966 joined what was then called the Tri-County District Health Department, is phasing out of the partnership, with plans to exit entirely by the end of this year. It has already taken over many of its own COVID relief efforts from Tri-County.
It is contracting things like COVID case investigation, contact tracing, and isolation and quarantine guidance to a private consultant, Jogan Health Solutions, founded in early 2021. The contract is reportedly worth $1.5 million.
"We believe the greatest challenges are behind us … those associated with being one of three counties with differing and competing public health demands, on a limited budget," Douglas County spokesperson Wendy Manitta Holmes said in a statement.
Daniel Dietrich, Jogan Health's president, declined a request for an interview. "All of the data that Jogan Health is collecting is being relayed directly to Douglas County so that public policy aligns with real-time data to keep the residents of Douglas County safe," Jogan Health spokesperson Sam Shaheen said in a prepared statement.
A similar situation is playing out east of Los Angeles, in West Covina, California. Its City Council has voted to terminate its relationship with the Los Angeles County Department of Public Health over disagreements about COVID shutdowns.
West Covina officials have criticized the county health department's COVID restrictions as a one-size-fits-all approach that may work for the second-largest city in the U.S., but not their suburb of about 109,500 people. West Covina plans to join Long Beach, Pasadena, and Berkeley as one of a small number of California cities with its own health agency. A date for the separation has not been set.
As in Douglas County, West Covina plans to contract some services to a private consultant, Transtech Engineers, that works mainly on city engineering projects and federal contracts, according to its website. Transtech officials did not respond to requests for comment.
West Covina Councilman Tony Wu and area family physician Dr. Basil Vassantachart are leading efforts to form the city's own department. They hope L.A. County's oversight of about 10 million people — "bigger than some states," as Vassantachart noted — can be broken up into regional departments.
Amitabh Chandra, who directs health policy research at the Harvard Kennedy School of Government, said the private sector won't necessarily have better answers to a public health problem. "It might be the case that they're good at delivering on some parts of what needs to be done, but other parts still have to be done in-house," Chandra said.
Jeffrey Levi, a professor of health policy and management at the George Washington University, suggests there are too many local health departments in the U.S. and there should be more regionalization, rather than splitting into smaller departments.
"It's very hard to effectively spend money and build the foundational capabilities that are associated with a meaningful public health department," Levi said. "Doing this just because of anger at something like a mask ordinance is really unfortunate."
Levi noted that public health departments are responsible for everything from restaurant and septic system inspections to administering the Special Supplemental Nutrition Program for Women, Infants, and Children, or WIC, a federal food assistance program. If a department is not adequately resourced or prepared, residents could see lapses in food or water safety efforts in their community, Levi said.
"L.A. County Public Health Department is one of the most sophisticated, and one of the most robust health departments in the country," Levi said. "You are losing access to just a wide, wide range of both expertise and services that will never be replicable at the local level. Never."
"The public will be hurt in ways that are not instantly measurable," he added.
The most recent major private-sector takeover of public health was a flop. A private nonprofit, the Institute for Population Health, took over Detroit's public health functions in 2012 as the city was approaching bankruptcy.
The experiment failed, leaving a private entity unable to properly oversee public funding and public health concerns placed on the back burner amid the city's economic woes. Residents also didn't have a say in where the money went, and the staff on the city's side was stripped down and couldn't properly monitor the nonprofit's use of the funds. By 2015, most services transferred back to the city as Detroit emerged from bankruptcy in 2014.
"That private institute thought it was going to issue governmental orders until it was informed it had no power," said Denise Chrysler, who directs the Network for Public Health Law's Mid-States Region at the University of Michigan School of Public Health.
In Colorado, Tri-County's deputy director, Jennifer Ludwig, expressed concerns about Douglas County creating non-COVID programs essential to the functioning of a public health department.
"We have programs and services that many single-county health departments are not able to do just because of the resources that we can tap into," Ludwig said. "Building that from scratch is a huge feat and will take many, many, many years."
There are also practical benefits. A larger health department, according to Ludwig, is more competitive in securing grant funding, can attract and retain high-quality expertise like a data team, and can buy supplies in bulk.
But West Covina's Wu accepts that the city will not be able to build its department overnight. "You have to start small," he said.
Douglas County and West Covina face another key snag: hiring amid a national public health worker shortage. Douglas County officials say they are conducting a national search for an executive director who will determine the new health department's staffing needs.
The drug industry, patient advocates, and congressional Republicans have all attacked federal officials' decision to decline routine Medicare coverage for a controversial Alzheimer's drug. They've gone as far as to accuse them of tacit racism, ageism, and discrimination against the disabled — and hinted at a lawsuit — over the decision to pay only for patients taking the drug in a clinical trial.
The drug, Aduhelm, with a listed price tag of $28,500 a year, has had few takers in the medical world. Brain doctors are leery of administering the intravenous drug because it appears dangerous and largely ineffective. Many of the nation's most prestigious hospitals — such as the Cleveland Clinic, Johns Hopkins Hospital, and Massachusetts General in Boston — have declined to offer it to patients.
While groups representing the pharmaceutical industry and patients press to undo Medicare's decision, industry critics applaud the Centers for Medicare & Medicaid Services for throwing obstacles in the way of a drug they think the FDA should never have approved in the first place.
For the industry, the campaign has a broader existential target: to prevent CMS from using its payment decisions to keep FDA-approved drugs off the market. In recent years, FDA programs to speed approval of new drugs have led to a rash of entries with often minimal scientifically sound evidence to prove they work, critics say.
The FDA's own expert panel recommended against approving Aduhelm for that reason. Last June, the agency approved it anyway.
CMS then announced Medicare would pay only when the drug was used in further clinical trials to assess its true benefit. That Jan. 11 announcement has drawn more than 9,000 comments to the agency's website — a tsunami compared with most approval decisions. The remarks are roughly divided among pros and cons, and many appear to be organized by groups on the pro side of the debate (such as the Alzheimer's Association) or those opposed (such as the nonprofit More Perfect Union). The agency could change or even reverse its decision, though experts believe the latter is unlikely.
"If the FDA were doing its job, CMS wouldn't have had to step in. But good for the CMS, they are helping to protect the public from drugs whose harms outweigh benefits," said Dr. Adriane Fugh-Berman, a Georgetown University professor of pharmacology who directs PharmedOut, a group that publicizes what it sees as poor industry practices.
Aduhelm is the first FDA approval for a class of laboratory-made antibodies designed to clear away so-called amyloid plaques, which gradually accumulate in the brains of people with Alzheimer's disease.
In clinical trials, Aduhelm did well dissolving the plaques, but its impact on the functioning of patients in earlier stages of Alzheimer's was so meager that an expert panel voted 10-0 (an 11th panelist was uncertain) in November 2020 to advise FDA to reject it. The science is unclear about whether the presence of such plaques — a so-called surrogate marker — correlates with the mental functioning of patients.
As such, the FDA gave "provisional approval" to Biogen, the maker of Aduhelm, allowing it nine years to provide evidence that the drug slows the progression of Alzheimer's. In that period, Biogen would make far more money than if the application had been rejected. Even under the CMS decision, it would reap Medicare payments from whatever is used in clinical trials, which would need to include thousands of participants to assess the drug's performance.
Drug companies and pharma investors have responded to CMS' ruling with special alarm because they have spent decades improving their relationships with the FDA, only to have CMS seemingly pull the rug out by exerting its own power over an expensive drug.
"The drug companies are worried that this could be a precedent for other drugs. And it should be," Fugh-Berman said. "This isn't just about money; it's about protecting the public."
This "accelerated approval" employed for Aduhelm got its start in 1992 and is aimed at moving promising new classes of drugs to the public faster. Companies whose drugs go through the process — more than 250 drugs or vaccines have been approved so far — are supposed to quickly gather evidence that the products likely improve health once they're on the market. But such follow-up studies often lag or are never performed. For example, the makers of the Duchenne muscular dystrophy drug eteplirsen, approved in 2016, didn't start recruiting patients into a post-marketing trial until 2020 and don't expect results until 2026.
Biogen originally said it would get confirmatory results for Aduhelm within seven years of approval. In response to the Medicare decision, it promised to trim that to four years. The company also hinted that it might sue the agency, calling its decision "arbitrary and capricious."
In the meantime, patients eager to get access to the drug are furious about the coverage decision. Jim Taylor, a New Yorker whose wife, Geri, says she improved on Aduhelm during a clinical trial, said Medicare had made an "unconscionable decision" that puts Alzheimer's patients "on a dark roller coaster."
Many patients' groups are organized or at least funded and fueled by drugmakers, providing sympathetic stories that buttress a manufacturer's commercial interests. Advocacy groups also receive large donations from the makers of certain drugs. A 2020 report by UsAgainstAlzheimer's shows at least $900,000 in donations from monoclonal antibody producers. The Alzheimer's Association's top corporate donors — Biogen, Lilly, Eisai, and Genentech — all have monoclonal antibody candidates and have provided the group $1.6 million in fiscal year 2021.
These donations are a tiny part of the group's funding, its policy director, Robert Egge, told KHN, and any alignment of its position with industry is "coincidental, because of what we and our constituents believe is right."
The Taylors appeared at an online news event with activists from UsAgainstAlzheimer's and the National Minority Quality Forum, a group focused on health inequities, who argued that the decision discriminated against Black and Hispanic patients, who are more likely to suffer from Alzheimer's and less likely to join clinical trials. In fact, CMS demanded that evidence for Aduhelm be collected more extensively from minority patients. Biogen's two major trials of the drug included only 19 Black patients out of a total of 3,285.
Groups representing people with Down syndrome wrote more than 1,000 letters to CMS because its decision requires that confirmatory trials exclude people who have additional neurological conditions. Rep. Cathy McMorris Rodgers, a top drug industry cash recipient and the leading Republican on the House Energy and Commerce Committee with significant sway over pharma issues, said at a hearing last week that it was "extremely concerning and unacceptable" that Down syndrome patients would be ineligible.
But neither Biogen nor any other drug company has recruited Down syndrome patients for a major trial of a monoclonal antibody treatment. AC Immune, a Swiss company, conducted a safety study last year on 16 people with Down syndrome.
It's not surprising that groups representing those suffering from Alzheimer's placed high hopes on the monoclonal antibody drugs, which have seemed like a ray in the darkness for the estimated 2 million Americans with early Alzheimer's symptoms.
When asked why his group is so gung-ho about a product in which the medical profession shows such little confidence, Egge said the drug seems to have some benefits and that its risks — especially to patients who lack other means to slow a miserable, deadly disease — may be exaggerated. He acknowledged that 40% of patients in the biggest Aduhelm trial experienced brain swelling or bleeding, but Biogen's research showed these resolved with no apparent harm in most cases.
That said, the sluggish purchases of the drug — which earned a modest $1 million in the last quarter of 2021 — signal the market is responding to its deficiencies.
In response to the lackluster response, Biogen halved its initial $56,000 price to $28,500. If CMS had granted full approval, that would have been followed by "marketing, marketing, marketing," said Dr. Joseph Ross, a public health professor at Yale University. Hospitals that wanted to attract patient business for a lucrative infusion — patients receiving the drug also require brain scans and other tests and monitoring — could advertise their willingness to give Aduhelm.
The agency's decision "is a little inelegant" because it puts the brakes on an FDA approval, said former CMS chief medical officer Dr. Sean Tunis, now a consultant and senior fellow at Tufts Medical Center, but "it seems completely justifiable since the evidence of benefit is pretty weak and the evidence of harm is pretty strong."
Before any Tennessee physicians could be reprimanded for spreading falsehoods about COVID-19 vaccines or treatments, Republican lawmakers threatened to disband the medical board.
This article was published on Tuesday, February 15, 2022 inKaiser Health News.
Tennessee's Board of Medical Examiners unanimously adopted in September a statement that said doctors spreading COVID misinformation — such as suggesting that vaccines contain microchips — could jeopardize their license to practice.
"I'm very glad that we're taking this step," Dr. Stephen Loyd, the panel's vice president, said at the time. "If you're spreading this willful misinformation, for me it's going to be really hard to do anything other than put you on probation or take your license for a year. There has to be a message sent for this. It's not OK."
The board's statement was posted on a government website.
But before any physicians could be reprimanded for spreading falsehoods about COVID-19 vaccines or treatments, Republican lawmakers threatened to disband the medical board.
The growing tension in Tennessee between conservative lawmakers and the state's medical board may be the most prominent example in the country. But the Federation of State Medical Boards, which created the language adopted by at least 15 state boards, is tracking legislation introduced by Republicans in at least 14 states that would restrict a medical board's authority to discipline doctors for their advice on COVID.
Dr. Humayun Chaudhry, the federation's CEO, called it "an unwelcome trend." The nonprofit association, based in Euless, Texas, says the statement is merely a COVID-specific restatement of an existing rule: that doctors who engage in behavior that puts patients at risk could face disciplinary action.
Although doctors have leeway to decide which treatments to provide, the medical boards that oversee them have broad authority over licensing. Often, doctors are investigated for violating guidelines on prescribing high-powered drugs. But physicians are sometimes punished for other "unprofessional conduct." In 2013, Tennessee's board fined U.S. Rep. Scott DesJarlais for separately having sexual relations with two female patients more than a decade earlier.
Still, stopping doctors from sharing unsound medical advice has proved challenging. Even defining misinformation has been difficult. And during the pandemic, resistance from some state legislatures is complicating the effort.
A relatively small group of physicians peddle COVID misinformation, but many of them associate with America's Frontline Doctors. Its founder, Dr. Simone Gold, has claimed patients are dying from COVID treatments, not the virus itself. Dr. Sherri Tenpenny said in a legislative hearing in Ohio that the COVID vaccine could magnetize patients. Dr. Stella Immanuel has pushed hydroxychloroquine as a COVID cure in Texas, although clinical trials showed that it had no benefit. None of them agreed to requests for comment.
The Texas Medical Board fined Immanuel $500 for not informing a patient of the risks associated with using hydroxychloroquine as an off-label COVID treatment.
In Tennessee, state lawmakers called a special legislative session in October to address COVID restrictions, and Republican Gov. Bill Lee signed a sweeping package of bills that push back against pandemic rules. One included language directed at the medical board's recent COVID policy statement, making it more difficult for the panel to investigate complaints about physicians' advice on COVID vaccines or treatments.
In November, Republican state Rep. John Ragan sent the medical board a letter demanding that the statement be deleted from the state's website. Ragan leads a legislative panel that had raised the prospect of defunding the state's health department over its promotion of COVID vaccines to teens.
Among his demands, Ragan listed 20 questions he wanted the medical board to answer in writing, including why the misinformation "policy" was proposed nearly two years into the pandemic, which scholars would determine what constitutes misinformation, and how was the "policy" not an infringement on the doctor-patient relationship.
"If you fail to act promptly, your organization will be required to appear before the Joint Government Operations Committee to explain your inaction," Ragan wrote in the letter, obtained by KHN and Nashville Public Radio.
In response to a request for comment, Ragan said that "any executive agency, including Board of Medical Examiners, that refuses to follow the law is subject to dissolution."
He set a deadline of Dec. 7.
In Florida, a Republican-sponsored bill making its way through the state legislature proposes to ban medical boards from revoking or threatening to revoke doctors' licenses for what they say unless "direct physical harm" of a patient occurred. If the publicized complaint can't be proved, the board could owe a doctor up to $1.5 million in damages.
Although Florida's medical board has not adopted the Federation of State Medical Boards' COVID misinformation statement, the panel has considered misinformation complaints against physicians, including the state's surgeon general, Dr. Joseph Ladapo.
Chaudhry said he's surprised just how many COVID-related complaints are being filed across the country. Often, boards do not publicize investigations before a violation of ethics or standards is confirmed. But in response to a survey by the federation in late 2021, two-thirds of state boards reported an increase in misinformation complaints. And the federation said 12 boards had taken action against a licensed physician.
"At the end of the day, if a physician who is licensed engages in activity that causes harm, the state medical boards are the ones that historically have been set up to look into the situation and make a judgment about what happened or didn't happen," Chaudhry said. "And if you start to chip away at that, it becomes a slippery slope."
The Georgia Composite Medical Board adopted a version of the federation's misinformation guidance in early November and has been receiving 10 to 20 complaints each month, said Dr. Debi Dalton, the chairperson. Two months in, no one had been sanctioned.
Dalton said that even putting out a misinformation policy leaves some "gray" area. Generally, physicians are expected to follow the "consensus," rather than "the newest information that pops up on social media," she said.
"We expect physicians to think ethically, professionally, and with the safety of patients in mind," Dalton said.
A few physician groups are resisting attempts to root out misinformation, including the Association of American Physicians and Surgeons, known for its stands against government regulation.
Some medical boards have opted against taking a public stand against misinformation.
The Alabama Board of Medical Examiners discussed signing on to the federation's statement, according to the minutes from an October meeting. But after debating the potential legal ramifications in a private executive session, the board opted not to act.
In Tennessee, the Board of Medical Examiners met on the day Ragan had set as the deadline and voted to remove the misinformation statement from its website to avoid being called into a legislative hearing. But then, in late January, the board decided to stick with the policy — although it did not republish the statement online immediately — and more specifically defined misinformation, calling it "content that is false, inaccurate or misleading, even if spread unintentionally."
Board members acknowledged they would likely get more pushback from lawmakers but said they wanted to protect their profession from interference.
"Doctors who are putting forth good evidence-based medicine deserve the protection of this board so they can actually say, 'Hey, I'm in line with this guideline, and this is a source of truth,'" said Dr. Melanie Blake, the board's president. "We should be a source of truth."
The medical board was looking into nearly 30 open complaints related to COVID when its misinformation statement came down from its website. As of early February, no Tennessee physician had faced disciplinary action.
The four free COVID-19 rapid tests President Joe Biden promised in December for every American household have begun arriving in earnest in mailboxes and on doorsteps.
A surge of COVID infections spurred wide demand for over-the-counter antigen tests during the holidays: Clinics were overwhelmed with people seeking tests and the few off-the-shelf brands were nearly impossible to find at pharmacies or even online via Amazon. Prices for some test kits cracked the hundred-dollar mark. And the government vowed that its purchase could provide the tests faster and cheaper so people, by simply swabbing at home, could quell the spread of COVID.
The Defense Department organized the bidding and announced in mid-January, after a limited competitive process, that three companies were awarded contracts totaling nearly $2 billion for 380 million over-the-counter antigen tests, all to be delivered by March 14.
The much-touted purchase was the latest tranche in trillions of dollars in public spending in response to the pandemic. How much is the government paying for each test? And what were the terms of the agreements? The government won't yet say, even though, by law, this information should be available.
The cost — and, more importantly, the rate per test — would help demonstrate who is getting the best deal for protection in these COVID times: the consumer or the corporation.
The reluctance to share pricing details flies against basic notions of cost control and accountability — and that's just quoting from a long-held position by the Justice Department. "The prices in government contracts should not be secret," according to its website. "Government contracts are 'public contracts,' and the taxpayers have a right to know — with very few exceptions —what the government has agreed to buy and at what prices."
Americans often pay far more than people in other developed countries for tests, drugs, and medical devices, and the pandemic has accentuated those differences. Governments abroad had been buying rapid tests in bulk for over a year, and many national health services distributed free or low-cost tests, for less than $1, to their residents. In the U.S., retailers, companies, schools, hospitals, and everyday shoppers were competing months later to buy swabs in hopes of returning to normalcy. The retail price climbed as high as $25 for a single test in some pharmacies; tales abounded of corporate and wealthy customers hoarding tests for work or holiday use.
"We don't know why that data isn't showing up in the FPDS database, as it should be visible and searchable. Army Contracting Command is looking into the issue and working to remedy it as quickly as possible," spokesperson Jessica R. Maxwell said in an email in January. This month, she declined to provide more information about the contracts and referred all questions about the pricing to the Department of Health and Human Services.
Only vague information is available in DOD press releases, dated Jan. 13 and Jan. 14, that note the overall awards in the fixed-price contracts: iHealth Labs for $1.275 billion, Roche Diagnostics for $340 million, and Abbott Rapid Dx North America for $306 million. There were no specifics regarding contract standards or terms of completion — including how many test kits would be provided by each company.
Without knowing the price or how many tests each company agreed to supply, it is impossible to determine whether the U.S. government overpaid or to calculate if more tests could have been provided faster. As variants of the deadly virus continue to emerge, it is unclear if the government will re-up these contracts and under what terms.
To put forth a bid to fill an "urgent" national need, companies had to provide answers to the Defense Department by Dec. 24 about their capacity to scale up manufacturing to produce 500,000 or more tests a week in three months. Among the questions: Had a company already been granted "emergency use authorization" for the test kits, and did a company have "fully manufactured unallocated stock on hand to ship within two weeks of a contract award?"
Based on responses from about 60 companies, the Defense Department said it sent "requests for proposals" directly to the manufacturers. Twenty companies bid. Defense would not release the names of interested companies.
Emails to the three chosen companies to query the terms of the contracts went unanswered by iHealth and Abbott. Roche spokesperson Michelle A. Johnson responded in an email that she was "unable to provide that information to you. We do not share customer contract information." The customers — listed as the Defense Department and the Army command — did not provide answers about the contract terms.
The Army's Contracting Command, based in Alabama, initially could not be reached to answer questions. An email address on the command's website for media bounced back as out-of-date. Six phone numbers listed on the command's website for public information were unmanned in late January. At the command's protocol office, the person who answered a phone in late January referred all queries to the Aberdeen Proving Ground offices in Maryland.
"Unfortunately, there is an issue with voicemail," said Ralph Williams, a representative of the protocol office. "Voicemail is down. I mean, voicemail has been down for months."
Asked about the bounced email traffic, Williams said he was surprised the address — acc.pao@us.army.mil — was listed on the ACC website. "I'm not sure when that email was last used," he said. "The army stopped using the email address about eight years ago."
Williams provided a direct phone number for Aberdeen and apologized for the confusion. "People should have their phone forwarded," he said. "But I can only do what I can do."
Joyce Cobb, an Army Contracting Command-Aberdeen Proving Ground spokesperson, reached via phone and email, referred all questions to Defense personnel. Maxwell referred more detailed questions about the contracts to HHS, and emails to HHS went unanswered.
Both the Defense and Army spokespeople, after several emails, said the contracts would have to be reviewed, citing the Freedom of Information Act that protects privacy, before release. Neither explained how knowing the price per test could be a privacy or proprietary concern.
A Defense spokesperson added that the contracts had been fast-tracked "due to the urgent and compelling need" for antigen tests. Defense obtained "approval from the Assistant Secretary of the Army for Acquisition, Logistics, & Technology to contract without providing for full and open competition."
KHN separately searched for the contracts on the sam.gov website during a phone call with a government representative who assisted with the search. During an extended phone session, the representative called in a supervisor. Neither could locate the contracts, which are updated twice a week. The representative wondered whether the numbers listed in the Defense press release were wrong and offered: "You might want to double-check that."
On Jan. 25, Defense spokesperson Maxwell, in an email, said that the Army Contracting Command "is working to prepare these contracts for public release and part of that includes proactively readying the contracts for the FOIA redaction." Three days later, she sent an email stating that "under the limited competition authority … DOD was not required to make the Request for Proposal (RFP) available to the public."
Maxwell did not respond when KHN pointed out that the contracting provision she cited does not prohibit the release of such information. In a Feb. 2 email, Maxwell said "we have nothing further to provide at this time."
On sam.gov, the COVID spreadsheets include a disclaimer that "due to the tempo of operations" in the pandemic response, the database shows only "a portion of the work that has been awarded to date."
In other words, it could not vouch for the timeliness or accuracy of its own database.
With studies showing that the fees led to fewer low-income adults signing up for coverage and fewer reenrolling, the Biden administration is moving to eliminate them.
This article was published on Thursday, February 10, 2022 in Kaiser Health News.
When Republican-led states balked at expanding Medicaid under the Affordable Care Act, President Barack Obama's administration tossed them a carrot — allowing several to charge monthly premiums to newly eligible enrollees.
Republicans pushed for the fees to give Medicaid recipients "skin in the game" — the idea they would value their coverage more — and to make the government program resemble employer-based insurance.
It will force Arkansas and Montana to phase out premiums by the end of 2022. Federal health officials have indicated they may do the same in six other states allowed to charge premiums — Arizona, Georgia, Indiana, Iowa, Michigan, and Wisconsin.
The policy flip is one of several moves the administration has made to change how states run their Medicaid programs, and it provides a stark example of how Medicaid changes depending on who has control of the White House and state capitols.
Medicaid, which has about 83 million enrollees, is a state-federal partnership that provides health coverage to people with low incomes. Washington is responsible for most of the funding and states handle operations. For decades, states have complained that the federal government sets too many rules and doesn't respond quickly enough when states want to make changes through a wide variety of waivers to improve care or control costs.
But in recent months, the power struggle has intensified around the waivers that states seek from those federal rules so they can test new approaches for delivering health services. Waivers have become an integral part of the Medicaid program, and some states have renewed theirs to last for decades.
With spending on Medicaid waivers now making up about a third of federal spending on the program, they've become a lightning rod for disputes between states and the federal government.
Such conflicts are not new, said Matthew Lawrence, an associate professor at Emory University's law school. But lately "the level of conflict is unprecedented."
"The conflicts are more consequential because there is so much more money on the table," said Josh Archambault, a senior fellow with the conservative Cicero Institute, a Texas-based think tank.
At stake for states is not merely retaining authority on how to run their Medicaid program, but often billions of dollars in federal funding. Because securing a waiver can often take years, states are dismayed the Biden administration is trying to withdraw previously approved ones before they are up for renewal, Archambault said.
Both Georgia and Texas have sued the Biden administration for revoking part of their waivers approved in the waning days of President Donald Trump's administration. The changes sought be each state varied widely.
Neither of these Republican-led states has expanded Medicaid to cover all adults with annual incomes under 138% of the federal poverty level, about $18,800, as 38 other states have done.
Georgia sued the Biden administration in January after the Centers for Medicare & Medicaid Services rejected key parts of its waiver — approved in October 2020 but never implemented by the state as it awaited a review by the Biden administration.
These provisions would have required newly eligible enrollees to pay a monthly premium and work or volunteer as part of a plan to modestly increase enrollment.
The lawsuit says the decision by CMS was an illegal and arbitrary "bait and switch of unprecedented magnitude."
The Texas lawsuit filed in May stems from the Biden administration's reversal of a 10-year waiver extension approved five days before Joe Biden was sworn in as president. That waiver allowed the Texas Medicaid program to reimburse hospitals for treating uninsured patients and included $30 billion in federal aid. The Biden administration said Texas did not appropriately seek public comments and the move was seen as a way to nudge Texas toward expanding Medicaid. A federal district judge in August sided with Texas and issued a temporary injunction.
In another example of reversing Trump's policies, CMS last year told Michigan, Wisconsin, Arkansas, and New Hampshire, which had previously received approval for work requirements for newly eligible adults, that the federal government was withdrawing that green light. The change, however, had little practical effect since the work requirements had been put on hold by federal courts.
Advocacy groups say Medicaid enrollees are caught in the middle of these political battles.
Laura Colbert, executive director of the consumer advocacy group Georgians for a Healthy Future, said the lawsuit brought by the governor and state attorney general is a waste of time and taxpayer dollars. "Federal courts have repeatedly struck down work requirements for Medicaid-eligible adults because work requirements ultimately act as a barrier to health coverage and care," she said.
Typically, CMS reserves the right to terminate or rescind a waiver as long as its decision is not considered "arbitrary or unreasonable," said MaryBeth Musumeci, associate director of KFF's Program on Medicaid and the Uninsured.
In the Texas case, in fact, the federal court said CMS was arbitrary and unreasonable in revoking the state's Medicaid waiver.
Brian Blase, a former Trump health adviser and president of Paragon Health Institute, a research firm, said having so much of the Medicaid program run through waivers is problematic because states are seldom held accountable for how the waivers work and that the program changes depending on which party is in power in Washington.
"States get whipsawed back and forth under the current structure of Medicaid," he said.
Blase and other conservatives want Congress to give states a defined amount of money — a block grant — for Medicaid each year and let states manage it as they see fit. Democrats have fought such proposals, saying they would limit how much money states have to help the poor, especially during difficult economic times.
The proposal to fund Medicaid through block grants is at the center of another simmering waiver feud. The Trump administration in its final days approved a new financing plan for Tennessee that would convert the state's federal Medicaid funding into a type of block grant. The Biden administration reopened the public comment period last summer. Nearly all of the 3,000 letters submitted opposed the plan.
Blase said that some Republican states expanded Medicaid only because they were allowed to implement it with work requirements and premiums. Taking away those provisions, he said, "is an affront to those states and will discourage other states from adopting the expansion."
But it's unlikely Republican-led states would turn away from the expansions they've implemented because it's politically difficult to kick people off the program.
Democrats have long opposed Medicaid premiums, so it's no surprise the Biden administration is moving away from them now that it has data to show their negative impact.
A 2021 study in Michigan found that the number of adults dropping out of Medicaid increased by nearly 12% after the state began charging them a monthly premium, which now averages about $18 a month. Disenrollment rose by nearly 1 percentage point for every dollar charged monthly, the study found.
States needed waivers because federal law prohibits charging premiums to most Medicaid enrollees.
Katharine Bradley, a senior researcher at Mathematica who recently helped evaluate premium policies in several Medicaid programs for CMS, said premiums as low as $1 a month act as a deterrent to signing up, she said.
"All the evidence points in the same direction — that premiums inhibit overall enrollment," Bradley said.
Michigan — like other states with premiums — stopped enforcing the provision during the pandemic. But even before the national health emergency, Michigan enrollees faced few consequences for not paying. If people did not pay, the state would deduct the amount from their state tax refund or any lottery winnings.
By contrast, before the pandemic, states such as Indiana, Iowa, and Montana disenrolled thousands of Medicaid enrollees who did not pay.
When asked late last year if CMS would eliminate premiums in all Medicaid waivers, CMS Administrator Chiquita Brooks-LaSure said: "We want our programs to be consistent."