Tag: Health Industry

March 23, 2023

Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

Sen. Bernie Sanders, who rose to national prominence criticizing big business in general and the pharmaceutical industry in particular, claimed the spotlight Wednesday on what might at first seem a powerful new stage from which to advance his agenda: chairmanship of the Senate health committee.

But the hearing Sanders used to excoriate a billionaire pharmaceutical executive for raising the price of a covid-19 vaccine showed the challenges the Vermont independent faces.

Though its formal name is the Committee on Health, Education, Labor, and Pensions (HELP), the panel Sanders chairs has little if any authority over drug prices. In the Senate, most of that leverage lies with the Finance Committee, which oversees Medicaid, Medicare, and Obamacare.

As far as drug prices go, the platform Sanders commands is essentially a bully pulpit. So Sanders was left to bully his way toward results. And while some committee Republicans sympathized with his complaints, others bristled at his approach.

By the end of the hearing, seeming to acknowledge the limits of his power, the former presidential candidate was pleading with Moderna chief executive Stéphane Bancel for a relatively modest concession on vaccine pricing.

The CEO made no promises. Then again, pulpit proclamations can lead to corporate action, even if delayed and informal; in the weeks following President Joe Biden’s State of the Union call for cheaper insulin, the companies that make it drastically cut their prices.

Sanders began Wednesday’s hearing with his usual fire and brimstone.

“All over this country people are getting sicker, and in some cases dying, because they can’t afford the outrageous cost of prescription drugs, while companies make huge profits and executives become billionaires,” Sanders thundered.

Bancel had won his place in the witness chair with federal assistance. Moderna, which was founded in 2010 and had not brought a drug to market before the pandemic, received billions in government funds for research, guaranteed purchases, and expert advice to help develop and produce its successful covid vaccine. The payoff has been handsome. As of March 8, Bancel held $3 billion in Moderna stock. He also held options to buy millions of additional shares.

Government research and support are foundational to many of the expensive drugs and vaccines in use today. But Bancel made himself the perfect foil for Sanders when he announced in January that Moderna planned to increase the price of its latest covid shot from about $26 to $110 — or as much as $130.

Denouncing greed, Sanders expounded on his dream of a system in which the government fully funds drug development — and in exchange controls drug prices. “Is there another model out there where, when a lifesaving drug is made, it becomes accessible to all those who need it?” he asked. “What am I missing in thinking that it’s cruel to make a medicine that people can’t afford?’”

Sanders’ overt moralizing and harsh attacks on big business make him an outlier in the Senate, even in his own party. Yet distaste for soaring drug prices extends across the aisle. On the HELP Committee, at least, Republican politicians seem about evenly split between populist and pro-business takes on the problem, showing both the possibilities and the pitfalls that Sanders faces.

Sen. Mike Braun (R-Ind.) expressed disgust with the lack of transparency in the health care system and called Moderna’s planned price hike “preposterous.” Sen. Roger Marshall (R-Kan.) called it “outrageous.”

Sen. Rand Paul (R-Ky.), who often bucks mainstream GOP views and has expressed rancor for the biomedical establishment, claimed Bancel was downplaying vaccine injuries to make money. (Paul vastly exaggerated those risks.)

Ranking member Bill Cassidy (R-La.), who has pledged to work with Sanders, responded to the chairman’s opening remarks with both a hedge and a warning. “I’m not defending salaries or profits,” Cassidy said, but he added that he hoped the hearing’s goal wasn’t to “demonize capitalism.”

Only Sen. Mitt Romney (R-Utah), a former private equity executive, came heartily to Bancel’s defense. “If I’m an investor, I have to expect that if a product I’m backing works, I get to make an awful lot of money,” he said. “I’ve heard people say, ‘That’s corporate greed.’ Yeah, that’s how it works.”

Sanders’ idealized vision of the pharmaceutical industry is, in any case, moot. Even the Biden administration, which successfully browbeat insulin makers into drastically lowering prices in March, revealed this week it would not use “march-in” rights to lower the price of a cancer drug, Xtandi, developed with government-licensed patents.

March-in rights were established in the 1980 Bayh-Dole Act, which enabled companies to license federally funded research and use it to develop drugs. But federal courts and administrations have consistently said the government can seize a product only if the license holder has failed to make it available — not because the price is too high. The administration did, however, announce a review of whether price might be considered in future march-in decisions.

Sanders said before the hearing that he was “extremely disappointed” with the Xtandi decision. But he was ultimately realist enough to aim his bully pulpit at a lower target. Late in Wednesday’s hearing, Sanders pushed for a minimal gimme from Moderna. “Will you reconsider your decision to quadruple the price of your vaccine to the U.S. government and its agents?” he asked politely.

Bancel dodged, saying pricing was more complex now that Moderna faced an uncertain market, had to fill separate syringes with its vaccine, and needed to sell and distribute the vaccine to thousands of pharmacies, where previously the government did all that work. Later, he left open the possibility that negotiations could drive down the price paid by some government agencies or private insurers.

For all the theatrics of such hearings and the mix of opinions among the senators, interrogations of figures like Bancel may help inspire a shift in how the National Institutes of Health “does business in giving away its science to the private sector,” said Tahir Amin, co-executive director of I-MAK, a nonprofit that advocates for equitable access to medicines.

“You have to prosecute it so you at least get these public comments on record,” Amin said. Eventually, he said, this type of hearing could lead to a recognition that, ‘Hey, we need to do this.’”

Despite the HELP Committee’s lack of direct jurisdiction over drug prices, said John McDonough, a Harvard professor who was senior adviser for health reform on the HELP Committee from 2008 to 2010, Sanders “uses his position of authority and influence to draw attention to this in a way that has been helpful.”

KHN correspondent Rachana Pradhan contributed to this report.

March 23, 2023

Legal Questions, Inquiries Intensify Around Noble Health’s Rural Missouri Hospital Closures

A year after private equity-backed Noble Health shuttered two rural Missouri hospitals, patients and former employees grapple with a broken local health system or missing out on millions in unpaid wages and benefits.

The hospitals in Audrain and Callaway counties remain closed as a slew of lawsuits and state and federal investigations grind forward.

In March, Missouri Attorney General Andrew Bailey confirmed a civil investigation. He had previously told local talk radio that there was an “ongoing” investigation into “the hospital issue.”

Bailey’s comment came weeks after the U.S. Department of Labor’s Employee Benefits Security Administration notified executives tied to Noble Health, a startup, that they had violated federal laws and asked them to pay $5.4 million to cover unpaid employee health insurance claims, according to a 13-page letter detailing “interim findings” that was obtained by KHN.

The January letter confirms KHN’s previous reporting, which was informed by employees and patients who described missing paychecks; receiving unexpected, high-dollar medical bills; and going without care, including cancer treatment. According to the letter from federal investigators, the Noble hospitals and their corporate owners collected employee contributions for medical, dental, and vision insurance in 2021 and 2022 but then failed to fund the insurance plans.

The owners and executives were “aware of the harm to participants and, in some cases, were attempting to resolve individual participant complaints,” the letter states, adding that “despite the volume and gravity of complaints and bills received,” they failed to respond.

A photo of a two-year-old boy with spina bifida in a walker. — Ryder Hagedorn was born with spina bifida. His parents have struggled to pay for specialty care since claims were denied by a health plan his mother, Marissa, was offered through her employer. She is one of several former employees of Noble Health who say they were left with substantial medical bills after the company shuttered its two rural Missouri hospitals.(Marissa Hagedorn)

‘Tomfoolery’ and Doing ‘Everybody Dirty’

Marissa Hagedorn, who worked as a hospital laboratory technician, has spent much of the past year starting a new job, caring for her 2-year-old son who was born with spina bifida, and haggling over unpaid medical bills. She told KHN the family owes at least $8,000 for son Ryder’s specialty care in St. Louis, with $6,000 of that in collections. As a Noble employee, Hagedorn said, she was told repeatedly that her employee health insurance would cover Ryder’s care. It didn’t.

Noble has “done everybody dirty,” she said. “We just would like for some responsibility to be taken by this company that didn’t feel the need to get their act together.” Hagedorn’s story of unpaid bills, which was first reported by the local newspaper, the Mexico Ledger, is common among former Noble employees a year after the hospitals closed.

A former employee of the Fulton hospital has filed a class-action lawsuit intended to represent hundreds of employees from both hospitals.

The Jan. 13 letter from federal officials called for responses by Jan. 27 from Noble corporate and hospital executives as well as Platinum Neighbors, which last April bought the hospitals and assumed all liabilities. The letter instructs executives to contact the agency “to discuss how you intend to correct these violations, fund participant claims, and achieve compliance.”

Former employees say their claims have not yet been paid. A Labor Department spokesperson, Grant Vaught, said the agency could not comment on an ongoing investigation.

Separately, the Kansas Department of Labor is reviewing Noble and Platinum’s failure to pay wages and severance to corporate employees. Agency spokesperson Becky Shaffer confirmed that hearings took place in early February on a half-dozen cases totaling more than $1 million in claims for unpaid wages and severance.

Dave Kitchens was among those who filed claims against Noble Health. Kitchens worked briefly as a contract employee and then was hired in October 2021 as a corporate controller, an accounting role in which he was responsible for financial reporting and data analytics. Kitchens provided an audio recording of his hearing to KHN and hopes to eventually get paid more than $90,000 in lost wages, benefits, and severance pay. During the hearing, Kitchens told the administrative judge: “I would just like to be paid what I’m owed.”

Kitchens, who is also named as a fiduciary on the federal investigation, said he was not on Noble’s executive team. When asked by Kansas Administrative Law Judge James Ward whether he expected Noble or the secondary buyer Platinum to pay his wages, Kitchens responded he had “no idea who was in charge.”

“I believe there was some tomfoolery,” Kitchens said.

A ‘Rabbit Hole’ of Responsibility

Noble launched in December 2019 with executives who had never run a hospital, including Donald R. Peterson, a co-founder who prior to joining Noble had been accused of Medicare fraud. Peterson settled that case without admitting wrongdoing and in August 2019 agreed to be excluded for five years from Medicare, Medicaid, and all other taxpayer-funded federal health programs, according to the Health and Human Services Office of Inspector General.

By March 2022, the hospitals had closed and Noble offered explanations on social media, including “a technology issue” and a need to “restructure their operations” to keep the hospitals financially viable. In April, Texas-based Platinum Neighbors paid $2 for the properties and all liabilities, according to the stock purchase agreement.

Despite receiving approval for nearly $20 million in federal covid-19 relief money before it closed the hospitals — funds whose use is still not fully accounted for — Noble had stopped paying its bills, according to court records. Contractors, including nursing agencies, a lab that ran covid tests and landscapers, have filed lawsuits seeking millions.

In Audrain County, where community members still hope to reopen the hospital or build a new one, county leaders filed suit for the repayment of a $1.8 million loan they made to Noble. Former Missouri state senator Jay Wasson also filed suit in September, asking for repayment of a $500,000 loan.

Two Noble Health real estate entities filed bankruptcy petitions this year. One Chapter 11 bankruptcy filing names the Fulton hospital property in Callaway County as an asset and lists nearly $4.9 million in liabilities. A third bankruptcy filing by FMC Clinic includes Noble Health as a codebtor.

In the U.S. District Court of Kansas, Central Bank of the Midwest is suing Nueterra Capital over a $9.6 million loan Noble used to buy the Audrain hospital. The bank alleges Nueterra, a private equity and venture capital firm that in 2022 included Noble as part of its portfolio, signed off as the guarantor of the loan.

Federal investigators listed nearly a dozen people or entities connected to Noble Health as fiduciaries who they say are personally responsible for paying back millions in unpaid medical claims. The letter also detailed Noble Health’s ownership for the first time. The owners included William A. Solomon with a 16.82% share, Thomas W. Carter with a 16.82% share, The Peterson Trust with a 19.63%, and NC Holdings Inc. with 46.72%.

NC Holdings is also listed on the stock sale agreement with Platinum along with several signatures including Jeremy Tasset, chief executive of Nueterra Capital.

Tasset did not respond to a request for comment for this article. In an email to KHN in March 2022, the Nueterra Capital CEO wrote, “We are a minority investor in the real estate and have nothing to do with the operations of the hospitals.” In May 2022, Tasset wrote in an email to KHN that “everything was sold (real estate included) to Platinum Neighbors, a subsidiary of Platinum Team Management.”

It is unclear who owns and controls The Peterson Trust, which federal investigators identified. Peterson, who is listed on Noble’s state registration papers as a director and in other roles, didn’t respond to requests for comment for this article. He previously told KHN that his involvement in Noble didn’t violate his exclusion, in his reading of the law.

He said he owned 3% of the company, citing guidance from the Office of Inspector General for the U.S. Department of Health and Human Services. Federal regulators may exclude companies if someone who is banned has ownership of 5% or more.

In March 2022, Peterson created Noble Health Services, which federal investigators note in their letter was “established to restructure the ownership of multiple Noble entities.” Peterson dissolved that company in July 2022, according to a Missouri business filing.

In September, Peterson posted on LinkedIn that he was “sitting in the Emirates Air lounge in Dubai” to finish up due diligence on “launching a new business.”

A 2013 OIG advisory states that “an excluded individual may not serve in an executive or leadership role” and “may not provide other types of administrative and management services … unless wholly unrelated to federal health care programs.”

KHN examined the federal system meant to stop health care business owners and executives from repeatedly bilking government health programs and found that it failed to do so.

The OIG keeps a public list of people and businesses it has banned from all federal health care programs, such as Medicare and Medicaid. KHN’s review found a system devoid of oversight and rife with legal gray areas.

In the wake of KHN’s reporting, Oregon Sen. Ron Wyden, a Democrat who is the chair of the powerful Senate Finance Committee, said “it’s imperative that federal watchdogs can ensure bad actors are kept out of Medicare.” Sen. Chuck Grassley (R-Iowa) said the government needs to do more and “it’s also up to private-sector entities to do a better job checking against the exclusions list.”

“We can’t just depend on one or the other to do everything,” Grassley said.

In recent months, the Missouri hospitals appear to have been sold twice more, according to public records. Oregon-based Saint Pio of Pietrelcina notified state officials of a change of ownership in December and requested an extension of the hospital licenses, which was denied. In January, Audrain County officials, in its lawsuit, revealed another owner named Pasture Medical, which registered as a Wyoming company on Dec. 27, 2022.

“We haven’t come out of the rabbit hole on this one,” said Steve Bollin, director of the division of regulation and licensure for the Missouri Department of Health and Senior Services. Bollin’s agency, which conducts inspections and approves hospital changes in ownership, said he would support his agency doing financial reviews.

“It’s probably not a bad idea that someone takes a little bit deeper dive. We don’t have that many changes of ownership, but we would need appropriate staffing to do that, including some really good CPAs [certified public accountants].”

March 22, 2023

End of Covid Emergency Will Usher in Changes Across the US Health System

The Biden administration’s decision to end the covid-19 public health emergency in May will institute sweeping changes across the health care system that go far beyond many people having to pay more for covid tests.

In response to the pandemic, the federal government in 2020 suspended many of its rules on how care is delivered. That transformed essentially every corner of American health care — from hospitals and nursing homes to public health and treatment for people recovering from addiction.

Now, as the government prepares to reverse some of those steps, here’s a glimpse at ways patients will be affected:

Training Rules for Nursing Home Staff Get Stricter

The end of the emergency means nursing homes will have to meet higher standards for training workers.

Advocates for nursing home residents are eager to see the old, tougher training requirements reinstated, but the industry says that move could worsen staffing shortages plaguing facilities nationwide.

In the early days of the pandemic, to help nursing homes function under the virus’s onslaught, the federal government relaxed training requirements. The Centers for Medicare & Medicaid Services instituted a national policy saying nursing homes needn’t follow regulations requiring nurse aides to undergo at least 75 hours of state-approved training. Normally, a nursing home couldn’t employ aides for more than four months unless they met those requirements.

Last year, CMS decided the relaxed training rules would no longer apply nationwide, but states and facilities could ask for permission to be held to the lower standards. As of March, 17 states had such exemptions, according to CMS — Georgia, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, and Washington — as did 356 individual nursing homes in Arizona, California, Delaware, Florida, Illinois, Iowa, Kansas, Kentucky, Michigan, Nebraska, New Hampshire, North Carolina, Ohio, Oregon, Virginia, Wisconsin, and Washington, D.C.

Nurse aides often provide the most direct and labor-intensive care for residents, including bathing and other hygiene-related tasks, feeding, monitoring vital signs, and keeping rooms clean. Research has shown that nursing homes with staffing instability maintain a lower quality of care.

Advocates for nursing home residents are pleased the training exceptions will end but fear that the quality of care could nevertheless deteriorate. That’s because CMS has signaled that, after the looser standards expire, some of the hours that nurse aides logged during the pandemic could count toward their 75 hours of required training. On-the-job experience, however, is not necessarily a sound substitute for the training workers missed, advocates argue.

Adequate training of aides is crucial so “they know what they’re doing before they provide care, for their own good as well as for the residents,” said Toby Edelman, a senior policy attorney for the Center for Medicare Advocacy.

The American Health Care Association, the largest nursing home lobbying group, released a December survey finding that roughly 4 in 5 facilities were dealing with moderate to high levels of staff shortages.

Treatment Threatened for People Recovering From Addiction

A looming rollback of broader access to buprenorphine, an important medication for people in recovery from opioid addiction, is alarming patients and doctors.

During the public health emergency, the Drug Enforcement Administration said providers could prescribe certain controlled substances virtually or over the phone without first conducting an in-person medical evaluation. One of those drugs, buprenorphine, is an opioid that can prevent debilitating withdrawal symptoms for people trying to recover from addiction to other opioids. Research has shown using it more than halves the risk of overdose.

Amid a national epidemic of opioid addiction, if the expanded policy for buprenorphine ends, “thousands of people are going to die,” said Ryan Hampton, an activist who is in recovery.

The DEA in late February proposed regulations that would partly roll back the prescribing of controlled substances through telemedicine. A clinician could use telemedicine to order an initial 30-day supply of medications such as buprenorphine, Ambien, Valium, and Xanax, but patients would need an in-person evaluation to get a refill.

For another group of drugs, including Adderall, Ritalin, and oxycodone, the DEA proposal would institute tighter controls. Patients seeking those medications would need to see a doctor in person for an initial prescription.

David Herzberg, a historian of drugs at the University at Buffalo, said the DEA’s approach reflects a fundamental challenge in developing drug policy: meeting the needs of people who rely on a drug that can be abused without making that drug too readily available to others.

The DEA, he added, is “clearly seriously wrestling with this problem.”

Hospitals Return to Normal, Somewhat

During the pandemic, CMS has tried to limit problems that could arise if there weren’t enough health care workers to treat patients — especially before there were covid vaccines when workers were at greater risk of getting sick.

For example, CMS allowed hospitals to make broader use of nurse practitioners and physician assistants when caring for Medicare patients. And new physicians not yet credentialed to work at a particular hospital — for example, because governing bodies lacked time to conduct their reviews — could nonetheless practice there.

Other changes during the public health emergency were meant to shore up hospital capacity. Critical access hospitals, small hospitals located in rural areas, didn’t have to comply with federal rules for Medicare stating they were limited to 25 inpatient beds and patients’ stays could not exceed 96 hours, on average.

Once the emergency ends, those exceptions will disappear.

Hospitals are trying to persuade federal officials to maintain multiple covid-era policies beyond the emergency or work with Congress to change the law.

Surveillance of Infectious Diseases Splinters

The way state and local public health departments monitor the spread of disease will change after the emergency ends, because the Department of Health and Human Services won’t be able to require labs to report covid testing data.

Without a uniform, federal requirement, how states and counties track the spread of the coronavirus will vary. In addition, though hospitals will still provide covid data to the federal government, they may do so less frequently.

Public health departments are still getting their arms around the scope of the changes, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

In some ways, the end of the emergency provides public health officials an opportunity to rethink covid surveillance. Compared with the pandemic’s early days, when at-home tests were unavailable and people relied heavily on labs to determine whether they were infected, testing data from labs now reveals less about how the virus is spreading.

Public health officials don’t think “getting all test results from all lab tests is potentially the right strategy anymore,” Hamilton said. Flu surveillance provides a potential alternative model: For influenza, public health departments seek test results from a sampling of labs.

“We’re still trying to work out what’s the best, consistent strategy. And I don’t think we have that yet,” Hamilton said.

March 21, 2023

Mental Health Care by Video Fills Gaps in Rural Nursing Homes

KNOXVILLE, Iowa ― Bette Helm was glad to have someone to talk with about her insomnia.

Helm lives in a nursing home in this central Iowa town of about 7,500 people, where mental health services are sparse. On a recent morning, she had an appointment with a psychiatric nurse practitioner about 800 miles away in Austin, Texas. They spoke via video, with Helm using an iPad she held on her lap while sitting in her bed.

Video visits are an increasingly common way for residents of small-town nursing homes to receive mental health care. Patients don’t have to travel to a clinic. They don’t even have to get cleaned up and leave their bedrooms, which can be daunting for people with depression or anxiety. Online care providers face fewer appointment cancellations, and they often can work from home. While use of some other telehealth services may dwindle as the covid-19 pandemic winds down, providers predict demand for remote mental health services will continue to increase in rural nursing homes.

“Are you anxious when you try to fall asleep? Is your mind racing?” asked the nurse practitioner, Ayesha Macon.

“Yeah, that’s sort of my time to think,” Helm said. Her thoughts can keep her up past 3 a.m., she said.

They discussed the anxiety Helm sometimes feels during the day and her routine of watching the TV news at 10 p.m. Macon suggested the news might wind Helm up, and she wondered if the 71-year-old patient could ease stress by skipping the news before going to bed.

“No,” Helm said. “I find it interesting. I want to know what’s going on in the world. I’ve always been a bit of a newshound.”

Macon smiled and said she understood. So they talked about other approaches, including using online meditation programs and spending quiet time reading the dozens of novels Helm keeps stacked in her room. “If I couldn’t read, I think I would go absolutely bananas,” she told Macon, who agreed it was a good habit.

Telemedicine visits became much more common throughout the American health care system during the pandemic, as guidelines on “social distancing” curtailed in-person appointments and insurers eased restrictions on what they would cover. The number of telehealth visits paid for by Medicare jumped tenfold in the last nine months of 2020 compared with the same period a year before.

Supporters of online treatment say it’s a good match for mental health care, especially in settings where in-person services have been hard to arrange. They cite small-town nursing homes as prime examples. The company that arranged Helm’s recent appointment, Encounter Telehealth, serves more than 200 nursing homes and assisted living centers, mostly in the Midwest. About 95% of those facilities are in rural areas, said Jen Amis, president of the company, which is based in Omaha, Nebraska.

Encounter Telehealth uses about 20 mental health professionals, many of whom are psychiatric nurse practitioners living in cities. The practitioners read the patients’ electronic medical records through a secure computer system, and they review symptoms and medications with nursing home staff members before each appointment. They complete up to 2,000 visits a month.

It’s important for seniors to have expert support as they face stress and uncertainty in aging, Amis said. “We’re all going to be there at some point,” she said. “Don’t you want that last chapter to be peaceful?”

The company saw demand for its services surge in care facilities when the pandemic hit. Nursing homes were closed to visitors for months at a time while the coronavirus caused thousands of illnesses and deaths among residents and employees. The stress could be overwhelming for everyone involved. “Oh, my gosh, the isolation and fear,” Amis said.

Amis said several developments have made her company’s services possible. Electronic medical records and video systems are crucial. Also, she said, many states have given more independent authority to nurse practitioners and other nonphysicians, and it has become easier to bill public and private insurance plans for mental health treatment.

The federal government could tighten rules for some kinds of telehealth care as the pandemic wanes. But Medicare paid for many remote mental health visits to rural areas before covid, and Amis expects the support to continue.

Jonathan Neufeld, program director of the Great Plains Telehealth Resource and Assistance Center at the University of Minnesota, said in-person mental health care can be hard to arrange in rural care facilities.

“You’ve got a double or even triple whammy going right now,” said Neufeld, a psychologist whose center is supported by federal grants.

He noted the number of mental health professionals nationally has been insufficient for many years, even before the pandemic. And all kinds of rural employers, including nursing homes, face critical staffing shortages.

Neufeld said telehealth visits can be a challenge for some care-facility residents, including those with dementia, who might not understand how a video feed works. But he said it also can be difficult to treat people with dementia in person. Either way, a staff member or relative needs to accompany them during appointments and the mental health professional generally consults with facility staff about a patient’s treatment.

Before telemedicine was available, more residents of rural nursing homes needed to be driven to a clinic in another town to see a mental health professional. That could eat up hours of staff time and add stress to the patients’ lives.

Seleta Stewart, a certified nursing assistant at the Accura HealthCare nursing home where Helm lives, said the facility’s need for the telehealth service is increasing, partly because the facility is home to several younger residents with mental illnesses. In the past, she said, many such Iowans would have been served by specialized facilities, such as two state mental hospitals that closed in 2015. But more now live in nursing homes.

“Iowa is just not a great state for mental health,” Stewart said.

A photo of a nursing home worker speaking to a mental health worker via video call. — Before visiting with patients in their rooms, psychiatric nurse practitioner Ayesha Macon, on video screen, consults with Shaina Flesher (right), a certified nursing assistant at the Accura HealthCare nursing home in Knoxville, Iowa. The two discuss how residents of the nursing home have been faring and what medications they’ve been taking.(Tony Leys / KHN)

Neufeld said that, even with telemedicine’s efficiencies, staffing can be a challenge for companies providing the service in nursing homes. Many mental health professionals already have more patients than they can handle, and they might not have time to pitch in online. He added that Medicare, which insures most seniors, pays lower rates than private insurers or patients paying on their own.

Amis, Encounter Telehealth’s president, said Medicare pays about $172 for an initial appointment and about $107 for a follow-up appointment; care providers collect roughly 30% to 75% more from patients who use private insurance or pay their own bills, she said. She added that nursing homes pay a fee to Encounter for the convenience of having mental health professionals visit by video.

Several patients and care providers said the shift to video appointments is usually smooth, despite seniors’ reputation for being uncomfortable with new technology.

Dr. Terry Rabinowitz, a psychiatrist and professor at the University of Vermont, has been providing telemedicine services to a rural nursing home in upstate New York since 2002. He said many patients quickly adjust to video visits, even if it’s not their initial preference.

“I think most people, if they had their druthers, would rather see me in person,” he said. “And if I had my druthers, I’d rather see them in person.” Online visits can have special challenges, including for patients who don’t hear or see well, he said. But those complications can be addressed.

Nancy Bennett, another resident of Helm’s Iowa nursing home, can attest to the benefits. Bennett had a video appointment with Macon on a recent morning. She told the nurse practitioner she’d been feeling stressed. “I’m 72, I’m in a nursing home, I’ve got no family around, so yeah, I’m a little depressed,” she said. “I do get sad sometimes.”

“That’s normal,” Macon assured her.

Bennett said she dislikes taking a lot of pills. Macon said she could taper some of Bennett’s medication.

In an interview afterward, Bennett said she’d gone to a clinic for mental health care in the past. That was before physical issues forced her into the nursing home, where she spends much of her time sitting in a blue recliner in her room.

If she’d had to get dressed and travel for her appointment with Macon, she said, she probably would have canceled. “There are days when I don’t want to be bothered,” she said.

But on this day, the mental health professional came to her on an iPad ― and helped Bennett feel a little better.

March 20, 2023

Judge Signals He Could Rule to Halt Sales of Common Abortion Pill

[embedded content]

During a four-hour hearing last week that could eliminate nationwide access to a common and widely used abortion pill, federal Judge Matthew Kacsmaryk, of the Northern District of Texas, signaled his conservative Christian beliefs early and often.

Speaking from the bench in a courtroom in Amarillo, Texas, Kacsmaryk repeatedly used language that mimicked the vocabulary of anti-abortion activists. It also reflected the wording of the lawyers seeking to overturn the FDA’s two-decade-old approval of mifepristone, one of the drugs in the two-pill regimen approved for early pregnancy termination.

Each time a lawyer from the Department of Justice, representing the FDA, referred to “medication abortion,” Kacsmaryk returned to the language of conservative Christian activists, using monikers like “chemical abortion” and “mail-in abortion,” phrases at odds with conventional medical terminology.

The stakes in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, are high: Abortion rights advocates fear that Kacsmaryk, an appointee of then-President Donald Trump and a former lawyer at the First Liberty Institute, a conservative Christian legal group, could rule within days to force manufacturers to pull mifepristone from the market nationwide. If that happens, clinics and obstetricians and gynecologists across the country will be able to prescribe only misoprostol, the second drug in the two-pill regimen, for miscarriages and early abortion care. Misoprostol is still extremely safe but less effective and comes with more side effects.

The ruling would be unprecedented in the history of approved drugs and could affect the health care of millions of women, even those in states where abortion is still legal.

“One conservative judge is impacting the rights of women in California and New York,” said Greer Donley, an associate professor of law at the University of Pittsburgh Law School and expert on reproductive health law. “The endgame is to stop as many abortions as possible by any means necessary.”

When the conservative majority on the Supreme Court eliminated the federal right to abortion, Justice Brett Kavanaugh, a Catholic, wrote that the court was not outlawing abortion throughout the United States. “On the contrary,” Kavanaugh wrote, “the Court’s decision properly leaves the question of abortion for the people and their elected representatives in the democratic process.”

But in the nine months since the announcement of the decision in Dobbs v. Jackson Women’s Health Organization, Christian legal groups have made their strategy clear: eliminate abortion nationwide by filing lawsuits in federal courts that make scientific claims, unsupported by mainstream medical organizations, to raise doubts about the safety of abortion pills and contraception.

These legal decisions, which conservatives might once have decried as “judicial activism,” are partially necessary because abortion rights continually poll positively, with voters even in solidly conservative states like Kansas and Kentucky refusing to enact bans.

“After Dobbs, there have been more and more efforts to move things away from the popular majority and into the hands of judges like Kacsmaryk,” said Mary Ziegler, a law professor and abortion historian at the University of California-Davis School of Law. “Because voters are not sold on fetal rights and because the only way to a national ban on abortion is likely to come from the conservative courts,” she said.

Ziegler added of anti-abortion campaigners, “They don’t want solutions that work only in Tennessee and Texas.”

The strategy of casting doubt on established and accepted science is not new in conservative circles, nor is it limited to abortion.

For decades, conservative Christian legal groups have introduced scientific uncertainty where there had been none: Claims that abortion causes breast cancer or infertility are unsupported by medical and scientific research but nevertheless made their way into state laws, requiring physicians in certain states to tell patients about risks from abortion that do not exist.

And in a recent opinion that ended birth control access for teens without parental consent in Texas, the same judge as in the mifepristone case — Kacsmaryk — exaggerated the health risks of prescription birth control in his decision, asserting that states have an interest in protecting the health of girls.

“Several popular methods of birth control carry serious side effects,” Kacsmaryk wrote, later quoting from Planned Parenthood educational material that read, “Complications are rare, but they can be serious. In very rare cases, they can lead to death.”

That case, Deanda v. Becerra, was filed by a Christian father who cited religious objections to a federal family planning program. And in the mifepristone case, fundamentalist Christian groups have argued that the drug is unsafe, despite ample research and decades of use testifying to the contrary.

Alliance Defending Freedom, which describes itself as the world’s largest legal organization committed to protecting “God’s design for marriage and family,” is pushing to outlaw abortion pills. Erik Baptist, an attorney for the group, said in a statement following the March 15 hearing that the “the FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground.”

He added, “It’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”

Conservative legal groups like ADF have been savvy about exploiting small wins in the courts and building on them, such as the 2007 decision Gonzales v. Carhart, which upheld a federal ban on a rarely used method of abortion.

The decision had minimal practical impact, as the procedure in question was rarely performed, but it established an important legal principle: When scientific uncertainty arises in legal disputes — is a medical procedure, device, or medication safe or not? — legislatures get to decide.

“The court said when there is scientific uncertainty the tiebreaker goes to the legislature,” said Ziegler.

But there is little question that mifepristone is safe: More than 5.6 million women have successfully used medication abortion since 2000, according to the FDA. In 2008, the Government Accountability Office investigated the FDA’s approval of mifepristone and concluded the process was consistent with FDA regulations.

In the courtroom, Baptist acknowledged that no court had ever ordered the FDA to remove a drug from the market over the agency’s objections, and legal observers say there remains a huge question whether the court can order the secretary of the Department of Health and Human Services, who oversees the FDA, to do so.

But Laurie Sobel, an associate director for women’s health policy at KFF, who listened to the hearing in a Dallas courtroom, said anti-abortion attorneys argued that the mailing of abortion medications strips states of their ability to protect women and children. (The hearing, which Kacsmaryk did not, initially, publicly announce, was not streamed to the public, and the court has yet to release a transcript.)

But Jessica Ellsworth, an attorney representing Danco Laboratories, a manufacturer of mifepristone, told the court that abortion remained legal in all states because it was allowed for preventing a patient’s death or serious bodily injury. Using mifepristone is the safest method of abortion, she argued, noting the judge’s decision in the case could ban it in every state.

“If Kavanaugh said, ‘We’re going to send it back to the states to be decided by their elected representatives,’ this is the exact opposite,” said Donley.

Kacsmaryk appeared ready to grant a preliminary injunction in favor of anti-abortion groups, asking ADF’s Baptist what kind of remedy he was seeking.

Baptist responded, “The court has an interest in preventing dangerous drugs from entering the marketplace.” He added, “Any relief you grant must be complete. The harm of chemical drugs knows no bound.”

March 20, 2023

Mobile Clinics Really Got Rolling in the Pandemic. A New Law Will Help Them Cast a Wider Safety Net.

Nearly 12 years ago, a nonprofit centered on substance abuse prevention in Lyon County, Nevada, broadened its services to dental care.

Leaders with the Healthy Communities Coalition were shocked into action after two of their food pantry volunteers used pliers to pull each other’s abscessed teeth. The volunteers saw no other option to relieve their overwhelming pain in the small town where they lived, 40 miles southeast of Reno, because of a dearth of dental care providers.

That drastic act, said Wendy Madson, executive director for the coalition, prompted her organization to use mobile clinics to offer health and dental services in rural communities where there aren’t enough patients to support brick-and-mortar offices.

The coalition now sends a van outfitted with dental equipment to county schools to treat hundreds of students per stop a few times each year. They also host events for adults in the region. The response has been overwhelming.

“Dental is the hot ticket,” Madson said. “Everybody wants dental. Availability of those services is what runs out first in those large mobile events.”

The coalition’s mobile programs mirror efforts nationwide to dispatch services to patients experiencing gaps in the health care system, especially in rural areas.

Rural residents face more significant health care provider shortages, including dentists, compared with their counterparts in larger cities. Since the beginning of the pandemic, mobile clinics have increased access to a range of services in hard-to-reach places with sparse populations.

A recently passed law, which makes it easier for rural communities to pay for new mobile clinics, could expand this trend. In the past, clinics that serve low-income rural residents couldn’t spend federal grant money, called new access point grants, on mobile services in communities where they didn’t already have facilities.

Then last fall, Congress passed the MOBILE Health Care Act, sponsored by Sens. Jacky Rosen (D-Nev.) and Susan Collins (R-Maine), which gives federally qualified health centers — health clinics serving medically underserved areas — greater flexibility to use federal funding to create and operate mobile units.

Since 2019, the number of mobile clinics on the road has expanded, according to the National Association of Community Health Centers. Many had been used for covid-19 testing and vaccinations. And health and community organizations have started using mobile units to bring primary care, behavioral health, and reproductive services to out-of-the-way patients. The new funding pathway could soon put even more mobile health vans on the road.

For now, the law is dependent on congressional funding, and experts predict it could be at least a year before health centers can access the grant money.

More than 2,000 health center advocates went to Washington, D.C., in early March to ask lawmakers to support multiyear grant funding, said Amy Simmons Farber, associate vice president of media relations for the National Association of Community Health Centers.

Once funded, the regulatory shift will allow health centers to collaborate with independent organizations like Madson’s Health Communities Coalition in Nevada to expand services in underserved regions. Because the coalition is not a federally qualified health center, it has relied on a mix of other federal and state grants.

Nearly 1,400 federally qualified health centers nationwide receive federal funding for providing comprehensive health services in underserved areas. The previous requirement that health centers establish brick-and-mortar clinics before expanding mobile clinics prevented many from applying, said Steve Messinger, policy director for the Nevada Primary Care Association. It was burdensome and costly for health centers.

But in rural areas with small populations, served well by mobile clinics, it wouldn’t make sense to first establish a building with a full-time provider, he said. That could eat up the budget of a federally qualified health center.

While health center advocates lobby Congress for base funding, the Healthy Communities Coalition is forging ahead with three dental events this year funded by a grant from the Health Resources and Services Administration, part of the Department of Health and Human Services.

At the first medical outreach event the coalition organized in 2012 in Lyon County, where 61,400 residents are spread across more than 2,000 square miles, more than 200 people showed up to receive free care and 150 teeth were pulled, Madson said. Since then, the organization has hosted several events a year — except in 2020, when the pandemic paused work.

A photo of a dental worker examining a student sitting at a desk inside a mobile clinic. — Healthy Communities Coalition executive director Wendy Madson says mobile dental clinics in Lyon County, Nevada, help reach young students whose parents might otherwise lack the means or insurance to schedule regular visits.(Wendy Madson)

Many of the dental events are school-focused and provide children with such services as screenings, X-rays, sealings, varnish, and cleanings. But an overwhelming need for care also exists among area adults, said Madson, because Medicare and Nevada’s Medicaid do not include comprehensive dental coverage for adults. It’s harder to fund those events, she said.

Of the five communities in Lyon County, at least one, Silver Springs, does not have a single dentist. There are 10 dentists total in Fernley and Dayton, communities with a combined population of 38,600 people, but only two of those practices accept Medicaid, which covers low-income people younger than 21 and limited dental services for adults.

Traci Rothman, who manages the coalition’s food pantries, said the dental outreach events made a difference for her 29-year-old son, who moved to Silver Springs last year. He went to two mobile clinics to receive free care, which Rothman said was a big relief because he’s uninsured and needed dental care badly.

“Otherwise, you’re going to somebody that you’re paying cash,” she said. “Oftentimes I cannot pay, honestly; it’s just out of reach for some people, or most people … in rural areas.”

Madson said the coalition stepped in to help a young student in desperate need of a root canal. The coalition is helping the girl’s family apply for Medicaid or Nevada Check Up, the state Children’s Health Insurance Program, and is paying $1,600 to cover the service with federal grant money. Another student had to be referred to several specialists before she had her decayed baby teeth surgically removed and received restorative treatment for adult teeth that had begun to decay.

“Her mom was so thankful, she was in tears,” Madson said. “She told me that her daughter woke up without instant pain for the first time in years.”

Madson said her organization has enough grant funding for three events through May, but she hopes the MOBILE Health Care Act will help expand services. Besides dental care, the group provides primary care mobile clinics for immigrant workers in Yerington, a small town in an agricultural region about 70 miles southeast of Reno.

Sara Rich, CEO of Choptank Community Health in Maryland, said she shares Madson’s hope.

Choptank serves five counties in Maryland, including small towns between the Chesapeake Bay and the Delmarva Peninsula. Amid the pandemic, the health organization struck an unlikely partnership with a car dealership and used federal covid relief money to buy a Ford Transit cargo van for mobile clinics.

Choptank used its new van to provide vaccines but has since started using it to provide primary care to immigrant workers and dental services to children at 36 schools. The mobile clinics have been so successful that the health center is working on purchasing more vans to expand its services.

Rich said the mobile clinics are “breaking down barriers that a lot of us have been working on for a long time.”

Among the new services Choptank seeks to provide are behavioral health, preventing and treating substance use disorders, and skin screenings for people working on the shores of Maryland.

“Flexibility has been a theme over the last few years,” Rich said. “I think this MOBILE Health Care Act will help us do that even more into the future.”

March 18, 2023

California eligió a la compañía de genéricos Civica para producir insulina de bajo costo

SACRAMENTO, CA. — El gobernador Gavin Newsom anunció el sábado 18 de marzo que se había seleccionado al fabricante de medicamentos genéricos Civica, con sede en Utah, para producir insulina de bajo costo para el estado, una medida sin precedentes que cumple su promesa de poner al gobierno estatal en competencia directa con las versiones de marca de las farmaceúticas que dominan el mercado.

“La gente no debería verse obligada a endeudarse para obtener recetas que salvan vidas”, dijo Newsom. “Los californianos tendrán acceso a algunas de las insulinas más económicas disponibles, lo que les ayudará a ahorrar miles de dólares cada año”.

El contrato, con un costo inicial de $50 millones que Newsom y los legisladores demócratas aprobaron el año pasado, estipula que Civica produzca insulina de marca estatal y ponga el medicamento a disposición de cualquier californiano que lo necesite, por correo y en las farmacias locales, independientemente de si tenga o no seguro de salud.

Y la insulina es solo el comienzo. Newsom dijo que el estado también buscará producir naloxona, el fármaco que revierte las sobredosis de opioides.

Allan Coukell, vicepresidente sénior de políticas públicas de Civica, le dijo a California Healthline que el fabricante de medicamentos sin fines de lucro también está en conversaciones con la administración de Newsom para producir potencialmente otros medicamentos genéricos. Pero se negó a dar más detalles y dijo que la compañía se enfoca primero en hacer que la insulina económica esté ampliamente disponible.

“Estamos muy entusiasmados con esta asociación con el estado de California”, dijo Coukell. “No buscamos tener el 100% del mercado, pero sí queremos que el 100% de las personas tenga acceso a insulina a un precio justo”.

A medida que los costos de la insulina para los consumidores se han disparado, los legisladores y activistas demócratas han pedido a la industria que los controle. Apenas unas semanas después que el presidente Joe Biden atacara a las grandes farmacéuticas por aumentar los precios de la insulina, los tres fabricantes de medicamentos que controlan ese mercado, Eli Lilly and Co., Novo Nordisk y Sanofi, anunciaron que reducirían drásticamente los precios de lista de algunos productos.

Newsom, quien anteriormente acusó a la industria farmacéutica de estafar a los californianos con “precios altísimos”, argumentó que el lanzamiento de la marca de genéricos estatal, CalRx, sumará competencia y ejercerá presión sobre la industria.

Funcionarios de la administración no dijeron cuándo estarían disponibles los productos de insulina de California, pero expertos dicen que podría ser tan pronto como en 2025. Coukell remarcó que el medicamento de marca estatal aún requerirá la aprobación de la Administración de Drogas y Alimentos (FDA), lo que puede demorar unos 10 meses.

La Pharmaceutical Research and Manufacturers of America, que cabildea en nombre de las empresas de marca, criticó la medida de California. Reid Porter, director senior de asuntos públicos estatales de PhRMA, dijo que Newsom solo “quiere sumar puntos políticos”.

“Si el gobernador quiere tener un impacto significativo en lo que los pacientes pagan por las insulinas y otros medicamentos, debería expandir su enfoque a otros en el sistema que a menudo hace que los pacientes paguen más por los medicamentos”, dijo Porter, culpando a las empresas intermediarias, conocidas como administradores de beneficios de farmacia, que negocian con los fabricantes en nombre de las aseguradoras para reembolsos y descuentos.

La Pharmaceutical Care Management Association, que representa a estos administradores, argumentó a su vez que son las compañías farmacéuticas las culpables de los altos precios.

Expertos en precios dicen que los administradores de beneficios farmacéuticos y los fabricantes de medicamentos comparten la culpa.

Funcionarios de la administración Newsom dicen que los costos inflados de la insulina obligan a algunos a pagar hasta $300 por vial o $500 por una caja de plumas inyectables, y que demasiados californianos con diabetes se saltan o racionan sus medicamentos. Esto puede provocar ceguera, amputaciones y afecciones potencialmente mortales, como enfermedades cardíacas e insuficiencia renal. Casi el 10% de los adultos de California tienen diabetes.

Civica está desarrollando tres tipos de insulina genérica, conocida como biosimilar, que estarán disponibles tanto en viales como en plumas inyectables. Se espera que sean intercambiables con productos de marca, incluidos Lantus, Humalog y NovoLog. Coukell dijo que la compañía pondría a disposición el medicamento por no más de $30 por vial, o $55 por cinco plumas inyectables.

Newsom dijo que la insulina estatal le ahorrará a muchos pacientes entre $2,000 y $4,000 al año, aunque siguen sin respuesta preguntas críticas sobre cómo California pondrá los productos en manos de los consumidores, incluida la forma en que persuadiría a las farmacias, las aseguradoras y los minoristas para que distribuyan los medicamentos.

El año pasado, Newsom también obtuvo $50 millones en capital inicial para construir una instalación para fabricar insulina; Coukell dijo que Civica está explorando la construcción de una planta en California.

El movimiento de California, aunque nunca antes lo había intentado un gobierno estatal, podría verse afectado por las recientes decisiones de la industria para reducir los precios de la insulina. En marzo, Lilly, Novo Nordisk y Sanofi se comprometieron a reducir los precios. Con Lilly ofreciendo un vial a $25 por mes, Novo Nordisk prometió importantes reducciones que llevarían el precio de un vial genérico particular a $48, y Sanofi fijó un vial a $64.

La oficina del gobernador dijo que le costará al estado $30 por vial para fabricar y distribuir insulina y se venderá a ese precio. Si lo hace, argumenta la administración, “evitará el atroz cambio de costos que ocurre en los juegos de precios farmacéuticos tradicionales”.

Expertos en precios de medicamentos dijeron que la producción de genéricos en California podría reducir aún más los costos de la insulina y beneficiar a las personas con planes médicos con deducibles altos o sin seguro.

“Este es un movimiento extraordinario en la industria farmacéutica, no solo para la insulina, sino potencialmente para todo tipo de medicamentos”, dijo Robin Feldman, profesor de la Facultad de Derecho de la Universidad de California en San Francisco. “Es una industria muy difícil de quebrantar, pero California está lista para hacer precisamente eso”.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

March 18, 2023

California Picks Generic Drug Company Civica to Produce Low-Cost Insulin

SACRAMENTO, Calif. — Gov. Gavin Newsom on Saturday announced the selection of Utah-based generic drug manufacturer Civica to produce low-cost insulin for California, an unprecedented move that makes good on his promise to put state government in direct competition with the brand-name drug companies that dominate the market.

“People should not be forced to go into debt to get lifesaving prescriptions,” Newsom said. “Californians will have access to some of the most inexpensive insulin available, helping them save thousands of dollars each year.”

The contract, with an initial cost of $50 million that Newsom and his fellow Democratic lawmakers approved last year, calls for Civica to manufacture state-branded insulin and make the lifesaving drug available to any Californian who needs it, regardless of insurance coverage, by mail order and at local pharmacies. But insulin is just the beginning. Newsom said the state will also look to produce the opioid overdose reversal drug naloxone.

Allan Coukell, Civica’s senior vice president of public policy, told KHN that the nonprofit drugmaker is also in talks with the Newsom administration to potentially produce other generic medications, but he declined to elaborate, saying the company is focused on making cheap insulin widely available first.

“We are very excited about this partnership with the state of California,” Coukell said. “We’re not looking to have 100% of the market, but we do want 100% of people to have access to fair insulin prices.”

As insulin costs for consumers have soared, Democratic lawmakers and activists have called on the industry to rein in prices. Just weeks after President Joe Biden attacked Big Pharma for jacking up insulin prices, the three drugmakers that control the insulin market — Eli Lilly and Co., Novo Nordisk, and Sanofi — announced they would slash the list prices of some products.

Newsom, who has previously accused the pharmaceutical industry of gouging Californians with “sky-high prices,” argued that the launch of the state’s generic drug label, CalRx, will add competition and apply pressure on the industry. Administration officials declined to say when California’s insulin products would be available, but experts say it could be as soon as 2025. Coukell said the state-branded medication will still require approval from the FDA, which can take roughly 10 months.

The Pharmaceutical Research and Manufacturers of America, which lobbies on behalf of brand-name companies, blasted California’s move. Reid Porter, senior director of state public affairs for PhRMA, said Newsom just “wants to score political points.”

“If the governor wants to impact what patients pay for insulins and other medicines meaningfully, he should expand his focus to others in the system that often make patients pay more than they do for medicines,” Porter said, blaming pharmaceutical go-between companies, known as pharmacy benefit managers, that negotiate with manufacturers on behalf of insurers for rebates and discounts on drugs.

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers argued in turn that it’s pharmaceutical companies that are to blame for high prices.

Drug pricing experts, however, say pharmacy benefit managers and drugmakers share the blame.

Newsom administration officials say that inflated insulin costs force some to pay as much as $300 per vial or $500 for a box of injectable pens, and that too many Californians with diabetes skip or ration their medication. Doing so can lead to blindness, amputations, and life-threatening conditions such as heart disease and kidney failure. Nearly 10% of California adults have diabetes.

Civica is developing three types of generic insulin, known as a biosimilar, which will be available both in vials and in injectable pens. They are expected to be interchangeable with brand-name products including Lantus, Humalog, and NovoLog. Coukell said the company would make the drug available for no more than $30 a vial, or $55 for five injectable pens.

Newsom said the state’s insulin will save many patients $2,000 to $4,000 a year, though critical questions about how California would get the products into the hands of consumers remain unanswered, including how it would persuade pharmacies, insurers, and retailers to distribute the drugs.

Last year, Newsom also secured $50 million in seed money to build a facility to manufacture insulin; Coukell said Civica is exploring building a plant in California.

California’s move, though never been tried by a state government, could be blunted by recent industry decisions to lower insulin prices. In March, Lilly, Novo Nordisk, and Sanofi vowed to cut prices, with Lilly offering a vial at $25 per month; Novo Nordisk promising major reductions to bring the price of a particular generic vial to $48; and Sanofi also slashing prices, with one vial pegged at $64.

The governor’s office said it will cost the state $30 per vial to manufacture and distribute insulin and it will be sold at that price. Doing so, the administration argues, “will prevent the egregious cost-shifting that happens in traditional pharmaceutical price games.”

Drug pricing experts said generic production in California could further lower costs for insulin, and benefit people with high-deductible health insurance plans or no insurance.

“This is an extraordinary move in the pharmaceutical industry, not just for insulin but potentially for all kinds of drugs,” said Robin Feldman, a professor at the University of California College of the Law-San Francisco. “It’s a very difficult industry to disrupt, but California is poised to do just that.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

March 17, 2023

California’s Covid Misinformation Law Is Entangled in Lawsuits, Conflicting Rulings

Gov. Gavin Newsom may have been prescient when he acknowledged free speech concerns as he signed California’s covid misinformation bill last fall. In a message to lawmakers, the governor warned of “the chilling effect other potential laws may have” on the ability of doctors to speak frankly with patients but expressed confidence that the one he was signing did not cross that line.

Yet the law — meant to discipline doctors who give patients false information about covid-19 — is now in legal limbo after two federal judges issued conflicting rulings in recent lawsuits that say it violates free speech and is too vague for doctors to know what it bars them from telling patients.

In two of the lawsuits, Senior U.S. District Judge William Shubb in Sacramento issued a temporary halt on enforcing the law, but it applies only to the plaintiffs in those cases. Shubb said the law was “unconstitutionally vague,” in part because it “fails to provide a person of ordinary intelligence fair notice of what is prohibited.” His ruling last month clashed with one handed down in Santa Ana in December; in that case, U.S. District Judge Fred Slaughter refused to halt the law and said it was “likely to promote the health and safety of California covid-19 patients.”

The legal fight in the nation’s most populous state is to some extent a perpetuation of the pandemic-era tussle pitting supporters of public health guidelines against groups and individuals who resisted masking orders, school shutdowns, and vaccine mandates.

California’s covid misinformation law, which took effect Jan. 1, is being challenged by vaccine skeptics and civil liberties groups. Among those suing to get the law declared unconstitutional is a group founded by Robert F. Kennedy Jr., who has questioned the science and safety of vaccines for years.

But doubts about the law are not confined to those who have battled the scientific mainstream.

Dr. Leana Wen, a health policy professor at George Washington University who previously served as president of Planned Parenthood and as Baltimore’s health commissioner, wrote in an op-ed a few weeks before Newsom signed the law that it would exert “a chilling effect on medical practice, with widespread repercussions that could paradoxically worsen patient care.”

The Northern California affiliate of the American Civil Liberties Union has weighed in against the law on free speech grounds, though the national organization has affirmed the constitutionality of covid vaccine mandates.

“If doctors are scared of losing their licenses for giving advice that they think is helpful and appropriate, but they don’t quite know what the law means, they will be less likely to speak openly and frankly with their patients,” said Hannah Kieschnick, an attorney with the ACLU of Northern California.

The law establishes that doctors who give false information about covid to patients are engaging in unprofessional conduct, which could subject them to discipline by the Medical Board of California or the Osteopathic Medical Board of California.

Proponents of the law sought to crack down on what they believe are the most clear-cut cases: Doctors who tout treatments such as ivermectin, an anti-parasitic agent that is unproven as a covid treatment and can be dangerous; who exaggerate the risk of getting vaccinated compared with the dangers of the disease; or who spread unfounded theories about the vaccines, including that they can cause infertility or harm DNA.

But the law lacks such specifics, defining misinformation only as “false information that is contradicted by contemporary scientific consensus contrary to the standard of care.”

Michelle Mello, a professor of law and health policy at Stanford University, said the wording is confusing.

“On a matter like covid, science is changing all the time, so what does it mean to say there is scientific consensus?” she asked. “To me, there are lots of examples of statements that clearly, with no vagueness involved, meet the definition of the kind of conduct that the legislature was going after. The problem is that there are all kinds of other hypothetical things that people can say that don’t clearly violate it.”

Dr. Christine Cassel, a professor of medicine at the University of California-San Francisco, said she expects the law to be applied only in the most flagrant cases. “I trust scientists enough to know where there’s a legitimate dispute,” she said.

Cassel’s view mirrors Newsom’s rationale for signing the legislation despite his awareness of potential free speech concerns. “I am confident,” he wrote in his message to lawmakers, “that discussing emerging ideas or treatments including the subsequent risks and benefits does not constitute misinformation or disinformation under this bill’s criteria.”

Plaintiffs in the Santa Ana case, two doctors who have sometimes diverged from public health guidelines, appealed Slaughter’s ruling allowing the law to stand. The case has been combined in the 9th U.S. Circuit Court of Appeals with another case in which a San Diego judge declined to rule on a similar request to temporarily halt the law.

Newsom spokesperson Brandon Richards said in early February that the administration would not appeal the two Sacramento cases in which Shubb issued the narrow injunction. The plaintiffs’ lawyers had expected the state to appeal the decision, thinking all four lawsuits would then be decided by the appeals court, providing greater clarity for all parties.

Richard Jaffe, lead attorney in one of the Sacramento cases — brought by a doctor, Kennedy’s Children’s Health Defense, and a group called Physicians for Informed Consent — said Newsom’s decision not to appeal is “just going to increase the level of chaos in terms of who the law applies to.”

But the Newsom administration has decided to wait for the appeals court to rule on the other two judges’ decisions that left the law intact for now.

Jenin Younes, a lawyer with the New Civil Liberties Alliance who is lead counsel in the other Sacramento case in which Shubb issued his injunction, said Newsom may be calculating that “you’re in a stronger position going up on a win than on a loss.”

A victory for Newsom in the appeals court, Jaffe and others said, could dampen the impact of the two Sacramento cases.

Opponents of California’s covid misinformation law question why it is needed at all, since the medical boards already have authority to discipline doctors for unprofessional conduct. Yet only about 3% of the nearly 90,000 complaints the Medical Board of California received over a decade resulted in doctors being disciplined, according to a 2021 investigation by the Los Angeles Times.

That could be good news for doctors who worry the new law could constrain their ability to advise patients.

“I don’t see medical boards being particularly vigorous in policing physicians’ competence in general,” said Stanford’s Mello. “You have to be really bad to get their attention.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

March 16, 2023

Judging the Abortion Pill

The Host

This week, the eyes of the nation are on Texas, where a federal judge who formerly worked for a conservative Christian advocacy group is set to decide whether the abortion pill mifepristone can stay on the market. Mifepristone is half of a two-pill regimen that now accounts for more than half of the abortions in the United States.

Meanwhile, Novo Nordisk, another of the three large drug companies that dominate the market for diabetes treatments, has announced it will cut the price of many of its insulin products. Eli Lilly announced its cuts early this month. But the push for more affordable insulin from activists and members of Congress is not the only reason for the change: Because of quirks in the way the drug market works, cutting prices could actually save the companies money in the long run.

This week’s panelists are Julie Rovner of KHN, Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.

Among the takeaways from this week’s episode:

The federal judge examining the decades-old approval of mifepristone could issue a decision at any time after a hearing largely behind closed doors, during which he appeared open to restricting access to the drug.
Democratic governors seek to counter the chill of Republican states’ warnings to pharmacies about distributing mifepristone, and a separate lawsuit in Texas seeks to set a precedent for punishing people who aren’t medical providers for assisting someone in obtaining an abortion.
In pandemic news, Congress is moving forward with legislation that would force the Biden administration to declassify intelligence related to the origins of covid-19, while the editor of Cochrane Reviews posted a clarification of its recently published masking study, noting it is “inaccurate” to say it found that masks are not effective.
Top federal health officials sent an unusual letter to Florida’s surgeon general, warning that his embrace of vaccination misinformation is harmful, even deadly, to Americans. While covid vaccines come with some risk of negative health effects, contracting covid carries a higher risk of poor outcomes.
Novo Nordisk’s announcement that it will cut insulin prices puts pressure on Sanofi, the remaining insulin maker that has yet to adjust its prices.
The Veterans Health Administration will cover Leqembi, a new Alzheimer’s drug. The decision comes as Medicare considers whether it will also cover the drug. Experts caution that new drugs shaking up the weight-loss market could prove costly for Medicare.
Washington is eyeing changes to federal rules that would affect the practice of medicine. One change would force health plans to speed up “prior authorization” decisions by health insurers and increase transparency around denials, which supporters say would help patients better access needed care. Another proposal would ban noncompete clauses in contracts, including in health care. Arguments for and against the change both cite the issue of physician burnout — though they disagree on whether the ban would make the problem better or worse.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: “Tradeoffs” podcast’s “The Conservative Clash Over Abortion Bans,” by Alice Miranda Ollstein and Dan Gorenstein

Alice Miranda Ollstein: Politico’s “Sharpton Dodges the Spotlight on Latest Push to Ban Menthol Cigarettes,” by Julia Marsh

Sarah Karlin-Smith: Allure’s “With New Legislation, You Can Expect More Recalls to Hit the Beauty Industry,” by Elizabeth Siegel and Deanna Pai

Jessie Hellmann: The New York Times’ “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs,” by Christina Jewett and Ellen Gabler

Also mentioned in this week’s podcast:

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

Related Topics

Related Topics

Related Topics

Related Topics

Related Topics

Related Topics

Related Topics

Related Topics

Related Topics

The Host

Related Topics