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Formula May Be Right for Infants, but Experts Warn That Toddlers Don’t Need It

Kaiser Health News:Health Industry - September 21, 2022

Formulas for toddlers are a burgeoning business in the United States: Sales of the drinks more than doubled in recent years as companies convinced parents that their little ones needed the liquid boost. But many experts warn that these products, designed for children ages 1 to 3, fill no nutritional needs beyond what is available in a typical toddler diet, are subject to less regulation than infant formula, and are expensive.

In addition, some parents feed the toddler versions to infants even though they do not meet federal standards for infant formula and may not provide babies with adequate nutrients to sustain their growth.

Pediatricians and federal health officials say that when most children turn 1, they can begin drinking cow milk or an unsweetened plant-based milk substitute. In a 2019 “consensus” statement, the American Academy of Pediatrics and other health and nutrition organizations recommended against using toddler formulas, saying “they offer no unique nutritional value beyond what could be obtained with healthy foods; furthermore, they may contribute added sugars to the diet.” The toddler formulas often contain sweeteners and fats that add calories.

Some of the same companies that produce infant formula — including Enfamil, Gerber, and Similac — also make toddler formulas, as do some smaller, boutique brands that advertise that they have organic or other special qualities. Toddler formulas are available nearly everywhere infant formulas are sold and are marketed as providing extra nutrients to help children’s brain, immune system, and eye development, among other benefits. They are different from medical formulas prescribed for children with specific needs.

A 2020 study found that sales of toddler formula in the U.S. rose to $92 million in 2015 from $39 million in 2006.

Parents are often confused by the marketing for the formulas, according to a study led by Jennifer Harris, a marketing and public health researcher at the University of Connecticut. She found that 60% of caregivers falsely believed toddler formulas have nutrients that toddlers can’t get from other foods.

Dr. Anthony Porto, a pediatric gastroenterologist and pediatrics professor at Yale University, said he is concerned these products could be giving toddlers more nutrients and calories than they need. Unlike what’s designed for infants, toddler formula has no nutritional regulations: Experts say standardizing a supplement to toddlers’ diets is impossible because no two children are alike.

In focus groups, Harris said, parents report feeding their children toddler formula to fill nutritional gaps when a child isn’t eating enough, a common concern among parents.

“Infants are often voracious eaters,” said Dr. Stephen Daniels, chair of pediatrics at Children’s Hospital Colorado. But at around a year of age, children’s growth plateaus, he said, and “they’re suddenly not hungry in the way they used to be anymore.” That can worry parents, he added, but “it’s a completely normal phenomenon.”

If parents have concerns about their children’s diet, Daniels said, they should consult a pediatrician or family doctor.

Blanche Lincoln, president of the Infant Nutrition Council of America, which represents the makers of Enfamil, Gerber, Similac, and store brands, said in an email that the toddler formulas can be helpful because they can fill “nutritional gaps during this period of transition to table foods.” Lincoln, a former U.S. senator from Arkansas, said the drinks “help contribute to the specific nutritional needs of toddlers by providing energy and important nutrients, as well as essential vitamins and minerals during this important period of growth and development.”

But toddler formula isn’t being ingested by toddlers alone — it’s also being fed to infants. In a recent study, Porto and colleagues found that 5% of infants’ parents reported giving their babies drinks marketed for the older age group. And Harris’ research indicated that 22% of parents of infants older than 6 months had fed their babies toddler formula in the previous month. Both studies were conducted before the recent infant formula shortage, which may have exacerbated the problem.

“Infant formulas and toddler formulas tend to be next to each other in the supermarket,” Harris said. “They look similar, but the toddler formulas are cheaper than the infant formulas. So people confuse them, and they grab the wrong one. Or they think, ‘Oh, this one is less expensive. I’ll get this one instead.’”

According to an email from FDA spokesperson Lindsay Haake, toddler drinks do not meet the definition of infant formula, so they are not subject to the same requirements. That means they do not have to undergo the clinical trials and pathogen safety testing that the infant versions do. “Unlike infant formulas, toddler formulas are not necessary to meet the nutritional needs of their intended consumers,” Haake said.

In a statement to KHN, the Infant Nutrition Council of America said, “Toddler drinks have a distinctive use and nutritional makeup from infant formula; the two are not interchangeable. The labeling of toddler nutritional drinks explicitly identifies the product as a toddler drink intended for children 12 months and older on the front of the package label.”

However, several expensive toddler formula brands made by smaller companies — often advertised as being made from goat milk, A2 whole milk (which lacks one common milk protein), or vegan ingredients that aren’t soy — do meet nutritional requirements for infants, and some advertise that.

Harris argued that this confuses parents, too, and shouldn’t be allowed. Just because a toddler formula has the nutritional ingredients required by the FDA for infant formula doesn’t mean it has met the other tests required of infant formula, she said.

Federal regulators have not forced any of the companies to withdraw those products. In an email, FDA spokesperson Marianna Naum said, “The FDA does not comment on potential compliance actions.”

One company, Nature’s One, whose toddler formulas are named “Baby’s Only,” received warning letters a decade ago from the FDA about marketing them for infants. That case was closed in 2016. The company’s website says that Baby’s Only formula “meets nutrient requirements for infant” and that “Baby’s Only Organic® can be served up to 3-years of age.” Critics say that language implies the formula is fine for babies younger than 1. The company’s website and its Instagram account feature customer testimonials from parents who report feeding the formula to their infants, as well as pictures of infants drinking it.

Jay Highman, CEO and president of Nature’s One, said that Baby’s Only is clearly labeled as a toddler formula and that the back of the can states that “Baby’s Only is intended for a toddler 1-year of age or older OR when directed by a healthcare professional.” He also said that since the company launched in 1999, its formulas have met all the nutritional, manufacturing, and safety standards required of infant formula even though they don’t have to. “We behaved like we are an infant formula, but we were selling it as a toddler formula,” Highman said.

He said that the clinical trials required by the FDA are a huge barrier to bringing a new infant formula to market and that many other countries don’t require a clinical trial. Baby’s Only recently completed a clinical trial, he said, and the company expects to be able to sell it as an infant formula soon.

Yet pediatricians and nutritional experts continue to caution parents about using the toddler drinks. “There’s no question that infant formula is very important in the first year of life,” Daniels said. But he doesn’t recommend the toddler version “because it’s not that useful, because it’s confusing, because it’s expensive.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Genetic Tests Create Treatment Opportunities and Confusion for Breast Cancer Patients

Kaiser Health News:Health Industry - September 21, 2022

The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.

But the clinical significance of many of the inherited mutations that can now be identified remains unclear, and experts are torn on when and how to deploy all the new tests available. Patients are sometimes left paying out-of-pocket for exams that are not yet the standard of care, and even the most up-to-date oncologists may be uncertain how to incorporate the flood of new information into what used to be standard treatment protocols.

A quarter-century ago, Myriad Genetics introduced the first breast cancer genetic test for BRCA mutations, two genes associated with a substantially elevated risk of getting breast cancer, opening the door to a new era in genetic testing. BRCA1 and BRCA2 mutations account for as many as half of all hereditary breast cancers, and people with a problematic mutation on one of those genes have a 45% to 72% chance of developing breast cancer during their lifetimes. They may also be at higher risk for ovarian and other cancers than people without harmful BRCA mutations.

But the clinical significance is murkier for many other genetic tests.

Testing for BRCA1 and BRCA2 genes used to cost thousands of dollars. Now, for a fraction of that, doctors can order multi-gene test panels from commercial labs that look for mutations in dozens of genes. Some direct-to-consumer companies offer screening panels for a few hundred dollars, though their reliability varies.

When Jen Carbary was diagnosed with breast cancer in 2017 at age 44, genetic testing identified a mutation in a gene called PALB2 that significantly increases the risk of developing breast cancer. Guidelines suggest that breast cancer patients with a PALB2 mutation, much like those with BRCA1 and BRCA2 mutations, consider having a mastectomy to reduce the chance of a breast cancer recurrence.

“I wish genetic testing was the standard of care,” said Carbary, who owed nothing for the test because her insurer covered the cost.

Carbary, who lives in Sterling Heights, Michigan, said the test results affirmed the decision she had already made to have a double mastectomy and provided important information for family members, including her 21-year-old daughter and 18-year-old son, who will likely be tested in their mid-20s or early 30s.

But some breast cancer experts are concerned that widespread testing may also identify genetic mutations whose impact is unclear, creating anxiety and leading to further testing and to treatment of questionable value that could raise costs for the health care system.

It can also confuse patients.

“It happens a lot, that patients find their way to us after getting confusing results elsewhere,” said Dr. Mark Robson, chief of the breast medicine service at Memorial Sloan Kettering Cancer Center in New York City. Robson said the cancer center has a clinical genetics service, staffed by doctors and genetic counselors, that helps people make decisions about how to manage genetic testing results.

For people diagnosed with breast cancer, many professional groups, including the influential National Comprehensive Cancer Network, or NCCN, recommend limiting testing to certain people, including those with high-risk factors, such as a family history of breast cancer; those who are 45 or younger when they’re diagnosed; and those with Ashkenazi Jewish ancestry.

But in 2019, the American Society of Breast Surgeons recommended a different approach: Offer genetic testing to all patients who are diagnosed with or have a personal history of breast cancer. The recommendation was controversial.

“The NCCN guidelines [cover] most of the women who needed testing, but we wanted to get them all,” said Dr. Eric Manahan, a general surgeon in Dalton, Georgia, and a member of the surgeons group’s board of directors.

Mutations on other genes that are associated with breast cancer are much less common than BRCA1 and BRCA2 mutations and generally don’t increase the risk of developing breast cancer as much. The cancer-causing impact of these genes may be less clear than that of the BRCA genes, which have been tested for since the mid-1990s.

And the appropriate response to the less common mutations — whether to consider a risk-reducing mastectomy or stepped-up screening — is often unclear.

“Things get sloppier and sloppier when you look at other genes,” said Dr. Steven Katz, a professor of medicine and health management and policy at the University of Michigan. “The risks tend to be lower for different cancers, and less certain and more variable. You might walk away wondering, ‘Why’d I have to know that?’”

After people are diagnosed with breast cancer, genetic testing can help inform their decisions about the types of surgery to pursue — for example, a high risk of recurrence or a new breast cancer might persuade some to opt for more extensive surgery, such as a double mastectomy. Testing can also provide important information to family members about their potential cancer risk.

(This type of “germline” genetic testing, as it’s called, looks at mutations in the genes that people inherit from their parents. It is different from genomic tumor tests that look at specific genes or proteins in the cancer cells and can help doctors understand the rate at which the cancer cells are dividing, for example, and the likelihood of a cancer recurrence.)

Increasingly, germline genetic testing can also help guide other treatment decisions. Some patients with metastatic breast cancer who have BRCA1 or BRCA2 mutations may be good candidates for PARP inhibitors, cancer drugs that target tumors with mutations in those genes.

But genetic testing that uncovers inherited mutations in many other genes yields less clearly actionable information, even though positive results may alarm people.

At Memorial Sloan Kettering, cancer specialists focus on “therapeutic actionability,” said Robson. Will testing help someone decide whether she should get a double mastectomy or provide other important guidance? “A policy of testing everyone will identify very few additional BRCA breast mutations but will cost a lot,” he said.

As a result, doctors are debating how best to deploy and incorporate new genetic knowledge. Insurers are trying to figure out which to pay for.

There is both underuse of tests that science says are relevant and overuse of tests that experts say provide information that can’t be interpreted with any scientific certainty.

The result may be confusion for patients newly diagnosed with breast cancer as they confront the expense of genetic tests and sometimes little guidance on the proper treatment.

Some doctors say the first step is to make sure that the small group of people who would clearly benefit are getting the genetic tests whose meaning is clearly understood. Only 15% of breast cancer patients who met select NCCN testing guidelines for inherited cancer received genetic testing, according to a 2017 study that examined data from a national household health survey between 2005 and 2015.

“I would argue that our focus needs to be on the people who are at high risk for breast cancer that aren’t even identified yet,” said Dr. Tuya Pal, associate director for cancer health disparities at Vanderbilt-Ingram Cancer Center and vice chair of the NCCN guidelines panel for genetic/familial high-risk assessment of breast, ovarian, and pancreatic cancers.

Patients may fall through the cracks because no one tells them they should be tested. In one analysis, 56% of high-risk breast cancer patients who didn’t get genetic testing said their doctors didn’t recommend it.

Even if doctors recommend genetic testing, they may lack the expertise to determine which tests people need and how to interpret the results. That’s the role of genetic counselors, but their ranks are stretched thin.

The consequences can be serious. In a study of 666 breast cancer patients who received genetic testing, half of those at average risk for inherited cancer got double mastectomies based on test results that found “variants of uncertain significance,” which aren’t clinically actionable. As many as half of surgeons reported managing such patients the same way as those with cancer-causing mutations.

“The bulk of our research would say that there is still room for improvement in terms of clinicians getting the understanding they need,” said Dr. Allison Kurian, director of the women’s clinical cancer genetics program at Stanford University and a co-author of the study.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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HHS Awards nearly $1 Million to Address Eating Disorders in Adolescent Girls

HHS Gov News - September 20, 2022
HHS Office on Women’s Health awarded nearly $1 million in grant awards to improve early detection and prevention of eating disorders in adolescent girls.

Statements by HHS Secretary Xavier Becerra, Other Department Leaders on National Sickle Cell Awareness Month

HHS Gov News - September 20, 2022
Today, HHS Secretary Xavier Becerra and other HHS leaders released the following statements to celebrate September as National Sickle Cell Awareness Month

Texas, Battling Teen Pregnancy, Recasts Sex Education Standards

Kaiser Health News:States - September 20, 2022

DALLAS — J.R. Chester got pregnant the summer before her senior year of high school. A bright student with good grades, she gave birth, graduated, and was pregnant again when she arrived at college that fall.

She was a teen mom — like her mother, her grandmother, and her great-grandmother. Her school did not teach sexual health education, and preventing pregnancy was a foreign concept. Her sons are now teenagers.

“If you don’t know your options, you don’t have any,” said Chester, now a program director for Healthy Futures of Texas, a nonprofit sexual health advocacy and education organization. “Everyone was pregnant. And it just felt like: When it happens, it happens.”

While teen pregnancies have declined in the state and across the country in recent decades, Texas continues to have one of the highest state rates of teens giving birth at 22.4 births per 1,000 girls and women ages 15-19 — the lowest, in Massachusetts, is 6.1. Along with Alabama, Texas has the nation’s highest rate of repeat teen pregnancies. This fall, school districts across Texas are marking a shift to what educators call an “abstinence-plus” curriculum — the first time the state has revised its standards for sexual health education in more than 20 years.

Although districts may choose their own curriculum and teach more than the state requires, the state’s minimum health standards now go beyond focusing on abstinence to stop pregnancies and include teaching middle schoolers about contraceptives and giving additional information about preventing sexually transmitted infections, such as the human papillomavirus (HPV) that has been linked to several cancers.

Previously, a 2017 report showed 58% of Texas school districts offered “abstinence-only” sexual health education, while only 17% offered curriculums that expanded beyond that. A quarter of schools offered no sex ed.

Research shows that sex education programs that teach about contraception are effective at increasing contraceptive use and even delaying sexual activity among young people. Abstinence-focused education programs, on the other hand, have not been shown to be particularly effective at curbing sexual activity among teens.

Whether Texas teens receive any sex ed at all, though, depends on whether their parents sign them up. While parents previously had to “opt out” of sex ed portions of their kids’ health classes, they now have to “opt in” for their children to receive those lessons. That means parents must sign and return a permission slip — a change some fear could lead to kids missing out not so much due to parental objections but because of lost forms and language barriers.

These changes in sex education come as the state ratchets down abortion access following the Supreme Court decision in June overturning Roe v. Wade, which guaranteed a constitutional right to abortion. Texas has one of the nation’s most restrictive abortion laws. The question of how schools educate young people about their sexual health and development has taken on new urgency now that many state governments have enacted abortion bans.

Health advocates say many women may have no choice but to carry a pregnancy to term and that has created a new class of haves and have-nots: those who have the knowledge, resources, and agency to protect themselves from getting pregnant, and those who do not.

Texas is big and diverse enough to need education policies that can be adapted for remote border towns and sprawling metropolitan areas — both of which have high rates of unintended teen pregnancy.

In 2019, the Texas Board of Education began rewriting the health education standards that had been in place since the 1990s. It kept in place the standards stating “that there are risks associated with sexual activity and that abstinence from sexual activity is the only 100% effective method to avoid risks.”

According to the Guttmacher Institute, a reproductive health research organization, 39 states, plus the District of Columbia, mandate that sex ed classes provide information about abstinence, with 29 of them requiring that it must be “stressed.” Just 20 states and D.C. require that the classes provide information about contraception.

Under Texas law, sex ed must still present abstinence as “the preferred choice.” When schools teach about condoms and other forms of contraception, they must provide what Texas calls “human use reality rates” — or, as it is described in medical literature, “typical use” — that detail the effectiveness of those methods outside laboratory settings.

The changes taking effect this year primarily address if and when a Texas student learns about certain sexual health subjects. Under the state’s previous standards, Texas schools could teach about birth control methods beyond abstinence, but only in high school health classes, which are optional. Now, information about contraceptives, as well as more about STIs, is taught in middle school health classes, which are required.

In May, the Dallas Independent School District, one of the nation’s largest, approved lesson materials to meet the state’s new requirements. But school officials here wanted to do more given the scope of the problem. Advocates say Dallas County has the highest rate of repeat teen pregnancies in the nation.

The district curriculum goes beyond the state minimum and includes gender identity and extra information about contraceptives, as well as a contract with Healthy Futures of Texas to teach an optional after-school program for high school students.

The previous curriculum was “very scientific” and “very dry,” said Dustin Marshall, a member of the school district’s board of trustees, and left out basic information about contraceptives, like how to put on a condom.

“One of the primary ways to reduce teen pregnancy and relieve generational poverty from teen pregnancy is to teach contraception,” he said. “Not to just assume that if you teach abstinence, every kid will obey. That’s a little too head-in-the-sand, from my perspective.”

Some critics say the state’s standards, while an improvement, are inadequate when it comes to consent and LGBTQ+ issues, including gender identity. The state board does require that schools teach about healthy relationships and setting personal boundaries for sexual activity.

Under Texas law, parents have the ultimate say over not only whether their child receives sexual health education, but also what is covered in those lessons.

For nearly 30 years, school districts have been required to create and appoint school health advisory councils, tasked with reviewing and recommending health curriculums, including on sexual health. Most members must be parents and not district employees, so the content of sex ed classes can still vary widely by district.

Jen Biundo, senior director of policy and research at Healthy Futures of Texas, described a study she helped conduct asking parents and teenagers who they would prefer to teach teens about sex. While parents and teens ranked them differently, she said their choices were the same: schools, doctors, and parents. Health advocates point out that not all parents can or do educate their children about sex — and that many teens live in unstable situations like foster care.

Biundo said that when they asked teens where they learn about sex, the top answers were “my friends and the internet.”

Indeed, some parents, especially those who were teen mothers themselves, may not know about birth control or how to access it. “Where are the parents supposed to get the knowledge from?” Chester said. “Because they came through the same school system that didn’t teach sex ed, and all of a sudden they’re supposed to know what to teach their kids.”

“We are trying to end that generational curse of being uneducated,” she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Centene to Pay $166 Million to Texas in Medicaid Drug Pricing Settlement

Kaiser Health News:Health Industry - September 19, 2022

Health insurance giant Centene Corp. has agreed to pay $165.6 million to Texas to resolve claims that it overcharged the state’s Medicaid program for pharmacy services.

It’s the biggest known payout by the nation’s largest Medicaid insurer over its drug pricing practices. The deal was signed July 11 but hadn’t been publicly announced until Monday after KHN obtained a copy of the settlement through a Texas public records request and began asking questions.

The agreement makes Texas at least the 12th state to settle pharmacy billing claims with St. Louis-based Centene.

Centene did not respond Monday to multiple requests for comment about the Texas settlement. But it has denied wrongdoing in several settlements, and Centene President and Chief Operating Officer Brent Layton said last year that settlements in Ohio and Mississippi reflected the company’s “commitment to making the delivery of healthcare local, simple and transparent” and allow it to continue its “relentless focus on delivering high-quality outcomes to our members.”

Most states contract with private insurance companies such as Centene to cover people who have disabilities or earn low incomes in their state Medicaid programs, which are jointly paid for by state and federal taxpayers. In many of those states, the insurance company handles Medicaid prescription medications through what is called a pharmacy benefit manager, or PBM, to get lower prices. Such benefit managers act as middlemen between drugmakers and health insurers and as intermediaries between health plans and pharmacies. Centene has provided both those services in multiple states.

Medicaid has provided a big launching pad for Centene’s growth and revenue. The company is the largest Medicaid managed-care insurer in the country, providing health insurance benefits to 15.4 million enrollees nationwide.

Multiple states have pursued allegations against Centene’s pharmacy manager business, alleging that it overbilled their Medicaid programs for prescription drugs and pharmacy services. The total number of states is not publicly known. Centene has settled with Arkansas, Illinois, Kansas, Mississippi, New Hampshire, New Mexico, Ohio, Texas, and Washington for a total of $475 million, according to news releases and settlement documents from attorneys general in those states. Three other states and their settlement amounts have not been identified by Centene or the states themselves.

The company’s first settlements came in 2021 with Ohio and Mississippi. The $88 million that Centene agreed to pay Ohio was its largest public settlement amount before the deal with Texas.

Exactly how the company may have overcharged states, or failed to meet the terms of its contracts, is not disclosed in the settlements, said Joey Mattingly, associate professor at the University of Maryland School of Pharmacy. “There are a lot of ways you could overcharge Medicaid,” Mattingly said. “It’s quite amazing that it’s this number of states.”

The Texas settlement isn’t expected to be Centene’s final PBM payout. In a July filing with the U.S. Securities and Exchange Commission, Centene wrote that “it is in discussions to bring final resolution” to drug billing concerns in “other affected states” but did not specify the states. It set aside $1.25 billion in 2021 to resolve the pharmacy benefit manager settlements.

Among the other states may be California, which is investigating Centene’s role in providing pharmacy benefits to its Medicaid enrollees, KHN first reported in April. Florida and South Carolina have signed legal agreements with a Mississippi-based firm, Liston & Deas, that has represented other states, including Texas, in their pharmacy benefit inquiries into Centene.

Still, the settlements haven’t caused the business relationships to end. In Ohio and Mississippi, the company has renewed key state managed-care contracts after settling the pharmacy benefit allegations.

And just last week, Centene announced that Texas had renewed the contract of the company’s Texas affiliate, Superior HealthPlan, to deliver health care to foster care children and youths — despite the July settlement over its prescription drug management. Centene did not disclose the new contract’s financial terms.

An undisclosed portion of the Texas prescription drug settlement is expected to go to the federal government because of its role in helping finance Medicaid. Centene’s agreement with Texas required the company to pay half the settlement amount in August.

Centene probably agreed to pay more to Texas than Ohio because of a larger number of prescription drug claims there, said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that has worked with Liston & Deas on drug billing issues.

“The results we achieved in this case send a clear message to providers that Texas expects transparency from its Medicaid partners as required by Texas law,” said Attorney General Ken Paxton in a statement. The office did not clarify why it didn’t disclose the settlement earlier.

Pharmacy benefit managers in general have drawn increasing scrutiny and criticism. The Federal Trade Commission announced in June that it was launching an investigation into the pharmacy benefit management industry and its impact on consumer access to prescription drugs and medication costs.

“You’re seeing increasing recognition that this is an important part of the drug affordability problem in our country,” said Erin Trish, associate professor at the University of Southern California School of Pharmacy. “This is actually a pretty consolidated and poorly functioning industry that’s hidden under the veil of opacity and secrecy for a decade or so now.”

Rebecca Grapevine contributed to this article.

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

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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HHS Awards $3 Million for Initiative to Promote Black Youth Mental Health

HHS Gov News - September 19, 2022
The driving event for this press release is the NOFO awardees notified and announced.

Médicos se apresuran a usar fallo de la Corte Suprema para liberarse de cargos por opioides

Kaiser Health News:Health Industry - September 19, 2022

El doctor Nelson Onaro admitió el verano pasado que había escrito recetas ilegales, aunque dijo que solo pensaba en sus pacientes. Desde una pequeña clínica en Oklahoma, repartió cientos de pastillas de opioides y docenas de parches de fentanilo sin un propósito médico legítimo.

“Esos medicamentos fueron recetados para ayudar a mis pacientes, desde mi propio punto de vista”, dijo Onaro en la corte, mientras, a regañadientes, se declaraba culpable de seis cargos de tráfico de drogas. Al confesar, podría haber recibido una sentencia reducida de tres años o menos en prisión.

Pero Onaro cambió de opinión en julio. En los días previos a su sentencia, le pidió a un juez federal que desestimara su acuerdo de culpabilidad, enviando su caso a juicio. Para tener la oportunidad de ser exonerado, enfrentaría cuatro veces más cargos y la posibilidad de una sentencia más severa.

¿Por qué correr el riesgo? Un fallo de la Corte Suprema ha elevado el umbral para condenar en casos como el de Onaro. En una decisión de junio, el tribunal dijo que los fiscales no solo deben probar que una receta no estaba médicamente justificada sino también que el que la escribió sabía del riesgo.

De repente, el estado mental de Onaro tiene más peso en la corte. Los fiscales no se han opuesto a que el médico retire su declaración de culpabilidad de la mayoría de los cargos, admitiendo en una presentación judicial que enfrenta “un cálculo legal diferente” después de la decisión de la Corte Suprema.

El fallo unánime de la Corte complica los esfuerzos continuos del Departamento de Justicia para responsabilizar penalmente a los que recetan de manera irresponsable por alimentar la crisis de opioides.

Antes, los tribunales inferiores no habían considerado la intención del que recetaba. Hasta ahora, los médicos enjuiciados en gran medida no podían defenderse argumentando que estaban actuando de buena fe cuando emitían recetas incorrectas. Ahora pueden, aunque no es necesariamente una garantía para salir de la cárcel, dicen los abogados.

“Esencialmente, a los médicos se los esposaba”, dijo Zach Enlow, abogado de Onaro. “Ahora pueden quitarse las esposas. Pero eso no significa que van a ganar la pelea”.

La decisión de la Corte Suprema en Ruan vs. Estados Unidos, emitida el 27 de junio, fue eclipsada por la controversia nacional tres días antes, cuando el tribunal anuló los derechos federales del aborto.

Pero el fallo, menos conocido ahora, se está filtrando en silencio a través de los tribunales federales, fortaleciendo a los acusados ​​en los casos de abuso de recetas y puede tener un efecto escalofriante en futuros juicios a médicos bajo el Controlled Substance Act.

En los tres meses desde que se emitió, la decisión de Ruan se ha invocado en al menos 15 juicios en curso en 10 estados, según una revisión de KHN de los registros de la corte federal.

Los médicos citaron la decisión en las apelaciones posteriores a la condena, las mociones para absoluciones, nuevos juicios, reversiones de culpabilidad y un intento fallido de excluir el testimonio de un experto en prescripciones, argumentando que su opinión ahora era irrelevante. Otros acusados ​​han solicitado con éxito retrasar sus casos para que la decisión de Ruan pueda verse utilizarse en sus argumentos en los próximos juicios o audiencias de sentencia.

David Rivera, ex fiscal estadounidense de la era Obama, quien lideró juicios sobre abuso de prescripciones en Tennessee, dijo que cree que los médicos tienen una “gran oportunidad” de anular las condenas si se les prohibió discutir una defensa de buena fe o se instruyó a un jurado que ignorara este argumento.

Rivera dijo que los acusados ​​que movilizaban cientos de miles de pastillas aún serían condenados, incluso si finalmente se requiriera un segundo juicio. Pero la Corte Suprema ha extendido un “salvavidas” a un grupo pequeño de acusados ​​que “dispensaron con su corazón, no con su mente”, dijo.

“Lo que la Corte Suprema está tratando de hacer es dividir entre un médico malo y una persona que podría tener una licencia para practicar la medicina pero que no actúa como médico y es un traficante de drogas”, dijo Rivera. “Un médico que actúa bajo una creencia sinceramente sostenida de que está haciendo lo correcto, incluso si puede ser horrible en su trabajo y no se le deben confiar vidas, incluso eso no es criminal”.

La decisión de Ruan fue el resultado de las apelaciones de dos médicos, Xiulu Ruan y Shakeel Kahn, quienes fueron condenados por separado por recetar píldoras en Alabama y Wyoming, respectivamente, y sentenciados a 21 y 25 años de prisión. En ambos casos, los fiscales se basaron en una táctica común para mostrar que las recetas eran un delito: los testigos expertos revisaron las recetas de los acusados ​​y testificaron que estaban fuera de lugar con lo que un médico razonable haría.

Pero al escribir la opinión de la Corte Suprema, el entonces juez Stephen Breyer insistió en que la carga de la prueba no debería ser tan simple de superar, devolviendo ambas condenas a los tribunales inferiores para su reconsideración.

Debido a que a los médicos se les permite, y se espera, que distribuyan drogas, escribió Breyer, los fiscales no solo deben demostrar que escribieron recetas sin propósito médico, sino que también lo hicieron “a sabiendas o intencionalmente”. De lo contrario, los tribunales corren el riesgo de castigar “conductas que se encuentran cerca, pero en el lado permitido de la línea criminal”, escribió Breyer.

Para los abogados defensores, el fallo unánime envió un mensaje inequívoco.

“Este es un tiempo hiperpolarizado en Estados Unidos, y particularmente en la corte”, dijo Enlow. “Sin embargo, este fue un fallo de 9-0 que decía que el mens rea, o el estado mental del médico, es importante”.

Tal vez en ninguna parte la decisión de Ruan fue más apremiante que en el caso del doctor David Jankowski, un médico de Michigan que estaba en juicio.

Jankowski fue condenado por crímenes federales de drogas y fraude y enfrenta 20 años de prisión. En un anuncio del veredicto, el Departamento de Justicia dijo que el médico y su clínica suministraron a las personas “sin necesidad de drogas”, que se “vendían en las calles para alimentar las adicciones de los adictos a los opioides”.

La abogada defensora Anjali Prasad dijo que el fallo de Ruan llegٕó antes de las deliberaciones del jurado en el caso, pero después de que los fiscales pasaran semanas presentando el argumento de que el comportamiento de Jankowski no fue el de alguien que prescribe de manera razonable, un estándar legal que ya no es suficiente para convencer.

Prasad citó la decisión de Ruan en una moción para un nuevo juicio, que fue denegada, y dijo que tiene la intención de utilizar la decisión como base para una próxima apelación. La abogada también dijo que está discutiendo con otros dos clientes sobre apelar sus condenas en base a Ruan.

“Espero que los abogados de defensa penal como yo estén más fortalecidos para llevar sus casos a juicio y que sus clientes estén 100% listos para luchar contra los federales, lo cual no es una tarea fácil”, dijo Prasad.

Algunos acusados ​​lo están intentando. Hasta ahora, algunos han obtenido pequeñas victorias. Y al menos uno sufrió una derrota aplastante.

En Tennessee, la enfermera practicante Jeffrey Young, acusada de intercambiar opioides por sexo y notoriedad para ser parte de un piloto de un reality show, retrasó con éxito su juicio de mayo a noviembre para dar cuenta de la decisión de Ruan, argumentando que “alteraría drásticamente el paisaje de la guerra del gobierno contra los que hacen recetas”.

También en Tennessee, Samson Orusa, un médico y pastor que el año pasado fue condenado por entregar recetas de opioides sin examinar a los pacientes, presentó una moción para un nuevo juicio basado en la decisión de Ruan, luego persuadió a un juez reacio a retrasar su sentencia durante seis meses. para considerarlo.

Y en Ohio, el doctor Martin Escobar citó el fallo de Ruan en un argumento de 11 horas para evitar la prisión.

En enero, Escobar se declaró culpable de 54 cargos de distribución de sustancias controladas, incluidas las recetas que causaron la muerte de dos pacientes. Después de la decisión de Ruan, Escobar intentó retirar su petición, diciendo que habría ido a juicio si hubiera sabido que los fiscales tenían que demostrar intencionalidad.

Una semana después, el día en que Escobar fue sentenciado, un juez federal negó la moción.

Su declaración de culpabilidad permaneció.

Escobar fue condenado a 25 años.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Private Equity Sees the Billions in Eye Care as Firms Target High-Profit Procedures

Kaiser Health News:States - September 19, 2022

ST. LOUIS — Christina Green hoped cataract surgery would clear up her cloudy vision, which had worsened after she took a drug to fight her breast cancer.

But the former English professor said her 2019 surgery with Ophthalmology Consultants didn’t get her to 20/20 vision or fix her astigmatism — despite a $3,000 out-of-pocket charge for the astigmatism surgical upgrade. Green, 69, said she ended up feeling more like a dollar sign to the practice than a patient.

“You’re a cow among a herd as you just move from this station to this station to this station,” she said.

Ophthalmology Consultants is part of EyeCare Partners, one of the largest private equity-backed U.S. eye care groups. It is headquartered in St. Louis and counts some 300 ophthalmologists and 700 optometrists in its networks across 19 states. The group declined to comment.

Switzerland-based Partners Group bought EyeCare Partners in 2019 for $2.2 billion. Another eye care giant, Texas-based Retina Consultants of America, was formed in 2020 with a $350 million investment from Massachusetts-based Webster Equity Partners, a private equity firm, and now it says on its website it has 190 physicians across 18 states. Other private equity groups are building regional footprints with practices such as Midwest Vision Partners and EyeSouth Partners. Acquisitions have escalated so much that private equity firms now are routinely selling practices to one another.

In the past decade, private equity groups have gone from taking over a handful of practices to working with as many as 8% of the nation’s ophthalmologists, said Dr. Robert E. Wiggins Jr., president of the American Academy of Ophthalmology.

They are scooping up eye care physician practices nationwide as money-making opportunities grow in medical eye care with the aging of the U.S. population. Private equity groups, backed by wealthy investors, buy up these practices — or unify them under franchise-like agreements — with the hopes of raising profit margins by cutting administrative costs or changing business strategies. They often then resell the practices at a higher price to the next bidder.

The profit potential for private equity investors is clear: Much like paying to upgrade plane seats to first class, patients can choose expensive add-ons for many eye procedures, such as cataract surgery. For example, doctors can use lasers instead of cutting eye lenses manually, offer multifocal eye lenses that can eliminate the need for glasses, or recommend the astigmatism fix that Green said she was sold. Often, patients pay out-of-pocket for those extras — a health care payday unconstrained by insurance reimbursement negotiations. And such services can take place in outpatient and stand-alone surgery centers, both of which can be more profitable than in a hospital setting.

The investments that private equity groups provide can help doctors market and expand their practices, as well as negotiate better prices for drugs and supplies, Wiggins said. But he warned that private equity companies’ quest to maximize profitability runs the risk of compromising patient care.

“The problems are accumulating and driving up prices,” added Aditi Sen, director of research and policy at the nonprofit Health Care Cost Institute, which provides data and analysis about the economics of health care.

Yashaswini Singh, a health economist at Johns Hopkins University, and her colleagues analyzed private equity acquisitions in ophthalmology, gastroenterology, and dermatology and found that practices charged insurance an extra 20%, or an average of $71, more after the acquisition. Private equity-owned practices also saw a substantial rise in new patients and more frequent returns by old patients, according to their research, published Sept. 2 in the JAMA medical journal.

A KHN analysis also found that private equity firms are investing in the offices of doctors who prescribe at high rates two of the most common macular degeneration eye drugs, meaning the doctors are likely seeing high volumes of patients and thus are more profitable.

KHN analyzed the top 30 prescribers of the macular degeneration eye drugs Avastin and Lucentis in 2019 through a Centers for Medicare & Medicaid Services database. Private equity companies went on to invest in 23% of the top Avastin prescribers, and 43% of the top Lucentis prescribers — far higher than the 8% of ophthalmologists in which private equity currently holds a stake. Retina Consultants of America, for example, has invested in the practices of four of the top Avastin prescribers, and nine of the top Lucentis prescribers.

“The private equity model is a model that focuses on profitability, and we know they are not selecting practices randomly,” Sen said.

She noted that the volume of patients would be attractive to private equity, as well as the idea of investing in practices utilizing expensive Lucentis prescriptions, which cost roughly $1,300 an injection. Furthermore, she said, after being acquired by private equity, doctors could potentially change their prescription habits from the cheaper Avastin that costs about $40 to Lucentis – improving the bottom line.

Retina Consultants of America did not respond to requests for comment.

Last summer, Craig Johnson, then 74, decided it was finally time to have cataract surgery to fix his deteriorating eyes. He decided to go to CVP Physicians in Cincinnati, calling it “the cream of the crop locally for having eye surgery” as they do “100 a day.” The practice was already part of a private equity investment but has since been acquired by another investor, behemoth EyeCare Partners, for $600 million.

Johnson, while happy with the results of his surgery, did not know about the manual cutting version of the surgery — the cheaper but just as effective alternative to using a laser. Johnson was using private insurance because he was still working, and he said that resulted in over $2,000 out-of-pocket charges for each eye. Laser surgery typically costs more than manual and may not be covered by insurance plans, according to the American Academy of Ophthalmology.

Johnson explained that a salesperson, as well as a physician, walked him through options to improve his eyesight.

“Seniors are a vulnerable population because they’re on a fixed income, they’re a little older, they trust you … you’re wearing a white coat,” said Dr. Arvind Saini, an ophthalmologist who runs an independent practice in California’s San Diego County.

Many patients have no idea whether private equity investors have a stake in the practices they choose because they are often referred to them by another doctor or are having an eye emergency.

David Zielenziger, 70, felt lucky to get a quick appointment at one of Vitreoretinal Consultants of NY’s practices after his retina detached. Zielenziger, a former business journalist, didn’t know it was associated with Retina Consultants of America. He loved his doctor and had no complaints about the emergency care he received — and continued to go there for follow-ups. Medicare covered just about everything, he said.

“It’s a very busy practice,” he said, noting that it has expanded to more locations, which must be making the investors happy.

In 2018, Michael Kroin co-founded Physician Growth Partners, a group that helps doctors sell their practices to private equity firms, to capitalize on the explosion of interest. Eye care is one of the largest areas of investment, he said, because the specialty health care services apply to such a broad market of people.

Sixteen of the 25 private equity firms identified by industry tracker PitchBook as the biggest health care investors have bought stakes in optometry and ophthalmology practices, a KHN analysis found.

Kroin expects private equity investment in practices will only continue to accelerate because of competition from the “1,000-pound gorilla” of hospitals that also are acquiring practices and as the bureaucracy of insurance reimbursement forces more physicians to seek outside help. “If you’re not growing, it’s going to be tough to survive and make a similar level of income as you had historically,” he said.

Some health care experts worry that private equity companies could eventually be left holding an overly leveraged bag if other firms don’t want to buy the practices they’ve invested in, which could lead to the closures of those practices and ultimately even more consolidation.

“I’m not sure that most physician practices are so inefficient that you can get 20% more profit out of them,” said Dr. Lawrence Peter Casalino, chief of the division of health policy and economics at Weill Cornell Medicine’s Department of Population Health Sciences. And, he said, investors count on reselling to a buyer who will pay more than what they paid. “If that doesn’t work, the whole thing unravels.”

KHN investigative reporter Fred Schulte contributed to this article.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Many Refugees Dealing with Trauma Face Obstacles to Mental Health Care

Kaiser Health News:States - September 19, 2022

As a young boy living in what was then Zaire, Bertine Bahige remembers watching refugees flee from the Rwandan genocide in 1994 by crossing a river that forms the two Central African nations’ border.

“Little did I know that would be me a few years later,” said Bahige.

Bahige’s harrowing refugee journey began when he was kidnapped and forced to become a child soldier when war broke out in his country, which became the Democratic Republic of Congo in 1997. He escaped at age 15 to a Mozambique refugee camp, where he lived for five years until he arrived in Baltimore in 2004 through a refugee resettlement program.

Bahige, now 42, said the way he grew up was to “just buckle up and tough it out,” and he carried that philosophy into adjusting to life in the U.S. He worked multiple jobs and took community college classes until he went to the University of Wyoming on a scholarship. He is now an elementary school principal in Gillette, Wyoming, and said his coping strategy, then and now, is to keep himself busy.

“In retrospect, I don’t think I ever even dealt with my own trauma,” he said.

Refugees are arriving in the U.S. in greater numbers this year after resettlement counts reached a 40-year low under President Donald Trump. These new arrivals, like those refugees before them, are 10 times as likely as the general population to have post-traumatic stress disorder, depression, and anxiety. Many of them, like Bahige, fled their homelands because of violence or persecution. They then must deal with the mental toll of integrating into new environments that are as different as, well, Wyoming is from Central Africa.

This has Bahige concerned about the welfare of the new generation of refugees.

“The type of system that a person lived in might be completely different than the new life and system of the world they live in now,” Bahige said.

While their need for mental health services is greater than that of the general population, refugees are much less likely to receive such care. Part of the shortfall stems from societal differences. But a big factor is the overall shortage of mental health providers in the U.S., and the myriad obstacles and barriers to receiving mental health care that refugees encounter.

Whether they end up in a rural area like the Northern Rocky Mountains or in an urban setting such as Atlanta, refugees can face months-long waits for care, plus a lack of clinicians who understand the culture of the people they are serving.

Since 1975, about 3.5 million refugees have been admitted to the United States. The annual admissions dropped during the Trump administration from about 85,000 in 2016 to 11,814 in 2020, according to the State Department.

President Joe Biden raised the cap on refugee admissions to 125,000 for the 2022 federal fiscal year, which ends Sept. 30. With fewer than 18,000 arrivals by the beginning of August, that ceiling is unlikely to be reached, but the number of people admitted is increasing monthly.

Refugees receive mental health screening, along with a general medical assessment, within 90 days of their arrival. But the effectiveness of that testing largely depends on a screener’s ability to navigate complex cultural and linguistic issues, said Dr. Ranit Mishori, a professor of family medicine at Georgetown University and the senior medical adviser for Physicians for Human Rights.

Although rates of trauma are higher in the refugee population, not all displaced people need mental health services, Mishori said.

For refugees dealing with the effects of stress and adversity, resettlement agencies like the International Rescue Committee provide support.

“Some folks will come in and immediately request services, and some won’t need it for a few years until they feel fully safe, and their body has adjusted, and the trauma response has started to dissipate a little bit,” said Mackinley Gwinner, the mental health navigator for the IRC in Missoula, Montana.

Unlike Bahige’s adopted state of Wyoming, which has no refugee resettlement services, IRC Missoula has placed refugees from the Democratic Republic of the Congo, Syria, Myanmar, Iraq, Afghanistan, Eritrea, and Ukraine in Montana in recent years. A major challenge in accessing mental health services in rural areas is that very few providers speak the languages of those countries.

In the Atlanta suburb of Clarkston, which has a large population of refugees from Myanmar, the Democratic Republic of the Congo, and Syria, translation services are more available. Five mental health clinicians will work alongside IRC caseworkers under a new program by the IRC in Atlanta and Georgia State University’s Prevention Research Center. The clinicians will assess refugees’ mental health needs as the caseworkers help with their housing, employment, education, and other issues.

Seeking mental health care from a professional, though, can be an unfamiliar idea for many refugees, said Farduus Ahmed, a Somali-born former refugee mental health clinician at the University of Colorado School of Medicine.

For refugees needing mental health care, stigma can be a barrier to treatment. Some refugees fear that if U.S. authorities find out they’re struggling with mental health, they could face deportation, and some single mothers worry they will lose their children for the same reason, Ahmed said.

“Some people think seeking services means they’re ‘crazy,’” she said. “It’s very important to understand the perspective of different cultures and how they perceive mental health services.”

Long wait times, lack of cultural and language resources, and societal differences have led some health professionals to suggest alternative ways to address the mental health needs of refugees.

Widening the scope beyond individual therapy to include peer interventions can rebuild dignity and hope, said Dr. Suzan Song, a professor of psychiatry at George Washington University.

Spending time with someone who shares the same language or figuring out how to use the bus to go to the grocery store are “incredibly healing and allow someone to feel a sense of belonging,” Song said.

In Clarkston, the Prevention Research Center will soon launch an alternative allowing refugees to play a more direct role in caring for the mental health needs of community members. The center plans to train six to eight refugee women as “lay therapists,” who will counsel and train other women and mothers using a technique called narrative exposure therapy to address complex and multiple traumas.

The treatment, in which patients create a chronological narrative of their lives with the help of a therapist, focuses on traumatic experiences over a person’s lifetime.

The therapy can be culturally adapted and implemented in underserved communities, said Jonathan Orr, coordinator of the clinical mental health counseling program at Georgia State University’s Counseling and Psychological Services.

The American Psychological Association, though, only conditionally recommends narrative exposure therapy for adult patients with PTSD, advising that more research is needed.

But the method worked for Mohamad Alo, a 25-year-old Kurdish refugee living in Snellville, Georgia, after arriving in the U.S. from Syria in 2016.

Alo was attending Georgia State while working full time to support himself when the covid-19 pandemic started. While downtime during the pandemic gave him time to reflect, he didn’t have the tools to process his past, which included fleeing Syria and the threat of violence.

When his busy schedule picked back up, he felt unable to deal with his newfound anxiety and loss of focus. The narrative exposure therapy, he said, helped him deal with that stress.

Regardless of treatment options, mental health is not necessarily the top priority when a refugee arrives in the United States. “When someone has lived a life of survival, vulnerability is the last thing you’re going to portray,” Bahige said.

But Bahige also sees resettlement as an opportunity for refugees to address their mental health needs.

He said it’s important to help refugees “understand that if they take care of their mental health, they can be successful and thrive in all facets of the life they’re trying to create. Changing that mindset can be empowering, and it’s something I am still learning.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Doctors Rush to Use Supreme Court Ruling to Escape Opioid Charges

Kaiser Health News:Health Industry - September 19, 2022

Dr. Nelson Onaro conceded last summer that he’d written illegal prescriptions, although he said he was thinking only of his patients. From a tiny, brick clinic in Oklahoma, he doled out hundreds of opioid pills and dozens of fentanyl patches with no legitimate medical purpose.

“Those medications were prescribed to help my patients, from my own point of view,” Onaro said in court, as he reluctantly pleaded guilty to six counts of drug dealing. Because he confessed, the doctor was likely to get a reduced sentence of three years or less in prison.

But Onaro changed his mind in July. In the days before his sentencing, he asked a federal judge to throw out his plea deal, sending his case toward a trial. For a chance at exoneration, he’d face four times the charges and the possibility of a harsher sentence.

Why take the risk? A Supreme Court ruling has raised the bar to convict in a case like Onaro’s. In a June decision, the court said prosecutors must not only prove a prescription was not medically justified ― possibly because it was too large or dangerous, or simply unnecessary ― but also that the prescriber knew as much.

Suddenly, Onaro’s state of mind carries more weight in court. Prosecutors have not opposed the doctor withdrawing his plea to most of his charges, conceding in a court filing that he faces “a different legal calculus” after the Supreme Court decision.

The court’s unanimous ruling complicates the Department of Justice’s ongoing efforts to hold irresponsible prescribers criminally liable for fueling the opioid crisis. Previously, lower courts had not considered a prescriber’s intention. Until now, doctors on trial largely could not defend themselves by arguing they were acting in good faith when they wrote bad prescriptions. Now they can, attorneys say, although it is not necessarily a get-out-of-jail-free card.

“Essentially, the doctors were handcuffed,” said Zach Enlow, Onaro’s attorney. “Now they can take off their handcuffs. But it doesn’t mean they are going to win the fight.”

The Supreme Court’s decision in Ruan v. United States, issued June 27, was overshadowed by the nation-shaking controversy ignited three days earlier, when the court erased federal abortion rights. But the lesser-known ruling is now quietly percolating through federal courthouses, where it has emboldened defendants in overprescribing cases and may have a chilling effect on future prosecutions of doctors under the Controlled Substances Act.

In the three months since it was issued, the Ruan decision has been invoked in at least 15 ongoing prosecutions across 10 states, according to a KHN review of federal court records. Doctors cited the decision in post-conviction appeals, motions for acquittals, new trials, plea reversals, and a failed attempt to exclude the testimony of a prescribing expert, arguing their opinion was now irrelevant. Other defendants have successfully petitioned to delay their cases so the Ruan decision could be folded into their arguments at upcoming trials or sentencing hearings.

David Rivera, a former Obama-era U.S. attorney who once led overprescribing prosecutions in Middle Tennessee, said he believes doctors have a “great chance” of overturning convictions if they were prohibited from arguing a good faith defense or a jury was instructed to ignore one.

Rivera said defendants who ran true pill mills would still be convicted, even if a second trial was ultimately required. But the Supreme Court has extended a “lifeline” to a narrow group of defendants who “dispensed with their heart, not their mind,” he said.

“What the Supreme Court is trying to do is divide between a bad doctor and a person who might have a license to practice medicine but is not acting as a doctor at all and is a drug dealer,” Rivera said. “A doctor who is acting under a sincerely held belief that he is doing the right thing, even if he may be horrible at his job and should not be trusted with human lives ― that’s still not criminal.”

The Ruan decision resulted from the appeals of two doctors, Xiulu Ruan and Shakeel Kahn, who were separately convicted of running pill mills in Alabama and Wyoming, respectively, then sentenced to 21 and 25 years in prison. In both cases, prosecutors relied on a common tactic to show the prescriptions were a crime: Expert witnesses reviewed the defendants’ prescriptions and testified that they were far out of line with what a reasonable doctor would do.

But in writing the opinion of the Supreme Court, then-Justice Stephen Breyer insisted the burden of proof should not be so simple to overcome, remanding both convictions back to the lower courts for reconsideration.

Because doctors are allowed and expected to distribute drugs, Breyer wrote, prosecutors must not only prove they wrote prescriptions with no medical purpose but also that they did so “knowingly or intentionally.” Otherwise, the courts risk punishing “conduct that lies close to, but on the permissible side of, the criminal line,” Breyer wrote.

To defense attorneys, the unanimous ruling sent an unambiguous message.

“This is a hyperpolarized time in America, and particularly on the court,” Enlow said. “And yet this was a 9-0 ruling saying that the mens rea ― or the mental state of the doctor ― it matters.”

Maybe nowhere was the Ruan decision more pressing than in the case of Dr. David Jankowski, a Michigan physician who was on trial when the burden of proof shifted beneath his feet.

Jankowski was convicted of federal drug and fraud crimes and faces 20 years in prison. In an announcement of the verdict, the DOJ said the doctor and his clinic supplied people with “no need for the drugs,” which were “sold on the streets to feed the addictions of opioid addicts.”

Defense attorney Anjali Prasad said the Ruan ruling dropped before jury deliberations in the case but after prosecutors spent weeks presenting the argument that Jankowski’s behavior was not that of a reasonable prescriber — a legal standard that on its own is no longer enough to convict.

Prasad cited the Ruan decision in a motion for a new trial, which was denied, and said she intends to use the decision as a basis for a forthcoming appeal. The attorney also said she is in discussion with two other clients about appealing their convictions with Ruan.

“My hope is that criminal defense attorneys like myself are more emboldened to take their cases to trial and that their clients are 100% ready to fight the feds, which is no easy task,” Prasad said. “We just duke it out in the courtroom. We can prevail that way.”

Some defendants are trying. So far, a few have scored small wins. And at least one suffered a crushing defeat.

In Tennessee, nurse practitioner Jeffrey Young, accused of trading opioids for sex and notoriety for a reality show pilot, successfully delayed his trial from May to November to account for the Ruan decision, arguing it would “drastically alter the landscape of the Government’s war on prescribers.”

Also in Tennessee, Samson Orusa, a doctor and pastor who last year was convicted of handing out opioid prescriptions without examining patients, filed a motion for a new trial based on the Ruan decision, then persuaded a reluctant judge to delay his sentencing for six months to consider it.

And in Ohio, Dr. Martin Escobar cited the Ruan ruling in an eleventh-hour effort to avoid prison.

Escobar in January pleaded guilty to 54 counts of distributing a controlled substance, including prescriptions that caused the deaths of two patients. After the Ruan decision, Escobar tried to withdraw his plea, saying he’d have gone to trial if he’d known prosecutors had to prove his intent.

One week later, on the day Escobar was set to be sentenced, a federal judge denied the motion.

His guilty plea remained.

Escobar got 25 years.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Journalists Look Into Wildfire Trauma and the South’s Monkeypox Response

Kaiser Health News:States - September 17, 2022

KHN reporter and producer Heidi de Marco discussed the impact of wildfire trauma on children in Northern California on CapRadio’s “Insight With Vicki Gonzalez” on Sept. 13.

KHN Florida correspondent Daniel Chang discussed the Southern response to the monkeypox outbreak on C-SPAN’s “Washington Today” on Sept. 14.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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A Disability Program Promised to Lift People From Poverty. Instead, It Left Many Homeless.

Kaiser Health News:States - September 16, 2022

CHARLOTTE, N.C. — After two months of sleeping in the Salvation Army Center of Hope homeless shelter, Margaret Davis has had no luck finding an apartment she can afford.

The 55-year-old grandmother receives about $750 a month from the federal government. She’s trying to live on just $50 cash and $150 in food stamps each month so she can save enough for a place to call home.

Davis is homeless even though she receives funds from the Supplemental Security Income program, a hard-to-get federal benefit that was created nearly 50 years ago to lift out of poverty Americans who are older, blind, or disabled.

Davis’ job options are limited because she gets dialysis treatment three times a week for kidney failure. As she prepared to spend another night in the crowded shelter, she checked her phone to see whether a doctor wanted her to have her left leg amputated.

“My therapist is trying to help me stay positive but sometimes I just want to end this life and start over,” Davis said.

Falling into homelessness is not a new issue for people who receive supplemental income from the Social Security Administration. But moving recipients out of shelters, crime-ridden motels, and tent encampments and into stable housing has been getting harder, according to nonprofit attorneys, advocates for people with disabilities, and academic researchers.

Rapidly rising rents and inflation deserve a share of the blame.

But SSI recipients, activists, and others said the issue underscores for them how the program itself locks millions of people into housing instability and deep poverty even as President Joe Biden promises to fix it.

“We are trapping people in a place where dignity is out of reach,” said Rebecca Vallas, a senior fellow at the Century Foundation, a progressive think tank that conducts research on economic equity. “The program started with good intentions,” she said. “It is hard for me to see this as anything but willful neglect.”

In a country where roughly 1 in 4 residents live with some type of disability, supplemental income is meant to ensure that the most vulnerable can get housing and other basic needs. Most SSI recipients automatically qualify for Medicaid, a joint federal and state program that covers medical costs for people with low incomes.

In addition to people who are blind or who are 65 or older, those who prove they have a medical condition that prevents them from working for at least one year are eligible for a monthly payment from SSI, which maxes out at $841. But there’s a catch that makes seeing a better financial future difficult for people like Davis. The monetary benefit decreases if the person earns more than $85 a month in additional income. And both the income and Medicaid benefits are revoked if the person saves more than $2,000, which critics say discourages people from saving.

The amount that recipients receive has not kept pace with rising rent prices, advocacy groups say.

The amount of money Davis said she gets each month from the program is about $60 more than the maximum amount offered 10 years ago, when she first started receiving the benefit. Yet the average apartment in Charlotte, where Davis lives, now rents for $1,500 a month, about 70% more than it did nearly a decade ago, according to Zumper, which has been tracking rental prices since 2014.

There’s no chance she can afford her dream: an apartment or house in a safe neighborhood where she can spend afternoons crocheting. “I don’t like to talk like this, but I am not sure what’s going to happen to me,” Davis said.

When Congress created SSI in 1972, the legislation promised that recipients “would no longer have to subsist on below-poverty-level incomes.”

Today, nearly 8 million people rely on the federal program for income.

Over the past five decades, Congress under both Republican and Democratic leadership has declined to make major changes to the program. The $85 outside income limit, for instance, has never been adjusted to account for inflation.

The Social Security Administration, which oversees the program, did not respond to multiple requests for comment about how the rates are set.

Biden committed to reforming SSI during his 2020 presidential campaign, saying that he would “protect and strengthen economic security for people with disabilities.”

But for seven months, Delisa Williams has been stuck in the same homeless shelter as Davis. Diabetes, hypertension, and osteoporosis have left her body weakened, and the stress of living in the Salvation Army Center of Hope is taking a toll on her mental health.

Williams’ only real chance to get out had been the combined $881 she got each month from SSI and the Social Security Disability Insurance program, which has similar limits and requirements. She quickly realized that would not be enough to afford the rent for most places.

“God will see me through,” she said. “He didn’t bring me this far for nothing.”

Among developed nations, the United States is one of the hardest places for people to meet the criteria for disability payments, according to the Organization for Economic Cooperation and Development, a global intergovernmental group the U.S. helped create to advance social well-being.

If a person applies for disability income, they can wait months or even years to get benefits. Thousands go broke or die while waiting for help. A data analysis by the U.S. Government Accountability Office found that from 2014 to 2019, about 48,000 people filed for bankruptcy while trying to get a final decision on a disability appeal. The same report said that from 2008 to 2019 more than 100,000 people died waiting.

The situation was made worse during the covid-19 pandemic because the Social Security Administration closed more than 1,200 field offices across the nation and kept them shuttered for roughly two years.

That decision left hundreds of thousands of needy people unable to seek benefits, since phone lines were jammed with calls and the agency provides no way to submit applications online, said David Weaver, a former associate commissioner for research, demonstration, and employment support at the Social Security Administration.

“The number of SSI awards just collapsed,” Weaver said.

Homeless shelters and other nonprofits often help clients apply for the supplemental income in hopes that the money will help get them a place to live. Rachael Mason, a social worker at the Triune Mercy Center in Greenville, South Carolina, has learned to temper people’s expectations.

“Any time someone shows up and says I want to pursue housing, my heart drops a little bit,” Mason said. “I have to be honest and tell them it could be a year to three years. Even if someone wants to just rent a room in a house, it could take up their entire check.”

As the 50th anniversary of SSI approaches this fall, Congress is deciding whether to make changes to the program.

In an April 2021 letter to Biden and Vice President Kamala Harris, more than 40 lawmakers lobbied them to raise cash benefits above the poverty level, increase the amount of money recipients can save, and eliminate reductions for taking help from loved ones, among other changes. “People with disabilities and older adults receiving SSI represent some of the most marginalized members of our society,” the letter said. “History will not forgive us if we fail to address their needs in the recovery effort.”

A group of Republican and Democratic legislators have now proposed the SSI Savings Penalty Elimination Act, which would raise the asset limit for recipients from $2,000 to $10,000 for individuals and from $3,000 to $20,000 for couples.

Davis, the woman whose leg might be amputated, is trying to remain hopeful. She started seeing a therapist to cope with depression. She stopped smoking to save money for an apartment.

Asked when she might be able to move out of the shelter, she said, “I don’t know.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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New Abortion Laws Jeopardize Cancer Treatment for Pregnant Patients

Kaiser Health News:Health Industry - September 16, 2022

As abortion bans go into effect across a contiguous swath of the South, cancer physicians are wrestling with how new state laws will influence their discussions with pregnant patients about what treatment options they can offer.

Cancer coincides with roughly 1 in 1,000 pregnancies, most frequently breast cancer, melanoma, cervical cancer, lymphomas, and leukemias. But medications and other treatments can be toxic to the developing fetus or cause birth defects. In some cases, hormones that are supercharged during pregnancy fuel the cancer’s growth, putting the patient at greater risk.

Although new abortion restrictions often allow exceptions based on “medical emergency” or a “life-threatening physical condition,” cancer physicians describe the legal terms as unclear. They fear misinterpreting the laws and being left in the lurch.

For instance, brain cancer patients have traditionally been offered the option of abortion if a pregnancy might limit or delay surgery, radiation, or other treatment, said Dr. Edjah Nduom, a brain cancer surgeon at Emory University’s Winship Cancer Institute in Atlanta.

“Is that a medical emergency that necessitates the abortion? I don’t know,” Nduom asked, trying to parse the medical emergency exception in the new Georgia law. “Then you end up in a situation where you have an overzealous prosecutor who is saying, ‘Hey, this patient had a medical abortion; why did you need to do that?’” he said.

Pregnant patients with cancer should be treated similarly to non-pregnant patients when feasible, though sometimes adjustments are made in the timing of surgery and other care, according to a research overview, published in 2020 in Current Oncology Reports.

With breast cancer patients, surgery could be performed early on as part of the treatment, pushing chemotherapy to later in the pregnancy, according to the research. Cancer experts typically recommend avoiding radiation therapy throughout pregnancy, and most chemotherapy drugs during the first trimester.

But with some cancers, such as acute leukemia, the recommended drugs have known toxic risks to the fetus, and time is not on the patient’s side, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society.

“You need treatment urgently,” she said. “You can’t wait three months or six months to complete a pregnancy.”

Another life-threatening scenario involves a patient early in her pregnancy who has been diagnosed with breast cancer that’s spreading, and tests show that the cancer’s growth is spurred by the hormone estrogen, said Dr. Debra Patt, an oncologist in Austin, Texas, who estimated she has cared for more than two dozen pregnant patients with breast cancer.

“Pregnancy is a state where you have increased levels of estrogen. It’s actually actively at every moment causing the cancer to grow more. So I would consider that an emergency,” said Patt, who is also executive vice president over policy and strategic initiatives at Texas Oncology, a statewide practice with more than 500 physicians.

When cancer strikes individuals of child-bearing age, one challenge is that malignancies tend to be more aggressive, said Dr. Miriam Atkins, an oncologist in Augusta, Georgia. Another is that it’s unknown whether some of the newer cancer drugs will affect the fetus, she said.

While hospital ethics committees might be consulted about a particular treatment dilemma, it’s the facility’s legal interpretation of a state’s abortion law that will likely prevail, said Micah Hester, an expert on ethics committees who chairs the department of medical humanities and bioethics at the University of Arkansas for Medical Sciences College of Medicine in Little Rock.

“Let’s be honest,” he said. “The legal landscape sets pretty strong parameters in many states on what you can and cannot do.”

It’s difficult to fully assess how physicians plan to handle such dilemmas and discussions in states with near-total abortion bans. Several large medical centers contacted for this article said their physicians were not interested or not available to speak on the subject.

Other physicians, including Nduom and Atkins, said the new laws won’t alter their discussions with patients about the best treatment approach, the potential impact of pregnancy, or whether abortion is an option.

“I’m going to always be honest with patients,” Atkins said. “Oncology drugs are dangerous. There are some drugs that you can give to [pregnant] cancer patients; there are many that you cannot.”

The bottom line, maintain some, is that termination remains a critical and legal part of care when cancer threatens someone’s life.

Patients “are counseled on the best treatment options for them, and the potential impacts on their pregnancies and future fertility,” Dr. Joseph Biggio Jr., chair of maternal-fetal medicine at Ochsner Health System in New Orleans, wrote in an email. “Under state laws, pregnancy termination to save the life of the mother is legal.”

Similarly, Patt said that physicians in Texas can counsel pregnant patients with cancer about the procedure if, for instance, treatments carry documented risks of birth defects. Thus, physicians can’t recommend them, and abortion can be offered, she said.

“I don’t think it’s controversial in any way,” Patt said. “Cancer left unabated can pose serious risks to life.”

Patt has been educating physicians at Texas Oncology on the new state law, as well as sharing a JAMA Internal Medicine editorial that provides details about abortion care resources. “I feel pretty strongly about this, that knowledge is power,” she said.

Still, the Texas law’s vague terminology complicates physicians’ ability to determine what’s legally permissible care, said Joanna Grossman, a professor at SMU Dedman School of Law. She said nothing in the statute tells a doctor “how much risk there needs to be before we label this legally ‘life-threatening.’”

And if a woman can’t obtain an abortion through legal means, she has “grim options,” according to Hester, the medical ethicist. She’ll have to sort through questions like: “Is it best for her to get the cancer treatment on the time scale recommended by medicine,” he said, “or to delay that cancer treatment in order to maximize the health benefits to the fetus?”

Getting an abortion outside Georgia might not be possible for patients with limited cash or no backup child care or who share one car with an extended family, Atkins said. “I have many patients who can barely travel to get their chemotherapy.”

Dr. Charles Brown, a maternal-fetal medicine physician in Austin who retired this year, said he can speak more freely than practicing colleagues. The scenarios and related unanswered questions are almost too numerous to count, said Brown, who has cared for pregnant women with cancer.

Take as another example, he said, a potential situation in a state that incorporates “fetal personhood” in its law, such as Georgia. What if a patient with cancer can’t get an abortion, Brown asked, and the treatment has known toxic effects?

“What if she says, ‘Well, I don’t want to delay my treatment — give me the medicine anyway,’” Brown said. “And we know that medicine can harm the fetus. Am I now liable for harm to the fetus because it’s a person?”

Whenever possible, physicians have always strived to treat the patient’s cancer and preserve the pregnancy, Brown said. When those goals conflict, he said, “these are gut-wrenching trade-offs that these pregnant women have to make.” If termination is off the table, “you’ve removed one of the options to manage her disease.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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HHS Awards More Than $3.6 Million to Bolster Support, Training on Substance Use Disorder During Pregnancy and Postpartum

HHS Gov News - September 16, 2022
HHS awarded over $3.6 million to 7 organizations to bolster support for individuals experiencing substance use disorder (SUD) during pregnancy and postpartum.

Statement from HHS Secretary Xavier Becerra on National Hispanic Heritage Month

HHS Gov News - September 15, 2022
Today, HHS Secretary Xavier Becerra issued the following statement to mark the beginning of National Hispanic Heritage Month

Court Ruling May Spur Competitive Health Plans to Bring Back Copays for Preventive Services

Kaiser Health News:States - September 15, 2022

Tom and Mary Jo York are a health-conscious couple, going in for annual physicals and periodic colorectal cancer screening tests. Mary Jo, whose mother and aunts had breast cancer, also gets regular mammography tests.

The Yorks, who live in New Berlin, Wisconsin, are enrolled in Chorus Community Health Plans, which, like most of the nation’s health plans, is required by the Affordable Care Act to pay for those preventive services, and more than 100 others, without charging deductibles or copays.

Tom York, 57, said he appreciates the law’s mandate because until this year the deductible on his plan was $5,000, meaning that without that ACA provision, he and his wife would have had to pay full price for those services until the deductible was met. “A colonoscopy could cost $4,000,” he said. “I can’t say I would have skipped it, but I would have had to think hard about it.”

Now health plans and self-insured employers — those that pay workers’ and dependents’ medical costs themselves — may consider imposing cost sharing for preventive services on their members and workers. That’s because of a federal judge’s Sept. 7 ruling in a Texas lawsuit filed by conservative groups claiming that the ACA’s mandate that health plans pay the full cost of preventive services, often called first-dollar coverage, is unconstitutional.

U.S. District Judge Reed O’Connor agreed with them. He ruled that the members of one of the three groups that make coverage recommendations, the U.S. Preventive Services Task Force, were not lawfully appointed under the Constitution because they were not nominated by the president and confirmed by the Senate.

If the preventive services coverage mandate is partly struck down, the result could be a confusing patchwork of health plan benefit designs offered in various industries and in different parts of the country. Patients who have serious medical conditions or are at high risk for such conditions may have a hard time finding a plan that fully covers preventive and screening services.

O’Connor also held that requiring the plaintiffs to pay for HIV prevention drugs violates the Religious Freedom Restoration Act of 1993. He’s also considering throwing out the mandate for first-dollar coverage for contraceptives, which the plaintiffs also challenged under that statute. O’Connor postponed ruling on that and legal remedies until after he receives additional briefs from the parties to the lawsuit on Sept. 16. No matter what the judge does, the case is likely to be appealed by the federal government and could reach the Supreme Court.

If O’Connor were to order an immediate end to the no-cost coverage mandate for services that won approval from the preventive services task force, nearly half the recommended preventive services under the ACA would be in jeopardy. These include screening tests for cancer, diabetes, depression, and sexually transmitted infections.

Many health plans and self-insured employers would likely react by imposing deductibles and copays for some or all the services recommended by the task force.

“Larger employers will evaluate what they cover first-dollar and what they don’t cover,” said Michael Thompson, CEO of the National Alliance of Healthcare Purchaser Coalitions, a nonprofit group of employer and union health plans that work together to help reduce prices. He thinks employers with high employee turnover and health insurance companies are the likeliest to add cost sharing.

That could destabilize the health insurance markets, said Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation.

Insurers will design their preventive service benefits to attract the healthiest people so they can reduce their premiums, she predicted, saddling sicker and older people with skimpier coverage and higher out-of-pocket costs. “It reintroduces the chaos that the ACA was designed to fix,” she said. “It becomes a race to the bottom.”

The most probable services to be targeted for cost sharing are HIV prevention and contraception, said Dr. Jeff Levin-Scherz, population health leader at WTW (formerly Willis Towers Watson), who advises employers on health plans.

Studies have shown that eliminating cost sharing boosts the use of preventive services and saves lives. After the ACA required that Medicare cover colorectal cancer screenings without cost sharing, diagnoses of early-stage colorectal cancer increased 8% per year, improving life expectancy for thousands of seniors, according to a 2017 study published in the journal Health Affairs.

Adding cost sharing could mean hundreds or thousands of dollars in out-of-pocket spending for patients because many Americans are enrolled in high-deductible plans. In 2020, the average annual deductible in the individual insurance market was $4,364 for single coverage and $8,439 for family coverage, according to eHealth, a private, online insurance broker. For employer plans, it was $1,945 for an individual and $3,722 for families, according to KFF.

O’Connor upheld the constitutional authority of two other federal agencies that recommend preventive services for women and children and for immunizations, so first-dollar coverage for those services seemingly is not in jeopardy.

If the courts strike down the mandate for the preventive services task force’s recommendations, health plan executives will face a tough decision. Mark Rakowski, president of the nonprofit Chorus Community Health Plans, said he strongly believes in the health value of preventive services and likes making them more affordable to enrollees by waiving deductibles and copayments.

But if the mandate is partly eliminated, he expects that competitors would establish deductibles and copays for preventive services to help make their premiums about 2% lower. Then, he said, he would be forced to do the same to keep his plans competitive on Wisconsin’s ACA marketplace. “I hate to admit that we’d have to strongly consider following suit,” Rakowski said, adding that he might offer other plans with no-cost preventive coverage and higher premiums.

The ACA’s coverage rule for preventive services applies to private plans in the individual and group markets, which cover more than 150 million Americans. It is a popular provision of the law, favored by 62% of Americans, according to a 2019 KFF survey.

Spending on ACA-mandated preventive services is relatively small but not insignificant. It is 2% to 3.5% of total annual expenditures by private employer health plans, or about $100 to $200 per person, according to the Health Care Cost Institute, a nonprofit research group.

Several large commercial insurers and health insurance trade groups did not respond to requests for comment or declined to comment about what payers will do if the courts end the preventive services mandate.

Experts fear that cost sharing for preventive services would hurt growing efforts to reduce health disparities.

“If it’s left up to individual plans and employers to make these decisions about cost sharing, underserved Black and brown communities that have benefited from the removal of cost sharing will be disproportionally harmed,” said Dr. A. Mark Fendrick, director of the University of Michigan Center for Value-Based Insurance Design, who helped draft the ACA’s preventive services coverage section.

One service of particular concern is preexposure prophylaxis for HIV, or PrEP, a highly effective drug regimen that prevents high-risk people from acquiring HIV. The plaintiffs in the lawsuit in Texas claimed that having to pay for PrEP forces them to subsidize “homosexual behavior” to which they have religious objections.

Since 2020, health plans have been required to fully cover PrEP drugs and associated lab tests and doctor visits that otherwise can cost thousands of dollars a year. Of the 1.1 million people who could benefit from PrEP, 44% are Black and 25% are Hispanic, according to the Centers for Disease Control and Prevention. Many also are low-income. Before the PrEP coverage rule took effect, only about 10% of eligible Black and Hispanic people had started PrEP treatment because of its high cost.

O’Connor, despite citing the evidence that PrEP drugs reduce HIV spread through sex by 99% and through injection drug use by 74%, held that the government did not show a compelling governmental interest in mandating no-cost coverage of PrEP.

“We’re trying to make it easier to get PrEP, and there are plenty of barriers already,” said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute. “If first-dollar coverage went away, people won’t pick up the drug. That would be extremely damaging for our efforts to end HIV and hepatitis.”

Robert York, an LGBT activist who lives in Arlington, Virginia, who is not related to Tom York, has taken Descovy, a brand-name PrEP drug, for about six years. Having to pay cost sharing for the drug and associated tests every three months under his employer’s health plan would force changes in his personal spending, he said. The retail price of the drug alone is about $2,000 a month.

But York, who’s 54, stressed that reestablishing cost sharing for PrEP would affect people in lower-income and marginalized groups even more.

“We’ve been working so hard with the community to get PrEP into the hands of people who need it,” he said. “Why is anyone targeting this?”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Montana Health Department Seeks to Ax Board That Hears Public Assistance Appeals

Kaiser Health News:Health Industry - September 15, 2022

Montana health officials are asking state lawmakers to eliminate a board that hears appeals from people who believe they were wrongly denied public assistance benefits.

Since 2016, the Board of Public Assistance has heard fewer than 20 cases a year, and very few of those are overturned, but preparing for those appeals and board meetings takes time from state Department of Public Health and Human Services’ staff members and attorneys, according to the department’s proposal.

Getting rid of the appellate board also would help public assistance applicants who are rejected appeal their cases directly to district court, health department Director Charlie Brereton recently told lawmakers. Currently, rejected applicants can take their cases to court only after the board hears their appeals, though very few do so, according to a board member.

“I want to be very clear, with this proposal we are not seeking to eliminate an appeals pathway; rather, we’re streamlining the process and eliminating what we see as an unnecessary and underutilized step,” Brereton said.

The plan to get rid of the Board of Public Assistance is one of 14 bills that the state Department of Public Health and Human Services has asked legislators to draft for the session that begins in January. The proposal comes from a review of the state agencies under Republican Gov. Greg Gianforte’s Red Tape Relief Task Force, which seeks to improve efficiency and eliminate outdated or unnecessary regulations.

The three-person Board of Public Assistance presides over appeals of denials made by the health department’s Office of Administrative Hearings in nine programs: Temporary Assistance for Needy Families, which provides cash to low-income households with children; the Supplemental Nutrition Assistance Program, formerly known as food stamps; Medicaid, the federal-state program that pays for health care for low-income people; developmental disabilities services; the Low Income Energy Assistance Program; the Weatherization Assistance Program; refugee assistance; mental health services; and Healthy Montana Kids, which is the state’s Children’s Health Insurance Program.

The proposal to eliminate the board came as a surprise to at least one of its members, who learned about it from KHN. “I haven’t heard anything from the department,” said Sharon Bonogofsky-Parker, a Billings resident appointed by Gianforte in March 2021.

The board meets every other month, Bonogofsky-Parker said. She recalled one “really good case” during her tenure in which the board restored benefits to a disabled military veteran who had lost them because of documents forged by someone else.

But Bonogofsky-Parker estimated that the board sides with the department’s decisions about 90% of the time because most cases involve applicants who didn’t understand or follow the programs’ rules, whose income level changed, or who have some other clear disqualifying factor.

The board provides a service by hearing appeals that would otherwise clog the court system, she said. “By and large, these cases are pretty frivolous,” Bonogofsky-Parker said. “The board is useful in keeping a lot of these cases out of court.”

The view contrasts with Brereton’s, who described the ability of applicants to file court grievances expediently as a benefit of the proposed change.

District courts charge a $120 fee to start a proceeding of this type, according to the Lewis and Clark County District Court clerk’s office. That would create a potential obstacle for people trying to prove they qualify for public assistance. By contrast, Board of Public Assistance appeals are free.

State health department spokesperson Jon Ebelt said people with low incomes can fill out a form to request a court fee waiver. “This issue was considered during conceptual stages of the bill,” he said.

Bonogofsky-Parker said she doesn’t plan to oppose the department’s proposal, despite her view that the board acts as a bulwark against frivolous court cases. The other two board members, Gianforte appointee Danielle Shyne and Carolyn Pease-Lopez, a holdover from former Democratic Gov. Steve Bullock, did not respond to phone or email messages.

The Children, Families, Health, and Human Services Interim Committee will draft the bill for consideration by the full legislature in the 2023 session.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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