By Jazmin Orozco Rodriguez, KFF Health News (TNS)

Natalie Holt sees reminders nearly everywhere of the serious toll a years-long syphilis outbreak has taken in South Dakota. Scrambling to tamp down the spread of the devastating disease, public health officials are blasting messages to South Dakotans on billboards and television, urging people to get tested.

Holt works in Aberdeen, a city of about 28,000 surrounded by a sea of prairie, as a physician and the chief medical officer for the Great Plains Area Indian Health Service, one of 12 regional divisions of the federal agency responsible for providing health care to Native Americans and Alaska Natives in the U.S.

The response to this public health issue, she said, is not so different from the approach with the coronavirus pandemic — federal, state, local, and tribal groups need to “divide and conquer” as they work to test and treat residents. But they are responding to this crisis with fewer resources because federal officials haven’t declared it a public health emergency.

The public pleas for testing are part of health officials’ efforts to halt the outbreak that has disproportionately hurt Native Americans in the Great Plains and Southwest. According to the Great Plains Tribal Epidemiology Center, syphilis rates among Native Americans in its region soared by 1,865% from 2020 to 2022 — over 10 times the 154% increase seen nationally during the same period. The epidemiology center’s region spans Iowa, Nebraska, North Dakota, and South Dakota. The center also found that 1 in 40 Native American and Alaska Native babies born in the region in 2022 had a syphilis infection.

The rise in infections accelerated in 2021, pinching public health leaders still reeling from the coronavirus pandemic.

Three years later, the outbreak continues — the number of new infections so far this year is 10 times the full 12-month totals recorded in some years before the upsurge. And tribal health leaders say their calls for federal officials to declare a public health emergency have gone unheeded.

Pleas for help from local and regional tribal health leaders like Meghan Curry O’Connell, the chief public health officer for the Great Plains Tribal Leaders’ Health Board and a citizen of the Cherokee Nation, preceded a September letter from the National Indian Health Board, a Washington, D.C.-based nonprofit that advocates for health care for U.S. tribes, to publicly urge the Department of Health and Human Services to declare a public health emergency. Tribal leaders said they need federal resources including public health workers, access to data and national stockpile supplies, and funding.

According to data from the South Dakota Department of Health, 577 cases of syphilis have been documented this year in the state. Of those, 430 were among Native American people — making up 75% of the state’s syphilis cases, whereas the group accounts for just 9% of the population.

The numbers can be hard to process, O’Connell said.

“It’s completely preventable and curable, so something has gone horribly wrong that this has occurred,” she said.

The Great Plains Tribal Leaders’ Health Board first called on HHS to declare a public health emergency in February. O’Connell said the federal agency sent a letter in response outlining some resources and training it has steered toward the outbreak, but it stopped short of declaring an emergency or providing the substantial resources the board requested. The board’s now months-old plea for resources was like the recent one from the National Indian Health Board.

“We know how to address this, but we do need extra support and resources in order to do it,” she said.

Syphilis is a sexually transmitted infection that can result in life-threatening damage to the heart, brain, and other organs if left untreated. Women infected while pregnant can pass the disease to their babies. Those infections in newborns, called congenital syphilis, kill dozens of babies each year and can lead to devastating health effects in others.

Holt said the Indian Health Service facilities she oversees have averaged more than 1,300 tests for syphilis monthly. She said a recent decline in new cases detected each month — down from 92 in January to 29 in September — may be a sign that things are improving. But a lot of damage has been done during the past few years.

Cases of congenital syphilis across the country have more than tripled in recent years, according to the Centers for Disease Control and Prevention. In 2022, 3,700 cases were reported — the most in a single year since 1994.

The highest rate of reported primary and secondary syphilis cases in 2022 was among non-Hispanic American Indian or Alaska Native people, with 67 cases per 100,000, according to CDC data.

O’Connell and other tribal leaders said they don’t have the resources needed to keep pace with the outbreak.

Chief William Smith, vice president of Alaska’s Valdez Native Tribe and chairperson of the National Indian Health Board, told HHS in the organization’s letter that tribal health systems need greater federal investment so the system can better respond to public health threats.

Rafael Benavides, HHS’ deputy assistant secretary for public affairs, said the agency has received the letter sent in early September and will respond directly to the authors.

“HHS is committed to addressing the urgent syphilis crisis in American Indian and Alaska Native communities and supporting tribal leaders’ efforts to mobilize and raise awareness to address this important public health crisis,” he said.

Federal officials from the health department and the CDC have formed task forces and hosted workshops for tribes on how to address the outbreak. But tribal leaders insist a public health emergency declaration is needed more than anything else.

Holt said that while new cases seem to be declining, officials continue to fight further spread with what resources they have. But obstacles remain, such as convincing people without symptoms to get tested for syphilis. To make this easier, appointments are not required. When people pick up medications at a pharmacy, they receive flyers about syphilis and information about where and when to get tested.

Despite this “full court press” approach, Holt said, officials know there are people who do not seek health care often and may fall through the cracks.

O’Connell said the ongoing outbreak is a perfect example of why staffing, funding, data access, and other resources need to be in place before an emergency develops, allowing public health agencies to respond immediately.

“Our requests have been specific to this outbreak, but really, they’re needed as a foundation for whatever comes next,” she said. “Because something will come next.”

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KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

By Taylor Sisk, KFF Health News (TNS)

On learning last year she was pregnant with her second child, Cailyn Morreale was overcome with fear and trepidation.

“I was so scared,” said Morreale, a resident of the small western North Carolina town of Mars Hill. In that moment, her joy about being pregnant was eclipsed by fear she would have to stop taking buprenorphine, a drug used to treat opioid withdrawal that had helped counter her addiction.

Morreale’s fear was compounded by the rigidity of the most common approach to treating babies born after being exposed in the womb to opioids or some medications used to treat opioid addiction.

For decades throughout the opioid crisis, most doctors have relied on medication-heavy regimens to treat babies who are born experiencing neonatal opioid withdrawal syndrome. Those protocols often meant separating newborns from their mothers, placing them in neonatal intensive care units, and giving them medications to treat their withdrawal.

But research has since indicated that in many, if not most, cases, those extreme measures are unnecessary. A newer, simpler approach that prioritizes keeping babies with their families called Eat, Sleep, Console is being increasingly embraced.

In recent years, doctors and researchers have found that keeping babies with their mothers and ensuring they’re comfortable often works better and gets them out of the hospital faster.

Despite her worst fears, Morreale was never separated from her son. She was able to begin breastfeeding immediately. In fact, she was told, the trace of buprenorphine in her breast milk would help her son withdraw from it.

Her experience was different because she had found her way to Project CARA, an Asheville, North Carolina-based program, administered through the Mountain Area Health Education Center, that supports pregnant people and parents with substance use disorders. Morreale’s care team assured her she did not need to discontinue buprenorphine and that her baby would be assessed and monitored using the Eat, Sleep, Console approach. The protocol deems babies OK to be sent home so long as they’re eating, sleeping, and consolable when upset.

“By the grace of God, he was awesome,” Morreale said of her son.

David Baltierra, former director of West Virginia University’s Rural Family Medicine Residency Program, chair of WVU’s Department of Family Medicine – Eastern Division, and a family physician, suggests this protocol could simply be called “parenting.”

The method is increasingly being used instead of the long-embraced approach to treating opioid-affected newborns called the Finnegan Neonatal Abstinence Scoring System. That tool includes a list of 21 questions (is the baby crying excessively, sweating, experiencing tremors, sneezing, etc.), the answers to which determine whether the newborn should get medication to counteract withdrawal symptoms, which would then require an extended stay in a neonatal ICU.

Baltierra, though, has issues with the Finnegan method. For example, it often results in a soundly sleeping baby being awakened to be scored. That didn’t make sense to Baltierra. If the baby is sleeping, she’s likely doing fine.

Instead, health professionals should look for the telltale signs of a baby experiencing opioid withdrawal syndrome, he said. “Their body is in tension, they have a high pitch, they don’t calm down.”

Baltierra and his colleagues have been training residents to use an Eat, Sleep, Console approach for a decade, progressively more so in the past six years. The results are persuading more health professionals to adopt the method.

A 2023 study found babies treated this way were discharged from the hospital in nearly half the time and less likely to receive medication than those receiving Finnegan-based care.

Matthew Grossman, an associate professor of pediatrics at the Yale School of Medicine, refers to the introduction of the model of treatment he has helped pioneer as “the least innovative” undertaking imaginable.

Research shows that optimal care for pregnant women who’ve experienced opioid use disorder includes treatment with buprenorphine or methadone, which carries the risk their newborn will have withdrawal symptoms. Grossman and colleagues found a non-pharmacological-first approach works best.

He said the Finnegan tool is useful but often too rigid. Under its scoring, one sneeze too many could send a baby to the NICU for weeks.

Grossman said he observed that some babies receiving medications did well for a few days but began to decline when their mothers were sent home without them. Those observations made him ask, “Did the kid need more medicine, or more mom?”

Research by Leila Elder and Madison Humerick, who each did their residency in WVU’s rural program, found that median stays for newborns in withdrawal dropped from 13 days in 2016 to three in 2020.

Elder said babies born at the 25-bed rural hospital where they performed deliveries received medications to treat their withdrawal symptoms only when unrelated issues sent them to other hospitals for NICU care.

The simpler treatment also means more babies born in rural communities can receive care closer to home and has reduced the likelihood a mother will be released before her baby is cleared to go home.

Grossman suggested that rural hospitals are better suited to employ the Eat, Sleep, Console approach than big-city institutions, given the latter’s generally easier access to a NICU and propensity to choose that option.

Sarah Peiffer recalls the first time, as a medical student, she witnessed a nurse administering the Finnegan protocol, discussing it in clinical terms at a new mother’s bedside.

“And I remember being kind of horrified,” she said. The process was clearly distressing to both mother and child. “I felt like there was almost a punitive feeling to it, like we were telling this mom, ‘Look what you did to your baby.’”

Peiffer is now a Project CARA practitioner and family health physician at Blue Ridge Health in western North Carolina and a vocal proponent of ESC and its approach to partnering with families. “You look at all the nonpharmacologic stuff you’re supposed to be doing — like keeping the lights low in the room, keeping the baby swaddled, doing as much skin-to-skin with mom as possible — and you really treat mom as medicine.”

Research suggests immediate postbirth skin‐to‐skin contact offers “vital advantages” to short‐ and long‐term health and bonding.

That contact, Elder said, “releases endorphins for mom,” which helps lower the risk of postpartum depression.

Grossman said developing the Eat, Sleep, Console protocol was simply a matter of pausing to reassess.

The original intent of the Finnegan tool wasn’t to render the process so rigid. But “everybody is excited to have a tool, and then this approach calcified around it,” he said.

Grossman said the objective of the simpler approach was to place the family at the core of care, and shorter hospital stays for babies was simply a fortuitous outcome. The shift in approach fits into a wider move toward judgment-free, family-centered care for those who’ve experienced addiction and for their children.

Now, he said, after five days, mothers often say “‘Can we go home? I think I got this,’” and they’re treated “with the same respect as any other mom.”

Peiffer said she has witnessed this mother-centric care counter “that sense of shame that people feel instead of families feeling empowered to care for their infant.” It represents “such a major shift in how we think about neonatal withdrawal both medically and culturally.”

(KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of KFF — the independent source for health policy research, polling and journalism.)

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

By Andy Miller, KFF Health News (TNS)

CUTHBERT, Ga. — While customers at Adams Family Pharmacy picked up their prescriptions on a hot summer day, some stopped in for coffee, ice cream, homemade cake, or cookies.

It wasn’t a bake sale, but the sweets bring extra revenue as pharmacist and co-owner Nikki Bryant works to achieve profitability at her business on the town square.

Bryant said she is doing all she can to bolster it against a powerful force that threatens her and other independent pharmacists: the middlemen who manage virtually all prescriptions written in the U.S., called pharmacy benefit managers, or PBMs. Serving as brokers among drugmakers, pharmacies, and health insurers, these health care entities have drawn scrutiny from Congress, the Federal Trade Commission, and state legislatures for their role in the increase in drug prices.

Bryant and other independent pharmacists say PBMs not only create higher costs but also make it harder for patients to access medications. So they were hopeful about state legislation this year that would have increased their reimbursement to match the average prices paid to retail chain pharmacies through the state employee health plan. But Gov. Brian Kemp vetoed the bill.

Kemp cited a fiscal estimate that it would cost the state as much as $45 million a year and said “the General Assembly failed to fund this initiative.”

Underlining the Georgia legislative reform effort against pharmacy benefit managers was an analysis by the American Pharmacy Cooperative, which represents independent pharmacies, that reviewed the price differential paid to a north Georgia pharmacy and nearby chain stores.

The analysis early this year showed chains were paid well beyond the family business for many of the same medications: For example, the chains received an average of nearly $54 for the antidepressant bupropion, while Bell’s Family Pharmacy in Tate, Georgia, got $5.54, the analysis said. For a drug used to treat blood pressure, amlodipine, chain pharmacies received an average of $23.55, while Bell’s got $1.51.

Bell’s Family Pharmacy closed earlier this year.

“The differences in Georgia are unbelievable,” Antonio Ciaccia, who runs Ohio-based consulting firm 3 Axis Advisors. “If you’re a pharmacist, you don’t have any control over which drugs you dispense and which you don’t.”

By controlling prices and availability, pharmacy benefit managers cause patients and employers to spend more for medications, according to the Federal Trade Commission and pharmacy groups. On Sept. 20, the FTC sued three of the largest PBMs — CVS Health’s Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum Rx, which together control about 80% of U.S. prescription drug sales. The agency said they created a “perverse drug rebate system” that artificially inflates the price of insulin. Each company denied the allegations.

The lawsuit followed a scathing FTC report in July that said the “dominant PBMs can often exercise significant control over which drugs are available, at what price, and which pharmacies patients can use to access their prescribed medications.”

The trade group that represents PBMs, the Pharmaceutical Care Management Association, said the insulin market is working well and blamed drugmakers for historically higher prices of the medication.

Bryant and other independent pharmacists, though, say they lose money filling certain prescriptions while reimbursements favor chain pharmacies like CVS that have corporate ties to pharmacy benefit managers. And even the chain pharmacies have retrenched, with CVS, Rite Aid, and Walgreens announcing layoffs or store closures in recent months.

“PBMs are like the mafia,” Bryant said. “They pay us what they want to pay us. They are sucking all the money out of health care.”

Pharmacy benefit managers will charge some health insurance plans more for a medication than what they reimburse a pharmacy, keeping the extra money as profit, critics say. This practice is known as “spread pricing.” Large PBMs also take money from drugmakers as a “rebate” to give their drugs preferential treatment on health plans’ lists of medications, independent pharmacies say. And by favoring certain pharmacies with whom they have business ties, experts say, these drug brokers help force independent stores such as Bell’s to close.

The veto by Kemp, a Republican, came despite the GOP-led General Assembly voting overwhelmingly for Senate Bill 198 on the last day of the legislative session.

Kemp spokesperson Garrison Douglas said, “The governor remains entirely and wholeheartedly supportive of Georgia’s independent pharmacists and the need for PBM transparency.”

In his veto message, Kemp voiced support for a study of independent pharmacy drug reimbursements and PBM practices. And he said independent pharmacists are getting an extra $3 dispensing fee this year on state employee prescriptions.

The state Department of Community Health, which oversees the State Health Benefit Plan, told KFF Health News that CVS Caremark, the PBM handling the state employee business, supplied the cost estimate Kemp used to justify his veto.

Fiona Roberts, a spokesperson for Community Health, said the department didn’t have time to conduct its own analysis.

CVS Caremark said it used historical claims data to calculate the cost impact of the higher reimbursement.

Nationally, criticism of PBM practices intensified over the summer with the Federal Trade Commission report.

The Pharmaceutical Care Management Association pushed back, saying the report “is based on anecdotes and comments from anonymous sources and self-interested parties and supported only by two cherry-picked case studies that are implied to be representative of the entire market.”

Members of both parties in Congress have tackled PBM reform. House members recently introduced another proposal, known as the Pharmacists Fight Back Act, which supporters say would add transparency, limit costs for patients, ensure they get the benefit of drugmaker discounts, and protect their pharmacy choices.

The consolidation that has combined health insurers with PBMs — including their operating their own retail, mail-order, and specialty pharmacies — has created financial behemoths, said U.S. Rep. Buddy Carter, a Georgia Republican and a pharmacist. “I’m interested in busting them up,” he said.

Alexander Oshmyansky, co-founder of Mark Cuban Cost Plus Drug Company, said the PBMs siphon off about a third of the $400 billion a year spent on pharmaceuticals.

“What we could do as a society with $100 billion as opposed to paying some companies to process drug payments,” Oshmyansky said.

PCMA, the trade group, cited a report funded by the three biggest pharmacy benefit managers that said their operating margins are less than 5%.

And the group says that discussions about congressional reform “reflect a one-sided view informed directly by the pharmaceutical industry’s blame game designed to vilify PBMs to keep prescription drug prices high and increase drug company profits.”

Underpayments by PBMs, however, have accelerated the closures of mom-and-pop pharmacies across the country, said the National Community Pharmacists Association, which represents independent pharmacies.

The U.S. loses almost one such pharmacy a day, said Anne Cassity, a senior vice president of the association. Rural pharmacies, which are hard to reach for patients lacking transportation, are especially vulnerable, she said.

Bryant’s two pharmacies deliver to several counties, including to patients who have a disability or no transportation. The cost to patients: zero.

Most states have passed some version of oversight or restrictions on pharmacy benefit managers.

In Montana, state officials have collected financial reports from pharmacy benefit managers over the past two years after passing a bill to promote transparency in these businesses.

Data from 2022 shows that rebates in Montana rarely are directly returned to people buying prescriptions. Instead, they’re pocketed by the PBMs or returned to health plans.

Josh Morris, who owns three independent rural pharmacies in southwestern Montana, said his pharmacies have seen reimbursement rates for medications bought under PBM-managed plans drop.

Morris said his business routinely either breaks even or loses money. “Our plan is that once we reach a certain level of cash, that we will be out,” Morris said. “As in ‘closed.’”

Frank Cote, with Montana’s insurance commissioner’s office, said that the state has tried to make business easier for small pharmacies but that state officials still don’t control how much PBMs pay. Cote said the state will look for ways within existing rules or future legislation to support rural pharmacies.

Following Kemp’s veto in Georgia, the pharmacy pay differential sparked criticism from an unusual place: within the board of the state Department of Community Health, the agency that runs the State Health Benefit Plan.

Mark Shane Mobley, a board member, said at an August meeting that independent pharmacies’ pay in the state employee plan should be on par with a chain’s. The PBM profit “is going to line people’s pockets that are far outside of the state,” said Mobley, president of Avilys Sleep & EEG, a Georgia provider of sleep disorder and electroencephalogram testing. “Our independent pharmacies, they’re hiring people locally. They’re taking care of the local community.”

Community Health Commissioner Russel Carlson said the agency has an ongoing dialogue with CVS Caremark, the PBM handling the state employee plan medications.

“We don’t have our head in the sand. We know there are some frustrations out there that exist in this space,” he said. “But we acknowledge that we do have contractual responsibilities.”

In Cuthbert, Bryant said she can make more profit on cake and coffee than with many medications.

Still, she’s in business while a nearby CVS pharmacy closed recently. “We outcompeted them on service,” Bryant said.

Montana correspondent Katheryn Houghton and senior correspondent Arthur Allen contributed to this report.

(KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of KFF — the independent source for health policy research, polling and journalism.)

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.