Tagged California Healthline

FDA Approves Scope With Disposable Part Aimed At Reducing Superbug Infections

Seeking to prevent superbug outbreaks, federal health officials said they have approved the first gastrointestinal medical scope with a disposable cap for use in the U.S.

The Food and Drug Administration said that the design of the new duodenoscope by Japanese device maker Pentax should make it easier to remove dangerous bacteria that can become trapped inside these reusable instruments.

“We believe the new disposable distal cap represents a major step toward lowering the risk of future infections associated with these devices,” said Dr. William Maisel, the acting director of the FDA’s Office of Device Evaluation, in a statement Wednesday. “We encourage companies to continue to pursue innovations that will help reduce the risk to patients.”

But some medical experts questioned whether this design change goes far enough to protect patients.

“This new scope will probably reduce the infection risk, but I’m not sure by how much,” said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa.

In addition, he and other experts said, this is just one scope, and its modest redesign will not address the shortcomings that plague many different medical scopes on the market and continue to put patients at risk of antibiotic-resistant infections.

Pentax didn’t provide any details Thursday about when the new duodenoscope will be available or what it may cost. In general, duodenoscopes can cost up to $40,000 apiece, and they can represent a major expense for hospitals that handle a large volume of procedures.

In a statement, the company said “the disposable distal cap design represents a significant advancement in infection control.”

One advantage of a removable cap is that it would allow hospital cleaning staff better access to tiny crevices and small parts at the tip of the scope. Some areas are hard to reach with brushes and washing machines, increasing the risk of bacteria being passed from one patient to another.

While the scope tip has proven troublesome, experts say harmful bacteria also have been found in other areas, such as biopsy ports and instrument channels.

“I think it may be a step in the right direction to have single-use components whenever possible. But we still have gaps here,” said Cori Ofstead, a researcher and epidemiologist in St. Paul, Minn.

She and other infection-control experts are urging manufacturers and regulators to move toward sterilization for all medical scopes, which would involve gas or chemicals and be a step above the current federal requirement for high-level disinfection. That change would likely require further design changes to enable complex scopes to withstand the process.

Other device manufacturers have gone in a different direction, developing scopes that are fully disposable, rather than just enabling the cap to be thrown away. The FDA recently approved two colonoscopes that are designed to be used just once. Other companies are promoting similar devices for use in the lungs and kidneys.

Doctors put duodenoscopes down a patient’s throat to diagnose and treat problems in the digestive tract, such as gallstones, cancers and blockages in the bile duct. There are about 700,000 of these ERCP procedures done annually in the U.S.

Since 2015, U.S. prosecutors, lawmakers and government regulators have been investigating dozens of infections and deaths tied to duodenoscopes.

The Los Angeles Times broke the news about a superbug outbreak at the Ronald Reagan UCLA Medical Center in February 2015, which triggered an FDA warning the next day. Those infections involved the industry’s leading scope maker, Tokyo-based Olympus Corp. The newspaper later reported that Olympus knew about infections and potential flaws with its duodenoscope as early as 2012 but failed to alert American hospitals or regulators.

Last year, the FDA said that as many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted duodenoscopes from January 2010 to October 2015.

A U.S. Senate report in 2016 identified four outbreaks tied to Pentax duodenoscopes at hospitals and clinics in Illinois and Massachusetts.

More recently, in January, the FDA issued a safety alert about Pentax’s current duodenoscope model. The agency warned medical providers that cracks and gaps can develop in the device’s tip that “could allow fluids and tissue to leak into the duodenoscope.” The FDA urged hospitals to immediately remove scopes from service that showed signs of damage.

Muscarella, the hospital-safety consultant, said it was surprising the FDA “didn’t require removal of the product from the market considering the risk of superbug infections. It would seem Pentax was prodded by the FDA to come up with another solution, and this disposable cap design might be the company’s response.”

In a statement last year, Pentax said, “We are dedicated to patient safety and are consistently evaluating advancements in flexible endoscope design.”

A number of recent studies have found evidence of persistent contamination in a wide range of reusable devices, including colonoscopes and ureteroscopes.

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

Categories: California Healthline, Cost and Quality, Health Industry

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High On Drugs? Anthem Cites Soaring Drug Costs To Justify 35% Rate Hike in California

Health insurance giant Anthem predicts Californians will pop a lot more pills next year.

To make the case for a hefty premium hike in the state’s individual insurance market, Anthem Blue Cross has forecast a 30 percent jump in prescription drug costs for 2018. Such a sharp increase is nearly double the estimates of two other big insurers, and it runs counter to industry trends nationally.

Prescription drug spending in the U.S. grew 6.1 percent over the 12 months ending in July, according to Altarum, a nonprofit think tank. That’s down from 12.9 percent in 2014, when expensive new hepatitis C drugs sharply lifted overall pharmaceutical spending.

“I can’t understand why Anthem is predicting 30 percent,” said Charles Roehrig, a health economist and founding director of Altarum’s Center for Sustainable Health Spending. “There are examples of egregious price increases for particular drugs that have gotten a lot of well-deserved attention. But those haven’t characterized what’s happening as a whole,” he added.

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The advocacy group Consumers Union also questioned why Anthem’s cost projections are so much higher than its competitors, and it has asked state regulators to demand additional documentation from the nation’s second-largest health insurer.

Overall, Anthem is proposing a 35 percent rate increase for about 135,000 consumers who buy their own insurance in and outside the Covered California exchange. It’s the largest increase statewide and assumes that federal subsidies for copays and deductibles will continue to be paid. The second highest, also assuming the U.S. government will continue paying those subsidies, is 28.6 percent by Molina Healthcare.

Some of Anthem’s rivals aren’t as pessimistic on the outlook for drug costs. Two other large insurers, Blue Shield of California and Health Net, projected drug costs will rise by 16.4 and 15 percent, respectively. Anthem came in even lower than that in its rate filing for Colorado’s individual market, projecting an 11.4 percent increase in prescription drug costs.

The company said it stands by its California cost projections in light of growing market volatility. In documents filed with regulators, the company expressed concern that declining enrollment in the individual market would saddle it with a sicker group of policyholders.

“As it pertains to pharmacy, our rates reflect the increasing utilization and rising cost of prescription drugs we have experienced in this market over the last couple of years,” said company spokesman Colin Manning.

In fact, Anthem emphasizes rising drug utilization over higher drug prices when justifying its rate increase — an argument Consumers Union challenged as unusual. Most other insurers in California have cited rising prices as a bigger factor in filings to state regulators.

“Anthem projects an extraordinary increase in its enrollees’ use of prescription drugs at four or more times the rate of enrollees at other carriers,” said Dena Mendelsohn, a staff attorney for Consumers Union in San Francisco.

The California Department of Managed Health Care said it is scrutinizing Anthem’s “underlying medical costs and trends” as part of its review of 2018 rate increases. The state agency, which expects to finish its review next month, can pressure insurers to reduce their rates, but it doesn’t have the authority to block them.

“We may ask [Anthem] questions and for additional information to support the plan’s proposed rate change,” said Rodger Butler, a spokesman for the Department of Managed Health Care.

Anthem is significantly curtailing its presence in Obamacare marketplaces nationally next year amid ongoing uncertainty from the Trump administration and Congress over whether they will continue the federal subsidies that lower out-of-pocket costs for low-income consumers.

In August, Anthem announced a partial withdrawal from California’s individual market, saying it will sell policies in only about half of the state’s counties.

Anthem’s chief executive, Joseph Swedish, told investors and analysts at a conference this month that the company may re-enter certain ACA markets across the country if Congress and the White House take steps to stabilize them.

Some experts wonder if Anthem made a mistake in its California rate filing. It wouldn’t be the first time.

In 2010, an outside actuary working for California regulators found a critical error in Anthem’s proposal to raise rates by up to 39 percent. President Barack Obama seized on the public outcry over that double-digit increase to help get the Affordable Care Act passed in Congress. Anthem later withdrew the increase after David Axene, an actuary in Murrieta, Calif., discovered problems with the company’s calculations.

Axene said this latest filing for 2018 health plans raises plenty of questions.

The pharmacy estimate “does seem high,” he said. “It’s a more mature marketplace now, so hopefully everybody knows how to price it. But I’m sure stupid mistakes still happen.”

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

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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Open Your Mouth And Say Goo-Goo: Dentists Treating Ever-Younger Patients

Allen Barron scrunches up his tiny face and wails as his mother gently tips him backward onto the lap of Jean Calvo, a pediatric dental resident at the University of California-San Francisco.

Allen’s crying may be distressing, but his wide-open mouth allows Calvo to begin the exam. She counts his baby teeth and checks for dental decay.

“Nothing I am going to do will hurt him,” Calvo tells Allen’s mother, Maritza Barron, who is holding her son’s hands.

To some, the 20-month-old toddler may seem far too young for a dental exam. In fact, he’s on the late side, according to leading dental and pediatric professional associations.

To stave off a lifetime of dental problems and make sure parents learn how to prevent children’s tooth decay, babies should have their first exam when they get their first tooth, or no later than their 1st birthday, according to guidelines from the American Academy of Pediatric Dentistry.

However, many dentists are uncomfortable treating babies, and that has created a significant gap in dental care for infants and toddlers of all backgrounds, experts say. The shortfall is hard to quantify because professional organizations, such as the American Dental Association, do not survey their members on whether they care for infants.

“People think that children are afraid of dentists, but really it’s that dentists are afraid of children,” said Pamela Alston, who is a dentist and dental director of the Oakland-based Eastmont Wellness Center, a publicly funded clinic that is part of the county-run Alameda Health System.

Hoping to narrow the gap in care, the public health agencies of San Francisco and Alameda counties are launching pilot programs to train dentists to treat babies. About 70 dentists will learn over the next three years how to coax infants into cooperating and help parents guard against tooth decay. The first training session in Alameda County is scheduled for early November; San Francisco will begin its training in January. The American Dental Association was not aware of any similar programs in other states.

The guidelines calling for earlier dental visits stemmed from a growing awareness that cavity-causing bacteria can be passed from parents to babies, through shared utensils, for example. Giving babies bottles of fruit juice or sugar water also can cause cavities. Decay in baby teeth has been linked to adult tooth decay.

“By the time children are age 3, they are often so far down the road that prevention is no longer an option,” said Ray Stewart, a pediatric dental professor at UCSF, who has treated infants for more than 15 years and is among the professionals enlisted by Alameda and San Francisco to train the dentists.

Communicating directly with children during dental exams can help reduce their stress, Stewart says. (Robert Durell for Kaiser Health News)

Dentists don’t regard exams of very young children as a means of boosting their income, said Alicia Malaby, spokeswoman for the California Dental Association. “Denti-Cal reimbursements are below actual costs for many procedures,” she said. Rather, they want to help “improve community health outcomes.”

Low-income children, who are more at risk of dental decay and have less access to care than their affluent peers, present the greatest need for early oral exams, dental professionals say.

A portion of the revenue from California’s new tobacco tax will be earmarked to help very young children from low-income families get the dental care they need. The money will be used to give dentists a 40 percent increase on top of the standard reimbursement for services to Denti-Cal patients, including oral exams of children age 3 and under. Denti-Cal provides dental care to beneficiaries of Medi-Cal, California’s version of Medicaid.

Alameda County will offer dentists an extra $20, on top of that statewide increase for appointments with Denti-Cal-covered children that include a thorough exam of the baby’s mouth, a fluoride varnish if needed, a talk with parents about prevention and a demonstration of how to brush their baby’s teeth.

The Alameda and San Francisco training programs, funded by grants from Medi-Cal, could be replicated throughout California if they are successful, according to the Department of Health Care Services.

Maritza Barron came to UCSF after her own dentist — despite the best of intentions — was unable to examine her baby’s mouth. “He tried to say ‘open up’ to him but he wouldn’t do it,” Barron said of the failed attempt, which left her son in tears.

Alston, the Oakland dentist, once faced similar challenges treating very young children, but she has since undergone a transformation. She blames dentists’ wariness of young patients on a lack of experience. When she graduated from dental school in 1982, she said, she had no training that prepared her to work with children younger than 6.

“I didn’t feel like I could manage their behavior,” Alston said.

Over time, however, it became increasingly clear to her that she wasn’t seeing children early enough.

Almost all of the kids who came to her for their first dental visit at age 6 had mouths riddled with tooth decay, Alston said. She had to refer them to specialists for treatment that required sedation. She kept lowering the minimum age for a first visit in her practice, then left it at age 3 for a long time.

But even 3-year-olds were coming in with cavities. Ultimately, she learned how to treat infants and toddlers through a program run by Alameda County’s public health department — not unlike the training to be offered by the new pilot programs.

Today, Alston is passionate about treating very young children and has lined up pediatricians to refer infants to her. And she has revised her guidance on when kids should get their first oral exam, advising parents to bring their children in when their first tooth starts to erupt.

People think that children are afraid of dentists, but really it’s that dentists are afraid of children.

Pamela Alston, Eastmont Wellness Center

She also trains dental students to examine infants. An important trick she teaches them is how to avoid being bitten: “Put your finger behind the last tooth!”

Communicating directly with children during dental exams can help reduce their stress, saod both Alston and Stewart, the UCSF dental professor.

At a recent visit to UCSF’s Pediatric Dentistry Faculty Clinic, 18-month-old Sebastian King scrutinized the dental mirror Stewart handed to him.

“That’s what I’m going to put in your mouth to look at your teeth!” Stewart told him exuberantly.

He asked the young boy to show him where his mouth was. Sebastian smiled with delight as Stewart handed him a blue exam glove he’d blown up into a balloon, and the young boy remained calm throughout the exam.

Helping parents understand their role is also critical, dentists say.

In addition to advising parents not to share eating utensils with their children, Stewart urges them not to let their kids fall asleep with a bottle of milk and to limit their consumption of fruit juice. He also says they should wipe their infants’ gums and teeth with a cloth after feeding them to remove residue that can cause cavities.

That’s the message Calvo, the dental resident, gave to Barron, whose baby sat happily on his mother’s lap after his exam. The boy had cavities because he had been falling asleep with his bottle.

Barron said she recognized that weaning Allen from the bottle at night would be a challenge.

But “it’s really logical,” she told Calvo, adding that she was determined to give it a try.

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

KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.

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