Tagged Cost and Quality

Viewpoints: Nursing Homes And Hurricanes; Winning The War On Drugs

A selection of opinions on health care from around the country.

Miami Herald: Protect Nursing Home Residents, Not Bad Facilities
When they get together in Tallahassee on Friday, the members of Florida’s nursing-home industry can either circle the wagons or lay the groundwork to take a deep, honest look at how best to confront the one the worst tragedies the industry seen. The Florida Health Care Association has called a “summit” to address emergency preparedness. This comes after eight, then nine and, as of Thursday, 10 elderly residents in a Hollywood Hills nursing home were left to suffer and die because they were in an stiflingly hot facility that lost electricity as Hurricane Irma blew through. (9/22)

USA Today: In Hurricane Irma, Why Did Nursing Home Patients Have To Die?
The deaths have set off the predictable round of finger-pointing among the nursing home, the electric utility, state agencies and the governor over responsibility for decisions and ineptitude that turned deadly. This blame game avoids the real problem. The facility had one operable backup generator, which did not run air conditioning. And no one — not the federal government, not the state and not the county — required the facility to have an emergency generator dedicated to keeping fragile residents cool in a state that regularly experiences hurricanes, flooding and sweltering heat. (9/21)

USA Today: Florida Health Care Association: We’re Dedicated
As caregivers dedicated to helping Florida’s frail elders, all of us at Florida Health Care Association grieve the loss of nine elderly residents of a single, non-member South Florida nursing home in the wake of Hurricane Irma. Our members accept the enormous daily responsibility of caring for Florida’s frailest residents. Ever since Florida’s horrendous storm season of 2004, we have committed to ongoing intensive disaster response training — most recently, the week before Hurricanes Harvey and Irma struck. (Emmett Reed, 9/21)

Bloomberg: Tom Price Flies Blind On Ethics
Under the lax ethical standards President Donald Trump brought to the White House, rampant conflicts of interest are treated with casual indifference. This disregard has sent a message to his entire administration that blurring lines — between public and private, right and wrong — will be not just tolerated but defended. At least one cabinet member appears to have taken the message to heart. (9/21)

The New York Times: How To Win A War On Drugs
Decades ago, the United States and Portugal both struggled with illicit drugs and took decisive action — in diametrically opposite directions. The U.S. cracked down vigorously, spending billions of dollars incarcerating drug users. In contrast, Portugal undertook a monumental experiment: It decriminalized the use of all drugs in 2001, even heroin and cocaine, and unleashed a major public health campaign to tackle addiction. Ever since in Portugal, drug addiction has been treated more as a medical challenge than as a criminal justice issue. … Portugal may be winning the war on drugs — by ending it. Today, the Health Ministry estimates that only about 25,000 Portuguese use heroin, down from 100,000 when the policy began. (Nicholas Kristof, 9/22)

The New England Journal Of Medicine: The Fate Of FDA Postapproval Studies
Both Congress and the Food and Drug Administration (FDA) have sought to accelerate the availability of new drugs by allowing sponsors to wait to resolve many questions about safety and benefit until after their drugs receive marketing approval. As a result, most approval letters require phase 4 studies to address issues such as optimal dosing, potential long-term side effects, and use in children or to confirm the clinical benefit of drugs that receive conditional approval on the basis of preliminary evidence. (Steven Woloshin, Lisa M. Schwartz, Brian White, and Thomas J. Moore, 9/21)

Chicago Tribune: Will Rauner Complete A ‘Full Obama’ On Abortion Rights?
Common usage notwithstanding, a flip-flop is actually a double inversion: First the flip — a reversal on an earlier position — then the flop — a return to the original position. A 360, to put it geometrically. A classic example is Barack Obama on same-sex marriage. In February 1996, when he was running for the state Senate, he expressed unequivocal support for gay marriage in candidate questionnaires, writing that he “would fight efforts to prohibit such marriages.” … A big question in Illinois these days is if Gov. Bruce Rauner will end up performing a “Full Obama” on the issue of Medicaid and state-employee health insurance funding of abortion services. (Eric Zorn, 9/21)

The New England Journal Of Medicine: A Nicotine-Focused Framework For Public Health
With the tools provided to the Food and Drug Administration (FDA) under the Family Smoking Prevention and Tobacco Control Act of 2009, the agency has taken consequential steps to prevent sales of tobacco products to children, expand the science base for understanding traditional and newer tobacco products, and conduct public education campaigns. But the agency needs to do more to protect Americans; in particular, we must shape a regulatory framework that reduces their use of combustible cigarettes. (Scott Gottlieb and Mitchell Zeller, 9/21)

Chicago Tribune: Cook County’s ‘Health’ Lie, In Black And White
Let Michael Bloomberg spend his millions to defend Cook County’s hated sweetened beverage tax. Opponents don’t need to pay a dime for advertising. That’s because taxpayers get a written reminder of this brazen cash grab every time they make a purchase. County Board members who are on the fence about next month’s vote to repeal the tax should keep that in mind. (9/21)

The New England Journal Of Medicine: Tuberculosis Elimination In The United States — The Need For Renewed Action
Once called “the captain of all these men of death,” tuberculosis continues to kill 1.8 million people globally each year. In 2014, the World Health Assembly embraced an ambitious resolution to reduce deaths from tuberculosis by 95% by 2035. But despite such global concern, tuberculosis has all but vanished from the U.S. public’s mind as a perceived threat. Although this lack of attention is understandable, given the substantial decrease in disease burden over the past several decades, it jeopardizes the prospect of tuberculosis elimination in the United States — a goal established by the Department of Health and Human Services in 1989. Critical ethical and policy questions must be addressed if elimination is to be pursued in earnest. (Ronald Bayer and Kenneth G. Castro, 9/21)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Research Roundup: Hospital Transportation; Medicaid Expansion; Obesity Treatment

Each week, KHN compiles a selection of recently released health policy studies and briefs.

Urban Institute: The Affordable Care Act Medicaid Expansions And Personal Finance 
Results demonstrate financial improvements in states that expanded their Medicaid programs as measured by improved credit scores, reduced balances past due as a percent of total debt, reduced probability of a medical collection balance of $1,000 or more, reduced probability of having one or more recent medical bills go to collections, reduction in the probability of experiencing a new derogatory balance of any type, reduced probability of incurring a new derogatory balance equal to $1,000 or more, and a reduction in the probability of a new bankruptcy filing. (Caswell and Waidmann, 9/17)

Health Affairs: Networks In ACA Marketplaces Are Narrower For Mental Health Care Than For Primary Care
Using data for 2016 from 531 unique provider networks in the Affordable Care Act Marketplaces, we evaluated how network size and the percentage of providers who participate in any network differ between mental health care providers and a control group of primary care providers. Compared to primary care networks, participation in mental health networks was low, with only 42.7 percent of psychiatrists and 19.3 percent of nonphysician mental health care providers participating in any network. (Zhu, Zhang and Polsky, 9/1)

Pediatrics: Cost-Effectiveness Of Family-Based Obesity Treatment 
We translated family-based behavioral treatment (FBT) to treat children with overweight and obesity and their parents in the patient-centered medical home. … For families consisting of children and parents with overweight, FBT presents a more cost-effective alternative than an IC group. (Quattrin, Cao, Paluch et. al., 9/1)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

State Highlights: In Calif., Gubernatorial Candidates Try To Prove Health Care Street Cred; Death Toll Rises In Fla. Nursing Home Tradgedy

Media outlets report on news from California, Florida, Texas, Illinois and Pennsylvania.

Los Angeles Times: The Push For Single-Payer Health Care Just Went National. What Does That Mean For The California Effort?
When Vermont Sen. Bernie Sanders visited Beverly Hills last May, he made a full-throated appeal for California to “lead the country” and pass a pending state proposal to establish single-payer health care. On Friday, he’ll return here for a San Francisco speech trumpeting his own higher-stakes plan — a bill to drastically overhaul the nation’s health-care system by covering everyone through Medicare. (Mason, 9/22)

Los Angeles Times: Two Top Candidates For California Governor Have Been Touting Their Healthcare Wins. Here’S What They Really Did
Gavin Newsom and Antonio Villaraigosa are depicting themselves as Democratic healthcare visionaries as they campaign to become California’s next governor. To prove his healthcare mettle, Newsom points to Healthy San Francisco, a first-of-its-kind universal system adopted while he reigned as the city’s mayor in 2006. Newsom’s work on the program helped him land an endorsement from the influential California Nurses Association, and a boast or two will surely punctuate his speech at their convention on Friday as hyper-partisan politics intensify over efforts to repeal the Affordable Care Act and implement a national single-payer plan. (Willon, 9/22)

Reuters: Death Toll From Overheated Florida Nursing Home Rises To 10
A 10th elderly patient at a Miami-area nursing home has died after she was exposed to sweltering heat in the aftermath of Hurricane Irma, police said on Thursday. The resident of the Rehabilitation Center at Hollywood Hills died on Wednesday, police in Hollywood, Florida, said in a statement, without giving details. (Simpson, 9/21)

Los Angeles Times: Multiple Cases Of West Nile Virus In Glendale Prompt Education Campaign
With eight cases of West Nile virus reported in Glendale so far this year, health officials took part in a door-to-door education campaign Wednesday, informing residents of what they can do to protect themselves from infection. Conducted by the Greater Los Angeles County Vector Control District, the effort informed residents in Glendale, Los Feliz and Atwater Village about the preventive measures they can take to reduce the risk of being bitten by mosquitoes. Levy Sun, a spokesman for vector control, said wearing insect repellent and dumping out any stagnant water near homes are measures people should take regularly. (Nguyen, 9/21)

Houston Chronicle: Residents Near Houston Superfund Site Await Answers After Hurricane Harvey
Bonner and others in Channelview, Baytown and Highlands neighborhoods along this industrial stretch of the river south of the Lake Houston dam worry about the toxicity of murky water, white dust and the foul-smelling sludge covering their properties. The question for dozens of people, who a week after the storm still guard wrecked riverfront properties from marauders seeking scrap, is whether their neighborhoods are now too contaminated to recover. (Olson, 9/22)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Drug’s $475K Cost Highlights Pricing Problems With Unique, Breakthrough Therapies

“We need a new payment model,” Steve Miller, chief medical officer at Express Scripts Holding Co., said while criticizing Novartis’ new drug.

Bloomberg: Novartis’s $475,000 Price On Cancer Therapy Meets Resistance
The $475,000 price tag on Novartis AG’s latest breakthrough cancer therapy came under fire from one of the biggest managers of drug costs in the U.S., underscoring the challenges the Swiss drugmaker will face in promoting the potential blockbuster. The cost of the leukemia treatment, called Kymriah, is “dramatically higher” than other such complex treatments, and the health-care system isn’t ready to pay for it, Steve Miller, chief medical officer at Express Scripts Holding Co., said Thursday in a blog post on his company’s website. Gene therapies like Novartis’s are targeted at a small number of patients and typically used just once, meaning that drug companies have limited chances to recoup their investment. (Lauerman and Paton, 9/22)

In other pharmaceutical news —

Bloomberg: FDA Warns Doctors After 19 Deaths On Intercept Liver Drug
Nineteen patients died after taking a liver-disease drug from Intercept Pharmaceuticals Inc., the U.S. Food and Drug Administration said, warning doctors about risks from a product that the company is seeking to make into a blockbuster. Shares of the drugmaker sank 24.9 percent to $73.70 at 4:00 p.m. in New York, the company’s biggest loss since November 2014. (Langreth, 9/21)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Money-Saving Offer For Medicare’s Late Enrollees Is Expiring. Can They Buy Time?

Many older Americans who have Affordable Care Act insurance policies are going to miss a Sept. 30 deadline to enroll in Medicare, and they need more time to make the change, advocates say.

A lifetime of late enrollment penalties typically await people who don’t sign up for Medicare Part B — which covers doctor visits and other outpatient services — when they first become eligible. That includes people who mistakenly thought that because they had insurance through the ACA marketplaces, they didn’t need to enroll in Medicare.

Medicare officials are offering to waive those penalties under a temporary rule change that began earlier this year, but the deal ends Sept. 30.

On Wednesday, more than 40 groups, including consumer health advocacy organizations and insurers, asked Medicare chief Seema Verma to extend the waiver deadline through at least Dec. 31, because they are worried that many people who could be helped still don’t know about it.

They also say more time is needed because of application delays at some Social Security Administration (SSA) local offices, where beneficiaries request the waiver.

“We know there are people who can still benefit from it,” said Stacy Sanders, the federal policy director at the Medicare Rights Center, a Washington-based advocacy group that coordinated the request to Medicare. “We know there have been delays, and those are good reasons to extend it.”

Counselors at the Medicare Rights Center have helped seniors apply for the waiver in Arizona, California, Florida, Minnesota, Missouri, New Jersey and New York, she said.

Since the marketplaces opened in 2014, the focus has been on getting people enrolled, Sanders added. “There’s no reason to expect that people would understand how to move out of the marketplace into Medicare.”

The waiver offer applies not only to people over 65 who have kept their marketplace plans, but also to younger people who qualify for Medicare through a disability and chose to use marketplace plans.

The waiver also allows Medicare beneficiaries who earlier realized their mistake in keeping a marketplace plan and have switched to ask for a reduction or elimination of the penalty.

In all cases, people had to be eligible for Medicare after April 1, 2013.

Officials at the Centers for Medicare & Medicaid, which runs Medicare, would not provide details about the number of waivers granted or pending applications. Nor would they comment on the likelihood of an extension.

Barbara Davis said that when she initially applied, a Social Security representative didn’t know about the waiver. She eventually contacted the Medicare Rights Center, where a counselor interceded on her behalf in June. A day later, a Social Security representative told her she would not have a penalty.

“My advice would be, find out your rights before you apply,” said Davis, 68, who lives with her husband in rural western New York. “Because they don’t seem to want to give you information to help you, you have to know this on your own.”

A Social Security spokeswoman said the agency is processing waiver applications from “across the country” but does not keep track of the number. She declined to comment on whether SSA employees know about the waiver.

Sanders suggested that people applying for the waiver ask Social Security officials for it by using its official name: “time-limited equitable relief.”

Since Medicare’s Part A hospitalization benefit is usually free, some seniors who liked their marketplace coverage thought — incorrectly — that they had nothing to lose by signing up for Part A and keeping their marketplace plan.

Some people receiving Social Security retirement or disability benefits opted to keep their marketplace plan and drop Part B after the Social Security Administration enrolled them automatically in Medicare when they became eligible.

If the temporary waiver expires, the only other way for beneficiaries to get an exemption is by proving they declined Part B because a government employee misinformed them.

The groups writing Verma argue that keeping the waiver in place past Sept. 30 could also help many beneficiaries who may be surprised by a little-known rule that will affect 2018 marketplace policies.

For the first time, insurers will be prohibited from issuing a marketplace plan if they know the member is eligible for Medicare and the 2018 policy is significantly different.

Those who find themselves without a marketplace plan could be in for another surprise: They won’t have insurance for outpatient care until July 1 because Medicare imposes a waiting period before Part B coverage kicks in for latecomers.

Extending the deadline “would lessen a significant hardship for many people … [who] are unaware of the repercussions that could result from keeping their marketplace coverage,” said Cathryn Donaldson, a spokeswoman for America’s Health Insurance Plans, an industry group.

For information on how to apply for the time-limited equitable relief waiver, go to the Medicare Rights Center’s Medicare Interactive webpage or call the center’s helpline at 1-800-333-4114.

KHN’s coverage of aging and long-term care issues is supported by The SCAN Foundation and coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

Categories: Aging, Cost and Quality, Insurance, Medicare, The Health Law

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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.

Categories: California Healthline, Cost and Quality, Health Industry, Insurance

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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.

Categories: California Healthline, Cost and Quality, Health Industry, Public Health

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Different Takes: What To Do With CHIP; Deal With Threats To Obamacare Before Single Payer

News outlets examine a variety of pressing health policy issues, ranging from the reauthorization of the Children’s Health Insurance Program to what’s next for the Affordable Care Act.

Forbes: Children’s Health Insurance Program Demands Quick, Bipartisan Passage
CHIP was a shared vision of Republicans and Democrats alike. It seems like ancient history now, but, in 1997, I joined with members from both sides of the aisle to debate health care policy forcefully but productively. Led by Senators Ted Kennedy (D-MA) and Orrin Hatch (R-UT), we crafted the CHIP language. Bipartisan action, so crucial to the health of the country and the economy, was never more important than when it came to insuring America’s children. Now, two decades later, that progress is in jeopardy. CHIP is set to expire on September 30. (Bill Frist, 9/14)

National Review: Continue To Fund Children’s Health Care, But Coordinate The Programs Better
CHIP, which helps states provide health-care coverage to low-income kids, is better structured than Medicaid to ensure that funds are targeted to those who need assistance most. Now, after the Affordable Care Act has created an entitlement to subsidized coverage through the exchange, CHIP-eligible families are often torn between two programs that fit together poorly. If a few minor flaws in its design are fixed, however, CHIP can fill a gap and enhance the rest of America’s health-care safety net. (Chris Pope, 9/18)

The Washington Post: Before Tackling Single-Payer, Save Obamacare
Before supporters of universal health coverage get all wrapped up debating a single-payer system, they need to focus on a dire threat to the Affordable Care Act likely to come up for a vote in the Senate before the end of the month. The latest repeal bill is an offering from Republican Sens. Lindsey O. Graham (S.C.) and Bill Cassidy (La.) that would tear apart the existing system and replace it with block grants to the states. Block grants — flows of money for broad purposes with few strings attached — are a patented way to evade hard policy choices. All the tough decisions are kicked down to state capitals, usually with too little money to achieve the ends the block grant is supposed to realize. (E.J. Dionne, 9/17)

The New York Times: Complacency Could Kill Health Care
I haven’t yet read Hillary Clinton’s “What Happened,” but it seems pretty clear to me what did, in fact, happen in 2016. These days, America starts from a baseline of extreme tribalism: 47 or 48 percent of the electorate will vote for any Republican, no matter how terrible, and against any Democrat, no matter how good. This means, in turn, that small things — journalists acting like mean kids in high school, ganging up on candidates they consider uncool, events that suggest fresh scandal even when there’s nothing there — can tip the balance in favor of even the worst candidate imaginable. (Paul Krugman, 9/18)

Baltimore Sun: Medicaid Cuts Shift Burdens To States
Thanks to massive grassroots mobilization efforts, our state narrowly averted disaster when Congress failed to pass any version of Affordable Care Act (ACA) repeal that would have restructured Medicaid and left thousands of my constituents without health care coverage. Stopping health care repeal was a huge victory, but the fight is not over yet. Even deeper cuts to Medicaid have been proposed in the 2018 budget resolution, which would slash health care by $1.5 trillion over the next 10 years to pay for billions in tax breaks to the rich and corporations over that same period. (Rep. C.A. “Dutch” Ruppersberger, 9/17)

The New York Times: The Best Health Care System In The World: Which One Would You Pick?
“Medicare for all,” or “single-payer,” is becoming a rallying cry for Democrats. This is often accompanied by calls to match the health care coverage of “the rest of the world.” But this overlooks a crucial fact: The “rest of the world” is not all alike. The commonality is universal coverage, but wealthy nations have taken varying approaches to it, some relying heavily on the government (as with single-payer); some relying more on private insurers; others in between. (Aaron E. Carroll and Austin Frakt, 9/18)

The Washington Post: A Century Ago, Women Fought For Access To Contraception. The Trump Administration Threatens To Undo Their Work.
Trump administration officials vow that they are going to take care of the health of moms and babies. But their pledge to cut funding to Planned Parenthood promises to do the opposite. The proposed cuts have focused not just on the procedure of legal abortion (which is, of course, another column), but also on eliminating access to contraceptives. These proposals ignore a fundamental truth: Access to birth control is central to women’s health. In fact, it always has been. (Lauren MacIvor Thompson, 9/15)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Under Pressure To Reduce Red Tape, FDA To Hold Hearing On Approval Process

The FDA implemented a more structured approach to how new drugs are approved based on their safety risks as part of the reauthorization of the Prescription Drug User Fee Act in 2010. At the meeting, the agency will likely hear testimony on experiences with this approach.

Modern Healthcare: FDA​ To​ Host​ Hearing​ On​ Assessing​ Risks,​ Benefits​ In​ New​ Drugs 
The Food and Drug Administration this week is holding a public hearing on how risk assessments are conducted on new drugs. The agency is under immense pressure to reduce review and approval times of drugs in order to lower costs but also ensure medications are safe before they go to market. In 2014, the FDA implemented a more structured approach to how new drugs are approved based on their safety risks, the severity of the disease and the availability of other drugs to treat that disease. The effort was part of the reauthorization of the Prescription Drug User Fee Act in 2010. At this week’s meeting, the FDA will likely hear testimony on experiences with this approach and ways to better incorporate the patient perspective into the process. (Castellucci, 9/16)

In other pharmaceutical news —

Bloomberg: Walgreens Said To Tweak Rite Aid Deal To Clinch U.S. Approval 
Walgreens Boots Alliance Inc. is poised to revise its agreement to buy individual Rite Aid Corp. stores, a move that may be enough to resolve outstanding antitrust concerns and clinch U.S. approval for a deal the companies have been pursuing in different forms for two years, said people familiar with the matter. Walgreens is in the final stage of negotiations with the Federal Trade Commission about its plan to buy more than 2,000 Rite Aid stores and is set to propose a modified deal that could be announced as soon as Monday, according to three people, who declined to be identified because the talks are confidential. (McLaughlin and Langreth, 9/18)

California Healthline: California Drug Price Bill Sweeping In Scope, Lacking In Muscle
A California bill headed to the governor’s desk may be the most sweeping effort in the nation to shine a light on drug pricing, but it lacks the muscle being applied in other states to directly hold those prices down. The idea behind the law is that if everyone knows when and why prices are rising, political leaders eventually will be more empowered to challenge those increases. (Bartolone, 9/18)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Without Price Breaks, Rural Hospitals Struggle To Stock Costly, Lifesaving Drugs

MOUNTAIN VIEW, Ark. — Hospital pharmacist Mandy Langston remembers when Lulabelle Berry arrived at Stone County Medical Center’s emergency department last year.

Berry couldn’t talk. Her face was drooping on one side. Her eyes couldn’t focus.

“She was basically unresponsive,” Langston recalls.

Berry, 78, was having a severe ischemic stroke. Each passing second made brain damage more likely. So, Langston reached for the clot-busting drug Activase, which must be given within a few hours to work.

“If we don’t keep this drug [in stock], people will die,” Langston said.

Berry survived. But Langston fears others could die because of an unintended bias against rural hospitals built into the U.S. health law. An obscure Obamacare provision forces rural hospitals like Langston’s to pay full price for drugs that many bigger hospitals buy at deeply discounted rates.

For example, Langston’s 25-bed hospital pays $8,010 for a single dose of Activase — up nearly 200 percent from $2,708 a decade ago. Yet, just 36 miles down the road, a bigger regional hospital gets an 80 percent discount on the same drug.

White River Medical Center, a 235-bed facility in Batesville, Ark., buys Activase for about $1,600 per dose. White River participates in a federal drug discount program Congress approved in the early 1990s. The program offers significant price breaks on thousands of drugs to hospitals that primarily serve low-income patients. One federal report found the average discount ranged from 20 to 50 percent, though as illustrated with Activase, it can be much higher.

Rural hospitals have long wanted to be part of the so-called 340B program, too, but were blocked from participating until the Affordable Care Act of 2010. That historic health law added rural hospitals to the overall program. But, unlike bigger hospitals, rural hospitals can’t get discounts on expensive drugs that treat rare diseases because of a last-minute exclusion written into the ACA.

That seemingly minor detail in the law has left rural hospital pharmacists and health care workers struggling to keep medicines in stock, and wondering if they will be able to adequately care for patients.

Arkansas, for example, is in the “stroke belt,” where medical staff depend on Activase to help them battle one of the highest rates of stroke deaths in the country. When Langston went to restock Activase this year, it was so expensive she left a reorder unfilled for more than week, anxiously keeping only one dose of the clot-busting drug on hand.

“Usually strokes come in clusters,” Langston said. “I didn’t want two people to come in and we were going to [have to] choose which one we were going to treat.”

In Atlantic, Iowa, pharmacy director Crystal Starlin sparingly stocks oncology drugs at Cass County Memorial Hospital. Newly diagnosed cancer patients might have to wait a couple of days to start treatment.

“We just can’t keep the extra [drugs] on hand,” Starlin said.

In Vermont, North Country Hospital closed its infusion center this spring due to the soaring cost of medicines.

“That was one area we could not afford to be in,” said chief executive Claudio Fort. North Country is the only hospital in a two-county region along the Canadian border and its roughly dozen active chemotherapy patients now must drive 45 minutes away for treatment.

The rare-disease exclusion was not publicly debated before being added into the ACA. Rather, it was tucked into the law at the very end of the process. How it wound up in the law is a bit of a mystery.

Former PhRMA chief executive Billy Tauzin said he doesn’t recall negotiating the exclusion. But, he said, the industry has consistently raised concerns about the drug discount program’s reach.

“It’s a question of how deeply you can afford to discount drugs that are expensive,” said Tauzin, who abruptly stepped down just before the ACA passed.

After the health law passed, PhRMA battled for years — in federal court — to keep rural hospitals from getting discounts on rare-disease drugs.

Congressman Peter Welch, a Democrat from Vermont who represents North Country, said it is clear whom the law hurts and helps.

“The pharma lobbyists pay attention, and their lawyers pay attention to the fine print,” Welch said. The pharmaceutical industry changes that fine print … [and] many legislators don’t even realize [that it] will have this adverse impact on hospitals in their communities.”

The rare-disease exclusion means that certain types of hospitals — including critical access, sole community and rural referral centers — cannot get discounts on rare-disease drugs, or on drugs that are “designated” to treat a rare disease. (Rare-disease drugs are also known as orphan drugs, which is a federally approved category of drugs that treat a disease affecting fewer than 200,000 people. Often, they carry price tags of up to $100,000 a year or more.)

The Food and Drug Administration gives the designation as a first step when it agrees with a drugmaker’s request to study whether a drug can be used to treat a specific rare disease. This can happen even if a drug is already FDA-approved and on the market for use in treating a common condition. The next step — the ability to market the medicine as an orphan drug — comes once research confirms that the drug is safe and effective in treating a specific, less common condition.

The popular clot-buster Activase has not won final approval to treat a rare disease but, on two separate occasions in 2003 and 2014, the FDA has given it the orphan designation while research is ongoing.

About 450 orphan drugs have been approved by the FDA. But thousands of drugs are “designated” and more are identified every week.

The list includes generic drugs such as the hormone melatonin and the autoimmune drug abatacept. In other words, medicines used to treat everything from sleep troubles to arthritis have ended up “designated.”

The small town of Mountain View, Ark., known for its crafts and music scene, is about two hours north of Little Rock and nestled in the rolling Ozarks. Arkansas’ mountainous terrain makes it essential for local hospitals to stock lifesaving stroke drugs. The state reports some of the nation’s highest rates of stroke deaths. (Sarah Jane Tribble/KHN)

Some drugmakers, such as Janssen Pharmaceuticals, have voluntarily offered discounts to rural hospitals on all of their orphan drugs including Remicade, whether they’re approved or designated. In contrast, drugmaker Genentech sent letters to rural hospitals on Jan. 1 listing dozens of drugs that would not qualify for discounts, including Activase and cancer drug Avastin.

Susan Willson, a Genentech spokeswoman, said the company is “deeply committed to ensuring that people have access to the medicines they need.” But, she added, the company believes the federal drug discount program has “grown well beyond its original intent.”

Several federal reports in recent years from the Medicare advisory board, as well as the Government Accountability Office and the Office of Inspector General, have evaluated the federal drug discount program’s growth. About 40 percent of U.S. hospitals now participate in the program and House Republicans held a hearing this summer questioning the program’s growth.

But for Dana Smith, director of pharmacy at Dallas County Medical Center in Fordyce, Ark., the discount program’s growth and problems are a separate issue.

“Basically, Genentech is saying to me that rural health care and the patients in rural America are not as important as patients in urban areas,” Smith said, adding the pharmaceutical industry “knows we have less manpower to fight them.”

Back at Stone County, emergency room medical director Dr. Barry Pierce paused one recent afternoon at the nursing station and recalled those tense days with just one dose of Activase. Stone County now keeps two doses of the stroke drug on hand.

Pierce noted that Stone County is at least 45 minutes away from the next nearest hospital and, echoing Langston’s concern, he said: “If we don’t have the drugs we need, people will die.”

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

Categories: Cost and Quality, Health Industry, Pharmaceuticals, The Health Law

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After Tragedy At Fla. Nursing Home, Advocates Say New Rule Protecting Residents Doesn’t Go Far Enough

A new federal rule will require that nursing homes have “alternate sources of energy to maintain temperatures to protect resident health and safety.” But some say it is too vague and wouldn’t have necessarily avoided the deaths of the 8 residents in Florida even if it had been in effect. Meanwhile, police have obtained a search warrant in their criminal investigation of the Florida nursing home, and The New York Times offers tips on choosing a reliable facility.

The New York Times: Nursing Home Deaths In Florida Heighten Scrutiny Of Disaster Planning
After an estimated 215 people died in hospitals and nursing homes in Louisiana following Hurricane Katrina in 2005, policy makers realized that the nation’s health care institutions were ill-prepared for disasters. One of the rules they created after years of discussion looked especially prescient in light of the tragic deaths on Wednesday of eight nursing home residents in Florida’s post-hurricane heat. But the rule, regarding power supplies and temperature control, will not be enforced until November, and even then, some patient advocates are concerned that it does not go far enough. (Reisner and Fink, 9/14)

Reuters: Police Obtain Search Warrant In Probe Of Eight Nursing Home Deaths
Police obtained a search warrant on Thursday in their criminal investigation of the deaths of eight elderly patients exposed to sweltering heat inside a Miami-area nursing home left with little or no air conditioning after Hurricane Irma struck. The loss of life in Hollywood, Florida, brought the overall death toll from Irma to 82, with several hard-hit Caribbean islands, including Puerto Rico and the U.S. Virgin Islands, accounting for more than half the fatalities. (Oliphant, 9/15)

Miami Herald: Hollywood Nursing Home Employees, Operators Could Face Charges For Deaths
The Hollywood Police Department has opened a criminal investigation that could lead to manslaughter charges if the Broward state attorney’s office concludes that employees, administrators or the owner of the center acted with culpable negligence — “an utter disregard for the safety” of the deceased elderly patients. (Weaver and Teproff, 9/14)

Los Angeles Times: ‘There For You 100%,’ Trump Tells Floridians; Elderly Plight In Spotlight After Nursing Home Deaths
President Trump told Florida hurricane victims his administration is “there for you 100%” as officials moved urgently to safeguard the state’s vulnerable elderly and restore power to millions of homes and businesses still without electricity. The president and First Lady Melania Trump arrived aboard Air Force One in Fort Myers on the peninsula’s southwestern Gulf coast, then traveled by helicopter to Naples, 40 miles away. It was Trump’s third disaster-zone visit in less than three weeks. (Lee, McDonnell and King, 9/14)

The Associated Press: Vulnerable Residents A Concern In Hurricane Irma Aftermath
Florida’s fits and starts toward post-Irma recovery have shifted to urgent efforts to protect its vulnerable elderly residents after a string of nursing home deaths. Several nursing homes have been evacuated because of a lack of power or air conditioning, while utility workers raced help dozens of others still lacking electricity as of Thursday. Homebound seniors found help from charities, churches and authorities. (Kay and Reynolds, 9/15)

Health News Florida: Heat Illness Can Be Deadly For Seniors Without Power
For the millions of people who are still without power across Florida, heat illness can be a concern. The old and the very young are most susceptible to heat-related health issues and the death of 8 residents at an assisted living facility in Hollywood that lost power after Hurricane Ivan illustrates the danger. (Ochoa, 9/14)

The Hill: Walden Hints At Nursing Home Oversight In Wake Of Irma Deaths 
House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said his committee may begin looking at oversight of nursing facilities following the deaths of eight people in a Florida nursing home. The deaths occurred after the South Florida facility apparently lost its air conditioning amid widespread power outages in the wake of Hurricane Irma. The storm knocked out power for millions of people across the state. (Weixel, 9/14)

The New York Times: Five Tips For Choosing A Reliable Nursing Home
The news that eight Florida nursing home residents died in the aftermath of Hurricane Irma has prompted a criminal investigation and spurred widespread outrage. But it also poses unsettling, difficult questions for people selecting a nursing home for themselves or a loved one. This emotionally fraught choice often must be made at a chaotic moment when a relative is sick, his or her time in the hospital is running short and the options seem confusing. (Thomas, 9/14)

WMFE: Hundreds Of Elderly Residents Evacuate In Osceola County
The assisted living facility, Good Samaritan Village in Kissimmee, experienced up to four feet of flooding after Hurricane Irma passed through. On Tuesday morning, 356 elderly residents were evacuated from the facility, while close to 200 residents chose to leave. (9/14)

In related news —

The Washington Post: Texas Officials: Hurricane Harvey Death Toll At 82, ‘Mass Casualties Have Absolutely Not Happened’
Texas officials said Thursday that they believe at least 82 people died as a result of Hurricane Harvey and the intense flooding it brought to Houston and coastal areas, although it could take weeks to determine the exact death toll. The picture could have been much bleaker, given the amount of flooding and that entire communities were cut off for days. Hospitals had to be evacuated as water rose into buildings that had never before flooded; some residents found themselves trapped in their homes while chest-deep floods took over their streets; and emergency responders along the Texas coast were overwhelmed, leading civilians with watercraft to rescue one another. (Moravec, 9/14)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Weeding Out The Rhetoric From The Facts On Sanders’ ‘Medicare For All’ Plan

The New York Times examines various claims — like that the majority of people are in support of a single-payer system — surrounding Sen. Bernie Sanders’ proposal. Meanwhile, Sen. John Barrasso (R-Wyo.) asks the Congressional Budget Office to score the bill, which could make it an even tougher sell than it already is.

The New York Times: ‘Medicare For All’: Is It Popular? And Is It The Same As Britain’s System?
As leading Democrats embrace Senator Bernie Sanders’s proposal to vastly expand Medicare to cover all Americans, Republicans are fighting back with familiar critiques of such a single-payer system. Mr. Sanders argued for his “Medicare for all” legislation in an Op-Ed published in The New York Times on Wednesday, while his Republican colleagues dismissed the idea in a news conference. Here’s an assessment of their claims. (Qiu, 9/14)

The Wall Street Journal: Single-Payer Health Care Could Be A Tough Sell, Polling Shows
Single-payer health care, or as Sen. Bernie Sanders (I., Vt.) calls it, “Medicare for all,” is becoming a rallying cry for many Democrats in Congress. But are Americans behind the idea of mandatory government-provided insurance? Polling from the summer tells us that it could be a tough sell. Only 33% of the overall public supports a “single payer” approach to health care, according to the Pew Research Center’s June poll. Among Democrats and those who lean Democrat, Pew says 52% support single-payer, up from 33% in March 2014. (Jamerson, 9/14)

The Hill: Senator Asks For CBO Score Of Sanders’s Single-Payer Bill
Sen. John Barrasso (R-Wyo.) is asking congressional scorekeepers to analyze the cost of Sen. Bernie Sanders’s (I-Vt.) “Medicare for all” bill, which could fuel Republican attacks that a single-payer health-care system would bankrupt the country. In a letter to the head of the nonpartisan Congressional Budget Office, Barrasso — the Senate Republican Policy Committee chairman — wrote he was “deeply concerned that Senator Sanders’ Medicare-for-All legislation is not only a government takeover of health care, but would also put financial burdens on the American people that they cannot sustain.” (Roubein, 9/14)

The Washington Post: Sanders Enlists Canadians To Sell Single Payer
The day after he finally unveiled his legislation to turn Medicare into universal health insurance, Sen. Bernie Sanders (I-Vt.) built on his momentum in an unusual way: a 32-minute interview with a Canadian doctor. “We have a very, very exciting show!” Sanders said, kicking off his occasional podcast and introducing Danielle Martin, a Toronto physician and academic. “She’s kind of a household name in America now.” (Weigel, 9/14)

The Hill: Trump Calls Sanders Single-Payer Plan A ‘Curse On The US’ 
President Trump on Thursday called Sen. Bernie Sanders’s (I-Vt.) “Medicare for all” plan a “curse on the U.S.” “Bernie Sanders is pushing hard for a single payer healthcare plan – a curse on the U.S. & its people,” Trump tweeted. “I told Republicans to approve healthcare fast or this would happen. But don’t worry, I will veto because I love our country & its people.” (Hellmann, 9/14)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Viewpoints: Cancer Drug Revolution; When The Cause Of Death Is ‘Inequality’

A selection of opinions on health care from around the country.

The Columbus Dispatch: New Cancer Drug Revolutionary?
The Food and Drug Administration approved a new treatment last month for acute lymphoblastic leukemia, an aggressive disorder of the blood and bone marrow that is the most common childhood cancer in the United States. On its face, this may not seem like big news. The government is approving it for use only on young people, only 3,100 of whom are diagnosed with the disease every year. So a relatively small number of Americans stands to benefit. (9/14)

Los Angeles Times: Prostate Cancer: Patience And Prevention
For more than a decade, we’ve known that prostate cancer is over-diagnosed and over-treated, putting men at risk of incontinence and sexual dysfunction to remove what might have been a slow-growing, non-lethal cancer. When active surveillance of prostate cancer was first proposed over a decade ago, men weren’t racing to be the first to try it. Active surveillance is the careful monitoring of cancer for signs of progression. Unlike lung, breast and colon cancer, there are indolent forms of prostate cancer that do not require surgery or radiation. (Jeffrey Yoshida, 9/13)

Chicago Tribune: I Watched My Patients Die Of Poverty For 40 Years. It’s Time For Single-Payer Health Care.
Sarai was 25 when she died of Wilson’s disease, an inherited disorder that causes liver failure. A liver transplant could have cured her, but she was uninsured and was denied an appointment at two prominent Chicago transplant hospitals, including my own. Sarai’s plight was brought to my attention when a local religious group held a hunger strike advocating transplant access for Sarai and other uninsured patients. When she died, her congregation marched seven miles, holding her photograph and lugging coffins emblazoned with her name, to launch a sit-in in front of Northwestern University Hospital. Her death certificate named liver disease as her cause of death, but that’s not true. The real cause was inequality. If the United States had a Medicare-for-all health insurance system, she might have been saved. (David A. Ansell, 9/13)

JAMA Forum: Long-Term Care: Investing In Models That Work
President Trump and the US Congress have promised to reduce federal spending, through tactics that include cutting Medicaid and Medicare. What they fail to take into account is that sometimes investing in programs that work well can reduce spending while improving the health and well-being of people. A case in point: programs that help older adults and those who are disabled remain in their homes and out of long-term care facilities. (Diana Mason, 9/13)

The Des Moines Register: In A Medical Emergency, WHERE You Live May Determine IF You Live
Did you know the majority of urban ambulance services are paid, while rural ambulance services are mostly volunteers? Sixty-seven percent of all ambulance services in Iowa are staffed by volunteers who receive no compensation. The majority of our higher level care hospitals are in urban areas served by paid ambulance services, most of which are at a paramedic level. In contrast, Iowa’s rural areas have community hospitals, accounting for 79 percent of the hospitals in our state. These hospitals can only stabilize and transfer critical patients to higher level care hospitals, typically located a significant distance away. Nine counties in Iowa have no hospital. (Sandy Heick, 9/12)

JAMA: What Should I Do When I Hear The Call For Medical Assistance In A Plane?
If there is a doctor on board, would you please make yourself known to a member of the cabin crew?” Reflexively, my hand shoots up to press the button. Seven times I have responded to such requests. Mostly it has worked out well. Twice I thought the passenger had had too much alcohol. Once I comforted an anxious woman. Another time a young army recruit heading for basic training had unexplained arm pain. Sometimes it was more serious. A man with abdominal pain told me he had cancer and he needed my attention and reassurances. A woman had a cardiac emergency, and I had to request an unscheduled landing. Another emergency on a trans-Pacific flight required the extended care of several physicians. (Gregory L. Eastwood, 9/12)

Stat: It’s Time To Give Those With Severe Brain Injuries The Civil Rights They Deserve
Several colleagues and I had proposed a project to study the legal rights of people with severe brain injury. Their plight is terrible: They are often dispatched from the hospitals where their lives had been saved to nursing homes where they receive what is euphemistically called custodial care rather than skilled medical care. (Joseph J. Fins, 9/13)

RealClear Health: It’s Time To Tackle Suicide Rates Smartly
September is Suicide Prevention Month and well-meaning suicide advocates are out in force calling for a greater effort to reduce it. But can we reduce suicide? While researching, “Insane Consequences: How the Mental Health Industry Fails the Mentally Ill,” I learned that mortality from strokes, AIDS, heart disease, and leukemia have decreased dramatically since the 1960s, but in spite of all we’ve spent on suicide, suicide mortality has remained the same. (DJ Jaffe, 9/14)

The Wall Street Journal: The Campus Left Vs. The Mentally Ill
Conservative commentator Ben Shapiro is scheduled to speak Thursday at the University of California, Berkeley, and school officials are prepared. A campuswide announcement promised “support and counseling services for students, staff and faculty” who feel Mr. Shapiro’s presence threatens their “sense of safety and belonging.” (Clay Routledge, 9/13)

The Kansas City Star: Josh Svaty May Be Pro-Lifeish. Will Kansas Democrats Allow Such A Thing?
Democratic gubernatorial candidate Josh Svaty got the question of the night, and of the year, from a man in suspenders in the third row: “For a lot of Democrats, particularly Democratic women, choice is a threshold issue. Can you say why, as a pro-choice Democrat, I should get enthusiastic about you?” Svaty, a 37-year-old farmer, former EPA official and ag secretary who successfully ran for the Kansas statehouse out of his college dorm room, voted with his heavily Republican, rural district on the abortion issue. He began the answer that will matter most to his candidacy this way: “That was part of being responsive to constituents. (Melinda Henneberger, 9/13)

The New York Times: The Economic Case For Letting Teenagers Sleep A Little Later
Many high-school-agechildren across the United States now find themselves waking up much earlier than they’d prefer as they return to school. They set their alarms, and their parents force them out of bed in the morning, convinced that this is a necessary part of youth and good preparation for the rest of their lives. It’s not. It’s arbitrary, forced on them against their nature, and a poor economic decision as well. (Aaron E. Carroll, 9/13)

Stat: Study On Flu Shot-Miscarriage Link Shows Science Prioritizes Vaccine Safety
[T]here is a scientific reason to think that the new findings may be a true signal we need to take seriously. While multiple studies in the past have found that women who received flu vaccine during pregnancy did not have a higher rate of miscarriage than women not vaccinated, this is the first study to focus on three important variables: 1) vaccines that contained the 2009 H1N1 flu virus strain, the virus that caused the 2009 influenza pandemic; 2) the 28 days after vaccination; and 3) the impact of repeat flu vaccination over two flu seasons. (Michael T. Osterholm, 9/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Reporter’s Notebook: In Health Care, A Good Price Is Hard To Find

A recent story about why Northern California is the most expensive place in the country to have a baby began as a tip from an obstetrician. Dr. Sarah Azad told me that insurers were paying her just a third of what they pay doctors employed by large hospital systems in her town of Mountain View, Calif.

Unfortunately, she explained, she could speak only in general terms. She couldn’t share her actual payment rates with me because she was barred from doing so by a gag clause in her contracts with insurers.

So, I called the insurers who pay her, and the hospital systems that employ most of the other obstetricians in Mountain View. They all had the same answer: It would be illegal for them to tell me the dollars and cents.

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As it turns out, the vast majority of contracts between doctors or hospitals and insurance companies are subject to a gag clause, which prohibits either party from disclosing negotiated rates. That means it’s almost impossible for consumers, researchers or journalists to find actual, accurate numbers, despite the fact that cost differentials among doctors can be so stark. And it’s particularly problematic for the growing number of people who have insurance plans with deductibles that can run more than $10,000 for a family.

The underlying problem of our health care system — beyond the corrosive partisan politics — is its high cost. I have long understood that the lack of price transparency is one reason our system stays so expensive. It was a surprise, though, to find out that this opacity is cemented by legally binding contracts.

Think about what this would look like for a mundane purchase, say, a gallon of milk. Advertisements and price tags would disappear, so you couldn’t compare prices at different stores. And you wouldn’t even know how much you had paid for the milk until you got a bill in the mail weeks or months later. On top of that, the store and the dairy farmer would be barred from telling a journalist or an economist what you had paid.

It’s absurd, but I wasn’t going to let the absurdity kill my story.

I started by asking all of the health policy analysts, researchers and economists I could find, “How can I find these rates, by physician, for an uncomplicated vaginal delivery?” Everyone told me the same thing: You can’t get that.

I searched online, but most of the websites claiming to offer health price transparency offered only “average costs” for specific services in your area. Not much help if you’re trying to compare the costs of individual doctors.

Next, I asked Castlight, a “transparency tool” that gathers payment data and allows employees of certain companies to estimate the costs of their medical care. But Castlight told me that as a journalist, I wasn’t allowed to have access to the exact pricing information of individual providers. It, too, was subject to the gag clause.

So I turned to the consumers who might have access to those tools. I asked friends and colleagues, and put out social media requests: Would anyone be willing to share the information from the cost estimators they got from their employers or insurers? I found a few willing sources and was able to mine the results of their inquiries to find out the basic cost differentials between independent doctors and those employed by large systems, including Sutter Health.

Unfortunately, these estimators are difficult to use and often provide incomplete data. And when I tried to confirm that information, I ran up against the gag clauses again.

Finally, I found out about a health data company called Amino that was willing to send me the claims data it had been gathering. At last! The Holy Grail! It had hundreds of claims for vaginal births performed by obstetricians in the Bay Area. KHN data correspondent Sydney Lupkin helped me decipher a Medicare provider database to determine where each doctor worked. In cases where the doctor’s employment status was unclear, I called the health system or physician directly. We then calculated the median billing amount, on average, for a routine vaginal birth for each health system.

Weeks of digging and data analysis confirmed the imbalance Dr. Azad had told me about at the start of my quest. The few independent doctors left in the Bay Area receive a median amount of $2,408.45 for a routine vaginal delivery, which includes prenatal and postnatal visits. That compares with $5,238.13 for the same bundle of services provided by Stanford physicians and $8,049.84 when the doctors are employed by University of California-San Francisco — a fourfold difference.

Hard data, hard won.

The database we built gave us a strong sense of the cost variation between doctors who work at other health systems and those who have remained independent. But it did not include enough claims from the largest hospital system in the region, Sutter Health. For Sutter, I used the data from the online cost estimators, and found that obstetricians employed by the system are reimbursed about $6,452 for a vaginal delivery.

It’s no accident that data on physician costs are so hard to find. Its inaccessibility allows hospitals to keep raising their prices. It’s simply not in their interest for the public to know how much they’re charging. And insurers don’t want other doctors or hospitals to see the high prices they’ve agreed to pay, for fear they would demand the same.

In the end, all of us — through our insurance premiums and our taxes — pay a price for non-transparency.

Categories: Cost and Quality, Health Care Costs, Health Industry

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FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program

The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.

In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases.

A KHN investigation earlier this year, which was published and aired by NPR, found many drugs that now have orphan status aren’t entirely new. Of about 450 drugs that have won orphan approval since 1983, more than 70 were drugs first approved by the FDA for mass-market use. Those include cholesterol blockbuster Crestor, Abilify for psychiatric disorders and rheumatoid arthritis drug Humira, the world’s best-selling drug.

Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children. He also signaled that bigger changes are being considered, announcing a public meeting to explore issues raised by scientific advances, such as the increase in precision medicine and biologics.

“We need to make sure our policies take notice of all of these new challenges and opportunities,” he wrote. Gottlieb, through his agency, declined multiple requests for interviews.

Over the years, drugmakers have fueled a boom in orphan drugs, which often carry six-figure price tags. Nearly half of the new drugs approved by the FDA are now for rare diseases — even though many of them also treat and are marketed for common diseases.

Gottlieb became commissioner in May, a few months after three key Republican senators called for a federal investigation into potential abuses of the Orphan Drug Act, and the Government Accountability Office agreed to investigate.

The GAO has yet to begin its investigation, saying it doesn’t expect to start work until late this year, when staff is available. Regardless, in late June, Gottlieb announced what would be the first in a series of updates that shift the way the FDA handles orphan drugs.

Those include:

  • Eliminating a backlog in drug applications for orphan designation or status. Getting a “designation” is a critical first step if a company wants to win orphan incentives once the drug is approved for treatment use. And, much like the rise in approvals, the requests by companies to get drugs designated with orphan status has also skyrocketed. Gottlieb said in June that he wanted to get rid of the backlog; on Tuesday, he said the effort was complete. About half of the 200 applications from drugmakers won orphan status.
  • Mandating that drugmakers prove their medicine is clinically superior before getting the market exclusivity that comes with being an orphan. The agency had lost a lawsuit in which a company said it was owed the exclusivity period regardless of whether its medicine was better. And two more lawsuits had been filed by Eagle Pharmaceuticals and, more recently, another by United Therapeutics. The FDA Reauthorization Act, which passed last month, made it law that a drug has to be clinically superior to get the incentives.
  • Closing the loophole for pediatric orphan drugs by requiring all drugs approved for common adult diseases, like inflammatory bowel disease, undergo pediatric testing when getting approval as a pediatric orphan drug. Pediatric testing is not required for orphan drugs, and last month Congress mandated that orphan drugs for cancer be tested for children. Still, the American Academy of Pediatrics celebrated the proposed change but warned it was only a “first step.” Dr. Bridgette Jones, chair of American Academy of Pediatrics Committee on Drugs, said late Tuesday that orphan drugs are “still mostly exempt from pediatric study requirements … children deserve access to safe, effective medications.”

Dr. Martin Makary, who wrote a critical 2015 paper on orphan approvals, said the changes at the agency indicate that Gottlieb seems “concerned about all the right things.”

“The government does a lot of lip service in general,” Makary said. “This is not lip service.”

The restructuring has been swift in some ways.

Sandra Heibel, a senior consultant at Haffner Associates, a firm that helps companies submit orphan drug applications, noted that the approval process for designations definitely sped up over the summer, and “we are absolutely getting responses from the FDA back in 90 days. That has come through.”

Other changes to the agency, though, will evolve slowly. For example, the orphan drug office has begun reaching across the FDA’s divisions for help in reviewing drugs. In May, the FDA’s orphan reviews began to work with the office of pediatric therapeutics to review pediatric applications — ideally increasing the expertise applied when considering a company’s request for orphan drug use in children.

In an emailed note Tuesday, the agency confirmed that Gottlieb’s orphan modernization plan is part of a larger effort to increase competition and decrease drug prices. One focus is on targeted drugs — especially those that affect rare diseases or diseases for which there is no effective therapy, the agency said.

“Such drugs present some of the biggest opportunities in medicine to treat and cure debilitating and very costly diseases,” the agency stated.

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

Categories: Cost and Quality, Health Industry, Pharmaceuticals

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When Exciting Breakthrough Treatments Come With Astronomical Price Tags

News outlets report on stories related to pharmaceutical pricing.

The New York Times: New Gene-Therapy Treatments Will Carry Whopping Price Tags
The first gene therapy treatment in the United States was approved recently by the Food and Drug Administration, heralding a new era in medicine that is coming faster than most realize — and that perhaps few can afford. The treatment, Kymriah, made by Novartis, is spectacularly effective against a rare form of leukemia, bringing remissions when all conventional options have failed. It will cost $475,000. (Kolata, 9/11)

NPR: R&D For Cancer Drugs May Cost A Fraction Of What Industry Claims
The analysis, published in the current issue of JAMA Internal Medicine, concludes that it costs, on average, $650 million to develop a new cancer drug. The authors add in another $100 million or so to account for income those companies could have had if that money had been invested in the stock market instead of in new products. That total is far lower than the $2.7 billion figure that the drug industry frequently points to when it justifies the soaring cost of medicine. (It’s far higher than $320 million — an inflation-adjusted figure from a 2001 study by the consumer group Public Citizen). (Harris, 9/11)

Stat: Why Is The FDA Chief So Worried About Pharma Profits?
Developing new drugs is a costly business. So, too, is paying for the ever more expensive therapies that come to market each year. Statutorily, neither of those things is the Food and Drug Administration’s problem. But the agency’s new commissioner argues forcefully that the FDA can bring down drug prices for patients — by making life a little easier for Big Pharma. (Garde, 9/11)

Stat: FDA’s Gottlieb Plans To Close An Orphan Drug Loophole
Amid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, the Food and Drug Administration plans to close at least one of them. In a blog post, FDA Commissioner Scott Gottlieb acknowledged concerns that the Orphan Drug Act, which allows the agency to approve medicines for treating rare diseases affecting fewer than 200,000 people, needs fixing. As he put it, some drug makers are using orphan designations “as a way to sidestep other important public health goals set out by Congress.” (Silverman, 9/12)

The Wall Street Journal: Drug Companies Tie Costs To Outcomes
For decades, health insurers and patients have paid for prescription drugs based on the volume of pills or vials purchased—whether or not the medicines helped individual patients as intended. Now the outcry over high drug prices has raised the profile of a different approach to paying for prescription drugs. Pharmaceutical companies increasingly are offering to tie a portion of their reimbursements from insurers to how well drugs work in patients. (Loftus, 9/12)

Modern Healthcare: Providers Reduce Waste To Work Around Ballooning Drug Prices
Cleveland Clinic is one of the most prolific users of the heart drugs nitroprusside and isoproterenol, so when their respective prices surged 30-fold and 70-fold over a three-year span, it caught the provider’s attention. Doctors have long relied on the widely used drugs during life-threatening situations. They use nitroprusside to lower blood pressure and treat critical hypertension and congestive heart failure, as well as to keep blood pressure low during surgery. Isoproterenol is used primarily for treating low heart rate and heart block and is used to increase a patient’s heart rate while doctors operate. Valeant Pharmaceuticals acquired the rights to the off-patent drugs in 2015 and drastically increased the prices. (Kacik, 9/11)

Stat: Pharma’s Five Favorite Tricks To Protect A Monopoly
If you invent a wonder pill, you get a patent and thus a monopoly. The catch is that the patent must one day expire, opening the door to cheap generics and forcing inventors back to the well to start the cycle all over again. But it can be quite hard to say goodbye to a monopoly and the riches it brings. And so drug companies tend to get creative in the waning days of patent exclusivity, stretching the law to translucent lengths in the name of protecting profits. That became quite evident (again) last week, when Allergan surprised the pharma world by announcing it had sold patent rights on a lucrative eye drug to a Native American tribe to avoid facing certain legal challenges by generics. (Garde, 9/11)

The New York Times: How To Protect A Drug Patent? Sell It To A Native American Tribe
The drugmaker Allergan announced Friday that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug from a patent dispute .Under the deal, which involves the dry-eye drug Restasis, Allergan will pay the tribe $13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive $15 million in annual royalties as long as the patents remain valid. (Thomas, 9/8)

The Wall Street Journal: Allergan Partners With Indian Tribe To Protect Drug Patents
Allergan has taken a novel step to protect top-selling drug Restasis from generic competition: The company has sold the drug’s patents to an Indian tribe in upstate New York. The aim is to block rivals from challenging the patents for the dry-eye drug at the U.S. Patent and Trademark Office based on the tribe’s special legal status as a sovereign government, which the tribe says gives it immunity from patent-office review. (Rockoff, 9/8)

Bloomberg: This Shield of Patents Protects the World’s Best-Selling Drug
Humira, a treatment for inflammatory diseases such as rheumatoid arthritis and psoriasis made by AbbVie Inc., is the planet’s best-selling drug. It’s also been around almost 15 years. Those two facts alone would normally have rival drugmakers eagerly circling, ready to roll out generic versions that could win a piece of the aging medicine’s $16 billion in annual sales. Yet last year, when the patent on Humira’s main ingredient expired, not a single competitor launched a copycat version. Figuring out how to manufacture it wasn’t the obstacle. The real challenge was the seemingly impregnable fortress of patents AbbVie has methodically constructed around its prized moneymaker. (Koons, 9/7)

NPR: First FDA-Approved Drug For Chagas Raises Price Concerns
The Food and Drug Administration recently approved the first U.S. treatment for childhood cases of Chagas disease — a parasite-driven illness that, over time and unless treated early, can cause serious heart problems in about a third of the people it infects. There are perhaps 300,000 cases in the U.S., according to the Centers for Disease Control and Prevention; the illness is much more common in Latin America, where it affects millions. (Columbus, 9/10)

Stat: Amgen’s Cholesterol Drug Would Have To Sell For Around $2,000 To Be Cost Effective
An updated analysis of Amgen’s (AMGN) Repatha, which is one of the newest cholesterol drugs, has been released and suggests the price would have to drop a whopping 85 percent to 88 percent off the existing list price of $14,500 in order to be considered cost effective. This works out to between $1,725 and $2,240, which is still substantially less than the $8,970 price after Amgen gives rebates and discounts to payers, according to sales data cited in the new report from the Institute for Clinical and Economic Review, a non-profit that assesses the value of medicines. (Silverman, 9/11)

NPR: One-Third Of People Stop Taking Prescriptions And Don’t Tell The Doctor
Almost one-third of people have stopped taking a prescription drug at some time without telling their health care provider, according to the latest NPR-Truven Health Analytics Health Poll. And while cost certainly influences whether and how people take their drugs, only 10 percent of people in this poll cited it as the reason for their behavior. A separate question asked people who filled a prescription recently whether they missed at least one dose. A full quarter said they had. (Hobson, 9/8)

Stat: California Moves Closer To Adopting A Drug Pricing Transparency Law
A California bill that would require drug makers to report and justify price hikes took a big step toward reality on Monday night. The state Assembly overwhelmingly passed the legislation and it now goes to the Senate for approval, which legislative sources say may occur as soon as today. The bill, which has been vociferously fought by the pharmaceutical industry, could become one of the most comprehensive state efforts to address pricing transparency. For instance, drug makers would have to provide 60-day notice to insurers and government health plans before increasing list prices of a medicine that costs more than $40, by 16 percent in a two-year period. (Silverman, 9/12)

San Jose Mercury News: California Assembly Passes Drug Price Transparency Bill
The California State Assembly on Monday overwhelmingly approved Senate Bill 17, controversial legislation that could soon become the nation’s most comprehensive law aimed at shining a light on prescription drug prices. … It would enable health insurers to negotiate lower prices for drugs or, in many cases, replace those drugs with cheaper alternatives, according to its supporters. (Seipel, 9/11)

Stat: Vertex Shuts Down Study Of Long-Acting Kalydeco But Insists Development Still On Track
Vertex Pharmaceuticals (VRTX) terminated a small clinical trial involving an important, long-acting version of its cystic fibrosis drug Kalydeco that was acquired from Concert Pharmaceuticals (CNCE) earlier this summer. An update to a listing on the government web site ClinicalTrials.gov shows Vertex shut down the study of the drug known as CTP-656 on Sept. 10. No reason other than “decision by sponsor” is given. (Feuerstein, 9/11)

The Wall Street Journal: Alexion To Cut Workforce By 20%, Shift Headquarters To Boston
Alexion Pharmaceuticals Inc. is cutting its workforce by 20%, relocating its headquarters to Boston and closing sites as it works to reduce its overhead and move on from a sales-practices controversy. The rare-disease drugmaker has seen a slew of management changes during the past year, including hiring a new chief executive, after an internal investigation showed senior management pressured staff to persuade customers to order its flagship drug earlier than needed to meet financial targets. (Hufford, Rockoff and de Avila, 9/12)

The Associated Press: Judge To Hear Arguments On Whether To Lock Up Pharma Bro
A judge is set to hear arguments about whether the provocative online antics of former pharmaceuticals company CEO Martin Shkreli are bad enough to put him behind bars. The hearing before U.S. District Judge Kiyo Matsumoto on a government demand to revoke the convicted Shkreli’s bail was scheduled for Wednesday in federal court in Brooklyn. (Hays, 9/13)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

State Highlights: Conn. Hospitals Wary Of Governor’s Tax Plan; Needs Of Appalachia Overlooked In Health Care Debate

Media outlets report on news from Connecticut, Virginia, Louisiana, California, Ohio, Kansas, Missouri, Wisconsin, Tennessee Pennsylvania and Florida.

The CT Mirror: CT’s Hospitals See Huge Risk In Malloy’s Fix For Budget Impasse
Gov. Dannel P. Malloy’s bid to end the state’s budget impasse hinges on convincing legislators to take a leap of faith about the state’s hospital tax. Specifically, the governor is asking for a 55 percent tax increase on hospitals and saying that his new plan to pump the proceeds of that tax hike — and more — back into the industry won’t evaporate as his original one did six years ago. (Phaneuf, 9/12)

The Associated Press: Appalachian Poor, Left Out Of Health Debate, Seek Free Care
They arrived at a fairground in a deep corner of Appalachia before daybreak, hundreds of people with throbbing teeth, failing eyes, wheezing lungs. They took a number, sat in the bleachers and waited in the summer heat for their name to be called so they could receive the medical help they can’t get anywhere else. (Lovan, 9/12)

New Orleans Times-Picayune: At Least 12 Patients Contract Rare Infection After Children’s Hospital Heart Surgeries: Report
At least 12 patients have contracted a rare infection after heart surgeries at Children’s Hospital in New Orleans, according to The New Orleans Advocate. The hospital pointed to a piece of operating room equipment as the source of the infection, which was caused by bacteria known as Mycobacterium Abscessus. …The Centers for Disease Control and Prevention notes that Mycobacterium Abscessus is commonly found in water, soil and dust, and can cause “a variety of infections.” Typically, “health-care associated infections” associated with it “are usually of the skin and soft tissues under the skin.” (Brasted, 9/11)

Los Angeles Times: Mexican Papaya Recalled After Salmonella Outbreak
A Southern California company has recalled papaya imported from Mexico after health authorities linked its fruit shipments to a salmonella infection that has killed one person and sickened 13 others in three states. Bravo Produce Inc. of San Ysidro, issued a recall notice Sunday, after federal investigators last week traced an infected sample of Maradol papayas to shipments the company imported from a Tijuana packer. (Mohan, 9/11)

The Washington Post: Pet-Store Puppies Linked To Bacterial Outbreak Among People In 7 States, CDC Says
Federal health officials said Monday that they are investigating a multistate outbreak of Campylobacter infections traced to puppies sold at Petland, a nationwide chain of about 80 pet stores. The bacteria, a common cause of diarrheal illness that can spread through contact with dog feces, has sickened at least 39 people in Ohio, Kansas, Missouri, Wisconsin, Tennessee, Pennsylvania and Florida. Nine people have been hospitalized since last September, but no deaths have been reported, according to officials with the Centers for Disease Control and Prevention. (Brulliard and Sun, 9/11)

San Francisco Chronicle: Software Strives To Shrink Emergency Room Waits
Qventus’ software helps health care institutions manage staffing in hospitals and pharmacies. It processes data, including the number of patients and doctors in the hospital, the length of wait times, and where slowdowns are occurring, so that, for example, more nurses can be sent to the area of the hospital where they are most needed, or managers can get the latest information on what rooms need to be cleaned. (Salian and Thadani, 9/11)

San Jose Mercury News: UC Aligns Cancer Centers To Battle Deadly Diseases
For the 176,000 Californians diagnosed with cancer this year, Monday’s announcement that the University of California’s five academic cancer centers are forming an alliance to stem the disease’s rising toll here couldn’t come soon enough. Experts say cancer is on its way to overtake heart disease as the Golden State’s leading cause of death. (Seipel, 9/11)

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Viewpoints: Coal Country Health Study Is ‘No Waste Of Time’; The Fight Against The Opioid Epidemic Continues

A selection of opinions on health care from around the country.

The Washington Post: Trump Says He Cares About People In Coal Country. So Why Halt A Study On Their Health?
One would imagine that the Trump administration, which swept into power claiming to support the people who live in coal country, would prioritize federal spending on those very people’s health. Instead, the Interior Department has halted a study on how so-called mountaintop-removal coal mining affects people who live around these landscape-stripping operations. Ostensibly, the halt is part of a broad budgetary review. If so, Interior should restart the study quickly. It is a worthwhile use of government research money, and it should proceed no matter which constituency the president had promised to support. (9/10)

The New York Times: A Helpful Tool To Combat The Opioid Crisis
The opioid crisis is so complex and so large — drug-related deaths now exceed those caused by cars, H.I.V. or guns — that there is no single solution. Among the partial ones: prescription drug monitoring programs, an approach highlighted in the draft report from President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. (Austin Frakt, 9/11)

Chicago Tribune: Illinois Vs. The Opioid Epidemic
The epidemic of opioid overdose deaths has been geographically lopsided. West Virginia has the highest rate, followed by New Hampshire, Ohio and Kentucky. Illinois’ rate is one-third of West Virginia’s, but that’s only modest comfort. Last year, 1,889 people died from opioid overdoses in Illinois. … In recent days, a report put together by a group of state agencies mapped out a comprehensive strategy to eliminate one-third of opioid overdose deaths by 2020. And Gov. Bruce Rauner appointed a task force to look for ways to implement the strategy. … A big need is greater access to “medication-assisted treatment” (MAT), which offers methadone and buprenorphine , drugs proven useful helping those with “opioid use disorder” (addiction, in common parlance) beat the habit. (9/11)

Kansas City Star: Medicaid Is Not To Blame For The Opioid Crisis
Saying that Medicaid expansion is fueling the opioid epidemic is kind of like saying that a sump pump can cause flooding in your basement. The iffy underpinning for this argument is the fact that many of the states that expanded Medicaid coverage under the Affordable Care Act do have higher overdose death rates. (9/10)

Topeka Capital Journal: Time To Debate Medicaid Expansion
Considering its significance for 150,000 Kansans — as well as hospitals and businesses around the state — Medicaid should be a major issue during this campaign. We should demand robust debate, and we can’t allow candidates to obscure the facts (for example, those who oppose expansion often cite its costs and ignore the economic benefits mentioned above). Kansans support Medicaid expansion, and we need to remind our future governor of this fact. (9/9)

Stat: How Good Is A Doctor At The End Of A 28-Hour Shift?
It isn’t terribly reassuring to know that doctors who might need to make life or death decisions about your health could be doing so after having been awake for so long. Would they be on top of their game at hour 16? What about hour 22? In medicine, the devil can be in the details — what if the doctor was too tired to notice something small that might not actually be that small? But according to the organization that sets the rules on how long resident physicians like me are allowed to work, the Accreditation Council for Graduate Medical Education (ACGME), this is OK. (Christopher Bennett, 9/8)

The Columbus Dispatch: Better Care For The Vulnerable
When it comes to caring for the most vulnerable elderly and mentally ill, Franklin County can take pride in the Guardianship Service Board. It has helped remake a system that once permitted shameful exploitation of wards into one of the state’s best. A new agreement between the board and Ohio State University’s Wexner Medical Center demonstrates how its impact can grow even more. (9/11)

Los Angeles Times: Trump And Sessions Are Ignoring Voters’ Overwhelming Support For Medical Marijuana. Will Congress Listen?
Never mind what President Trump said on the campaign trail. His administration and GOP leaders appear determined to eliminate protections for medical marijuana growers, sellers and users. Every year since 2014, Rep. Dana Rohrabacher (R-Costa Mesa) has inserted an amendment into a federal spending bill to prevent the Justice Department from prosecuting medical marijuana businesses that comply with their state’s laws. It’s been a temporary but necessary fix to address a fundamental contradiction: that even though 26 states have legalized medical marijuana, the drug is still prohibited under federal law. … But last week, the House Rules Committee killed the amendment at the urging of Atty. Gen. Jeff Sessions, a hard-line marijuana prohibitionist. (9/9)

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Despite Serious Safety Issues, Hospital Watchdog Didn’t Change Its Rating Of Facility

An investigation by The Wall Street Journal finds that the Joint Commission, which is the accrediting organization for almost 80 percent of U.S. hospitals, typically takes no action to revoke or modify accreditation when state inspectors find serious safety violations. Meanwhile, an expert talks to Politico about hospitals and health care spending.

The Wall Street Journal: Hospital Watchdog Gives Seal Of Approval, Even After Problems Emerge
Patient-safety problems were so serious at Cooley Dickinson Hospital in Northampton, Mass., that the federal Medicare agency threatened to cut it off. Most patients never knew. Two babies died within six weeks in late 2013 and early 2014. That was just a couple of months after a pregnant woman died when the hospital didn’t ensure she was treated for high blood pressure from a condition called pre-eclampsia, according to a federal inspection report. (Armour, 9/8)

And in news from the states —

Boston Globe: Humane Treatment Comes At Last To Bridgewater State Hospital, Where Prisoners Have Become ‘Persons Served’
In April, a private firm hired by the Baker administration replaced almost all the guards at Bridgewater State Hospital with a specially trained security force, along with psychiatrists and other clinicians equipped to provide more humane methods of handling distressed patients. … Five months in, the results are remarkable, beyond the imagining of mental health advocates. (Rezendes, 9/8)

KCUR: KU Hospital Denies Patient’s Allegations Of Cancer Misdiagnosis And Cover-Up 
The University of Kansas Hospital is denying allegations by a patient that it wrongly diagnosed her with pancreatic cancer and then covered it up. In an answer filed this week, the hospital says that many of the allegations made by Wendy Ann Noon Berner “reference undisputable hearsay and speculation, and many would arguably constitute defamation” if they were not part of a lawsuit. (Margolies, 9/8)

Boston Globe: Former Medical Center Site Said To Have No Takers
Boston-area health care providers have not shown interest in locating their operations at the former Quincy Medical Center site, according to its owner, who had hoped to have a reuse plan for the property before the end of the year. FoxRock Properties, a Quincy commercial real estate firm that bought the former hospital in December 2016, has been marketing the property to health care providers, but they have told FoxRock that the complex is too old and outdated, company representative Chet Clem told more than 50 people at a recent neighborhood meeting. (Terreri Ramos, 9/8)

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In Search Of Genetic Marker For Suicide: Scientists Envision Medication That Could Save Lives

It will be a long and complicated path even if it’s successful, but researchers think searching DNA for links to suicide will eventually lead to them being able to create a pill to stop it. In other public health news: melanoma, doctors and Yelp, breast milk, chemotherapy, tick saliva and more.

Stat: Could A Pill Prevent Suicide? A New Genetics Study In Utah Seeks The Answer
The project, unveiled Friday, seeks to advance existing genetic research on suicide by potentially developing new medications that could help prevent patients from ending their lives. Utah’s famously expansive DNA database makes it an ideal setting for the research. The state also has one of the highest suicide rates in the country — more than 22 per 100,000 people — and suicide is the leading cause of death among youths between the ages of 10 and 17. (Ross, 9/11)

The Washington Post: New Clinical Trial Might Change The Standard Treatment For Melanoma
In a head-to-head comparison of two immunotherapy drugs used to prevent relapse in certain patients with advanced melanoma, one treatment was the clear winner — and it’s not the one that most people get. The international study, released Sunday, involved 900 patients whose tumors were removed by surgery but who remained at high risk of recurrence of melanoma, an often aggressive form of skin cancer. (McGinley, 9/10)

Bloomberg: Don’t Yelp Your Doctor. Study Finds Ratings Are All Wrong. 
If you’re looking for the best doctor, online ratings are unlikely to be much help. That’s the determination of researchers at Cedars-Sinai Medical Center in Los Angeles, who compared reviews of 78 of the medical center’s specialists on five popular ratings sites with a set of internal quality measures and found there was essentially no correlation. The results suggest that in a world awash in online feedback for seemingly every consumer choice, reliable, easy-to-interpret information on how good doctors are at their jobs remains scarce. (Tracer, 9/8)

The Washington Post: Neonatal Facilities Increasingly Use Donated Breast Milk To Save Premature Babies
The weekly shipment arrived at noon Thursday — 300 ounces of breast milk donated by women across the country and pasteurized at a milk bank in Austin. It was packed with dry ice and shipped via FedEx to feed the most medically fragile premature infants in the neonatal intensive care unit at Children’s National Health System. “Liquid gold,” said Victoria Catalano, a NICU dietitian at the children’s hospital in Washington, holding up a plastic bottle containing three ounces of frozen milk. Then she corrected herself. “Well, that’s liquid gold,” she said, pointing to two large deep freezers stocked with milk the infants’ mothers had produced. “This is the next best thing,” she said. (Chandler, 9/10)

The Washington Post: She Rejected Chemotherapy And Chose To Die Of Cancer — So She Could Give Birth To Her Child
The headaches began sometime in March. They didn’t think much of them, other than that they were possible migraines — until she started vomiting.An initial scan showed a mass in Carrie DeKlyen’s brain. More tests showed that it was a form of cancer, possibly lymphoma, but treatable. But a pathology exam revealed a more grim diagnosis. The 37-year-old mother of five from Wyoming, Mich., had glioblastoma, an aggressive form of brain cancer. If lucky, she could live for five more years. (Phillips, 9/10)

Pittsburgh Post-Gazette: Tick Saliva May Be A Secret Ingredient To Help HIV Patients
The blacklegged tick — the one that carries Lyme disease — may have some value: its spit. The insect’s saliva — which helps it feed on hosts by blocking blood coagulation — is now part of experiments examining ways to reduce heart disease in people living with HIV. Their risk of heart attack and stroke is nearly double that of the general population, according to a study last year. That risk was found even in people whose virus was undetectable in their blood because of antiretroviral drugs. (Daly, 9/9)

The Oregonian: Genetic Test Bumps Breast Cancer Patients Down A Stage Or 2 
For decades, tumor size has been crucial to the treatment and prognosis of breast cancer. Bigger usually meant the cancer was more advanced and at a higher stage, required more treatment and brought a worse outlook. But now physicians have biological tests that help them determine how aggressive the cancer is likely to be and the best course of treatment. (Terry, 9/10)

The Washington Post: e Cyclists’ recovery from brain injuries can be slow, but death rate has dropped
On the day that would change his life forever, Ryan Brown went on his regular morning run. He rode his bicycle the quick mile to work at the U.S. Trademark and Patent Office in Alexandria, Va., where he was an examiner for plant molecular biology patents. Late in the afternoon, he headed home to take his two sons to dinner while his wife finished teaching a piano lesson. He never made it. (Arcement, 9/9)

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