KFF Health News

KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Broker Websites Expand Health Plan Shopping Options While Glossing Over Details

KFF Health News, March 15, 2019

Consumers who use alternative portals don't have the same shopping experience as applicants accessing state or federal marketplaces.

This article was first published on Friday, March 15 in Kaiser Health News.

By Julie Appleby

Some websites consumers use to buy their own health insurance don’t provide full information on plan choices or Medicaid eligibility, and appear to encourage selection of less comprehensive coverage that provides higher commissions to brokers, according to a report released Friday by the left-leaning Center on Budget and Policy Priorities.

These direct-enrollment broker websites — including eHealth, ValuePenguin, GetInsured.com and some named after the insurance carriers they represent — are not the state-based marketplaces or the federal exchange, known as healthcare.gov.

The commercial sites promise more options to consumers shopping for health insurance. They can offer Obamacare plans, for instance, as well as lower-cost but less comprehensive plans, such as short-term policies and other types of coverage that don’t meet the federal Affordable Care Act’s requirements.

About 42% of enrollments for 2018 ACA plans were arranged through sales agents or brokers, with many of them relying on such alternative websites to enroll their clients, noted the report.

But consumers who use alternative portals, the report warned, don't have the same shopping experience as applicants accessing state or federal marketplaces. That's because government sites must provide full information on all available ACA choices and cannot steer consumers to non-ACA plans. The government marketplace also is responsible for accurately processing applicants' eligibility for Medicaid or premium subsidies. The commercial sites generally don't have those responsibilities.

Two years after sharp financial cuts by the Trump administration for enrollment outreach and funding for navigators and other assistants helping people sign up for ACA plans, the administration encouraged consumers to seek out brokers for help.

For next year’s enrollment period, it is considering changing the rules to allow federally funded navigators to also use the alternative websites to enroll consumers.

There are differences among the alternative websites. “Not all entities have these problems,” the report concludes. “But the program lacks safeguards to protect consumers from harm.”

It found that some direct enrollment websites:

Use default settings, chat boxes and other design methods to highlight alternatives that earn the web brokers higher commissions, such as low-cost, short-term insurance plans, which cover less and can reject people with preexisting conditions.
Either fail to inform or provide inaccurate assessments of whether applicants or their family members might qualify for Medicaid or premium subsidies to help them get coverage.
Fall short of providing full information on premium costs and deductibles for all the plans available in a region.

The commercial websites are "under-policed," said report author Tara Straw, a senior policy analyst at the center.

The administration, she said, should more closely monitor website design and how well the sites inform consumers of their potential eligibility for government assistance in purchasing coverage.

Because of the drawbacks, consumers who use some of these websites are at a disadvantage, lacking the ability to adequately comparison shop, the report warned.

As a result, some may choose non-ACA plans, such as short-term insurance, which may not be their best option. Others may be discouraged from applying for coverage at all if the websites inaccurately indicate they might not qualify for a subsidy or Medicaid.

"That's the problem," said Straw. "The websites can say, 'We're telling people to complete the application [to assess subsidy eligibility],' but who is going to do that when they're showing all the plans at the unsubsidized price?"

Comparison shopping on some of the websites is limited.

An example outlined in the report focuses on Duval County, Fla., where the eHealth website shows a list of ACA policies described as "17 of 17 plans" available. Each of those 17 shows the costs of premiums, deductible amounts and other details. At the bottom of the screen, however, eHealth lists the names of 32 additional plans available from Florida Blue, the state's largest insurer, without any specifics on cost and coverage.

If consumers stopped there, they would not know that on Florida Blue's website they could find 15 plans that are less expensive than the lowest-cost plan listed on eHealth, according to the report.

"Without visiting multiple websites, consumers would have difficulty finding and comparing their plan options," the report said. "This is the type of fractured shopping experience the marketplace is designed to remedy." It noted, however, that one web broker, HealthSherpa, did list all 49 plans available in Duval County.

An eHealth spokeswoman countered that the website makes it easy for consumers to get additional information on available plans it may not sell directly.

"When they get to the bottom of the page, they see 32 additional plans available through the federal marketplace, with a hyperlink directly to that marketplace," said eHealth’s Lisa Zamosky.

To avoid having to visit multiple sites, Straw offered consumers simple advice: "Go to healthcare.gov."

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Judge Vows To Rule On Medicaid Work Requirements By End Of March

KFF Health News, March 15, 2019

A ruling against a Medicaid work requirement would have vast repercussions in states that have been approved for the mandate.

This article was first published on Thursday, March 14 in Kaiser Health News.

By Phil Galewitz

The federal judge who shot down a Medicaid work requirement plan last June remained deeply skeptical Thursday of the Trump administration's renewed strategy to force enrollees to work.

U.S. District Judge James Boasberg, who last year blocked Kentucky's work requirement, heard testimony on a revised federal approval. He also had a hearing on Arkansas' Medicaid work requirement — which took effect last July and has led to 18,000 Medicaid enrollees losing coverage.

After the court hearings in Washington, Boasberg said he would rule on both states' programs by April 1, which is when the next round of Arkansas enrollees could be kicked off the program. Kentucky plans to implement its work requirement this summer.

A ruling against a work requirement would have vast repercussions in more than a dozen other states that have been approved for new work requirements in Medicaid, the federal-state health program, or are seeking them from the Trump administration.

Throughout the two-hour-long hearings, Boasberg questioned Justice Department lawyer James Burnham on whether the work requirement plans approved by the Trump administration were helping to achieve Medicaid's goal of promoting health coverage.

When Burnham argued that work requirements would give people incentives to find work and improve their lives, Boasberg interjected: "That is not the purpose of Medicaid."

On Capitol Hill, Democrats grilled Health and Human Services Secretary Alex Azar about the work requirements. Azar testified this week before three separate committees, two in the House and one in the Senate, on the administration's budget request for the department.

Addressing the Senate Finance Committee on Thursday, Azar disputed the idea that everyone who lost Medicaid in Arkansas was now uninsured. "Only 1,000 of those 18,000 people appealed" their loss of Medicaid, he said. "Only 1,452 of those 18,000 even reapplied for Medicaid when open enrollment came again."

Azar said that "seems a fairly strong indication" that the rest of those cut from the program "got a job and insurance elsewhere."

Top health officials for the Trump administration have said getting people on Medicaid into jobs will make them healthier — which they call a key goal of the program.

States can implement work requirements since Congress has given the HHS secretary permission to approve their experiments with the Medicaid program, the administration asserts.

But advocates for the poor say an experiment that leaves thousands of people without coverage runs counter to Medicaid's aim to improve access to healthcare.

In his ruling last year, Boasberg, who was appointed by President Barack Obama, said Azar's approval of Kentucky's plan failed to consider whether the strategy would "help the state furnish medical assistance to its citizens, a central objective of Medicaid."

He said promoting health generally or helping someone get a job was not the point of the state-federal program created in 1965.

Kentucky last year became the first state to win federal approval for its proposal requiring that certain Medicaid recipients work, go to school or fulfill community service. After Boasberg’s ruling last June, the state filed a new waiver application seeking to meet the judge’s requirements, and the Trump administration approved it.

Federal officials have approved work requirement proposals in seven states — Arizona, Arkansas, Indiana, Kentucky, Michigan, New Hampshire and Wisconsin. In each of those states, the requirements would apply only to people who gained Medicaid coverage under the expansion promoted by the Affordable Care Act.

Ten other states — Alabama, Kansas, Mississippi, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Utah and Virginia — also have requested approval. Some of those states have not expanded Medicaid and are seeking to add work requirements to their regular programs.

Kentucky Gov. Matt Bevin, a Republican, has threatened to scrap the Medicaid expansion unless his state is allowed to proceed with the new rules, a move that would cause the more than 400,000 new enrollees to lose their coverage. He said the work requirement will help move some adults off the program so the state has enough money to help others on the program.

Boasberg questioned whether the state has proven its case to the federal government that it needs work requirements to keep its Medicaid program financially sustainable. "At the end of the day, isn't the centerpiece of your case the fiscal sustainability argument?" Boasberg asked the Trump administration’s lawyer.

Burnham argued neither Kentucky nor Arkansas was kicking people off their programs and causing them to lose benefits. He said people were just choosing to not comply with the state's new reporting requirements to show they were working, doing volunteer work or meeting one of the states' exceptions.

Ian Gershengorn, a lawyer representing the National Health Law Program and other plaintiffs trying to overturn the work requirements, said Kentucky’s financial sustainability argument "seems absurd" because the federal government this year is paying 94% of the costs for the Medicaid expansion population.

He said HHS should not be approving Kentucky's waiver based on the governor threatening to kill the entire Medicaid expansion if he doesn't get work requirement authority.

Gershengorn said Azar cannot argue in approving Kentucky's waiver that he has no idea how many people would lose coverage since the Arkansas experience already shows thousands lost Medicaid coverage.

The Kaiser Family Foundation has estimated that 1.4 million to 4 million Americans could lose their coverage if work requirements were imposed nationwide. Most of the coverage losses would result from enrollees failing to report their compliance to the state, not because they were failing to fulfill the work or job search criteria. (Kaiser Health News is an editorially independent program of the foundation.)

The Justice Department attorney tried to show the difference between the first Kentucky approval in January 2018 and the second one made last November was that the HHS secretary analyzed what effect the experiment would have on health coverage. He said keeping the Kentucky program would ensure the expansion stayed in place as well as give adult enrollees access to vision and dental coverage.

But Gershengorn argued the difference between the two approvals is that the state and the federal government now know the implications work requirements can have on enrollees.

"There is massive harm," Gershengorn said. "It is not speculative."

KHN chief Washington correspondent Julie Rovner contributed to this report.

New Health Plans Expose The Insured To More Risk

KFF Health News, March 13, 2019

New types of insurance plans are sprouting up as employers face rising costs and individuals who buy their own coverage without an ACA subsidy struggle to pay premiums.

This article was first published on Wednesday, March 13 in Kaiser Health News.

By Julie Appleby

One health plan from a well-known insurer promises lower premiums but warns that consumers may need to file their own claims and negotiate over charges from hospitals and doctors. Another does away with annual deductibles but requires policyholders to pay extra if they need certain surgeries and procedures.

Both are among the latest efforts in a seemingly endless quest by employers, consumers and insurers for the holy grail: less expensive coverage.

Premiums are 15% to 30% lower than conventional offerings, but the plans put a larger burden on consumers to be savvy shoppers. Even with those concerns, the offerings tap into a common underlying frustration.

"Traditional health plans have not been able to stem high cost increases, so people are tearing down the model and trying something different," said Jeff Levin-Scherz, health management practice leader for benefit consultants Willis Towers Watson.

New types of insurance plans are sprouting up as employers face rising healthcare costs and individuals who buy their own coverage without an Affordable Care Act subsidy struggle to pay premiums. That has led some people to experiment with new ways to pay their medical expenses, such as short-term policies or alternatives like Christian sharing ministries, which are not insurance at all, but rather cooperatives where members pay one another’s bills.

Now some insurers — such as Blue Cross Blue Shield of North Carolina and a Minnesota startup called Bind Benefits, which is partnering with UnitedHealth Group — are coming up with their own novel offerings.

Insurers say the two new types of plans meet the ACA's rules, although they interpret those rules in new ways. For example, the new policies avoid the federal law's rule limiting consumers' annual in-network limit on out-of-pocket costs: one by having no network and the other by calling additional charges premiums, which don't count toward the out-of-pocket maximum.

But each plan could leave patients with huge costs in a system where it is extremely difficult for a patient to be a smart shopper — in part, because they have little negotiating power against big hospital systems and partly because illness is often urgent and unpredicted.

If the plans prompt doctors and hospitals to lower prices, "then that is worth taking a closer look," said Sabrina Corlette, a research professor at Georgetown University's Health Policy Institute. "But if it's simply another flavor of shifting more risk to employees, I don't think in the long term that's going to bend the cost curve."

Balancing Freedom, Control And Responsibility

The North Carolina Blue Cross Blue Shield "My Choice" policies aim to change the way doctors and hospitals are paid by limiting reimbursement for services to 40% above what Medicare would pay. The plan has no network of doctors and hospitals.

This approach "puts you in control to see the doctor you want," the insurer says on its website. The plan is available to individuals who buy their own insurance and small businesses with one to 50 employees, aiming particularly at those who cannot afford ACA plans, said Austin Vevurka, a spokesman for the insurer. The policies are not sold on the ACA's insurance marketplace, but can be purchased off-exchange from brokers.

With that freedom, however, consumers also have the responsibility to shop around for providers who will accept that amount. Those who don't shop, or can't because it's an emergency, may get "balance-billed" by providers unsatisfied with the flat amount the plan pays.

"There's an incentive to comparison shop, to find a provider who accepts the benefit," said Vevurka.

The cost of balance bills could range widely, but could be thousands of dollars in the case of hospital care. Consumer exposure to balance bills is not capped by the ACA for out-of-network care.

"There are a lot of people for whom a plan like this would present financial risk," said Levin-Scherz.

In theory, though, paying 40% above Medicare rates could help drive down costs over time if enough providers accept those payments. That's because hospitals currently get about double Medicare rates through their negotiations with insurers.

"It's a bold move," said Mark Hall, director of the Health Law and Policy Program at Wake Forest University in North Carolina. Still, he said, it's "not an optimal way" because patients generally don’t want to negotiate with their doctor on prices.

"But it's an innovative way to put matters into the hands of patients as consumers," said Hall. "Let them deal directly with providers who insist on charging more than 140% of Medicare."

Blue Cross spokesman Vevurka said My Choice has telephone advisers to help patients find providers and offer tips on how to negotiate a balance bill. He would not disclose enrollment numbers for My Choice, which launched Jan. 1, nor would he say how many providers have indicated they will accept the payments.

Still, the idea — based on what is sometimes called "reference pricing" or "Medicare plus" — is gaining attention.

North Carolina's state treasurer, for example, hopes to put state workers into such a pricing plan by next year, offering to pay 177% of Medicare. The plan has ignited a firestorm from hospitals.

Montana recently got its hospitals to agree to such a plan for state workers, paying 234% of Medicare on average.

Partly because of concerns about balance billing, employers aren't rushing to buy into Medicare-plus pricing just yet, said Jeff Long, a healthcare actuary at Lockton Companies, a benefit consultancy.

Wider adoption, however, could spell its end.

Hospitals might agree to participate in a few such programs, but "if there's more take-up on this, I see hospitals possibly starting to fight back," Long said.

What About The Bind?

Minnesota startup Bind Benefits eliminates annual deductibles in its "on-demand" plans sold to employers who are opting to self-insure their workers' health costs. Rather than deductibles, patients pay flat-dollar copayments for a core set of medical services, from doctor visits to prescription drugs.

In some ways, it's simpler: no need to spend through the deductible before coverage kicks in or wonder what 20% of the cost of a doctor visit or surgery would be.

But not everything is included.

Patients who discover during the year that they need any of about 30 common procedures outlined in the plan, including several types of back surgery, knee arthroscopy or coronary artery bypass, must "add in" coverage, spread out over time in deductions from their paychecks.

"People are used to that concept, to buy what they need," said Bind's CEO, Tony Miller. "When I need more, I buy more."

According to a company spokeswoman, the add-in costs vary by market, procedure and provider. Less than 7% of members should need add-in services in any given year, Bind estimates.

On the lower end, the cost for tonsillectomy and adenoidectomy ranges from $900 to $3,000, while lumbar spine fusion could range from $5,000 to $10,000.

To set those additional premiums, Bind analyzes how much doctors and facilities are paid, along with some quality measures from several sources, including UnitedHealth. The add-in premiums paid by patients then vary depending on whether they choose lower-cost providers or more expensive ones.

The ACA's out-of-pocket maximums — $7,900 for an individual or $15,800 for a family — don't include premium costs.

The Cumberland School District in Wisconsin switched from a traditional plan, which it purchased from an insurer for about $1.7 million last year, to Bind. Six months in, Superintendent Barry Rose said, it is working well.

Right off the bat, he said, the district saved about $200,000. More savings could come over the year if workers choose lower-cost alternatives for the "add-in" services.

"They can become better consumers because they can see exactly what they’re paying for care," Rose said.

Levin-Scherz at Willis Towers said the idea behind Bind is intriguing but raises some issues for employers.

What happens, he asked, if a worker has an add-in surgery, owes several thousand dollars, then changes jobs before paying all the premiums for that add-in coverage? "Will the employee be sent a bill after leaving?" he said.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

'Medieval' Diseases Flare As Unsanitary Living Conditions Proliferate

KFF Health News, March 12, 2019

Infectious diseases — some that ravaged populations in the Middle Ages — are resurging in California and around the country, and are hitting homeless populations especially hard.

This article was first published on Tuesday, March 12 in Kaiser Health News.

By Anna Gorman

Jennifer Millar keeps trash bags and hand sanitizer near her tent, and she regularly pours water mixed with hydrogen peroxide on the sidewalk nearby. Keeping herself and the patch of concrete she calls home clean is a top priority.

But this homeless encampment off a Hollywood freeway ramp is often littered with needles and trash, and soaked in urine. Rats occasionally scamper through, and Millar fears the consequences.

"I worry about all those diseases," said Millar, 43, who said she has been homeless most of her life.

Infectious diseases — some that ravaged populations in the Middle Ages — are resurging in California and around the country, and are hitting homeless populations especially hard.

Los Angeles recently experienced an outbreak of typhus — a disease spread by infected fleas on rats and other animals — in downtown streets. Officials briefly closed part of City Hall after reporting that rodents had invaded the building.

People in Washington state have been infected with Shigella bacteria, which is spread through feces and causes the diarrheal disease shigellosis, as well as Bartonella quintana, which spreads through body lice and causes trench fever.

Hepatitis A, also spread primarily through feces, infected more than 1,000 people in Southern California in the past two years. The disease also has erupted in New Mexico, Ohio and Kentucky, primarily among people who are homeless or use drugs.

Public health officials and politicians are using terms like "disaster" and “public health crisis” to describe the outbreaks, and they warn that these diseases can easily jump beyond the homeless population.

"Our homeless crisis is increasingly becoming a public health crisis," California Gov. Gavin Newsom said in his State of the State speech in February, citing outbreaks of hepatitis A in San Diego County, syphilis in Sonoma County and typhus in Los Angeles County.

"Typhus," he said. "A medieval disease. In California. In 2019."

The diseases have flared as the nation's homeless population has grown in the past two years: About 553,000 people were homeless at the end of 2018, and nearly one-quarter of homeless people live in California.

The diseases spread quickly and widely among people living outside or in shelters, fueled by sidewalks contaminated with human feces, crowded living conditions, weakened immune systems and limited access to healthcare.

“The hygiene situation is just horrendous” for people living on the streets, said Dr. Glenn Lopez, a physician with St. John’s Well Child & Family Center, who treats homeless patients in Los Angeles County. “It becomes just like a Third World environment where their human feces contaminate the areas where they are eating and sleeping.”

Those infectious diseases are not limited to homeless populations, Lopez warned. “Even someone who believes they are protected from these infections are not.”

At least one Los Angeles city staffer said she contracted typhus in City Hall last fall. And San Diego County officials warned in 2017 that diners at a well-known restaurant were at risk of hepatitis A.

There were 167 cases of typhus from Jan. 1, 2018, through Feb. 1 of this year, up from 125 in 2013 and 13 in 2008, according to the California Public Health Department.

Typhus is a bacterial infection that can cause a high fever, stomach pain and chills but can be treated with antibiotics. Outbreaks are more common in overcrowded and trash-filled areas that attract rats.

The recent typhus outbreak began last fall, when health officials reported clusters of the flea-borne disease in downtown Los Angeles and Compton. They also have occurred in Pasadena, where the problems are likely due to people feeding stray cats carrying fleas.

Last month, the county announced another outbreak in downtown Los Angeles that infected nine people, six of whom were homeless. After city workers said they saw rodent droppings in City Hall, Los Angeles City Council President Herb Wesson briefly shut down his office to rip up the rugs, and he also called for an investigation and more cleaning.

Hepatitis A is caused by a virus usually transmitted when people come in contact with feces of infected people. Most people recover on their own, but the disease can be very serious for those with underlying liver conditions. There were 948 cases of hepatitis A in 2017 and 178 in 2018 and 2019, the state public health department said. Twenty-one people have died as a result of the 2017-18 outbreak.

The infections around the country are not a surprise, given the lack of attention to housing and health care for the homeless and the dearth of bathrooms and places to wash hands, said Dr. Jeffrey Duchin, the health officer for Seattle and King County, Wash.

“It’s a public health disaster,” he said.

In his area, Duchin said, he has seen shigellosis, trench fever and skin infections among homeless populations.

In New York City, where more of the homeless population lives in shelters rather than on the streets, there have not been the same outbreaks of hepatitis A and typhus, said Dr. Kelly Doran, an emergency medicine physician and assistant professor at NYU School of Medicine. But Doran said different infections occur in shelters, including tuberculosis, a disease that spreads through the air and typically infects the lungs.

The diseases sometimes get the “medieval” moniker because people in that era lived in squalid conditions without clean water or sewage treatment, said Dr. Jeffrey Klausner, a professor of medicine and public health at UCLA.

People living on the streets or in homeless shelters are vulnerable to such outbreaks because their weakened immune systems are worsened by stress, malnutrition and sleep deprivation. Many also have mental illness and substance abuse disorders, which can make it harder for them to stay healthy or get health care.

Saban Community Clinic physician assistant Negeen Farmand checks Millar at a homeless encampment near a Hollywood freeway one morning.(Heidi de Marco/KHN)

“To get these people to come into a clinic is a big thing,” Farmand said. “A lot of them are distrustful of the health care system.”(Heidi de Marco/KHN)

One recent February afternoon, Saban Community Clinic physician assistant Negeen Farmand walked through homeless encampments in Hollywood carrying a backpack with medical supplies. She stopped to talk to a man sweeping the sidewalks. He said he sees “everything and anything” in the gutters and hopes he doesn’t get sick.

She introduced herself to a few others and asked if they had any health issues that needed checking. When she saw Millar, Farmand checked her blood pressure, asked about her asthma and urged her to come see a doctor for treatment of her hepatitis C, a viral infection spread through contaminated blood that can lead to serious liver damage.

“To get these people to come into a clinic is a big thing,” she said. “A lot of them are distrustful of the health care system.”

On another day, 53-year-old Karen Mitchell waited to get treated for a persistent cough by St. John’s Well Child & Family Center’s mobile health clinic. She also needed a tuberculosis test, as required by the shelter where she was living in Bellflower, Calif.

Mitchell, who said she developed alcoholism after a career in pharmaceutical sales, said she has contracted pneumonia from germs from other shelter residents. “Everyone is always sick, no matter what precautions they take.”

During the hepatitis A outbreak, public health officials administered widespread vaccinations, cleaned the streets with bleach and water and installed hand-washing stations and portable toilets near high concentrations of homeless people.

But health officials and homeless advocates said more needs to be done, including helping people access medical and behavioral health care and affordable housing.

“It really is unconscionable,” said Bobby Watts, CEO of the National Health Care for the Homeless Council, a policy and advocacy organization. “These are all preventable diseases.”

Anna Gorman: agorman@kff.org, @AnnaGorman

Heidi de Marco: heidid@kff.org, @Heidi_deMarco

'Medicare-For-All' Gets Buzzy In Unexpected Locales

KFF Health News, March 12, 2019

The battle over healthcare reform is playing out in heated rhetoric on the national stage, and the coalition pushing Medicare-for-all is widening.

This article was first published on Tuesday, March 12 in Kaiser Health News.

By Shefali Luthra

COLUMBIA, S.C. — It was a sleepy Saturday in mid-February. But Virginia Sanders was speaking, and the audience was rapt.

"One might not have the power. But a thousand has the power," she said. "Don't let anybody fool you that you don't."

Sanders, 76, has been an organizer and activist all her life. She marched in the civil rights movement. She protested against the Vietnam War. During the 2016 primary, friends recall, this petite black woman marched up to men in Ku Klux Klan robes to distribute flyers about then-candidate Bernie Sanders — no relation. (They took the papers, she said.)

Now, she is focused on a different battle, one that has captured liberals' imagination across the country: "Medicare-for-all."

Outside Washington, Sanders is among the ranks of activists readying for a fight, even in states where, backers acknowledge, this approach often isn't considered mainstream.

Organizers working with National Nurses United, the largest union and professional association for registered nurses in the U.S., have launched a grassroots campaign, championing a sweeping Medicare-for-all bill introduced in Congress late last month by Rep. Pramila Jayapal (D-Wash.) and Rep. Debbie Dingell (D-Mich.).

In states including Texas, Arizona, Louisiana, Idaho and Missouri, a series of events have been held to harness energy on the ground and to showcase enthusiasm — even in unlikely places — for the Medicare-for-all idea.

And that enthusiasm is sizable.

Sanders was speaking at what activists call a "barnstorm." The event was meant to turn the roughly three dozen people in this gray hotel conference room into foot soldiers in what's at best a sharply uphill health care fight.

Winning Medicare-for-all wouldn't be easy, Sanders told her audience of would-be activists, but she is still a believer.

"When I say South Carolina is a red state, it's a blood-red state," Sanders said after the event. "[But] if we can just educate people who live at or below the poverty level to vote with their best interest, we can change South Carolina."

The battle over healthcare reform is playing out in heated rhetoric on the national stage. Polling shows the concept has general support. But that backing wanes if respondents are told about potential consequences, such as eliminating private insurance or raising taxes.

Democrats seeking the party's 2020 presidential nomination are for the most part adopting the Medicare-for-all slogan head-on, though often hedging on specifics. Health industry interests are lining up in opposition. And Republicans decry it as "socialized medicine."

At this barnstorm in South Carolina's capital, about 36 people showed up to munch sandwiches and potato chips at what was effectively a two-hour organizing lesson in an off-election year — and on the same day as a visit here from Sen. Kirsten Gillibrand, a New York Democrat running for president.

The following afternoon, in Fayetteville, W.Va., about 30 came to a similar event, this one hosted above a local sandwich shop and bar. Activists sipped beers, swapped healthcare stories and planned phone banks and canvassing events to spread the word.

It's an unusual kind of energy around a policy that, before 2016, had been relegated to a progressive pipe dream.

"There is an incredible amount of activism among liberal communities, which also exist in conservative states," said Robert Blendon, a professor of health policy and political analysis at Harvard University. That activism, he added, could shape the Democratic primary and, by proxy, the 2020 presidential contest.

The Vibe On The Ground

The coalition pushing Medicare-for-all is widening — with what started as a signature proposal for Sen. Sanders' presidential campaign taking on broader appeal.

In Fayetteville, local Democrats who had fiercely supported Sanders or Hillary Clinton in the 2016 primary came together to learn about Medicare-for-all, said Chris Pennington, a 36-year-old substitute teacher and Bernie Sanders delegate in 2016.

Columbia's event certainly drew a familiar crew, said Lucero Mesa, 61, who organized it and co-chairs the local chapter of Our Revolution, a political action group with ties to Sanders' 2016 presidential campaign. But then her eyes widened as more attendees filed in: "I'm starting to see faces I don't recognize!"

On a national level, Medicare-for-all earns ire from Republican lawmakers. But "it's not a partisan issue" in a place like West Virginia, Pennington said. Indeed, polling from the Kaiser Family Foundation suggests that as many as a third of Republicans support the idea. (Kaiser Health News is an editorially independent program of the foundation.)

Following that Sunday's event, Pennington announced plans to set up a canvassing booth at the Fayetteville High School basketball game two days later.

Meanwhile, the thorny issue of whether to keep private insurance, a question that has already ensnared candidates, has less impact among these activists.

In the same breath as embracing legislation introduced by Sen. Sanders, which would effectively eliminate the insurance industry, organizers expressed openness to other policy approaches, as long as they kept certain broad principles intact.

When asked if the system in Sanders' bill — which is inspired by the Canadian health care model — would best serve American interests, Lawrence Nathaniel, a 25-year-old Columbia activist, didn't hesitate.

"I don't think we should be fighting to be like other countries. We should be fighting to be like our own," said Nathaniel, who campaigned for Sanders and then Clinton in the 2016 election and is planning his own campaign for Congress.

Virginia Sanders went a step further. Calling to get rid of private insurance might actually be "a mistake," she said.

"We can let the American people have input," she added.

To be sure, even though the Medicare-for-all message faces skepticism in many other red-state locations, it still tilts the health care debate. In Texas, for instance, activists acknowledge that this kind of sweeping reform is improbable but say it has opened the discussion up to incremental ideas, such as pursuing the Affordable Care Act's Medicaid expansion — also still considered a long shot.

It also could have far-reaching political ramifications. The activists organizing now, Blendon noted, are likely to vote in the upcoming Democratic primaries.

"A lot of these groups will … turn out in states you don't expect," he said. "There is a general principle running through part of the Democratic Party. And the principle is they want universal coverage, and a very strong role for government."

For someone like Virginia Sanders, it's not so much a political issue as a moral one.

"We have to fight. Freedom isn't free," she said. "Power concedes nothing. It has to be taken."

Shefali Luthra: ShefaliL@kff.org, @Shefalil

How Much Difference Will Eli Lilly's Half-Price Insulin Make?

KFF Health News, March 12, 2019

Between 2009 and 2017 the wholesale price of a single vial of Humalog, the Eli Lilly and Co.-manufactured insulin, nearly tripled — rising from $92.70 to $274.70.

This article was first published on Tuesday, March 12 in Kaiser Health News.

By Bram Sable-Smith

When Erin Gilmer filled her insulin prescription at a Denver-area Walgreens in January, she paid $8.50. U.S. taxpayers paid another $280.51.

"It eats at me to know that taxpayer money is being wasted," said Gilmer, who has Medicare and was diagnosed with Type 1 diabetes while a sophomore at the University of Colorado in 2002.

The diagnosis meant that for the rest of her life she'd require daily insulin shots to stay alive. But the price of that insulin is skyrocketing.

Between 2009 and 2017 the wholesale price of a single vial of Humalog, the Eli Lilly and Co.-manufactured insulin Gilmer uses, nearly tripled — rising from $92.70 to $274.70, according to data from IBM Watson Health.

Six years ago, Gilmer qualified for Social Security Disability Insurance — and thus, Medicare — because of a range of health issues. At the time, the insulin she needed cost $167.70 per vial, according to IBM Watson Health.

"When it's taxpayer money paying for medication for someone like me, it makes it a national issue, not just a diabetic issue," Gilmer said.

Stories about people with Type 1 diabetes dying when they couldn’t afford insulin have made headlines. Patient activists like Gilmer have protested high prices outside Lilly’s headquarters in Indianapolis.

Last October in Minnesota, state Attorney General Lori Swanson sued insulin manufacturers, alleging price gouging. Pharmaceutical executives were grilled about high drug prices by the Senate Finance Committee on Feb. 26.

This is the backdrop for Lilly's announcement last week that it is rolling out a half-priced, generic version of Humalog called "insulin lispro" The list price: $137.35 per vial.

"Patients, doctors and policymakers are demanding lower list prices for medicines and lower patient costs at the pharmacy counter," Eli Lilly CEO David Ricks wrote in a blog post about the move. "You might be surprised to hear that we agree – it's time for change in our system and for consumer prices to come down."

No Panacea

When Lilly’s Humalog, the first short-acting insulin, came to market in 1996, the list price was about $21 per vial. The price didn’t reach $275 overnight, but yearly price increases added up.

In February 2009, for example, the wholesale price was $92.70, according to IBM Watson Health. It rose to $99.65 in December 2009, then to $107.60 in September 2010, $115.70 in May 2011, and so on.

"There's no justification for why prices should keep increasing at an average rate of 10% every year,” said Inmaculada Hernandez of the University of Pittsburgh School of Pharmacy, who was lead author of a January report in Health Affairs attributing the skyrocketing cost of prescription drugs to accumulated yearly price hikes.

"The public perception that we have in general is that drugs are so expensive because we need to pay for research and development, and that's true," Hernandez said. "However, usually research and development is paid for in the first years of life of a drug."

At $137.35 per vial, Lilly’s generic insulin is priced at about the same level as Humalog was in 2012, 16 years after it came to market.

"We want to recognize that this is not a panacea," said company spokesman Greg Kueterman. "This is an option that we hope can help people in the current system that we work with."

It's worth noting that Humalog is a rapid-acting insulin, but that’s only one of the two types of insulin most people with Type 1 diabetes use every day. The second kind is long-lasting. Lilly makes one called Basaglar. The most popular long-lasting insulin is Lantus, produced by Sanofi. Neither has a lower-cost alternative.

Still, Lilly's move on Humalog could put pressure on the other two big makers of insulin to act.

Novo Nordisk called Lilly's lower-priced generic insulin "an important development," in an emailed statement.

"Bringing affordable insulin to the market requires ideas from all stakeholders," Novo Nordisk's Ken Inchausti said in an email, which also listed steps the company has taken, such as a patient assistance program. The statement didn't say whether Novo Nordisk is considering offering a lower-priced version of its popular insulin Novolog, a rival of Humalog.

A statement from Sanofi, the third major insulin maker, also didn't say whether the company would offer lower-priced versions of its insulins.

"Sanofi supports any actions that increase access to insulins for patients living with diabetes at an affordable price," spokewoman Ashleigh Koss said in the email, which also touted the company’s patient assistance program.

A Different Kind Of Generic

One twist in this story is that Lilly's new insulin is just a repackaged version of Humalog, minus the brand name. It's called an "authorized generic."

"Whoever came up with the term 'authorized generic'?" Dr. Vincent Rajkumar said, laughing. Rajkumar is a hematologist at the Mayo Clinic in Rochester, Minn.

"It's the same exact drug" as the brand name, he continued.

Typically, Rajkumar said, authorized generics are introduced by brand-name drugmakers to compete with generic versions of their drugs made by rival companies.

But in the case of Humalog and other insulins, there are no generics made by competitors, as there are for, say, the cholesterol medicine Lipitor or even other diabetes drugs, such as metformin.

So when Lilly's authorized generic comes to market, the company will have both Humalog insulin and the authorized generic version of that medicine on the market.

Rajkumar said it's a public relations move.

"There's outrage over the price of insulin that is being discussed in Congress and elsewhere. And so the company basically says, 'Hey, we will make the identical product available at half price.' On the surface that sounds great," Rajkumar said.

"But you look at the problems and you think, 'OK, how crazy is this that someone is actually going to be buying the brand-name drug?'"

In fact, it's possible that Lilly could break even or profit off its authorized generic compared to the name-brand Humalog, according to University of Pittsburgh's Hernandez.

The profit margin would depend on the rebates paid by the company to insurers and pharmacy benefit managers. Rebates are getting a lot of attention these days as one factor that pushes drug prices higher. They're usually not disclosed and increase as a drug's price increases, providing an incentive to some companies to raise prices.

"Doing an authorized generic is nothing else than giving insurers two options," Hernandez said: pay the full list price for a brand-name drug and receive a higher rebate, or pay the lower price for the authorized generic and receive a presumably smaller rebate.

"What we really need to get insulin prices down is to get generics into the market, and we need more than one," Hernandez said, adding that previous research has shown that prices begin to go down when two or three generics are competing in the marketplace.

Even so, Lillly's Kueterman said the authorized generic insulin "is going to help hopefully move the system towards a more sustainable model."

"I can guarantee you the reason that we're doing this is to help people," Kueterman said, noting the company's Diabetes Solution Center has also helped "10,000 people each month pay significantly less for their insulin" since it opened in August.

For Erin Gilmer, the news about an authorized generic insulin from Lilly has left her mildly encouraged.

"It sounds really good, and it will help some people, which is great," Gilmer said. "It's Eli Lilly and pharma starting to understand that grassroots activism has to be taken seriously, and we are at a tipping point."

This story is part of a partnership that includes NPR and Kaiser Health News.

Bram Sable-Smith: @besables

Why Measles Hits So Hard Within N.Y. Orthodox Jewish Community

KFF Health News, March 11, 2019

As healthcare providers battle to get the outbreaks under control, one of their biggest challenges is communicating to people that measles is a menacing disease to be taken seriously.

This story was first published Monday, March 11, 2019, by Kaiser Health News.

By Michelle Andrews

The Rockland County, N.Y., woman hadn't told her obstetrician that she had a fever and rash, two key signs of a measles infection. A member of the Orthodox Jewish community there, she went into premature labor at 34 weeks, possibly as a result of the infection. Her baby was born with measles and spent his first 10 days in the neonatal intensive care unit.

The infant is home now, but "we don’t know how this baby will do," said Dr. Patricia Schnabel Ruppert, the health commissioner for Rockland County. When young children contract measles, they face a heightened risk of complications from the disease, including seizures or hearing and vision problems down the road.

The measles case Ruppert described is just one of many. New York state's outbreaks, which began last October, have gone on longer and infected more people than any other current outbreak nationwide. More than 275 cases of the disease have been confirmed statewide through the first week of March, primarily in the New York City borough of Brooklyn and in Rockland County towns northwest of the city.

That total makes up about half of the 578 confirmed cases in 11 states that were reported nationwide by the federal Centers for Disease Control and Prevention from January 2018 through the end of last month. Washington state, with 76 cases by the end of February, has the second-highest number of cases.

Measles cases in New York have been concentrated among children from Orthodox Jewish families, many of whom attend religious schools where vaccination rates may have been below the 95% threshold considered necessary to maintain immunity. The outbreaks began when unvaccinated travelers returned from Israel, where an outbreak persists, and spread the disease here.

Besides geographic proximity, cultural identity may contribute to an outbreak taking hold in the close-knit Orthodox community — a feeling that their worldview is not in keeping with modern secular society, said Samuel Heilman, a Queens College sociology professor who has authored several books about Orthodox Jews.

"It's about a view that we have our ways and they have their ways," he said.

Although some Orthodox Jews claim that vaccinations are against Jewish law, that’s not correct, said Dr. Aaron Glatt, who is also a rabbi and chairman of the department of medicine at South Nassau Communities Hospital on Long Island. "There's not a single opinion that says vaccination is against Jewish law," he said.

As public health officials and health care providers battle to get the outbreaks under control, one of their biggest challenges is communicating to people that measles is a menacing disease to be taken seriously.

"People don't want to get vaccines because they don't think they need them," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

The public may have grown complacent. Before the vaccine program began in the United States in 1963, as many as 4 million people became infected every year. Nearly 50,000 were hospitalized and up to 500 people died annually. By 2000, measles was a disease that public health officials said was essentially eradicated in the U.S., thanks to a comprehensive vaccine program that reduced the number of cases by 99%.

But measles has crept back in recent years, in part because of fears fanned by anti-vaccine activists who have claimed, without evidence, that vaccines cause a variety of problems, including autism.

The measles virus is still a problem in some other countries, and unvaccinated people may bring the virus back with them and infect others.

The virus is exquisitely contagious. If an infected person coughs or talks, droplets can remain in the air or land on a surface and cause infection for hours. Ninety percent of people who are exposed and susceptible will become infected. While a fever and red rash that spreads from the face down along the body are common symptoms, side effects can be serious and even lethal, especially for young children and people with compromised immune systems.

In an effort to contain New York's outbreaks, Ruppert initially prohibited 6,000 children at 60 mostly religious schools and day care centers in Rockland County from attending class because they hadn't been vaccinated. As more children have been vaccinated and the school vaccination rates have reached 95%, those numbers have dropped. But about 3,800 students at 35 schools are still excluded from attending.

In Brooklyn, 1,800 students at 140 schools were originally affected, said Dr. Jane Zucker, assistant commissioner for the Bureau of Immunization at the New York City Health Department. Those numbers have declined somewhat as well.

Since the outbreaks began, Rockland County health care providers have administered more than 16,000 vaccines, while New York City has provided more than 7,000 shots.

The measles, mumps and rubella vaccine is given in two doses, the first when a child is between 12 and 15 months old, and the second between ages 4 and 6. It is 97% effective in preventing the disease.

In New York and nearly every other state, children may be exempted from vaccination requirements for medical or religious reasons. Seventeen states allow parents not to vaccinate their children for philosophical reasons, according to the National Conference of State Legislatures, but New York is not one of them.

Concerns about contracting measles aren't limited to people who are part of the Orthodox Jewish community. Heilman said that one of his daughters-in-law likes to shop at a kosher supermarket in Rockland County, not far from her home in suburban White Plains. But with an 11-month-old daughter who hasn't yet been vaccinated, she doesn't want to take any risks. As long as the threat of measles continues, his daughter-in-law is shopping elsewhere, Heilman said.

Michelle Andrews: andrews.khn@gmail.com, @mandrews110

Military Doctors In Crosshairs Of A Budget Battle

KFF Health News, March 11, 2019

The Department of Defense has reportedly drafted proposals to convert more than 17,000 medical positions into fighting and support positions — a 13% reduction in medical personnel.

This story was first published Monday, March 11, 2019, by Kaiser Health News.

By Jordan Rau

The U.S. military is devising major reductions in its medical corps, unnerving the system's advocates who fear the cuts will hobble the armed forces' ability to adequately care for health problems of military personnel at home and abroad.

The move inside the military coincides with efforts by the Trump administration to privatize care for veterans. The Department of Veterans Affairs last month proposed rules that would allow veterans to use private hospitals and clinics if government primary care facilities are not nearby or if they have to wait too long for an appointment.

Shrinking the medical corps within the armed forces is proving more contentious and complex. In 2017, a Republican-controlled Congress mandated changes in what a Senate Armed Services Committee report described as "an under-performing, disjointed health system" with "bloated medical headquarters staffs" and "inevitable turf wars." The directive sought a greater emphasis for military doctors on combat-related needs while transferring other care to civilian providers.

Details of reductions have yet to be finalized, a military spokeswoman said. But within the system and among alumni, trepidation has increased since Military.com, an online military and veterans organization, reported in January that the Department of Defense had drafted proposals to convert more than 17,000 medical positions into fighting and support positions — a 13% reduction in medical personnel.

"That would be a drastic first cut," said Dr. David Lane, a retired rear admiral and former director of the Walter Reed National Military Medical Center in Bethesda, Md.

At most risk in the current planning are positions that aren't considered essential to troops overseas, such as training spots for new doctors and jobs that can be outsourced to private physicians and hospitals — obstetricians and primary care doctors, for example. The reductions may also limit the military’s medical humanitarian assistance and relief for foreign natural disasters and disease outbreaks.

Even in war zones, Lane warned, it would be a mistake to downplay the importance of contributions by doctors who do not specialize in trauma. In the 1991 invasion of Kuwait, for instance, cases of diseases and non-battle injuries rather than combat injuries created the most medical work, he said.

Doctors who train in the military's highly regarded medical school — who have committed to serve in the armed forces after training— and those who do military residencies account for much of the staff serving troops overseas. A major deployment could leave the military flatfooted, said Dr. John Prescott, a former Army physician.

"The majority of folks in the military don't stay in for their whole career, they stay in for a few years," Prescott said. "I'm concerned there will be a very small cohort that will be available for deployment in the future."

The military health system is responsible for more than 1.4 million active-duty and 331,000 reserve personnel, with 54 hospitals and 377 military clinics around the world. Split among the Navy, Army and Air Force, each with its own doctors and hospitals, the service has been targeted for years for overhaul to reduce redundancies and save costs.

The department has already started moving administrative functions under one bureaucracy, called the Defense Health Agency, which is slated to take over the service branch hospitals in 2021.

The budget for the next fiscal year is still being developed and final decisions have not yet been made, a Department of Defense spokeswoman, Lt. Col. Carla Gleason, said in an email. "Any reforms that do result will be driven by the Department's efforts to ensure our medical personnel are ready to provide battlefield care in support of our forces, and to provide the outstanding medical benefits that Service members, retirees and their families deserve," she said.

For years, critics of the broad role of the military health services have argued that many medical corps services — such as maternity care and pediatrics on bases — could be provided more effectively by civilian doctors and hospitals.

But Lane said there is too much focus on the high-profile trauma cases on the battlefield "that at the end of the day are a small portion" of medical care. "When we're trying to put things back together that got broken during a war," he said, "that's what you need the most of — pediatricians, public health doctors, primary care doctors."

Some studies commissioned by the department have concluded private hospitals could deliver less costly care, in part because doctors at hospitals take care of more patients. But the Congressional Budget Office said savings were not at all certain and that military hospitals might be less expensive if the government arranged for greater use of them.

Brad Carson and Morgan Plummer, who held senior jobs in the Department of Defense during President Barack Obama's administration, argued in a 2016 essay that the military isn't the best training for surgeons because it doesn't provide them with a sufficient number of cases to develop expertise.

The military health system "has too much infrastructure, the wrong mix of providers, and predominantly serves the needs of beneficiaries who could easily have their healthcare needs satisfied by civilian providers at far less cost and with equal or better quality," they wrote.

The government this year is spending $50 billion on the military health system, including Tricare insurance for more than 9 million active-duty service members, veterans, families and survivors, according to Congress’ budget office. That is roughly a tenth of the military budget. The CBO projected costs are on track to increase to $63 billion in 2033.

Defenders of the system reject the idea that non-wartime jobs can be eliminated without it hurting that core mission.

"Military healthcare providers between deployments maintain their clinical skills by treating service members and millions of beneficiaries," Dr. Arthur Kellermann, dean of the school of medicine at the Uniformed Services University in Bethesda, wrote in a 2017 Health Affairs article. "Military hospitals provide valuable platforms for teaching the next generation of uniformed healthcare professionals and standby capacity for combat casualties."

Prescott, the former Army doctor, said that the military may have trouble turning to civilian doctors in some regions given physician shortages, which he said the military cuts would exacerbate.

"Most hospitals are already pretty full, most healthcare providers are pretty busy,” said Prescott, now chief academic officer at the Association of American Medical Colleges.

Doctor shortages would increase if the military cut the slots it now has to train doctors, because there wouldn't be new civilian residencies created to compensate. "Those positions basically disappear," he said.

Kathryn Beasley, a retired Navy captain who is director of government relations for health affairs at the Military Officers Association of America, said she was also concerned with unforeseen consequences of dramatic cuts.

"Everything's tied together, there’s a lot of interdependencies in these things," she said. "You pull a string on one and you might feel it in an area you don't expect."

Jordan Rau: jrau@kff.org, @JordanRau

As Hospitals Post Price Lists, Consumers Are Asked To Check Up On Them

KFF Health News, March 8, 2019

CMS Administrator Seema Verma has enlisted the public in an unusual effort to monitor whether hospitals are complying with a new requirement that they post their 'list' prices on line.

This story was first published Friday, March 8, 2019, by Kaiser Health News.

By Steven Findlay

With much fanfare, federal officials required hospitals nationwide this year to post their "list" prices online. But it’s not yet clear how many are doing it, even as the government has taken the rare step of asking consumers to monitor hospital compliance.

Most hospitals appear to be complying with the rule, according to hospital officials and a small sampling of websites.

However, the feds acknowledge they are not yet enforcing the rule, industry groups are not monitoring compliance, many hospitals are burying the information on their websites, and debate continues about whether the price lists are creating more confusion than clarity among consumers.

The rule took effect Jan. 1, after a year-long controversy about its necessity and usefulness. It requires every hospital in the country — about 6,000 — to post its full price list online.

The lists, known in the industry as "chargemasters," present prices for the thousands of individual services and products for which a hospital may bill — everything from the price for a bed per day, blood tests and surgical operating room time (billed in 15-minute intervals) to the cost of a single Tylenol tablet.

The problem: Services and products are identified in obscure abbreviations, billing codes and medical terminology that even doctors or nurses often don't understand.

Additionally, the chargemaster lists only rarely reflect final billed charges because insurers and the government generally negotiate significantly lower prices. In most cases, these posted rates are the highest a hospital would ever charge per service.

Even so, officials at the Centers for Medicare & Medicaid Services said full public disclosure was a logical first step in a transparency initiative aimed at eventually encompassing physician and prescription drug prices.

CMS contends the listings will help patients compare facilities, spur competition among hospitals to lower prices and prompt software developers to build tools that consumers can use to comparison shop.

"We think this information will empower patients," said Seema Verma, the CMS administrator. "And we look forward to seeing consumers continue to drive the demand for hospitals to provide greater price transparency."

Verma has enlisted the public in an unusual effort to monitor whether hospitals are complying. In appearances, opinion pieces and through social media, she has urged consumers to check their local hospitals’ websites to see if chargemaster lists are posted and let the agency know if they are not.

While putting off enforcing the law, CMS has instead invited hospitals, other health care stakeholders and the public to weigh in on possible enforcement mechanisms, as well as to suggest future price transparency measures. Hundreds of comments have been submitted.

At the agency-initiated Twitter site #WheresthePrice, a dialogue has ensued. In one case, a Texas man, Matt Kleiber, checked 31 hospitals and medical centers in Houston and found one health system, Memorial Hermann, which operates 16 hospitals, not in compliance.

After a reporter's inquiry, Kathryn Williams, a spokeswoman for Memorial Hermann, said in early February that the hospital system was in compliance. She said they interpreted the government's rule as allowing a shorter, easier-to-understand price list to be posted.

Subsequently, in late February, the hospital posted its full chargemaster list, as the regulation requires.

"What we posted [initially] was much easier for our patients to understand," said Williams. "We don't think the chargemaster list is helpful … and we stand by our position that the information we have had posted on our website since Jan. 1 is consistent with CMS’s guidance."

Other reports of noncompliance at #WheresthePrice appeared to be the result of incomplete website explorations by consumers. A KHN check of the websites of six cited hospitals showed the price lists were posted. On all but one of the sites, however, the information was not prominently displayed.

About a dozen hospital websites reviewed by KHN included an accompanying — and often prominent — disclaimer saying the information doesn't reflect typical final charges and is difficult to understand.

Accompanying its chargemaster list, for example, Saline Memorial Hospital in Benton, Ark., states: "The amount listed [for each service] is not necessarily reflective of your actual financial responsibility. … We recommend that all patients contact their insurer or Saline Health System to discuss their individual situations and determine the potential out-of-pocket costs of their care."

Ariel Levin, senior associate director of state issues at the American Hospital Association, said hospitals have been reluctant to draw too much attention to their price lists.

"Most hospitals think this information will not help patients," Levin said. "And many think it only confuses people."

Levin said the AHA is not monitoring its members' compliance, and she doesn't think other hospital trade groups are either.

"But all the hospital websites we have checked so far have been in compliance, and we believe the vast majority are abiding by the rule," Levin said. Small rural hospitals may take longer to comply, she added.

CMS and the AHA said a few hospitals offer consumer-friendly price transparency that goes significantly beyond the chargemaster price lists.

St. Luke's University Health Network, a 10-hospital system with 300 outpatient clinics in Pennsylvania and New Jersey, several years ago launched an online tool with two features, "PriceLock" and "PriceChecker."

Francine Botek, the hospital's senior vice president for finance, said PriceLock allows patients to get an all-inclusive price for most — 80% — of the hospital's outpatient services even if a patient doesn't enter insurance information. PriceChecker permits people to enter insurance information and other data to help calculate their out-of-pocket costs.

The tools are only slowly gaining traction among consumers, said Botek. In 2018, 35,200 people used PriceChecker, averaging about 2,500 a month. Over the past three years, about 3,600 have used PriceLock.

The University of Utah, which owns four hospitals, has a similar online out-of-pocket cost estimator for about 600 common (mostly outpatient) services and procedures — giving a single price that rolls up itemized charges for each. People with or without insurance can use the tool. Those without insurance get an across-the-board 30% discount off the list price, and deeper discounts are sometimes available.

Kathy Delis, who oversees billing at University of Utah Health, said the hospital system plans this year to market the tool to the public more aggressively.

"It's going to take time to engage patients," Delis said. "We have urged CMS to move beyond the chargemaster rule as soon as possible."

A few states require hospitals to give consumers price estimates. The laws are limited in scope, however. In 2018, Colorado became the latest state to enact such a law. It mandates that hospitals post "self-pay" prices for the 50 conditions that yield the most revenue from Medicare. Doctors must also post prices for their 15 most popular procedures.

An older California law requires hospitals to disclose prices for the top 26 outpatient services by revenue.

A spokesperson for CMS said the agency plans to issue its next regulation on hospital price transparency this year.

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

KFF Health News, March 7, 2019

The FDA has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark.

This story was first published Thursday, March 7, 2019, by Kaiser Health News.

By Christina Jewett

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration's public database that tracks medical device failures and "there was nothing," he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special "exemption" allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

"I don't want to sound overdramatic here, but it seemed like a cover-up," said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal "alternative summary reporting" repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

An FDA official said that the program is for issues that are "well-known and well-documented with the FDA" and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.

KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

"The public has a right to know about this," said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.

FDA spokeswoman Deborah Kotz confirmed that the "registry exemption" was created without any public notice or regulations. "Any device manufacturer can request an exemption from its reporting requirements," she said in an email.

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Alison Hunt, another FDA spokeswoman, said the majority of device makers' "exemptions" were revoked that year as a program took shape that requires a "placeholder" report to be filed publicly.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency's new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.

The long-standing exemption program "has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive," Hunt said in an email.

To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.

"The FDA is basically giving away its authority over device manufacturers," said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. "If they've given that up, they've handed over their ability to oversee the safety and effectiveness of these devices."

Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the "unacknowledged" problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.

Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.

The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.

Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital in Ohio.

Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.

Told of the reporting "exemption" for surgical staplers, his wife, Doris Levering, was incredulous.

"Why would this information not be made available to doctors? The true information — I mean the actual numbers …" she said. "People's lives are at stake. Mark's life will never be the same."

The Stapler Problem

The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.

Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into "code blue" mode to rescue a patient from bleeding to death.

The severity of some of the injuries caught former FDA official Brown's attention in the early years of its reporting exemption. Her 2004 article on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the "alternative summary" program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.

She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a "reason for concern."

In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.

Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.

In Michigan, Eugene Snook's surgeon was in the process of removing part of his lung when he cut but couldn't seal a major vessel due to a "stapler malfunction," the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.

The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien's control and also that the surgeon used it improperly. The case reached a confidential settlement in 2017.

Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.

The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn't prove that the stapler had a specific defect.

Covidien reached an agreement to settle the family’s claims for $250,000, part of a larger settlement in the case.

Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler "misfired," according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.

Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark's bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were "prudent, proper" and "lawful."

Covidien denies any defect with the stapler or that it caused Levering's injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that "we always make patient safety our top priority" and that the company complies with FDA requirements.

The company's reports of stapler problems in the public database remain relatively low. But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien's staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.

Rolling Out The Program

The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.

Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.

Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was "mind-numbing." Kessler went to the FDA's legal department and to device manufacturers to propose a solution.

Device makers would be able to seek a special "exemption" to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.

That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.

"I don't know why it's not [made public] now," he said. "I'm surprised about that."

Starting in September, KHN filed Freedom of Information Act requests for "exemption" agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no "compelling need" for haste. For one request, the records were estimated to arrive in 22 months.

The FDA declined to provide a complete list of "about 100" devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.

An FDA spokeswoman said "alternative summary" exemptions remain in place for pacemaker electrodes and implantable defibrillators.

Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.

He said he regularly scans the FDA's public device-injury reports. Asked about "alternative summary" reports, he said, "I've got to tell you, that's a new term to me."

Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he's the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.

In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a "nothing burger," but the data would be meaningful to his forensic investigations.

The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual "Top 10" in medical technology hazards. Its tagline: "Separating fact from fiction in healthcare."

Among the institute's "top medical device subject matter experts," spokeswoman Laurie Menyo said in an email, "none of them had any familiarity with FDA's Alternative Summary Reporting Program."

Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. "Never heard anything about it," he said. "It's interesting."

Companies that get the exemptions tend to be very "tight-lipped" about them, said Christine Posin, a former device firm manager and consultant to device companies.

The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what's buried elsewhere.

That creates a business opportunity to persuade a doctor to try a different device. "'We have a good product that does the same thing,'" Posin said a sales representative might tell a physician.

Exemptions Multiply

The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.

Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a "safety communication" saying "serious complications" like pain or infection were "not rare."

The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.

Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.

Under what the FDA calls the "litigation complaint summary reporting" exemption, device makers can file a single placeholder "injury" report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits.

To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details on the 1,175 cases submitted directly to the FDA.

According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.

Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is "horrible" and "unethical."

"We need to know the good and the bad," said Margolis, who treats patients in his urogynecology practice. "If you're trying to hide complications from me, well that's … wrong, my God, it's heinous."

The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a "haphazard" system that is "not independent and not transparent."

Within months, the FDA allowed the makers of the robots to file a single report, noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches of 99 and 130 injuries at a time.

"This is very frustrating," said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.

Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.

Under the "registry exemption," device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz.

Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.

Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that's snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve will last in the body.

The summary reports offer potential patients few answers. Such reports document as many as 297 deaths or 1,800 injuries in a single filing, with virtually no detail readily available to the public. In all, Edwards has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.

Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide "comprehensive evidence for device safety."

"The approval of alternative reporting protects against duplicate reports coming from multiple sources," Huoh said.

Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial, with some scientists saying it is crucial for a certain subset of patients, and others pointing to the harm it can cause to the heart.

The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many as 347 deaths or 1,000 injuries in a single filing, also shipping the details straight to the agency, FDA records show.

An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip's safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.

Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they'll be filing a public summary report in MAUDE.

The FDA has deemed the makers of more than 5,600 types of devices eligible to file "voluntary malfunction summary reports." Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves.

The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.

"It's just another example of a flawed oversight system," he said, "bent toward making it easier for industry rather than making protection of public health the primary goal."

California Healthline reporter and producer Heidi de Marco contributed to this report.

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

Heidi de Marco: heidid@kff.org, @Heidi_deMarco

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