In An Effort To Curb Drug Costs, States Advance Bills To Prod Feds On Importation

KFF Health News, February 16, 2018

For years, American consumers have tried to buy cheaper drugs from their northern neighbor. But the practice is illegal.

This article first appeared February 14, 2018 on Kaiser Health News.

By Shefali Luthra

Norm Thurston is a “free-market guy” — a conservative health economist in Republican-run Utah who rarely sees the government’s involvement in anything as beneficial.

But in a twist, the state lawmaker is now pushing for Utah to flex its muscle to spur federal action on ever-climbing prescription drug prices.

“This is something that a red state like Utah could do. I don’t think this is a partisan issue,” Thurston said. “Those outrageous cost increases are not the result of the free market.”

The approach: Let the state contract with wholesalers in Canada, importing cheaper prescriptions from up north and distributing them to the state’s health care system.

Other states — Vermont, West Virginia and Oklahoma, among them — are following similar paths, pushing legislation that would seek permission from the Trump administration to launch their own plans to import drugs from Canada.

For years, American consumers have tried to buy cheaper drugs from their northern neighbor, sometimes packing into buses for day trips to Canadian pharmacies, or patronizing American stores that help them order drugs from abroad. But the practice is illegal.

The states want to change that, and set up a formal process that nets broader savings. The idea is for the state health department to set up a wholesale program that buys drugs from Canada and resells them to local pharmacies and hospitals. Individual states would be responsible for ensuring that the medications are safe and that importing them does save money.

“This statute is putting pressure on the federal government to take a harder look at these questions,” said Rachel Sachs, an associate law professor at Washington University of St. Louis, who researches drug price regulations. “The state legislatures can say, ‘Look, we’re doing everything we can, but we do need the federal government to help us out on this.’”

The federal government has been slow to act on this issue, and skeptics say a 30-page Trump administration memo on drug pricing released late last week would likely have only limited impact.

But states, whose budgets for Medicaid and state employee health programs are squeezed by these costs, are moving forward.

In Vermont alone, drug spending has gone up by 35 percent from 2010 to 2015, the most recent year for which data are available.

Backers of the state plans say the strategy is a no-brainer that could save hundreds of millions of dollars. They discount concerns about drug safety, arguing that drugs from Canada are made by reputable companies, often in the same facilities and by the same firms that sell them in the U.S. — but at much higher prices.

“We would be bringing in drugs intended for the Canadian market, and therefore at Canadian pricing,” Thurston said. “One would assume if we could come up with a program that meets the recommendations of federal law, what justification would the [Health and Human Services] secretary have for saying no?”

The state measures follow model legislation developed by the National Academy for State Health Policy that uses a framework put in place by the 2003 federal law that created the Medicare Part D program. That law says the U.S. Department of Health and Human Services can approve drug importation plans if it is convinced the plans will save money and will not create any public health concerns.

Once passed, these laws task state health departments with overseeing the development of these programs. After the health department settles on the specifics, state officials must negotiate implementation with HHS. That could take years.

It is also likely to be an uphill battle.

In 15 years, HHS has never acted upon the 2003 law by approving any drug importation program.

Last spring, when members of Congress pushed a national bill, a bipartisan group of former Food and Drug Administration commissioners came out in opposition, arguing it would be impossible to verify drug safety absolutely. That bill ultimately failed to garner a majority vote.

It’s unclear where the current administration stands on this issue.

Alex Azar, the newly confirmed HHS secretary, has been coy on the subject — though in a confirmation hearing last fall, he said importing drugs from Canada could create safety concerns. Despite multiple requests, HHS did not provide comment for this story by the publication deadline.

The pharmaceutical industry echoed the cautions about safety.

“The proposals we are seeing in states across the country threaten the safety of patients and families and will not deliver the savings they promise,” said Priscilla VanderVeer, a spokeswoman for the trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

In the states, though, backers say their bills address that concern.

And other analysts argued that, regardless, safety of Canadian drugs isn’t a real issue.

“A lot of the drugs used in the United States and in Canada are made in the same plants, in countries like India or Europe,” said Michael Law, a pharmaceutical policy expert and associate professor at the University of British Columbia’s Center for Health Services and Policy Research. “The U.S. FDA and other regulatory agencies rely on other agencies’ inspections — the idea that Canadian drugs are these dangerous drugs is a red herring.”

A bigger question, he said, is the amount of savings these bills would generate.

Thurston pointed to Utah state analyses that suggest the state could save $70 million in the private sector, and another $20 million to $30 million in state-funded insurance programs. If approved, he said, the state would target 15 to 20 drugs to import — insulin, for instance, because it is bought in large quantities, or expensive drugs that treat hepatitis C or HIV.

Others expressed skepticism.

For one thing, the true price of prescription drugs isn’t always clear. There’s the list price — and generally, those are much higher in the United States. But insurance plans often negotiate rebates, or discounts, from the drug company — meaning they can end up paying far less than what’s advertised. Those discounts aren’t public, making it much harder to compare prices between the two countries.

The drug industry would also likely employ strategies to counter importation.

Pharmaceutical companies, Law noted, stand to lose if American states are importing cheaper drugs. That could motivate them to tamp down how many prescriptions they sell in Canada, or find other ways to discourage Canadian wholesalers from participating.

“My guess is any Canadian distributor to engage in that would find their [medication] supply dwindle quickly, because the drug companies would stop supplying,” he said. “The supplier systems in the United States would probably find it hard to get a [Canadian drug] supply in the long term.”

That’s certainly a real concern, said Claire Ayer, a Vermont state senator and Democrat who chairs her legislature’s Health and Welfare Committee.

“We can’t tell drug companies or wholesalers what to do in Canada,” she added.

VanderVeer said PhRMA could not speculate on how individual drug companies may react to importation.

Still, these state efforts could spur the federal government to take action, Sachs suggested — even if it’s unclear how large an impact importation would have.

“Importation will not solve all the problems — and I don’t think states see it as such,” she said. “But it could be a useful way to put pressure on a federal government and White House that has thus far largely been inactive on this topic.”

Idaho Blue Cross Jumps Into Controversial Market For Plans That Bypass ACA Rules

KFF Health News, February 15, 2018

The decision ups the ante for HHS Secretary Alex Azar. Will he use his authority to compel Idaho to follow the ACA and reject the plans?

This article first appeared February 14, 2018 on Kaiser Health News.

By Julie Appleby

That didn’t take long.

It’s barely been two weeks since Idaho regulators said they would allow the sale of health insurance that does not meet all of the Affordable Care Act’s requirements — a controversial step some experts said would likely draw legal scrutiny and, potentially, federal fines for any insurer that jumped in.

On Wednesday, Blue Cross of Idaho unveiled a menu of new health plans that break with federal health law rules in several ways, including setting premiums based on applicants’ health.

“We’re trying to offer a choice that allows the middle class to get back into insurance coverage,” said Dave Jeppesen, the insurer’s executive vice president for consumer health care.

The firm filed five plans to the state for approval and hopes to start selling them as soon as next month.

The Blue Cross decision ups the ante for Alex Azar, the Trump administration’s new Health and Human Services secretary. Will he use his authority under federal law to compel Idaho to follow the ACA and reject the Blues plans? Or will he allow state regulators to move forward, perhaps prompting other states to take more sweeping actions?

At a congressional hearing Wednesday, even as Blue Cross rolled out its plans, Azar faced such questions.

“There are rules. There is a rule of law that we need to enforce,” Azar said. Observers noted, however, he did not specifically indicate whether the federal government would step in.

Robert Laszewski, a consultant and former insurance industry executive, thinks it should.

“If Idaho is able to do this, it will mean other … states will do the same thing,” he said. “If a state can ignore federal law on this, it can ignore federal law on everything.”

Idaho’s move stirs up more issues about individual insurance market stability.

Policy experts say that allowing lower-cost plans that don’t meet the ACA’s standards to become more widespread will pull younger and healthier people out of Obamacare, raising prices for those who remain. Supporters say that is already happening, so this simply provides more choices for people who earn too much to qualify for subsidies to help them purchase ACA coverage.

The state’s move to allow such plans, announced in January, drew harsh and swift criticism.

“Crazypants illegal,” tweeted Nicholas Bagley, a law professor at the University of Michigan and former attorney with the civil division of the U.S. Department of Justice, who said that states can’t pick and choose which parts of federal law to follow. Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms, pointed out that health insurers could be liable for sharp fines if they are found to be in violation of the ACA.

But both Idaho regulators and Blue Cross officials say they are not worried.

Jeppesen said the ACA gives states regulatory authority “to make sure the market works and is stable,” and the insurer is simply “following what the state has given us guidance” to do.

Other insurers in Idaho are taking a much more cautious approach, telling The Wall Street Journal they are not stepping up immediately to offer their own plans.

Laszewski said they are likely waiting to see what legal challenges develop.

“If I were running an insurance company, there’s no way I would stick my neck out until the high court has ruled in favor of this — and they’re not going to,” he said.

Jeppesen said his company has consulted with legal experts and is moving ahead with confidence. The aim is to bring people back into the market, particularly the young, the healthy and those who don’t get a tax credit subsidy and can’t afford an ACA plan.

For some people — especially younger or healthier applicants — the new plans, which the insurer has named Freedom Blue, cost less per month than policies that meet all ACA rules.

They accomplish that by limiting coverage. If they are allowed to be sold, consumers will need to weigh the lower premiums against some of the coverage restrictions and variable premiums and deductibles, policy experts say.

The plans, for example, will include a “waiting period” of up to 12 months for any preexisting conditions if the applicant has been without coverage for more than 63 days, Jeppesen said.

Additionally, they cap total medical care coverage at $1 million annually. And premiums are based, in part, on a person’s health: The healthiest consumers get rates 50 percent below standard levels, while those deemed unhealthy would be charged 50 percent more.

All those caveats violate ACA rules, which forbid insurers from rejecting coverage of preexisting conditions or setting dollar caps on benefits or higher premiums for people with health problems.

But the rates may prove attractive to some.

Premiums for a healthy 45-year-old, for example, could be as low as $195 a month, according to a comparison issued by the insurer, while a 45-year-old with health problems could be charged $526. In that case, the 45-year old would find a lower price tag — $343 a month — for an ACA-compliant bronze plan.

While Freedom Blues plans cover many of the “essential health benefits” required under the ACA, such as hospitalization, emergency care and mental health treatment, they do not include pediatric dental or vision coverage. One of the five plans does not include maternity coverage.

When compared with one of the Blues’ ACA-compliant plans — called the Bronze 5500 — the new standard Freedom Blue plan’s annual deductibles are a mixed bag.

That’s because they have two separate deductibles — one for medical care and one for drugs. If a consumer took only generic drugs, the new plan would be less expensive, according to details provided by the plan. But with a $4,000 deductible for brand-name drugs, the Freedom Blue plan requires more upfront money before full coverage kicks in than the ACA-compliant plan it was compared with.

Jeppesen said the insurer hopes to attract many of the “110,000 uninsured state residents who cannot afford [ACA] coverage.”

That’s the total number of uninsured people who earn more than 100 percent of the federal poverty level in the state, he said.

Sarah Lueck, senior policy analyst for the Center on Budget and Policy Priorities, cautioned that some of those residents might actually be eligible for subsidies under the ACA, which are available to people earning up to four times as much.

“Many … could be getting subsidies for more comprehensive coverage through the [ACA-compliant state exchange] and would be better off,” Lueck said.

The Training Of Dr. Robot: Data Wave Hits Medical Care

KFF Health News, February 14, 2018

After years of experimentation, machine learning's predictive powers are well-established. Some say it's poised to move from labs to broad real-world applications.

This article first appeared February 14, 2018 on Kaiser Health News.

By John McQuaid

The technology used by Facebook, Google and Amazon to turn spoken language into text, recognize faces and target advertising could help doctors combat one of the deadliest killers in American hospitals.

Clostridium difficile, a deadly bacterium spread by physical contact with objects or infected people, thrives in hospitals, causing 453,000 cases a year and 29,000 deaths in the United States, according to a 2015 study in the New England Journal of Medicine. Traditional methods such as monitoring hygiene and warning signs often fail to stop the disease.

But what if it were possible to systematically target those most vulnerable to C-diff? Erica Shenoy, an infectious-disease specialist at Massachusetts General Hospital, and Jenna Wiens, a computer scientist and assistant professor of engineering at the University of Michigan, did just that when they created an algorithm to predict a patient’s risk of developing a C-diff infection, or CDI. Using patients’ vital signs and other health records, this method — still in an experimental phase — is something both researchers want to see integrated into hospital routines.

The CDI algorithm — based on a form of artificial intelligence called machine learning — is at the leading edge of a technological wave starting to hit the U.S. health care industry. After years of experimentation, machine learning’s predictive powers are well-established, and it is poised to move from labs to broad real-world applications, said Zeeshan Syed, who directs Stanford University’s Clinical Inference and Algorithms Program.

“The implications of machine learning are profound,” Syed said. “Yet it also promises to be an unpredictable, disruptive force — likely to alter the way medical decisions are made and put some people out of work.

Machine learning (ML) relies on artificial neural networks that roughly mimic the way animal brains learn.

As a fox maps new terrain, for instance, responding to smells, sights and noises, it continually adapts and refines its behavior to maximize the odds of finding its next meal. Neural networks map virtual terrains of ones and zeroes. A machine learning algorithm programmed to identify images of coffee cups might compare photos of random objects against a database of coffee cup pictures; by examining more images, it systematically learns the features to make a positive ID more quickly and accurately.

Shenoy and Wiens’ CDI algorithm analyzed a data set from 374,000 inpatient admissions to Massachusetts General Hospital and the University of Michigan Health System, seeking connections between cases of CDI and the circumstances behind them.

The records contained over 4,000 distinct variables. “We have data pertaining to everything from lab results to what bed they are in, to who is in the bed next to them and whether they are infected. We included all medications, labs and diagnoses. And we extracted this on a daily basis,” Wiens said. “You can imagine, as the patient moves around the hospital, risk evolves over time, and we wanted to capture that.”

As it repeatedly analyzes this data, the ML process extracts warning signs of disease that doctors may miss — constellations of symptoms, circumstances and details of medical history most likely to result in infection at any point in the hospital stay.

Such algorithms, now commonplace in internet commerce, finance and self-driving cars, are relatively untested in medicine and health care. In the U.S., the transition from written to electronic health records has been slow, and the format and quality of the data still vary by health system — and sometimes down to the medical practice level — creating obstacles for computer scientists.

But other trends are proving inexorable: Computing power has grown exponentially while getting cheaper. Once, creating a machine learning algorithm required networks of mainframe computers; now it can be done on a laptop.

Radiology and pathology will experience the changes first, experts say. Machine learning programs will most easily handle analyzing images. X-rays and MRI, PET and CT scans are, after all, masses of data. By crunching the data contained in thousands of existing scan images along with the diagnoses doctors have made from them, algorithms can distill the collective knowledge of the medical establishment in days or hours. This enables them to duplicate or surpass the accuracy of any single doctor.

Machine learning algorithms can now reliably diagnose skin cancers (from photographs) and lung cancer, and predict the risk of seizures.

Google research scientist Lily Peng, a physician, led a team that developed a machine learning algorithm to diagnose a patient’s risk of diabetic retinopathy from a retinal scan. DR, a common side effect of diabetes, can lead to blindness if left untreated. The worldwide rise in diabetes rates has turned DR into a global health problem, with the number of cases expected to rise from 126.6 million in 2011 to 191 million by 2030 — an increase of nearly 51 percent. Its presence is indicated by increasingly muddy-looking scan images.

Peng’s team gathered 128,000 retinal scans from hospitals in India and the U.S. and assembled a team of 54 ophthalmologists to grade them on a 5-point scale for signs of the disease. Multiple doctors reviewed each image to average out individual differences of interpretation.

Once “trained” on an initial data set with the diagnoses, the algorithm was tested on another set of data — and there it slightly exceeded the collective performance of the ophthalmologists.

Now Peng is working on applying this tool in India, where a chronic shortage of ophthalmologists means DR often goes undiagnosed and untreated until it’s too late to save a patient’s vision. (This is also a problem in the U.S., where 38 percent of adult diabetes patients do not get the recommended annual eye check for the disease, according to the Centers for Disease Control.)

A group of Indian hospitals is now testing the algorithm. Ordinarily, a scan is done, and a patient may wait days for results after a specialist — if available — reads the image. The algorithm, via software running on hospital computers, makes the results available immediately and a patient can be referred to treatment.

Last year, the Food and Drug Administration approved the first medical machine learning algorithm for commercial use by the San Francisco company Arterys. Its algorithm, “DeepVentricle,” performs in 30 seconds a task doctors typically do by hand — drawing the contours of ventricles from multiple MRI scans of the heart muscle in motion, in order to calculate the volume of blood passing through. That takes an average of 45 minutes. “It’s automating something that is important — and tedious,” said Carla Leibowitz, Arterys’ head of strategy and marketing.

If adopted on a broad scale, such technologies could save lots of time and money. But such change is disruptive.

“The fact that we have identified potential ways to gut out costs is good news. The problem is the people who get gutted are not going to like it — so there will be resistance,” said Eric Topol, director of the Scripps Translational Science Institute. “It undercuts how radiologists do their work. Their primary work is reading scans — what happens when they don’t have to do that?”

The shift may not put a lot of doctors out of work, said Topol, who co-authored a piece in JAMA exploring the issue. Rather, it will likely push them to find new ways to apply their expertise. They may focus on more challenging diagnoses where algorithms continue to fall short, for instance, or interact more with patients.

Beyond this frontier, algorithms can provide a more precise prognosis for the course of a disease — potentially reshaping treatment of progressive ailments or addressing the uncertainties in end-of-life care. They can anticipate fast-moving infections like CDI and chronic ailments such as heart failure.

As the U.S. population ages, heart failure will be a rising burden on the health system and on families.

“It’s the most expensive single disease as a category because of the extreme disability it causes and the high demand for care it imposes, if not managed really tightly,” said Walter “Buzz“ Stewart, vice president and chief research officer at Sutter Health, a health system in Northern California. “If we could predict who was going to get it, perhaps we could begin to intervene much earlier, maybe a year or two years earlier than when it usually happens — when we admit a patient to the hospital after a cardiac event or crash.”

Stewart has collaborated on several studies aiming to address that problem. One, done with Georgia Tech computer scientist Jimeng Sun, predicts whether a patient will develop heart failure within six months, based on 12 to 18 months of outpatient medical records.

These tools, Stewart said, are leading to the “mass customization of health care.” Once algorithms can anticipate incipient stages of conditions like heart failure, doctors will be better able to offer treatments tailored to the patient’s circumstances.

Despite its scientific promise, machine learning in medicine remains terra incognita in many ways. It adds a new voice — the voice of the machine — to key medical decisions, for instance. Doctors and patients may be slow to accept that. Adding to potential doubts, machine learning is often a black box: Data go in, and answers come out, but it’s often unclear why certain patterns in a patient’s data point, say, to an emerging disease. Even the scientists who program neural networks often don’t understand how they reach their conclusions.

“It’s going to make a big difference in how decisions are made — things will become much more data-driven than they used to be,” said John Guttag, a professor of computer science at MIT. Doctors will rely on these increasingly complex tools to make decisions, he said, and “have no idea how they work.” And, in some cases, it will be hard to figure out why bad advice was given.

And while health data are proliferating, the quantity, quality and format vary by institution, and that affects what the algorithms “learn.”

“That is a huge issue with modeling and electronic health records,” Sun said. “Because the data are not curated for research purposes. They are collected as a byproduct of care in day-to-day operations, and utilized mainly for billing and reimbursement purposes. The data is very, very noisy.”

This also means that data may be inconsistent, even in an individual patient’s records. More important, one size does not fit all: An algorithm developed with data from one hospital or health system may not work well for another. “So you need models for different institutions, and the models become quite fragile, you might put it,” Sun said. He is working on a National Institutes of Health grant studying how to develop algorithms that will work across institutions.

And the tide of available medical data continues to rise, tantalizing scientists. “Think about all the data we are collecting right now,” Wiens said. “Electronic health records. Hospitalizations. At outpatient centers. At home. We are starting to collect lots of data on personal monitors. These data are valuable in ways we can’t yet know.”

Doctors Learn How To Talk To Patients About Dying

KFF Health News, February 12, 2018

Doctors can be so focused on trying to fix each ailment that 'no one is addressing the big picture.'

This article first appeared February 08, 2018 on Kaiser Health News.

By Melissa Bailey

Lynn Black's mother-in-law, who had lupus and lung cancer, was rushed into a hospital intensive care unit last summer with shortness of breath. As she lay in bed, intubated and unresponsive, a parade of doctors told the family "all good news."

A cardiologist reported the patient's heart was fine. An oncologist announced that the substance infiltrating her lungs was not cancer. An infectious-disease doctor assured the family, "We’ve got her on the right antibiotic."

With each doctor's report, Black recalled, most of her family "felt this tremendous sense of relief."

But Black, a doctor herself, knew the physicians were avoiding the truth: "She's 100 percent dying."

"It became my role," Black said, to tell her family the difficult news that her mother-in-law, who was in her mid-80s, was not going to make it out of the hospital alive. Indeed, she died there within about a week.

The experience highlights a common problem in medicine, Black said: Doctors can be so focused on trying to fix each ailment that "no one is addressing the big picture."

Now Black, along with hundreds of clinicians at Massachusetts General Hospital in Boston, is getting trained to talk to seriously ill patients about their goals, values — and prognoses — while there's time to spare.

The doctors are using a script based on the Serious Illness Conversation Guide, first created by Drs. Atul Gawande and Susan Block at Ariadne Labs. Since its inception in Boston in 2012, the guide has been used to train over 6,500 clinicians worldwide, said Dr. Rachelle Bernacki, associate director of the Serious Illness Care Program at Ariadne Labs.

At Mass General, Dr. Juliet Jacobsen, a palliative care physician, serves as medical director for the Continuum Project, a large-scale effort to quickly train clinicians to have these conversations, document them and share what they learn with one another. The project ramped up in January with the first session in a series that aims to reach 250 primary care providers at the hospital.

For patients with advanced cancer, end-of-life conversations with clinicians take place a median of 33 days before a patient’s death, research shows. When patients have end-stage diagnoses, fewer than a third of families recall having end-of-life conversations with physicians, another study found.

That's despite evidence that patients have better quality of life, fewer hospitalizations, more and earlier hospice care and higher satisfaction when they talk to doctors or other clinicians about their values and goals, according to recent research.

At a recent training session, Jacobsen gave clinicians a laminated page with scripted language to help them along. When the participants role-played with professional actors, difficulties quickly emerged.

Dr. Thalia Krakower, a primary care physician, faced an emotional "patient" whose condition was on the decline.

"I can't imagine it being any worse," said the patient, hanging her head in tears.

"How long should we let them be silent and sad?" Krakower asked Jacobsen. "We always step in too soon."

Physicians let patients speak an average 18 seconds before interrupting them, research has found. Jacobsen encouraged doctors to allow more silence, and to respond to patients’ emotions, not just to their words.

The scripted conversation is quite different from what doctors have been trained to do, Jacobsen acknowledged. It doesn't aim to reach any decision, nor to fill out end-of-life paperwork.

"For the average doctor, this might feel like you're not getting anything done," she said. The goal is to step back from day-to-day problem-solving and talk about the patients’ understanding of their illness, their hopes and worries, and the trajectory of their disease.

In a pilot at Brigham and Women's Hospital in Boston, Jacobsen noted, the conversations typically lasted 22 to 26 minutes.

At another moment during role-play, Jacobsen stepped in when a doctor skipped over the section in the script where she was supposed to share prognostic information.

The topic is avoided for many reasons, Jacobsen later said: Clinicians' schedules are crammed. They may not want to scare families with a timeline that turns out to be wrong. And they may not know what language to use, especially when the disease trajectory is uncertain.

When a doctor’s message moves abruptly from "everything's great" to "she's dying," Jacobsen said, patients and their families don't have enough time to adjust to the bad news.

To address that problem, Jacobsen's team suggests language that helps clinicians discuss a prognosis without asserting certainty: "I worry the decline we have seen is going to continue," or, "I worry something serious may happen in the next few months."

After the training, Jacobsen's team plans to follow up with doctors to make sure they are having the conversations with patients, starting with those deemed likely to die within three years.

The guide is also being rolled out at Baylor Scott & White Health in Texas, Lowell General Hospital in Massachusetts, the University of Pennsylvania and hospitals in 34 foreign countries, Bernacki said.

And Ariadne Labs has teamed up with VitalTalk, a communications training company, and the Center to Advance Palliative Care to rapidly disseminate the Serious Illness Conversation Guide across the country. They aim to train 200 trainers by June 2019, Bernacki said. (This initiative and other activities at Ariadne Labs are funded by the Gordon and Betty Moore Foundation, which also supports some of KHN's reporting.)

Right now, she said, whether patients have these discussions depends too much on geography. “Our goal,” she said, “is for every patient with serious illness to have a meaningful conversation about what they care about, in every place.”

Upsurge Of Suburban Poor Discover Health Care's Nowhere Land

KFF Health News, February 9, 2018

Suburban areas have historically received a fraction of health funding that cities have, leaving them with inadequate infrastructure and forcing people to scramble for the medical attention they need.

This article first appeared February 09, 2018 on Kaiser Health News.

By Elaine Korry

The promise of cheaper housing brought Shari Castaneda to Palmdale, Calif., in northern Los Angeles County, about nine years ago.

The single mom with five kids had been struggling to pay the bills. “I kept hearing that the rent was a lot cheaper out here, so I moved,” she said.

But when she developed health problems — losing her balance and falling — Castaneda found fewer care options in her new town. Unable to find local specialty care, she traveled nearly 65 miles to a public hospital in Los Angeles, where doctors discovered a tumor on her spine.

Then she had to drive nearly 75 miles to the City of Hope cancer center in Duarte, Calif., for an operation to remove the growth. The procedure left her partially paralyzed. “I walked into the hospital and I never really walked again.”

Castaneda, 58, receives Social Security disability payments and is enrolled in Medi-Cal, the state’s Medicaid program for low-income people. “There are no doctors available here,” said Castaneda. “I called every single one of them in the book, and nobody takes Medi-Cal out here.” Instead, Castaneda now sees doctors nearly 50 miles away in Northridge.

Suburbs in the United States, often perceived as enclaves of the affluent, are home to nearly 17 million Americans who live in poverty — more than in cities or rural areas — and growing demand for care strains the capacity of suburban health services to provide for them, according to a recent study in Health Affairs. Suburban areas have historically received a fraction of health funding that cities have, leaving them with inadequate infrastructure and forcing people like Castaneda to scramble for the medical attention they need.

The Health Affairs study found that about a fifth of the suburban poor are uninsured, and many who do have health insurance — especially people on Medi-Cal — either can’t find providers or must travel far for appointments.

The Affordable Care Act cut California’s uninsured rate from 17 percent in 2013 to about 7 percent last year due largely to the Medicaid expansion, which added more than 3.7 million adults to the state’s Medi-Cal rolls. But that has not ensured access to health care for millions of suburbanites, said Alina Schnake-Mahl, a doctoral candidate at the Harvard T.H. Chan School of Public Health in Boston, who was lead author of the Health Affairs study.

“That really goes against the idea that everyone in the suburbs is insured because everyone has a white-collar job with coverage,” she said.

Coverage doesn’t equate to care even for patients with Medi-Cal, as Castaneda can attest. Before the health law, they had trouble finding doctors who would see them because of Medi-Cal’s low payment rates. That problem intensified as millions more signed up for Medi-Cal, driving many enrollees to seek services at safety-net care facilities.

Health care services in the suburbs “are not robust enough to fill the needs” of a growing low-income population, said Charlie Gillig, supervising attorney at the Health Consumer Center of Neighborhood Legal Services of Los Angeles County, which has advised Castaneda about medical transportation services under Medi-Cal.

One-half of California’s 39 million residents live in suburbs, and rates of poverty among them range from nearly 25 percent around Bakersfield, in the Central Valley, to about 8 percent in the suburbs outside San Francisco, according to an analysis by Elizabeth Kneebone, research director at University of California-Berkeley’s Terner Center for Housing Innovation and a senior fellow at the Brookings Institution. The same analysis showed that 2.7 million suburban Californians lived below the poverty line in 2016, compared with 1.9 million in major cities.

Castaneda, who uses an oversized power wheelchair, says it’s difficult — “often impossible” — to arrange for a ride in a van. Getting to the doctor has become a long, painful ordeal.

And that’s if she can even schedule a visit, said Castaneda, noting that she also faces long wait times for her doctor in Northridge, a suburb that has seen an influx of patients from poorer areas. “You can’t get an appointment when you’re sick … so I’ve just been waiting and waiting,” she said. “They told me, ‘If you get sick enough, just go to the emergency room.’”

Of course, it can also be tough to get a clinic appointment or see a specialist in cities, but in the suburbs, Gillig said, “geography exacerbates an already existing problem.”

In his recent book on the changing geography of poverty, Scott Allard, a professor of public policy and governance at the University of Washington, showed that funding for human services was as much as eight times higher in urban areas than in the suburbs.

California’s metropolitan areas have had many decades to build up massive health care systems to serve the poor, including county hospitals, federally qualified health centers and community clinics. But the current scale of suburban poverty is a recent development.

Policymakers struggle to serve the health needs of cities in eastern Contra Costa County, about 50 miles from San Francisco. In Oakley, for example, business and community leaders lobbied hard for a new health center, which opened in 2011.

“There’s a huge need out here, especially for people who are undocumented or uninsured. They don’t have anywhere else to go,” said Leticia Cazares, regional manager for La Clinica, which operates the new health center. The clinic has two doctors and a nurse practitioner to serve 3,000 patients, most of whom are on Medi-Cal.

Many of the people who visit community clinics like the one in Oakley lack insurance, either because they are undocumented immigrants or because they make too much money to qualify for Medi-Cal — or subsidized coverage under Obamacare — and can’t afford it on their own.

Alex G.’s family fits both scenarios. Her husband, Edward, and 8-year-old son — also named Alex — are U.S. citizens, but she is an undocumented immigrant. The family lives in Brentwood, a town of about 60,000 in eastern Contra Costa County.

A 32-year-old community college student who declined to give her last name for fear of deportation, Alex has applied for permanent residency — a long process with an uncertain outcome.

Her husband has “a good job” as a programmer of industrial machines. He has employer-based insurance, but it covers only him. For Alex and her son to be covered, the family would have to pay $1,200 a month. Given California’s high cost of living, “we just can’t afford to pay that,” Alex said. Her husband’s salary of $70,000 is too high for Medi-Cal or Obamacare subsidies.

Alex recently experienced sharp stomach pains and had to wait several days for a mobile clinic that parks in front of a nearby community center once a week.

Whenever her son has an ear infection or a fever, Alex takes him to the free mobile clinic. “Not having insurance, I worry all the time about him getting sick,” she said.

Despite Changes That Undermined ACA Enrollment, Marketplaces 'Remarkably Stable'

KFF Health News, February 8, 2018

About 11.8 million Americans enrolled in 2018 coverage, down 3.7% from last year's total, according to the National Academy for State Health Policy.

This article first appeared February 07, 2018 on Kaiser Health News.

By Julie Appleby

After much drama leading to this year’s open enrollment for Affordable Care Act coverage — a shorter time frame, a sharply reduced federal budget for marketing and assistance, and confusion resulting from months of repeal-and-replace debate — the final tally paints a mixed picture.

With all states now reporting, ACA plan enrollment ticked downward this year, a report out Wednesday shows, but states running their own marketplaces saw slight gains and did better than those relying on the federal exchange.

About 11.8 million Americans enrolled in 2018 coverage, down 3.7 percent from last year’s total, according to the National Academy for State Health Policy.

Open enrollment began shortly after the Trump administration sharply cut federal enrollment outreach efforts and ended a type of cost-sharing subsidy paid directly to insurers, which generally responded by raising premiums to make up for the loss.

“Despite all that, enrollment in the marketplaces across the nation was remarkably stable,” said Trish Riley, executive director of the academy, a nonprofit, non-partisan group.

Enrollment in marketplaces fully or partially run by states, for example, showed a small overall increase of 0.2 percent over the previous year, while the 34 states that rely entirely on the federal hub saw sign-ups drop by 5.3 percent, the report said.

Officials from states operating their own exchanges said their ability to make changes led to their gains.

“We could extend our open-enrollment period, control our marketing budget and nimbly mitigate the impact of the loss of cost-sharing subsidies [to insurers], which led to a very successful open enrollment,” said Zachary Sherman, director of Rhode Island’s state-run market.

Enrollment there is up 12 percent this year, he said, with sharp increases in the number of newly enrolled and policyholders aged 18 to 34.

California, which has the nation’s largest state market with about 1.5 million enrollees, saw a 2.3 percent drop in overall sign-ups. Covered California Director Peter Lee attributed some of that to efforts by the state to encourage off-market purchases by consumers who don’t qualify for subsidies.

Marketplace plans were more expensive than those sold outside healthcare.gov for unsubsidized consumers because California and other states asked insurers to load the premium increases stemming from Trump administration directives onto on-market plans. Those on-market price hikes were largely offset by jumps in tax credits for consumers receiving subsidies.

Despite their upbeat tone about this year’s enrollment, directors of several state marketplaces warned that 2019 looks grim.

“Just the removal of the [individual mandate penalty in Congress’ recently enacted tax overhaul] will mean premiums go up 15 percent to 30 percent or more depending on the state,” said Lee.

People who get subsidies will be largely shielded from those increases because the subsidies rise along with the premiums.

Still, the burden of higher premiums would fall on the 6 million or so people who buy their own insurance but don’t get a federal tax credit to help them purchase coverage, according to an earlier study done by Covered California. The median income of those consumers was $75,000.

The report also showed that enrollment dropped sharply in some states.

Arizona, Louisiana and West Virginia, for example, all saw enrollment falling by more than 15 percent, which may also not bode well for 2019.

Health plans are likely to raise rates there “because drops in enrollment already mean bad risk,” such as greater numbers of older or sicker members, California’s Lee warned.

Congress should act soon to mitigate those expected increases, according to the five state exchange directors who participated in a press call detailing the report’s findings, by providing funding for states to create reinsurance programs, which pay insurers for medical costs for the most expensive enrollees.

Several states, including Alaska and Minnesota, already have reinsurance programs.

Legislation to provide such funding is before Congress. While the proposals have bipartisan support – and the idea is endorsed by many health industry groups – the legislation faces opposition from some lawmakers who see it as a bailout for the insurance industry.

Allison O’Toole, the CEO of Minnesota’s state insurance marketplace, invited those who are skeptical to look at her state’s reinsurance program.

“We saw it work,” said O’Toole. “Our premium rates are flat after a number of years of steep increases. We need to talk about a long term, federally financed reinsurance program if these markets are to stabilize.”

Several states, including Rhode Island, are also looking at steps they can take independent of congressional action to prepare for next year.

One idea: the use of state penalties for people who go uninsured to replace the loss of the individual mandate’s federal tax fine. Without some kind of mandate to purchase coverage, Rhode Island estimates that premiums there could rise 50 percent over three years.

“The idea that premiums would go up at that rate is something that scares us quite a bit,” said Sherman.

Nurse Calls Cops After New Mom Seeks Help For Depression. Right Call?

KFF Health News, February 7, 2018

When patients reference violent thoughts, it forces doctors to think about things in a different way. The laws and medical protocols don't always line up.

This article first appeared February 07, 2018 on Kaiser Health News.

By April Dembosky, KQED

Four months after having her second baby, Jessica Porten started feeling really irritable. Little things would annoy her, like her glider chair.

"It had started to squeak," she said. "And so when I'm sitting there rocking the baby and it's squeaking, I would just get so angry at that stupid chair."

She read online that this could be a symptom of postpartum depression — a condition that affects up to 1 in 7 women during or after pregnancy, according to the American Psychological Association. In California, where Porten lives, those rates are even higher, spurring state lawmakers to introduce a package of bills to improve mental health screening and treatment for new moms.

Porten said she hopes the legislation will help women avoid what she went through.

She went to Capital OB/GYN, a women's clinic in Sacramento, Calif., that accepts her Medicaid coverage as payment, to talk about medication options and therapy. Porten admitted to the nurse that she was having some violent thoughts.

"I described maybe hitting myself or squeezing the baby too tight," she said. "But I was very adamant through the entire appointment that I was not going to hurt myself and I was not going to hurt my children."

Porten said the nurse's manner toward her changed at that point. "I could see in that moment that she stopped listening to me," Porten said.

The nurse called the police. The police escorted Porten and her baby to a nearby emergency room. Hospital staff made her change into a gown and took her purse, but they let her keep her diaper bag for the baby. They put them both in a room, under constant watch, though the hospital staff was sympathetic, Porten said.

"It's like, everybody knows I'm not crazy," she said. "Everybody knows that this is normal — but they're following protocol."

Finally, at midnight, 10 hours after she first got to the doctor's office, a social worker sent her home. Porten wrote on Facebook that the whole thing made her feel like a criminal.

"It was all legality," Porten said. "Everybody was protecting their own liability instead of thinking of me."

Administrators at Capital OB/GYN declined to comment. Gary Zavoral, a spokesman for Sutter Health, which runs the emergency room where Porten was taken, said once a patient arrives in the ER for assessment, hospital staff must follow strict protocols.

"The process is to make sure everybody is safe: the individual's safe, the family's safe, the staff is safe," he said. "The process does take some hours, so 10 hours is not unusual."

When patients reference violent thoughts, it forces doctors to think about things in a different way, said Dr. Melanie Thomas, a psychiatrist at the University of California-San Francisco and Zuckerberg San Francisco General Hospital.

California law allows doctors to involuntarily confine a person with a mental disorder if they are a danger to themselves or others. But Thomas said what constitutes imminent danger can be vague.

"You can imagine a provider, a social worker, any number of people might interpret that phrase in different ways, about what is necessary to report and what isn't," she said.

The laws and medical protocols don't always line up, Thomas said. There have been times she felt asked to rely on legal reasoning over her clinical judgment.

"The fragmented aspects of our system of care make it difficult to get women the help that they really want," Thomas said.

That's one reason lawmakers in Sacramento are introducing a package of bills to specifically address maternal mental health. Assemblyman Brian Maienschein (R-San Diego) backs two of them. One would require doctors to screen new moms for depression — under current law in California, it's voluntary.

"The numbers here are so significant that I think it's something that doctors really should understand and should be prepared to both diagnose and treat," he said. Screening, he added, also "educates a woman in that situation that this is an issue that may impact her."

Maienschein's other bill would direct the state to tap into a new federal pot of money set aside for postpartum programs and awareness campaigns. It was established under the 21st Century Cures Act, which was passed in the final months of the Obama administration.

"Getting federal money is a great thing," Maienschein said. "It's federal money that's available that I'd like to see California have, versus another state."

The legislation has given Jessica Porten a new purpose. People have told her she should sue Capital OB/GYN for calling the police. But she rejected that idea.

"I walk into that waiting room and I see tons of Medi-Cal recipients — so they're all low-income," she said. "If I sue, it's only going to cause monetary damages to a facility that is clearly short on resources."

Instead, Porten said she'll advocate to get the new bills passed in California. She thinks that's the way to help the clinic's physicians and nurses do a better job of helping new moms get the care they need.

"I'm not going to take that away," she said. "I'm going to build it up."

Cut In Federal Subsidies Threatens Basic Health Programs In N.Y., Minn.

KFF Health News, February 6, 2018

The funding dispute is tied to a decision by President Donald Trump to stop paying cost-sharing reduction subsidies. Money that would have paid for subsidies also helps fund the Basic Health Program.

This article first appeared February 06, 2018 on Kaiser Health News.

By Michelle Andrews

Comprehensive coverage for more than 800,000 low-income people in New York and Minnesota who pay a fraction of the typical cost of a marketplace plan may be in jeopardy after the federal government partially cut funding this year.

The Basic Health Program, in which these consumers are enrolled, was created under the Affordable Care Act to provide another coverage option for people with incomes up to 200 percent of the federal poverty level ($24,280 in 2018) who would otherwise qualify for subsidized marketplace coverage. Only New York and Minnesota have set up such programs.

The funding dispute is tied to a high-profile decision by President Donald Trump to stop paying cost-sharing reduction subsidies, which reduce the deductibles and out-of-pocket costs for people in marketplace plans whose incomes are up to 250 percent of the federal poverty level (about $30,000 for one person). Money that would have paid for cost-sharing reduction subsidies also helps fund the Basic Health Program in New York and Minnesota.

These plans must be as comprehensive and affordable as marketplace plans, but for many they’re significantly cheaper, with monthly premiums of either zero or $20 in New York and up to $80 in Minnesota, along with a very small or no deductible, combined with nominal copayments.

In November, when May Brown lost her job as a produce repacker — breaking 40-pound boxes of fruits and vegetables down into 10-pound boxes for grocery stores — she lost her employer health coverage, too. On the advice of a friend, the 62-year-old signed up for MinnesotaCare this month. Her $50 monthly premium is about half what she was paying for coverage on the job.

Brown, who lives in St. Paul, said she is pretty healthy but having this coverage gives her peace of mind.

“You never know. Life is unpredictable,” she said. “I like to have something.”

Under the Basic Health Program, the federal government is responsible for paying states 95 percent of the amount it would have paid in premium subsidies and cost-sharing reduction payments on the marketplace for these enrollees. In December, the Department of Health and Human Services notified the two states it would withhold the cost-sharing reduction portion of the payments — nearly $300 million in the first quarter of 2018, about a quarter of the total amount expected. Over the course of a year, the amount withheld will exceed $1 billion.

When it cut back on funding of the Basic Health Program, the administration cited its October decision to eliminate cost-sharing reduction payments to insurers.

Last month, the attorneys general of the two states filed suit in U.S. District Court for the Southern District of New York to restore the federal funding.

Noting that New York’s Essential Plan, as it’s called, covers more than 700,000 low-income New Yorkers, Attorney General Eric Schneiderman said in a press release, “I won’t stand by as the federal government continues to renege on its most basic obligations in a transparent attempt to dismantle the Affordable Care Act.”

In their lawsuit, Schneiderman and Minnesota Attorney General Lori Swanson argue that, among other things, the adminstration’s decision to cut off CSR payments is procedurally flawed and violates its obligations under the health law. They want the court to restore the states’ Basic Health Program funding.

Regardless of the lawsuit’s outcome, officials in both states have offered assurances that the program is safe — for now.

In New York, Gov. Andrew Cuomo’s budget included sufficient funds to leave the Basic Health Program intact for this year.

Officials at the Minnesota Department of Human Services said in a statement, “People enrolled in MinnesotaCare should feel confident in their coverage based on current information.”

Under the health law, any state can offer coverage under the Basic Health Program. One possible reason New York and Minnesota adopted the program is because they were already covering many in the target population through Medicaid, and typically sharing the cost equally with the federal government. Under the Basic Health Program, the state’s funding responsibility drops to just 5 percent.

So what happens next year? If federal funding isn’t restored, advocates are concerned that costs may rise and coverage shrink.

“It could trigger major changes to the eligibility structure, the benefits or increases in premiums,” said Maureen O’Connell, president of Health Access MN, which helps people enroll in marketplace coverage.

Elisabeth Benjamin said she’s “really worried” about the program next year if the courts don’t order the federal government to start making payments. Benjamin, the vice president for health initiatives at the Community Service Society of New York, an advocacy group, said there’s a snowball effect as states grapple with the delayed approval of Children’s Health Insurance Program funding for low-income kids amid continued uncertainty over federal funding for community health centers.

“It’s terrifying how much the feds can do, particularly for states like New York that are so reliant on federal funding,” Benjamin said.

Indiana Gets Federal Approval For Medicaid Plan That Could Slice Enrollment

KFF Health News, February 5, 2018

Indiana's Medicaid expansion is being closely watched in part because it was spearheaded by then-Gov. Mike Pence, who is now vice president, and his top health consultant, Seema Verma, who now heads the federal Centers for Medicare & Medicaid Services.

This article first appeared February 02, 2018 on Kaiser Health News.

By Phil Galewitz

Indiana on Friday became the second state to win federal approval to add a work requirement for adult Medicaid recipients who gained coverage under the Affordable Care Act, but a less debated “lockout” provision in its new plan could lead to tens of thousands of enrollees losing coverage.

The federal approval was announced by Health and Human Services Secretary Alex Azar in Indianapolis.

Medicaid participants who fail to submit in a timely manner their paperwork showing they still qualify for the program will be blocked from enrollment for three months, according to the updated rules.

Since November 2015, more than 91,000 enrollees in Indiana were kicked off Medicaid for failing to complete the eligibility redetermination process, according to state records. The process requires applicants to show proof of income and family size, among other things, to see if they still qualify for the coverage. Until now, these enrollees could simply re-apply anytime. Although many of those people likely were no longer eligible, state officials estimate about half of those who failed to comply with its re-enrollment rules were still qualified.

Indiana’s Medicaid expansion began in February 2015, providing coverage to 240,000 people who were previously uninsured, helping drop the state’s uninsured rate from 14 percent in 2013 to 8 percent last year. The HHS approval extends the program, which was expiring this month, through 2020.

The new lockout builds on one already in place in the state for people who failed to pay monthly premiums and had annual incomes above the federal poverty level, or about $12,200 for an individual. They are barred for six months from coverage. During the first two years of the experiment, about 10,000 Indiana Medicaid enrollees were subject to the lockout for failing to pay the premium for two months in a row, according to state data.

In addition, more than 25,000 enrollees were dropped from the program after they failed to make the payments, although half of them found another source of coverage — usually through their jobs.

Another 46,000 were blocked from coverage because they failed to make the initial payment.

“The ‘lockout” is one of the worst policies to hit Medicaid in a long time,” said Joan Alker, executive director of the Georgetown University Center for Children and Families. “Forcing people to remain uninsured for months because they missed a paperwork deadline or missed a premium payment is too high a price to pay. From a health policy perspective it makes no sense because during that period, chronic health conditions such as hypertension or diabetes are just likely to worsen.”

Indiana’s Medicaid expansion is being closely watched in part because it was spearheaded by then-Gov. Mike Pence, who is now vice president, and his top health consultant, Seema Verma, who now heads the federal Centers for Medicare & Medicaid Services.

The expansion, known as Healthy Indiana, enabled non-disabled adults access to Medicaid. It has elicited criticism from patient advocates for complex and onerous rules that require these poor adults to make payments ranging from $1 to $27 per month into health savings accounts or risk losing their vision and dental benefits or even all their coverage, depending on their income level.

Indiana Medicaid officials said they added the newest lockout provision in an effort to prompt enrollees to get their paperwork submitted in time. The state initially requested a six-month lockout.

“Enforcement may encourage better compliance,” the state officials wrote in their waiver application to CMS in July.

The new rule will lead to a 1 percent cut in Medicaid enrollment in the first year, state officials said. It will also lead to a $15 million reduction in Medicaid costs in 2018 and about $32 million in savings in 2019, the state estimated.

The number of Medicaid enrollees losing coverage for failing to comply with redetermining their eligibility has varied dramatically each quarter from a peak of 19,197 from February 2016 to April 2017 to 1,165 from November 2015 to January 2016, state reports show. In the latest state report, 12,470 enrollees lost coverage from August to October 2017.

The Kentucky Medicaid waiver approved by the Trump administration in January included a similar lockout provision for both failing to pay the monthly premiums or providing paperwork on time. Penalties there are six months for both measures. But the provision was overshadowed because of the attention to the first federal approval for a Medicaid work requirement.

Like Kentucky, Indiana’s Medicaid waiver’s work requirements, which mandate adult enrollees to work an average of 20 hours a month, go into effect in 2019. But Indiana’s waiver is more lenient. It exempts people age 60 and over and its work-hour requirements are gradually phased in over 18 months. For example, enrollees need to work only five hours per week until their 10th month on the program.

Most Medicaid adult enrollees do work or go to school or are too sick to work, studies show.

Indiana also has a long list of exemptions and alternatives to employment. This includes attending school or job training, volunteering or caring for a dependent child or disabled parent. Nurses, doctors and physician assistants can give enrollees an exemption due to illness or injury.

Three patient advocacy groups have filed suit in federal court seeking to block the work requirements.

Robin Rudowitz, associate director for the Kaiser Family Foundation’s Program on Medicaid and the Uninsured, said it’s difficult to gauge whether work requirements or renewal lockouts will have more of an impact on coverage. She noted both provisions apply to most demonstration beneficiaries. (KHN is an editorially independent program of the foundation).

“Any documentation requirement could lead to increased complexity in terms of states administering the requirements and individuals complying,” she said, adding that it could result “in potentially eligible people falling off of coverage.”

As States Target High Drug Prices, Pharma Targets State Lawmakers

KFF Health News, February 1, 2018

With federal officials seemingly unwilling or unable to come up with legislation to control skyrocketing drug prices, that task is increasingly moving to the states. But so is pharma muscle and money opposing the measures.

This article first appeared February 01, 2018 on Kaiser Health News.

By Jay Hancock and Shefali Luthra

It was expected to be a perfunctory statehouse meeting — three lobbyists and a legislator discussing a proposal to educate Louisiana doctors about the price of drugs they prescribe.

The bill seemed like a no-brainer in a country where even decades-old medicines can cost thousands and consumers are urged to make smart choices in buying health care. The legislation simply required pharmaceutical sales reps promoting medicines at doctors’ offices to also reveal a price.

No one expected the industry scrum that materialized.

About 10 pharma lobbyists flooded the room in Baton Rouge’s art deco state Capitol, some of them hired guns — lobbyists who’d never represented drug companies before, remembers Jeff Drozda, an insurance lobbyist at the 2016 meeting.

“The message was: We’re going to bring everything at you against these bills,” he said.

They did. Pharmaceutical Research and Manufacturers of America, the powerful trade group known as PhRMA, donated directly to more lawmakers in Louisiana than in any other state in 2016, a new IRS filing shows. When discussion of the measure reached its peak last year, the industry hired a lobbyist for every two legislators.

PhRMA spent thousands entertaining lawmakers at Baton Rouge venues such as Mike Anderson’s Seafood, specializing in shrimp-and-crab gumbo, and the Mestizo Restaurant, home of the Daredevil Margarita, lobbying records show.

“I’ve been in the legislature 10 years. I’ve never in my life seen that kind of effort,” said Kirk Talbot, a Republican who sponsored the bill in the Louisiana House.

With federal officials seemingly unwilling or unable to come up with legislation to control skyrocketing drug prices, that task is increasingly moving to the states. But so is pharma muscle and money opposing the measures, regulatory disclosures and corporate filings from the last two years show.

State lawmakers are likely to consider drug-price transparency bills this year in Connecticut, Michigan, Oregon, Washington and New Jersey, to name just a few. Many of the measures are similar to a new California law that requires drugmakers to justify big price increases. (To fight that law, the industry hired 45 lobbying firms.)

Meanwhile, activists who backed a 2017 law enabling Maryland officials to challenge “unconscionable” price increases for generic drugs now advocate price regulation for all expensive pharmaceuticals. Policymakers in New Mexico, Massachusetts and Arizona are talking about limiting drug coverage or negotiating drug prices under Medicaid.

In Washington, D.C., PhRMA, is widely credited with stalling federal drug-price measures for years, with lobbying, advertising and political contributions.

Now states are getting a dose of the same medicine.

PhRMA set the stage in 2016 by establishing a group that ultimately spent $110 million to defeat a high-profile California ballot initiative requiring state agencies to pay no more for drugs than does the federal Department of Veterans Affairs. A PhRMA-linked group spent more than $50 million to defeat a similar ballot measure last year in Ohio.

Traditionally well represented in statehouses, PhRMA wrote checks to hundreds of legislative candidates and political action committees in dozens of states in 2016, newly available IRS filings show. So did many of its member companies, according to new data published by the Center for Political Accountability, a nonprofit that works to shed light on corporate political spending.

Merck, maker of a hepatitis C drug called Zepatier that costs $54,600 according to Truven Health Analytics, gave $19 million to PhRMA in 2016 but also gave about $500,000 to candidates and political committees in some two dozen states, sometimes in checks as small as $100, according to the CPA data, compiled from voluntary disclosures on corporate websites.

Amgen, maker of leukemia drug Blincyto, which costs $173,000 for an average treatment, according to the company, donated to more than 100 statehouse candidates in about a dozen states for the 2016 elections. Johnson & Johnson, Pfizer, Bristol-Myers Squibb and Allergan also directly or indirectly supported state candidates in 2016, CPA data show.

Pharma companies “definitely have not seen that kind of activity aimed at them at the state level before and have raised their presence to address that,” said Leanne Gassaway, top state lobbyist for America’s Health Insurance Plans, a major insurance trade group.

Few states got as much pharma attention the past two years as Louisiana, though the money spent there fell short of the tens of millions invested in swaying referenda in California and Ohio. It’s cheaper to influence scores of lawmakers than millions of voters.

I’ve been in the legislature 10 years. I’ve never in my life seen that kind of effort.

Kirk Talbot, Republican member of the Louisiana House of Representatives

Drug prices are “something that’s completely out of control,” Talbot said, adding that he gets constituent requests to rein in prescription medicine prices.

Neither Talbot, chairman of the House insurance committee, nor many others in the conservative state are moving to regulate drug prices. But he and other lawmakers saw promise in an idea from Blue Cross and Blue Shield of Louisiana, a big insurer whose premiums have been driven up partly by rising drug expenses.

The proposal, which got little news coverage even in Louisiana, would have required sales reps promoting their latest, greatest medicines to give doctors the wholesale prices at the same time. Physicians, who are largely unaware of prescription costs, might think twice about ordering $500 worth of brand-name pills when a $30 generic could deliver the same benefit, the thinking went.

The measure died in committee after the pharma lobby staged its flash mob at the 2016 meeting. When the idea came up again last spring, this time with backing from Talbot and Sen. Fred Mills, Republican chairman of the Senate health committee, the industry shifted into high gear.

Mills got “a tremendous amount of calls” on his cellphone from pharma lobbyists as well as emails and texts almost immediately after his bill landed on a legislative website, he recalled. First in line was Pete Martinez, PhRMA’s top Louisiana operative.

“I’ve had this volume” of special-interest pressure “but not the speed,” said Mills, a small-pharmacy owner from St. Martin Parish who said he sees the rising price of pills firsthand. Mills recalled phone calls from “top government affairs people” at Pfizer, “telling me the problems with this bill.”

No fewer than 84 lobbyists representing pill companies blanketed Baton Rouge at the height of the legislative session last year, state records show — the most in at least nine years.

In 2016, PhRMA gave directly to about 80 Louisiana state politicians, more than those in any other state, the IRS filing shows. PhRMA and individual drug companies have made more than $600,000 in contributions to Louisiana state and local political races in the past three years, according to campaign finance files.

Martinez did not respond to requests for an interview. At hearings in Louisiana, PhRMA argued that informing doctors of wholesale drug prices is irrelevant to patients. What matters is consumers’ out-of-pocket payment, not the rest of the cost that’s often picked up by insurance, they said.

“We are committed to engaging with lawmakers, patients and others to find solutions that actually help patients,” a PhRMA spokesman said in a statement for this article.

Proponents countered that rising total drug costs are an increasingly painful burden on taxpayers, employers, workers and everybody else who pays them indirectly through insurance plans and government programs.

PhRMA’s opposition had an effect.

Instead of making salespeople disclose prices, the legislation that lawmakers eventually passed and that Gov. John Bel Edwards signed in June requires the Louisiana Board of Pharmacy to host a website listing the information. Rather than ordering drug reps to tell doctors about the site, the act says they “may” give prescribers the internet address if they choose.

The law “is quite watered-down and basically meaningless,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School who follows pharma laws.

Talbot says he may have lost this battle but will continue the war.

“I’m going to take another stab at it” this year, he said. “We’re on the front wave of this thing. All the states are jumping on this bandwagon.”

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