But soon after Hudak, 28 at the time, got the Essure implants in 2000, she said she developed health problems, including severe pelvic and lower back pain, difficult menstrual periods and pain during intercourse.

She complained to researchers at the Cleveland Clinic and was told her problems were not related to the implant. In an affidavit to the Food and Drug Administration, Hudak alleges that answers she gave researchers in response to questions about pain, adverse health effects and even whether her period was late had been altered on her medical record, without her knowledge. Those statements were part of the usual data collection for FDA approval of the device.

Users have filed with the FDA citing chronic pelvic pain, debilitating periods, pregnancies that occurred with Essure including five that ended in fetal death, hysterectomies to remove devices that moved to other organs or broke apart, and four patient deaths, including one by suicide.

Officials with Bayer HealthCare Pharmaceuticals, which purchased Essure in 2013 for $1.1 billion from the company that developed it, Conceptus Inc., said they have full confidence in the device and are not concerned about alterations in medical records.

“It seems like the proper clinical practice procedures were followed,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs and women’s affairsÌýwho has not seen all the clinical trial records. “If a mistake was identified, it was crossed out, initialed and dated. … There was full transparency.”

Officials at the Cleveland Clinic echoed that statement. The investigator, Dr. Linda Bradley, refused requests for an interview, but a clinic spokeswoman said that “it is common practice” to update documentation over the course of a clinical trial “to reflect all possibilities related to medical events.”

The FDA noted in its briefing materials for Thursday’s hearing it was aware of the allegations from women that records had been altered but said its monitoring of the study showed no evidence of that.

But a in the New England Journal of Medicine on Wednesday offered harsh criticism of the clinical trials on the implant. “Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the pre-marketing approval evaluation indicated,” Drs. Sanket S. Dhruva, Joseph S. Ross and Aileen M. Gariepy wrote.

The physicians criticized the lack of a comparison group and the rush to approve the permanent implant after only a year of followup for most clinical trial participants. They also noted concerns “about incomplete followup and biased results” in longer-term studies, and they suggested the fact that nearly one-third of the trial participants did not complete the trial meant that “adverse events including unintended pregnancies were probably missed.”

Changes In The Charts

The Essure implants consist of small coils, made of a nickel alloy and a polyester-like fiber that are placed in the Fallopian tubes, where they trigger inflammation that causes scar tissue to form, blocking the tubes and preventing conception.

Bayer refuses to say how many devices have been used in the United States,Ìýbut says over one million units have been sold worldwide and 750,000 women use them.

Hudak, the mother of one son, joined an early Essure trial. She said that researchers did not think the symptoms she developed were related to the device. She said she was surprised, however, to find in her records that the answers she gave in response to questions about pain, adverse health effects and even whether her period was late had been altered, with no changed to yes and vice versa. Some answers had been crossed out completely. All of the changes were initialed and dated, according to the copies she provided to a reporter.

In those records, Bradley wrote on her chart on Jan. 28, 2002, that the cause of the back pain, which was worse before her menstrual period, was unknown but “does not appear to be gynecologic.”

Later that year, on Nov. 14, Hudak called to report she had been bleeding after intercourse for the past two months, and the clinic note says Bradley referred Hudak to “her regular gyn.”

Hudak said that over the years, she started to suffer from migraines, rashes, joint pain and fatigue. But she said that after she got the implants removed, “that pain I had in my back all those years, every single day, went away.”

Kimberly Lira Huddleston says she found her records also did not reflect her answers to researchers at Women’s Health Research in Phoenix. After getting the implants in 2000, she says she was in constant pain. She complained to the clinical investigators for three years, she said, finally showing up at the research center and demanding they remove the implants. The researchers ordered her to leave the premises, she recalled.

“They had no concern for me,” said Huddleston, now 39, who still has chronic pelvic pain. “Once I wanted the implants out, I was of no use to them.”

When Huddleston, who has not filed a lawsuit or statements with the FDA, obtained her records from the study recently, she said she found a document signed by the principal investigator stating that she had no problems with Essure but had withdrawn from the trial and couldn’t be found, despite numerous attempts to reach her.

The clinical trial record she provided to a reporter shows the word “severe” crossed out from her report of “severe menstrual cramping.” The word “ongoing” was crossed out from a response about abdominal cramping. The changes were initialed and dated by researchers.

Officials at the Phoenix center did not respond to repeated phone calls. The founder of the center, the late Dr. Jay M. Cooper, is one of the chief authors of research papers on Essure. He in those publications that he owned equity stock in the company.

Patricia Reese Rhodes was also a participant in the trial at the Phoenix center. Born in 1976, she discovered that her medical record listed her birth year as 1956, as she points out in an affidavit to the FDA, making it appear she was in her mid-40s rather than in her mid-20s when she was sterilized.

While clinical trials generally prefer young healthy participants who are less likely to develop complications, the FDA required that women as old as 44 be represented in the Essure trial.

Side Effects Dismissed

Several other clinical trial participants who developed serious health complications said they were also told the problems were not related to the device.

But that raises concerns among some experts such as Dr. Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer think tank and research group based in Washington, D.C. “The whole point of a trial is to capture things you wouldn’t know would happen. It doesn’t matter if you think the symptoms are related or not. They should be counted,” she said.

A clinical trial participant at the Greenville, S.C., trial site said she was dropped from the study after complaining of acute pain. Crystal Johnson Brown, now 39, said investigators told her the pain came from , an infection of the female reproductive organs, and since it was a sexually transmitted disease, she should seek treatment elsewhere.

“After that, they never called me no more,” she said in a recent interview. “I never heard from them again.”

Brown said she still has severe debilitating lower back and pelvic pain and often seeks help at emergency rooms because she has no insurance. But Zuckerman says that her infection, like all health problems, should have been recorded in the trial data.

Gabriella Avina, a study participant at a San Ramon, Calif., trial site, was so enthusiastic about Essure that she became a paid spokeswoman for Conceptus for several years, answering questions women wrote in to “Ask Gaby.”

Avina was in her mid-30s when she had Essure implanted in 2000. Just a few months after getting the implant, Avina developed a thyroid disease, which is not uncommon among women.Ìý Then, in 2002, she started bruising and was diagnosed with the blood platelet disorder thrombocytopenia, and in 2004, she was diagnosed with celiac disease. In 2009, she started falling and was diagnosed with myasthenia gravis, and in 2011, she was diagnosed with Sjogren’s Syndrome, which causes dry eyes and dry mouth.

All five of the diseases are auto-immune diseases. Avina, a nurse who will be testifying at the FDA hearing, said that even though there is no evidence the conditions were triggered by an immune response to the implant, they should have been recorded in the clinical data. She said researchers were unable to locate her records when she sought to get them, but she does not believe they noted the other problems she was encountering.ÌýÌýShe has always been unable to wear cheap jewelry that contains nickel, andÌýthinks her problems may have been related to a possible response to the nickel in the device.

“The interesting thing is that because I worked in the clinical research center, they knew I was sick,” said Avina, who had a hysterectomy to remove the implants last year. Her health conditions have not resolved.

No Comparison Group

One of the problems with clinical trials of medical devices is that there is rarely a control group of similar women for comparison, which is standard in clinical trials of drugs, where a comparison group receives a placebo, said Dr.ÌýWilliam Maisel, theÌýchief scientist and deputy center director for science at the FDA’s Center for Devices and Radiological Health.

“These studies did not have a comparison group of women who did not get the Essure device, so the ability to conclude the relative rates of symptoms in Essure patients compared to other patients can’t be correctly done through these studies,” Maisel said.

Maisel said the FDA believes the benefits of Essure still outweigh the risks, and that all birth control choices have risks as well as benefits.

But to Zuckerman, telling a patient that the pain in the pelvis is definitely not related to the device is not defensible. “If you put something in the pelvic area, it’s ridiculous to assume that pelvic pain has nothing to do with it,” she said.

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Her decline was precipitous. She fell repeatedly. She stopped driving and she could no longer ride her bike in a straight line along the C& O Canal. The woman who taught me the sidestroke couldn’t even stand in the shallow end of the pool. “I feel like I’m drowning,” she’d say.

A retired psychiatrist, my mother had numerous advantages — education, resources and insurance — but still, getting the right diagnosis took nearly 10 years. Each expert saw the problem through the narrow prism of their own specialty. Surgeons recommended surgery. Neurologists screened for common incurable conditions.

The answer was under their noses, in my mother’s hunches and her family history. But it took a long time before someone connected the dots. My mother was using a walker by the time she was told she had a rare condition that causes gait problems and cognitive loss, and is one of the few treatable forms of dementia.

“This should be one of the first things physicians look for in an older person,” my mother said recently. “You can actually do something about it.”

‘Did Mom Tell You? She Fell Again.’

The falls started in 2004. My mother fell in the bedroom of her Bethesda home. She fell in the airport while returning from a trip to see my sister. Sometimes she told me, and sometimes a sibling would call or e-mail. “Did Mom tell you? She fell again.”

Millions of older adults fall every year, but it was my mother’s uneven gait that tripped her up. She was unsteady on her feet; the slightest incline threw her off stride. Sometimes she quickened her pace involuntarily. Sometimes she bent over before straightening back up.

She went to doctor after doctor. “I want a diagnosis,” she would say before the next appointment with a neurologist, geriatrician, urologist or orthopedist. “I’m convinced this is something organic — that it has an underlying biological cause.”

A series of neurological evaluations ruled out the obvious suspects: My mother didn’t have the tremor typical of Parkinson’s, a devastating, progressive disorder, and she did well on cognitive tests, so it wasn’t Alzheimer’s disease.

Next, my mother went to see an orthopedic surgeon. He said she had stenosis, or a narrowing of the open spaces of the spine, and recommended surgery. She underwent a complicated, potentially dangerous back operation, and she seemed to be walking more smoothly afterward — for a few months.

As time went by, though, she developed other symptoms. Perhaps because she wasn’t exercising, her blood pressure went up. She gained weight and was at risk for diabetes. She developed a persistent hacking cough, but no one could identify the cause since her lungs were clear.

She was also having trouble getting to the bathroom on time, so she had more surgery, this time to implant mesh designed to alleviate urinary incontinence. Medicare and private insurance picked up the tab, but once again the relief was temporary.

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Several factors are driving the spending spike, including the introduction of expensive new hepatitis C drugs and fewer drug patent expirations than in previous years, the report found. Such expirations typically lead to savings as cheaper generics replace brand-name drugs.

The 11.7 percent rise is a dramatic departure from the more modest average increases of 3.6 percent in annual drug spending during the past five years.

The report anticipates the pace of spending increases will slow to 7 to 9 percent in 2015, as the impact of the new hepatitis C drugs declines, less expensive biosimilar products become available and several brand-name drugs — such as cancer drug Gleevac and the antipsychotic Abilify — are replaced by generics.

“We expect this bubble of innovation around hepatitis C will pass, so we won’t see such a contribution to growth in outer years,” said Murray Aitken, executive director of IMS Health. “We think the spike in growth will moderate next year, and further moderate in 2016.”

Drug costs are projected to increase between 3 percent and 5 percent in 2016, he said. The new hepatitis C drug Sovaldi, made by Gilead Sciences and approved in December 2013, costs $1,000 a pill, with a 12-week course of treatment running about $84,000. Another hepatitis C drug — Harvoni — approved by the FDA in October, costs $1,125 a pill, or $94,500 for a 12-week course of treatment.

An estimated 3 to 4 million Americans have hepatitis C and are potentially eligible for treatment. Hepatitis drug treatments accounted for $8 billion of the approximately $40 billion in projected increased drug spending this year.

“The hepatitis C drugs are Exhibit A when you look at escalating drug costs,” said Brian Henry, a spokesman for Express Scripts, the country’s largest pharmacy benefits manager. “You never had a drug that costs that much that can treat so many people.” The price of Sovaldi “caught payers by surprise,” he said.

Innovative new therapies, especially in the area of cancer, have also pushed up costs. The Affordable Care Act, which expanded access to health care and medications, may also have played a role, along with a new emphasis on preventive care and adherence to medications, Aitken said.

Holly Campbell, director of communications for the drug industry trade group, PhRMA, said the cost of developing drugs has skyrocketed, pointing to a report this week by the Tufts Center for the Study of Drug Development that estimated the price of bringing a drug to market at $2.6 billion. The process can take a decade, the report said.

“These most recent findings underscore the ongoing challenges our industry faces,” Campbell said.

An AARP report noted the increase in prices of brand-name drugs. The report found that the prices of 227 brand name prescription drugs used by many older Americans increased by 12.9 percent on average last year, well above the 1.5 percent rate of inflation, bringing the average cost of a brand-name drug used regularly to $3,000.

“We have started to hear from members who have to decide between taking a drug they need and paying their electric bill,” said Leigh Purvis, director of health service research at the AARP Public Policy Institute and a co-author of the report.

But, she added, the impact goes beyond seniors. “This is a concern not just for our members but for everyone.”

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What Paul Westbrook specialized in was customer service. His background is in the hotel business – Marriott and The Ritz-Carlton, to be precise.

He is one of dozens of hospital executives around the country with a new charge. Called chief patient experience officers, their focus is on the service side of hospital care: improving communication with patients and making sure staff are attentive to their needs, whether that’s more face time with nurses or quieter hallways so they can sleep.

It’s a dimension of hospital care that has long been neglected, patient advocates say, and it was put high on hospitals’ agendas only when Medicare started tracking patient satisfaction and, in late 2012, shaving payments to hospitals that fell short.

“There is a new recognition that the patient is important,” said Leah Binder, president and chief executive of the Leapfrog Group, an employer-based coalition that advocates for greater health-care quality and safety.

Hospital routines have traditionally been designed to suit employees, not customers, she said. “The patient used to be maybe 10th on the list of a hospital’s priorities.”

The financial penalties introduced by the Affordable Care Act are part of a broader effort to transform health-care delivery and improve quality while reining in costs, increasing transparency and holding hospitals and providers accountable for their work.

The penalties — which for now make up only a fraction of Medicare reimbursements — are based on a hospital’s ranking relative to other hospitals. One component is how they do on surveys of recently discharged patients. The hospitals are judged on answers to such questions as how well their doctors and nurses communicated with them, how clean and quiet the hospital was, whether they received help when they needed it and how well providers explained the drugs they were given.

Many hospitals commission additional surveys to use for their own purposes, such as marketing and branding.

Chief patient experience officers treat these survey results like sacred texts.

“The one thing I’m not trying to do is to put a mint on the pillow,” said Westbrook, who reports directly to Inova’s president and chief operating officer. “This is a different customer, with very different needs.”

But as patients’ out-of-pocket costs have risen, he said, they have become savvier, more demanding consumers.

“They are going to look on the Internet and on Medicare’s site comparing hospitals, and they are going to read comments,” he said, and increasingly, they will select hospitals based on the reviews. “It’s no different from TripAdvisor.”

Lofty Goals, Practical Implementation

Unlike Westbrook, most chief patient experience officers rise through the ranks of a health system. Like him, though, they speak in lofty terms about teamwork, leadership and developing a philosophy and culture of compassion, service and respect at their institutions.

Westbrook, for instance, talks constantly about the “Inova promise” to “meet the unique needs of each person we are privileged to serve – every time, every touch.” That phrase had “always hung on a wall,” Westbook said. “Now, we don’t begin a meeting without an Inova promise story.”

On the ground, the focus is doggedly practical. One common innovation is hourly rounds, a system where nurses are expected to check in on each patient regularly, not wait for the person to use the call button. And the interaction is supposed to be meaningful and thorough.

“This doesn’t mean just pausing at the door, saying, ‘Are you okay? Can I get you anything?’ and off you go,” said Susan Eckert, chief nursing executive at MedStar Washington Hospital Center. “We’re telling our nursing staff that you should actually sit down, look at the patient, talk a little bit, and give them several minutes of time during which they are the only thing that exists in the world . . . It’s a very powerful experience.”

Hospitals that have put hourly rounding in place say the practice does not require extra staffing because it is more efficient to prevent problems before they occur. Taking time to reposition a patient prevents bedsores, for example, and helping patients to the bathroom prevents falls.

Another priority is having nurses call patients at home within 48 hours of their discharge, to keep their recoveries on track. (One Medicare question specifically asks patients whether they got good instructions about what to do when they get home. Hospitals can also be penalized if too many patients bounce back to them.)

Hospitals are increasingly taking their cues from patients, both by listening to the advice from new patient and family advisory councils and by using the surveys to identify weak spots.

At Yale-New Haven Hospital, where an executive director of patient relations and a medical director work together to improve the patient experience, officials have made a concerted effort to lower noise so patients can get optimal rest. Hospital staff are told to use “library voices 24/seven” and not to “vent” where patients might hear them. Overhead page calls have been eliminated, beepers are kept on vibrate, doors are closed when staff discuss cases and efforts are made to reduce alarms, pings and beeps at the bedside.

The Cleveland Clinic requires all 3,000 staff physicians to take a day-long relationship and communication class. In 2010, the hospital showed each doctor what patients had said about him or her in surveys. About half the comments were negative — and most of those had to do with how physicians talk to patients.

Doctors were stunned when they saw the results, said James Merlino, a surgeon who is Cleveland Clinic’s chief experience officer.

“Physicians were shocked, dismissive, disbelieving. They said, ‘This isn’t true, the methodology is bad, the sample size is too small,’ ” he said.

Now, he said, “we put physicians through communication training so they learn how to listen better, let the patient set the agenda and organize the encounter better.”

The result is a big increase in physician communication scores since 2008.

At UCLA Health System, parents of pediatric patients created an educational video about central-line catheters that is shown to physicians and nursing staff “to remind them how scary that catheter is for patients and their family members,” said Tony Padilla, UCLA’s chief patient experience officer, adding that catheter-related infections can be dangerous and even fatal.

“It drives home the message that during your very busy day as a nurse or physician, please remember: You’re accessing the child’s lifeline.”

Moving The Needle

Moving the needle on Medicare surveys can be a hard slog. Inova Mount Vernon’s composite score went up from 66.6 percent to 68.4 percent from 2010-11 to 2012-13. That means that on average, 68.4 percent of patients gave top marks to the hospital on survey questions in 2012-13. Scores at Inova Fairfax dropped and scores at Inova’s other three hospitals remained about the same.

Hospitals face a balancing act.

“We want to be attentive to a patient’s needs and wants, yet not do things just to please the patient, like overprescribing pain medication,” said Atul Grover, chief public policy officer for the Association of American Medical Colleges, which represents nearly 400 major teaching hospitals and health systems, in addition to U.S. medical schools. “You want to make sure patient satisfaction isn’t driving patient care.”

Some question whether the hospitals that score best on patient surveys are also the ones that provide the best care. Grover, for example, worries that hospitals that don’t offer amenities, such as single rooms, will be dinged in the surveys.

But some research suggests a strong correlation between patient satisfaction and outcomes, said Richard Staelin of Duke University’s Fuqua School of Business.

One of his studies, published in the journal Circulation in 2013, found that the death rate among heart attack patients was lower at hospitals where patient satisfaction scores were high, even when researchers controlled for the quality of care, meaning the care was equivalent.

Another study found higher overall patient satisfaction was associated with lower readmission rates a month after patients were discharged.

Studies have also found that hourly nurse rounds result in more-satisfied patients, with fewer falls and pressure sores.

“Patients co-produce the service,” Staelin said. “What I mean by that is that when someone is sick, the doctors can’t solve the problem without their help. … As a patient, I have to communicate with the doctor or nurse, I have to listen to the doctor, I have to follow the instructions.”

“There are still lots of doctors who don’t believe it, but gradually the medical profession is coming around,” he added.

Indeed, several patient experience officers said some physicians at their hospitals resisted doing things differently until it was no longer an option.

The financial penalties “are brilliant,” Westbrook said. “That’s what’s driving change.”

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The American Medical AssociationÌýasked the Obama administration to abandon its “all or nothing approach” requiring Medicare providers to go digital or be penalized. The group also wants the governmentÌý to develop better certification criteria for vendors selling electronic record systems.

ItÌýoutlined eight areas for overhaulingÌýthe record systems, with the top priority being to make sure the technology enhances, rather than disrupts patient care. Electronic health records should also promote coordination, enable physicians to delegate to other health care providers and be able to interact with patients’ mobile devices.

Under the 2009 economic stimulus package, to switch from paper to electronic records with the goal of reducing costly errors and duplication and boosting coordination.ÌýÌýThe law offers doctors who treat Medicare patients up to $63,750 over five years to help pay for the change if they can prove they’re making “meaningful use” of the systems by, say, submitting prescriptions electronically. ÌýThose who do not go digital are supposed to have a percentage of their Medicare payments withheld beginning next year.Ìý However, the government recently agreed to giveÌýcertain providersÌýmore time and flexibility.

The AMA says that isn’t sufficient to address the problems.

“The meaningful use program and the regulatory structure associated with it initially has been a wonderful impetus to get health systems to adopt [electronic health records],” said Dr. Steven J. Stack, president-elect of the AMA, adding: ButÌýthe “processes associated with it have become overly prescriptive, rigid and unreasonable and have themselves become a barrier.”

The group said that one of physicians’ chief concerns is that the programs often have clunky menus that require what it called “the collection of time-consuming information of questionable value” and data that is no more than “clutter,” such as lists that do not differentiate between a patient’s current and out-of-dateÌýmedications.

ThatÌýinformation distracts the physician, is often irrelevant to the care of the patient and leads to “excessive clicking and scrolling” on behalf of the doctor, the organization said.

“We do not want to go back to paper records, but today’s current E.H.R. products are immature, costly and not well designed to improve clinical care,” Stack said. “Requiring electronic health records to be all things to all people — regulators, payers, auditors and lawyers — diminishes the ability of the technology to perform the most critical function, helping physicians care for their patients.”

Asked whether they’re seeking delays to the programs penalties beginning next year, Stack said that’s not the group’s goal.

“We would not shy away from accepting delays but have not made that our focus,” he said.

In addition toÌýthe criticisms laid out Tuesday,Ìýthe AMA had joined with the American Hospital Association and 15 other groups to ask the administrationÌýto let providers show meaningful use of electronic health records for three months in 2015, as opposed to a full year — arguing the program’s success hinges on the agency offering flexibility.

A spokesman for the Obama administration encouraged doctors to communicate what they need to vendors and others.

“We support the AMA’s efforts to improve EHRs for the end user – the health care providers who use these products to treat their patients,” said Peter Ashkenaz, spokesman for the Office of the National Coordinator for Health Information Technology at the Department of Health & Human Services.

But, he added, “We also know that no software is perfect, and therefore no EHR is perfect.”

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But that was nearly six years ago, and the state Medicaid program was generous then. Tasheiko was eligible because of her modest income, and MaineCare, as it is called, paid for all of her treatment, including the surgery, an $18,000 drug to treat nerve damage that made it impossible to hold a paintbrush, physical therapy and continuing checkups.

But while much of America saw an expansion of coverage this year, low-income Maine residents like Tasheiko lost benefits. On Jan. 1, just as the Affordable Care Act was being rolled out nationwide, MaineCare terminated her coverage, leaving her and thousands of others without insurance.

Maine Gov. Paul LePage’s decision to shrink Medicaid instead of expanding it was a radical departure from a decade-long effort to cover more people in this small rural state of farmers, lobstermen, craftsmen and other seasonal workers, which at least until recently, .

Maine was the only state ­in New England, and one of 23 nationally, to decline federal money to expand Medicaid under the federal law. In most of those states, Republican lawmakers or executives argued that Congress could withdraw the health law’s funding and that their states couldn’t afford the expense. Many also objected to expanding a program they regard as broken.

“It’s nerve-wracking,” said Tasheiko, who like many working poor in this rugged state makes ends meet by raising laying hens, heating her home with a woodstove and eating and canning vegetables she raises in her garden. “Cancer doesn’t just stop — it’s not over. But my health coverage is over.”

LePage’s decisions are also having ripple effects on safety net hospitals and clinics, which are reporting a surge in uninsured patients, including many who are so poor they cannot pay even a nominal $10 to cover a fraction of their care. Many hospitals have already cut staff to trim costs. Others have reduced pay and hours.

“The really sad part about it is that Maine used to lead the nation with regard to health coverage, and now we’re way behind,” said Sara Gagne-Holmes, executive director of Maine Equal Justice Partners, an advocacy organization for poor and low-income residents, noting the state’s motto, “Dirigo,” is Latin for “I lead.”

“We were among the first to provide subsidized coverage for low-income people —Massachusetts built off what Maine did,” Gagne-Holmes said.

A Precarious Safety Net

The Maine experience underscores how precarious the health law’s safety net became after the 2012 Supreme Court ruling that states could opt out of expanding the insurance program for the poor. As a result, millions of the nation’s poorest adults remain uninsured because of state politics and budget concerns.

Even in a state with a strong social welfare tradition like Maine, a quirky election — like the five-way gubernatorial race that brought LePage to power in 2010 with 38 percent of the vote — can alter policies that affect thousands of people.

Maine’s Democratic-controlled state legislature has passed five Medicaid expansion bills with bipartisan support, said Rep. Mark Eves, speaker of Maine’s House of Representatives. But LePage, who is up for re-election this fall, vetoed each one, calling them “ruinous” for the state’s future.

LePage’s spokeswoman Adrienne Bennett explained his decision with a familiar refrain. “We can’t afford it,” she said.

Under the Affordable Care Act, the federal government is picking up the entire cost of new enrollees for the first three years and never less than 90 percent thereafter.

But Bennett said there is no guarantee the government would honor that pledge.

“They have rolled back on their Medicaid promises in the past,” she said. “We’re going to be footing that bill. It could be a matter of years, it could be less than that. It’s not a guarantee.”

LePage’s policies represent a stark turnabout from those of his predecessor, John Baldacci, a two-term Democrat who had campaigned on a pledge to deliver universal health coverage to state residents.

Baldacci signed the Dirigo Health initiative in 2003— a plan that prefigured both Massachusetts’ coverage expansionÌý as well as the Affordable Care Act—expanding Medicaid to more poor and low-income residents, not just those with dependent children or the disabled, while offering subsidized private coverage to middle-income residents.

The subsidies, which were funded through a tax on private insurance, were phased out at the end of last year as the federal health care law’s subsidized coverage took effect.

Nearly one-quarter of the state’s residents eventually enrolled in Medicaid, which consumed 29.6 percent of state spending by 2010. But Maine struggled with budgetary shortfalls and .

After LePage, a brash tea party businessman, was elected on a platform of fiscal responsibility, he pushed through $400 million in tax cuts, and severely restricted Medicaid eligibility, cutting 14,500 parents and roughly 10,000 childless adults off MaineCare at the end of last year.Ìý

Had the state expanded Medicaid with federal funds, an additional 45,000 people would have gained coverage.

‘A Double Whammy’ For Providers

But yanking a patient’s Medicaid card doesn’t mean they won’t get sick.

When Tasheiko had worrying symptoms recently, she went to Waldo County General Hospital in nearby Belfast and was accepted into their charity care program.

Gail MacLean, 64, who boards horses on her farm in Gray, 20 minutes from Portland, was also cut off of MaineCare because she doesn’t have dependent children. Although she is hardy, she said, “It’s one thing after another on a farm.”

In early June, MacLean was fixing one of the barn’s Dutch doors when a gust of wind blew the top part of the door shut and it slammed into her head. When her headache didn’t go away, she saw a doctor at Care Partners, an affiliate of Maine Medical Center in Portland, that charged her $10, and a CT scan was ordered, the cost of which will likely be borne by the hospital.

Meanwhile, hospitals are already hurting because of declining government reimbursements, which were supposed to be offset by payments from the newly insured. In Maine, the decision to trim the Medicaid rolls is straining resources for charity care.

That’s already had an impact on the bottom line, said Maine Hospital Association spokesman Jeffrey Austin. In a normal year, about one-third of the association’s 36 acute-care hospitals finish the year in the red, but 24 had negative margins last year.

Similar strains are evident at Portland Community Health Center, a federally qualified health center where more than half the patients are immigrants. Last year, roughly half of the center’s patients were on MaineCare and about one-third had no insurance. In one recent month, over half were uninsured,Ìý according to CEO Leslie Clark Brancato.

“We’re really struggling with what to do,” she said.

Vanessa Santarelli, CEO of the Maine Primary Care Association in Augusta, the umbrella group forÌý community centers which provide care to one in seven state residents, calls the combination of failing to expand Medicaid and terminating coverage “a double whammy.”

“We’re very proud and want to provide services and access to more people,” Santarelli said. “But there is a breaking point, and we’re getting close to it.”

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For another common blood test called a basic metabolic panel, the average hospital charge was $371, but prices ranged from a low of $35 to a high of $7,303, more than 200 times more.

The wide disparity in hospitals’ listed charges for routine blood tests at California hospitals was revealed in a study published in the August issue of . The study examined the listed charges for routine blood tests performed in 2011.

Researchers said their analysis found no rational explanation for the stark variation in listed prices, though teaching hospitals and government hospitals generally set lower charges than other facilities.

“People say our health care system needs to be more marketplace-driven, but the charging system and payment system are irrational,” said Dr. Renee Hsia, the paper’s lead author, an associate professor of emergency medicine at University of California, San Francisco. “When people try to understand why prices are the way they are, we have no ability to explain it. That is the take-home message. That is what is so disturbing.”

“If you ask an automotive maker, they will know how much it costs to make a Honda. If you ask a hospital CEO how much an appendicitis admission costs, they will not be able to tell you. They have never been asked to determine prices that way.”

Officials with the California Hospital Association dismissed the report as irrelevant, saying that the vast majority of patients pay discounted rates that have been negotiated by their insurance plans.

“Charges are meaningless data — virtually no one pays charges,” said Jan Emerson-Shea, the association’s vice president for external affairs.

“It is true that an uninsured person will receive a hospital bill based on charges,” she said, but California law requires the bill to “include text referencing the availability of free or discounted care to persons who meet income guidelines.” Those discounted fees must be based on what government programs pay for services, under California law, she said.

But researchers say the list prices are a starting point for negotiations with insurers and patients, so they play a role in driving up health-care costs. ÌýSome uninsured patients, as well those with insurance who have gone out of network, may also be billed for the full charges.

Earlier studies by Hsia identified variations in listed charges for labor and deliveries and for appendectomies in California, with labor and delivery charges varying eight to 11-fold between hospitals, and charges for a routine appendectomy ranging from $1,500 to $182,955.

But, she said, she did not expect to see so much variation on a single line item like a blood test.

“This was even more surprising to me,” Hsia said. “There is always some variation in patients, even among young healthy adults, and there are variations in physician practice. But these are very basic, standard blood tests. It doesn’t matter if you’re sick or not, a complete blood count is a complete blood count. You draw the blood, send it to the lab and put it in a machine.”

In addition, she said, patients are increasingly being asked to play a role in keeping health care costs down by being smart shoppers, but it is almost impossible to get prices of health care services in advance and comparison shop. The study’s findings suggest that price setting for many services is arbitrary, since there is little difference between standard blood tests done at different institutions.

While the disparities in charges for cholesterol tests were the most extreme, they were not an aberration. Charges for a complete blood cell count and a thyroid stimulating hormone assay ranged from as low as $20 in some hospitals to as much as $7,439 and $8,392, respectively.

The smallest discrepancy in charges was for a creatine kinase assay, often used to diagnose a heart attack; the lowest listed charge was $10 but some hospitals charged as much as $628.

The researchers obtained the hospital charges for blood tests from reports that non-federal hospitals in California are required to submit each year to the Office of Statewide Health Planning and Development.

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The analysis is believed to be the first to examine the impact that emergency department closures have on the quality of patient care at other hospitals within the same service area.

Six percent of the nation’s emergency rooms have closed their doors in recent years, including many that serve poor inner-city and rural communities. At the same time, the number of emergency visits throughout the country has increased by 51 percent, a combination of developments that has led to more overcrowding and longer waits for emergency care.

The study was published Monday in the August issue of the journal .

“Emergency department closures generally happen in vulnerable communities, but their ripple effects extend to other hospitals,” said the senior author, Dr. Renee Y. Hsia, an associate professor in the department of emergency medicine and the Institute of Health Policy Studies at the University of California, San Francisco.

While many people hearing about an emergency department closing at a hospital that is not where they normally would go may feel relief ,ÌýHsia said, “It’s important for people to know that it still does affect them.”

The researchers used data from the California Office of Statewide Health Planning and Development as well as other sources to identify 48 hospitals that closed their emergency departments in that state between 1999 and 2010. They then analyzed inpatient deaths among 16 million adult inpatients admitted through emergency departments during the same period.

They found that 4 million of those admissions were to hospitals located near another emergency department that had closed. Patients at the affected hospitals were more likely than patients at unaffected hospitals to be black, Hispanic, female and under the age of 65; they were also more likely to be uninsured or on Medicaid, and to be sicker overall.

Even after adjusting for the different patient and hospital characteristics, however, the researchers found that among inpatients at hospitals affected by an emergency room closure, 5 percent were more likely to die than patients at other hospitals. The increase in the risk of death for affected adults under 65 was even greater: their risk of dying in the hospital increased by 10 percent compared with similar patients who were not affected by a closure.

And heart attack, stroke and sepsis patients faced a 15 percent greater risk of dying in the hospital if there had been a closure nearby, when compared with similar patients at unaffected hospitals.

The researchers said emergency room closures at nearby facilities may contribute to mortality at other hospitals because they increase the distance and travel time to an emergency room, while exacerbating crowding and prolonging waiting times for care. Closures may also cause some patients to postpone seeking care, so that they are in worse shape by the time they arrive at a hospital,ÌýHsia said.

“An important part of the puzzle is which hospitals are closing down: they’re the ones located in underserved areas with poorer populations,” noted Dr. Rebecca Parker, a member of the board of directors of the American College of Emergency Physicians, who was not involved in the study.

Meanwhile, she said, the need for emergency care will inevitably increase as the baby boom generation ages. “This is something we need to plan for,” she said.

The number of emergency rooms nationwide dropped between 1996 and 2009 from 4,884 to 4,594, while the number of emergency department visits increased from 90.3 million in 1996 to 136.1 million in 2009, according to the National Center for Health Statistics.

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Doctors say the new requirements have made maintaining specialty certifications a process that never ends. Younger doctors already retake the arduous certification exam every seven to 10 years to keep their credential, long considered the gold standard of expertise. But physicians of all ages must now complete a complex set of requirements every two to three years, or risk losing their certification.

Supporters contend the new process will ensure doctors incorporate the latest medical advances into their practices, but many critics dismiss it as meaningless, expensive and a waste of time.

More than 16,000 doctors have signed an online petition urging medical specialty boards to do away with the new requirements. Some older physicians – who were once board certified for life and exempted from the periodic exams — warn they may simply retire.

“I’m at an age where, if anybody does anything to force me to participate, I’d say ‘adios.’ I’d retire. It’s not worth it for me,” said Dr. Marc Frager, 65, of Boca Raton, Fla., who is board certified in internal medicine, nuclear medicine and endocrinology and cares for elderly patients, most of whom are on Medicare. “It should be a concern to the health care system. Who’s going to take care of the patients?”

Lisa Mancuso, a board-certified anesthesiologist in Hartsville, S.C., says the new rules will make it even harder to attract physicians to rural areas, especially if hospitals and insurers require the certifications.

“They have a hard enough time bringing younger, well qualified physicians to these rural areas, and if they tie maintenance of certification to hospital privileges, it will exacerbate the problem of not being able to attract specialists,” she said.

‘A Badge Of Quality’

The conflict comes at a time when the credentials are increasingly relied upon as a quality indicator. Many consumers check a physician’s board status before making appointments, and some medical centers and insurers require maintenance of certification for doctors seeking hospital privileges or entrée to their health insurance panels.

“Right now, for better or for worse, board certification is one of the best quality indicators we have,” said Leah Binder, president and CEO of The Leapfrog Group, an employer-based coalition that advocates for greater health care quality and safety.

If physicians want to improve the process, she said, they should appeal to their specialty boards, “but you can’t throw the baby out with the bathwater.”Ìý

Since its origins in 1933, board certification has always been voluntary, rather than a condition of licensure.Ìý Most medical specialties granted certification for life until the 1980s; physicians took the exams only once, after completing their training.

Over time, most of the 24 specialty boards started requiring recertification every 7 or 10 years. In 2000, they adopted additional requirements. Earlier this year, those standards became even tougher for internal medicine and many other specialties with the transition to continuous maintenance of certification activities. This is in addition to fulfilling state licensing boards’ requirements for getting continuing medical education credits.

“Medical knowledge doubles every eight years, and having a process where a physician does something once in their professional lifetime or every 10 years just doesn’t seem to cover what physicians need to know to take care of their patients,” said Dr. Mira Irons, senior vice president for academic affairs at the American Board of Medical Specialties, the group that owns the certification program.

While the exams test knowledge, the new requirements are geared to ensuring that doctors integrate that knowledge into their practices.

‘None Of This Makes Me A Better Doctor’

Physicians may be asked to review patient charts to see how many of their diabetic patients are getting recommended eye exams or how many female patients had a mammogram recently. Or they may be required to have their patients fill out questionnaires, or to survey fellow physicians.

The efforts are time-consuming, and have earned the wrath of some doctors, who say they have not been shown to improve practice.

“From the day you enter medical school, they put certification up on a pedestal like it’s a holy grail, and you never doubt that it’s worth your time,” said Dr. Jonathan Weiss, 52, a physician in upstate New York who is board certified in three areas. “Now all of a sudden, doctors like me who have just done this without questioning it are saying, ‘Wait a second… None of this makes me a better doctor.’”

Physicians also complain about the cost of maintaining the credential, which is about $2000 every 10 years, not to mention the additional costs of test prep courses, materials and travel expenses, as well as the cost of having to close their practices when they take the test.

Of greatest concern to physicians is that state medical boards might incorporate the new rules into licensure requirements.

Dr. Humayun ‘Hank’ Chaudhry, the chief executive officer of the Federation of State Medical Boards, said the state licensing boards want to recognize the value of specialty certification. But he insisted that board certification will continue to be voluntary and not a condition of licensing.

Roughly 200,000 of the nation’s 878,000 medical doctors and osteopaths are not board certified and never have been.

“Why in the world would you unlicense 200,000 physicians when there is a shortage of physicians and difficulty with access to care?” he said. “It doesn’t make sense, and it’s not something we have a plan for.”

Still, those who are not board certified or are not renewing the certification would likely have to prove they are doing other things to stay current in their fields to maintain their licenses.

Surgeons Group Files Suit

To date, the highest-profile pushback to the new rules has come from the Association of American Physicians and Surgeons, which last year sued the American Board of Medical Specialties, and accused the organization of restraint of trade.

It cited the case of John Eck, a 64-year-old family practice physician in New Jersey who lost his hospital privileges three years ago because he had not kept up his board certification in family medicine.

“I was getting the best continuing medical education through the New England Journal of Medicine, and taking two exams a year [to stay current with new medical information and practice guidelines] – more frequently than the Family Practice board exams would have been,” Eck said.

Several medical specialty societies (which are separate entities from the certifying boards) have also criticized the requirements. The American Association of Clinical Endocrinologists wrote that they have “no proven benefit to physician or patient,” and proposed its own alternative certificate for endocrinologists who engage in ongoing education.

Dr. Richard Baron, president and chief executive officer of the American Board of Internal Medicine, one of the largest certification groups, defends his group’s requirements.

In his own practice, he said, he learned through patient surveys that diabetics did not think he understood what it was like to live with the condition. “I really changed the way I talk to my patients.”

But he acknowledged doctors’ frustration and said the specialty group was looking to make its program “less burdensome.”

Still, he noted that physicians have little choice but to participate. “There is an increased expectation of professional accountability,” Baron said. “Payers, hospitals, health systems are all looking for a credential to figure out who’s keeping up [and] who’s not.”

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And those are just average prices; some drugs may cost as much as $30,000 a month.

In Europe, where governments negotiate for national discounts, the list prices of cancer drugs are at least 20 to 40 percent lower than in the U.S., the report found.

Americans are also paying higher prices because more patients are being treated by oncologists whose practices have been bought by hospitals, whichÌýmay chargeÌýdouble or more for the same treatments, the report said.

The report’s authors calculated prices for 10 common chemotherapy treatments and found hospitals charged 189 percent more on average — or nearly triple — what the same infusions would cost in an independent doctor’s office. The higher charges, which hospitals say are needed to support overhead and administrative costs, often translate into steeper out-of-pocket costs for insured patients, depending on how their benefits are set up.

The report calculated that for commonly used cancer drugs, the average increased cost to the patient is $134 per dose if received in a hospital outpatient setting rather than in an oncologist’s office. And since patients frequently receive multiple therapies at once, the results may result in “significant increases in member financial burden,” it said.

Patients who face higher out-of-pocket costs are more likely to drop out of treatment, the report noted, citing a study showing that a bump of as little as $30 in copays caused some breast cancer patients to skip or drop care.

Steve Weiss of the American Cancer Society’s Cancer Action Network said advocates are concernedÌýthat the trends identified inÌýthe report could limit access to life-saving care by driving up patients’ costs. While the Affordable Care Act takes important steps to make care more accessible to patients, “health care costs remain a concern as they have been for decades,” he said. “As we’ve seen repeatedly over the years, there are no easy answers.”

The higher charges come even as a federal program expanded under the health law enables many hospitals to purchase cancer drugs for as much as half the wholesale price, the report said. Yet hospitals can use those less-costly drugs in the oncology practices they bought and charge steeper fees, according to the IMS Health report.

Meanwhile, the proportion of uncompensated care provided by hospitals — a proxy for the proportion of patients enabling a hospital to qualify for discounts — has remained static, the report noted.

Congress created what’s called the 340B Drug Discount Program in 1990, requiring drugmakers to provide medications at significantly reduced prices to health care organizations that treat a large number of underserved people.

A spokesperson for the American Hospital Association said hospitals can qualify for the discount program only if they serve a disproportionate share of low-income and uninsured patients or provide essential services to rural communities.

“Hospitals today face many challenges to maintain the services their communities have come to expect. This vital role 340B hospitals play in their communities cannot be boiled down into a few data points derived from publicly reported information,” according to a statement from the trade group.

A spokesperson from the Health Resources and Services Administration (HRSA) said that hospitals and other health centers may purchase drugs at discounts of up to 50 percent if they meet the criteria for the program, but the agency cannot dictate how they use the savings.

Overall, global spending worldwide on cancer drugs reached $91 billion last year, with the United States accounting for $37.2 billion, or 41 percent of that, the report said.

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