FDA Heads Into Uncharted Territory Of ‘Biosimiliar’ Drugs

Mark McCamish spent more than five years preparing for a presentation he gave at the Food and Drug Administration’s headquarters this winter.

McCamish is in charge of biopharmaceutical drug development at the Sandoz division of Switzerland’s Novartis. He and his colleagues made the case to a panel of 14 cancer specialists and a group of regulators that a company drug codenamed EP2006 should be approved for sale in the U.S.  The drug, brand name Zarxio, is similar to but not quite identical to Amgen’s Neupogen, a medicine approved by the FDA back in 1991 to fight infections in cancer patients.

Industry representatives, patient advocates and investors paid close attention to the evidence under review. Some came in for the day from Europe, their suitcases propped against the wall. That’s because Novartis’ drug application represented uncharted territory.

The FDA approved Zarxio on Friday, and it’s the first time the agency has approved a so-called biosimilar, or close copy of an existing biotech medicine.

Dr. Jay Siegel, chief biotechnology officer at Johnson & Johnson and a former FDA regulator, says biosimilars are a little like the generic drugs we’re used to. The key difference is that they’re copycats of more complex medicines called biologics, made with living cells.

“In a simplistic sense, biologics are typically much larger molecules, usually made by living organisms,” Siegel says. “They can be antibodies whereas most drugs are smaller chemical entities that can be synthesized in the laboratory,” he explains.

It is difficult to make exact copies of biotech drugs because they are manufactured differently than tablets or syrups.

Think of it a little like drinks. If you want to copy the cocktail you had at your local bar, you buy the ingredients and faithfully follow the steps and proportions laid out in the bartender’s recipe. Voila! A generic cocktail mixed more cheaply (probably) at home than at the bar itself — and just as good.

Now, let’s say you fell in love with the glass of Bordeaux you had with your meal. Want to copy that? Good luck. At the least, you’ve got to account for the grapes and their unique character, the fermentation and the aging process. Making wine is a biological process that’s more complicated than simply combining ingredients in a cocktail shaker.

OK, back to the medicine.

Many biologics are approved for sale in the U.S. to treat conditions ranging from anemia to multiple sclerosis. The medicines make up a small but costly portion of the U.S. drug market. Amye Leong is a patient advocate who came in for the FDA hearing from California. Leong has rheumatoid arthritis. She was in a wheelchair for five years. No more, thanks in part to biologics. But she says it’s important to approve biosimilars because biologics are so expensive that they’re often out of reach for patients.

For example, she says, to treat some forms of autoimmune inflammatory arthritis, the medicine costs at least $1,800 a month.

“Now you want to pay rent, [buy] food, get a child through school or do you want the drug that will hopefully make a difference in your disease and life? It should not have to be about that,” she says.

The hope is that like generics, biosimilars could offer cheaper options for patients like Leong that are just as effective.

The copycat drugs have been on the market in Europe for nearly a decade and led to a 20 to 30 percent reduction in some prices for some biologics. An estimate from Express Scripts, a drug benefit manager, projects Zarxio alone could save the health system nearly $6 billion over the next decade.

But while Europe passed a law establishing an approval pathway for biosimilars a decade ago, that didn’t happen in the U.S. until the Affordable Care Act took effect. Specifically, there’s a 40-page section called the Biologics Price Competition and Innovation Act. Like the Hatch-Waxman Act that paved the way for generics in the 1980s, this law established the framework for the FDA to assess and approve biosimilars.

The legislation “was anticipated to save money,” says Gillian Woolette, a consultant at Avalere Health who attended the meeting. “So therefore, if you put it in the Affordable Care Act, both the timing was right but also the CBO estimate was a savings of $14 billion [over the next 10 years],” which helped the law pay for itself.

Other estimates have that savings even higher.

Everyone at the meeting knew cost is a huge issue, but the FDA panel’s task was to examine whether this drug is similar enough to the original to be given to patients. It’s a higher standard than what’s required for traditional generics. After a brief, anticlimactic back and forth, all 14 advisers recommend the FDA approve the drug, which it did last week.

Dr. Scott Waldman, a clinical pharmacologist from Thomas Jefferson University in Philadelphia, was on the panel. He says the Zarxio application, unlike others in the pipeline, had it easy because the drug has been used in Europe for years and there’s a lot of data to support its use.

“I think this is a pretty high bar to set and that other compounds that come through are going to have to leap over this bar,” he says.

This story is part of a reporting partnership with NPR, WHYY and Kaiser Health News.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Better Safe than Sorry

“You know the sound a bowling ball makes, when it strikes the pins? That crash happened inside my head.”

Maureen Holder is describing the July 13, 2012 punch by a patient that, 20 years into her career as an ER nurse, changed her entire life. While waiting for a CT scan, Holder’s patient, a professional boxer with possible head trauma, needed a urinal. Radiology staff was delayed, security was busy handling a different patient, and her facility, St. Francis Memorial Hospital in San Francisco, had made staffing cuts the previous year, leaving her alone without the tech who might otherwise have been by her side.

Concerned with making her patient more comfortable, she quickly ran across the hall for the urinal. When she returned, her patient was off the gurney, with his back turned, falling. Holder reached out to help catch him, and with all the force of a pro boxer, he turned around and swung.

“I thought I had ruptured my eyeball,” she said. Holder turned out to have an orbital floor fracture underneath her eye, a nasal fracture, fractures in her cheek, a concussion, and a traumatic brain injury, all of which required two eye surgeries, one nose surgery, physical therapy, and chiropractic treatments. And the psychological wounds ran deep.

“I had counseling for about two years. I didn’t want to leave my house,” says Holder. Acupuncture and weekly cognitive behavioral therapy worked to curb residual trauma, but Holder still had lingering double vision, ringing in her ears, difficulty lifting, and post-traumatic stress disorder. She was unable to return to ER nursing. Her workers’ comp payments, a fraction of her original salary, eventually ran out, and she was essentially forced, for lack of funds, to move to Florida to live with one of her daughters and her family. Now, still experiencing vision and hearing issues as well as “a significant number of headaches every week,” she has returned to school at age 59 in an attempt to qualify for an office job.

“I am keeping a positive attitude and refuse to allow this to define me going forward,” said Holder. “But this has been life-changing, and I feel let down by the system.”

No job comes without some degree of risk. But for registered nurses, the dangers of being hurt by workplace violence while doing their jobs have not only reached unprecedentedly high levels, but are also now much more frequent. The U.S. Bureau of Labor Statistics reports that violence against hospital workers is almost five times greater than the average worker in all other industries combined, and the rates appear to be rising.

For too long, nurses have simply put up with the violence. Or, worse yet, they actually assimilated and normalized the violence as a routine part of their jobs.

Hospitals must be held accountable for having violence prevention plans and for practices, such as unsafe staffing levels, that directly contribute to the inability to stave off violent incidents, say RNs. They must also be prepared to deal with increasingly mentally unstable patients, and even their family members, due to the abandonment of psychological services across both the public and private health sectors. The healthcare industry’s plans to maximize profits by shifting the burden of care onto the patient’s family members at home may also be putting undue stress on both patients and relatives. By having a plan to prevent violence, employers will not only be protecting RN and other healthcare staff, but also other patients, families, and visitors.

Across the country, RNs are now demanding that hospitals and clinics take responsibility for creating and maintaining safe work environments – as employers across all sectors are required to do. Nurses in California in 2014 passed a law directing their state Occupational Health and Safety Administration to draft tougher workplace violence rules for hospitals and spell out what is required of them. Nurses in Minnesota, Florida, Texas, and Massachusetts are also trying to pass legislation requiring similar safeguards.

Holder said RNs understand that with the confusion and fear brought on by illness, medication, old age, and mental illness, there is some amount of risk that a patient will occasionally become agitated or lash out. She’s been bitten, hit, and scratched by “little old ladies,” but the scenarios RNs face now are wholly different. Today, nurses are constantly put in risky situations that should have been avoided in the first place had the hospital had better protections and policies in place. No staff should have been left alone with a boxer suspected to suffer from a head injury.

“We feel like we’re putting our life on the line for no reason,” said Holder. “Now I have a permanent injury. As far as having any kind of light at the end of the tunnel after all this, or [the hospital saying], ‘Here, we’re going to make up for your lost wages.’ There have been no phone calls [from administration], no card. They forget about you.”

 

* * * * *

 

Ask a convention hall packed full of thousands of registered nurses, “Who has suffered violence at work?” and almost all will raise their hands. Violence comes in many forms, whether physical, verbal, or psychological, and can be committed by patients, their friends and family members, and even doctors, hospital management, and administrators.

“We’ve always considered workplace violence a critical issue,” said Karen Higgins, a Massachusetts RN and a copresident of National Nurses United. “Now, the concern is that the violence seems to be escalating.”

According to the Bureau of Labor statistics, violence against healthcare workers is, indeed, on the rise. In 2013, thirteen percent of the injuries and illnesses requiring health care and social assistance workers to miss workdays were the result of violence. That’s an increase, for the second year in a row, of 16.2 cases per 10,000 workers, up from 15.1 in 2012, according to the BLS. Again, these rates are almost five times greater than typical workers.

And those are just the recorded figures. According to the U.S. Department of Justice, Federal Bureau of Investigation, actual statistics regarding violence committed against healthcare workers may be even higher, due to a “likely under-reporting of violence and a persistent perception within the healthcare industry that assaults are part of the job. Under-reporting may reflect a lack of institutional reporting policies, employee beliefs that reporting will not benefit them, or employee fears that employers may deem assaults the result of employee negligence or poor job performance.”

In her 40 years as a nurse, Kathy Britten, RN, of Sanford Thief River Falls Medical Center, in Thief River Falls, Minn., has seen violence go unreported, due, she believes, to factors such as worries about getting fired and not wanting to be reprimanded. “I keep telling my younger coworkers, you need to fill things out,” she said, stressing that it’s critical to report and document violence in order to establish patterns and hold management accountable.

In the face of escalating workplace violence, possibly even more widespread than the reported numbers, nurses have been mobilizing to call for greater protections. The California Nurses Association, for example, shepherded passage of the 2014 Healthcare Workplace Violence Prevention Act. This landmark bill requires California hospitals to adopt comprehensive workplace violence prevention plans and also forces hospitals to document and report incidents of violence to the California Occupational Safety and Health Association (Cal/OSHA).

At a National Nurses Organizing Committee conference in January, around 100 RNs from Florida, Texas, Missouri, Kansas, and Nevada, echoed California’s call for stepped-up action to reduce hospital violence. They gathered in Tampa for a rally piggybacking on proposed Florida legislation geared, much like California’s, to standardizing and formalizing workplace violence prevention.

“Such a large percentage of us are assaulted at work,” said rally attendee Kim Scott, an intensive care unit RN at Oakhill Hospital in Brooksville, Fla. Her own violent experiences range from verbal assaults, to watching a coworker get kicked “hard in the chest.” She joined RNs holding signs that read “Assaulted” and “Physically Assaulted,” while Bonnie Castillo, RN and director of National Nurses United’s Registered Nurse Response Network, read statistics from the Journal of Emergency Nursing citing that 76 percent of nurses with at least 10 years of experience had experienced some form of workplace assault in 2013.

 

* * * * *

 

There are a multitude of reasons why violence against healthcare workers is on the rise. But in discussion with registered nurses across the country, several key factors attributable to the hospitals and healthcare industry’s prioritization of profits over its staff and patients are most prominent.

One main way hospitals can prevent workplace violence, agreed nurses, is to simply increase staffing. More staff means more sets of eyes on the patients, more hands and bodies to step in if a patient or family member acts out. Better care also means patients and families are less likely to become agitated. This applies across all levels to not just registered nurses, but techs, aids, and sitters to watch potentially volatile patients. California’s recent legislation, for example, involves safe staffing protocols written into its standards for healthcare facilities.

Holder points out that not being left alone may have prevented the patient from slugging her. “The hospital is always trying to save money, downsizing, making staff cuts,” she said. “We used to have a person on every shift who would help nurses with transporting, drawing blood, getting people undressed or helping us with agitated patients. They cut those positions, so we didn’t have help at all. It really made a difference.”

A second is that patients today tend to be sicker and more likely to present with emotional and psychological volatility – if not outright untreated mental illnesses. Millions of people lost their jobs and, subsequently, their health insurance during the Great Recession and have had to go long periods without primary healthcare, therapy, or needed prescription medication. Private and public services for patients suffering from mental health issues have been cut, cut, cut.

According to a 2014 report by the National Association on Mental Illness (NAMI), the lack of acute inpatient or crisis stabilization services for patients who are experiencing psychiatric emergencies has “contributed to the problems with ‘psychiatric boarding’ in emergency rooms.”

“There’s a serious problem throughout the country with ERs housing psych patients because there aren’t enough psych beds,” said Judy Lerma, an RN of the Center for Healthcare Services (CHS) Crisis Care Center in San Antonio, Texas and an active member of NNOC-Texas. Lerma’s facility assesses adult patients having a psychiatric emergency, and accomplishes a 48-hour crisis observation in order to keep these patients “out of jail — or the hospital.”

“The idea is that [our facility] will stabilize them, and they won’t need to end up sitting in the ER, waiting in a bed there.” But many psychiatric patients across the country still wind up in the emergency room, nonetheless.

Last, nurses point to changes in hospital visitor policies intended to maximize hospital profits that result in many more people besides just patients and hospital personnel to be present on a unit.

When Scott became an ICU nurse 27 years ago, RNs had to buzz visitors in. Today, she said, there is minimal security and few rules about who and when someone can be on the unit.

Hospitals will never admit it, but they actually need and want patients’ families and friends to stay and do the work – helping patients to the toilet, feeding them, refilling their water – that was once performed by paid staff they’ve now eliminated.

As the industry has continued to commodify healthcare as a “product” and pushed the concept of patients and their families as “customers,” hospitals have further relaxed visitor policies for family members who, understandably, would like unrestricted access to be with their loved ones. Some nurses reported that they felt visitor policies were geared more toward encouraging higher scores on patient satisfaction surveys, rather than facilitating care. Sadly, payments to hospitals today are tied to patient satisfaction scores and reward the patient’s perception of care instead of the reality of care they receive. “The hospital cares more about patient and family satisfaction because it impacts their bottom line,” said Scott.

The two drivers are, in fact, interrelated. Instead of spending money on increased hospital staffing and services, which would naturally improve actual patient care, outcomes, and satisfaction, the hospitals have a calculated strategy to shift the burden, cost, and responsibility for care onto unpaid family members. If relatives and friends were not available to step in to fill that void, that would surely lead to greater suffering and upset by patients. Hence the current situation where many more people are on the unit, introducing potentially violent variables into the work equation.

Scott understands the calming effect friends and family can have on patients and always encourages them to ask questions and advocate for the best care for their loved ones. But she noted that RNs sometimes have to perform job duties or procedures where, even under the most ideal circumstances, it would be best if visitors were not present. For example, when an RN asks a post-operative patient to turn and cough, the patient will likely feel pain – something that worried relatives don’t understand and could further upset them. “Families will be angry at us, yelling at us,” said Gwynn Pepin, an RN at St. John’s Hospital in Maplewood, Minn., where a brutal Nov. 2, 2014 attack by a patient stunned the country. “There are times we don’t even think about it as verbal harassment, and we just try to deal with it, to do our best.”

Even living on the edge of violence, via verbal threats, can take its toll. A recent study by the Manitoba Nurses Union, on the prevalence of PTSD among nurses, revealed that nurses who did not sustain any injuries, but just “anticipated some sort of violence at work, reported higher levels of stress than nurses with minor injuries.”

And when an RN’s best isn’t enough to deescalate visitors, with hospital policies barring nurses from controlling which “customers” are on their unit, the threat of violence looms.

 

* * * * *

 

This attack had no prelude. Through security camera footage, you can see nurses calmly working and charting at their nurses’ station; one RN even had her hands relaxed and folded behind her head. Seconds later, around 2 a.m., RNs at St. John’s Hospital in Maplewood, Minn. were blindsided when 68-year-old patient Charles Logan rushed into the med-surg station, wielding a metal bar he had stripped from his bed, and began striking nurses.

Surveillance video of the assault exploded across both mainstream and social media. Reports focused on the shocking footage and subsequent injuries to four nurses (including a collapsed lung and a fractured wrist), and also on Logan’s apprehension by police, several blocks from the hospital, where he collapsed while resisting arrest and ultimately died.

What’s not obvious in the video, according to Pepin, is that even in the midst of panic, there was also strategy. The pattern of movement, on the part of RNs, purposely led Logan away from other patients. RNs also pressed a panic button that notified a trained team of respondents, including hospital security. In the aftermath, RNs were provided with workers’ comp and ongoing counseling, all as part of the facility’s workplace violence plan, dubbed “Code Green.”

Every hospital must have a plan, say NNU nurses, not only for how to prevent workplace violence but how to handle any incidents that arise on any unit and the subsequent trauma.

Any workplace violence prevention training RNs have received has traditionally focused on ER nurses in emergency and psychiatric departments, since they were often dealing with patients in crisis. However, Higgins points out that these units cannot be the only areas of the hospital prepared for violence. All units, she said, in all communities, also need access to a plan.

“You don’t know where violence is going to show up,” she emphasizes. “It has spread through all areas of the hospital. You can never assume just because RNs are in a certain area of the hospital or in a sleepy community, that they’re safe. We should always make sure we have training in place — everywhere.”

Public health nurse Laarni San Juan, RN, of California’s San Mateo County takes the call for training a step further, advocating for plans extending beyond the hospital walls, into the community.

“Public health nurses go out and visit the most vulnerable and marginalized patients, the most unlikely to have health insurance,” said San Juan. “We are aware of the inherent risk, but that’s why we chose this work: to help those who are vulnerable.”

In her 17 years with the county, San Juan has been in homes with evidence of abuse, had a drug dealer jump in her car, and navigated a number of situations where her facility’s basic guidelines, such as “lock your car door” or “trust your gut,” did not feel sufficient.

“I cannot even recall the last training we’ve had,” San Juan said. “It’s one thing to have a general guideline, but what’s missing is: If I were to get into a situation where law enforcement was involved and I needed medical attention, I don’t know what the protocols are. There’s nothing in place. It’s scary to think an [institution] that employs nurses who are at most risk, going in their cars into the community, does not have that in place.” 

Jon Tollefson, who handles governmental affairs for the Minnesota Nurses Association, explained that an upcoming Minnesota bill seeks to guarantee hospital staff is fully trained for violent scenarios.

“Not just training for RNs in ER or psych,” Tollefson said, “but for all healthcare workers employed or contracted. We have some hospitals where they have a contractor, and who knows what kind of training they get? They have to get the same as in-house staff.”

RNs want change. Last year, before moving to Florida, Holder lobbied for passage of California’s Healthcare Workplace Violence Prevention Act. She was encouraged to do so by her friend Nicole van Stijgeren, an ER nurse at San Mateo Medical Center, in San Mateo, Calif., who also participated.

“I asked her to go because I thought it would be cathartic. She was a powerful speaker; she had such a powerful personal story,” said van Stijgeren, who was “devastated” to witness the impact of workplace violence on Holder. In fact, while van Stijgeren had encountered violence in her own career, it was seeing her friend in so much physical and emotional pain that motivated van Stijgeren to take collective action through her union.

“This turned me into an activist for the violence that I was seeing and experiencing myself. It really made me want to speak out,” said van Stijgeren. And she is not alone in her activism; nurses across the country are increasingly rallying, lobbying, and saying they have had enough of hospital workplace violence. The unions of National Nurses United are providing nurses an avenue by which to fight to protect workers and communities.

“Maureen’s experience gave me a voice and [so did] meeting my CNA rep, who is an activist,” said van Stijgeren. “It inspired me to fight to better protect nurses.”

In a system where violence is both normalized and on the rise, Holder’s story and others like it are fueling a movement to ensure that no more RNs will feel that their lives and careers are considered expendable before the hospital industry is held accountable for change.

Hundreds Of Hospitals Struggle To Improve Patient Satisfaction

SALISBURY, N.C. — Lillie Robinson came to Rowan Medical Center for surgery on her left foot. She expected to be in and out in a day, returning weeks later for her surgeon to operate on the other foot.

But that’s not how things turned out. “When I got here I found out he was doing both,” she said. “We didn’t realize that until they started medicating me for the procedure.” Robinson signed a consent form and the operation went fine, but she was told she would be in the hospital far longer than she had expected.

“I wasn’t prepared for that,” she said.

Disappointing patients such as Robinson is a persistent problem for Rowan, a hospital with some the lowest levels of patient satisfaction in the country. In surveys sent to patients after they leave, Rowan’s patients are less likely than those at most hospitals to say that they always received help promptly and that their pain was controlled well. Rowan’s patients say they would recommend the hospital far less often than patients do elsewhere.

Feedback from patients such as Robinson matters to Rowan and to hospitals across the country. Since Medicare began requiring hospitals to collect information about patient satisfaction and report it to the government in 2007, these patient surveys have grown in influence.  For the past three years, the federal government has considered survey results when setting pay levels for hospitals. Some private insurers do as well.

In April, the government will begin boiling down the patient feedback into a five-star rating for hospitals. Federal officials say they hope that will make it easier for consumers to digest the information now available on Medicare’s Hospital Compare website. Hospitals say judging them on a one-to-five scale is too simplistic.

Some Hospitals Improve As Others Stagnate 

Nationally, the hospital industry has improved in all the areas the surveys track, including clean and quiet their rooms are and how well doctors and nurses communicate. But hundreds of hospitals have not made headway in boosting their ratings, federal records show.

“For the most part, the organizations that are doing really wonderfully now were doing well five years ago,” said Deirdre Mylod, an executive for Press Ganey, a company that conducts the surveys for many hospitals. “The high performers tend to continue to be the high performers and the low performers tend to be low performers.”

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Some hospitals have made great gains. The University of Missouri Health System, for example, created a live simulation center at its medical school in Columbia to help doctors learn to communicate better with patients. The simulations use paid actors. Instead of having to diagnose the patient, doctors must respond to nonmedical issues, such as a feuding teenager and mother or a patient angry that he was not given information about his condition quickly enough.

“My scenario was I was late to the appointment and the patient’s husband was upset,” said Dr. Kristin Hahn-Cover, a physician at Missouri’s University Hospital. In 2013, the most recent year that the government has provided data for, 78 percent of patients at University Hospital said doctors always communicated well, a 10 percentage point jump from 2007. Other scores rose even more.

At Virginia Hospital Center in Arlington, executives credit improvements in patient satisfaction to their psychological screening methods in hiring and rigorous job reviews. Potential nurses and other staff must first pass a behavioral screening test and then be interviewed and endorsed by some of the staffers with whom they would be working. In the third element of the program, every six months, managers rate employee performance as high, medium or low. Low performers are told to improve or find work elsewhere.

“Those are the three most defining things we did as an organization,” said Adrian Stanton, the hospital’s chief marketing officer. “Without that, I can guarantee you we wouldn’t have had the successes.”

Nudging up scores has been a frustrating endeavor elsewhere, like at Novant Health, a nonprofit hospital system that runs Rowan Medical Center and 13 other hospitals in North Carolina, South Carolina and Virginia. While some Novant hospitals have excellent patient reviews, Rowan’s scores have remained stubbornly low since Novant took over the hospital in 2008.

Last fall, Rowan’s president, Dari Caldwell, replaced the physician group that ran the emergency room because the doctors had not reduced wait times. ER waits are down to half an hour, a spokeswoman said. Doctors and nurses also are being coached on their bedside manner, like being advised not to stare at their computer when a patient is talking.

Rowan’s nurses now spend 70 percent of their time with patients, swinging by every hour. Even the president makes rounds once a day. The hospital has made lots of small improvements to provide a warmer environment, such as putting white poster boards in each room where nurses can list a few personal details about their patients.

“I can go in there and say ‘Oh, you have three dogs’ or ‘You have a grandchild, that’s great, great,’” said Jennifer Payne, a nurse manager. “And they can talk for hours about that.”

Payne said she pores over patient comments and surveys, passing around the good ones and tackling complaints. “We’re very driven by what these patients say,” she said. “Everything I do is based around how these patients come back [in comments in the surveys] and say, ‘Hey is this working’ or ‘This isn’t working.’ ”

Perceptions Sometimes Hard To Change 

Rowan executives fear scores may not be going up because patients still harbor bad memories from previous hospitalizations.

“I was treated like a dog,” Carl Denham, 76, said about a stay two years ago. He said the hospital was doing loud construction work that kept him awake, and it took nurses all day to deliver an oxygen tank his doctor ordered.

Admitted again in Rowan in December, Denham said that visit was different. “It is fantastic from what it used to be if you want my opinion,” he said as he lay in his hospital bed a few days after he came back. “I’ve been both ways and the way it is now, it is great. No waiting and the doctors are all pleasant. I never thought I’d see it like this.” He said he would give the hospital top marks.

His daughter Benicia said that in the last visit she had to nag the nurses to get her dad his medication. This time, it has not been an issue. “It’s like a totally different hospital,” she said. “I had to say, ‘Did I come to Rowan Regional?’ ”

Despite the unexpected operation on both feet, Robinson also said nurses have been attentive to her pain. “They do the best they can,” she said. “At times it gets so bad I’m crying because it’s overwhelming to me.”

But “the best they can” is not good enough for Medicare. In determining how much to pay hospitals, the government only gives credit when patients says they “always” got the care they wanted during their stay, such as their pain was “always” well-controlled. If a patient says that level of care was “usually” provided, it does not count at all. Likewise, the surveys ask patients to rank their stays on a scale of 0 to 10; Medicare only pays attention to how many patients award the hospital a 9 or 10.

“Sometimes what we see and hear from our patients doesn’t show up on their surveys,” Rowan’s president Caldwell said.

Another challenge for hospitals is that Medicare does not take into account the inexact nature of these ratings, which can be based on as few as 100 patients over a year. Medicare recommends a minimum of 300 surveys, but even those have imprecisions that Medicare does not highlight when publishing ratings on Hospital Compare, or take into account when determining financial bonuses or penalties.

In its hospitals with lower ratings, Novant is trying to replicate some of its successes at its Medical Park Hospital in Winston-Salem, a surgical center, which has the best patient satisfaction scores in the Novant system. Sean Keyser, Novant’s vice president for patient experience, interviewed the staff to figure out how it performed so well.

“The first thing they suggested was the relationship between the physician and the nurses,” he said. “They tend to round more together; they tend to huddle more together. It doesn’t matter how long we study health care organizations, personal relationships that caregivers have with each other translates into better relations with patients.”

Staff members from Medical Park now conduct the pre-surgical discussions for patients at several bigger Novant hospitals. Those preparatory talks, which take place a week or two before planned operations, give nurses the chance to allay fears and make sure that patients have realistic expectations of what will happen.

Dr. Scott Berger, a surgeon, said the smallness of the hospital—Medical Park has only 22 beds, while Rowan has 268 — gives Medical Park an advantage over other hospitals in pleasing patients. “We also think that because we only do surgery here, that we’re really able to have kind of a sharp edge, if you will, of focus on good outcomes and good patient care,” he said. “And that really carries over to the nurses as well. Because all day every day, that’s all they see, is the same kind of surgical patients over and over again.”

Even patients who had not prepared to come to Medical Park are impressed. George Stilphen, who was admitted for emergency colon cancer surgery, said he planned to rate the hospital a 10.

“They said that they’d take great care of us,” he said as he recovered from surgery in the hospital. “They were very soothing, comforting, they weren’t condescending. It was a great experience.”

Michael Tomsic, a reporter for WFAE, contributed to this report.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

The Boss May Be Able To Force You To Buy Company Insurance

Under the health law, large employers that don’t offer their full-time workers comprehensive, affordable health insurance face a fine. But some employers are taking it a step further and requiring workers to buy the company insurance, whether they want it or not. Many workers may have no choice but to comply.

Some workers are not pleased. One disgruntled reader wrote to Kaiser Health News: “My employer is requiring me to purchase health insurance and is automatically taking the premium out of my paycheck even though I don’t want to sign up for health insurance. Is this legal?”

The short answer is yes. Under the health law, employers with 100 or more full-time workers can enroll them in company coverage without their say so as long as the plan is affordable and adequate. That means the employee contribution is no more than 9.5 percent of the federal poverty guideline and the plan pays for at least 60 percent of covered medical expenses, on average.

“If you offer an employee minimum essential coverage that provides minimum value and is affordable, you need not provide an opt out,” says Seth Perretta, a  partner at Groom Law Group, a Washington, D.C., firm specializing in employee benefits.

If a plan doesn’t meet those standards, however, employees must be given the opportunity to decline those company plans, under the health law. They can shop for coverage on the health insurance marketplaces and may qualify for premium tax credits if their income is between 100 and 400 percent of the federal poverty level.

Those premium subsidies aren’t available to workers whose employer offers good coverage that meets the law’s standards.

Experts say they don’t expect many employers to strong arm their workers into buying health insurance. Those that do may be confused about their responsibilities under the health law, mistakenly believing that in order to avoid penalties they have to enroll their workers in coverage.

“That is just dead wrong,” says Timothy Jost, a law professor at Washington and Lee University who’s an expert on the health law.

“Nothing in the Affordable Care Act directs employers to make their coverage mandatory for employees,” says a Treasury Department spokesperson. The law requires large employers “to either offer coverage or pay a fee if their full-time workers access tax credits to get coverage on their own in the marketplace.” 

Employer penalties for not offering insurance that meets the health law’s standards can run up to $3,000 per employee.

For employers, forcing coverage on their workers could be counterproductive. “Do you really want to limit employees’ ability to select whether they get this coverage? What impact does that have from talent management perspective?” says Amy Bergner, managing director at human resources consultant PwC.

The practice of automatically enrolling employees in health insurance isn’t new. Many employers have been doing it for years. Some enroll new employees in the least expensive company plan, for example. But employees have generally had the option to opt out of the coverage if they wish.

Automatic enrollment makes it simple to satisfy the health law’s requirement that most people have health insurance, experts say.

The health law stipulates that employers with more than 200 full-time workers are required to enroll newly hired full-time employees in a plan unless the employee specifically opts out of the coverage. However, the provision won’t take effect until the Department of Labor issues regulations.

Employees who are unhappy about being required to buy into a company plan could complain to the Department of Labor, some experts say. It’s unclear whether such efforts would succeed.

Employment law experts point to a 2008 decision by the Department of Labor dealing with state laws that restrict employers from making deductions from workers’ paychecks without their consent. The department issued an advisory opinion saying that federal ERISA law pre-empted a Kentucky law that required an employer to get an employee’s written consent before withholding wages to contribute to a group health plan. 

Although that decision doesn’t have the force of law, it suggests how the Labor Department views such issues, says Cheryl Hughes, a principal at Mercer’s Washington Resource Group.

Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.