PSNA Awards 2015

It is a staggering number — 218,000 Pennsylvania nurses! Every rural, urban and suburban community in Pennsylvania is served by this brave army of compassionate caregivers. For more than 110 years, PSNA has been the bugler for this extraordinary band of men and women. Join us as we take some time to celebrate the work and lifetime achievements of a special handful of individuals. Here’s to nurses! Here’s to veteran service and a rising generation of new leaders! Here’s to each of you who offers light and hope to neighbors in need!

Award Criteria

PSNA is accepting nominations for the following:

Distinguished Nurse Award

John Heinz Friend of Nursing Award

Lifetime Achievement Award

Emerging Nurse Leader Award (open to graduates of PSNA’s Star Leadership Institute)

Access the 2015 Nomination Template

Prior Recipient List

Click here to view our list of previous award recipients.

 

Dates to Remember

Deadline to submit is May 31, 2015.

Nominees and nominators will be notified of decisions by August 15, 2015.

Recipients will be recognized at their place of employment or a regional PSNA event.

 

Efforts To Instill Empathy Among Doctors Is Paying Dividends

The patient was dying and she knew it. In her mid-50s, she had been battling breast cancer for years, but it had spread to her bones, causing unrelenting pain that required hospitalization. Jeremy Force, a first-year oncology fellow at Duke University Medical Center who had never met the woman, was assigned to stop by her room last November to discuss her decision to enter hospice.

Employing the skills he had just learned in a day-long course, Force sat at the end of her bed and listened intently. The woman wept, telling him she was exhausted and worried about the impact her death would have on her two daughters.

“I acknowledged how hard what she was going through was,” Force said of their 15-minute conversation, “and told her I had two children, too” and that hospice was designed to provide her additional support.

A few days later, he ran into the woman in the hall. “You’re the best physician I’ve ever worked with,” Force remembers her telling him. “I was blown away,” he says. “It was such an honor.”

Force credits “Oncotalk,” a course required of Duke’s oncology fellows, for the unexpected accolade. Developed by medical faculty at Duke, the University of Pittsburgh and several other medical schools, “Oncotalk” is part of a burgeoning effort to teach doctors an essential but often overlooked skill: clinical empathy. Unlike sympathy, which is defined as feeling sorry for another person, clinical empathy is the ability to stand in a patient’s shoes and to convey an understanding of the patient’s situation as well as the desire to help.

Clinical empathy was once dismissively known as “good bedside manner” and traditionally regarded as far less important than technical acumen. But a spate of studies in the past decade has found that it is no mere frill. Increasingly, empathy is considered essential to establishing trust, the foundation of a good doctor-patient relationship.

Studies have linked empathy to greater patient satisfaction, better outcomes, decreased physician burnout and a lower risk of malpractice suits and errors. Beginning this year, the Medical College Admission Test will contain questions involving human behavior and psychology, a recognition that being a good doctor “requires an understanding of people,” not just science, according to the American Association of Medical Colleges. Patient satisfaction scores are now being used to calculate Medicare reimbursement under the Affordable Care Act. And more than 70 percent of hospitals and health networks are using patient satisfaction scores in physician compensation decisions.

While some people are naturally better at being empathic, said Mohammadreza Hojat, a research professor of psychiatry at Jefferson Medical College in Philadelphia, empathy can be taught. “Empathy is a cognitive attribute, not a personality trait,” said Hojat, who developed the Jefferson Scale of Empathy, a tool used by researchers to measure it.

“The pressure is really on,” said psychiatrist Helen Riess. The director of the empathy and relational science program at Massachusetts General Hospital, she designed “Empathetics,” a series of online courses for physicians. “The ACA and accountability for health improvement is really heightening the importance of a relationship” between patients and their doctors when it comes to boosting adherence to treatment and improving health outcomes.

“Demographics and economics are driving this,” said James A. Tulsky, one of the developers of “Oncotalk.” (The original course for oncologists has been adapted for other specialties under the aegis of Vital Talk.) “Baby boomers have higher expectations” and are less willing to tolerate doctors they consider arrogant or unapproachable, added Tulsky, director of the Duke Center for Palliative Care. A 2011 study he headed found that doctors who took the course inspired greater trust in their patients than those who did not.

While empathy courses are rarely required in medical training, interest in them is growing, experts say, and programs are underway at Jefferson Medical College and at Columbia University School of Medicine. Columbia has pioneered a program in narrative medicine, which emphasizes the importance of understanding patients’ life stories in providing compassionate care.

While the curricula differ, most focus on self-monitoring by doctors to reduce defensiveness, improve listening skills (one study found that, on average, doctors interrupt patients within 18 seconds) and decode facial expressions and body language. Some programs use actors as simulated patients and provide feedback to individual doctors.

Too Busy For Empathy

“In the 1980s, when I trained, the emphasis was on medical knowledge and technical skills,” said Debra Weinstein, vice president for graduate medical education at Partners HealthCare, the largest provider of medical services in Massachusetts. But in the past decade, “the profession has been more attuned to patient satisfaction and the connection between satisfaction and outcomes and incentives.”

Partners, which includes Mass General and other Harvard teaching hospitals, is requiring that its 2,000 residents take “Empathetics.” In a 2012 study involving 100 residents, researchers found that doctors randomly assigned to take the course were judged by patients as significantly better at understanding their concerns and making them feel at ease than residents who had not undergone the training.

Riess said that while some doctors have told her they don’t have the time to be empathic, the skill has proved to be a timesaver rather than a time sink. It can help doctors zero in on the real source of a patient’s concern, short-circuiting repeated visits or those “doorknob moments” doctors dread, when the patient says “Oh, by the way . . . ” and raises the primary concern as the doctor is headed out of the room.

Because a lack of empathy and poor communication drive many malpractice cases, a large malpractice insurer, MMIC, is urging doctors it insures to take the “Empathetics” course. Another benefit: Empathy training appears to combat physician burnout.

“Empathy training is naturally self-rewarding,” said Laurie Drill-Mellum, a former emergency room doctor who is chief medical officer of the Minneapolis-based insurer. “It gives [doctors] the love back,” she said, referring to the positive feedback empathic doctors receive from their patients.

‘Doctors Are Explainaholics’

Both Riess and Tulsky say their interest in empathy was sparked by personal experience. In Riess’ case, it was the flood of patients in her psychiatric practice a decade ago who spent their time in therapy discussing devastating interactions with doctors. “These are not just innocuous effects,” she said, “but often experiences that were profound and deeply affected people’s lives.”

Tulsky said that his father, an obstetrician-gynecologist in a solo practice, routinely talked about his patients at dinner. “His stories were about their lives, so I got this idea that medicine was about more than the illness,” he recalled. In medical school, Tulsky said, “I was very drawn to challenging moments in patients’ lives and volunteered to give bad news,” particularly when he believed other doctors would botch it.

“I saw a lot that disturbed me,” Tulsky said. One memorable incident involved his chief resident loudly berating a frightened, impoverished and very sick old man, saying, “If you don’t have this operation, you’ll die. Don’t you understand?”

Tulsky said that researchers have found that some doctors don’t respond with empathy because they are clueless when it comes to reading other people. Many others, he said, do recognize distress but fear unleashing a flood of emotion in the patient, and sometimes in themselves.

“Doctors are explainaholics,” Tulsky said. “Our answer to distress is more information, that if a patient just understood it better, they would come around.” In reality, bombarding a patient with information does little to alleviate the underlying worry.

The “Empathetics” program teaches doctors “how to show up, not what to say,” said Riess. “We do a lot of training in emotional recognition and self-monitoring.” That includes learning to identify seven universal facial expressions — using research pioneered by psychologist Paul Ekman — and to take stock of one’s own emotional responses to patients or situations.

Some of the course is explicitly prescriptive: Make eye contact with the patient, not the computer. Don’t stand over a hospitalized patient, pull up a chair. Don’t conduct a monologue in off-putting medicalese. Pay attention to tone of voice, which can be more important than what is said. When delivering bad news, schedule the patient for the end of the day and do not allow interruptions. Find out what the patient is most concerned about and figure out how best to address that.

One Doctor’s Experience

Andy Lipman has taken the Duke course twice: first as an oncology fellow in 2004 and last year as a practicing oncologist in Naples, Fla., when he felt in need of a “booster shot.” Oncology, he said, “is a full-contact” specialty with a high burnout rate.

Among the most important lessons Lipman said he learned during both sessions was to let go of “my own medical agenda, the desire to fix something or make something happen in that visit.” He learned to pace himself, monitor his reactions and talk less.

Every day, he said, he thinks about what he was told in 2004: “Never answer a feeling with a fact.” That means responding to a patient in a six-month remission from cancer who reports having a sore elbow by saying, “Tell me more about your elbow. This is probably scary stuff” and not “Your scans show no evidence of disease.”

One technique Lipman routinely employs is taking 15 seconds before entering an exam room to ask himself, “What is needed here?”

On the day he was interviewed, Lipman said, he used what he has learned with a patient with end-stage cancer. She was scheduled for a brief appointment but began weeping loudly as she told Lipman how alone she felt.

“I engaged, I expected the emotional response and I hung in there,” he said of the meeting, which lasted 45 minutes. “It felt good to me,” Lipman said, and he hoped it gave his patient some comfort.

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

RN Delegation Lobbies, Protests in Sacramento to Stop TPP, Fast Track

Dozens of nurses and supporters gathered Tuesday in Sacramento, to protest what they say is the REAL “trade” being faced by the U.S. and 11 other countries, under an impending, secretive trade agreement called the Trans-Pacific Partnership (TPP): Public health in exchange for corporate profits.

“The TPP is going to cause a lot of harm to people in this country,” emphasized Kaiser Oakland RN Kathy Donahue, during a rally at the Sacramento offices of PhRMA, the lobbying arm of the pharmaceutical industry. RNs are particularly concerned about the major risks the TPP poses to public health as a result of numerous provisions written by corporate lobbyists—including inflating drug costs, threatening food safety, and nullifying environmental protections.

“Senior citizens are not going to be able to buy their drugs at the rate they have been in the past,” said Donahue, citing a 12-year monopoly drug pricing that would be given to global healthcare corporations. “HIV and AIDS patients may no longer be able to afford medication. Families may no longer be able to afford medications for their child.

Earlier in the day, Donahue joined RNs Diane McClure (South Sacramento Kaiser) and Dolores Trujillo (Kaiser Roseville) for a meeting at the offices of Congressman Ami Bera, to lobby against “Fast Track” authority, which would allow the TPP to slide through Congress unchallenged.

“We expect congressman Bera to be a champion on this issue. The TPP undermines health protections for our community,” says Trujillo. I

Nurses are visiting several members of Congress – including Congress members Scott Peters and Susan Davis in San Diego, and Norma Torres in Ontario –

Congresswoman Barbara Lee recently said, “I join the vast majority of Americans, from both parties, in opposing Fast Track for the Trans-Pacific Partnership. If the U.S. is going to pursue a free trade agreement in the Pacific, Congress needs to have public debates and hearings so the deal is fair and the American people know what’s in it”—a sentiment RNs say they hope for from all congress members they are visiting this week.

After the Bera visit, the nurses reconvened at PhRMA’s offices, now dozens strong, along with supporters from the Sacramento Central Labor Council, to demand a stop to Fast Track and the TPP. Chanting, “Stop TPP now!” the group marched down K street, then into the lobby, demanding to speak with a PhRMA rep. The gigantic pharmaceutical corporation responded by locking down the elevators and stairs.

“We’re here to let PhRMA know we are against fast track and the TPP!” Donahue said, in a raucous rally the group held in the lobby, in lieu of being allowed onto PhRMA’s floors. “We’re giving a loud message: Stop TPP now!”

Supporters from the Sacramento Central Labor Council also voiced solidarity with the California Nurses Association/National Nurses United, in the nurses’ fight against TPP.

“What you’re doing is working,” said Robert Longer, Legislative-Political Director of the Communications Workers of America. “If we can stop Fast Track, we can stop the TPP. We can protect your patients—our health, our safety. Keep up the good work; we are all fighting the same fight, and we are going to win this thing!”

Holding a giant prescription pill bottle breaking down the inflated costs of medicine under the TPP, and a banner warning “TPP, Fast Track Puts Our Health in Danger!” the nurses and supporters managed to disrupt the morning at PhRMA’s otherwise quiet offices. And at the end of their spirited rally, they left behind, in the spacious lobby, the echo of their final chanted words: “We’ll be back! We’ll be back!”

For more information on Fast Track/TPP:

Bemidji Clinic RNs say yes to new contract

bemidji vote 3
bemidji vote 2
miranda krippner bemidji

 

RNs at Sanford Bemidji Clinic ratified their first contract in February after being officially recognized as part of MNA last October.

RNs say they’re happy to have a contract that protects patients and nurses alike.

“We’re excited about having a contract that protects our rights and ensures we’re all treated fairly,” said negotiating team member Christine Sheikholeslami.

“The new contract creates a wage scale, so raises are allocated fairly and consistently,” said member Tina Hawver.

Previously, managers gave raises arbitrarily.

The contract raises wages for all members, creates security in scheduling, and provides all other contract language to the Clinic RNs that hospital employees receive, such as more affordable health insurance and a cap on mandatory low-census days.

In 2017, the hospital and clinic nurses will bargain together for a new contract as one united group.

 

 

 

Republican Lawmakers Sink Montana Governor’s Medicaid Expansion Plan

Obamacare’s tenuous toehold in Montana appears to be growing no firmer. Despite a hearing crowded with supporters of the Democratic governor’s Medicaid expansion bill, Republican legislators have dealt the measure a likely death blow.

Republicans control both houses of the Montana legislature, which meets only every other year, and the health law has been controversial. The legislature refused to set up a state-run insurance marketplace before enrollment began and in 2013 it turned down a proposal to expand Medicaid. But statehouse Democrats were hopeful they could ally with enough moderate Republicans to gain a majority of votes in favor of their bill this year.

House Republicans, however, refused to advance  the bill  and invoked a rule requiring a three-fifths majority of House members to vote  for the bill to continue to the floor. That threshold is widely regarded as unattainable.

“This is a clear abuse of the power of a committee chairman,” complained House Minority Leader Chuck Hunter, a Democrat from Helena.

But the committee chairman, Rep. Art Wittich, said he and fellow Republican committee members were well within their rights to deny advancing the minority party’s bill.

“We are not a democracy by decibel,” said Wittich, who comes from Bozeman. “The democracy includes how the legislature is made up. There is a Republican majority in each house. We are the majority, and we play by the rules.”

Wittich’s move to forestall debate came at the end of the bill’s marathon first hearing last Friday, where more than 200 Montanans spent hours urging Medicaid expansion. Speakers represented the state’s hospital association, it’s low-income clinics, doctors and nurses groups, Native American tribes and the state public health association. Expansion is also backed by the state chamber of commerce.

Only a dozen people testified against the bill, including one self-proclaimed Tea Party member and two staffers from Americans for Prosperity, a group funded by the conservative Koch brothers that is campaigning against Medicaid expansion in several states.

Republicans on the committee were unmoved by proponents. They voted as a block to give the bill a “do not pass” recommendation, meaning it dies barring three-fifths of the entire House voting to revive it.

Wittich cited last November’s election outcomes as a mandate from the electorate.

“Most people in Montana do not want to increase government and grow our welfare state,” Wittich said. “So even though there may have been more people that particular night who were bussed in, and who came in, and they were organized, doesn’t dictate the outcome.”

Governor Bullock said Friday’s party-line committee vote, “told Montanans that…members of the legislature value the voices of out-of-state, dark money groups over the voices of thousands of Montanans who spoke out in favor” of his expansion plan.

But, Bullock said, “I’m not done working on this. My door remains open to legislators willing to find real solutions.”

A Great Falls Republican, Sen. Ed Buttrey, is pitching a plan that would extend Medicaid to as many Montanans as Bullock’s bill proposed. The Great Falls Tribune says Buttrey’s bill proposes premiums and co-pays for Medicaid recipients, as well as means testing.

“This is a Republican bill crafted by conservatives,” Buttrey told the Tribune. “There’s more personal responsibility and accountability. Everybody pays.”

Buttrey’s bill is still being drafted, but Bullock has already rejected another Republican Medicaid expansion plan that would cover far fewer people than the 70,000 the governor says need it. That bill, by Sen. Fred Thomas, excludes “able-bodied” adults without dependent children.

“It’s hard to put them in the same boat as somebody that’s disabled, and say we’re gonna give you the same thing that we’re giving to this disabled person,” said Thomas, who represents a largely rural area south of Missoula.

Thomas proposes that childless, non-disabled Montanans who make less than the $11,760 a year required to qualify for Affordable Care Act premium subsidies, “up your hours and do what you can to get above the federal poverty level…. That’s a reasonable solution for that individual.”

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

Mental Health Providers Look For Federal Incentives To Go Digital, Too

John Duggan, a mental health counselor in Silver Spring, Md., pays for an electronic health record system to keep track of his patients. He started using the cloud-based system five years ago to eliminate paper and make his practice more efficient.

But unlike some other health professionals, Duggan has not received any financial support from the federal government to move his practice to digital records.

For now, he doesn’t qualify for any of the $26 billion available from the federal government’s Medicare and Medicaid Electronic Health Record Program, which was part of the 2009 stimulus package. That program has offered thousands of doctors and hospitals financial incentives to adopt electronic record systems that meet certain requirements, known as “meaningful use,” with the goal of reducing medical errors and boosting coordination.

Mental health clinics, psychologists and psychiatric hospitals were left out of the incentive and penalty program, along with nursing homes, emergency medical services and others. It’s been estimated by the consulting firm Avalere Health that including them would require an additional $1 billion.

“Fundamentally it came down to cost,” said Laurel Stine, director of congressional affairs at the American Psychological Association.

But there are other obstacles too, among them, concerns about safeguarding the privacy of patients who might face job loss and other consequences if their treatment for issues such as substance abuse were shared inappropriately. And critics of the existing program say it’s premature to invest more taxpayer money in electronic record systems that are balky and in many cases, unable to share information easily.

Nevertheless, Duggan is part of a coalition of mental health professionals and advocates that is pushing Congress to give them the same incentives enjoyed by other health care providers. Their efforts helped increase interest on Capitol Hill, where five bills introduced last year included help for mental health providers. None, however, made it out of committee.

“There is a lot of traction to do this, but ultimately we’re not over the finish line,” Stine said.

Rep. Tim Murphy, R-Pa., plans to reintroduce broad bipartisan legislation later this month to improve mental health services, which, among other things, would extend incentives to go digital to mental health providers. The bill is similar to a measure he introduced last year that did not advance.

But even some mental health providers who support the effort, see potential drawbacks. Burt Bertram, a mental health counselor in Orlando, Fla., noted that mental health records may include not only a person’s current treatment plan, but their past history which might include the issues of family members and former spouses.

“If a broad base of health professionals had access to mental health records that include psychotherapy notes, I am concerned about the potential for privacy violations … not only for the patient, but also for the others who are involved in the patient’s life,” he said.

Greg Simon of Depression and Bipolar Support Alliance, a patient advocacy group, said that more than half of the 400 members responding to an online 2013 survey agreed that mental health and medical records should be combined, while only 22 percent said they should not be combined.

On the same survey, however, more than half said they feared their doctors might discriminate against them if they knew they had mental health problems.

“People did express concern about discrimination even while they generally supported the idea of a shared record,” said Simon, a psychiatrist with Seattle-based Group Health, and an investigator with an affiliated research group. “My interpretation of that is that people recognized the value of a shared record and thought it outweighed the risk of discrimination.

Recent provider backlash against the existing government program may also be a roadblock.

Earlier this year, 37 medical societies led by the American Medical Association asked federal regulators to shift direction, arguing that today’s electronic records systems are cumbersome, inefficient and can also present safety problems for patients. Despite the billions of taxpayer dollars spent, they say many of the new systems cannot readily share information. Critics suggest it does not make sense to extend the program to others until those issues are fixed.

“The almost $30 billion spent on medical providers and hospitals was not well spent, so to take more money and throw it at psychologists before we have properly diagnosed why we didn’t get good … outcomes … we need to take a breather and reassess,” said John Graham, senior fellow at the National Center for Policy Analysis, a Dallas-based think tank that seeks to limit government regulation.

In March, the Office of the National Coordinator for Health Information Technology is scheduled to issue new information-sharing standards, and mental health advocates are hoping that will help their efforts.

For now, Duggan, like many other mental health professionals, must cover the costs of digital records himself and it runs about $500 a month, including his $90 fee for the cloud service, a fee to exchange information with primary care providers, and a billing and claims service.

In a few years, he says he hopes the technology will enable him to access his patients’ full medical records — both those he has created and those from other health professionals — to find out if patients are on medications, or have other conditions that could be contributing to their mental health problems. “It’ll be a beautiful day when that happens,” Duggan said.

Al Guida, a lobbyist for Guide Consulting Services who works on mental health issues, says the ability to share information seamlessly among providers is the ultimate goal. “The only way we’ll be able to coordinate care is if we use the same electronic health records as our medical/surgical colleagues.”

That’s particularly important for patients with mental health issues because many have high rates of substance abuse disorders and physical illnesses, said Laura Fochtmann, a professor of psychiatry at New York’s Stony Brook University Hospital, who serves on the American Psychiatric Association’s Committee on Electronic Health Records.

Such patients also tend to see a larger number of physicians and can be on a range of medications and treatment regimens that require coordination, she said.

“The fact that behavioral health is carved out of this is unfortunate and problematic. The more we can integrate care, the better it is for patients,” she added.

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

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.