ST. LOUIS — Dr. Laurie Punch plunged her gloved hands into Sidney Taylor's open chest in a hospital's operating room here, pushing on his heart to make it pump again after a bullet had torn through his flesh, collarbone and lung. His pulse had faded to nothing. She needed to get his heart beating.
She couldn't let the bullet win.
Bullets are Punch's enemy. They threaten everything the 44-year-old trauma surgeon cherishes: her patients' lives, her community, even her family. So, just as she recalled doing two years ago with Taylor, Punch has made it her life's mission to stem the bleeding and the damage bullets cause — and excise them if she can.
In the operating rooms at Barnes-Jewish Hospital, Punch treats gunshot victims, removing bullets that studies show can poison bodies with lead and fuel depression. And in her violence-racked community, she teaches people how to use tourniquets to stop bleeding, creating a legion of helpers while building trust between doctors and community members.
Punch feels a calling to St. Louis, a place with the nation's highest murder rate among big cities, where at least a dozen children were shot to death this summer alone, including a 7-year-old boy playing in his backyard. Punch believes all she's learned has prepared her for now, when gun violence kills an average of 100 Americans a day and mass shootings are so common that two this summer struck less than 24 hours apart.
To her, the battle is personal, in more ways than one.
Besides being a surgeon, she's a multiracial single mom living in Ferguson, Mo., just over a mile from where Michael Brown Jr., a black teenager, was shot and killed by a white police officer five years ago.
She has a son the same age as the little boy killed in the backyard in August. And she said, "I hear the gunshots echoing through my 2-acre backyard all the time."
The 23-year-old was brought to Punch's hospital last summer, shot seven times. While the nurses gave him blood, Punch said, she cut open his chest, trying to force life back into his body — to no avail.
"I watched his wife sink, as the floodwaters of vulnerability and risk came into her eyes, thinking about the life of her and her child and how they would live without him," Punch told the assembled lawmakers. "I watched his father rage. And I heard his mother wail."
Punch placed the black-and-yellow, blood-splattered Adidas sneakers she'd worn the day of the shooting on the table before her in the hearing room.
"I can't wash these stains out," she told lawmakers.
The trauma surgeon was adamant: Violence is a true medical problem doctors must treat in both the operating room and the community. Until they do that, she said, violence victims will continue to be vectors who spread violence.
"The disease that bullets bring does not yet have a name," she told Congress that day. "It's like an infection, because it affects more than just the flesh it pierces. It infects the entire family, the entire community. Even our country."
But healing also can be contagious — spreading among victims, families and the physicians themselves.
Punch, who regularly visits the neighborhoods where her patients live, attended an event last year for Saint Louis Story Stitchers, an artist and youth collective working to prevent gun violence. She remembers spotting a volunteer she knew — Antwan Pope, who'd been shot some years earlier but had found renewed purpose helping young people.
Punch told Pope about Hibler's case, and learned Hibler was Pope's cousin. Hibler's dad was at the community event, too, and he handed Punch a lapel pin with his son's picture.
She wore it on her white coat for months.
Two Worlds
Punch was born in Washington, D.C., the only child of a Trinidadian father and white Midwestern mother. They separated six months after her birth.
Until she was 7, Punch moved every year with her mom. They eventually settled with Punch's grandmother in the tiny town of Wellsville, Ohio, a close-knit but segregated community.
Classmates bullied her for being different, Punch recalls.
"I was different in every way because I wasn't black; I wasn't white," said Punch, who later came out as gay.
From the time Punch was 9, she took $2 piano lessons from Elizabeth Carter. The local music teacher had transformed former drug dens into places with music lessons, free clothes and meals, and put all the kids who sought her help to work. Punch's assignment was serving food.
"You show someone that they can help," Punch said, "it's revolutionary."
That lesson guided her life as a child and when Punch moved on to Yale University, the University of Connecticut's medical school and then the University of Maryland Medical Center in Baltimore, where poverty and trauma scarred many of her patients' lives.
Punch spent her early career in the shock trauma center in Baltimore, throwing everything she had into saving others.
After marrying a woman she met as a medical intern, Punch became pregnant with twins at 35.
The next few years were marked by highs and lows in her personal life and the unrelenting stress of dealing with the aftermath of violence at work.
She miscarried at five months. No one could tell her why.
Five months later, she became pregnant again, this time giving birth to a healthy boy, Sollal Braxton Punch. But not long later, she and her wife separated. Now she found herself as a single parent as the pressures of her job mounted.
One morning, three shooting victims arrived at the trauma center, quickly followed by a car crash victim who was pregnant. Punch's nanny texted her, saying Sollal had a fever of 102.3.
"I realized I can't do this anymore," Punch said. "I just can't."
The Call Of Community
So, she took a break from trauma for more than two years, focusing on general surgery at Houston Methodist Hospital in Texas.
But in 2015, a former colleague contacted her about a job as a trauma surgeon and educator at Washington University in St. Louis.
She feared going back to another troubled city. Michael Brown Jr. had been killed in Ferguson, Mo., a little more than a year earlier, triggering unrest and riots in that city just outside St. Louis.
Despite the area's well-known history of violence, she flew to St. Louis for interviews, then rode around Ferguson with Dr. Isaiah Turnbull, an assistant professor. He pointed out the spot on Canfield Drive where Brown's body had lain in the road for more than four hours.
"It was almost like seeing Ground Zero," Punch said. "This is where it all went down. And it went down because of deep structural realities that caused the experience of black and brown people in north St. Louis to be fundamentally different. I went from not wanting to go to wanting to be right in the middle of it."
And now she is.
On a recent hot summer evening, 20 people — some black, some white — gathered around Punch. A few feet away, a doctor, a trauma nurse and a medical student stood near tables stacked with "pool noodles," the long foam cylinders kids play with in swimming pools — these happened to be about the width of a human arm.
Punch told the class that a person can bleed to death in a minute, but an ambulance can take 15 minutes to arrive.
"If you can stop the bleed, you can save a life," she said. "Time is life and minutes matter."
Participants practiced packing wounds by pressing gauze into holes in the pool noodles. They tightened tourniquets — first on the foam cylinders, then on each other.
Punch knows one of the doctors who created the "Stop the Bleed" training sessions after the mass shooting at Sandy Hook Elementary School in Connecticut. She realized the same training could save lives after street shootings, too.
Since March 2018, she and her team have trained more than 7,000 community members in the St. Louis metropolitan area. Many come to a rented space she dubbed "The T," for trauma, tourniquet and time. But Punch's team has also held classes in schools, a juvenile detention center and a firing range.
"It's far more than teaching people what to do," Punch said. "They learn: 'I am not simply a victim or a perpetrator or an observer; I'm a helper. I have the capacity to help.'"
Contagious Healing
Two years ago, Sidney Taylor was shot outside his brother's comedy club in north St. Louis County while trying to help a friend who was drunk. When Taylor arrived at Punch's hospital, profuse bleeding had left his blood pressure dangerously low.
At one point, the father of four technically died on the operating table, but Punch and her team pulled him back.
After 10 days in intensive care, the longtime wrestling coach was still in physical and mental agony.
That's the point when many patients slip back to their communities unhealed. But Taylor, now 47, showed up in Punch's clinic a month after he had been shot, and they bonded during a 25-minute visit. Punch described to him how her team had removed part of his lung and inserted a breathing tube.
"Wow," he told her. "I have another chance at life."
Punch mulled a thought, then asked. "Would you ever want to share your story?"
Taylor agreed.
Punch recruited his hospital caregivers to create a video of their memories of saving him. When the taping finished, Taylor hugged each one.
Punch uses the video during talks, sometimes inviting Taylor to join her. Giving back to the community in that way has saved him a second time, he said.
After getting shot, "I could've basically turned to the dark side and done straight revenge," Taylor said. "But I didn't because of her."
No clear split between conservative and liberal Supreme Court justices emerged Tuesday as justices heard arguments over whether the federal government could renege on Congress' promise to pay health insurance companies billions to motivate them to participate in the Obamacare marketplaces.
Health insurers hope to recoup $12 billion they believe is owed to them from that Affordable Care Act incentive program.
During the hour of oral arguments, six justices appeared to favor the insurers' argument — Chief Justice John Roberts, plus justices Ruth Bader Ginsburg, Stephen Breyer, Sonia Sotomayor, Elena Kagan and Brett Kavanaugh. Samuel Alito seemed to side with the Trump administration. Neither Clarence Thomas nor Neil Gorsuch spoke during the session.
The Trump administration argues it doesn't have to pay the money because a Republican-controlled Congress stripped away most of the funding in 2014 and only Congress can appropriate money under the law.
The so-called risk-corridor payments were designed to help health plans recover some losses in the first three years of the Obamacare marketplaces. Congress gave the incentive because of the uncertainty insurers faced regarding how sick or costly this previously uninsured population would be.
Insurers that made large profits were to pay some of it back to the government to share with money-losing insurers. But the money taken in under the program fell billions short of the amount owed to insurers. The Obama administration told insurers it would make up the difference with funds from the Centers for Medicare & Medicaid Services' budget. But in late 2014 ― after insurers began selling policies to millions of Americans with the expectation that the safeguard would back them up ― Congress barred the federal government from using that funding stream.
Kagan noted how the profitable insurers are still obligated to pay money into the risk-corridor program even though the federal government says it no longer has to pay out.
"You pay in, that's obligatory. We commit ourselves to paying out. It turns out, if we feel like it. What, what kind of, what kind of a statute is that?" she asked.
No justice was more critical of the administration's position than Breyer. He questioned why the 2010 health law promised money to insurers who lost money but later took it away after the insurers began covering millions of customers.
"My hat's on the flagpole. If you bring it down, I'll pay you $10. You bring it down. I owe you $10. Now how does this differ?"
Deputy Solicitor General Edwin Kneedler, who was arguing the case for the Justice Department, responded that insurers had many reasons to participate in the Obamacare marketplaces beyond the promised risk-corridor payments, most notably that they are the only places millions of people could get federal subsidies to lower their health insurance premiums.
Roberts interjected: "It's a good business opportunity for them because the government promised to pay."
Kavanaugh, the newest and one of most conservative justices, suggested to Kneedler that a high court ruling against the insurers could set a precedent to not fund other federal programs with no specific appropriation amount. "If we were to rule for you, everyone will be on notice going forward, private parties and Congress itself, that 'shall pay' doesn't obligate actual payments."
A ruling on the case, Maine Community Health Options v. United States, is expected in the spring.
There's a new question that anti-hunger advocates want doctors and nurses to ask patients: Do you have enough food?
Public health officials say the answer often is "not really." So clinics and hospitals have begun stocking their own food pantries in recent years.
One of the latest additions is Connectus Health, a federally qualified health clinic in Nashville, Tenn. This month, part of LaShika Taylor's office transformed into a community cupboard.
"It's a lot of nonperishables right now, just because we're just starting out," she said, but the clinic is working on refrigeration so it can also stock fresh food.
It's not that patients are starving, Connectus co-director Suzanne Hurley said. It's that they may have a lot of food one day and none the next. That's no way to manage a disease like diabetes, she said.
"I can prescribe medications all day, but if they can't do the other piece—which is a decent diet and just knowing they're not going to have to miss meals," she said, "medications have to be managed around all of those things."
Second Harvest Food Bank of Middle Tennessee, a local food bank, is encouraging more health care providers to consider on-site pantries. The food bank also wants every patient—not just those suspected of being low income—to be asked about their food situation.
"We're really pushing for universal screening, so you're not picking who you're asking that question to. The doctor already asks you really personal questions, and we don't think twice about it," said Caroline Pullen, Second Harvest's nutrition manager. "I think people have always been scared to ask this question because they didn't really have the resources of where to send them."
"Food insecurity," as it's known, has become a particular concern among seniors. The anti-hunger group Feeding America found that more than 5 million older Americans don't have enough food to lead a healthy life—a figure that has doubled in the last two decades.
In response, food banks are increasingly meeting seniors where they get their health care. Hospitals from Utah to Massachusetts are sending patients home with food.
Trudy Hoffman now gets free groceries at her monthly visits to Nashville General Hospital.
"They just asked me, did I want a bag of food to carry home?" she recalled. "And I said, 'Yeah.'"
The city-funded hospital started its pantry just for cancer patients in recent years but opened it to all patients this year and received a $100,000 grant in October to fund its expansion.
Organizers call it a "food pharmacy," following the lead of places like Children's Hospital of Philadelphia, with patients getting a "prescription" for what to pick up. Some shelves have high-calorie superfoods for cancer patients to keep their weight up. Others have low-sugar staples for people with diabetes and low-sodium items for patients with hypertension.
Vernon Rose, who oversees the Nashville General Hospital Foundation, said no one is surprised to see dozens of patients using the pantry each day.
"Because when you're in a place like ours, where 40% of the folks can't even afford their health care, you can imagine the choices they're making," she said—such as deciding whether to pay for food, utilities or medicine.
The pantry operates mostly with grant funding. So Rose said the biggest challenge now is keeping it fully stocked with important but more expensive items like fresh produce and spices, which can be used to help patients keep some flavor while reducing salt in their diet.
This story is part of a partnership that includes WPLN, NPR and Kaiser Health News.
More than $12 billion is at stake for the nation's health insurers Tuesday when the Supreme Court hears another Affordable Care Act case.
For the federal government, the potential damages could be far greater, as its reputation as a reliable partner to private businesses is on the line.
Unlike earlier Obamacare cases before the high court—where the entire 2010 law and health coverage for millions of Americans was at risk—the latest case has largely flown under consumers' radar.
The case revolves around a temporary Obamacare provision—called the "risk-corridor" program—that was designed to help health plans recover some losses in the first three years of the health law marketplaces.
The Republican-controlled Congress in late 2014 stripped most of the money out of the program in a budget bill signed by President Barack Obama. This occurred a year after insurers began selling policies to millions of Americans with the expectation that the safeguard would back them up.
Republicans led by Sen. Marco Rubio (R-Fla.), who were determined to repeal the ACA, called the original provision an insurer "slush fund." But researchers later found that the loss of the risk-corridor program was largely responsible for soaring premiums in 2016 and 2017, and contributed to several startup insurers going out of business.
Dozens of insurers have cried foul and sued the government. Lower courts were split on whether the government should be forced to make the payments.
Here are five reasons you should pay attention to the case:
1. The integrity of the federal government is at stake.
Health insurers say the government's decision on the risk-corridor program amounts to a bait-and-switch. The health plans took a chance with the new marketplaces, where they had little knowledge of how sick or expensive new enrollees would be. They said they expected the risk-corridor funding would back them up.
The latest data shows the government owes insurers more than $12 billion in payments to cover losses on the insurance exchanges between 2014 and 2016.
"This case warrants comparison to Lucy Van Pelt pulling the football away from Charlie Brown—with our nation's government cast as the capricious bully," the Association for Community Affiliated Plans, an industry group representing nonprofit health plans, wrote in an amicus brief to the Supreme Court. "If the Federal Circuit's rule stands, then from now on no business can trust a statutory promise of payment from the government."
The risk-corridor program was one of several ACA safeguards for insurers. The law called for insurers that made large profits to pay some of it back to the government to share with money-losing plans.
But the money taken in under the program fell billions short of the amount owed to insurers. The Obama administration told insurers that it would make up the difference with funds from the Centers for Medicare & Medicaid Services' budget. The General Accountability Office, the investigative arm of Congress, supported that decision for 2014.
The Trump administration argued the federal government never had power under the law to make the payments out of the CMS budget. The December 2014 budget deal confirmed that, according to the administration.
The federal government's top lawyer rejects insurers' notion that the risk-corridor money was ever guaranteed to them.
Congress did not "lure private parties into expensive undertakings with clear promises, only to renege after private parties have relied to their detriment and incurred actual losses," Solicitor General Noel Francisco argued in court briefs.
2. Obamacare consumers may benefit if the court sides with the insurers.
The Supreme Court case combined suits from four insurers: Moda Health Plan of Oregon, Maine Community Health Options, Blue Cross Blue Shield of North Carolina and Land of Lincoln Mutual Health Insurance, a now-defunct health plan from Illinois. But dozens of other insurers also have filed lawsuits. If the court rules in favor of insurers, it could force the federal government to pay them $12 billion.
Experts say that could have a marginal effect on those insurers in setting future premiums. It could also force some plans to make rebate payments to customers based on another ACA provision that plans pay money back to members if they spend more than 20% of their premium dollars on administration, marketing and profits.
Meg Murray, CEO of the Association for Community Affiliated Plans, said the government owes $627 million to about 20 of her organization's plans. "The money would help them going forward in paying back debts or investing their plans or reducing premiums," she said.
3. The co-ops have been stymied.
When the Affordable Care Act was nearing its final votes, Democrats removed a controversial provision that would have set up a government-operated plan that would be a "public option" for consumers. It was replaced with federal money to start new, nonprofit insurers to bring more competition into many markets, which lawmakers hoped would help hold down premium costs. There were 23 new health cooperatives that started enrolling members in 2014. Today, just four are still in business.
More than other insurers, the co-ops were most at risk when the money was eliminated because they operated on the smallest budgets.
"This was a huge factor in the failure of the co-ops," said Timothy Jost, a retired law professor at Washington and Lee University in Lexington, Va., who has studied the ACA.
Kevin Lewis, CEO of Maine Community Health Options, said his company is owed $59 million. Without that money, his plan had to withdraw from New Hampshire and raise premiums in areas it still serves. Community Health Options is one of three health plans on the marketplace in Maine and has 38,000 members.
Lewis said that, while many factors caused the demise of the co-ops, the loss of risk-corridor money is high among them.
4. The U.S. Chamber of Commerce—a leading opponent of Obamacare—is defending the risk-corridor provision.
The chamber has spent nearly a decade and millions of dollars fighting to overturn the Affordable Care Act. That's why its amicus brief supporting insurers' fight to restore its risk-corridor funding is so notable.
In its brief, the chamber said the health law promised funding to private insurers, and when the government reversed its commitment, "it pulled the rug out from under them."
The court's ruling would reverberate well beyond just the health insurance industry if it does not reverse lower court rulings, according to the chamber.
"If allowed to stand, the decision will chill the business community from working with the federal government in the future," the chamber said.
5. A ruling could influence another big Obamacare case.
If the justices rule in favor of the insurers on this case, they may strengthen the industry's argument in a separate ACA lawsuit working its way through lower courts.
Insurers have sued the federal government for $2.3 billion in unpaid "cost-sharing reduction" payments after the Trump administration stopped making the payments in 2017. Six insurers—in front of three different federal judges—have succeeded in their challenges over unpaid payments.
These ACA payments were intended to compensate insurers for reducing deductibles, copayments and coinsurance mandated by the ACA for marketplace enrollees with low incomes.
Some lawsuits from insurers have been stayed, pending the court's ruling on risk corridors.
SAN DIEGO—When Mary Prehoden gets dressed for work every morning, her eyes lock on the bite-shaped scar on her chest.
It's a harsh reminder of one of the worst days of her life. Prehoden, a nurse supervisor at Scripps Mercy Hospital San Diego, was brutally attacked last year by a schizophrenic patient who was off his medication. He lunged at her, threw her to the ground, repeatedly punched and kicked her, and bit her so hard that his teeth broke the skin and left her bleeding.
The incident lasted about 90 seconds, but the damage lingers.
"Even if I didn't have a scar, the scar is in your head," said Prehoden, 58. "That stays with you for the rest of your life."
Violence against health care workers is common—and some say on the rise.
According to the Occupational Safety and Health Administration, workplace violence is four times more common in health care settings than in private industry on average, yet it still goes underreported. Patients account for about 80% of the serious violent incidents reported, but stressed-out family and friends also are culprits. Co-workers and students caused 6% of the incidents.
In a 2018 poll of about 3,500 emergency room doctors conducted for the American College of Emergency Physicians, nearly 70% said violence in the emergency department has increased in the past five years.
About 40% of the doctors believed the majority of assaults were committed by psychiatric patients, and half said the majority were committed by people seeking drugs or those under the influence of drugs or alcohol.
In California, a state law requires hospitals to adopt workplace violence prevention plans and report the number and types of attacks to the state. The state then compiles the data into annual reports.
In the first full report, 365 hospitals tallied 9,436 violent incidents during the 12-month period that ended Sept. 30, 2018, ranging from scratchings to stabbings. Workers were punched or slapped in one-third of the assaults and were bitten in 7% of cases.
"I don't know that you ever expect to have to defend yourself at your workplace," Prehoden said. "It's not anything you're prepared for."
Scripps Mercy Hospital officials have made a number of changes to help protect employees from what they refer to as an epidemic of violence. They've launched a "rapid response" team made up of staff members who try to defuse potentially violent situations. And the hospital has introduced a behavioral screening tool to help identify patients prone to violence. When patients get flagged, they must wear a green wristband, and a green peace sign is placed on their door.
Ryan Sommer, who is the head of security at Scripps Memorial Hospital Encinitas, leads violence de-escalation training for Scripps staff at different locations throughout San Diego County.
On one recent morning, about 20 employees at the Encinitas facility learned how to deter an agitated and combative patient. One tip Sommer shared: Behavior influences behavior, so listen with empathy and establish a personal rapport with the patient. And, he told them, don't lose your cool; the goal is to get agitated patients to calm down.
Sommer also taught self-defense tactics should the situation escalate. In groups of two, employees practiced how to disengage from a hold and block strikes from an attacker.
"How many of you have been attacked on the job?" Sommer asked. Nearly all the participants raised their hands.
"This happens daily. They get punched, scratched, spit on, yelled at," he said later.
Sommer said the number of violent incidents at the Scripps hospitals is rising and the injuries are becoming more severe.
Since earlier this year, security guards at all Scripps hospitals have been armed with stun guns, said Janice Collins, a spokeswoman for Scripps Health. They wear stab-proof vests and are stationed strategically around the facilities. The stun guns are used when security guards believe they are needed to protect life, Collins said. Prehoden's situation would have met that criteria, she said.
Hospitals across California are taking similar measures with the hope of reducing violent confrontations, said Gail Blanchard-Saiger, the California Hospital Association's vice president of labor and employment.
Some sites use panic buttons, metal detectors, security dogs, increased police presence and security cameras, in addition to de-escalation training.
The efforts vary by location and risk, Blanchard-Saiger said.
Additional support from local law enforcement would make a difference, she said. "Unfortunately, I've heard plenty of stories where they don't even come to the hospital," she said. "They're short-staffed, underfunded. They're prioritizing."
Prehoden has attended the de-escalation training and is now on the rapid response team at Scripps Mercy Hospital.
It took her three weeks to return to work after she was beaten in August 2018. A nurse for almost 40 years, she admits being a little on edge now, and feels as if her attacker robbed her of her confidence. He served six months in jail for the attack.
"This cannot be the new face of nursing," Prehoden said. "We can't afford to lose our staff because somebody decides not to take his medication."
Although CMS has earned praise for responding to errors identified by Plan Finder users, some people may have signed up for plans before the mistakes were caught.
Saturday is the deadline for most people with Medicare coverage to sign up for private drug and medical plans for next year. But members of Congress, health care advocates and insurance agents worry that enrollment decisions based on bad information from the government's revamped, error-prone Plan Finder website will bring unwelcome surprises.
Beneficiaries could be stuck in plans that cost too much and don't meet their medical needs—with no way out until 2021.
On Wednesday, the Centers for Medicare & Medicaid Services told Kaiser Health News that beneficiaries would be able to change plans next year because of Plan Finder misinformation, although officials provided few details. And the Medicare.gov website and representatives at Medicare's call center had no information about that option.
The overhauled Plan Finder debuted at the end of August, and 2020 plan information was added in October. Over the past three months, Plan Finder problems reported to CMS by the National Association of Insurance Commissioners, the National Association of Health Underwriters, and state and national consumer advocates included inaccurate details about prices, covered drugs and dosages, and difficulty sorting and saving search results, among other things.
CMS made almost daily corrections and fixes to the website, which is the only tool that can compare dozens of private drug and medical plans―each with different pharmacy networks, covered drugs and drug prices. The website provides information for more than 60 million people with Medicare and their families, as well as state Medicare counselors and the representatives who answer the 800-MEDICARE help line.
In an unsigned blog article published on a Medicare website last week, officials said they're "not done improving the Plan Finder." And they promised "in the coming months we'll be scoping out additional improvements that we can implement based on lessons we learn this year."
Although CMS has earned praise for responding to errors identified by Plan Finder users, some people may have signed up for plans before the mistakes were caught―mistakes they may not notice until their coverage kicks in next year.
"Seniors should be able to choose the plans that work best for them," said Sen. Susan Collins (R-Maine), chairwoman of the Senate Special Committee on Aging. "Issues with Medicare's new Plan Finder website, however, have reportedly created confusion among beneficiaries as well as those assisting them." She added that she was concerned "this problem even occurred."
Medicare's response, Collins said, "must be vigorous with extensive outreach to inform seniors of special enrollment periods."
Sen. Bob Casey of Pennsylvania, the senior Democrat on that committee, also said Medicare needs to reach out so people know they can request a "special enrollment period" if they discover next year they made a wrong choice due to inaccurate Plan Finder information.
"People with Medicare must be aware that this reprieve exists and should not have to jump through hoops to qualify," he said. The administration should "use all means necessary" to let beneficiaries know about their options for a special enrollment period.
In the statement to KHN Wednesday, CMS said it provides special enrollment periods for a number of reasons. It added that beneficiaries can get a special enrollment period related to Plan Finder issues anytime next year.
They can "call 1-800-MEDICARE and explain to our call center representatives that they have an issue with their plan choice. It is not CMS's expectation that beneficiaries will have documentation or screenshots," the statement said. The call center representatives "are trained and ready to help the beneficiary through the rest of the process."
CMS officials refused to be identified but would not give a reason.
Information about Plan Finder special enrollment periods will be available on the Medicare.gov website and at the call center, a CMS spokesman said.
However, nothing was posted on the website Thursday, and when Kaiser Health News called Medicare twice Thursday, both representatives said it would not be possible to switch plans next year because of inaccurate information from the Plan Finder.
Applying for a special enrollment period could be tricky. In the blog post, Medicare officials said the information on the Plan Finder is "the most current and accurate information on premiums, deductibles and cost sharing that Medicare Advantage and Prescription Drug Plans provide." They noted that the "information changes frequently because plans regularly update drug formularies and renegotiate drug prices."
America's Health Insurance Plans, the trade group representing health insurers, "is not aware of any systematic problems with the Plan Finder, which is operated by CMS," said spokeswoman Cathryn Donaldson.
People who enroll in a private Medicare Advantage policy, an alternative to traditional government-run Medicare that covers both drugs and medical care, already have an alternative. They have until March 31 to change plans or enroll in traditional Medicare.
Collins and Casey are not the only members of Congress raising the issue. Sen. Sherrod Brown (D-Ohio) wants CMS to provide a special enrollment period in these cases and clearly communicate the details, a spokesman said.
Rep. Richard Neal (D-Mass.), who chairs the House Ways and Means Committee, believes Saturday's deadline should be extended, a committee aide said. The committee has heard about the Plan Finder's problems from numerous seniors' advocates and counselors from state health insurance assistance programs, as well as the insurance companies that sell coverage.
Since enrollment for 2020 coverage began Oct. 1, the National Association of Health Underwriters, which represents 100,000 insurance agents, has sent CMS officials 54 Plan Finder problems and is still receiving reports from agents, said John Greene, the vice president for congressional affairs.
The Medicare counselors at Nebraska's Senior Health Insurance Information Program flagged more than 100 issues as of mid-November, said Alicia Jones, the program's administrator.
After receiving complaints about the Plan Finder, Delaware's insurance commissioner, Trinidad Navarro, issued a consumer alert last week.
Tatiana Fassieux, education and training specialist at California Health Advocates, said her organization wants CMS to offer a blanket, nationwide special enrollment period instead of granting it case by case. The group helps train Medicare counselors for California's Health Insurance Counseling and Advocacy Program, known as HICAP.
Leslie Fried has been an elder law attorney in Washington, D.C., since 1985, so imagine her surprise when she was stumped last weekend helping her mother pick a policy through the Plan Finder.
Fried, who is also senior director of the Center for Benefits Access at the National Council on Aging, did the same search three times for the least expensive plans that cover her mother's drugs and came up with a different result each time.
"Beneficiaries should be able to have confidence in the Plan Finder after a single search," she said.
For assistance reviewing drug and medical plans, call your state's Senior Health Insurance Information Program at 877-839-2675 or the Medicare Rights Center at 800-333-4114.
The current complexity is an outgrowth of countless decisions over the past 30 years, many of which sounded logical at the time but which grew out of financial considerations.
This story, which ran as an opinion piece in The Boston Globe, was published December 6, 2019, by Kaiser Health News.
In this highly partisan political moment, there's one issue that nearly every American can agree on: Our health care system is a mess and in need of dramatic overhaul.
That's not just because it is absurdly expensive compared with the systems of other developed countries. It's also because it is so dauntingly complex.
That complexity, in large part, derives from the fact that the health care system has been driven significantly by profit, rather than by measures of health. Countless providers, companies, consultants and intermediaries are trying to get their piece of the $3.5 trillion pie that is U.S. health care. Nora Ephron said, "Everything is copy." In 21st-century U.S. health care, everything is revenue, and so everything is billed.
That has led to a maze-like system—with twists and turns and barriers and blind alleys and incomprehensible signposts—that ordinary people are expected to navigate.
We say American patients should be happy because our system gives consumers choices. We tell people that to benefit they just need to be smarter shoppers.
What we are really telling them is to perform the impossible.
How can they choose an insurance policy when there are endless permutations involving personal budget calculations and modeling that would defy a post-doc in economics? For each policy, there's an in-network deductible and an out-of-network deductible, overlapping for the family and each individual. There are copays and coinsurance (yes, they're different), as well as an annual maximum personal out-of-pocket outlay (which may not include some of the above).
Likewise, how to choose between a PPO and an HMO, especially when the PPO network may be—or may become—so narrow during the term of the policy that it affords little or no choice of doctors? Should patients pair an insurance plan with a tax-advantaged flexible spending account or health savings account—and how to understand the difference anyway?
I'm a medical doctor and have spent years as a journalist covering health care. But I am grateful that my company chooses my PPO health plan—not just because it's good, but also because it means I don't have to try to decide between hundreds of options when there is no good way to make a rational choice.
The system is rigged against patients—thanks largely to its opacity and complexity. Insurance plans list an array of covered services but then can refuse to pre-certify a prescribed treatment or decide it was not medically necessary and deny coverage after the fact. For example, a patient goes to the emergency room with chest pain, which turns out to be just a pulled muscle. So, in retrospect, it wasn't an emergency. Coverage denied!
Informed consent is regarded as a moral and legal obligation by physicians; for every procedure performed, doctors are required to tell patients the chance of success, potential side effects and problems. And yet when it comes to navigating our convoluted system, patients travel in the dark.
The current complexity is an outgrowth of countless decisions over the past 30 years, many of which sounded logical at the time but which grew out of financial considerations. All the players are effectively licensed to reach into our wallets when they can't get the money they want from one another.
As prices spiraled upward, insurers (backed by economists) imposed copayments and coinsurance so patients would have "skin in the game," to encourage them to use health care more sparingly, more wisely. But with prices in medicine now so high, the skin-in-the-game theory now means many patients live with debilitating symptoms, delay needed treatment or don't get treated at all.
In one study, 1 in 4 diabetics reported taking less insulin than prescribed because of costs. Another found that one-fifth of cardiac patients with "financial hardship" cut back on both food and medicines.
In a world where everything is billable (and nothing is under warranty), and when part of the system is found to be broken, the answer has often been to add another layer of complexity rather than to remedy the underlying flaw.
We've turned somersaults not to do what almost every other developed country has done: restrain charges by setting prices or by large-scale national negotiations. We hope that by structuring incentives for providers and patients—with PPOs, HMOs, HSAs, FSAs, coinsurance, copayments, pre-authorization, drug tiering, PBMs and more—the market will respond.
And it does, but often not with cheaper, simpler health care.
"Innovation" in our profit-oriented system is not just about developing lifesaving treatments, but also about inventing new ways to bill and new charges that don't exist elsewhere.
Consider this analysis from a report urging patients to consider changing Medicare drug plans to save money:
"The millions of patients with CVS Health's popular SilverScript drug plan will see a $2 decrease in their average monthly premium, from $31 in 2019 to $29 in 2020 …" That's good, right? Here's the catch: The plan will go from no deductible, in most areas in 2019, to a deductible of $215 to $435 in 2020.
So patients who feel like they're getting a good deal when they hear their premiums are going down will actually pay more.
Americans trying to be smart shoppers are understandably confused about navigating the open enrollment season, as they are doing currently. And just when they have figured it out for one year, they have to do it all over again. The odds of success are small.
Physicians say the law's constraints on what insurers now pay has given the companies an unfair advantage in negotiations with doctors, which is leading to major changes in the industry that may affect patients.
More than two years after California's surprise-billing law took effect, there's one thing on which consumer advocates, doctors and insurers all agree: The law has been effective at protecting many people from bills they might have been saddled with from doctors who aren't in their insurance network.
But the consensus stops there.
"In general, the law is working as intended," said Anthony Wright, executive director of Health Access California, a patient advocacy group that pushed for the measure, AB-72. "Patients are protected and the providers are getting paid."
Physicians beg to differ. They say the law's constraints on what insurers now pay has given the companies an unfair advantage in negotiations with doctors, which is leading to major changes in the industry that may affect patients.
Recent analyses by some researchers, however, cast doubt on some of the doctors' dire warnings.
"The problem is that AB-72 is creating imbalances in the health care marketplace that are decreasing access to care," said Dr. Antonio Hernandez Conte, an anesthesiologist whose specialty is among those most affected by the law.
The California law, which took effect in July 2017, protects consumers who use an in-network hospital or other facility from being hit with surprise bills when cared for by a doctor who has not contracted with their insurer. If that happens, consumers are responsible only for the copayment or other cost sharing that they would have owed if they had been seen by an in-network doctor.
Federal lawmakers are eyeing the California law as a possible model as they debate legislative proposals that would address surprise billing at the national level.
The California law applies to nonemergency services, since most state consumers were already protected for emergency care through an earlier court ruling.
It's not unusual for patients who visit a hospital or ambulatory surgical center that is covered by their insurance to encounter specialists who aren't, even in nonemergency situations.
For example, someone who has knee replacement surgery with an in-network surgeon at an in-network hospital may not realize that the anesthesiologist and assistant surgeon also scrubbing in on the operation are not.
Or a couple may be surprised to learn that the neonatologist caring for their baby in intensive care is outside their insurance network, even though the hospital where they gave birth is inside it. Diagnostic specialists like radiologists and pathologists whom patients rarely see may be out-of-network at an in-network hospital as well.
Under the California law, the doctor's payment from an insurer in those situations is based on either the average contracted rate for similar services in the area or 125% of what Medicare would have paid, whichever is greater.
In a California Medical Association online survey released last month ― in which 855 physician practices responded ― nearly 90% of the doctors said that the law allowed insurers to shrink physician networks, thus limiting patients' access to in-network doctors. Physicians blame the new law's reimbursement rates for surprise out-of-network care. The payment standard made insurers less inclined to negotiate payments and reduced doctors' bargaining power, the physicians say.
Those surveyed said they faced insurer payment rate cuts, refusal to renew their contracts and contract termination, among other problems.
This has led some physicians to try to gain leverage by consolidating practices, a move that can drive up health care costs significantly, the doctors warn.
The medical association did not respond to calls for comment on the survey.
Hernandez Conte, who chairs the legislative and practice affairs division of the California Society of Anesthesiologists, also pointed to data from the California Department of Managed Health Care showing that consumer complaints about access to care have risen from 415 in 2016 to 614 in 2018, a 48% jump.
Those complaints represent a minuscule number of consumers in the context of the more than 30 million Californians covered by commercial insurance or Medi-Cal, said Loren Adler, associate director at the University of Southern California-Brookings Schaeffer Initiative for Health Policy. Adler noted that there's no way to know if the complaints had anything to do with the surprise-billing law.
Hernandez Conte also pointed to a study published in August by the research firm Rand Corp. that he said showed the law is eroding doctors' leverage with insurers.
But that study ― a series of 28 interviews with doctors and others about their experiences in the first year after the law took effect ― wasn't definitive, said author Erin Duffy, an adjunct policy researcher at Rand and postdoctoral fellow at the Schaeffer Center for Health Policy and Economics at USC.
"It's more a reflection of what are some of the potential things we should look at down the road," she said.
Aside from individual examples of contracting problems cited by the physician group, researchers cite little evidence that patients are losing access to doctors who accept their insurance because of dwindling insurance networks.
The opposite appears to be true. USC-Brookings researchers published an analysis in September examining more than 17 million specialty claims by California physicians affected by the law. They found the share of services that specialty physicians delivered out-of-network at hospitals and ambulatory surgical centers declined by 17% after the law took effect.
When the law went into effect, there was a "precipitous" movement by affected physicians into insurance networks, said Adler, a co-author of the study.
Similarly, when the trade group America's Health Insurance Plans surveyed 11 large California health insurers about in-network providers during the two years after the law took effect, it found that the numbers grew or remained flat across specialties. There was a 16% increase in the number of in-network physicians overall, including a 26% rise in diagnostic radiologists and an 18% bump in anesthesiologists.
The plight of consumers who go to an in-network facility and, unbeknownst to them, receive treatment from out-of-network doctors has garnered plenty of attention in recent months.
In a typical scenario, the doctor charges the insurance company for services, then turns around and bills the patient for whatever amount the insurance company doesn't pay, a practice called balance billing. With no contract between the insurer and the doctor to set payment rates, the amounts billed by physicians are often higher than market rates, and the balance bills that patients face are many times higher than the regular copayment they would owe for in-network care.
Federal lawmakers are debating a number of measures that would address the issues at the federal level. The leading House and Senate bills would set minimum payment standards based on insurers' median in-network rate for a service for applicable out-of-network care, similar to the California law.
A federal law is key to broadening the surprise-billing protections provided by California's law, Wright said.
Since AB-72 was implemented, the Department of Managed Health Care hasn't taken any enforcement actions against physicians for balance-billing patients in nonemergency situations, according to agency spokeswoman Rachel Arrezola. It has pursued a handful of cases against doctors for out-of-network balance billing in emergency situations, however.
As doctors and patient advocates wrangle over AB-72, lawmakers are pressing new protections for consumers. A state law recently barred balance billing by air ambulance services.
Starting in January, California consumers who are airlifted by an out-of-network air ambulance won't be responsible for any more than their regular cost sharing for in-network providers.
Herman Ware got his seasonal flu shot while sitting at a small, wobbly table inside a mobile health clinic. The clinic-on-wheels is a large converted van, and on this day it was parked on a trash-strewn, dead-end street in downtown Atlanta where homeless residents congregate.
The van and Ware’s flu shot are part of a “street medicine” program designed to bring health care to people who haven’t been able to pay much attention to their medical needs. For those who struggle to find a hot meal or a place to sleep, health care can take a back seat.
As he anticipated the needle, Ware recalled previous shots and said, “It might sting.” He grimaced slightly as the nurse injected his upper arm.
After filling out paperwork, he climbed down the van’s steps and walked back to a small cluster of tents. Ware lives in the nearby homeless encampment tucked below an interstate overpass, next to a busy rail line.
Mercy Care, a health care nonprofit in Atlanta, operates brick-and-mortar clinics throughout the city that mainly treat poor residents. Since 2013, Mercy has also sent out teams of health care providers to treat homeless people.
It’s a public health strategy that can be found in dozens of cities in the United States and around the world, according to the Street Medicine Institute, which works to spread the practice.
Relationship Leads To Care
Getting homeless patients to accept help, whether it’s a vaccination or something simpler — like a bottle of water — can be challenging. And giving shots and conducting exams outside the walls of a health clinic often requires a different approach to health care.
“When we’re coming out here to talk to people, we’re on their turf,” said nurse practitioner Joy Fernandez de Narayan, who runs Mercy Care’s Street Medicine program.
“We’ll sit down next to someone, like, ‘Hey, how’s the weather treating you?'” she said.
“And then kind of work our way into, like, ‘Oh, you mentioned you had a history of high blood pressure. Do you mind if we check your blood pressure?'”
It can take several encounters to gain someone’s trust and get them to accept medical care, so the outreach workers spend a lot of time forging relationships with homeless clients.
Their persistent encouragement was helpful for Sopain Lawson, who caught a debilitating foot fungus while living in the encampment.
“I couldn’t walk,” Lawson said. “I had to stay off my feet. And the crew, they took good care of my foot. They got me back.”
“This is what street medicine is about — going out into these areas where people are not going to seek attention until it’s an emergency,” said Matthew Reed, who’s been doing social work with the team for two years.
“We’re trying to avoid emergencies, but we’re also trying to build relationships.”
‘Go To The People’
The street medicine team members use the trust they’ve built with patients to eventually connect them to other services, such as mental health counseling or housing.
Access to those services may not be readily available for many reasons, said Dr. Stephen Hwang, who studies health care and homelessness at St. Michael’s Hospital in Toronto.
Sometimes the obstacle — not having money for a bus ticket, for example — seems small, but is formidable.
“It may be difficult to get to a health care facility, and often there are challenges, especially in the U.S., where people [may not] have health insurance,” Hwang said.
Georgia is among a handful of states that have not expanded Medicaid to all low-income adults, which means many of its poorest residents don’t have access to the government-sponsored health care program.
But even when homeless people are able to get health coverage and make it to a hospital or clinic, they can run into other problems.
“There’s a lot of stigmatization of people who are experiencing homelessness,” Hwang said, “and so often these individuals will feel unwelcome when they do present to health care facilities.”
Street medicine programs are designed to break down those barriers, said Dr. Jim Withers.
He’s the medical director of the Street Medicine Institute and started making outreach visits to the homeless in 1992, when he worked at a clinic in Pittsburgh.
“Health care likes people to come to it on its terms,” Withers said, while the central tenet of street medicine is, “Go to the people.”
Help And Respect
Mercy Care in Atlanta spends about $900,000 a year on its street medicine program. In 2018, that sum paid for direct treatment for some 300 people, many of whom got services multiple times. Street clinics can help relieve the care burden of nearby hospitals, which Withers said don’t have a great track record in treating the homeless.
“We’re not dealing with them well,” Withers said, speaking about American health care in general. In traditional health settings, homeless patients do worse compared with other patients, he said.
Those extra days and clinical complications mean additional costs for hospitals. One estimate cited in a 2017 legislative report on homelessness suggested that more than $60 million in medical costs for Atlanta’s homeless population were passed on to taxpayers.
Mercy Care said its program makes homeless people less likely to show up in local emergency rooms and healthier when they do — which saves money.
It’s past sundown when the street medicine team rolls up to the day’s final stop: outside a church in Atlanta where the homeless often gather. A handful of people have settled down for the night on the sidewalk. Among them is Johnny Dunson, a frequent patient of the Street Medicine program.
Dunson said the Mercy Care staffers have a compassionate style that makes it easy to talk to them and ask for help.
“You gotta let someone know how you’re feeling,” Dunson said. “Understand me?
Sometimes it can be like behavior, mental health. It’s not just me. It’s a lot of people that need some kind of assistance to do what you’re supposed to be doing, and they do a wonderful job.”
Along with medical assistance, the staff at Mercy Care give patients doses of respect and dignity.
This story is part of a partnership that includes WABE, NPR and Kaiser Health News.
For nearly two decades, malfunctions and injuries linked to more than 100 medical devices were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.
Lorraine Bonner felt as though she was the only one. The surgical staples used to seal her colon after surgery had leaked, she has alleged in a lawsuit, spurring additional surgeries and a long, difficult recovery.
And then, just over a year after the ordeal, she read a Kaiser Health News investigation that described worse cases. KHN revealed that the Food and Drug Administration had allowed stapler maker Covidien to quietly file tens of thousands of reports of stapler malfunctions into a then-hidden database.
Alarmed that others had been harmed and reports had been hidden, Bonner, a retired Oakland, Calif., doctor, decided to go forward with a lawsuit against the stapler maker.
"If the information had been out there, then maybe Covidien would have changed the design of the staplers and made them safer," she said, "and that would have obviated the problem in the first place."
Bonner's lawsuit is one example of how a vast cache of records that were released this summer are taking on a life of their own.
For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.
In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an "alternative summary reporting" program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.
KHN's investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.
Since then, researchers, lawyers and the FDA's own officials have taken a closer look at the data to learn more about which devices malfunctioned, and how often.
Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, discovered that the devices in the hidden database were much riskier than other devices tracked by the FDA.
Her firm concluded that the hidden reports were "more likely to be associated with life-threatening devices and to contain potentially serious problems."
For example, just 10% of the devices tracked in the MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient's body, including pacemakers and heart valves.
The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.
The once-hidden reports also figured into the ECRI Institute's annual list of health technology hazards, a list circulated to hospitals and health systems.
ECRI found that this year's No. 1 hazard was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA.
"Most of these [stapler] reports had not previously been accessible to the public," the ECRI report notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.
"If a hazard is getting a lot of attention, hospitals want to have a plan to address that," said Rob Schluth, a senior project officer with the institute.
Bonner says her long, difficult recovery after several surgeries kept her from tending to her garden for about a year. (Heidi de Marco/KHN)[/caption]
For Bonner, the problems with a surgical stapler became apparent just over a week after she had colon surgery in November 2017. Retired from a career as a hospital physician, she knew the steps to take toward recovery. But she felt nauseated all the time and could barely hold down water.
"I was trying to get up and walk," she said. "I was doing everything, but I just got worse and worse."
Doctors went in for a second surgery on Dec. 6 and found infected pus filling her abdomen. They routed her colon's contents to be collected outside her body. It took additional surgeries to restore her colon function and address hernias caused by the procedures.
Bonner's lawsuit alleges that a Covidien stapler caused her bowel leak and that the company, by not reporting malfunctions to the public database for years, "have hidden the true risks of using the device from surgeons and patients."
In court records filed in the ongoing case, Covidien denied all of Bonner's claims but did say that the FDA invited the company in 2001 to submit stapler malfunctions with quarterly "alternative summary" reports.
Medtronic spokesman John Jordan said the company does not have a comment on the pending legal case.
Other devices are under scrutiny. The once-hidden data showed more than 2 million problems with dental implants.
During an October FDA webinar on dental devices, an FDA official said her office was "taking a deeper dive and trying to identify lessons learned" from dental implant incidents.
Dr. Malvina Eydelman, of the Division of Dental Devices in the agency's device branch, acknowledged that the number of events was "very high" and said her team was trying to develop a plan to share information with the public.
Also under scrutiny are the textured breast implants made by Allergan. The company's Biocell implants, recalled in July, have been linked to 12 deaths and 481 of the 573 worldwide cases of "breast implant-associated" lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated.
Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company's heavy use of the "alternative summary reporting" program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.
A class action case filed in Florida notes FDA rules say that alternative summary reports cannot include severe or unexpected events, "yet it is believed that these incidents were kept hidden in ASRs," including at least one lymphoma case.
An ongoing federal securities lawsuit also alleges that Allergan used "inappropriately nonpublic" alternative summary reports, disregarding the "risk that some [lymphoma] cases would go undetected by the FDA."
Allergan has not yet responded to the class action cases or to calls for comment. It denied the "threadbare" allegation in the securities lawsuit, citing the KHN article, which "makes clear that the filing of ASRs was permissible and even encouraged by the FDA to reduce 'redundant paperwork.'"
While the FDA has ended the alternative summary reporting program, it opened the door for makers of more than 5,000 device types to file quarterly summaries of reported malfunctions. In each case, the device maker must file a public report to the MAUDE database noting how many reports were filed directly with the agency.
An FDA spokeswoman said the agency has stopped accepting summary reports of injuries cited in pelvic mesh lawsuits. The agency does continue to accept hundreds of death report summaries under a special exemption for devices tracked in a "registry" held by a specialty medical society.
"We are in the process of reviewing the effects of these changes and will continue working to improve the usability and transparency of information in the MAUDE database — whether that information was submitted as a summary or individual report," FDA spokeswoman Stephanie Caccomo said in an email.
The release has not been as informative as Madris Tomes had hoped, she said, given that the FDA did not disclose data on how the devices harmed patients. Tomes is a former FDA manager who runs the company Device Events, which analyzes FDA data.
For instance, she said a breast implant injury report might say there was a "biocompatibility" problem, but it's unclear what happened to the patient.
"Did it result in lymphoma or the patient needing a device replacement?" asked Tomes. "Without that outcome, we're still a little bit in the dark on what this data means."