Device-Safety Experts To FDA: Make Data Public

KFF Health News, March 27, 2019

Researchers say the agency needs to open the data on scores of medical devices, which have included mechanical ventilators and pacemaker electrodes.

This article first appeared on Wednesday, March 27, 2019 in Kaiser Health News.

By Christina Jewett

Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices.

A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous 'exemptions' from the standard rules of publicly reporting harm related to devices.

One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible to doctors, medical researchers or the public.

While the FDA pledged quickly to review the safety of one such device — the surgical stapler — researchers say the agency needs to open the data on scores of other devices, which have included mechanical ventilators and pacemaker electrodes.

"The FDA absolutely should be making all of this information available," said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA about device safety.

During a recent interview, FDA Commissioner Scott Gottlieb said that he had no immediate plans to release the device-safety reports, but that the matter is under review. In an updated statement Tuesday, he added that "we are looking at ways to make ASR [alternative summary reporting] data received prior to 2017 more easily accessible."

"I think that the imperative of the agency is to make as much of this information available to the public as possible," Gottlieb said during the interview last week. "I think these databases by and large should be searchable to the public."

An agency spokeswoman said the FDA revoked most of the "alternative summary reporting" exemptions in mid-2017 and asked device makers who kept their exemptions to file a public report summarizing what information they'd send in a spreadsheet directly to the agency. That new approach doesn't affect the hidden reports dating to 2000.

Agency data show that more than 2 million alternative summary reports have been filed since the start of 2014.

In a February guidance statement for device makers, the FDA said summary reporting can streamline reporting for the industry and simplify the agency's review process "while maintaining or enhancing the quality, utility, and clarity of MDRs [device reports] through a more holistic view of reportable event trends."

Makers of about 100 devices filed reports that way over the years, and the FDA has not disclosed the reports' content beyond responding to KHN's questions about specific devices. Among the devices involved are implantable defibrillators and the staplers, which in 2016 were linked to under 100 public reports of harm, even as nearly 10,000 malfunction reports were filed discreetly within the FDA.

Asked for more detail on staplers and other devices with exemptions, the agency referred to the Freedom of Information Act process, which can take nearly two years.

That's not soon enough for organizations like the ECRI Institute. Chief policy officer Ronni Solomon said the nonprofit does device-safety analyses for the government and evidence-based reports for hospitals and performs device-related accident investigations.

Having thorough data on device-related harm is key on all fronts, she said, noting that the organization is exploring ways to get access to more FDA data. 

Dr. Alan Shapiro, an associate professor at the New York University School of Medicine who has used the agency's public device-safety database, called MAUDE, in his research, said paring down patient-safety data and keeping it in-house is the wrong move in the current era of artificial intelligence and automation.

He noted that an important safety tenet in hospitals is: the more eyes on the patient the better. He said there's a clear parallel to the work researchers do with agency data to identify device-safety lapses.

"The FDA isn't so capable that they can afford to hide data," he said.

Hani Elias, chief executive of Lumere, said his consulting company uses the open FDA device data to advise health systems across the nation on device safety for purchasing decisions. He co-founded the company after seeing hospitals make device-buying decisions based on the effectiveness of the sales force rather than on quality and safety.

"There's a lot of benefit in opening up this data," Elias said.

Among the benefits of greater transparency would be the peer pressure among device makers — stripped of reporting exemptions — to make their products safer.

"You don't want to be the people known for the products known for hurting people," said Alan Card, an assistant professor and patient-safety researcher at the University of California-San Diego School of Medicine.

In 2018, the FDA approved a new pathway for makers of 5,600 device types to file malfunction reports in summary format. That program relieves the device makers of seeking a special exemption. It requires one public report detailing a novel or unique type of malfunction. Information about subsequent, similar malfunctions can be sent straight to the FDA in a spreadsheet.

The agency has also quietly granted device makers other summary-reporting exemptions for injury information gleaned from litigation and from device-specific registries used for research. Device makers filing such reports also have to file a public report summarizing the data that is sent directly to the FDA and isn't readily available to the public.

Agency records show that some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.

Prior to the KHN investigation, Zuckerman said she was aware the FDA granted reporting exemptions but the sheer number of reports 'takes my breath away.'

In the interview, Gottlieb said he "wasn't aware of the full scope of the reports that weren't going into MAUDE." Gottlieb has announced his resignation; his last day will be April 5.

Card also said the KHN report was a surprise, but now that it's out, it's time for the FDA to open the records to help doctors and patients make the safest choices. "There are a lot of people out there who are trying to make reasonable decisions on data that isn't what it was purported to be," he said.

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

 

Medicaid Expansion Boosts Hospital Bottom Lines — And Prices

KFF Health News, March 27, 2019

While Colorado hospitals are financially better off since the expansion, they have increased the costs they shift to commercial health plans since 2009.

This article first appeared on Wednesday, March 27, 2019 in Kaiser Health News.

By Phil Galewitz

The Medicaid expansion promoted by the Affordable Care Act was a boon for St. Mary's Medical Center, the largest hospital in western Colorado. Since 2014, the number of uninsured patients it served dropped by more than half, saving the nonprofit hospital more than $3 million a year.

But the Grand Junction hospital's prices did not go down.

"St. Mary's is still way too costly," said Mike Stahl, CEO of Hilltop Community Resources, which provides insurance to about half of its nearly 600 employees and their families in western Colorado. "We are not seeing the decreases in our overall health bills that I believe the community overall should be feeling."

Stahl and other employers in Colorado hoped that as hospitals saved millions of dollars in charity care from the Medicaid expansion, it would lead to a curb in consumer and employer health costs and insurance premiums.

A new state report found that didn't happen.

While hospitals are financially better off since the expansion, they have increased the costs they shift to commercial health plans since 2009, the state researchers said.

The state report noted the average hospital profit per each patient discharge rose to $1,359 in 2017, twice the amount in 2009. For patients covered by commercial and employer-based health plans, margins per discharge rose above $11,000 in 2017 compared with $6,800 in 2009.

Julie Lonborg, a spokeswoman for the Colorado Hospital Association, said the state agency that did the study was biased against hospitals and had a "predetermined conclusion." Hospitals in the state are not doing as well as the report suggests, she added, noting that a third of them face operating losses.

And some insurers have not passed along savings to customers that hospitals give them, she said.

Hundreds of thousands of state residents gained coverage under the Medicaid expansion, lowering Colorado's uninsured rate by half to 7 percent. In addition, hospitals' uncompensated care costs dropped by more than 60%, or more than $400 million statewide.

Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, said that hospitals have used their expanded revenues to focus on adding services that provide high profits or expanding operations in wealthier areas of the state that often duplicate what is already available.

"They used those dollars to build free-standing [emergency departments], acquired physician practices, build new facilities where there was already sufficient capacity," she said. "Hospitals had a fork in the road to either use the money coming in to lower the cost shift to employers and consumers or use the money to fuel a healthcare arms race. With few exceptions, they chose the latter."

Hospital's Profit Margin Doubles

In written testimony to the state legislature last year, Colorado officials pointed to St. Mary's as an example of a hospital with high overhead and operating costs — factors they said can lead to higher insurance premiums.

The facility's profit margin was above 14 percent from 2015 to 2017, according to the latest available tax returns. Those figures are nearly double St. Mary's margin before expansion and twice the margin of the average U.S. hospital in 2017, according to American Hospital Association data.

Colorado is the first state to analyze whether hospital cost-shifting — often referred to as a "hidden tax" on health plans — dropped following Medicaid expansion.

But a conservative think tank in Arizona said hospitals there did not cut prices following that state's Medicaid expansion.

"Not only did [it] fail to deliver on the promises of alleviating the hidden healthcare tax, it allowed urban hospitals to increase charges on private payers dramatically," said a report from the Phoenix-based Goldwater Institute.

Some critics point out that hospitals are also benefiting because Congress has repeatedly delayed a key ACA provision that would have cut federal funding for hospitals with large numbers of Medicaid and uninsured patients.

The continuation of the program — called Medicaid disproportionate share payments — has provided Colorado hospitals a total of $108 million.

How Outside Costs May Factor In

The hospital industry disputes reports that it has merely pocketed profits from Medicaid expansion. They say many factors influence how much they charge employers and private insurers, including the need to upgrade technology and meet rising health and drug costs.

Lonborg of the state hospital association said hospitals need to shift costs to private employers to make up for lower prices paid by Medicare and Medicaid and to make up for care hospitals give for free to the uninsured.

But, she added, other factors, including the need to keep up with rapid population growth, have kept costs from dropping.

Janie Wade, chief financial officer for SCL Health, the Broomfield, Colo., hospital chain that owns St. Mary's and seven other facilities, said its costs are higher because it has sicker and older patients than most.

She said looking at just the hospital profit margins on St. Mary's IRS-990 form is not a fair assessment because it doesn't take into account costs that are outside the hospital, such as its 93 physician practices. The hospital lost nearly $12 million on those doctor practices in 2017, she said.

Across all operations, she added, the hospital's operating margin fell from 9.5 percent in 2015 to 4.5 percent in 2018.

Wade said the hospital used some of its new revenue to purchase 14 physician practices in recent years. That was designed, she added, not to ensure they send their patients to St. Mary's but to help keep those doctors in the city so they can staff important services such as trauma and maternity care.

"Medicaid expansion was a good thing and, of course, we supported it," Wade said.

But she pointed out that the hospital loses money on Medicaid and Medicare, which together cover more than three-quarters of its patients.

St. Mary's has sought to keep price increases for commercial insurers and employers to no more than the general inflation rate and made it even lower for some, according to Wade. If employers' rates were rising more than that, she said, it was likely because insurers were adding price increases.

Officials from Rocky Mountain Health Plans, which was recently acquired by UnitedHealthcare and is one of Grand Junction's largest insurers, would not comment.

Dave Roper, who used to oversee employee benefits for the city of Grand Junction and now heads a local employer coalition, said the state report confirms what local businesses leaders have long known. "St. Mary's has no incentive to reduce its costs," he said.

Edmond Toy, a senior adviser for the nonprofit Colorado Health Institute, said the argument that pursuing the ACA policy would help lower insurance premiums "broadened the appeal of Medicaid expansion … and conceptually it makes total sense."

But he noted health experts have long debated whether the higher prices hospitals charge people with private insurance are designed to make up for the losses they take on with Medicare, Medicaid and uninsured patients.

He said the state report shows how hospitals in heavily consolidated markets don't have to cut prices as their bottom lines improve. "They can charge whatever the market will bear."

Marianne Udow-Phillips, director of the Center for Health and Research Transformation at the University of Michigan, said hospitals have considerable bargaining power in many places because of health system consolidations and their purchases of many physician practices.

"It does appear Colorado hospitals have a strong negotiating position with payers, or payers there are not negotiating very effectively," said Udow-Phillips. "Hospitals are not going to give it away."

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Price Of A Brace Brings Soccer Player To His Knees

KFF Health News, March 26, 2019

After a sports injury, Esteban Serrano owed $829.41 for a knee brace purchased with insurance through his doctor's office. The same kind of braces sell for less than $250 online.

This article first appeared Tuesday, March 26, 2019 in Kaiser Health News.

By Paula Andalo

Last October, Esteban Serrano wrenched his knee badly during his weekly soccer game with friends.

Serrano, a software engineer, grew up playing soccer in Quito, Ecuador, and he has kept up his sport since moving to the United States two decades ago.

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR's Bill-of-the-Month Club and tell us about your experience. We'll feature a new one each month.

He hobbled off the field and iced the knee. But the pain was so severe, he made an appointment with Rothman Orthopaedic Institute, a network of orthopedists practicing in Greater Philadelphia, New Jersey and New York.

The doctor diagnosed a strain of the medial collateral ligament, or MCL, and prescribed over-the-counter pain medication as well as a hinged knee brace, which he used for several weeks until he'd healed.

He expected his insurance to cover his treatment as a plan from a previous job had covered him when he needed surgery to fix a broken nose sustained in another soccer game in 2017.

Then the bill came.

 "The doctor told me that he thought I didn't have damage, that it was more of an inflammation, but he ordered an MRI just to make sure," said Serrano. (The MRI confirmed that suspicion.)

Serrano said the brace did ease the discomfort and stabilized his knee as it healed. However, the shocking bill was almost more painful — he owed the orthopedic practice $829.41.

"You can find the same brace for less than $250 online," he said.

The bill came close to Christmas, when Serrano's 12-year-old daughter wanted her first iPhone. "I told her 'Sorry, honey, but I already paid a price of an iPhone for the hinged knee brace,'" Serrano joked.

Serrano emphasized that he felt lucky to have the money to handle a bill that for many people could equal a month's rent or three months of groceries.

Knee braces fall into a category of products called "durable medical equipment," whose prices can vary widely. Items range from slings and braces to wheelchairs and commodes to glucose meters and breast pumps for new mothers. Doctors and hospitals that dispense and prescribe such equipment for patients to take home almost always bill for them and add hefty markups that can catch patients unaware.

Bottom of Form

Braces and other products "are often marked up two or three times what the cost is, and unfortunately, that is the standard practice," said Dr. Matthew Matava, an orthopedic surgeon and chief of sports medicine for Washington University Physicians in St. Louis.

Rothman Orthopaedic didn't respond to requests for comments.

The type of hinged knee brace Serrano bought was a Donjoy Playmaker. Donjoy is one of the nation's largest producers of braces. A customer service representative for the company said it charges a retail price of $242.51 for the model Serrano got. Serrano paid more than three times that price.

In an emailed statement about the case, an Aetna spokesman wrote that "while the cost of a knee brace, or any other health care service, is determined by the negotiated rate between the health care provider and the health plan, the starting point is the charge from the health care provider."

It is not even clear that such an elaborate knee brace was needed for Serrano's injury.

Dr. Elizabeth Matzkin, chief of Women's Sports Medicine at Brigham and Women's Hospital in Boston and an assistant professor at Harvard Medical School, said that while it is helpful to give patients some kind of knee brace for support after MCL injuries, the use of a hinged knee brace does not influence recovery, according to studies. She called hinged braces "luxury products." Simpler, cheaper braces also offer support.

Resolution: Serrano recalled that when he received the brace, the practitioner showed him a form with its estimated cost in writing. He remembered his share was more than $700, but he didn't pay too much attention because he assumed his insurance would cover it.

After receiving the bill, he made several phone calls to the doctor's practice to get a copy of the form he'd signed. It stated that the product could be returned within seven days. A month had already passed. Because he had not met his deductible, his $829.41 balance was even more than the estimate.

The Takeaway: These days, many types of equipment dispensed by doctors' offices or hospitals involve a charge. Don't assume generosity. Ask the doctor to identify precisely what you need and explain why you need it.

When a doctor or hospital offers you a piece of equipment to help your healing, decide if you really need it or will use it. Say "no" if you will not. Ask if you will be billed for it and how much.

Many items can be purchased at a fraction of the cost online or from a pharmacy just down the block.

Know your insurance plan's copay for medical equipment (often 20 percent). The cost of purchasing the equipment yourself online may well be less than the copay if you purchase through a medical office.

NPR produced and edited the interview with KHN Editor-in-Chief Elisabeth Rosenthal for broadcast.

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR Bill-of-the-Month Club and tell us about your experience.

Paula Andalo: paulaA@kff.org, @paula_andalo 

New Rules Will Ease Patients' Access To Electronic Medical Records, Senate Panel Says

KFF Health News, March 26, 2019

The rules proposed by HHS take aim at data blocking, in which tech companies or health systems limit the sharing or transfer of information from medical files.

This article first appeared Tuesday, March 26, 2019 in Kaiser Health News.

By Fred Schulte and Erika Fry, Fortune

The chairman of the Senate health committee on Tuesday backed new federal regulations to remove roadblocks patients can face in obtaining copies of their electronic medical records.

"These proposed rules remove barriers and should make it easier for patients to more quickly access, use and understand their personal medical information," Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor & Pensions Committee, said in a statement prepared for a hearing on the rules that kicks off Tuesday at 10 a.m.

The rules, proposed last month by the Department of Health and Human Services, take aim at so-called information blocking, in which tech companies or health systems limit the sharing or transfer of information from medical files.

Alexander said HHS believes the new rules should give more than 125 million patients easier access to their own records in an electronic format.

"This will be a huge relief to any of us who have spent hours tracking down paper copies of our records and carting them back and forth to different doctors' offices. The rules will reduce the administrative burden on doctors so they can spend more time with patients," Alexander said.

The proposal requires manufacturers to fashion software that can readily export a patient's entire medical record — and mandates that healthcare systems provide these records electronically at no cost to the patient.

Congress jump-started the nation's switch from paper to electronic health records in 2009 using billions of dollars in financial stimulus funding to help doctors and hospital purchase the equipment. Officials expected the shift to cut down on medical errors, reduce unnecessary medical testing and other waste and give Americans a bigger role in managing their health care.

Yet in the decade since the rollout, critics have argued that the government spent billions financing software that can cause some new types of errors and typically cannot share information across health networks as intended.

"Botched Operation," a recent investigation published by KHN and Fortune, found that the federal government has spent more than $36 billion on the initiative. During that time, thousands of reports of deaths, injuries and near misses linked to digital systems have piled up in databases — while many patients have reported difficulties getting copies of their complete electronic files.

Jonathan Lomurro, a medical malpractice attorney in New Jersey, said his clients usually have to go to court to get their complete medical record. The information that health care providers fight most bitterly to keep from them, he said, are the audit logs — or the data that show every time a record has been accessed or edited, and by whom and when.

Related: Death By A Thousand Clicks: Where Electronic Health Records Went Wrong

That "metadata," he and other plaintiff attorneys argue, is critical for patients to understand the history of their care, particularly in cases where something has gone wrong.

In an interview prior to Tuesday's hearing, Lomurro criticized the HHS proposal, saying it limits a patient's ability to obtain these logs. While the proposed rule requires the systems to share most data from a medical record with a patient, it excludes audit trails from that classification.

"While the proposal talks about the need of patient access … they then strip the greatest protections from the patient," said Lomurro. "I am at a loss on how this could ever be a beneficial change to the rules and help patients."

Seema Verma, who heads the Centers for Medicare & Medicaid Services, agreed that patients should be entitled to audit log information. "At the end of the day, it's all of the patient's data. If it affects and touches their medical record, then that belongs to them," Verma said in an interview last month.

The HHS proposal also encourages doctors and other users of EHR technology to share information about software problems they encounter by prohibiting "gag clauses" in sales contracts. Critics have long argued that the clauses have prevented users from freely discussing flaws, including software glitches and other breakdowns that could result in medical errors and patient injuries. In 2012, an Institute of Medicine report blamed the confidentiality clauses for impeding efforts to improve the safety of health information technology.

But a major remaining problem in wiring up medicine is the lack of interoperability across rival data systems, said Christopher Rehm, chief medical informatics officer of LifePoint Health, a hospital system in Brentwood, Tenn. In testimony prepared for the Tuesday hearing, Rehm called it "the equivalent of telling people they must buy cars and move those cars from place to place, but there are no roads and no agreed-upon design for the roads, let alone the funding to actually pay for the construction."

According to Rehm, the average-sized community hospital (161 beds) spends nearly $760,000 a year on information technology investments needed to meet federal regulations. He said the costs "are crushing our industry where margins are already thin."

Fred Schulte: fschulte@kff.org, @fredschulte

States Push For Caregiver Tax Credits

KFF Health News, March 25, 2019

AARP is pushing bills in eight state legislatures that would give home caregivers tax credits to help offset the cost of care.

This article first appeared Monday, March 25, 2019 in Kaiser Health News.

By Samantha Young

Gloria Brown didn't get a good night‘s sleep. Her husband, Arthur Brown, 79, has Alzheimer‘s disease and had spent most of the night pacing their bedroom, opening and closing drawers, and putting on and taking off his jacket.

So Gloria, 73, asked a friend to take Arthur out for a few hours one recent afternoon so she could grab a much-needed nap. She was lucky that day because she didn't need to call upon the home health aide who comes to their house twice a week.

The price of paying for help isn't cheap: The going rate in the San Francisco Bay Area ranges from $25 to $35 an hour. Gloria Brown estimates she has spent roughly $72,000 on caregivers, medications and supplies since her husband was diagnosed four years ago.

"The cost can be staggering," said state Assemblyman Jim Patterson (R-Fresno), author of a bill that would give family caregivers in California a tax credit of up to $5,000 annually to help offset their expenses.

A 2016 study by AARP found that the average caregiver spends $6,954 a year on out-of-pocket costs caring for a family member. The expenses range from $7 for medical wipes to tens of thousands of dollars to retrofit a home with a walk-in shower or hire outside help.

AARP, a lobbying organization for people 50 and older, is pushing similar bills in at least seven other state legislatures this year, said Elaine Ryan, the group‘s vice president of State Advocacy and Strategy Integration. Arizona, Illinois, Nebraska, New Jersey, New York, Rhode Island and Wisconsin are considering legislation, and AARP expects measures also to be introduced in Florida, Massachusetts and Ohio.

In Wisconsin, two Republicans and two Democrats are behind that state's tax credit measure.

"We need a whole discussion about how we can best keep people at home and meet their needs," said state Rep. Debra Kolste, a Democrat who explained that most people know someone who is caring for a family member. She hopes the measure can make it through the Republican legislature and be signed by Wisconsin's Democratic governor.

New Jersey approved a state income tax credit in 2017 specifically for caregivers of wounded veterans. However, efforts in other states have failed, including in Arizona last year and Mississippi and Virginia this year.

At the federal level, bills that would have created a federal income tax credit of up to $3,000 never got out of congressional committees last year.

"Whether I'm in Billings, Mont., or in Mississippi, the caregiver tax credit is something that people are asking for," Ryan said. "All they're asking for is a little financial help to offset these costs."

A tax credit, said Brown and other caregivers, would be welcome relief to the estimated 4.5 million family caregivers in California who care for a loved one with a chronic, disabling or serious health condition. Nationwide, the AARP estimates there are about 40 million people caring for family members.

As her husband's disease progresses, Gloria Brown expects costs to escalate. For instance, she wants to install bars in the bathroom to help prevent her husband from falling, and anticipates she will need more professional help.

"I think we're just moving into that stage where I'm going to see the dollars going out for things that will help to make things easier for him at home and more comfortable," Brown said. "It's a cost you just hadn't anticipated."

Long-term caregiving has emerged as one of the major issues in California's Capitol this year, with proposals ranging from naming a state "Aging Czar" to funding a new cash benefit for long-term care services. In his State of the State address last month, Gov. Gavin Newsom called for a master plan for aging.

"I've had some personal — and painful — experience with this recently," Newsom told the joint session of the legislature.

Newsom, whose father had dementia and died last year, also has tapped former first lady Maria Shriver to lead a new Alzheimer's Prevention and Preparedness Task Force, and has asked lawmakers to approve $3 million in state funds for Alzheimer's disease research.

Patterson's bill would provide up to a $5,000 state income tax credit to family caregivers for five years, starting in tax year 2020. They would be reimbursed for 50% of eligible expenses, such as retrofitting a home, hiring an aide and leasing or buying specialty equipment. The credit would be available to individuals who make up to $170,000 a year, or joint income tax filers who make up to $250,000.

Patterson, a Republican in the minority, is hopeful he can convince his colleagues that giving people a tax credit is financially sound because it would enable caregivers to keep their loved ones at home rather than relying on more expensive government services.

"If members of the legislature and the governor would look through the eyes of their own families, friends and neighbors … I think it can be passed and be signed," Patterson said.

But the measure faces competition for a slice of California's $21 billion surplus, from proposals by the governor and lawmakers to boost funding for education, healthcare, housing and dozens of other programs.

For Pam Sogge of Oakland, Calif., a tax credit would allow her to hire a home health aide for an additional three hours a week.

Her husband, Rick Sogge, 61, has early-onset Alzheimer‘s and becomes frantic when left by himself. Sometimes when she leaves him alone in another room of their home, he searches for her every two minutes.

Because Rick Sogge is still physically healthy, most of the couple's caregiving expenses pay for part-time help to take him on outings so Pam can work, run errands or go to the doctor's office.

"You have a very uncertain financial future. You don't know what‘s going to happen. You don't know how long it‘s going to take. So you're very conservative," said Pam Sogge, 56, who has been caring for her husband for five years. "A tax credit, in a way, it's permission and encouragement to get some help."

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Samantha Young: syoung@kff.org, @youngsamantha

She Was Dancing On The Roof And Talking Gibberish. A Special Kind Of ER Helped Her

KFF Health News, March 25, 2019

ERs increasingly have become the care of first and last resort for people in the grips of a psychiatric episode. Now, hospitals around the country are opening emergency units that calmly cater to patients with mental health needs.

This article first appeared on Monday, March 25, 2019 in Kaiser Health News.

By Anna Gorman

For decades, hospitals have strained to accommodate patients in psychiatric crisis in emergency rooms. The horror stories of failure abound:

Patients heavily sedated or shackled to gurneys for days while awaiting placement in a specialized psychiatric hospital, their symptoms exacerbated by the noise and chaos of emergency medicine. Long wait times in crowded ERs for people who show up with serious medical emergencies. High costs for taxpayers, insurers and families as patients languish longer than necessary in the most expensive place to get care.

"If you are living with schizophrenia or bipolar disorder, that is a really tough way to begin that road to recovery," said Dr. Jack Rozel, president of the American Association for Emergency Psychiatry.

In pockets across the country, hospitals are trying something new to address the unique needs of psychiatric patients: opening emergency units specifically designed to help stabilize and treat patients and connect them to longer-term resources and care. These psychiatric ERs aim to address the growing number of patients with mental health conditions who end up hospitalized because traditional emergency rooms don't have the time or expertise to treat the crisis.

The rate of ER visits involving psychoses, bipolar disorder, depression or anxiety jumped more than 50% from 2006 to 2013, according to the federal Agency for Healthcare Research and Quality. Roughly 1 in 8 emergency department visits now stem from mental illness or substance use disorders, the data show.

The psychiatric ERs, staffed with nurses, social workers and psychiatrists, work to treat and release patients in under 24 hours, much as traditional emergency rooms handle physical ailments. Those who are well enough to go home get discharged, while those who need more treatment are admitted to the hospital or transferred to an inpatient facility.

There are now roughly 100 such units across the country, said Dr. Scott Zeller, vice president of acute psychiatry at Vituity, a physician-led organization that provides staffing and consulting services to medical centers nationwide.

Zeller pioneered the approach while working as chief of psychiatric emergency services at John George Psychiatric Hospital in Alameda County, Calif. Over time, he transformed the center from a traditional ward where restraints were common into one that treated patients in a more supportive, living-room like setting. The results — in terms of both patient outcomes and cost-savings — made Zeller a believer.

He is helping design 10 new units, including in California, Florida, Illinois and Tennessee. Each is distinct, accepting patients in somewhat different circumstances and offering a slightly different range of services.

Patients who arrive at an emergency room for psychiatric or substance use disorders are more than twice as likely to be admitted than other patients, federal data show. And yet about 80 percent of the time, Zeller said, patients‘mental health crises can be resolved without a costly inpatient hospital stay. A patient may be having a psychotic episode because he fell off his medications, for example, or having drug-induced hallucinations.

"We need to treat people at the emergency level of care," he said. "The vast majority of psychiatric emergencies can be resolved in less than 24 hours."

Nowhere To Hide

Wearing a hospital gown, Rachel Diamond lay back in her recliner in a spacious room in a relatively new ward at Providence Little Company of Mary Medical Center San Pedro, a hospital near the Port of Los Angeles. Nearby, a few patients slept on identical recliners, draped in soft blankets. Others communed at a kitchen table over microwaved meals. A nurse walked through the locked unit with a rolling cart, dispensing medications.

Except for a nursing station in the middle of the room, the unit didn't look much like a health care facility. The room was divided into men's and women's sides, with separate TVs. A few smaller rooms — where patients could meet with a psychiatrist or social worker — lined the unit's edge.

Anya Price, interim clinical supervisor and a nurse, said the unit was designed to feel more like a home than a hospital. "We're operating from an understanding that they're coming here to get better," Price said.

The open design of the unit, known as the "Outpatient Behavioral Health Center," allows patients to move freely. Staff said it also helps reduce problems because they can quickly spot a patient who may be getting agitated. Dr. Herbert Harman, a psychiatrist and medical director for the facility, said violence and the need for restraints are rare.

The unit is in a building a short walk from the medical center emergency room. It opened in 2017 and accepts patients from emergency rooms across Los Angeles County once they are deemed stable medically. So far this year, its staff has treated about 400 patients, Price said.

One recent morning, the patients included a man in his 40s found on the railroad tracks after an alcohol binge, and a woman with a history of schizophrenia who said she was seeing spirits. Some were there on involuntary holds because authorities had decided they were at risk of hurting themselves or others because of their illness.

Diamond, 30, said she has been diagnosed with depression and anxiety and has landed in multiple ERs over the past decade when her symptoms spiked out of control. During those stays, she said, she often felt isolated and in the dark about her treatment. Doctors typically numbed her with medications and consigned her to a guarded room. "No one really talked to me," said Diamond, who lives in Torrance, Calif. "It was like I was a caged animal."

She had been living in a car and fighting with her boyfriend in late February when she decided she wanted to end her life. She tried jumping out of a moving car, and when that didn't work, she grabbed a bottle of pills. She gets help for her mental health issues, but sometimes, she said, the stress becomes too much. This time, she was taken to a hospital emergency room in Torrance before being transferred to the San Pedro unit.

During her time in the behavioral health center — about 26 hours — she slept, received medications and met with nurses, a social worker and a psychiatrist. She said it was calmer than a regular ER, and the staff had time to talk, listen and help her through the worst of the crisis.

"I genuinely feel better enough to leave," she said. "I haven't been able to say that in a while."

A Return On Investment

Zeller argues that the use of emergency psychiatric clinics is both humane and cost-effective. Research on the Alameda County model found such units can dramatically reduce how long patients spend in medical emergency rooms, and that about three-quarters of patients treated in the units can be discharged to the community rather than to inpatient care. That, Zeller said, can lessen the overwhelming demand for inpatient psychiatric beds and preserve available spots for those who truly require them. The model saves money for hospitals in part because the patients spend less time in emergency care.

"The return on investment is exponential," he said.

In Montana, the Billings Clinic opened a psychiatric stabilization unit last April across the street from the traditional ER. Dr. Eric Arzubi, psychiatry department chair, said nearly 10 percent of the visits in the Billings Clinic emergency room involve people in psychiatric crisis. Since the new unit opened, wait times for psychiatric patients have dropped from about 10 hours to four hours, and fewer patients are being admitted to the inpatient unit. Arzubi said his staff isn't trying to cure people of their mental illness but rather stabilize them and get them the care they need.

"Just like in the emergency room, you don't get comprehensive care," Arzubi said. "But you can stop the bleeding, you stabilize the patient and get them to the right level of care."

In some cases, that means a transfer to an inpatient facility.

Staff at the San Pedro unit decided soon after Chantelle Unique arrived that she would be one of those patients. Unique, who is 23, has been diagnosed with bipolar disorder and schizophrenia. She had been dancing on the roof and speaking gibberish when her mother called 911.

Unique said she has had a hard time in regular emergency rooms. "There are a million people," she said. For most of a morning at the San Pedro facility, she sat calmly watching TV, talking to nurses and eating spaghetti. But at one point, she started pacing and yelling at other patients. Nurses and security guards quickly surrounded her and persuaded her to return to her recliner and take additional medication.

Finding an inpatient bed for a patient like Unique with more progressed mental illness is not always easy, said clinical social worker Mark Tawfik. But he's committed to finding a way. "We have to make sure we find them adequate resources," he said. "Otherwise, they will come right back."

For Price, the clinical supervisor, even when a patient requires a transfer for more intensive care, there's satisfaction in knowing that person is headed in the right direction. If Unique hadn't been brought in, Price said, she would have been out in the community, lost to her delusions, putting herself at risk of accident or arrest.

In the unit, staff made sure she was safe, Price said, in addition to providing "a warm bed, some food and some compassion."

Heidi de Marco: heidid@kff.org, @Heidi_deMarco

Anna Gorman: agorman@kff.org, @AnnaGorman

FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records

KFF Health News, March 22, 2019

Secretary Scott Gottlieb said Congress would need to enact legislation to define when an electronic health record would require government oversight.

This article was first published on Thursday, March 21, 2019 at Kaiser Health News.

By Fred Schulte and Erika Fry, Fortune

Food and Drug Administration Commissioner Scott Gottlieb on Wednesday called for tighter scrutiny of electronic health records systems, which have prompted thousands of reports of patient injuries and other safety problems over the past decade.

"What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they're doing things that could create risk for patients," Gottlieb said in an interview with Kaiser Health News.

Gottlieb was responding to "Botched Operation," a report published this week by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries and near misses linked to EHRs have piled up in databases — including at least one run by the FDA.

Related: Death By A Thousand Clicks: Where Electronic Health Records Went Wrong

Gottlieb said Congress would need to enact legislation to define when an electronic health record would require government oversight. He said that the digital records systems, which store a patient's medical history, don't fit neatly under the agency's existing mandate to regulate items such as drugs and medical devices.

Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a "unique tool," noting that the risks posed by their use aren't the same as for a traditional medical device implanted in a patient. "You need a much different regulatory scheme," he said.

The 21st Century Cures Act of 2016 excludes the FDA from having oversight over electronic health records as a medical device.

Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn't want their products to fall under FDA jurisdiction. He added that he was "not calling" for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.

How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency's interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.

At the time, many industry groups argued that FDA regulation would "stifle innovation" and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.

The debate became public in February 2010, when Jeffrey Shuren, an FDA official, testified at a public hearing that the agency had tied six deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous two years of "malfunctions with the potential for patient harm."

The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested "significant clinical implications and public safety issues." In one case cited, lab tests done in a hospital emergency room were sent to the wrong patient's file. Since then, several government and private repositories have associated thousands of injuries, near misses and deaths to EHR technology.

Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to "assure patient safety."

While some safety proponents agree that EHRs offer tremendous benefits, they also see greater opportunities to improve their safety.

Dean Sittig, a professor of bioinformatics and bioengineering at the University of Texas Health Science Center, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and "there wasn't a lot of interest in talking about things that could go wrong," Sittig told KHN and Fortune.

Earlier this month, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.

KHN correspondents Sarah Jane Tribble, Sydney Lupkin and Julie Rovner contributed to this report.

Fred Schulte: fschulte@kff.org, @fredschulte

 

Aspiring Doctors Seek Advanced Training In Addiction Medicine

KFF Health News, March 22, 2019

The opioid epidemic is spurring medical institutions around the country to create fellowships for aspiring doctors who want to treat the disorder with the same precision and science as other diseases.

This article was first published on Friday, March 22, 2019 at Kaiser Health News.

By Will Stone, KJZZ

The U.S. Surgeon General's office estimates that more than 20 million people have a substance use disorder. Meanwhile, the nation's drug overdose crisis shows no sign of slowing.

Yet, by all accounts, there aren't nearly enough physicians who specialize in treating addiction — doctors with extensive clinical training who are board-certified in addiction medicine.

The opioid epidemic has made this doctor deficit painfully apparent. And it's spurring medical institutions around the country to create fellowships for aspiring doctors who want to treat substance use disorder with the same precision and science as other diseases.

Now numbering more than 60, these fellowship programs offer physicians a year or two of postgraduate training in clinics and hospitals where they learn evidence-based approaches for treating addiction.

Such programs are drawing a new, talented generation of idealistic doctors — idealists like Dr. Hillary Tamar.

Driven To Connect With Patients In Need

Tamar, now in the second year of a family medicine residency in Phoenix, wasn't thinking about addiction medicine when she first started medical school in Chicago.

"As a medical student, honestly, you do your ER rotation, people label a patient as 'pain-seeking,' and it's bad," Tamar said. "And that's all you do about it."

But in her fourth year of med school, she happened to be assigned to a rotation at a rehab facility in southern Arizona.

"I was able to connect with people in a way that I haven't been able to connect with them in another specialty," the 28-year-old recalled.

Working with patients there transformed Tamar's understanding of addiction, she said, and showed her the potential for doctors to change lives.

"They can go from spending all their time pursuing the acquisition of a substance to being brothers, sisters, daughters [and] fathers making breakfast for their kids again," she said. "It's really powerful."

When Tamar finishes her residency, she plans to pursue a fellowship in addiction medicine. She sees addiction medicine, like primary care, as a way to build lasting relationships with patients — and a way to focus on more than a single diagnosis.

"I love when I see addiction patients on my schedule, even if they're pregnant and on meth," she said. "More room to do good — it's exciting."

Build A Program And They Will Come

Doctors with Tamar's enthusiasm are sorely needed, said Dr. Anna Lembke, medical director of Addiction Medicine at Stanford University School of Medicine and a longtime researcher in the field.

"Even 10 years ago," Lembke said, "I couldn't find a medical student or resident interested in learning about addiction medicine if I looked under a rock. They were just not out there."

But Lembke sees a change in the upcoming generation of doctors drawn to the field because they care about social justice.

"I now have medical students and residents knocking on my door, emailing me; they all want to learn more about addiction," Lembke said.

Historically, the path to addiction medicine was through psychiatry. That model started to change in 2015, when the American Board of Medical Specialties — considered the gold standard in physician certification in the U.S. — recognized addiction medicine as a bona fide subspecialty and opened up the training to physicians from other medical fields.

Until then, Lembke said, there had been no way to get addiction fellowships approved through the nationally recognized Accreditation Council for Graduate Medical Education. And that made recruiting young talent — and securing funding for their fellowships — difficult.

Last year, ACGME began accrediting its first batch of addiction medicine fellowship programs.

"We have got an enormous gap between the need and the doctors available to provide that treatment," Lembke said.

"At least the medical community has begun to wake up to consider not only their role in triggering this opioid epidemic, but also the ways they need to step up to solve the problem," she said.

Laying The Foundation

When Dr. Luke Peterson finished his residency in family medicine in Phoenix in 2016, there were no addiction medicine fellowships in Arizona.

So he moved to Seattle to complete a year-long fellowship at Swedish Cherry Hill Family Medicine Residency. There he learned, among other things, how to treat pregnant women who are in recovery from drug use.

"I really needed to do a fellowship if I was going to make an impact and be able to teach others to make the same impact," said Peterson, who went on to help found an addiction medicine fellowship program in Arizona. His program is based in Phoenix at the University of Arizona's medical school and its teaching hospital, run by Banner Health and the Phoenix VA.

Arizona's two addiction medicine fellowships received ACGME accreditation last year — a stamp of approval that made the programs desirable choices for up-and-coming physicians, Peterson said.

Not every doctor who plans to treat substance use disorder needs to do a fellowship, he said. In fact, his goal is to integrate addiction medicine into primary care settings.

But a specialist can serve as a referral center and resource hub for community doctors.

For example, physicians can learn from a specialist such as Peterson how to provide medication-assisted treatment like buprenorphine.

Public health leaders have been pushing to get more physicians trained in evidence-based treatment like buprenorphine, which has been shown to reduce the risk of death among people who have recovered from an opioid overdose.

"As we provide more education and more support to primary care physicians, they will feel more comfortable screening and treating for addiction," Peterson said.

Peterson's own journey into addiction medicine began during a rotation with a family doctor in rural Illinois.

"In moments that most doctors find uncomfortable — maybe a patient comes in to request pain medication and you're seeing the negative side effects — he did not shy away from that situation," Peterson said. "He addressed it head-on."

It was a formative experience for Peterson — one he wants other young doctors to have. And he recognizes the urgency.

"In 20 or 30 years from now," Peterson said, "those medical students are going to look back at my current generation of doctors, and we will be judged by how we responded to this epidemic," in the same way he and his peers now look back at how doctors handled the HIV epidemic.

One of the first steps in stopping the epidemic, he said, is making sure there are enough doctors on the ground who know how to respond.

Many of today's medical students, people like Michelle Peterson (no relation to Luke), say they feel the calling, too.

She's in her first year at the University of Arizona College of Medicine and became interested in addiction after working at an outpatient treatment center.

She said she's already learning about addiction in her classes, hearing from doctors in the field and seeing others classmates equally engaged.

"It's definitely not just me," she said. "There are quite a few people here really interested in addiction."

It's a trend she and her mentors hope will continue.

This story is part of a partnership that includes KJZZ, NPR and Kaiser Health News.

Will Stone, KJZZ: @WStonereports

Health Plans For State Employees Use Medicare's Hammer On Hospital Bills

KFF Health News, March 21, 2019

States are moving to control costs of employee health plans, and it's triggering alarm from hospitals. The strategy: Use Medicare reimbursement rates to recalibrate how they pay hospitals.

This article was first published on Thursday, March 21, 2019 in Kaiser Health News.

By Julie Appleby

States. They're just as perplexed as the rest of us over the ever-rising cost of health care premiums.

Now some states are moving to control costs of state employee health plans. And it's triggering alarm from the hospital industry. The strategy: Use Medicare reimbursement rates to recalibrate how they pay hospitals.  If the gamble pays off, more private-sector employers could start doing the same thing.

"Government workers will get it first, then everyone else will see the savings and demand it," said Glenn Melnick, a hospital finance expert and professor at the University of Southern California. "This is the camel's nose. It will just grow and grow."

In North Carolina, for instance, state Treasurer Dale Folwell next year plans to start paying hospitals Medicare rates plus 82 percent, a figure he said would provide for a modest profit margin while saving the state more than $258 million annually.

"State workers can't afford the family premium [and other costs]. That's what I'm trying to fix," he said. The estimated $60 million in savings to health plan members, he said, would mainly come from savings in out-of-pocket costs.

That approach differs from the traditional method of behind-the-scenes negotiating, in which employers or insurers ask for discounts off hospital-set charges that rise every year and generally are many times the actual cost of a service. Private-insurer payments, even with those discounts, can be double or triple what Medicare would pay.

This state-level activity could be a game changer, fueling a broad movement toward lower hospital payments. Montana's state employee program made the adjustment two years ago; Oregon will start this fall. Delaware's state employee program is also considering such "Medicare-based contracting" as one of several options to lower spending.

The bold move comes as other factors — notably marketplace competition among hospitals and high-deductible insurance plans aimed at getting consumers to "shop" for lower prices — have largely failed to slow rising health care premiums.

For hospitals, though, it can be viewed as "an existential threat," said USC's Melnick.

Indeed, the treasurer's plan in North Carolina has drawn heated opposition, with a hospital industry-associated group running television ads warning of dire consequences, especially for rural hospitals, some of which they say might be forced to close. When the plan first came out, the state's hospital association complained it would reduce statewide hospital revenue by an estimated $460 million.

Hospitals in areas with large concentrations of state workers "would be getting reimbursed less than the cost of care," said Cody Hand, the association's senior vice president and deputy general counsel. "Our biggest concern is this is not something that we were at the table for in discussion."

Rural hospitals are particularly at risk, Hand said, because many were already teetering on the brink financially and the payment change would be an additional problem.

After months of acrimony, the North Carolina treasurer in mid-March agreed to grant a 20 percent boost in payment to rural hospitals that would give those hospitals an additional $52 million a year. On average, rural hospitals would be paid 218 percent of the Medicare rate.

Nationwide, hospitals have long complained that Medicare underpays them, and some hospital and business groups have warned employers that tying payments from state workers' plans more closely to Medicare could result in higher charges to private-sector businesses.

"The result will be a cost shift of tens of millions of dollars to other Oregonians," wrote the Oregon Association of Hospitals and Health Systems as lawmakers there debated a plan (that eventually became law) paying hospitals 200 percent of Medicare rates.

But policy experts are skeptical.

"Even if Medicare pays a bit below cost, 177 percent of Medicare should be at least 50 percent above cost," said Mark Hall, director of the health law and policy program at Wake Forest University. "Is that a reasonable margin? I guess that's up for debate, but to most people 50 percent margin might sound reasonable."

Another concern some people have raised is that hospitals might refuse to join networks that employ these states' Medicare-based strategy.

Indeed, Montana officials worked hard to get all hospitals in the state to agree to accept for the state worker program an average of 234 percent of Medicare's reimbursement rates. A few hospitals held out, right up to the deadline, backing down only after pressure from employee unions.

The risk if hospitals opt to remain out-of-network is that workers could be "balance billed" for the difference between those Medicare-plus rates and their generally much higher charges, amounts that could be hundreds or even thousands of dollars.

To prevent that, Oregon lawmakers set the law's in-network reimbursement for hospitals at 200 percent of Medicare. But those that opt out would receive only 185 percent.

The measure also bars hospitals from billing state workers for the difference between those amounts and the higher rates they might like to charge.

"Oregon thought it through," said Gerard Anderson, a professor at Johns Hopkins who researches health care costs. "Hospitals need to go on a diet. The private sector has not put them on a diet, but maybe the state employee plans will."

And In The Private Sector …

For decades, health insurance costs for employers and workers have risen faster than inflation despite various efforts to rein them in.

Currently, a typical family plan offered by employers tops $19,000 a year in premiums, while the price tag for a single employee is close to $7,000.

To be sure, hospital costs make up just one part of what premiums cover, along with doctor costs, drug payments and other services. Spending on hospital care accounts for about one-third of the nation's $3.5 trillion health care tab.

"Health care is just becoming unaffordable," said Cheryl DeMars, president and CEO of The Alliance, a group of 240 private-sector, self-insured employers that directly contract with hospitals in Wisconsin, northern Illinois and eastern Iowa.

In January, The Alliance began what it calls "Medicare-plus" contracting. As new hospitals join and existing contracts come up for renewal, the group is negotiating rates, basing them on what Medicare pays, DeMars said.

And it will likely save money: Under its old method of paying, the group was forking out between 200 to 350 percent of Medicare for inpatient and outpatient hospital services in its network. Two new contracts have been signed so far, averaging 200 percent of Medicare across inpatient, outpatient and physician payments, according to The Alliance.

"We want to pay a fair price and we're in the process of determining what that should be," said Kyle Monroe, vice president of network development for The Alliance. "Is it 200 percent? Is it something less?"

Under traditional payment methods, the negotiated prices insurers for public- and private-sector employers pay for hospital care vary widely, by facility, treatment and insurer. But they're generally above Medicare rates by a substantial margin.

A group of self-insured employers recently commissioned Rand Corp. to study what private insurers pay hospitals in 22 states, compared with Medicare rates.

Initial results found private employers were paying, on average, 229 percent of Medicare rates to hospitals across the states in 2017, according to Chapin White, an adjunct senior policy researcher at Rand who conducted the study.

Economists like Melnick say they would prefer that market competition — consumers voting with their feet, so to speak — would drive business to the highest-quality, lowest-cost providers.

But, so far, hospitals have held the line against this scenario and that's not likely to change. "They're going to fight like crazy," Melnick said.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Does It Make Sense To Delay Children's Vaccines?

KFF Health News, March 20, 2019

Delaying vaccines is risky. Many pediatricians say a more gradual approach to vaccinations is better than no vaccinations, but they offer hard advice to parents considering it.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

By Bernard J. Wolfson

When Elyse Imamura's son was an infant, she and her husband, Robert, chose to spread out his vaccinations at a more gradual pace than the official schedule recommended.

"I was thinking, 'OK, we're going to do this,'" says Imamura, 39, of Torrance, Calif. "'But we're going to do it slower so your body gets acclimated and doesn't face six different things all of a sudden.'"

Seven years later, Imamura says her son, Amaru, is a "very healthy," active boy who loves to play sports.

But delaying vaccines is risky. Many pediatricians will tell you a more gradual approach to vaccinations is better than no vaccinations at all, but they offer some hard advice to parents who are considering it.

"Every day you are eligible to get a vaccine that you don't get one, the chance of an invasive disease remains," says Dr. Charles Golden, executive medical director of the Primary Care Network at Children's Hospital of Orange County.

Recent outbreaks of measles, mumps and whooping cough have once again reignited a war of words over vaccinations.

The squabble is often painted as two-sided: in one camp, the medical establishment, backed by science, strongly promoting the vaccination of children against 14 childhood diseases by age 2. In the other, a small but vocal minority — the so-called anti-vaxxers — shunning the shots, believing the risks of vaccines outweigh the dangers of the diseases.

The notion that there are two opposing sides obscures a large middle ground occupied by up to one-quarter of parents, who believe in vaccinating their children but, like the Imamuras, choose to do so more gradually. They worry about the health impact of so many shots in so short a period, and in some cases they forgo certain vaccines entirely.

Alternative vaccine schedules have been around for years, promoted by a few doctors and touted by celebrities such as Jenny McCarthy. Donald Trump endorsed the idea during a 2015 Republican presidential debate.

The concept gained a large following more than a decade ago, when Robert W. Sears, an Orange County, Calif., pediatrician, published "The Vaccine Book," in which he included two alternative schedules. Both delay vaccines, and one of them also allows parents to skip shots for measles, mumps and rubella (MMR), chickenpox, hepatitis A and polio.

Sears' book became the vaccination bible for thousands of parents, who visited their pediatricians with it in tow. But his ideas have been widely rejected by the medical establishment and he was punished by the Medical Board of California last year after it accused him of improperly exempting a 2-year-old from all future vaccinations. He declined to be interviewed for this column.

Imamura, who describes herself as "definitely not an anti-vaxxer," says she and her husband "followed Sears to a T." They limited the number of vaccines for their son to no more than two per appointment, compared with up to six in the official schedule. And they skipped the shot for chickenpox.

She concedes, however: "If there'd been outbreaks like now, it would have affected my thinking about delaying vaccines."

The ideas promoted by Sears and others have contributed to parents' worries that front-loading shots could overwhelm their babies' immune systems or expose them to toxic levels of chemicals such as mercury, aluminum and formaldehyde.

But scientific evidence does not support that. Infectious-disease doctors and public health officials say everyday life presents far greater challenges to children's immune systems.

"Touching another human being, crawling around the house, they are exposed to so many things all the time on a daily basis, so these vaccines don't add much to that," says Dr. Pia Pannaraj, a pediatric infectious-diseases specialist at Children's Hospital Los Angeles.

The same is true of some of the metals and chemicals contained in vaccines, which vaccination skeptics blame for autism despite numerous studies finding no link — the most recent published earlier this month.

In the first six months of life, babies get far more aluminum from breast milk and infant formula than from vaccines, public health experts say.

"When you look at babies that have received aluminum-containing vaccines, you can't even tell the level has gone up," says Paul Offit, professor of pediatrics at Children's Hospital of Philadelphia (CHOP) and director of the hospital's Vaccine Education Center. The same is true of formaldehyde and mercury, he adds.

(Offit co-invented Merck's RotaTeq vaccine for rotavirus, and CHOP sold the royalty rights to it for $182 million in 2008. CHOP declined to comment on what Offit's share was.)

Parents who are concerned about mercury, aluminum or other vaccine ingredients should avoid information shared on social media, which can be misleading. Instead, check out the Vaccine Education Center on CHOP's website at www.chop.edu by clicking on the "Departments" tab.

The Centers for Disease Control and Prevention also provides a detailed breakdown of the ingredients in every vaccine at http://www.cdc.gov/vaccines.

If your child has a condition you fear might be incompatible with vaccinations, discuss it with your pediatrician. The CDC gives very specific guidelines on who should not receive vaccines, including kids who have immune system deficiencies or are getting chemotherapy or taking certain medications.

If your children are not among them, vaccinate them. That will help prevent outbreaks, protecting those who, for medical reasons, have not received the shots.

When parents resist, Pannaraj says, she emphasizes that the potential harm from infections is far more severe than the risks of the vaccines. She notes, for example, that the risk of getting encephalitis from the measles is about 1,000 times greater than from the vaccine.

Still, side effects do occur. Most are mild, but severe cases — though rare — are not unheard of. To learn about the potential side effects of vaccines, look on the CDC website or discuss it with your pediatrician.

Emily Lawrence Mendoza, 35, says that after her second child, Elsie, got her first measles, mumps and rubella (MMR) shot at 12 months of age, she spiked a fever and developed a full body rash that looked like a mild version of the disease.

It took three visits to urgent care before a doctor acknowledged that Elsie, now almost 5, could have had a mild reaction to the vaccine. After that, Mendoza, of Orange, Calif., decided to adopt a more gradual vaccination schedule for her third child.

Yet Mendoza says Elsie's adverse reaction made her realize the importance of vaccinations: "What if she'd been exposed to a full-blown case of the measles?"

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Bernard J. Wolfson: bwolfson@kff.org, @bjwolfson

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