Month: November 2016

Efforts to strengthen the country’s tattered mental health system, and help millions of Americans suffering from mental illness, are getting a big boost this week, thanks to a massive health care package moving through Congress.

Key provisions from a mental health bill approved last summer by the House of Representatives have been folded into the $6.3 billion 21st Century Cures Act, which aims to speed up drug development and increase medical research. The act also would provide $1 billion in the next two years for prevention and treatment of opioid addiction.

The legislation aims to make mental health a national priority and coordinate how mental health care is delivered, said Rep. Tim Murphy, R-Pa., a psychologist who treats patients with PTSD and traumatic brain injuries at the Walter Reed National Military Medical Center in Bethesda, Md. Murphy, the mental health bill’s author, said it places a strong emphasis on science, pushing federal agencies to fund only programs that are backed by solid research and to collect data on whether patients are actually helped. Among other provisions, the bill pushes states to provide early intervention for psychosis, a treatment program that has been hailed as one of the most promising mental health developments in decades.

Murphy began researching how to improve the mental health system after the Newtown shootings in 2012, which raised awareness about the problem of untreated mental illness. He introduced his bill the following year. “That horror is etched on our collective memories,” Murphy said Tuesday at a committee meeting of the House Rules Committee.

The House of Representatives is scheduled to vote on the Cures Act Wednesday, with a vote in the Senate expected next week. Although the health care package has strong support, its passage is not assured. Sen. Elizabeth Warren, D-Mass., has said the bill favors the pharmaceutical industry at the expense of patient safety. Heritage Action for America, a conservative group, also opposes the bill because it would increase federal spending.

Many advocates for the mentally ill praised the bill.

“The mental health field has lagged way behind other health disciplines in identifying services that really work,” said Ronald Honberg, national director of policy and legal affairs at the National Alliance on Mental Illness. Honberg called the bill’s mental health provisions “necessary and promising.” He said he appreciated the bill’s focus on “preventing the most horrific consequences of untreated mental illness,” including homelessness, incarceration and suicide.

Dr. T. Scott Stroup, a professor of psychiatry at Columbia University College of Physicians and Surgeons in New York, said he was encouraged by the focus on “evidence-based treatment, rather than ideology- or opinion-based treatments.” That focus “will prevent people from wasting time on treatments that don’t work,” Stroup said.

The bill generally requires states to use at least 10 percent of their mental health block grants on early intervention for psychosis, using a model called coordinated specialty care, which provides a team of specialists to provide psychotherapy, medication, education and support for patients’ families, as well as services to help young people stay in school or their jobs. Research from the National Institutes of Health shows that people who received this kind of care stayed in treatment longer; had greater improvement in their symptoms, personal relationships and quality of life; and were more involved in work or school compared to people who received standard care.

The bill also sets up a $5 million grant program to provide assertive community treatment, one of the most successful strategies for helping people with serious mental illnesses, such as schizophrenia. Like the early intervention program, assertive community treatment provides a team of professionals who are on call 24 hours a day. The bill also expands a grant program for assisted outpatient treatment, which provides court-ordered care for people with serious mental illness who might otherwise not seek care.

Although the bill authorizes these grants, a future Congress would have to approve funding for the programs. “The fact that a program has been authorized is no guarantee that it will be funded,” Honberg said. “It’s a necessary first step.”

If the bill passes, mental health advocates will lobby for Congress to approve funding for the most critical programs, Honberg said.

Other sections of the bill, based on legislation introduced by Sen. John Cornyn, R-Texas, give communities more flexibility in how they use federal grants. For example, communities could use community policing grants to train law enforcement officers to deal with patients in the midst of a psychiatric crisis. Another provision would require the U.S. Attorney General to create at least one drug and mental health court pilot program, which aim to help people with mental illness or drug addiction receive treatment, rather than jail time, after committing minor offenses.

The bill recognizes that “we have a crisis in the way we treat serious mental illness and we’re going to do something about it,” said John Snook, executive director of the Treatment Advocacy Center, which advocates on behalf of people with serious mental illness. “It takes all the best ideas in criminal justice and mental health and makes sure the federal government is supporting them.”

The mental health provisions have been in the works for nearly four years. Murphy acknowledged that some key provisions in his original bill were removed in order to garner broader support. “We didn’t get everything we needed, but we needed everything we got,” he said.

An earlier version of the bill would have changed a federal privacy law to allow doctors, under certain circumstances, to share mentally ill patients’ medical information with their family caregivers. Murphy said the change was needed, because doctors today often shut families out of their loved one’s care, refusing to share even basic information, such as appointment times, for fear of violating the Health Information Portability and Accountability Act, or HIPAA. Many health professionals misunderstand the law, refusing to even listen to the families of patients who are too disabled by psychosis to provide key details of their medical history.

Some advocates for the disabled objected to that change, however, arguing that patient privacy is essential, and that people might avoid care if they don’t believe their doctors might disclose confidential information.

The new bill simply instructs the Secretary of Health and Human Services to clarify when doctors can share patients’ medical information with family caregivers, as well as educate health care providers about what the law actually says.

“It’s a step in the right direction,” Honberg said. “There is so much misinformation about HIPAA. It’s one of the most mischaracterized laws out there.”

The bill also aims to better coordinate mental health care. Although eight federal agencies today fund 112 programs that provide mental health care, these agencies rarely coordinate their efforts to make sure patients get the help they need and to avoid duplicating services, Murphy said.

The bill would make structural changes to the way federal agencies provide mental health services.

• A new committee would link leaders of key agencies involved in mental health care, such as the Department of Veterans Affairs, the Department of Justice and the Substance Abuse and Mental Health Services Administration, or SAMHSA.
• A new position — the Assistant Secretary for Mental Health and Substance Use — would oversee SAMHSA and disseminate the most successful approaches to treating mental illness.
• An advisory board, the National Mental Health and Substance Use Policy Laboratory, would also analyze treatments and services to help decide which ones should be expanded.

“We want the states to tell us what makes a difference, so other states can benefit from their success and learn from their failures,” Murphy said. “Let’s fund programs that work and keep them going.”

Categories: Mental Health, Public Health, Syndicate

Tags: Legislation, U.S. Congress

Substantially more health plans on the federal insurance marketplaces require consumers next year to pay a hefty portion of the cost of the most expensive drugs, changes that analysts say are intended to deter persistently ill patients from choosing their policies.

The class of medicines known as specialty drugs often treat chronic illnesses such as multiple sclerosis, rheumatoid arthritis, HIV, hemophilia, some cancers and hepatitis C. Individual doses can be priced at more than $600. Many newer medicines cost $5,000 to $10,000 a month. That means patients with even a small cost-sharing requirement have to come up with thousands of dollars. For many patients there are no cheaper and equally effective alternatives.

In the four years that the healthcare.gov marketplaces have existed, plans requiring consumers to pay roughly a third or more of the cost of specialty drugs have expanded to 63 percent of all offerings from 37 percent, according to a Kaiser Health News analysis.

High cost sharing is one reason that the marketplaces have been subject to criticism. The marketplaces, also called exchanges, may be phased out by a hostile Republican Congress and new president. Nonetheless, they remain important in 2017 — and possibly longer — for the millions of people who are buying insurance on or off the marketplaces.

This KHN story also ran on Money. It can be republished for free (details).

Six of every seven policies in Maine, Missouri, New Jersey, Tennessee and Illinois, and every plan in Alaska, require consumers to pick up 30 percent or more of the cost of specialty drugs, the analysis found. Around the nation, some plans make consumers split the cost of these drugs with the insurer, and a few make consumers pick up the majority of the tab. In West Virginia, five Highmark Blue Cross Blue Shield plans require a $1,000 copayment for each specialty drug prescription.

As a practical matter, people relying on specialty drugs quickly run through their deductibles and maximum annual out-of-pocket costs, which next year will be no more than $7,150 for individuals. After that, the insurer must pick up the entire cost.

Researchers suspect some insurers are designing their plans with stingy specialty drug benefits to discourage patients who need them from signing up in the first place.

“Plans are no longer able to actively exclude people based on health status, but they still have an incentive to try to end up with healthier enrollees,” said Benjamin Sommers, a health economist at Harvard’s T.H. Chan School of Public Health. “This isn’t just about drugs. These drugs can be a signal of other types of high health care spending. The people who use them have conditions that make them more likely to end up in the hospital or emergency room.”

Ben Woodworth, a 28-year-old in Atlanta, said he pays $380 a month for medications that prevent his body from rejecting a transplanted kidney. The Blue Cross Blue Shield of Georgia policy he is considering for next year, which is not sold on the exchange, would require him to pay either 40 or 50 percent of the price of specialty drugs, depending on how the insurer classifies them.

“What seems so unreasonable about it was that for many years, on several different insurance plans, I paid no more than $20 a month” for the drugs, said Woodworth, who had previously been covered through a university at which he was studying or by his parents’ plan. “To have that suddenly turn into about $400 a month was hard.”

Even with high cost sharing, people using specialty drugs are less vulnerable financially than they were before the Affordable Care Act created the marketplaces. In addition to the limits on how much patients have to pay, insurers can no longer refuse to sell policies or charge more based on consumers’ health. The government also pays for much of the cost sharing for lower-income people in the marketplaces, although this, too, is on the chopping block of a Republican Congress.

The majority of Insurance plans being sold on the health marketplaces require consumers to pick up a large share of the cost of specialty drugs.

This chart shows the percent of plans in each state that require consumers to pay for 30 percent or more of the cost of those drugs.

Get The Data

Rising Costs ‘Unstainable’

The insurance industry and President Barack Obama’s administration say benefit changes are a reaction to the increasing cost and use of the medicines, especially unique ones where drug makers can dictate prices. Express Scripts, a pharmacy manager, estimated 576,000 people took more than $50,000 worth of medications during 2014.

“Rising prescription drug costs are an issue throughout the health care system, especially specialty drugs,” said Aaron Albright, a spokesman for the Department of Health and Human Services.

Kristine Grow, a spokeswoman for the trade group America’s Health Insurance Plans, denied that insurers are raising cost sharing to avoid expensive patients. “The true issue here is that the ever-increasing costs of specialty drugs are simply unsustainable,” she said.

But Caroline Pearson, an executive at the health consulting firm Avalere, said insurers have an incentive to repel patients in poor health because of flaws in the government’s method of reimbursing them if they get an unexpectedly large share of very ill customers.

“The model doesn’t adjust for the severity of your disease,” she said. For instance, she added, the government recognizes that a rheumatoid arthritis diagnosis means a patient is sicker than many others, but people with severe cases and mild ones are considered to be equal in health. People who use specialty drugs are more often suffering from acute ailments than are those who use other types of medicines, she said.

“It’s effectively a race to the bottom,” Pearson said. “You don’t want to be the single plan in a region with really good coverage for high-cost conditions.”

The government is proposing tweaks to its models that would do a better job of assessing patient health, but that would not take effect next year.

Other Costs Up, Too

Consumers are not just being squeezed by their share of the rise in specialty drug costs. High cost-sharing requirements for brand-name drugs that are not on insurers’ preferred lists have increased at a similar rate as for specialty drugs, KHN’s analysis found.

Some insurers are making high cost sharing for specialty drugs — 30 percent or more — a component of the majority of their plans. KHN’s analysis found that 85 percent of BlueCross BlueShield of Illinois and Florida Blue have that level of cost sharing. Of 373 plans offered by Anthem subsidiaries that KHN examined, 81 percent require consumers to pay 40 percent or more of the cost of specialty drugs.

Greg Thompson, a spokesman for Health Care Service Corp., which owns BlueCross BlueShield of Illinois, said in an email that its high cost sharing for specialty drugs allows it to pick up more of the cost of generic and brand-name drugs “and allows us to design plans that have a broader appeal across the entire marketplace.” But KHN’s analysis found insurers are also increasing patients’ contributions for the cost of the brand name drugs that are on those lists. In 2014, 38 percent of plans charging copays made customers pay $50 or more per prescription. By 2017 that portion had risen to 67 percent.

Robert Zirkelbach, a spokesman for the drug industry trade group PhRMA, said insurers had “powerful tools” to negotiate lower prices for medicines with drug companies, including the threat of not covering them at all. “At the end of the day, for any particular medicine, they make a determination of whether they are going to cover it and what formulary it’s going to sit on,” he said.

Paul Kluding, a spokesman for Florida Blue, said in an email that many drug makers offer coupons that can reduce some of the cost that consumers pay out of pocket for the drugs. That does not cut the insurers’ costs, however.

In September, the Center for Health Law and Policy Innovation at Harvard’s law school filed civil rights complaints with the federal government charging that insurers in eight states are using high cost sharing and other methods to discriminate against people with HIV or other chronic conditions.

Jane Parker, who runs a small business with her husband in Naples, Fla., expects to pay $15,643 in premiums and out-of-pocket costs next year. The monthly infusion she receives of Orencia, which treats her rheumatoid arthritis, costs $11,000 a month, including the hospital charges for the procedure.

Parker, 57, said she expects she will have to pay her new plan’s out-of-pocket maximum of $6,350 in January, but it is unavoidable since no other medication has worked for her.

Without the infusions, she said, “I wouldn’t be walking.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Cost and Quality, Insurance, Syndicate, The Health Law

Tags: Out-Of-Pocket Costs, Pharmaceuticals

The Pfizer logo is seen at their world headquarters in New York April 28, 2014.

REUTERS/Andrew Kelly/File photo – RTX2MJU3

President-elect Donald Trump’s selection of Rep. Tom Price to head the Department of Health and Human Services signals that the new administration is all-in on both efforts to repeal the Affordable Care Act and restructure Medicare and Medicaid.

Price, a Georgia Republican who currently chairs the House Budget Committee, was among the first to suggest that not just the ACA but also Medicare are on the near-term agenda for newly empowered Republicans.

Privatizing the Medicare program for seniors and disabled people and turning the Medicaid program for the poor back to the states are long-time goals for Republicans in Congress and the White House. They say the moves could help put the brakes on health spending. Opponents argue, however, that both changes are aimed instead at shifting the financial burden of health care from the federal budget to states and individuals.

That question — should the federal government continue to provide open-ended health benefits? — could prove to be a key battle line.

Democrats and consumer advocates say the changes would break a promise to guarantee health services made when Medicare and Medicaid were enacted in 1965.

“That is the explicit intent of these proposals, to cap liability and shift costs,” said Edwin Park of the left-leaning think tank the Center on Budget and Policy Priorities.

Len Nichols of George Mason University agreed: “It’s about fixing the growth rate so they can be certain of a lower federal commitment to health care.”

Republicans, however, say in the face of rising federal deficits, it would be irresponsible not to rein in the programs’ spending.

“We have a moral obligation to the country to do this,” House Speaker Paul Ryan told the New York Times in 2011, when he first proposed the plans as chairman of the House Budget Committee.

Medicare, which covers roughly 57 million elderly and disabled Americans, and Medicaid, which covers more than 77 million people with low incomes, are among the biggest items in the federal budget, together costing an estimated $1 trillion in 2016, according to the Congressional Budget Office.

And, more importantly, both programs are expected to keep growing, consuming ever more of the budget. According to the CBO, over the next 30 years, the percentage of federal spending claimed by the major federal health programs (primarily Medicare and Medicaid) is expected to rise from just over 6 percent to more than 10 percent.

“By reforming these programs in the future, we can preserve them for the present,” said Ryan in another 2011 interview.

Both GOP proposals for the major medical entitlement programs date back decades.

Proposals to replace the open-ended Medicaid program, in which the federal government matches whatever states spend, with a block grant that would limit the federal government’s financial responsibility first surfaced in the early 1980s, during the Reagan administration. When Republicans took over Congress in 1994, the idea reemerged, was passed and sent to President Bill Clinton, who vetoed it. President George W. Bush revived the idea again in 2003, but he could not get Congress to act on it.

The latest version of the proposal offered by House Republicans would give states the option of modifying the plan so that the federal payments to states would be based on a per capita funding formula.

A number of Republican governors have supported the idea, because the program would generally relieve states from rules governing who and what to cover in Medicaid in exchange for accepting limited funding.

But advocates for the poor say it would lead to fewer people getting fewer services. Because the federal contribution proposed by Ryan is specifically set to increase more slowly than predicted inflation in health care, “states could either contribute much more to their Medicaid programs, or, more likely, use that flexibility to make deep cuts to the program,” said Park.

A 2012 estimate from the Urban Institute said that year’s proposal could result in 17 million people losing coverage, and payments to health care providers could be cut by nearly a third.

Thomas Miller of the conservative American Enterprise Institute says more recent proposals have gotten less draconian. “It’s gotten a little better because as opposed to a big block grant, it’s gone to the per capita allotments” that would be based on the number of people enrolled in the program.

Park of the CBPP said that would be better than simply giving states a single pot of money. With a per-capita cap, the federal contribution would rise as more people are added to the program. But the cuts would still be deep, he said, because “you’re achieving similar savings by slashing spending per beneficiary.”

In Medicare, the concept of “premium support,” which would give enrollees a set amount of money to spend on the health plan of their choice, emerged in the mid-1990s. The original proposal was geared to using competition to slow the growth of Medicare spending.

But later iterations of the Medicare proposal would increase contributions intended to pay for insurance more slowly than the expected rate of health inflation. That means that instead of covering the government’s share of a set package of benefits, what is currently referred to as Medicare’s defined benefit, the program would instead pay a specific amount, often referred to as a defined contribution, that might not be able to pay for those benefits.

“Right now, the federal government says you pay [a set share] of those costs” through Medicare premiums, deductibles and co-pays and beneficiaries get government funding to cover guaranteed benefits in return, said Park. “Under premium support there would no longer be that guarantee and there would no longer be a defined set of benefits.”

Miller of AEI said any effort to push these GOP plans for Medicare and Medicaid will run into stiff headwinds — even in a Republican-controlled Congress — because it’s difficult to take something away from people.

Congress can’t simply cut the programs, he said. “You have to tell people why you’re doing this. You have to say this is actually going to improve the health care system.”

Categories: Medicaid, Medicare, Syndicate, The Health Law

Tags: U.S. Congress

At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015.

He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated. By fall he was so short of breath, nauseated and overwhelmed by fatigue that he needed to be rehospitalized in York, Pa.

There, doctors diagnosed a new problem: a serious mycobacterial infection that was acquired during his surgery, according to his subsequent lawsuit. Aggressive treatment with antibiotics left him with partial hearing and vision loss.

Federal regulators acknowledge they were aware of infections tied to a heart-surgery device used in Karst’s operation by the summer of 2014. But they waited 14 months before issuing a public alert about the risks, and it wasn’t until last month — more than two years later — that they issued detailed recommendations to hospitals and patients on what to do.

Critics say a swifter response could have saved thousands of patients like Karst from being exposed to potentially deadly bacteria. Some patients fell ill or died without knowing the real cause, doctors say.

Now hospitals, which consider the heater-cooler machines crucial in open-heart surgery, are scrambling for ways to protect patients. And authorities have urged hospitals from New Jersey to California to notify hundreds of people who underwent surgery in recent years that they might be harboring a dangerous infection. Patients have sued, claiming they were infected in Pennsylvania, Iowa, South Carolina and Quebec.

Experts and patient advocates say these cases are only the latest to expose holes in the nation’s approach to spotting and responding to dangerous deficiencies in medical devices.

“It’s another example of the poor oversight of medical devices and how the industry has accepted infection as the cost of doing business,” said Helen Haskell, founder of the patient advocacy group Mothers Against Medical Error in Columbia, S.C.

About 60 percent of U.S. hospitals that do heart surgeries rely on the Sorin 3T heater-cooler device used in Karst’s surgery, which was approved for sale in 2006. But five other manufacturers sell heater-coolers in the U.S., and FDA officials say they share similar design features that make them prone to contamination.

The devices circulate water to warm or cool patients during bypass surgery, valve replacements and some transplants. More than 250,000 heart bypass operations using heater-cooler devices are performed annually in the U.S. The infections caused by the devices can be slow-growing and often don’t trigger symptoms for months or even years, making them difficult to track.

As a result, the risk is hard to quantify. At least 79 cases of infection tied to Sorin heater-cooler units in the U.S. and worldwide have been reported to the FDA since 2010, including 12 deaths. Those numbers are expected to rise.

“This particular machine is everywhere and it will be quite a while until we know the real extent of how many people were infected by this,” said Dr. Michael Edmond, an epidemiologist at the University of Iowa Hospitals & Clinics.

It’s In The Air

The potential for contamination of heater-coolers was raised as early as 2002. In a published study, doctors at a German hospital found that “germs and particles pollute” the units and that disinfecting them is very difficult.

The study, presented at a medical conference in New Orleans, said the makers of the devices often “do not provide any technology to reduce bacterial or other contamination,” posing potentially serious consequences for patients.

The study focused primarily on water spilling out of the unit and contaminating the operating room. But it also raised the prospect of waterborne pathogens causing infection through “aerosolization” — which is believed to be the way the recent infections occurred. The units examined were not Sorin devices.

The FDA visited Sorin’s Munchen, Germany plant in April 2011 to address safety concerns about the heater-cooler machine, according to a lawsuit filed this month. That suit says Sorin’s instructions for disinfecting the heater-cooler every two weeks allowed for “bacterial overgrowth well in excess of safe standards” in just a day and a half.

Despite the 2002 German study, a spokeswoman for Sorin, Karen King, said the company wasn’t aware of the threat of airborne mycobacteria until receiving a report from Swiss authorities in January 2014. (Sorin merged with another company last year to form London-based LivaNova.)

The water in the devices doesn’t come in direct contact with patients so there wasn’t much concern about infection until recently, health officials say. But it turns out lethal bacteria can grow inside the machine and then become aerosolized through the unit’s exhaust fan. The germs can float down into the patient’s open chest or stick to an implantable heart valve.

King said the initial details concerning bacteria transmission were limited and Sorin began investigating in 2014. The results led the company to notify hospitals in July 2014 that some of its heater-coolers had become contaminated and there was a risk of mycobacteria infecting cardiac patients.

Still, the company has maintained to the FDA that “post-surgical infection appears to be exceedingly uncommon.”

“We are working with regulators to develop a solution that addresses their concerns and ensures continued clinician access to this important device which enables lifesaving cardiac surgery,” LivaNova said in a statement. The company declined to answer additional questions.

LivaNova posted $1.2 billion in sales for all of its devices last year and says that half of the world’s cardiac surgeries rely, at least in part, on its equipment.

May 2014: A South Carolina hospital asks state, federal officials to investigate infections and potential link to heater-coolers.

July 2014: Device maker Sorin notifies hospitals that its heater-coolers can become contaminated.

August 2014: U.S. Food and Drug Administration becomes aware of Sorin alert; investigation underway.

April 2015: European authorities warn hospitals about infection risk from heater-cooler units.

October 2015: FDA issues its first safety alert about heater-coolers.

June 2016: FDA convenes expert panel to examine risk posed by the devices.

Oct. 13, 2016: U.S. officials tie infections to Sorin machines; advise hospitals to look for more patient infections.

Sources: KHN reporting, FDA, Sorin

‘An Evolving Story’

The FDA said it too was caught off guard by the danger posed by heater-coolers and has defended its handling of the matter.

“This is an evolving story in terms of new information that became available as a result of ongoing studies and efforts in the U.S. as well as outside the U.S.,” said Suzanne Schwartz, an associate director at the FDA’s center for regulating medical devices. “It might seem to have taken a fair amount of time, but one of the challenges has been raising awareness in the health care community that this is a problem that needs to be addressed.”

An FDA spokeswoman, Angela Stark, said the agency received at least two reports of infection tied to heater-coolers in 2009 and 2010. Details of those reports weren’t available in the FDA’s public database of injury reports.

The agency didn’t begin investigating until mid-2014. That was when it learned of the alert Sorin sent to hospitals and also around the time of an unusual infection outbreak at a South Carolina hospital, Schwartz said. The FDA said it only learned in spring 2015 that heater-coolers could blow bacteria across the operating room.

“It came as a surprise to the health care community at large,” Schwartz said. “Once that recognition was there, we have been working very proactively with all the device manufacturers.”

Dangerous And Resilient

Many — but not all — of the confirmed infections involved an organism called Mycobacterium chimaera, a species commonly found in soil and tap water. They aren’t generally harmful to healthy people, but officials said they can lead to serious infections in patients who are already ill or have weakened immune systems.

The source of the contamination from heater-coolers can be two-fold — at the manufacturing plant and in hospitals themselves.

Last month, the U.S. Centers for Disease Control and Prevention announced that an analysis of patient samples had confirmed that contaminated Sorin machines had been shipped through the summer of 2014 from the company’s German factory.

The company told the FDA it addressed the contamination by introducing sterile water at the plant and adopting new disinfection measures in August 2014.

Still, the heater-cooler machines can also become contaminated from the local water hospitals pour into the units. And however the contamination occurs, the FDA has said the bacteria can be difficult to remove even when the manufacturer’s cleaning instructions are followed.

Some medical experts say the South Carolina outbreak in 2014, at Greenville Memorial Hospital, should have triggered a more forceful response by U.S. health officials, including the FDA.

That year, when investigating mysterious infections among more than a dozen patients, the CDC found a form of mycobacteria different from the one in the German plant in an operating room sink and in the Sorin heater-cooler being used.

Dr. Michael Bell, a CDC deputy director, said the outbreak was complicated because some of the infected patients had no link to the heater-cooler during their treatment. Nonetheless, he said the heater-cooler contamination could have contributed to some of the patient infections. Four patients infected with the mycobacterium died.

Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa., said federal officials should have sounded the alarm over mycobacteria and heater-coolers after the 2014 Greenville hospital outbreak. “Some deaths might have been avoided if the FDA and CDC had performed a more proactive investigation.”

According to a lawsuit filed this month, a patient treated in a North Carolina hospital alleged that he was infected during a June 2015 liver transplant after a heater-cooler machine exposed him to the same bacteria implicated in South Carolina.

‘A Wake-Up Call’

Some patients and their families are left wondering why the device maker and government officials didn’t notify the public sooner. “Why wasn’t more being done?” said Jaime Jackson, an attorney representing Karst, the York patient.

Follow KHN’s continuing coverage of medical devices from Senior Correspondent Chad Terhune:

WellSpan York Hospital and LivaNova both declined to comment on Karst’s lawsuit, citing the pending litigation. Overall, the Pennsylvania hospital has reported 12 infections tied to the heater-coolers, and six of those patients have died. It has notified roughly 1,300 patients about possible exposure dating to 2011, according to WellSpan.

Meanwhile, the FDA has said heater-coolers “remain critical to patient care” and can’t be removed without a viable alternative.

That has put many hospitals in a quandary. Some hospitals, such as the University of Iowa, chose to cut holes in the operating room walls, moving the units next door so the fan exhaust isn’t falling on patients and surgical instruments. “If I was having cardiac surgery, I would want that machine out of the room,” said Edmond, the University of Iowa doctor.

But the CDC said that approach isn’t always feasible. Other hospitals have put enclosures around the machines or pointed the exhaust fan away from patients and the surgical field. Many are now using sterile or filtered water in their machines, as health officials have recommended.

“I don’t think we have a one-size-fits-all solution for this,” the CDC’s Bell said. “The reality is this is a wakeup call for the design of many medical devices, especially those in critical places like the operating room.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Categories: California Healthline, Health Industry, Public Health, Syndicate

Tags: FDA, Hospitals, Medical Devices