APRA – APRA

Free-standing ERs Charging Patients 10X More Than an Urgent Care Center or Doctor’s Office

APRA — Fri, 21 May 2021 18:19:57 +0000

By Phil Galewitz, Kaiser Health News, May 21, 2021.

Colorado health officials so abhor the high costs associated with free-standing emergency rooms they’re offering to pay hospitals to shut the facilities down.

The state wants hospitals to convert them to other purposes, such as providing primary care or mental health services.

At least 500 free-standing ERs have set up in more than 20 states in the past decade. Colorado has 44, 34 owned by hospitals.

The trend began a decade ago with hopes these stand-alone facilities would fill a need for ER care when no hospital was nearby and reduce congestion at hospital ERs.

But that rarely happened.

Instead, these emergency rooms — not physically connected to hospitals — generally set up in affluent suburban communities, often near hospitals that compete with the free-standing ERs’ owners. And they largely treated patients who did not need emergency care, but still billed them and their insurers at expensive ER rates, several studies have found.

“We don’t want hospitals to have stand-alone ERs, so we are willing to pay to shut them down,” said Kim Bimestefer, executive director of Colorado’s Department of Health Care Policy & Financing, which oversees the state’s Medicaid program. She said using these facilities to treat common injuries and illnesses leads to higher costs for Medicaid, which the state partly finances, and other insurers.

Colorado’s move is part of a new initiative that requires hospitals to improve their quality of care to qualify for millions of dollars in Medicaid payments. Hospitals can choose among goals provided by the state such as lowering readmission rates or screening patients for social needs such as housing. Converting free-standing ERs to meet other needs is one of those goals.

“Money talks,” Bimestefer said in explaining why the state is offering the financial incentives.

Money has been a major driver of the boom in free-standing emergency centers. Hospitals used them to attract patients who could be referred to the main hospital for inpatient care. They are also seen as a way to compete with rivals. For instance, in Palm Beach County, Florida, for-profit hospital chain HCA Healthcare has opened free-standing ERs near competing hospitals in Palm Beach Gardens and Boynton Beach.

In addition, the massive amounts of private equity funds flowing into health care have further fueled the growth of independently owned stand-alone ERs.

The Denver-based Center for Improving Value in Health Care found that most conditions treated in these facilities are more appropriate for lower-acuity, lower-cost urgent care centers. Patients can pay 10 times more in a free-standing ER than in an urgent care center for treatment of the same condition, the organization’s studies show.

Adam Fox, deputy director of the Colorado Consumer Health Initiative, said free-standing ERs have not been placed where health care services are scarce. Instead, they’ve opened in middle- and upper-income neighborhoods where most people have health insurance and access to care. “This push from the state will help” as hospitals rethink whether these facilities still make sense financially, he said.

In the past few years, Colorado has moved to make owning these facilities less attractive with laws preventing them from sticking patients with surprise bills for high fees because the ER was out of their insurer networks. It also has required that patients without true emergencies be told they can get treatment for a lower price at an urgent care facility.

The law requires a free-standing ER to post a sign informing patients it is an emergency room that treats emergency conditions. It must also specify the prices of the 25 most common services it provides.

Even before the new policy begins to roll out later this year, some Colorado hospitals started converting these facilities. UCHealth has turned nine in the past two years into primary or urgent care centers and one into a specialty center. It still has nine others in operation across the state.

The conversions were not prompted by state actions, according to Dan Weaver, a spokesperson for UCHealth, part of the University of Colorado. “Neither surprise billing legislation nor price transparency played a role in these decisions — we converted them because we felt patients in these communities needed urgent care, primary care and/or specialty care services close to home,” Weaver said.

He added that the hospital system always stressed that people should use lower-cost services, including urgent care, primary care or virtual urgent care, in nonemergencies.

Ryan Westrom, senior director of finance at the Colorado Hospital Association, said hospitals have converted some of these centers to services such as urgent care in response to changes in insurance reimbursement and other factors. He said he wasn’t sure whether many hospitals will accept the state payments to close their free-standing ERs.

HealthONE, which has eight free-standing ERs in the Denver area, said it has no plans to close any despite the state incentive payment.

Vivian Ho, a health economist at Rice University in Houston who has tracked the growth of these stand-alone emergency rooms, applauded Colorado’s effort.

But she worries hospitals may decide it’s not worth closing a free-standing emergency department and forfeiting the profits: “You have to attack free-standing EDs from multiple angles to get people to stop going to them and to get hospitals from using them as a way to generate extra revenues for care that can be delivered at lower-cost sites.”

Ho said the covid pandemic, which dampened demand for emergency care, and recent federal surprise billing legislation may hurt the growth of free-standing ERs.

They are already facing headwinds. Adeptus Health, the Texas company that’s been leading the trend there and started dozens of the free-standing emergency rooms, often in conjunction with hospitals, filed for bankruptcy this year. And numerous stand-alone facilities closed at least temporarily during the pandemic as demand for care fell dramatically.

Advisers to Medicare are also pushing back on the growth. A recent proposal from the Medicare Payment Advisory Commission, which reports to Congress, would cut Medicare payment rates 30% on some services at stand-alone facilities within 6 miles of an emergency room in a hospital.

According to a MedPAC analysis of five markets — Charlotte, North Carolina; Cincinnati; Dallas; Denver; and Jacksonville, Florida — 75% of free-standing facilities were within 6 miles of a hospital with an emergency department. The average drive time to the nearest such hospital was 10 minutes.

Markian Hawryluk, KHN’s senior Colorado correspondent, contributed to this article.

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To Vax or Not to Vax – A COVID Quiz for Anti-Vaxxers and Hesitators

APRA — Wed, 19 May 2021 21:56:28 +0000

MOUNT DORA, Fla. May 20, 2021 – A lot of misinformation has been circulated about the
COVID-19 vaccine. To convince people who are hesitating or refusing to get vaccinated,
the American Patient Rights Association, a nonprofit membership organization established
by patients to help people pay less for and avoid being harmed by their medical treatment,
has released a COVID quiz. It offers responses to the most common anti-vaxxer
objections to getting the vaccine.

“More people need to get vaccinated in order for our country to reach herd immunity
without the number of deaths increasing”, said Ron Liss, president of the organization.
“Unless you have an underlying health issue that prevents you from getting the vaccine
there is no good reason not to, and we’re hoping that people who are still on the fence or
refuse to get vaccinated will take our quiz and learn why they shouldn’t be so concerned.”

According to Johns Hopkins, the U.S. has had more than 33 million confirmed cases of
COVID and 587,000 deaths, the most in the world.

“People in other countries that don’t have the vaccine would do anything to get it. Since
our country now has a large supply we have the responsibility to make the best use of it”,
Liss added. “It’s widely available here and getting the jab is so quick and painless that
most people don’t even realize when it’s done. People should get it to protect their loved
ones as well as themselves. It would be horrible to get COVID and then pass it on to
someone who dies from it.”

“The sooner everyone has immunity to COVID, either by getting the vaccine or the
disease, the sooner we can all return to a normal life and not hear about it anymore. The
less risky way is to get vaccinated.”

10 Best Hospital Cities’ in the US

APRA — Fri, 18 Oct 2019 15:24:32 +0000

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New Round of Medicare Readmission Penalties Hits 2,583 Hospitals

APRA — Fri, 18 Oct 2019 15:06:05 +0000

By Jordan Rau, KHN. October 01, 2019.

Medicare cut payments to 2,583 hospitals Tuesday, continuing the Affordable Care Act’s eight-year campaign to financially pressure hospitals into reducing the number of patients who return for a second stay within a month.

The severity and broad application of the penalties, which Medicare estimates will cost hospitals $563 million over a year, follows the trend of the past few years. Of the 3,129 general hospitals evaluated in the Hospital Readmission Reduction Program, 83% received a penalty, which will be deducted from each payment for a Medicare patient stay over the fiscal year that begins today.

Although Medicare began applying the penalties in 2012, disagreements continue about whether they have improved patient safety. On the positive side, they have encouraged hospitals to focus on how their patients recuperate, and some now assist them in procuring medications and follow-up appointments.

But the hospital industry and some academics have raised concerns that some hospitals may be avoiding readmitting patients who require additional inpatient care out of fear of the financial repercussions, while others have said the program is not showing major benefits.

“A lot of hard work has gone into trying to reduce readmissions, and the needle has not moved very far,” said Dr. Karen Joynt Maddox, co-director of the Center for Health Economics and Policy at Washington University in St. Louis, who has been skeptical of the initiative. “It’s been a huge investment by hospitals but not very much in outcomes, but some good things have come out of it.”

A few studies have even found an increase in mortality since the penalties took effect, but other studies, including a recent one by the Medicare Payment Advisory Commission (MedPAC), an independent body that helped devise the approach for Congress, identified no such link.

“I don’t believe the HRRP kills people,” David Grabowski, a commission member and health policy professor at Harvard Medical School, said at the commission’s meeting last month, using the acronym for the penalty program.

The MedPAC staff’s preliminary analysis, made public last month, found that the frequency of Medicare patients being readmitted within 30 days of discharge dropped from 16.7% in 2010 to 15.7% in 2017. However, the analysis said the decrease was more significant once it took into consideration that the average patient was frailer in 2017 than in 2010 and thus more likely to end up back in the hospital, with all other things being equal.

“On a risk-adjusted basis, it appears that readmissions have declined in 2010 to 2018 without causing a material increase in mortality,” Jeff Stensland, a MedPAC analyst, told the commission.

The penalties are based on the frequency of readmissions of Medicare patients who had originally been treated for heart failure, heart attack, pneumonia, chronic lung disease, hip and knee replacement or coronary artery bypass graft surgery. Readmissions that were scheduled to occur are not counted.

Medicare counts the readmission of patients who returned to a hospital within 30 days even if that hospital is not the one that originally treated them. In those cases, the penalty is applied to the first hospital. This year’s penalties are based on discharges from July 1, 2015, to June 30, 2018.

“This is like driving your car by looking in the rearview mirror of the car three cars behind you,” Dr. Jonathan Perlin, the chief medical officer of HCA Healthcare in Nashville and a MedPAC commission member, said at last month’s meeting. “It’s very difficult to operationalize.”

The average penalty will be a 0.71% decrease in payment for each Medicare patient who leaves the hospital over the next year, according to a Kaiser Health News analysis. The KHN analysis also found:

1,177 hospitals received a higher penalty than they did last year.
1,148 hospitals received a lower one than last year.
64 hospitals received the same penalty as last year.
194 hospitals that had not been penalized last year are being punished this year.
The maximum penalty — a 3% reduction in payments — was assessed against 56 hospitals.
372 hospitals avoided penalties in both years.

These figures do not include 2,142 hospitals that Medicare exempted from the program this year, either because they had too few cases to judge; were veterans’ hospitals, children’s hospitals, psychiatric hospitals or were critical-access hospitals, which are the only hospitals within reach of some patients. Also, Maryland hospitals were excluded because Congress lets that state set its own rules on how to distribute Medicare money and handle readmissions.

The Centers for Medicare & Medicaid Services determines its penalties by looking at national averages for each of the conditions, so hospitals that have reduced their readmissions from previous years can still take a hit. The hospital industry argues it may be approaching the limits of how much it can do to prevent readmissions. A repeat stay, hospitals say, is sometimes necessary no matter what precautions are taken.

Akin Demehin, director of policy at the American Hospital Association, said: “It raises the question: Is the value of the program to improve care or just to enact penalties on hospitals?”

Patient Dies in Pennsylvania’s WellSpan York Hospital ER

APRA — Fri, 18 Oct 2019 00:53:25 +0000

By Shelly Stallsmith, York Daily Record, Oct. 15, 2019.

WellSpan York Hospital emergency staff were seen on video walking past a patient in a wheelchair approximately 12 times on Aug. 16.

No one approached the man for more than 70 minutes. Roughly 3 ½ hours after arriving at the hospital by ambulance, the man was dead, according a patient care inspection report by the Pennsylvania Department of Health.

Determined to be out of compliance

WellSpan York Hospital was determined to be out of compliance of Pennsylvania’s Medical Care Availability and Reduction of Error Act after a special monitoring visit was made Aug. 22, 23 and 30.

By law, the hospital was supposed to report the death within 24 hours. An interview confirmed that the report was not entered until after the facility conducted a “Root Cause Analysis,” which is in violation of the law that states the “report will not be delayed for peer review or other quality investigating activities.”

A tragic timeline

According to the timeline in the report, the man arrived by ambulance to the hospital at 9:59 a.m. Aug. 16, complaining of nausea. The triage notes said the patient had complained of dizziness since the night before and had a history of vertigo. The patient’s temperature was low, and staff was having difficulty getting a pulse oxygen reading.

At 10:15, staff determined he had no signs/symptoms of sepsis and an acuity level of 3 was given. Triage was completed.

Five minutes later, the acuity level was upgraded to 2.

At 10:25, the patient’s vital signs were heart rate, 120; respiration, 28; and blood pressure, 115/89.

Between 10:25 a.m. and 12:05 p.m., the man’s name was called three times, and the patient failed to respond each time. After the third time, he was marked LWBS (left without being seen), and his name was removed from a tracking board.

At approximately 12:25 p.m., the patient was found to be unresponsive, according to the report, and moved to a private treatment room. He was pronounced dead at 1:31 p.m.

Investigators also turned to security camera footage, which showed that the patient had his oxygen discontinued when he was transferred from the ambulance stretcher to the wheelchair.

Footage shows vital statistics being taken by a nursing assistant, but that the pivot nurse (responsible for identifying each patient and comparing to tracking board) never spoke with the patient.

“At no time was any staff observed to complete Rounding on [the patient] as per their Rounding policy,” the report states. “No movement by the patient was noted from approximately 11:09 a.m. until approached by staff at 12:20 p.m.”

The report shows that two other patients, with less-severe ailments, were triaged, examined and discharged while the man in question was still in the waiting room.

“We have reviewed what happened and taken immediate steps to correct any issues which contributed to this event,” Birenberg said. “We are committed to doing our very best, every day, for every patient, and we will continue to work hard to make sure that happens.

“To that end, we continue to redesign our processes to ensure access to high-quality, timely care for all.”

Steps to be taken

WellSpan York Hospital had until Oct. 14 to implement its plan of correction:

- Nurses have been reassigned in the department to make sure there is 24/7 coverage in pivot and triage areas.

- A nurse has been assigned to reassess patients in the lobby area, whenever the length of stay in the lobby exceeds one hour.

- The hospital contracted for 15 traveling nurses. Six positions have been filled and the hospital is recruiting to fill the remaining spots.

- No patient will be taken off of the tracking board without physical confirmation of their departure.
- All patients arriving by ambulance will be taken directly to a private bed or to triage. Anyone with an acuity of 2 or greater will be given a bed.

York Hospital held emergency department town halls twice in September to reinforce the changes and give staff the chance to discuss them. Nearly 100 staff members attended the meetings. Those who couldn’t, were given the information in smaller groups or in newsletters throughout the month.

Common Joint Pain Treatment May be More Harmful Than Thought

APRA — Tue, 15 Oct 2019 20:03:27 +0000

The shots may speed up the progression of arthritis and hasten the need for surgery.

By Jacqueline Stenson, NBC Health News. Oct. 15, 2019.

A common therapy for joint pain may not be as safe as experts believed, according to a new report published Tuesday.

Corticosteroid injections are often given to reduce pain and inflammation from osteoarthritis.

But these injections may do more harm than good: The report found corticosteroid shots in the hips and knees may accelerate the progression of osteoarthritis and potentially even hasten the need for joint replacement surgeries in the long run, said lead author Dr. Ali Guermazi, a professor of radiology at the Boston University School of Medicine.

“The intra-articular corticosteroid injections in the hips and knee are not as safe as we thought,” Guermazi, whose paper is published in the journal Radiology, said.

It’s estimated that more than 30 million Americans have osteoarthritis, a chronic condition that causes cartilage loss, joint inflammation, pain, swelling and, in severe cases, bone destruction, according to the Arthritis Foundation.

Corticosteroid injections into the hips and knees are a common treatment for patients in significant pain; in one study of more than 16,500 patients who underwent knee or hip joint replacement, half had received corticosteroid injections in the prior two years. The injections often are covered by insurance.

In the new paper, Guermazi’s team reviewed existing literature on corticosteroid injections for osteoarthritis, and also looked at data on 459 patients at Boston Medical Center who received one to three corticosteroid injections in the hip or knee in 2018. The researchers found that 8 percent of patients developed complications, including cartilage loss, stress fractures, bone deterioration and joint destruction, in the two to 15 months following the injections.

The rate of complications surprised Guermazi, who added that the figure may actually be an underestimate because 218 of the patients did not have follow-up imaging tests to assess the health of their joints.

While patients may report temporary pain relief from the corticosteroid injections, he said, the injections may be detrimental in the long run. “They may actually harm your knee or your hip,” he said.

An exact explanation for the findings is unclear, Guermazi said, but there is some evidence that corticosteroid injections, which typically are combined with an anesthetic, can be toxic to cartilage, and more studies are needed to understand their effects and clarify their benefits and risks.

Dr. Antonia Chen, an associate professor of orthopaedic surgery at Harvard Medical School and a spokesperson for the American Academy of Orthopedic Surgeons, said corticosteroid injections can help relieve pain in some, but not all, patients for as long as days or months. But patients should be informed that the injections carry risks, as the new paper and others have shown, which is why it’s recommended the injections be given no more frequently than every three months, she said.

“There are definitely benefits and there are definitely risks, and these risks must be mentioned to patients,” Chen said. “Some patients will say they don’t want to undergo temporary relief and they don’t want to have the chance of progressing their arthritis, and some say they need some sort of pain relief to just live day to day.”

But before turning to injections or other medications, Chen recommends that patients with osteoarthritis first talk with a physician about noninvasive approaches, such as exercise, physical therapy and weight loss.

Guy Eakin, senior vice president of scientific strategy for the Arthritis Foundation, agreed, telling NBC News that a healthy lifestyle remains the key to managing osteoarthritis.

“Exercise is really one of the best things that can be done,” he said.

Indeed, research indicates that exercise helps ease pain, improve mobility and strengthen muscles around the joints. Stretching activities such as yoga and tai chi may help increase flexibility and reduce joint stiffness. Exercise also can aid in weight loss to reduce pressure on the joints.

While arthritis patients in chronic pain may try to get relief from pain relievers or injections of corticosteroids or hyaluronic acid, there is no cure for the condition. Patients who ultimately end up with bone rubbing against bone may be in such severe pain and have such difficulty moving that they opt for a total joint replacement.

Millions of Americans’ Medical Images and Data Are Available on the Internet. Anyone Can Take a Peek.

APRA — Tue, 15 Oct 2019 14:18:50 +0000

By Jack Gillum, Jeff Kao and Jeff Larson, for ProPublica. Sep 17, 2019.

Medical images and health data belonging to millions of Americans, including X-rays, MRIs and CT scans, are sitting unprotected on the internet and available to anyone with basic computer expertise.

The records cover more than 5 million patients in the U.S. and millions more around the world. In some cases, a snoop could use free software programs — or just a typical web browser — to view the images and private data, an investigation by ProPublica and the German broadcaster Bayerischer Rundfunk found.

We identified 187 servers — computers that are used to store and retrieve medical data — in the U.S. that were unprotected by passwords or basic security precautions. The computer systems, from Florida to California, are used in doctors’ offices, medical-imaging centers and mobile X-ray services.

The insecure servers we uncovered add to a growing list of medical records systems that have been compromised in recent years. Unlike some of the more infamous recent security breaches, in which hackers circumvented a company’s cyber defenses, these records were often stored on servers that lacked the security precautions that long ago became standard for businesses and government agencies.

“It’s not even hacking. It’s walking into an open door,” said Jackie Singh, a cybersecurity researcher and chief executive of the consulting firm Spyglass Security. Some medical providers started locking down their systems after we told them of what we had found.

Our review found that the extent of the exposure varies, depending on the health provider and what software they use. For instance, the server of U.S. company MobilexUSA displayed the names of more than a million patients — all by typing in a simple data query. Their dates of birth, doctors and procedures were also included.

Alerted by ProPublica, MobilexUSA tightened its security last week. The company takes mobile X-rays and provides imaging services to nursing homes, rehabilitation hospitals, hospice agencies and prisons. “We promptly mitigated the potential vulnerabilities identified by ProPublica and immediately began an ongoing, thorough investigation,” MobilexUSA’s parent company said in a statement.

Another imaging system, tied to a physician in Los Angeles, allowed anyone on the internet to see his patients’ echocardiograms. (The doctor did not respond to inquiries from ProPublica). All told, medical data from more than 16 million scans worldwide was available online, including names, birthdates and, in some cases, Social Security numbers.

Experts say it’s hard to pinpoint who’s to blame for the failure to protect the privacy of medical images. Under U.S. law, health care providers and their business associates are legally accountable for securing the privacy of patient data. Several experts said such exposure of patient data could violate the Health Insurance Portability and Accountability Act, or HIPAA, the 1996 law that requires health care providers to keep Americans’ health data confidential and secure.

Although ProPublica found no evidence that patient data was copied from these systems and published elsewhere, the consequences of unauthorized access to such information could be devastating. “Medical records are one of the most important areas for privacy because they’re so sensitive. Medical knowledge can be used against you in malicious ways: to shame people, to blackmail people,” said Cooper Quintin, a security researcher and senior staff technologist with the Electronic Frontier Foundation, a digital-rights group. “This is so utterly irresponsible,” he said.

The issue should not be a surprise to medical providers. For years, one expert has tried to warn about the casual handling of personal health data. Oleg Pianykh, the director of medical analytics at Massachusetts General Hospital’s radiology department, said medical imaging software has traditionally been written with the assumption that patients’ data would be secured by the customer’s computer security systems.

But as those networks at hospitals and medical centers became more complex and connected to the internet, the responsibility for security shifted to network administrators who assumed safeguards were in place. “Suddenly, medical security has become a do-it-yourself project,” Pianykh wrote in a 2016 research paper he published in a medical journal.

ProPublica’s investigation built upon findings from Greenbone Networks, a security firm based in Germany that identified problems in at least 52 countries on every inhabited continent. Greenbone’s Dirk Schrader first shared his research with Bayerischer Rundfunk after discovering some patients’ health records were at risk. The German journalists then approached ProPublica to explore the extent of the exposure in the U.S.

Schrader found five servers in Germany and 187 in the U.S. that made patients’ records available without a password. ProPublica and Bayerischer Rundfunk also scanned Internet Protocol addresses and identified, when possible, which medical provider they belonged to.

ProPublica independently determined how many patients could be affected in America, and found some servers ran outdated operating systems with known security vulnerabilities. Schrader said that data from more than 13.7 million medical tests in the U.S. were available online, including more than 400,000 in which X-rays and other images could be downloaded.

The privacy problem traces back to the medical profession’s shift from analog to digital technology. Long gone are the days when film X-rays were displayed on fluorescent light boards. Today, imaging studies can be instantly uploaded to servers and viewed over the internet by doctors in their offices.

In the early days of this technology, as with much of the internet, little thought was given to security. The passage of HIPAA required patient information to be protected from unauthorized access. Three years later, the medical imaging industry published its first security standards.

Our reporting indicated that large hospital chains and academic medical centers did put security protections in place. Most of the cases of unprotected data we found involved independent radiologists, medical imaging centers or archiving services.

One German patient, Katharina Gaspari, got an MRI three years ago and said she normally trusts her doctors. But after Bayerischer Rundfunk showed Gaspari her images available online, she said: “Now, I am not sure if I still can.” The German system that stored her records was locked down last week.

We found that some systems used to archive medical images also lacked security precautions. Denver-based Offsite Image left open the names and other details of more than 340,000 human and veterinary records, including those of a large cat named “Marshmallow,” ProPublica found. An Offsite Image executive told ProPublica the company charges clients $50 for access to the site and then $1 per study. “Your data is safe and secure with us,” Offsite Image’s website says.

The company referred ProPublica to its tech consultant, who at first defended Offsite Image’s security practices and insisted that a password was needed to access patient records. The consultant, Matthew Nelms, then called a ProPublica reporter a day later and acknowledged Offsite Image’s servers had been accessible but were now fixed. “We were just never even aware that there was a possibility that could even happen,” Nelms said.

In 1985, an industry group that included radiologists and makers of imaging equipment created a standard for medical imaging software. The standard, which is now called DICOM, spelled out how medical imaging devices talk to each other and share information.

We shared our findings with officials from the Medical Imaging & Technology Alliance, the group that oversees the standard. They acknowledged that there were hundreds of servers with an open connection on the internet, but suggested the blame lay with the people who were running them.

“Even though it is a comparatively small number,” the organization said in a statement, “it may be possible that some of those systems may contain patient records. Those likely represent bad configuration choices on the part of those operating those systems.”

Meeting minutes from 2017 show that a working group on security learned of Pianykh’s findings and suggested meeting with him to discuss them further. That “action item” was listed for several months, but Pianykh said he never was contacted. The medical imaging alliance told ProPublica last week that the group did not meet with Pianykh because the concerns that they had were sufficiently addressed in his article. They said the committee concluded its security standards were not flawed.

Pianykh said that misses the point. It’s not a lack of standards; it’s that medical device makers don’t follow them. “Medical-data security has never been soundly built into the clinical data or devices and is still largely theoretical and does not exist in practice,” Pianykh wrote in 2016.

ProPublica’s latest findings follow several other major breaches. In 2015, U.S. health insurer Anthem Inc. revealed that private data belonging to more than 78 million people was exposed in a hack. In the last two years, U.S. officials have reported that more than 40 million people have had their medical data compromised, according to an analysis of records from the U.S. Department of Health and Human Services.

Joy Pritts, a former HHS privacy official, said the government isn’t tough enough in policing patient privacy breaches. She cited an April announcement from HHS that lowered the maximum annual fine, from $1.5 million to $250,000, for what’s known as “corrected willful neglect” — the result of conscious failures or reckless indifference that a company tries to fix. She said that large firms would not only consider those fines as just the cost of doing business, but that they could also negotiate with the government to get them reduced. A ProPublica examination in 2015 found few consequences for repeat HIPAA offenders.

A spokeswoman for HHS’ Office for Civil Rights, which enforces HIPAA violations, said it wouldn’t comment on open or potential investigations. “What we typically see in the health care industry is that there is Band-Aid upon Band-Aid applied” to legacy computer systems, said Singh, the cybersecurity expert.

She said it’s a “shared responsibility” among manufacturers, standards makers and hospitals to ensure computer servers are secured. “It’s 2019,” she said. “There’s no reason for this.”

How Do I Know if My Medical Imaging Data is Secure?

If you have had a medical imaging scan (e.g., X-ray, CT scan, MRI, ultrasound, etc.) ask the health care provider that did the scan — or your doctor — if access to your images requires a login and password. Ask your doctor if their office or the medical imaging provider to which they refer patients conducts a regular security assessment as required by HIPAA.

Drug Shortages Putting Patients At Risk

APRA — Tue, 15 Oct 2019 14:09:49 +0000

By Julie Appleby, The Washington Post, September 24, 2019

Medical treatment has knocked down tumors in 6-year-old Easton Daniels’s brain, but the drug that helped him also wiped out his immune system. To bolster his immune function and help keep him healthy, he has visited a hospital for intravenous infusions of immune globulin about every month for the past year and a half.

But in July, his family was stunned by a letter from Cincinnati Children’s Hospital Medical Center: “All of Easton’s appointments canceled until further notice,” said his dad, Jeremy Daniels, who works in custodial services for a school. Like Cincinnati Children’s, hospitals and clinics nationwide report a shortage of the medication, whose long manufacturing process starts with donated blood plasma.

Often referred to as IVIG, intravenous immune globulin is used for a wide variety of medical conditions beyond those for which it was first targeted — some treatments effective and some not. It is rich in antibodies, which are proteins that help fight off infection.

With IVIG in short supply, hospitals are left to make tough choices about who receives it, setting up a type of triage, like that faced by Easton’s family, who find themselves caught in a gray area over which conditions qualify. The hospital said it couldn’t comment on individual cases but that it had made those with life-threatening needs a priority.

“IVIG can be a useful treatment for evidence-based purposes, but it’s also often used as a last-chance, nothing-is-working Hail Mary kind of approach for myriad conditions even when there is not clear evidence that it helps the patient,” Jerry Avorn, a professor of medicine at Harvard Medical School, said in an email. He was speaking in general, not about any specific patient.

Nationwide, drug shortages of all kinds — from antibiotics to heart drugs to saline solution — are increasing and having a high impact on public health, the Food and Drug Administration said in a November public meeting. They often result from manufacturing problems — such as when a factory shuts down or too few suppliers exist to meet demand.

But the reasons for shortages of expensive infused drugs are particularly complicated, involving complex manufacturing processes, scientific uncertainty and financial motivations. In the case of IVIG, the expensive treatment may be a victim of its own widening use.

Dating to the 1950s, immune globulin is often the only therapy for certain genetic, life-threatening conditions that disable the body’s infection-fighting function. Its intravenous form is FDA-licensed for six conditions, including primary immunodeficiencies; Kawasaki disease, which causes inflammation in the blood vessels; preventive care after bone marrow transplants; and a neurological condition called chronic inflammatory demyelinating polyneuropathy.

Today it is also prescribed for secondary immunodeficiency, which can occur when the body’s immune system is compromised by viruses or treatments for cancer, although there may be other medicines for reinvigorating the immune system in those cases.

And Avorn said a portion of these uses may be encouraged by financial motivations. Cincinnati Children’s, for example, charges $6,800 to $10,000 for every 10-gram dose, according to the hospital’s list prices, which are generally higher than insurers pay. Adults often get more than 10 grams per infusion.

“And anytime an extremely costly infusion medicine is used in any setting, it’s worth looking at who benefits economically from its use, especially for conditions in which data on effectiveness is limited or absent,” Avorn said.

Nonetheless, increasing demand helped create the shortages, say pharmacists and others who study shortfalls. Immune globulin takes up to a year to produce, which includes plasma collection from healthy donors, processing, packaging and shipping — often at overseas manufacturing centers. There are several manufacturers, with combined global sales of about $22.6 billion.

Aside from trying to boost plasma collection to deal with a shortfall, “the other piece is stewardship [of the supply] and that really is up to the hospitals, by and large,” said John Boyle, chief executive of the Immune Deficiency Foundation, a group that advocates on behalf of people with genetic defects of the immune system. “Hospitals use an enormous portion of the plasma products out there.”

Many are scrambling to come up with ways to stretch their supplies. Some, like Cincinnati Children’s, give top priority to patients with no other alternatives, often those with primary immune deficiencies, and those for whom not getting the treatment would be life-threatening.

Others, whose indications “were not as clear-cut or it was not necessarily dangerous to them to forgo it, were placed on the bottom of the list,” said Derek Wheeler, chief of staff at Cincinnati Children’s.

Shortages are not affecting every hospital or clinic. That variation occurs because facilities have contracts with specific distributors or manufacturers, each of which can have a different supply line.

Cristina Porch-Curren, an immunologist in Camarillo, Calif., said her patients have not run into problems getting the treatment, although one had to change brands. She is concerned about the increasing use of immune globulin for “off-label” conditions.

“Off-label doesn’t always mean bad. If you have someone who is really sick, with some terrible infection, on occasion that may be okay,” she said. But with limited supplies, she worries about growing interest by researchers and some physicians in using immune globulin for more widespread or ongoing conditions, such as dementia. “That’s concerning, especially for patients with primary immune deficiencies” who have no other alternatives, she said.

Back in Cincinnati, a temporary solution has been found for Easton. FFF Enterprises offered to supply his family with a different type of immune globulin after Easton’s father contacted the company, which is one of the largest distributors of the therapy.

Instead of an intravenous dose, it will give Easton a subcutaneous form, which can be injected as a shot at home. His doctor approved the switch, Daniels said, and the drug distributor said it would pick up the cost if his insurer, the state’s Medicaid program, balks.

Heart Valve Infection Risk on the Rise in Hospitals

APRA — Tue, 15 Oct 2019 13:51:44 +0000

By John Commins, Healthleaders Media, September 30, 2019.

New infection sources have emerged for people with heart disease, and defective or artificial heart valves. That’s according to a new study from researchers at Rutgers Robert Wood Johnson Medical School, published this month in The American Journal of Cardiology.

The researchers warned that these potentially lethal cardiac infections pose an increasing threat to hospital patients admitted for other diseases. “In the past, infective endocarditis was associated with rheumatic heart disease and most often caused by bacteria in the mouth,” study lead author Abel Moreyra, MD, a professor of medicine at Rutgers, said in comments accompanying the study.

“However, new risk factors, such as intravenous opiate abuse, compromised immune systems, hemodialysis and implanted heart devices have emerged,” Moreyra said. In 2007, the American Heart Association revised guidelines and recommended antibiotics only for patients at high risk for infection.

The researchers looked to find how the revised guidelines changed infection rates. They analyzed 21,443 records of people who were diagnosed with infective endocarditis in New Jersey hospitals from 1994 to 2015.

The researchers were surprised to find that, beginning in 2004, there was a significant decline in the number of patients hospitalized with infective endocarditis as the primary diagnosis for their reason for admission.

Coupled with that was a significant increase in the number of patients developing the infection in the hospital, or a secondary diagnosis. In total, 9,191 people were hospitalized with infective endocarditis as the primary diagnosis and 12,252 with secondary diagnosis, the researchers found

The decline in primary diagnosis was attributed by researchers to improved dental care and the rarity of rheumatic heart disease, where streptococcus plays a key role in the infection.

“However, 60% of infective endocarditis that developed after admission were caused by a different microorganism, staphylococcus bacteria, which is abundant in hospitals and implicates health care as a possible source of infection,” Moreyra said.

The researchers believe that, by identifying the different time trends of primary and secondary diagnosis of infective endocarditis, the findings can help hospitals tailor different strategies for the prevention of this potentially lethal infection.

Employer Health Insurance Is Increasingly Unaffordable, Study Finds

APRA — Tue, 15 Oct 2019 13:43:13 +0000

By Reed Abelson, The New York Times

Jessie McCormick had to quit her job to afford health care. Ms. McCormick, 27, who has a heart condition, had an opportunity to move from part time to full time in her job at a small nonprofit in Washington. Working full time would qualify her for the firm’s health plan.

But she calculated that her out-of-pocket costs would be at least $1,200 per month, about double the money she had left after paying her rent and utilities. Instead, she quit her job last summer so her income would be low enough to enroll in Medicaid, which will cover all her medical expenses. “I’m trying to do some side jobs,” she said.

Employers remain the main source of health insurance in the United States, covering about 153 million people. But premiums and deductibles are pushing employer-based coverage increasingly out of reach, according to a new analysis released Wednesday by the Kaiser Family Foundation, which conducts a survey of employers every year.

The average premium paid by the employer and the employee for a family plan now tops $20,000 a year, with the worker contributing about $6,000, according to the survey. More than a quarter of all covered workers and nearly half of those working for small businesses face an annual deductible of $2,000 or more.

The new data on employer coverage come as the Democratic presidential candidates’ debate sweeping reforms to diminish the role of private insurance in the American health system, including expanding the federal Medicare program to everyone or giving people the option to enroll in a government-run plan.

Many of the arguments for both systems center on expanding health insurance to more of the estimated 27 million people who lack it. But millions of people who already have coverage are deeply dissatisfied with the current system as well.

“For some reason, we like to focus on coverage when the issue for workers, people and the public generally is cost,” said Drew Altman, the chief executive of the foundation. About 2,000 small and large businesses responded in detail to the survey. Small employers in particular, and their workers, are struggling.

“Health insurance in the United States is incredibly prohibitive for small businesses,” said Shalin Madan, the founder of a small investment advisory firm in Florida. He is not required to provide health insurance to his workers, because his business is too small, and he outsources much of the work.

A policy for his own family, he said, runs about $2,000 a month ($24,000 per year), with a $13,000 deductible. “I’m out $37,000 before I see a return on investment, if you will,” Mr. Madan said.

A recent Wall Street Journal/NBC News poll found that a majority of registered voters, 56 percent, are opposed to the idea of a government-run system like Medicare-for-all that would replace private insurance. But Mr. Madan said the current system results in a schism between those who have good employer coverage and those who do not. “I had phenomenal health insurance being employed,” said Mr. Madan of his time working for a larger corporation.

One of Senator Elizabeth Warren’s applause lines on the Democratic presidential campaign trail is that no one likes their insurance company. But employer coverage “isn’t monolithic,” said Mr. Altman. While some people, usually higher-paid professionals or union members, enjoy generous coverage from their job, people making $25,000 or less — about 36 million Americans — are the most likely to be priced out of coverage, he said.

People who work at companies where a large share of the employees are low-wage workers pay an average of $7,000 annually for a family plan, according to the survey, about $1,000 more than those working at companies made up of better-paid workers.

Only one in three of these workers is enrolled in an employer’s plan, about half the rate at better-paying companies. “This is a group that really deserves a lot more attention,” Mr. Altman said.

While some low-wage workers may qualify for Medicaid in states that expanded it under the Affordable Care Act, those with private insurance who are not eligible for government help are having a more difficult time affording care, said Dr. Benjamin Sommers, a health economist at the Harvard T.H. Chan School of Public Health.

“The arc of the A.C.A. really tried, and largely succeeded, in leaving the employer market as is,” he said. For many businesses, it’s a Sophie’s choice between raising an employee’s share of premiums or increasing the size of the deductible.

“I try to keep the benefits pretty much the same,” said Joel Sturm, chief operating officer of the New York College of Podiatric Medicine. The majority of workers are in a plan that comes with a deductible of $1,000 for an individual and asks them to pay about 10 percent of their medical bills. “It doesn’t kill them if they go,” Mr. Sturm said.

But the employees must pay a hefty share of the overall premiums, about $950 a month for a couple. Some employees have quit as a result of having so much taken out of their paycheck and still having to cover some out-of-pocket costs, Mr. Sturm said. “They’d rather be unemployed than have very little take-home pay,” he said, adding that Medicaid can seem like a more attractive option.

Many businesses have opted to increase deductibles instead of premiums. “A lot of employers with lower-paid employees want to offer a low-cost option that is typically a high-deductible plan,” said Chris Bartnik, a senior vice president at Lockton Companies who advises businesses on their coverage.

But some of his clients who once embraced high deductibles have changed their minds, worried their workers can’t afford to go to the doctor. Some large employers are adjusting the premiums and deductibles based on an employee’s income. JPMorgan Chase pays 80 percent of the premiums for workers making under $60,000, and the company lowered the annual deductible by $750 to $2,000 or less, depending on the plan they choose. (JPMorgan Chase is also part of the trio of big corporations behind Haven, a new venture trying to reinvent employer-based coverage.)

H.A. Cover & Son Lumber, in Thayer, Mo., has decided to pay the bulk of premiums for workers, but the plans come with a deductible of $2,500 for an individual and $5,000 for a family. The company is paying about $16,000 a month to cover the 11 people enrolled in the plan.

The deductible “is higher than we wanted to go,” said Marion Cowen, who oversees benefits for the business, but the cost for more comprehensive coverage was prohibitive. “We don’t know what we’re going to do if it goes up much more,” she said.

She is intrigued by the idea of being allowed to buy into a government plan, like Medicaid or Medicare, that is being floated by some of the candidates. “We would consider it, yes, we would,” she said, if the option saved money and provided employees with high-quality coverage.

The Wall Street Journal/NBC News poll found that about two-thirds of voters supported the idea of allowing people to buy into Medicare. “Some states are looking at a public option,” said David Chase, who leads the national outreach efforts for Small Business Majority, an advocacy group that supported the Affordable Care Act. He said the group is talking to various states about allowing small businesses the option of buying into a government program.

“There are a lot of hypothetical proposals out there,” said Neil Trautwein, vice president of health care policy at the National Retail Federation, who said his members are increasingly concerned about rising health care costs. Companies are not as keen on offering less generous plans, he said, but would be open to other alternatives.

At Bagel Grove in Utica, N.Y., most of the 20 employees are now covered by Medicaid, said Anne Wadsworth, one of the owners. She took advantage of the tax credits available to small businesses that helped pay for the cost of coverage under the Affordable Care Act, but the credits ran out. While she still covers 45 percent of the premiums, all but one of her employees, herself included, have found better plans on their own.

“I was all on board for Obamacare,” she said, but it proved not to be “a long-term solution. It doesn’t lower the costs for people.”

Ms. Wadsworth is wary of the sweeping plans now proposed by the Democratic presidential candidates, which she worries will become a political football, like the Affordable Care Act, and fail to address the underlying issues.

“I just think health care costs need to go down,” she said.