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An intensive care unit nurse in a small-town hospital on Maryland’s scenic Eastern Shore suspected that a patient had necrotizing fasciitis, the so-called “flesh-eating” disease.

The condition is rare. Even experienced intensive care doctors seldom see it, and, since it was nighttime, no such physician was in the ICU. Pinning down the diagnosis was critical—and in this case Berlin, Md.’s had back-up.

Doctor Marc T. Zubrow, medical director at the University of Maryland Medical System’s eCare, says he can use a bank of monitors to care for up to 100 patients in eight different hospitals all over the state of Maryland. Patients can be visually monitored and their lab tests and medical information are contained on the screens (Photo by Barbara Haddock Taylor/Baltimore Sun).

A critical care doctor 125 miles away was monitoring the patient’s health via voice, video and high-speed data lines constantly streaming information about vital signs, medications, test results and X-rays, a telemedicine service known as . The physician quickly verified that the patient had the deadly infection and arranged immediate transfer to another hospital with a surgeon who could remove the infected tissue.

Atlantic General is one of Maryland eCare’s six original community hospital clients, which have a total of 72 ICU beds. By the end of the year, the program will go live in three more Eastern Shore hospitals, adding 18 more ICU beds.

Studies have shown that patients do better and leave sooner from ICUs managed by intensivists, another term for critical care doctors. But intensivists are in short supply nationwide, and small community hospitals like Atlantic General have a difficult time recruiting and retaining them, let alone paying their salaries. Connecting intensivists to small ICUs via telemedicine, proponents say, is the next best thing to hiring them.

Telemedicine, the exchange of medical information between sites via electronic communications, is being used not only by ICUs but also by other hospital departments, home health agencies and private doctors’ offices. But skeptics suggest that small ICUs might be able to improve care with less expensive measures. Telemedicine now costs hospitals roughly $40,000 to $50,000 a year for each covered bed. Initially, adaptation of telemedicine in ICUs nationwide was rapid, but a new study suggests it is slowing.

One of Maryland eCare’s 20 intensivists monitors ICU patients from 7 p.m. to 7 a.m. weeknights and for 24 hours on Saturdays and Sundays.  They’re stationed at computers in Maryland eCare’s COR—Central Operations Room—which last year moved from the Christiana Care Health System in Wilmington, Del., to the University of Maryland Medical Center in Baltimore. On weekdays, when the hospitals’ critical care doctors are at work, eCare critical care nurses staff the COR computers.

Physicians and nurses at the University of Maryland can monitor ICU patients using voice, video and high-speed data lines that constantly stream information about their vital signs using a telemedicine service known as Maryland eCare (Photo by Barbara Haddock Taylor/Baltimore Sun).

Critical care specialist Atif Zeeshan and another intensivist work in Atlantic General’s ICU from 7 a.m. to 7 p.m. on alternating weeks, and they’re on call 24/7. Zeehan said he was at first leery of telemedicine. Four years after his eight-bed ICU hooked up with Maryland eCare, Zeehan is a believer. “There have been cases where lives were saved with eCare intervention,” he says. 

Maryland eCare was established with a $3 million grant from CareFirst BlueCross BlueShield, which helped cover capital expenses, such as computer and video connections. Participating hospitals pay Maryland eCare an annual fee for each ICU bed. Other eCare clients are in Salisbury, in Elkton, in Hagerstown, in Prince Frederick and in Leonardtown.

Zeeshan’s initial skepticism isn’t unusual. “Nobody wants to be dictated to,” acknowledges Marc Zubrow, a critical care and lung specialist and eCare Maryland’s medical director. “An absolutely huge part of my job,” says Zubrow, is to “convince the local medical community that this will not negatively impact patient care and might possibly improve patient care.”

Hospital representatives routinely visit the Baltimore COR, and Zubrow and members of his team regularly visit the community hospitals and “get very close with the local bedside people.”

And sometimes to patients’ families.  Zubrow shared an eCare doctor’s notes about an interaction with a patient’s daughter (stripped of information that could identify the patient). The woman, who’d flown in to be at her critically ill mother’s bedside, arrived  around 3 a.m. and spent a few minutes video-chatting with the eCare intensivist on duty.

“I told her that nothing we do medically is going to improve her mother’s condition or meaningfully prolong her life,” according to the doctor’s notes. “I urged her to allow us to focus on treating her mother’s pain and suffering…I offered my support and told her I would speak with her again at any point tonight.”

Community hospitals say telemedicine helps critically ill patients be treated close to home and family. Even with extra oversight, however, these hospitals are still not equipped to care for all critically ill patients, so telemedicine intensivists help them decide which patients should be transferred.

Telemedicine has helped improve the care of ICU patients says registered nurse Anne Lockhart, who directs the unit at Calvert Memorial. Lockhart says that includes a reduction in the number of patients contracting pneumonia as a result of being on a ventilator.

Since implementing telemedicine, “we dramatically reduced our ICU mortality rate,” says Ed Grogan, vice president of information services and chief information officer at Calvert Memorial.

But Jeremy Kahn is skeptical. An associate professor of critical care, medicine and health policy at the University of Pittsburgh, he says assessing telemedicine’s effectiveness in the ICU is tricky. Comparing mortality rates before and after implementation of telemedicine doesn’t account for the fact that “outcomes in the ICU get better over time, no matter what,” Kahn says.

A better comparison would be to other, less-expensive, measures, such as using more non-physician providers—physician assistants and nurse practitioners—at ICU patients’ bedsides, Kahn said.

While Maryland eCare is adding hospitals, Kahn says adoption of telemedicine in ICUs nationwide is slowing. In published online in October by Critical Care Medicine, Kahn and his colleagues found that the number of U.S. hospitals using telemedicine in ICUs increased from 16, or 0.4 percent, in 2003, to 213, or 4.6 percent, in 2010, with usage doubling in the first four years but dropping to average growth of 8.1 percent in the last four.

 “In an era of cost constraints, I feel we need to be simultaneously exploring cheaper ways to get the same outcome,” Kahn says. “That’s not to say we should not explore telemedicine.”

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For nearly a quarter century, doctors have ordered annual PSA tests for men of a certain age to screen for prostate cancer, despite a lack of evidence that the benefits outweighed the risks — especially when tiny, slow-growing tumors were detected.

Dr. H. Ballantine Carter (Photo by Barbara Haddock Taylor/Baltimore Sun).

But the landscape appears to be changing. While questions about PSA screening remain, physicians increasingly recognize the need to discuss both the harms and benefits with patients. 

°Õ³ó±ðÌý shook up the status quo last July when it advised against using the simple blood test, which measures levels of a protein called prostate specific antigen, with average-risk men of any age who had no prostate cancer symptoms. That recommendation prompted a backlash from urologists, who argued that screening saves lives, but gave pause to primary care doctors. 

In recent weeks, though, urology and internal medicine groups have published surprisingly similar directives.

“I would say it’s a shift toward a more targeted screening approach rather than a one-size-fits-all screening approach,” said Dr. H. Ballentine Carter, a Johns Hopkins urologist, of the  released May 3 and developed by a committee he chaired. The international association has more than 19,000 members worldwide.

Carter’s committee noted that the greatest benefit appears to be for those 55 to 69 but urged that men in that age group discuss the pros and cons with their doctor before deciding whether to proceed. For those who opt for screening, waiting at least two years between tests could minimize potential harms — namely false-positives and the detection of slow-growing tumors that wouldn’t have caused any symptoms — while preserving most benefits.

Similarly, the , representing internists, released guidelines April 9 advising members to discuss the test’s “limited benefits and substantial harms” with patients 50 to 69 years old and let them decide.

Both groups agreed that doctors should not screen men younger or older than their guidelines’ age ranges or those expected to live less than 10 to 15 years because of other health conditions.

An elevated PSA level doesn’t necessarily signify prostate cancer, but it can trigger a cascade of tests and treatments that could be riskier than the disease itself, potentially causing impotence, incontinence or even death from prostate cancer surgery.

Even before the latest sets of guidelines were released, Dr. Michael Albert, a Hopkins internist, said he began to change his approach, spurred by the Preventive Services Task Force recommendations and a 2009 U.S. study that concluded PSA screening didn’t save lives. “It used to be much easier for me to click on the PSA button and order it,” said Albert, medical director of the East Baltimore Medical Center, part of Johns Hopkins Community Physicians.

Dr. Gene Green, a board-certified family practice doctor and internist who is president of the Hopkins-affiliated Suburban Hospital in Bethesda, said he’s been screening a smaller percentage of patients and referring fewer of them with a PSA level of 4 — traditionally the point at which prostate cancer concerns are raised in older men — to urologists.

Carter, head of adult urology at Hopkins, said the AUA guidelines “had absolutely nothing to do with the task force,” and though the two groups’ guidelines were based on similar scientific evidence, they viewed the evidence differently.

“We interpreted the evidence from an individual’s perspective vs. a public health perspective,” he said. Prostate cancer might not represent a threat to the public health the way diabetes or heart disease does, but it’s a “major risk to an individual who’s in your office and who may be very concerned about the possibility,” Carter said.

Dr. Kenny Lin, a family physician, called the informed-consent approach a “cop-out.” Simply by raising the subject of screening, doctors push patients toward it, said Lin, who as a medical officer at the Agency for Healthcare Research and Quality wrote the evidence review on which the Preventive Services Task Force based its recommendation. So, said Lin, now on the faculty at the Georgetown University School of Medicine, “I don’t bring it up necessarily.”

Meanwhile, the , whose website said its membership includes 45 percent of U.S. urologists, warns in a statement that these recent sets of guidelines could leave the impression that early detection of prostate cancer is no longer needed. 

The Preventive Services Task Force and the AUA committee agree that one life is saved for every 1,000 men screened.

“There’s really no doubt [it] saves lives,” said Dr. William Nelson, a medical oncologist and urologist who directs Hopkins’ Sidney Kimmel Comprehensive Cancer Center.

The death rate from the disease has been declining since it peaked 20 years ago, although it isn’t clear how much is due to PSA screening and how much to improved treatment. Still, Nelson acknowledged, “a lot more men die with prostate cancer than will ever die of it. The greatest threat to their health and happiness is attempts to treat them.”

Since the 1990s, screening has led to a diagnosis of early-stage prostate cancer in more than a million U.S. men who probably never would have developed symptoms. More than nine out of 10 of them chose aggressive treatment.

Mark Humphrey, now 71, a retired General Electric executive, lived in western Massachusetts when a 2006 test showed his PSA had nearly doubled to 3.5. Although still in the normal range below 4, the rapid increase spurred his doctor to refer him to a urologist for a biopsy, which revealed abnormal cells.

But his cancer appeared unlikely to be aggressive. That information, coupled with memories of his late brother-in-law’s experience with incontinence and impotence after surgery, led Humphrey to take a pass on the aggressive approach. 

So Humphrey, who now lives in Baltimore, enrolled in the world’s first prostate cancer “active surveillance program,” which Carter directs at Hopkins. Instead of treating Humphrey’s disease, Carter is keeping an eye on it, with PSA testing and a rectal exam every six months.

Approximately 1,000 men have opted for active surveillance since the program launched more than 16 years ago. By following the participants, Carter said, he and his colleagues hope to learn more about what distinguishes slow-growing from aggressive cancers. Their goal: to build a better screening test.

“And then we want to learn more about the personal preferences of patients,” Carter said. For example, are they comfortable living with cancer?

Albert remembers seeing one patient, an otherwise healthy man in his early 60s with a PSA-detected tumor. After six months in the program, the man chose surgery. “He couldn’t fathom the idea that you’d sit on a cancer that could metastasize.”

Carter, Nelson and Green are among a group of Hopkins urologists and primary care doctors working on an app to help doctors discuss the risks and benefits of PSA screening with patients. The app, to be tested later this year, takes into account such factors as life expectancy and prior PSA levels. It will be integrated into patients’ electronic medical records.

Notes Green: “Very few times in our lives can we say ‘always’ or ‘never.'”

This article was produced by Kaiser Health News with support from .

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When Ramona Burton became pregnant with her second child this year, the 37-year-old Upper Marlboro woman knew that her age put her baby at an elevated risk for Down syndrome, even though screening with ultrasound and standard blood tests raised no warning flags.

Burton and her husband didn’t want to risk amniocentesis, the gold standard for prenatal diagnosis, because it carries a small chance of miscarriage. So when her doctor offered an alternative – a new test that requires only a sample of the mother’s blood – they leapt at it. In less than two weeks, they got the news: no Down syndrome. The baby, a boy, is due next month.

Three versions of this test, which can be performed as early as 10 weeks into a pregnancy, have come onto the market since December.

Tens of thousands of women have used them, according to the companies that sell the tests. But they are not subject to regulation by the Food and Drug Administration, and questions have been raised about a technology whose accuracy and role are still being assessed. As a result, no major insurance company has yet agreed to cover the tests, whose list prices range up to $1,900.

New medical technologies often challenge a health-care industry grappling with pressures to control costs. It’s not yet clear whether the new tests will cut costs and miscarriages by reducing invasive prenatal diagnostic procedures such as amniocentesis or inflate costs because they’re used by women who probably would never have opted for amnio because of miscarriage fears. (The established tests are performed about 200,000 times annually in the United States and cost roughly $2,500 in the Washington area.)

More is not better

With the new tests, fragments of fetal DNA extracted from the mother’s blood sample are checked for increased amounts of material from chromosomes 21, 18 and 13, a sign that the fetus carries three instead of the normal two copies of those chromosomes.

In this case, more is not better. Having an extra copy of 21, a condition called trisomy 21, is the main cause of Down syndrome, while having a third copy of 18, a condition called trisomy 18, causes a less common disorder named Edwards syndrome. Trisomy 13 is also known as Patau syndrome. All three conditions are linked to serious developmental and medical problems.

Standard first-trimester screening for these genetic conditions can be performed as early as 11 weeks’ gestation. It consists of a blood test to check levels of pregnancy-associated proteins and hormones in the mother’s blood and an ultrasound to look for extra fluid under the skin at the back of the fetus’s neck. The results are usually available within a week.

Used together, the standard blood tests and ultrasound can detect about 90 percent of Down syndrome cases and an even greater proportion of trisomies 18 and 13. But there’s a false-positive rate of about 5 percent, and only amniocentesis or the much less commonly used chorionic villus sampling, another invasive test that can cause miscarriage, can provide a definitive answer.

The new blood tests that assess fetal DNA rather than maternal blood perform better than standard screening, says Tufts scientist Diana Bianchi, whose research helped lay the groundwork for them. Bianchi sits on the scientific advisory board of Verinata Health, which launched its test, called Verifi, in March. “The problem is they’re more expensive, so they can’t be a primary screen,” she says.

The tests generally are offered only to women whose age, family history or standard screening put their fetus at a higher risk of having a chromosome abnormality – not to all women, as the standard screening tests are.

So far, major insurance companies, citing limited studies about the tests’ accuracy and impact on patient care, consider them to be experimental and do not cover them. (Sequenom, the marketer of the MaterniT 21 Plus test, asserted this month that 15 percent of the U.S. population is covered by plans that will pay for the test, though it did not identify those plans.)

‘Not a clear endorsement’

The American College of Obstetricians and Gynecologists published its first opinion on the tests Nov. 20 and concluded they “should not be part of routine prenatal laboratory assessment.” However, ACOG said, the tests can be offered to patients at increased risk of having a baby with a trisomy, as long as they are counseled beforehand about the tests’ limitations. Previously, the National Society of Genetic Counselors and the International Society for Prenatal Diagnosis reached similar conclusions.

Because research has not yet proved that the new tests are as accurate as the standard invasive tests, all three organizations recommend that women with a positive result undergo amniocentesis or chorionic villus sampling to be sure.

“We clearly take ACOG’s opinion into consideration as we evaluate coverage policy,” says Julie Kessel, senior medical director of Cigna’s coverage policy unit. But, she adds, “it’s not a clear endorsement.”

Cigna typically reviews coverage of technologies annually, unless a “sentinel event,” such as firm new guidelines about their use, suggests the company needs to take another look sooner, Kessel says. The ACOG opinion is not such an event, she says, so the company likely won’t revisit the blood tests until July.

Aetna spokeswoman Tammy Arnold says her company is awaiting the results of more research into the tests’ accuracy and how testing affects women’s decisions about amniocentesis. Once studies of patients prove that the tests add value, Arnold says, “cost savings to the health-care system would be a welcomed bonus.”

Women are asking for the tests right now, however. “I don’t think anybody really anticipated that the consumers would drive this as much as they’re doing,” Bianchi says.

For now at least, the companies that market the new tests appear to be eating much of the cost. For example, the most that women with insurance have to pay out of pocket is $235 for the MaterniT21 Plus test (list price $1,900) and $200 for Verifi (list price $1,200), even if their plan declines to cover the test. Both companies offer self-pay options for women without insurance: The price is $450 to $500 for MaterniT21 Plus and an “introductory price” of $495 for Verifi.

Jeffrey Spencer, Ramona Burton’s OB-GYN at the Anne Arundel Medical Center in Annapolis, says that although questions remain about how best to use the tests, he needs to make his patients aware of them. “It’s so new we’re not sure the best way to do it. I feel I have an ethical obligation to make patients aware of the option.” (Spencer says he is a member of the speakers’ bureau of Sequenom, which markets the MaterniT21 Plus test, and is paid a fee when he speaks at the company’s request.)

Burton is one of several hundred higher-risk patients in his practice who have opted for MaterniT 21 Plus, Spencer says.

Mark Evans, a Manhattan OB-GYN, says his patients want to skip the standard screening tests and go right to the new tests.

“My patients are the average New Yorkers,” he says, “who want their answers yesterday.”

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