NYU Langone to open new high-rise hospital with superstorm protection

When Hurricane Sandy caused destructive flooding along the East Coast in 2012, the New York University Langone Medical Center campus sustained significant damage.

Power was cut, health providers were forced to evacuate more than 300 patients, and officials had to not only renovate and weatherproof existing buildings but ensure their planned campus construction wouldn’t allow the campus to be impacted by flooding that way ever again.

The Kimmel Pavilion (NYU Langone)

Now, as NYU Langone prepares to open the 21-story Helen L. and Martin S. Kimmel Pavilion on the east side of Manhattan later this month, officials said they are not only marking the delivery of the final step of a long-planned upgrade to health services in the city: They have finished the final piece of the effort to protect against future superstorms.

“It completes that perimeter wall for us to protect that entire campus,” Vicki Match Suna, NYU Langone’s senior vice president and vice dean for real estate development and facilities, told FierceHealthcare.

The Kimmel Pavilion was the final phase of $6 billion campus plan, which included the creation of a new energy facility and science research building. Those projects were already well underway but needed a revamp after Sandy hit, Match Suna said. “We quickly had to reassess our campus plan in terms of resiliency for the future and very rapidly made a lot of changes to the design,” she said.

That involved changing plans such as moving much of the mechanical and electrical infrastructure up to the first floor, she said. A new protection wall that protects the campus from one end to the other has gates at every necessary break in the perimeter that can be shut when any kind of surge from the river is expected.

It’s one of the unique design features of the new 830,000-square-foot Kimmel Pavilion project, the largest and most extensive revitalization in NYU Langone Health’s history. The building officially opens June 24.

An operating room in the new building.
(NYU Langone)

Among its other features, the building includes 374 private inpatient rooms as well as outdoor landscaped gardens and roof terraces with views of the city.

The new Hassenfeld Children’s Hospital with two floors will be dedicated to 68 inpatient pediatric beds, When it opens, it will be the only pediatric inpatient facility in Manhattan with all private patient rooms, officials said. The 160,000-square-foot children’s hospital has its own designated building entrance on 34th Street and will include a pediatric intensive care unit, congenital cardiovascular unit, surgery services and a pediatric emergency department.

The pavilion will greatly increase the health system’s capacity for procedure-based volumes with 30 new operating rooms and image-guided labs, as well as acute care and critical care services in hematology/oncology, bone marrow and solid organ transplantation, Match Suna said. The health system’s bed count has not increased significantly because the new building is helping create private patient rooms while officials plan to renovate the existing NYU Langone Tisch Hospital, she said.

In January, NYU opened its 16-floor science building, which includes more than 365,000 square feet and 10 floors of laboratory space covering medical research such as neuroscience, the Institute for System Genetics, Institute for Computational Medicine, cardiology, endocrinology and rheumatology.

The Energy Building, which opened in May 2016, allows the campus to be more environmentally sustainable but also allows the health system to power its buildings and remain operational in the event of a utility power interruption, with two different sources of backup power for critical areas.

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VBL Therapeutics gains after CEO comments on series of antibodies

In a statement, CEO of VBL Therapeutics, Dror Harats, M.D, said, “Our research has shown that MOSPD2 plays a key role in the regulation of cell motility.We have generated data indicating that MOSPD2 is required for directional movement, or chemotaxis, of tumor cells and certain immune cells, and therefore appears to play a central role in both oncology and inflammation. We continue to advance our exciting VB-600 series of antibodies as drug candidates for oncology and inflammatory indications.” Shares of VBL Therapeutics are up about 47% to $3.20 per share in after-hours trading.

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Exact Sciences, Mayo ID liver cancer biomarker

Researchers at Exact Sciences Corp. (Nasdaq: EXAS) and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver.1 The researchers detailed their findings during a presentation today at Digestive Disease Week, the world’s largest gathering of gastroenterologists and scientists in the field.

The biomarker panel was shown to be 95 percent sensitive for detecting HCC across all stages. Sensitivity among patients with curable-stage disease was 91 percent. The panel has overall specificity of 93 percent, demonstrating its ability to discriminate between normal and diseased patients. Sensitivity and specificity are the most important statistical measures of a cancer detection test’s performance.

“These results are further validation of our advanced DNA technology and our multi-biomarker approach for the detection of the deadliest forms of cancer,” said Kevin Conroy, chairman and CEO of Exact Sciences. “We look forward to advancing this important research in early stage cancer with Mayo Clinic.”

HCC accounts for nearly 90 percent of all liver cancers and is the fastest-growing cause of cancer-related death in the United States.1 Mayo Clinic experts predict that liver and bile duct cancers will be the third-leading cause of cancer deaths in the United States by 2030 due, in part, to the obesity epidemic.2,3

Individuals diagnosed with cirrhosis have the greatest risk of developing HCC, and it is recommended that they undergo ultrasound and blood monitoring every six to 12 months. The three-year survival rate for patients regularly surveilled is approximately 60 percent, compared to approximately 30 percent for those who don’t undergo regular surveillance.4 When HCC is detected early and treated, patient survival rates improve significantly.1 Exact Sciences estimates that more than 3 million Americans are eligible for HCC surveillance.

“The potential of an accurate, non-invasive blood test that can identify early-stage disease is very exciting,” said John Kisiel, M.D., the gastroenterologist and assistant professor of medicine at Mayo Clinic Medical School who led the study. “This could potentially transform the way patients are monitored and lead to the identification of many more curable-stage tumors than we typically see today.”

Dr. Kisiel said the current options for monitoring at-risk patients are “sub-optimal.”

“We estimate that fewer than half of at-risk patients are tested regularly, and some estimates suggest the monitoring rate is less than 20 percent in primary care settings, where most people get their care,” Dr. Kisiel said.

Using DNA extracted from the blood samples of 244 people, including 95 diagnosed across all stages of HCC, 51 with cirrhosis, and 98 healthy volunteers, researchers tested the samples against 15 biomarkers to identify the combination of six biomarkers that yielded the most accurate detection of HCC.

“Now we must confirm the accuracy of the biomarkers we’ve studied for the detection of HCC,” Dr. Kisiel said. “We are seeking to apply this DNA assay technology to all cancers, and these findings are an important step toward that goal.”

Exact Sciences and Mayo Clinic have been collaborators since 2009. The collaboration previously yielded Cologuard, the stool-based, advanced-DNA screening test for colorectal cancer. The non-invasive test was approved by the U.S. Food and Drug Administration in 2014 and has been used by more than 1 million patients. Exact Sciences has identified biomarkers associated with 10 of the deadliest cancers and is advancing a pipeline of non-invasive diagnostic and screening tests based on those biomarkers.

The study results can be found at: https://www.sciencedirect.com/science/article/pii/S0016508518337041

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Bluebird Bio’s Multiple Myeloma Data Reinforces Canaccord’s Bullish Thesis

Canaccord Genuity is maintaining its bullish stance on bluebird bio Inc BLUE 0.86% and projects upside for the biotech following a positive patient response to bb2121, the company’s multiple myeloma treatment.

The Analyst 

John Newman maintains a Buy rating on bluebird bio with a $250 price target.

The Thesis

The potential for the multiple myeloma treatment is just beginning to become visible, Newmansaid in a Monday note.

“As the drug moves earlier and is combined or sequenced with other therapies, we would expect a massive improvement in both [progression-free survival] and [overall survival],” the analyst said.

Bb2121 showed a median progression-free survival of 11.8 months, which fell in line with expectations, and the analyst said is impressive given the fact that the patients receiving the drug had already failed every therapy on the market.

Bluebird’s next data catalyst could come at the Amercian Society of Hematology conference in December in San Diego and should “allay any concerns on an efficiency level,” Newman said.

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Intensive Outpatient Services Do Not Save Money

In the drive to reduce costs, some health systems have been testing intensive management models to augment primary care for high-risk, “sickest-of-the-sick” patients who might otherwise require expensive inpatient care. Now a new study suggests that any hoped-for savings may actually be elusive, although it could point to more effective ways in which resources might be directed.

The analysis included more than 2000 patients at five sites managed by the US Department of Veterans Affairs (VA) and showed that individuals who received care from an intensive management team working in conjunction with their usual primary care clinicians incurred no net changes in costs, but made greater use of outpatient services such as health coaching, home visits, and medication reconciliation than patients assigned to usual care, Jean Yoon, PhD, MHS, and coauthors write.

This shifting of costs from inpatient to outpatient care and the overall cost “neutrality” of the added intensive services suggest “that a potential exists to change how care is delivered,” they explain. “Primary care practices may consider implementing intensive management programs with these findings in mind.”

However, to realize their full potential, those intensive programs must be redesigned to maximize patient participation, the authors add. They publishedtheir findings online June 4 in the Annals of Internal Medicine.

Yoon, from the VA Health Economics Resource Center and Center for Innovation to Implementation, Menlo Park, California, and the University of California, San Francisco, School of Medicine, and coauthors conducted a randomized controlled, quality improvement trial at five VA sites in geographically diverse areas across the United States. The study included patients with a recent history of a visit to a hospital or emergency department, and a score in the 90th percentile for 90-day hospitalization on a validated risk-predicting algorithm.

The study recruited participants from July 21, 2014, to August 28, 2015, and randomly assigned them by site and sex to the intensive management team or to usual care. The intensive management team conducted patient evaluations, made care recommendations on the basis of those evaluations, and actively followed patients who accepted the intensive services in addition to their usual primary care. The authors compared resource utilization and costs for each patient during the 12 months before and the 12 months after their assignment.

The groups each consisted of 1105 patients. Men made up approximately 90% of each cohort, with a mean age of 63.3 years (standard deviation, 12.4) in the intensive-management group and 62.3 years (standard deviation, 12.7) in the usual-care group (P = .08). There were no significant differences in other baseline characteristics between the two groups.

In general, patients in the intensive management group were older, less likely to be never married, had higher rates of chronic illnesses such as diabetes and depression, had used more primary care services at baseline, and had lower rates of schizophrenia and drug or alcohol dependence compared with patients in the usual care group (all standardized mean differences, >0.01).

Only 487 (44%) of the patients in the intensive management group received the full intervention, which the authors defined as “three or more encounters in person or by telephone from the intensive management team.” These patients had a mean of 14.0 encounters (range, 3 – 116) compared with 0.4 (range, 0 – 2) experienced by the other individuals in that group. Most of the intensive interventions were for home care, social work services, and mental health or substance use disorder care.

Of the patients in the intensive management group, 204 (18%) did not fully participate or were offered only limited services, and the team determined that 414 (37%) would not benefit from those services or could not be contacted.

Few Differences Between Groups

On unadjusted analysis, patients in the intensive management group incurred a mean of $31,956 (95% confidence interval [CI], $29,480 – $34,433) in total healthcare costs in the 12 months before the study, and a mean of $31,878 (95% CI, $28,848 – $34,909) in the 12 months afterward. For patients in the usual care group, unadjusted mean costs were $32,536 (95% CI, $29,851 – $35,222) and $31,904 (95% CI, $28,528 – $35,280), respectively.

After adjustment for patient demographic factors and health conditions diagnosed during the year before randomization, total healthcare costs for patients in the intervention group were $471 (95% CI, −$6347 to $7290) higher than in the control group. Patients in the intervention group had higher mean adjusted costs for primary care, including home-based primary care, but lower costs for mental health intensive case management. There were no other significant cost differences between the groups.

The authors also found no significant differences between the groups in rates of hospitalization “with regard to mean number of inpatient stays, inpatient days, or emergency department visits in the postintervention period,” they write. Patients in the intensive management group did have significantly fewer nursing home days than the usual care group (incidence rate ratio, 0.35; 95% CI, 0.13 – 0.95). The intensive management group also made greater use of outpatient services such as primary care, care management, mental health and substance use disorder care, and home, geriatrics, and palliative or hospice care.

Mortality during the 12-month follow-up period in the intensive management and usual care groups was 5.9% vs 5.5%, respectively (P = .93).

“[O]verall, the intensive management programs seem to have been associated with cost shifting from inpatient to outpatient care,” the authors write. Thanks to the comprehensive assessments performed by the intensive management teams, the findings suggest that these programs “could identify unmet needs and connect patients to important resources.”

However, the authors add that patients with substance use disorders or more serious mental illnesses may find it harder to engage with the management team and may require different models of care.

Study limitations include inability to generalize from these five VA sites to the rest of the country, the possibility that a 12-month follow-up may have been insufficient for detecting significant changes in use of care, no information on prescription drug use or visits to non-VA sites, and lack of access to Medicare data.

Although the intensive management teams were able to help complex patients find outpatient services that met their needs, the fact that only 62% participated “suggests that better methods are needed to efficiently target the high-risk patients most likely to benefit from outpatient care,” the authors conclude. “Overall, our findings and those of other studies suggest that improvements in the design of intensive management programs are not only possible but necessary for this approach to achieve its full desired benefits.”

The authors have disclosed no relevant financial relationships.

Ann Intern Med. Published online June 4, 2018. Abstract

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What if your doctor offered genetic testing as a way to keep you healthy?

If you have a genetic mutation that increases your risk for a treatable medical condition, would you want to know? For many people the answer is yes. But such information is not commonly part of routine primary care.

For patients at Geisinger Health System, that could soon change. Starting in the next month or so, the Pennsylvania-based system will offer DNA sequencing to 1,000 patients, with the goal to eventually extend the offer to all 3 million Geisinger patients.

The test will look for mutations in at least 77 genes that are associated with dozens of medical conditions, including heart disease and cancer, as well as variability in how people respond to pharmaceuticals based on heredity.

“We’re giving more precision to the very important decisions that people need to make,” said David Feinberg, Geisinger’s president and CEO. In the same way that primary-care providers currently suggest checking someone’s cholesterol, “we would have that discussion with patients,” he said. “ ‘It looks like we haven’t done your genome. Why don’t we do that?’ ”

Some physicians and health policy analysts question whether such genetic information is necessary to provide good primary care — or feasible for many primary-care physicians.

The new clinical program builds on a research biobank and genome-sequencing initiative called MyCode that Geisinger started in 2007 to collect and analyze its patients’ DNA. That effort has enrolled more than 200,000 people.

Like MyCode, the new clinical program is based on whole “exome” sequencing, analyzing the roughly 1 percent of the genome that provides instructions for making proteins, where most known disease-causing mutations occur.

Using this analysis, clinicians might be able to tell Geisinger patients that they have a genetic variant associated with Lynch syndrome, for example, which leads to increased risk of colon and other cancers, or familial hypercholesterolemia, which can result in high cholesterol levels and heart disease at a young age. Some people might learn they have increased susceptibility to malignant hyperthermia, a hereditary mutation that can be fatal because it causes a severe reaction to certain medications used during anesthesia.

Samples of a patient’s blood or spit are used to provide a DNA sample. After analysis, the results are sent to the patient’s primary-care doctor.

Before speaking with the patient, the doctor takes a 30-minute online continuing education tutorial to review details about genetic testing and the disorder. Then the patient is informed and invited to meet with the primary-care provider, along with a genetic counselor, if desired. At that point, doctor and patient can discuss treatment and prevention options, including lifestyle changes such as diet and exercise that can reduce the risk of disease.

About 3.5 percent of the people who’ve been tested through Geisinger’s research program had a genetic variant that could result in a medical problem for which clinicians can recommend steps to influence their health, Feinberg said. Only actionable mutations are communicated to patients. Geisinger won’t inform them if they have a variant of the APOE gene that increases their risk for Alzheimer’s disease, for example, because there’s no clinical treatment. (Geisinger is working toward developing a policy for how to handle these results if patients ask for them.)

Wendy Wilson, a Geisinger spokeswoman, said that what they’re doing is very different from direct-to-consumer services such as 23andMe, which tests customers’ saliva to determine their genetic risk for several diseases and traits and makes the results available in an online report.

“Geisinger is prescribing DNA sequencing to patients and putting DNA results in electronic health records and actually creating an action plan to prevent that predisposition from occurring. We are preventing disease from happening,” she said.

Geisinger will absorb the estimated $300 to $500 cost of the sequencing test. Insurance companies typically don’t cover DNA sequencing and limit coverage for adult genetic tests for specific mutations, such as those related to the breast cancer susceptibility genes BRCA1 or BRCA2, unless the patient has a family history of the condition or other indications they’re at high risk.

“Most of the medical spending in America is done after people have gotten sick,” Feinberg said. “We think this will decrease spending on a lot of care.”

Some clinicians aren’t so sure. H. Gilbert Welch is a professor at the Dartmouth Institute for Health Policy and Clinical Practice who has written books about overdiagnosis and overscreening, including “Less Medicine, More Health.”

He credited Geisinger with carefully targeting the genes in which it looks for actionable mutations instead of taking an all-encompassing approach. He acknowledged that for some conditions, like Lynch syndrome, people with genetic mutations would benefit from being followed closely. But he questioned the value of DNA sequencing to identify other conditions, such as some related to heart disease.

“What are we really going to do differently for those patients?” he asked. “We should all be concerned about heart disease. We should all exercise, we should eat real food.”

Welch said he was also concerned about the cascading effect of expensive and potentially harmful medical treatment when a genetic risk is identified.

“Doctors will feel the pressure to do something: start a medication, order a test, make a referral. You have to be careful. Bad things happen,” he said.

Other clinicians question primary-care physicians’ comfort with and time for incorporating DNA sequencing into their practices.

A survey of nearly 500 primary-care providers in the New York City area published in Health Affairs this month found that only a third of them had ordered a genetic test, given patients a genetic test result or referred one for genetic counseling in the past year.

Only a quarter of survey respondents said they felt prepared to work with patients who had genetic testing for common diseases or were at high risk for genetic conditions. Just 14 percent reported they were confident they could interpret genetic test results.

“Even though they had training, they felt unprepared to incorporate genomics into their practice,” said Carol Horowitz, a professor at the Icahn School of Medicine at Mount Sinai in New York, who co-wrote the study.

Speaking as a busy primary-care practitioner, she questioned the feasibility of adding genomic medicine to regular visits.

“Geisinger is a very well-resourced health system and they’ve made a decision to incorporate that into their practices,” she said. In Harlem, where Horowitz works as an internist, it could be a daunting challenge. “Our plates are already overflowing, and now you’re going to dump a lot more on our plate.”

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#ASCO18: In cervical cancer, minimally invasive surgery safer, cheaper

Minimally invasive surgery (MIS) for cervical cancer had fewer side effects and cost less than open radical hysterectomy, a researcher said here.

But in some cases where the tumor is >2 cm, such procedures may have an increased risk of death, reported Daniel Margul, MD, of Northwestern University in Chicago, at theAmerican Society of Clinical Oncology (ASCO) annual meeting.

The findings come on the heels of two other studies with much the same results and might be enough to change clinical practice, which has seen an increasing reliance on minimally invasive techniques in recent years.

“We really need to dig into the data to see if we should change practice, but this is the way practice is changed,” commented Shannon Westin, MD, of MD Anderson Cancer Center in Houston.

Margul’s group analyzed retrospective data on women with stage 1B1 cervical cancer — cases in which the tumor is visible to the eye but still <4 cm at its largest diameter — might or might not have spread to nearby lymph nodes, and has not spread to distant sites.

Such cancers are regarded as early stage but are the most advanced in that category to still be treated with surgery.

In March 2018, two studies — one prospective and one retrospective — found significantly greater recurrence and worse survival for minimally invasive surgery, although the absolute numbers were small and the cancer staging was slightly different

“What we are seeing is that the same findings have been repeated now three times,” Westin, who was not involved in the study, told MedPage Today. She suggested that it might be time to take closer look at minimally invasive surgery, which includes laparoscopic procedures as well as robot-assisted surgery.

The advantage of the study by Margul’s group is that it had enough power to tease out the effect of tumor size, and it will be important to see if the data from the other studies can confirm that the risk is confined to the larger tumors, she stated.

Margul’s group used the 2010-2013 National Cancer Database to evaluate the 5-year survival of women with stage IB1 cervical squamous cell carcinoma or adenocarcinoma after radical hysterectomy performed open or by minimally invasive surgery.

Then they used the 2010-2015 Premier Healthcare Database to compare complications, length of stay, readmission rates, and hospital costs between the surgical types.

The cancer database showed that 854 women had open surgery and 807 women underwent MIS radical hysterectomy. There were 87 deaths overall.

The key finding from that analysis was that 5-year overall survival was significantly worse for women who had open surgery, with a hazard ratio 1.92 for death.

That was driven by women with a tumor size of ≥2 cm, who had a 5-year survival rate of 81.3%, compared with 90.8% for open surgery. Those numbers yielded an HR 2.39 for death. On the other hand, if tumors were <2 cm, there was no significant difference in survival, he reported.

Both of the earlier studies also showed a marked increase in the risk of death with minimally invasive surgery.

The difference might be a function of the greater experience needed to use minimally invasive surgery safely in patients with larger tumors, commented ASCO discussant Ginger Gardner, MD, of Memorial Sloan Kettering Cancer Center in New York City.

The study is a “very important piece of work,” she said, because it focuses attention on the larger malignancies.

Margul reported that the Premier hospital database had information on 2,830 women who had a radical hysterectomy, including 45.1% with open surgery, 48.9% with robotic surgery, and 6% with laparoscopic surgery.

Open surgery was associated with a median of 3 days in hospital, compared with 1 day for robotic surgery, and no hospital stay with laparoscopic procedures. Total surgical and hospital costs were significantly in favor of minimally invasive procedures, at $12,080 for open surgery, $1,1562 for robotic surgery, and $9,649 for laparoscopic operations.

On the other hand, open surgery had a 44.9% composite complication rate, compared with than 13.9% and 12.4% for robotic and laparoscopic procedures, respectively. Specifically, open surgery had increased bowel injuries, infections, electrolyte or fluid disorders, transfusions, and ileus.

Margul disclosed no relevant relationships with industry.

• Primary Source

  American Society of Clinical Oncology

  Source Reference: Margul DJ, et al “Outcomes and costs of open, robotic, and laparoscopic radical hysterectomy for stage IB1 cervical cancer” ASCO 2018; Abstract 5502.

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