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DAILY UPDATE

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August 20, 2014   Download print version

Woman suspected of Ebola dies in the UAE

HPN to sponsor the annual UDI Conference!

CMS gives doctors more time to review open payments data

Massachusetts hospitals’ mistakes list widens

Transplant brokers in Israel lure desperate kidney patients to Costa Rica

MedAssets signs definitive agreement to acquire Sg2

Hospital makes house calls to high-risk patients

 
 

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Woman suspected of Ebola dies in the UAE

The national airline of the United Arab Emirates said Monday it has disinfected one of its planes after health authorities there announced that a Nigerian woman who died after flying in to the capital, Abu Dhabi, may have been infected with the Ebola virus.

The health authority in Abu Dhabi said in a statement carried by state news agency WAM that the 35-year-old woman was traveling from Nigeria to India for treatment of advanced metastatic cancer.

Her health deteriorated while in transit at Abu Dhabi International Airport. As medics were trying to resuscitate her, they found signs that suggested a possible Ebola virus infection. The health authority noted, however, that her preexisting medical condition also could have explained her death.

Medical staff treating the woman followed safety and precautionary measures in line with World Health Organization guidelines, the health authority statement added.

The woman's husband, who was the only person sitting next to her on the plane, as well as five medics who treated her are being isolated pending test results on the deceased woman. All are in good health and show no symptoms of the illness, according to health officials.

Etihad Airways, the UAE's national carrier, said the plane was disinfected in line with guidelines laid out by the airline industry's main trade group. It said it continues to monitor the situation and is working with health authorities "to ensure the implementation of any and all measures necessary to ensure the safety and well-being of its passengers and staff."

Abu Dhabi is the capital and largest of seven sheikdoms that make up the United Arab Emirates. The country has grown into a major long-haul aviation hub. It is home to Abu Dhabi-based Etihad and Dubai-based Emirates, the Middle East's largest airline. (Associated Press) Visit ABC News for the story.

 

 

HPN to sponsor the annual UDI Conference!

As an educational authority on UDI, the 6th industry stakeholders together with the FDA UDI Team will meet to ensure accurate UDI implementation and continued adoption momentum. The annual UDI conference is being held October 28-29, 2014, in Baltimore, MD.

HPN is proud to sponsor the UDI Conference - The annual industry gathering is important for medical device manufacturers, distributors, and hospitals to learn about the UDI Regulation and the Global UDI Database (GUDID).

Attend the conference to:

·         Learn the technical details about the UDI Regulation from the FDA Team

·         See how to best utilize the Global UDI Database (GUDID) to harness the data

·         Understand the requirements for your automatic identification systems

·         Create your plan for implementation

·         Gain the knowledge and establish resources needed to guide your organization

Teams from the following should attend: Medical Device Manufacturers; Health Care Distributors; Group Purchasing Organizations; Hospitals and Health Care Providers;  and Health Care Industry Professionals.

** NEW this year – special “Provider Track” offered as part of the Conference Program, hosted by the Association for Healthcare Resource & Materials Management (AHRMM).

The UDI Regulation requires new/improved systems and processes to efficiently mark/tag equipment, scan device information at various points in its life cycle, and transmit that data to the GUDID and other software systems. The UDI Conference allows attendees to interact directly with the FDA UDI team, investigate UDI technology in the exhibit hall, plan a migration path, and network with peers in the healthcare industry in one place, at one time.

To secure a seat at the best price, register by September 5th. Enter "HPN" in the promotional code field to automatically save $100. Team registrations are encouraged. If 2 or more from the same company are planning to attend, contact nicole@clariongroupinc.com to receive a discount code. Register today at http://udiconference.com/register.html.

For additional conference details and the most up-to-date information, please visit www.UDIconference.com.

For information on the FDA UDI Rule & GUDID Guidance, visit here.

The UDI Conference is produced and managed by The Clarion Group, Inc. 1-800-560-1980.

 

 

CMS gives doctors more time to review open payments data

The CMS Open Payments system is back online after being suspended Aug. 3, allowing physicians to register to review and dispute payment information about them provided to the Centers for Medicare & Medicaid Services by drug and device companies, according to a CMS subscriber e-mail sent Aug. 15.

“To account for system down time, CMS is extending the time for physicians and teaching hospitals to review their records to September 8, 2014,” the e-mail said, also noting that a public website containing the payment information will still be available on its target date, Sept. 30. Before the system was taken offline, physicians had until Aug. 27 to review and dispute their payment information.

The Open Payments system was created by the Physician Payments Sunshine Act; it requires manufacturers of drugs, devices and other medical supplies and group purchasing organizations to report certain payments to physicians or teaching hospitals. Payment data for the last five months of 2013 were due to the CMS June 30. Visit CMS for the ruling.

 

 

Massachusetts hospitals’ mistakes list widens

Massachusetts acute-care hospitals reported 753 serious medical errors and other patient injuries last year, a 70 percent annual jump that health officials attributed mostly to expanded definitions of what constitutes medical harm. So-called serious reportable events in other types of hospitals, including those that provide psychiatric or rehabilitative care, rose 60 percent from 2012, to 206.

Instances where patients underwent a procedure on the wrong body part, were burned by an operating room fire or a too-hot heating pack, or were subject to contaminated drugs or improperly sterilized equipment saw some of the largest increases in reporting since 2012. Hospitals also reported more patient falls, serious bed sores, assaults, and suicides and suicide attempts.

Dr. Madeleine Biondolillo, associate commissioner of the Department of Public Health, which collects the information, said it’s unclear whether incident rates are going up because the state broadened the type of incidents hospitals are required to report. The department also adopted a computerized system to replace faxes, making notifying health officials easier. Even so, the numbers show that even after more than a decade of focus on improving patient safety, lapses still occur regularly in hospitals across the country, medical safety experts said.

Hospital executives are paying more attention to reducing hazards and some are more openly discussing problems with patients and regulators, but they are simultaneously under growing pressure to care for more and sicker patients and to cut costs.

The focus on eliminating patient harm dates back to 1999, when the Institute of Medicine released a groundbreaking report revealing that tens of thousands of patients die each year because of preventable medical errors.

Since 2008, Massachusetts hospitals have been required to notify the health department about serious reportable events, a rule that is intended to help regulators and hospital administrators better understand how errors happen and how to prevent them. In certain cases, regulators also investigate and cite individual hospitals for their mistakes. Hospitals also must report these lapses to patients or their families.

The health department — as well as the federal government — prohibits facilities from charging insurers and government payers for services provided as the result of a serious reportable event, such as follow-up surgery to remove a clamp or sponge left inside a patient, as incentive to prevent these mistakes.

Biondolillo said the state has followed national guidelines and broadened what hospitals are required to report. Before October 2012, for example, hospitals were required to notify the state only about incidents that left a patient with a “serious disability.” Now, they must report any “serious injury.’’ Health officials also added four categories to the reporting requirement, including a patient death or serious injury resulting from “failure to follow up or communicate laboratory, pathology, or radiology test results.’’

Hospital reports for 2014 should give regulators a better idea of whether errors are rising, because no more major changes to the notification system are planned, Biondolillo said. That information will allow regulators to better target prevention strategies, she added. Visit the Boston Globe for the report.

 

 

Transplant brokers in Israel lure desperate kidney patients to Costa Rica

RAMAT GAN, Israel — Aside from the six-figure price tag, what was striking was just how easy it was for Ophira Dorin to buy a kidney. Two years ago, as she faced the dispiriting prospect of spending years on dialysis, Dorin set out to find an organ broker who could help her bypass Israel’s lengthy transplant wait list. Only 36, she had a promising job at a software company and dreams of building a family. For five years, Dorin had managed her kidney disease by controlling her diet, but it had gradually overrun her resistance. Unable to find a matching donor among family and friends, she faced a daily battle against nausea, exhaustion and depression.

A broker who trades in human organs might seem a difficult thing to find. But Dorin’s mother began making inquiries around the hospital where she worked, and in short order the family came up with three names: Avigad Sandler, a former insurance agent long suspected of trafficking; Boris Volfman, a young Ukrainian émigré and Sandler protégé; and Yaacov Dayan, a wily businessman with interests in real estate and marketing.

The men were, The New York Times learned during an investigation of the global organ trade, among the central operators in Israel’s irrepressible underground kidney market. For years, they have pocketed enormous sums for arranging overseas transplants for patients who are paired with foreign donors, court filings and government documents show.

The brokers maintain they operate legally and do not directly help clients buy organs. Dodging international condemnation and tightening enforcement, they have nimbly shifted operations across the globe when any one destination closes its doors.

The supply of transplantable organs is estimated by the World Health Organization to meet no more than a tenth of the need. Although there is no reliable data, experts say thousands of patients most likely receive illicit transplants abroad each year. Almost always, the sellers are poor and ill-informed about the medical risks.

The vast marketplace includes the United States, where federal prosecutors in New Jersey won the first conviction for illegal brokering in 2011.

Religious objections to recovering organs from brain-dead patients, combined with cultural discomfort with living donation, has resulted in a severe kidney shortage in Israel and helps explain the tiny nation’s outsize role in the global organ trade.

But a Times analysis of major trafficking cases since 2000 suggests that Israelis have played a disproportionate role. That is in part because of religious strictures regarding death and desecration that have kept deceased donation rates so low that some patients feel they must turn elsewhere.

That desperation was evident in the workings of the transplant tourism pipeline that delivered Dorin and other foreign patients to Costa Rica from 2009 to 2012. Through more than 100 interviews and reviews of scores of documents, The Times traced the network from the barrios of San José, Costa Rica’s gritty capital, to the glass towers of Ramat Gan, a bustling commercial district near Tel Aviv.

The Costa Rican government is not sure how many foreigners received suspicious transplants there. But The Times identified 11 patients — six Israelis, three Greeks and two American residents — who traveled to San José for transplants using kidneys obtained from locals. Two other Israelis who were located brought donors from Israel with them for procedures that most likely would not have been approved in their own country.

The network was built by a cast that included high-rolling Israeli brokers, a prominent Costa Rican nephrologist and middlemen who recruited donors from the driver’s seat of a taxi and the front counter of a pizzeria. In interviews and documents, four Israeli patients or sources close to them identified Dayan, known as Koby, as their conduit to Costa Rica.

The authorities in Costa Rica have been investigating the operation for more than a year. But it is not clear that the police in either country have linked the transplants to Dayan or other Israeli brokers. None of the organ recipients contacted by The Times said they had been interviewed.

The odyssey began when her family was referred to Avigad Sandler, who explained that he was sending clients to Sri Lanka for $200,000 in cash, Dorin said. Her co-workers staged a fund-raiser, and her parents mortgaged their house to cover the rest.

She said that some of the money was wired to a hospital in San José, and that she delivered a payment to Dr. Francisco José Mora Palma, the kidney specialist who oversaw her transplant. Dr. Mora then paid the equivalent of $18,500 to an unemployed 37-year-old man for his kidney, according to a confidential Costa Rican court document.

Just hours after Dorin arrived in San José in June 2012, Dr. Mora met with her and the donor at her hotel. There, she said, they signed affidavits in Spanish, a language she could not read, swearing that money would not change hands. Dorin said she had doubts about Dayan’s assurances that everything was legal, but did not feel she had much choice.

Because most people can live with only one kidney, that organ accounts for the vast majority of living-donor transplants. Laparoscopy has made the surgery to remove a kidney fairly routine, although it is not risk-free. Living donors account for about 40 percent of the roughly 80,000 kidney transplants performed worldwide each year, according to the W.H.O.

Long criminalized across the globe, the organ trade was handed an unequivocal rebuke at a worldwide conference of transplant practitioners in 2008. The group’s manifesto, called the Declaration of Istanbul, asserted that trafficking violated “the principles of equity, justice and respect for human dignity and should be prohibited.” And yet the prospective market for trafficked kidneys has grown unabated as the gap between supply and demand widens each year.

In the United States, the number of kidney transplants has remained static for a decade at 16,000 to 17,000 a year. During the same period, the waiting list for kidneys from deceased donors has nearly doubled, passing 100,000 this year. The median wait time for an adult is more than four years, and more than 4,000 die waiting each year.

Some physicians and ethicists question the relative morality of allowing thousands to die just because the means of saving them is considered repugnant. A regulated marketplace, they say, could all but eliminate the shortage. It is no accident, they argue, that the only country that allows compensation for donors — Iran — effectively has no waiting list.

Experts list China, Egypt, India, Pakistan, Sri Lanka, Turkey, Eastern Europe and the former Soviet republics as hot spots for organ trafficking. But illicit transplants usually go undetected unless there is a surgical mistake or a payment dispute. Prosecutions are thwarted by false affidavits, toothless laws and lack of international cooperation, particularly regarding extradition.

The Times found that brokers in recent years typically have charged clients $100,000 to $200,000 to cover expenses associated with a transplant. As with other scarce luxuries, pricing can be elastic. Three of the central operators in Israel’s underground kidney market, which has flourished in a country where deceased organ donation rates are low.

In Costa Rica, doctors are paid by the case, so the more transplants they perform, the more they make. One nephrologist in San José, Dr. José Fernando Mangel Morales, said he sometimes doubled his monthly income by handling a single transplant at a private hospital.

Dr. Mora, the chief of nephrology at the state-run Hospital Rafael Ángel Calderón Guardia, also had privileges at two private hospitals — Hospital Clínica Bíblica and Hospital La Católica. The Costa Rican authorities believe he had been arranging transplants for foreigners at the hospitals at least since 2009.

The Costa Ricans who provided kidneys to foreigners were mainly men who had not finished high school and were either unemployed or held low-income jobs. Visit the New York Times for the full story.

 

 

MedAssets signs definitive agreement to acquire Sg2

MedAssets, Inc., announced it signed a definitive agreement to acquire privately held SG-2, LLC (Sg2) for approximately $142 million. Based in Skokie, IL, Sg2 is a provider of healthcare market intelligence, strategic analytics and clinical consulting services that help more than 1,400 hospitals, health systems, as well as pharmaceutical and medical device companies understand current and future market dynamics in order to capitalize on growth and performance improvement opportunities.

"In today's rapidly evolving healthcare environment, industry leaders cannot rely alone on analysis of past performance or even current best practices to drive strategic business decisions and adequately prepare for future market dynamics," said John Bardis, chairman, president and chief executive officer, MedAssets. "Sg2's predictive analytics, market intelligence and consulting expertise help healthcare executives formulate and forecast a highly-informed strategic path for future growth. Sg2's knowledge and market insight is highly respected, and we share a common mission to help healthcare organizations make better decisions to improve performance," added Bardis."

Sg2's SaaS-based EDGE intelligence and analytics platform provides a valuable lens into national, regional and local trends and forecasts throughout the full healthcare continuum. The EDGE platform enables healthcare organizations and other market participants to optimize their system of care in their community and business results while adapting towards a shift to value-based care models.

MedAssets believes this compelling combination of companies can propel further growth for the expanded business enterprise in several ways:

·         Improved channel access: MedAssets offers existing relationships with more than 4,400 U.S. acute care hospitals to provide a powerful sales and distribution channel for Sg2 software and services.

·         Broader data utilization: The addition of proprietary cost, claims reimbursement, and episode-of-care datasets and tools from MedAssets to Sg2 analytics promises to create innovative new products and additional value for providers.

·         Complementary business intelligence and consulting businesses: MedAssets Advisory Solutions capabilities — clinical resource management, process improvement, workforce management, revenue cycle consulting, and clinical, cost and operational analytics — complement Sg2's strategic analytics and clinical business intelligence and consulting teams. Together, these expanded capabilities will help providers identify and act on the strategic and operational implications of the changing healthcare marketplace.

Under the terms of the agreement, MedAssets will acquire Sg2 for approximately $142 million to be funded with cash on hand and borrowings under its existing credit facility. Sg2 financial results and additional terms of the transaction were not disclosed. The transaction is subject to customary closing conditions and regulatory approvals, and is expected to be completed within 60 to 90 days. Visit MedAssets for the release.

 

 

Hospital makes house calls to high-risk patients

PITTSBURGH (AP) - Allegheny Valley Hospital says, “We want to keep the patient at home where they want to be.” The hospital’s approach is fueled partly by the government’s goal to curb readmissions, which cost an estimated $12 billion in Medicare spending. Three-quarters of readmissions are preventable, according to an analysis of claims data by the Medicare Payment Advisory Commission.

Records show Allegheny Valley in the past two years received among the steepest fines for hospitals in Western Pennsylvania - 1 percent of its Medicare reimbursement. Penalties nationwide have averaged about $127,000 per hospital every year.

Experts say the fines have pushed hospitals to send workers to patients’ homes, where they might learn some people can’t get a handle on their health. The task falls primarily on nurses; it’s unusual for doctors to visit homes, said Dr. Karen Joynt, an instructor at Harvard University School of Public Health who studies readmissions.

The impetus to address readmissions at Allegheny Valley came in March 2012 when administrators noted just over 19 percent of patients were returning within a month of discharge. They established the high-risk care team - nurses, social workers and paramedics - to meet daily and review details of recently discharged patients who they suspected might return. Most such patients are elderly with diabetes, congestive heart failure or other chronic conditions.

They do not follow specific guidelines when deciding who should get a home visit.

Officials at Allegheny Health Network consider the program successful enough to try it at other hospitals. Readmission rates at Allegheny Valley dropped to 11.8 percent in May, the lowest since officials recorded the 19.2 percent readmission rate in March 2012.

UPMC Health Plan started a similar program about a month ago that is run by doctors from an internal medicine practice at UPMC Montefiore in Oakland. The program has enrolled 20 patients, said Dr. Jodie Bryk, who leads the program with Dr. Gary Fischer. Visit the Washington Times for the story.