August 23, 2016 Another epidemic: Yellow fever in Africa and Asia Angola and the Democratic Republic of Congo are suffering a devastating yellow fever epidemic that has claimed the lives of more than 400 people and has sickened thousands. The World Health Organization (WHO) and the government of those countries are struggling to control the disease due to a vaccine shortage. According to The New York Times, the outbreak is believed to have begun in late 2015 in Luanda, Angola. The Angolan government and the WHO have tried to stop the spread of yellow fever since it was first reported. The problem is that it takes more time to produce the vaccine than the disease’s pace of transmission. The 17D vaccine was developed by Max Theiler and his colleagues in 1930, and the process they invented to prevent people from getting the disease - there is no cure for yellow fever - involves embryonated chicken eggs and technology that has changed little since 1940. Currently, there are six manufacturers of yellow fever vaccines in the world, and collectively they produce 50 million to 100 million doses each year. This is not enough to fight the outbreak in Africa and has let the virus spread to thousands. The problem is that of those six companies, only four are “prequalified” by the WHO to distribute the doses internationally. The other two manufacturers make vaccines for the domestic market, and they are located in the United States and China. The World Health Organization said last month that the organization was short about nine million doses, although Angola received nearly 12 million vaccines. On May 20, 2016, there were 2,420 suspected cases, including 298 deaths, only in Angola. Unfortunately, the virus has spread to other countries including the Democratic Republic of Congo (DRC), Kenya, and even China, which reveals that there is a weakness in the current International Health Regulations that prevent people from entering a country with potential for yellow fever outbreaks without evidence of immunization. Due to the outbreak in Angola and the DRC, the WHO convened an emergency committee under the International Health Regulations to review the situation of the virus in those regions. The committee decided that the yellow fever outbreak is a serious public health concern, but it does not reach the status of Public Health Emergency of International Concern as Zika does, The New England Journal of Medicine reports. The disease is caused by the yellow fever virus, a mosquito-borne flavivirus mostly found in sub-Saharan Africa and tropical South America. The bite of Aedes aegypti mosquitoes can infect a human and could be the cause of the cases reported in Angola and the DRC. Only 15 percent of people that get yellow fever progress to a severe form. If yellow fever symptoms progress, people suffer from jaundice, meaning that their skin, mucous membranes or eyes will turn yellow, because the virus affects the levels of bilirubin in the body. Between 20 to 50 percent of those who get truly affected by the disease, die. Usually, the virus manifests itself in the jungle in a yellow fever cycle of monkey-mosquito-monkey, where humans are accidental hosts of the condition. But in Angola and the DRC, yellow fever cases have been reported in cities, complicating the cycle to an urban manner. An urban yellow fever cycle means that the disease is spreading almost exclusively by the Aedes aegypti mosquito. The World Health Organization is giving people one-fifth of the standard dose to compensate the lack of vaccines for Angola and the DRC population. With a full dose, the person is believed to be immune for a lifetime or at least more than 30 years. With a fifth of the vaccine, people can avoid yellow fever for around 12 months. Visit Pulse for the article. Nonprofit hospitals’ business relationships can present conflicts Nonprofit hospitals have extensive business ties that can pose conflicts of interests for their administrators and board members, a Wall Street Journal analysis of newly released Internal Revenue Service data shows. While having relationships with companies doing business with a nonprofit hospital isn’t necessarily improper—as long as the deals are disclosed and at market rate—administrators and board members sometimes may be forced to choose between what’s best for the hospital and what’s best for their private interests. “Just because something is legal doesn’t mean that it’s appropriate,” said James Orlikoff, a Chicago-based hospital governance consultant. “You run the real risk of violating the public trust.” Hospitals rank among the largest nonprofits in the country. Because they often are big employers and have complex business arrangements, they face these dilemmas far more often than most other kinds of nonprofits. In 2014, 46% of more than 2,300 nonprofit hospitals had at least one trustee or officer with business ties to the hospital—either directly or through a relative. That is compared with 7% of all nonprofits in the Journal’s analysis of tax-return data compiled by the IRS. At more than 270 nonprofit hospitals, the arrangements topped $1 million each. Many of the largest transactions involve hospitals and medical companies that have common board members. But in other instances, hospitals have multimillion-dollar contracts with companies owned by trustees in areas such as advertising and construction. Avera McKennan Hospital & University Health Center in Sioux Falls, SD., had one of the largest contracts with a company that had ties to a director in 2014. The $20.9 million construction deal with the subsidiary of Avera Health, which includes a 545-bed hospital, five rural hospitals and dozens of clinics, followed years of similarly large payouts to the same company. Between 2010 and 2014, Avera McKennan paid $91.2 million to Journey Group, the construction company where hospital trustee David Fleck is board chairman. Fleck sold his stake in Journey Group in 2012, but declined to say if the company currently pays him. Journey Group and Avera Health’s general counsel didn’t respond to questions about Fleck’s compensation. An Avera spokeswoman declined to say whether Journey Group competitively won its contracts or offered the lowest prices. She said the hospital typically awards contracts to the lowest bidder but may consider other factors. Avera’s conflict-of-interest policies are in line with state and federal laws, and Avera hasn't received complaints regarding Journey Group’s contracts, she added. Fleck said hospital trustees disclose conflicts at each board meeting, and he didn’t discuss or vote on Journey Group contracts. Fleck, like most board members at nonprofits, isn’t paid for serving. In addition to deals with board members, nonprofit hospitals are required to disclose transactions with families of officers and directors. At California-based Dignity Health, the chief executive’s son has a multimillion-dollar marketing contract. Nathan Dean, son of Dignity CEO Lloyd Dean, landed a contract in 2011 to create an online market for Dignity’s branded goods and to produce those items, including lapel pins and badge clips. The 39-hospital chain paid $3.8 million during two years to eLead Resources, Inc., and the contract was renewed in 2014. The younger Dean owns 51% of the company, said an attorney for Dignity. The elder Dean said the hospital behaved ethically, and he avoided internal conversations about his son’s contracts. He didn’t balk at eLead’s bid for the business because his son’s company is qualified to compete for the work and Dignity has policies to prevent conflicts of interest, Lloyd Dean said. “eLead met the criteria for the open-bidding process,” he said. Unlike government entities that solicit contracts, nonprofits aren’t required to disclose their bidders. Hospitals in small towns may face a particular dilemma when it comes to managing conflicts, said Michael Peregrine, a Chicago-based lawyer and governance consultant. They may think that because “governance gurus are telling us we’ve got to get the best and brightest people,” their only choice is to turn to the local business leaders known by the hospitals. Rob Montagnese, chief executive of Licking Memorial Health Systems in Newark, OH, said his hospital banned business contracts with board members in the early 2000s. The hospital, he said, wanted to make sure “our community had confidence that our board members were truly here as volunteers. Montagnese said it hasn’t been a problem to find qualified board members under the ban, even in a small community. At the time, Montagnese said, there were three trustees with hospital business—a bank leader, a local attorney, and a real-estate developer—who faced giving up either their board seats or their hospital business. All three resigned the board. Visit the Wall Street Journal for the article. CMS releases new prescription drug cost data Continuing the commitment to greater data transparency, the Centers for Medicare & Medicare Services (CMS) today released privacy-protected data on the prescription drugs that were paid for under the Medicare Part D Prescription Drug Program in 2014. This is the second release of the data on an annual basis, which shows which prescription drugs were prescribed to Medicare Part D enrollees by physicians and other healthcare professionals. “With this data release, patients, researchers and providers can access valuable information about the Medicare prescription drug program,” said Niall Brennan, CMS Chief Data Officer. “Today’s release joins a series of actions the Administration is taking to improve transparency around government data, including the cost of prescription drugs.” The 2014 data set contains information from over one million distinct health care providers who collectively prescribed approximately $121 billion in prescription drugs paid for under the Medicare Part D program. This represents a 17 percent increase compared to the 2013 data set. The March 2016 Department of Health and Human Services report provided a detailed analysis of prescription drug spending trends, and noted that overall prescription drug spending in the United States rose by 12.6 percent between 2013 and 2014. The 2014 data set describes the specific medications prescribed for 38 million Medicare Part D enrollees, who represent about 70 percent of all Medicare beneficiaries. The data set was created using information submitted by Medicare Advantage Prescription drug plans and stand-alone Prescription Drug Plans. With two years of data, it will now be possible to conduct analyses of trends from 2013 to 2014 as well as to conduct a wide array of analyses that compare prescribing habits for specific providers, brand versus generic drug prescribing rates, and state- and local-level differences in drug utilization and costs. The 2014 data set includes new aggregated information on opioids, antibiotics, antipsychotics, and high-risk medications among the elderly. In addition, a prescriber enrollment status field has been added to indicate whether the prescriber is enrolled, not enrolled or opted out of the Medicare program. The availability of the 2014 Medicare Part D prescription drug data adds to the unprecedented information previously released on services and procedures provided to Medicare beneficiaries. This public data release is part of the Administration’s broader strategy to improve the health care system by paying practitioners for what works, unlocking healthcare data, and finding new ways to coordinate and integrate care to improve quality. Visit here to view a fact sheet on the 2014 Medicare Part D prescriber data. Visit here to access the 2014 Medicare Part D prescriber data. Results of 2016 Survey of Healthcare Provider Executives on leadership development and succession have been tabulated Jamie C. Kowalski Consulting, LLC announces the completion of the 2016 edition of its annual survey of Healthcare Provider Executives. The survey is an update to the questions asked about Leadership and Succession, in the (first), 2015 edition on this topic, plus includes new questions. Approximately 180 Supply Chain Leaders received a personal invitation via email. The 2016 Survey was produced in collaboration with the Bellwether League, Inc. (BLI), the Hall of Fame for Healthcare Supply Chain leaders and this year’s Sponsors:  Presenting Sponsor: Intalere, a leading national healthcare Supply Chain solutions company that helps members elevate their operational health by delivering optimal cost, quality and clinical outcomes.  Sponsor: Owens & Minor, Inc., the largest medical supply distributor in the healthcare industry, serving all types of healthcare providers, with products and solutions for their supply chain. Note that in the 2015 survey, 47% of the respondents stated that they would be retiring within the next 3- 4years. Will there be enough talent in the industry to fill all these expected vacancies? The 2016 Survey found that number has been reduced, but is still large enough to beg the question. The findings and subsequent analysis will be presented at several venues during 2016/2017. Those who have an interest in the Survey, should contact Jamie C. Kowalski ([email protected]). Improper care of contact lenses can cause serious eye infections Nearly 1 in 5 contact lens-related eye infections reported to a federal database involved a patient who experienced eye damage, according to a report published in CDC’s Morbidity and Mortality Weekly Report (MMWR). The infections, submitted to the U.S. Food and Drug Administration’s (FDA) Medical Device Report Database, included patients who had a scarred cornea, needed a corneal transplant, or otherwise suffered a reduction in vision. These contact lens-related eye infections can lead to long-lasting eye damage but are often preventable. Contact lens manufacturers, eye care providers, and patients can report adverse events related to contact lens use to the FDA, which regulates contact lenses as medical devices. The report reviewed 1,075 contact lens-related infections reported to FDA between 2005 and 2015. More than 10 percent of the reports indicated that the patient went to an emergency department or urgent care clinic for immediate care. Whether eye infections are minor or lead to long-lasting damage, they can be painful and disrupt daily life. For instance, the reports describe patients’ daily visits to an eye doctor or hourly administration of eye drops to treat the infection. The MMWR was released in advance of Contact Lens Health Week, which runs August 22-26 and promotes healthy wear and care practices that can help contact lens wearers reduce their chances of getting an eye infection. Contact lens wearers can help prevent infections by properly using lenses and supplies and following directions on the lens labels. More than 1 out of 4 reports of infections mentioned easily avoidable behaviors that increase the chance of getting an eye infection, such as wearing contact lenses while sleeping and wearing them longer than recommended. “Around 41 million people in the United States wear contact lenses and benefit from the improved vision and comfort they provide,” said Jennifer Cope, M.D., M.P.H., medical epidemiologist in CDC’s Waterborne Disease Prevention Branch. “While people who get serious eye infections represent a small percentage of those who wear contacts, they serve as a reminder for all contact lens wearers to take simple steps to prevent infections.” The findings in this report highlight the need for contact lens wearers to take good care of their lenses to help prevent contact lens-related eye infections. Three recommendations related to commonly reported and risky behaviors:  Don’t sleep in contact lenses without discussing with your eye doctor. Sleeping in contact lenses increases the chance of an eye infection by 6 to 8 times.  Don’t top off, or add new contact lens solution to old solution that has been sitting in the case. Adding new solution to used solution can lower germ-killing power.  Replace your contact lenses as often as recommended by your eye doctor. People who do not replace their lenses as often as recommended have more complications and report more eye problems than those who follow the replacement recommendations. Visit CDC for the report. Surgeons need to guard tongue in 'awake' operations As "awake" surgical procedures become more common, surgeons increasingly find themselves in the potentially awkward position of being overheard by patients. A new study suggests that surgeons who work with awake patients are very aware that the patients are listening, and are thus careful to limit their communication with trainees and staff. These patient safeguards change the way surgeons communicate with their team and may limit their ability to teach the next generation of surgeons. Awake surgical procedures occur while the patient is under no sedation, light sedation, or conscious sedation. Although these surgeries benefit the patient through shorter recovery times and decreased hospital stays, they can also cause patients significant anxiety and distress. Surgeons are aware of this risk, and thus try to minimize patient stress during the procedure. Claire Smith, MFA, from the University of Chicago in Illinois, and colleagues published the results of their interviews with 23 surgeons online June 29 in the American Journal of Surgery. Their study included surgeons who practiced at two related medical centers in the Midwest (a university medical center and a university-affiliated hospital system). The researchers recruited surgeons from various specialties to answer questions about their experiences operating on awake patients. The surgeries ranged from vasectomy to angiogram to eyelid blepharoplasty. The authors note in their article that surgeons who value communication and consider themselves to be good at communication may have been more likely to respond to the request for an interview. As expected, most emphasized the importance of managing patients' expectations by preparing them for any anticipated changes in sensation. They also noted that although awake surgeries tend to be more efficient and satisfying for the patients, they also come with challenges; for example, the surgical team must manage the risk that the patient may move during surgery. "In particular, our findings highlight the tensions that exist between a surgeon's duty to care for the patient, efficiently manage the procedure room, and properly instruct and give experience to trainees," explain the authors. The researchers found that most surgeons modify their communication and interactions with staff and trainees when in the presence of an awake patient. This includes the creation of code words for use during surgery and using medical jargon the patient is unlikely to understand. Surgeons also described the efforts required to balance the necessary training of surgeons with patient comfort. "To our knowledge, this research is the first to broadly examine surgeon-patient communication during awake procedures and to report challenges to this relationship related to teaching during awake procedures," the authors write. Many patients can be uncomfortable with the idea that a student is operating on them. Surgeons thus tend to obscure trainee involvement in awake procedures. Some surgeons may go even further and be reluctant to let trainees participate in awake surgeries. The researchers also note that the interviews raised the possibility that surgeons may have a tendency to conceal trainee involvement from unconscious patients, should surgeries be monitored for quality improvement purposes. Visit Medscape for the article. Osteoporosis, a disease with few treatment options, may soon have one more A large clinical trial of a new osteoporosis drug found that it stimulates bone growth and prevents fractures at least as well as the only other such drug on the market. The new drug, expected to win approval from federal regulators, would offer another much-needed treatment for some of the 10 million Americans, 80 percent of them women, who have a disease that weakens bones and often leads to years of pain, disability and early death. Experts agree that new drugs are urgently needed for this debilitating disease. People with osteoporosis have bones that are fragile and break easily. Bone is naturally lost with age. But osteoporosis is an extreme, abnormal bone loss that can cause devastating fractures, particularly of the spine and hip. Yet most with osteoporosis do not take medications to prevent fractures, according to the National Osteoporosis Foundation. The new drug looks promising, according to the clinical trial conducted by Radius, whose results were published in JAMA, the journal of the American Medical Association. The trial compared the new drug, abaloparatide, with a placebo and with the only other bone-building drug on the market, Eli Lilly’s Forteo. If the Radius drug is approved, it would compete with Forteo, whose average retail price is now $3,100 for a four-week supply, said Michael Rea, the chief executive of Rx Savings Solutions, a company that provides prescription pricing information. That is triple the drug’s average 2010 retail price, he said, adding that for the past three years Lilly has raised Forteo’s price twice per year by 9 to 15 percent each time. Lilly confirmed the twice-yearly price increases and supplied wholesale prices for its drug. In 2010, Forteo’s wholesale price was $947.20, and in 2016 it was $2,551.77. Although medical specialists fervently hope the Radius drug, if approved, will cost less than Forteo, that is far from certain. Dr. Lorraine A. Fitzpatrick, the chief medical officer at Radius, the small start-up that makes the new drug, declined to discuss price. If Radius’s drug is approved, it will be the company’s first product. With Forteo’s high price, insurers balk at covering it and even when they do, patients can face high deductibles, say doctors who treat the disease. Insurers often insist that high-risk patients first try a cheaper option, a class of drugs called bisphosphonates, which includes Fosamax. Those slow the loss of existing bone but do not build bone. They can cost just pennies a day but can have very rare side effects — a sudden shattering of the thighbone or an erosion of the jawbone. Many high-risk patients are terrified of the drug’s side effects and decide to just take nothing rather than try those drugs first. Like Forteo, the new drug must be injected daily, but it is a derivative of a different hormone — one that almost entirely stimulates bone growth. Lilly’s drug stimulates both bone growth and bone loss, though the net effect is a gain in bone. With the Radius drug, holes in osteoporotic bone appeared to fill faster than with the Lilly drug. But the study was not large enough to determine whether that translated to fewer fractures. Both drugs were far better than a placebo. After 18 months, four women of the 824 taking the Radius drug had a new spine fracture, compared with six of the 818 taking Lilly’s drug and 30 of the 821 taking a placebo. Radius has filed an application with the Food and Drug Administration to market the drug. Visit the New York Times for the story. HIMSS 2016 Cybersecurity Survey finds providers are enhancing cybersecurity programs but improvements needed Health information is under attack, and U.S. healthcare providers are responding to these concerns, or so suggests data from the newly released 2016 HIMSS Cybersecurity Survey. With over 85 percent of respondents reporting that cybersecurity efforts within their organization were elevated as a business priority during the past year, healthcare providers are clearly concerned about the growing threats surrounding health information. These concerns are well placed given the increase in news stories involving patient data breaches during the past year. “Stories surrounding the breach of hospital and health systems data are unfortunately no longer infrequent occurrences,” said Rod Piechowski, senior director, health information systems, HIMSS. “Cybersecurity attacks have the potential to yield disastrous results for healthcare providers and society as a whole. It is imperative that healthcare providers acknowledge the need to address cybersecurity concerns and act accordingly. Fortunately, the evidence from this study suggests providers are taking steps to address cybersecurity concerns. However, more progress needs to be made so that providers can truly stay ahead of the threats.” Instituted as an annual research program in 2015, the HIMSS cybersecurity study gauges the perceptions and experiences of U.S. healthcare organizations on a number of cybersecurity topics. The 2016 HIMSS Cybersecurity Survey – sponsored by FairWarning – reflects the first year follow-up from the baseline report established in 2015. This year’s report focuses exclusively on the responses from 150 information security leaders who report having some degree of responsibility for information security in a U.S.-based healthcare provider organization, such as a hospital or long-term care facility. Key findings from the 2016 survey include notable differences between acute and non-acute providers:  87% of acute providers and 81% of non-acute providers made information security a higher priority.  Barriers to elevating cybersecurity were the lack of appropriate cybersecurity personnel 58% (acute) 62% (non-acute), and lack of financial resources 50% (acute) 71% (non-acute).  Motivations for increased cybersecurity are phishing attacks 80% (acute), 65% (non-acute); virus/malware 68% (acute), 65% (non-acute); and results of risk assessment 64% (acute), 77% (non-acute).  Vulnerabilities include email, mobile devices and internet of things.  Common reason for attacks is medical identify theft 77% (acute), 74% (non-acute).  The perceived ability to detect and protect are brute force attacks 75%, exploitation of known software vulnerabilities 74%, and negligent insider attacks 73%.  Most feared future threats include ransomware 69%, advanced persistent threat attacks 61%, and phishing attacks 61%. Visit HIMSS for the report.