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The U.S. Department of Health and Human Services (HHS) has issued email guidance regarding a recent ransomware attack on healthcare organizations. Ransomware restricts user access to the computer until the user pays a fee to the attackers, and can be delivered via email by attachments or links within the email. In the recent series of attacks, malicious users have been directing attacks at Remote Desktop Protocol (RDP) servers open to the internet. HHS advises the following:
- If you do not need RDP, disable the service on the computer.
- If you need RDP, block unauthorized network connections using Access Control Lists or firewalls, especially from any address on the Internet.
In addition, HHS urges users to use caution when opening emails, as attackers can impersonate other senders; not to click unexpected links in emails; and to keep their antivirus software up to date.
STAT reports that, under a bipartisan budget deal agreed to by the U.S. Congress, the National Institutes of Health (NIH) will receive a $2 billion increase in funding over the next 5 months. President Trump had previously proposed a $1.2 billion cut for the agency in the current fiscal year. The deal does not address funding for 2018; the president has previously called for a cut of $5.8 billion to the agency during FY 2018.
Open Payments data
A study in The Journal of the American Medical Association (JAMA; May 2) examines 2015 data from the U.S. Centers for Medicare & Medicaid Services (CMS) Open Payments system. The authors conducted an observational, retrospective, population-based study of licensed physicians in the United States linked to 2015 Open Payments reports of industry payments. They found that 449,864 of 933,295 physicians (48.2 percent) reported a total of $2.4 billion in industry payments, including approximately $1.8 billion for general payments, $544 million for ownership interests, and $75 million for research payments. Overall, 47.7 percent of primary care physicians and 61 percent of surgeons reported receiving general payments. After adjustment for geographic spending region and sole proprietorship, the authors noted that male physicians within each specialty had increased likelihood of receiving general payments and royalty or license payments compared to female physicians.
MIPS participation status
CMS has announced the availability of an online tool to help healthcare providers determine their participation status in the Merit-based Incentive Payment System (MIPS). To determine your status, enter your national provider identifier number into the entry field. Information will be provided on whether MIPS participation is required, along with links to additional resources. MIPS participation is required for providers who bill Medicare Part B more than $30,000 per year and see more than 100 Medicare patients per year.
The U.S. Centers for Disease Control and Prevention (CDC) has released updated information on the emerging, often multidrug-resistant fungus, Candida auris. The agency reports that, as of May 12, 2017, 77 clinical cases of C. auris had been reported from seven states: New York (53), New Jersey (16), Illinois (4), Indiana (1), Maryland (1), Massachusetts (1), and Oklahoma (1). Among the 77 clinical cases, median patient age was 70 years (range: 21–96 years). C. auris was cultured from the following sites: blood (45 isolates), urine (11), respiratory tract (8), bile fluid (4), wound (4), central venous catheter tip (2), bone (1), ear (1), and a jejunal biopsy (1). Antifungal susceptibility testing at CDC of the first 35 clinical isolates revealed that 30 (86 percent) were resistant to fluconazole, 15 (43 percent) were resistant to amphotericin B, and one (3 percent) was resistant to echinocandins.
According to an article in MedPage Today, at least 17 states are considering bills that, if enacted, would limit the ability of health plans, hospitals, and/or state licensing agencies to require physicians to be board certified and/or participate in periodic maintenance of certification (MOC) programs. Supporters argue that some MOC programs are outdated and have little impact on quality of care. The article also cites concerns among providers that some states may begin requiring board certification as a condition of state licensure.
FDA drug safety
According to a study in JAMA (May 9), nearly one-third of drugs approved by the U.S. Food and Drug Administration (FDA) from 2001 to 2010 had subsequent safety issues leading to some type of action by the agency. The authors reported that of 222 novel therapeutics approved in those years, 71 warranted a postmarket safety event, with three of the drugs withdrawn and the remainder requiring a black-box warning on side effects or a safety announcement about newly detected risks. The median time from approval to a postmarket event for affected drugs was 4.2 years, with such action more common for psychiatric drugs, biologics, and drugs granted accelerated approval status.
FDA approval processes
A study published in The Journal of Bone & Joint Surgery (May 3) finds wide variation in reporting and strength of clinical research methodology accepted by FDA to approve high-risk orthopaedic devices. The researchers audited study design and methodology of 49 studies used by the FDA to evaluate the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. They found that 46 were prospective, 37 were randomized, and 47 were controlled in some form. Of 35 studies that reported it, 13 were double-blind and 8 were single-blind. Of the 37 randomized trials, outcome assessors were clearly blinded in six (16 percent), while 15 (41 percent) were deemed impossible to blind, as implants could be readily discerned on imaging. When the Checklist to Evaluate a Report of a Nonpharmacological Trial was applied to the 37 randomized trials, more than 70 percent of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors.
A study of hospitalization of Medicare beneficiaries 65 years and older found that lower mortality rates were recorded at major teaching hospitals compared with nonteaching hospitals. The study, published in JAMA (May 23/30), looked at 21,451,824 total hospitalizations at 4,483 hospitals, of which 250 (5.6 percent) were major teaching, 894 (19.9 percent) were minor teaching, and 3,339 (74.3 percent) were nonteaching hospitals. Unadjusted 30-day mortality was 8.1 percent at major teaching hospitals, 9.2 percent at minor teaching, and 9.5 percent at nonteaching, with a 1.5 percent mortality difference between major teaching and nonteaching hospitals. The primary outcome for the study was 30-day mortality rate for all hospitalizations and for 15 common medical conditions, one of which was hip fracture, and six surgical conditions, one of which was hip replacement. Mortality differences among hospital types for those two orthopaedic hospitalization types were not significant.
Findings from a study published in the Journal of Patient Safety (online) highlight differences in viewpoints between clinicians and patients regarding disclosure of medical errors. The researchers surveyed 50 clinicians and 65 patients and family members from a hospital patient and family advisory council. They found that patients' and family members' views about disclosure were significantly different from clinicians' in 70 percent of disclosure expectation items and 100 percent of disclosure vignette items. Compared with clinicians, patients and family members more strongly agreed that "patients want to know all the details of what happened" and more strongly disagreed that "patients find explanation(s) more confusing than helpful." In the medication error vignette, compared to clinicians, patients and family members more strongly agreed that the error should be disclosed and that the patient would want to know, and more strongly disagreed that disclosure would do more harm than good. The researchers write that after completing a workshop on medical error disclosure, both groups' viewpoints on information sharing, fallibility, truth telling, and threshold for disclosure displayed greater concordance.
Imaging use trend
Rapid growth in the use and complexity of imaging occurring from 2000 to 2007 plateaued in 2008 and then entered a downward trend through 2014, according to a study in Health Affairs. The study reports that in most of the first decade of the millennium, the use of imaging grew faster than any other physician service in the United States. The researchers also noted that the use of imaging as well as the fees charged for it were higher than in any other developed country in 2007. The researchers note that between 2008 and 2013, CMS and commercial insurers instituted payment cuts to reduce the rise of imaging usage. Using Medicare data, the authors found that during the years 2001 to 2008, the rate of utilization of all noninvasive diagnostic imaging increased steadily from 3,520 per 1,000 beneficiaries to a peak of 4,422. Over the next 3 years, substantial declines were seen, but were primarily attributable to the effect of code bundling. However, no major code bundling occurred from 2012 to 2014, and the rate further declined in each of those years. "Federal policies appear to have achieved the desired effect of ending the rapid growth of imaging that had been seen in earlier years," the researchers write.
Iowa court ruling
AMA Wire reports that the Iowa Supreme Court has ruled that the state's Morbidity and Mortality Study Law can prevent information from being given to a patient who filed a medical liability suit. At issue was a patient safety network incident report and related peer review documents filed with the hospital. A trial court had initially ordered the institution to turn over the documents, but the hospital and others argued that doing so would breach staff confidentiality and reduce incentive for future internal error reporting. The high court agreed that the hospital is not required to share the protected information.