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Monday, April 22, 2019

Intuitive Surgical weakness on Q1 would be unwarranted, says Cantor Fitzgerald

Cantor Fitzgerald analyst Craig Bijou thinks any potential weakness in shares of Intuitive Surgical today would be unwarranted, given the momentum of the company’s underlying business. The slight revenue miss in Q1 was driven by a higher proportion of system placements via lease, which lowers upfront revenue but provides a more stable recurring revenue going forward, Bijou tells investors in a research note. While the analyst expects the stock to see pressure today, he thinks investors should focus on the “impressive underlying business metrics that appear as strong as ever.” Bijou reiterates an Overweight rating on Intuitive Surgical with a $620 price target.

Emergent shares largely pricing in Teva approval, says Cantor Fitzgerald

The FDA on Friday granted Teva Pharmaceutical (TEVA) final approval for its generic version of Narcan, Cantor Fitzgerald analyst Brandon Folkes tells investors in a research note. The analyst views the announcement as largely anticipated following the expiration of Teva’s 30- month stay last month. Shares of Emergent BioSolutions (EBS) are down 18.7% since reporting Q4 earnings, largely driven by the anticipation of a final approval of Teva’s generic naloxone, says Folkes. While Friday’s approval is a negative and will continue to create an overhang on Emergent shares, the recent weakness has “adequately accounted for this overhang,” he contends. As such, Folkes keeps an Overweight rating on Emergent BioSolutions with a $75 price target.
https://thefly.com/landingPageNews.php?id=2894993

JPMorgan upgrades Neurocrine to Overweight after 15% pullback

JPMorgan analyst Anupam Rama upgraded Neurocrine Biosciences to Overweight from Neutral and raised his price target for the shares to $106 from $100. The stock is down ~15% from the mid-January highs, Rama tells investors in a research note. The analyst, however, says his “multiple proprietary analyses” since January “underscore the solid fundamentals of Neurocrine,” For example, his March U.S. tardive dyskinesia physician survey shows a preference for Ingrezza over Austedo, anticipated overall branded market growth, and Ingrezza continuing to gain dominant market share over the next 12-24 months. Further, Rama believes the Q1 consensus estimate for Ingrezza could be beatable.

Tonix breakthrough therapy designation for Tonmya reinstated

Tonix Pharmaceuticals announced the FDA has withdrawn its previously issued breakthrough therapy designation rescind letter and confirmed that the breakthrough therapy designation granted in December 2016 remains in effect for Tonmya for the treatment of posttraumatic stress disorder, or PTSD, which is in Phase 3 development. Tonix also announced that FDA has reversed itself and granted the company a meeting in June to present additional data to support continuing breakthrough therapy designation.

Sunday, April 21, 2019

ObamaCare has not cut ER visits: study

Emergency department visits have continued to rise even as more Americans gained health insurance after the Affordable Care Act came into play, according to a new study.
ED visits increased by 2.3 million a year between 2006 and 2016, with the proportion of uninsured ED visits relatively unchanged from 2006 to 2013, making up between 14% and 16% of visits, the study published Friday in JAMA Network Open found.
But uninsured ED visits dropped after the ACA’s 2014 implementation, which included allowing states to expand Medicaid and requiring individuals to have health insurance. Uninsured ED visits made up 8% all ED visits by 2016.
Hospital discharges also declined. Uninsured patients made up 6% of discharges every year from 2006 to 2016 but then decreased to 5% in 2014 and 4% in 2016.
Study author Dr. Adam Singer, professor and vice chairman for research in the department of emergency medicine at Stony Brook University’s Renaissance School of Medicine, said the findings point to a continued overreliance on hospital emergency departments as a primary site for healthcare services. That has continued despite increased insurance coverage and alternative provider options, such as urgent care centers and retail health clinics.
“When one in 10 patients ED visits and one in 20 hospital discharges are among patients with no insurance, it shows that there is still a lot of work that needs to be done to expand access to coverage,” Singer said.
Previous studies have come to similar conclusions regarding the ACA’s impact—or lack thereof—on ED use.
The latest analysis looked at the law’s impact years after its implementation and found the only substantive change in ED use was in the proportion of patients now covered by some form of insurance.
More than 20 million Americans have gained health insurance coverage since the ACA was signed into law in 2010. Studies have shown a strong relationship between having health insurance coverage and having better health outcomes. A 2017 analysis in the Annals of Internal Medicine concluded the evidence supporting the idea that health insurance reduced mortality had only increased since the Institute of Medicine made the finding in its 2002 report.
The study’s findings raise questions as to whether other factors beyond increasing insurance coverage are impeding the effort to direct patients away from the ED and toward other healthcare settings.
“I think at the end of the day my question would be, do you have access to care because of insurance, or are there still financial impediments to that process,” said Dr. Rade Vukmir, spokesman for the American College of Emergency Physicians. “If you look around you’ll find that there may be.”
The findings suggest the rise in ED visits may be less preventable than hospitalizations, which have come down partly due as more patients obtain care in outpatient settings. More hospitals also put patients who come to the ED on observation status rather than admitting them.

VA snafus prompt bipartisan call for more EHR oversight

  • Bipartisan legislation introduced by two members of the Senate Committee on Veterans Affairs would establish a third party oversight group to monitor the VA’s beleaguered $16 billion EHR rollout. The 11-member EHR Advisory Committee would include medical professionals, IT and interoperability specialists and veterans receiving care from the VA, and would operate as an independent entity.
  • Sens. Jon Tester, D-Mont., and Marsha Blackburn, R-Tenn, introduced the bill Wednesday after a month of critical watchdog reports and revealing congressional hearings. The VA is expected to have an electronic records system in place that’s interoperable with the Defense Department’s by 2020 and with private providers’ before the launch of the private sector focused community care program June 6.
  • The VA’s EHR overhaul has been riddled with troubles from the jump, when Cerner was awarded a no-bid, 10-year, $10 billion contract in 2017. The new committee is the latest attempt to stabilize the project.

The efforts signal mistrust by lawmakers and other watchdogs over the agency, which has been dogged by controversy for several years over its EHR contracting.
VA Secretary Robert Wilkie assured lawmakers in September that the agency is “committed to a timeline that makes sense” and “working with DOD to understand the challenges and obstacles” they faced during their implementation. The initiative was already a year behind schedule by the time Cerner signed the no-bid $10 billion contract, and it’s only gotten bigger and messier since.
The first oversight committee was established by the House VA Committee in June and was followed by a call for the GAO to monitor the project carefully. Wilkie was in the middle of his Senate confirmation process in July when the VA announced the Office of Electronic Health Record Modernization to oversee the project.
HHS’ Genevieve Morris was originally tapped to lead the office, but resigned the following monthThe department attributed the departure to differences in opinion over where the project should be heading.
John Windom stepped into the role as interim director and was immediately tasked with filling hundreds of unfilled positions while configuring a shared oversight office with DOD. Meanwhile, Cerner had subcontracted 24 other businesses to assist with the implementation.
Windom told members of the House VA committee in November that he considered the project a “moving target”: There were too many stakeholders, the cost of the 10-year project rose by billions, and progress was stifled by unfilled positions and leadership challenges.
Lawmakers and VA officials agreed last year that the project wasn’t likely to get easier. That much was certain by March, when a handful of GAO reports shunned the VA for failing to implement EHR recommendations, among many other things. In addition to EHR troubles, OIG reports found the VA had “significant challenges” complying with information security laws and ProPublica published an unfinished United States Digital Service report alleging the agency’s software is currently “flawed” and could “significantly disrupt” patient care.
The agency was also requesting $4.6 billion for its 2020 budget.
“USDS raises credible concerns that Community Care should have a veteran-centric approach, but despite these critiques, VA appears to be ignoring the problem or at least is unwilling to revisit its approach,” House VA Committee Chairman Mark Takano, D-Calif., said in a statement. “Nowhere is this clearer than VA’s intention to formally request a funding transfer to implement the very IT solutions USDS raises concerns about.”
If Tester and Blackburn’s bill is passed, the forthcoming EHR Advisory Committee will be tasked with addressing those concerns by analyzing progress, managing risk, making sure medical staff and VA employees have a say in the EHR rollout, and bringing their findings to Wilkie — who, according to the bill, must meet with them at least twice a year.

First 48 hours with hearing aids

As an editor and writer for Medical News Today, I am constantly exploring the causes and effects of a range of different diseases and conditions.
From time to time, I find that a particular article will pop up and alert me to my own health issues. And that is exactly what happened when I looked into deafness and hearing loss around a year ago.
I was going through the questions a doctor might ask during diagnosis, and I was staggered to find that as few as 5 percent of them did not apply to my own ears.
Sure enough, I took these issues to a doctor, and entered the referral process for treatment by an ear, nose, and throat specialist.
After 8 months of waiting, I now have two hearing aids. At the time of writing, I have only been wearing them for 2 days, yet their impact is already significantly greater than I could ever have imagined.

A gradual, creeping impact on your life

To recap, I’m lucky enough to have retained at least half of my hearing in each ear. At present, I can lead a mostly active, healthy life, I don’t need to communicate with sign language, and my work is unaffected.
However, it’s all too easy to dismiss the impact of a gradual, creeping condition such as hearing loss. It can develop suddenly, or, as in my case, take 20 years to reach a diagnosable level.
I will be 30 years old this year, and those 20 years mark a hugely important period in anyone’s life.
Whether you are trying to make an impact as a young professional starting out, rounding off your formal education, building a family, or all of the above, you will undoubtedly be taking account of parts of your life that are becoming increasingly important and complex.
Communication is a huge part of navigating this formative stage. If any element of communication is lacking, it can have a significant impact on the way your personality develops, and the methods you use to connect with the outside world.
The big kicker with gradual-onset hearing loss is that you are not aware of how it’s changing you until the physical symptoms have become moderate to severe.

Socializing becomes too much of a risk

Every pang of guilt or embarrassment after saying “what?” or “huh?” might lead to another night when you don’t risk going out to socialize. You end up distancing softly-spoken colleagues, friends, and even family members, simply because the effort it takes to process their speech can become draining.
I’ve forgotten what it’s like to chat with a friend at a concert or even a bar. Very often, I will have great difficulty separating conversational frequencies from noises in the environment, making it almost impossible to fully focus on what people are saying.
Something as trivial as needing subtitles when watching television programs and movies with other people can create an isolating feeling of being stigmatized.
Even though your friends are probably understanding, and although subtitles exist to significantly improve the viewing experience for people who cannot hear as well as others, it can still be hard to ignore the underlying feeling of being ‘different.’
As a result of these fleeting moments and hang-ups, I developed subtle, invisible coping mechanisms to anchor my social interactions.
For example, I cycle between a set of 10–15 stock phrases that I wheel out based on tone of voice and general context.
“Absolutely!”
“100 percent!”
“I can fully understand that.”
“Tell me about it!”
None of these seem out of place in a conversation. However, once they become a substitute for genuine responses and coherent conversational flow, they develop into a cornerstone of shame and awkwardness in daily encounters.
Until you start looking at hearing loss as a condition, it simply feels like part of your worldview. Even if it hasn’t yet reached the stage of impairing daily function, it can still strip at least 30–50 percent of the human experience from your day.
After writing the MNT article on hearing loss, I followed this journey to hearing aids on my doctor’s recommendation.
Even though I’m missing only one layer of frequencies, the difference is remarkable.

Even food comes alive with hearing aids

My new hearing aids are discreet yet powerful — sometimes, to my underused ears, excessively so.
A packet of chips opening 20 feet away sounds like it’s crinkling next to my head; I can hear the wheels of a stroller from a balcony five floors up; even the cacophony during bathroom breaks sounds like a National Geographic documentary.
There are unexpected changes, too. My experience of food has completely altered — the additional frequencies adding a lightness of bite and extra crunch that I was previously unaware of.
Using a hearing loop system for the first time at a concert was emotionally overwhelming. My balance and spatial awareness have also greatly improved in these first few days of wearing my hearing aids.
My hearing no longer feels impaired — that is, until I remove the hearing aids. Those few moments in the day without them, such as going to the gym or grabbing a shower, are now pretty draining by comparison.
However, I have heard about 20 birdsongs for the first time in the last 48 hours, and I’ve listened to the phasing hiss of the sea as I’ve never listened before.
And, I was hit by a hailstorm that might genuinely be the single most impressive thing I’ve ever heard, although until 2 days ago, the bar was not all that high.
I have a lot to learn about life with hearing aids, but my first lesson was that no one close to me sees it as a negative life event. Everyone has been congratulating me as if I’ve just become a parent for the first time.
I’ve realized that however self-conscious you might feel about wearing hearing aids, people only see it as a connection with the world, and this is a huge deal. I see my hearing aids as an opportunity, rather than as debilitating or cumbersome devices.

My hearing aids are a game-changer

There’ll be occasional squeals of feedback, and keeping them wedged in my ears can be a challenge, especially while moving around. However, I’m in the early stages of treatment and already connecting with the world more closely.
While my hearing aids are not perfect yet, they remain a genuine game-changer.
If conversations have started to become a struggle for you, or if you’ve passed on getting a hearing aid because of the visual aspect, then I urge you to look into your options. Visit your doctor, speak to your insurer about coverage, and weigh up hearing assistance as a real option.
Sound is 20 percent of your experience as a human. Conversation, music, and background noise are all part of keeping a steady headspace and progressing with your day. Protecting and enhancing that is a life-changing step to take for people who can’t process sound as well as others do.
I cannot wait to stick these bad boys in upon waking up tomorrow and seeing what else I can discover for the first time.