Friday, September 28, 2018
Novo Nordisk: Growth hormone med phase 2 data demonstrates potential
Novo Nordisk announced that somapacitan, a novel growth hormone derivative in development for once-weekly administration of growth hormone, matched the therapeutic benefits of once-daily Norditropin in a phase 2 trial in children with growth hormone deficiency. The REAL 3 trial data were presented today at the 57th Annual Meeting of the European Society for Paediatric Endocrinology. The trial compared three somapacitan doses to Norditropin 0.034 mg/kg/day. Annualized height velocity did not differ significantly for the 0.08 and 0.16 mg/kg/wk doses compared to Norditropin. The mean annualized height velocity for the three dose levels of somapacitan was 8.0 cm, 10.9 cm and 12.9 cm, respectively, as compared to 11.4 cm for daily Norditropin. Somapacitan was well tolerated at all doses investigated, with no clinically relevant safety or local tolerability issues identified.
https://thefly.com/landingPageNews.php?id=2796921
Thursday, September 27, 2018
Many Drivers Rely Too Much on New Car Safety Features
New cars are now coming out with high-tech safety features designed to prevent crashes. But if you don’t know how they work you could be inviting an accident, new research suggests.
These advanced driver assistance systems (ADAS) — including blind-spot monitoring, forward-collision warning and lane-keeping assist — can, when used properly, make your driving safer. But many drivers are unaware of the limitations of these advances, the authors of the report said.
“When properly utilized, advanced driver assistance system technologies have the potential to prevent 40 percent of all vehicle crashes and nearly 30 percent of traffic deaths,” said Dr. David Yang, executive director of the AAA Foundation for Traffic Safety.
But the new findings, published Sept. 26 by the foundation, show that a lot of work needs to be done in educating drivers about the limitations of these devices and their proper use, he added.
For example, nearly eight out of 10 drivers with blind-spot monitoring systems didn’t know the limitations of this feature. These systems only work when a car is traveling in a driver’s blind spot, and many systems do not detect vehicles traveling at high speeds.
Not understanding driver assistance systems may lead to misuse or over-reliance and could result in a deadly crash, the researchers said.
In the United States in 2016, more than 37,400 people were killed in traffic crashes — a 5 percent increase from 2015, according to a AAA news release.
For the new study, researchers from the University of Iowa surveyed drivers who purchased a 2016 or 2017 car with ADAS technologies.
The investigators evaluated drivers’ opinions, awareness and understanding of these safety features, and found that most did not know or understand the limitations of these systems.
Most drivers (80 percent) did not know the limitations of blind-spot detectors. Many incorrectly believed that the systems could monitor the road behind the car or reliably detect bicycles, pedestrians and vehicles passing at high speed.
As for forward-collision warning and automatic emergency braking systems, nearly 40 percent did not know the systems’ limits or confused the two technologies.
Drivers incorrectly assumed that forward-collision warning would apply the brakes in the case of an emergency, but the technology is only designed to deliver a warning signal, the researchers said.
In addition, one in six drivers didn’t know if their vehicle had automatic emergency braking.
About 25 percent of drivers felt comfortable that blind-spot systems would pick up pedestrians and traffic, so they didn’t do visual checks or look over their shoulder for oncoming traffic or pedestrians.
Moreover, about 25 percent of drivers with forward-collision warning or lane-departure warning systems felt comfortable doing other tasks while driving.
“New vehicle safety technology is designed to make driving safer, but it does not replace the important role each of us plays behind the wheel,” Yang said in the news release.
These findings should motivate more focus on the importance of educating new and used car buyers about how safety technologies work, the study authors said.
Only about half of the drivers who purchased a new car from a dealership recalled being offered training on the new technology. Among those who were, nearly 90 percent completed the training.
AAA advises all new car owners to read up on the car’s safety devices and actually see how they work. Drivers should also ask the dealer questions to be sure they understand what these safety features will and will not do.
More information
Visit the AAA Exchange for more on driving safety.
SOURCE: AAA Foundation for Traffic Safety, news release, Sept. 26, 2018
Supreme Court takes up multibillion DSH payment dispute
The justices agreed to review a Circuit Court ruling that HHS had violated the Medicare Act in its reimbursement calculation for disproportionate share hospitals.
KEY TAKEAWAYS
The Supreme Court agreed to review the appellate ruling written by Judge Brett Kavanaugh.
At issue in this case is whether HHS has the discretion to engage in “interpretive rulemaking” without public notice-and-comment steps.
The dispute implicates up to $4 billion in reimbursements.
The U.S. Supreme Court agreed Thursday to review a case with major consequences for hospitals that serve high numbers of low-income patients.
The justices granted a request from Health and Human Services to revisit a lower court’s decision that had invalidated a piece of the government’s Medicare reimbursement calculations for disproportionate share hospital (DSH) payments.
Only nine hospitals, led by Allina Health Services, are party to the case. But their claims total $48.5 million in additional reimbursement for a single year. Since hundreds of similarly situated hospitals have filed dozens of follow-on lawsuits making similar claims, the total amount implicated in this dispute is $3-4 billion for fiscal years 2005 through 2013, HHS said in court filings.
By taking up the case, the Supreme Court agreed to review a ruling issued last year by the D.C. Circuit Court, which declared HHS in violation of the Medicare Act for changing the reimbursement formula without going through a public notice-and-comment rulemaking process for fiscal year 2012.
That decision, which overruled a District Court judgment in favor of HHS, was written by Judge Brett Kavanaugh, who is now President Donald Trump’s nominee to replace recently retired Justice Anthony Kennedy on the Supreme Court.
“Unlike the [Administrative Procedure Act], the text of the Medicare Act does not exempt interpretive rules from notice-and-comment rulemaking. On the contrary, the text expressly requires notice-and-comment rulemaking,” Kavanaugh wrote, knocking down a series of arguments HHS had raised.
This position is not universally agreed upon, however, as even Kavanaugh acknowledged.
“We recognize that we are breaking with several other courts of appeals by holding the Medicare Act does not incorporate all of the APA’s exceptions to the notice-and-comment requirement. … But we respectfully disagree with those opinions,” he wrote.
This disagreement among the circuit courts was one reason HHS cited in its request for the Supreme Court to review the case. But there were also suggestions that the eight sitting justices could shy away from reviewing this case at this time if they would expect a 4–4 tie.
“If the justices saw themselves as likely to be evenly divided on the merits in Allina, they could well decide to leave the issue for another day,” A.E. Dick Howard, a professor at the University of Virginia School of Law, told Bloomberg Law in August.
There were concerns, also, that Kavanaugh’s pending nomination could factor into the justices’ decision, since he is likely to recuse himself from the case, if confirmed.
The court’s order states that the justices will review one very specific question: “Whether 42 U. S. C. §1395hh(a)(2) or §1395hh(a)(4) required the Department of Health and Human Services to conduct notice-and-comment rulemaking before providing the challenged instructions to a Medicare Administrator Contractor making initial determinations of payments due under Medicare.”
Medicare Advantage plans could be denying claims to boost profits: HHS
The HHS’ Office of Inspector General fears that Medicare Advantage plans could be denying needed medical services to maximize profits, according to a new report released Thursday.
When beneficiaries and providers appealed preauthorization and payment denials, Medicare Advantage organizations, or MAOs, overturned 75% of their own denials between 2014 and 2016. They overturned approximately 216,000 denials each year, HHS OIG said.
During the same period, independent review entities, which handle the second level of appeals for denials, overturned additional claims denials in favor of beneficiaries and providers.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the HHS OIG said in the report. “MAOs may have an incentive to deny preauthorization of services for beneficiaries, and payments to providers, in order to increase profits.”
Beneficiaries and providers rarely used the appeals process. Over the two years studied, beneficiaries and providers appealed only 1% of denials.
Patient advocates have raised concerns that the appeals process can be confusing and overwhelming, particularly for critically ill beneficiaries. The HHS OIG noted that patients may either be going without needed services or paying for them out of pocket because of this.
HHS’ OIG said that some denials may stem from legitimate issues such as a plan determining that its original decision was incorrect, or they may have lacked necessary information to approve a claim, only to receive what they needed later.
Nevertheless, the HHS OIG wants the CMS to increase its oversight of Medicare Advantage plans to help ensure denials made by insurance companies are truly valid.
The agency should provide technical assistance, training, education and increased monitoring or enforcement actions for MAOs that exhibit higher denial rates. The CMS could impose civil money penalties if it finds claims are being denied for the wrong reasons or appeared to be motivated by profit, the watchdog said.
The CMS also could also require plans with repeated violations to hire independent auditors to perform program audits more frequently than the CMS is able to.
The CMS told the HHS OIG that it agreed that enhanced oversight of Medicare Advantage plans was needed, but it did not say what actions it will take to do so.
AHIP pushed back against the report highlighting the fact that MA plans approve the vast majority of prior authorization and payment requests they receive, according to Cathryn Donaldson, a spokeswoman for the trade association.
“It is also important to distinguish between patients getting needed care and providers receiving payment for services delivered, which the OIG reports in a combined fashion,”Donaldson said.
“A denial does not necessarily equate to patients not getting the care they need.”
In addition, researchers often rank Medicare Advantage plans higher in terms of quality of care provided compared to Medicare fee-for-service, according to John Rother, who heads the National Coalition on Healthcare, a group of insurers and employers,
“Many researchers actually fear the converse that the incentives in the fee for service sector promote over treatment due to financial considerations [by providers],” Rother said. “Over treatment often results in extra expenses but can also result in harm to the patient.”
Medicare Advantage enrollment has grown steadily over the past decade and shows no signs of slowing. About 21.4 million seniors are currently enrolled in Advantage plans, up 7.8% over last year, according to the latest data from the CMS. That represents about one-third of all Medicare beneficiaries.
Why Are STD Rates Soaring Nationwide
Hello. I’m Dr Arefa Cassoobhoy, a primary care internist, Medscape advisor, and senior medical director for WebMD. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
The United States has the highest sexually transmitted disease (STD) rates in the industrialized world. After decades of watching rates decline, the incidence of three sexually transmitted infections hit an all-time high in 2017.
Chlamydia, gonorrhea, and syphilis combined were diagnosed in 200,000 more people in 2017 compared with 2016. Rates of syphilis, in particular, have doubled in the past 4 years. About half of these cases are in men who have sex with men. Another major concern is the rise in gonorrhea that is resistant to ceftriaxone.
These alarming trends point to a public health crisis. One reason for the increase is a lack of awareness. It can be an uncomfortable conversation. Patients rarely ask for STD testing or treatment. And providers often fail to take sexual histories or screen for STDs. The opioid crisis adds to the problem, as individuals trade sex for drugs, becoming infected.
When testing for chlamydia or gonorrhea, clinicians should ask patients if they have had anal-receptive intercourse. If so, a rectal culture should also be obtained, because genital testing alone will miss about 20% of STDs.
When treating gonorrhea, give a single injection of ceftriaxone, plus an oral dose of azithromycin, to prevent the development of resistance. For syphilis, screen any patient at elevated risk—including pregnant women—at the earliest opportunity, without waiting for symptoms.
What’s New in Cannabis Clinical Trials
There has been quite a lot of big news coming out involving cannabis as of late, with much of this news being in regard to clinical trials and government approvals.
All of these clinical trials are helping to further our knowledge of cannabis’s potential medical benefits and safety as a medication, and they are opening the way for more research to be done down the line as well. While many of these studies are still only in the beginning phases, others are already starting to show positive results.
Nebraska clinical trial shows promise
A two-year clinical trial on cannabidiol (CBD) oil in Nebraska has produced results showing that CBD can help treat the seizures caused by epilepsy.
The majority of the patients involved in the trial showed improvement with their epilepsy symptoms by taking CBD oil. All of the patients have a form of epilepsy that isn’t easily treated by normal methods, and so the results of this study show that CBD oil could potentially be a valuable treatment for more severe forms of epilepsy.
With that said, four of the patients did drop out of the trial because they began suffering from side effects such as sleepiness and lethargy. However, one of the researchers noted that the side effects could be improved by adjusting the dosage.
The medication that is being used for this clinical trial is Epidiolex, which is a solution containing CBD that was approved for medical use by the FDA back in June. This approval was specifically for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, which are both severe forms of epilepsy that are often resistant to normal epilepsy medication.
Cannabis as a treatment for essential tremor
A new clinical trial that will study cannabis’s safety and effects on essential tremor is slated to begin in early 2019 at University of California School of Medicine. This will be an innovative trial as cannabis has never before been studied for its effects on essential tremor. If it has positive results, then cannabis may serve as a safe alternative to the beta blockers and anticonvulsants that are used to treat essential tremor today.
The specific medication being tested in this study is an oral solution that contains CBD along with a low dose of tetrahydrocannabinol (THC), which is the primary psychoactive substance found in cannabis.
Tilray, a Canadian cannabis company, has received DEA approval to begin importing the marijuana that will be required for this clinical trial. This is a monumental decision by the DEA as this makes Tilray the first company to export legal marijuana to the US. Because of this news, Tilray’s stock has risen by 29% and has many predicting a bubble for the marijuana industry.
CBD for psychosis
A study being done in the United Kingdom has found that CBD oil may be effective in treating psychosis. This could prove to be an enormous discovery as a safe alternative to conventional antipsychotics has long been desired.
THC on its own is considered a risk factor for inducing psychosis. However, by its very nature, CBD counteracts the effects of THC and through this same mechanism, is able to help aid with psychosis.
According to the study’s findings, it only takes a single dose of CBD in order to decrease the amount of abnormal brain activity that causes the symptoms of psychosis, making it quick and easy to administer.
With the positive results from this study, the research team are now working towards starting a major clinical trial spanning multiple hospitals in order to research CBD’s effectiveness as an alternative to antipsychotics.
Cannabis to treat Huntington’s disease and multiple sclerosis
Some potentially good news for those who suffer from either Huntington’s disease or MS: MMJ International has filed two applications with the FDA to start clinical trials. These studies will test whether or not cannabis has an effect on Huntington’s disease and MS.
MMJ International also hopes to meet with the FDA soon to discuss the development of a new drug to treat these debilitating illnesses and to create a strategy for bringing this new medication to market faster.
Both Huntington’s disease and MS are neurodegenerative disorders that progress slowly and severely cripple those who suffer from them. Neither one currently has a known cure and there are few medications available to help treat them, making the outlook quite bleak.
In preliminary studies, CBD has shown to be neuroprotective, so the hope is that it may be able to help combat the degenerative effects of these disorders. If all goes well, then this could lead to a novel medication that will give some hope to those afflicted with Huntington’s disease and MS.
Medical office space gets tight
The swelling demand for healthcare services is undebatable. The age 65-and-older cohort will rise to just over 56
million by 2020, comprising 17% of the nation’s total population. This represents an annual growth rate of 3.5%,
which is approximately 14 times the rate of those aged 64 and younger.
As the senior age bracket grows, it will drive physician growth and subsequent need for medical office space.
Through 2019, expenditures on professional medical services is projected to grow 5.2% annually, compared to 4.3% historically. Those 65
and older will require more healthcare services, as this group visits doctors well above the rate of any other age group.
million by 2020, comprising 17% of the nation’s total population. This represents an annual growth rate of 3.5%,
which is approximately 14 times the rate of those aged 64 and younger.
As the senior age bracket grows, it will drive physician growth and subsequent need for medical office space.
Through 2019, expenditures on professional medical services is projected to grow 5.2% annually, compared to 4.3% historically. Those 65
and older will require more healthcare services, as this group visits doctors well above the rate of any other age group.
Given rising demand for healthcare services, current projections
estimate that just over 150,000 healthcare practitioners will be
added to the economy over the next two years.
The required space demanded by most practitioners ranges
from 1,000 square feet to 1,500 square feet, dependent on if they
are starting their own practice or adding additional practitioners
to their staff, per MedScape. Therefore, total demand for medical
office space across the U.S. could range from 150.5 million
square feet to 225.8 million square feet by 2019.
estimate that just over 150,000 healthcare practitioners will be
added to the economy over the next two years.
The required space demanded by most practitioners ranges
from 1,000 square feet to 1,500 square feet, dependent on if they
are starting their own practice or adding additional practitioners
to their staff, per MedScape. Therefore, total demand for medical
office space across the U.S. could range from 150.5 million
square feet to 225.8 million square feet by 2019.
There is an estimated 110 million square feet of available medical
office space in existing and under-construction buildings in the
U.S. as of the second quarter of 2018. If all healthcare practitioners
added to the economy through 2019 aim to locate within medical
office space, absorption of this demand is impossible.
More specifically, when drilling down to the top 10 most populous
metros and several other select markets, for most areas the
ability to handle this increased demand is unlikely – even at the
low end of the projected range – without a major shift in how
people expect and receive healthcare. New York, Dallas/Fort Worth,
Atlanta, Denver, and Miami/Fort Lauderdale would be the most
challenging for practitioners wishing to locate within medical
office space.
office space in existing and under-construction buildings in the
U.S. as of the second quarter of 2018. If all healthcare practitioners
added to the economy through 2019 aim to locate within medical
office space, absorption of this demand is impossible.
More specifically, when drilling down to the top 10 most populous
metros and several other select markets, for most areas the
ability to handle this increased demand is unlikely – even at the
low end of the projected range – without a major shift in how
people expect and receive healthcare. New York, Dallas/Fort Worth,
Atlanta, Denver, and Miami/Fort Lauderdale would be the most
challenging for practitioners wishing to locate within medical
office space.
However, medical practitioners could explore leasing space in
conventional office buildings, of which there is currently ample
space available, or accelerate the trend of repurposing empty
retail space for medical uses. In addition, the emergence of new
forms of healthcare, such as telemedicine, digital health, and
shared service centers, could suppress future demand to some
degree, depending on how quickly these new approaches are
adopted by the healthcare industry.
conventional office buildings, of which there is currently ample
space available, or accelerate the trend of repurposing empty
retail space for medical uses. In addition, the emergence of new
forms of healthcare, such as telemedicine, digital health, and
shared service centers, could suppress future demand to some
degree, depending on how quickly these new approaches are
adopted by the healthcare industry.
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