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Wednesday, July 4, 2018

Study reveals cannabis is not a miracle pain reliever


It’s safe to say most people think cannabis chills you out.
Now researchers have discovered that perception may be stronger than the drug itself.
In a large study of the effect cannabis has on pain in sufferers across Australia, the team from the National Drug and Alcohol Research Center (NDARC) uncovered some unexpected results.
While they found most people “perceived it to help,” in reality, it didn’t really change their level of pain.
Researchers think this might be simply because medicinal cannabis can help people sleep so their pain is more tolerable the next day.
The University of New South Wales study followed 1,500 people over four years to see how pain interfered with their everyday life and whether using medicinal cannabis would change their prescribed opioid use.
Worldwide interest in the area has been growing, particularly for chronic non-cancer pain.
There has also been increasing speculation that using cannabis for pain may allow people to reduce their prescription opioid use.
The results, published in Lancet Public Health on Tuesday, suggest that there is a need for caution given there were “no strong findings supporting a clear role for cannabis for these reasons.”
Participants who were using cannabis had greater pain and anxiety, were not coping as well with their pain, and reported that pain was interfering more in their life.
They found there was no clear evidence that cannabis reduced pain severity or pain interference or led participants to reduce their opioid use or dose.
NDARC director Professor Michael Farrell said medicinal cannabis had been a very hard sell and people needed to approach it with caution.
“People who otherwise wouldn’t have gone near cannabis have been experimenting with it,” he said.
“One of the things we think happens when people report benefits is the sleep and sedation effects it has.”
“Often when you get a good night’s sleep, your pain is a lot more tolerable.”
In what was one of the world’s longest in-depth community studies on pharmaceutical opioids and chronic non-cancer pain, participants were recruited through community pharmacies and completed comprehensive assessments of their pain, physical and mental health, medication and cannabis use annually.
They had been in pain for a median of 10 years and taken prescribed opioids for their pain for a median of four years, with “very high rates of physical and mental health problems.”
Lead author Dr. Gabrielle Campbell said chronic non-cancer pain was a complex problem.
“For most people, there is unlikely to be a single effective treatment,” she said.
“In our study of people living with chronic non-cancer pain who were prescribed pharmaceutical opioids, despite reporting perceived benefits from cannabis use, we found no strong evidence that cannabis use reduced participants’ pain or opioid use over time.”

Ampio publishes on anti-inflammatory mechanisms of med


Ampio Pharmaceuticals, Inc. (NYSE: AMPE) today announced a basic science manuscript entitled “The Anti-Inflammatory Effect of LMWF5A and N-Acetyl Kynurenine on Macrophages: Involvement of Aryl Hydrocarbon Receptor in Mechanism of Action” has been accepted for publication in Biochemistry and Biophysics Reports.
Dr. David Bar-Or, Ampio’s CSO explained, “This biochemical research uncovered an important part of the mechanism of action of Ampion™ or the low molecular weight fraction of 5% human serum albumin (LMWF5A). We had previously demonstrated that Ampion promotes the activation of anti-inflammatory macrophages while decreasing the activation of pro-inflammatory macrophages.
Here, we show that Ampion significantly decreases the release of pro-inflammatory biomarkers from LPS-stimulated macrophages and that one of the known components of Ampion (N-acetyl kynurenine or NAK) also decreased these biomarkers – albeit to a smaller extent. When an inhibitor of the aryl hydrocarbon receptor (AhR) was included, the anti-inflammatory effect of Ampion was partially blocked while the effect of NAK was completely prevented.
This is a significant finding since activation of the AhR suppresses inflammation by limiting the secretion of pro-inflammatory cytokines and promoting the overexpression of immuno-modulatory mediators. In the literature, it is well known that kynurenine is an agonist of AhR, but our study is the first to describe NAK as a potential AhR agonist. These findings suggest that Ampion and (through) one of its active components (NAK) promote the suppression of activated macrophages, partially via the AhR receptor. Therefore, Ampion, which contains NAK and other anti-inflammatory active moieties, is potentially a useful therapeutic in medical conditions where inflammation is prevalent such as trauma, osteoarthritis, sepsis, and wound healing.”
A link to the full manuscript will be made available when it is published online.
Regulatory Exclusivity and IP protection:The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a “reference product” upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.

Tesla Stops Critical Brake and Roll Test to Meet Production Goals


Tesla likes to cut corners. Following news it eliminated 300 welds, comes news it stopped a brake and roll test.
There are several Tesla stories today, none of them any good.
Brake and Roll
Elon Musk ordered Tesla engineers to stop doing a critical brake and roll test on Model 3s cars.
Tesla CEO Elon Musk ordered his employees to stop putting nearly finished Model 3s through a critical test before leaving the company’s factory in Fremont, California, according to an internal document viewed by Business Insider.
Ron Harbour, a consultant at Oliver Wyman who founded and writes “The Harbour Report,” a worldwide guide to manufacturing, told Business Insider that after everything is installed in a car during the manufacturing process, a manufacturer would have to be very lucky for everything on a car to be in alignment.
“If you just abandon [the test], you could potentially have a lot of quality issues with your customers,” he said. “Every plant does that … It’s part of finishing the build of the car.”
Harbour told Business Insider he was unaware of any test that could adequately replace the brake-and-roll test on a manufacturing line.
Reservations and Deliveries Decline
  • Goldman Sachs is not impressed with Tesla’s production announcement and reiterates its sell rating for the company’s shares, noting net Model 3 reservations declined to 420,000 from 455,000 last year.
  • Tesla said Monday it reached its one-week production goal of 5,000 Model 3 cars for the last week of the June quarter. But the company fell short on its second-quarter deliveries by posting 40,740 vehicles delivered versus the Wall Street consensus expectation of approximately 51,000.
Shouting Elon Musk Changes Rules on the Fly
A tense and short-tempered Chief Executive Elon Musk barked at engineers on the Fremont, California assembly line. Tesla pulled workers from other departments to keep pumping out the Model 3 electric sedans, disrupting production of the Model S and X lines. And weekend shifts were mandatory.
Leading up to Sunday morning’s production milestone, Musk paced the Model 3 line, snapping at his engineers when the around-the-clock production slowed or stopped due to problems with robots, one worker said. Tesla built a new line in just two weeks in a huge tent outside the main factory, an unprecedented move in an industry that takes years to plan out its assembly lines, and said the tented production area accounted for 20 percent of the Model 3s produced last week.
“They were borrowing people from our line all day to cover their (Model 3) breaks so the line would continue to move,” said a Model S worker on Sunday.
Because of the focus on the Model 3, the S line is about 800 cars behind, the worker said.
“They’ve been throwing Model 3s ahead of the S to get painted to try to assure that they make their goal of 5,000,” the worker said. “The paint department can’t handle the volume.”
“He (Musk) is gonna go through an awful lot of people because people are gonna start getting hurt left and right,” by the fast-moving assembly line, a worker said.
Crap Quality
For discussion of the 300 dropped welds, please see Model 3 Assembly Line: Detailed Images of Tesla’s “On the Fly” Manufacturing.
The quality of these rushed vehicles is guaranteed to be crap, just to make a self-imposed production number.

The Institutions Americans Trust Most And Least


In this era of “fake news”, trust is always being called into question, whether it’s the content in the president’s Twitter feed or the creepy notion that your Amazon Echo is listening in on your private conversations with sinister intentions. Even though “In God We Trust” is the official motto of the United States, distrust is rampant in 21st century America.
But, as Statista’a Niell McCarthy notes, when it comes to the nation’s institutions which are bedrocks of the country, however, trust levels are remaining consistent.
Gallup recently polled U.S. adults about their confidence levels in 15 different societal institutions, finding only three had a majority-level of trust.
Infographic: The Institutions Americans Trust Most And Least  | Statista
You will find more infographics at Statista
Average confidence across the institutions has still remained consistent over the past three decades and all of them garner at least some trust. In 2018, the military remains the most trusted institution with 74 percent of Americans having some or quite a lot of confidence in it.
It comes as little surprise that small business is widely trusted given its importance to the community and it comes second with 67 percent. Even though the police has attracted criticism due to heavy-handed arrests and a spate of controversial shootings, it is the only other institution with majority trust at 54 percent.
When it comes to the church and organized religion, trust levels stand at 38 percent while the presidency is close behind with 37 percent.
Television news and Congress come last with just 20 and 11 percent trust among the public respectively.

Missouri adds new Medicaid leverage for managed-care companies


Tension between managed-care contractors and Medicaid-reliant hospitals is boiling in Missouri, where the state is docking Medicaid payments for providers who don’t join one of the three managed-care networks.
Missouri’s move, which went into effect July 1, has sparked an outcry from hospitals, who frame it as the state tipping its hand in what are often fraught negotiations with payers. The new regulation imposes a 10% fee-for-service cut on any provider who doesn’t opt into the networks run by Centene, which does business in Missouri as Home State Health Plan, UnitedHealthcare and WellCare. Twelve of the state’s 160 hospitals have not yet joined at least one of three plans’ networks.
A spokesperson for the Missouri Health Plan Association, representing all three managed-care insurers, defended the new mandate as simply an incentive for the outlying hospitals to engage with Medicaid now that managed care is the direction the state wants to go. The spokesperson said Missouri’s managed care reimburses at no less than 100% of the Medicaid fee for service rate.
But hospitals say the state is handing over all leverage for how they get paid to these plans. The carriers didn’t fully absorb Medicaid coverage for the state’s designated managed-care market—made up of poor parents or guardians of young children, children and pregnant women—until May 2017. As of this year, they hold about $2.3 billion of the state’s $8.8 billion annual Medicaid spending, the association’s spokesperson said. For acute-care patients and the chronically ill, the state still pays providers directly through fee for service.
“By tipping the leverage toward the state’s MCOs, the change gives the plans unilateral rate-setting power,” Missouri Hospital Association CEO Herb Kuhn wrote in the group’s publication last month. “If a hospital doesn’t agree to accept whatever payment rate the Medicaid managed-care plan offers, the plan can simply refuse to sign a contract, locking in the fee-for-service level cut.”
Steven Edwards, president of the CoxHealth system of six hospitals in and around Springfield, said he thinks the scale is already tipping. He has been negotiating a contract over the past year with the last of the three managed-care plans, whose network he hasn’t yet joined, when suddenly last month the talks broke down.
This signals, to him, that the rule limiting him to 90% of fee-for-service Medicaid if he doesn’t enter the plan network is turning the tables. This affects his Medicaid-heavy rural hospitals since Missouri already has one of the lowest Medicaid reimbursements in the country.
“We’re negotiating a contract right now,” Edwards said. “You would think that there is no motivation for the payer to pay more than 90%, because it will fall back to that for us.”
Edwards and other practitioners and hospitals are gauging how the regulation might affect obstetrics especially, since pregnant women are one of the largest segments of managed care and Medicaid covers the births of just over 40% of the state’s babies. Medicaid deducts obstetric gynecologists by another 10 points, and typically hospitals subsidize them. Edwards projects that his system’s 800-bed flagship hospital in Springfield, which delivers about 4,000 babies per year, would see a $5 million hit. About 30% to 40% of the babies delivered in that hospital are on Medicaid, Edwards said.
Amid all the hospital outcry, the future of the regulation is uncertain as hospitals gear up to lobby the new governor. Republican Gov. Eric Greitens resigned last month and was replaced by GOP Lt. Gov. Mike Parson.
“Our hope is that when attention is drawn to this matter and he realizes he has inherited something from his predecessor with implications probably not well understood — we would like to convince him to pause and get the Legislature involved,” Edwards said.
The fallout comes amid another new Medicaid controversy triggered late last month when Parson signed a $2.7 million contract with the consulting firm McKinsey & Co. to complete a comprehensive analysis of Medicaid.
House Minority Leader Gail McCann Beatty, a Democrat, immediately flagged the award as potentially problematic because it was more than twice as much as all three competing bids combined. One of the rival contractors, Navigant, has already filed a complaint and asked for a rebid.
According to the Jefferson City News Tribune, McCann Beatty alerted Parson by letter to McKinsey’s “close ties” to a high-ranking Greitens hire, Drew Erdmann, the state’s first chief operating officer. She also criticized the bidding process, begun on Greitens’ watch, as “highly questionable.”
Kuhn is blasting the administration for pursuing the regulation before the analysis is done. In addition, he wrote, hospital leaders and the health department have already started discussions about managed care in the state.
“This process should be allowed to play out,” Kuhn said. “A half-baked solution could only compound the problems providers are experiencing currently.”
While the Medicaid transition into managed care has become the norm nationwide, plenty of states and rural states in particular have seen ongoing issues with the transition—particularly in places like Missouri that did not expand Medicaid and where the slim numbers translate into much tighter margins for managed-care plans.
Iowa under former GOP Gov. Terry Branstad moved to managed care so quickly, after underestimating the per-person cost, that the state last year sought hundreds of millions in federal dollars to essentially bail out its program and keep the plans in their contracts.
Faulty estimates for capitation have gone the other way too, particularly in expansion states. Rhode Island auditors in 2015, after the state expanded Medicaid under Obamacare, found the state had overpaid Neighborhood Health Plan and UnitedHealthcare more than $200 million and had to start clawing back the funds.

California law introduces new data concerns for healthcare organizations


California legislators are giving companies dealing in personal data—including some health information—yet another set of restrictions to contend with thanks to a new broad privacy law passed last week.
The California Consumer Privacy Act of 2018 gives consumers more control over the personal data that businesses collect. Companies have to tell people what data they’ve collected, what they’re using the data for, and which third parties they’ve given access to the data, among other requirements.
Although healthcare companies already comply with HIPAA, the new state law will create another layer of compliance when it goes into effect in a year and a half.
“It’s going to have a significant impact on the healthcare sector,” said Mark Brennan, a partner with Hogan Lovells. “From an operational perspective, it’s going to be interesting to see how companies work to sort out these requirements.”
For some organizations, like those that make consumer-facing wellness apps that collect personal information, the law will apply to all the personal data they collect.
For others, like those defined as covered entities under HIPAA, the law does not apply to protected health information regulated by HIPAA’s privacy, security and breach notification rules.
But it does apply to other information held by an organization that does business in California.
For instance, if a consumer requests that an organization delete their personal information other than protected health information, the organization has to take the request into consideration.
“Healthcare provider organizations need to start thinking about what data they have and whether or not it is covered by HIPAA and what data they might be getting from other sources they may not be covered by HIPAA,” said Dominique Shelton, co-chair of Perkins Coie’s ad tech privacy and data management group.
Healthcare organizations must also be careful when investing in outside companies that develop and market consumer-facing health or wellness mobile apps and solutions or when launching their own internal ventures that do the same.
“The privacy, and security administrative and technological infrastructure for complying with the newly-established rights of the consumer under this new and far-reaching law will be a key feasibility consideration,” said Bernadette Broccolo, a partner with the law firm McDermott Will & Emery.
Businesses that work with covered entities will also need to pay close attention to the type of data they’re collecting.
“Groups that may buy and sell data from EHRs—this may have a significant effect on their business,” Brennan said. “There’s the possibility that this law could put U.S. companies at a disadvantage in global competition,” he said. “It’s going to be difficult for California courts to enforce this law against non-U.S. companies.”
But many of those companies, and some U.S. companies too, are already paying attention to similar requirements by the European Union’s General Data Protection Regulation policies.
“The good news is everyone’s been thinking along these same terms for GDPR,” said David Ross, principal and cybersecurity growth leader for the risk, internal audit and cybersecurity practice at Baker Tilly. “Everything you’ve done for GDPR pretty much ports over, since it shares a tremendous amount in common from a conceptual level with GDPR.”
So, much as healthcare organizations needed to prepare for those regulations, which went into effect on May 25, they’ll need to figure out which patients’ data this law applies to, Shelton said. “Everybody’s going to need to update their privacy policies when this goes into effect,” she said.
Some expect the California law, like GDPR, to start a domino effect, with other states soon following suit, Ross said. “California’s always been kind of a trendsetter.”

Tennessee seeks to update strategy for hospital uncompensated care


Tennessee plans to seek federal permission to change how it doles out uncompensated-care funds to hospitals.
The state is collecting comments on a proposed state plan amendment to update how Medicaid distributes disproportionate-share hospital, or DSH, funds, which cover unpaid bills at hospitals with high amounts of Medicaid patients. Tennessee receives $53 million in Medicaid DSH funds annually.
Currently, each eligible hospital receives a set amount of DSH money. If they have been overpaid, the state recovers the excess DSH funds and redistributes them to other hospitals within the same DSH funding group. These categories include essential service safety net hospitals, children’s safety net hospitals, and free-standing psychiatric hospitals. The state plan amendment will allow recovered funds to be redistributed to any DSH-eligible hospital.
Tennessee is looking to make the change as its hospitals face mounting financial pressure, largely due to the state’s decision not to expand Medicaid. Eight hospitals in the state closed between January 2010 and January 2018, according to a database created by the North Carolina Rural Health Research Program.
Only Texas has had more hospitals close during that eight-year period, according to the database.
Patient revenue hasn’t covered total hospital expenses in the state since 2010, according to the Tennessee Hospital Association, which tracks the finances of acute-care hospitals. By 2014, expenses were $240 million more than patient revenue, according to the association’s most recent figures.
The trade group supports the proposed change and plans to work with the state to implement it, according to Yolanda James, an association spokeswoman.
Erlanger Health System, a Chattanooga, Tenn.-based system with seven hospitals, also praised the move as it gives the state more flexibility in handling the distribution of funds, according to Stephen Johnson, vice president of governmental and payer relations at Erlanger.