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Wednesday, June 6, 2018

CVS announces management team after CVS-Aetna deal


CVS Health Corp. CVS, +2.76% announced early Wednesday the management team that will serve once its acquisition of health insurer Aetna Inc. AET, +1.91%closes. Aetna Chief Financial Officer Shawn Guertin will serve as CVS Health’s executive vice president and chief financial officer, with CVS Health current CFO David Denton planning to leave the company at the deal’s close. Rick Jelinek, Aetna’s executive vice president, head of enterprise strategy, will serve as CVS Health’s executive vice president. Karen Lynch, who is currently Aetna’s president, will also be CVS Health’s executive vice president. Several Aetna executives will also continue on in their roles, with Aetna serving as a standalone business unit within CVS Health. Other executives who plan to leave once the deal is finalized include Aetna executives Steven Kelmar, Thomas Sabatino and Thomas Weidenkopf; Aetna Chief Medical Officer Harold Paz and EVP Meg McCarthy will remain for some time to help with the transition. Until the deal closes, the two companies will continue to operate separately. Many CVS executives will also continue on with the company, including CVS Health Chief Operating Officer Jon Roberts, EVP and General Counsel Thomas Moriarty, CMO Troyen Brennan, EVP and Chief Human Resources Officer Lisa Bisaccia and Alan Lotvin, who will serve as executive vice president of transformation. CVS shares rose 0.6% in premarket trade. Shares have dropped 6.4% over the last three months, compared with a 0.8% rise in the S&P 500 SPX, +0.86% and a 0.3% decline in the Dow Jones Industrial Average DJIA, +1.40%

Amazon and Uber Could Teach Medicine About Electronic Health Records


The software and medical communities should look for models outside of healthcare as they work to make electronic recordkeeping more meaningful for patients and less frustrating for physicians, said panelists at a Stanford University School of Medicine symposium held Monday.
New research conducted by The Harris Poll for the university suggests that a clear majority of primary care physicians (59%) support a complete overhaul of electronic health records (EHRs), Stanford said in a press release. The poll also indicates that 40% of doctors find more challenges than benefits with EHRs, and 71% think they greatly contribute to physician burnout, while only 18% of those polled reported being “very satisfied” with their current EHR systems.
Physicians often doubt that the time spent on EHRs will improve the health of their patients, with these systems sometimes demanding seemingly irrelevant data, panelists at the Monday symposium said. Panelist Taylor Davis, vice president of analysis and strategy at research firm KLAS, contrasted the different attitudes about computers seen in medicine and aviation. Working with regulators, the airline industry has developed systems over decades that allow pilots to rely heavily on the instruments in their cockpits.
“If I were getting on a plane and I heard a pilot say ‘Stupid computer system. It’s not my job to know how to use this computer system,’ I’d turn around and walk back out off the plane,” Davis said, stressing the need to build similar confidence in computers used in healthcare. “The challenge is that today there are clinically stupid things in EHRs that are hurting the trust that clinicians have.”
Taylor has conducted over 3000 interviews with healthcare professionals over the 11 years he has been with KLAS, according to the biography listed for him for the Stanford symposium. He cited an example from his recent work to explain why healthcare professionals have ample reason to doubt the value of their recordkeeping tasks.
“I read a comment from a physician who said ‘I can’t trust this EHR because it’s still asking me to input whether infants are chewing tobacco,’ Davis said.
The research presented by Stanford does indicate that physicians see some value in EHRs. In this online poll of more than 500 primary care physicians, 63% indicated that EHRs have generally improved patient care, Stanford said. And 66% were at least somewhat satisfied with their current systems.
But primary care physicians also reported spending a “disproportionate amount” of time per visit interacting with EHRs, with many saying that recordkeeping competes with their patients for already limited time and attention, according to Stanford. On average, the physicians polled reported that interacting with EHRs consumed about 8 minutes of a 20-minute, in-person patient visit, with another 11 minutes of EHR interaction following once the patient visit had concluded.
And 49% of those polled reported through the poll that using an EHR detracts from their clinical effectiveness, Stanford said.
“If pilots didn’t trust autopilot, they wouldn’t turn it on,” Davis said. “Physicians often don’t trust their EHRs, so they don’t use it the same way. So we’ve got to get to a place where physicians trust their EHRs the way that pilots trust autopilot.”

Fighting “Information Chaos”

Christine A. Sinsky, MD, vice president of professional satisfaction for the American Medical Association, picked up on Davis’ suggestion. She urged more thoughtful choices about the data recorded and transmitted through EHRs.
In aviation, engineers and planners weed out information that’s judged to be only incrementally beneficial in deference to the cognitive workload of pilots, she said. There needs to be the same mandate for a “manageable cockpit” to combat the “information chaos and information overload” in medicine, Sinsky said.
“What we need to do is model after the airline industry where a group of engineers studiously determines whether or not a new light, a new warning, a new buzzer is warranted within that cockpit,” she said. “As we start to recognize the importance of the cognitive workflow cost and we recognize the importance of the manageable cockpit, we will design, implement and regulate differently.”
Sinky said she’s worked with two of the most widely used EHRs as a practicing physician, using one for a dozen years and the other for the past 4 years.
“It’s gotten harder and harder over that period of 16 years, not because the EHRs have changed, but because of the expectations of use, the expectations that every act must go through the EHR, that we translate the clinical experience into digital data for the convenience of others, and not for advancing clinical care,” she said. “Those pressures have increased.”
EHRs still heavily reflect the demands of medical billing more than medical practice, said panelist Amy Abernethy, who serves as chief medical officer, chief scientific officer, and senior vice president of oncology, at Flatiron, a technology company focused on cancer research. She argued for a need to envision a different model that’s centered around healthcare professionals and patients.
“We are seeing a world where software has been built to the specs at hand,” she said. “If you look across the United States, the predominate decision making about which EHR to purchase was made more at the CFO level.”

Looking to Uber and Amazon

Several of the panelists spoke about how the rapid changes in consumers’ retail experiences, due to data sharing among companies and contractors, will boost their expectations for what’s possible in EHRs.
“Our experiences in healthcare are going to be colored by our experiences in purchasing retail on Amazon, or taking a ride with Uber,” said panelist Judy Murphy, RN, the chief nursing officer at IBM Global Healthcare and a former top federal health information technology official.
“People are starting to say already ‘I don’t understand why you don’t have my allergies. I don’t understand why you don’t know about that thing I had taken care of across the street’ ” when getting medical care, Murphy said.
Consumers have grown used to being able to quickly compare prices and shop online. Murphy said this attitude may soon carry into their approach to elective procedures.
“We’re not going to walk into a hospital not knowing how long we’re going to be there, how much it’s going to cost, who’s going to touch us, when we’re going to get a chance to leave,” she said. “In what other aspects of our lives do we do that kind of stuff? Nowhere.”
In many fields, increased use of computers has led to automation of more mundane tasks, while the opposite has proven true with EHRs, said panelist Don Rucker, MD, MS, MBA, who leads the Office of the National Coordinator for Health IT (ONC) under the US Department of Health and Human Services.
“What other industries use computers to make more work for (themselves)?” Rucker said. “Medicine is the one holdout in a funny kind of way.”
As the nation’s top health information technology official, Rucker is overseeing efforts to bring to medicine the same kind of innovations that other fields have experienced due to an easier flow of digital information. The success of businesses like Amazon and Uber rests on rapid exchange of orders among interested parties, such as the companies selling their products through the online retail giant and drivers signaling that they will accept a fare.
“There’s ground for optimism” about EHRs, Rucker said. The 21rst Century Cures Act includes several mandates related to EHRs. The law mandates that ONC encourage use of open application programming interfaces. The 21st Century Cures Act also requires ONC to lead a public-private initiative to create a trusted exchange network and a common agreement that will include rules for trusted exchange.
These are part of the groundwork for a major shift that Rucker expects in EHRs.
“We think all of those things are going to create an ecosystem that is going to absolutely transform what we have had…[which is] a very, very narrow vision of up until now,” he said.

Icahn buys small stake in drugmaker Allergan


Billionaire investor Carl Icahn has acquired a small stake in Allergan Plc (AGN.N) at a time when the drugmaker is under pressure from other activist shareholders, people familiar with the matter said on Wednesday.
Icahn’s intentions are not clear, though he has been a longtime supporter of Allergan Chief Executive Brent Saunders, pushing for him in 2013 to become CEO of Forest Laboratories, which through mergers and acquisitions became Allergan.
Icahn, who had invested in Allergan in the past, believes the company’s stock is undervalued, the sources said, asking not to be identified because the matter is confidential.
Icahn did not respond to a request for comment.
“We welcome all investments in the company,” Allergan spokeswoman Amy Rose said.
Bloomberg News first reported on Icahn’s new position in Allergan.
Earlier this week, investment firms Appaloosa LP and Senator Investment Group LP wrote a letter to Allergan’s board of directors urging it not to pursue transformative acquisitions but instead shake up its board, including separating the roles of CEO and chairman, which are both held by Saunders.
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The letter came shortly after Allergan said it had concluded a strategic review it launched earlier this year.
As a result of the review, Allergan is exploring divesting its women’s health and infectious disease businesses, opting to focus on areas where it has strong leadership positions.
It also said it would pursue a more disciplined capital allocation strategy.
Icahn last showed his support for Saunders in 2016, when he unveiled a stake in Allergan after its planned $150 billion sale to Pfizer Inc (PFE.N) was shot down by changes the U.S. government implemented to the rules on corporate tax inversions.
In 2016, Allergan sold its generic drug business to Teva Pharmaceuticals Inc for about $40 billion. In April, Allergan said it was considering an offer for rare disease drug maker Shire Plc (SHP.L), only to reverse course after Allergan shares plummeted on the news.
It has spent much of the money on stock buybacks, debt reduction and a series of small-to-midsized acquisitions, including medical technology company ZELTIQ Aesthetics Inc and drugmaker Tobira Therapeutics.

Immunomedics started at buy by B. Riley


Immunomedics initiated with a Buy at B. Riley FBR. B. Riley FBR analyst Madhu Kumar started Immunomedics with a Buy rating and $53 price target and added the shares to his firm’s Alpha Generator list. The company has the makings of a blockbuster cancer drug, Kumar tells investors in a research note.

Eisai, Purdue reveal eye-opening data for sleep drug lemborexant


Eisai and Purdue Pharma have presented new clinical trial results of their dual orexin receptor antagonist lemborexant, which they think could become a new force in the sleep disorder market.
The SUNRISE 1 trial—which reported top-line data in March—plus two new phase 1 studies were presented at the SLEEP 2018 conference in Baltimore yesterday and, say the partners, reinforce their view that lemborexant can help improve sleep with no hangover effect on waking and no grogginess if patients have to get up in the night.
The phase 3 trial included a head-to-head assessment of lemborexant and an extended-release form of widely used sleep drug zolpidem, which is available generically, and found that Eisai and Purdue’s drug was more effective at keeping patients over the age of 55 asleep throughout the night, avoiding early awakening. The two new phase 1 trials looked at other variables that are important to getting a good night’s sleep.

Study 108 compared the effects of lemborexant, zolpidem and placebo given at bedtime on postural instability after patients were awoken in the night by exposure to noise. The main measure was body sway, and while lemborexant-treated patients overall weren’t as steady on their feet as those on placebo, they did significantly better than those on zolpidem.
With the widely used insomnia drug, body sway occurred at almost three times the level that would be seen if the subject had drunk enough alcohol to put them close to the legal driving limit. A lower dose of lemborexant (5 mg) caused no clinically meaningful increase in body sway, while a higher (10 mg) dose increased it “to just above the clinically meaningful threshold.”
The study also checked on the effects of the drugs the following morning and found no difference between Eisai and Purdue’s drug and placebo on postural instability, which Eisai Chief Medical Officer Lynn Kramer, M.D., notes is “the single best predictor of falls” in older people.
There was no significant difference between placebo and both study drugs in the noise threshold needed to wake subjects up, but those on lemborexant found it easier to fall asleep again thereafter.
The second trial, Study 106, investigated the tendency of lemborexant and another widely used generic sleep drug called zopiclone to impair driving ability in the morning after a bedtime dose. It tested the amount of weaving—or standard deviation of lateral position in scientific parlance—and found that lemborexant had no significant effect on performance, while zopiclone significantly increased SDLP compared to placebo.
No test drives were stopped on safety grounds before completion in the lemborexant group, while three in the zopiclone group were halted, although overall that accounted for less than 1% of all drives tested.
Eisai said earlier this year it intends to file for approval of lemborexant for insomnia later this year once the results of a second, confirmatory phase 3 trial come in.
It’s also got a phase 2 in play for lemborexant in patients with irregular sleep-wake rhythm disorder, and in mild to moderate Alzheimer’s dementia, which is already underway.

Psychosis Tends to Follow Cannabis Use, Not Vice Versa


Cannabis use preceded onset of psychosis symptoms in teens more often than the reverse, according to researchers analyzing data from a longitudinal study conducted in Quebec.
A total of 3,966 adolescents volunteered to participate annually in an online survey in which they reported their cannabis use in the past year (on a 6-point scale ranging from “never” to “every day”) and any psychosis symptoms they experienced as per the Adolescent Psychotic-Like Symptoms Screener.
With the survey data, a statistical model was created showing the relationship between marijuana use and psychosis symptoms over ages 13-16 (χ2=48.22). Once the model incorporated time-lagged associations between earlier cannabis use and psychosis symptom onset 12 months later, the model acquired a better fit (χ2=26.07, P=0.001), according to Patricia Conrod, PhD, of the University of Montreal, CHU Sainte-Justine Research Center, and colleagues, reporting online in a research letter in JAMA Psychiatry.
“This analysis demonstrates a predominant association at the individual level of cannabis use frequency with increased psychosis symptoms, and not the opposite, in the general population at a developmental stage when both phenomena have their onset.
“[T]hese results emphasize the need for targeted cannabis use prevention as jurisdictions revise their cannabis regulatory policies,” the researchers suggested. Canada is on the verge of legalizing marijuana nationwide, possibly as soon as this week.
“Promoting evidence-based interventions and policies that reduce access to and demand for cannabis among youth could lead to population-based reductions in risk for major psychiatric conditions,” Conrod and colleagues wrote.
The investigators used data from teenagers in the Co-Venture cohort, representing 76% of all grade 7 students at 31 secondary schools in the Montreal area. Data from 3,720 were included in the analysis. The researchers acknowledged that the study’s reliance on unverified, self-reported cannabis use and psychosis symptoms were an important limitation.
Conrod and co-authors reported having no conflicts of interest.

Medicare’s Future: Bad but Not Totally Bleak


Economists agreed that the latest report on the Medicare trust fund — predicting that the hospital insurance trust fund will be depleted by 2026 — was largely without surprises.
“The message … has always been the same, which is, at some point, the program is going to face huge financial challenges unless policy makers take action, and unless the health sector finds ways to deliver appropriate care more efficiently to patients,” said Joseph Antos, PhD, a resident scholar in healthcare and retirement policy at the American Enterprise Institute (AEI).
At an AEI briefing Wednesday, Antos, along with Robert Moffit, PhD, a senior fellow at the Heritage Foundation, did highlight several shortcomings of the 2018 Medicare Trustees report such as the lack of independent expert involvement.
This year’s report was signed only by Trump administration officials, noted Moffit. Such reports should be reviewed by independent experts to “instill confidence” in findings, he pointed out.
“The current situation is simply not good public policy,” Moffit stated.
The report, released Tuesday, forecasts for both the Hospital Insurance and Supplementary Medical Insurance trust funds. The 2026 depletion forecast is 3 years earlier than trustees reported in a 2017 analysis.
Paul Spitalnic, chief actuary for the Centers for Medicare and Medicaid Services, said what’s behind the trustees report is “predominately a revenue story.”
Because payroll taxes were significantly lower than anticipated in the 2017 report, there’s been less income feeding into the hospital insurance trust fund, which is one reason the depletion date of the fund has been bumped up. In addition, since certain taxes on Social Security benefits also funnel into the trust fund, and the 2017 tax billlowered individual tax rates, which had the effect of narrowing the revenue stream, Spitalnic said.
While projections have not “materially changed” over the last 5 years — a 2013 Trustees Report also suggested a 2026 depletion — Spitalnic noted differences between the total projected expenditures for Medicare Part D between 2013 and 2018, which he attributed to a slowdown in hepatitis C virus treatment expenses, and greater reliance on generic drugs.
Antos said the trustees’ supplementary “illustrative” analysis was “somewhat more realistic” than the main findings.
The illustrative example shows that long range costs in the program may be higher if certain cost reduction measures under current law don’t work as intended, Spitalnic explained.
Under the report’s main analysis, Medicare’s current share of gross domestic product (GDP) is expected to grow from 3.7% in 2017, to 6.2% under current law in 2090, and even higher to 8.9% in 2090, under the “illustrative” scenario.
While the main analysis assumes no changes in current law, the illustrative analysis zeroes in on two current policies that could “problematic,” Antos explained, and one of these is the Medicare Access and CHIP Reauthorization Act (MACRA).
MACRA repealed sustainable growth rate formula (SGR), but MACRA itself isn’t a “bed of financial roses” for physicians either, he said.
Under MACRA, payment updates are typically less than 1% a year, whether physicians are in Alternative Payment Models, or the default Merit-based Incentive Payment System.
“It’s unreasonable to think that general inflation will be as low as 1% a year in the future,” he said, adding that it’s accepted that healthcare inflation is expected to rise faster than general inflation.
In other words, basing any forecast on those updates remaining unchanged seems unwise, he stressed. And it’s unlikely that Congress will maintain the current system of updates, he noted.
“They’ll change it…. They’ll buckle under the obvious and probably reasonable pressure coming from the physician community [who will argue] that they really can’t live with such modest increases given their likely cost of operation rising much more quickly,” Antos stated.
Another problem area is the productivity adjustments established under the Affordable Care Act (ACA).
While finding ways for the healthcare sector to become more productive sounds good in theory, using a formula that links payment to productivity improvements in the general economy is flawed, Antos said.
“Economy-wide productivity generally has been measured to grow… much faster than health … sector productivity,” he stated. “Yet payments are going to be reduced because of that factor.”
In 2018, economy-wide productivity is estimated to increase around 1.1% per year over the long-term, while hospital productivity has increased by about 0.4 % a year in recent years, and is expected to have “essentially zero” growth over the long term, he explained.
The core issue is one of feasibility, Antos said. Can the health sector find ways to meet the required productivity adjustments? And if it does “will we be able to detect it?,” he stated, expressing skepticism on both fronts.
Moffit cautioned against taking the report out of its proper context. The media and politicians are likely to claim “Medicare trust fund is going bankrupt,” he said. “The [hospital insurance] trust fund hasn’t gone bankrupt in the last half-century, and I can’t imagine that it will go bankrupt in the next half-century.”
“Medicare has serious financial challenges,” Moffit acknowledged. “It’s better to address them sooner, rather than later, and Congress is going to have to come to grips with this.”
Historically, the two main ways of addressing these issues has been to raise payroll taxes or to reduce hospital payments, he noted, but payment reductions are already scheduled under the ACA, so any more cuts seem unlikely.
Moffit said he wants to see Medicare Parts A and B combined, a catastrophic benefit added, the age of eligibility raised, and a requirement that wealthier enrollees pay more for their benefits.
He said he also supports taking the defined contribution approach of Medicare Advantage and expanding it to the entire program.
“The Medicare trustees have done their job,” he stressed. “It’s time for Congress and the White House to do their job.”
But, he added, “I’ll make an iron-clad prediction that, in 2018, nothing will happen.”