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Thursday, June 7, 2018

Trump OMB Appointee Blasts Obama-Era Value Programs


The Obama-era strategy to move the healthcare system from volume to value is too complicated and isn’t working well, a Trump administration health official said here Wednesday.
The volume-to-value push has resulted in “a big sprawling complicated series of byzantine programs that few people understand” and it “sucks more value out of the system than it delivers,” Joseph Grogan, associate director for health programs for the Office of Management and Budget (OMB), said at the start of a three-day conference on accountable care organizations (ACOs), bundled payments and MACRA. The OMB oversees $3 trillion in healthcare spending.
Grogan took specific aim at the Center for Medicare & Medicaid Innovation (CMMI), a division of the Centers for Medicare & Medicaid Services (CMS) created by the Affordable Care Act. He said his office recently sent a rescission package that includes an $800 million cut from what Congress has appropriated to CMMI, “because so far, CMMI has failed to deliver.”
Take, for example, CMMI’s experiment with ACOs — groups of doctors and hospitals working together to deliver high-quality, low-cost care to a defined group of patients. When the Congressional Budget Office scored ACOs in 2011, it estimated that the ACO model called the Medicare Shared Savings Program “would save $4.9 billion over 10 years,” Grogan said. But so far, programs using that model have cost over $384 million, according to CMS actuaries.
“There were a lot of broken promises and failed estimates in the ACA. But the hope and promise of these complicated value designs is certainly one of them,” he added.
In effect, these designs are trying to get doctors and hospitals to act more like insurance companies, absorbing any losses if their enrollees and beneficiaries end up using too many expensive services, Grogan said. But the complexity of these program designs has become overwhelming.
The Trump administration, he said, is trying to reduce reporting requirements, use broader claims data, begin to move toward passive data collection efforts, “and see if we can get people to spend less time treating codes and entering on an iPad, and concentrate more on the patient.”
One problem is the way defenders of these models have tried to justify them, saying the metrics used are unfair, and if different data were used, the picture would be different, Grogan said. “If we’re constantly using counterfactuals to evaluate (the programs) and waiting for another study to bear out … They’ll never be termed as failures.”
Under the current system, he said, it takes 18 months for a new model to get off the ground at CMMI because it must work through at least six different government offices. “Is that because we can’t find simple examples of waste to be wrung out of the system, with $1.3 trillion in healthcare spending, there’s no low-hanging fruit?”
Solutions are on their way under CMMI’s new director, former Landmark Health CEO Adam Boehler, appointed in May by HHS secretary Alex Azar, Grogan said. “He understands the need for simple high-impact models that can be stood up quickly and deliver value to taxpayers,” or be shut down fast if they don’t work.
One example of Azar’s efforts to improve the system is drug pricing proposals designed to reduce costs, which “may be the most promising area for value to be captured from the system,” Grogan said.

MiMedx Audit Results In Restatement Of 5 Years Of Financials


MiMedx Group Inc MDXG 23.39% plunged nearly 21 percent Thursday after announcing:
  • The departure of its CFO;
  • The board-directed requirement to restate financial results related to sales recognition for the 2012 through 2016 fiscal years and interim periods of 2017; and
  • The related withdrawal of all guidance for 2018.
The financial disclosure more than offset concurrent news of international progress demonstrating “meaningful operational progress which will result in expanded revenue contribution” over the next few years.
“The company’s underlying business remains strong,” a press release said.

Why It’s Important

MiMedx intimated investors may have been acting on inaccurate revenue figures through the last two quarters.
Additionally, it suggested the metric may be further adjusted throughout an ongoing audit committee investigation that’s evaluating sales, distribution practices and customers, which could expand the scope of restated financial items.

What’s Next

The company said it will not release additional updates until the investigation is closed, and it did not provide a timeframe for the filing of restated statements.
“It is diligently pursuing completion of the restatement and intends to make such filings as soon as reasonably practicable,” MiMedx’s release said.

Bayer CEO Predicts ‘Great Value And Growth’ After Monsanto Acquisition


Germany drugmaker Bayer’s acquisition of Monsanto closed this week after a challenging two-year-long review process. Despite creating the world’s largest seed and agricultural chemicals maker, the “highly competitive environment” will remain unchanged, Bayer CEO Werner Baumann told CNBC on Thursday.

What Happened

One of the biggest challenges facing the combined entity is satisfying its “very smart” customer base, Baumann said. Customers have multiple choices, including Syngenta, Corteva Agriscience or the “substantially strengthened” BASF, to which Bayer sold some of its agricultural assets as part of the merger.

Why It’s Important

Bayer’s Monsanto acquisition could give it an advantage over rivals, as it could innovate using 2.4 billion euros, or $2.84 billion, in R&D funding annually, Baumann said. The company expects to invest in seeds, biological and digital initiatives to generate “better yield, better quality and, frankly, a better environmental footprint.”

What’s Next

The “first, second and third priority” for Bayer is to integrate Monsanto’s business into its own, Baumann said. Liam Condon, the president of Bayer’s crop science division, has been tasked with leading a combined executive team that will feature a “balance” of executives from both legacy businesses.
While Bayer’s European-listed stock is trading at a discount to its peers, Baumann expressed confidence that the investment community will develop greater confidence in the company, as any merger-related uncertainty has “gone away,” he said.
“I’m absolutely certain our shareholder base [and] new shareholders who come in to the stock see the great value and growth that the company is going to provide going forward.”

Lilly CEO Calls For Uniform Prices, Better Use Of Technology In Health Care


The American health care system is an unsustainable, half-century-old design that engages in price discrimination and has failed to employ technology to its potential to lower costs and expand access, Eli Lilly And Co LLY 0.06% CEO David Ricks told the Detroit Economic Club Thursday.
The pharma exec’s proposed solution is threefold: the health care system must be digitized to “unleash the power of data,” consumers need to be empowered to manage costs and the payment system for health care products and services should be based on the value they produce.
Ricks, 49, who has served as Eli Lilly’s CEO since 2017 and worked there for 20 years, offered a stark projection to illustrate the need for reform.
“Thirty years from now, one disease — Alzheimer’s — will generate more spending in Medicare and Medicaid than the entire military budget.”

A Call For Uniform Drug Pricing

Insulin, Eli Lilly’s No. 1 product, shows the wide gap between the amount paid by government-sponsored insurance with “artificially depressed” prices and the amount paid by individuals, Ricks said.
Medicaid pays 10 cents per vial, the lowest price for insulin in the world, he said: “I can assure you that’s far below our cost to produce it.”
Cash patients pay $300 per vial and are barred from receiving rebates, Ricks said.
“Their payments are actually subsidizing the Medicaid system.”
On June 1, the FDA approved Olumiant, Eli Lilly’s rheumatoid arthritis drug with partner Incyte Corporation INCY 0.69%.
Olumiant is being launched at a 60-percent discount to competitors, Ricks said Thursday.
“This is a kind of experiment to test out a low-price, low-rebate, less cost-shifting type of model.”
At many hospitals, the average markup for drugs is 250 percent, and medicine is used to generate profit, Ricks said.
Ricks spoke optimistically of the health care initiative formed by JPMorgan Chase & Co. JPM 0.4% CEO Jamie Dimon, Amazon.com, Inc. AMZN 0.38% CEO Jeff Bezos and Berkshire Hathaway Inc. (NYSE: BRK-A) (NYSE: BRK-B) CEO Warren Buffett.
“If these three companies can use their scale and technology to create real change and move to value-based payments, it could help move the [health care] system forward.”

Targeting Costs, Outcomes With Technology

Advancements in digital technology such as telehealth services, remote monitoring and artificial intelligence present opportunities for cost savings and better outcomes in health care, Ricks said.
The CEO described the proposed shift from a largely destination, or inpatient, health care system to a delivery model as an “Amazon-like” solution to cost control.
“More than a decade after we have iPhones and Skype … there’s still spotty reimbursement and scant use of something like telehealth.”
The Australian health care system provided remote coordination services to Type 2 diabetes patients, Ricks said.
Patients recorded a corresponding 1-percentage point drop in blood glucose levels — “that’s a large enough effective size to get a new drug approved by the FDA,” Ricks said — and saw their costs fall by $900 annually.

Mergers, Opioids, The ACA And ‘Right To Try’

Ricks offered his take Thursday on other topics at the forefront of health care policy discussions.
The opioid crisis
The number of Americans dying from opioid overdoses daily is equivalent to an airplane crash, Ricks said.
“Believe me, if we were crashing an airplane everyday, we’d be doing something radically different about it.”
The most important thing the industry can do is to invent non-addictive pain medication, he said. Eli Lilly has several late-stage non-opioid candidates, he said, including one it plans to submit to the FDA in late 2019 or early 2020 for osteoarthritis and chronic back pain indications.
The Right To Try Act
Eli Lilly has supplied medication “for years” to the patient population affected by The Right To Try Act signed May 30 by President Donald Trump and participated in the FDA’s expanded access program for experimental drugs, Ricks said.
Right-to-try could simplify the paperwork for doctors, the FDA and drug companies “a little bit,” Ricks said. “We’re sympathetic to the population. This is one more avenue to address what has been a longstanding request. We’ve been very forward leaning and accommodating of those requests.”
M&A
When asked about mergers such as CIGNA Corporation CI 1.25%‘s proposed purchase of Express Scripts Holding Co ESRX 2.12% and the CVS Health Corp CVS 0.09%Aetna Inc AET 0.41% tie-up, Ricks said the deals could help break down silos in health care and apply technological benefits to medical services.
The Affordable Care Act
The drug industry was supportive of the ACA when it was introduced because it promised to expand access to care, Ricks said. “What we’ve learned is that access does not equal affordability,” he said, adding that ACA rules that drove up costs resulted in states and insurance companies shifting costs to individuals.
The question now is whether to pursue a consolidated nationwide system or a localized one with more customization, Ricks said.
“We strongly favor choice in this debate. That’s not uniformly true, but that’s our company’s position.”

LivaNova started at buy by Stifel

LivaNova initiated with a Buy at Stifel. Stifel analyst Rick Wise initiated LivaNova with a Buy rating and $115 price target. Wise said he believes LivaNova’s valuation multiples will likely increase, as the company “continues making consistent and steady progress across key commercial, regulatory and pipeline initiatives.”

Genomic Health gains on test for breast cancer chemo benefit


Shares in Genomic Health gained by about one-third in pre-market trading following the publication of a study showing a genetic test made by the company could be used to predict which women with early stage breast cancer would benefit from chemotherapy. The study, based on a trial of more than 10,000 patients, showed chemotherapy did not improve their survival prospects in about 70 per cent of cases and could mean hundreds of thousands of women diagnosed with the disease could be spared the gruelling post-surgery treatment. Genomic Health makes the genetic test, called Oncotype DX. Shares in the Californian diagnostics company were up 33.5 per cent in pre-market trading on the Nasdaq. Among companies that are major players in the oncology drugs market, shares in Novartis were up 0.7 per cent in pre-market trade, Celgene was up 1 per cent, Johnson & Johnson was up 0.3 per cent. Bristol-Myers Squibb was down 0.9 per cent.

Philip Morris plans to target Indian smokers with iQOS device


Philip Morris International Inc (PM.N) is planning to launch its iQOS smoking device in India, four sources familiar with the matter told Reuters, as the tobacco giant seeks a foothold in a country with the world’s second-biggest smoker population.
Philip Morris says the sleek, penlike iQOS heats but does not burn tobacco, producing a nicotine-containing vapor rather than smoke and making it less harmful than conventional cigarettes. The company says it wants to one day stop selling cigarettes altogether.
India has stringent laws to deter tobacco use, which the government says kills more than 900,000 people every year. But the country still has 106 million adult smokers, second only to China according to the World Health Organization, making it a lucrative market for Philip Morris to target.
A government source said New Delhi would keep an “open mind” if Philip Morris approached it to discuss a device that helped people quit smoking, but added such devices, including e-cigarettes, could be banned if found to be harmful.
The health ministry did not respond to a request for comment. (Graphics of ‘Philip Morris’ iQOS device – tmsnrt.rs/2LuUsd8)
Philip Morris plans to start strategist an iQOS launch in India, which would include work on branding and pricing, as well as reaching out to media and regulators, sources aware of the plan said. The company’s top corporate affairs executive in India, R. Venkatesh, has been interviewing candidates for a senior executive who would focus on iQOS, the sources said.
The company wants “to put together a strategy to achieve its acceptability as a reduced risk product”, said one of the sources, adding that Philip Morris wanted to have a public relations strategy in place before moving ahead.
A Philip Morris spokesman said “we do not comment on our launch plans, but are committed to working hard to replace cigarettes with scientifically substantiated smoke-free products”. Venkatesh did not respond to a request for comment.
But the company appears to have already started building a public case for iQOS in India.
On “World No Tobacco Day” last week, Venkatesh wrote a column for India’s Economic Times newspaper, calling for “effective regulations” for alternative smoking devices.
“With alternatives to cigarettes available and countries already delivering on their smoke-free ambitions, the incentive is there for lawmakers to support Indian smokers – who deserve a better option,” Venkatesh said.

INDIA’S TOBACCO MARKET

Philip Morris has for years promoted its Marlboro cigarettes in India. Though its market share has quadrupled in recent years, Marlboro still accounts for only about 1.4 percent of India’s $10 billion cigarette market.
According to internal documents published by Reuters last year here:%2033738-the-philip-morris-files, the company sees India as a “high potential market” where it aimed at “winning the hearts and minds” of people between 18, the minimum legal age to buy tobacco products, and 24.
IQOS is currently used by nearly 5 million people in more than 30 countries, led by Japan which effectively bans regular e-cigarettes but allows “heat not burn” devices.
India could offer Philip Morris a huge opportunity due to its burgeoning middle class, said Shane MacGuill, head of tobacco research at Euromonitor International.
FILE PHOTO: The Philip Morris iQOS heat-not-burn electronic cigarette is pictured in this illustration photo, April 23, 2018. REUTERS/Toru Hanai/Illustration/File Photo
“It’s a bet on the future,” MacGuill said. “In the longer term, there could be very big rewards for them in India.”
Philip Morris’ so-called reduced risk products, such as iQOS, helped the company clock $3.8 billion in net revenues last year, compared with $739 million in the previous year.
To garner support for iQOS in India, Philip Morris plans to reach out to influential people who could voice public support for the device ahead of its launch, two of the sources said.
Still, if Philip Morris seeks Indian approvals, it would need to convince a government that has in recent years raised cigarette taxes, ordered companies to print bigger health warnings on tobacco packs and launched a quit-smoking helpline.
Prakash C. Gupta, director at the Healis Sekhsaria Institute of Public Health near Mumbai, criticized Philip Morris’ plans.
“They point out some of the toxicants may be less than cigarettes, but that doesn’t establish the safety of the product,” Gupta said. “It will be used by affluent youth, which will be harmful for public health.”
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Philip Morris has also applied to the U.S. Food and Drug Administration (FDA) for permission to market the device as being less harmful than cigarettes. In January, a panel of FDA advisers said iQOS exposes users to lower levels of harmful chemicals, but added the company had not shown that lowering exposure to those chemicals was reasonably likely to translate into a measurable reduction in disease or death.

REGULATION PUZZLE

India’s health ministry has for years said it wants to regulate e-cigarettes – devices which use a nicotine-laced liquid. Still, there is no federal regulation for the product that activists say is harmful and acts as a gateway to tobacco.
In a filing to a Delhi court that is hearing a plea to regulate e-cigarettes, the federal health ministry in April described such Electronic Nicotine Delivery Systems (ENDS) as “new emerging threats”.
The ministry, in its filing seen by Reuters, said it was developing guidelines for regulating – including possibly banning – the manufacture, import or sale of e-cigarettes.
“Glamorizing marketing techniques of ENDS as less harmful products purely mimics the marketing techniques used by the cigarette industry,” the ministry said, without specifically mentioning heat-not-burn smoking devices such as iQOS.
Despite that stance, the government source said the health ministry was still undecided on whether to ban or regulate e-cigarettes, and wanted more consultation to decide whether their efficacy as an aid to help people stop smoking regular cigarettes outweighed any potential harm.
Globally, Philip Morris also lobbies regulators to not classify iQOS as a regular cigarette, an argument that, if won, can lead to lower taxes. The company says the tobacco plugs inserted into the iQOS do not produce smoke, and the device itself is an electronic product.
It plans to do the same in India.
“The first thing is to ensure the customs duties are not prohibitively high,” said one of the sources.