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Saturday, September 8, 2018

Cal. consolidation causes rising premiums, outpatient visit prices


Ongoing consolidation in the Golden State’s provider market is creating higher prices for ACA premiums and outpatient vists, according to a new study.


KEY TAKEAWAYS

California’s provider market consolidation has caused a noticeable increase in ACA premium prices along with outpatient visit prices.
In 2016, 40% of physicians worked in a practice owned by a hospital, up from 25% in 2010.
Researchers urge state legislators to pass additional oversight measures to examine the potential consequences of healthcare M&A activity.
Provider consolidation in the last eight years has spurred on rising healthcare prices across California, according to a new academic study released Tuesday afternoon.
The influx of provider mergers and hospital acquisitions has resulted in more than a dozen California counties being deemed “hot spots,” or markets that deserve additional regulatory review. These “hot spots” have been part of a statewide trend where ACA marketplace premiums rose 12% from 2013 to 2016, physician outpatient visit prices rose 9% for specialists, and primary care prices increased 5%.
The study was conducted by researchers from the RAND Corporation in coordination with the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare School of Public Health at the University of California, Berkeley, which also issued a report on provider consolidation in March.

The study highlighted three primary areas of concern: the adverse effects of horizontal and vertical consolidation, cross-market power, and the ability of providers to acquire systems which force rivals to close their business or drastically raise prices.
  • As a result of widespread vertical integration, the percentage of physicians working in practices owned by a hospital rose by 15% from 2010 to 2016.
  • The report also found that 41 counties with populations totalling less than 500,000 people had highly concentrated hospital markets for the entirety of the study period.
  • While the effects have been closely followed across the state, the most consolidated provider markets are in rural northern California.
As was the case in the Berkeley study issued in March, researchers suggest legislative action to counteract the effects of rapid provider consolidation. Some state leaders have already taken steps to curb anticompetitive behavior, like state Attorney General Xavier Becerra, who sued Sutter Health in late March for anticompetitive practices.
Below are three policy proposals the study cited as potentially effective measures to address the adverse effects of provider consolidation.
  • SB-932, proposed in 2016, would have any proposed merger subject to public hearings to ensure no adverse effects from its passage, along with required approval from the director of the California Department of Managed Health Care.
  • Additionally, the bill would prohibit anticompetitive demands from negotiations with insurers.
  • AB-595, which was proposed in 2017, outlined similar measures found in SB-932.
  • SB-538, proposed in 2017, would institute anticompetitive rules for how hospitals negotiate with insurers. One provision would bar systems from requiring insurers cover every partnered hospital in the system as part of the agreement.

Health coverage dropped for 4,574 Arkansas Works enrollees


More than 4,500 Arkansas Works enrollees lost their health coverage Saturday for failing to comply with the program’s work requirement for three months, according to information from the state Department of Human Services.
Those enrollees had until 9 p.m. Wednesday to visit a state website to report their work hours or an exemption for August to restore their coverage or be locked out of the program for the rest of the year.
But the Human Services Department announced late Wednesday that it would extend that deadline by one month for enrollees whose access to the website, access.arkansas.gov, was hampered by a computer problem that it said affected several state agencies.
The enrollees can submit a request for a “good cause exemption” to the Human Services Department at a county office or by emailing the request to AWgoodcauserequest@dhs.arkansas.gov, department spokesman Amy Webb said in an email.
The request must be submitted by the close of business Oct. 5 and should contain the information on the work hours or exemption for August that the enrollee had attempted to report, Webb said.
Those who lost coverage were the first to face the penalty for failure to comply with the requirement to spend 80 hours a month on work or other approved activities.
Out of about 26,000 enrollees who became subject to the requirement in June, 4,574 had not met the requirement for June, July or August as of Monday, Webb said.
More Arkansans are expected to lose their coverage for noncompliance as the requirement is phased in this year for enrollees age 30-49 and next year for those age 19-29.
Enrollees who fail to comply with the requirement for three months during a year have their coverage terminated and are locked out of the program for the rest of the year.
When it is fully implemented, the work requirement is expected to apply to more than half of the 265,000 people on Arkansas Works, as the expanded part of the state’s Medicaid program is known.
For enrollees who lose coverage due to noncompliance this year, the next opportunity to sign up will be Nov. 1. Coverage will start Jan. 1.
In interviews with 18 Medicaid recipients in northeast Arkansas in mid-August, Jessica Greene, a health policy professor at the City University of New York’s Baruch College, reported finding a “profound lack of awareness” about the requirement.
In a blog post on the Health Affairs website on Wednesday, Greene wrote that two-thirds of the recipients had not heard about the requirement and that a third said they would not be able to access the state website due to a lack of computer skills or Internet access.
“Clearly, there has not been adequate communication about the policy to those who are being affected by it,” Greene wrote.
In a statement, Gov. Asa Hutchinson said the Human Services Department made “every effort to assure compliance,” including through letters, emails and phone calls to enrollees, a social media campaign and “hours-long television appearances with the sole focus of notifying and educating current enrollees.”
He said some enrollees found other coverage or moved out of state without notifying the department, while others “simply chose not to comply.”
“Personal responsibility is important,” Hutchinson said. “We will continue to do everything we can to ensure those who qualify for the program keep their coverage, but we will also make sure those who no longer qualify are removed. Otherwise, the taxpayers would be paying for health insurance premiums for those that are not eligible.”
David Wroten, executive vice president of the Arkansas Medical Society, said the rate of noncompliance is “a little concerning.”
The Human Services Department should try to talk to enrollees whose coverage was terminated and explore whether the program or the department’s outreach strategy should be adjusted, he said.
“There’s no reason whatsoever for any able-bodied person to not be able to comply with the work requirement,” Wroten said. “If they’re just ignoring it, I can’t say much to help them.”
Arkansas in June became the first and so far only state to implement a work requirement for some of its Medicaid recipients. It is also the only state that has been approved to lock enrollees out of coverage for noncompliance for up to nine months.
In Indiana and New Hampshire, which have received federal approval to implement work requirements next year, enrollees who lose their coverage for failing to comply will be able to restore it by coming back into compliance.
A federal judge in Washington, D.C., blocked a similar requirement in Kentucky from taking effect in July.
Two of the groups that filed the lawsuit over Kentucky’s requirement have filed a suit in the same court to stop Arkansas’ requirement, arguing that President Donald Trump’s administration exceeded its authority when it approved the measure.
While Arkansas Works covers people with incomes of up to 138 percent of the poverty level, the work requirement applies only to those with incomes below the poverty level.
For that reason, those who are locked out of coverage in Arkansas won’t qualify for subsidized coverage available through healthcare.gov unless their incomes increase.
That assistance is available only to people with incomes of 100-400 percent of the federal poverty level.
Most Arkansas Works enrollees receive the coverage through private plans, with the Medicaid program paying the premium.
Marquita Little, health policy director for Arkansas Advocates for Children and Families, said many people whose coverage was terminated were likely working or qualified for an exemption, but didn’t visit the state website because they didn’t know about the requirement or lacked access to a computer or the Internet.
Terminating their coverage will make it harder for people with chronic health issues to visit the doctor and fill prescriptions, she said. If their health worsens, she said, they may have more difficulty working.
“We know that a lot of people are going to fall through the cracks and a lot of people who actually need it will end up being the victims of this particular policy,” she said.
Bo Ryall, chief executive of the Arkansas Hospital Association, said hospitals have already reported seeing an increase in patients who lack insurance as the state has terminated coverage for Medicaid enrollees who failed to report address changes to the state.
The work requirement will likely have a similar effect, he said.
“When thousands of people lose their health insurance, it’s going to increase uncompensated care for hospitals who will be providing care and will not get reimbursed for that care in some instances,” he said.
Joe Thompson, director of the Arkansas Center for Health Improvement, said the effect on the state’s health care system will depend on why people aren’t complying. Some may have moved out of the state or found other coverage, while others may need the Arkansas Works coverage but “have not navigated the process” to comply.
“I think over time we’ll have to see which is the more consistent pattern,” he said.

Post-Monsanto deal, Bayer pharma holds on as consumer health continues slide


After swallowing massive agrochemical company Monsanto, Bayer has offered a look at what the combined company’s financial firepower will look like—and if current numbers are any guide, it won’t depend much on consumer health.
On Wednesday, the German company reported second-quarter earnings that beat expectations, despite that unit’s 18% skid. All told, Bayer generated €9.48 billion in sales in the second quarter, with €4.22 billion of that from its pharma business, slightly ahead of consensus estimates of €4.16 billion, according to a note from Jefferies analyst Ian Hilliker.
Consumer healthcare lagged expectations, needless to say, with its sales of €1.41 billion falling short of €1.43 billion. The company’s crop sciences and animal health segments each beat estimates.
Within pharma, Bayer’s key anticoagulant Xarelto, eye drug Eylea, cancer med Nexavar and hemophilia med Kogenate beat expectations. Sales for Mirena, a birth control device, missed analyst estimates.
The results come just one day after Reuters reported that Bayer is considering job cuts as part of a wide-ranging business review following the Monsanto buy. The review is set to conclude by November. Last week, a German business publication reported that Bayer was eying up to 1,000 layoffs, though the company declined to confirm the layoffs and said it continually reviews operations.

Bayer’s move to buy Monsanto has frequently been questioned by pharma watchers. Following the results announcement Wednesday, Berenberg analyst Alistair Campbell wrote that the division between the company’s units “remains highly problematic,” as quoted by Reuters.
Any future reorganizations will follow the company’s move last year to combine its pharma R&D into one group led by Joerg Mueller. The unit houses teams in cardiology, gynecology, ophthalmology, hematology, oncology and more.

As Bayer works to integrate Monsanto and reviews its business, a legal issue poses a potential distraction for the company and investors alike. Last month, a California jury ordered the company to pay $289 million to a plaintiff who argued the Monsanto weed killer Roundup caused his cancer. Bayer pledged to appeal. Now, the company faces 8,700 lawsuits alleging a link between glyphosate products and cancer. Bayer maintains its products are safe and pledged to defend against the suits.

Teva eases debt with $400M tender offer as turnaround effort escalates


Last year, troubled Teva was so overburdened with debt that credit rating agency Fitch knocked its rating down to junk status, citing “significant operational stress.” In February, the company started the long climb back to health by restructuring its disastrous $40.5 billion purchase of Allergan’s generics unit, in an agreement that brought a much-needed $700 million influx of cash.
Now, Teva is slashing its debt even further thanks to a tender offer it announced earlier this week. The company intends to pay up to $400 million of notes that were due in 2019 and 2020, it said.
It’s the latest move in an arduous turnaround battle that some Wall Street analysts believe is finally bearing fruit. The company beat consensus earnings expectations in the second quarter by a full 13 cents, thanks largely to its debt strategy. “Importantly, Teva continues to execute well on debt reduction, having reduced net debt by ~$1B to $28.4B during Q2,” wrote Jefferies analyst David Steinberg in a note to investors, adding that the company has cut its total debt by $7 billion in the last eight quarters.
That said, Teva’s stock took a dive when it announced Q2 results in early August. The company upped its 2018 earnings expectations for the second time this year, but it didn’t increase its revenue guidance—a disappointment, acknowledged Credit Suisse analyst Vamil Divan in a note to investors.
The main challenge to Teva’s top line is Copaxone, its blockbuster multiple sclerosis drug, which has come under significant pricing pressure since Mylan pounded down the price of its generic version to $1,950 from $5,000 in July. Copaxone outperformed expectations in Q2, leading Divan to raise his full-year sales forecast for the product from $1.85 billion to $2.17 billion. But he warned that 2019 “will clearly be another down year for Teva’s topline as Copaxone continues to erode.” He expects total revenues to decline again in 2020 before growth ramps up in 2021, he added.
The key question plaguing Teva now is whether its new products and late-stage pipeline will deliver the growth investors are expecting. The company recently launched Austedo to treat tardive dyskinesia (TD), hoping to mount a significant challenge to Neurocrine’s Ingrezza. Analysts initially predicted Teva wouldn’t be able to capture more than 35% of the market, because the two drugs are so similar, but the tide may be turning in the company’s favor. A June survey by Leerink Partners revealed many doctors are starting to favor Austedo, leading analysts there to predict the drug will capture at least 45% of the market and hit blockbuster status by 2023.

A bigger challenge may be migraine med fremanezumab, which has a PDUFA date at the FDA of Sept. 16. The approval was delayed due to FDA concerns about the Celltrion plant in South Korea that’s producing the API for the product. The FDA reinspected the plant in July, after issuing a warning letter about it earlier this year, and noted several deficiencies, including poorly trained employees. Teva initially said it was “on track” for the PDUFA date, but lingering questions have Divan predicting the product won’t be approved and launched until the second half of next year.
Regardless of the timing, Teva will face significant competition once fremanezumab finally hits the market. The manufacturing delay gave Amgen and Novartis a significant head start with their rival drug, Aimovig. Eli Lilly will be launching a competing product later this year, as well.
Given the competition, Leerink analyst Ami Fadia told investors to expect minimal sales of the migraine product in 2019, “as we assume Teva will give out mostly free drug to promote uptake,” she said in a note.
Echoing what appears to be a growing consensus among analysts, Fadia further advised investors not to expect meaningful growth from Teva until 2021.

Friday, September 7, 2018

Trupanion Big Opportunity In $1B Pet Insurance: Raymond James Initiation


The health insurance industry has been in flux as the debate over U.S. health care reform rages.
That’s not the case with insurance for four-legged patients, according to Raymond James.

The Analyst

Raymond James analyst John Ransom initiated coverage of Trupanion Inc TRUP 2.35% with an Outperform rating and $46 price target.

The Thesis

The North American pet health insurance market is already a $1-billion market, but it is growing at an 18-percent compound annual rate and has reached just 1-percent penetration, Ransom said in the initiation note. (See the analyst’s track record here.)
Trupanion has been gaining market share in the space, growing subscription revenue at a 30-percent clip.
“Our investment thesis is that the company’s underwriting expertise, superior product design, superior payment technology (Trupanion Express), Territory Partner sales force model and continued improvement in operating leverage are defensible and will drive a sustainable trend of 20-percent-plus top-line growth and improving profitability,” the analyst said.
Although the pet insurance market is relatively new, overall pet spending has grown at a 6.3-percent rate since 1994. Millenials are now reaching peak pet-owning age and are spending even more on their pets than previous generations, Ransom said.
Trupanion has differentiated its products by focusing on simplicity, offering easy-to-understand policies, a 10-percent copay and a customizable deductible, the analyst said. Raymond James forecast 24.5-percent revenue growth for the company in 2018 and is targeting for annual revenue to grow from $302 million this year to $442 million by 2020.

J&J to work with India on compensation for recalled hip implants


Johnson & Johnson (J&J) said it would work with the Indian government to compensate patients who had suffered from hip implants that were recalled by the U.S. healthcare firm eight years ago after data showed high failure rates.

This follows last week’s recommendation from a government panel that J&J pay at least 2 million rupees ($27,812) to each patient for the faulty ASR hip implant. The federal government has asked states to help patients get relief soon.
About 93,000 people worldwide received ASR implants which were recalled in 2010. The Indian panel said in its report that about 4,700 of those people were in India.
Given the recent committee report, “we are seeking to work with the Indian government to develop an appropriate process for providing further support and compensation for patients in need”, a J&J spokeswoman said in a statement to Reuters, adding the firm was committed to support all ASR patients in India.
Sushobhan Dasgupta, a senior J&J executive in India, has, however, told Indian newspaper Mint that the company “will not pay people who had an ASR implant if they are doing well”.
The company is not okay with the methodology used by the Indian panel, Dasgupta told the paper in an interview https://www.livemint.com/Companies/d5JxJ6YLFqLsUu8sRtf2fO/Not-all-hip-implants-faulty-everyone-wont-be-compensated.html published on Friday. The report has “factual inaccuracies” and “the conclusions could also be inaccurate”, he added.
In 2013, J&J agreed to pay http://reut.rs/I20AZB nearly $2.5 billion to settle thousands of lawsuits from patients in the United States who said they were injured by the implants.
In India, the company paid $2 million to patients for repeat surgeries and about $250,000 in related diagnostic costs under its ASR reimbursement programme, but the government panel has criticised J&J for offering no compensation.
Metal hip implant systems such as ASR were designed to be more durable than a traditional metal-on-plastic, ball-and-socket design. But many Indian patients suffered adverse reactions to the implant, the panel said.
J&J entered the Indian market in 1947 when it started selling its now-ubiquitous baby powder. It has in recent years faced issues such as price caps on medical devices.

Dyadic to collaborate with Sanofi-Aventis


Dyadic International, Inc. (“Dyadic”) (OTCQX: DYAI), a global biotechnology company focused on further improving and applying its proprietary C1 gene expression platform to speed up the development and lower the cost of biologic vaccines and drugs at flexible commercial scales, today announced that it has entered into a fully funded proof of concept research collaboration to explore the potential of its C1 technology to produce multiple types of biologic vaccines and drugs of interest for human health indications with Sanofi-Aventis Deutschland GmbH, a company of the Sanofi group, one of the World’s top tier biopharmaceutical companies.
“We are very pleased to have the opportunity to collaborate with Sanofi to express multiple types of important therapeutic compounds using our C1 production platform,” said Mark Emalfarb, Dyadic’s CEO. “This research and development program is aiming to overcome specific gene expression challenges and to further demonstrate the potential of C1 to become a platform of choice for manufacturing protein-based biologics because of its speed of development and low cost of goods.”
Under the agreement, Sanofi will fund the collaborative research which will utilize the proprietary and patented C1 Gene Expression Platform Technology to express multiple genes for vaccine and drug applications. The research is expected to be completed in the second half of 2019.  Other terms of the research collaboration are confidential.