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Tuesday, May 15, 2018

California assisted death law overturned in court

A judge in Riverside County on Tuesday overturned California’s controversial assisted death law nearly two years after it took effect, ruling that the Legislature improperly passed the measure during a special session on health care funding.
The court is holding its judgment for five days, according to representatives for supporters and opponents of the law, to give the state time to file an emergency appeal.
“We’re very satisfied with the court’s decision today,” said Stephen G. Larson, lead counsel for a group of doctors who sued in 2016 to stop the law. “The act itself was rushed through the special session of the Legislature and it does not have any of the safeguards one would expect to see in a law like this.”
The state plans to seek expedited review in an appellate court, according to Attorney General Xavier Becerra, who said in a statement that he strongly disagreed with the ruling.
Assemblywoman Susan Talamantes Eggman, the Stockton Democrat who carried the bill, said Californians who are in the process of obtaining life-ending drugs through the law have had “the carpet ripped out from under their feet.”
“It’s a reminder for all of us that there are those out there who would like to take our rights away,” she said. “When we move forward, there are those who would like to drag us back.”
Signed by Gov. Jerry Brown in 2015, the assisted death law allows doctors to prescribe lethal drugs to patients with six months or less to live. Hundreds of Californians have already taken advantage of that option, including 111 individuals who died from taking the drugs in the first seven months of their availability.
Proponents say it provides dignity to terminally ill patients by affording them more control over the end of their lives.
But the legislative push originally fell short amid opposition from oncologists, Catholic hospitals, clergy and disability rights groups, who argued that the policy was immoral and could have a detrimental impact on health care for the state’s most vulnerable patients.
After failing in regular session, lawmakers successfully revived the assisted death proposal in a special session called that summer by Brown to find a source of funding for public health programs.
Larson said his clients are most concerned about a lack of protections in the law, including an inadequate definition of terminal illness and a provision exempting doctors who prescribe the lethal drugs from liability. But he said they also challenged the manner in which the law was passed, an argument the judge sided with on Tuesday.
“That special session was called to address funding shortages caused by Medi-Cal,” Larson said. “It was not called to address the issue of assisted suicide.”
Supporters noted that the ruling was not about the legality of assisted death and that public polls have indicated the law has widespread approval in California. Advocacy group Death With Dignity National Center sent out a fundraising email Tuesday afternoon decrying “shadowy, religious-right groups attempting to derail the law any way they can” for “disrespecting the will of the people.”
Eggman said Brown would have known “what he intended with the breadth of the special session,” which also included objectives to “improve the efficiency and the efficacy of the health care system,” and he signed the law.
Compassion & Choices, the organization that led the effort to legalize assisted death in California, also objected to the judge’s interpretation.
“He’s not acknowledging it’s a health care issue, even though we believe it is,” spokesman Sean Crowley said. “It deals with medication.”

UroGen target upped by Ladenburg

Ladenburg Thalmann raised its price target on UroGen Pharma (NASDAQ: URGN) to $72.00 (from $65.00) while maintaining a Buy rating.

VA finalizes rule easing virtual care delivery

  • The U.S. Department of Veterans Affairs released a final rule Monday allowing its healthcare providers to treat patients in any state using telehealth.
  • The rule, which takes effect June 11, “clarifies that VA healthcare providers may exercise their authority to provide healthcare through the use of telehealth, notwithstanding any State laws, rules, licensure, registration or certification requirements to the contrary,” according to the Federal Register notice.
  • Plans to expand the VA’s telehealth program were first revealed in August, when former VA Administrator David Shulkin announced the Anywhere to Anywhere VA Care initiative. That was followed in October by a proposed regulation standardizing telehealth services for VA practices irrespective of location.

The pre-emption of state laws frees the VA from having to lobby each state to remove barriers that impede its ability to deliver telehealth services, which would be impractical and costly and would delay treatment for veterans and their families, according to the notice.
The agency says it needs the rule to continue expanding its telehealth program, which is especially crucial for rural patients and those with mental health issues.
Several states are in the process of easing telehealth regulations as more providers embrace virtual care as an option for their patients. Last May, for example, Texas enacted a law allowing doctors to provide remote care and patient consultations without a prior in-patient visit, ending a heated legal dispute between Teladoc and the Texas Medical Board.
The American Medical Association previously expressed its support for the rule and the VA’s expansion of telehealth, praising the decision to limit the multi-state licensure exception to VA-employed providers.
Health IT Now, a coalition of patient, provider, payer and employer groups, also welcomed the rule. “This final rule is a victory for our nation’s heroes — particularly those in rural areas — who deserve access to prompt medical care when and where they need it,” Joel White, executive director of Health IT Now, said in a statement.
Meanwhile, there is a larger debate surrounding the VA on possible privatization of its services. Shortly after he was ousted, Shulkin wrote in an op-ed that efforts to privatize were gaining steam, but he opposes the idea and thinks it would undermine care for veterans. The Trump administration has yet to nominate a new head for the agency after its first pick, White House doctor Ronny Jackson, took his name out of the running amid allegations of unprofessional behavior.

Athenahealth has yet to respond to buyout offer, Elliott says

  • Elliott Management has not heard from athenahealth regarding its buyout proposal, a letter sent to athenahealth’s board of directors on Monday said. “We find this lack of communication concerning because, unfortunately, this is the same pattern of behavior we experienced when we tried to get the company to engage in November,” Elliott Management wrote.
  • A week ago, the investment firm sent athenahealth an unsolicited acquisition bid for $160 a share, a deal valued at nearly $6.5 billion.
  • Reached for comment, an athenahealth spokesperson referred to a May 7 statement that the company’s board of directors is reviewing the proposal and will determine the course of action it believes to be in best interest of the company and its shareholders. “For now, this remains our comment,” the spokesperson told Healthcare Dive in an email.

Elliott’s bid wasn’t a huge surprise, but the investment firm run by Paul Singer looks to be losing its patience regarding athenahealth’s performance and lack of communication.
Last month, athenahealth reported a 12% increase in total revenue for the first quarter of this year, but noted bookings had declined to $52.2 million, down from $77.3 million for the same quarter last year.
“We have received no direct communication despite our emails and messages to athenahealth offering to discuss next steps or to answer any questions regarding our proposal,” Elliott wrote in its letter. “None of the company’s advisors has contacted us.”
A year ago, Elliott said the company was “substantially undervalued.” In the past year athenahealth’s stock has seen its ups and downs.
Athenahealth’s stock has seen two big increases after Elliott disclosed its interests.
Athenahealth, for its part, has attempted to adapt its internal structure and products for new consumers.
Internally, the company cut 9% of its workforce, sold its corporate jet, declined to host a HIMSS after-party, closed its San Francisco office and restructured its management layers. Former GE executive Jeff Immelt joined the company as a board chair.
For its product, athenahealth retrofitted its network to move toward offering platform-as-a-service, a model CEO Jonathan Bush touted last week at HLTH 2018 in Las Vegas.
But bookings are still down, and the company has lost a lot of its senior management, including the recent exit of CPO Kyle Armbrester to act as CEO at Censeo+Advance.
Elliott also said it is “aware that other parties have conveyed directly to the company interest in acquiring athenahealth” but added the company “failed to engage” with those offers as well.
“[F]or the benefit of shareholders and the company, this pattern of behavior needs to stop,” Elliott wrote. “Our proposal to acquire athenahealth represents an attractive proposition, and numerous shareholders, research analysts and media sources have agreed that athenahealth should engage with us to explore whether a value-maximizing transaction is achievable.”
Elliott has a reputation as an activist investor and its clear the firm isn’t backing down from its athenahealth bid. Bush and company also don’t seem ready to run from the fight. Bush, alongside former U.S. CTO and current Devoted Health Executive Chairman Todd Park, started the company more than 20 years ago and has been with it for its entire lifespan.

Berkshire doubles Teva stake

Warren Buffett’s Berkshire Hathaway Inc on Tuesday said it has more than doubled its investment in generic drugmaker Teva Pharmaceutical Industries Ltd, and confirmed it has become Apple Inc’s second-largest shareholder.

Berkshire also shed an investment dating to the mid-1970s that reflected Buffett’s longstanding love for newspapers, selling its stake in Graham Holdings Co, the former publisher of the Washington Post.
The changes were disclosed in a regulatory filing detailing Berkshire’s U.S.-listed stock holdings as of March 31.
Berkshire owned about $173 billion (£128 billion) of equities, as well as dozens of businesses in the railroad, insurance, energy, chemical, food and retail and other sectors.
Berkshire said it owned about 40.5 million Teva American depositary receipts (ADRs) worth about $693 million as of that date, up from 18.9 million ADRs three months earlier.
Teva’s share price rose 5.1 percent in after-hours trading on Tuesday. Stocks often rise in price when Berkshire reveals new or increased stakes.
Larger stock investments are normally made by Buffett, while smaller bets come from his investment managers Todd Combs and Ted Weschler. The filing does not say who bought which stocks.

Nestle to cut more sugar and salt in its products

Nestle will make further cuts to the amount of sugar, salt and saturated fats in its products as it tries to improve the image of packaged foods in the eyes of health-conscious consumers, the Swiss group said on Tuesday. Nestle and its rivals are under pressure from a shift in consumer preferences toward healthier food and away from processed products such as instant noodles and frozen pizza.
The maker of KitKat chocolate bars and Maggi soups is responding with healthier products and is also moving into higher growth categories, such as coffee, pet care, bottled water and infant nutrition. The company said it wanted to cut sugar by another 5 percent, on top of the more than 34 percent reduction achieved since 2000, and salt by another 10 percent in addition to the more than 20 percent saved since 2005.
It also confirmed its commitment made in 2014 to reduce saturated fats by 10 percent in all relevant products that do not meet World Health Organisation recommendations. “The trend toward healthier foods is to be observed worldwide,” Chief Executive Mark Schneider told journalists at a briefing in Vevey on Lake Geneva, where the company has its headquarters. “We are putting a lot of resources into this,” Schneider said. Nestle spent 1.72 billion Swiss francs ($1.71 billion) on R&D last year. Food and drinks for children were a particular area of focus, Schneider said as he presented a “Nestle for Healthier Kids” campaign that also includes programmes and online services to educate parents and carers on what children should eat. Nestle said it had launched more than 1,000 new products last year to meet the nutritional needs of children and would further enhance products for kids with fruits, vegetables, fibre-rich grains and micronutrients. Reformulating recipes to make its products healthier is part of Nestle’s effort to keep its products attractive for consumers.
This year it launched a new “Milkybar” white chocolate bar that has 30 percent less sugar. “Combining the convenience of packaged foods with healthy good nutrition, that is where our sweet spot is,” said Schneider, who took the top job at Nestle last year with the declared goal of reigniting sales growth. To achieve this, Nestle has also been shedding underperforming businesses such as U.S. confectionery and expanded Nestle’s footprint in health foods, with vitamin maker Atrium, and coffee thanks to a deal with Starbucks announced just last week.

Doctors slow to switch diabetes treatment when drugs don’t work

When type 2 diabetes isn’t well controlled with oral medications, doctors are often slow to switch patients to more intensive treatment, a U.S. study suggests.
Researchers found that only about one-third of patients with poorly controlled blood sugar on oral drugs were switched to higher doses, different drugs or insulin within six months.
At the start of the study, all of the patients had been taking two oral diabetes drugs for at least six months. But they still had poorly controlled diabetes based on blood tests showing so-called hemoglobin A1c levels, which reflect average blood sugar levels over about three months. Readings above 6.5 signal diabetes, and everyone in the study had readings of at least 7.
Under U.S. guidelines for managing diabetes, all such patients should be switched to more intense treatment, researchers note in Diabetes Care.
But six months after the start of the study, doctors had only prescribed more intense therapy for 37 percent of these patients.
“Generally speaking, if a patient’s A1c is above target, it will either remain there or get worse,” said lead study author Dr. Kevin Pantalone of the Cleveland Clinic in Ohio. “It does not usually get better.”
Globally, about one in 10 adults has diabetes, according to the World Health Organization. Most have type 2 diabetes, which is associated with obesity and aging and occurs when the body can’t make or process enough of the hormone insulin.
Medications as well as lifestyle changes such as improved diet and exercise habits can help manage diabetes and keep symptoms in check. When diabetes isn’t well managed, however, dangerously high blood sugar can eventually lead to blindness, amputations, kidney failure, heart disease and stroke.
Too often, doctors and patients will find reasons not to intensify treatment, making these complications more likely, Pantalone said by email.
“Whether it be the patient saying for the fifth time ‘I will start watching my diet and start exercising,’ or a physician saying ‘the A1c is close to goal and I don’t really want to add yet another medication and copay, we will wait and see what happens in another 3 months,’ the end result is lack of intensification and A1c goal attainment,” Pantalone said.
In the current study, researchers examined electronic health records for 7,389 patients with poorly controlled diabetes who were treated at the Cleveland Clinic between 2005 and 2016.
People with the most poorly controlled blood sugar were more likely to get more intense treatment, the study found.
Among patients with A1c readings from 7 to 7.9, just 28 percent of patients were switched to more intense treatment during the study.
However, about 47 percent of patients with A1c readings from 8 to 8.9 were switched, as were almost 60 percent of patients with A1c readings of 9 or higher.
The study wasn’t a controlled experiment designed to prove whether or how treatment intensification might directly improve blood sugar. Researchers also lacked data to explain why doctors or patients might have decided against a change in therapy. And the study didn’t show whether failure to switch treatment regimens resulted in diabetes complications.
Still, such complications can become more likely the longer patients go with poorly controlled blood sugar, said Dr. Vanessa Arguello of the David Geffen School of Medicine at the University of California, Los Angeles.
“When appropriate, patients need to be involved in escalating their diabetes care to prevent diabetic complications and stay healthy,” Arguello, who wasn’t involved in the study, said by email.
“Patients should empower themselves by checking their blood sugars daily, knowing what their target blood sugar levels should be, and having regular appointments with their doctor,” Arguello added. “If patients are having blood sugars above their target blood sugar levels then this may be a warning sign that they need to talk with their physician on how to take a different approach in managing their diabetes.”