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Tuesday, March 10, 2020

United Therapeutics raised to Buy from Hold by Jefferies

Target to $123 from $115
https://www.benzinga.com/stock/UTHR/ratings

Change Healthcare upped to Overweight from Equal Weight by Wells Fargo

Target $19
https://www.benzinga.com/stock/CHNG/ratings

New Trump rules aim to fuel sharing of patient health records by smartphone

President Trump’s top health care aides on Monday said they will finalize federal rules requiring health providers and insurers to make health records available to patients in an easily accessible electronic format, a policy shift aimed at fueling broader efforts to use patient data to develop new software tools and services.
In a briefing with reporters, Trump’s aides essentially doubled-down on policies they first announced last March, saying they will press forward with the rules despite warnings from electronic health record companies and some hospitals that they could compromise the privacy of patient information.
“Health care providers will be required to provide easy digital access to your records at no cost,” said Alex Azar, Trump’s health secretary, adding that the information will be made available through smartphones to allow it to be shared easily with app developers. “We hope to see a whole ecosystem of condition or disease-specific apps to help patients monitor and improve their health in real time.”
The rules are meant to accomplish for health data what the creation of the federal interstate system did for automobiles in the 1950s: They seek to set up a standardized infrastructure that will increase the pace and volume of traffic, supporting commerce and innovation through expanded access to health information.
But the level of access the rules provide can also have drawbacks in terms of security and privacy, especially in an era when these sensitive data are being monetized by massive technology companies seeking to grab a greater share of the nation’s $3.5 trillion health care industry.

The Trump administration did make some changes in response to privacy concerns raised over the past year, enabling hospitals and insurers to warn consumers about apps that fail to meet privacy standards. The rules also require that patients be given clear information about the uses they are consenting to when they provide their information to third-party technology companies and app developers.
“Privacy and security are paramount,” said Seema Verma, the administrator of the Centers for Medicare and Medicaid Services. “… These tools ensure that [health] plans and [app] developers have the technical tools they need to build secure application interfaces.”
The rules, most of which will go into effect in 2022, are broadly aimed at unlocking access to health data that are now trapped in silos controlled by hospitals, health insurers, and vendors of electronic health records. Over the last decade, federal taxpayers have spent $48 billion to digitize these data, but those digital records are mainly used for billing purposes and inaccessible to patients and other parties.
The federal efforts to make the information more available and portable are a boon to digital health startups and large technology companies such as Amazon, Microsoft, Facebook, Apple, and Google, which are seeking to leverage patient data to disrupt health care delivery using artificial intelligence and other software tools.
In a call with STAT after Monday’s press briefing, Verma said she expects the rules will make developing novel software products faster, easier, and less expensive.
“What this rule does is unleash that data and allows patients to have access to it and allows them to direct where they want it to go,” she said. “In an era of artificial intelligence, we have an ability to analyze this data to advance medical science, and to advance clinical guidelines that provide better, more personalized services, hopefully at a lower cost.”
Monday’s announcement seeks to implement provisions in the 21st Century Cures Act that seek to make health records accessible to patients and prevent so-called information blocking by health care entities that tend to guard patient data for their own commercial purposes. Two sets of final rules were released, one from the Centers for Medicare and Medicaid Services, and another by the Office of the National Coordinator for Health Information Technology.
Epic, the nation’s largest seller of electronic health records, which had forcefully criticized an earlier version of the rules, issued a brief statement Monday that didn’t comment on the new policies specifically: “We have been working closely with HHS and ONC to try to improve the rule, and we appreciate their willingness to hear our feedback,” the statement said, referring to the federal agencies in charge of drafting the regulation.
While administration officials trumpeted the rules as a historic shift that will fuel data accessibility and innovation, their impact on the marketplace remains to be seen. Several presidential administrations have tried — and failed — to create a freer exchange of health data that would ultimately benefit patients, a concept known as data interoperability. But many health care organizations, including insurers, hospitals, and health record vendors, have effectively blocked those prior efforts because of concerns about privacy, excessive red tape, and their own financial interests.
Health data specialists who have been following the development of the rules said there is reason to be optimistic this time around, as the rules go farther than the prior policies in specifying that those entities must make data accessible in a standardized electronic format that patients can easily access and share. That, in turn, may also allow public health agencies to gather better data on the safety and effectiveness of drugs or track the spread of diseases such as Covid-19.
“It’s a big deal,” said Kenneth Mandl, a Harvard professor who directs the Computational Health Informatics Program at Boston Children’s Hospital. “The appetite for interoperability and the appetite for moving medicine toward a data-driven enterprise has increased dramatically.”
A decade ago, Mandl helped to develop a standardized data-sharing framework known as SMART on FHIR (Fast Healthcare Interoperability Resources), an interface that allows data housed in different systems and formats to be seamlessly shared among health providers, and between providers and patients. The rule requires that those parties now use the SMART on FHIR framework to make the data available via smartphone, so that it can be exchanged with limited effort and expense.
While the rules seek to prevent information blocking, they do not entirely eliminate the ability of entities that now control the information to make it difficult to access. For example, electronic health record vendors can still charge fees to app developers to gain access to information housed in their systems. Depending on the circumstances, those costs can be prohibitive, scuttling access to the data and efforts to make use of it for novel products and services.
Verma told STAT, however, that health care organizations will no longer have an ability to throw up such barriers to patients, who will be free to share it with whomever they want.
“Patients can donate their data to science,” she said. “Imagine what that looks like if innovators and researchers have the ability to analyze all of your data.”
Currently, hospitals are giving large technology companies access to patient data through private contracts that enable the development of new software products. But those arrangements are being made without disclosure to patients or the broader public, leaving people in the dark about how their information is being used.
Verma said those transactions are enabled by general consent forms most patients sign when they get care and that the new rules will make it easier for patients to control their data and become educated about efforts to leverage it for commercial purposes.
“It’s always been a focus of this administration to empower consumers with the information that they need,” she said, adding that patients will be able to consent to specific uses of the data when they share it. “It’s one of the things we’ve done in [Medicare] to train app developers on the front end to make sure they have plain language around their privacy and security practices in what they share with patients.”
New Trump rules aim to fuel sharing of patient health records by smartphone

Citron Showed ‘Lack Of Understanding’ Of Science Behind DNA Medicines – Inovio

Inovio Pharmaceuticals Inc. INO on Monday defended its claim of having developed a vaccine for novel coronavirus (COVID-19) in three hours.
Citron Research tweeted on Sunday, asking the United States Securities and Exchange Commission to halt the trading of Inovio’s stock and investigate the “dangerous claim that they designed a vaccine in [three] hours.”
“This has been a serial stock promotion for years,” Citron said. “This will trade back to $2. Investors have been warned.”
As Inovio’s shares tanked by more than 32% in Monday’s trading following Citron’s comments, the pharma company fired back without naming it directly.
“A third-party report today demonstrated a lack of understanding of the science behind DNA medicines,” Inovio said in a statement.
The company said that it developed a DNA vaccine construct named INO-4800 in less than three hours after the coronavirus sequence became publicly available.
The pretrials for the vaccine were conducted in January, and the results are under considerations at Nature Communications journal, Inovio noted. The company expects to move into human trials in April.
Innovio’s shares surged to more than double over the last week as it announced the development of the vaccine even as the overall stock market suffered losses from fears over the continued spread of the coronavirus.
The stock was headed for further gains, opening about 37% higher at $18.85 on Monday, until Citron’s comments ended the rally.
Earlier in February, the Wall Street Journal reported that Moderna Inc. MRNA had sent the first coronavirus vaccine to the National Institute of Health for clinical trials to be conducted in April.
https://www.benzinga.com/news/20/03/15513625/citron-showed-lack-of-understanding-of-science-behind-dna-medicines-inovio-says

SEC 1st federal agency to tell employees to stay home amid coronavirus

The Securities and Exchange Commission (SEC) became the first federal agency to direct some employees to work from home due to fears of a coronavirus case on Monday.
In an email to staff first reported by The Washington Post, SEC officials asked employees working on the ninth floor of the agency’s Washington, D.C., headquarters to stay home after an employee reported symptoms and was informed by a doctor that they may have coronavirus and should be tested.
“Out of an abundance of caution, effective immediately the SEC is requiring all Headquarters personnel (employees and contractors) who work on the 9th floor to telework,” read the email.
SEC officials added that the employee did not exhibit any symptoms at any point while working in the agency’s office.
“To the best of our knowledge, the employee remained asymptomatic during the employee’s time in the building,” the email read.
Ten cases of the coronavirus have been confirmed in the Washington, D.C., area while the global case total has climbed past 100,000. The number of cases across the U.S. climbed past 600 on Monday, while health officials have warned that shortages of test kits for the disease are occurring in the U.S.
“The slow federal action on this matter has impeded our ability to beat back this epidemic,” one New York health official wrote to the Centers for Disease Control and Prevention on Friday.
https://thehill.com/policy/healthcare/486742-sec-becomes-first-federal-agency-to-tell-employees-to-stay-home-amid

Washington state gears up for primary election amid coronavirus

Washington state elections officials and Democratic Party leaders are hoping changes to the voting system put in place to boost turnout will also help protect voters and poll workers in the state with the worst coronavirus outbreak in the nation.
Washington is the only one of the six states holding primaries on Tuesday that has a significant number of known cases of the novel coronavirus and officials there are taking extra precautions.
Still, they are hopeful the Washington Democratic Party’s decision to conduct its primary by mail-in and drop-off ballots rather than with caucuses, as in previous election cycles, reduces the risk of spreading the highly contagious virus.
The change means voters in Tuesday’s race will avoid crowds that come with long lines at polling locations or in rooms used for caucuses.
Each voter received a ballot three weeks ago and has until Tuesday to mail it in or drop in off at a designated location.
“I think the mail-in system is one that is made for situations like this, frankly, and it’s made it super easy for people to be able to vote in that context,” Washington State Democrats Chairwoman Tina Podlodowski said.
The swap has also increased voter turnout, she added. In the 2016 presidential caucus, Washington had a record attendance of about 230,000 people. As of 5 p.m. Friday, about 1.3 million Washington residents had voted in the primary, Podlodowski said.
She said she’d urge all states to opt for a similar mail-in system, with an 18-day voting period and ballots with paid postage.
Some voting centers will be operating across the state Tuesday, where residents can both register and vote. But officials don’t expect the level of crowds that turn out at traditional polling sites, King County director of elections Julie Wise said.
Wise said voters are also encouraged to reach out if they need assistance.
“It’s more than likely you don’t even need to leave your home [to vote],” Wise said.
Caucuses or traditional in-person polling locations could place voters at higher risk of spreading and contracting the virus. Coronavirus spreads between people in close contact with each other and through respiratory droplets produced when an infected person coughs or sneezes, which can carry about a meter, according to the Centers for Disease Control and Prevention.
King County, Washington’s most populous county, has been the hardest hit in the state, with 83 of the state’s 136 confirmed cases, as of Monday afternoon. Seventeen people from King County have died from the infection; an additional death in the state was reported in Snohomish County, according to the state health department.
Despite the outbreak, 500,000 of King County’s approximately 1.3 million registered voters had already turned in ballots as of Monday, Wise said.
Even with the less risky vote by mail system, Washington officials are taking precautions, including recommending voters seal their envelopes with a wet sponge or cloth rather than by licking them shut.
Officials are also taking precautions to limit the risk of exposure for staffers opening ballots. Staff regularly wear gloves when opening mail-in ballots, Wise said, but now “every single employee” is wearing gloves as they work.
She also said staff are doing regular sanitation cleanings of the area and taking hand washing breaks.
Employees are being told to stay home if they’re under the weather, but Wise said she hasn’t had any more staff than usual calling in ill.
“[We’re] optimistic we’ll get through tomorrow … and be able to continue counting ballots until we certify on March 20,” Wise said.
The Democratic National Committee (DNC) said health officials in the state and at the federal level are working with the state Democratic Party to prioritize voters’ safety.
“We are taking this situation very seriously and remain committed to ensuring all eligible voters are able to make their voices heard without jeopardizing anyone’s health and safety,” DNC spokeswoman Maya Hixson said. “We are in close touch with health and government officials and will continue to monitor and assess the situation as it unfolds.”
https://thehill.com/homenews/campaign/486674-washington-state-gears-up-for-primary-election-amid-coronavirus-outbreak

Meadows self-quarantines after possible exposure to coronavirus

Rep. Mark Meadows (R-N.C.), who President Trump last week selected as his next acting chief of staff, will self-quarantine at his home after learning that he may have come into contact with a person who later tested positive for the novel coronavirus, his office said.
“Out of an abundance of caution, Meadows received testing which came back negative,” Meadows spokesman Ben Williamson said. “While he’s experiencing zero symptoms, under doctors’ standard precautionary recommendations, he’ll remain at home until the 14 day period expires this Wednesday.”
Meadows is one of several GOP lawmakers who attended the Conservative Political Action Conference (CPAC) in Maryland last month to announce that they’ve gone under a self-quarantine.
Reps. Doug Collins (R-Ga.), Paul Gosar (R-Ariz.), Matt Gaetz (R-Fla.) and Sen. Ted Cruz (R-Texas) have said they were in contact with the individual at the convention who later tested positive for the virus. In response to health officials’ recommendations, they’ve all said they will stay home until 14 days had passed between their encounters.
Rep. Julia Brownley (D-Calif.) also said Monday that she and her staff would work remotely after learning that she had interacted with a person in Washington, D.C., who tested positive for the virus.
The American Conservative Union (ACU) first disclosed on Saturday that a CPAC attendee had tested positive for COVID-19 at a New Jersey hospital shortly after attending the convention. The patient had been exposed to the virus before attending the convention and is now under quarantine in the hospital, ACU said.
Cruz and Gosar said in separate statements on Sunday that they had interacted with the individual and shook his hand. Gosar said that he and three members of his staff were with the individual “for an extended period of time,” adding that they “shook hands several times.”
Gaetz and Collins confirmed earlier Monday that they had come into contact with the CPAC attendee. All of the lawmakers have noted that they have not experienced any virus symptoms, but that they were going under self-quarantine as a precaution.
Collins and Gaetz were in contact with Trump and other administration officials before being notified. Collins visited the Centers for Disease Control and Prevention (CDC) in Atlanta with Trump and other officials on Friday. Gaetz traveled on Air Force One with Trump on Monday, and reportedly quarantined himself on the flight after learning he had been in contact with someone who tested positive for the virus.
Trump and Pence attended CPAC, though they did not come in direct contact with the attendee who later tested positive for coronavirus. White House press secretary Stephanie Grisham said late Monday that Trump had not been tested for the coronavirus “because he has neither had prolonged close contact with any known confirmed COVID-19 patients, nor does he have any symptoms.”
Trump has been in contact with at least three people who went into a self-quarantine after interacting with the CPAC attendee. The president shook ACU chairman Matt Schlapp’s hand at the conference. Schlapp said that he shook hands with the infected individual days earlier.
The president abruptly announced last week that Meadows would become his fourth chief of staff and that Mick Mulvaney would move into the role of U.S. special envoy for Northern Ireland. The North Carolina congressman is expected to work with Mulvaney to ensure a “smooth transition in the coming weeks,” the White House said.
Meadows is set to come into the role as confirmed cases of the coronavirus continue to rapidly climb throughout the world, causing stocks to plunge and governments to enforce strict measures designed to curb an outbreak. Trump announced on Monday night that he would ask Congress to approve a payroll tax cut and relief for hourly workers in an effort to combat the economic fallout from the disease.
The proposal came the same day that Trump downplayed the seriousness of the virus, while also contradicting health officials and comparing it to the flu.
https://thehill.com/homenews/administration/486737-meadows-self-quarantines-after-possible-exposure-to-coronavirus