U.S. Ocaliva® net sales of $77.6 million; 16.4% growth over the prior year quarter
Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and narrows non-GAAP adjusted operating expense guidance to $350 million to $365 million
As of September 30, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $497.8 million
Company remains on track to resubmit new drug application (NDA) for obeticholic acid (OCA) in liver fibrosis due to NASH by end of 2022 based on the positive Phase 3 REGENERATE study
INGREZZA® (valbenazine) Third Quarter Net Product Sales of $376 Million
INGREZZA® (valbenazine) 2022 Net Product Sales Guidance Raised to $1.4 - $1.425 Billion
Supplemental New Drug Application (sNDA) of Valbenazine For the Treatment of Chorea in Patients with Huntington Disease Submitted to the U.S. Food and Drug Administration
The latest front in the Biden administration’s crusade to bypass the congressional appropriations process and expand the welfare state comes in the form of themedicalization of everyday life through Medicaid coverageof “health-related social needs.”
The Centers for Medicare and Medicaid Services recently approved three section 1115 demonstration initiatives that allow Oregon, Massachusetts and Arizona to use Medicaid funds to pay nonmedical expenses such as housing supports (rent, relocation expenses, furniture), meals, air conditioning and air purifiers “during climate emergencies” and transportation services.
CMS Administrator Chiquita Brooks-LaSure argues such measures are needed “to address the root social causes of health concerns, like lack of access to nutritious food and housing insecurity.”
This is an unnecessary and potentially enormous expansion of Medicaid, the government-funded health program for low-income families, children and the disabled — and, in Medicaid expansion states, low-income adults. Medicaid covers roughly one in four Americans. It is financed partly by the federal government (about two-thirds on average) and partly by the individual states. States have leeway in spending their portion, but strict rules limit how they can use the federal chunk.
Before these recent approvals, adding nonmedical services to the program could have been considered fraud, waste and abuse. But section 1115 waivers allow state Medicaid programs to create demonstration projects that use federal Medicaid and Children’s Health Insurance Program funds in ways federal rules would not otherwise permit.
Of course, once Medicaid spending can be used for housing and food, there’s no logical stopping point. Clothing, heating fuel, gasoline, phones and computers could all arguably be linked to Medicaid recipients’ health and well-being.
And since states pay on average only one-third of the cost, they have a tremendous incentive to include all kinds of good and services, particularly ones previously provided with state-only dollars, under the Medicaid umbrella. Expect a slew of waiver applications with an ever-expanding list of health-related “social needs” to cover.
Section 1115 waivers are supposed to be budget neutral, meaning federal spending under the waiver cannot exceed what it would have been without the waiver. But, as the Government Accountability Office has noted, CMS budget-neutrality determinations are lax, “lack transparency” and often increase federal financial liability. And new, more flexible CMS policies allow purported savings from previous waiver cycles to offset federal spending for new waivers.
The Centers for Medicare and Medicaid Services is also creating Medicare Advantage models that will include benefits like meal delivery and rental support.AP Photo/Pablo Martinez Monsivais, File
Indeed, Medicaid has been on GAO’s “list of high-risk programs” since 2003, “in part because of concerns about inadequate fiscal oversight, including oversight of section 1115 demonstrations.”
Team Biden is not stopping with Medicaid either. CMS’s Center for Medicare and Medicaid Innovation announced it’s developing Medicare Advantage models that address the social determinants of health by providing supplemental benefits such as nonmedical transport, meal delivery and rental support to some 3.7 million “underserved” MA enrollees.
It’s also testing a Health-Related Social Needs Screening Tool for Medicare and Medicaid beneficiaries. The agency claims — without any sense of irony — that clinicians can “easily” use the eight-page, 26-question tool “as part of their busy clinical workflows with people of all different ages, backgrounds, and settings” to “inform patients’ treatment plans and make referrals to community services.”
Expanding the definition of government-funded health care is consistent with other administration actions to expand the welfare state. It has repeatedly extended the public-health emergency — an emergency President Joe Biden acknowledged is over — which prohibits states from removing an estimated 16 million ineligible beneficiaries from the Medicaid rolls. Now these beneficiaries can look forward to nonmedical benefits too.
Taxpayers should ask their elected officials why Medicaid is paying for housing, food, air conditioners and other nonmedical services. Other public-welfare programs with large federal funding streams already address these areas, and most Medicaid recipients already receive benefits from these programs.
-ADVERTISEMENT-
And Congress should ask why the administration is unilaterally subverting a medical-welfare program to cover nonmedical services that Congress has already funded. Expanding Medicaid to cover health-related social needs is a bad policy, and it’s one that Congress, not executive-branch bureaucrats, should decide.
Joel Zinberg is a senior fellow at the Competitive Enterprise Institute and director of the Paragon Health Institute’s Public Health and American Well-Being Initiative. Gary Alexander is director of Paragon’s Medicaid and Health Safety Net Reform Initiative.
Wall Street analysts will be focusing on sales of Eli Lilly and Co's newly approved diabetes drug Mounjaro when the company reports results on Tuesday, as sales of its older drugs come under pressure from increased competition and low pricing.
At least five analysts have raised their price target on the stock in the run-up to earnings on hopes that Mounjaro, which is approved to improve blood sugar levels in diabetics, will get U.S. approval for treating obesity next year.
"We remain bullish on Mounjaro's sales potential because we anticipate additional U.S. payer coverage this winter," SVB Securities analyst David David Risinger said in a research note on Monday.
The company's sales could quickly jump once Lilly gets more insurers to cover its costs, according to Risinger.
Obesity is the largest chronic health problem in the United States and also leads to many other illnesses such as liver disease and heart issues. Novo Nordisk's Wegovy is a rival treatment option for obesity.
Analysts expect Mounjaro sales of $81 million in the third quarter, months into its U.S. launch, according to Refinitiv data.
While that accounts for just a fraction of Lilly's total sales, revenue from the drug is expected to cross the $1 billion mark next year as it gains approval for obesity and other conditions.
Lilly's sales are expected to increase to $30.23 billion in 2023, versus reported sales of $24.54 billion in 2021, with Mounjaro expected to bring in $1.34 billion in sales and become the company's third-biggest selling drug, according to Refinitiv data.
Tasked with leading Democrats in their fight to keep the House, DCCC chair Maloney must now focus on his own NY race against Republican Mike Lawler
'You will have an open door to my administration,' Biden reportedly promised Rabbi David Twersky in a 15-minute phone call
Political strategist Hank Sheinkopf said Twersky is revered by Hasidic Jews in New Square and they will heed his advice and vote for Maloney if he tells them to
The phone call suggests Democrats are worried about Maloney's race which has recently been rated a 'toss-up'
President Biden called a prominent New York rabbi and offered him unfettered access to the White House in exchange for throwing his support behind Rep. Sean Patrick Maloney, chair of the Democrat's campaign arm who is locked in a tight race.
Tasked with leading Democrats in their fight to keep the House, Democratic Congressional Campaign Committee (DCCC) chair and New York Rep. Maloney must now focus on his own race against Republican assemblyman Mike Lawler on Nov. 8. It has turned into a 'toss-up' race, despite Biden carrying the district by 10 points.
'You will have an open door to my administration,' Biden promised Rabbi David Twersky in a 15-minute phone call, according to Rockland Daily. Jewish Forward reporter Jacob Kornbluh confirmed the call.
Twersky is the chief rabbi for the Hasidic sect in New Square, N.Y. in the 17th Congressional District.
The phone call came before First Lady Jill Biden heads to Mount Kisko, N.Y. on Sunday for a political finance event with Maloney.
New York-based political strategist Hank Sheinkopf said Twersky is revered by Hasidic Jews in New Square and they will heed his advice and vote for Maloney if he tells them to do so.
Sheinkopf also said the call signals trouble for Maloney.
'You don't have the President of the United States call someone for support unless you're in trouble in a political campaign,' he told the New York Post. 'If you're up by 10 points, you don't ask the president for help.'
'For all his fake bravado, Sean Patrick Maloney sure is behaving like a very scared man,' National Republican Congressional Campaign (NRCC) spokesperson Samantha Bullock told DailyMail.com. 'Maloney's fellow vulnerable Democrats are probably less than thrilled their DCCC chair is using whatever political capital he has left to try and save himself.'
Maloney's campaign could not be reached for comment on the matter.
Earlier this month Biden stumped for Democrats in Poughkeepsie, where he was joined by Maloney and New York Gov. Kathy Hochul. Hochul is facing an increasingly competitive challenge from GOP Rep. Lee Zeldin.
On Sunday Hochul met with ultra-religious Jewish leaders in Rockland County as she fights for the orthodox Jewish vote against Zeldin, who is Jewish.
Jewish groups hailed Maloney's win over progressive challenger Alessandra Biaggi in August's primary, as Biaggi had expressed support for the boycott, divest and sanctions (BDS) movement against Israel.
Meanwhile, Republicans are pouring in funds to defeat the Democrat Party leader. The Congressional Leadership Fund, a super PAC aligned with House Republican Leadership, has dumped $6 million into the race, including $4 million announced just last week.
They're shifting the focus back to crime, with ads highlighting Maloney's 2018 comments calling ending cash bail reform a 'top priority.'
The race for the newly drawn district comes after a messy redistricting process that split the DCCC chair's district in two. Instead of running in the current version of his district, he ran in the more Democratic-leaning new district where his house is located, pushing out progressive Rep. Mondaire Jones. Jones subsequently ran in a New York City district's primary and lost. Maloney's handling of the process drew sharp intra-party criticism.
Complaints also arose across the nation about Maloney over the DCCC's choice to elevate far-right candidates in Republican primaries who they believed they would have an easier time beating in general elections.
New GOP funding for Lawler led the DCCC to put up a $600,000 buy in TV ads, with some other vulnerable Democrats voicing frustration that the party has had to dip into its coffers to save its chairs rather than focusing on helping others who are under water.
Maloney also prompted questions when he paid his and his husband's personal trainer over $7,000 from campaign and taxpayer funds, as DailyMail.com first reported. A Maloney spokesperson said the trainer, Erick Ramos, was paid as a part-time driver for the congressman.
Maloney's staffing choices have raised eyebrows as to whether he used campaign funds for personal use before. In July the New York Post reported on Harold Leath, Maloney's former 'body man' or as Maloney's office calls it, 'executive assistant.'
'I was pretty much with the congressman everywhere he went within the district — if he went to a meeting, if he went out running. I would drive him everywhere he needed to go,' he told The Post.
'When I first started, my main responsibility was to make sure the congressman and his family never needed anything,' Leath recalled. 'I was to be there.'
'Everything I got paid for was either for his campaign, in the beginning, or doing something for him.'
In August, Meta CEO Mark Zuckerberg admitted on the Joe Rogan podcast that the FBI approached the company warning of "Russian propaganda" shortly before the Hunter Biden laptop story broke at the NY Post.
"Basically, the background here is the FBI, I think, basically came to us- some folks on our team and was like, 'Hey, just so you know, like, you should be on high alert… We thought that there was a lot of Russian propaganda in the 2016 election. We have it on notice that, basically, there's about to be some kind of dump of that's similar to that. So just be vigilant," Zuckerberg told Rogan.
Now, leaked documents provided to The Intercept reveal that government collusion with big tech goes much deeper.
The effort began in 2018, after former President Donald Trump signed the Cybersecurity and Infrastructure Security Agency Act in the wake of several high-profile hacking incidents, forming a new wing of DHS devoted to protecting critical national infrastructure.
The Department of Homeland Security is quietly broadening its efforts to curb speech it considers dangerous, an investigation by The Intercept has found. Years of internal DHS memos, emails, and documents — obtained via leaks and an ongoing lawsuit, as well as public documents — illustrate an expansive effort by the agency to influence tech platforms.
The work, much of which remains unknown to the American public, came into clearer view earlier this year when DHS announced a new “Disinformation Governance Board”: a panel designed to police misinformation (false information spread unintentionally), disinformation (false information spread intentionally), and malinformation (factual information shared, typically out of context, with harmful intent) that allegedly threatens U.S. interests. While the board was widely ridiculed, immediately scaled back, and then shut down within a few months, other initiatives are underway as DHS pivots to monitoring social media now that its original mandate — the war on terror — has been wound down.
Behind closed doors, and through pressure on private platforms, the U.S. government has used its power to try to shape online discourse. According to meeting minutes and other records appended to a lawsuit filed by Missouri Attorney General Eric Schmitt, a Republican who is also running for Senate, discussions have ranged from the scale and scope of government intervention in online discourse to the mechanics of streamlining takedown requests for false or intentionally misleading information. -The Intercept
"Platforms have got to get comfortable with gov’t. It’s really interesting how hesitant they remain," said Microsoft exec and former DHS official Matt Masterson in a February text to Jen Easterly, a DHS director.
Then, in a March 2022 meeting, FBI official Laura Dehmlow warned that the 'threat of subversive information on social media' could undermine support for the US government - stressing "we need a media infrastructure that is held accountable."
Twitter has denied the report, telling The Intercept: "We do not coordinate with other entities when making content moderation decisions, and we independently evaluate content in line with the Twitter Rules."
Except...
More via The Intercept:
This apparatus had a dry run during the 2020 election, when CISA began working with other members of the U.S. intelligence community. Office of Intelligence and Analysis personnel attended “weekly teleconferences to coordinate Intelligence Community activities to counter election-related disinformation.” According to the IG report, meetings have continued to take place every two weeks since the elections.
Emails between DHS officials, Twitter, and the Center for Internet Security outline the process for such takedown requests during the period leading up to November 2020. Meeting notes show that the tech platforms would be called upon to “process reports and provide timely responses, to include the removal of reported misinformation from the platform where possible.” In practice, this often meant state election officials sent examples of potential forms of disinformation to CISA, which would then forward them on to social media companies for a response.
Under President Joe Biden, the shifting focus on disinformation has continued. In January 2021, CISA replaced the Countering Foreign Influence Task force with the “Misinformation, Disinformation and Malinformation” team, which was created “to promote more flexibility to focus on general MDM.” By now, the scope of the effort had expanded beyond disinformation produced by foreign governments to include domestic versions. The MDM team, according to one CISA official quoted in the IG report, “counters all types of disinformation, to be responsive to current events.”
What's more, the DHS plans to accelerate their efforts.
According to a draft copy of DHS’s Quadrennial Homeland Security Review, DHS’s capstone report outlining the department’s strategy and priorities in the coming years, the department plans to target “inaccurate information” on a wide range of topics, including “the origins of the COVID-19 pandemic and the efficacy of COVID-19 vaccines, racial justice, U.S. withdrawal from Afghanistan, and the nature of U.S. support to Ukraine.”
Why? Racism, apparently.
"The challenge is particularly acute in marginalized communities, which are often the targets of false or misleading information, such as false information on voting procedures targeting people of color," reads the report.
Shares of Stryker Corp. fell more than 4% in the extended session Monday after the maker of surgical equipment and other medical devices reported third-quarter results above analyst expectations but lowered its profit outlook for the year, thanks to inflation and a stronger dollar. Striker earned $816 million, or $2.14 a share, in the quarter, compared with $495 million, or $1.14 a share, in the year-earlier period. Adjusted for one-time items, Stryker earned $2.12 a share. Sales rose to $4.48 billion, from $4.16 billion. Analysts polled by FactSet expected GAAP earnings of $1.77 a share on sales of $4.46 billion. "Worsening foreign currency and ongoing inflation, including premiums on spot buys for key components, pressured our adjusted earnings and will impact our full year results. We are taking additional actions to address these persistent issues," Chief Executive Kevin Lobo said in a statement. Stryker said it expects 2022 net sales to be "adversely impacted" by about 4%, and adjusted EPS down by about 35 cents to 40 cents in the year. It called for adjusted EPS between $9.15 a share and $9.25 a share for the year considering the "continued inflationary pressures" as well as a stronger dollar. In July, the company guided for adjusted EPS between $9.30 and $9.50 for the year. Shares of Stryker ended the regular trading day flat.
