The Centers for Medicare and Medicaid Services on Wednesday warned all 50 states that children may be improperly losing their health coverage under Medicaid and the Children's Health Insurance Program (CHIP). All states must determine whether eligibility systems issues are causing people, especially children, to lose coverage under the programs when they remain eligible and act immediately to correct the problems and reinstate coverage, the regulator said. Since the end of pandemic-era waivers that modified Medicaid and CHIP eligibility requirements, states have resumed their regular process for reviewing enrollment in the programs. At least 5.5 million Medicaid enrollees have ben disenrolled since the pandemic-era waivers ended, according to health policy nonprofit KFF. CMS said it believes that eligibility systems in a number of states are programmed incorrectly and are processing automatic renewals at the family level and not the individual level, even though individual family members have different eligibility requirements. Children have higher eligibility thresholds and are more likely to be eligible for Medicaid or CHIP even when their parents no longer qualify, CMS said.
Wednesday, August 30, 2023
Why Medicare's drug pricing list didn't impact company stocks
Investor sentiment was indifferent towards the historic announcement Tuesday by the Biden Administration, which revealed the first 10 drugs that would face Medicare price negotiations next year under the Inflation Reduction Act.
Stocks for all the US-publicly traded companies on the list — Bristol Meyers Squibb (BMY), Eli Lilly (LLY), Merck (MRK), AstraZeneca (AZN), Novartis (NVS), Amgen (AMGN), Johnson & Johnson (JNJ), AbbVie (ABBV) and Novo Nordisk (NVO)— were either flat or up at the end of trading Tuesday.
Most experts weren't surprised by the drugs on the list, and prices don't go into effect until 2026. But analysts are eagerly awaiting final prices, which have yet to be negotiated.
In a note Tuesday, Goldman Sachs analysts said the minimal impact to the companies' stocks was because much remains unknown.
"We see relatively limited scope for stocks to react materially to the contents of [yesterday] morning’s announcement, given that in our view, potentially the more impactful update will come with the potential disclosure ... of CMS’ initial maximum fair price offer," the analysts said.
In lawsuits filed by companies to block or delay negotiations, plaintiffs allege there is uncertainty around what the Centers for Medicare & Medicaid Services (CMS) will determine to be a fair price.
Medicare Director and CMS Deputy Administrator Dr. Meena Seshamani told Yahoo Finance that the agency intends to engage in a "true back and forth process" for negotiations.
The goal, she said, is to figure out what the real world impact is for the drugs, so that can be taken into consideration for the price of medications.
Analysts have repeatedly said that while the CMS data shows that these drugs account for $50.5 billion, or about 20%, of Part D spend inclusive of out-of-pocket spend, some of the drugs are not necessarily top sellers for the drug manufacturers.
"Overall, [yesterday’s] update was largely expected, with key drugs included for price negotiations consisting of Eliquis (BMY) and Imbruvica (ABBV), although the inclusion of Stelara was somewhat unexpected. With biosimilars expected in 2025, however, we do not see this having a large impact on JNJ [Johnson & Johnson]," JPM analyst Chris Schott said in a note to clients.
"The rest of the drugs, meanwhile, are relatively small revenue/EPS [earnings per share] contributors to their respective stories, and we do not see any meaningful impact to our estimates from today’s update," he added.
The list included heart disease and diabetes drugs, including insulin from Novo Nordisk (NVO), some cancer drugs and J&J's autoimmune disease treatment Stelara. The latter was a surprise to experts, in part because it will face generic competition before 2026.
Senior administration officials told reporters Tuesday there could be some adjustment to the price based on generic or biosimilar competition hitting the market before September 2024, when the prices are published, but the list would remain the same through 2026 at the least.
Leerink Partners estimates the limited impact is also due to the prices only lasting a year, before CMS begins the process again for 2027.
"JNJ’s Xarelto and NVS’s Entresto will only be affected for 1 year since they are both expected to lose exclusivity in 2027. If generics are approved for Xarelto or Entresto prior to Mar. 31, 2027 then either would be deselected on Jan. 1, 2028. MRK’s (Graybosch, OP) Januvia and AZN’s Farxiga both have [patents expiring] in 2026, thus minimizing the price control impact of these products given the likelihood of imminent generic entry," Leerink analysts said in a note.
Meanwhile, until Medicare negotiations start in February, there are several lawsuits that have been filed by drug companies and trade groups calling the process unconstitutional, in hopes of delaying or derailing negotiations.
Neera Tanden, domestic policy advisor to President Joe Biden, told reporters Tuesday that the government's health agencies negotiate prices for other parts of the health care system all the time.
"The only reason why Medicare has not been negotiating drug prices is because pharma got a sweetheart deal decades ago to basically prohibit negotiations. Negotiations are part of market systems; it's very normal," Tanden said.
The Congressional Budget Office estimates $90.5 billion in savings over 10 years to the Medicare program through these negotiations. Analysts expect roughly 40% reduction in prices for drugs from the negotiations.
In response to the companies trading flat on the news Tuesday, Seshamani said, "I think we know that the pharmaceutical industry is strong and thriving and innovates and will continue to innovate."
CEO of Cutera Purchased $297K In Stock
Taylor C Harris, Chief Executive Officer at Cutera
, reported a large insider buy on August 30, according to a new SEC filing.
What Happened: A Form 4 filing from the U.S. Securities and Exchange Commission on Wednesday showed that Harris purchased 30,000 shares of Cutera. The total transaction amounted to $297,300.
Cal. school district settles with mom for $100K after school ‘transitioned’ daughter without her consent
In what’s been called a landmark victory for parental rights, a California school district has settled for $100,000 with a mother who said her daughter was “socially transitioned” to a boy without parental knowledge or consent.
Jessica Konen said her 11-year-old daughter, Alicia, was told by her school in the Spreckels Union School District in Monterey County that she may be upset because she didn’t know who she “truly was inside.”
From there, the school allowed her to use the boy’s bathroom, used male pronouns to refer to her and was “socially transitioned” away from her biological gender.
Once Konen found out that her daughter was being identified as a male and socially transitioning without her knowledge, she sued the district.
Her daughter has since decided to re-identify as a girl, and the California single mother vowed to keep fighting for parental rights after the settlement in which she was represented by the Center for American Liberty.
“They need to understand their place, and they need to stay in their place. And schools nowadays, they’re awful. So, I’m going to fight this fight and keep fighting this fight,” Konen told Fox News Digital.
“I am not going to allow this to keep happening to children,” Konen continued.
“I feel that the fight, it has to continue.”
The Spreckels Union School District is not admitting fault with the settlement.
But it’s nonetheless a significant moment amid the nationwide debate over parental rights related to schooling decisions that affect children.
“At its core, this case is about upholding the sacred bond between parents and their children,” Mark Trammell, Executive Director of the Center for American Liberty, told Fox News Digital.
“Parents have an inherent right to be involved in pivotal decisions concerning their children’s lives.”
Konen said she avoided pronouns at first, calling her daughter by terms such as “sweetie” and “kiddo” instead of making a potentially offensive comment.
Their relationship was strained as a result, but she said they are doing great now and are eager to work together and help remove “the parental secrecy” out of schools.
“I think it took a lot of guts for both of us to be able to open up publicly and explain what is happening,” Konen said.
“Parents, be vigilant, you know, pay attention. Those gut feelings you have, they’re real. I feel like this just opened doors.”
Ultimately, Konen feels she received justice with the settlement and hopes other parents can learn from her experience.
“We definitely are going to be at peace and be able to try to move on from this. But parents, pay attention, ask the questions that are offered. Put yourself in uncomfortable situations because you don’t know what someone’s going through. You don’t know what they’re teaching in schools anymore,” Konen said.
“Just be active in your kid’s lives and don’t be scared to speak up.”
The Spreckels Union School District did not respond to a request for comment.
Biden Looks To Prevent Future President From Ending Ukraine War
by Dave DeCamp via AntiWar.com,
The Biden administration is working to reach a deal with Ukraine for long-term military support to keep backing the war with Russia that would be difficult for a future president to exit, The Wall Street Journal reported on Tuesday.
The effort is part of a commitment made by G7 nations at the recent NATO summit in Vilnius to negotiate their own bilateral security deals with Ukraine. Besides the G7 nations, 18 other countries have agreed to provide long-term military support for Kyiv.
The idea of the long-term commitment is to show Russia that it can’t wait out the Biden administration. The Journal report reads:
"Western officials are looking for ways to lock in pledges of support and limit future governments’ abilities to backtrack, amid fears in European capitals that Donald Trump, if he recaptures the White House, would seek to scale back aid."
Trump, who escalated US involvement in Ukraine during his term by taking the step to provide Javelin missiles, has said he would end the Ukraine war within "24 hours" if elected in 2024. The former president is the current frontrunner for the Republican nomination.
The Journal report acknowledged that the Biden administration could not legally bind a future president from exiting a deal with Ukraine, but Republican hawks in Congress could make it difficult.
During his time as president, Trump withdrew from the Iran nuclear deal, but the majority of Republicans in Congress supported exiting the agreement.
A US official told the Journal that one proposal being considered for Ukraine would be a memorandum of understanding (MOU), which would not require congressional approval. President Biden has previously floated the idea of an "Israel model" for Ukraine.
The US provides Israel with $3.8 billion in military aid each year under a 10-year MOU but does not provide mutual defense guarantees. The Journal report said that French officials have suggested military aid commitments for Ukraine should be over a four-year period.
https://www.zerohedge.com/geopolitical/biden-looks-prevent-future-president-ending-ukraine-war
Downgrades to Aravive: Grapples With Trial Setback, Strategic Alternatives
Last week Aravive Inc
filed its quarterly 10Q for the quarter ended 30 June with the SEC.
To preserve cash, the company terminated Phase 1b/P2 trials of batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC) and pancreatic adenocarcinoma. It will not continue either the ccRCC or the pancreatic adenocarcinoma programs unless it raises additional capital.
Earlier this month, Aravive's Phase 3 AXLerate-OC trial evaluating batiraxcept in platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in the pre-specified subset of patients naïve to prior bevacizumab treatment.
Advancing ccRCC or pancreatic cancer program would require the company to raise significant additional capital or engage a strategic partner, which would be very difficult in light of recent PROC trial results and market conditions.
Aravive estimated that a Phase 2 clinical trial of batiraxcept in renal cancer patients will require funding of between $30-$50 million and that a Phase 3 clinical trial of batiraxcept in ccRCC patients will require funding of between $80-$100 million.
The company is exploring various strategic alternatives.
Suppose the company does not raise capital or successfully engage a strategic partner in the next several weeks. In that case, Aravive will be forced to cease operations, liquidate assets and possibly seek bankruptcy protection or engage in a similar process.
In August, the company's Board of Directors approved a workforce reduction of approximately 70% of the current employee base.
Cantor Fitzgerald downgraded the ARAV stock to Neutral from Overweight (OW) and lowered the price target to $0.25 from $18, driven by removing sales for batiraxcept.
Following the setback in platinum-resistant ovarian cancer, William Blair downgraded the stock to Market Perform.
The analysts Andy Hsieh and Alexandra Ramsey say that based on the minimal clinical activity of batiraxcept observed in the Phase III AXLerate-OC trial, confidence in its potential success in other indications is reduced.
Given the capital constraint, William Blair views the prospect of reinvigorating the batiraxcept program as unlikely, and it does not have sufficient visibility into management's plans to hold a favorable rating on the stock.