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Friday, June 7, 2024

'Bariatric Surgery Linked With Lower Mortality vs GLP-1 Drugs in Study, but ...'

 

Analysis of patients with obesity and diabetes only looked at first-generation GLP-1 agonists

For people with obesity and diabetes, bariatric metabolic surgery was associated with a greater reduction in mortality compared with first-generation GLP-1 receptor agonists if the individuals had their diabetes for a decade or less, according to an observational, retrospective cohort study from Israel.

Over a median follow-up of 6.8 years, bariatric surgery among patients with this shorter diabetes duration was associated with a 62% reduction in mortality compared with GLP-1 agonists (HR 0.38, 95% CI 0.25-0.58), reported Orna Reges, PhD, of Ariel University in Israel, and colleagues.

This link became non-significant when accounting for maximal change in body mass index (BMI), however (HR 0.79, 95% CI 0.43-1.48).

"The fact that the survival advantage disappeared after adjusting for maximal weight loss during follow-up suggests that the association between treatment type and all-cause mortality is mediated by the amount of weight loss," the authors wrote in JAMA Network Openopens in a new tab or window.

As for those with a diabetes duration longer than 10 years, about a fifth of the study cohort, bariatric surgery did not yield a survival advantage compared with GLP-1 receptor agonists (HR 0.65, 95% CI 0.39-1.08), despite a long-term decrease in BMI that was greater than with GLP-1 agonists (-21.9% vs -7.2% change from baseline).

"This finding may be explained by the adverse effects of prolonged diabetes duration, which masked the benefit associated with weight reduction," the researchers explained. "This result is in line with reports of greater prevention of diabetes complications after BMS [bariatric metabolic surgery] among individuals with a shorter duration of diabetes."

Other factors like aging and the smaller sample size of patients with a long diabetes duration could have played a role in this null association, they added.

Neither treatment significantly reduced the risk for nonfatal major adverse cardiovascular events, including myocardial infarction, stroke, and ischemic heart disease:

  • Diabetes duration of ≤10 years: HR 0.74 (95% CI 0.49-1.10)
  • Diabetes duration over 10 years: HR 1.21 (95% CI 0.80-1.85)

Of note, the analysis only included first-generation GLP-1 agonists: liraglutide (Victoza; 61.9%), dulaglutide (Trulicity; 21.2%), exenatide (Byetta, Bydureon; 13.6%), lixisenatide (1.4%), insulin degludec and liraglutide (1.6%), or insulin degludec and lixisenatide (0.3%). The study did not include newer agents such as semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound), which are known for their more substantial weight-loss effects.

Reges and colleagues used electronic health record data from Clalit Health Services, the largest healthcare organization in Israel, and included 6,070 members ages 24 and older with diabetes diagnosed after age 21. All had a BMI of 30 or greater. They underwent bariatric surgery or received GLP-1 receptor agonists from January 2008 through December 2021, and were matched 1:1 by age, sex, and clinical characteristics

Mean age was 51, and 64.9% were women. Most had hyperlipidemia and/or hypertension at baseline. Mean Hba1c levels were significantly higher at baseline in GLP-1 agonist users versus surgery patients (9.1% vs 7.5%). Some exclusion criteria included cancer diagnosis in the 2 years prior, end-stage kidney disease, pregnancy, and a history of ischemic heart disease, ischemic stroke, or congestive heart failure.

Bariatric surgeries included laparoscopic banding (12.4%), Roux-en-Y gastric bypass (46.4%), and laparoscopic sleeve gastrectomy (41.2%). GLP-1 agonists were taken for at least 6 months within a period of 12 consecutive months.

Models were adjusted for diabetes duration; age; ethnicity; BMI; HbA1c level; socioeconomic status; diagnosis of atrial fibrillation, hyperlipidemia, and hypertension; smoking status; and use of renin-angiotensin system agents, lipid-modifying agents, insulin, SGLT2 inhibitors, and other blood glucose-lowering drugs.

Individual types of bariatric surgery weren't compared with types of GLP-1 receptor agonists, which was a limitation to the study, Reges and team noted. Furthermore, patients who switched between the treatments were excluded, but initiation of GLP-1 agonists after bariatric surgery could be a signal that the surgery wasn't successful.

Disclosures

Reges and co-authors reported grants from the Israel Science Foundation, the NIH, and the American Heart Association, and relationships with Novo Nordisk, Eli Lilly, and Boehringer Ingelheim.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowDicker D, et al "Bariatric metabolic surgery vs glucagon-like peptide-1 receptor agonists and mortality" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.15392.


https://www.medpagetoday.com/endocrinology/diabetes/110538

New Medicaid Regulations Unlikely to Improve Accessibility and Transparency

 On April 22, 2024, the Center for Medicare and Medicaid Services (CMS) released a new rule that purportedly “enhances quality and fiscal and program integrity standards.” Unfortunately, this rule will likely increase Medicaid expenditures without achieving most of its stated goals.

Managed Care and “State‐​Directed Payments”

Most of the CMS’s new rules contain regulations on Medicaid managed care and state‐​directed payments. Explaining these terms will be essential in understanding the new rule’s shortcomings.

In the early 1980s, states began contracting with insurance companies to provide Medicaid care. This new delivery system, called “managed care,” was supposed to reduce the growth of Medicaid expenditures. By 2011, most states had adopted the system. Figure 1 shows that such cost savings did not occur. 

In managed care, states pay for services through a per‐​member monthly premium. This replaced an older delivery system called “fee‐​for‐​service,” whereby Medicaid paid providers for each specific service.

The switch from fee‐​for‐​service to managed care led to major problems for states. Generally, in a fee‐​for‐​service setting, Medicaid pays lower than Medicare and private insurance. To compensate, state Medicaid agencies provided hospitals with additional cash on top of their Medicaid patient revenues. The federal government forbade the sum of these additional payments and base Medicaid rates from exceeding what Medicare would have paid for the same services. As such, these payments came to be known as the “upper payment limit” (UPL) payments.

States could finance UPL payments using “hold‐​harmless arrangements.” As described in Figure 2, these arrangements exploit the Federal Medical Assistance Percentage (FMAP) to gain more money from the federal government. States liked hold‐​harmless arrangements, as it allowed them to receive more federal funds. Providers liked them because they would receive more revenue through increased reimbursement rates.

Historically, states with managed care could not make UPL payments as managed care payments were made through premiums and not by service. This meant that switching to managed care would have closed off hold‐​harmless arrangements.

The situation changed in 2016 when the federal government allowed state Medicaid agencies to direct additional provider payments through contracted insurance companies. These payments came to be known as “state‐​directed payments” (SDPs).

From 2017 to 2023, SDP expenditures grew from $10 billion to $69 billion, representing a compound annual growth of 38 percent. Multiple organizations, like the GAO and Medicaid Access and Payment Commission (MACPAC), have expressed concern about this rapid escalation. A large portion of the CMS’s new rule was written in response to these concerns.

The CMS’s New Rules

The first major SDP regulation found in the CMS’s new rule sets “a regulatory limit on the total payment rate using the ACR (average commercial rate) for inpatient hospital services, outpatient hospital services, qualified practitioner services at an academic medical center, and nursing facility services.”

The CMS believes that this reform will increase Medicaid expenditures, stating that “at least two thirds of the SDP submissions intended to raise total payment rates up to the ACR.” The CMS sees some value to this, claiming that rate increases will incentivize more providers to participate in managed care networks, thus increasing Medicaid accessibility.

The CMS’s claim is tenuous. It is unclear whether increasing Medicaid reimbursements improves Medicaid accessibility. In fact, a 2020 survey of physicians’ Medicaid acceptance found that the main barrier for accepting new Medicaid patients was capacity. Reimbursement rates were a tertiary concern. Moreover, a 2005 study found that the “effects of Medicaid fees on Medicaid acceptance are substantially lower in areas with high Medicaid managed care penetration and for physicians who practice in institutional settings.” Any rate increases, especially through managed care, are unlikely to increase accessibility.

In fact, increased Medicaid rates may also increase healthcare prices for other consumers. North Carolina’s SDP program increases Medicaid prices to 226 percent of Medicare rates. Much of this increased revenue goes to hospitals. According to Johns Hopkins professor Ge Bai, hospitals can then use “SDPs to subsidize and bolster physician practices they own, gaining a competitive advantage over other physician practices.” Acquisition lowers competition, which directly reduces the ability for insurers to negotiate lower prices for their members.

The CMS will also require states to “ensure that participating providers in an SDP arrangement attest that they do not participate in any hold‐​harmless arrangement for any health care‐​related tax.” (This regulation will not take effect until 2028.) The CMS also explicitly requires all SDP financing to conform “with all Federal legal requirements for the financing of the non‐​Federal share.”

The CMS believes that this regulation will improve program transparency and end hold‐​harmless arrangements.

However, seeing how this new regulation would increase transparency is hard. The CMS, for one, does not require these attestations to be made public. They will only be reviewed by government bureaucrats, who are not necessarily the model of transparency. Moreover, the hold‐​harmless attestations are simply that: attestations. This regulation does not change the underlying incentives for providers and states to enter into hold‐​harmless deals.

Moreover, making SDPs conform to federal regulations will probably not end hold‐​harmless arrangements. In general, federal regulations ban hold‐​harmless arrangements. An exception is made if the hold‐​harmless arrangement costs less than six percent of the provider’s revenues. A 2021 MACPAC review found that the vast majority of states’ arrangements cost less than this level. This rule will most likely lead states to restructure their hold‐​harmless arrangements to fit the six percent loophole.

Time for Congressional Action

The CMS’s new regulations are unlikely to accomplish any of its goals. Increasing Medicaid reimbursement rates is unlikely to improve accessibility. It may even harm non‐​Medicaid patients. Making providers sign attestations, but not making the attestations public, will add another layer of bureaucracy. And current federal regulations are not robust enough to prevent the rise of hold‐​harmless arrangements. These policies also have a high price tag of $50–220 billion over the next decade.

Congress needs to correct the careless policymaking of CMS bureaucrats. Closing the six percent loophole and other sensible Medicaid financial reforms may reduce Medicaid expenditures by $1.4 trillion over ten years. However, Medicaid has become too complicated. Congress should go further and consider turning Medicaid into a block grant program. My colleagues Chris Edwards and Michael Cannon have written extensively on the fiscal benefits of block‐​granting Medicaid.

https://www.cato.org/blog/new-medicaid-regulations-unlikely-improve-accessibility-transparency

Brazil Finance Chief Remarks Fuel Fiscal Worries, Roiling Assets

 

  • Haddad expressed concern in Friday meeting with investors
  • Swap rates surged as minister sought to contain damage

Brazil Finance Minister Fernando Haddad expressed concern about the country’s fiscal outlook during a Friday afternoon meeting with investors, tanking assets and sparking a public attempt to contain the damage.

Haddad told investors that he would need to make significant spending cuts to hit the country’s fiscal target if Congress does not approve revenue measures he has proposed, according to multiple people with knowledge of the matter. He also spoke about the importance of discussing other ways to reduce spending, including delinking pension benefits from minimum wage increases, the people said.

https://www.bloomberg.com/news/articles/2024-06-07/brazil-finance-chief-remarks-fuel-fiscal-worries-roiling-assets

Biden Claims He Knew Putin As A Young KGB Agent

 In the mid-1980s Vladimir Vladimirovich Putin was an unknown but up-and-coming KGB officer in his early 30s, and a then 42-year old Joe Biden was a US Senator from Delaware. 

It was still the Cold War, and there was very little contact between Western officials and representatives of the Soviet Union, given this was still the era of an 'Iron Curtain' separating Europe. With all of this in mind, watch what now 81-year old President Biden claimed in an ABC interview from France this week:

Biden faces growing warning signs from ‘uncommitted’ vote

 President Biden lost more than half a million voters to the “uncommitted” movement in this year’s Democratic primaries, an effort that has netted 30 delegates across five states that has underscored frustration within his own party over his handling of the Israel-Hamas war.

With this week marking the last Democratic primaries in U.S. states for the 2024 election year, the “Uncommitted” movement netted 10 percent of the vote in New Mexico and 9 percent in New Jersey, a state with a significant Arab American population.

Those states fall behind Michigan, where more than 101,000 voters earlier this year cast ballots against Biden, and Minnesota, whose 45,000 votes netted the movement 11 delegates, the highest of any state.

The protest vote shows the increasingly challenging task Biden faces of pulling those voters back in before it’s too late, something Democrats say the campaign should be taking seriously.

“Of course they should be concerned,” one former Biden campaign aide said. “If they’re not planning to vote for [Biden], they’ve already been disappointed. Donald Trump is a disruptor and a change agent, so he might be an appealing  alternative for some of those people.”

Polls show Biden and his political rival former President Trump running neck and neck, including in battleground states such as Michigan — and several polls have shown Trump running just ahead of Biden.

Trump netted just a fraction of the Arab American voters that Biden did in 2020, but anger over the Israel-Hamas war could mean many of those same voters might just sit out the election this year.

The Abandon Biden movement, which is behind much of the effort for protest votes, declared Thursday “the conclusion of the primary season and our relentless march toward the general election.”

“Our mission is clear: Joe Biden must be defeated,” the group said in a press release. “We will not stand by. We are mobilized, we are furious, and we are committed to ensuring Joe Biden is defeated in the general election. The time for accountability is now.”

Since the protest vote effort was launched, Biden has offered a cease-fire deal that would, for the first time, lead to a lasting end to the war in Gaza — but that has done little to appease some of those behind the effort to go against the Democratic president.

While those angered by Biden’s handling of the war told The Hill in November that the president could still work to earn their vote, Abandon Biden’s rhetoric has become a full-throated refusal to vote for the presumptive Democratic presidential nominee in November.

The movement said Thursday that “Biden’s speeches are nothing but Diplomacy Theater, a grotesque display of blame-shifting while the massacre rages on” and that Israel’s “death machine is fueled by Biden’s policies.”

Trump, meanwhile, has called Biden “weak” on Israel and vowed to “fix his mess” if he returns to the White House, though he remains short on specifics on how he would do so. The 45th president’s Middle East policies also angered many Arab Americans, highlighted by Trump’s policy of banning people from Muslim-majority countries from traveling to the U.S.

The 30 delegates earned by the “Uncommitted” vote spans five states, with Minnesota granting 11 delegates, Kentucky and Hawaii granting seven delegates apiece, Missouri granting three delegates and Michigan granting two delegates. 

Michigan voters, however, turned out the most out of any state, with more than 100,000 votes cast. A total of 650,000 votes were cast across those states.

Biden may also be facing a problem with lawmakers of his own party.

One Democratic lawmaker, who asked to not be identified, told The Hill that some of their colleagues, such as Rep. Rashida Tlaib (D-Mich.), are telling people not to vote for Biden over his handling of the war — and people are listening, adding to issues for the Biden campaign.

Tlaib, a progressive lawmaker, said earlier that year she was “proud” to vote uncommitted in the Michigan primary to voice her frustration over the war in Gaza.

“The president obviously has to reach out to uncommitted voters and appeal to their concerns,” said David Castagnetti, who was top liaison to Congress for former Democratic nominee John Kerry’s presidential run.

He reiterated the notion, however, that polling indicates voters are more concerned about the economy than foreign policy issues in this cycle — an argument the Biden campaign has also used to address the protest vote.

New York Times/Siena College/Philadelphia Inquirer poll conducted from April 28 to May 9 found Trump leading in five of the six battleground states and found the economy was the most important issue deciding who people will vote for in November, with foreign policy ranking the ninth most important issue.

Arab and Muslim Americans and young Americans are the most prominent uncommitted voters, but many Black and Hispanic voters, who were critical to Biden’s win in 2020, are also voicing concerns.

The NAACP said Thursday that Biden could build his support with Black voters if he halts sales of weapons to Israel. A poll from In Our Own Voice: National Black Women’s Reproductive Justice Agenda with PerryUndem found 24 percent of Black voters identified the Israel-Hamas war as “extremely important” to them ahead of the election.

While there’s the threat of these voters staying home or voting for a third-party candidate, Biden can make up for losing them by expanding to moderate voters, some say.

“The trap for the Biden team is the temptation to overtly appeal to these stray Democratic primary voters on the far left. They will never be satisfied,” said Jim Kessler, executive vice president for policy at Third Way.

“The gold mine of new votes for Biden will be in the center. Biden has to continue to make a strong case about securing the border, reducing crime and bringing inflation down. That’s the ticket,” he added.

The idea for Biden to expand his campaign to not rely only on the voters who won him the White House in 2020, which includes progressives who may be voting against him over Israel, comes as Biden is polling 0.8 percentage points behind Trump, according to an aggregation of polls from Decision Desk HQ/The Hill.

When asked about the uncommitted movement, with the Democratic primaries being all but over, the Biden campaign responded, “The President believes making your voice heard and participating in our democracy is fundamental to who we are as Americans.”

“He shares the goal for an end to the violence and a just, lasting peace in the Middle East. He’s working tirelessly to that end,” a campaign spokesperson added.

While voters angered by Biden’s handling of the war in Gaza have to decide whether they’d prefer another Trump White House over Biden, Democrats also point to protest votes against Trump as something he also has to worry about.

“Since Super Tuesday and [former South Carolina Gov. Nikki] Haley’s exit from the race, Donald Trump has won 80 percent of the vote, while Biden has won 87 percent. It shows that both candidates have work to do, but Trump has significantly more,” Kessler said.

https://thehill.com/homenews/campaign/4708708-uncommitted-biden-protest-vote-democratic-primaries/

'CNN host, Dr. Phil disagree over Trump trial details'

 CNN’s Abby Phillip and “Dr. Phil” McGraw disagreed over former President Trump’s hush money trial on air Thursday evening, with the host eventually saying she doesn’t understand how he came to his opinion.

McGraw joined Phillip shortly after sitting for an interview with Trump where they discussed the specifics of the former president’s trial, just a week after the guilty verdict was handed down.

“You’re clearly sympathetic to Trump, but you believe that he should drop this talk of revenge. Did he commit to not pursuing that if he was elected president?” Phillip asked about their interview.

McGraw answered by saying he would be sympathetic to President Biden, too, if he was the one in that situation.

“Well, first of all, I’m sympathetic to what Trump has gone through in this particular trial, because I think it was not proper due process for him,” McGraw responded. “I would say the same thing if was Biden or anyone else in that process. So, I want to be clear.”

Phillip then pressed the famous talk show therapist, asking why he thought Trump didn’t get due process in the criminal case that resulted in his historic conviction.

“I mean, the proceedings — we have reporters in there; I was in there for a lot of it. There was a judge and he adjudicated a lot of these questions,” Phillip said. “Why do you think he wasn’t given a fair process?”

“Well, I think it’s a number of things. I think they’re, from a jury standpoint. And again, let me be clear: I’m not a lawyer. I look at it in terms of what the jury was given to solve this puzzle,” he said. “And I think they heard some things that were very prejudicial that had nothing to do with solving the problem of the case at hand.”

McGraw continued, hinting that Trump’s former fixer, Michael Cohen, testifying in the case as “someone that is considered to be an accomplice” is not appropriate.

Cohen, a star witness in the case, paid porn actor Stormy Daniels to keep quiet ahead of the 2016 election about her alleged affair with Trump. Cohen pleaded guilty in 2018 to federal campaign finance charges and was sentenced to three years in prison.

Phillips responded, saying it’s not uncommon for accomplices to testify in subsequent trials for their alleged co-conspirators.

“That’s kind of how a lot of these prosecutions work,” she said.

McGraw responded by pressing Phillip to give him examples of when that has been considered appropriate. She said prosecutors are working to prosecute organized crime “all the time” and rely on co-conspirators often.

“I just, I don’t understand how you can say that because someone … was not prosecuted, that signed a nonprosecution agreement … that information or their testimony cannot be presented before the jury if they were a part of the alleged crime,” Phillip continued.

The host pressed McGraw if he was saying Cohen should not have been allowed to testify in Trump’s trial.

“No, that’s not what I’m saying. I said what I said. I think the fact that he made an agreement to say that he is guilty of the crime that the defendant is being tried for prejudices the jury that ‘Hey, here’s someone that’s supposedly an accomplice that has said, I’m guilty of this,’” McGraw said. “That prejudices a jury about the person that’s currently on trial for the same crime.”

Phillip disagreed, noting Cohen was not charged with and prosecuted for falsifying business records, as Trump was.

Phillip then attempted to steer the conversation back toward McGraw’s recent interview with Trump.

https://thehill.com/regulation/court-battles/4709140-cnn-host-dr-phil-disagree-trump-trial/

'Trump hush money judge flags Facebook user claiming early knowledge of verdict'

 The judge overseeing former President Trump’s hush money criminal case informed the parties Friday that a person on Facebook claimed to have advance knowledge of the verdict in the case.

Judge Juan Merchan wrote to Trump’s attorneys and the Manhattan district attorney’s office that on May 29 — the day 12 New Yorkers began deliberating Trump’s case and a day before he was convicted — a Facebook user left the comment on the New York State Unified Court System’s page. 

“My cousin is a juror and says Trump is getting convicted,” the comment read, along with a celebrating emoji. “Thank you folks for all your hard work!!!!” 

It’s unclear whether the user was being facetious or speaking truthfully about their relation to one of Trump’s jurors, but on their personal page, they described themself as a “professional s‑‑‑ poster” — a term that generally refers to trolling on the internet.  

The Hill identified a second comment by the Facebook user, made on May 29, that celebrated “hard (work) against the MAGA crazies” and again suggested that the user’s cousin was a juror and planned to convict.  

A commenter in that exchange wrote that, if true, the Facebook user had implicated their cousin in a crime, to which the user replied: “Now we are married,” in apparent reference to their supposed cousin.  

The Hill has requested comment from the Facebook user in question.  

In a statement, court spokesperson Al Baker said the court notified the parties about the comment once it learned of it “as appropriate.”

“Take it easy, I’m a professional sh**poster,” the user wrote Friday in a social media post. They also added a definition of the word, which the user said means to post content that is “aggressively, ironically and trollishly poor quality.”

“Sh**posts are generally intentionally designed to derail discussions or cause the biggest reaction with the least effort,” they wrote.

Trump was convicted on 34 counts of falsifying business records on May 30 after the jury deliberated for about 11 hours.  

Jurors were instructed not to discuss the facts of the case with anyone — including the judge — once the trial was underway. Under New York law, a breach of that agreement could serve as grounds to set aside the jury’s verdict.  

Trump, who pleaded not guilty, has vowed to appeal his conviction. His sentencing is scheduled for July 11, just days before he’s set to become the Republican Party’s official presidential nominee.

The Hill requested comment from Trump’s attorneys and the Manhattan district attorney’s office. 

https://thehill.com/regulation/court-battles/4710930-trump-hush-money-judge-flags-facebook-user-claiming-early-knowledge-of-verdict/