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Monday, September 9, 2024

Has The Electricity Reality Check Arrived?

 by Todd Snitchler via RealClearEnergy,

At meetings of energy regulators, policymakers, consumer advocates, and industry this summer, the content and tone of the conversations around electric system reliability have changed dramatically. Executives from across the industry all agree that dispatchable generation is needed now and will be needed for many years to come.

Most prominently, the realization and willingness to say publicly that dispatchable resources like natural gas-fired generation will be needed as the energy expansion continues and load growth accelerates for the first time in decades is a welcome admission.

For several years the discussion around the future of the electrical grid was about how inexpensive it will be and how “out of political favor” resources would be moved off the grid in favor of politically favored ones without creating any disruptions or reliability challenges. And just like that, the story has changed – dramatically. Why?

First, load growth – and a substantial amount of it is expected in the short term. The second is the pace of dispatchable generation retirements, without replacement generation with similar performance characteristics. The third is consistent and increasing warnings coming from reliability organizations and grid operators that a crisis is coming and coming quickly if system planning does not improve.

What does this mean? In short, it is a long-awaited recognition of the reality of grid operations combined with the acknowledgment (albeit grudgingly in some circles) that dispatchable resources, like natural gas, will need to be retained and operated for a longer time horizon than many were willing to admit. This recognition matches the significant number of credible studies, including work done by McKinsey and EFI, that all said dispatchable natural gas generation would be needed even in a high renewable resource penetration scenario.

As the reality of load growth, supply chain issues, permitting, siting, and construction challenges impacting all types of resources settled in and the sharp warnings of imminent reliability issues combined, it became clear that the rhetoric was far ahead of reality. Recognizing the problem is the first step in solving it.

Because all resources are now accountable for reliability, including dispatchable, intermittent, and storage resources, the requirement to acknowledge and adapt to grid realities is no longer optional – it’s mission critical. The retirement of significant amounts of dispatchable resources without adequate replacements has pushed us ever closer to a system with zero margin of error. 

To correct this situation, policymakers and regulators should take steps to minimize the risk to customers. First, the timing gap between retirements and additions to the system must be addressed; we can’t let existing resources off the grid before the replacements are ready. The process for connecting new generation to the grid must be reformed to ensure projects match system needs, not just policy pronouncements. Permitting and siting reforms are needed so we can deliver development of all types of energy projects.

Second, policymakers must temper enthusiasm and set goals that align with the reality of system needs and operational constraints. This could mean pausing policies that hinder the deployment of needed resources or including offramps in legislation to ensure grid reliability.

Third, grid operators must move more quickly to adjust markets to send the appropriate signals that will drive investment of the required resources. States must recognize the broader benefits of market participation and positive outcomes for their constituents and stop merely demanding grid operators do what one state wants to the detriment of another. States must again appreciate that the benefits of their utilities joining markets far outweigh their ability to dictate resources and timelines and then disclaim responsibility for the issues those decisions create.

To close, lest anyone accuse market participants of not wanting to reduce emissions or only wanting to profit from their current resources, this reality check in no way means walking away from striving to meet policy goals. Bottom line – we can set goals, but they must be tethered to operational reality to ensure success and reliability are both achieved.

Todd Snitchler is President and CEO of the Electric Power Supply Association (EPSA)

https://www.zerohedge.com/energy/has-electricity-reality-check-arrived

In "Last Hurrah", Credit Card Debt Soars Amid Record High APRs, Record Low Savings Rate

 One month ago, when multiple discount retailers (here and here) were lamenting the sudden collapse in US consumer purchasing power, we observed the reason this unexpected hit to US consumption: as the US personal savings rate had collapsed, the growth in consumer credit was slowing, and in July, credit card debt growth posted its first decline since the covid crash, just in time for another month of record high credit card rates.

But fast forwarding just one month later, when in a stunning reversal, July consumer credit growth unexpectedly reversed the dramatic June slowdown, and soared more than $25 billion, to a new record high of $5.093 trillion.

Looking at the components, the sudden spike in revolving credit was most notable as credit card debt growth suddenly reversed its recent slowdown, surging by $10.6 billion, the biggest monthly increase since February and the 2nd biggest of the year.

But what may be even more notable is that after two years of gradual declines in the monthly rate of increase, non-revolving credit suddenly surged by almost $15 billion, ir biggest increase since June 2023 and second biggest since late 2022!

A closer look at the surge reveals that in Q2 there was also a reversal in the two components that make up non-revolving credit as total student debt unexpectedly dropped by $8.3 billion to $1.745 trillion, a reversal from the $24.2 billion increase in the previous quarter. At the same time, Car Loans accelerated, and after declining by $0.8 billion in Q1, rose by $8.5 billion in the second quarter.

And while the Fed's first rate cuts is not just a matter of time, with Powell expected to cut the Fed Funds rate by 25bps on Sept 18, we have previously observed just how sticky consumer credit is on the way up, and how slow it is to decline on the way down. Sure enough, the sudden surge in credit card debt was a big surprise because according to the Fed, the average rate on interest-bearing credit card accounts just hit a new record high of 22.76%, which is a vivid reminder that while banks are happy to hike credit card rates, they rarely if ever cut them.

Yet with consumers ever more strapped for actual cash and equity, as the personal savings rate in the US collapses from over 5% to 2.9% - the lowest since the Lehman bankruptcy - in just one year, as all the excess savings from covid are long gone...

... there is only so much more credit card maxing out that can take place before reality finally sets in, as can be seen in the next and perhaps most striking chart yet: total credit card debt is at an all-time high while the personal savings rate is record low!

Then again, with the election less than two months away - one which ensures that any credit-card fueled spending must be encouraged - don't be surprised if the White House directly orders banks to just ignore soaring delinquency and charge-off rates...

... only for the credit shock hammer to fall on the first day of Trump's new presidency.

https://www.zerohedge.com/economics/last-hurrah-credit-card-debt-unexpectedly-soars-despite-record-high-aprs-savings-rate

Blinken Visited Haiti As US-Backed Police Fail To Wrestle Control From Gangs

 by Kyle Anzalone via The Libertarian Institute,

Secretary of State Antony Blinken recently traveled to Haiti to show support for the US-backed government and Kenyan police in their struggle for legitimacy. As the Kenyans have been unable to take Port-au-Prince from the gangs and paramilitary groups, the White House is considering changing the status of the mission in Haiti to a UN Peacekeeping force. 

According to the Washington Post, Blinken’s trip to Haiti is an "unusual attempt to boost the country’s interim leader and deliver a message of support for a US-backed international policing mission that has so far failed to make a significant impact."

After Haitian President Jovenal Mosie was assassinated in 2021, the Joe Biden administration backed Ariel Henry’s claim to power in Port-au-Prince. Under Henry, Haiti descended into chaos, with paramilitaries and gangs taking control of most of the capital city. 

In response, the White House and Henry worked out a plan with Nairobi to have armed Kenyans deployed to Haiti to take control from the armed groups and transfer it to the US-backed government

However, the plan backfired, and gangs shut down the airport in Port au Prince while Henry was in Nairobi inking the deal to have the Kenyan soldiers – dubbed police – deployed to Haiti, and he was unable to return to the country. 

The White House then pulled support from Henry and forced his resignation. Then, Washington formed a new government headed by Prime Minister Garry Conille.

Under Conille, the Kenyan police finally arrived in Haiti with US financing and military equipment. So far, Nariobi’s security force has failed to have a major impact on the ground and Conille’s government has not gained legitimacy among Haitians. 

With its Haiti policy failing, the White House is seeking to escalate the Kenyan mission to Haiti by declaring the police official UN Peacekeepers. Brian A. Nichols, U.S. assistant secretary for Western Hemisphere affairs, affirmed the Biden administration was considering pursuing that path. 

"A (peacekeeping operation) is one of the ways we could accomplish that," he said. "But we are looking at multiple ways."

Washington will likely struggle to gain support for the UN Peacekeeping mission from both the Security Council and Haitians. Peacekeepers have a dark legacy in Haiti, including causing a cholera outbreak that killed over ten thousand people and committing rampant acts of sexual violence against women

https://www.zerohedge.com/geopolitical/secretary-blinken-visits-haiti-us-backed-police-fail-wrestle-control-gangs

Unitedhealth to Launch 'Gold Card' Program to Skip Prior Authorization

 Physicians frequently cite prior authorization requirements as a significant source of administrative burden. Now, UnitedHealthcare, one of the largest U.S. insurance companies, says it will launch a national "Gold Card" program in an effort to improve the process.

The program -- set to launch October 1 -- is part of the company's efforts to "modernize the prior authorization process and simplify the healthcare experience for consumers and providers," a spokesperson for UnitedHealthcare said in an email.

"Provider groups don't need to apply to be part of the UnitedHealthcare Gold Card program," the spokesperson added. "Qualification is awarded if eligibility criteria are met."

Specifically, provider groups must be in network for at least one UnitedHealthcare plan; Gold Card status will apply across commercial, Individual Exchange, Medicare Advantage, and Medicaid plans, according to the company.

Additionally, provider groups must meet a minimum annual volume of at least 10 eligible prior authorizations each year for 2 consecutive years across eligible codes, and have a prior authorization approval rate of 92% or more across all eligible codes for each of the review years, the company noted.

Currently, a little more than 500 eligible current procedural terminology (CPT) codesopens in a new tab or window for medical services are listed online by the company, with a note that eligible codes may be added or eliminated in the futureopens in a new tab or window based on the latest clinical evidence. In total, there are more than 11,000 CPT codesopens in a new tab or window, according to the American Medical Association (AMA).

Ultimately, the expectation is that Gold Card provider groups will see a reduction in their total prior authorization request volume, according to UnitedHealthcare.

For instance, rather than the prior authorization process, provider groups will follow a notification process for eligible procedure codes that will confirm eligibility and network status, but will not require clinical information, the company said.

The move by UnitedHealthcare comes amid a bevy of efforts -- at the state and federal level -- aimed at limiting prior authorization delays and helping physicians with the burdensome process. The company did not specifically comment on whether such efforts factored into the decision to launch its Gold Card program, though it did note that the program will be effective in all states and modified, when needed, to meet state requirements.

The company "will apply the state criteria first, as required, for the applicable line of business, and then the UnitedHealthcare Gold Card program will take effect for qualifying care provider groups and codes where it does not conflict with state requirements," it stated.

In 2021, the state of Texas made wavesopens in a new tab or window when a law to exempt certain physicians from prior authorization requirements first took effect.

Then in 2023, nine states and the District of Columbia passed legislation that reformed the prior authorization processopens in a new tab or window in their jurisdictions, the AMA said.

And in January, a final rule from CMS setting time limits and other requirements related to prior authorizations drew generally positive reviews from healthcare organizationsopens in a new tab or window. However, some groups did express concerns.

A 2022 report from America's Health Insurance Plans (AHIP) detailing survey responses from 26 plansopens in a new tab or window that cover 122 million commercial enrollees stated that prior authorization programs were evidence-based, that the vast majority of plans were streamlining their prior authorization process, and that a majority of plans reported negative impacts of state regulation of prior authorization programs.

The report also noted more frequent use of gold carding by plans in 2022 than in 2019, jumping from 9% to 21% for prescription medications, and from 32% to 58% for medical services. However, Gold Card programs received mixed reviews from plans in a number of areas, such as reducing administrative burden, being easily implemented, and maintaining or improving patient safety.

AHIP did not immediately respond to a request for comment on UnitedHealthcare's new Gold Card program.

As for the AMA, its 2023 prior authorization surveyopens in a new tab or window of 1,000 physicians (400 primary care and 600 specialists) indicated that the process "continues to have a devastating effect on patient outcomes, physician burnout, and employee productivity," according to the organization.

For instance, nearly one in four physicians reported that prior authorization has led to a serious adverse event for a patient in their care, and more than one in four physicians reported that prior authorizations are often or always denied. Survey results also suggested physicians and their staff spend 12 hours each week completing prior authorizations.

"Several national insurers announced plans to voluntarily reduce the number of services that require prior authorization in 2023," the AMA further stated of its survey results. "However, despite these claims and the commitments made [in a previously issued consensus statementopens in a new tab or window on improving the process], physicians report consistently high prior authorization burdens across major health plans."

The AMA declined to comment on UnitedHealthcare's Gold Card program until the organization knows more about it.

UnitedHealthcare said last year that, in an effort to reduce the administrative burden on healthcare professionals and their staff, the company would begin an effort to eliminate prior authorization requirements for certain procedure codes that accounted for nearly 20% of the company's prior authorization volume.

However, the company has also held that prior authorization "plays an important role in reducing costs and improving quality."

Nevertheless, the company said that its new Gold Card program will help to streamline the process, and that it will continue to be evaluated to add more improvements.

https://www.medpagetoday.com/special-reports/features/111826

'NIH Stops Clinical Study After Investigating Coercion Claims'

 The NIH has stopped its study of U.S. government personnel who experienced the anomalous health incidents (AHIs) known as Havana syndrome, the agency said.

The decision was made after investigating concerns that arose about the NIH studyopens in a new tab or window that was published in JAMA in March 2024.

The investigation found that regulatory and NIH policy requirements for informed consent were not met due to coercion, the agency said in an email to MedPage Today. The coercion was not on the part of NIH researchers, the agency clarified.

"In March 2024, the National Institutes of Health initiated an investigation in response to concerns from participants who were evaluated as part of a study on anomalous health incidents, the results of which were published in the journal JAMA," the agency wrote in its email.

"The investigation was conducted by the NIH Office of Intramural Research and the NIH Research Compliance Review Committee, an institutional review board within the NIH," the email continued. "Given the role of voluntary consent as a fundamental pillar of the ethical conduct of research, NIH has stopped the study out of an abundance of caution."

The study, one of several conducted about AHIs and government personnel, reported that despite severe symptoms, no significant evidence of brain injury and no abnormalities in most clinical measures were found.

The investigation's findings did not affect the study's conclusions, the NIH said.

The agency began studying AHIs in early 2018, engaging experts and enrolling individuals in an exploratory natural history study, noted Leighton Chan, MD, MPH, of the NIH Clinical Center in Bethesda, Maryland, and colleagues in their JAMA paperopens in a new tab or window.

Before the findings were published, Tim Bergreen, JD, of the Bethesda law firm Hogan Lovells, sent an email to JAMA editors and the NIH with a document listing concerns from some study participantsThe document, which Bergreen shared with MedPage Today, included allegations about ethical issues involving participant recruitment and how medical information was handled, among other things.

AHIs have been referred to as Havana syndrome because the first cases involved American officialsopens in a new tab or window and their families living and working at the U.S. Embassy in Cuba. Since then, AHI symptoms have emerged in other countries.

Symptoms usually followed a loud noise and intense pain in the ears and head and included severe headaches, dizziness, blurred vision, tinnitus, or vertigo. In some cases, they led to persistent cognitive, sensory, and balance problems.

Two of the most comprehensive studies on AHIs involved the Havana cases in 2018 and 2019, Chan and colleagues notedopens in a new tab or window in their JAMA paper earlier this year.

In 2018opens in a new tab or window, researchers at the University of Pennsylvania in Philadelphia documented that some Havana embassy personnel experienced visual and balance problems, headaches, sleep problems, and deficits in working memory, sustained attention, and concentration.

In 2019opens in a new tab or window, the Penn team showed that Havana personnel with AHI symptoms had imaging differences in whole brain white matter volume, regional gray and white matter volume, cerebellar tissue microstructural integrity, and functional connectivity compared with healthy individuals.

The overall picture was one of "concussion without concussion," Penn researcher Douglas Smith, MD, who led the Havana clinical studies, previously told MedPage Today.

The NIH study published in 2024 was not a replication study, he pointed out. The populations and exposures were different: "It is like trying to compare apples with artichokes," Smith told MedPage Today when the study was published.

"The patients who overlapped were seen in NIH after they had rehab, so there is no comparison to their brains when they were seen at Penn, prior to any kind of treatment," Penn researcher Ragini Verma, PhD, said previously.

A number of other institutions, including the CDCopens in a new tab or window and the National Academies of Sciencesopens in a new tab or window, have studied AHIs. To date, the etiology of AHIs remains unknown. Last month, the FBI released a redacted portion of a 2019 reportopens in a new tab or window that said AHI symptoms were the result of social contagion.

The total number of people with AHIs also is unknown. At least 334 Americans, mostly intelligence community employees, have qualified for medical AHI care through a federal program run by the Department of Defense (DOD), according to the Government Accountability Officeopens in a new tab or window (GAO).

Of these, only 33 people were entered in the DOD's AHI Registry as of May 2024, GAO said. Key agencies have not signed agreements with DOD, which has contributed to the slow inclusion of AHI patients, the GAO report noted.

https://www.medpagetoday.com/neurology/generalneurology/111871

'FDA Should Do More to Ensure Food Safety'

 After a ground-beef substitute sickened nearly 400 customers in 2022, an investigation found that the illnesses were most likely from a new ingredient called tara flour, bringing to light an alarming truth: food manufacturers are not required to clear new food ingredients with the FDA.

Because of this, it's almost impossible to know if a given ingredient added to the food supply is safe, wrote Pieter Cohen, MD, of Harvard Medical School, and Emily Broad Leib, JD, of Harvard Law School, in a perspective in the New England Journal of Medicineopens in a new tab or window.

This recently became even more clear to consumers after over 150 people fell ill from mushroom-containingopens in a new tab or window candy and chocolate bars.

The FDA's Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) in 1958 required that all food ingredients be vetted for safety before being sold. But to keep commonly used substances that were "generally recognized as safe," or GRAS, like vinegar and baking powder, on the market, an alternate regulatory pathway was created.

GRAS substances are not considered food additives, and, according to the FDA, for an ingredient to be considered generally safe, "all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts."

However, Cohen and Broad Leib wrote, "the GRAS exception has increasingly been applied to not only well-known food ingredients but also various new substances used to affect the flavor, texture, or shelf life of products or used as substitutes for meat, eggs, or nuts."

Over time, they argued, this pathway has served as a loophole for manufacturers to circumvent FDA scrutiny. Under its framework, "the approach taken by a company to determine that a substance is GRAS is left to the firm's discretion; evidence isn't required to be shared with the FDA or the public," they noted, adding that while manufacturers may assemble an expert panel to assess the safety of an ingredient, they aren't required to do so.

In the 1960s, the FDA would review the safety of ingredients and publish a list of GRAS substances in the Federal Register. But in 1972, the agency eliminated independent evaluation and began letting companies voluntarily inform them of a GRAS determination.

The Center for Food Safety and Applied Nutrition filed more than 600 GRAS noticesopens in a new tab or window from 1998 through 2015, for an average of approximately 34 GRAS notices per year, including 69 GRAS notices filed during 2014 and 51 GRAS notices filed during 2015.

Cohen told MedPage Today that these notices were likely a small fraction of the total number of new food ingredients that entered the market.

He also noted that the companies that submit their safety information to the FDA are likely those that serve large portions of the market, with the resources to assemble an independent safety panel, and a legal team to uphold their reputation.

Daily Harvest, the mail-order company behind the illnesses from the ground-beef substituteopens in a new tab or window, which was comprised of French lentil and leek crumbles, may not have had this kind of infrastructure. "Tara flour is typical in terms of that process, because, like ... why would a company ever want to spend the time and energy to submit something formally to the FDA when they don't need to?" Cohen said.

Even if a company does submit a notice to the FDA and the agency asks for more safety data, the company may withdraw their notification and introduce the new ingredient anyway, Cohen and Broad Leib pointed out.

When consumer advocacy groups sued the FDAopens in a new tab or window in 2021, arguing that the pathway "allows FDA to abdicate its core duty under the FDCA ... to be responsible for the safety of the food supply," the court upheld the GRAS legal framework. In essence, they determined, the FDA was within its discretion to decide to compel companies to share safety information or not.

Cohen suspects this lack of oversight may be behind worrying long-term health trends. "Our thinking is that most of the time the new ingredients are going to do things that are subtle and long term," he added.

He pointed to a recent rise in colon canceropens in a new tab or window among younger people. "But tying it back to figure out what's going on is literally impossible these days," he said, "because no one's tracking what new ingredients are being introduced in the food supply and how much of those new ingredients are being consumed by individuals."

States like California and New York have already begun to take matters into their own hands, banning certain food additives and attempting to gather more safety information from food manufacturers.

Cohen and Broad Leib argued that the FDA should be more proactive in its approach, requiring manufacturers to share all new GRAS determinations with them, and to base determinations on high-quality studies.

However, Cohen pointed out that even high-quality studies might not be enough to identify contributors to long-term health trends.

The agency could also periodically review the safety of previously introduced GRAS substances, similar to the Dietary Guidelines Advisory Committee, they added. Another option is for Congress to pass new laws on food safety.

"Neither of those two scenarios -- more proactive FDA in this space, or new laws regarding new food ingredients -- are anywhere in the near horizon," Cohen said, but "we need to at least acknowledge, as clinicians, as U.S. consumers, that whenever you're buying something that's not traditional food ... it's [a] complete black box in terms of what kind of safety evaluation was done of new ingredients."

Disclosures

Cohen reported financial relationships with the CDC, Consumer Reports, and Pew Charitable Trusts.

Broad Leib reported no conflicts of interest.

Primary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowCohen PA, Broad Leib EM "Ingesting risk -- the FDA and new food ingredients" N Engl J Med 2024; DOI: 10.1056/NEJMp2403165.


https://www.medpagetoday.com/special-reports/features/111872

Baby bottle maker says microplastics inescapable, health risks unproven, in bid to toss lawsuit

 Handi-Craft Co on Friday pushed back against claims that the company failed to warn parents that their plastic baby bottles leach microplastics when heated, arguing in part that microplastics are ubiquitous and their health effects are unproven.

Handi-Craft and another baby bottle maker, Philips North America, are each facing proposed class actions claiming they failed to warn parents that the polypropylene bottles and cups sold under the brands Philips Avent and Handi-Craft’s Dr. Brown's, when heated as part of regular use, could expose infants to tiny flecks of plastic that can interfere with their digestive, reproductive and immune systems. Both companies have moved to dismiss the claims against them.

In its motion to dismiss, Handi-Craft argued that the consumers suing hadn’t dealt with “the intractable problem of assigning liability when microplastics are so ubiquitous and ‘inescapable’ that humans constantly ingest and inhale them from countless sources.”

In a statement, attorneys representing the consumers said Handi-Craft's argument ignored parents' desire for harm reduction.

"Caregivers might reasonably make a different choice than using a product that results in babies unnecessarily swallowing microplastics," the attorneys said in the statement.

A spokesperson from PhilipsNorth America said in a statement that the company disagrees with the allegations. The statement said that Philips Avent plastic bottles are safe to use and are compliant with all applicable safety requirements globally.

Handi-Craft did not respond to requests for comment.

The consumers, who are California residents, filed the parallel lawsuits against Philips and Handi-Craft in the U.S. District Court for the Northern District of California in June. The plaintiffs, who hope to represent both classes covering California purchasers and nationwide purchasers of the products, are seeking damages and an injunction barring the sale of the products and marketing that implies they are safe.

In its motion to dismiss, filed on Sept. 3, Philips argued that the plaintiffs had failed to quantify how many microplastics the bottles supposedly leach or whether that amount could be dangerous.

Handi-Craft is also asking the judge overseeing its case to strike some of the claims for the nationwide class, arguing in part that state laws governing consumer products are too different for them to proceed as a nationwide class.

The cases are Miller v. Philips North America LLC and Cortez v. Handi-Craft Co Inc, U.S. District Court for the Northern District of California, Nos. 3:24-cv-03781 and 4:24-cv-03782.

https://www.xm.com/research/markets/allNews/reuters/baby-bottle-maker-says-microplastics-inescapable-health-risks-unproven-in-bid-to-toss-lawsuit-53921639