Tuesday, April 25, 2023

Abortion A Tale of Two Lawsuits - by Jessica Valenti

Politics has no place in healthcare.  How the world turned.
 
Congress, when it formed Medicare inserted a message that Medicare could not practice medicine and would not interfere with professional judgment.  That did not last very long.  Soon new regulations imposed restrictions on treatments.  

When Medicare in 1965 went into effect professional medical organizations warned that open and free access to medical care would bankrupt the country in short order.  

It is a conundrum to deliver health care to all who need it since demand is infinite and supply is limited. Health care has its own algorithm outside of the free market enterprise.

NHE Fact Sheet.  (National Health Expenditure Data)

As decades have passed the percentage of the GDP has risen to 18%, although at a slower rate due to balanced budget restrictions.

Historical NHE, 2021:

NHE grew 2.7% to $4.3 trillion in 2021, or $12,914 per person, and accounted for 18.3% of Gross Domestic Product (GDP).

Medicare spending grew 8.4% to $900.8 billion in 2021, or 21 percent of total NHE.

Medicaid spending grew 9.2% to $734.0 billion in 2021, or 17 percent of total NHE.

Private health insurance spending grew 5.8% to $1,211.4 billion in 2021, or 28 percent of total NHE.
Out-of-pocket spending grew 10.4% to $433.2 billion in 2021 or 10 percent of total NHE.

Other Third Party Payers and Programs and Public Health Activity spending declined 20.7% in 2021 to $596.6 billion, or 14 percent of total NHE.

Hospital expenditures grew 4.4% to $1,323.9 billion in 2021, slower than the 6.2% growth in 2020.

Physician and clinical services expenditures grew 5.6% to $864.6 billion in 2021, slower growth than the 6.6% in 2020.

Prescription drug spending increased 7.8% to $378.0 billion in 2021, faster than the 3.7% growth in 2020.

The largest shares of total health spending were sponsored by the federal government (34 percent) and the households (27 percent). The private business share of health spending accounted for 17 percent of total health care spending, state and local governments accounted for 15 percent, and other private revenues accounted for 7 percent.

Projected NHE, 2021-2030:

On average over 2021-30, National Health Expenditures (NHE) and Gross Domestic Product (GDP) are both projected to grow 5.1 percent per year; as a result, the projected NHE share of GDP in 2030 (19.6 percent) is similar to 2020 (19.7 percent).

Near-term NHE patterns are significantly influenced by the COVID-19 pandemic.  NHE growth in 2021 is projected to have slowed to 4.2 percent (down from 9.7 percent growth in 2020) as federal COVID-19 supplemental funding declined substantially. 

Following the declines observed in 2020, healthcare utilization is expected to rebound starting in 2021 and normalize through 2024.  By 2024, the government's (federal and state & local) share of health spending is expected to fall to 46 percent as COVID-19 supplemental funding is expected to wane, down from an all-time high of 51 percent in 2020.

The percentage of the population with health insurance is expected to peak in 2022 at 91.1% (mainly due to Medicaid enrollment) before falling back towards pre-pandemic levels as the public health emergency is assumed to end.  The 2030 rate is projected to be 90.5%.

For 2025-2030, factors that typically drive changes in health spending and enrollment, such as economic, demographic, and health-specific factors, are again expected to primarily influence trends in the health sector.




The Judicial Branch has now stepped in to overrule Congress and the Federal Drug Administration attempting to overrule scientific decisions.  Not only that they are conflicting rulings between state jurisdictions.  Legal maneuvering delays treatment plans.
 
Two federal courts —one in Washington and one in Texas—issued conflicting rulings on mifepristone, one of the two drugs used for medication abortions. Matthew Kacsmaryk, the Trump-appointed federal judge in Texas, ruled to invalidate the FDA approval of mifepristone (with a stay of 7 days)—a decision we anticipated after the hearing earlier this spring. But a Washington federal judge, who also has the power to bind the FDA, ruled that the FDA shouldn’t restrict mifepristone and that the role of an Article III judge is not to second guess the expertise of the FDA.




This is important: Both have equal bearing over abortion access going forward. And medically-safe sources of medication abortion pills, including mifepristone, are still available, despite the ruling out of Texas. Fear is just as strong of a tool in the anti-abortion movement as any legal ruling.


To get a clearer picture of what the two conflicting federal opinions mean and what the FDA and the Biden administration can do to protect mifepristone, Abortion, Every Day went to law professors Greer Donley and Rachel Rebouche—who have been leading the national conversation on abortion medication and the FDA approval process since Roe fell.



A Tale of Two Lawsuits - by Jessica Valenti

Monday, April 24, 2023

Line up children, the COVID sniffing dog is here to judge you

A recent paper in JAMA Pediatrics shows how badly adults dehumanized children.

Commentary from the author:

                                   Commentary :  Ten hours of dog sniffing
 
A recent paper in JAMA Pediatrics shows how badly adults dehumanized children. Before I explain, as background, I work as a health care provider in California. During the pandemic, I never had to asymptomatically test even during hospital work. No dog ever smelled me. Keep that in mind as I tell you about this. Because these CA kids have more restrictions than doctors working in the hospital with the sickest patients!

It strikes me as a bit dehumanizing to treat children like this. Especially since ~100% would later go on to develop COVID. The vast majority would get COVID without getting a vaccine. Seems that lining them up in the schoolyard, and having a dog sniff them— something I have only been subject to in airports, where I assume they are sniffing for bomb residue or drugs— is a bit extreme.

I worry how a child might feel if they go to school feeling fine, and the dog sits down beside them. Their classmates— even though they are told to face away— will still know. The dog will stop moving. And let’s be honest, kids will look around. Did they pull the kid from school then? Did any kids start crying? Seems messed up to me. Why did they have to do this with children?

Why do I note this: isn’t it something that not a single person flagged this idea and said: if we are going to do this, let’s do it for doctors or nurses, or at least adults. It is kinda fucked up to treat children like this, and future generations may look at us like we are out of our minds. When they look back at the IFR in kids, they may think we are actually insane.

Regardless of a pandemic emergency, this sort of behavior is unconscionable.  These children are in the protective custody of the school.  There is no mention of parental consent for involuntary testing.  Were the parents even notified beforehand?

The article also did not mention what was done if a child tested as positive. 

What I don't know is whether individual parents complained or protested about this event.  I assume if the testing was done in the schoolyard (probably in the morning) the child wouldn't be permitted to enter the school.

If this was done during the masking mandate why would they still test if kids were masked?

This procedure raises many more questions than answers.

The article was published by authors in California so I assume the testing was done there.

This was obviously done for deriving data for a public health study rather than protecting innocent children.

I am also certain the authorities used the Public Health Emergency Order by the State of California, the Governor, and all others who use immunity as a protection against legal action.

What do you think? Reasonable or messed up?

I predict it will only get worse.

Just remember,  "We're doing this for your protection"












Line up children, the COVID sniffing dog is here to judge you

AskAnExpert: Anesthesia 101 SCIENCE FRIDAY NPR

AskAnExpert: Anesthesia 101 (SciFri Zoom Call-in)



Your surgeon recommends you have surgery. He gives you an informed consent form and asks you to sign it.  

Are you signing your life away? He/she explains the risks and benefits of the procedure and should also tell you what can happen if you don't have the surgery.

What other risks do you face ? If general or local anesthesia is necessary you should be aware of those risks as well.  They can be substantial and usually, the anesthetist should explain them in an informed consent separate from the consent form given to you by the surgeon's office. But caution is advised because some hospitals or ASCs do not do this.  If there is an adverse event or even death if this has not b been explained the perpetrators are open to clear-cut malpractice/negligence, separate from the surgeon's liability.

Contrary to what most people think, going to sleep is not the same as anesthesia.

This video clearly explains those risks. 

Tuesday, April 11, 2023

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

HJR 7 - Relating to a national emergency declared by the President on March 13, 2020. Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That, pursuant to section 202 of the National Emergencies Act (50 U.S.C. 1622), the national emergency declared by the finding of the President on March 13, 2020, in Proclamation 9994 (85 Fed. Reg. 15337) is hereby terminated.   https://www.whitehouse.gov/briefing-room/legislation/2023/04/10/bill-signed-h-j-res-7/

What does this mean?

There are other laws passed by Congress that leaves in place certain actions.

Biden rescinding Trump-Biden Proclamation 9994 under the 1976 National Emergencies Act does not terminate Azar Becerra’s Public Health Emergency authorities under the 1983 PHE amendment to the 1944 PHSA.

Under the terms of. 1944PHSA, U.S. Congressional law still permits emergency quarantines for ensuing epidemics, or results of biological warfare or terrorism.

President Joe Biden on April 10 signed a measure that immediately ended the COVID-19 national emergency more than three years after it was enacted, the White House announced.

HJ Res 7 passed through the Senate on March 29 by a 68-23 margin, with 21 Democrats joining 47 Republicans to support the measure. 

Four Republicans and five Democrats did not cast a vote—and 23 Democrats voted against the short resolution—which was introduced by Rep. Paul Gosar (R-Ariz.) last month and passed by the House 229-197 on Feb. 1.

Concerned citizens should be aware that the terms of declaring a national emergency due to infectious disease outbreaks remain vague, leaving it open to interpretation by politicians, and local, tribal, and state government officials.


There are certain rules regarding the roles of Federal, State, and local government which introduce possible competing and adversarial roles for quarantine and enforcement.

If a quarantinable disease is suspected or identified, CDC may issue a federal isolation or quarantine order.

Public health authorities at the federal, state, local, and tribal levels may sometimes seek help from police or other law enforcement officers to enforce a public health order.

U.S. Customs and Border Protection and U.S. Coast Guard officers are authorized to help enforce federal quarantine orders.

Breaking a federal quarantine order is punishable by fines and imprisonment.

Federal law allows the conditional release of persons from quarantine if they comply with medical monitoring and surveillance.

In the rare event that a federal order is issued by CDC, those individuals will be provided with an order for quarantine or isolation. An example of a Quarantine Order for Novel Coronavirus (print-only) [PDF – 5 pages] is provided. This document outlines the rationale of the federal order as well as information on where the individual will be located, quarantine requirements including the length of the order, CDC’s legal authority, and information outlining what the individual can expect while under federal order.


The United States was ill-prepared for COVID-19.  Conflicting advice from individuals, governors, and others led to confusion and a lack of trust on the part of the American people.

In addition to the above the First Amendment allowed mis- information to be propagated by social media. This has and will continue in the future without strict guidelines to monitor misinformation via the internet. This will require massive monitoring of internet traffic, using Artificial Intelligence. The First Amendment could be used to strike down internet monitoring.  Who will set the standards for what is correct or not?  Will there be penalties for internet abuse?

There are many issues to be decided before the next epidemic.

Wednesday, April 5, 2023

Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed - WSJ

UnitedHealthcare, Cigna and Aetna move to revamp prior-authorization programs.


The paperwork required by health insurers to get many medical procedures or tests—one of the biggest gripes of doctors and patients—is getting rolled back.

UnitedHealth Group Inc.’s UnitedHealthcare, the largest health insurer in the U.S., said Wednesday it would cut its use of the prior authorization process. Starting in the third quarter, it will remove many procedures and medical devices from its list of services requiring signoff.

I go into a great deal about his issue in my Substack article Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed



For more than two decades patients have heard their physician say I will have to obtain “prior authorization” from your insurance company for this test, drug, or treatment. The paperwork required by health insurers to get many medical procedures or tests—one of the biggest gripes of doctors and patients—is getting rolled back.

This is a major advance in eliminating physician ‘burnout’. Besides the use of electronic health records, many physicians have abandoned their dream of being doctors. Many have said this has become a moral dystopia for providers. For patients, it has meant delays in necessary treatments, causing anxiety, worsening health, and rarely death. It will eliminate stacks of paperwork, and endless waiting on hold to speak to an insurance representative.

Angus Worthing, a rheumatologist in Washington, D.C., whose practice has to employ roughly one prior-authorization-focused staffer for every two doctors, said. Patients typically wait two to four weeks to get medications under the process, he said, and while they wait, he sometimes needs to put them on other drugs that cause side effects. Several decades ago it was presumed that doctors ordered too many tests, and at times treatments that had no evidence for improvement of health. Prior authorizations were thought to decrease these occurrences. Initially, this had the immediate effect to reduce utilization.

Continue reading....... 










Dreaded Medical Paperwork Required by Health Insurers to Be Trimmed - WSJ: Prior authorization has generated so much resentment in recent years that some health insurers have been making tweaks.

Monday, April 3, 2023

Coverage for Preventive Services Struck Down

Holy healthcare, Batman!

Toni Brayer, MD who writes in Every Thing Health

The Texan judiciary strikes again.  



You have probably forgotten that Obamacare (the Affordable Care Act) ensured that Health Insurance Companies cover preventive services.  This includes immunizations, screening tests for cancer (mammograms, colon cancer, prostate cancer), blood pressure, diabetes, and cholesterol tests, physical exams and well-baby, well-child visits, HIV, and mental health services.  Americans have benefited from this mandated coverage since 2010.


A Federal judge in Texas, who once said the ACA was unconstitutional, has struck down the requirement that preventive care be covered and that decision could affect more than 150 million people who would lose these "free" services. I say "free" because they are now covered under the exorbitant premiums that Insurance companies charge. 

Insurers say that they will not claw back on this coverage that people have come to expect.  But I see changes in formularies, co-pays, deductibles, and requirements for pre-authorization that seem to change month by month.  I have absolutely no doubt that these preventive services will be whittled away one by one if this ruling is allowed to remain.  

The ruling stemmed from a case brought by six individuals and two Christian-owned businesses who argued that they should not be mandated to offer coverage of HIV PrEP because they did not want to encourage "homosexual behavior."

Why make this change for these small businesses ? Do they want to "damn" those who have contracted HIV or prevent it? Has the Vatican taken a stand on this?  

 "Instead of attacking the coverage that patients have, we should be looking for ways to bolster the ACA and increase access to care." The US repeatedly ranks last in health outcomes compared to other industrialized nations and this will further widen the gap. 

Today (Friday, March 31), President Biden appealed the decision and it will be heard in the US Fifth Circuit Court of Appeals. "All preventive services are kind of up for grabs as we go through the appeals process," said Laurie Sobel, associate director for women's health policy at Kaiser Family Foundation.


 It may ultimately go to the US Supreme Court. 

Let's see of the rule of law overturns common sense and the Affordable Care Act.

Malignancy may start small but always metastasizes


Wednesday, March 8, 2023

Abbott's lab-based blood test for concussion scores FDA nod


Two years after Abbott landed FDA clearance for a hand-held blood test that could detect signs of mild traumatic brain injuries (TBIs) in the span of about 15 minutes, the concussion-spotting test is heading to the big leagues.

The FDA has now cleared a version of the diagnostic that’s designed to run on Abbott’s Alinity i laboratory instruments. Because the Alinity systems are installed in hospitals and labs across the U.S., the regulatory clearance vastly scales up the availability of the test for the millions of Americans who experience concussions every year, Abbott noted in its Tuesday announcement. This vastly increases accessibility for clinicians from their office.  The test is already available outside the U.S., having reeled in CE mark approval in Europe at the end of 2021.

The lab test works by analyzing a blood sample drawn from the arm. It looks for two biomarkers in the blood, both of which have been closely linked to TBIs when found in elevated concentrations. In studies, it was able to churn out results with 96.7% sensitivity and 99.4% negative predictive value, per Abbott.

The test returns results within about 18 minutes and has been authorized to assess patients aged 18 and older within 12 hours of a suspected concussion. It’s meant to be used as a triaging step before a CT scan, following a physician’s assessment of a patient’s visual, verbal and motor responses—which is often the only test they undergo before being sent off for a confirmatory CT scan.

According to Abbott, using the test as a first step in diagnosing concussion can help reduce the number of unnecessary CT scans performed on patients without actual brain injuries by as much as 40%—and will therefore cut down on the amount of time they need to spend in a hospital’s emergency department—while also flagging the patients who do need further imaging to confirm a concussion.

The newly FDA-cleared diagnostic offers a high-throughput alternative to Abbott’s i-STAT TBI Plasma test, which was given the green light to spot signs of traumatic brain injuries at the start of 2021.

That version of the concussion-detecting blood test runs on the i-STAT Alinity platform, a smartphone-sized, hand-held device that’s able to separate out plasma from a blood sample and conduct its biomarker analysis within 15 minutes.

A study published last year looked at the pair of biomarkers measured in both versions of the TBI test. After examining test results and longer-term outcome data for nearly 1,700 patients, the researchers concluded that higher concentrations of those biomarkers were linked to a higher probability of severe disability and death within six months of the initial brain injury.




SyncThink clocks FDA nod for concussion test based on AI-powered eye tracking

This device mimics the usual test of following a finger test given by an emergency room physician. Using AI it measures more accurately abnormal eye tracking movement and creates a graphic representation of the eye movement.

The Eye-Sync platform from SyncThink uses AI to analyze the results of a series of fast-paced eye-tracking assessments, in tandem with standard neurocognitive tests, patient records and reported symptoms, to determine the type and severity of cognitive dysfunction caused by a head injury.

The technology previously received 510(k) clearance from the FDA in 2016 for use in detecting impairments in patients’ gaze and visual tracking abilities. The new clearance extends the platform’s indications, allowing healthcare providers in the U.S. to use it to help diagnose both concussion and mild traumatic brain injury.

The Eye-Sync platform from SyncThink uses AI to analyze the results of a series of fast-paced eye-tracking assessments, in tandem with standard neurocognitive tests, patient records and reported symptoms, to determine the type and severity of cognitive dysfunction caused by a head injury.

The technology previously received 510(k) clearance from the FDA in 2016 for use in detecting impairments in patients’ gaze and visual tracking abilities. The new clearance extends the platform’s indications, allowing healthcare providers in the U.S. to use it to help diagnose both concussion and mild traumatic brain injury.

SyncThink isn’t the only medtech developer attempting to clear the thorny pathway to concussion diagnosis.


BrainScope, for one, added an FDA-cleared, concussion-detecting algorithm of its own to its point-of-care brain-scanning headset in March. The Concussion Index analyzes multiple EEG readings from the headset to monitor the progression of traumatic injuries, hidden bleeds and concussions.

Abbott, too, has thrown its hat in the ring. In January, the FDA doled out yet another clearance for concussion detection, this time for Abbott’s i-STAT Alinity platform, a hand-held rapid blood-testing system that measures the amount of certain proteins in the bloodstream after a head injury to determine whether further testing is required.




Abbott's lab-based blood test for concussion scores FDA nod

Thursday, February 23, 2023

 The Norfolk Southern train derailment in Ohio brought forth the real dangers of toxic chemical transportation via rail in the United States.  The EPA and DOT  have jurisdiction in these areas as guardians of public safety in transportation and environmental health.


These occurrences happen more than we like to know.  Many trains may travel through your city or town with the local population being notified.   Transportation routes are governed by the legal right of way granted when the lines are built.

In this particular case, vinyl chloride was being transported in large amounts for industrial purposes. Vinyl chloride, also called vinyl chloride monomer (VCM), is exclusively used as a precursor to PVC.(common use for producing pipes. Due to its hazardous nature, VCM is not found in other products. When burned vinyl chloride produces dioxin.

I  emphasize the urgency of testing for dioxin exposure stemming from the East Palestine train catastrophe, and I publicly challenge the EPA, Gov. DeWine, and Sen. JD Vance to carry out dioxin testing across the affected areas.  Dioxin residues are persistent, long term and reside in the soil. Senator Vance aptly displayed this 'dipstick test' which revealed the residue in a local creek, after the EPA declared the area as "safe" Safe for what?





According to some sources, the EPA has not done any dioxin testing at all. That's because they know they will find extreme levels of dioxins contaminating tens of thousands of acres of farmland, and Ohio exports over three billion dollars worth of agricultural products each year.  

This event is not just local or regional, it has the potential to be a national emergency.  Some of these agricultural products (animal and plant) are distributed nationally.



Tuesday, February 14, 2023

Data brokers are now selling your mental health status - The Washington Post

Capitalizing on the pandemic explosion in telehealth and therapy apps that collect details of your mental health needs, data brokers are packaging that information for resale, a new study finds. There’s no law stopping them.

One company advertised the names and home addresses of people with depression, anxiety, post-traumatic stress or bipolar disorder. Another sold a database featuring thousands of aggregated mental health records, starting at $275 per 1,000 “ailment contacts.”

Does your telehealth app sell your information?  There is no law against it if they get your data.

HIPAA regulations protect your data in your electronic health records. However, there may be some telehealth applications that do not comply with HIPAA regulations.  



Telemedicine and HIPAA Compliance


The portions of HIPAA governing telemedicine are the Privacy Rule and the Security Rule. The HIPAA Privacy Rule sets standards to protect patient medical records or any personal health information (PHI) transmitted between health insurance companies, clinicians, testing facilities, or anywhere this data is shared.

If you are using an EHR portal or connect via a text link from your provider, the telehealth application is HIPAA compliant.




Most of what you need to know about health information technology



Data brokers are now selling your mental health status - The Washington Post

Tuesday, February 7, 2023

Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients

 

Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients

NEW YORK — The fear started when a few patients saw their nurses and dietitians posting job searches on LinkedIn.

Word spread to Facebook groups, and patients started calling Coram CVS, a major U.S. supplier of the compounded IV nutrients on which they rely for survival. To their dismay, CVS Health confirmed the rumors on June 1: It was closing 36 of the 71 branches of its Coram home infusion business and laying off about 2,000 nurses, dietitians, pharmacists, and other employees.

Many of the patients left in the lurch have life-threatening digestive disorders that render them unable to eat or drink. They depend on parenteral nutrition, or PN — in which amino acids, sugars, fats, vitamins, and electrolytes are pumped, in most cases, through a specialized catheter directly into a large vein near the heart.

The day after CVS’ move, another big supplier, Optum Rx, announced its own consolidation. Suddenly, thousands would be without their highly complex, shortage-plagued, essential drugs and nutrients.

“With this kind of disruption, patients can’t get through on the phones. They panic,” said Cynthia Reddick, a senior nutritionist who was let go in the CVS restructuring.

“It was very difficult. Many emails, many phone calls, acting as a liaison between my doctor and the company,” said Elizabeth Fisher Smith, a 32-year-old public health instructor in New York City, whose Coram branch closed. A rare medical disorder has forced her to rely on PN for survival since 2017. “In the end, I got my supplies, but it added to my mental burden. And I’m someone who has worked in health care nearly my entire adult life.”

CVS had abandoned most of its less lucrative market in home parenteral nutrition, or HPN, and “acute care” drugs like IV antibiotics. Instead, it would focus on high-dollar, specialty intravenous medications like Remicade, which is used for arthritis and other autoimmune conditions.

Home and outpatient infusions are a growing business in the United States, as new drugs for chronic illness enable patients, health care providers, and insurers to bypass in-person treatment. Even the wellness industry is cashing in, with spa storefronts and home hydration services.

But while reimbursement for expensive new drugs has drawn the interest of big corporations and private equity, the industry is strained by a lack of nurses and pharmacists. And the less profitable parts of the business — as well as the vulnerable patients they serve — are at serious risk.

This includes the 30,000-plus Americans who rely for survival on parenteral nutrition, which has 72 ingredients. Among those patients are premature infants and post-surgery patients with digestive problems, and people with short or damaged bowels, often the result of genetic defects.

While some specialty infusion drugs are billed through pharmacy benefit managers that typically pay suppliers in a few weeks, medical plans that cover HPN, IV antibiotics, and some other infusion drugs can take 90 days to pay, said Dan Manchise, president of Mann Medical Consultants, a home care consulting company.

In the 2010s, CVS bought Coram, and Optum bought up smaller home infusion companies, both with the hope that consolidation and scale would offer more negotiating power with insurers and manufacturers, leading to a more stable market. But the level of patient care required was too high for them to make money, industry officials said.

“With the margins seen in the industry,” Manchise said, “if you’ve taken on expensive patients and you don’t get paid, you’re dead.”

In September, CVS announced its purchase of Signify Health, a high-tech company that sends out home health workers to evaluate billing rates for “high-priority” Medicare Advantage patients, according to an analyst’s report. In other words, as CVS shed one group of patients whose care yields low margins, it was spending $8 billion to seek more profitable ones.

CVS “pivots when necessary,” spokesperson Mike DeAngelis told KHN. “We decided to focus more resources on patients who receive infusion services for specialty medications” that “continue to see sustained growth.” Optum declined to discuss its move, but a spokesperson said the company was “steadfastly committed to serving the needs” of more than 2,000 HPN patients.

DeAngelis said CVS worked with its HPN patients to “seamlessly transition their care” to new companies.

However, several Coram patients interviewed about the transition indicated it was hardly smooth. Other HPN businesses were strained by the new demand for services, and frightening disruptions occurred.

Smith had to convince her new supplier that she still needed two IV pumps — one for HPN, the other for hydration. Without two, she’d rely partly on “gravity” infusion, in which the IV bag hangs from a pole that must move with the patient, making it impossible for her to keep her job.

“They just blatantly told her they weren’t giving her a pump because it was more expensive, she didn’t need it, and that’s why Coram went out of business,” Smith said.

Many patients who were hospitalized at the time of the switch — several inpatients stays a year are not unusual for HPN patients — had to remain in the hospital until they could find new suppliers. Such hospitalizations typically cost at least $3,000 a day.

“The biggest problem was getting people out of the hospital until other companies had ramped up,” said Dr. David Seres, a professor of medicine at the Institute of Human Nutrition at Columbia University Medical Center. Even over a few days, he said, “there was a lot of emotional hardship and fear over losing long-term relationships.”

To address HPN patients’ nutritional needs, a team of physicians, nurses, and dietitians must work with their supplier, Seres said. The companies conduct weekly bloodwork and adjust the contents of the HPN bags, all under sterile conditions because these patients are at risk of blood infections, which can be grave.

As for Coram, “it’s pretty obvious they had to trim down business that was not making money,” Reddick said, adding that it was noteworthy both Coram and Optum Rx “pivoted the same way to focus on higher-dollar, higher-reimbursement, high-margin populations.”

“I get it, from the business perspective,” Smith said. “At the same time, they left a lot of patients in a not great situation.”

***

Smith shares a postage-stamp Queens apartment with her husband, Matt; his enormous flight simulator (he’s an amateur pilot); cabinets and fridges full of medical supplies; and two large, friendly dogs, Caspian and Gretl. On a recent morning, she went about her routine: detaching the bag of milky IV fluid that had pumped all night through a central line implanted in her chest, flushing the line with saline, injecting medications into another saline bag, and then hooking it through a paperback-sized pump into her central line.

Smith has a connective tissue disorder called Ehlers-Danlos syndrome, which can cause many health problems. As a child, Smith had frequent issues such as a torn Achilles tendon and shoulder dislocations. In her 20s, while working as an EMT, she developed severe gut blockages and became progressively less able to digest food. In 2017, she went on HPN and takes nothing by mouth except for an occasional sip of liquid or bite of soft food, in hopes of preventing the total atrophy of her intestines. HPN enabled her to commute to George Washington University in Washington, D.C., where in 2020 she completed a master’s in public health.

On days when she teaches at LaGuardia Community College — she had 35 students this semester — Smith is up at 6 a.m. to tend to her medical care, leaves the house at 9:15 for class, comes home in the afternoon for a bag of IV hydration, then returns for a late afternoon or evening class. In the evening she gets more hydration, then hooks up the HPN bag for the night. On rare occasions she skips the HPN, “but then I regret it,” she said. The next day she’ll have headaches and feel dizzy, sometimes losing her train of thought in class.

Smith describes a “love-hate relationship” with HPN. She hates being dependent on it, the sour smell of the stuff when it spills, and the mountains of unrecyclable garbage from the 120 pounds of supplies couriered to her apartment weekly. She worries about blood clots and infections. She finds the smell of food disconcerting; Matt tries not to cook when she’s home. Other HPN patients speak of sudden cravings for pasta or Frosted Mini-Wheats.

Yet HPN “has given me my life back,” Smith said.

She is a zealous self-caretaker, but some dangers are beyond her control. IV feeding over time is associated with liver damage. The assemblage of HPN bags by compounding pharmacists is risky. If the ingredients aren’t mixed in the right order, they can crystallize and kill a patient, said Seres, Smith’s doctor.

He and other doctors would like to transition patients to food, but this isn’t always possible. Some eventually seek drastic treatments such as bowel lengthening or even transplants of the entire digestive tract.

“When they run out of options, they could die,” said Dr. Ryan Hurt, a Mayo Clinic physician and president of the American Society for Parenteral and Enteral Nutrition.

***

And then there are the shortages.

In 2017, Hurricane Maria crippled dozens of labs and factories making IV components in Puerto Rico; next came the covid-19 emergency, which shifted vital supplies to gravely ill hospital patients.

Prices for vital HPN ingredients can fluctuate unpredictably as companies making them come and go. For example, in recent years the cost of the sodium acetate used as an electrolyte in a bag of HPN ballooned from $2 to $25, then briefly to $300, said Michael Rigas, a co-founder of the home infusion pharmacy KabaFusion.

“There may be 50 different companies involved in producing everything in an HPN bag,” Rigas said. “They’re all doing their own thing — expanding, contracting, looking for ways to make money.” This leaves patients struggling to deal with various shortages from saline and IV bags to special tubing and vitamins.

“In the last five years I’ve seen more things out of stock or on shortage than the previous 35 years combined,” said Rigas.

The sudden retrenchment of CVS and Optum Rx made things worse. Another, infuriating source of worry: the steady rise of IV spas and concierge services, staffed by moonlighting or burned-out hospital nurses, offering IV vitamins and hydration to well-off people who enjoy the rush of infusions to relieve symptoms of a cold, morning sickness, a hangover, or just a case of the blahs.

In January, infusion professionals urged FDA Commissioner Robert Califf to examine spa and concierge services’ use of IV products as an “emerging contributing factor” to shortages.

The FDA, however, has little authority over IV spas. The Federal Trade Commission has cracked down on some spa operations — for unsubstantiated health claims rather than resource misuse.

Bracha Banayan’s concierge service, called IVDRIPS, started in 2017 in New York City and now employs 90 people, including 60 registered nurses, in four states, she said. They visit about 5,000 patrons each year, providing IV hydration and vitamins in sessions of an hour or two for up to $600 a visit. The goal is “to hydrate and be healthy” with a “boost that makes us feel better,” Banayan said.

Although experts don’t recommend IV hydration outside of medical settings, the market has exploded, Banayan said: “Every med spa is like, ‘We want to bring in IV services.’ Every single paramedic I know is opening an IV center.”

Matt Smith, Elizabeth’s husband, isn’t surprised. Educated as a lawyer, he is a paramedic who trains others at Columbia University Irving Medical Center. “You give someone a choice of go up to some rich person’s apartment and start an IV on them, or carry a 500-pound person living in squalor down from their apartment,” he said. “There’s one that’s going to be very hard on your body and one very easy on your body.”

The very existence of IV spa companies can feel like an insult.

“These people are using resources that are literally a matter of life or death to us,” Elizabeth Smith said.

Shortages in HPN supplies have caused serious health problems including organ failure, severe blisters, rashes, and brain damage.

For five months last year, Rylee Cornwell, 18 and living in Spokane, Washington, could rarely procure lipids for her HPN treatment. She grew dizzy or fainted when she tried to stand, so she mostly slept. Eventually she moved to Phoenix, where the Mayo Clinic has many Ehlers-Danlos patients and supplies are easier to access.

Mike Sherels was a University of Minnesota Gophers football coach when an allergic reaction caused him to lose most of his intestines. At times he’s had to rely on an ethanol solution that damages the ports on his central line, a potentially deadly problem “since you can only have so many central access sites put into your body during your life,” he said.

When Faith Johnson, a 22-year-old Las Vegas student, was unable to get IV multivitamins, she tried crushing vitamin pills and swallowing the powder, but couldn’t keep the substance down and became malnourished. She has been hospitalized five times this past year.

Dread stalks Matt Smith, who daily fears that Elizabeth will call to say she has a headache, which could mean a minor allergic or viral issue — or a bloodstream infection that will land her in the hospital.

Even more worrying, he said: “What happens if all these companies stop doing it? What is the alternative? I don’t know what the economics of HPN are. All I know is the stuff either comes or it doesn’t.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Friday, February 3, 2023

Blog Off

 I have decided to take a respite from blogging.  I see my readership has declined due to changes in the algorithm, and other changes in the internet space, such as Metaverse, Web3, AR, VR, and AI.


I will continue to write on my Substack 

Thursday, February 2, 2023

Physical interventions to interrupt or reduce the spread of respiratory viruses - Cochrane Library


The Cochrane Review on Masks is Damning






Cochrane Library has existed for 35 years.  I was a young physician when it came into existence. Its publication was based on real clinical results.  I its infancy few physicians even knew about it rarely referring to it for treatment recommendations.  The gold standard was the New England Journal of Medicine and the National Library of Medicine, or specialty journals and reviews.

Now it ranks up there with those bastions of information.  Cochrane is for anyone interested in using high-quality information to make health decisions. Whether you are a clinician, patient or carer, researcher, or policy-maker, Cochrane evidence provides a powerful tool to enhance your healthcare knowledge and decision-making.

Cochrane's members and supporters come from more than 190 countries, worldwide. We are researchers, health professionals, patients, carers, and people passionate about improving health outcomes for everyone, everywhere. Our global independent network gathers and summarizes the best evidence from research to help you make informed choices about treatment and we have been doing this for 30 years.

We do not accept commercial or conflicted funding. This is vital for us to generate authoritative and reliable information, working freely, unconstrained by commercial and financial interests.

Unfortunately, Cochrane is rarely quoted or referred to as a source of reliable information by the national media, social media, or even google.  It does not appear on page one in my google searches for medical information, or treatment plans. Cochrane has become sensitized to this lack of visibility and initiated an RCT (Randomized Clinical Trial)) to evaluate what the impact of using Twitter to disseminate Cochrane Reviews as a source of information.


I want to highlight what just came out: the Cochrane review on masking. It shows that community mask recommendations have no firm data to support them. The authors write:

“There is a need for large, well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk”

Let me be clear: The science did not change. Public health experts started lying. We never had good data that mask mandates help, or that mask advice (a softer policy) improves outcomes. Yet it was widely pushed— most likely to distract from true federal failures.

After vaccination, not only do we not have evidence. It is irrational to mask. At best you marginally delay the inevitable, and unlike pre-vax, there is no milestone you are waiting for. Let’s take a closer look.

Here is the big summary finding. With 276,000 participants in RCTs or cluster RCTs, masking does nothing. No reduction in influenza-like or Covid like illness and no reduction in confirmed flu or COVID. That’s stone-cold negative. See those effect sizes and confidence intervals.




Masks have no good data to support them| It is a religion, not a science.







Physical interventions to interrupt or reduce the spread of respiratory viruses - Jefferson, T - 2023 | Cochrane Library