This Healthcare Tech Company Has Become The First To Receive FDA De Novo Authorization For An OTC COVID-19 Test

There are still an average of over 2,000 patients with COVID-19 admitted to hospitals every day in the United States. For both the flu and COVID-19, early diagnosis and treatment are critical to preventing serious illness and even death.

The healthcare technology company Cue Health Inc.  has become the first company to get De Novo authorization from the U.S. Food and Drug Administration (FDA) for an over-the-counter COVID-19 test — as well as being the first FDA De Novo authorization for any over-the-counter molecular test for a respiratory disease. The Cue COVID-19 Molecular Test is designed for both at-home and point-of-care use. 

The at-home and point-of-care COVID-19 tests deliver lab-quality results to connected mobile smart devices in about 20 minutes. The test integrates into Cue Care, the company's state-of-the-art test-to-treatment service where patients can connect with a healthcare provider through the Cue Health App to discuss their results, form a treatment plan and have prescribed medications delivered straight to their door. 

COVID-19 Diagnostics Market Remains As The Disease Becomes Endemic

Cue’s De Novo authorization comes as public health officials and epidemiologists have been continuously reporting that COVID-19 has transitioned from pandemic to endemic. Similar to the flu, COVID-19 cases will likely continue to cycle between highs and lows, but in a relatively more predictable manner. Movement into endemic status only means that testing will be even more important and needed over a much longer period of time.

Early diagnosis of a respiratory illness can potentially lead to a milder infection and a decreased likelihood of hospitalization. Maintaining vigilance in preventing infection and opting for early detection and treatment at the first sign of symptoms (especially in households with children, senior citizens, family members with disabilities, or other at-risk individuals) can be crucial, especially for COVID-19.

Cue Health’s diagnostic platform is able to help both patients and care providers stay ahead of COVID-19 over the long term, as the disease enters its endemic stage. By providing fast and accurate results, the platform could help minimize the spread of the disease and the risk of hospitalizations.

Cue’s Molecular Diagnostic Platform — A Game Changer For Testing

Cue’s test is a NAAT (Nucleic Acid Amplification Test) that amplifies and detects the virus’s RNA. Because it can amplify the genetic material, Cue’s test is much more sensitive than an antigen test. In clinical studies, the Cue COVID-19 Molecular Test matched three FDA-authorized, lab-based PCR tests with 98% accuracy. The company’s innovative technology turned the complex test into a user-friendly kit that requires no advanced training. 

Cue’s molecular test is proven to deliver accurate results even in the early days after exposure whereas antigen results are not nearly as reliable. This is important as, according to the CDC, treatment must be started within days after you first develop symptoms to be effective. Cue's molecular test, which delivers results in 20 minutes, is also much faster than a PCR test, which can take anywhere from 12 hours to five days. 

The test can be used on adults or children with or without signs or symptoms of COVID-19 and it is self-contained, meaning it doesn’t involve mixing fluids or running an involved testing procedure. Users simply insert the cartridge into their Cue Reader, collect a nasal sample with a Cue Sample Wand, and insert the Wand into the cartridge. About 20 minutes later, results are sent to the Cue Health App on the user’s phone.

With its head start in the transition from EUA to permanent market authorization for its at-home COVID-19 molecular test and a slate of additional at-home tests compatible with the same Cue Reader device, analysts have expressed optimism about the healthcare tech company’s future earnings potential.

The device is still in development, pending FDA approval for marketing.

UnitedHealth cutting back on prior authorizations

Health payers are catching up on precision medicine.   Physicians are complaining about the increasing work burden and administrative expenses associated with providing services to patients.

Starting next month, UnitedHealthcare says it will move forward with plans to drop prior authorization requirements for a range of procedures, including dozens of radiology services and genetic tests, among others.

Why it matters: UnitedHealth is among the health insurance giants who have announced plans to cut back on prior authorization as federal regulators consider tougher curbs on the practice.

Catch up quick: Prior authorization is often criticized by patients and doctors, who complain they are an administrative burden or impede necessary care. Insurers, meanwhile, say prior authorization provides important guardrails against improper health care utilization, helping to keep costs down.

UnitedHealth, the largest commercial U.S. insurer, previously said its prior authorization removals will represent roughly 20% of its overall prior authorization volume.

Cigna and Aetna also announced plans to roll back some prior authorization requirements.

The Centers for Medicare and Medicaid Services proposed a rule to limit the amount of time insurers have to review requests on services for which they require prior approval, BenefitsPro previously reported.

Congress is also eyeing a plan to streamline and add transparency to the process by which Medicare Advantage plans can deny coverage for services via prior authorization.

Zoom in: UnitedHealth says the removals will take effect Sept. 1 and Nov. 1 across the vast majority of its plans.

The company also spelled out which procedures would see prior authorization requirements removed. For instance, hundreds of codes for genetic testing — accounting for tens of thousands of prior authorization requests a year from commercial and Medicaid members — are among those that will be removed, officials said.

A code for cardiology stress test prior authorization for Medicare Advantage members will also be eliminated, reducing roughly 316,000 prior authorization requests a year.

The company next year also will roll out a "gold card" program eliminating most prior authorization requirements for doctors who have high approval rates.

Flashback: Earlier this summer, UnitedHealth walked back a controversial plan to require prior authorizations for colonoscopies and other endoscopic procedures.

UnitedHealthcare, Cigna, Aetna revamping prior authorization ahead of CMS rule

UnitedHealth cutting back on prior authorizations

FREE E-BOOK -all you (never) wanted TO HAVE TO KNOW about the C19 mRNA injections - 156 pages of text and 20 pages of citations

 

Complete Text

Free e-book by some very smart people who actually give a crap about the quality of life and avoidance of needless death of people – as opposed to the Cult, that cares only about death – and causing billions of deaths along a “pathway” of suffering, poverty and disease.

mRNA Vaccine Toxicity – Doctors for COVID Ethics (doctors4covidethics.org)

It is split into these chapters and sections: (each section is clickable in the document - not from the below - from the main document contents page).

1 Introduction

1.1 Are mRNA vaccines dangerous in principle, or is the observed harm accidental?

1.2 COVID-19 vaccines were never about your health

1.3 The misuse of emergency use authorizations, and the breakdown of regulatory safeguards

1.4 Why this book was written

2 Some elements of virology and immunology

2.1 The life cycle of a virus

2.2 Immunity to viruses

2.3 How do the highly diverse T-cell and B-cell reservoirs originate?

2.4 Immunological memory

2.5 Cross-immunity

2.6 Who really controls viral infections: antibodies, or cytotoxic T-cells?

2.7 Immunity to respiratory viruses: systemic versus mucosal

2.8 Vaccination strategies

2.9 Appendix: some evidence of fraud in Pfizer’s clinical trials .

3 Immunological mechanisms of harm by mRNA vaccines

3.1 mRNA vaccines are distributed throughout the body and prominently affect the blood

3.2 The expression of spike protein in the body is widespread and long-lasting

3.3 The mRNA vaccine LNPs fly under the radar of the immune system

3.4 Induction of autoimmune disease

3.5 Vaccine-induced immunosuppression

3.6 The fundamental mechanism of damage by mRNA vaccines is completely general

4 Pathological evidence of immunological harm due to mRNA vaccines

4.1 Key techniques used in histopathology

4.2 Sources of evidence

4.3 Vasculitis induced by mRNA vaccination

4.4 Immune attack on organ-specific cells and tissues

5 Pharmacokinetics and lipid toxicity of mRNA vaccines

5.1 Structure and function of lipid nanoparticles

5.2 Pharmacokinetics of mRNA vaccines

5.3 Lipid nanoparticle toxicity

5.4 Appendix: Evidence of substandard manufacturing Quality of COVID-19 mRNA

6 Genotoxicity of mRNA vaccines

6.1 Genotoxicity of synthetic cationic lipids

6.2 Reverse transcription of vaccine mRNA sequences into DNA

6.3 Contaminating plasmid DNA in Pfizer’s and Moderna’s mRNA vaccines

6.4 Known and plausible risks posed by DNA copies of non-self

7 Epidemiology of COVID-19 mRNA Vaccine Adverse Events Margot DesBois, B.A. and Brian S. Hooker, Ph.D.

7.1 Introduction

7.2 General Adverse Events, Serious Adverse Events, Death, Hospitalization, Life-Threatening Events

7.3 Cardiac Events

7.4 Thrombotic Events

7.5 Neurological Events

7.6 Immunological Events

7.7 Reproductive Events

7.8 Conclusion

8 AIDS & HIV: The Blueprint for the Perversion of Medical Science David Rasnick, Ph.D.

8.1 AIDS does not behave like a novel contagious disease

8.2 AIDS and drug abuse

8.3 Peter Duesberg’s scientific critique of the HIV/AIDS

8.4 HIV is not sexually transmitted

8.5 Kary Mullis’ quest for evidence that HIV causes AIDS

8.6 The crucifixion of a dissident

8.7 AIDS in Africa

8.8 Thabo Mbeki’s ill-fated attempt to get at the truth about AIDS

8.9 Some evidence to challenge the AIDS orthodoxy

9 Summary and conclusions

9.1 The key mechanism of mRNA vaccine toxicity

9.2 The immunological mechanism of harm is completely general

9.3 Could a return to good manufacturing practices abolish the toxicity of the mRNA vaccines?

9.4 If mRNA vaccines are inherently dangerous, why are they urged and even forced on us?

9.5 What can we do?

Afterword by Catherine Austin Fitts

New lawsuit accuses health insurer Cigna of denying claims in bulk

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it is estimated, she would be ready to leave her nursing home.

On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone. Meanwhile, medical notes in June 2019 showed Walter’s pain was maxing out the scales and that she could not dress, go to the bathroom, or even push a walker without help. 

It would take more than a year for a federal judge to conclude the insurer’s decision was “at best, speculative” and that Walter was owed thousands of dollars for more than three weeks of treatment. While she fought the denial, she had to spend her life savings and enroll in Medicaid just to progress to the point of putting on her shoes, her arm still in a sling.

Health insurance companies have rejected medical claims for as long as they’ve been around. But the investigation found artificial intelligence is now driving their denials to new heights in Medicare Advantage, the taxpayer-funded alternative to traditional Medicare that covers more than 31 million people.

Behind the scenes, insurers are using unregulated predictive algorithms, under the guise of scientific rigor, to pinpoint the precise moment when they can plausibly cut off payment for an older patient’s treatment. The denials that follow are setting off heated disputes between doctors and insurers, often delaying the treatment of seriously ill patients who are neither aware of the algorithms nor able to question their calculations.

Older people who spent their lives paying into Medicare, and are now facing amputation, fast-spreading cancers, and other devastating diagnoses, are left to either pay for their care themselves or get by without it. If they disagree, they can file an appeal, and spend months trying to recover their costs, even if they don’t recover from their illnesses.

“We take patients who are going to die of their diseases within a three-month period of time, and we force them into a denial and appeals process that lasts up to 2.5 years,” Chris Comfort, chief operating officer of Calvary Hospital, a palliative and hospice facility in the Bronx, N.Y., said of Medicare Advantage. “So what happens is the appeal outlasts the beneficiary.”

In other words, "Deny until dead".  Or don't diagnose or treat patients with less than six months to live.

The algorithms sit at the beginning of the process, promising to deliver personalized care and better outcomes. But patient advocates said in many cases they do the exact opposite — spitting out recommendations that fail to adjust for a patient’s individual circumstances and conflict with basic rules on what Medicare plans must cover.

“While the firms say [the algorithm] is suggestive, it ends up being a hard-and-fast rule that the plan or the care management firms really try to follow,” said David Lipschutz, associate director of the Center for Medicare Advocacy, a nonprofit group that has reviewed such denials for more than two years in its work with Medicare patients. “There’s no deviation from it, no accounting for changes in condition, no accounting for situations in which a person could use more care.”

Medicare has its own set of guidance (rules) for benefit determination as set forth in the Code of Federal Regulations. 

As the influence of these predictive tools has spread, a recent examination by federal inspectors of denials made in 2019 found that private insurers repeatedly strayed beyond Medicare’s detailed set of rules. Instead, they were using internally developed criteria to delay or deny care. Although some insurers follow Medicare's guidelines private insurers often set their own guideline.  Since MA plans are private plans they are free to do so unless Medicare restricts it.

In interviews, doctors, medical directors, and hospital administrators described increasingly frequent Medicare Advantage payment denials for care routinely covered in traditional Medicare. UnitedHealthcare and other insurers said they offer to discuss a patient’s care with providers before a denial is made. But many providers said their attempts to get explanations are met with blank stares and refusals to share more information. The black box of AI has become a blanket excuse for denials. 

New lawsuit accuses health insurer Cigna of denying claims in bulk

'Misleading': Alarm raised about Medicare Advantage 'scam' -

'Misleading': Alarm raised about Medicare Advantage 'scam' - Raw Story - Celebrating 19 Years of Independent Journalism

Democratic U.S. lawmakers on Tuesday joined senior citizens, people with disabilities, and healthcare campaigners at a Capitol Hill press conference to kick off a week of action demanding Congress move to stop abuses by so-called Medicare Advantage programs peddled by profiteering insurance companies and "reclaim Medicare."

Congressional Dems, Activists 'Raise the Alarm' About Medicare Advantage 'Scam'

"It is time to call out so-called Medicare Advantage for what it is," said Rep. Rosa DeLauro. "It's private insurance that profits by denying coverage and using the name of Medicare to trick our seniors."

"We are here to raise the alarm about Medicare Advantage. We are here to protect our Medicare," Sen. Elizabeth Warren (D-Mass.) said to robust applause.

The Evolution of Private Plans in Medicare

Issue: Since the 1980s, private plans have played an increasingly important role in the Medicare program. While initially created with the goals of reducing costs, improving choice, and enhancing quality, risk-based plans — now known as Medicare Advantage plans — have undergone significant policy changes since their inception; these changes have not always aligned with the original policy objectives. 

"This year, for the very first time, more than half of all beneficiaries are enrolled in Medicare Advantage instead of traditional Medicare," she continued. "But Medicare Advantage substitutes private insurance companies for traditional Medicare coverage, and that private coverage is failing both Medicare beneficiaries and taxpayers."

"Not only do Medicare Advantage insurers rip off the government, they routinely deny care to patients who need it."

"It's all about the money," Warren said. "Private insurers are in Medicare Advantage to play games to extract more money from the government."

"Experts estimate that Medicare Advantage insurers will receive more than $75 billion in overpayments this year alone, and that's the real punch to the gut," she continued. "Not only do Medicare Advantage insurers rip off the government, they routinely deny care to patients who need it."

History of Changes in Payment and Quality in Medicare Private Plans

Act	Payment	Quality Improvement and Measurement
TEFRA (1982)	• 95% of per capita traditional Medicare costs • Risk adjustment based on demographics	• Evidence of increased preventive care • HEDIS created in 1991
BBA (1997)	• Traditional Medicare spending controlled and capitation rate updates reduced by 2.8% • Rates fixed at 1997 level and adjusted to pay highest of floor rate, annual update of 2%, and blended rate • Risk adjustment based on health status and demographics	• No change in quality or quality measurement
BBRA (1999)	• Bonus for first risk plan entering market • Increase in traditional Medicare spending, on which plan payment was based	• No change in quality or quality measurement
BIPA (2000)	• Minimum update temporarily raised to 3% • Floors in rural and urban counties raised • Risk adjustment based on demographics and diagnostic categories	• No change in quality or quality measurement
MMA (2003)	• Highest of urban or rural floor, 100% of average county-level traditional Medicare costs, higher of 2% or national traditional Medicare cost growth update over 2003 rate, and blended rate update • Bidding system with rebate at 75% of difference between benchmark and bid	• Star rating for plan quality instituted in 2008
MIPPA (2008)	• No change in payment	• Quality reporting and provider network reporting mandated for PFFS by 2011
ACA (2010)	• Counties ranked from lowest to highest traditional Medicare costs and divided into four assemblages: county benchmarks at 115%, 107.5%, 100%, and 95% of county traditional Medicare costs • Rebates at 50% but higher at 65% and 70% for plans with 3.5–4 and 4+ stars, respectively • 5% bonus to benchmarks of plans with 4+ stars • Risk adjustment updated to correct for coding intensity	• Nearly 50% of plans had 4+ stars in 2017 • Enrollment in plans with 4+ stars

Reclaim Medicare (video)

"We can strengthen traditional Medicare, and by doing that, we can save money and we can use some of those savings to expand benefits, like hearing, dental, and vision... and add an out-of-pocket cap for all beneficiaries... and lower the eligibility age for Medicare."

"Medicare money should be spent to deliver services for people," Warren added, "not to boost profits for insurance."

Rep. Rosa DeLauro (D-Conn.) said that "it is time to call out so-called Medicare Advantage for what it is. It's private insurance that profits by denying coverage and using the name of Medicare to trick our seniors.

Like the lawmakers, Alex Lawson, executive director of the advocacy group Social Security Works, blasted "bad actors in Medicare Advantage" who he said "are delaying and denying the care seniors and people with disabilities need."

"Corporate insurance is designed to generate profits by delaying and denying care, harming and killing patients instead of providing care,"

Wendell Potter, who heads the Center for Health and Democracy, repeated the common refrain that "so-called Medicare Advantage is neither Medicare nor an advantage. It is simply another scheme by the insurance companies to line their pockets at the expense of consumers by denying and delaying care."

"The healthcare market is confusing for consumers and the misleading branding of calling private insurance Medicare only makes this worse," Potter stressed.

Progressive lawmakers have also criticized President Joe Biden for delaying promised curbs on Medicare Advantage plans amid heavy insurance industry lobbying.

ERIC TOPOL AND A.I.

The amazing power of "machine eyes"

A COLLECTION OF TOPOL'S BEST

PART I

https://erictopol.substack.com/i/134587450/your-chest-x-ray-indicates-you-may-have-diabetes

https://erictopol.substack.com/i/134587450/your-chest-x-ray-indicates-your-ejection-fraction-may-be-low-and-the-presence-of-valve-disease

https://erictopol.substack.com/i/134587450/your-electrocardiogram-shows-you-are-having-a-heart-attack

https://erictopol.substack.com/i/134587450/large-language-models-are-answering-medical-questions-increasingly-correctly

https://erictopol.substack.com/i/134587450/ai-outshines-in-health-care-at-paperwork

PART II

https://erictopol.substack.com/i/134767572/a-randomized-trial-of-generative-ai

https://erictopol.substack.com/i/134767572/ai-and-bias-in-healthcare

https://erictopol.substack.com/i/134767572/ai-and-infectious-disease

https://erictopol.substack.com/i/134767572/robots-for-rehab-and-promoting-empathy

https://erictopol.substack.com/i/134767572/chatbots-instead-of-research-participants

https://erictopol.substack.com/i/134767572/summary