How going digital can transform the patient experience

In today’s environment of rapid disruption, every healthcare company must go through a digital transformation to survive and develop a strategy that will align its evolution to rapidly changing patient expectations. But what lies beyond the buzzwords? Join us for the real talk. The way we work and how we engage our customers has to fundamentally change but how can you make actual progress and drive transformation?

Webinar Registration

In this session we will explore:

Real lessons and learnings from people who are actively walking the path of digital transformation
How to change the way you think so you can change what you do
The role of people, process, and technology in digital transformation
How to think about partners, performance, and key activations
How to deliver connected patient experiences that deliver impact, build trust and promote loyalty
No matter where you are on your transformation journey this session will present valuable information on how you can create an ecosystem of connected patient experiences.

Register now.

This goal applies to all providers, pharma, and the health ecosystem. Connecting the dots is more important than ever.

What if you can deliver the next generation of healthcare?

How Technology Is Helping (and Hurting) Health Care

Technology is everywhere in health care — and for many reasons, that's a good thing. It's fast, it's efficient, and it can reduce errors. And yet, technology is not a cure-all. It can make people complacent, introduce new errors, and get in the way of meaningful face-to-face interactions.

Technology is here to stay and we need to learn how to get the most value from the digital world that health care increasingly relies upon. That was the focus of our conversation on the June 1 WIHI, The Digital Transformation: How Technology Is Helping (and Hurting) Health Care. 

How Technology Is Helping (and Hurting) Health Care

The Digital Health Care Transformation


Insurers' message on 'Medicare for All': We're part of the answer | Healthcare Dive: Healthcare

National Nurse's Day

These are the ones who are on the front lines. Nurses make doctor's days better !  Nurses care more ! Take a nurse to lunch, bring in some snacks (healthy ones) to the nurse station.  Thank a nurse today, bring a flower.  Where would we all be without nurses ?

On behalf of the editorial staff here at Health Train Express

HHS To Deliver Value-Based Transformation in Primary Care | CMS

HHS To Deliver Value-Based Transformation in Primary Care

The CMS Primary Cares Initiative to Empower Patients and Providers to Drive Better Value and Results

Medicare and CMS have been emphasizing their role in revising our health system to advantage primary care, and to increase reimbursement to primary care physicians.  The health care reimbursement system heavily favors specialists whose fees are heavily weighted for procedures. In the past family physicians, some internists, and pediatricians have been at the bottom of the pay scale.

In the past several years this has improved. The statistics just released in early 2019 reflect the improvement .


“For years, policymakers have talked about building an American healthcare system that focuses on primary care, pays for value, and places the patient at the center. These new models represent the biggest step ever taken toward that vision,” said HHS Secretary Alex Azar. “Building on the experience of previous models and ideas of past administrations, these models will test out paying for health and outcomes rather than procedures on a much larger scale than ever before. These models can serve as an inflection point for the value-based transformation of our healthcare system, and American patients and providers will be the first ones to benefit.”

Empirical evidence shows that strengthening primary care is associated with higher quality, better outcomes, and lower costs within and across major population subgroups. Despite this evidence, primary care spending accounts for a small portion of the total cost of care and is even lower for patients with complex, chronic conditions. Primary care clinicians serve on the front lines of the healthcare delivery system, furnishing services across a wide range of specialties, from family medicine to behavioral health to gerontology. For many patients, the primary care clinician is the first point of contact with the healthcare delivery system. CMS’s experience with innovative models, programs and demonstrations to date have shown that when incentives for primary care clinicians are aligned to reward the provision of high-value care, the quality and cost-effectiveness of patient care improves.

Base upon maximizing the value of health care, HHS has proposed the following new categories of payment using several new criteria.

Primary Care First and Direct Contracting.

The five payment model options are:

Primary Care First (PCF)
Primary Care First – High Need Populations
Direct Contracting – Global
Direct Contracting – Professional
Direct Contracting – Geographic

Readers should refer to these details for each category


















HHS NEWS: HHS To Deliver Value-Based Transformation in Primary Care | CMS: HHS To Deliver Value-Based Transformation in Primary CareThe CMS Primary Cares Initiative to Empower Patients and Providers to Drive Better Value and Results

Overdose Attempts Skyrocket Among Teens, Young Adults

Suicide attempts by drug overdoses and other "self-poisonings" more than doubled among U.S. youth in the last decade, a new study reveals.

And attempts by girls and young women more than tripled during that time period, according to the analysis of National Poison Data System information.

Most of the self-poisonings "are drug overdoses, but they use a lot of over-the-counter meds [such as] acetaminophen, antihistamines, along with their prescription meds," explained study co-author Henry Spiller. He directs the Central Ohio Poison Center at Nationwide Children's Hospital in Columbus.

The findings showed that there were more than 1.6 million intentional self-poisoning cases among 10- to 24-year-olds nationwide between 2000 and 2018 -- more than 71% (1.1 million) involving females.

Suicide is the second-leading cause of death among Americans in that age group. While more males die by suicide, females attempt suicide more than males. Self-poisoning is the most common method in suicide attempts and third-most common method of suicide in teens, the researchers said.

"In youth overall, from 2010 to 2018, there was a 141% increase in attempts by self-poisoning reported to U.S. poison centers, which is concerning," Spiller said.

In a hospital news release, he added that "the severity of outcomes in adolescents has also increased, especially in 10- to 15-year-olds."

The study was published online May 1 in The Journal of Pediatrics.

Study co-author John Ackerman is the suicide prevention coordinator at the Center for Suicide Prevention and Research at Nationwide Children's Hospital.

"Suicide in children under 12 years of age is still rare, but suicidal thoughts and attempts in this younger age group do occur, as these data show," he said in the news release.

Ackerman called on parents and caregivers not to panic, but to talk to their children and undertake suicide prevention strategies, such as storing medications safely and limiting access to things that could be deadly.

"There are many resources and crisis supports available around the clock to aid in the prevention of suicide, and suicide prevention needs to start early," he said.

Parents should regularly ask children how they are doing and if they ever have thoughts about suicide, Ackerman advised. That's especially important if parents detect warning signs, such as social media posts about feeling hopeless or wanting to die; a young person giving away prized possessions or suddenly becoming calm or cheerful after a long period of depression.

"There is no need to wait until there is a major crisis to talk about a plan to manage emotional distress. Actually, a good time to talk directly about suicide or mental health is when things are going well," Ackerman suggested.

If you or your child need immediate help due to suicidal thoughts, go to your local emergency department immediately or call the Nationwide Suicide Prevention Lifeline at 1-800-273-TALK (1-800-273-8255). You can reach the Crisis Text Line by texting "START" to 741-741.

If you suspect an overdose, call the national Poison Help hotline at 1-800-222-1222.






























ReachMD

Why Can't I Get My Prescription Filled

Electronic health records offer a function called CPOE *Computerized Order Entry" which provides an electronic means for ordering medications and tests within the hospital. EHRs also allow prescriptions to be sent to a pharmacy.  However many drugs require prior authorization (PA).

That has been a manual process. The provider is required to send a form detailing what medications have already been tried and failed due to ineffectiveness, side effects or a complication. The authorization is then sent manually from the health plan to the pharmacy manually.  The process is inefficient and is repeated many times a day, occupying time which can be better used caring for patients.

A critical process is still performed manually ten years after the implementation of the EHR. This arduous and repetitive process often causes the prescriber to write a prescription that may be less expensive even though it will be less effective to avoid the bureaucracy of requesting a PA.

Prior Authorizations (PAs) have become increasingly burdensome for providers — they contribute to 92 percent of care delays and an estimated 77 million are submitted manually each year. In fact, the process has become so burdensome that many physicians get fed up with the process end up writing for less-effective prescriptions because they know the preferred drug will require prior authorization.

Regardless of the decision, this is a problem that has yet to be resolved despite the development of new technology and software — such as electronic prior authorizations (ePAs) — that have tried to streamline the process. While these solutions have helped, they are temporary at best, as their lack of widespread adoption still leaves physicians and their staff responsible for the time and financial commitment associated with PAs.


What if there was a way to remove the responsibility from providers’ shoulders entirely? I believe there is, and it’s as simple as making prior authorizations a pharmacy responsibility.

Why should PAs be a pharmacy responsibility?

The answer is simple: they’re the pharmacy’s to lose.

There is no financial incentive for a provider to file a PA. Instead, they do so out of moral obligation to their patients (and because that’s the way it’s always been done, since providers are the only ones with access to the patient information needed to complete the PA). Pharmacies, on the other hand, have all the financial incentive to become principal participants in the process. After all, the faster a prescription is approved by an insurance company, the sooner (and more frequently) those prescriptions can get filled.

The problem is, most pharmacies don’t identify PAs as a financial incentive. The process can be time-consuming and tedious — as providers know well — so most pharmacies haven’t even considered it as an option. Of those who have, few choose to take on such a task, opting instead to let the system run its course and simply take whatever prescriptions come in organically. This leads not only to delays in patient care but also to alarmingly lengthy gaps between getting prescriptions filled. But the fact remains approvals (or denials) of PAs ultimately affect a pharmacy’s ability to bring in prescriptions and revenue, so pharmacies should be more proactive in participating with physicians in the care process.

Why hasn’t this been considered before?

The biggest roadblock to efficiently dealing with PAs is the pharmacy’s lack of access to relevant and necessary patient information. By default, providers have been assigned the responsibility for filing PAs simply because they have access to all the information required to submit them. Pharmacies, on the other hand, only have part of the information needed. Software companies like CoverMyMeds help to fill in some of the gaps, but PAs still ultimately find their way back to providers for missing patient information and submission. And since there’s no financial incentive for providers to complete them, PAs get put on the backburner, piling up until finally time is set aside to complete them.

What the industry ultimately needs is a solution that removes the burden from providers entirely, while still giving pharmacies secure and confidential access to the information they need from the get-go.

Pharmacies can do this by proactively coordinating with providers to obtain the information necessary to correctly and completely fill and submit a PA, perhaps through (read-only) access to the provider’s electronic medical records (EMR) system. Doing so creates a touchless system for providers that decreases downtime in the prescription-filling process and ultimately gets patients the best prescriptions, faster.

The Tufts Center for the Study of Drug Development most recently estimated the cost of bringing a new drug to pharmacy shelves at $2.7 billion. But that cost only increases when PAs enter the picture.

Physicians often hesitate to prescribe new drugs (even if they’re the best option) because of PA requirements, making it more difficult for a new medication to enter the market and for patients to get the prescriptions they need. By shifting the responsibility of PAs from providers to pharmacies, physicians can feel more confident in prescribing the medication they want the first time, making it easier for new medications to make it from shelves to homes, and ultimately driving healthcare costs down.

In the end, prior authorizations can never be a single party’s responsibility — a successful solution depends on the partnership of pharmacies and providers who work together for the benefit of patients. In doing so, pharmacies and providers can build stronger working relationships and, together, provide patients with a better quality of care.






The answer to your prior authorization problem is simpler than you think: Pharmacies and providers can build stronger working relationships and, together, provide patients with better quality of care.

Health insurance deductibles soar, leaving Americans with unaffordable bills - Los Angeles Times

Soaring health insurance deductibles have strained family budgets, saddled many with debt and driven millions to skip care. It's the result of a revolution that has transformed U.S. health insurance, shifting a growing share of costs to workers and their families.

A medical crisis has largely been ignored by the media and Congress for the past year or more during the turmoil of investigations and congressional polarization during non-productive investigations of self-interest groups in Congress

Soaring deductibles and medical bills are pushing millions of American families to the breaking point, fueling an affordability crisis that is pulling in middle-class households with health insurance as well as the poor and uninsured.

In the last 12 years, annual deductibles in job-based health plans have nearly quadrupled and now average more than $1,300.

Yet Americans’ savings are not keeping pace, data show. And more than four in 10 workers enrolled in a high-deductible plan report they don’t have enough savings to cover the deductible.

One in six Americans who get insurance through their jobs say they’ve had to make “difficult sacrifices” to pay for healthcare in the last year, including cutting back on food, moving in with friends or family, or taking extra jobs. And one in five says healthcare costs have eaten up all or most of their savings.  Those are among the key findings of a Times examination of job-based health insurance — the most common form of coverage for working-age Americans — which has undergone a rapid transformation, requiring patients to pay thousands of dollars out of their own pockets.

The conclusions are based in part on a nationwide poll conducted in partnership with the nonprofit Kaiser Family Foundation, or KFF. Two Washington-based think tanks — the Health Care Cost Institute and the Employee Benefit Research Institute — provided supplemental analysis.

How the LA Times/Kaiser Family Foundation poll was conducted »

The Times also interviewed doctors, business leaders, researchers and dozens of Americans with high-deductible coverage and reviewed scores of studies and surveys of health insurance in the U.S.

At a time when healthcare is poised to be a central issue in the 2020 presidential election, these sources provide a comprehensive look at changes that have profoundly reshaped insurance.

The explosion in cost-sharing is endangering patients’ health as millions, including those with serious illnesses, skip care, independent research, and the Times/KFF poll show.

The shift in costs has also driven growing numbers of Americans with health coverage to charities and crowd-funding sites like GoFundMe in order to defray costs.

Health insurance deductibles soar, leaving Americans with unaffordable bills - Los Angeles Times:

Shared Decision Making

"The best interest of the patient is the only interest to be considered"

This sentence is from the 1910 Rush Medical College commencement address by W. J. Mayo, M.D.  The full sentence included an important requirement:

"In order that the sick may have the benefit of advancing knowledge, the union of forces is necessary."

These two statements have been updated with the terms Patient-Centered Medicine, and Shared Decision Making.

The concepts are far from new and current events make them very relevant.  In today's practice world where the ten-minute encounter is the norm, shared decision making becomes almost impossible. Physicians are between a rock and a hard place.  We need constant reminders in the face of mounting bureaucracy, coding requirements, and electronic health record data input.

The union of forces is necessary to meet these needs.  Nurses, educators, medical assistants all should be engaged with patients.  The addition of readily available teaching aids, and electronic aids can assist us with these duties.

The modern EHR has new functionalities which incorporate instructions and educational material that can be given to a patient at the encounter or made available via a portal or direct secure email to the patient. 

Patients and clinicians have different expertise when it comes to making consequential clinical decisions.  While clinicians know information about the disease, tests, and treatments, the patient knows information about their body, their circumstances, their goals for life and healthcare.  It is only collaborating on making decisions together that the idea of evidence-based medicine can come true.

This process of sharing in the decision-making tasks involves developing a partnership based on empathy, exchanging information about the available options, deliberating while considering the potential consequences of each one, and making a decision by consensus. This process -- sometimes called patient-centered decision making, empathic decision making, or shared decision making -- demands the best of systems of care, clinicians, and patients and as such remains an ideal.



The Mayo Clinic and the Minnesota Shared Decision Making Collaborative have developed a comprehensive paradigm to meet this need.

The study reported in the BMC Medical Informatics and Decision Making 2013, 13(Suppl 2):S2

Study: Most mental health apps give Facebook, Google access to personal info without users' knowledge

It comes as no surprise that social media sites share your personal information. But, do you know that smartphone app that you download to your iPhone or Android phone share your personal information with companies that buy social media personal information.   All those 'FREE" apps are supported by unknown information harvesting companies. BEWARE.

A new study published in JAMA Network Open found that a majority of mental health and wellness apps surveyed distribute users' personal data to commercial third parties like Facebook and Google without explicitly informing users.

Researchers from the University of New South Wales Sydney, the Sydney-based Black Dog Institute, and the Beth Israel Deaconess Medical Center's Department of Psychiatry in Boston examined 36 apps for depression and smoking cessation that was highest ranked in the iOS and Android app stores in early 2018. Results show that 33 of the programs transmitted user data to Facebook, Google or other entities for advertising or analytical purposes, but only 12 fully disclosed this practice to users.

Just 23 of the surveyed apps incorporated privacy policies mentioning that data would be transmitted to a third party, and many of those fail to explicitly describe how the data will be used, and by which third parties.

According to the study's authors, despite the mental health benefits of these and similar apps, the lack of disclosure "may limit their ability to offer effective guidance to consumers and health care professionals," who would likely prefer to know whether and how their personal health information is accessed by advertising and analytical firms.

Data-sharing by free apps is ‘out of control’ with almost 90% of free apps on Google Play sharing your details with companies, Oxford University study finds.

Even paid apps have the same attendant risks.

Google Play Store                       

Apple App Store



How can you find where Google and Apple share their user information? Even this may be irrelevant because the information sharing is done by the App developer.



Readers should evaluate the worth of a free app vs the real risk of sharing their personal data from a health-related app.

Related Cybersecurity implemented by Google

Google set to purge Play store of apps lacking a privacy policy

Knowing When Apps Are Safe to Install

How do you know if an app marketplace is trustworthy?

Some characteristics of a safe marketplace are:

Terms of service that is well developed.

Clear contact information and a troubleshooting FAQ.

Strict app developer criteria.

A history of removing vendors with poor content.

Learn About the Vendor or Developer

Some questions to ask about app vendors are:

Do they have a professional website?

What is the privacy policy?

How is the information collected and used?

What information is available to advertisers?

What is the policy for disclosure of personal information?

Does the vendor have clear security policies?

Is there clear contact information?

There is no centralized source listing unsafe apps. The number of new apps that appear daily is enormous. The Food and Drug Administration is begining to evaluate and regulate health care apps.  Caveat emptor!

Study: Most mental health apps give Facebook, Google access to personal info without users' knowledge:

Alarm raised over tripling in cancelled NHS surgery and clinic appointments

Could this happen in the United States?

In a report from the U.K. Telegraph, an alarm has been raised.

Nine million patients a year are seeing crucial hospital appointments and operations canceled by administrators - almost triple the number a decade ago, official statistics show.

The rise has occurred over the past ten years, at a steady rate, according to a chart developed by the Telegraph. 

While the NHS has targets for diagnosis and treatment, and to reschedule surgery within 28 days, if it is canceled, there are no penalties to prevent trusts repeatedly putting outpatients appointments on hold.  

Will health IT save the day?  

The plan, launched in January, says that within five years, up to 30 million hospital appointments - one in three - should be scrapped, with patients instead having Skype consultations or being monitored via smartphone. Officials say this will mean the most vulnerable patients who need face-to-face slots will not face such long waits and delays.

 Caroline Abrahams, charity director at Age UK, said too many patients were seeing their health worsen, while appointments were delayed. She said: “More outpatient appointments being canceled by hospitals translates into growing anxiety, distress and pain for hundreds of thousands of older people. While some clinic appointments are routine, others are crucial steps in the effective and timely treatment of very serious and escalating health problems.”

Professor Andrew Goddard, President of the Royal Royal College of Physicians said the rise in cancellations was a symptom of rising pressure on hospitals, and growing numbers of cases arriving via Accident & Emergency. "Emergency admissions have risen by around 28 percent in the same period of time, putting more stress on an overstretched system," he said.

The pensioner who was blind by the time he finally got his appointment

Bob Dalton, 74, should have been given a follow-up outpatient appointment at Southampton General Hospital within a fortnight, following an operation to repair a detached retina. However, he wasn’t seen until over a month later - by which point he was blind in his right eye. Mr. Dalton, a retired RAF administrator, from Alton, was worried about changes in his eyesight and repeatedly made calls to the hospital.  By the time he finally saw his surgeon, he had suffered a total detachment of his retina.

These are but symptoms of an overstretched and underfunded health system in the U.K. The NHS is divided into trusts (smaller regional group administrations). All have suffered the same changes in canceled surgeries and hospital appointments. During 2017-2018 some disparities were noted:  Patients in the South were more likely to see appointments canceled. The U.S. health system is struggling to cope with its aging population, more advanced and more effective treatments, and better outcomes. While the U.S. system has already deteriorated somewhat by inconsistent federal regulations, penalties, incentives and a polarized politic we are considering a Universal Payer plan. The proposed system although called socialized medicine, it is not. Socialism is where the government owns the assets. The proposed system for the United States mandates a uniform payment model for private capitalistic infrastructure.  What will our solution accomplish? 

Alarm raised over tripling in cancelled NHS appointments: Nine million patients a year are seeing crucial hospital appointments and operations cancelled by administrators - almost triple the number a decade ago, official statistics show.

Best Buy, Target jump into at-home medical device market |

FDA Cleared and Reviewed*

Remote medical monitoring is reaching the consumer market at retail businesses such as Target, and Best Buy.  This is a major development for consumers.  This development opens a door for promotion, education and also competitive pricing for such devices.  Remote medical monitors are no longer a niche in health information technology, Best Buy and Target signal the beginning of a new age.  These devices will soon appear on the shelves in the health section or pharmacy alongside thermometers, blood pressure, and glucose monitors.

It simplifies the provider's direction for patients as to how to obtain an FDA approved device.  it does not require a prescription. A consumer can purchase a device on impulse.  However, a patient should consult with their physician to see if he approves and has access to reading the results.

Tyto's Remote Monitor

What's Included

A TytoHome telehealth visit is $59, possibly less if health insurance covers medical phone consultations, the company said. Tyto Care works with LiveHealth Online, which is an offer for those who buy the devices at BestBuy.com and live outside of current coverage areas. Otherwise, the company is partnering with regional healthcare systems to provide medical care to consumers throughout the country, according to the release. That includes the not-for-profit healthcare system Sanford Health for users in Minnesota, North Dakota, and South Dakota.

No matter what monitor you chose, it is only part of a system.  The remote monitor must be integrated as a one end-to another, the clinicians' office.  It requires a secure reliable network, either by cell phone or internet connection. Optimally it should integrate with the electronic health record to capture the images and the voice content. As part of the integrated electronic health record, it must be interoperable in accordance with ONCHIT guidelines.

Tytocare is cloud-based. If there are no local providers Tyto provides a network of qualified telemedicine providers that will help you until you are able to see your personal physician.

Telemedicine is growing exponentially and the latest availability should be checked out by telephone with Tytos.

Be wary of any telehealth provider, and use due diligence.

This article is neither a recommendation or testimonial for Tyco.  It is provided only as an information service





FDA Cleared and Reviewed*





















Best Buy, Target jump into at-home medical device market | Healthcare Dive: TytoHome

Burnout Declared A Health Crisis According To Harvard, Health Organizations

A number of academic institutions have belatedly reported on physician burnout and suicide.  Burnout, depression, and  PTSD amongst physicians and health providers has been reported in numerous blogs and in personal stories from physicians and their families.

Pamela Wible MD, an independent physician from Oregon has been an advocate for preventing physician suicide and bringing the truth out, rather than hiding it as a shameful act, or weakness. Physician suicided is often denied or covered up when it occurs. Pamela Wible M.D, along with professional film producer Robyn Simon produced the film, Do No Harm, was released in 2018.  It is available for group shows. The project was a Kickstarter, reaching its goal in one week from over 300 contributors (When the campaign ended we had 857 backers and $131,313 pledged. )

Producer Robyn Simon

Final Meeting of the Kickstarter Group for "Do No Harm"

Burnout is not limited to health care professionals. In today's world mounting frustrations, a decrease in living standards for millennials gives yield to hopelessness and sometimes despair and even suicide.

 A survey among Human Resources leaders showed that 95 percent feel as though burnout is “sabotaging workplace retention.” One reason for this, they say, is the overly heavy workloads put on employees.  If you’re experiencing physical or emotional ailments that may be symptomatic of burnout, it’s important to take the right steps to focus on your health.

Take an increased effort to practice self-care: physical exercise, sleep, and real-life social connections can be major influencers that help combat the emotional turmoil of burnout. And of course, never hesitate to seek professional help.

It may be difficult to take a few steps back from your obligations, but it’s often necessary to ground yourself, provide clarity, improve wellbeing and rediscover the purpose in your everyday life.

To view the survey conducted by Harvard and Massachusetts medical organizations, click here.







Burnout Declared A Health Crisis According To Harvard, Health Organizations | Darien Daily Voice: Are you emotionally exhausted, cynical and feeling hopeless? You could be experiencing burnout, which is now being considered a legitimate public health crisis by Harvard as well as several health organizations.Burnout is more than ...

FDA permits marketing of a medical device for treatment of ADHD

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

The device known as a transneuronal stimulator is not new on the market. It has previously been approved for the treatment of other disorders.

A diagram of it's the mechanism of action for a transneuronal stimulator

Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder.
An eight-week,  study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity  
The potential use of trigeminal nerve stimulation in the treatment of epilepsy.
Central mechanisms of cranial nerve stimulation for epilepsy.

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person’s functioning and cause the person to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone-sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion, and behavior.

The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects.

The Monarch eTNS System’s efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD were enrolled in the trial and used either the eTNS therapy each night or a placebo device at home for four weeks. The trial's primary endpoint was an improvement on a clinician-administered ADHD Rating Scale, ADHD-RS.  ADHD-RS scales are used to monitor the severity and frequency of ADHD symptoms. A higher score is indicative of worsening symptoms. The ADHD-RS uses questions about the patient’s behavior, such as whether they have difficulty paying attention or regularly interrupt others. The trial showed that subjects using the eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

The most common side effects observed with eTNS use are drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or with active implantable neurostimulators. Patients with body-worn devices such as insulin pumps should not use this device. The eTNS System should not be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI), because it has not been tested in an MRI machine, or cell phones, because the phone’s low levels of electromagnetic energy may interrupt the therapy.

The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma. 

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This is not a recommendation for treatment.  See your physician for diagnosis and treatment.

Press Announcements > FDA permits marketing of first medical device for treatment of ADHD: FDA permits marketing of first medical device for treatment of ADHD

The 2020 Final Payment Notice, Part 1: Insurer and Exchange Provisions

On April 18, 2019, the Centers for Medicare and Medicaid Services (CMS) released its final 2020 Notice of Benefit and Payment Parameters rule. The final rule was accompanied by a fact sheet, the final letter to insurers in the federal marketplace, and key dates for the calendar year 2019.

This is the latest that a payment rule has ever been finalized. From here, insurers can develop their products for 2020 and get these products reviewed and approved by state regulators or CMS.

The complexity of rules changes requires almost one year to process. The process if nothing else traces a route through providers, hospitals, and patients.  There is a public commentary period.

Overall, CMS made very few major changes from its proposed rule, which was released on January 17. Where the final rule deviates from the proposed rule, CMS mostly opted not to implement certain proposed changes. The final rule does not, for instance, require the sale of “mirror” abortion plans, adopt many significant changes to prescription drug standards, or allow navigators and other assisters to use web broker websites. In terms of significant changes that were adopted, the final rule allows insurers to adopt accumulator adjustment programs in limited circumstances and maintains an increase in the 2020 premium adjustment percentage as proposed. The latter is described as a “technical” change to the methodology that will result in higher consumer costs, reduced access to premium tax credits, and more uninsured people.

There were more than 26,000 comments on the proposed rule, about 500 of which were unique. Most of the remaining 25,000 comments were like one of eight different letters and focused on the rule’s abortion coverage proposal. This post addresses final changes in plan benefits, eligibility, and enrollment changes. A second post will consider the final changes to the risk adjustment program.

The “payment notice” is issued on an annual basis to adopt a variety of major changes that CMS intends to implement for the next plan year in areas such as the marketplaces, the risk adjustment program, and the market reforms. Historically, the payment rule has been issued in early fall and finalized in early spring (typically late February or early March) to give insurers, states, and other stakeholders time to understand the rules for the next year as new products are developed and approved for sale. 

This is the latest that a payment rule has been finalized and reduces the window of time for insurers and state regulators or CMS to develop, adjust, review, and approve plans for 2020. This delay notwithstanding, CMS did not alter its timeline for qualified health plan (QHP) certification for 2020: insurers must submit their 2020 QHPs  to CMS by June 19, 2019, for approval. CMS has already released its final rate filing timeline for 2020.

Much of the rule is devoted to changes regarding direct enrollment and risk adjustment, but the 401-page final rule addresses the following topics:

Changes in plan benefits and qualified health plan provisions;
Eligibility and enrollment changes, such as a new special enrollment period, changes to navigator requirements, and new standards for direct enrollment;
The 2020 payment parameters, such as the federal exchange user fee, annual limits on cost-sharing, and a new way of determining premium growth; and
Changes to the risk adjustment program.

In 2018 large increases were prevented by "silver loading" premiums.  How 'silver-loading' helped save the ACA's exchanges in 2018

In contrast to the 2019 payment rule, CMS proposes very few changes regarding the essential health benefits (EHB) and plan design. For 2019, CMS allowed states to choose from among many more EHB-benchmark plan options on an annual basis, deferred additional responsibility to state regulators, and eliminated standardized plan options and meaningful difference standards, among other changes. The 2020 final rule maintains these changes and makes no additional changes beyond laying out new timelines and providing additional background on discriminatory benefit design.

Toll-Free Hotline for SHOPs
The final rule includes a very minor change to the SHOP program. This is because the 2019 payment rule (and guidance before that) essentially wound down the SHOP exchanges after CMS concluded it is no longer cost-effective for the federal government to maintain a SHOP website and functionality. Thus, small employers no longer enroll using the SHOP platform and, instead, enroll through a SHOP-registered agent or broker or directly with an insurer.

CMS did, however, retain some SHOP standards, including a requirement that SHOPs continue to provide a call center to answer SHOP-related questions. Noting that SHOP call center volume has been extremely low, CMS will allow “leaner” SHOPs to operate a toll-free hotline in lieu of a call center. (CMS explained the difference between a hotline and a call center in the 2017 payment rule.) The toll-free hotline must allow for automated messages, pre-recorded responses to common questions, ways to reach local agents and brokers, and the option to leave a message.






















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