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Friday, February 28, 2020

Amazon discreetly launches into health

The world champion of e-commerce has launched an offensive in the medical sphere. Less visible than that of Google, its global strategy includes telemedicine, pharmacy, and insurance.

ALEXA. " I need to see a doctor "



That request is not so far fetched, and will probably be the reality very soon.  The hardware and technology have come together exponentially in the past two years.  The use of the internet, voice recognition, machine learning, poor access to health care in rural areas, combining with telehealth combining with consumer demand assure the success of this method of medical care for many consumers. 

Combining this with secure medical records and pharmaceutical records, Amazon will also offer prescription ordering and renewals, all charged to your Amazon rewards card.

Imagine an American woman named Jenna Miller. After a day spent nose taken, she decides in the evening to take care of herself. She opens the Amazon Care application on her phone and clicks on "online chat with a nurse". On the other side of the screen, the caregiver is assisted by Health Navigator, software to aid in the diagnosis and orientation of patients using artificial intelligence. The nurse concluded that she had sinusitis and advised Ms.  Miller to see a doctor within 24 hours. The next morning, the patient opted for a "video consultation", still through Amazon Care.

Patients will have a choice of Smart Speaker, as long as it uses Amazon's Alexa. There are multiple manufacturers in the market, some with video capability which would simplify telehealth in one device.

Popular Smart Speakers

From a distance, the doctor prescribes an antibiotic and accompanying treatment. The oral exchange is transcribed in writing by the Transcribe voice recognition software. Then entered in the patient's file, stored online by the AWS host.

In the evening, Ms. Miller receives her medication, delivered by the Pillpack company, at home. The next morning, on the Echo connected speaker in her kitchen, the voice assistant Alexa reminds her to take her pills. The cost of care is borne by Haven Health, the health insurer of Jenna Miller's employer.

The common point between the services mentioned in this fiction is that they all belong to Amazon. The champion of e-commerce is however better known for the sale of books, clothing or electronic devices than as a player in health. After revolutionizing commerce, could Jeff Bezos' business shake up our access to medical care?

"Digital entry door"

It is not yet as advanced as the use case invented for Ms. Miller suggests: Amazon Care is currently only offered to Amazon employees based at the company's American headquarters, Seattle (Washington State).

This is a powerhouse of backers, from J.P. Morgan, Berkshire Hathaway (Warren Buffet) and Jeff Bezos (Amazon).  For the time being the pilot program is limited to Amazon employees.



The British Health Service (N.H.K.) has also thrown its hat into the ring as a user.

"Alexa I'm in pain": the British public health service calls on Amazon

" Alexa, what are the symptoms of the flu?" : The British government has announced that its citizens can now find out from the NHS public health service through smart speakers produced by Amazon.

Now we can add an MD icon

Speaking aloud to these speakers, users will be able to ask questions, considered simple by the medical profession, such as: " Alexa, how do I treat a migraine?" "Or" Alexa, what are the symptoms of chickenpox? Amazon's algorithm will respond to it via voice assistant Alexa after doing its research on the NHS website.

" It's just an alternative mechanism for accessing medically certified NHS information on various medical conditions instead of information from US sites or other sources, " said a spokesman for the Department of Health. But he will not provide " any form of diagnosis or advice, " he insisted.

" This kind of technology is a great example of how people can get reliable advice (...) from the NHS from the comfort of their own homes, thereby reducing the pressure on our doctors and pharmacists, " said in a statement. Health Minister Matt Hancock, saying it would be particularly helpful for the blind and elderly.

This new service provided by the American technology giant must relieve NHS staff, overworked and tired of bad medical advice that proliferates online.







Amazon discreetly launches into health:

Thursday, February 27, 2020

As The Coronavirus Spreads, Americans Lose Ground Against Other Health Threats | California Healthline

Health care experts thought the battle was won against heart disease, measles, smoking, STDs and other life-threatening conditions and behaviors. Better think again.


For much of the 20th century, medical progress seemed limitless.

Antibiotics revolutionized the care of infections. Vaccines turned deadly childhood diseases into distant memories. Americans lived longer, healthier lives than their parents.

Yet today, some of the greatest success stories in public health are unraveling.

Even as the world struggles to control a mysterious new virus known as COVID-19, U.S. health officials are refighting battles they thought they had won, such as halting measles outbreaks, reducing deaths from heart disease and protecting young people from tobacco. These hard-fought victories are at risk as parents avoid vaccinating children, obesity rates climb and vaping spreads like wildfire among teens.

Things looked promising for American health in 2014 when life expectancy hit 78.9 years. Then, life expectancy declined for three straight years — the longest sustained drop since the Spanish flu of 1918, which killed about 675,000 Americans and 50 million people worldwide, said Dr. Steven Woolf, a professor of family medicine and population health at Virginia Commonwealth University.

Although life expectancy inched up slightly in 2018, it hasn’t yet regained the lost ground, according to the Centers for Disease Control and Prevention.

“These trends show we’re going backward,” said Dr. Sadiya Khan, an assistant professor of cardiology and epidemiology at Northwestern University Feinberg School of Medicine.

Health-Wealth Disparities

To be sure, some aspects of American health are getting better.
Yet the health gap has grown wider in recent years. Life expectancy in some regions of the country grew by four years from 2001 to 2014, while it shrank by two years in others, according to a 2016 study in JAMA.
The gap in life expectancy is strongly linked to income: The richest 1% of American men live 15 years longer than the poorest 1%; the richest women live 10 years longer than the poorest, according to the JAMA study.
“We’re not going to erase that difference by telling people to eat right and exercise,” said Dr. Richard Besser, CEO of the Robert Wood Johnson Foundation and former acting director of the CDC. “Personal choices are part of it. But the choices people make depend on the choices they’re given. For far too many people, their choices are extremely limited.”
The infant mortality rate of black babies is twice as high as that of white newborns, according to the Department of Health and Human Services. Babies born to well-educated, middle-class black mothers are more likely to die before their 1st birthday than babies born to poor white mothers with less than high school education, according to a report from the Brookings Institution.

In trying to improve American health, policymakers in recent years have focused largely on expanding access to medical care and encouraging healthy lifestyles. Today, many advocate taking a broader approach, calling for systemic change to lift families out of the poverty that erodes mental and physical health.

“So many of the changes in life expectancy are related to changes in opportunity,” Besser said. “Economic opportunity and health go hand in hand.”

The best-performing counties in the United States have average life expectancies that are now 20 years greater than the lowest-performing counties.

And earned income tax credits — which provide refunds to lower-income people — have been credited with keeping more families and children above the poverty line than any other federal, state or local program, according to the CDC. Among families who receive these tax credits, mothers have better mental health and babies have lower rates of infant mortality and weigh more at birth, a sign of health.

Improving a person’s environment has the potential to help them far more than writing a prescription, said John Auerbach, president, and CEO of the nonprofit Trust for America’s Health.

“If we think we can treat our way out of this, we will never solve the problem,” Auerbach said. “We need to look upstream at the underlying causes of poor health.

It now appears that a major influence on health lies in the Social Determinants of Health


Upward mobility seems to have a positive effect on health.


Some hospitals and government programs (such as Medicaid) are allocating funds to improve social determinants of health.  Early studies reveal a significant ROI (return of investment). 



In Chicago, Advocate Health Care saved nearly $5 million by screening for malnutrition risk factors and establishing an enhanced nutrition care program.  In Boston, a six-months-or-longer, home-delivered meals benefit for dual Medicare-Medicaid eligible patients was associated with significant reductions in emergency room visits and overall health care cost savings. An initiative to link WellCare Medicaid and Medicare Advantage plan members to social service organizations resulted in an annual savings of $2,400 per person. In Hennepin County, Minnesota, millions of dollars were saved by offering unconventional services to patients with complex health, housing, and social service needs. The University of Illinois at Chicago reduced costs by 18 percent by identifying homeless patients who could benefit from housing support. These are just a few of the studies and reports documenting the health care system’s efforts to go beyond its own walls to improve health outcomes, decrease the consumption of medical services, and reduce costs.

Most health care professionals have known this for decades. At last, the SDOH  is officially recognized, studied and the statistics reveal what actions need to be accomplished. Investments in these determinants will be offset by a significant reduction in direct health costs. 


Summary of Progress for. SDOH         Charts





The Coronavirus Spreads, Americans Lose Ground Against Other Health Threats | California Healthline






Catalyst. Three Key Opportunities for Excellence in Health Care Delivery

Pre-release:


A Webinar

Register in the Catalyst link below


Ochsner Health System


We have access to the content for this webinar from Health Catalyst

Redefining excellence for health care, with sessions on chronic care, centers of excellence, and information technology.

Excellence in care delivery is the goal of every health care leader and provider. Why, then, do so many organizations fall short of what is possible? This free, live Web event from NEJM Catalyst, hosted by Ochsner Health System, will feature an outstanding slate of experts who will share their experiences, best practices, and frameworks for excellence with you.

The challenges of health care today are different than in the past, and so are the solutions. Through engaging talks and live, moderated Q&A, we will address three pain points shared across the health care continuum: chronic care, centers of excellence, and health IT. Our speakers and moderators – health care leaders, researchers, and entrepreneurs – will address each of these challenges and share innovative solutions.

Agenda


11:00 - 11:05
 Welcome
11:05 - 11:20
 Keynote Talk: Redefining Excellence in Care Delivery
To deliver care that patients and providers alike consider excellent, health systems will need to do things very differently in the future. The president of Ochsner Health System highlights technology and other drivers of change.

 

11:20 - 12:20
Care of chronic diseases is humbling for many clinicians. Improving the health of the increasing number of patients with chronic diseases – including diabesity, hypertension, COPD, and other expensive and prevalent conditions – requires rethinking the infrastructure of care models, addressing social determinants, and applying new technology.12:35 - 1:35
12:35-1:35       Session 2: Centers of Excellence
                         Focused centers of excellence for musculoskeletal care and                            other procedures show great promise for improved outcomes,                         controlled costs, and better patient experience. But adoption                           by patients and payers is not assured, as early adopters                                  learned. 
Marcia Peterson, MHA
Benefit Design and Strategy Manager, Washington State Health Care Authority
David Carmouche, MD
President, Ochsner Health Network; Senior VP of Community Care, Ochsner Health System; Executive Director, Ochsner Accountable Care Network
1:50 - 2:50.      Session 3: The Provider-Digital Interface







Clinicians bemoan the experience of using EHRs and other health IT, and health care leaders are frustrated by the cost. Clearer thinking about the digital interface with providers can improve the future of health care technology.

Presenters

Julie Adler-Milstein, PhD
Associate Professor, UCSF School of Medicine; Director, Center for Clinical Informatics and Improvement Research, UCSF
Amy Merlino, MD, FACOG
Enterprise Chief Medical Information Officer, Cleveland Clinic Health System
Thomas H. Lee, MD, MSc
Editor-in-Chief and Editorial Board Co-Chair, NEJM Catalyst Innovations in Care Delivery; Chief Medical Officer, Press Ganey Associates; Editorial Board, New England Journal of Medicine
2:50 - 3:00
 Closing Remarks
The president of the Ochsner Health System highlights technology and other drivers of change.

11:20 - 12:20
Session 1: Chronic Care

Care of chronic diseases is humbling for many clinicians. Improving the health of the increasing number of patients with chronic diseases – including diabesity, hypertension, COPD, and other expensive and prevalent conditions – requires rethinking the infrastructure of care models, addressing social determinants, and applying new technology.

12:35 - 1:35. Session 2: Centers of Excellence

Focused centers of excellence for musculoskeletal care and other procedures show great promise for improved outcomes, controlled costs, and better patient experience. But adoption by patients and payers is not assured, as early adopters learned.

1:50 - 2:50  Session 3: The Provider-Digital Interface

Clinicians bemoan the experience of using EHRs and other health IT, and health care leaders are frustrated by the cost. Clearer thinking about the digital interface with providers can improve the future of health care technology.

 2:50 - 3:00. Closing Remarks










Catalyst

Wednesday, February 26, 2020

Humanizing the Annual Physician Performance Review

Transforming the review process from a punitive, deflating experience to a valuable one that strengthens the relationship between physician and organization.

With increasing health system consolidation and growing pressure to standardize care delivery, ineffectual annual performance reviews have flourished. These physician performance assessments are often superficial, and comments are not actionable, timely, nor constructive, leaving physicians feeling deflated. At their worst, these assessments may contribute to physician burnout. Meaningful physician engagement is essential to organizational success.

Despite their common use, little has been written about how to do physician reviews well. We propose a framework for an annual physician performance review that aims to learn about the physician, share organizational values, and identify specific improvements to achieve individual and organizational goals.
Administrative reviews have little to do with clinical excellence or quality of care. Physicians are used to peer review, where fellow physicians critique their performance, quality of patient care and search for significant deviations from patient treatments.  While in training clinical reviews have to do with learning diagnosis, treatment, patient communication, and skill development.  While stressful, trainees accept this a learning experience.

Now drop the freshly minted highly trained neophyte into the clinic or new office, here is a case study of what happens.

"The time on the clock turned to 1:59 p.m. I clicked a final button to complete my visit note in the electronic medical record and locked my computer. Sliding my chair neatly under my desk, I made my way from the office I shared with our practice’s physician assistant, dietician, and pharmacist down the hall to our practice manager’s office. It was time for my first annual performance review since completing residency, and I anticipated generally positive feedback. I had excelled in medical school and performed well in a competitive residency program. I felt confident. I was not anxious. Knocking lightly on the practice manager’s door, I was motioned inside to the chair next to her desk. Shuffling some papers, she gathered up a few and turned away from her computer to face me. We made small talk about the latest antics of our toddlers and plans for the weekend. 

She cleared her throat and turned to the papers in her hands. We glossed over rows of metrics and checkboxes, all with “Meets Expectations” or “Exceeds Expectations” selected. Then she moved to the 360-degree feedback, elicited anonymously from all staff in the clinic. “Well,” she said, sighing, “the staff say you’re ‘tough.’” The downward inflection in her tone and a disapproving cast of her eyes said it all. I was “not a team player” and I, “asked a lot” of the staff. There were no concrete examples and no suggestions for improvement.

My cheeks burned and my mouth went dry. I had never received feedback like this before — my “performance” whittled down to checkboxes and unsubstantiated claims by anonymous staff members. Was this what it was like in the “real world?” Clearly, I would need to make adjustments. Was there something wrong with me? Had I been mistaken about my skills all along? Was I a bad doctor? A bad teammate? The practice manager clearly disapproved of my performance. What about the medical director?

Perhaps there was more feedback that day, more positive takeaways. I don’t recall. My only desire was to rush back to my desk and bury myself in my work until the clock struck 5:00 and I could go home. Passing the clinical workspace, I wondered which staff members found working with me burdensome. Who smiled to my face and then scowled behind my back?

As a new physician, still forming my professional identity and building up my confidence as an independent provider, I found that annual performance reviews devastating. For months, self-doubt hung over me and crept into my interactions with team members. I felt isolated. Subsequent reviews induced anxiety and dread. Boxes were checked, feedback given. Expectations were met or exceeded, but not my expectations. The annual performance review, an opportunity to engage me as part of the team and support my development and that of the practice, failed. I wanted to be an integral member of a successful and high-functioning team providing excellent care to patients, but I ultimately left the practice."

When a new physician joins a practice, he is scrutinized by other physicians and workers for a period of time. Usually, the physician is employed for two years or more depending on the practice.  At the end of that period if all is well he/she may be offered a partnership. However, in today's world it is more likely the clinic is a corporation or LLC.  The physician may be offered stock and not require a buy-in.  Nevertheless, the initial shock transferring from an academic world to the commercial world is a shock.  The neophyte physician is ill-equipped to be evaluated by an administrator.

Without a doubt, a well-functioning interdisciplinary care team is essential to success in every industry. But is there another business where the success of an individual “franchisee” is as integral to the financial success of an organization as a primary care physician is to her local clinic site? With burnout affecting an estimated 50% of physicians in some specialties and each physician turnover costing $500,000–$1 million to an organization, failing to fully engage physicians in the annual review process may be proving costly.

In a recent Medscape survey of more than 15,000 physicians, “lack of respect from administrators/employers, colleagues, and staff” was identified by 1 in 4 physicians as contributing to burnout. Feeling like a “cog in a wheel” was identified by 1 in 5.



A New Model for Physician Reviews
How We Got Here
Medical groups and hospital systems have undergone rapid consolidation and the rate of growth of health care administrators has risen exponentially, far outpacing the growth of frontline physicians. With this influx of health care leaders trained in business models and pressured to standardize processes across hundreds, if not thousands, of physicians, the problem of awkward and ineffective physician performance assessments has spread. Often, the same person reviewing the receptionist, phlebotomist, and medical assistant also delivers the physician performance review.
Prior to each review conversation, physicians are provided with their standard quality, productivity, and patient experience data and asked to reflect and complete a self-assessment. Additionally, we ask each provider in this self-assessment: “What do you love to do and how can we get you more of it?” and set goals related to enhancing fulfillment in practice. These prompts are modeled after the “humble inquiry” behavior for leaders described by Edgar Schein and used at the Mayo Clinic as a tool to frame physician performance reviews. The humble inquiry approach emphasizes building a collaborative relationship and approaching the conversations with genuine curiosity and vulnerability, believing that we have much to learn from clinicians about how to improve care for our patients.
Where do we go from here?
We include in the review packets our organizational goals and performance data related to the quality of care, patient experience, and physician and staff experience. Also included are data at the clinic and physician level, when available. We aim to have physicians answer the question of “What is my role” in the organization’s success, being sensitive to the problem of physicians feeling like they are “cogs in the wheel.” By sharing individual, team, and organizational performance, we strive to emphasize the connection of individual physicians to their local teams and to the organization.
Addressing the risk of burnout during the review is a high priority for our organization. To demonstrate clearly as an organization that we value healthy and balanced physicians, we chose to include a page listing each physician’s vacation balance. If the vacation balance is excessively high, it allows the medical directors to broach the subject of burnout in a nonjudgmental manner. Any physician would be loath to tell a fellow worker about burnout.
In today's world where physicians are constantly being evaluated or judged the very real possibility of being reported to a medical board strikes terror in the heart of a new (or old) doctor. A medical board has the authority to suspend or place a physician on probation. Despite being vocal about physician rehabilitation, the process is punitive emotionally and financially.
Dedication to serving the interest of the patient is at the heart of medicine’s contract with society. When physicians are well, they are best able to meaningfully connect with and care for patients. However, challenges to physician well-being are widespread, with problems such as dissatisfaction, symptoms of burnout, relatively high rates of depression, and increased suicide risk affecting physicians from premedical training through their professional careers. These problems are associated with suboptimal patient care, lower patient satisfaction, decreased access to care and increased health care costs.
Addressing physician well-being benefits patients, physicians, and the health care system. Governing bodies, policymakers, medical organizations, and individual physicians share a responsibility to proactively support meaningful engagement, vitality, and fulfillment in medicine. Furthering these ideals within the culture of medicine and across its diverse members may help to strengthen health care teams and improve health care system performance. 

Complete recommendations are in the article referenced here: Humanizing the Annual Physician Performance Review

I wanted to care for people, so I became a primary care doctor

Are we still steadfastly patient-focused? Do we still show patients that we care in all our actions?

The twelve-minute visit with your doctor


In line with my desire to have a career that served others, I had the opportunity to do my residency in family medicine at a federally qualified health center in Denver that also served as that metro area’s international refugee intake clinic. We saw people from all walks of life and tended to each and every person in the same way, under the same constraints and system that dominates health care.

As I advanced in my training, more and more patients were added to my schedule. At first, I was expected to see 12 patients in a day. Then it crept to 16, 18, 20 and peaked at 22 at the end of my training. A schedule like that meant I was starting a new patient visit every 20 minutes. If I wanted to place any orders, coordinate care, look up the best medical evidence, seek advice (I was, after all, in training), or simply document the visit, that face-to-face time with the patient was squeezed to 12 minutes or less. This time crunch was further complicated by the fact that more than half of our visits were translated — leaving half the amount of time to realistically care for and communicate with someone.

This was my reality: If I wanted to help a vulnerable population, I needed to figure out how to learn about their concerns, ask clarifying questions and communicate a plan of action back to them in six minutes if they were non-English-speaking, 12 minutes if they spoke English. It didn’t matter that patients had taken off work, navigated several bus lines, waited all afternoon as I slowly became more and more delayed in my schedule, and had multiple issues to discuss. None of that mattered. The 12 minutes mattered. Because if I ran late, people would get angry. If I ran late, people would cancel. If I ran late, fewer patients could be seen. And if I ran late, ultimately, the clinic lost money.

So, I created a routine for getting through each visit: I’d enter the exam room, flip on the computer, pull up a timer in the bottom right corner of the screen — 12:00 exactly — and explain, “We only have 12 minutes, so please prioritize the most important concern you came with today.” Then I’d click “start,” and the timer would tick away — 11:59, 11:58 …

During my last year in training, the behavioral health professor scheduled a visit where she’d record my interaction with a patient, and we’d play it back to review for pluses and minuses after the session. Days in the clinic were always exhausting, so when we finally sat down at the end of the day to review my visit with an Iraqi refugee, I was actually grateful to be excused from the onslaught of patient visits. The professor explained how this would work: We’d watch the video together, either of us could pause it to reflect on what was happening, and we’d come up with things that I did well and things that could be done better.


She hit “play” and the screen buzzed to life, showing me — seated, back turned, hair a little unkempt and creased in ways that made me cringe, hunched over the computer, explaining my timer and my spiel about prioritizing — and the man. He sat, facing the camera, his view cast just to the left of the screen. His skin was a chestnut brown, his hair dark and groomed nicely, his frame carried a little more weight than it should have, and his clothes were generic and clean. Arms crossed, he began his story in fluid Arabic.

His story was the story of the refugee: He had fled due to war and violence. As he spoke, the interpreter would interject to fill me in, and even before she could finish interpreting, he’d begin again. He had lost siblings, children, and friends. He lost his home, his profession, his identity. He was suffering intolerable pain — abdominal pain, pain from bones broken during torture, and joints that no longer worked.

The timer on the video showed that a little more than four minutes had elapsed since the start of the visit. Had I been able to see it in the video, the timer on my own computer screen would have told me we had about seven and a half minutes left. And I knew — both as the doctor in the video, listening, and now as the person watching the video and being reviewed — that the clock was ticking down. In the video, I sat, not speaking, nodding, and intermittently making noises of understanding, not interrupting.

My professor clicked pause and asked how I thought the visit had gone so far, seeing as a third of it had transpired.

I don’t think I managed to say a word before I realized I was swallowing hard, gazing toward the ceiling, feeling my eyes well up.

Everything — everything — about that visit was terrible. It was terrible that this is the world we live in. It was terrible that this man had so much hardship. It was terrible that I didn’t have the skills to do the “right thing” — interrupt and reorient the patient. And it was terrible that on the video, I sat there, feeling simply impotent. And I felt impotent all over again watching it unfold.

What I wanted to say was this: “I know medicine can’t solve all this man’s problems, but I — as another, caring human being — want to sit with him and hear his story. I want to be present and empathetic and bear witness. I want to nod and make him feel heard. I want him to know that he is the most important person to me right now. And yes, we’ll talk about his high blood pressure, his pain, his debilitated joints in good time. And I don’t really know if we’ll ever truly cure any of them, but we’ll work on it. But the only thing I can offer this man at this moment is to be with him. And everything about the system is keeping me from offering the most basic elements of being human: compassion and love.”

But instead, I probably mumbled something bland about not being focused or missing the opportunity to agenda-set or whatever nonsense and let the tears flow.

At the end of my residency, months after this encounter, I realized I couldn’t keep being a doctor and care — truly care — if I stayed, so I left the system. Because it is a broken system.

And it was breaking me, too.

So, I set out to work for my patients — and only my patients. I wanted to take the third parties out of the room. I wanted to return the control of the health care industry to physicians, who, in turn, are responsive to patients sitting in front of them. I wanted the opportunity to be present with patients. I became a direct primary care doctor.

To care.

This is why my staff and I ask ourselves on a daily basis, “How can we show those we serve that we care — in all our actions?” More tangibly, how can we bring the patient back to the center of the health care experience?

January 2019 marked the two-year anniversary of my practice. We’ve been through a ton in the past year. I’ve started to understand many aspects of business, and although we’ve done some pretty amazing things in the past two years, we’ve also made people frustrated and mad while trying to care for them. And so, I still reflect on these basic questions frequently, like checking the vitals of one of my patients. Are we still meeting that goal? Are we still steadfastly patient-focused? Do we still show patients that we care in all our actions?

Allison Edwards is a family physician and founder, Kansas City Direct Primary Care. She can be reached on Twitter @KansasCityDPC. This post was originally published in the Kansas City Direct Primary Care new employee handbook and in the AAFP’s Fresh Perspectives Blog.





I wanted to care for people, so I became a direct primary care doctor:

Tuesday, February 25, 2020

Biotech company Moderna says its coronavirus vaccine is ready for first tests


London (CNN Business)US biotech firm Moderna has shipped an experimental coronavirus vaccine to US government researchers just six weeks after it started working on the immunization.
Initial trials of the potential vaccine could begin in April, but the process of testing and approvals would last at least a year.
Moderna (MRNA) said in a statement Monday that the first batch of its novel coronavirus vaccine, called mRNA-1273, has been sent to the National Institute of Allergy and Infectious Diseases (NIAID).

Moderna said the first vials of the experimental vaccine would be used in a planned Phase 1 study in the United States, which typically involves testing a vaccine on a small number of healthy humans.
NIAID Director Anthony Fauci said that a clinical trial could start by the end of April, the "first step" in potentially making a vaccine available for use. Fauci previously announced researchers could expedite the approval process for a vaccine following a successful Phase 1 trial in an attempt to halt the spread of the virus. Even if the clinical trial is successful, further testing and regulatory approvals would be needed before the vaccine could be deployed widely. But even when proceeding at an "emergency speed," a vaccine would not be available for use for at least a year or 18 months, he said Tuesday. Health officials and pharmaceutical companies around the world are working at a breakneck pace to identify treatments or a vaccine to help fight the coronavirus, which has infected more than 80,000 people around the world.
While the experimental vaccine developed by Moderna remains unproven, the speed at which it was created represents a breakthrough.
According to Moderna, the vaccine was developed within 42 days of the company obtaining genetic information on the coronavirus.
By comparison, it took researchers about 20 months to start human tests of the vaccine for SARS, an older coronavirus, according to a journal paper written by Fauci.
Economic Impacts:


 References:

Moderna says its coronavirus vaccine is ready for first tests



Monday, February 24, 2020

Hormone Blocker Shocker: Drug Costs 8 Times More When Used For Kids

Two drug implants are nearly identical. The one for children has a list price of $37,300. For adults, the list price is $4,400. One dad fought for his daughter to be able to use the cheaper drug. Read this for a great explanation of how to deal with an outrageous hospital or pharmaceutical bill.

More often than not your hospital bill has been generated by a computer with fees taken from a file that organizes charges for services, operating rooms, drugs, and supplies. The system automatically reads a CPT code that assigns a dollar amount.  It is a dumb blind process, and most likely not reviewed by anyone without authority. In some circumstances, the charges may be adjusted according to an algorithm assigned to your insurance company.  Much of the time it gets mailed out to patients, unreviewed or audited for accuracy.

The takeaway from this article is to always review and question charges that do not make sense.  It will trigger a review from someone knowledgable and you should speak directly to that person.

Hormone Blocker Shocker: Drug Costs 8 Times More When Used For Kids

Sydney Lupkin, NPR News


Dr. Sudeep Taksali, an orthopedic surgeon, became worried that his 8-year-old daughter had already grown taller than his 12-year-old son. And sometimes she had an attitude more befitting a teenager. Something seemed wrong.
Taksali and his wife, Sara, realized their daughter had grown 7 inches in two years and was showing signs of puberty. They took her to the doctor, who referred her to a pediatric endocrinologist for a work-up.
Eventually, their daughter was diagnosed with central precocious puberty. It’s a rare condition that meant she would go through sexual development years earlier than her peers and would likely stop growing prematurely, too.
Adopted two years ago from India, she’s a bright, avid reader who loves to do kettlebell workouts with her dad and Zumba with her mom. Still, moving across the world and learning a new language is no easy feat.
“Having one more thing for her to deal with … where there might be maybe some negative attention drawn to her changing body,” Taksali said. “That was one of my big concerns.”
On the advice of their daughter’s doctors, the Taksalis decided to put her early puberty on hold. The recommended treatment is a product commonly known as a hormone blocker. Implanted beneath the skin in her arm, it releases a small dose of a drug each day that increases the body’s production of some hormones while decreasing others. The result is the child’s progression toward adulthood slows.
The doctors told them there were two nearly identical drug implants — each containing 50 milligrams of histrelin acetate — made by the same company, Endo Pharmaceuticals, an American drugmaker domiciled in Ireland. But one was considerably cheaper.
Taksali wanted his daughter to get the less expensive option, but his insurer said it would cover only the more expensive option. Resigned, he asked the hospital how much it would charge for the expensive drug he had been hoping to avoid.
Then the estimated bill came.
The Patient: Sudeep Taksali’s daughter, 8. She is insured through her father’s high-deductible UnitedHealthcare plan.
Total Estimated Bill: The hospital told Taksali the insurer wouldn’t cover the cheaper version of the drug, Vantas. After that, he spent hours trying to get an estimated bill ahead of the scheduled implantation. Supprelin LA would cost around $95,000 plus the cost of implantation, the hospital’s billing department told him. Under his health plan, he has a $5,000 deductible and 20% coinsurance obligation, so he was worried how much he might owe.
An extended-release subcutaneous insert of Supprelin



Service Provider: OHSU Hospital in Portland, Oregon, part of Oregon Health & Science University.
Medical Procedure: Implantation of a drug-delivery device containing 50 mg of histrelin acetate, to stave off early puberty.
What Gives: Supprelin LA was approved by the Food and Drug Administration in 2007 for central precocious puberty and has a list price of $37,300. Vantas was approved by the FDA in 2004 for late-stage prostate cancer and has a list price of $4,400.
An extended-release subcutaneous insert of Vantas

The main difference between the two medicines is that Supprelin LA releases 65 micrograms of the drug a day, and Vantas releases 50 micrograms a day. Each implant lasts about a year.

The 15-microgram difference in daily dose with Vantas is less than the weight of an eyelash, and the doctors who recommended the treatment said it has the same effectiveness for children with central precocious puberty.

The much higher price for the children’s version of the drug grated on Taksali. “From a parent standpoint, as a physician, as a consumer, it feels abusive,” he said. “There’s sort of predation on parents who have that sense of vulnerability, who will do anything within their means to help their children.”

Drugmakers can use the same chemical compound to create different branded drugs with different disease targets ― and apply for FDA approval for each. FDA spokesperson Brittney Manchester said by email, “Generally, it is the sponsor’s decision.” Endo makes both Supprelin LA and Vantas.

Indeed, other drugmakers have used the maneuver: Pfizer makes two versions of sildenafil citrate: Viagra for erectile dysfunction and Revatio for pulmonary arterial hypertension.
When we asked Endo Pharmaceuticals why Supprelin LA and Vantas had such different price tags, the company said the implants aren’t identical and treat very different conditions. It didn’t respond to questions about why that meant the prices should be different and whether it was somehow more expensive to manufacture one versus the other.

Resolution: Taksali spent more than a month trying to make sure his daughter could use the cheaper drug and, finally, the week his daughter was scheduled to have the procedure, it was approved. The hospital submitted the request again and UnitedHealthcare said it would cover it.

Many times a drug manufacturer, when called out publicly, will change prices to avoid negative publicity.  Supprelin is used much less frequently than Vantas.  The truth is that Endo wanted to capitalize on that fact and charge much more.

“Our coverage policies are aligned with FDA regulations and Vantas is not FDA approved to treat central precocious puberty,” UnitedHealthcare spokesperson Tracey Lempner said in an email. “In this specific case, when the provider expressed concern over the cost of Supprelin LA, we worked with them to allow for coverage of Vantas.”
Taksali’s daughter got the Vantas implant in late January.

When he got a breakdown of charges afterward, it listed $608 for the implantation and $12,598.47 for Vantas — about three times its list price. (Hospitals add markups to the list prices.) Still, that’s far less than the $95,000 the Supprelin LA bill would have been.

According to his explanation of benefits, after insurance, Taksali will owe $4,698.45 ― most of his high deductible. Because it is early in the year, the family had not yet spent any of its 2020 deductibles.
Taksali said he fought for the lower cost drug on principle.

“Even if it is the insurance company’s money, it’s still somebody’s money,” he said. “We are still contributing to those premium dollars.”

The Takeaway: If you need an expensive drug, the first thing you should do is ask your doctor if there are cheaper alternatives. Often different formulations of the same chemical compound carry vastly different prices. In this family’s case, the version to treat prostate cancer patients was far cheaper than the pediatric version for a hormone imbalance.
More commonly, the different formulations relate to different dosages ― two 250 mg tablets may be cheaper than a 500 mg pill. Likewise, a pill you have to take three times a day may be far less expensive than the once-a-day extended-release version.
When a coverage denial leads to costly care, patients can ally with their health care providers or employers to appeal, though it can be time-consuming. Self-insured employers, in particular, won’t want to waste health care dollars either. For Taksali, using social media to direct-message UnitedHealthcare garnered prompt responses and some answers.
If there aren’t other options, drug manufacturers often offer coupons to help patients with their copays. You can find some using GoodRx or by visiting the drugmaker’s website directly.

KHN senior correspondent JoNel Aleccia contributed to this report.
Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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