INNOVATIONS AT CMS ARE ABOUT TO HAPPEN (AT LONG LAST)

There is a new sheriff in town, and she is a woman.  Under the guidance of the administrator of CMS, Seema Verma and the Secretary of Health and Human Services, Alex Azar,  a large number of innovations are being proposed at CMS.

Follow along here, here, here, here, and here.

The categories of innovation are organized into seven categories.

Categories

Accountable Care

Accountable Care Organizations and similar care models are designed to incentivize health care providers to become accountable for a patient population and to invest in infrastructure and redesigned care processes that provide for coordinated care, high quality and efficient service delivery.

Episode-based Payment Initiatives (bundled care/payments)

Under these models, health care providers are held accountable for the cost and quality of care beneficiaries receive during an episode of care, which usually begins with a triggering health care event (such as a hospitalization or chemotherapy administration) and extends for a limited period of time thereafter.

Primary Care Transformation

New Evidence Report is Now Available

Primary care providers are a key point of contact for patients’ health care needs. Strengthening and increasing access to primary care is critical to promoting health and reducing overall health care costs. Advanced primary care practices – also called “medical homes” – utilize a team-based approach, while emphasizing prevention, health information technology, care coordination, and shared decision making among patients and their providers.

Initiatives Focused on the Medicaid and CHIP Population

Medicaid and the Children’s Health Insurance Program (CHIP) are administered by the states but are jointly funded by the federal government and states. Initiatives in this category are administered by the participating states.

Initiatives Focused on the Medicare-Medicaid Enrollees

The Medicare and Medicaid programs were designed with distinct purposes. Individuals enrolled in both Medicare and Medicaid (the “dual eligibles”) account for a disproportionate share of the programs’ expenditures. A fully integrated, person-centered system of care that ensures that all their needs are met could better serve this population in high quality, cost-effective manner.
Initiatives to Accelerate the Development and Testing of New Payment and Service Delivery Models
Many innovations necessary to improve the health care system will come from local communities and health care leaders from across the entire country. By partnering with these local and regional stakeholders, CMS can help accelerate the testing of models today that may be the next breakthrough tomorrow.

Initiatives to Speed the Adoption of Best Practices

Recent studies indicate that it takes nearly 17 years on average before best practices - backed by research - are incorporated into widespread clinical practice—and even then the application of the knowledge is very uneven. The Innovation Center is partnering with a broad range of health care providers, federal agencies professional societies and other experts and stakeholders to test new models for disseminating evidence-based best practices and significantly increasing the speed of adoption.

Alternative Payment Models are part and parcel of the overall process and are not mutually exclusive from ACO, Bundled Payments, Primary care transformation nor the rest of CMS innovation.

Discussion:

1.  ACOs

 2018. There are 649 ACOs across the U.S., according to the National Association of ACOs, including Medicare ACO program participants and independent ACOs. Around 12.3 million Medicare beneficiaries — 20 percent of all Medicare beneficiaries — participate in an ACO

As of July 2019, there are 559 Medicare ACOs serving more than 12.3 million beneficiaries with hundreds more commercial and Medicaid ACOs serving millions of additional patients. This is a reduction of 90 ACOs or roughly 20%.  The survival rate is about 80% after one year.  Organizing and implementing a new "group practice" in its own right and adding the goal of increasing savings if a challenge.  Administrative costs for the organization, marketing and recruitment are substantial. It is surprising that almost 80% survived their first year of operation. Many of the still-functioning ACOs are in hazardous waters financially.  It will be interesting to see what plays out in the next five years.

2. Episode-based Payment Initiatives

Problems with bundled medical codes

Problems arise when a patient needs something extra that isn’t included in a bundled payment. Payers may not reimburse for the extra outside of the bundle. That may make a provider reluctant to provide the service if he or she cannot be reimbursed for it. They may even charge the patient extra, at full price, to provide the service. Patients need to be on the look-out for this kind of extra-billing because it can result in balance billing or upcoding, both of which are illegal.  Most hospitals already have an idea of how much specific diagnosis costs and are already being paid using a DRG (diagnosis-related code). 

Traditionally, Medicare makes separate payments to providers for each of the individual services they furnish to beneficiaries for a single illness or course of treatment. This approach can result in fragmented care with minimal coordination across providers and health care settings. Payment rewards the number of services offered by providers rather than the quality of care furnished. Research has shown that bundled payments can align incentives for providers – hospitals, post-acute care providers, physicians, and other practitioners – allowing them to work closely together across all specialties and settings. This sounds wonderful in theory, however, in the actual reality of individual practices coordinating providers and hospitals is very challenging. Rather than aligning hospitals and providers it may devolve into competition for the limited resources medicare or any other payor funds.

Initiatives to Speed the Adoption of Best Practices

The System Thinkers

Barriers at the Gate

The first hurdle to an organization adopting best practices as a routine way of doing business may be adjusting how we think and speak about this concept. The words we use to describe embracing others’ practices reflect our culture’s deep ambiguity about doing so. For example, when referring to best practices, do leaders in your organization use terms such as transfer, replicate, emulate, duplicate, translate, benchmark, roll out, propagate, or disseminate? Or are they more likely to employ words like imitating, evangelize, clone, copy, and shamelessly steal? The name of Motorola’s first benchmarking initiative, “Operation Bandit,” captured this tension well. The connotations of knowledge sharing hinge tightly on people’s sense of boundaries, and on the existing customs for moving knowledge across them. 

Some family doctors ditch insurance for simpler approach

Dr. Emilie Scott was only a few months into her first job when she started hearing the complaint: She was spending too much time with each patient. Like many primary care doctors working in large medical systems, Scott was encouraged to see a new patient every 20 minutes. But that was barely enough time to talk and do a physical.

She eventually quit her job to try a new approach aimed at eliminating many of the headaches of traditional health care: tight schedules, short appointments, and piles of insurance paperwork.

Instead of billing insurers, Scott now charges patients a $79 monthly fee that covers office visits, phone calls, emails, texts, and certain medical tests and procedures. Scott typically sees six patients a day, down from around 30, and spends more time at each appointment. She hired two assistants to help handle paperwork compared with working with a department of billing specialists.

This approach —direct primary care — aims to leverage the extra time and money from avoiding insurance into improving care for patients.

But health care researchers question its cost-effectiveness and whether it will ever be capable of serving large numbers of people.

Patients considering direct primary care should press doctors on exactly what services are covered by their monthly fee, said Michael Gusmano of the nonprofit Hastings Center.

Most direct primary care doctors acknowledge the limitations and recommend patients carry some type of insurance to cover medical emergencies, surgery and expensive tests.

Only about 4% of family doctors reported working in direct primary care practices last year, according to a survey by the American Academy of Family Physicians. There are currently 1,200 practices in the U.S, according to the Direct Primary Care Journal. Typical patient fees are around $75 per month or $900 annually, studies show.

Dr. Thomas White — who runs a direct care practice in Cherryville, North Carolina — sees the problem differently. He said abandoning insurance could help boost the supply of family physicians by providing them a less stressful way to practice medicine.

“We’ve got to embrace this model of care and figure out a way to roll it out gradually, because I think it can save family medicine,” he said.

This model is not for everyone, doctors or patients.

Patients: Seventy-five dollars out of pocket per month compares favorably to people who go to Starbucks every morning for a five-dollar shot of brew (five days a week) for four weeks (100.00). And you would have unlimited access to your physician.  A policy for catastrophic coverage would supplement your DPC coverage.  However, you must be near your PCP.  Most DPC doctors limit their patient census.  They are more interested in giving each patient sufficient time to get to know you.  Most DPC physicians take their own call since they know all their own patients.

Physicians.  There is no billing and payment can be made via an autopay arrangement. There are fewer employees.  A far simpler electronic health record can be used, since the DCP is not contracted with any insurers, including medicare. The DCP only has to obey the law, not that of medicare nor the byzantine coding for billing. Physicians can obtain routine laboratory work by contracting with labs that offer low prices. (usually not a hospital) . This type of practice often functions with one employee who greets the arriving patient and serves as the DCP assistant. With today's artificial intelligence and natural language processing, most (if not all) can be accomplished by the autonomous receptionist.

We are on the threshold of major change, which may eliminate insurer intrusion into decision making for doctors and patients.

Google Play already has an app for that. It can be downloaded to a tablet/kiosk for little cost, and be programmed for physician offices.

iPad offers a virtual receptionist as well

White Receptionist in a box (iPad) includes software.



Other formats

 Wall Mount

Floor Stand









For physicians who are interested in reducing personnel costs contact us at Digital Health Space










Some family doctors ditch insurance for a simpler approach:

New WHO-led study says majority of adolescents worldwide are not sufficiently physically active

New WHO-led study says a majority of adolescents worldwide are not sufficiently physically active, putting their current and future health at risk.

The first-ever global trends for adolescent insufficient physical activity show that urgent action is needed to increase physical activity levels in girls and boys aged 11 to 17 years. The study, published in The Lancet Child & Adolescent Health journal and produced by researchers from the World Health Organization (WHO), finds that more than 80% of school-going adolescents globally did not meet current recommendations of at least one hour of physical activity per day – including 85% of girls and 78% of boys.

The study – which is based on data reported by 1.6 million 11 to 17-year-old students – finds that across all 146 countries studied between 2001-2016 girls were less active than boys in all but four (Tonga, Samoa, Afghanistan, and Zambia).

The difference in the proportion of boys and girls meeting the recommendations was greater than 10 percentage points in almost one in three countries in 2016 (29%, 43 of 146 countries), with the biggest gaps seen in the United States of America and Ireland (more than 15 percentage points). Most countries in the study (73%, 107 of 146) saw this gender gap widen between 2001-2016.

Young people’s health compromised by insufficient physical activity

The authors say that levels of insufficient physical activity in adolescents continue to be extremely high, compromising their current and future health. “Urgent policy action to increase physical activity is needed now, particularly to promote and retain girls’ participation in physical activity,” says study author Dr. Regina Guthold, WHO.

The health benefits of a physically active lifestyle during adolescence include improved cardiorespiratory and muscular fitness, bone and cardiometabolic health, and positive effects on weight. There is also growing evidence that physical activity has a positive impact on cognitive development and socializing. Current evidence suggests that many of these benefits continue into adulthood.

To achieve these benefits, the WHO recommends for adolescents to do moderate or vigorous physical activity for an hour or more each day.

To improve levels of physical activity among adolescents, the study recommends that:

Urgent scaling up is needed of known effective policies and programs to increase physical activity in adolescents;

Multisectoral action is needed to offer opportunities for young people to be active, involving education, urban planning, road safety, and others;

The highest levels of society, including national, city and local leaders, should promote the importance of physical activity for the health and well-being of all people, including adolescents.

“The study highlights that young people have the right to play and should be provided with the opportunities to realize their right to physical and mental health and wellbeing,” says co-author Dr. Fiona Bull, WHO. “Strong political will and action can address the fact that four in every five adolescents do not experience the enjoyment and social, physical, and mental health benefits of regular physical activity.  Policymakers and stakeholders should be encouraged to act now for the health of this and future young generations.”

Gender differences

Physical activity trends show slight improvement for boys, none for girls

The new study estimated for the first time how trends changed between 2001-2016 – applying the trends from 73 countries who did repeat surveys during that period to all 146 countries.

Globally, the prevalence of insufficient physical activity slightly decreased in boys between 2001 and 2016 (from 80% to 78%), but there was no change over time in girls (remaining around 85%).

National, Cultural and Ethnic Differences

The countries showing the greatest decreases in boys being insufficiently active were Bangladesh (from 73% to 63%), Singapore (78% to 70%), Thailand (78% to 70%), Benin (79% to 71%), Ireland (71% to 64%), and the USA (71% to 64%). However, among girls, changes were small, ranging from a 2 percentage-point decrease in Singapore (85% to 83%) to a 1 percentage-point increase in Afghanistan (87% to 88%).

The authors note that if these trends continue, the global target of a 15% relative reduction in insufficient physical activity – which would lead to a global prevalence of less than 70% by 2030 – will not be achieved. This target was agreed to by all countries at the World Health Assembly in 2018.

In 2016, the Philippines was the country with the highest prevalence of insufficient activity among boys (93%), whereas South Korea showed the highest levels among girls (97%) and both genders combined (94%). Bangladesh was the country with the lowest prevalence of insufficient physical activity among boys, girls, and both genders combined (63%, 69%, and 66%, respectively).

Some of the lowest levels of insufficient activity in boys were found in Bangladesh, India and the USA. The authors note that the lower levels of insufficient physical activity in Bangladesh and India (where 63% and 72% of boys were insufficiently active in 2016, respectively) may be explained by the strong focus on national sports like cricket.

For girls, the lowest levels of insufficient activity were seen in Bangladesh and India, and are potentially explained by societal factors, such as increased domestic chores in the home for girls.

Goals

To increase physical activity for young people, governments need to identify and address the many causes and inequities – social, economic, cultural, technological, and environmental – that can perpetuate the differences between boys and girls, the authors said.

“Countries must develop or update their policies and allocate the necessary resources to increase physical activity,” says Dr. Bull. “Policies should increase all forms of physical activity, including physical education that develops physical literacy, more sports, active play and recreation opportunities – as well as providing safe environments so young people can walk and cycle independently. Comprehensive action requires engagement with multiple sectors and stakeholders, including schools, families, sport and recreation providers, urban planners, and city and community leaders.”









New WHO-led study says a majority of adolescents worldwide are not sufficiently physically active:

Health Care System Accepting New Math: Housing = Health

The social determinants of health are often the primary contributing factor to a lack of wellness. A lack of adequate housing with running water, toilets, heating or air conditioning can cause or exacerbate illness. Living in a developed country does not rule out third-world conditions. Some of health care costs from recurrent emergency room visits are due to homelessness.

United Health Group, the nation's largest health insurer, is trying a new strategy -- improving care for Medicaid enrollees with complex medical problems by providing social assistance, including housing.

The Residences at Camelback West in Phoenix has 500 rental units ranging from studios to two-bedroom apartments, of which 100 are set aside for homeless UnitedHealth Medicaid members. Photo: Tiempo Development & Management

In its home base of Oakland, California, health system Kaiser Permanente has invested $200 million in an affordable housing project, Hannah Norman reported in the San Francisco Business Times. Its help is not targeted exclusively at Kaiser members, instead aiming to benefit any residents who live in communities it serves.

“The return’s only going to work out if we target the right people,” Brenner told Tozzi. The myConnections team selects patients who are enrolled in UnitedHealth, are homeless, and who have annual medical spending greater than $50,000 mostly because of ER visits and inpatient stays. Those high-cost patients are UnitedHealth’s best bet for recovering the cost of its housing investment.

Kaiser and United Health Medicaid are tracking the two groups to compare the cost of medical care in each group

Bay Area Homeless analysis (click here)

Encampments beneath a freeway or light rail are common in many regions.

Metro and Light Rail Encampments






The Village in Oakland

This model would serve well in most communities with a collaboration of government, health insurers, and private enterprise. It would also serve to reduce public costs for sanitation, policing and crime.






Health Care System Accepting New Math: Housing = Health - California Health Care Foundation:

CF Foundation | Plenary | Emerging Technologies "The Path to a Cure"

The Path to a Cure for Cystic Fibrosis

 Plenary I

Plenary II

Looking back to 1988 when my second son was born and diagnosed with cystic fibrosis from a vantage point over thirty years ago the path has been clear.  He was born fortuitously around the time when the CFTR gene was localized after the human genome was analyzed.  The future looks bright, and hopeful.    The Cystic Fibrosis Foundation is committing 500 million dollars over the next five years (2025) for future developments in treatment for CF.

Please watch and join Francis T. Collins, M.D., Ph.D., the Director of the National Institutes of Health and one of the discoverers of the double helix of DNA.

Please go to the time slot at 1:24:00/1:34 for his musical rendering of two songs dedicated to patients with cystic fibrosis

Anti-5Gers to replace anti-Vaxxers

There is no science that proves ill-health impacts from 4G or 5G, Telstra chair John Mullen has said.

There is no magic about 5G. It uses a higher portion of the electromagnetic spectrum (radiofrequency). The 4G LTE spectrum has just about run out of spectrum.

Rumors about the safety of 5G coming from Australia are not scientifically valid. Other rumors such as 5G being more hazardous in the northern hemisphere due to a shift in the magnetic poles and anti 5Gers have joined the likes of anti-vaxxers.  5G is not required to enter kindergarten.

Health care

It is anticipated that 5G will have effects on healthcare, but not due to any effect on human health or wellness. Ultra-reliable low latency communications (URLLC) component of 5G could fundamentally change health care. Since URLLC reduces 5G latency even further than what you’ll see with enhanced mobile broadband, a world of new possibilities opens up. Expect to see improvements in telemedicine, remote recovery, and physical therapy via AR, precision surgery, and even remote surgery in the coming years.

Remember massive Machine-Type Communications? mMTC will also play a key role in health care. Hospitals can create massive sensor networks to monitor patients, physicians can prescribe smart pills to track compliance, and insurers can even monitor subscribers to determine appropriate treatments and processes.

5G and mMtC will allow the use of installed power line infrastructure to transmit 5G

Autonomous vehicles

Expect to see autonomous vehicles rise at the same rate that 5G is deployed across the U.S. In the future, your vehicle will communicate with other vehicles on the road, provide information to other cars about road conditions, and offer performance information to drivers and automakers. If a car brakes quickly up ahead, yours may learn about it immediately and preemptively brake as well, preventing a collision. This kind of vehicle-to-vehicle communication could ultimately save thousands of lives.

Remote device control
Since 5G has remarkably low latency, remote control of heavy machinery will become a reality. While the primary aim is to reduce risk in hazardous environments, it will also allow technicians with specialized skills to control machinery from anywhere in the world.

IoT
One of the most exciting and crucial aspects of 5G is its effect on the Internet of Things. While we currently have sensors that can communicate with each other, they tend to require a lot of resources and are quickly depleting LTE data capacity.

Telstra chair likens 5G health truthers to anti-vaccination and Flat Earth movements | ZDNet:

Burnout Among Physicians Compared With Individuals With a Professional or Doctoral Degree in a Field Outside of Medicine - Mayo Clinic Proceedings

Physician burnout has become the 21st Century indicator for physician dissatisfaction. How accurate is that statement comparing physician burnout with executive burnout, CEOs, and the military command structure?

For one thing, the different professions attract far different personalities. The personality traits of a physician are far different than those of attornies or corporate executives.

In the past patients were aware of the challenge of being a 'doctor'.  Today in the 21st century there are now measurements and data points to prove the vulnerability of a physician.

When a patient enters the examination room, how often does the patient wonder, "Is my doctor burned out?" A normal-appearing doctor may be compensating by substance abuse and/or self-medication and may appear to function quite well.

In a study by 

Tait D. Shanafelt, MD
Stanford University, Palo Alto, CA
Christine Sinsky, MD
American Medical Association, Chicago, IL
Lotte N. Dyrbye, MD, MHPE
Mayo Clinic, Rochester, MN
Mickey Trockel, MD, PhD
Stanford University, Palo Alto, CA
Colin P. West, MD, PhD
Mayo Clinic, Rochester, MN

published in the Proceedings of the Mayo Clinic, the authors state,

"Medicine is a demanding profession with a long and arduous training process. Once physicians complete training, they engage in meaningful and professionally fulfilling work. They also typically work long hours and deal with a number of profession-specific challenges (eg, dealing with medical errors, risk of malpractice suits, frequent exposure to human suffering, and a rigorous maintenance of the certification process). In recent years, a host of regulatory changes and the more widespread use of electronic health records have increased clerical burden and changed the nature of the physician’s workday.1 Collectively, these and other challenges contribute to professional burnout, a syndrome characterized by emotional exhaustion, cynicism (depersonalization), and a decreased sense of efficacy.2

Since 2011, we have conducted a series of studies evaluating the point prevalence of burnout among physicians as well as US workers in other fields.3, 4, 5 These studies have consistently found physicians to be at higher risk for burnout than workers in other fields, even after adjusting for age, sex, relationship status, and work hours. Notably, although increasing levels of education have a protective effect on the risk of burnout among workers in general, this is not true of physicians.3

Although we have previously reported associations between the level of education and the risk of burnout, we have not previously performed a focused analysis comparing physicians with individuals with a professional (eg, JD) or doctoral level (eg, Ph.D.) degree in another discipline. Although the precise nature of their work may differ, these professionals have an educational journey more analogous to that of physicians and may have a more similar set of expectations with respect to work hours and responsibility.

Since 2011, we have conducted a series of studies evaluating the point prevalence of burnout among physicians as well as US workers in other fields.3, 4, 5 These studies have consistently found physicians to be at higher risk for burnout than workers in other fields, even after adjusting for age, sex, relationship status, and work hours. Notably, although increasing levels of education have a protective effect on the risk of burnout among workers in general, this is not true of physicians.3
Although we have previously reported associations between the level of education and the risk of burnout, we have not previously performed a focused analysis comparing physicians with individuals with a professional (eg, JD) or doctoral level (eg, Ph.D.) degree in another discipline. Although the precise nature of their work may differ, these professionals have an educational journey more analogous to that of physicians and may have a more similar set of expectations with respect to work hours and responsibility.

To explore this, we used data from our 2017 survey of physicians and US workers in other fields.5 The methods for this study have been described previously. Among the 5198 employed US workers in the study, 285 (5.5%) had a professional degree or doctoral-level degree in a field outside of medicine. A comparison of the demographic characteristics, work hours, satisfaction with work-life integration (WLI), and symptoms of burnout among these individuals and the 3971 employed physicians in the study from the same age range (age, 29-65 years) is shown in Table 1. Physicians worked more hours per week, were less satisfied with WLI, and were more likely to experience symptoms of professional burnout. The higher rates of burnout and decreased satisfaction with WLI in physicians persisted in a multivariable analysis adjusted for age, sex, relationship status, and hours worked per week (Table 2).

Table 1

Comparison of Employed Physicians in the Sample Aged 29 to 65 y With Employed US Adults Aged 29 to 65 y With a Doctoral Level Degree in a Field Outside of Medicinea

Characteristic Physicians (n=3971) Adults with a PhD/doctoral degree outside of medicine (n=285) P value

Sex
 Male 2279 (57.5) 158 (55.4) .47
 Female 1674 (42.2) 127 (44.6)
 Other 11 (0.3) –
Age
 Median 50.0 51.0 .51
Relationship status
 Single 498 (12.7) 55 (19.3) <.001
 Married 3233 (82.2) 203 (71.2)
 Partnered 168 (4.3) 20 (7.0)
 Widowed/widower 35 (0.9) 7 (2.5)
 Missing 37 0
Hours worked per week <.001
 Mean ± SD 52.6±16.1 44.5±11.7
 Median 50.0 40.0
 <40 h="" span="" style="white-space: pre;">
569 (14.6) 43 (15.1) <.001 40-49 h 801 (20.5) 140 (49.3)
 50-59 h 1017 (26.0) 65 (22.9)
 60-69 h 887 (22.7) 26 (9.2)
 70-79 h 323 (8.3) 7 (2.5)
 ≥80 h 309 (7.9) 3 (1.1)
 Missing 65 1

Distress

Burnout
Emotional exhaustionb P.001
Never 473 (12.0) 29 (10.2)
A few times a year 863 (21.9) 68 (23.9)
Once a month or less 553 (14.0) 59 (20.7)
A few times a month 618 (15.7) 57 (20.0)
Once a week 390 (9.9) 21 (7.4)
A few times a week 585 (14.8) 33 (11.6)
Every day 462 (11.7) 18 (6.3)
Missing 27 0
% High scorec 1437 (36.4) 72 (25.3) <.001

Depersonalization .46
Never 1435 (36.4) 119 (41.8)
A few times a year 917 (23.3) 67 (23.5)
Once a month or less 462 (11.7) 32 (11.2)
A few times a month 417 (10.6) 29 (10.2)
Once a week 209 (5.3) 12 (4.2)
A few times a week 299 (7.6) 14 (4.9)
Every day 199 (5.1) 12 (4.2)
Missing 33 0
% High scored 707 (18.0) 38 (13.3) .05
Burnoute 1566 (39.8) 82 (28.8) P;.001
 
Satisfaction with work-life integration
Work schedule leaves me enough time for my personal/family life:
Strongly agree 422 (10.7) 58 (20.4) <.001
Agree 1157 (29.3) 103 (36.3)
Neutral 641 (16.2) 55 (19.4)
Disagree 1103 (27.9) 57 (20.1)
Strongly disagree 626 (15.9) 11 (3.9)
Missing 22 1







Burnout Among Physicians Compared With Individuals With a Professional or Doctoral Degree in a Field Outside of Medicine - Mayo Clinic Proceedings: range

UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication | FDA

It is important for patients and providers to know what nutritional supplements, vitamins and other health foods you consume.  Many cross-react with other medications, and/or interfere with standard blood tests. Some of these reactions, side effects are uncommon. You should also consult with your pharmacist. Bring the actual bottle or container to your pharmacy. The ingredients are listed on the container label..

The FDA released a safety communication alerting patients and physicians about the possible reaction from Biotin to laboratory tests. Biotin

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events.

As noted in the original safety communication, while biotin in patient samples can cause falsely high or falsely low results, depending on the type of test, the FDA is particularly concerned about biotin interference causing a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious clinical implications. The FDA continues to receive adverse events reports indicating biotin interference caused falsely low troponin results.

Since the FDA's safety communication on this topic in 2017, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it. The FDA remains concerned about troponin laboratory tests that have not addressed the risk of biotin interference. The FDA has posted a webpage on Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference to notify the public about troponin assays where the risk of biotin interference has not yet been addressed.

Recommendations for Consumers
Talk to your doctor if you are currently taking biotin (also called vitamin B7) or are considering adding biotin, or a supplement containing biotin, to your diet.
Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and supplements for hair, skin, and nail growth in levels that may interfere with laboratory tests.  However, the amount of biotin can vary significantly among different products. Consider that the daily recommended allowance for biotin is 0.03 mg and that amount does not typically cause interference in lab tests
Be aware that some supplements, particularly those labeled to benefit hair, skin, and nails, may have high levels of biotin, which may not always be clear from the name of the supplement. FDA is aware of many supplements containing 20mg of biotin, and some containing up to 100mg per pill, with recommendations to take multiple pills per day. Supplements containing high biotin levels may interfere with affected lab tests.
Sufficient information is not available to know if stopping biotin consumption for any number of hours prior to testing will prevent incorrect test results.
If you had a lab test done and are concerned about the results, talk to your health care provider about the possibility of biotin interference.
For more information, see NIH Biotin Fact Sheet for Consumers
Recommendations for Health Care Providers
Talk to your patients about any biotin supplements or multivitamin supplements they are taking that may contain biotin, including supplements marketed for hair, skin, and nail growth.
Know that biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth in levels that may interfere with lab tests.
Be aware that many lab tests, including but not limited to cardiovascular diagnostic tests and hormone tests, that use biotin technology are potentially affected, and incorrect test results may be generated if there is biotin in the patient's specimen.
Communicate to the lab conducting the testing if your patient is taking biotin.
If a lab test result does not match the clinical presentation of your patient, consider biotin interference as a possible source of error.
Report to the lab test manufacturer and the FDA if you become aware of a patient experiencing an adverse event following potentially incorrect laboratory test results due to biotin interference.
Recommendations for Lab Personnel
If you use assays with biotin technology, be aware that it is difficult to identify samples that contain biotin; therefore, it is important to communicate with health care providers and patients to prevent incorrect test results.
If you are collecting samples in the lab, ask whether the patient is taking biotin or a biotin containing supplement.
Educate health care providers about biotin interference with certain lab tests used in your lab.
Consider that the daily recommended allowance for biotin is 0.03 mg for adults and these biotin levels do not typically cause significant interference. However, supplements containing high biotin levels including those marketed for hair, skin, and nail benefits, may contain up to 20 mg of biotin, and physicians may recommend up to 300 mg per day for conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests.
Be aware that specimens collected from patients taking high levels of biotin may contain more than 100 ng/mL biotin. Concentrations of biotin up to 1200 ng/mL may be present in specimens collected from patients taking up to 300 mg per day.
Currently available data is insufficient to support recommendations for safe testing using affected tests in patients taking high levels of biotin, including about the length of time for biotin clearance from the blood.
Communicate with the lab test manufacturer if you have questions about biotin interference.
Be aware of certain troponin assays where the risk of biotin interference has not yet been addressed. See Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference.
Recommendations for Lab Test Manufacturers and Developers

If your assay uses biotin technology, contact the FDA to discuss biotin interference.
Investigate interference from biotin (up to at least 1200 ng/mL biotin) in your assays that use biotin technology. Determine the lowest concentration of biotin that may cause clinically significant interference with your test(s). Communicate with your customers if they may be unaware that your test uses biotin technology and how it may be affected.

Contact the FDA if you have any questions about biotin technology and interference.

Biotin Interference with Certain Lab Tests May Lead to Incorrect Test Results
Many lab tests use biotin technology due to its ability to bond with specific proteins which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin. Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multivitamins, prenatal vitamins, and dietary supplements marketed for hair, skin, and nail growth.

Biotin in blood or other samples were taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. The FDA continues to see reports of adverse events, in addition to the one death reported prior to the 2017 safety communication, related to biotin interference with lab tests.

Incorrect test results may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications. Prior to the 2017 safety communication, the FDA had received a report that one patient taking high levels of biotin died following low troponin test results when a troponin test subject to biotin interference was used.

The FDA is aware of people taking high levels of biotin that would interfere with lab tests. Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). Biotin levels higher than the recommended daily allowance may cause interference with lab tests.

Patients and physicians may be unaware of biotin interference in laboratory assays. Even physicians who are aware of this interference are likely unaware as to whether, and how much biotin, patients are taking. Since patients are unaware of biotin interference, patients may not report taking biotin supplements to their physicians and may even be unaware they are taking biotin (for example, when taking products generally labeled for their benefits to hair and nails).

FDA Actions

On November 28, 2017, the FDA issued a Safety Communication, The FDA Warns that Biotin May Interfere with Lab Tests, that discussed concerns with biotin interference in certain laboratory tests.

On November 5, 2019, the FDA published this updated Safety Communication because the FDA remains concerned about certain laboratory tests that have not addressed the risk of biotin interference.

In addition, the FDA also published a webpage Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference to notify the public about troponin assays.  (The detection of a rise and/or fall of cardiac troponin (cTn) plays a key role in the earlier diagnosis of myocardial infarction (MI). Cardiac troponins are markers of myocardial necrosis, and, because of their high cardiac-specificity, are the preferred biomarker for the diagnosis of MI.) where the risk of biotin interference has not yet been addressed. 

The FDA continues to monitor reports of adverse events associated with biotin interference with laboratory tests and will update the public if significant new information becomes available.









UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication | FDA: The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication.

AMA says Walmart “refusal to fill” policy interferes with the practice of medicine

Recent concerns about opioid misuse and abuse have led payors, policymakers and retail pharmacies to attempt to restrict the dispensing of prescribed opioid dosage and duration.

One such policy of great concern is Walmart’s corporate policy that limits opioid prescriptions to seven days or 50 morphine milligram equivalents, which is causing harm to patients with acute, palliative, cancer-related, chronic pain and other medical conditions requiring amounts or doses greater than the policy allows. 

Walmart is inappropriately interpreting the Center for Disease Control (CDC) guidelines for prescribing opioids to set these policies. Such arbitrary prescribing thresholds interfere with the patient-physician relationship, physician practice and patients’ access to quality care and treatment.

In some cases, physicians have been inexplicably “blacklisted” where Walmart refuses to fill their prescriptions for controlled substances without explanation, and the physicians are left without a means of contesting the decision.

Walmart in explaining it's policy

On multiple occasions, AMA has requested that Walmart be transparent by explaining the algorithm it uses to justify restrictions to prescriptions, but according to AMA, all of its  letters have gone “without a meaningful response.”  As part of continued efforts to resolve the issue with Walmart, the American Medical Association (AMA) sent a letter to Thomas Van Gilder, M.D., Chief Medical and Analytics Officer for Walmart, Inc. on September 24, 2019, regarding its corporate prescription opioid restriction policy, also referred to as its “refusal to fill” policy.

 “Your ‘refusal to fill‘ policy also has disrupted legitimate medical practices that receive form letters telling them their prescribing rights under state law will be superseded by a Walmart-created algorithm that deems a physician unfit to prescribe,”

This is not an isolated occurrence. It follows on the actions of the DEA to decrease opioid prescription negligence by providers. The number of opioid prescriptions has decreased markedly due to education efforts by the DEA and education in alternatives to opioids for pain management.

Undoubtedly a corporate decision was made by Walmart that it could be held liable for overdoses by patients. Usually when a pharmacist questions a prescription he/she contacts the physician directly. The danger of computer algorithms acting

The CDC released an advisory in regarding to their guidelines for opioids.   CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain

Some policies, practices attributed to the Guideline are inconsistent with its recommendations







AMA says Walmart “refusal to fill” policy interferes with the practice of medicine: Recent concerns about opioid misuse and abuse have led payors, policymakers and retail pharmacies to attempt to restrict the dispensing of prescribed opioid dosage and duration.

Suicide rate for kids ages 10 to 14 nearly tripled in last decade: CDC -

The suicide rate among children aged 10 through 14 has nearly tripled from 2007 to 2017, while the suicide rate among older teenagers has increased by 76% between 2007 and 2017, new federal data show.

Meanwhile, homicide ranked as the third most common cause of death for teens aged 15-19 and adults aged 20-24, and the fifth most common cause for children aged 10-14.

“After a stable period from 2000 to 2007, suicide rates for persons aged 10-24 increased from 2007 to 2017, while homicide rates increased from 2014 to 2017,” the report explains.

“The pace of increase for suicide was greater from 2013 to 2017 (7 percent annually, on average) than from 2007 to 2013 (3 percent annually).”

Although it declined from 2000 to 2007, the suicide rate for children ages 10 through 14 has nearly tripled from 2007 (0.9 deaths per 100,000 persons) to 2017 (2.5 deaths per 100,000 persons).

Though stable from 2000 to 2007, the suicide rate for U.S. adolescents aged 15 to 19 increased from 6.7 per 100,000 persons in 2007 to 11.8 per 100,000 persons in 2017. The pace of increase was greater from 2014 to 2017 with an increase of 10 percent per year on average.

“Not only is suicide trending upward, but the pace of increase is actually accelerating,” said the report’s co-author, Sally Curtin, in an interview with NPR.

“It is important to recognize that suicide is not caused by one single factor but instead a range of factors that include mental health conditions, but also include important situational factors that many of us will experience in a lifetime — including social, physical, emotional or financial issues,” Carr was quoted as saying.

Factors such as a reduction in quality of life, the poor job market for college graduates, political polarization, an overload of information due to internet usage, and the effects of social media. Other factors such as prolonged immobility and lack of exercise coincident with the increasing use of the internet.

Glenn Thomas, a clinical director of community-based services for behavioral health at the Nationwide Children’s Hospital in Ohio, told CBS News that the rates of depression have increased consistently with the suicide rate.

Suicide was the 10th most common cause of death among all Americans in 2017.





The suicide rate for kids ages 10 to 14 nearly tripled in the last decade: CDC - The Christian Post:

If you are a fruitfly stay away from the light......It may shorten your life

https://tinyurl.com/yy95675k


Daily blue-light exposure shortens lifespan and causes brain neurodegeneration in Drosophila

Light is necessary for life, but prolonged exposure to artificial light is a matter of increasing health concern. Humans are exposed to increased amounts of light in the blue spectrum produced by light-emitting diodes (LEDs), which can interfere with normal sleep cycles. The LED technologies are relatively new; therefore, the long-term effects of exposure to blue light across the lifespan are not understood. We investigated the effects of light in the model organism, Drosophila melanogaster, and determined that flies maintained in daily cycles of 12-h blue LED and 12-h darkness had significantly reduced longevity compared with flies maintained in constant darkness or in white light with blue wavelengths blocked. Exposure of adult flies to 12 h of blue light per day accelerated aging phenotypes causing damage to retinal cells, brain neurodegeneration, and impaired locomotion. We report that brain damage and locomotor impairments do not depend on the degeneration in the retina, as these phenotypes were evident under blue light in flies with genetically ablated eyes. Blue light induces expression of stress-responsive genes in old flies but not in young, suggesting that cumulative light exposure acts as a stressor during aging. We also determined that several known blue-light-sensitive proteins are not acting in pathways mediating detrimental light effects. Our study reveals the unexpected effects of blue light on fly brain and establishes Drosophila as a model in which to investigate long-term effects of blue light at the cellular and organismal level.

Natural light is essential for the entrainment of circadian clocks, which leads to temporal coordination of physiology and behavior. However, emerging evidence suggests that increased exposure to artificial light is a risk factor for sleep and circadian disorders.1,2 With the prevalent use of LED lighting and device displays, humans are subjected to increasing amounts of light in the blue spectrum since commonly used LEDs emit a high fraction of blue light, often peaking at 460 nm (these lights appear white due to the addition of broad-spectrum yellow garnet phosphor).3 Blue light may affect human eyes,4 and recent data suggest that extraocular light may impact human brain physiology.5 However, the consequences of daily exposure to blue-enriched light across the lifespan are not known.

Laboratory study of drosophila melanogaster

Flies are used extensively to understand the mechanisms of aging in laboratories across the world, but the specifics of light conditions in terms of intensity and spectral composition are usually not provided. Our study suggests that the light used in fly facilities may critically affect experimental outcomes and should be reported in aging studies to facilitate the consistency of the results coming from different labs. Our discovery that lifetime exposure to artificial light may cause extra-retinal damage and reduce longevity in a complex model organism provides a novel opportunity to understand the molecular mechanisms of the increasingly evident harmful side of light.


This was a good scientific method with data for analysis.  The results seem to confirm the posit of the article.  However is this data relevant to primates or humans.?

Such is the  challenge of translating animal studies to humans.

What is the problem, exactly?

Galen Senior Fellow Doug Badger and Heritage Research Fellow Jamie Bryan Hall shed new light on the core problem that health policy experts have focused on for decades—covering the uninsured.

Badger and Hall find, based upon their analysis of Census Bureau data, that “More than 99 percent of Americans have access to health coverage, regardless of their income or medical condition.” 

                                                                                         A doctor speaks to patients at his office in Peoria, Ill., in 2013. (Jim Young/Reuters)

A topic for political disagreements, discussion,  and solutions, access to health care,  in the United States is broken down in this article. (one of the best, I have read, and one I would recommend to any Senator or Congressman.  I am relatively certain that few know the details. The problem lies in the education of the public. 

Please pass it on.

“Millions remain uninsured, not because the federal government is doing too little, but because it is doing (and spending) a lot and doing it badly” including getting people already eligible enrolled, they write. 

Policymakers would do well to focus on solving the problem for this one percent—the uninsured—rather than turning our whole health sector over to the federal government, as many are advocating. 

The recent Census Bureau report on the uninsured overlooked an important point: More than 99 percent of Americans have access to health coverage, regardless of their income or medical condition.

The overwhelming majority of those lacking insurance could have obtained coverage but did not enroll.

Many of those with lower incomes may not sign up for subsidized coverage because they know they can receive care at little or no cost to themselves even if they remain uninsured until they arrive at a clinic.

Those in the top two income quintiles may remain uninsured because government intervention in health insurance markets has created a menu of unattractive products at unattractive prices.

Either way, Americans across the income spectrum deserve a better approach to health care.

Understanding the challenge

It’s critical that policymakers understand the distinction between lack of coverage and lack of access to coverage.

A Kaiser Family Foundation analysis of last year’s Census Bureau report found that of the estimated
27.4 million non-elderly people who were uninsured in 2017:

6.8 million (25 percent) were eligible for Medicaid or CHIP but not enrolled.
8.2 million (30 percent) were eligible for Obamacare subsidies but did not enroll.
3.8 million (14 percent) declined an offer of employer-sponsored coverage.
1.9 million (7 percent) were not eligible for subsidies because they had income more than four times the federal poverty threshold, which put them in the top two income quintiles.
4.1 million (15 percent) were ineligible for subsidies because they were not lawful U.S. residents. Their situation is a matter to be settled by immigration policy, not health care policy.
2.5 million (9 percent) were under the poverty line but ineligible for federal assistance. They represented just 0.7 percent of the population.
These 2.5 million lawful U.S. residents ineligible for federal assistance lived in states that had not expanded Medicaid eligibility to non-elderly, non-disabled adults with incomes up to 138 percent of the federal poverty level.

Here, it is important to draw a second crucial distinction: between access to coverage and access to care.

These 2.5 million individuals are eligible for free care at 3,000 federally-funded health centers in the non-expansion states and 11,000 nationwide. In addition, all public and non-profit hospitals are required to have programs to provide free or low-cost care to low-income patients. These hospitals can enroll low-income people in Medicaid when they show up for care, which is another reason some Medicaid-eligible people wait until they need to see a doctor sign up for their free coverage.

What is the problem, exactly?