Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical? | Law and Medicine | JAMA | JAMA Network

As the rate of Covid 19 decreases behold thresholds social distancing will be discontinued as well as masking.  Some venues may require masking and vaccination to enter.  Some are planning to use a vaccine passport to screen entrants to large venues.  Questions arise as to the legality of this being required.

With the use of smartphone apps or even a printed vaccination. card, much like the yellow one we used as children, it will be easy to carry your vaccine passport where ever you go.

Smartphone app developers are already in the process of having these available on the Google Play Store 

Once you activate your passport, a quick flash of your phone (QR code) will be your entry ticket to large sporting events or other large gatherings.

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment).1 The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings.2 This Viewpoint examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Benefits of DHPs

Digital health passes offer health and economic benefits until herd immunity is achieved. By allowing a safe return to a more normal life, DHPs encourage people to be vaccinated. Digital health passes also allow a gradual reopening of the economy in key sectors such as food, retail, entertainment, and travel. Consumers are likely to rejoin recreational and commercial activities if they are confident doing so is safe. Digital health passes offer a less restrictive means to relax COVID-19 preventive measures such as quarantines, business closures, and stay-at-home orders.

Are DHPs Lawful?

Public-Sector DHPs

Governments have the power to validate and monitor vaccination status while requiring proof of vaccination for access to certain privileges. International law poses few restrictions on DHPs. The International Health Regulations, signed by 196 countries, grant wide discretion to exercise evidence-based public health powers. Article 31 of these regulations specifically allows governments to require “proof of vaccination or other prophylaxis,” while Annex 7 authorizes yellow fever vaccination certificates for international travel.

In the US, individual states hold primary public health powers. States already condition school entry on proof of vaccination. During the COVID-19 pandemic, states and localities have also required masks and social distancing in certain venues. They similarly could authorize or require DHPs, authenticating vaccination status either through public or private digital platforms.

The president has broad power to require vaccination for entry to airports and federal buildings and land, just as President Biden did for masks. However, a federal DHP system would likely require congressional action, and a clear necessity to prevent the interstate spread of infectious diseases. Congress could also allocate funding for state DHPs, even conditioning further COVID-19 relief spending on state adoption of DHPs.

Government DHPs must navigate constitutional and civil rights constraints. While the Supreme Court grants public health agencies wide discretion, it is more protective of First Amendment freedoms, including religion, speech, and assembly. The Court has struck down COVID-19 public gathering restrictions as applied to houses of worship. The Court would likely subject government-run DHPs to high-level scrutiny if they prevented unvaccinated individuals from attending religious services or infringed other constitutionally protected rights.

Private-Sector DHPs

The private sector has a particular interest in ensuring that employees and customers are vaccinated because it facilitates a return to social and commercial activities. Businesses could rely on government-run or proprietary DHPs. The Equal Employment Opportunity Commission (EEOC) issued guidance on SARS-CoV-2 vaccinations, which applies to any vaccine “approved or authorized by the Food and Drug Administration,” suggesting that employers could require vaccinations even under an Emergency Use Authorization.

The EEOC allows employers to require SARS-CoV-2 vaccination to return to the workplace, thus ensuring employees do “not pose a direct threat to health or safety.”5 Employers also can use DHPs for proof of vaccination. Businesses can require employees to “provide proof they have received a COVID-19 vaccination.” Requiring a proof of vaccination, moreover, does not violate the Americans With Disabilities Act or the Genetic Information Nondiscrimination Act. However, employers should caution employees “not to provide any medical information as part of the proof.”

Digital health passes also would be unlikely to violate privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). Employers typically are not “covered entities” under HIPAA. Digital health passes could actually be advantageous because they provide proof of vaccination without sharing any other medical information.

Although employers may require proof of vaccination, they must abide by civil rights law. Thus, employers, whenever possible, should afford persons with disabilities “reasonable accommodations,” such as through telework. Similarly, employers should provide reasonable accommodations to individuals who hold a “sincere religious belief, practice, or observance.” Some states are considering prohibiting private-sector use of DHPs, but courts may decide whether they have the legal authority to do so.

Ethics and Equity

As long as there is supply scarcity, DHPs would unfairly exclude individuals who cannot access vaccines. Yet once everyone can gain access to vaccines, there is a strong ethical justification for DHPs designed to create safer environments to work, shop, recreate, and travel, as they represent a less restrictive alternative to current public health measures.6 Unvaccinated individuals have no right to impose risks on others, thus impeding a return to normal activities. Digital health passes therefore must be fully and equally available to all members of society, including the most disadvantaged people. Individuals who cannot be vaccinated for medical reasons also should not be excluded from DHP privileges. Consideration should also be given to granting exemptions for genuine religious or conscientious objections.

Health disparities based on race have been a persistent challenge. Black and Hispanic individuals in the US have had a significantly lower uptake of SARS-CoV-2 vaccines compared with the overall population.7 Racial minorities’ historic distrust of the health system should not disqualify them from economic and social opportunities. Governments should amply fund community-based outreach to encourage vaccine uptake.

Governments or airlines could soon introduce “vaccine passports” to facilitate international travel. Yet requiring proof of vaccination as a condition of travel would unfairly burden most low- and middle-income countries, which may lack adequate doses to fully vaccinate their populations for several years. Approximately 70 countries have not even begun vaccination campaigns, including most sub-Saharan African nations. COVAX, the global vaccine facility, aims to vaccinate only 20% of lower-income populations by 2022. Compounding the unfairness, high-income countries have contributed to supply scarcity by signing advance purchase agreements with vaccine companies. High-income countries could help ameliorate inequities through funding and donating vaccine doses to COVAX while building manufacturing capacities in low- and middle-income countries, including technology transfer.8

Digital health passes could become an important vehicle for a rapid return to commerce, recreation, and travel. To ensure their success, they must be scientifically well-grounded and the least restrictive alternative. Above all, DHPs must be administered equitably, ensuring that everyone has a fair chance to return to a normal life.

Scientific and Technical Challenges

Digital health passes involve considerable scientific and technical challenges, including variable effectiveness by vaccine type, effectiveness in preventing transmission, the durability of immunity, and the emergence of variant strains. Currently, the overall efficacy of 6 SARS-CoV-2 vaccines, mRNA-1273 (Moderna/NIAID), BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen/Johnson & Johnson), ChAdOx1 nCoV-19 (University of Oxford/AstraZeneca), Gam-COVID-Vac/Sputnik V (Gamaleya Research Institute of Epidemiology and Microbiology), and BBIBP-CorV (Sinopharm/Beijing Institute of Biological Products), authorized for use in select countries, ranges from 65.5% to 94.6% in preventing symptomatic COVID-19 based on published clinical trial data. Each vaccine could have variable effectiveness against currently circulating and future SARS-CoV-2 variants. Considerable variability in vaccine effectiveness in preventing symptomatic disease could affect the usefulness of DHPs. If DHPs were limited to only certain vaccine products, it would also exacerbate inequities based on access to particular vaccines.

The duration of protection afforded by SARS-CoV-2 vaccines is uncertain. Coronavirus infections, such as from the 2002-2004 SARS-CoV-1 outbreak, generally afford limited protection for 1 to 2 years.3 Reinfection with SARS-CoV-2 has occurred, albeit rarely. Yet there is limited evidence of vaccine-induced immunity beyond limited follow-up of clinical trial participants. Waning vaccine immunity will be better understood with follow-up of clinical trial participants, along with observational studies. Digital health passes should include dates of series completion to determine expiration once longevity of vaccine protection is better defined.

Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical? | Law and Medicine | JAMA | JAMA Network

Study: 99.75% of hospitalized COVID-19 patients weren't vaccinated - Axios

Vaccination has made a tremendous difference decreasing serioius illness and hospitalization.

The Good News

The Cleveland Clinic on Tuesday released a study showing that 99.75% of patients hospitalized with COVID-19 between Jan. 1 and April 13 were not fully vaccinated, according to data provided to Axios.

Why it matters: Real-world evidence continues to show coronavirus vaccines are effective at keeping people from dying and out of hospitals. The Pfizer-BioNTech and Moderna vaccines have been found to be 95% and 94% effective, respectively, at preventing symptomatic infections.

Details: The study also looked at 47,000 Cleveland Clinic employees who had received one shot, both shots or no shots at all.

The Cleveland Clinic found that 99.7% of its employees who were infected with the coronavirus were not vaccinated, and 0.3% of infections occurred in those who were fully vaccinated.

The study found that in this group, mRNA vaccines were more than 96% effective in protecting against coronavirus infections.

What you should know about Vaccines

Vaccines are complicated. Here’s what you need to know about how they work to prevent deadly diseases; the different kinds of vaccines; and why herd immunity matters.

1. Key information about the effective COVID-19 vaccines

2. Demand for coronavirus vaccines is outstripping supply

3. Fauci: U.S. could achieve herd immunity by fall if vaccine rollout goes to plan

4. Tech's hidden hand in the vaccine rollout

5. Vaccine distribution information mess

6. Fighting the coronavirus infodemic

7. America’s vaccine trust crisis

The Bad News

Despite the paradigm shift in vaccine manufacturing which involved an entirely new process using messenger RNA, several things diminished the rollout of the covid19 vaccine.

A coincidental major national election intensified disagreements between political parties who are already deeply divided on most things.  An "infodemic" of misinformation and disinformation has helped cripple the response to the novel coronavirus.

Why it matters: High-powered social media accelerates the spread of lies and political polarization that motivates people to believe them. Unless the public health sphere can effectively counter misinformation, not even an effective vaccine may be enough to end the pandemic.

How to protect yourself in the infodemic?

Driving the news: This month the WHO is running the first "infodemiology" conference, to study the infodemic of misinformation and disinformation around the coronavirus.

What they're saying: While fake news is anything but new, the difference is the infodemic "can kill people if they don't understand what precautions to take," says Phil Howard, director of the Oxford Internet Institute and author of the new book "Lie Machines."

Beyond its effect on individuals, the infodemic erodes trust in government and science at the moment when that trust is most needed.

A study by the Reuters Institute found 39% of English-language misinformation assessed between January and March included false claims about the actions or policies of authorities.

The infodemic has spread nearly as widely as the pandemic itself in the U.S.

As early as March, about half of surveyed Americans reported they had encountered at least some completely made-up news about the pandemic.

38% of Americans surveyed by Pew in June said that compared to the first couple of weeks of the pandemic, they found it harder to identify what was true and what was false about the virus.

In that same survey, roughly a third of Americans exposed to a conspiracy theory that the COVID-19 outbreak was intentionally unleashed by people in power said that they saw some truth in it.

How it works: Misinformation and disinformation have always been a destabilizing feature of infectious disease outbreaks. But several factors have made the situation worse with COVID-19.

An evolving outbreak: COVID-19 is new, and as scientists have learned more about the virus, they've had to change recommendations. That's how science works, but "if you're distrustful of authorities, an expert taking a position different than it was three days ago just confirms your bias," says Joe Smyser, CEO of the Public Good Projects.

Social media: While experts give some credit to companies like Facebook and Twitter for their efforts to stem the spread of coronavirus misinformation, the reality is that platforms built on engagement will often end up as conduits of conspiracy content, which Howard notes tends to be unusually "sticky." A review by the Reuters Institute of 225 pieces of misinformation spread by political figures and celebrities made up only 20% of the sample but accounted for 69% of engagement.

Disinformation warfare: In June, the European Commission issued a joint communication blaming Russia and China for "targeted influence operations and disinformation campaigns around COVID-19 in the EU." And those campaigns are effective — in a recent study, Howard found disinformation from Russian and Chinese state sources often reached a bigger audience on social media in Europe than reporting by major domestic outlets.

Political and media polarization: "In our hyper-polarized and politicized climate, many folks just inherently mistrust advice or evidence that comes from an opposing political party," notes Alison Buttenheim of the University of Pennsylvania School of Nursing. Conservatives are particularly vulnerable — an April study found Americans who relied on conservative media were more likely to believe conspiracy theories and rumors about the coronavirus.

Public health experts must take an active role in combating the infodemic, says Timothy Caulfield, research director of the University of Alberta's Health Law Institute.

One example is the "Nerdy Girls," an all-female team of experts who spread accurate information about the pandemic on social media in a way that aims to "engender trust," says Buttenheim, one of the group's members. 

(Who are the Nerdy Girls ?)   Those Nerdy Girls, a volunteer team of female PhDs, MDs, and DOs curating COVID-19 content for the greater good. We love facts. For educational purposes; nothing here substitutes for advice from your healthcare provider. Stay safe, stay sane.

Individuals can do their part by practicing information distancing as well as social distancing. "If you can just nudge people to pause before they share on social media, you can actually decrease the spread of misinformation," says Caulfield.

Study: 99.75% of hospitalized COVID-19 patients weren't vaccinated - Axios: The study found that 0.3% of infections occurred in people who were fully vaccinated.

To Vaccinate Younger Teens, States and Cities Look to Schools, Camps, Even Beaches -

At the beach, Pacific Beach, San Diego

As usual, especially along either the left or right coast or the river or lake, young people head to the beach to picnic swim, surf, sunbathe, or just plain relax this summer vaccination will be offered to young people. Now that the FDA has approved Covid 19 vaccination for 12-15 year olds. 

The F.D.A.’s authorization of Pfizer’s Covid shot for 12- to 15-year-olds is a milestone in battling the coronavirus, but actually getting them vaccinated involves new challenges.

Even more incentives could include a free joint (with parental permission). Let's face it almost all kids have tried marijuana or want to try it. Marijuan is no. longer consiered a 'gateway drug"The scientific risk of a joint is far less than contracting covid, or at least equal. (my own personal opinion) and not to be taken as medical advice.  Public health concerns should outweigh other issues.

Any parent knows this age group is particularly independent, contrary and unlikely to go to a public health vaccination site.  In addition this group does not drive, in the no mans land of pubescence and adulthood. Peer pressure and conformance with their peers is an overriding feature of this age group.  Wanting to belong is almost the only personal objective of teenagers.

Other possible venues for vaccination are music festivals, pop concerts, sporting events.  Go to where they are decreases the likelihood young people will avoid the 'shot'.

Colorado River, a favorite place on the California Arizona Border

To Vaccinate Younger Teens, States and Cities Look to Schools, Camps, Even Beaches - The New York Times

 

Hit by Higher Prices for Gear, Doctors and Dentists Want Insurers to Pay

SACRAMENTO — Treating patients has become more expensive during the pandemic, and doctors and dentists don’t want to be on the hook for all the new costs.

This story also ran on Los Angeles Times. It can be republished for free.

For instance, the box of 100 gloves that cost $2.39 in February 2020 costs $30 now, said Dr. Judee Tippett-Whyte, president of the California Dental Association, who has a private dental practice in Stockton.

Her practice used to rely on surgical masks that cost 20 cents each but has upgraded to N95 masks at $2.50 a pop. On top of that, her office is scheduling two or three fewer patients each day to accommodate physical distancing and give staff members time to disinfect between patients, she said.

“We’ve sustained a lot of financial costs,” Tippett-Whyte said. “We shouldn’t have to bear the cost of this for ourselves.”

Her argument raises a fundamental covid question: Who should pay for pandemic expenses? Should it be health care providers contending with new pandemic-era protocols or insurance companies, which may pass on their additional costs to customers in the form of higher premiums?

California’s dentist and doctor lobbies say insurance companies are flush with cash after collecting premiums during the pandemic but paying fewer claims than usual — and should foot the bill. The California Medical Association, which represents doctors, has sponsored legislation that would require insurers to reimburse medical and dental practices for pandemic-related expenses like personal protective equipment, disinfectant and the staff time required to screen patients for symptoms before an appointment.

A request by doctors to bill Medicaid and Medicare for supplies and other pandemic-related costs recently failed at the federal level. But in Washington state, a new law sponsored by the state doctors’ lobby requires private health insurers to reimburse a portion of those costs.

Insurance trade groups have opposed both state measures.

Reimbursing the cost of nonmedical supplies isn’t typically the responsibility of insurers, said Mary Ellen Grant, spokesperson for the California Association of Health Plans.

“Here we are with treatment and office levels back at pre-pandemic levels. Now they want additional payment from plans to pay for nonmedical expenses,” Grant said.

The insurance industry also points out that doctors and dentists haven’t had to fend for themselves when it comes to PPE and other pandemic-related expenses. Since April 2020, the U.S. Department of Health and Human Services has distributed $9.9 billion to more than 50,000 California medical providers through the Provider Relief Fund, out of $178 billion available nationally.

And more than 900,000 businesses in the “health care and social assistance” category — including some medical practices and dentists — have gotten Paycheck Protection Program loans from the Small Business Administration since March 2020.

A letter from insurance groups opposing California’s bill points to other assistance, such as advance payments on insurance claims from the federal government and insurance plans, state-based grants and loans, and programs that distributed free PPE to some practices.

“They’ve gotten plenty of help from the feds to cover these costs,” Grant said.

Health insurance companies saw their margins and profits skyrocket at the beginning of the pandemic when they were collecting premiums while patients put off non-urgent medical care. Those tapered off when people started returning to the doctor. Still, the nation’s largest medical insurer, UnitedHealth Group, recently announced its net income for the first quarter of 2021 was 44% higher than in the same quarter last year.

Allison Hoffman, a professor who researches health policy at the University of Pennsylvania’s law school, said she has little sympathy for health insurance companies that “made a fortune over the past year” by collecting premiums without paying for the typical number of treatments and doctors’ visits.

“We’re starting to see a kind of broader definition of what health insurance might pay for in order to keep people healthy,” Hoffman said. “There’s nothing like a public health emergency to shine a light on the fact that sometimes it’s not a prescription drug or surgical procedure that’s going to improve health.”

Late last year, the American Medical Association lobbied the federal Centers for Medicare & Medicaid Services to approve a procedure code doctors could use to bill those public insurance programs for PPE, disinfecting materials, office modifications to keep people apart, and staff time spent instructing patients before their visits and checking their symptoms. Often, when federal regulators approve a new billing code for Medicare and Medicaid, private insurers start reimbursing for the corresponding costs as well.

Allowing doctors to bill for that code would help them follow infection control protocols without further cutting into revenues, the association wrote to the federal agency.

But CMS denied the request, saying it considers payment for those costs as part of the payment for the rest of the appointment, according to an agency spokesperson.

In the wake of that decision, two state medical associations took up the cause themselves.

The Washington State Medical Association backed a law, which took effect April 16, that allows health care providers to bill state-regulated private insurance companies $6.57 when they see a patient in person — on top of billing for whatever services they provide — to cover the cost of extra PPE, staff time and materials to conduct and transport covid tests. The new rules last through the rest of the federally declared public health emergency.

For a law that put the state’s medical association and insurance association on opposite sides of the bargaining table, it was remarkably uncontentious, said state Sen. David Frockt (D-Seattle), who introduced the bill.

California’s legislation, which is still being debated, is more open-ended than Washington’s.

SB 242 doesn’t specify a dollar amount but would require private health plans regulated by the state to reimburse dental and medical practices for the “medically necessary” business expenses associated with a public health emergency.

The California Medical Association said physician practice revenues fell by one-third while PPE costs rose by 14% in the first six months of the pandemic, according to an October 2020 survey of its members. Of the survey respondents, 87% said they were worried about their financial viability.

“When you look at the record profits on some of these publicly traded companies and what they’re showing their shareholders, this would be a drop in the bucket,” association spokesperson Anthony York said of health insurers. “We’re not surprised plans don’t want to pay more, but ultimately this is a fight we’ll have in the legislature.”

The bill is intended to keep small and medium-sized practices from closing their doors in the face of rising costs, said its author, state Sen. Josh Newman (D-Fullerton). The state medical and dental associations warn that anything that adds costs and cuts into revenues could force smaller practices to close or consolidate, exacerbating physician and dentist shortages around the state.

“What I’m doing, as a legislator, is to deliberately offset some of these burdensome costs so we don’t lose physicians and practices,” Newman said. “It would be a shame if those communities lost access to health care.”

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

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CVS and Walgreens Have Wasted More Vaccine Doses Than Most States Combined

Joshua Eaton and Rachana Pradhan May 3, 2021

Two national pharmacy chains that the federal government entrusted to inoculate people against covid-19 account for the lion’s share of wasted vaccine doses, according to government data obtained by KHN.

This story also ran on NBC News. It can be republished for free.

The Centers for Disease Control and Prevention recorded 182,874 wasted doses as of late March, three months into the country’s effort to vaccinate the masses against the coronavirus. Of those, CVS was responsible for nearly half, and Walgreens for 21%, or nearly 128,500 wasted shots combined.

CDC data suggests that the companies have wasted more doses than states, U.S. territories and federal agencies combined. Pfizer’s vaccine, which in December was the first to be deployed and initially required storage at ultracold temperatures, represented nearly 60% of tossed doses.

It’s not completely clear from the CDC data why the two chains wasted so much more vaccine than states and federal agencies. Some critics have pointed to poor planning early in the rollout, when the Trump administration leaned heavily on CVS and Walgreens to vaccinate residents and staff members of long-term care facilities. In response to questions, CVS said “nearly all” of its reported vaccine waste occurred during that effort. Walgreens did not specify how many wasted doses were from the long-term care program.

One thing is clear: Months into the nation’s vaccination drive, the CDC has a limited view of how much vaccine is going to waste, where it’s wasted and who is wasting it, potentially complicating efforts to direct doses to where they are needed most. Public health experts say having a good handle on waste is crucial for detecting problems that could derail progress and risk lives.

The Pfizer-BioNTech and Moderna vaccines, which come in multidose vials, are fragile and have limited shelf lives. Overall, waste has been minuscule: As of March 30, the U.S. had delivered roughly 189.5 million vaccine doses and administered 147.6 million, including 7.7 million in long-term care facilities, according to the CDC.

Among other things, tracking wasted doses helps to identify bottlenecks where distribution adjustments might be needed, said Dr. Bruce Y. Lee, a professor of health policy and management at the City University of New York. Because the federal government is footing the bill for the country’s doses, any waste amounts to “basically throwing [taxpayer] money down the chute,” he said. CVS, Walgreens and other retailers don’t pay for the vaccine. The government provides it. And under the Medicare program, it pays providers roughly $40 for each dose administered.

Particularly early on, officials didn’t adequately assess where there would be demand and set up sites in response, Lee said — something that’s especially important when trying to jab as many people as possible as quickly as possible.

“If you think of any business, they’re going to determine where the customers are first,” he said. “It’s not just a matter of loading up vaccine and going to a place.”

KHN’s survey of vaccine waste is based on public records requests to the CDC and all 50 states, five major cities, Puerto Rico and Washington, D.C. Combined, the records document more than 200,000 wasted doses. However, the data has clear shortcomings. Data from 15 states, the District of Columbia and multiple U.S. territories are not included in the CDC’s records. And, in general, waste reporting has been inconsistent.

In addition to the CDC, 33 states and D.C. provided at least some data to KHN in response to those records requests. They reported at least 18,675 additional doses that have been wasted across 10 jurisdictions not represented in the CDC figures. They include 9,229 doses wasted in Texas as of March 26 and 2,384 in New Hampshire as of March 10.

An additional eight states told KHN of more wasted doses than they reported to the CDC.

But no city or state comes close to the waste reported by CVS and Walgreens, whose long-term care vaccination drive was criticized by some officials as slow and ineffective. Among nursing home staffers, a median of 37.5% reported they got a shot in the first month, according to a February CDC study.

“To me, this ultimately correlates with just poor planning,” said Dr. Michael Wasserman, immediate past president of the California Association of Long Term Care Medicine and a critic of the corporate effort.

Wasserman said the companies’ approach was too restrictive and their unfamiliarity with long-term facilities’ needs harmed the effort.

“CVS and Walgreens didn’t have a clue when it came to interacting with nursing homes,” he said. “Missed opportunities for vaccination in long-term care invariably results in deaths.”

A CVS spokesperson, Michael DeAngelis, in an email blamed wasted doses on “issues with transportation restrictions, limitations on redirecting unused doses, and other factors.”

“Despite the inherent challenges, our teams were able to limit waste to approximately one dose per onsite vaccination clinic,” he added.

Walgreens said its wastage amounted to less than 0.5% of vaccines the company administered through March 29, which totaled 3 million shots in long-term care facilities and 5.2 million more through the federal government’s retail pharmacy partnership.

“Our goal has always been ensuring every dose of vaccine is used,” company spokesperson Kris Lathan said in an email. Before scheduled clinics, she said, Walgreens would base doses it would need on registrations, “which minimized excess and reduced overestimations.”

CDC spokesperson Kate Fowlie said that because the retail pharmacy giants were tasked with administering a large number of doses, “a higher percentage of the overall wastage would not be unexpected, particularly in an early vaccination effort that spanned thousands of locations.” Since President Joe Biden took office in January, his administration has directed pharmacies to prioritize vaccinations for teachers and school personnel.

Overall, pharmacies accounted for almost 75% of wasted doses reported to the CDC. States and some large cities accounted for 23.3% of vaccine waste reported, and federal agencies, including the Bureau of Prisons and the Indian Health Service, for just 1.54%. The Virgin Islands — the only U.S. territory in the federal data — was 0.19%.

“Though every effort is made to reduce the volume of wastage in a vaccination program, sometimes it’s necessary to identify doses as ‘waste’ to ensure anyone wanting a vaccine can receive it, as well as to ensure patient safety and vaccine effectiveness,” Fowlie said. Even still, the CDC has provided guidance and worked with health departments to train staff members to reduce wastage, and clinic staffers should do “everything possible” to avoid wasting shots, she added.

Vaccine waste could increase in the coming weeks as officials shift tactics to inoculate harder-to-reach populations, public health experts say.

“I think we are getting to a place where, to continue to be successful with vaccination, we’re going to have to tolerate some waste,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. People unwilling to travel to a mass-vaccination site might go to a primary care physician or smaller rural pharmacy that might not be able to use every dose in an open vial, he said.

Claire Hannan, executive director of the Association of Immunization Managers, said concerns about waste should not trump getting shots into arms.

“If someone’s there, you need to vaccinate them,” she said. “In our efforts not to waste a dose, we may be missing opportunities to vaccinate because we don’t have 15 people lined up or 10 people lined up.”

CDC Numbers Don’t Match State Data

The federal government collects information about vaccine waste through federal systems called VTrckS, which manages ordering and shipments, and Tiberius, a platform run by the Department of Health and Human Services that monitors distribution. VTrckS can exchange data with state and local immunization registries that track who has received a shot, but some states rely on manual data entry, Hannan said.

The 15 states not included in the CDC’s data are Alaska, California, Colorado, Kansas, Louisiana, Maine, Maryland, Michigan, Nebraska, Nevada, New Hampshire, Ohio, Oklahoma, Oregon and Texas. The District of Columbia is also missing.

Of those jurisdictions, 11 provided data to KHN: Alaska, Colorado, Kansas, Maryland, Nebraska, Nevada, New Hampshire, Ohio, Oregon, Texas and D.C.

Most of those reported minimal waste to KHN: Colorado, Kansas, Nebraska and D.C. together registered just 1,090 wasted doses.

In others, the numbers are more significant. On March 19, the Maryland Department of Health said it knew of 3,175 wasted doses.

Texas had the most wasted doses of any state in either the CDC’s data or the data states provided to KHN. Its records showed 9,229 wasted doses as of March 26, putting it third in overall waste behind CVS and Walgreens.

Fowlie, the CDC spokesperson, said the agency is “working closely” with states that have technical issues to ensure accurate reporting.

Broken Freezers, Bent Needles, No-Shows

The reasons states gave for waste varied, from broken vials and syringes, to provider storage errors, to leftover doses from open vials that couldn’t be used.

The largest waste incidents, in which hundreds of doses were lost at a time, tended to be due to freezer malfunctions or workers leaving doses at room temperature too long.

But state records also register the little things that can go wrong.

On Dec. 16, the public health department in Gunnison County, Colorado, lost a single dose of the Pfizer vaccine when someone bumped into a table and a vial spilled. On Jan. 5, the Tri-County Health Department in Westminster, Colorado, reported that it wasted a Moderna dose because a hypodermic needle bent.

Remi Graber is a registered nurse who has vaccinated people at mass sites and community health clinics in Rhode Island. They said it’s not uncommon for a vial to have one too many or one too few doses, which can lead to a dose being counted as wasted. There are also sometimes syringe problems that result in waste.

But Graber said the biggest problem is people not showing up. Once a vial is punctured, Pfizer’s vaccine must be used within six hours. On April 1, Moderna announced that an opened vaccine vial was good for 12 hours — double what it had been previously.

“What could happen is you get people who just decide, ‘You know what? I don’t need my vaccine today. I’m not going to show up,’” they said. “Well, now we’re scrambling to find somebody to take the vaccine, because we don’t want to waste it.”

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Haven -- the joint health care venture by Amazon, Berkshire and JPMorgan -- is shutting down - CNN

Rich companies and investors with tremendous cash reserves often try to add health care to their book of companies.  Not many are successful.  Often their ventures last one to three years due to their unprofitability due to lack of demand for their services (often because there is much competition for others who have much more experience.   I try to be optimistic as to their intentions, thinking they are here to help, but more often than not there is a profit motive. These folks really do not have a clue about providing health care when they come at it from a consumer or business approach.  Those in health care already are more altruistic and continue to operate at a loss, until a financial backer, bank or otherwise begins to lose money on their own stake in the game.  

Haven, an ambitious health care company formed just three years ago as a partnership between Amazon, Warren Buffett's Berkshire Hathaway and JPMorgan Chase is shutting down.  The only thing the investors did correctly was to hire Atul Gwande M.D, a well-respected medical writer, researcher and surgeon. Always willing to have additional income he accepted the position as COO. However after 12 months, he recognized the perverse incentives and lack of forethought forming Haven, he bailed out.  His reputation remains only slightly blemished the brush with entrepreneurs. 

"Haven will end its operations at the end of February," said Haven spokesperson Brooke Thurston in an email to CNN Business. The news was first reported by CNBC.

Why Haven Healthcare Failed HBR

Insufficient Market Power

Perverse Incentives

Poor timing

The venture was created in 2018 with the goal of helping provide better health care services and insurance at a lower cost to workers and families at these three leading American firms -- and potentially to other US companies as well.

But Haven had struggled to make inroads beyond its three partners since its inception. Haven CEO Atul Gawande stepped down last May and chief operating officer Jack Stoddard also left the firm in 2019 after just a few months' tenure.

JPMorgan CEO Jamie Dimon wrote in an email to employees, "Haven worked best as an incubator of ideas, a place to pilot, test and learn -- and a way to share best practices across our companies. Thurston told CNN Business that "moving forward, Amazon, Berkshire Hathaway, and JPMorgan Chase & Co. will...continue to collaborate informally to design programs tailored to address the specific needs of our individual employee populations and locations." Amazon was encouraged by it's foray into buying a pharmacy, relabelling it "Pillpak" and applying some of. its experience with unique packaging and mail orders. It probably did not require much capitalization to purchase an already existing pharmacy (mail order) and adopt their rich experience in software and shipping experience.

 The original three partners did not have a focused goal for the new entity. Operationally it was established as a tool for their own enterprises, and their own employees.  The plan was to throw money at the wall, and see if stuck, and go on from there. 

The risk became apparent when their easy money becomes hard and they withdrew.  Business people are averse to any loss in the short or long term unless they see profits within a reasonable time.  Knowledgeable people know healthcare is not a profit center.  It is there to maintain people's health, for better or worse. It is a never-ending struggle. 

Berkshire Hathaway, run by billionaire Warren Buffett, has recently been looking for bargains in the health care sector.

Berkshire disclosed in November that it bought shares of Covid-19 vaccine developer and Big Pharma leader Pfizer (PFE) in the third quarter. Buffett's firm also invested in AbbVie (ABBV), Bristol-Myers Squibb (BMY) and Merck (MRK).

Haven -- the joint health care venture by Amazon, Berkshire and JPMorgan -- is shutting down - CNN

Primary Care Doctors Look at Payment Overhaul After Pandemic Disruption

Three-quarters of the more than 500 doctors contacted in an online survey by McKinsey & Co. said they expected their practices would not make a profit in 2020.
A study in the journal Health Affairs, published in June, put a hard number on that. It estimated that primary care practices would lose an average of $68,000, or 13%, in gross revenues per full-time physician in 2020. That works out to a loss of about $15 billion nationwide.

The pandemic impacted an already festering economic climate for primary care physicians as well as specialty physicians. Surgical and other specialists such as Radiologists who depend upon referrals, and the ability to perform routine procedures also saw a precipitous decrease in volume and income.

The addition of telehealth worked well for patients, however, it did not offset the decrease in-office visits.  The saving grace was emergency authorization for reimbursement of telehealth visits by CMS, Medicaid, and private payers.

Primary Care Doctors Look at Payment Overhaul After Pandemic Disruption

The Silent Pandemic--Malaria

The general public knows little about this ongoing tragedy. The  World Health Organization knows about it, and some wealthy philanthropists (Bill and Miranda Gates Foundation) fund vaccine efforts for Malaria and HIV/AIDS.  Great progress has been made against HIV/AIDS when funds become available for these efforts.

Culex Larva growing in water, developing into mosquitoes

which transmits the Plasmodium parasite,

Malaria is a life-threatening disease transmitted to humans by infected mosquitoes. In 2018 alone there were 228 million cases and 405,000 deaths worldwide, affecting mostly children under five years of age. Scientists have long been looking for an effective vaccine, but haven’t yet been able to produce one.

Culex and Plasmodia have a complex life cycle, the mosquito, and a vector and warm-blooded animals as a host.

As weird as it seems, spit actually seems to play a big role in how blood-sucking bugs transmit infections to humans (or other animals) that they feed on.

Red blood cells with an intracellular plasmodium parasite. (see life cycle video above)

Malaria vaccines have been developed in the past, with varying results. 1,2,3,4

Malaria is predominant in Africa, however certain genetic mutations that cause sickle cell anemia afford resistance to the parasite. The gene is most prevalent in people of African descent.

A new malaria vaccine made from the rodent malaria parasite is effective in humans

Warnings about the Use of Dietary Supplements.

While the age of health and wellness and good nutrition are upon us, the marketplace is overrun about natural supplements. 

These supplements are regulated by the Federal Food, Drug, and Cosmetic Act (FDCA). It is enforced by the Department of Justice.  Despite the regulations, supplements are sold which do not meet the requirements, nor have ever been subject to regulation.  Many are imported from foreign countries and manufactured in uninspected facilities.

 The United States Court for the Eastern District of New York has permanently enjoined a New York company and its operators from manufacturing or distributing dietary supplements unless and until they comply with the law, the Department of Justice Civil Division’s Consumer Protection Branch, and the United States Attorney’s Office for the Eastern District of New York announced today.

A complaint filed May 23, 2019, alleged that defendants Confidence USA Inc., of Port Washington, New York, the company’s president Helen Chian, and manager Jim Chao violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing adulterated dietary supplements. The complaint alleged that inspections conducted by the U.S. Food and Drug Administration (FDA) in 2016, 2017, and 2018 showed that the defendants repeatedly failed to verify that their finished dietary supplements met product specifications for identity, purity, strength, composition, and contamination limits, and failed to verify the identity of each dietary ingredient used in the manufacture of the supplements. The United States filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA.

According to the complaint, the defendants made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store.

The current opioid addiction has stimulated the marketing of some herbal compounds alleged to aid withdrawal symptoms (Kratom)

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” Ned Sharpless, the current acting FDA chief, said in a statement. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.

Kratom, the herb of last resort was used by opioid users in the period 2011-2017 despite reports of illness, and deaths.   Investigations revealed troubling incidents, side effects, and deaths of people using Kratom

District Court Orders Long Island Company and its Operators to Stop Distributing Adulterated Dietary Supplements | USAO-EDNY | Department of Justice

OrCam Read - For theVisually Impaired

This is a well-designed device that converts text to speech.  It has been designed for all visually impaired people.  The video explains the OrCam Read.  It is expensive.  While there are other devices for the 'low vision' community, they are inadequate in many circumstances.

Many of these patients are in the senior group, covered by Medicare.  However Low Vision devices, magnifiers, or optical lenses are NOT covered by CMS.  In 2017 H.R. 2050 was proposed by Rep. Carolyn Maloney (D N.Y.). However, it was not passed.  CMS reimburses for other aids, such as wheelchairs, crutches, and other ambulatory aids.  Vision is certainly necessary to ambulate safely.

This a glaring discrimination again low vision patients.   It is expensive however it can be purchased over time at a reasonable rate.  CMS often leases expensive wheelchairs or another prosthesis.  Why not the Orcam.  I urge you to call your representative today to lobby for the legislation to be reintroduced and ask them to sign on to the bill.

Please consider signing the petition. You will find it at change.org.

OrCam Reader

Some Covid-19 Vaccines Are Effective After One Dose, Can Be Stored in Normal Freezers, Data Show - WSJ

In a win for global vaccination goals, the BioNTech-Pfizer (Moderna)vaccine is shown to generate a strong response with one dose and to maintain potency in standard freezers for two weeks.

The daily story of the covid19 vaccine is a story of poor logistics and outright lies.  The plan for distribution was not well thought out.  Perhaps it was written down in a "playbook" and it was not implemented as written.  Although the vaccine was developed in record time, the amounts to be produced were exaggerated to fit political ambitions during a year of a Presidential election.  It was delayed by political rhetoric, and the covid pandemic itself requiring distancing, masking, and sanitizing requirements.   It is an ongoing learning experience.

The Israel's seem to have a leg up with their process. This is no surprise, it is a small country of about 8-10 million, with a universal health care system. There is a centralized health information system

https://www.wsj.com/21e48f86-5968-47d4-b508-a418d0056e5f










Some Covid-19 Vaccines Are Effective After One Dose, Can Be Stored in Normal Freezers, Data Show - WSJ: In a win for global vaccination goals, the BioNTech-Pfizer vaccine is shown to generate a strong response with one dose and to maintain potency in standard freezers for two weeks.