Sunday, February 28, 2021

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A controversial herbal concoction has been in the news again in India, with renewed claims that it is effective against coronavirus.The substance, called Coronil, was launched recently at an event attended by some Indian government ministers.

But there is no evidence that it works, and misleading claims have been made about approval for its use.


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What do we know about the substance?

It's a combination of herbs used in traditional Indian medicine and sold by Patanjali, a big consumer goods company in India, under the name of Coronil.


It first appeared in June last year, promoted by popular yoga guru Baba Ramdev, and described - without any basis - as a "cure" for Covid-19.


But marketing had to stop after an intervention by the Indian government, which said there was no data to show it worked as a treatment.


However, the government said it could continue to be sold as "an immunity booster".



On 19 February this year, the company held another event - with Health Minister Dr Harsh Vardhan present - at which claims were repeated that it could prevent and treat Covid-19.


India's coronavirus health claims fact-checked

Fake 'Covid immunity booster' sold in shops

Dr Vardhan's presence attracted criticism from India's largest doctors' body, the Indian Medical Association.


They described the promotion of an "unscientific medicine" in the presence of the health minister as an "insult to the people of India", and asked the minister to clarify whether he supported it as a cure.


We contacted the health ministry to ask about Dr Vardhan's presence at the event, but had not received a response by the time of publication.


The Patanjali company defended the minister's attendance, saying "he neither endorsed ayurveda [India's traditional medicine], nor undermined modern medicine".


What are the claims made about Coronil?

The company continues to insist its product works against Covid-19.


"It has treated and cured people," Acharya Balkrishna, managing director of Patanjali told the BBC.


It referred us to scientific trials, the results of which it says have been published in several peer-reviewed journals.


It pointed specifically to a study from November 2020 in a journal published by the Swiss-based MDPI, which was based on a laboratory trial.

Covid:19: Robin Swann hopes for memorial in NI

 Health Minister Robin Swann said he hopes that after the pandemic there will be a memorial for people who died with Covid-19 in Northern Ireland.


It has been a year since the first case of coronavirus was recorded in Northern Ireland.


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The death toll recorded by the Department of Health is 2,055, with three more deaths reported on Sunday.


Mr Swann said he wanted his colleagues on the Stormont executive to consider a proposal for a memorial.


He said conversations had been held within the Department of Health about remembering those who had lost their lives.


"It's how we do this in a respectful way but also acknowledging the sacrifice of loss and also, at the same time, the sacrifice of service from our health service families," he told BBC Radio Ulster's Sunday Sequence programme.


"From many across our voluntary and communities sector as well, who helped their communities at the time that they were at their most vulnerable.


"So it's something I'm very keen to put a proposal forward to my executive colleagues about how we do that."


Reflecting on the beginning of the pandemic, Mr Swann said the projected number of deaths in Northern Ireland "shook" ministers and they had to prepare for the "worst-case scenario".


He said there would be a period of reflection and inquiry but that for now the world remained "in the teeth" of the crisis.


The former Ulster Unionist Party leader said that when he was appointed health minister in January last year it was originally intended he would serve as health minister for a "few months until things settled down".


However, there was a "conscious decision to keep that continuity" when the pandemic started.


Coronavirus

IMAGE COPYRIGHTGETTY IMAGES

image captionAbout 35% of the adult population in Northern Ireland have received a dose of a Covid-19 vaccine

A total of 112,493 positive cases of coronavirus have been recorded in Northern Ireland, with 136 confirmed on Sunday.


Saturday marked exactly one year since Northern Ireland recorded its first case.


In the Republic of Ireland six more Covid-19 deaths were recorded on Sunday, taking the country's total to 4,319.


Another 612 people have tested positive in the country in the past day.


More than half a million people in Northern Ireland have had a first dose of a Covid-19 vaccine.


That is about 27% of the overall population and about 35% of the adult population.


'Lockdown breaches'

On Sunday police said a gathering of about 250 people at an "organised fight" was a "clearly a breach" of the Covid-19 lockdown restrictions.


The incident happened at a disused yard near Benburb, County Tyrone.


Police in Belfast issued 11 fines and four prohibition notices after a house party on Melrose Street in the early hours of Sunday.


They found a number of people at the property, some of whom were hiding in locked rooms and underneath beds.


A community resolution notice was also issued to a boy.

Covid-19: More than 20 million in UK have had first jab

 More than 20 million people in the UK have now had their first dose of the coronavirus vaccine, Health Secretary Matt Hancock has said.


He said it was "a magnificent achievement for the country" and "the vaccine is our route out".


The government is aiming to offer all adults a first dose by the end of July.


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From Monday, nearly two million people aged 60 to 63 in England will start receiving letters inviting them to book their vaccine.


The government's next target is to offer a first dose to all over-50s by 15 April, as well as people aged 16-64 with certain underlying health conditions and unpaid carers for disabled and elderly people.


After that, they will start offering jabs to people by age group.


There are no plans yet to vaccinate children, although trials have been announced to test the Oxford University jab on children.


When will it be my turn to be vaccinated?

"When you get the call, get the jab," said Mr Hancock.


In a video on Twitter, he said: "I'm absolutely delighted that over 20 million people have now been vaccinated across the UK - it's absolutely fantastic.


"I want to thank every single person who's come forward to get the jab because we know with increasing confidence that the jab protects you, it protects your community and it also is the route out of this for all of us."


Meanwhile, vaccines minister Nadhim Zahawi tweeted: "Bingo!" adding, "What an achievement for February 2021. What a team! Proud to be with you on this journey."


The government has not yet published its daily coronavirus figures - but the 20 million figure will apply to the number of people who have had their first dose.


According to Saturday's figures, more than 19.6 million people in the UK had received their first dose while the number of people who had had their second was 768,810.


Meanwhile, NHS England said people in the 60-63 age bracket would start receiving letters on Monday explaining how to book a jab through the national booking service, with those aged 50 to 60 set to be invited "shortly".


It said the vaccine rollout was gaining "fresh momentum", with medical director Prof Stephen Powis urging anyone who had been invited to take up the offer.


"It doesn't matter when you were invited you can still come forward and protect yourself and others," he said.


NHS England Sir Simon Stevens said vaccine supplies are expected to increase in March, adding: "We're planning for further acceleration as we head towards Easter."

Saturday, February 27, 2021

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 Covid-19: Nearly 20 million people in UK have first vaccine dose


As of Friday, more than 19.6 million people had received their first dose - an increase of more than half a million in a day.


Meanwhile, the number of people who have had their second jab has risen to 768,810.


The government is aiming to offer all adults the vaccine by the end of July.


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When will it be my turn to be vaccinated?

The next target is to offer a first dose to all over-50s by 15 April, as well as people aged 16-64 with certain underlying health conditions and unpaid carers for disabled and elderly people.


After that, they will start offering jabs to people by age group.


There are no plans yet to vaccinate children, although trials have been announced to test the Oxford University jab on children.



The latest government statistics show a total of 20,450,858 jabs have been administered in the UK - including 19,682,048 first doses, equivalent to more than one in three adults in the UK.


This includes more than 16.6 million first doses in England, more than 1.5 million in Scotland, 916,336 in Wales and 515,678 in Northern Ireland.


The figures also show another 7,434 cases and a further 290 people have died within 28 days of testing positive for coronavirus.


In a tweet on Saturday, Health Secretary Matt Hancock said he was "delighted" at the latest figures.


"The vaccine roll-out shows what we can achieve when we work together," he said.



Meanwhile, Labour is calling on the government to set out a "proper plan" for how the local elections in May will be run safely.


Earlier this month it was announced the elections would go ahead on 6 May but with some changes - for example plastic screens in polling stations and people told to bring their own pens.


But deputy leader Angela Rayner accused the government of a "failure to take any action to encourage people to sign up to vote safely from home", meaning people could be disinclined to vote or face "dangerous crowds at polling stations".


A Cabinet Office spokesman said a "strong set of measures" had been put in place to make polling stations Covid-secure and a comprehensive public information campaign would be launched soon "so that voters are fully informed about how to participate".

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 US regulators have formally approved the single-shot Johnson & Johnson coronavirus vaccine, the third jab to be authorised in the country.


The vaccine is set to be a cost-effective alternative to the Pfizer and Moderna vaccines, and can be stored in a refrigerator instead of a freezer.


Trials found it prevented serious illness but was 66% effective overall when moderate cases were included.


The US is the first country to approve the jab, made by Belgian firm Janssen.


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The company has agreed to provide the US with 100 million doses by the end of June. The UK, EU and Canada have also ordered doses, and 500 million doses have also been ordered through the Covax scheme to supply poorer nations.


President Joe Biden hailed it as "exciting news for all Americans, and an encouraging development", but warned that the "fight is far from over".


"Though we celebrate today's news, I urge all Americans - keep washing your hands, stay socially distanced, and keep wearing masks," he said in a statement.


"As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse."


Results from trials conducted in the US, South Africa and Brazil showed it was more than 85% effective at preventing serious illness, and 66% effective overall when moderate cases were included.


Notably, there were no deaths among participants who had received the vaccine and no hospital admissions after 28 days post-vaccine.


Overall protection was lower in South Africa and Brazil, where virus variants have become dominant, but defence against severe or critical illness was "similarly high".


South Africa began administering the Johnson & Johnson jab to healthcare workers earlier this month after early trials suggested the Oxford-AstraZeneca vaccine offered "minimal protection" against mild disease from the variant dominant in large parts of the country.


Johnson & Johnson says it plans to deliver 20 million doses in total by late March.


Because the vaccine will require fewer doses than its two-shot Pfizer and Moderna counterparts, it will also require fewer vaccine appointments and medical staff.


The Johnson & Johnson vaccine uses a common cold virus that has been engineered to make it harmless.


It then safely carries part of the coronavirus's genetic code into the body. This is enough for the body to recognise the threat and then learn to fight coronavirus.


This trains the body's immune system to fight coronavirus when it encounters the virus for real.


This is similar to the approach used by the University of Oxford and AstraZeneca.


What is the situation in the US?

About 72.8 million Americans have already been vaccinated and about 1.3 million doses are being administered across the country each day. President Biden has pledged to administer 100 million vaccines in his first 100 days in office.


More than 508,000 people in the US have died of Covid but new cases, hospitalisations and deaths have all been on the decline over the past few weeks.


Top public health experts, however, continue to warn that mutations of the virus can still threaten progress.

Covid jabs reach one million milestone in Wales

 A total of 916,336 people have received their first dose, of which 89,053 have had a second jab, a total of 1,005,389.


It means one in three of the country's adult population have received at least one dose.


Health Minister Vaughan Gething said it was a "fantastic testament" to the hard work of staff involved in the roll-out.


He said it was an "incredible marker within just 12 weeks of the first vaccines arriving in the country".


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It means 29.1% of the Welsh population have had a first dose and 2.8% have had a full vaccination.


The majority of care home residents and other target groups aged over 70 have had their first doses.


On Friday, Wales' chief medical officer Dr Frank Atherton said people aged in their 40s will be next in line to get the coronavirus vaccine.


Last week saw a stock of 46,000 Pfizer-BioNTech doses being used in Wales and another 56,000 Oxford-AstraZeneca vaccines available.


Along with this week, there was a planned reduction in supply, as manufacturers prepare their processes for a significant ramp-up of production from March onwards, when between 160,000 and 190,000 doses are expected to be available.


Friday, February 26, 2021

Covid-19: Birmingham's ethnic 'disparities' over jab in focus

 Covid-19: Birmingham's ethnic 'disparities' over jab in focus


More than 600 community champions have been recruited by Birmingham City Council to address low vaccine take up and misinformation around Covid-19.

Figures show the poorest and most ethnically diverse communities are seeing the lowest levels of uptake.

Local community leaders have said trusting the government and health officials is an issue.

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The 645 champions span the city's 69 wards and are working with groups to share information.

While disparities for some groups have improved from the first wave of the pandemic, it has not changed for others, particularly within Pakistanis and Bangladeshis communities, the government said.


High rates of infection have been recorded in Alum Rock, but it has seen the lowest number of people coming forward for vaccination - just six in 10 of those aged over 80 have had the jab.

In nearby Sutton Four Oaks, close to 95% of over-80s have been vaccinated.


'A reliable source'

The council set up its Community Champion network in September as part of a £23m national government scheme and is working with the NHS to target ethnic communities.


Officials will meet faith leaders on a weekly basis, stage vaccine awareness and understanding sessions, encourage GP practices to approach individuals about why they have not taken up first vaccine appointments and expand vaccination sites.


Last month, The Al-Abbas Islamic Centre in Balsall Heath, became the first mosque in the UK to open as a Covid vaccination centre, aiming to reach 500 people a day.


One volunteer, Paresh, said he wanted to become involved because "the first lockdown had a lasting effect on communities who had little or no information".


"Being a champion helps to deliver the right messaging at grassroots, enabling communities we live in to have the right level of information and not just go on hearsay like this," he said.


Sunita, another volunteer, said she "wanted to hear facts from a reliable source in public health".

Thursday, February 25, 2021

Queen says Covid vaccine 'didn't hurt at all'

 The monarch, 94, and the Duke of Edinburgh, 99, received their first doses of the vaccine in January.


In a video call with health leaders delivering the Covid vaccine across the UK, the Queen was asked about her experience of having the jab.


She smiled as she replied: "Well, as far as I can make out it was quite harmless.


"It was very quick, and I've had lots of letters from people who've been very surprised by how easy it was to get the vaccine."


"It didn't hurt at all," the Queen said, adding that she has since felt "protected".


The monarch said she understood getting a jab could be a "difficult" experience for some people but urged everyone to "think about other people rather than themselves".


Queen and Prince Philip vaccinated against Covid

Who has had the vaccine?

Will I get side effects from the vaccine?

It comes after UK vaccines minister Nadhim Zahawi said figures suggested 11-15% of people were vaccine-hesitant, with data skewed toward some black and ethnic minority communities.


Some studies have also found disparities between poorer and wealthier areas.


Dr Emily Lawson, who is leading the vaccine deployment programme for the NHS in England, said the Queen's comments about her vaccine experience were an "incredibly important vote of confidence in the programme".


"We just want to make sure we create the conditions where everybody feels able to take up the offer of a vaccination when they're called," she said.


"And Her Majesty offering her view on that is a huge boost to our confidence and I hope to confidence more broadly in the programme."


The Queen also said the speed of the UK's vaccination rollout had been "remarkable" so far.


Speaking to the four officials overseeing the programme in England, Scotland, Wales and Northern Ireland, she added: "Keep up the good work."


During the video call, which was held on Tuesday, the monarch likened the pandemic to a "plague" that has swept across the globe.


After Derek Grieve, head of the Scottish government's vaccine rollout, told the head of state he would like to "bottle" the community spirit he had witnessed during the epidemic, she said it felt "very much like" the wartime spirit she experienced.


Meanwhile, the Countess of Wessex has begun volunteering at a vaccination centre in south-west London.


Sophie, who is a St John Ambulance care volunteer, completed the required training to help provide reassurance and information to vaccine recipients.

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St John Ambulance said it was "delighted" to welcome the countess to its team of more than 10,000 trained volunteers in vaccine centres across England.


More than 18 million people have had a first vaccine dose - equivalent to one in three adults in the UK.


The vaccine rollout has entered its next phase, after everyone in the top four priority groups was offered a jab. Many areas are now offering vaccine appointments to over-60s, adult carers of disabled people and younger adults in care homes.


The Prince of Wales and Duchess of Cornwall have both received their first doses of the vaccine, with Camilla saying she "leapt for joy" after getting her jab.


And the Duke of Cambridge said at a vaccine centre in Norfolk on Monday that he would be at the "front of the queue" for a vaccine to help to reassure people of its safety, but that he would "wait my turn".


During his visit William also said his grandfather, Prince Philip, was "OK" after being admitted to hospital last week.


The Duke of Edinburgh remains at King Edward VII's Hospital in central London where he is being treated for an infection.

Johnson and Johnson vaccine: FDA finds the single-shot jab safe

 US regulators have found the single-shot Johnson & Johnson coronavirus vaccine is safe and effective.

It paves the way for it to become the third Covid-19 vaccine to be authorised in the US, possibly within days.

The vaccine would be a cost-effective alternative to the Pfizer and Moderna vaccines, and can be stored in a refrigerator instead of a freezer.

Trials found it prevented serious illness but was 66% effective overall when moderate cases were included.

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The company has agreed to provide the US with 100 million doses by the end of June. The UK, EU and Canada have also ordered doses and 500 million doses have also been ordered through the Covax scheme to supply poorer nations.


Will vaccines always work against Covid?

Covid map: Where have the 111m cases been?

What does trial data say?

The briefing document published by the US Food and Drug Administration (FDA) gives more detail on the data submitted by Janssen, a pharmaceutical branch of Johnson & Johnson, to the regulator. The FDA concludes that the Johnson & Johnson vaccine has "known benefits" in reducing both symptomatic and severe illness.


It comes after the firm released data last month.


Results from trials conducted in the US, South Africa and Brazil found its efficacy against the worst outcomes of the virus was "similarly high" but overall protection was lower in South Africa and Brazil, where virus variants have become dominant.


Data showed it was more than 85% effective at preventing serious illness, but only 66% effective overall when moderate cases were included, when considering cases at least 28 days after vaccination.


Notably, there were no deaths among participants who had received the vaccine and no hospital admissions after 28 days post-vaccine.


What happens now?

An external committee of experts will meet on Friday to recommend whether the FDA should authorise the vaccine, possibly adding to a coming surge in vaccine availability in the US. The US would be the first country in the world to approve the vaccine.


A White House official said the administration anticipated distributing at least three million doses of the Johnson & Johnson vaccine next week, should it receive emergency authorisation from the FDA.


The company says it plans to deliver 20 million doses in total by late March, in line with an agreement to supply the US with 100m doses by the end of June.


Not only will the vaccine require fewer doses than its two-shot Pfizer and Moderna counterparts, it will also require fewer vaccine appointments and medical staff as a result.


Who else has ordered the Johnson & Johnson jab?

UK - 30 million doses

EU - 200 million doses

Canada - 38 million doses

Covax nations - 500 million doses

Wednesday, February 24, 2021

Moderna sends vaccine modified for South African variant to NIH for testing

 Moderna, which produces one of two coronavirus vaccines authorized for use in the U.S., announced on Wednesday that it has shipped a vaccine modified to fight the variant first discovered in South Africa to the National Institutes of Health for testing in humans.

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The company said the National Institute of Allergy and Infectious Diseases, part of the NIH, will conduct a phase one trial to determine if the modified vaccine boosts immunity against the variant, which has caused concerns due to being more resistant to the current vaccines.


"We look forward to beginning the clinical study of our variant booster and are grateful for the NIH's continued collaboration to combat this pandemic," Stéphane Bancel, Moderna's chief executive officer, said in a statement. "As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic."


Moderna said last month that a six-fold reduction in protection was noted for the variant first found in South Africa, versus other strains of the virus, but also said that neutralizing antibodies created by the vaccine "remain above levels that are expected to be protective."


If the booster is proven necessary, and thus subsequently authorized by the U.S. Food and Drug Administration for use, Moderna said the it be "provided to the global community in late 2021 and 2022."


The pharmaceutical company also reported it is taking a three-pronged approach to the variant testing. In addition to the variant-specific booster candidate, it is testing a combination of the current vaccine and the new booster and, finally, a third dose of the current vaccine. Moderna has already begun dosing a cohort of participants with the booster.


Moderna also said its current vaccine still works well against variants and the testing is precautionary.


In addition to the news about testing for the South African variant, Moderna also announced it is stepping up production of its currently authorized vaccine -- now being injected across the U.S.


"We believe from our discussions with governments around the world that there will continue to be significant demand for our COVID-19 vaccine and we now are committed to materially increasing our manufacturing capacity," Bancel said in a statement.


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<p>&nbsp;</p>


"We expect our additional capital investments to drive our capacity to 1.4 billion doses for 2022, assuming the current 100 μg dose," he added. "If our variant vaccine booster requires a lower dose, such as 50 μg, we could have more than 2 billion doses of capacity for 2022."


Moderna reported it is increasing its plan from delivering 600 million doses in 2021 to 700 million globally.


On Tuesday, executives from the major vaccine companies producing the COVID-19 vaccines told Congress that they remain on track to ramp up production of doses as promised in their government contracts, which President Joe Biden has pledged will deliver enough doses of the Pfizer and Moderna vaccines to fully vaccinate 300 million Americans by the end of July.


To date, the company reports it has shipped 55 million doses to the U.S. government. The U.S. expects to see another 140 million vaccine doses delivered by the end of March, as well another 20 million doses of Johnson & Johnson's single-dose vaccine if the FDA authorizes it for emergency use later this week.

Pulse oximeters, used to fight COVID-19, may be inaccurate on people of color: FDA

 Pulse oximeters, medical devices used in battling COVID-19, may not work effectively on people of color, according to health officials.


The small devices clamp onto a patient's finger and measure oxygen levels in blood. During the pandemic, they've been used by people at home and in hospitals to monitor COVID-19 patients as the virus attacks the lungs, often leading to a drop in oxygen levels.


"The devices may be less accurate in people with dark skin pigmentation," The U.S. Food and Drug Administration said in a statement on Friday.


Black patients are nearly three times as likely to have dangerously low blood oxygen levels go undetected by pulse oximetry compared with white patients, the FDA said, citing December research.


Pulse oximeters use infrared light beams to estimate the oxygen saturation of the blood and pulse rate, and darker skin pigment may absorb some of that light and alter results.


"Melanin is a primary light absorber in the skin, and it's going to absorb the light. This abounds more in individuals with darker skin," Dr. Panagis Galiatsatos, an assistant professor in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins, told ABC News. "These devices were evaluated on a certain population. It doesn't take into account confounders like darker skin. We'd love to calibrate for darker skin variations -- it's just never been done before."


He said these devices appear to be just another example of health care disparities that result from when studies are too focused on a homogenous group.


Pulse oximeters are popular because they're a painless way to measure blood oxygen levels. Other factors that affect the accuracy of pulse oximeters include skin temperature and thickness, tobacco use and the use of fingernail polish.


MORE: Black Americans lagging behind in COVID-19 vaccinations, data shows

Galiatsatos warned patients who use pulse oximeters at home to closely monitor their symptoms and call a doctor if they experience trouble breathing.


"It's crucial because if there's low oxygen that's untreated, it'll result in organ failure," he said.


The FDA is now reviewing the effects of skin pigmentation on the accuracy of these devices. Similarly, the Centers for Disease Control and Prevention updated its coronavirus clinical guidance to flag that skin pigmentation may adversely affect results.

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However, this issue isn't new.


Nearly a month ago Democratic Sens. Elizabeth Warren of Massachusetts, Corey Booker of New Jersey, and Ron Wyden of Oregon, called on the FDA to review the efficacy of blood oximeters among different racial groups.


"Racial disparities in health care stem from a wide variety of factors, and it is particularly disturbing that racism may be embedded in key clinical tools," the lawmakers said in a statement.


They noted that sales of pulse oximeters skyrocketed during the pandemic even though studies from 2005, 2007 and 2020 found that the devices "provide misleading measures of blood oxygen levels to patients of color."


MORE: Disparities persist as US tops 500,000 COVID deaths

The health disparity comes as the pandemic already has disproportionately affected communities of color.


According to CDC data, Native Americans are nearly four times more likely to be hospitalized for COVID-19 compared with non-Hispanic whites. Black and Hispanic individuals are twice as likely to die from COVID-19 as white Americans and three times more likely to be hospitalized with the virus.


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Tuesday, February 23, 2021

Not to be sniffed at: Agony of post-COVID-19 loss of smell

 The doctor slid a miniature camera into the patient’s right nostril, making her whole nose glow red with its bright miniature light.


“Tickles a bit, eh?” he asked as he rummaged around her nasal passages, the discomfort causing tears to well in her eyes and roll down her cheeks.


The patient, Gabriella Forgione, wasn't complaining. The 25-year-old pharmacy worker was happy to be prodded and poked at the hospital in Nice, in southern France, to advance her increasingly pressing quest to recover her sense of smell. Along with her sense of taste, it suddenly vanished when she fell ill with COVID-19 in November, and neither has returned.


Being deprived of the pleasures of food and the scents of things that she loves are proving tough on her body and mind. Shorn of odors both good and bad, Forgione is losing weight and self-confidence.


“Sometimes I ask myself, ’Do I stink?'" she confessed. “Normally, I wear perfume and like for things to smell nice. Not being able to smell bothers me greatly.”


A year into the coronavirus pandemic, doctors and researchers are still striving to better understand and treat the accompanying epidemic of COVID-19-related anosmia — loss of smell — draining much of the joy of life from an increasing number of sensorially frustrated longer-term sufferers like Forgione.


Even specialist doctors say there is much about the condition they still don't know and they are learning as they go along in their diagnoses and treatments. Impairment and alteration of smell have become so common with COVID-19 that some researchers suggest that simple odor tests could be used to track coronavirus infections in countries with few laboratories.


For most people, the olfactory problems are temporary, often improving on their own in weeks. But a small minority are complaining of persistent dysfunction long after other COVID-19 symptoms have disappeared. Some have reported continued total or partial loss of smell six months after infection. The longest, some doctors say, are now approaching a full year.


Researchers working on the vexing disability say they are optimistic that most will eventually recover but fear some will not. Some doctors are concerned that growing numbers of smell-deprived patients, many of them young, could be more prone to depression and other difficulties and weigh on strained health systems.


“They are losing color in their lives,” said Dr. Thomas Hummel, who heads the smell and taste outpatients clinic at University Hospital in Dresden, Germany.


“These people will survive and they'll be successful in their lives, in their professions,” Hummel added. “But their lives will be much poorer.”


At the Face and Neck University Institute in Nice, Dr. Clair Vandersteen wafted tube after tube of odors under Forgione's nose after he had rooted around in her nostrils with his camera.


“Do you perceive any smell? Nothing? Zero? OK,” he asked, as she repeatedly and apologetically responded with negatives.


Only the last tube provoked an unequivocal reaction.


“Urgh! Oh, that stinks," Forgione yelped. “Fish!”


Test complete, Vandersteen delivered his diagnosis.


“You need an enormous amount of an odor to be able to smell something,” he told her. “You haven’t completely lost your sense of smell but nor is it good.”


He sent her away with homework: six months of olfactory rehab. Twice daily, choose two or three scented things, like a sprig of lavender or jars of fragrances, and smell them for two to three minutes, he ordered.


“If you smell something, great. If not, no problem. Try again, concentrating hard on picturing the lavender, a beautiful purple bloom," he said. “You have to persevere."


Losing the sense of smell can be more than a mere inconvenience. Smoke from a spreading fire, a gas leak, or the stink of rotten food can all pass dangerously unnoticed. Fumes from a used diaper, dog's dirt on a shoe or sweaty armpits can be embarrassingly ignored.


And as poets have long known, scents and emotions are often like lovers entwined.


Evan Cesa used to relish meal times. Now they're a chore. A fish dinner in September that suddenly seemed flavorless first flagged to the 18-year-old sports student that COVID-19 had attacked his senses. Foodstuffs became mere textures, with only residual hints of sweet and saltiness.


Five months later, breakfasting on chocolate cookies before classes, Cesa still chewed without joy, as though swallowing cardboard.


“Eating no longer has any purpose for me," he said. "It is just a waste of time.”


Cesa is among the anosmia sufferers being studied by researchers in Nice who, before the pandemic, had been using scents in the diagnosis of Alzheimer’s disease. They also used comforting fragrances to treat post-traumatic stress among children after a truck terror attack in Nice in 2016, when a driver plowed through holiday crowds, killing 86 people.


The researchers are now turning their expertise to COVID-19, teaming up with perfumers from the nearby fragrance-producing town of Grasse. Perfumer Aude Galouye worked on the fragrant waxes that were wafted under Cesa's nose to measure his olfactory impairment, with scents at varying concentrations.

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“The sense of smell is a sense that is fundamentally forgotten," Galouye said. "We don’t realize the effect it has on our lives except, obviously, when we no longer have it.”


The examinations on Cesa and other patients also include language and attention tests. The Nice researchers are exploring whether olfactory complaints are linked to COVID-related cognitive difficulties, including problems with concentrating. Cesa stumbled by picking the word “ship” when “kayak” was the obvious choice on one test.


“That is completely unexpected," said Magali Payne, a speech therapist on the team at the Côte d’Azur University's CoBTeK lab. “This young man shouldn’t be experiencing linguistic problems.”

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“We have to keep digging,” she said. “We are finding things out as we see patients.”


Cesa longs to have his senses restored, to celebrate the taste of pasta in carbonara sauce, his favorite dish, and a run through the fragrant wonders of the great outdoors.


“One might think that it is not important to be able to smell nature, trees, forests," he said. “But when you lose the sense of smell, you realize how truly lucky we are to be able to smell these things.”

Friday, February 19, 2021

Biden to announce US will donate $4 billion for COVID-19

 President Joe Biden plans to announce on Friday that the United States will contribute $2 billion to a U.N.-backed program seeking to distribute COVID-19 vaccine doses to people in the poorest countries in the world, according to senior Biden administration officials.

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Congress had already allocated the money in December for the U.S. Agency for International Development to provide to Gavi, an international vaccine distribution alliance. Congress provided a total of $4 billion and the officials said that the U.S. would give the rest to Gavi over the course of this year and 2022.


The move, which the White House said Biden intends to announce during a virtual meeting of the Group of Seven leaders, comes as the United States grapples with not yet having enough doses to vaccinate its own population, although the situation in poorer nations is far worse.


To date, 10 countries have administered 75% of all COVID-19 vaccines, while more than 130 countries have not yet received a single dose, the United Nations said Wednesday.


Many countries are unable to compete with wealthier ones like the U.S. to purchase the limited amounts of vaccine doses available from manufacturers. In conjunction with the World Health Organization and the Coalition for Epidemic Preparedness Innovations foundation, Gavi runs a worldwide vaccination initiative called COVAX that aims to address that disparity by more equitably distributing doses.


Even though then-President Donald Trump signed into law a December bill that allocated the $4 billion to Gavi, he had previously refused to back COVAX and his administration also moved to cut ties with the World Health Organization.


Biden has dramatically reversed that approach, keeping the U.S. in the WHO and making battling the COVID-19 pandemic worldwide a national security priority.


But bringing the global outbreak to an end has proved complicated with limited availability of vaccine doses.


The United States has so far purchased 600 million vaccine doses, but it does not intend to give any of them to other countries until -- as Biden directed in a Jan. 21 memorandum -- "there is sufficient supply in the United States."


A senior administration official said Thursday that "this pledge to COVAX does not impact the vaccination program in the United States at all."


"While we're not able to share vaccine doses at this time while we're focused on American vaccinations and getting shots into arms," the official said, "we're working hard to support COVAX, strengthen global vaccination around the world and determining the timeline for when we will have a sufficient supply in the United States and be able to donate surplus vaccines."


"Decreasing the burden of disease decreases the risk to everyone in the world, including Americans," the official said. "It also decreases the risk of variants occurring, like those that we're seeing now. So it's critically important to surge vaccination globally, while we're, of course, prioritizing vaccinations here at home."


The official said the first $2 billion tranche would be donated "within days to weeks" and "ideally by the end of this month." Of the additional $2 billion, the U.S. plans to contribute the first $500 million of it "rather quickly" to "spur some of those initial doses to be out there," but it intends to at least initially hold back the rest to encourage other countries to make pledges of their own, the official said.


"This pandemic is not going to end unless we end it globally," the official added.

Wednesday, February 17, 2021

Vaccine delays leave grocery workers feeling expendable

 As panicked Americans cleared supermarkets of toilet paper and food last spring, grocery employees gained recognition as among the most indispensable of the pandemic's front-line workers.


A year later, most of those workers are waiting their turn to receive COVID-19 vaccines, with little clarity about when that might happen.


A decentralized vaccine campaign has resulted in a patchwork of policies that differ from state to state, and even county to county in some areas, resulting in an inconsistent rollout to low-paid essential workers who are exposed to hundreds of customers each day.

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“Apparently we are not front-line workers when it comes to getting the vaccine. That was kind of a shock,” said Dawn Hand, who works at a Kroger supermarket in Houston, where she said three of her co-workers were out with the virus last week. She watches others getting vaccinated at the in-store pharmacy without knowing when she'll get her turn.


Texas is among several states that have decided to leave grocery and other essential workers out of the second phase of its vaccination effort, instead prioritizing adults over 65 and people with chronic medical conditions.


Focusing on older adults is an approach many epidemiologists support as the most ethical and efficient because it will help reduce deaths and hospitalizations faster. People over 65 account for 80% of deaths in the country, according to the Centers for Disease and Control Prevention.


“Our main goals with vaccines should be reducing deaths and hospitalizations,” said William Moss, executive director of the International Vaccine Center at Johns Hopkins University School of Public Health. “In order to do that, we need to begin vaccinating those at the highest risks.”


But many grocery workers have been surprised and disheartened to find that they've been left out of such policies, in part because a CDC panel had raised their expectations by recommending the second phase of the vaccine rollout — 1B — include grocery and other essential employees.


Even when grocery workers are prioritized, they still face long waits. New York opened up vaccines to grocery workers in early January, along with other essential employees and anyone 65 and over. But limited supply makes booking an appointment difficult, even more so for the workers who don’t have large companies or unions to advocate for them.


Edward Lara had to close his small grocery store — known as a bodega — in the Bronx for 40 days when he and his employees contracted the virus last spring. He has tried for weeks to get a vaccine appointment and finally figured out he could register through the website of a network of health care providers, which will notify him when a slot opens.


Lara’s father-in-law died of the virus in March. His mother-in-law died in November. Last week, a friend who manages his bodega’s insurance policy also died. And a cousin in New Jersey got the virus for a second time, leaving him terrified it could happen to him.


“Nothing to be done. Cross my fingers and hope that God protects me,” Lara said after registering for the waitlist.


Only 13 states are currently allowing grocery workers to sign up for vaccines, according to the United Food and Commercial Workers union, which represents 1.3 million U.S. grocery, meatpacking and other front-line workers.


Some states are still working through an initial phase that prioritizes health workers and nursing home residents. Many states have divided the second phase into tiers that put grocery workers lower than others, including people 65 and over, teachers and first responders. Eleven states have no clear plan for prioritizing grocery workers at all, according to research from United 4 Respect, a labor group that advocates for workers at Walmart, Amazon and other major retailers.


At MOM’s Organic Market, a 21-store grocery chain in the Mid-Atlantic region, chief culture officer Jon Croft initially thought the company’s 1,500 workers would be vaccinated by the end of January. He now thinks it will be more like March or April. The company has only been able to pre-register workers from two stores in Maryland and two in Virginia.


“Folks feel they deserve to have an opportunity to be vaccinated having been on the front line,” Croft said. "The politicians and the health departments have been singing the praises of grocery workers but now they have been silent.”


Major food retailers say they are doing their part to get their workers vaccinated. Kroger, the nation’s largest grocery chain, said it has been vaccinating employees in Illinois ever since they became eligible, but grocery workers aren’t yet eligible in most of the jurisdictions in which the company operates. Target and Walmart also said they would offer their workers vaccines at their own pharmacies as soon as they are eligible.


Kroger, Trader Joe's, Target and online delivery service Instacart have offered bonuses or extra paid time off for workers who get the vaccine.


When grocery chain Lidl got word from Suffolk County on Long Island that it would be given appointments for its local workers, it immediately contacted those who it knew to be at highest risk. So far, more than 100 employees in Suffolk County have now gotten shots.


Joseph Lupo, a Lidl supervisor who fell ill with the virus in March, is one of them.


“I never ever want to get COVID again, or see anybody else get it,” said Lupo, 59.


But for many grocery workers, the realization that they won’t be eligible any time soon adds to the sense of being expendable. They have fought a mostly losing battle for hazard pay, which a handful of companies offered in the spring but ended despite multiple resurgences of the virus.


A year into the pandemic, some shoppers still refuse to wear masks and managers often don’t force them to follow the rules.


“There are the people who come in wearing a mask halfway down or take it off as soon as they get in the door,” said Drew Board, who makes $13.50 an hour handling grocery pick-up orders at a Walmart in Albemarle, North Carolina. “I ask them politely to pull it back up and they do and then take it back down when they walk away.”

Tuesday, February 16, 2021

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Therapeutic Drugs and the Blood Brain Barrier: How to Break on Through to the Other Side

 We have all seen the headlines on traumatic brain injuries (TBI) and litigation – they run the gamut from sports injuries to motor vehicle accidents. What we don’t hear about is one of the biggest obstacles in treating brain injuries or disorders: the difficulty in delivering therapeutics across the blood brain barrier (BBB).  Most drugs do not contain the appropriate chemical properties allowing them to cross the BBB. The need for safe drug delivery technologies that can permeate the BBB and effectively target involved areas is a driving force in the market.

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Current research is exploring the implementation of biotechnology to assist drugs in crossing the BBB. One potential approach uses nanoparticles (particles ≤ nm) to encapsulate therapeutic drugs. This approach offers advantages due to non-invasiveness, targeting efficiencies, biodegradability, and stability to release drugs. 


Researchers at Brigham and Women’s Hospital and Boston Children’s Hospital have studied a particular polymer-based nanoparticle used to deliver a therapeutic across the BBB in TBI. TBI can lead to long-lasting secondary injuries, such as neurological and cognitive deficits, behavioral changes and gait abnormalities and neurodegenerative diseases like Parkinson’s disease and Alzheimer’s disease.  The researchers employed a therapy based on small interfering RNA (siRNA), a short sequence of RNA that silences gene expression, designed in this study to silence the expression of a microtubule-associated protein called tau. Although tau is normally involved in the stabilization of microtubules for healthy cell growth, abnormal buildup of this protein has been implicated in various neurodegenerative diseases including Alzheimer’s disease. In order to develop a therapeutic that can cross the BBB, the scientists encapsulated the siRNA in nanoparticles consisting of polylactide-co-glycolide (PLGA), a biodegradable and biocompatible polymer. Using a mouse model, Li et al. demonstrated a threefold higher brain accumulation of the nanoparticles and 50% reduction of tau expression, indicating delivery of the siRNA was therapeutically effective in crossing the BBB and silencing tau in TBI mice.

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Currently, the FDA has approved PLGA for approximately 20 drugs to treat various illnesses, including cancer, diabetes, and mood disorders. However, the FDA has not approved a PLGA drug delivery device for the treatment of TBI or neurodegenerative diseases. In fact, the FDA has not approved any new therapeutics for treating Alzheimer’s disease since 2003. Li et al. suggest that, based on the efficacy of their novel drug delivery system, doors could open up for the possibility of treating other neurological disorders in a similar manner. Jeffery Karp, a co-author of the paper, stated: “‘For clinical translation, we want to look beyond tau to validate that our system is amenable to other targets . . . . We used the TBI model to explore and develop this technology, but essentially anyone studying a neurological disorder might find this work of benefit. We certainly have our work cut out, but I think this provides significant momentum for us to advance toward multiple therapeutic targets and be in the position to move ahead to human testing.’"


While still in the pre-clinical stages of testing, this new drug delivery device offers future hope for the pharmaceutical community, as we work toward effectively treating brain injuries and disorders.

Monday, February 15, 2021

Top 12 Biden Executive Orders Related to Healthcare and COVID-19

 During President Biden’s first few weeks in office, he signed 30 executive orders (EO), many of which are designed to improve and protect the safety, well-being, and future of the United States. This blog post provides a high level summary of the top 12 executive orders related to healthcare and the Covid-19 pandemic response.

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1. EO 14007: President's Council of Advisors on Science and Technology

Establishes the President's Council of Advisors on Science and Technology (PCAST). PCAST must advise the President on topics relating to the economy, worker empowerment, education, energy, environment, public health, national and homeland security, and racial equity.


2. EO 14009: Strengthening Medicaid and the Affordable Care Act

Revokes two of former-President Trump’s executive orders that shortened the period during which people could enroll for coverage under the Affordable Care Act. In addition, this executive order directs the Secretary of Health and Human Services (HHS) to “consider” making a Special Enrollment Period for the Federally Facilitated Marketplace so that uninsured and under-insured Americans can sign up for coverage.


3. EO 13987: Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security

Creates two new positions: 1) Coordinator of the COVID-19 Response and Counselor to the President (COVID-19 Response Coordinator) and 2) Deputy Coordinator of the COVID-19 Response. The COVID-19 Response Coordinator and Deputy Coordinator will identify and help agencies incentivize, support, and encourage widespread mask-wearing. In addition, they will provide ongoing guidance to heads of agencies on the continuity of government functions during COVID-19.


4. EO 13994: Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats

Increases the gathering, sharing, and publication of COVID-19-related data through the newly created COVID-19 Response Coordinator position. The data sharing will help create policies and responses to COVID-19 and future public health threats. The goal of this order is to further public understanding of the pandemic and to prevent the spread of misinformation.


5. EO 13995: Ensuring an Equitable Pandemic Response and Recovery

Establishes a COVID-19 Health Equity Task Force within the HHS to address the impact of COVID-19 on communities of color and other underserved populations.


6. EO 13996: Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats

Addresses the cost of COVID-19 testing by guiding the Secretary of the Treasury, the HHS, the Secretary of Labor, and the COVID-19 Response Coordinator to 1) facilitate the provision of COVID-19 testing free of charge to those who lack comprehensive health insurance, and 2) clarify group health plans' and health insurance issuers' obligations to provide coverage for COVID-19 testing.


7. EO 13997: Improving and Expanding Access to Care and Treatments for COVID-19

Directs HHS and the National Institutes of Health to develop plans to 1) accelerate COVID-19 therapy development and 2) improve access to quality and affordable healthcare. This order urges various federal departments and agencies to provide targeted surge assistance to critical and long-term care facilities. HHS must also issue recommendations on how states and healthcare providers can increase their healthcare workforce capacities. Finally, this order recommends prioritizing investments in readily administered and scaled therapeutics through grants for research and development.


8. EO 13998: Promoting COVID-19 Safety in Domestic and International Travel

Requires masks in/on airports, international flights, trains, buses, and ferries.


9. EO 13999: Protecting Worker Health and Safety

Orders the Occupational Safety and Health Administration to 1) revise its guidance on workplace safety during COVID-19 and 2) launch a national program that will increase enforcement on workplace violations.


10. EO 14000: Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers

Requires the Secretary of Education, the Secretary of HHS and the Director of the Institute of Education Sciences to use evidence-based guidance, data collection, and technical assistance to assist schools in deciding whether and how to reopen, and how to remain open.


11. EO 14001: A Sustainable Public Health Supply Chain

Secretary of Defense, the Secretary of HHS, and the Secretary of Homeland Security, among others, are directed to create a pandemic supply chain resilience strategy by securing necessary supplies and pricing, including critical materials, treatments, supplies, and resources necessary to produce and distribute tests and vaccines at scale.


12. EO 14002: Economic Relief Related to the COVID-19 Pandemic

All executive departments and agencies should identify actions they can take to address the current economic crisis resulting from the pandemic. The departments are instructed to specifically consider how to better use data and improve access to, reduce unnecessary barriers to, and improve coordination among programs wholly or partially funded by the federal government.


Looking Forward

A January 28, 2021 press release from the White House states that President Biden plans to sign an executive order titled “Protecting Women’s Health at Home and Abroad.” This order will expand access to comprehensive reproductive health and direct the HHS to take immediate action to consider whether to rescind regulations under its Title X family planning program. Further, this executive order would rescinds the “global gag rule,” or the “Mexico City Policy,” which currently prevents international non-profits from receiving U.S. funding if they provide abortion counseling or referrals. As a result, this order will provide women across the country and around the world with increased health care rights and access. For more information, please see here.


A full list of President Biden’s executive orders is available here. The orders are related, but not limited to, immigration efforts, migration protection, the climate crisis, and incarceration system formation.

Is This the Worst Medicare Telehealth Law of 2020?

 The Public Health Emergency introduced a myriad of changes to federal and state telemedicine and digital health laws and rules. There were expansions to telehealth coverage and reimbursement, suspension of enforcement on HIPAA security for digital health, expedited FDA review processes, DEA exemptions of controlled substance prescribing rules, and state waivers of medical licensure requirements. Nearly all these changes, whether permanent or temporary, were telemedicine-friendly and promoted the use of digital health technology to deliver medical care.


But one change, signed into law in the last days of December 2020, has raised confusion (and eyebrows) in the telemental health provider community. It is a single sentence, contained in Section 123 of the Consolidated Appropriations Act of 2021. It reads:

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“Payment may not be made under this paragraph for telehealth services furnished by a physician or practitioner to an eligible telehealth individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder unless such physician or practitioner furnishes an item or service in person, without the use of telehealth …” (emphasis added).


In short, the Act changes the Medicare telehealth coverage statute, expanding Medicare payment beyond substance use disorder treatment (already required under the SUPPORT Act) to more broadly cover treatment of mental health disorders. Most telemedicine industry stakeholders would support expanded Medicare coverage of telehealth-based mental health services. The need for access to mental health care is high, considering the well-documented shortage of mental health practitioners nationwide, particularly in rural areas. However, under this new law, Medicare will cover the telehealth mental health service only ifthe practitioner has conducted an in-person consult with the patient in the prior six months and subsequently continues to conduct in-person exams (at such a frequency to be determined by HHS). Otherwise, Medicare will not pay for the telehealth service.


Here is the language of Section 123 in its entirety.


SEC. 123. EXPANDING ACCESS TO MENTAL HEALTH SERVICES FURNISHED THROUGH TELEHEALTH.

(a) TREATMENT OF MENTAL HEALTH SERVICES FURNISHED THROUGH TELEHEALTH.—Paragraph (7) of section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—


(1) by striking ‘‘DISORDER SERVICES FURNISHED THROUGH TELEHEALTH.—The geographic’’ and inserting ‘‘DISORDER SERVICES AND MENTAL HEALTH SERVICES FURNISHED THROUGH TELEHEALTH.—


‘‘(A) IN GENERAL.—The geographic’’;


(2) in subparagraph (A), as added by paragraph (1), by inserting ‘‘or, on or after the first day after the end of the emergency period described in section 1135(g)(1)(B), subject to subparagraph (B), to an eligible telehealth individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder, as determined by the Secretary,’’ after ‘‘as determined by the Secretary,’’; and


(3) by adding at the end the following new subparagraph: ‘


‘(B) REQUIREMENTS FOR MENTAL HEALTH SERVICES FUR- NISHED THROUGH TELEHEALTH.—


“(i) IN GENERAL.—Payment may not be made under this paragraph for telehealth services furnished by a physician or practitioner to an eligible telehealth individual for purposes of diagnosis, evaluation, or treatment of a mental health disorder unless such physician or practitioner furnishes an item or service in person, without the use of telehealth, for which payment is made under this title (or would have been made under this title if such individual were entitled to, or enrolled for, benefits under this title at the time such item or service is furnished)—


“(I) within the 6-month period prior to the first time such physician or practitioner furnishes such a telehealth service to the eligible telehealth individual; and


“(II) during subsequent periods in which such physician or practitioner furnishes such telehealth services to the eligible telehealth individual, at such times as the Secretary determines appropriate.


‘‘(ii) CLARIFICATION.—This subparagraph shall not apply if payment would otherwise be allowed—


‘‘(I) under this paragraph (with respect to telehealth services furnished to an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or cooccurring mental health disorder); or


‘‘(II) under this subsection without application of this paragraph.’’.


(b) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary may implement the provisions of, or amendments made by, this section by interim final rule, program instruction, or otherwise.


This is not the first time restrictions have been imposed on Medicare reimbursement for telehealth or virtual care services. For example, certain CPT service codes are limited to established patients, select items of durable medical equipment have had a “face-to-face encounter” requirement, and the geographic and originating site restrictions on telehealth have been in place for nearly 20 years. Yet, this law may very well be the first and only instance of a federal statute expressly mandating an in-person exam as a prerequisite for Medicare coverage of a telehealth-based service.


Little legislative history is readily available that reflects Congressional lawmakers discussing the merits of Section 123’s requirement for an in-person exam. To be fair, at 5,593 pages and $2.3 Trillion, this legislation is the longest bill ever passed by Congress and one of the largest spending measures ever enacted. But the in-person exam requirement is at odds with the direction that telehealth policy has moved over the last decade. It disrupts Medicare’s historical approach, which is to defer to state laws on professional practice requirements and clinical standards of care.


State laws vary on their specific requirements and practice standards, but at this point generally allow the creation of valid doctor-patient relationships via telemedicine without an in-person exam, assuming the standard of care is met. Additionally, 43 States now have telehealth coverage laws requiring commercial health plans to cover services delivered via telehealth. Some states, like Massachusetts’ recent telemedicine law, even take extra steps to ensure reimbursement of telehealth-based mental health care, and CMS itself includes new patient evaluation/management (E/M) service codes (e.g., CPT Codes 99201-99205) among the Medicare-covered telehealth services. 


Moreover, Section 123’s new prerequisite for an in-person visit applies only to mental health treatment. Medicare beneficiaries seeking medical services via telehealth are not subject to this requirement. It is only those patients seeking treatment of mental health disorders who are required to “mask up” and head to their practitioner for an in-person exam. It prompts consideration as to why mental health care is being held to different payment restrictions than medical care, despite years of efforts on mental health parity and the passage of the Mental Health Parity and Addiction Equity Act.


While expansion of Medicare coverage for telehealth services can increase access to care, particularly as the Public Health Emergency continues, the policy implications of Section 123’s in-person exam requirement may leave patients and practitioners wondering if the Act actually gives as much as it takes.