30% of health providers not complying with new CMS price transparency rule

 Approximately 30% of hospitals are not complying with a new rule that requires them to post payer-negotiated rates, with a lack of resources the main reason, a new analysis found.

The analysis of more than 1,000 providers across 27 states completed by consulting firm Guidehouse found larger health systems were more likely to comply with the rule that went into effect Jan. 1.

The Centers for Medicare & Medicaid Services (CMS) rule requires hospitals to post prices in one of two ways: a machine-readable file containing all standard charges for the facility’s items and services or a consumer-friendly file that lists 300 shoppable services. A hospital can use a patient price estimator tool to comply with the requirement.

The analysis found 30% of hospitals weren’t complying with either method.

The reasons for noncompliance ranged from a lack of resources due to COVID-19 or other issues, a lack of understanding about the rule and waiting to see what their competitors do.

“Larger hospitals and health systems were most likely to be compliant and are using existing tools (i.e., MyChart) to meet the requirements via the consumer-friendly shoppable services file,” the analysis said.

Guidehouse found 60% of the providers chose to comply with the rule via the consumer-friendly file, and 48% used the machine-readable file.

The analysis, released Tuesday, also found major inconsistencies with how hospitals are complying with the machine-readable file.

“There is a general lack of consistency in format and content, making it difficult for anyone (e.g. CMS, providers, payers) to scan, consolidate and derive insights without significant data transformation and enhancements,” the analysis said.

Guidehouse noted that its analysis also underscored the “herculean task” CMS faces in evaluating compliance with the rule. CMS can fine hospitals $300 a day for each day they are not in compliance.

The firm believes more providers will comply with the rule as resource constraints, especially those related to the COVID-19 pandemic, lessen and with more clarity on how to comply.

“However, having a strategic plan to mitigate risks and capitalize on the benefits of appropriate compliance is key,” the analysis said.

https://www.fiercehealthcare.com/hospitals/analysis-30-providers-not-complying-cms-new-rule-price-transparency

Boston Leaders Eye More Oversight On Lab Development Amid Building Boom

 Boston city councilors are taking a harder look at the region’s life sciences surge as residents are wary of the proliferating research facilities in their neighborhoods.

Developers are increasingly pivoting building plans to accommodate life sciences tenants, while others are spending hundreds of millions to convert existing office structures in the city’s hottest neighborhoods. Record private and public funding has fueled the need for quicker delivery for emerging companies, and lab conversion announcements have become a near-weekly occurrence.

Flickr/Paul Sableman

West Broadway road in South Boston.

City Councilors Wednesday voted to hold an expedited committee hearing to address zoning and community outreach issues surrounding rising life sciences projects in Boston. Councilors and community leaders said this week residents are worried about displacement, proximity to scientific research, job opportunities at the facilities and the cultural fit of such sites in each neighborhood.

City Councilor Ed Flynn requested a hearing Tuesday to address the large volume of life sciences plans around the city, including sites in his Chinatown and South Boston district. As a result of the council vote Wednesday, the city's Committee of Planning, Development and Transportation will take up the zoning and community outreach discussion at a date to be determined.

Flynn took aim at citywide projects in his hearing order, but focused on the 51 Sleeper St. site in Wednesday's virtual meeting, a life sciences development by China-based Nan Fung Life Sciences.

“Because the lab was in an area zoned as restricted manufacturing, it allowed the proponent to bypass a community process, as the project was deemed zoning-compliant,” Flynn said in Wednesday’s meeting.

Nan Fung didn't immediately respond to a request for comment. 

At-Large City Councilor Michael Flaherty Wednesday doubled down on the need for a longer discussion among city officials.

“We’ve also seen some developers get a little cute too, they put in their (letter of intent) with respect to the BRA that they’re looking to do a commercial building, but they never mention the possibility of a lab space,” Flaherty said, using the former acronym for the Boston Planning and Development Agency. “Direct abutters go up in arms because they thought it was going to be sort of a regular office building and now it’s a lab, and they want to know what’s going to be tested there.”

Changes in letters of intent to capture the lab demand have already occurred at Related’s Kenmore Square redevelopment, under the iconic Citgo Sign, and at 75 Morrissey Blvd., where project head David Raftery submitted plans nixing a residential tower for a 250K SF research and development and office building.

Courtesy of Brookfield Properties

A past rendering of 51 Sleeper St., in Boston's Seaport.

Community leaders like South Boston Neighborhood Development Corp. Executive Director Donna Brown said developers should seek to engage with their communities and be more transparent about what specifically could happen in their projects, rather than hide behind generalities.

“I think that’s what makes people nervous, they don’t know,” Brown said. “It's kind of a vague term when you say lab development, or life sciences work.”

Brown pointed to the joint venture project at 80 West Broadway, where The Matteson Cos. and GFI Partners recently filed plans to build an eight-story research and development building in the parking lot of the neighborhood’s longtime Amrheins restaurant. The project will keep Amrheins intact while building residential space alongside the eight-story building, which would be the tallest in the neighborhood.

Representatives for the companies didn't respond to requests for comment.

Smaller projects within the neighborhood and massive plans along the Seaport’s Fort Point channel will have to integrate with their neighborhood the same way the Gillette factory once did, Brown said. 

“If you talk to South Boston folks who grew up here, so many people, they've either been able to earn extra money to be testers for Gillette, their families were employed,” Brown said. “It was a path to a career. Gillette’s been such an important part of this community. We’d like to see these newcomers be the same kind of employers.”

The community relationship is on the mind of Chinatown residents, where Oxford Properties Group plans to meet with residents next Thursday in a BPDA meeting regarding its own life sciences move, reducing existing plans for a taller office tower at 125 Lincoln St.

Oxford Properties has been in conversations with the Chinatown and Leather District communities for its Lincoln Street build since 2019 and plans to update nearby residents on the types of tenants the site would accommodate, a company spokesman said in a statement Thursday.

Reducing the project's size means less affordable housing funds from the development, and residents want to know if the site’s existing retail tenants would have a chance to return if Oxford pursues a life sciences build-out, Asian Community Development Corp. Executive Director Angie Liou said.

“If they do this new building, what’s the ground floor, what’s the second floor commercial spaces, are those going to be maybe for the banquet space and the barbecue space to go back?” Liou said. “That will be what people’s concerns are.”

https://www.bisnow.com/boston/news/life-sciences/boston-leaders-want-more-lab-development-oversight-amid-boom-107719

Aged 40+ With Diabetes Hit Badly by COVID-19, Should Be Vaccine Priority

 People with type 2 diabetes as young as 40 years of age face a disproportionately increased risk of dying from COVID-19 infection, indicates a UK analysis of three large-scale datasets that shines a light on the need to prioritize vaccinations in younger vulnerable patient groups.

The research was published February 8 in the journal Diabetologia.

The majority of European countries have prioritized COVID-19 vaccinations for people with type 2 diabetes, but typically only at age 50 and older. However, the data from the current study suggest that this age limit should be lowered.

"It's important to remember the risk to middle-aged people with diabetes of dying from COVID-19 is very low in absolute terms compared with the elderly," said lead researcher Andrew P. McGovern, MD, of Royal Devon & Exeter Hospital, Exeter, United Kingdom, in a press release from his institution.

However, he said that "strategies to define priority groups for vaccination must consider the disproportionate relative risk of COVID-19 mortality in middle-aged people with type 2 diabetes whose COVID-19 risk is already elevated by their age."

McGovern told Medscape Medical News that the magnitude of the effect of type 2 diabetes on COVID-19 deaths "is really what's surprising" about these new findings, and "not what you would expect."

He said it is therefore crucial that people with diabetes are put "into the queue" for the vaccine "in the right place, and obviously in countries where the vaccine rollout will be slower, it is more important."

Bridget Turner, director of policy campaigns and improvement at Diabetes UK, which funded the study, said the results give "important new insights into how much type 2 diabetes adds to the overall risk of dying from coronavirus at different ages, particularly the additional risk that the condition adds in middle-age."

"The UK has made good progress on prioritizing those who are most vulnerable for vaccination, which includes all adults with diabetes," she added in the press release, "but we need to continue to work at pace to identify and protect those individuals at higher risk."

Relationship Between COVID Death and Diabetes Is Complex

The authors note that the relationship between COVID-19-related mortality and type 2 diabetes is not simply an "additive effect of diabetes and age-related risk" but appears to be a "more complex" association, with a "disproportionately higher excess relative mortality risk in younger people with diabetes."

To investigate this, they examined data from two UK population-based studies that had previously reported age-specific hazard ratios for COVID-19 mortality associated with diabetes:

• OpenSAFELY, which included 17.2 million people, of whom 8.8% had diabetes, and had an overall 90-day mortality rate of 0.06%

• QCOVID, comprising 6 million individuals, of whom 7% had diabetes, and had an overall 97-day mortality rate of 0.07%.

The team also looked at data on type 2 diabetes patients with severe COVID-19 from the COVID-19 Hospitalisation in England Surveillance System (CHESS), which contained 19,256 patients admitted to critical care in England, of whom 18.3% had diabetes.

The 30-day in-hospital mortality rate in this study was 26.4%.

They translated the mortality hazard ratios associated with COVID-19 infection in people with diabetes into a "COVID-age," which equates to the additional years of "death risk" added to an individual's chronological age if diabetes is present.

Taking the QCOVID dataset as an example, the results showed that the "COVID-age" associated with diabetes for someone aged 40 years was 20.4 years; that would indicate that their "mortality risk [for COVID-19] is similar to that of a 60-year-old person without diabetes."

The impact of diabetes on the COVID-19 death risk decreased with increasing age, such that a diabetes patient aged 50 years had a COVID-age of 16.4 years. This fell to 12.1 years in someone aged 60, and 8.1 years in someone 70 years of age, which means the latter has the same risk of death from COVID-19 as someone without diabetes who is 78.

Similar results were obtained when the team looked at data from the OpenSAFELY study.

But when they looked at the effect of diabetes on COVID-19 mortality risk in the CHESS dataset, it was less pronounced.

Just Looking at Diabetes Is Oversimplistic, but It's an Easy Marker for Vaccination

The researchers acknowledge that "considering only age and diabetes status when assessing COVID-19-associated risks...is an oversimplification," as factors such as body mass index (BMI), diabetes duration, and glycemic control are also known to play a role.

However, they say consideration of these factors is "not practical for population-level vaccine rollout."

"The time-critical nature of population COVID-19 vaccination necessitates pragmatic group-level prioritization, which is the approach initiated by governments thus far," the team concludes.

This study was supported by Diabetes UK. Study author John M. Dennis is supported by an Independent Fellowship funded by Research England's Expanding Excellence in England (E3) fund and by the NIHR Exeter Clinical Research Facility. McGovern is supported by the NIHR Exeter Clinical Research Facility.

Diabetologia. Published online February 8, 2021. Full text

https://www.medscape.com/viewarticle/945829

Existing heart failure drug may treat potential COVID-19 long-hauler symptom

 In a new study out of University of California San Diego School of Medicine, researchers found a drug used for heart failure improves symptoms associated with postural orthostatic tachycardia syndrome, otherwise known as POTS. This complex, debilitating disorder affects the body's autonomic nervous system, causing a high heart rate, usually when standing.

Writing in the February 15, 2021 online issue of the Journal of the American College of Cardiology, study authors investigated the drug ivabradine and its effects on heart rate, quality of life and plasma norepinephrine levels in persons living with POTS. Norepinephrine is a stress hormone and neurotransmitter. In blood plasma, it is used as a measure of sympathetic nervous system activity. Trial participants experienced a reduction in heart rate, improvement in their symptoms and overall quality of life one month after taking the drug.

"Ivabradine is a novel agent that's FDA-approved for heart failure, but based on its mechanism we thought it could be helpful for patients with POTS as it reduces heart rate without impacting blood pressure," said Pam Taub, MD, cardiologist at the Cardiovascular Institute at UC San Diego Health and associate professor of medicine at UC San Diego School of Medicine. "When we can lower the heart rate, we're providing these patients with the ability to stand up, something they couldn't do without difficulty before due to their POTS diagnosis."

The study involved 22 individuals whose average age was 32 years. Each participant had been screened and recruited from cardiology clinics at UC San Diego Health from 2018 to 2020.

The study utilized a randomized, double-blinded, placebo-controlled crossover design in which patients started on either ivabradine or a placebo for one month. At the end of the month, all participants underwent a washout period where neither drug nor placebo was taken for one week. After the washout period, the participants who had previously received ivabradine switched to placebo and vice versa for one month.

Over the course of the two months, patients also met with researchers for seven different clinic visits in which plasma norepinephrine levels were measured and head-up tilt testing conducted to observe the patient's heart rate when sitting, lying down or standing up.

"Before the study, these patients would be living with elevated heart rates ranging between 100 to 115 beats per minute when standing," said Taub. "After taking ivabradine twice a day for one month, the standing heart rate decreased significantly to around 77 beats per minute compared to the placebo group. Participants also reported improvement in quality of life measures when on the drug."

The researchers also noted ivabradine was well-tolerated with no significant side effects while other drugs used to lower heart rate, such as beta blockers, can cause fatigue and decreased blood pressure.

Taub said the study was the first randomized clinical trial using ivabradine to treat POTS.

POTS is typically caused by a viral infection, trauma, surgery or enforced bedrest, and most commonly affects young women who are either athletes or highly active. Currently, there is no FDA-approved treatment for POTS and the condition can severely impact quality of life. Other symptoms of POTS include "brain fog," lightheadedness, palpitations, tremors, weakness, blurry vision and fatigue.

Recently, POTS has been identified as a potential "long-hauler" symptom of COVID-19.

"In our contemporary practice, we are seeing patients who have previously been infected with COVID-19 present with symptoms consistent with POTS," said Jonathan Hsu, MD, cardiologist at UC San Diego Health. "Given the similarities, this study leads to the question whether therapy with ivabradine may help patients who experience similar symptoms after a COVID-19 infection, and provide an important area for future study as well."

The authors said they hope ivabradine will be considered as a possible treatment option for those with a confirmed diagnosed of POTS. Currently, the drug is not FDA-approved for the disease and when used clinically it would be "off-label" use.

"Similar to patients with COVID-19, patients with POTS need to be followed carefully," said Taub. "Treatment for POTS needs to be personalized for each individual and with this drug, paired with lifestyle therapy, including exercises specific for POTS, we hope we will see more individuals overcome this unfortunate condition."

More information: Journal of the American College of Cardiology (2021). DOI: 10.1016/j.jacc.2020.12.029

https://medicalxpress.com/news/2021-02-heart-failure-drug-potential-covid-.html

WHO Approves AstraZeneca Covid-19 Vaccine for Emergency Use

 The World Health Organization approved AstraZeneca PLC's Covid-19 vaccine for emergency use on Monday, clearing the way for the first shipments of free vaccines from the West's main effort to inoculate the world's poorest nations.

Many developing countries rely on the WHO's emergency-use listing -- which signals that a vaccine is considered safe and effective and that its supply chain has been checked -- to authorize the shots at home. It also triggers purchase orders that the WHO-supported Covax facility made with vaccine manufacturers.

The Covax facility, which is financed mostly by rich Western governments and charitable groups such as the Bill & Melinda Gates Foundation, aims to supply some 2.27 billion vaccine doses this year to 145 countries, the majority of them free. Doses produced by AstraZeneca and its manufacturing partners are expected to make up about a third of that effort, and more than half of the vaccines due to be supplied in the first half of 2021.

"Today's announcement...allows everybody to access vaccines," said Deusdedit Mubangizi, who heads the WHO unit that approved the listing.

The initial approval covers doses produced by AstraZeneca and South Korea-based company SK Bioscience. A separate emergency-use listing for the same shots made by the Serum Institute of India is expected to follow as early as Tuesday.

By the end of 2021, Covax aims to vaccinate 20% of the populations of the world's 92 poorest countries. That effort is likely to far outstrip vaccine donations from China, Russia and India, three nations that have in recent weeks flown vaccines to numerous developing nations, sparking criticism over the West's slow pace to share its shots.

Rich nations have bought up the majority of vaccine doses due to be produced this year, often covering their population multiple times over as they wait for different shots to pass clinical trials and be cleared by national regulators. The WHO said last week that three-quarters of the shots administered so far were given in just 10 countries that account for 60% of global gross domestic product. Almost 130 countries, with 2.5 billion people, have yet to administer a single dose, it said.

WHO officials said Monday that the AstraZeneca listing should start to change that dynamic, although they stopped short of giving a date for when the first Covax vaccines will actually be sent. Last month, the WHO approved an emergency-use listing for the Covid-19 vaccine made by Pfizer Inc. and BioNTech SE.

However, that shot is more expensive than the AstraZeneca one and needs to be stored at minus 94 degrees Fahrenheit, which is challenging for many poor countries that don't have the required sophisticated freezers. Supplies of the Pfizer shot are also much more limited, with Covax expecting to receive just 1.2 million doses by June and 40 million by the end of the year.

By contrast, Covax has secured some 336 million doses of the AstraZeneca vaccine, which the company developed with the University of Oxford, for the first half of 2021.

Covax's dependence on the AstraZeneca vaccine has come under scrutiny since a small clinical trial showed earlier this month that the shot doesn't appear to prevent mild and moderate Covid-19 from a new coronavirus variant first identified in South Africa. The South African government has suspended a planned rollout of the shot to healthcare workers, even though WHO officials recommended that countries continue using the vaccine.

The officials, and other vaccine experts, say they are confident that the vaccine can still protect against severe cases of Covid-19, including hospitalizations and deaths, from new virus strains.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/WHO-Approves-AstraZeneca-Covid-19-Vaccine-for-Emergency-Use-Update-32445944/

Fauci Stumps For Stimulus After CDC Changes School Reopening Guidelines To Appease Lobbyists

 Anthony Fauci is pushing for Congress to pass the next round of stimulus in order for schools to 'safely reopen.'

Speaking with ABC's "This Week," the nation's top infectious disease specialist told host George Stephanopoulos on Sunday that schools need more resources, "and that's the reason why the national relief act that we're talking about getting passed — we need that. The schools need more resources."

"It's the first time that it’s been put down in a document based on scientific observations and data over the last several months to a year, both in the United States and elsewhere. Part of that is to indicate and to suggest strongly that a preference be given to teachers to get vaccinated," Fauci said, though he suggested that schools could reopen without having all teachers vaccinated beforehand.

As The Hill notes, Fauci's comments expanded on new guidelines recently released by the Centers for Disease Control and Prevention (CDC) - which Director Rochelle Walensky admitted on Friday were dictated in part by lobbying groups - which, need we remind anyone, are not 'the science.'

So, special interest groups are demanding more 'protection' for teachers, and Fauci is now urging Congress to pass the next round of stimulus in order to reopen 'safely.'

What's more, even after everyone is vaccinated, Walensky says the CDC still might not recommend reopening schools full-time, and that there may be some "combination of mitigation strategies" instead.

Fauci - who told ABC that he doesn't think schools have the resources available to abide by the new CDC guidelines.

"I think that the schools really do need more resources and that's the reason why the national relief act that we're talking about getting passed — we need that. The schools need more resources."

House committees have begun marking up portions of President Biden's $1.9 trillion stimulus plan, and Democrats have vowed to pass a final bill into law by early next month.

However, Fauci on Sunday appeared to be optimistic about reopening schools, a move that he has been supportive of throughout the pandemic, arguing the detriment to young students was too great.

“I think it can be done. I mean, obviously it's not a perfect situation, but it's really important to get the children back to school in a safest way as possible. Safe for the children, but also safe for the teachers and the other educators,” Fauci said. -The Hill

The CDC, in its new guidelines, said that it's "critical for schools to open as safely and as soon as possible," due to the benefits of in-person learning as well as negative effects on mental health and academic performance based on data from last year.

https://www.zerohedge.com/covid-19/fauci-stumps-stimulus-after-cdc-changes-school-reopening-guidelines-appease-lobbyists

'A Few Months before We Reach Full Capacity'

In an interview, pharmaceuticals executive Sierk Poetting of BioNTech discusses problems in vaccine production and bottlenecks that are slowing distribution of the life-saving drugs. 

DER SPIEGEL: Mr. Poetting, BioNTech and its partner Pfizer announced this week, just in time for the German government’s vaccine summit, that they would significantly increase global production of your COVID-19 vaccine, from 1.3 billion planned doses to 2 billion doses. How was that possible? Did you build a half dozen new factories overnight?

Poetting: We announced the production target in mid-January and confirmed it again this week. To facilitate this, we began planning a significant expansion of capacities in the autumn. We asked ourselves: Which existing plants could we expand, in what areas can we cooperate with partners who have capacities, and what can our new factory in Marburg contribute? It all had to come together.

DER SPIEGEL: How many doses will the Marburg plant be able to produce each month?

Poetting: About 750 million doses a year, or around 65 to 70 million a month once the factory has really ramped up. This would make it one of the largest production facilities for mRNA-based vaccines in Europe. However, it will still take a few months before we reach full capacity.

DER SPIEGEL: Are 2 billion doses the maximum, or could you increase that figure again in the summer – to 2.5 billion, perhaps?

Poetting: For now, we're anticipating the 2 billion doses for this year. But I think we need to prepare for the demand to be greater. There are countries that are currently being underserved, a third dose of vaccine may be needed against mutated variants of the virus, or entirely new mutations could develop. That’s why we are working on expanding further locations and adding new partners to our network.

DER SPIEGEL: Would it help if the European Union or the German government not only guaranteed the purchase of the vaccine doses, but also invested directly in production?

Poetting: Last year, more money wouldn’t have helped us because we first had to set up the large-scale production process safely. The 50 million doses we produced in 2020 was the maximum possible. Even if there had been billions of euros and thousands of additional employees, there wouldn’t have been more. However, money would help now. Even more so if we are to anticipate a capacity of 3 billion doses next year, as was already requested this week.

DER SPIEGEL: How can the government best help? By pre-financing raw materials? Or by investing money directly into the construction of factories?

Poetting: All that would help, of course. Now it’s up to the politicians. There needs to be an approach to how the pharmaceutical industry wants to position itself in Europe. We have had good discussions about this in recent days.

DER SPIEGEL: Are you thinking of a European supplier network?

Poetting: Yes, that would be a path that we are already pursuing. We added Pfizer as a strategic partner because we knew we couldn’t manage this on our own in the beginning. We have since built up a network consisting of 13 production partners, with Marburg as the major production site at the heart. We could expand this further into a European network. We anticipated from the beginning that things could get difficult with the U.S., with or without Trump, when it comes to protectionism. So we said: We also need to order, build and produce elsewhere.

DER SPIEGEL: European Commission President Ursula von der Leyen has proposed using money from the EU budget to support the expansion or repurposing of existing production facilities. How seriously are you taking that?

Poetting: We would have to look into the proposal. Ideally, it could lead to an increase in capacity in the medium term.

DER SPIEGEL: Do you fear that materials from the U.S. will no longer be exported because the Americans want to take care of providing supplies for themselves first?

Poetting: There's an executive order from Donald Trump that Joe Biden has upheld. It essentially says that the vaccine will remain in the country. On top of that, there’s the Defense Production Act, which stipulates that certain substances be prioritized for domestic companies. We almost had problems with that, but we were able to get the shipment to Europe. There are still a few materials on the list. We are in contact with (Angela Merkel’s) Chancellery so that we have the necessary clearance if worse comes to worst.

DER SPIEGEL: What kind of materials are we talking about?

Poetting: In some cases, it's about completely ordinary things, like sterile plastic bags, for example. They are approved for a certain level of production, but if they are not available, then this leads to delays in the work done by the supplier.

DER SPIEGEL: What is the biggest production bottleneck?

Poetting: It's continually changing. Currently, it's two synthetic molecules. If there were just 250 grams more of it, you could manufacture a million more doses. So we should be working to ensure the free movement of goods with countries outside the EU. During the second quarter, further suppliers will ramp up their capacities. That will help ease the situation.

DER SPIEGEL: What happens if the vaccine has to be changed because of mutations? Will it then have to go through a whole new approval process that lasts for months and once again leads to scarcity of supplies?

Poetting: That is not yet entirely clear and depends on the regulatory authorities. It is quite possible you would only need to do a small clinical trial to prove safety. But it could also be that, as with flu shots, the vaccine can be adapted without trials.

https://www.spiegel.de/international/world/biontech-executive-on-new-vaccine-plant-it-will-take-a-few-months-before-we-reach-full-capacity-a-359055d1-5102-4d41-8f2e-75f676537018