Hospitals May Consider Relaxing No-Visitor Policies During Pandemic

 As the COVID-19 pandemic continues, hospitals should consider whether their visitor policies are too restrictive and potentially adopt more nuanced policies that account for community transmission of the virus, careful use of personal protective equipment and vaccine status, according to a group of doctors in Canada.

Many hospitalized patients lacked support this year and struggled emotionally, particularly in intensive-care units, the group writes in the Canadian Medical Association Journal.

"Despite how busy our ICUs were during the first wave of the pandemic, the absence of family presence was palpable," said lead author Dr. Laveena Munshi of Mount Sinai Hospital in Toronto.

"Families and designated care partners are essential members of patient-centered care in the ICU and their role extends beyond comfort," she told Reuters Health by email. "They are patient advocates, they help minimize the impact of delirium, they listen in on our daily ICU rounds and add their insight, and they are substitute decision makers during times when we cannot communicate with patients."

Dr. Munshi and colleagues discuss the research behind hospital visitor policies, ways to bring family members to the bedside safely and how to communicate with family members if they can't visit. During the first wave of the pandemic, they found, hospitals across Canada adopted "no visitor" policies that barred nearly all visitors in an effort to prevent the spread of COVID-19 and reserve personal protective gear for healthcare providers.

As scientists and public-health researchers have learned more about COVID-19, though, more flexible policies may be useful, the authors suggest. Previous studies of visitor policies for the flu and other respiratory diseases found that the benefits of allowing visitors outweigh the harms, especially when visitors wear masks.

Studies have shown that family members and caregivers provide emotional support, help with language barriers, play a role in end-of-life decisions and assist with daily activities such as feeding and mobility.

Hospitals could adapt their policies to distinguish between general visitors and immediate family members or designated caregivers, the authors write, and allow certain visitors in ICUs, hospices, surgical recovery wards and labor and delivery units. Face masks, rigorous cleaning procedures and visitor screening with rapid COVID-19 tests could help as well.

Hospitals should also consider the best ways to communicate with family members and caregivers as the pandemic continues, the authors write. In areas with a high rate of COVID-19 transmission or in instances where visitors aren't allowed, healthcare workers could use video conferencing tools to allow patients to connect with others. When feasible, some hospitals may be able to coordinate visits in outdoor spaces.

"Open communication is foundational to establishing a therapeutic relationship between healthcare providers and the patients and families they serve," said Dr. Joanne Gould Kuntz of the Emory University Hospital in Atlanta, Georgia. Dr. Kuntz, who wasn't involved with the new paper, has researched virtual family meetings for palliative care during the pandemic.

"While video virtual visits do help . . . there is no equal substitute for in-person visitors that can replicate the safety, support and communication that occurs when key family members are able to be present at the bedside," she told Reuters Health by email.

As the pandemic continues in the months ahead, hospitals need a tailored approach based on local and regional infections and should potentially consider visitors' COVID-19 vaccine status, the authors write.

"I am hopeful that widespread vaccination in the coming months will not only reduce the overall infection rates of COVID-19 but also facilitate a return to more normal hospital policies," said Dr. Jordan Cloyd of the Ohio State University Wexner Medical Center in Columbus, who has researched COVID-19 visitor policies and the effect on surgery patients.

"As we embrace another surge of COVID-19 and are set to begin the second year of this pandemic, it is important to modify our policies to reflect what we have learned over the past year in order to optimally balance the benefits and risks to patients, staff and our communities," Dr. Cloyd, who also was not involved with the new report, told Reuters Health by email.

https://www.medscape.com/viewarticle/943208

Medicaid to Cover Routine Costs for Patients in Trials

 Congress has ordered the holdouts among US states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower income.

A massive wrap-up spending/COVID relief bill that was signed into law December 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.

Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, said ASCO in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.

"We believe that the trials can bring extra benefits to patients," said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston, Massachusetts. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.

Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Bertagnolli, who is the chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.

"Many of them just say, 'I can't take that financial risk, so I'll just stay with standard of care,' " Bertagnolli told Medscape Medical News.

Equity Issues

Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act (ACA) of 2010.

To date, 38 of 50 US states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation's working poor access to healthcare, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.

Medicaid is the nation's dominant health insurer. Enrollment has been around 70 million in recent months.

That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There's some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.

Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO's Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on February 15, 2020.

"Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research," the groups wrote. "Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country."

The ACA's Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.

Black and Hispanic adults are almost twice as likely as White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.

The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.

There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people's access to cancer screening or care.

The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities (CBPP). The efforts were blocked by courts.

Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don't work as intended, according to the CBPP report.

"In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape," wrote CBPP analysts Jennifer Wagner and Jessica Schubel in their report.

In 2019, The New England Journal of Medicine (NEJM) published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their healthcare coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, Massachusetts, and colleagues wrote in their article.

For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas' Medicaid work policy already met its requirements or should have been exempt, they wrote.

Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.

Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.

People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don't need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.

"We have to take care of people who are sick. That's just the way it is," Bertagnolli said.

https://www.medscape.com/viewarticle/943381

Los Angeles Vaccine Recipients Can Add Proof to Their Smartphones

 Los Angeles County residents who receive a COVID-19 vaccine will be offered a digital record that they can add to their Apple Wallet or a Google app, according to Bloomberg News.

The initial goal is to make sure people receive the second dose of their two-shot regimen of either the Pfizer-BioNTech or Moderna vaccine. The program, which starts this week through a partnership with the Los Angeles-based startup Healthvana, includes follow-up notifications to remind people about a second appointment.

The digital record could also serve as a way for people to verify that they've been vaccinated, which may be helpful for flights, events and schools, Ramin Bastani, the CEO of Healthvana, told Bloomberg. The company has delivered test results to patients for HIV and sexually transmitted infections for several years and began working with L.A. County officials earlier this year to provide COVID-19 test results.

Vaccine recipients will also receive a paper card that tracks which vaccine they received and when, but public health officials worry that the cards could be lost or forgotten.

"We're really concerned. We really want people to come back for that second dose," Claire Jarashow, director of vaccine preventable disease control at the county's Department of Public Health, told the news outlet.

"We just don't have the capacity to be doing hundreds of medical record requests to find people's first doses and when they need to get their second," she said.

Healthvana is also talking to concert venues, employers, universities and schools about using the platform. Ultimately, numerous companies across the country will likely play a role in providing digital records to vaccine recipients, Bastani told Bloomberg.

"It's not going to be like one credit card you can use across the U.S.," he said. "Sometimes you can pay cash, sometimes you can use your Apple Wallet."

https://www.medscape.com/viewarticle/943306

Bristol-Myers says CVR Agreement is terminated

 

• With no FDA decision on liso-cel before December 31, Bristol Myers Squibb (NYSE:BMY) says, the Contingent Value Rights Agreement that followed its acquisition of Celgene, automatically terminated.
• The Biologics License Application for isocabtagene maraleucel (liso-cel) in adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies remains under the FDA review with no new action date. As a result, one of the three required milestones for payment was not met, and, therefore, CVRs would no longer trade on the NYSE from January 01, the company said in a statement.
• According to Bloomberg, nearly 715 million Contingent Value Rights (NYSE:BMY.RT) were outstanding, with a potential all-or-nothing payout of $6.4 billion in total, or $9 a share, if three drug candidates from Celgene won regulatory approval before key deadlines.
• https://seekingalpha.com/news/3648168-bristol-myers-says-cvr-agreement-is-terminated

AstraZeneca COVID vaccine set to become first one approved in India

 India’s drug regulator is set to approve on Friday a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, three sources with knowledge of the matter said.

The decision would pave the way for the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of COVID-19 infections in the world.

Britain and Argentina have already authorised the vaccine for urgent public use.

India’s Central Drugs Standard Control Organization (CDSCO), whose experts were meeting for the second time this week, could also approve a vaccine locally developed by Bharat Biotech, two of the sources said on condition of anonymity.

“Both AstraZeneca and Bharat Biotech will get approval today,” said one of the sources. “All preparations are on with today’s date in mind.”

The other sources were less certain about Bharat Biotech’s prospects.

“We are hopeful,” another source said about the vaccine developed with the government-run Indian Council of Medical Research.

A CDSCO representative declined to comment. The group is meeting a day ahead of a nationwide trial run here for vaccine delivery in the country with more than 10 million coronavirus infections.

More than 50 million doses of the AstraZeneca vaccine have already been stockpiled by its local manufacturer, Serum Institute of India (SII), and one of the sources said the shots could start to be transported from cold storage to Indian states as early as Saturday.

SII said in an email it would “wait for the final approval to come” before commenting.

India’s government said on Wednesday that Pfizer Inc had sought more time to present data for emergency authorisation of a vaccine it has developed with Germany’s BioNTech.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine/astrazeneca-covid-vaccine-set-to-become-first-one-approved-in-india-sources-idUSKBN296292

Wisconsin pharmacist arrested on charges of sabotaging COVID vaccine doses

 A Wisconsin hospital pharmacist was arrested on Thursday on suspicion of sabotaging more than 500 doses of coronavirus vaccine by deliberately removing them from refrigeration to spoil, police and medical authorities said.

The pharmacist, an employee of Aurora Medical Center in Grafton, Wisconsin, at the time that 57 vials of vaccine were found left out of cold storage earlier this week, has since been fired but has not been publicly identified, officials said.

Each vial contains 10 doses. Nearly 60 of the doses in question were administered before hospital officials determined the medication had been left unrefrigerated long enough to render the vaccine ineffective. The remaining 500-plus doses were then discarded.

Moderna Inc, maker of the vaccine, has assured the hospital that receiving an injection of any of the doses removed from refrigeration poses no safety issue, other than leaving the recipient unprotected from COVID infection, said Dr. Jeff Bahr, Aurora Health Care Medical Group president.

Neither Aurora Health nor law enforcement offered any possible motive for the sabotage.

Those who received the ineffective doses have been notified and will need to be re-vaccinated. The episode means that immunization will be delayed for 570 people who should by now have received their first shot of the two-dose vaccine.

Speaking to an online press briefing on Thursday, Bahr said there was no evidence the pharmacist tampered with the vaccines in any way besides removing them from refrigeration, or that any other doses were disturbed.

Grafton police said in a statement that the pharmacist “knew the spoiled vaccinations would be useless and that people who received the vaccinations would think they had been vaccinated against the virus when in fact they were not.”

The incident comes amid public opinion surveys showing widespread skepticism about the safety of the COVID-19 vaccines, which were granted emergency-use authorization by federal regulators just 11 months after the virus emerged in the United States.

Reluctance to take the vaccine has even been expressed by some healthcare workers who are among those designated as first in line to receive them.

When initially questioned after the misplaced vials were discovered on Dec. 26, the pharmacist said it was an inadvertent error, but during further review of the matter admitted on Wednesday to intentionally removing the vaccine from refrigeration, hospital officials said.

The individual, a resident of Grafton in the Milwaukee suburbs, was arrested on Thursday and booked into the Ozaukee County jail on felony charges of recklessly endangering safety, adulterating a prescription drug and criminal damage to property, police said.

https://www.reuters.com/article/us-health-coronavirus-usa-pharmacist/wisconsin-pharmacist-arrested-on-charges-of-sabotaging-covid-vaccine-doses-idUSKBN2961YF

BioNTech founders warn of vaccine supply gaps

 BioNTech is working flat out with partner Pfizer to boost production of their COVID-19 vaccine, its founders said, warning there would be gaps in supply until other vaccines were rolled out.

The German biotech startup has led the vaccine race but its shot has been slow to arrive in the European Union due to relatively slow approval from the bloc’s health regulator and the small size of the order placed by Brussels.

The delays have caused consternation in Germany, where some regions had to temporarily close vaccination centres days after the launch of an inoculation drive on Dec. 27.

“At the moment it doesn’t look good - a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,” BioNTech CEO Ugur Sahin told news weekly Spiegel in an interview.

A shot from Moderna is expected to be cleared by the European Medicines Agency (EMA) on Jan. 6.

German Health Minister Jens Spahn has urged the EMA to also quickly approve a vaccine developed by Oxford University and AstraZeneca that Britain cleared this week. The EU timeline for that treatment remains uncertain.

Sahin said the BioNTech/Pfizer vaccine, which uses messenger RNA to instruct the human immune system to fight the coronavirus, should be able to cope with a variant first detected in Britain that appears to be more contagious.

“We are testing whether our vaccine can also neutralise this variant, and will soon know more,” he said.

Asked about coping with a strong mutation, he said it would be possible to tweak the vaccine as required within six weeks - though such new treatments might require additional regulatory approvals.

NEW PRODUCTION LINE PLANNED

Sahin founded BioNTech with his wife, Oezlem Tuereci, who is the company’s chief medical officer. Both faulted the EU’s decision to spread orders in the expectation that more vaccines would be quickly approved.

The United States ordered 600 million doses of the BioNTech/Pfizer vaccine in July, while the EU waited until November to place an order of half that size.

“At some point it became clear that it would not be possible to deliver so quickly,” Tuereci told Spiegel. “By then it was already too late to place follow-on orders.”

BioNTech hopes to launch a new production line in Marburg, Germany, in February that could produce 250 million doses in the first half of the year, said Sahin.

Talks are under way with contract manufacturers on boosting output and there should be greater clarity by the end of January, he added.

Sahin also said BioNTech would make its vaccine, which requires storage at around minus 70 Celsius (minus 94 Fahrenheit), easier to handle. A next-generation vaccine that would keep at higher temperatures could be ready by late summer.

https://www.reuters.com/article/us-health-coronavirus-vaccines-biontech/biontech-founders-warn-of-vaccine-supply-gaps-spiegel-idUSKBN296283