Sanjay Pattani, MD
Associate Chief Medical Officer
AdventHealth Orlando

Just as Florida came off its second COVID-19 surge this past spring and mass vaccination efforts were in full swing, the Delta variant began ravaging India. The headlines of death and despair dominated the news, and the impact on one of the most populous countries in the world was devastating. At its peak in early May, India experienced one of the largest COVID-19 surges the world had seen, with more than 400,000 new infections and 4,000 deaths reported each day.

These were more than headlines to me. They hit close to my home and heart. My parents are first-generation immigrants from India, and I continue to have deep roots in the country. Many of my relatives are still there, including two of my cousins who are primary care physicians. I also have numerous physician colleagues I have met and stayed connected with over the years who live and work in India.

As this new stage of the pandemic progressed, I kept hearing more and more first-hand accounts from my family and friends about the tragedies they were seeing and experiencing each day. My wife’s best friend’s grandmother died without family being able to conduct the usual and customary Hindu ceremony and cremation. Listening to all of their fear and suffering broke my heart and propelled me to find a way to do something to help.

The Challenge

From a medical standpoint, India was experiencing some of the same issues we had in the U.S. during our first two COVID-19 surges but with a significantly different and hugely underfunded healthcare infrastructure. The country has almost no emergency medical services (EMS) system — just getting patients to the hospital is a huge barrier to accessing care. Compounding the challenge, severe staff and supply shortages plagued India’s hospitals before the Delta variant hit. As the virus surged, the healthcare system rapidly became overrun. Two of the greatest challenges that emerged were capacity and lack of oxygen. Quite literally, millions of sick people were starving for air.

I am a physician, trained in emergency medicine, serving as associate chief medical officer for AdventHealth Orlando, a quaternary hospital in the U.S. As an American doctor, I have access to the very best medical resources and the ability to provide the highest level of patient care. In medical training, we are taught to be proactive, to do no harm and to never give up. I also have an innate humanitarian desire to help others. That is what drew me to a career in medicine in the first place. As the Delta variant was consuming my family’s homeland, I knew I had skills, knowledge, financial resources and the desire to help, but how could I from such a distance? It was an overwhelming and paralyzing feeling.

Developing a Plan to Provide Relief

Despite the initial despair, I knew I wasn’t alone in my quest to do something to help. When the warning signals began ringing in India early last spring, my AdventHealth colleagues in Central Florida began discussing how we could apply the basic principles we knew as physicians to deliver some sort of relief in a compassionate way. However, with each idea we generated, we encountered obstacles, including travel restrictions, supply chain issues, limited manpower and government regulations. Finding the right contacts and resources would be essential to launching a successful disaster relief effort.

At AdventHealth, I am blessed to work for a faith-based organization whose breadth and depth extends into various programs such as AdventHealth Global Missions . They already had relationships with a number of hospitals in India and helped us to establish direct communication with these health care providers to learn how we could best support their most urgent needs.

One of the most heartbreaking things we learned during these initial outreach and conversations was that at some hospitals, despite the tremendous influx of COVID-19 patients, some ventilators were sitting unused simply because of a lack of available oxygen.

With input from our colleagues on the frontlines in India, we decided to focus our combined relief efforts on two critical areas of need: 1) Supplies and equipment, including personal protective equipment (PPE) and ventilators and 2) addressing the oxygen shortage.

Working through AdventHealth Global Missions, we were able to secure and ship five pallets of surgical masks, respiratory circuits and ventilators to Southern India in June. They were also able to connect us with the Adventist Development and Relief Agency (ADRA), a humanitarian organization based in Maryland and operated by the Seventh-day Adventist Church.

Working with ADRA, we set a goal to help them raise enough funds to provide eight hospitals in India with medical oxygen-generating plants. These plants not only met the immediate need, but also ensured the hospitals could meet their long-term oxygen needs as well. The first oxygen-generating plant was quickly established at a hospital in the western Indian city of Surat over the summer, and three more plants are currently in progress.

Maintaining Global Health Connections to Extend Compassionate Care

While the COVID-19 pandemic has touched us all in different ways, its effects were felt across the globe, demonstrating just how connected we truly are. The immediate, crushing crisis may have waned, but no doubt our world will continue to experience viral surges and other health challenges. In the years to come, how can we sustain our cooperative efforts and become more proactive and prepared to respond?

As physicians, we are called to communicate and collaborate for the greater good, for the health of people across our planet. It is the oath we take when we put on the white coat and the core of our basic humanity. We can’t afford to stand on the sidelines and watch medical crises occur even if they are an ocean away. We must harness the power and innovation of the virtual world to bridge our geographic divides so that we can connect, organize and work together on plans and processes to address our most pressing needs and better prepare for those yet to come. We must forge new international forums to discuss best practices and develop new ideas. And most importantly, we must continue to share our strengths — our medical expertise, financial resources, leadership skills and intellectual capital — to help each other and find new solutions to our greatest healthcare challenges. Embracing our strength and the common good, our medical communities will continue to advocate for humanity.

November 5, 2021 
 
Expanding Populations Eligible to Receive the Pfizer-BioNTech COVID-19 Vaccine to Include Persons 5 Years Through 11 Years of Age

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On October 29, 2021, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include children 5 years through 11 years of age. 
 
For more information regarding the latest guidelines, please use the links below:

• FDA News Release
• Fact Sheet for Health Care Providers Administering Vaccine
• Fact Sheet for Recipients and Caregivers 

Florida COVID-19 Vaccine Ordering and Distribution Information
 
Health care providers may now place orders for Pfizer-BioNTech pediatric COVID-19 vaccines in Florida SHOTS. All enrolled COVID-19 vaccine providers who wish to order Pfizer-BioNTech pediatric COVID-19 vaccine may order in 300 dose increments; however, on November 9, 2021 pediatric COVID-19 vaccine may be ordered in 100 dose increments. According to the Centers for Disease Control and Prevention (CDC), doses ordered on or before November 9, 2021 are expected to arrive by November 12, 2021.

The Florida Department of Health’s Immunization Section placed pre-book orders for eleven county health departments (CHDs) to serve as regional hubs for vaccine storage and distribution. These CHDs were selected based on location, population size, storage capacity and capability to transfer vaccine to other health care providers. According to the CDC, vaccine shipments are expected to arrive between November 6-12, 2021.
  
Vaccine Adverse Event Reporting System (VAERS) Reporting
 
Health care providers should report the following adverse events to VAERS:
Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event,
Vaccine administration errors,
Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention.
 
Health care providers are required to report the following adverse events to VAERS:
Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations,
An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.
 
Online reporting is strongly encouraged. Please report clinically important adverse events that occur after vaccination of children and adults, even if you are not sure whether the vaccine caused the adverse event. To make a report, please visit: https://vaers.hhs.gov/reportevent.html and notify the state health department of any severe reactions reported.  
 
 
Pre-book Ordering
 
Should you choose to obtain vaccines from the pre-book order from the CHDs, please use the following contact information:
 
Alachua County Health Department: Vicki Ennis, 352-334-8811
Broward County Health Department: Barbara Bateman, 954-847-8007
Clay County Health Department: Robin Thomas, 904-838-5424
Duval County Health Department: Tawanda Washington, 904-253-1055
Escambia County Health Department: Beate Bolton, 850-595-6500 Ext., 1200
Hillsborough County Health Department: Jylmarie Lewis, 813-559-4649
Indian River County Health Department: Maryjo Sullivan, 772-794-7478
Lee County Health Department: Marie George, 239-332-9505
Leon County Health Department: Eugene Buerkle, 850-404-6270
Marion County Health Department: Michael Smith, 352-644-2660
Miami-Dade County Health Department: Jean Toussaint, 305-575-3831
Okaloosa County Health Department: Suzanne Clemons, 850-344-0606
Orange County Health Department: Gissella Suarez, 407-723-4081 or 407-340-1910
Palm Beach County Health Department: Dana Marie Heinlein, 561-671-4052
Pinellas County Health Department: Norma Osgood, 727-820-4105
Polk County Health Department: Tammy Durden, 863-578-2113
Sarasota County Health Department: Donna Keith, 941-861-2914
St. Lucie County Health Department: Daniel Buchin, 772-873-4885
Volusia County Health Department: Patricia Boswell, 386-274-0799

Source: Florida Board of Medicine

On Monday, September 13, 2021, the U.S. Department of Health and Human Services (HHS) transitioned from a direct ordering process to a state/territory-coordinated distribution system similar to that used for the distribution of monoclonal antibodies (mAbs) from November 2020 to February 2021.

HHS will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization. State and territorial health departments will subsequently identify which sites in their respective jurisdictions receive product as well as the amount each site receives.

As of Monday, September 13, 2021:

• Administration sites no longer order directly from AmerisourceBergen (ABC).
• Weekly distribution amounts for each state/territory will be determined by HHS based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and use submitted to the federal government.
• State/Territorial Health Departments will determine where product goes in their jurisdictions.

For more information regarding the distribution of monoclonal antibody therapeutics, please visit the HHS website.

Florida's monoclonal antibody distribution process is as follows:

All pending orders have been cancelled and the new process will be used for any new orders. For existing sites, please use the below link to make a request each week by 5:00 p.m. on Tuesdays. Note that ABC stated it may take up to two days before all orders are shipped. Delivery time is usually two days after shipping, but you can track your order with the information below. Your request will reflect the inventory needed to administer doses for one week.

You will need to continue reporting your inventory into HHS Protect each Wednesday as well.

The State has been given a weekly allocation which may adjust depending on the usage and inventory you report into HHS Protect. Since we are on allocation, your order may be adjusted.

Order link for existing sites currently receiving product - https://fdoh.readyop.com/fs/4cNI/577f

For new sites that have never received mAbs for outpatient use, use the below link to start registration with ABC. Someone from the covid.therapeutics@flhealth.gov mailbox will follow up with you: https://fdoh.readyop.com/fs/4cNG/08dd

Please see further updates from ABC below.

HHS-Protect account information

For all questions about an HHS-Protect account, reach out directly to HHS.

If you do not have an account, you can register for one by visiting https://teletracking.protect.hhs.gov. Keep your ABC account number handy. If you are unsure if you have an HHS-Protect account please contact TeleTracking's Technical Support at hhs-protect@teletracking.com for assistance. If you already have an HHS-Protect account please continue to submit your weekly reporting every Wednesday as this information helps inform allocations.

Florida's monoclonal antibody distribution process is as follows:

If your state Department of Health allocates to your site, you will receive an email notification from ABC that advises of your allocation quantity and shipping status.

1. If you have ABC Order access (our online ordering system), you will be able to view tracking under your order history. For access to ABC Order please contact customersystemssupport@amerisourcebergen.com.
2. You can also use this tracking tool to locate your allocation.

Sotrovimab

Sotrovimab is an additional mAb authorized for use under an Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Sotrovimab is not offered through the federal allocation process at this time and is only available through ABC during the EUA period approved by the FDA. Sotrovimab is approved for infusion in appropriate patients as defined in the Sotrovimab Fact Sheet for Healthcare Providers.

Glaxosmithkline (GSK), with guidance from the National Infusion Center Association, has developed an in-depth resource entitled Detailed Guide for the Use of Sotrovimab.

Ordering from ABC

Sotrovimab is available for customers to purchase directly with ABC as the sole Specialty Distributor during the Emergency Use Authorization period. Customers can purchase directly by:

Placing purchase order through the customer ordering portal at abcorder.amerisourcebergen.com, calling ABC Customer Service at 1-800-746-6273 Monday through Thursday 7:00 AM to 6:30 PM, and Friday 7:00 AM to 6:00 PM CT or placing the purchase order through any of the ABC ordering platforms. Customers may search by product name, material item number, or NDC. For new customers, please call ABC Customer Service or email c19therapies@amerisourcebergen.com

Please allow 1 to 2 days for product arrival following order placement. For new customers, please allow up to 2 days for the initial order following receipt of the required customer documentation. For any additional information regarding orders, product availability, or access/log-in information, please email c19therapies@amerisourcebergen.com or contact ABC’s Customer Service Department.

Sites will be required to:

• Provide ABC with a Board of Pharmacy license or physician letter of authorization if not already on file
• Attest to their designated class of trade and that they will administer Sotrovimab according to terms of the FDA-issued EUA

Additional information

• Product availability may be subject to established criteria for minimum and maximum amounts based on previous orders and utilization history
• GSK and ABC will ensure that the authorized labeling (e.g., Fact Sheets) will accompany the authorized Sotrovimab. Please see most current Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers
• GSK and ABC will ensure that appropriate storage and cold chain is maintained until the product is delivered to healthcare facilities and/or healthcare providers

Source: Washington Post (Log in required)

By: Carolyn Y. Johnson, Laurie McGinley, and Joel Achenbach

September 17, 2021 at 7:00 p.m. EDT

Expert advisers to the Food and Drug Administration voted unanimously Friday to recommend that the agency authorize a booster shot of the Pfizer-BioNTech coronavirus vaccine six months after vaccination for people 65 years and older and for anyone at risk for severe illness.

The vote is not binding, and Peter Marks, the FDA official overseeing coronavirus vaccines, indicated that the final decision could be slightly different, encompassing people who are at higher risk of infection because of their professions, such as health-care workers and front-line employees, including teachers. The advisory committee members were polled on whether they would agree with making boosters available to people who were at risk of infection because of workplace exposure, and they all said yes.

A decision about boosters from the FDA is expected by next week, and a Centers for Disease Control and Prevention advisory committee is slated to meet Wednesday and Thursday to recommend how a third shot should be used. The FDA advisory committee, following Pfizer’s lead, recommended that the third shot be given at least six months after the second.

Friday’s protracted online meeting, the most important FDA advisory committee meeting since the vaccines were first authorized, gave the Biden administration and Pfizer some, but not all, of what they wanted. Boosters will be on the way into many millions of arms — with the exact number depending on how the FDA and the CDC decide who meets the criteria for being at high risk of serious illness.

The consideration of booster shots comes as the United States endures a fourth wave of covid-19 infections, with hospitals in some corners of the nation confronting the long-feared prospect of rationing care and having to decide which patients receive access to treatments and medical equipment. And the debate has sparked criticism from some officials in the global health community who argue that the U.S. discussion of boosters betrays selfishness, as many in the world do not have access to a first dose of vaccine.

The recommendation to target shots primarily to older adults is far narrower than what the companies and top officials in the Biden administration had sought: a blanket approval to boost anyone 16 and older. The panel voted resoundingly against a broadly available booster. Many committee members said they felt uncomfortable about whether the benefits outweighed the risks to younger adults, citing the lack of robust safety data.

The meeting then took an unusual turn. The voting question was reformulated, to ask if members of the committee thought a booster would be safe and effective for a narrower slice of the population. The panel voted unanimously yes.

FDA panel endorses coronavirus vaccine boosters only for older adults and those at high risk

Expert advisers to the Food and Drug Administration on Sept. 17 recommended a coronavirus vaccine booster to people 65 and older and those at high risk. (The Washington Post)

The vote and the variety of views on display during hours of debate Friday, even among experts, could complicate the Biden administration’s effort to extend boosters to all adults beginning next week — and exacerbate public confusion.

“Today was an important step forward in providing better protection to Americans from COVID-19,” White House spokesman Kevin Munoz said in a statement. “We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week.”

The committee’s deliberations did not address many of the questions circulating among the public, including the roughly 81 million people who have received shots made by Moderna and Johnson & Johnson and whose eligibility for a booster may not be decided for weeks.

The all-day meeting revealed an array of opinions among America’s top medical experts on whether boosters are necessary and, if so, when and for whom.

“It would be great to wait until we have all the data about safety,” said Jay M. Portnoy, a professor of pediatrics who works at Children’s Mercy Hospital in Kansas City, Mo. “I’d rather not get the covid disease. I’d rather get the third dose of the vaccine.”

After Pfizer’s initial request for a booster broadly available to the general population was voted down, the panelists had a freewheeling discussion about what the age limit should be for getting an additional shot.

Paul A. Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he favored boosters for people age 65 and up, after which Eric J. Rubin, editor in chief of the New England Journal of Medicine, said, “I’m 63, so I like the 60 age instead of the 65 age.” Portnoy said he planned to get his dose next week — and then said he would get one the very next day.

Those divisions extended even within the FDA.

“We know that there may be differing opinions about the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex and evolving,” Marks said at the introduction of the meeting.

Marks, in addressing the panel, showed his hand about his views without explicitly spelling them out. He noted that many vaccines require additional doses six months down the line, so it “should not be a surprise” if the coronavirus vaccines need another dose as well.

He also said many other vaccines are used not just to prevent severe illness and hospitalizations but also mild cases. And he mentioned the importance of preventing the spread of the virus to vulnerable populations such as younger children, for whom a vaccine has not been approved.

Two career FDA scientists who co-authored a highly unusual paper in the medical journal Lancet this month, arguing that boosters were not needed in the general population, also asked questions that betrayed their inclinations. Both have announced that they will soon step down from the agency.

Phil Krause, one of those FDA officials, asked a pointed question about some of the data Pfizer is using to support the case for boosters.

“Part of this, of course, is the difficulty of looking at this kind of data, without having the chance for FDA to review it or allowing for this kind of data to go through the peer-review process,” Krause said, adding that Pfizer was a co-sponsor of the study.

Marion Gruber, the other FDA official, raised the issue of safety earlier in the meeting, pointing out that the risk of heart inflammation after vaccination, though rare, is highest among younger males, who may have different risks and benefits from the vaccine than do older adults.

Some Americans have already found unofficial ways to get additional vaccine doses, and that number is only expected to increase, experts said. A third dose is already recommended for people with compromised immune systems.

Advisory panel members heard presentations from the FDA, the CDC and Pfizer. The data was often conflicting.

CDC scientist Sara Oliver presented data showing that while protection against milder infections has waned over time, protection against severe disease remains robust, even among older adults. She showed unpublished data that found that through July, adults 75 and older were 88 percent protected against hospitalization.

But scientists from Israel showed that in their highly vaccinated population, protective immunity from vaccination had clearly waned as the country confronted the delta surge this summer. That resulted in a huge uptick in infections, they found — and in severe cases, even among people who were fully vaccinated.

The government there decided to implement a booster campaign at the end of July, beginning with people older than 60, and presented data suggesting that it may have helped save hospitals from being overwhelmed.

Cases “were doubling every 10 days, and we got to places with thousands of cases, doubling every 10 days. It was scary,” said Sharon Alroy-Preis, director of public health services for Israel’s Ministry of Health. “If we had not started boosters at the end of July, we would have come to the capacity of Israeli hospitalization capabilities — and gone beyond it.”

One of the studies from Israel, published Wednesday in the New England Journal of Medicine, showed that people 60 and older who were given a booster shot had an 11-fold lower risk of contracting an infection than people who did not receive the additional shot. Research data from Israel’s Ministry of Health, posted online Wednesday by the FDA in advance of its presentation at Friday’s advisory committee meeting, also showed that the booster campaign dramatically lowered the rate of severe cases among people 60 and older.

Pfizer officials have depended heavily on the data from Israel in making their case that boosters are necessary.

“The Israeli experience could portend the U.S. covid-19 future — and soon,” said William C. Gruber, senior vice president of vaccine clinical research and development at Pfizer.

The booster issue has been swamped with scientific and political controversies in recent weeks. Senior Biden administration officials, worried about data showing a waning of vaccine efficacy, announced in mid-August that boosters would be available the week of Sept. 20, pending FDA and CDC sign-offs.

Many scientists were outraged by the decision to make a political announcement ahead of the scientific confirmation that boosters were safe, effective and necessary. Those scientific agencies subsequently told the White House that only the Pfizer-BioNTech product, whose data was the first to be filed at the agency, could be cleared by then.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, has spoken forcefully in favor of boosters. In an interview Thursday with The Washington Post, he said the Israeli data suggests that a third shot might prevent viral transmission — something that could help curb the pandemic.

Fauci said some scientists seem to believe “it is okay” for vaccinated people to get infected as long as they experience only mild or moderate symptoms and don’t end up in the hospital. But, he said, “as a clinical person who sees a lot of patients, that isn’t okay,” adding that even mild infections can result in missed work, disruptions of family life and potential cases of long covid, with its debilitating effects.

Yasmeen Abutaleb and Lena H. Sun contributed to this report.

The Department of Labor’s Occupational Safety and Health Administration (OSHA) is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work. OSHA will issue an Emergency Temporary Standard (ETS) to implement this requirement. This requirement will impact over 80 million workers in private sector businesses with 100+ employees.

Requiring Employers to Provide Paid Time Off to Get Vaccinated

To continue efforts to ensure that no worker loses a dollar of pay because they get vaccinated, OSHA is developing a rule that will require employers with more than 100 employees to provide paid time off for the time it takes for workers to get vaccinated or to recover if they are under the weather post-vaccination. This requirement will be implemented through the ETS.

Requiring COVID-⁠19 Vaccinations for Over 17 Million Health Care Workers at Medicare and Medicaid Participating Hospitals and Other Health Care Settings

The Centers for Medicare & Medicaid Services (CMS) is taking action to require COVID-19 vaccinations for workers in most health care settings that receive Medicare or Medicaid reimbursement, including but not limited to hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies. This action builds on the vaccination requirement for nursing facilities recently announced by CMS, and will apply to nursing home staff as well as staff in hospitals and other CMS-regulated settings, including clinical staff, individuals providing services under arrangements, volunteers, and staff who are not involved in direct patient, resident, or client care. These requirements will apply to approximately 50,000 providers and cover a majority of health care workers across the country. Some facilities and states have begun to adopt hospital staff or health care sector vaccination mandates. This action will create a consistent standard across the country, while giving patients assurance of the vaccination status of those delivering care.

https://www.whitehouse.gov/covidplan/

 TALLAHASSEE, FL – Florida’s two largest health organizations, the Florida Hospital Association and the Florida Medical Association released a new series of public service announcements today promoting COVID-19 vaccines in English and Spanish. Partnering with the Florida Association of Broadcasters and hundreds of radio and television stations in every market in the state, these ads will run through the end of November. The broadcast spots will be supported by statewide digital advertising.

“The overwhelming majority of the people currently hospitalized with COVID-19 in Florida are unvaccinated,” said Mary C. Mayhew, President and CEO of the Florida Hospital Association. “The delta variant is ravaging younger and unvaccinated people. If you don’t think this could happen to you, listen to one of our nurses sadly recall the passing of a young woman in her 30s who left behind a husband and three young children.”

“Young people may think they are invincible, but there are many after-effects of getting COVID-19 that physicians are seeing having an impact on their younger, unvaccinated patients,” said Doug Murphy Jr., MD, President of the Florida Medical Association. “Long-term health concerns shouldn’t be a lifetime sentence for those who took a chance in not getting the vaccine. Don’t take that chance. Get vaccinated.”

60-second TV Public Service Announcement / English – “Mommy”

Juana Diaz, RN – COVID-19 ICU: “We're still in the same circumstances that we were when there wasn't a vaccine. Where you're watching people just pass away. You know, and just -- it's so devastating to watch unfold. We had someone in her 30s, a young mommy. She left her husband and three little kids, ages four, two, eight. They're saying, ‘Mommy, come home. Mommy, I miss you.’ She's not saying anything because she's intubated. It's rough. It's rough to watch every day. It's very rough.”

Watch Here

30-second TV Public Service Announcement / Spanish – “Normal”

Dr. Madelyn Espinosa Butler – OB/GYN: “Las infecciones de COVID han aumentado porque la nueva variación se transmite más fácilmente. La única forma que vamos a poder tener nuestra vida normal otra vez es que todo el mundo se vacune contra el COVID-19. Para poder volver a nuestros trabajos, a nuestras familias y todas las cosas que nosotros hacíamos normalmente antes de la pandemia. Para poder volver a la normalidad.”

Watch Here

30-second Radio Public Service Announcement / English – “After Effects”

Dr. Sanjay Pattani – Emergency Medicine Physician: “My name is Sanjay Pattani, and I'm an emergency medicine physician. It's the after effects of getting COVID that the young population should be concerned about. There's chronic fatigue syndrome, blood clotting disorders, heart problems. There are long chronic lung problems. The essence of this vaccine is not to prevent you from getting coronavirus. It is from preventing you from getting seriously ill and potentially dying.”

Listen Here

Additional PSAs will be released for broadcast and on social media in the future. The PSAs were filmed with Florida physicians and nurses in an unscripted setting.

###

About the Florida Hospital Association

Founded in 1927, the Florida Hospital Association is the leading voice for health care in the State of Florida. Through representation and advocacy, education and informational services, the Florida Hospital Association supports the mission of more than 200 hospitals and health care systems to provide the highest quality of care to the patients we serve. Led by President and CEO Mary Mayhew, the Florida Hospital Association has offices in Tallahassee and Orlando and is governed by a Board of Trustees and officers elected by the member institutions. For more information, visit www.fha.org.

In this declaration the Governor authorized each state agency to suspend the provisions of regulatory statutes, orders or rules of that agency if strict compliance would hinder or delay necessary action in coping with the emergency.

Many of these rules directly affected the practice of medicine.

Click here to read a full explanation from FMA General Counsel, Jeff Scott of the provisions and important changes resulting from the expiration of the order.

https://medone.informz.net/medone/data/images/ExecutiveOrder-ends.pdf

Source: Florida Medical Association (FMA)

Alaska is the sole state where average rural rates of fully vaccinated people have grown faster than urban rates since April 19, when every state opened shots to anybody 16 and older, according to NPR's latest analysis of county-level vaccination data from the Centers for Disease Control and Prevention.

Everywhere else, rates in urban counties have outpaced those in rural counties.

Over a dozen states where rural rates were actually beating urban ones seven weeks ago have flipped, so they now trail their urban counterparts. Those include Oregon where rural places now trail urban by 9 percentage points and Maine where they're now behind by 7 points.

Florida, Massachusetts and Nebraska have the largest disparity, with rural counties lagging by 14 percentage points. For Florida and Nebraska those gaps are about double what they were in mid-April.

Though stark, these gaps may hide a more complex story of vaccination rates, as the data reveals plenty of rural counties well above average and urban areas dragging their feet.

"There's a lot of, let's call it judgment of rural communities and a lot of blame that's being placed on them for masks, for vaccinations," says Mark Holmes, a professor at the University of North Carolina Gillings School of Global Public Health. "There's a continuum overall, and it's not as simple as all the large areas are doing great and all the rural areas are not."

Indeed, a CDC report from mid-May included one detail that caught Holmes by surprise: The suburban counties ringing his state's largest cities, Charlotte and Raleigh, N.C., had significantly lower vaccination rates than their urban cores.

Not only that, these suburbs were worse off than even rural counties scattered across the state. Counties surrounding Minneapolis, Birmingham, Ala., Seattle, Denver and Portland, Ore., all repeated this pattern, with the suburbs trailing both urban and rural counties of their states, according to the CDC's analysis.

Pockets of lower vaccination rates are a problem for people everywhere, experts say. If COVID-19 flares up in any unvaccinated rural or suburban area, those outbreaks would likely ripple into nearby cities, according to Keith Mueller, director of the University of Iowa's Rural Policy Research Institute.

"If we've learned anything from 18 months of this pandemic, we've learned that it can spread from any place to any place. We're far too mobile a society," Mueller says.

As COVID-19 restrictions ease and the summer travel season heats up, more Americans will likely venture to national parks and other outdoor destinations in rural areas.

"You're stopping to get gas, and all of a sudden, that's your contact," Holmes says. "It's ineffective to look at our borders, whether those are national, state or county, and say that's over there. It's not coming here."

Socioeconomically vulnerable counties struggling more

A second CDC report from early June sheds light on the demographic and social factors linked to lower vaccination rates among all counties, whether rural or urban.

The CDC ranks over 3,000 counties nationwide using a social vulnerability index that measures 15 factors such as poverty, poor transit and crowded housing that weaken a community's capacity to respond to disaster.

Researchers divided counties into four categories — large urban, suburban, small-to-medium urban, and rural — and looked for which demographic profiles were linked to lower vaccination rates. Across all these categories, counties with more households with children, more people living with disabilities and more single-parent households were more likely to see lower vaccination rates. And researchers say these gaps are particularly pronounced in suburban and rural counties.

Counties with higher numbers of mobile home residents, as well as those with higher poverty and lower education rates, also lagged significantly behind other counties within their rural-urban category, according to the CDC report.

"Rural communities often have a higher proportion of residents over 65 years of age, lacking health insurance, living with underlying medical conditions or disabilities, and with limited access to health care facilities with intensive care capabilities, which may make them more likely to get sick or die from COVID-19," says Vaughn Barry, a CDC epidemiologist and one of the report's lead authors.

Battling hesitancy should be 'hyperlocal'

The CDC reports present vaccine hesitancy as the primary barrier to reaching rural areas and call for public health leaders to do more to overcome it. One in five rural Americans said they would "definitely not" get a vaccine, according to a Kaiser Family Foundation poll published in April. It found the most resistance among Republicans, white Evangelical Christians, essential workers in fields other than health care, and adults under 50.

Strategies to overcome that hesitancy will look different for the hundreds of rural counties nationwide, says White House COVID-19 Health Equity Chair Marcella Nunez-Smith, but they will likely share one critical aspect.

"Partnering with trusted, local community leaders is a must," Nunez-Smith said at a news conference in May. "Equity work is always hyperlocal. Communities are the experts in what they need."

Doctors on the Navajo Nation, once among the hardest-hit areas of the country, say constant communication with their tribal members about fighting the "monster" of COVID-19 has helped this remote region achieve some of the highest vaccination rates in New Mexico and Arizona.

Like most Native American tribes, the Navajo Nation has dozens of paid community health representatives who work with the Indian Health Service to reach into rural areas and forge relationships.

"They know their areas extremely well. They all speak the language," says Dr. Loretta Christensen, acting chief medical officer for the Indian Health Service and a member of the Navajo Nation. "They can take that one-on-one with the people that may be hesitant, and sometimes it has been because they're afraid to leave their home, by the way, but we have gone out to the homes and given those vaccinations."

Friends and family can be among the most influential in convincing a hesitant person, adds Dr. Chris Percy with the Northern Navajo Medical Center in Shiprock, N.M.

Patients frequently recount to him what has convinced them to show up at recent vaccination events: "They'll just volunteer that 'My mom and my sisters have been ... on my case to get in here,'" Percy says.

Christensen and Percy say they can't beat anyone over the head with data or strongarm unwilling patients into taking the vaccine, but what they can do is seem welcoming and lower all barriers.

"Our systems that we set up on Navajo don't have a pre-registration component or, you know, you need to do these five things before you can get an appointment," Percy says. "If you're going to come in on Tuesday, just show up. ... When you make up your mind, and you're ready, we're going to be here."

Barry's report echoes Percy, suggesting walk-in clinics with flexible evening and weekend hours to accommodate work schedules and reach people in socially vulnerable communities. The CDC researchers also suggest organizing vaccine clinics near childcare facilities and partnering with schools could improve the lower rates they observed among single-parent households in suburban and rural counties.

Methodology

Data used for this story comes from county-level counts of fully vaccinated people updated daily by the Centers for Disease Control and Prevention and the Texas Department of State Health Services. The CDC has not released data for Hawaii and California's smallest counties. NPR excluded a handful of states where less than 80% of vaccination records included a person's county of residence.

NPR coded each county as rural or urban according to the National Center for Health Statistics 2013 Urban-Rural Classification Scheme, marking non-core and micropolitan counties as rural and small, medium and large metro counties as urban. NPR excluded Delaware, the District of Columbia, New Jersey and Rhode Island because they have no rural counties.

For the remaining 43 states, NPR used 2019 Census population estimates for county residents to calculate the average vaccination rates for each state's rural and urban counties, weighted by county population. Finally, NPR compared the change in these rates between April 19 and June 10.

Source: https://news.wjct.org/post/rural-communities-fall-farther-behind-covid-19-vaccination-rates

While many Medicare beneficiaries can receive a COVID-19 vaccine at a retail pharmacy, their physician’s office, or a mass vaccination site, some beneficiaries have great difficulty leaving their homes or face a taxing effort getting around their communities easily to access vaccination in these settings. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of both doses, or approximately $70 more than the current rate.

“CMS is committed to meeting the unique needs of Medicare consumers and their communities – particularly those who are home bound or who have trouble getting to a vaccination site. That’s why we’re acting today to expand the availability of the COVID-19 vaccine to people with Medicare  at home,” said CMS Administrator Chiquita Brooks-Lasure. “We’re committed to taking action wherever barriers exist and bringing the fight against the COVID-19 pandemic to the door of older adults and other individuals covered by Medicare who still need protection.”

Delivering COVID-19 vaccination to access-challenged and hard-to-reach individuals poses some unique challenges, such as ensuring appropriate vaccine storage temperatures, handling, and administration. The Centers for Disease Control and Prevention (CDC) has outlined guidance to assist vaccinators in overcoming these challenges. Today’s announcement now helps to address the financial burden associated with accommodating these complications.

The additional payment amount also accounts for the clinical time needed to monitor a beneficiary after the vaccine is administered, as well as the upfront costs associated with administering the vaccine safely and appropriately in a beneficiary’s home. The payment rate for administering each dose of a COVID-19 vaccine, as well as the additional in-home payment amount, will be geographically adjusted based on where the service is furnished.

How to Find a COVID-19 Vaccine

As today’s action demonstrates, a person’s ability to leave their home should not be an obstacle to getting the COVID-19 vaccine. As states and the federal government continue to break down barriers – like where vaccines can be administered – resources for connecting communities to vaccination options remain key. Unvaccinated individuals and those looking to assist friends and family can:

1. Visit vaccines.gov (English) or vacunas.gov (Spanish) to search for vaccines nearby.
2. Text GETVAX (438829) for English or VACUNA (822862) for Spanish for near-instant access to details on three vaccine sites in the local area.
3. Call the National COVID-19 Vaccination Assistance Hotline at 1-800-232-0233 (TTY: 1-888-720-7489) for assistance in English and Spanish.

Coverage of COVID-19 Vaccines

The federal government is providing the COVID-19 vaccine free of charge or with no cost-sharing for all people living in the United States. As a condition of receiving free COVID-19 vaccines from the federal government, vaccine providers cannot charge patients any amount for administering the vaccine.

Because no patient can be billed for COVID-19 vaccinations, CMS and its partners have provided a variety of information online for providers vaccinating all Americans regardless of their insurance status:

• Original Medicare and Medicare Advantage: Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible.
   
• Medicaid and the Children’s Health Insurance Program (CHIP): State Medicaid and CHIP agencies must cover COVID-19 vaccine administration with no cost sharing for nearly all beneficiaries during the COVID-19 public health emergency (PHE) and for over a year after it ends. For the very limited number of Medicaid beneficiaries who are not eligible for this coverage (and do not receive it through other coverage they might have), providers may submit claims for reimbursement for administering the COVID-19 vaccine to underinsured individuals through the COVID-19 Coverage Assistance Fund, administered by the Health Resources and Services Administration (HRSA), as discussed below.
  
  Under the American Rescue Plan Act of 2021 (ARP), signed by President Biden on March 11, 2021, the federal matching percentage for state Medicaid and CHIP expenditures on COVID-19 vaccine administration is currently 100% (as of April 1, 2021), and will remain 100% for more than a year after the COVID-19 PHE ends. The ARP also expands coverage of COVID-19 vaccine administration under Medicaid and CHIP to additional eligibility groups. CMS recently updated the Medicaid vaccine toolkit to reflect the enactment of the ARP at https://www.medicaid.gov/state-resource-center/downloads/covid-19-vaccine-toolkit.pdf. 
   
• Private Plans: The vaccine is free forpeople enrolled in private health plans and issuers COVID-19 vaccine and its administration is covered without cost sharing for most enrollees, and such coverage must be provided both in-network and out-of-network during the PHE. Current regulations provide that out-of-network rates must be reasonable as compared to prevailing market rates, and the rules reference using the Medicare payment rates as a potential guideline for insurance companies.
  
  In light of CMS’s increased Medicare payment rates, CMS will expect health insurance issuers and group health plans to continue to ensure their rates are reasonable when compared to prevailing market rates. Under the conditions of participation in the CDC COVID-19 Vaccination Program, providers cannot charge plan enrollees any administration fee or cost sharing, regardless of whether the COVID-19 vaccine is administered in-network or out-of-network.

The Biden-Harris Administration is providing free access to COVID-19 vaccines for every adult living in the United States. For individuals who are underinsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine through the COVID-19 Coverage Assistance Fund administered by the Health Resources and Services Administration (HRSA) after the claim to the individual’s health plan for payment has been denied or only partially paid. Information is available at https://www.hrsa.gov/covid19-coverage-assistance.

For individuals who are uninsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA). Information on the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program is available at https://www.hrsa.gov/CovidUninsuredClaim.

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available at https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.

More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.

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As summarized below, the two Executive Orders do not impede upon the ability of businesses and individuals to continue to follow the safety precautions for employees and customers that were operationalized during the pandemic.   Nor do they impact the recommendations from the CDC and OSHA requirements for preventing the spread of COVID-19.   Business owners, customers, and the General Public are free to continue to follow those precautions that they feel are best given their circumstances, operations and other authoritative guidance.

Below is the summary of the two Executive Orders:

Executive Order 21-101, effective July 1, mandates that “any emergency order issued by a political subdivision due to the COVID-19 emergency which restricts the rights or liberties of individuals or their businesses is invalidated.”

Executive Order 21-102 suspended “all local COVID-19 restrictions and mandates on individuals and businesses” and went into effect immediately.

https://www.flgov.com/2021-executive-orders/

CDC Guidance for Workplaces and Businesses:

https://www.cdc.gov/coronavirus/2019-ncov/community/workplaces-businesses/index.html

US Department of Labor OSHA Guidance for Workplaces and Businesses:

https://www.osha.gov/coronavirus

Renewal of Determination That A Public Health Emergency Exists

https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-15April2021.aspx 

Most Physicians Experienced Little Relief from Prior Authorization as COVID-19 Cases Soared
Insurers’ requirements for advanced approvals associated with treatment delays, care disruption, and patient harm


CHICAGO - As new cases of COVID-19 in the United States were peaking in late 2020, most physicians reported that health plans continued to impose bureaucratic prior authorization policies that delay access to necessary care and sometimes result in serious harm to patients, according to new survey results issued today by the American Medical Association (AMA).

“As the COVID-19 pandemic began in early 2020, some commercial health insurers temporarily relaxed prior authorization requirements to reduce administrative burdens and support rapid patient access to needed drugs, tests and treatments,” said AMA President Susan R. Bailey, M.D. “By the end of 2020, as the U.S. health system was strained with record numbers of new COVID-19 cases per week, the AMA found that most physicians were facing strict authorization hurdles that delayed patients’ access to needed care.”

According to the AMA survey, almost 70% of 1,000 practicing physicians surveyed in Dec. 2020 reported that health insurers had either reverted to past prior authorizations policies or never relaxed these policies in the first place. More than nine in 10 physicians (94%) reported care delays while waiting for health insurers to authorize necessary care, and nearly four in five physicians (79%) said patients abandon treatment due to authorization struggles with health insurers.

“Delayed and disrupted treatment due to an archaic prior authorization process can have life-or-death consequences for patients, especially during a public health emergency,” said Dr. Bailey. “This hard- learned lesson from the current crisis must guide a reexamination of administrative burdens imposed by health insurers, often without any justification.”

Nearly one-third (30%) of physicians reported that prior authorization requirements have led to a serious adverse event for a patient in their care, according to the AMA survey. More specifically, prior authorization requirements led to the following repercussions for patients:

• Patient hospitalization – reported by 21% of physicians
• Life-threatening event or intervention to prevent permanent impairment or damage – reported by 18% of physicians
• Disability or permanent bodily damage, congenital anomaly, birth defect, or death – reported by 9% of physicians

While the health insurance industry says prior authorization criteria reflect evidence-based medicine, the physician experience casts doubt on the credibility of this claim. Only 15% of physicians reported that prior authorization criteria were often or always based on evidence-based medicine.

Other critical physician concerns highlighted in the AMA survey include:

• Nine in 10 physicians (90%) reported that prior authorizations programs have a negative impact on patient clinical outcomes.
• A significant majority of physicians (85%) said the burdens associated with prior authorization were high or extremely high.
• Medical practices complete an average of 40 prior authorizations per physician, per week, which consume the equivalent of two business days (16 hours) of physician and staff time.
• To keep up with the administrative burden, two out of five physicians (40 %) employ staff members who work exclusively on tasks associated with prior authorization.

The findings of the AMA survey illustrate a critical need to streamline or eliminate low-value prior-authorization requirements to minimize delays or disruptions in care delivery. The AMA has taken a leading role in advocating for prior authorization reforms and convening key industry stakeholders to develop a roadmap for improving the prior authorization process.

In January 2018, the AMA and other national organizations representing pharmacists, medical groups, hospitals and health plans signed a consensus statement outlining a shared commitment to improving five key areas associated with the prior authorization process. However, health plans have made little progress in the last three years toward implementing improvements in each of the five areas outlined in the consensus statement.

The AMA continues to work on every front to streamline prior authorization. Through our research, collaborations, advocacy and leadership, the AMA is working to right-size prior authorization programs so that physicians can focus on patients rather than paperwork. Patients can share their own personal experiences with prior authorization at FixPriorAuth.org

Providers Authorized to Administer the COVID-19 Vaccine

The list below contains health care professions whose governing practice act or federal guidance authorizes the administration of vaccines, including COVID-19 vaccines. If you have specific questions regarding a profession, please contact the respective regulatory board office at MedicalQualityAssurance@flhealth.gov

The U.S. Department of Health and Human Services (HHS) issued new guidance on March 12, 2021, to expand the pool of qualified professionals able to serve as COVID-19 vaccinators. HHS has used its authority under the Public Readiness and Emergency Preparedness Act (PREP Act) to add additional categories of qualified people authorized to prescribe, dispense, and administer COVID-19 vaccines authorized by the U.S. Food and Drug Administration, including dentists, emergency medical technicians, midwives, optometrists, paramedics, physician assistants, podiatrists, respiratory therapists, and veterinarians. This action also authorizes medical students, nursing students, and other health care students in the professions listed under the PREP Act with proper training and professional supervision to serve as additional COVID-19 vaccinators under an established COVID-19 vaccine enrolled provider. More information about the PREP Act and requirements to administer the COVID-19 vaccine for health care practitioners authorized under this guidance can be found at PHE.gov. Some of the requirements include:

Documentation of completion of the Centers for Disease Control and Prevention

COVID-19 Vaccine Training Modules,

Documentation of an observation period by a currently practicing health care professional experienced in administering intramuscular injections, and Current certificate in basic cardiopulmonary resuscitation.

HHS has also authorized physicians, advanced practice registered nurses, registered nurses, practical nurses, pharmacists, pharmacy interns, midwives, paramedics, emergency medical technicians, respiratory therapists, dentists, physician assistants, podiatrists, optometrists who have held an active license within the last five years, which is inactive, expired, or retired, to serve as COVID-19 vaccinator under an established COVID-19 vaccine enrolled provider. Employers can view the licensure status and disciplinary history for retired and inactive health care practitioners on the Department of Health’s website located here.

COVID-19 Vaccine Reporting Requirements

Florida Department of Health, Emergency Rule 64DER21-4, Florida Administrative

Code, requires all enrolled COVID-19 vaccine providers to report vaccination data in

Florida SHOTS within 24 hours of administration. This emergency rule follows Emergency Rule 64DER20-43, Florida Administrative Code, which expired March 14, 2021. The following data elements are required when reporting:

How Can I Become a COVID-19 Vaccine Provider?

To become a COVID-19 vaccine provider, your practice or organization must be enrolled in the Florida State Health Online Tracking System (Florida SHOTS) and the Vaccines for Children/Adults Program (VFC/VFA). For questions or additional information, please contact the COVID-19 Vaccine Enrollment Desk at 833-701- 1397, or email CovidVaccineProgram@flhealth.gov.

Click here to view the flyer with enrollment instructions:

http://www.floridahealth.gov/programs-and-services/immunization/COVID19VaccineInfo/_documents/covid-vaccine-provider-flowchart.pdf

Florida SHOTS has a number of trainings available to help providers. These trainings can be accessed by visiting http://flshotsusers.com/.

Florida COVID-19 Vaccine Weekly Pre-Book Request Opens

The Florida COVID-19 vaccine weekly pre-book request is now open in Florida SHOTS. Weekly pre-book requests allow COVID-19 vaccine enrolled providers to share their ability and desire to receive COVID-19 vaccines. Requests do not guarantee an allocation will be made. This information will be used to assist leadership with planning activities throughout the state.

For more detailed information, please click here.

Helpful Resources

Health care provider notifications - www.flhealthsource.gov/covid19 Florida Department of Health Immunization Section COVID-19 vaccine webpage http://www.floridahealth.gov/programs-and-services/immunization/COVID-

19VaccineInfo/index.html

Florida Department of Health COVID-19 webpage - www.floridahealthcovid19.gov

As authorized in Executive Order 20-315, hospital providers may continue to vaccinate individuals ages 16 to 64 who are medically vulnerable. All health care providers authorized to administer COVID-19 vaccines in Florida may vaccinate patients deem to be extremely vulnerable to COVID-19 by a physician.

Effective for COVID-19 vaccines administered on or after March 15, 2021, the national average payment rate for physicians, hospitals, pharmacies and many other immunizers will be $40 to administer each dose of a COVID-19 vaccine. This represents an increase from approximately $28 to $40 for the administration of single-dose vaccines, and an increase from approximately $45 to $80 for the administration of COVID-19 vaccines requiring two doses. The exact payment rate for administration of each dose of a COVID-19 vaccine will depend on the type of entity that furnishes the service and will be geographically adjusted based on where the service is furnished. 

These updates to the Medicare payment rate for COVID-19 vaccine administration reflect new information about the costs involved in administering the vaccine for different types of providers and suppliers, and the additional resources necessary to ensure the vaccine is administered safely and appropriately.

CMS is updating the set of toolkits for providers, states and insurers to help the health care system swiftly administer the vaccine with these new Medicare payment rates. These resources are designed to increase the number of providers that can administer the vaccine, ensure adequate payment for administering the vaccine to Medicare beneficiaries, and make it clear that no beneficiary, whether covered by private insurance, Medicare or Medicaid, should pay cost-sharing for the administration of the COVID-19 vaccine.

Coverage of COVID-19 Vaccines

As a condition of receiving free COVID-19 vaccines from the federal government, vaccine providers are prohibited from charging patients any amount for administration of the vaccine. To ensure broad and consistent coverage across programs and payers, the toolkits have specific information for several programs, including:

Medicare: Beneficiaries with Medicare pay nothing for COVID-19 vaccines and there is no applicable copayment, coinsurance or deductible.

Medicare Advantage (MA): For calendar years 2020 and 2021, Medicare will pay providers directly for the COVID-19 vaccine (if they do not receive it for free) and its administration for beneficiaries enrolled in MA plans. MA plans are not responsible for paying providers to administer the vaccine to MA enrollees during this time. Like beneficiaries in Original Medicare, Medicare Advantage enrollees also pay no cost-sharing for COVID-19 vaccines.

Medicaid: State Medicaid and CHIP agencies must provide vaccine administration with no cost sharing for nearly all beneficiaries during the public health emergency (PHE) and at least one year after it ends. Through the American Rescue Plan Act signed by President Biden on March 11, 2021, the COVID vaccine administration will be fully federally funded. The law also provides an expansion of individuals eligible for vaccine administration coverage. There will be more information provided in upcoming updates to the Medicaid toolkit at: https://www.medicaid.gov/state-resource-center/downloads/covid-19-vaccine-toolkit.pdf. 

Private Plans: CMS, along with the Departments of Labor and Treasury, is requiring that most private health plans and issuers cover the COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing during the public health emergency (PHE). Current regulations provide that out-of-network rates must be reasonable, as compared to prevailing market rates, and reference the Medicare reimbursement rates as a potential guideline for insurance companies. In light of CMS’s increased Medicare payment rates, CMS will expect commercial carriers to continue to ensure that their rates are reasonable in comparison to prevailing market rates.

Uninsured: For individuals who are uninsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA).

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available at https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.

More information regarding the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program Provider Requirements, and how the COVID-19 vaccine is provided at 100% no cost to recipients is available at: https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.

Information on the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program is available at https://www.hrsa.gov/CovidUninsuredClaim.

Survey results will help inform other healthcare providers and patients about what to expect in the coming months. Thank you for taking a few minutes to complete the survey and for delivering care during the past year under conditions previously unimaginable in the United States.

Florida Medicaid will provide transportation to Medicaid recipients to get the COVID-19 vaccine at no cost. Recipients should set up a time to get their vaccine and let their Medicaid plan know they need a ride.  Recipients who are not enrolled in a plan can call the Medicaid Helpline at 1-877-254-1055 to find out the name and phone number for a transportation service.

When scheduling a vaccine appointment, the appointment should be made several days in advance to allow time to schedule Medicaid-covered transportation.

If the recipient has any special needs (e.g., they use a wheelchair), they should tell the transportation service when the ride is scheduled.  Once they know when and where they will receive the second dose, that information should be shared with the transportation provider and they will schedule the next trip.

Individuals eligible to receive the vaccine may visit http://myvaccine.fl.gov to find a location distributing the vaccine and to schedule an appointment.

When scheduling transportation for a vaccine, the ride should be scheduled at least three business days before the appointment.  The following information must be provided to the transportation service:

• Full name
• Medicaid Identification Number
• Address (pick-up and drop off locations)
• Date of birth
• Name of health plan (if you are enrolled in a plan)
• Date and time of the appointment
• Phone number

The transportation provider may ask questions to make sure they send a vehicle that meets the person’s needs. The recipient may have someone travel with them if it is medically necessary. Recipients should be sure to call the transportation service if their appointment is canceled or changed to a different time.

A Medicaid Transportation for COVID-19 Vaccinations flyer with this information is also available on the Medicaid COVID-19 website.

DeSantis issued an executive order late Friday afternoon that allows physicians to vaccinate people who are deemed “extremely vulnerable” to the disease. The executive order also will allow advanced practice registered nurses and pharmacists to provide shots to such people if physicians determine that the recipients are extremely vulnerable.

Under a Dec. 23 executive order, hospitals --- but not the other types of health-care providers --- were allowed to vaccinate people considered extremely vulnerable to COVID-19. But the primary focus of the December order was DeSantis’ push to vaccinate people age 65 or older.

DeSantis’ office did not issue an announcement about Friday’s change but posted the executive order on its website. The order said Florida is “leading the effort to distribute the vaccine to the elderly and vulnerable populations of the state.”

The order also kept in place approval to vaccinate seniors, long-term care facility residents and staff members and health-care workers who have direct patient contact.

Through Saturday, the state Department of Health reported that 3,017,661 people had been vaccinated in Florida. Of those, 1,680,230 had completed the two-dose series required with vaccines produced by the drug companies Pfizer and Moderna. The remaining 1,337,431 had received first doses.

DeSantis has barnstormed the state for weeks promoting vaccinations for seniors, who are particularly vulnerable to COVID-19. Through the Saturday count, 2.29 million of the people who had been vaccinated in Florida were 65 or older, according to the Department of Health report.

The vulnerability of seniors to the disease has shown up in death numbers throughout the pandemic. The Department of Health reported Sunday that 30,852 Florida residents have died of COVID-19, with 25,761 age 65 or older. --- an 83 percent rate that has remained largely unchanged for months.

Friday’s executive order, like the December order, did not define people who can be vaccinated because they are extremely vulnerable. It appears to leave that determination up to physicians.

While the numbers of new cases reported daily in Florida have slowed somewhat, the state reported Sunday that it has had 1.9 million cases since the pandemic started. That included an additional 5,539 cases reported Sunday.

DeSantis on Friday also issued an executive order that extended for 60 days a state of emergency because of the pandemic. The state of emergency was originally issued nearly a year ago, on March 9, as COVID-19 began hitting the state and was later extended.

Source: News Service Florida https://newsserviceflorida.com/app/post.cfm?postID=39964

And this is a good thing, because it reinforces the key role physicians play as the source of information and guidance that patients trust above all others. Our role as “vaccine ambassadors,” and the recommendations we routinely share with our patients on this and other aspects of their health, are critical in boosting their acceptance and ensuring their well-being.     

Our patients bring a wide range of life experiences, viewpoints and mindsets to their interactions with us, and their questions and concerns can vary widely as a result. Black, Latino and Indigenous patients deserve thoughtful and culturally relevant messaging to overcome longstanding (and well-founded) distrust in the medical system. The “Trustworthiness & Vaccines” installment in our AMA’s “Prioritizing Equity” video series is a great place to learn about these cultural concerns.

To further advance the mission of vaccine education and boost patient confidence, our AMA is partnering with the Ad Council and the COVID Collaborative today to launch “It’s Up to You,” one of the largest and most comprehensive public health information efforts ever undertaken.

Created in cooperation with the Centers for Disease Control and Prevention (CDC), this campaign helps people make sense of the available scientific information about the vaccines so they can make informed decisions about vaccination for themselves and their families. All the details can be found at GetVaccineAnswers.org (or in Spanish at DeTiDepende.org).   

Our AMA supports the principles for equitable allocation outlined by CDC’s Advisory Committee on Immunization Practices (ACIP), which have become guidelines for state and local officials. These principles are fully aligned with the fundamental values of medicine and the ethical responsibilities of physicians as defined in the AMA Code of Medical Ethics, and directly address the disproportionate impact of COVID-19 on people of color through increased exposure, illness and mortality.

The two mRNA vaccines now being administered are the result of research that has been underway for decades, and both have been studied rigorously in large randomized controlled trials across varied populations. Our confidence in the safety and efficacy of these vaccines is bolstered by the rigorous, evidence-based and wholly transparent vaccine authorization and recommendation for use process followed by both the Food and Drug Administration (FDA) and the CDC.

That same process involved recommendations from external advisory groups serving both agencies, including ACIP. Our AMA recognizes ACIP recommendations as the standard physicians should follow in making decisions about vaccines with patients. Also, members of the FDA’s Vaccine and Regulated Biological Products Advisory Committee carefully evaluated the safety and effectiveness data submitted by the vaccine manufacturers before the final decision on emergency use authorization was made solely by the FDA.

Although the vaccine deliveries are increasing and newly opened vaccination sites are accepting more appointments and patients nationwide, it remains painfully clear that demand will continue to outstrip supply as winter gives way to spring. As the number of doses increases in the weeks ahead, it is critical that physician practices receive an adequate supply—which has not been the case to date. The direct and open conversations we share with our patients, and the trust that is at the heart of the patient-physician relationship, will help boost vaccine confidence.

Patients who have questions or doubts should be encouraged to discuss them with a physician, nurse or other health care professional. Frontline caregivers and others who have received vaccinations should eagerly share their experiences with others. Our AMA’s COVID-19 resource center  and our COVID-19 vaccine guide for physicians offer tips and advice on answering patients’ questions, along with a wealth of other valuable information.

The monumental public health effort now underway to provide a vaccine to everyone able to receive it needs all the support we can render to end the scourge of COVID-19. Our AMA will remain your powerful ally in this and every other effort to improve the health of our nation.

Source: https://www.ama-assn.org/about/leadership/physicians-provide-key-voice-building-vaccine-confidence