Daily Archives: May 20, 2021

The following is information about the City of San Joss response to slow and reduce the spread of COVID-19 and support our most at-risk communities.

SOURCE:City of San JosEmergency Operations Center

Contact:Carolina Camarena / Vicki Day, City of San Jos Media Line: 408-535-7777City of San Jos Customer Contact Center: 3-1-1 or 408-535-3500

Email: News/Media: EOC_PIO@sanjoseca.govResidents: 311@sanjoseca.govBusinesses: covid19sjbusiness@sanjoseca.govNon-Profits: covid19sjcbo@sanjoseca.gov

Moving to Yellow Tier: Effective today Santa Clara County enters the least restrictive Yellow Tier under the State's Blueprint for a Safer Economy. The move to the yellow tier means many businesses such as bars, restaurants, gyms and movie theaters will be allowed to expand their capacity for indoor operations to 50 percent, and for the first time bars not providing meals can resume indoor operations at 25 percent capacity.

The County has placed a limited local health order that will:

Registration for swim lessons is open in-person and online at the PRNS Registration System. There are also scholarships available for those who qualify. Families must apply in-person at a community center and scholarships can be used at any program location.

In preparation for summer Swim San Jos programming, PRNS is recruiting for part-time, unbenefited Lifeguard; Lifeguard Instructor; Pool Manager; and Assistant Pool Manager positions. A Lifeguard Training certificate is not required to apply or interview. If selected for a position, the Swim San Jos program will provide training upon request. The application deadline is May 26 at 11:59 p.m.

For more information about swimming pool locations, lessons, hiring positions and scholarships, please visit the PRNS swimming and pools web page.

Appointments can be made starting seven days in advance of the testing date until all slots are reserved at http://www.sccfreetest.org. Appointments at the Fairgrounds site are now available five days in advance. Testing is free at all these sites.

All healthcare systems are required by the County order to offer free testing to symptomatic persons, persons who have been exposed to a confirmed COVID-19 case, and all essential workers. For more information on testing rights, see our Frequently Asked Questions page.

All test sites are mapped on the Countys website at http://www.sccfreetest.org. The site is available in English, Spanish, Vietnamese, Chinese, and Tagalog. Information is also available by calling 2-1-1.

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A persons risk for COVID-19 is not related to race, ethnicity or culture. City employees must abide by the Discrimination and Harassment policy, and treat colleagues and members of the public with courtesy and respect. Discrimination and/or Harassment of any kind is a violation of the policies and will not be tolerated.

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Excerpt from:

FLASH REPORT #160 - COVID-19 Response and Recovery | News - City of San Jose, CA

Overview

The COVID-19 pandemic created overwhelming demand for tests that diagnose the disease or identify past infection. The U.S. Food and Drug Administration (FDA) has responded by authorizing the emergency use of more than 300 coronavirus tests that medical device manufacturers and laboratories have developed to meet the varying needs of health care providers and public health authorities.1

This brief examines FDA oversight of COVID-19 tests and how events during the pandemic reinforce the need for legislationsuch as the bipartisan Verifying Accurate Leading-Edge IVCT Development (VALID) Actthat would improve regulation of all in vitro clinical tests (IVCTs). Also called in vitro diagnostics (IVDs), these tests analyze samples from the human body such as blood, mucus, and saliva and are among the most widely used tools in medicine. Their results guide diagnosis and treatment of cancer, genetic disorders, and hundreds of infectious diseases, including COVID-19.

FDA oversight of diagnostic tests is critical to protecting patients and public health. For example, in January 2021, FDA warned that Curative Inc.s SARS-CoV-2 test, a COVID-19 diagnostic, presented a risk of false results, particularly false negatives, when not used according to its authorized labeling, which advises performing the test on symptomatic individuals within 14 days of symptom onset, under a health care workers direct supervision. The agency emphasized the importance of following these guidelines and recommended that test administrators consider retesting individuals if a recent inaccurate result was suspected, as failure to adhere to the guidelines could increase the risk that infected people do not receive appropriate treatment and unknowingly spread the disease to others.2 At the time of FDAs announcement, clinicians were administering the test nearly a million times per week, often on asymptomatic people including residents of Chicago, Houston, and Los Angeles; personnel at military facilities; members of Congress; and Capitol Hill staff.3

Despite the public health benefits of the agencys oversight, tests developed and used within a single laboratory are generally not required to undergo FDA review, nor does the agency always know which of these lab developed tests (LDTs) are being used on patients. However, during public health emergencies, the agency has generally required all developersincluding both device companies and labsto apply for emergency use authorizations (EUAs) for any test marketed to diagnose or screen for the disease that is the subject of the declared emergency. This allows FDA to know which diagnostics are entering the market, conduct risk-based reviews of their accuracy and reliability, monitor their performance, and, when necessary, amend or revoke a tests EUA in response to new information.

FDA should have such fundamental regulatory tools for all IVDs, no matter where they are made and used, and whether or not theres a pandemic. A legislative solution is needed to ensure the agency has these authorities, particularly in light of a Department of Health and Human Services (HHS) decision in 2020 that undermined oversight of LDTs even during a public health emergency.4 According to the HHS statement, FDA would not be able to require makers of LDTs to submit their products for review before using them on patients unless the agency first went through a lengthy rule-making process. This policy could lead to test accuracy problems, with potentially significant consequences for patient health, especially during an already dangerous pandemic.

HHSs decision to limit FDAs emergency oversight powers demonstrates why lawmakers should act to strengthen the agencys review of the growing market for diagnostic tests. Congress should pass reforms that would create a flexible and risk-based FDA oversight system, while also preserving the EUA powers that FDA effectively used to expand COVID-19 testing capacity. The most comprehensive legislative proposal to address such reforms is the bipartisan VALID Act, which would unify regulation of all diagnostic tests and help level the playing field for the companies and labs creating these important products. Although the measure needs a few key improvementsincluding strengthening FDAs postmarket powers and narrowing the bills criteria for tests that would be excluded from premarket review requirementsit is a strong start to creating a risk-based review system that delivers reliable IVDs for patients.5

Following then-HHS Secretary Alex Azars declaration of a public health emergency on Jan. 31, 2020, FDA announced that, under the Pandemic and All Hazards Preparedness Act, the agency would need to grant an EUA to any test marketed to diagnose or screen for COVID-19, as had been the case in prior emergencies. An EUA temporarily allows makers of a specific FDA-regulated productincluding diagnostic teststo market these items without completing the agencys standard safety and efficacy review process. This flexibility lets the agency make products available quickly in an emergency while still ensuring that their known and potential benefits outweigh their risks.6

The emergency powers granted to the agency during a pandemic also allow it to amend or revoke authorizations as it learns more about a products safety, effectiveness, or performance in the field. Through this process, FDA can move quickly to issue a safety warning or recall a product when subsequent evidence reveals that it is ineffective, unreliable, or has a safety issue.

Until August 2020, both test kits developed by device manufacturers and LDTs were required to receive an EUA. In order to speed access to testing, the agency also allowed test developersincluding laboratoriesto bring a test to market immediately, provided that the developer validated the test for accuracy prior to its use on patients, notified FDA of its intent to offer the test, and submitted an EUA request within 15 days of that notification. The agency could then follow up as necessary to ensure that the tests met the authorization standards. This follow-up was critical: When the agency subsequently reviewed a sample of the EUA applications that came from labs, it found that nearly two-thirds of them had design or validation issues that needed to be addressed before the tests could be authorized. FDA was able to work with many of these developers to help correct the initial problems.7

FDA was able to use its EUA flexibility to ensure a variety of tests reached the market during the pandemic. (See Table 1.) This is critical given the scale of the need and the many different types of settings in which testing may be carried out.

The authorized tests for COVID-19 can be grouped into two main categories, depending on their intended use: diagnostic tests and antibody tests. Diagnostic tests identify active COVID-19 infection using samples collected from a patients respiratory systemeither through a nasopharyngeal, nasal, or throat swabor from a saliva sample. Clinicians can then refer patients who test positive for treatment or isolation to protect others and mitigate spread of the virus. Thus far, two main types of diagnostic tests have been developed: molecular tests, which detect the presence of the viruss genetic material; and antigen tests, which detect the presence of specific proteins on the viruss surface.8

Antibody tests, on the other hand, use a blood sample to determine whether a patient was previously infected with the virus.9 While antibody tests cannot diagnose or rule out a current COVID-19 infection, they serve an important public health role in measuring exposure within communities and mapping outbreaks.

See more here:

COVID-19 Tests Highlight Need for Strengthened FDA Oversight and Diagnostics Legislation - The Pew Charitable Trusts

Overview

Workplaces outside of healthcare facilities can be also settings for transmission of COVID-19. Outbreaks of COVID-19 has been reported in various types of workplaces and job categories.

All workers should be protected from acquiring COVID-19 because of their work. The prevention of COVID-19 in work settings should be combined with measures for protecting physical and mental health, safety and wellbeing of workers from other occupational hazards in the operation, closures and reopening of workplaces.

This joint WHO/ILO policy brief provides a summary of the evidence for transmission of COVID-19 in general workplaces and an overview of WHO and ILO recommendations for prevention and mitigation of COVID-19 and for protecting health and safety at work in the context of the pandemic.

The document is intended for public health and labour authorities, businesses, employers, workers and their representatives at the national, local and workplace levels to facilitate the implementation of public health and social measures for COVID-19 while maintaining full and productive employment and decent work during the pandemic.

Read the original here:

Preventing and mitigating COVID-19 at work - World Health Organization

As of 18 May 2021, there were163,312,429confirmed casesof COVID-19, including3,386,825deaths, reported to WHO. Vaccination remains a critical tool to help prevent further illness and death and to control the pandemic.

The Johnson & Johnson (J&J)/Janssen vaccine was listed for emergency use by WHO on 12 March 2021. The vaccine has been authorized for use in Europe, the United States and other countries, with the widest experience to date in the United States, where more than 8 million doses of the J&J vaccine had been administered as of 7 May.

The GACVS COVID-19 subcommittee met virtually on 11 May 2021 to review available information and data on thromboembolic events (blood clots) and thrombocytopenia (low platelets) after vaccination with the adenoviral vectored J&J vaccine. This condition is referred to as thrombosis with thrombocytopenia syndrome (TTS). Current evidence suggests a plausible causal association between the J&J COVID-19 vaccine and TTS. Clinically, the features of TTS following vaccination with this vaccine appear similar to those observed following another adenoviral vectored vaccine, the AstraZeneca COVID-19 vaccine. TTS does not appear to be associated with the mRNA COVID-19 vaccines. The exact mechanism by which this rare condition occurs is not fully understood. (1) To date, the only possible risks factors identified are age and gender (with more cases reported in women).

The subcommittee reviewed detailed surveillance data from the United States, which included stimulated passive surveillance and a small active surveillance cohort.

Based on a careful scientific review of the available information, the subcommittee came to the following conclusions and recommendations:

- The benefits of the J&J COVID-19 vaccine continue to outweigh the risks of TTS. As the only single dose COVID-19 vaccine approved for use to date, the vaccine may be an important tool for accessing difficult-to-reach populations, thus playing a key role in preventing infections and reducing deaths across the world.

- Very rare thromboembolic events, in combination with thrombocytopenia, have been reported following vaccination with the J&J vaccine in the United States. As of 7 May 2021, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) had reviewed 28 reports of TTS out of a total of more than 8 million vaccinations; TTS was reported in persons between 18-59 years of age (median age of 40 years) and occurring after 3-15 days (a median of 9 days).(2) To date, the US FDA and CDC have not identified any cases of TTS after use of over 240 million doses of mRNA vaccines.

- Reports of TTS following vaccination with the J&J vaccine have a similar clinical picture to those reported following vaccination with the AstraZeneca COVID-19 vaccine. On 16 April 2021 the GACVS COVID-19 subcommittee issued an updated statement on blood coagulation events and the AstraZeneca COVID-19 vaccine. (3)

- Although most cases of TTS have typically involved thrombosis in unusual locations, including cerebral venous sinuses, portal vein, splenic vein and other rare venous and arterial thrombosis, cases including thrombosis in more common locations, such as deep vein thrombosis and pulmonary embolism, have been identified in the United States.

- When setting their immunization policies, the risk of TTS from use of the J&J vaccine should be assessed against the benefits. Countries should perform such a benefit-risk analysis taking into account local epidemiology (including incidence and mortality from COVID-19 disease), age groups targeted for vaccination, and the availability of alternative vaccines.

- Adequate education should be provided to health-care professionals and persons being vaccinated to recognize the signs and symptoms of all serious adverse events after vaccinations with all COVID-19 vaccines, so that people may seek and receive prompt and relevant medical care and treatment.Early identification of TTS is important in order to initiate appropriate treatment.

- Clinicians should be alert to any new, severe, persistent headaches or other significant symptoms, such as severe abdominal pain and shortness of breath, with an onset between 4 to 20 days after adenovirus vectored COVID-19 vaccination. At a minimum, countries should encourage clinicians to measure platelet levels and conduct appropriate investigation of thrombosis. Clinicians should also be aware that although heparin is generally used to treat blood clots, administration of heparin in TTS may be dangerous and alternative treatments such as immunoglobulins and non-heparin anticoagulants should be considered.

- The GACVS subcommittee recommends that countries continue to monitor the safety of all COVID-19 vaccines and promote reporting of suspected adverse events. In particular, any blood clots following receipt of any COVID-19 vaccine should be reported.

- The GACVS subcommittee acknowledges that TTS has occurred with two adenoviral-vectored vaccines. Ongoing assessment for and review of TTS cases, as well as related research, should include all vaccines using adenoviral vector platforms.

The GACVS COVID-19 subcommittee will continue to review the safety data from all COVID-19 vaccines and update any advice as necessary. Open, transparent, and evidence-based communication about the potential benefits and risks to recipients and the community is essential to maintain trust. WHO is carefully monitoring the rollout of all COVID-19 vaccines and will continue to work closely with countries to manage potential risks, and to use science and data to drive the response and update recommendations.

The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for the new COVID-19 vaccines, and can be accessedhere.

(1) Updated recommendations from the US Advisory Committee on Immunization Practices for use of the Janssen (Johnson & Johnson) COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome among vaccine recipients United States, April 2021: https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e4.htm#contribAff

(2) Update: Thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination US Advisory Committee on Immunization Practices (ACIP), 12 May 2021: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-05-12/07-COVID-Shimabukuro-508.pdf.

(3) Global Advisory Committee on Vaccine Safety (GACVS) review of latest evidence of rare adverse blood coagulation events with AstraZeneca COVID-19 Vaccine (Vaxzevria and Covishield) 16 April 2021: (https://www.who.int/news/item/16-04-2021-global-advisory-committee-on-vaccine-safety-(gacvs)-review-of-latest-evidence-of-rare-adverse-blood-coagulation-events-with-astrazeneca-covid-19-vaccine-(vaxzevria-and-covishield.

Link:

Statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) on safety signals related to the Johnson &...

Richa Srivastava (rear left) with her husband, Shalabh Pradhan (rear right), and their two fathers, Sudheer Kumar Pradhan (front left) and Sheo Prakash Srivastava (front right), in an undated family photo. The two family patriarchs died within three days of one another in April. Pradhan Family hide caption

Richa Srivastava (rear left) with her husband, Shalabh Pradhan (rear right), and their two fathers, Sudheer Kumar Pradhan (front left) and Sheo Prakash Srivastava (front right), in an undated family photo. The two family patriarchs died within three days of one another in April.

MUMBAI Watching his young children gleefully celebrate Holi, the Indian festival of colors, with his father in March, Shalabh Pradhan thought: "This is exactly why we moved back to India."

Pradhan, 42, is a human resources manager who has lived and worked all over the world Kansas, Minnesota, Kuwait. He lost his mother 12 years ago and wanted to spend more time with his father, a retired defense scientist. So in 2018, Pradhan and his wife, Richa Srivastava, 40, a fashion retail buyer, relocated from the U.S. back to their native India. They settled first in the southern tech hub of Bengaluru and then moved north to be closer to their parents after the pandemic began.

"We came back, me and my wife, because [of] my dad and her dad. We thought, 'We will go back to India, and we will take care of them in their elder years,' " Pradhan says.

But they all had less time together than they'd hoped. This was the last Holi that Pradhan and Srivastava would celebrate with their fathers.

As India battles the world's biggest COVID-19 wave, the country has confirmed about 25.5 million cases and about 283,000 deaths. Experts say those numbers are likely a vast undercount. With only about 3% of people in India fully vaccinated, the population of 1.4 billion is nowhere near immunity and India is likely to overtake the United States as the most-infected country in the world.

Sheo Prakash Srivastava and Sudheer Kumar Pradhan Pradhan Family hide caption

Sheo Prakash Srivastava and Sudheer Kumar Pradhan

Buried in those statistics is the pain of families such as the Pradhans and Srivastavas, who, in the course of three days in April, lost two beloved fathers.

"Just take him away!"

About two weeks after Holi, Pradhan's 78-year-old father, Sudheer Kumar Pradhan, developed a dry cough. At the time, people weren't very alarmed about COVID-19, and his son didn't think much of it.

"He was healthy. His willpower was very strong," Pradhan recalls.

Cases, though, were rising. On April 11, the day Pradhan's father began coughing, India's Health Ministry confirmed 152,879 new coronavirus cases up from record lows of around 10,000 a day in early February. Daily confirmed cases eventually would reach a peak of 414,188 on May 7.

In mid-April, India's news was dominated by state elections. Prime Minister Narendra Modi had been holding huge rallies in West Bengal, a state his Bharatiya Janata Party, or BJP, was hoping to win again.

"They were not talking about this COVID second wave, that it's coming," Pradhan recalls. "They were not talking about precautions. They were not talking about symptoms. Nothing was there."

So Pradhan shrugged off his father's cough. But he did buy an oximeter to measure his father's blood oxygen levels just in case.

Sudheer Kumar Pradhan in an undated family photo. He developed a dry cough about two weeks after Holi, the Indian festival of colors. Pradhan Family hide caption

Sudheer Kumar Pradhan in an undated family photo. He developed a dry cough about two weeks after Holi, the Indian festival of colors.

Three days later, his dad developed a fever. And on the next day, April 15, he fell as he tried to walk to the bathroom in the middle of the night.

"I went and I picked him up, put him in the bed. It was alarming for me," Pradhan recalls. "So I checked his oxygen level. It was 87."

His dad was very sick. Pradhan rushed him to the hospital, but staff turned them away.

"The counter, where the reception is, he was not able to stand," he says. "The [hospital attendant] came and said, 'No, we cannot take him.' "

The hospital wouldn't admit Pradhan's father without proof of a positive coronavirus test. He'd had a test but the results were delayed.

A second hospital also refused to admit him. Officials said the hospital was completely full. His father was clearly having trouble breathing, but staff refused to give him oxygen.

"He could barely walk, barely stand. They put a stretcher out and said, 'No, take him out!' " Pradhan tells NPR, his voice breaking. "It's difficult for me to remember those moments. Nobody was willing to help."

Srivastava says she can't get it out of her mind.

"They were like, 'Just take him! Keep him in the house, keep him wherever you want. Just take him away!' " she says. "I was just praying that day should pass. It was one of the worst days of our lives."

Pradhan and his cousins worked the phones. His brother Saurabh did, too, all the way from Chicago. They eventually found their father a bed at a third hospital. He was put on a ventilator.

Sudheer Kumar Pradhan with his grandchildren in an undated family photo. He died of COVID-19 on April 21. Pradhan Family hide caption

Sudheer Kumar Pradhan with his grandchildren in an undated family photo. He died of COVID-19 on April 21.

But by then it was too late. On the evening of April 21, Pradhan's father died at age 78.

Another loss

The hospital demanded that Pradhan pick up his father's body immediately, in the middle of the night and pay the bill right away, too, including a separate charge for his bedsheets. The charges amounted to 250,000 rupees more than $3,400. The hospital wouldn't release the body without full payment. Pradhan had to find a 24-hour ATM.

He cremated his father the next day, alone. No one was able to accompany him, out of fear of infection.

Pradhan's children, 7 and 9 years old, were stunned. They had just celebrated Holi with their grandfather.

"They were crying a lot," Pradhan says. "They just kept a photograph in front of them and kept crying."

The family performed Hindu rituals in Kanpur in honor of Pradhan's father. On the third day after his death, they drove to the house of Srivastava's parents, about two hours away, in Lucknow, the state capital of Uttar Pradesh. They wanted to gather to grieve together.

But when they arrived, they found Srivastava's father, Sheo Prakash Srivastava, suffering from COVID-like symptoms: weakness, shortness of breath. His oxygen was low.

He died that night. There wasn't even time to hospitalize him.

"Everything happened so quick and so fast!" Srivastava recalls.

Doctors later told the family the cause of death was likely a blood clot. They tested him for the coronavirus. Two days after his death, the result came back positive.

Sudheer Kumar Pradhan wears an elephant mask while playing with his grandchildren in an undated family photo. He was 78 when he died of COVID-19. Pradhan Family hide caption

Sudheer Kumar Pradhan wears an elephant mask while playing with his grandchildren in an undated family photo. He was 78 when he died of COVID-19.

The retired insurance officer was 71 and is survived by his wife and two daughters and friends and neighbors who loved his company.

"He was very social. He used to sit downstairs with my neighbors. So people were flabbergasted. How come the person who was sitting there just four or five days before is now gone?" Srivastava says. "He just left all of us."

Remembering the patriarchs

In the weeks since the deaths of these two men, India has broken world records for confirmed daily coronavirus case numbers and deaths. Scientists suggest the wave may have peaked, though they're not sure because the virus is spreading in rural areas, where testing and medical care are inadequate. On Wednesday, India confirmed the highest single-day death toll (4,529) from COVID-19 anywhere in the world since the pandemic began.

Srivastava, her mother, Pradhan and their children have been isolating at home, grieving. Meanwhile, Pradhan tested positive for the coronavirus. He hadn't realized his own symptoms while so preoccupied with trying to save his father.

Richa Srivastava (from left); her mother; her father, Sheo Prakash Srivastava; her husband, Shalabh Pradhan; his father, Sudheer Kumar Pradhan; and their children in an undated family photo at the Statue of Liberty. Pradhan Family hide caption

Richa Srivastava (from left); her mother; her father, Sheo Prakash Srivastava; her husband, Shalabh Pradhan; his father, Sudheer Kumar Pradhan; and their children in an undated family photo at the Statue of Liberty.

The family relives the trauma with every TV report about COVID-19 and India's collapsing health system. Unlike in mid-April, the virus now dominates the Indian news.

Srivastava and Pradhan aren't sure what they will do next. Right now they're just sorting through old photos of their fathers at a family wedding, at the Statue of Liberty, playing with grandchildren.

"A lot of memories! That is why it hurts even more, because I keep on recalling those little things how [my father] used to cut fruit for me. No one will ever cut fruit for me like that again," Srivastava says. "All of these small gestures."

Pradhan recently wrote a poem to mourn both of his parents:

Who should I tell that I am in pain? Whose shoulder do I cry on? Everyone forgets, you just remain in our memories.

He's trying to concentrate on memories from the past few months their final Holi together when the pandemic gave his family a precious opportunity to come closer before taking two loved ones away.

NPR producer Sushmita Pathak contributed to this report from Hyderabad, India.

Excerpt from:

They Returned To India To Be Near Their Fathers, But Lost Them Both To COVID-19 - NPR

Introduction

Telehealth, the provision of health care services to patients from providers who are not at the same location, has experienced a rapid escalation in use during the COVID-19 pandemic, among both privately-insured patients and Medicare beneficiaries. Before the pandemic, coverage of telehealth services under traditional Medicare was limited to beneficiaries living in rural areas only, with restrictions on where beneficiaries could receive these services and which providers could be paid to deliver them. Soon after the federal government declared a public health emergency due to COVID-19 in early 2020, Congress and the Centers for Medicare & Medicaid Services (CMS) expanded traditional Medicares coverage of telehealth services in order to make it easier for beneficiaries to get medical care and minimize their exposure to coronavirus in health care settings. When the public health emergency ends, however, Medicares coverage of telehealth services will revert back to the more limited availability that existed before the pandemic, unless policymakers take action to extend the expanded coverage.

In light of the rapid, but time-limited, expansion of telehealth coverage under traditional Medicare, this brief provides an overview of the changes made during the COVID-19 pandemic to Medicares coverage of telehealth. It also presents new analysis of Medicare beneficiaries utilization of telehealth between the summer and fall of 2020, and discusses issues and questions related to extending telehealth coverage under traditional Medicare beyond the public health emergency. Our analysis of beneficiaries use of telehealth services is based on survey data of Medicare beneficiaries living in the community from the CMS Medicare Current Beneficiary Survey (MCBS) Fall 2020 COVID-19 Supplement. All differences reported in the text are statistically significant, unless otherwise noted. (See Data and Methods for details.)

Before the COVID-19 pandemic, coverage of telehealth services under traditional Medicare was limited. Medicare paid for approximately 100 services provided by telehealth, and there were limitations on how these services could be delivered and which beneficiaries could access them. Such limitations do not apply in Medicare Advantage plans, which have flexibility to offer additional telehealth benefits not covered by traditional Medicare outside of the public health emergency (see below for more information). Prior to the pandemic, the utilization of telehealth among traditional Medicare beneficiaries was extremely low, with only 0.3% of traditional Medicare beneficiaries enrolled in Part B using telehealth services in 2016, accounting for only 0.4% of traditional Medicare Part B spending. Similarly, analysis of primary care visits in traditional Medicare found that only 0.1% of these visits were provided via telehealth before the pandemic in February 2020.

To make it easier and safer for beneficiaries to seek medical care during the COVID-19 pandemic, the HHS Secretary waived certain restrictions on Medicare coverage of telehealth servicesfor traditional Medicare beneficiaries during the COVID-19 public health emergency, based on waiver authority included in theCoronavirus Preparedness and Response Supplemental Appropriations Act(and as amended by theCARES Act). The waiver, effective for services starting on March 6, 2020, significantly loosened coverage restrictions for telehealth under traditional Medicare during the public health emergency, as described below. The public health emergency was most recently renewed in April 2021, and, according to the Biden Administration, is expected to remain in place for the duration of 2021.

Before the public health emergency, telehealth services were generally available only to beneficiaries in rural areas originating from a health care setting, such as a clinic or doctors office. Beneficiaries in urban areas were ineligible for telehealth services, and beneficiaries could not receive telehealth services in their own homes. During the public health emergency, beneficiaries in any geographic area can receive telehealth services, and can receive these services in their own home, rather than needing to travel to a distant site (i.e., a health care setting).

Under Medicares existing telehealth benefit, a telehealth visit must be conducted with two-way audio/video communications and the use of smartphones or audio-only telephones in lieu of video is not permitted. For the duration of the COVID-19 public health emergency, telehealth services can be conducted via an interactive audio-video system, as well as using smartphones with real-time audio/video interactive capabilities without other equipment. Additionally, a limited number of telehealth services can be provided to patients via audio-only telephone or a smartphone without video.

Before the public health emergency, only physicians and certain other practitioners (such as physician assistants, clinical social workers, and clinical psychologists) were eligible to receive Medicare payment for telehealth services provided to eligible beneficiaries in traditional Medicare, and they must have treated the beneficiary receiving the services in the last three years. During the public health emergency, any health care professional that is eligible to bill Medicare for professional services can provide and bill for telehealth services, and does not need to have previously treated the beneficiary. Also, federally qualified health centers and rural health clinics are allowed to provide telehealth services to Medicare beneficiaries during the COVID-19 public health emergency; these settings were not authorized as providers of telehealth services for Medicare beneficiaries prior to the pandemic.

Before the public health emergency, traditional Medicare covered about 100 services that could be administered through telehealth, including office visits, psychotherapy, and preventive health screenings, among other services. During the public health emergency, the list of allowable telehealth services covered under traditional Medicare expanded to include emergency department visits, physical and occupational therapy, and certain other services. Some evaluation and management, behavioral health, and patient education services can be provided to patients via audio-only telephone.

Separate from Medicares coverage of telehealth services, traditional Medicare covers brief, virtual check-ins (also called brief communication technology-based services) via telephone or captured video image, andE-visits for all beneficiaries, regardless of whether they live in a rural area. Both of these services, which were not amended during the public health emergency, are more limited in scope than a full telehealth visit. For example, virtual check-ins can only be reported by providers with an established relationship to the patient, cannot be related to a recent medical visit (within the past 7 days), and cannot lead to a medical visit in the next 24 hours (or the soonest available appointment, and payment is intended to cover only 5-10 minutes of medical discussion.

Before the public health emergency, Medicares payment for a telehealth service was the same regardless of whether it was provided in a non-facility setting, such as a clinicians office, or a facility setting, such as a hospital outpatient department, and the payment rate was based on the lower amount paid to facility-based providers for a service delivered in person. (Under Medicares physician fee schedule, the payment to facility-based-providers for in-person services is lower than the payment to non-facility providers because Medicare makes a separate payment to facilities to cover practice expenses, such as physical space, medical supplies, medical equipment, and clinical staff time.) The rationale for using the lower facility payment amount for telehealth services was that practice expenses for the delivery of telehealth services should be lower than those for an in-person visit.

During the public health emergency, Medicare pays for telehealth services, including those delivered via audio-only telephone, as if they were administered in person, with the payment rate varying based on the location of the provider, which means that Medicare pays more for a telehealth service provided by a doctor in a non-facility setting than by a doctor in a hospital outpatient department. This also means that during the public health emergency, doctors in non-facility settings are receiving a higher payment for services provided by telehealth than they did before the public health emergency.

Beneficiary cost sharing for telehealth services has not changed during the public health emergency. Medicare covers telehealth services under Part B, so beneficiaries in traditional Medicare who use these benefits are subject to the Part B deductible of $203 in 2021 and 20% coinsurance. However, the HHS Office of Inspector General hasprovided flexibilityfor providers to reduce or waive cost sharing for telehealth visits during the COVID-19 public health emergency, although there is no publicly-available data to indicate the extent to which providers may have done so. Most beneficiaries in traditional Medicare have supplemental insurance that may pay some or all of the cost sharing for covered telehealth services.

Separate from the time-limited expanded availability of telehealth services, CMS has granted providers participating in some alternative payments models, including Next Generation accountable care organizations (ACOs) and Medicare Shared Savings Program ACOs, greater flexibility to provide care through telehealth, including billing for telehealth services provided to both urban and rural beneficiaries and to beneficiaries when they are at home. Telehealth flexibilities in the Next Generation ACO demonstration are granted via benefit enhancement waivers administered by CMS. From 2016-2018, few Next Generation ACOs received and implemented telehealth waivers (4 ACOs; 8% of all ACOs in the model).

Medicare Advantage plans have been able to offer additional telehealth benefits not covered by traditional Medicare outside of the public health emergency, including telehealth visits provided to enrollees in their own homes and services provided outside of rural areas. In 2021, virtually all Medicare Advantage plans (98%) offer a telehealth benefit.

Medicare Advantage plans are paid a capitated amount by Medicare to provide basic Medicare benefits covered under Parts A and B; legislative changes implemented in 2020 allow plans to include additional telehealth benefits beyond what traditional Medicare covers in their bids for basic benefits. Therefore, the cost of additional telehealth services offered by Medicare Advantage plans are reflected in the capitated payment that plans receive.

Medicare Advantage plans have flexibility to waive certain requirements with regard to coverage and cost sharing in cases of disaster or emergency, such as the COVID-19 outbreak. In response to the coronavirus pandemic,CMS has advised plans thatthey may waive or reduce cost sharing for telehealth services, as long as plans do this uniformly for all similarly situated enrollees. Many Medicare Advantage plans have waived or reduced cost sharing for enrollees for some or all services administered via telehealth during the public health emergency.

As of Fall 2020, six months after the expansion of telehealth benefits in traditional Medicare for the COVID-19 pandemic, nearly two-thirds of community-dwelling Medicare beneficiaries who say they have a usual source of care (64%, or 33.6 million beneficiaries), such as a doctor or health professional, or a clinic, reported that their usual provider offers telehealth appointments, up from roughly 1 in 5 (18%, or 6.1 million) beneficiaries who said their usual provider offered telehealth before the pandemic (Figure 2; Table 1). (The majority of community-dwelling Medicare beneficiaries, 95% or 52.7 million, report having a usual source of care). Conversely, 13% of beneficiaries with a usual source of care said their provider does not currently offer telehealth, a substantial decrease compared to the 52% who said their provider did not offer telehealth before the COVID-19 pandemic.

While the reported availability of telehealth has increased during the pandemic, nearly a quarter of Medicare beneficiaries with a usual source of care (23% or 11.9 million beneficiaries) said they do not know if their usual provider currently offers telehealth appointments.

The reported rates of beneficiaries who say their provider currently offers telehealth was similar across most demographic groups (Figure 3). However, a smaller share of Medicare beneficiaries living in rural areas than those living in urban areas said their provider currently offers telehealth (52% vs. 67%, respectively), and a larger share of rural beneficiaries report not knowing if their usual provider offers telehealth appointments than beneficiaries living in urban areas (30% vs 21%, respectively).

A larger share of Black Medicare beneficiaries with a usual source of care (23%) say their usual provider does not currently offer telehealth appointments than White (12%) and Hispanic (15%) beneficiaries with a usual source of care. Additionally, a larger share of Medicare beneficiaries enrolled in both Medicare and Medicaid (19%) say their usual provider does not currently offer telehealth appointments than Medicare beneficiaries who are not enrolled in both Medicare and Medicaid (12%).

Among the two-thirds of Medicare beneficiaries with a usual source of care who reported in the Fall of 2020 that their usual provider offers telehealth during the pandemic (33.6 million beneficiaries), nearly half (45%, or 14.9 million beneficiaries) reported having a telehealth visit since July 2020. Some groups of Medicare beneficiaries were more likely than others to report having a telehealth visit with a doctor or other health professional since July 2020, including Medicare beneficiaries under age 65 with long-term disabilities, Black and Hispanic beneficiaries, Medicare beneficiaries enrolled in both Medicare and Medicaid, and beneficiaries with multiple chronic conditions (Figure 4; Table 2).

Among Medicare beneficiaries who have a usual source of care and whose usual provider offers telehealth:

Notably, among Medicare beneficiaries with a usual source of care and whose usual provider offers telehealth, we found no significant difference between the share of rural and urban Medicare beneficiaries who had a telehealth visit (43% and 45%, respectively). However, based on the overall population in these groups, rural Medicare beneficiaries were less likely than urban beneficiaries to have a telehealth visit with a doctor or other health professional (21% vs. 28%, respectively). This difference is likely driven by the fact that rural Medicare beneficiaries were more likely than urban Medicare beneficiaries to say they do not know if their usual provider offers telehealth (30% vs. 21%, respectively).

Similarly, among Medicare beneficiaries with a usual source of care whose usual provider offers telehealth, we found that a larger share of Black and Hispanic beneficiaries had a telehealth visit compared to White beneficiaries (52%, 52%, and 43%). However, among the total Medicare population, the difference in the share of Black and White beneficiaries who reported having a telehealth visit was not statistically significant (30% vs. 26%), while a larger share of Hispanic beneficiaries than White beneficiaries had a telehealth visit (33% vs. 26%). For Black Medicare beneficiaries, this result is likely related to the fact that nearly a quarter of Black beneficiaries overall (23%) say their usual provider does not offer telehealth appointments, compared to 12% of White beneficiaries and 15% of Hispanic beneficiaries.

Among Medicare beneficiaries with a usual source of care whose provider offers telehealth appointments, the majority of those who had a telehealth visit since July 2020 accessed the service by telephone (56%), compared to 28% who reported having a telehealth visit by video and 16% who used both telephone and video (Figure 5; Table 3). This may be related to the fact that while more than 8 in 10 Medicare beneficiaries report having access to the internet (83%), smaller shares say they own a computer (64%) or a smartphone (70%) (Figure 6, Table 4).

There are notable differences by demographic characteristics in how beneficiaries have accessed telehealth services during the pandemic and the availability of technology that enables access to telehealth, for example:

Our analysis finds that 1 in 4 Medicare beneficiaries have had a telehealth visit during the COVID-19 public health emergency, representing a substantial increase in use since before the pandemic. Our finding that, among beneficiaries whose provider offers telehealth, a greater share of those with disabilities, with low incomes, and in communities of color have used telehealth suggests that the temporary expansion of telehealth coverage may be helping some of Medicares more disadvantaged populations continue to access needed care. At the same time, in light of our finding that a quarter of Medicare beneficiaries overall (and an even larger share of those in rural areas) do not know if their doctor currently offers telehealth, efforts to increase awareness of covered telehealth services under Medicare during the public health emergency could help to broaden its reach.

Currently, policymakers are considering a variety of proposals to expand some or all of the existing flexibilities surrounding telehealth services under Medicare beyond the public health emergency, and many have expressed support for doing so. Among the telehealth-related bills that have been introduced in the 117th Congress include proposals to permanently cover some of the telehealth expansions provided during the public health emergency, expand Medicare-covered mental health services and evaluation and management services administered via telehealth, and expand the scope of providers eligible for payment for telehealth services covered by Medicare. Other bills are aimed at assessing the impact of expanded telehealth services on the quality of patient care and program spending.

Under Medicares existing telehealth benefit, a telehealth visit must be conducted with two-way audio/video technology, while under the current public health emergency waiver, a limited number of telehealth services can be provided to patients via audio-only telephone. Given that the majority of Medicare beneficiaries in our analysis reported accessing telehealth services by telephone only, an expanded telehealth benefit that requires two-way video communication could be a barrier to care for subgroups of the Medicare population that relied more heavily on telephones than video-capable devices during the pandemic.

MedPAC has recommended that Medicare continue a modified version of expanded telehealth coverage for another year or two after the public health emergency ends, giving Medicare time to assess the effects of telehealth use on total costs, access, and quality of care. During this additional time, MedPAC recommends that Medicare pay for specified telehealth services regardless of where a beneficiary lives; cover some additional telehealth services beyond those covered prior to the public health emergency if there is potential for clinical benefit; and cover audio-only telehealth visits if there is potential for clinical benefit. MedPAC has also recommended that payment for telehealth services after the public health emergency revert to the lower facility-based payment rate in effect before the pandemic, and that providers should not be allowed to waive or reduce beneficiary cost sharing.

Expanded coverage of telehealth beyond the public health emergency could affect the quality of patient care as well as program and beneficiary spending. Broadening telehealth coverage has the potential to improve access to needed care, but there is uncertainty as to whether it would lead to an overall increase or decrease in program spending. Some telehealth services may be substitutes for in-person care, such as a behavioral health care visit, though easier access to telehealth could lead to an overall increase in visits and costs. Other telehealth services may not fully replace the need for (or occurrence of) an in-person visit, such as a visit to evaluate a skin rash or where lab work is determined to be needed. In building evidence on the cost and quality impacts of telehealth use in Medicare, the Administration could also potentially gain insights based on telehealth use by enrollees in Medicare Advantage plans, or by testing different approaches through Center for Medicare and Medicaid Innovation models.

The potential expansion of telehealth coverage brings with it concerns about the potential for fraudulent activity. There have been several large fraud cases involving telehealth companies in recent years, most of which involved the submission of fraudulent claims for items, services, and tests to Medicare and other insurers that were never given or administered to patients. HHS Office of the Inspector General (OIG) is conducting several studies to assess the appropriateness of use of telehealth during the public health emergency, including an analysis of provider billing patterns in order to identify providers that could pose a risk for program integrity and an audit of telehealth services under Part B to assure that services are meeting Medicare requirements. MedPAC has recommended that Medicare apply additional scrutiny to outlier clinicians who deliver more telehealth services than others, as well as requiring in-person visits before clinicians can order high-cost equipment or services for beneficiaries.

The temporary expansion of coverage for telehealth services has allowed many people with Medicare to access medical care during the coronavirus pandemic. Given that the temporary waiver of restrictions on coverage of telehealth services under Medicare will come to an end with the expiration of the public health emergency, the question of whether and how to ensure continued access to these services, while balancing concerns about quality of care and spending, looms large.

In order to determine the share of Medicare beneficiaries whose provider offers telehealth, beneficiaries who answered affirmatively to the question Is there a particular doctor or other health professional, or a clinic you usually go to when you are sick or for advice about your health? (9,216 out of 9,686 respondents) were asked Does your usual provider offer telephone or video appointments, so that you dont need to physically visit their office or facility? (5,644 respondents answered affirmatively).

In order to determine the share of Medicare beneficiaries who had a telehealth visit, beneficiaries with a usual source of care whose usual provider offers telehealth appointments were asked Since July 1, 2020, have you had an appointment with a doctor or other health professional by telephone or video? (2,515 respondents answered affirmatively). Similarly, beneficiaries with a usual source of care whose provider offers telehealth were asked Did your usual provider offer telephone or video appointments before the coronavirus pandemic? (1,035 respondents answered affirmatively).

To determine how beneficiaries accessed telehealth appointments, beneficiaries who had a telehealth appointment since July 2020 were asked Was it a telephone appointment, video appointment, or both? The majority of Medicare beneficiaries who had a telehealth visit since July 2020 had a visit via telephone (n=1,460), while fewer had a telehealth visit via video (n=653) or via both telephone and video (n=393).

Based on the questionnaire skip patterns, beneficiaries were only asked about their use of telehealth if they answered affirmatively that they had a usual source of care and that their usual provider offers telehealth. In order to determine the share of Medicare beneficiaries who had a telehealth visit among Medicare beneficiaries overall, we created a categorical variable that included beneficiaries whose provider did not offer telehealth or it was unknown. The variable had three categories: 1) usual provider offers telehealth and beneficiary had a telehealth visit (n=2,515); 2) usual provider offers telehealth and beneficiary did not have a telehealth visit (n=3,074); 3) usual provider does not offer telehealth or it was unknown (n=4,097).

Results from all statistical tests were reported with p<0.05 considered statistically significant.

More:

Medicare and Telehealth: Coverage and Use During the COVID-19 Pandemic and Options for the Future - Kaiser Family Foundation

What GAO Found

GAO analysis of data from the Centers for Disease Control and Prevention (CDC) shows that, from May 2020 through January 2021, nursing homes commonly experienced multiple COVID-19 outbreaks. According to CDC, an outbreak starts the week a nursing home reports a new resident or staff COVID-19 case and ends when there are 2 weeks with no new cases. GAO found that nursing homes had an average of about three outbreaks during the review period, with most of the nursing homes (94 percent, or 12,555 of the 13,380 nursing homes) experiencing more than one COVID-19 outbreak.

Note: Percentages may not add to 100 due to rounding. Data are from the weeks ending May 31, 2020, through January 31, 2021. An outbreak begins when a nursing home reports a new case of COVID-19 in residents or staff.

For each nursing home's longest-lasting COVID-19 outbreak, GAO found that about 85 percent (11,311 nursing homes) had outbreaks lasting 5 or more weeks. Conversely, for about 15 percent of nursing homes (2,005 homes), the longest outbreak was shorter in duration, lasting between 1 and 4 weeks, with 267 of those homes able to control their outbreaks after the initial week.

Note: Of 13,380 nursing homes reviewed, 13,316 nursing homes had COVID-19 outbreaks and 64 nursing homes did not. Data are from the weeks ending May 31, 2020, through January 31, 2021.

The COVID-19 pandemic has had a disproportionate impact on the 1.4 million elderly or disabled residents in the nation's more than 15,000 Medicare- and Medicaid-certified nursing homes. The Centers for Medicare & Medicaid Services (CMS) is responsible for ensuring that nursing homes nationwide meet federal quality standards.

The CARES Act includes a provision directing GAO to monitor the federal pandemic response. GAO was also asked to review CMS oversight of nursing homes in light of the pandemic. This report describes the frequency and duration of COVID-19 outbreaks in nursing homes. Future GAO reports will further examine nursing homes' experiences with COVID-19 outbreaks.

To conduct this work, GAO analyzed CDC data on COVID-19 reported by nursing homes each week of the review period from May 2020 through January 2021, the most recent data available at the time GAO conducted its review. Using CDC's definition of an outbreak, GAO determined the number and duration of outbreaks each nursing home experienced during the review period. GAO included data from the 13,380 Medicare- and Medicaid-certified homes (88 percent of Medicare- and Medicaid-certified homes) that passed CDC and CMS quality checks each week of the review periodthe most reliable data for calculating the number and duration of outbreaks. GAO also categorized the nursing homes into two groups based on the duration of their longest outbreak: 1) those nursing homes with outbreaks lasting less than 5 weeks and 2) those nursing homes with outbreaks lasting at least 5 weeks.

For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.

Excerpt from:

COVID-19 in Nursing Homes: Most Homes Had Multiple Outbreaks and Weeks of Sustained Transmission from May 2020 through January 2021 - Government...

19 May, 2021

Media Contact:Orange County Fire RescuePhone: 407-836-9890Email: FirePIO@ocfl.net

Orange County, Fla. May 19, 2021 Orange County will be distributing weather radios, ahead of hurricane season, at five Orange County Government COVID-19 vaccination sites this week.

In anticipation of the 2021 Hurricane Season, that begins June 1, 2021 continues until November 30th, the Office of Emergency Management at Orange County Fire Rescue will distribute 500 radios throughout the course of the week at all five vaccination sites in the County.

The sites include:

Orange County wants to assure that our citizens are prepared for the upcoming Hurricane Season by making sure that everyone is vaccinated and prepared for any hazardous weather that may impact our area, said Lauraleigh Avery, Emergency Manager, Orange County Office of Emergency Management. Orange County families that visit our five vaccination sites can receive a free weather alert radio and an Orange County Emergency Preparedness Guide while supplies last. Preparing today, provides for a safer tomorrow.

Orange County will be providing 25 free weather radios per day, at the five Orange County COVID-19 vaccination sites on a first-come, first-serve basis. One weather radio will be provided, per family that participates in getting vaccinated. It is the goal of Orange County Fire Rescue to make sure all residents can stay informed during a weather emergency by using weather radios in the home.

The 500 radios will be given away to citizens participating in getting vaccinated starting Thursday, May 20th through Sunday May 23rd.

For more information about the sites and times, please go to http://www.ocfl.net/vaccine.

About Orange County Government:Orange County Government strives to serve its residents and guests with integrity, honesty, fairness and professionalism. Located in Central Florida, Orange County includes 13 municipalities and is home to world-famous theme parks, one of the nations largest convention centers and a thriving life science research park. Seven elected members make up the Board of County Commissioners, including the Mayor, who is elected countywide. For more information, please visitwww.OCFL.netor go toOrange County Governments social media channels.

More here:

Orange County Distributing Weather Radios at COVID-19 Vaccination Sites - Orange County Government, Florida