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For a long time Cubans were proud of their health-care system, and justifiably so. Between 2000 and 2020 the small communist-run island outspent most other countries in Latin America and the Caribbean. Life expectancy is higher than in the United States. Cuba has qualified doctors and nurses to spare. When covid-19 first struck, Cuba sent some of its medics to countries struggling with their initial wave of patients. An impressive 89% of Cubas population is now fully vaccinated with its homegrown covid jabswhich boast efficacy rates of up to 92.4% after three doses. But according to The Economists excess mortality tracker, Cuba has one of the highest estimated death tolls from the pandemic, relative to its size. Where did it go wrong?
Officially, by August 2022 covid had killed 8,529 of Cubas 11m people. But our model estimates that the true toll could be far higher. Excess mortalitythe gap between how many people have died in a given period, regardless of cause, and how many deaths would normally have been expectedsuggests that up to 62,000 Cubans may have died as a result of the pandemic. That 600% increase over the official toll is probably the result of inadequate testing and other problems. It is possible that officials underreported the deaths, too.
Cubas estimated tally of excess deaths per 100,000 people is 550. This revised death toll would place it among the 20 worst countries in the world. It would also make Cuba an outlier in the region: the average across the Americas is 368.
Its ageing populationalmost 20% of Cubans are over 60, more than anywhere else in the regionmade Cuba especially vulnerable to covid. But other factors were avoidable. Budget cuts and a shortage of essential supplies were taking a toll even before the pandemic. After the outbreak hospitals quickly became overwhelmed; oxygen, personal protective equipment and medicines ran short. And although plenty of Cubans are now vaccinated, the country was slow off the mark. Deaths peaked as late as August 2021, during the Delta wave. In that month only around 35% of Cubans had received a full course of covid vaccinations, compared with 64% of Britons and 54% of Americans. The pandemic has brought to light something Cubans have known for some time, but that officials wanted to keep under wraps: the countrys health-care system is not what it used to be.
Increasing population immunity decreased transmission of COVID-19 and allowed for reductions in quarantine and testing, encouraging 2-dose vaccine and booster uptake.
Maintaining high population immunity, preferably by booster uptake, is essential in determining appropriate quarantine duration for controlling the spread of SARS-CoV-2, according to a study recently published in PNAS Nexus.
The CDCs reduction of the recommended 7-day quarantine for close contacts of a COVID-19 case to 5 days for the unvaccinated and no quarantine for the vaccinated may not effectively mitigate transmission, according to the authors. Quarantine and testing strategies were found to depend on the incubation period and the transmissibility and level of population immunity against infection.
Researchers compared the probability of post-quarantine transmission and the effective reproduction number with serial testing and isolation for the original SARS-CoV-2 strain and 3 variants of concern, Alpha, Delta, and Omicron, at different levels of vaccination. The comparison of the number of post-quarantine secondary infections between vaccinated and unvaccinated individuals demonstrated that the effect of vaccination status of an individual had only a limited effect on quarantine duration.
Vaccinated cases were less likely to exhibit symptoms than unvaccinated cases, which resulted in less frequent self-isolation. The decreases in case detection and self-isolation increased the probability of releasing an infectious case from quarantine.
Variants of concern produced increased transmission and earlier transmission in the disease time course than the original SARS-CoV-2 strain, challenging the effectiveness of current quarantine and testing strategies. The findings also suggested that determining optimal disease control strategies also depends on the level of population immunity.
Increasing population immunity through vaccine and booster uptake was found to mitigate transmission. Improving 2-dose vaccine uptake led to a substantial decrease in the probability of post-quarantine transmission during serial testing. Increasing uptake of 2-dose vaccines also notably reduced quarantine durations.
However, increasing booster uptake only provided substantive benefit to serial testing compared to quarantine. The decrease in probability of post-quarantine transmission concomitant with an increase in booster uptake was found to diminish as quarantine duration lengthened.
The effectiveness of serial testing in reducing transmission was greatly improved through an increase in booster uptake, according to the study.
Researchers found that scaling up vaccine-acquired immunity from no vaccination to 100% booster intake yielded a reduction in quarantine by 6 days for the original SARS-CoV-2 strain, but only yield a 2-day reduction in quarantine for the Omicron variant. In a population with 100% 2-dose vaccination, scaling up booster intake could justify a reduction of quarantine by as much as 3 days.
However, boosting only has a moderate impact of quarantine duration for Omicron, decreasing it by almost a day. Increasing booster uptake can result in significant differences in the required frequency of serial testing.
Increased 2-dose vaccine uptake also justified reduced surveillance through serial testing, according to the study. Additionally, the findings suggested that rapid antigen testing requires a frequency of every 6 days to curtail transmission within a population that is 100% boosted, encouraging booster uptake.
Overall, an individuals vaccination status was found to have limited influence on post-quarantine transmission compared to vaccination coverage of the population. Increasing population immunity through vaccination not only decreases transmission, but can also allow for substantial relaxation of requirements for quarantine and testing.
The authors note that surveillance of the immunological status of the population is much more important than the status of the quarantined individual when determining effective quarantine durations. They recommend continued efforts to administer vaccines and booster doses to lessen the burden on health care systems and prevent large outbreaks with emerging variants of concern or their subvariants.
Reference
Wells C R, Pandey A, Gokcebel S, et al. Quarantine and serial testing for variants of SARS-CoV-2 with benefits of vaccination and boosting on consequent control of COVID-19. PNAS Nexus. 2022;1(3). https://doi.org/10.1093/pnasnexus/pgac100
Abstract
The introduction of COVID-19 vaccination has been unprecedented in scope and challenges. While the risk of severe disease is lower in children and adolescents, vaccination significantly reduces the risk of severe complications in young people. Not only does vaccination protect children and adolescents from severe illness and death on an individual level, but increasing COVID-19 vaccination coverage among young people is critical to curbing overall community transmission of the disease at the population level.
Drawing on the UNICEF Innocenti Children and COVID-19 Research Library, this issue of the digest summarizes evidence of factors influencing caregiver decision-making attitudes and behaviours regarding vaccinating children and adolescents against COVID-19. Eleven research papers are spotlighted along with some practical tools to support caregiver decision-making and enhance vaccine uptake. The evidence, insights and lessons from these studies can help policymakers and health practitioners better support caregivers to make important decisions related to the health of their children and communities.
Read more.
Kathleen Connelly is a partner in Lindabury, McCormick, Estabrook & Cooper (based in Westfield, NJ) who serves as the Co-Chair of the Firms Labor & Employment Practice Group. She provided the following insight into the updated guidance from the Equal Employment Opportunity Commission (EEOC) on mandatory COVID-19 testing in the workplace.
Early in the onset of the COVID-19 pandemic the Equal Employment Opportunity Commission (EEOC) issued guidance clearing the way for all employers to mandate COVID-19 viral testing for all employees without the need for any individualized justification or assessment. The health risks posed by the virus at that time prompted the agency to conclude that the health emergency trumped the Americans with Disabilities Acts prohibition against medical testing that was not job related and consistent with business necessity.The Heightened job Related and Consistent with Business Necessity Requirement.
In a hopeful sign that the COVID-19 pandemic may be waning, on July 12, 2022, the EEOC revised its mandatory testing guidance to now require employers to assess whether current pandemic circumstances and individual workplace circumstances justify COVID 19 testing of employees to prevent workplace transmission. The EEOC cautioned that the reinstitution of the job related and consistent with business necessity standard is not meant to suggest that such testing is or is not warranted; rather, the revised [guidance] acknowledges that evolving pandemic circumstances will require an individualized assessment by employers to determine whether such testing is warranted.
The updated guidance lists the following possible factors that an employer may want to consider during the assessment to satisfy the heightened standard: The currently levels of COVID-19 community transmission The vaccination status of employees The degree of breakthrough infections of fully vaccinated employees The transmissibility of current variants The potential severity of illness from current variants The level of contacts employees may have with others during the course of their work The potential impact upon the employers operations if an infected employee enters the workplace
The EEOC further cautioned that when making these assessments, employers should check the latest CDC guidance (and any other relevant sources) to determine whether COVID-19 testing is appropriate for these employees.
Other Screening Measures Not Affected.These revisions do not impact the employers ability to implement other non-invasive screening measures, such as temperature checks, questionnaires about an employees symptoms or vaccination status, or to mandate vaccinations for those entering the workplace, subject to the reasonable accommodation requirements for medical conditions or religious practices.
Employer Actions.Employers who currently have mandated COVID-19 viral testing programs should immediately conduct an assessment, applying the factors listed by the EEOC, to ensure the testing meets the job-related and consistent with business necessity standard. A failure to meet this standard could prompt claims that the employers testing program was in violation of employee rights under the ADA. Employers should document the assessment to create a record of how the suggested EEOC factors were evaluated to defend against any challenges to the testing program. These records should be retained for at least two years.
About Lindabury, McCormick, Estabrook & Cooper, P.C. (www.lindabury.com)Lindabury, McCormick, Estabrook & Cooper, P.C., (Lindabury) is a mid-sized general practice law firm, located in Central New Jersey. From its offices across New Jersey, New York and Pennsylvania, the firm services clients throughout the Mid-Atlantic region. Lindabury provides litigation and transactional counsel to a broad spectrum of clients, including corporations, privately held businesses, insurance firms, healthcare institutions, trade associations, employee benefit funds, banks and financial institutions, nonprofit organizations and individuals.
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Pregnancy is a really exciting time, to be sure. But lets be real: It can also be stressful especially during this era of COVID-19.
Pregnant people are one of several groups at a higher risk of becoming very ill from COVID-19. COVID-19 can also lead to serious pregnancy complications as well.
The good news is that the COVID-19 vaccine can protect against severe illness and complications. The Centers for Disease Control and Prevention (CDC) recommends that anyone who is pregnant, breastfeeding, or plans to become pregnant get a COVID-19 vaccine and booster.
Getting vaccinated during pregnancy may feel intimidating, but were here to help. Keep reading as we go over eight facts about the COVID-19 vaccine that are backed by research.
According to the CDC, if youre pregnant, you have a higher risk of serious illness from COVID-19. This can include things like:
Thats not all, though: COVID-19 can also have serious consequences for your pregnancy. Thats because if you get COVID-19 while pregnant, you have a higher risk of pregnancy complications.
A March 2022 review of research notes that various studies have found that getting COVID-19 while pregnant is associated with an increased risk of:
Vaccination can go a long way in helping prevent these complications.
Lets get a big concern out of the way next: COVID-19 vaccines are indeed safe and effective during pregnancy.
Since the COVID-19 vaccines have been available, many studies have supported this. Were not going to cover each one of them here (that would take all day), but lets explore what some of them say.
Researchers in a 2021 study looked at the effectiveness of the Pfizer-BioNTech COVID-19 vaccine in pregnant women. They compared 7,530 vaccinated pregnant women and 7,530 unvaccinated pregnant women.
Overall, researchers found vaccinated women had a significantly lower risk of contracting the coronavirus that causes COVID-19 than their unvaccinated counterparts.
Further, none of the vaccinated women reported serious side effects from vaccination. The most common side effects were similar to those seen in the general population and included:
Vaccines work by introducing your immune system to a germ. Your immune system crafts a response, which includes antibodies, to the vaccine. Your immune system can then call upon this response to protect you from the actual germ in the future.
Another bit of good news is that pregnant people appear to make the same immune response to COVID-19 vaccination as nonpregnant people.
In a 2021 study, researchers compared immune responses in 131 pregnant, lactating, or nonpregnant women. They found the levels of antibodies made in response to vaccination were similar between all three groups. Side effects were also similar in all groups.
And theres more: Antibody levels made in response to vaccination during pregnancy were higher than the antibodies made from infection during pregnancy.
Despite the safety and effectiveness of the COVID-19 vaccine during pregnancy, vaccination in this group is still low compared with the general population.
For example, a January 2022 study in Scotland found that in October 2021, only 32.3% of women giving birth had received two doses of a COVID-19 vaccine, compared with 77.4% of the total female population.
A 2021 study found that out of a group of 1,328 pregnant women, less than one-third got the COVID-19 vaccine when it was offered to them. Vaccinated women still had similar pregnancy outcomes to those who were not vaccinated.
Raising vaccine coverage is vital for preventing severe illness and complications during pregnancy. However, concerns about the vaccine and its potential effects have made people hesitant. Lets explore some of these concerns next.
One concern about the COVID-19 vaccine is whether it increases the risk of miscarriage. Research says this isnt the case.
A 2021 research letter outlines a study on this topic. For the study, researchers used the Vaccine Safety Datalink database to analyze COVID-19 vaccines and miscarriage rates. Data from about 3% of the U.S. population is included in this database.
Researchers found 105,446 unique pregnancies, 92,286 of which were ongoing and 13,160 of which resulted in miscarriage. All three COVID-19 vaccines used in the United States were represented within this large group.
Researchers wanted to see whether COVID-19 vaccines were linked with miscarriage. They were specifically looking to see whether people who had a miscarriage were more likely to have received a COVID-19 vaccine in the past 28 days.
This isnt what they found. Instead, researchers saw that, compared with those with ongoing pregnancies, women who had a miscarriage were not more likely to have received a COVID-19 vaccine in the previous 28 days.
COVID-19 vaccination is also not associated with birth and delivery complications.
Researchers in a March 2022 study reviewed data from a population-based survey. Among a group of 97,590 pregnant people, 22,660 (23%) had gotten at least one dose of a COVID-19 vaccine during their pregnancy.
Researchers compared people who were vaccinated during their pregnancy to those who got vaccinated after their pregnancy. They found that vaccination during pregnancy did not lead to a significantly increased risk of:
Another large March 2022 study also supports these findings. This study used data from 157,521 deliveries of single babies (no twins, triplets, etc.) in Sweden and Norway.
Within this group, 28,506 pregnancies (18%) included COVID-19 vaccination at some point during pregnancy. Compared with pregnancies in which no COVID-19 vaccine was given, researchers found that among the pregnancies with vaccination, there was no increased risk of:
If youre not yet pregnant but plan to be in the near future, you may wonder whether the COVID-19 vaccine could affect your fertility. According to the CDC, theres currently no evidence that COVID-19 vaccines cause fertility issues.
Research supports this statement. A January 2022 study included 2,126 self-identified female participants ages 21 through 45 who were trying to get pregnant. Participants completed surveys every 8 weeks about:
After analyzing the data, researchers concluded that COVID-19 vaccination was not associated with long-term decreased fertility in either females or males.
But researchers did find that getting COVID-19 itself was associated with a potential temporary decline in male fertility for about 60 days.
Now that weve debunked the main concerns about COVID-19 vaccination during pregnancy, lets take a look at some of the benefits that vaccination may give your baby.
Antibodies that your body makes after vaccination can be passed to your baby through the placenta. These antibodies can go on to protect them when theyre particularly vulnerable to germs in the months after birth.
A June 2022 study included 21,643 babies, 9,739 (45%) of whom were born to mothers who had gotten their second or third dose of a COVID-19 vaccine during pregnancy.
Researchers found these babies had a lower risk of having a positive COVID-19 test within 4 months of birth. This finding persisted during both the Delta and Omicron coronavirus variant waves, although protection was stronger against Delta.
A February 2022 study included 379 hospitalized babies; 176 of them had COVID-19 and the other 203 babies were hospitalized for other reasons.
Researchers wanted to see how effective maternal vaccination was at preventing COVID-19 hospitalization of a baby within their first 6 months of life. Using this parameter, researchers found that vaccine effectiveness was:
How long does this protection last, though? Researchers aimed to find this out.
According to a February 2022 research letter, experts compared antibody levels in babies whose mothers had either been vaccinated against COVID-19 during pregnancy or who had actually had COVID-19 during pregnancy.
Overall, researchers found that antibody levels in babies whose mothers had been vaccinated against COVID-19 while pregnant stuck around for longer.
Six months after birth, 57% of babies born to vaccinated mothers still had detectable antibodies. Only 8% of babies whose mothers had COVID-19 during pregnancy had detectable antibodies.
Its known that breastfeeding parents pass antibodies to their babies through breast milk. These antibodies can help protect a baby from various germs.
Antibodies made in response to COVID-19 vaccination have been detected in breast milk. Lets look at a research letter about a 2021 study that discussed this.
The study included 84 breastfeeding mothers who provided 504 breast milk samples over the course of the study. After getting the first dose of the Pfizer-BioNTech vaccine, participants were followed up weekly for 6 weeks.
Researchers looked for two types of antibodies to COVID-19 called IgA and IgG. IgA is found earlier in the immune response. IgG appears later.
They found the amount of breast milk samples with IgA rose early after vaccination. They peaked at week 4 (1 week after the second dose) before beginning to drop at week 6.
Few breast milk samples contained IgG after the first vaccine dose. However, by weeks 4 and 6, more than 90% of breast milk samples had detectable IgG.
This all sounds great, right? There are some caveats: The number of participants was small, and its unknown how long these antibodies last or the strength of protection they provide to a baby. More research will help find these things out, though.
The COVID-19 vaccine is safe and effective during pregnancy. Its vital for preventing serious illness and pregnancy complications from COVID-19.
The COVID-19 vaccine has not been associated with an increased risk of infertility, miscarriage, or other pregnancy and delivery complications.
In fact, vaccinated pregnant people can pass antibodies to their baby both through the placenta and breast milk. These antibodies can continue to protect babies after theyre born.
The COVID-19 vaccine is recommended for all people who are pregnant, breastfeeding, or plan to get pregnant. If you ever have questions or concerns about getting the COVID-19 vaccine, be sure to raise them with your doctor or another healthcare professional.
The COVID-19 pandemic is not over. Despite the success of safety protocols and life-saving vaccines, vaccine inequality has allowed dangerous variants to develop, threatening the lives of people everywhere.
Now, the Centers for Disease Control and Prevention (CDC) warns that the BA.5 variant is now the dominant strain of COVID-19 in the United States and has led to a surge in cases and hospitalizations.
I completely understand the frustration and the pandemic fatigue; Im feeling it, and I know other health care professionals are too, Dr. Purvi Parikh told Global Citizen. But the reality of the situation is, the virus is still here and were still seeing a lot of new cases.
Parikh is an immunologist based in New York City, where shes been involved with the COVID-19 vaccine trials at New York University since the beginning of the pandemic. Over the past few months, she has personally diagnosed patients with COVID-19 every single day.
More than 78% of Americans are at least partially vaccinated, but the latest wave of cases is making it difficult to know who is most at risk of contracting a serious case of COVID-19. For this reason, Parikh spoke to Global Citizen about adjusting to life with COVID-19 and how booster shots can help end the pandemic globally.
According to a poll from the Pew Research Center conducted between January and May of this year, fewer Americans think COVID-19 is a major threat to public health than at the beginning of the pandemic. Meanwhile, current data about the BA.5 variant suggests that it is the most contagious strain of COVID-19, with the added bonus of being able to partially evade immunity from past infection and vaccination.
One thing I want to clarify (thats a big misconception) is that the current variant is not mild, Parikh said. We are seeing an uptick in hospitalizations and deaths, though mostly in unvaccinated individuals.
Pandemic fatigue has led some people to take risks they would not have taken before, such as forgoing masks or ignoring symptoms. Though fully vaccinated individuals may experience more protection than those who have not received a COVID-19 vaccine, the risks of contracting the virus still exist. This means that getting a booster shot is more important than ever.
Dont underestimate this virus even if youre fully vaccinated because everyones risk profile is different. If youre immunocompromised, elderly, have heart disease youre still at high risk, Parikh added.
Additional risks that come with contracting COVID-19 are becoming clearer as health care professionals learn more about the virus. Parikh, in particular, is studying long COVID, or the illness in which people who have recovered from COVID-19 experience lingering symptoms.
Some of Parikhs patients plagued by long COVID report neurological symptoms like brain fog, loss of taste and smell, and prolonged ringing in their ears. Others are experiencing extreme fatigue, difficulty breathing, heart palpitations, and nausea, months or years after their initial diagnosis of COVID-19.
Its only been two years so we dont really know the long-term effects [of COVID-19], Parikh said. But there are centers around the country studying long COVID.
Parikh shared that sensationalist headlines can make it seem like booster shots are futile when up against contagious subvariants, but the data doesnt lie. According to the CDC, hospitalization rates are 4.6 times higher for unvaccinated adults than for those who are up to date with their COVID-19 vaccination.
The boosters still protect you against hospitalization, death, and the people were mostly seeing getting admitted to hospitals havent gotten their boosters, or havent gotten vaccinated at all, Parikh said.
Like many other vaccines, the COVID-19 vaccines lose part of their efficacy over time, but that doesnt mean they arent effective at all. Ongoing research and clinical trials prove that receiving an additional dose of the vaccine after the initial two-shot series improves immunity, keeping people from getting extremely sick.
The doctor also pointed out that antibodies arent the only factors to consider when it comes to immunity.
T cells [which are part of the immune system] are much more important for fighting viruses than antibodies and are still very effective against the newer variants, she said. You need that T cell immunity to keep you off a breathing machine in the ICU, to keep you from dying, or from getting bad complications.
Guidance about the COVID-19 vaccines cannot rely on a one-size-fits-all approach, which is why Parikh underscored the importance of speaking with a physician about your personal risk of COVID-19. Depending on your age and health status, getting one or two booster shots may be the best way to protect yourself and others.
[Boosters shots] are very effective, especially if youre in a high risk group. Most people should have a third [dose of a COVID-19 vaccine], and some people should have a fourth depending on their risk profile, Parikh said.
Additionally, getting a booster shot now can help end the pandemic faster. According to Our World in Data, only 19.9% of people in low-income countries have received at least one dose of a COVID-19 vaccine, compared with 80% in wealthier nations. If COVID-19 continues to spread globally, newer variants will keep developing, putting more people at risk.
One of my favorite sayings from the UN Foundation is: An outbreak anywhere is an outbreak everywhere. This pandemic is case in point, Parikh said. The quicker everyone gets their vaccine, the quicker everyone is protected.
COVID-19 has been a scary, daily part of life for the past two years. While we cant let our guard down just yet, its important to recognize just how far weve come.
Were in a much better place than we were two years ago, Parikh said. If someone is diagnosed with COVID, I can treat them with an antiviral right away.
She added: The other good news is the vaccine. If you get sick, [being vaccinated] reduces your chances of death and hospitalization significantly.
Parikh also shared that clinical trials are continuously taking place, helping health care professionals get one step closer to ending the pandemic. Until we get there, however, we all have to do our part to protect each other.
Be up to date with your vaccines, whether thats with one booster or two boosters. Wash your hands, wear a high quality mask, and have a plan in place if you get sick because we do have the tools to fight this virus, she said. If you take these precautions, you can still live your life normally.
This article is part of a series focused on vaccine hesitancy funded by the Rockefeller Foundation.
The West Virginia Department of Health and Human Resources (DHHR) reports as of August 3, 2022, there are currently 3,166 active COVID-19 cases statewide. There have been six deaths reported since the last report, with a total of 7,169 deaths attributed to COVID-19.
DHHR has confirmed the deaths of a 65-year old female from Hardy County, an 86-year old male from Marshall County, a 74-year old male from Jackson County, a 51-year old male from Mercer County, an 86-year old male from Kanawha County, and an 85-year old female from Braxton County.
We extend our deepest sympathies to all grieving the loss of their loved ones, said Bill J. Crouch, DHHR Cabinet Secretary. Please schedule a COVID-19 vaccine or booster today to protect yourself and those around you.
CURRENT ACTIVE CASES PER COUNTY: Barbour (51), Berkeley (169), Boone (60), Braxton (14), Brooke (27), Cabell (158), Calhoun (8), Clay (8), Doddridge (8), Fayette (94), Gilmer (11), Grant (17), Greenbrier (70), Hampshire (32), Hancock (32), Hardy (41), Harrison (119), Jackson (36), Jefferson (80), Kanawha (288), Lewis (21), Lincoln (44), Logan (82), Marion (106), Marshall (59), Mason (51), McDowell (50), Mercer (152), Mineral (34), Mingo (47), Monongalia (128), Monroe (38), Morgan (16), Nicholas (44), Ohio (68), Pendleton (3), Pleasants (9), Pocahontas (12), Preston (26), Putnam (110), Raleigh (204), Randolph (25), Ritchie (16), Roane (38), Summers (27), Taylor (28), Tucker (10), Tyler (12), Upshur (40), Wayne (55), Webster (19), Wetzel (12), Wirt (11), Wood (194), Wyoming (52). To find the cumulative cases per county, please visit coronavirus.wv.gov and look on the Cumulative Summary tab which is sortable by county.
West Virginians ages 6 months and older are recommended to get vaccinated against the virus that causes COVID-19. Those 5 years and older should receive a booster shot when due. Second booster shots for those age 50 and over who are 4 months or greater from their first booster are recommended, as well as for younger individuals over 12 years old with serious and chronic health conditions that lead to being considered moderately to severely immunocompromised.
Visit the WV COVID-19 Vaccination Due Date Calculator, a free, online tool that helps individuals figure out when they may be due for a COVID-19 shot, making it easier to stay up-to-date on COVID-19 vaccination. To learn more about COVID-19 vaccines, or to find a vaccine site near you, visit vaccinate.wv.gov or call 1-833-734-0965.
To locate COVID-19 testing near you, please visit https://dhhr.wv.gov/COVID-19/pages/testing.aspx.
The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2023,[1] which clarified the timeline for increased COVID-19 vaccine administration fees and coverage of monoclonal antibody (mAb) products for the remainder of the public health emergency (PHE) and into the future.
The CY 2023 PFS proposed rule will become effective in 2023, and the deadline for public comment is September 6, 2022.
More broadly, CMS has reiterated that its goal for CY 2023 includes program expansions that create a more equitable health care system by providing better accessibility, quality, affordability, and innovation.[2] CMSs CY 2023 PFS proposed rule highlights the federal agencys goals to promote broad and timely access to both COVID-19 vaccines and mAb products.[3]
This Insight highlights four Medicare coverage and payment changes related to COVID-19 vaccines and mAb products in the CY 2023 PFS proposed rule and provides key takeaways for the commercialization of preventive vaccines and mAb products in the near future.
Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, COVID-19 was added to the vaccine coverage benefit under Part B of the Medicare program.[4] In its CY 2022 PFS final rule,[5] CMS established payments under Part B for COVID-19 vaccine administration at $40 per dose while existing preventive vaccines, such as pneumococcal, influenza, and Hepatitis B (HBV), remained at a payment rate of $30.[6]
CMS continues its efforts to establish payment for vaccine administration for the long-term in the CY 2023 PFS proposed rule. Through 2021, vaccine administration payment rates for pneumococcal, influenza, or HBV vaccines were established using a crosswalk for similar services paid under the PFS. In its CY 2022 PFS final rule, CMS responded to commenters concerns that the codes were improperly linked and did not reflect the unique costs of administering vaccines. Therefore, CMS finalized administration fees for non-COVID-19 vaccines (pneumococcal, influenza, and HBV) at $30, while establishing a $40 administration fee for COVID-19 vaccines.
CMS now proposes to update the payment for Part B vaccine administration by making adjustments to reflect cost differences for the geographic locality.[7]
CMS also proposes to continue the $40 administration fee for COVID-19. The agency anticipates vaccinating providers will continue to experience rising costs associated with staffing, scheduling, and reporting requirements as the number of patients increases, especially as boosters remain an important tool in the COVID-19 response. While CMS previously intended to maintain increased payment for COVID-19 vaccine administration through the end of the PHE, it has determined this transition will occur on January 1 in the year following the termination of the March 27, 2020, Emergency Use Authorization Declaration (EUA Declaration). The payment rate for COVID-19 vaccine administration will then be set at a rate that aligns with other Part B preventive vaccine administration payment rates, which are currently at $30.[8]
In June 2021, CMS announced an add-on payment with a national rate of $35 for COVID-19 vaccine in-home (at-home) administration, bringing the national average for at-home COVID-19 vaccine administration payments to $75 per dose ($40 for the COVID-19 vaccine administration and an additional $35 for administration in the home). By August 2021, CMS had expanded the circumstance for when the add-on payment was available, allowing providers and suppliers who administered the COVID-19 vaccine at a patients home to bill Medicare. These policies were established to ensure beneficiaries received access to COVID-19 vaccines during the PHE.
After hearing multiple requests from commenters to extend the add-on payment past the PHE, CMS acknowledged in the CY 2022 PFS final rule that the costs of at-home COVID-19 vaccine administration would not diminish immediately after the PHE, thereby stating that it would allow the $35 add-on payment to continue until the end of the calendar year of the PHE. CMSs CY 2023 PFS proposed rule suggests the continuation of the additional $35 payment for at-home vaccination beyond the PHE, which allows the agency to maintain expanded COVID-19 vaccine access for vulnerable housebound beneficiaries. The CY 2023 PFS proposed rule also underscores the agencys need to better understand COVID-19 vaccine inaccessibility barriers in the Medicare population.[9]
While the CY 2023 PFS proposed rule provides a continuation of the additional $35 payment for at-home COVID-19 vaccine administration, it does not include other preventive vaccines. CMS requests comments related to the inclusion of other Part B preventive vaccines (such as pneumococcal, influenza, and HBV).
Once COVID-19 mAb products for treatment and post-exposure prophylaxis were granted EUAs, CMSs CY 2022 PFS final rule finalized coverage and payment for COVID-19 mAb products under the Part B vaccine benefit. Notably, this determination absolved beneficiaries of cost-sharing responsibility for both the mAb product and its administration.
The payment for administration of mAb products for treatment or post-exposure prophylaxis under Part B ranges between $150.50 and $750.00. CMS intends to continue coverage under the Part B vaccine benefit at these reimbursement levels until the EUA Declaration is terminated. In the year following termination of the EUA Declaration, CMS intends to then transition coverage of these products to ordinary system coverage for complex biological products under Part B.
Following the CY 2022 PFS final rule, a mAb product was granted an EUA for use as pre-exposure prophylaxis prevention of COVID-19. Although the CMS policies regarding coverage of COVID-19 mAb products did not address mAb products used for prevention of COVID-19, the agency covered and paid for them without subjecting patients to out-of-pocket costs.
CMS proposes to continue coverage of preventive mAb products under the Part B vaccine benefit beyond the termination of the EUA Declaration, so long as a product has market authorization. CMS also proposes to maintain the current payment amounts for administration for pre-exposure prophylaxis mAb products under Part B of either $150.50 or $250.50, depending on a products administration setting.
While the Biden administration has yet to detail plans for a full market transition for COVID-19 vaccines and therapeutics,[10] CMSs articulation of timelines for coverage of vaccines and monoclonals provides a degree of future payment clarity for these products under Medicare.
CMSs decision to cover mAb products the same as vaccines under the Part B benefit is potentially precedent setting as future prophylactic monoclonals are licensed.[11] The agencys decision to shift coverage of mAb products for treatment to ordinary biological product coverage under Part B means that patients will begin to bear out-of-pocket costs for these products once the EUA Declaration is terminated.
CMSs continued consideration of its methods for setting vaccine administration fees and intent to extend at-home administration add-ons provides opportunities for commenters to encourage policies that promote better access to vaccines for Medicare beneficiaries.
Nija Chappel, a Summer Associate (not admitted to the practice of law) in the firms Washington, DC, office, contributed to the preparation of this Insight.
[1] CMS Proposed Rule, CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies, 87 Fed. Reg. 45860 (July 29, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-14562.pdf (hereinafter CMS CY 2023 PFS Proposed Rule).
[2] CMS Fact Sheet, Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule (July 7, 2022), available at https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-proposed-rule.
[3] CMS CY 2023 PFS Proposed Rule, supra note 1, at 46225-46226.
[4] Id. at 46218.
[5] CMS Final Rule, Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies (Nov. 19, 2021), available at https://www.federalregister.gov/documents/2021/11/19/2021-23972/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part.
[6] CMS CY 2023 PFS Proposed Rule, supra note 1, at 46219.
[7] Id. at 46222.
[8] Id.; CMS uses this example: [I]f the COVID-19 PHE ends in CY 2022, the payment amount for COVID-19 vaccine administration would change from $40 to $30 effective January 1, 2023, and would apply the proposed geographic adjustments and the proposed annual update as proposed for the other preventive vaccine administration services . . . .
[9] Inaccessibility barriers include patients having a condition due to illness or injury that limits their ability to leave home without a device or help from a caregiver, a condition that makes the patient more likely to contract COVID-19, or the patient is generally unable to leave the home and if they do, they consider it a considerable and taxing effort. CMS CY 2023 PFS Proposed Rule, supra note 1, at 46223.
[10] See Richard Hughes, As Congress, Biden administration squabble over COVID-19 funds, an ongoing pandemic response posture strains public health, HealthCareDive (July 14, 2022), available at https://www.healthcaredive.com/news/biden-administration-covid-19-funds-oped/627105/.
[11] Sara Rosenbaum, A Twenty-First Century Vaccines for Children Program, Health Affairs (July 12, 2022), available at https://www.healthaffairs.org/content/forefront/twenty-first-century-vaccines-children-program.
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Politics | Coronavirus
(PAP) emer/mb/mrb August 03, 2022
Poland will allow a fourth dose of coronavirus vaccine to be received by people aged over 18 in September, the health minister has announced.
Since July 22 a second booster dose has been available for people in the 60-79 age group and an additional vaccination for people aged over 12 years with immune deficiency. Before, the fourth dose had been offered to everybody over 80.
On Wednesday, Health Minister Adam Niedzielski wrote on Twitter that "everything indicates that the fourth dose for the wider population, at least 18 plus, will be available in early September."
He added that so far 750,000 people from the 60 plus and 12 plus groups with immune deficiency had already registered for the second booster jab and that 300,000 had already taken the vaccine.
