SNOO is Granted FDA De Novo Approval For Keeping Sleeping Babies Safely Positioned on the Back

Marking a significant advance in infant safety, the U.S. Food and Drug Administration (FDA) has given De Novo approval to Happiest Baby’s SNOO Smart Sleeper. This is the first time the FDA has given De Novo approval to a product designed to keep sleeping babies safely positioned on the back. Babies who are positioned to sleep on the back are at a lower risk of SIDS.

Every year, 3,500 American babies die in their sleep from suffocation and unexplained causes including SIDS (Sudden Infant Death Syndrome). These deaths are collectively referred to as SUID (Sudden Unexpected Infant Death) and constitute the leading cause of death of healthy, full-term infants during the first year of life (90% of SUID cases occur in the first six months).

Tragically, the number of these deaths has continued unchanged at 3500 every year for over 20 years.

In the 1990s, doctors discovered that sleeping on the back dramatically reduced the incidence of SUID. Today, it is one of the key safe sleep recommendations of the American Academy of Pediatrics. The National Institutes of Health encourages back sleeping as “the single most effective action that parents and caregivers can take to lower a baby’s risk of SIDS.” And, the CDC advises that “babies who sleep on their backs are much less likely to die of SIDS than babies who sleep on their sides or stomachs.”

Despite this universal recommendation, almost two-thirds of SUID deaths still occur when babies roll to, or are placed on, the side or stomach. SNOO is the first and only bed that facilitates back (supine) sleeping. The SNOO Sack safely swaddles babies and attaches to the bed, keeping them securely on the back throughout sleep.

SNOO is for use by babies under 6 months of age or until they have demonstrated they can consistently roll from stomach to back during sleep. In a study of 1,012 infants, SNOO was found to reduce unsafe stomach sleeping by 91.5%. However, SNOO has not directly demonstrated a reduction in the incidence of SIDS/SUID.

“As a pediatrician for over 40 years, I’ve witnessed far too many times the unbearable pain of parents who placed their baby in bed at night, only to find them lifeless in the morning,” said Dr. Harvey Karp, co-founder and CEO of Happiest Baby, Inc. “Stomach sleeping leads to the tragic death of thousands of healthy infants every year. Yet, we routinely put babies in bed totally unsecured for 12 to 14 hours every day. Just as infant seats dramatically improve car safety, we hope to dramatically improve sleep safety by keeping babies on the back and reducing risky rolling.”

On March 30, 2023, the FDA granted the De Novo application of Happiest Baby’s SNOO Smart Sleeper:

“The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the SNOO Smart Sleeper, an over-the-counter device under 21 CFR Part 801 Subpart C with the following indications for use:

“The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.

“FDA concludes that this device should be classified into Class II. This order, therefore, classifies the SNOO Smart Sleeper, and substantially equivalent devices of this generic type, into Class II under the generic name infant supine sleep system.

“FDA identifies this generic type of device as:

“Infant supine sleep system. An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).”

Click here for more information regarding the De Novo approval.

ABOUT SNOO

SNOO was created by renowned pediatrician and child development expert, Dr. Harvey Karp. Launched in 2016, SNOO helps lull babies to sleep faster and keep them sleeping longer. In recognition of these landmark advances, SNOO has received over 30 top honors, including the National Sleep Foundation’s Innovation of the Year and Fast Company’s World Changing Idea. SNOO has been featured at the London Design Museum, Victoria and Albert Museum, SF MOMA, and is in the permanent collection of the Smithsonian Institution.

In an advance in pediatric sleep science, SNOO uses specially designed, continuous rhythmic sensations that mimic the motion, sound, and tactile embrace babies experience in the womb. Although the current practice is to place babies to sleep in a dark, still, silent room, babies actually sleep better with constant motion, sound, and snug holding (e.g., rocking in a lounger, long walks in a carrier or stroller, car rides, etc.). This was shown in a large infant sleep study (7,157 babies, 0-6 months of age). It demonstrated that SNOO’s constant rhythms were associated with an unprecedented one hour per night average increase in sleep. Furthermore, by two months, SNOO increased the longest continuous period of night sleep from an average of five hours to almost seven hours; a 40% boost in the sleep most precious to new parents—and most helpful for infant well-being—consolidated, continuous sleep.

Hundreds of thousands of families have used SNOO as their baby’s first bed. Most parents obtain it directly through Happiest Baby’s rental program and thousands get a free, six month SNOO rental from their employer. Over 60 top American companies, including, JP Morgan, Activision-Blizzard, Snapchat, Children’s Hospital of New Orleans, and Under Armour, offer SNOOs to support new parents.

ABOUT HAPPIEST BABY

Happiest Baby is an LA-based company co-founded by Dr. Harvey Karp and Nina Montée Karp. It’s a

mission-driven company dedicated to protecting the health and wellness of children, parents, and healthcare workers across America and around the world. The company develops innovative, science-based products and content to solve every-day childcare challenges and to enhance the well-being of families and healthcare providers.

Dr. Karp is the author of the celebrated parent books and streaming videos, The Happiest Baby on the Block and The Happiest Toddler on the Block and the book, The Happiest Baby Guide to Great Sleep: Birth to 5,which have been used by millions of families and translated into dozens of languages.

In addition to SNOO, the company makes numerous other parent-support products, including Sleepea (an award-winning, “5-second” swaddle), SNOObear (a white noise, plush toy that aids infant/toddler soothing and sleep), and SNOObie (a white noise and nightlight device to improve a child’s sleep and teach mindful breathing, used from birth to school age).

For Inquiries: [email protected]

SOURCE Happiest Baby, Inc.

Expanded telehealth services are ‘here to stay’ in Virginia as public health emergency ends

As the federal public health emergency spurred by the COVID-19 pandemic expires this May, so will waivers that expanded the amount of health care services patients can access through telehealth.

But Virginia officials say most of the services the waivers allowed, such as being able to have virtual appointments instead of in-person visits at a provider’s office, have been signed into state law and are here to stay for both Medicaid enrollees and those with commercial insurance.

“Virginia really stepped up – the General Assembly codified many of the waivers that were put in place early on in the public health emergency,” said Dr. Karen Rheuban, director and co-founder of the University of Virginia Center for Telemedicine and a decades-long advocate for expanding access to virtual health care. When the public health emergency expires on May 11, she said, Virginia “won’t fall off the telemedicine cliff.”

Telehealth is an umbrella term for a broad spectrum of health care tools and services. That includes…

Read the Full Article at Virginia Mercury

SafeHaven Health and Wellness Coaching Certification

The Medical Society of Virginia is thrilled to partner with Georgetown University to offer the SafeHaven Coaching Certification program as part of Georgetown’s Health & Wellness Coaching Certificate. Download the program flyer.

Participants of the program will:

  • Be a part of the first cohort to expand the SafeHaven coaching network
  • Pave the way for privileged, protected access to care for all healthcare professionals seeking support
  • Receive up to 50 hours of CME upon completion (AMA PRA CATEGORY 1 CREDITS™)

Register for our upcoming information session

Tuesday, April 11, 2023 | 6PM – 7PM | REGISTER NOW

Want to learn more about this unique opportunity? Register here to join Georgetown faculty lead Petra Platzer, PhD NBC-HWC PCC, and MSV and SafeHaven leadership, to learn more the program curriculum and how to apply. 

Already interested? Apply to the course now!  

If you are unable to attend, this webinar will be posted to the MSV website! If you have additional questions about coaching, please reach out to [email protected].  

Increase in Candida auris and Carbapenemase-producing Organisms

via VDH.gov

Dear Colleague,

The Virginia Department of Health continues to respond to reports of cases and outbreaks of Candida auris (C. auris) and/or carbapenemase-producing organisms (CPOs). C. auris is an emerging fungus that presents a serious global health threat. It is often resistant to antifungal drugs used to treat Candida infections and can cause outbreaks in healthcare settings. This advisory provides an update on the current epidemiology of these organisms in Virginia and recommendations for prevention and control.

VDH is observing a concerning increase in C. auris and CPO cases in Virginia. While most reported cases of C. auris and CPOs remain concentrated in Northern Virginia, increasing cases and outbreaks in the Central Region and detection of cases in all regions of Virginia indicate healthcare facilities across the state should be on alert for C. auris and CPOs. Case data and additional information can be found on the VDH C. auris and VDH CPO websites.

bar chart of candida cases

Source – Cases – Virginia Electronic Disease Surveillance System, data entered by 3/14/2023. Data is preliminary and subject to change.

CPOs and C. auris can cause asymptomatic colonization in patients, which can later lead to infection and transmission of the organism to other patients within a healthcare facility. Co-colonization of CPOs and C. auris has also been frequently observed. CPOs are highly antibiotic-resistant organisms that can cause infections that are difficult to treat, and in some cases, infections are resistant to all classes of available antibiotics.

Patients at highest risk for C. auris and/or CPO colonization are those who reside in or who have had prolonged admissions to high-risk healthcare facilities (particularly long-term acute care hospitals or ventilator-capable skilled nursing facilities). Persons who have recently spent time in hospitals and have invasive devices (e.g., mechanical ventilation or tracheostomy, feeding tubes, or central venous catheters) are also at high risk.

Prompt implementation of infection prevention and control measures is essential to prevent patient-to-patient transmission of C. auris and CPOs in healthcare settings. VDH recommends the following actions for health care providers:

  • Be aware auris and CPO cases are on the rise and are causing outbreaks in healthcare facilities. Every region of the state has identified persons infected or colonized with C. auris or CPOs.
  • Review and implement prevention measures to limit the spread of C. auris and CPOs as recommended on the CDC C. auris website and the CDC Carbapenem-resistant Enterobacterales website.
  • Inquire about high-risk exposures in all newly admitted patients and consider auris and CPO screening and/or empiric contact precautions in patients at high risk, including those who:
  • Had close contact in a healthcare setting to someone diagnosed with auris or CPO infection or colonization.
  • Were admitted from a long-term acute care hospital or a ventilator-capable skilled nursing facility.
  • Had international healthcare exposure within the past year.
  • Immediately report any suspected or confirmed auris or CPO cases to public health by contacting your local health department per the Virginia Reportable Disease List.
  • Ensure the implementation of appropriate infection prevention and control practices:
  • All healthcare workers should have high adherence to hand hygiene.
  • Patients with suspected or confirmed auris or CPOs in healthcare facilities should be managed using contact precautions. Some residents in nursing homes might be eligible to be managed with enhanced barrier precautions instead of contact precautions.
  • When auris is suspected, use healthcare grade disinfectants that are registered with EPA for claims against C. auris (List P). Additionally, high-risk healthcare facilities should consider switching to a List P product prior to identification of C. auris due to increasing cases in Virginia.
  • Use checklists to identify who is responsible for cleaning each item and cleaning frequency (e.g., environmental services staff versus clinical staff).
  • Reinforce and audit core infection prevention practices in healthcare facilities.
  • Conduct periodic education on multi-drug resistant organisms and training on appropriate infection prevention and control practices to healthcare workers.
  • Communicate information about colonization or infection with auris or CPOs during care transitions within and transfers between healthcare settings.

Thank you for your partnership in HAI/AR prevention.

Sincerely,

Laurie Forlano, DO, MPH
Acting State Epidemiologist
Acting Director, Office of Epidemiology

Emergency Medicaid Authorizations are Live in Kepro

You can now request authorizations for inpatient stays for your Emergency Medicaid members in Kepro: https://dmas.kepro.com/

If you have already sent a spreadsheet to DMAS requesting an authorization due to a denial, they are working on those and will return them asap. If you have not yet requested an authorization, please use Kepro going forward for dates of service 7/1/2022 or later.

Medicaid Unwinding: AAP Resources for Preserving Medicaid and CHIP Coverage

A policy that kept individuals continuously enrolled in Medicaid during the COVID-19 public health emergency (PHE) will end on March 31, 2023.

Over the next 14 months, states must check whether every person currently enrolled in Medicaid is still eligible, then either renew or terminate that person’s coverage; starting April 1, 2023, states may begin disenrolling individuals who are no longer eligible for Medicaid. Those families who are no longer eligible for Medicaid may lose their coverage and/or be moved to other forms of coverage, like CHIP or the marketplace. This process of redetermining the eligibility of all 90 million Americans enrolled in Medicaid is being called the “unwinding.”

The AAP has a suite of resources to help members, patients, and families understand and navigate the Medicaid Unwinding.

See the resources here.

10 Tips to Enhance Small Healthcare Practice Profit

via Ballast Consulting Group

Managing a healthcare practice can be an incredibly difficult challenge in the current environment.

Practices face headwinds regarding labor shortage pressures, increase costs, and ‘the new normal’ for patient volumes and fluctuations. To make matters worse, large payers are often unwilling to increase claim reimbursements to account for these challenges, meaning practices must make more with less.

The need for improved operational finance within small-to-medium-sized healthcare practices is more essential than ever; finance leaders must provide financial visibility to make the necessary improvements to keep the practice growing and profitable. Here are 10 simple changes your finance team can implement to improve your practice’s bottom line, without sacrificing staff morale or quality care:

  1. Review claim amount and revenue collected per visit monthly to ensure maximum value earned per encounter. Your finance team should consistently review the total amounts billed each month, and what is subsequently collected from insurance to identify deviations from historical and expected data.
    • Is the average E&M code per encounter going up or down, and why? Are you seeing a different mix of patient visit types and what is driving it? Is the profit per patient visit increasing or decreasing?
    • Monitoring charges and collections per visit ensures that payer’s contracted rates are being paid and give an accurate breakdown of patients per payer, which can be helpful for future payer negotiations.
    • Monitoring the time lapse between claim creation and full payment (time in accounts receivables) is helpful for a variety of reasons, including alerting the practice of payer issues or disputes, and cash flow planning. Understanding your accounts receivables can be helpful in securing lines of credit from a bank to ease cash availability.

Learn how Ballast measures and monitors billing data for healthcare clients.

  1. Review and report profit per patient visit. Determine the driving cost factors for a healthcare facility when the volume of patient visits change. On average, how much does your practice spend treating a patient, and how much does that vary depending on the nature of the visit? How does seasonality, and/or staffing pressures change your practice’s gross profits? Answers to these questions can help you do the following:

One Ballast client saved ~$250,000 a year in supply costs by negotiating pricing with its primary distributor of supplies.

    • Understand the impact of labor on your profit per visit and staff appropriately. How much does it cost the practice if providers see one less patient per hour? Practices need to understand the embedded costs of the provider compensation, as well as all the clinical staff costs and how much might be saved or is wasted if throughput (patients per staff-hour) fluctuates. Your finance team should routinely provide metrics to your leadership team on throughput, ideally on a provider-basis. This can be incredibly valuable information for your operations team when establishing schedules which:
      • Maximize revenue per provider hour
      • Reduce required provider hours to essential patient-care functions (ie. Hire scribes if excess provider time spent charting)
      • Provide sufficient capacity for quality care
      • Provide sufficient capacity for sustainable staff morale
      • Determine appropriate compensation/bonus plans for staff using objective data

Learn more here about how Ballast provides healthcare practices insights on labor efficiency by centralizing their ecosystem of data sources.

  1. Actively monitor and track inventory of supplies purchased and used. Efficient management of inventory on-hand can help a practice:
    • Understand how much inventory is used on patients rather than purchased (necessary to review true profit per patient visit)
    • Reduce practice investment in excess inventory to improve cash flow
    • Reduce costs of excess inventory related to unnecessary storage, spoilage or slippage
    • Creating an inventory management process is not as difficult or tedious of a task as one might expect.

Learn how Ballast helps healthcare practices implement and manage an efficient inventory management system.

  1. State revenues and expenses on a ‘modified accrual-basis’. Measuring and monitoring many of the previous items will be far more difficult to accomplish if your profit & loss doesn’t show you what occurs in the months that your revenues are earned, and expenses are incurred. Producing accrual-basis revenue for payer-based medical practices is challenging, here is how we approach:
    • Accounting for medical claims on an accrual basis
    • Accounting for supplies/inventory usage on an accrual basis
    • Accounting for labor/staff expenses on an accrual basis
  2. Build a financial forecast to measure the impact of key decisions. A financial forecast that is rooted in the historical data of the practice is imperative for understanding future trends.  Forecasting the next several months of revenues, expenses, and other impacts to cash flow, while predicting the next 2-3 years trends will ensure the practice’s Executive team a clear vision of the financial direction of the practice. The financial forecast should be a tool that leadership regularly reviews (monthly at a minimum), and use to scenario-plan new service offerings, hirings, new facility buildouts, etc.
  3. Create an annual plan and measure performance against the plan. Use the financial forecast as a tool to proactively manage the operations of your business. Simplifying the key goals to 3-4 of the most important will allow easier retrospective analysis and allow your team to better focus on just the essentials. Things to consider:
  4. Make your goals SMART – an example of a SMART goal for a healthcare practice might be:
    • “Increase patient visit volume in 2023 by 8% above 2022, of which 5% comes from new patients.”
    • “Improve profit margins by a minimum of 5% by reducing supply costs per visit”
  5. Determine the requirements to achieve those goals, and what roadblocks or risk factors stand in the way. What investments in sales & marketing does the practice need to make to grow visit volumes by 8%? Does the practice have sufficient staff capacity to handle that kind of increase? Break the achievement of those goals into smaller steps, set deadlines to achieve, and assign responsibility to a key individual for achievement (i.e.: “create a marketing budget to allocate spend by channel for 2023 by January – Head of Marketing’s responsibility”).
  6. Measure the upside and downside to achievement/failure of these goals. Use the financial forecast model to determine if the rewards outweigh the risks for attempting to accomplish the goals. What will happen to profit and cash flow if your practice achieves its goals? What will happen if you make the necessary investments, and the practice does not achieve the desired outcome? Forecasting these in advance can help the leadership team of a practice prioritize the objectives that provide the best risk-adjusted benefit to the practice.
  7. Use your accounting data ecosystem to track progress toward those goals. Just as a practitioner has regular ‘check-ups’ with his/her patients to monitor the patient’s health towards their desired outcomes, the executives of a healthcare practice should review the financial health of the practice in comparison to the goals set out by the organization during its planning session. What goals did you focus on achieving this year, and what do your financials tell you about how you are tracking toward those goals? What improvements need to be made to reach them? What unforeseen circumstances caused you to fall short or exceed your expectations?

Learn more here about how Ballast creates and manages a plan for continuous improvement for its clients.

Regulated Medical Waste (RMW) Updates

The Virginia Department of Environmental Quality (DEQ) recently updated the regulations concerning its regulated medical waste (RMW), effective March 15. There were several key changes for MSV membership:

  1. The definition of “sharps” has been expanded and now explicitly includes culture slides and culture dishes, which shall be disposed of in sharps containers.
  2. Records of RMW treatment or shipment to offsite facility shall be maintained for 3 years by the generator.
  3. Generators of less than 250 gallons of RMW per calendar month must arrange for removal of such waste at least once per calendar month. No RMW may be stored for more than 45 calendar days.  Generators of more than 250 gallons must arrange for removal once a week.
  4. The definition of “storage” was updated to include all generators of RMW; whereas, previously it only applied to generators of 200+ gallons of RMW. There is a whole new section regarding storage, requiring RMW to be stored in a manner that maintains integrity of packaging, minimize potential for spills, is clean and orderly, and meets packaging and labeling requirements in the regulation.
  5. New rules pertaining to reusable RMW containers to ensure properly disinfected.
  6. New rules on how to handle spills of RMW—anyone handling RMW shall have a spill containment and cleanup kit onsite within the vicinity of where RMW is stored/managed. Such a kit must include material designed to absorb any liquids, one gallon of EPA-registered hospital grade disinfectant in a spray container, enough red plastic bags to enclose at least 150% of the RMW managed at the site, and relevant PPE.

If there are questions as to the new regulations, we encourage our members to work seek legal counsel, and if necessary, reach out to DEQ.

Inflation Reduction Act Tamps Down on Prescription Drug Price Increases Above Inflation

New Medicare Prescription Drug Inflation Rebate Program protects people with Medicare and taxpayers when drug companies increase prices faster than the rate of inflation

HHS announces savings for some people with Medicare on 27 Part B prescription drugs

via CMS Newsroom – The Biden-Harris Administration has made lowering prescription drug costs in America a key priority — and President Biden is delivering results. Today, the Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), announced 27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. Thanks to President Biden’s new law to lower prescription drug costs, some people with Medicare who take these drugs may save between $2 and $390 per average dose starting April 1, depending on their individual coverage. Through the Inflation Reduction Act, President Biden and his Administration are lowering prescription drug costs for American seniors and families.

“The Biden-Harris Administration believes people with Medicare shouldn’t be on the hook when drug companies inexplicably jack up the prices of their drugs,” said HHS Secretary Xavier Becerra. “President Biden made lowering prescription drug costs for Americans a top priority and we’re using every lever we have to deliver results. With the inflation rebate program, we are fighting to ensure seniors can afford the treatments they need, taxpayers aren’t subsidizing drug company excess prices, and the Medicare program is strong for millions of beneficiaries now and in the future.”

The Medicare Prescription Drug Inflation Rebate Program is one of the many important tools Medicare has to address rising drug costs. By reducing coinsurance for some people with Part B coverage and discouraging drug companies from increasing prices faster than inflation, this policy may lower out-of-pocket costs for some people with Medicare and reduce Medicare program spending for costly drugs. ​

“The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies while improving access and affordability for the millions of people with Medicare coverage,” said CMS Administrator Chiquita Brooks-LaSure. “Continued implementation of the new drug law strengthens Medicare, faithfully guards taxpayer dollars, and improves the long-term sustainability of the program for generations to come.”

CMS has released information about these 27 Part B drugs and biological products in the quarterly ASP public file, available here.  A fact sheet is available here.

Lower Part B coinsurance will go into effect on April 1, 2023. This coinsurance adjustment applies to certain drugs and biologicals covered under Medicare Part B. The Part B drugs impacted by this coinsurance adjustment may change quarterly.

See the initial guidance detailing the requirements and procedures for the Medicare Prescription Drug Inflation Rebate Program here.

In addition, HHS released a report on how much Medicare Part D enrollees would have saved on vaccine cost-sharing if the Inflation Reduction Act has been in effect in 2021.

Resources

  1. Medicare Part B Drug ASP Webpage
  2. List of Part B Rebatable Drugs with a coinsurance adjustment for April 1-June 30, 2023
  3. Fact Sheet/FAQs
  4. ASPE Vaccine Cost-Sharing Brief

VDH Clinician Letter: Meningococcal Disease Outbreak Update, Invasive Group A Strep Infections

Via vdh.gov

Dear Colleague:

I am writing to provide you with important updates on several emerging conditions of public health significance.

Meningococcal Disease Outbreak in Eastern Virginia

The Virginia Department of Health continues to respond to a community outbreak of meningococcal disease in the eastern region of Virginia.  Twelve cases of invasive meningococcal disease (IMD) serogroup Y have been reported since June 2022 in eastern Virginia,  a doubling of cases since VDH notified eastern region providers in September 2022.  Most case-patients have presented with symptoms of IMD meningococcemia, including fever, chills, nausea, and vomiting.  All isolates available for sequencing (9 out of 12) were genetically related and susceptible to ciprofloxacin and penicillin.  VDH has not identified a common risk factor; we suspect the cases are connected by asymptomatic community transmission.  Case-patients are all residents of Hampton Roads and most are Black or African American adults between 30-60 years of age.  Eleven case-patients are unvaccinated for serogroup Y, and one is partially vaccinated.  Three case-patients have died from complications associated with the disease, indicating this outbreak strain may have a higher case fatality rate (25% CFR) than is commonly observed in serogroup Y cases.  This strain is believed to be circulating more widely, both in Virginia and other states.

VDH responds to reports of suspect meningococcal disease by rapidly identifying close contacts for whom short-term antibiotics are recommended for prophylaxis and recommending one dose of the meningococcal conjugate vaccine (MenACWY) to all outbreak-associated close contacts who are identified as high-risk for meningococcal disease.

Healthcare Providers should maintain a high index of suspicion for IMD.  Immediately notify your local health department (LHD) of clinical findings or laboratory results of gram-negative diplococci or Neisseria meningitidis from a normally sterile site. Your LHD can coordinate sending specimens/isolates from newly identified cases to the Division of Consolidated Laboratory Services (DCLS) for serotyping.  Ensure that all individuals who are high-risk for meningococcal disease are up-to-date on the MenACWY vaccine.  Continue to encourage routine administration of the MenACWY vaccine in younger children and adolescents, as required for students enrolled in the 7th and 12th grades.

Increase in Invasive Group A Strep Infections

The Centers for Disease Control and Prevention (CDC) have noted an increase in invasive group A Streptococcus (iGAS) infections in children in the United States.  Although the number of iGAS cases reported in children in Virginia is not above average for this time of year, we are observing increased activity in general.  Group A Streptococcus bacteria can cause a range of illnesses; severe iGAS infections include necrotizing fasciitis and streptococcal toxic shock syndrome and require immediate treatment, including appropriate antibiotic therapy.

VDH responds to reports of suspect iGAS infections by rapidly identifying close contacts for whom short-term antibiotics are recommended for prophylaxis, and urgently investigating clusters of GAS infections, especially in high-risk settings such as among residents of long-term care facilities and school aged children.

Please consider the following actions:

  • Consider iGAS as a possible cause of severe illness, including in children and adults with concomitant viral respiratory infections. Be mindful of potential alternative agents for treating confirmed GAS pharyngitis in children due to the shortage of amoxicillin suspension.
  • Offer prompt vaccination against influenza and varicella to eligible persons. Educate patients, especially those at increased risk, on signs and symptoms of iGAS requiring urgent medical attention, especially necrotizing fasciitis, cellulitis and toxic shock syndrome.
  • Notify your local health department (LHD) as soon as possible about severe iGAS cases affecting minors or clusters of any iGAS infections. All cases of Streptococcal disease, Group A, invasive or toxic shock should be reported within 3 days to VDH.  Laboratories in Virginia are required to submit GAS isolates to DCLS when cultured from a normally sterile site.

Thank you for your attention and partnership.

Sincerely,

Laurie Forlano, DO, MPH
Acting State Epidemiologist and Director
Office of Epidemiology