The Centers for Medicare and Medicaid Services (CMS) are responsible for the oversight and health and safety of 

 residents. Over the past decade, through the work of the 

 to improve dementia care, CMS has been monitoring antipsychotic medication use in nursing homes. Though steps have been taken to reduce the use of these drugs, there continue to be concerned that nursing home residents may be inappropriately prescribed antipsychotic medications as a result of being misdiagnosed and coded as having schizophrenia, see the 

 for more information. Antipsychotic medications are dangerous among the vulnerable nursing home population because of their potential side effects, including death.

To increase our focus on this issue, CMS will conduct off-site nursing home audits to assess the accuracy of Minimum Data Set (MDS) data. Specifically, to determine whether or not the facility is appropriately assessing, diagnosing, and coding schizophrenia in the MDS for residents in their facility. These efforts are aligned with the latest actions under 

Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Home

If the audit reveals a pattern of inaccurate coding, this practice will negatively impact a facility’s Five-Star Quality Measure Rating on Nursing Home Care Compare. 

In addition to CMS’ actions, we believe that some of these instances may represent actions that are inconsistent with the expectations of the board of licensure. As such, if there are instances where a practitioner has not followed the expected standards for diagnosing individuals and/or prescribing medications, we believe these practitioners should be referred to their respective state boards for investigation.

See the following resources related to reducing the use of antipsychotic medications and appropriately assessing, diagnosing, and coding of schizophrenia in the MDS:

Minimum Data Set (MDS) 3.0 Resident Assessment Instrument (RAI) Manual

(Manual (page 2 of the Errata (v2) effective July 15, 2022)

Refer to pg. 352 for the process of appropriately assessing and coding a diagnosis of schizophrenia in the MDS for residents of your long-term care facility. Specifically, you should ensure the medical record of a resident diagnosed with schizophrenia contains documentation of a comprehensive medical and psychiatric evaluation, completed by diagnosing a Medical Director or licensed psychiatric practitioner, that meets professional standards of practice (for example, The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)), at the time of the initial diagnosis of schizophrenia. Listing of schizophrenia as a diagnosis on a medical record (i.e., problem list) is not sufficient.

State Operations Manual Appendix PP - Guidance to Surveyors for Long-Term Care Facilities

F658 - Services Provided Meet Professional Standards

F758 - Free from Unnecessary Psychotropic Meds/PRN Use

Facilities can locate their QIO by visiting Locate Your QIO | 

Humayun “Hank” Chaudhry, DO, MS, MACP, FRCP (Lon.) 

1775 Eye Street NW, Suite 410 | Washington, DC 20006

CMS Nursing Homes Misdiagnosis and Coding of Schizophrenia Education 

This Health Alert Network Advisory is from the CDC and being sent by the Louisiana Department of Health Emergency Operations Center (LDH EOC) via Louisiana Health Alert Network (LA HAN) to LA HAN Recipients regarding 

Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears. 

Please see the message below and share/distribute any/all of this information to all partners and stakeholders as deemed appropriate.

Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears

This Health Alert Network Advisory is from the CDC about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant 

While no cases have been identified to-date in Louisiana, the below recommendations are applicable statewide

Most patients reported using artificial tears. Patients reported more than 10 different brands of artificial tears, and some patients used multiple brands. The majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles. CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states. Patients and healthcare providers should immediately discontinue using EzriCare artificial tears pending additional guidance from CDC and the Food and Drug Administration (FDA).

As of January 31, 2023, CDC in partnership with state and local health departments identified 55 case-patients in 12 states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant 

. Thirty-five patients are linked to four healthcare facility clusters. Dates of specimen collection were from May 2022 to January 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (13), cornea (11), urine (7), other nonsterile sources (4), blood (2), and from rectal swabs (25) collected for surveillance; some patients had specimens collected from more than one anatomic site. These specimens were collected in both outpatient and inpatient healthcare settings. Patients had a variety of presentations including keratitis, endophthalmitis, respiratory infection, urinary tract infection, and sepsis. Patient outcomes include permanent vision loss resulting from cornea infection, hospitalization, and one death due to systemic infection.

Isolates in this outbreak are sequence type (ST) 1203, harbor 

combination not previously observed in the United States) and are closely related based on analysis of whole genome sequencing (WGS) data. These isolates are not susceptible to cefepime, ceftazidime, piperacillin-tazobactam, aztreonam, carbapenems, ceftazidime-avibactam, ceftolozane-tazobactam, fluoroquinolones, polymyxins, amikacin, gentamicin, and tobramycin; the subset of isolates that underwent antimicrobial susceptibility testing for cefiderocol were susceptible to this agent.

Review of common exposures revealed that most patients, including most patients with eye infections, used artificial tears prior to identification of VIM-GES-CRPA infection or colonization. Patients reported more than 10 brands of artificial tears, and some patients used multiple brands. The majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free product dispensed in multidose bottles. This was the only common artificial tears product identified across the four healthcare facility clusters. CDC laboratory testing identified the presence of VIM-GES-CRPA in opened EzriCare Artificial Tears bottles from multiple lots; these bottles were collected from patients with and without eye infections in two states. These product-related VIM-GES-CRPA match the outbreak strain. VIM-GES-CRPA recovered from opened bottles could represent either bacterial contamination during use or during the manufacturing process. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing.

Recommendations for Clinical Laboratories

Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears 

This message is from LDH re: Increase in Pediatric Invasive Group A Streptococcal Infections

The Centers for Disease Control and Prevention (CDC) and the Louisiana Department of Health (LDH) are issuing this Health Alert Network (HAN) Health Advisory to notify clinicians and public health authorities of a recent increase in pediatric invasive group A streptococcal (iGAS) infections. In November 2022, CDC was notified of a possible increase in iGAS infections among children at a hospital in Colorado. Potential increases in pediatric iGAS cases in other states were subsequently noted by contributors to the Infectious Diseases Society of America’s provider-based 

and by certain jurisdictions participating in CDC’s 

Active Bacterial Core Surveillance System (ABCs) 

. A similar increase has been observed in Louisiana. The number of iGAS cases reported among pediatric patients in Louisiana remains relatively low. However, the number of cases reported year to date in 2022 is approximately 3 times higher than the average annual number of cases reported during the preceding 10 years.

This increased number of pediatric iGAS cases in some jurisdictions, including Louisiana, has occurred in the setting of increased circulation of respiratory syncytial virus (RSV), influenza viruses, SARS-CoV-2, and other respiratory viruses. This Health Advisory highlights the recent rise in iGAS infections in children, the increased seasonal risk of iGAS disease for all age groups, and the importance of early recognition, diagnosis, and appropriate treatment of these diseases in children and adults.

 (GAS) bacteria can cause a range of illnesses, from pharyngitis (i.e., strep throat) and skin and soft tissue infections to uncommon but severe diseases such as sepsis, streptococcal toxic shock syndrome, and necrotizing fasciitis. These severe and invasive diseases are associated with high mortality rates and require immediate treatment, including appropriate antibiotic therapy.

Similar to other agents spread primarily by the respiratory route, cases of GAS, including both iGAS and streptococcal pharyngitis (“strep throat”), tend to have a pronounced seasonal pattern with a peak in December through April in the United States. Strep throat is most common among school-aged children (i.e., 5–15 years of age), and exposure to someone with strep throat is a risk factor for iGAS infection. In addition, increased rates of iGAS infection have been noted during times of increased influenza activity. Seasonal influenza activity is currently high in the US and above the levels seen in recent years.

People with concurrent or preceding viral infections, such as influenza and varicella (chickenpox), are at increased risk for iGAS infection. Other groups at higher risk for iGAS include:

iGAS cases reported to ABCs, CDC’s active laboratory-and population-based surveillance system for invasive bacterial pathogens, were lower than usual among all age groups during the COVID-19 pandemic. This decrease started in April 2020 and was partly due to associated respiratory disease mitigation measures. A review of preliminary ABCs data from 2022 demonstrated a monthly increase in the number of confirmed iGAS cases in children between September to November, above what was seen in the same period in 2020 and 2021. However, it is too early to determine whether this rise is beyond what would be expected for pre-COVID-19 GAS seasonal patterns.

1 Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, et al. 

Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America 

Increase in Pediatric Invasive Group A Streptococcal Infections 

regarding Increase in Pediatric Invasive Group A Streptococcal Infections

The Centers for Disease Control and Prevention (CDC) and the Louisiana Department of Health are issuing this Health Alert Network (HAN) Health Advisory about a recently confirmed outbreak of Ebola virus disease (EVD) in Uganda caused by Sudan virus (species 

to summarize recommendations for clinicians, case identification and testing, and clinical laboratory biosafety considerations. No suspected, probable, or confirmed EVD cases related to this outbreak have yet been reported in the United States. However, as a precaution and to remind clinicians about best practices, LDH is issuing this update to raise awareness of this outbreak.

On September 20, 2022, the Ministry of Health of Uganda officially declared an outbreak of EVD due to Sudan virus (species 

in Mubende District, Central Uganda. As of October 6, 2022, a total of 44 confirmed cases, 10 confirmed deaths, and 20 probable deaths of EVD have been identified in Uganda. CDC is working closely with the Ministry of Health of Uganda, the World Health Organization (WHO), and other partners to support the response to this outbreak.

 This is the fifth outbreak of EVD caused by Sudan virus in Uganda since 2000. The current outbreak is in the same area as Uganda’s most recent EVD outbreak caused by Sudan virus, which occurred in 2012. During the 2012 outbreak, limited secondary transmission was reported, and the outbreak was effectively contained.

 As of October 6, 2022, no suspected, probable, or confirmed EVD cases related to this outbreak have been reported in the United States or other countries outside of Uganda. The geographic scope of this outbreak in Uganda is currently limited to five districts in central Uganda and not the capital Kampala or the travel hub of Entebbe. While there are no direct flights from Uganda to the United States, travelers from or passing through affected areas in Uganda can enter the United States on flights connecting from other countries.

 Starting the week of October 10, 2022, CDC and Department of Homeland Security will implement funneling of U.S.-bound air passengers who have been to Uganda in the prior 21 days. These passengers will fly into 5 U.S. airports where they will undergo entry health screenings. LDH epidemiologists will follow-up with air travelers from Uganda with a Louisiana destination, conducting health assessments, providing additional information, and doing check ins with the travelers.

 It is important for clinicians to obtain a detailed travel history from patients with suspected EVD, especially those that have been in affected areas of Uganda. Early consideration of EVD in the differential diagnosis is important for providing appropriate and prompt patient care, diagnostics, and to prevent the spread of infection. Healthcare providers should be alert for and evaluate any patients suspected of having EVD, particularly among people who have recently traveled to affected areas in Uganda.

A person infected with EVD is not contagious until 

 appear (including fever, headache, muscle and joint pain, fatigue, loss of appetite, gastrointestinal symptoms, and unexplained bleeding). Sudan virus is spread through direct contact (through broken skin or mucous membranes) with the body fluids (blood, urine, feces, saliva, droplet, or other secretions) of a person who is sick with or has died from EVD, infected animals, or with objects like needles that are contaminated with the virus. EVD is not spread through airborne transmission.

There is currently no FDA-licensed vaccine to protect against Sudan virus infection. The Ebola vaccine licensed in the United States (

genus (species Zaire ebolavirus), and based on studies in animals, it is not expected to protect against Sudan virus or other viruses in the Ebolavirus genus. Also, there is currently no FDA-approved treatment for Sudan virus.

 In the absence of early diagnosis and appropriate supportive care, EVD is a disease with a high mortality rate; occasional outbreaks have occurred mostly on the African continent. With intense supportive care and fluid replacement, mortality rates may be lowered. The genus 

 but only four (Ebola, Sudan, Taï Forest, and Bundibugyo viruses) are known to cause EVD in humans. Infection with any Ebola species presents as clinically similar disease. Previous outbreaks of Sudan virus have had a mortality rate of approximately 50%.

Clinicians who evaluate patients with clinical symptoms such as fever, headache, muscle and joint pain, fatigue, loss of appetite, gastrointestinal symptoms, and unexplained bleeding should suspect possible VHF or EVD on the differential diagnosis and clinicians should be prompted to immediately take a travel history. Healthcare providers should be alert for and evaluate any patients suspected of having VHF or EVD, particularly among people who have recently traveled to affected areas in Uganda, and place in a private room while performing clinical evaluation. If performing an aerosol generating procedure, conduct in an Airborne Infection Isolation Room (AIIR) when feasible. Testing for diseases in returning travelers which may present similarly to EVD, such as malaria, should be considered, but clinical consultation should be pursued if there is still a high index of suspicion for EVD.

 Louisiana clinicians with concerns about a patient with suspected EVD should immediately contact the Infectious Disease Epidemiology (IDEpi) 24/7 clinician hotline: 800-256-2748.

 Early recognition and identification of a suspected EVD 

 is critical. If a diagnosis of EVD is considered, clinical teams should coordinate with 

 and CDC to ensure appropriate precautions are taken to help prevent potential spread of EVD.

 As a resource for public health departments, CDC’s Viral Special Pathogens Branch (VSPB) is available 24/7 for consultations regarding suspected VHF or EVD cases by calling the CDC Emergency Operations Center at 770-488-7100 and requesting VSPB’s on-call epidemiologist, or by e-mailing 

 Healthcare personnel can be exposed to Ebola virus by touching a patient’s body fluids, contaminated medical supplies and equipment, or contaminated environmental surfaces. Splashes to unprotected mucous membranes (for example, the eyes, nose, or mouth) are particularly hazardous. Procedures that can increase environmental contamination with infectious material or create aerosols should be minimized. CDC recommends a combination of measures to 

 with more LRN laboratories working toward the ability to test. The Warrior Panel can detect Ebola, Sudan, Tai Forest, Bundibugyo, and Reston viruses.

Clinical and Laboratory Biosafety Considerations

All personnel handling specimens from patients with suspected EVD (especially patients with travel history to Uganda three weeks before symptom onset) should adhere to recommended 

 to prevent infection and transmission among laboratory personnel. As a component of the Occupational Safety and Health Administration’s (OSHA’s) Bloodborne Pathogens Standard, laboratories handling blood and body fluids must have an 

 in place to eliminate or minimize employees’ risk of exposure to pathogens. Laboratories should conduct 

 to identify and mitigate hazards associated with handling Ebola specimens to create the safest environment.

 needs to be identified, available, and staff trained to properly don and doff their PPE. Staff need to be specially trained, have passed 

 and attended drills to safely receive, handle, and process these specimens. A laboratory should have dedicated space, equipment for handling and testing specimens from ill patients, and plans for minimizing specimen manipulation. A 

 needs to be in place for lab reagents and Category A waste, including PPE and sample material. If a facility does not have the appropriate risk mitigation capabilities, then the specimen should be forwarded to another facility that does.

General Resources for Ebola Virus Disease

Outbreak of Ebola virus disease (Sudan ebolavirus) in Central Uganda

This message is from the State Health Officer regarding 

Increasing HIV Diagnoses across Louisiana. 

 Please see the message below to share and distribute with relevant stakeholders and partners through your own distribution channels.

Medical Providers and Community Leaders in Louisiana

Joseph Kanter, MD, Louisiana State Health Officer

Increasing HIV Diagnoses across Louisiana

The rise in people newly diagnosed with HIV is alarming and, notably, this increase is occurring in both rural and urban areas of the state. The Louisiana Department of Health‘s

 Office of Public Health requests that all healthcare professionals and community leaders in the state join us in addressing the rise of new HIV diagnoses.

All community and medical providers should ensure their patients are aware of HIV prevention options.

 These include Pre-Exposure Prophylaxis (PrEP), Post Exposure Prophylaxis (PEP), and an understanding that people with HIV who take their HIV medicine as prescribed and who achieve and maintain viral suppression (undetectable) can stay healthy and will not transmit HIV to their sex partners. – this is known as undetectable equals untransmittable (or U=U). More information can be found at 

Healthcare professionals are additionally encouraged to take the following steps to help reduce the rate of new diagnoses, especially in our most vulnerable communities.

As of October 1, 2022, LSBME will no longer accept paper applications. All applications (and payments) must be made online through your 

.  If you have any questions you may contact our licensure department at 

Paper Applications

Increasing Numbers of Syphilis and Congenital Syphilis Diagnoses Across Louisiana.  

to share and distribute with relevant stakeholders and partners through your own distribution channels.

Increasing Numbers of Syphilis and Congenital Syphilis Diagnoses Across Louisiana

FDA Authorizes and CDC Recommends Updated COVID-19 Vaccine Boosters Targeted to be More Effective Against Current Variants.

This week, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) authorized bivalent formulations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for use as a single booster dose at least two months following primary or booster vaccination. These updated boosters are formulated to offer continued protection against the ancestral strain while also offering better protection against two lineages of the omicron variant, BA.4 and BA.5, which represent over 90% of currently circulating virus. See the 

FDA Authorizes and CDC Recommends Updated COVID-19 Vaccine  Boosters Targeted to be More Effective Against Current Variants

FDA Authorizes and CDC Recommends Updated COVID-19 Vaccine Boosters Targeted to be More Effective Against Current Variants

The Louisiana Department of Health (LDH) has expanded the eligibility criteria for JYNNEOS vaccine (monkeypox vaccine). See the 

Update for Louisiana Clinicians on Expanded Eligibility for JYNNEOS Vaccine and TPOXX Availability

FBI warns healthcare professionals of ongoing scam

Nathan Tucker - Tuesday, August 23rd, 2022

 healthcare workers across the U.S. they may be targeted by scammers impersonating law enforcement officials who will attempt to extort money from them.

The warning, issued Aug. 22, noted an ongoing risk of widespread fraud schemes in which scammers impersonate law enforcement or government officials to extort money or steal personally identifiable information.

Scammers associated with wider criminal networks research background information on intended targets through official websites and social media and supplement that information with commonly found social media information to appear legitimate. Additionally, scammers spoof authentic phone numbers and names while using fake credentials from well-known government agencies. 

Victims are told they were subpoenaed to provide expert witness testimony in a criminal or civil court case. They are told they are in violation of the subpoena since they did not appear in court, and they have been held in contempt with an arrest warrant issued for them. 

Victims are often told if they pay a court fine, they will no longer be held in contempt. Scammers reinforce this information with an urgent and aggressive tone paired with scare tactics, like claiming that the victim is already under surveillance and the arrest warrant will be executed by an early morning police raid. 

Scammers demand payment in various forms such as prepaid cards, wire transfers, cash sent by mail, or converted into cryptocurrency ATMs. If victims pay, a new reason to send funds is introduced, such as additional court costs, etc. 

Law enforcement or government officials will never contact members of the public or medical practitioners by telephone to demand any form of payment or to request personal or sensitive information. Individuals should always ask for credentials to validate identity. Furthermore, no legitimate law enforcement or government official will request payments via prepaid cards or cryptocurrency ATM. 

Individuals can report suspected scammers by filing a complaint with the FBI Internet Crime Complaint Center at 

FBI Scam Warning

Guidance for Administering Second Dose of JYNNEOS Vaccine.  

 to share and distribute with relevant stakeholders and partners through your own distribution channels.

Guidance for Administering Second Dose of JYNNEOS Vaccine

Interim Clinical Considerations for Use of JYNNEOS Vaccine . 

Interim Clinical Considerations for Use of JYNNEOS Vaccine 

Update for Clinicians on Testing and Treatment for Monkeypox.  

Please see the message below to share and distribute with relevant stakeholders and partners through your own distribution channels.

As of July 28, 2022, the Centers for Disease Control and Prevention (CDC) and state and local public health partners are reporting 5,189 cases of monkeypox in the United States across 47 states, Washington, D.C., and Puerto Rico. Globally, 22,141 monkeypox cases have been identified across 72 countries that normally do not report monkeypox. In Louisiana, 49 monkeypox cases have been detected as of August 1, 2022. Monkeypox cases in Louisiana have been identified across 4 of the 9 Louisiana Department of Health (LDH) regions.

This Health Alert Network (HAN) Health Update serves to alert clinicians on commercial testing capability, collecting clinical specimens for testing, using TPOXX® (tecovirimat) for treating monkeypox, and vaccine eligibility and availability in Louisiana.

Recommendations for Healthcare Providers on Diagnostic Testing

Healthcare providers in Louisiana should be on alert for patients who have rash illnesses 

. Distinguishing features of the rash include papules, vesicles, pustules, or scabs that are deep-seated, firm or rubbery, and have well-defined round borders. Vesicular or pustular 

 are often umbilicated (i.e., have a dent in the middle of them). They may be painful, painless, or itchy. People with monkeypox may develop 

 including fever, headache, muscle aches, exhaustion or swollen lymph nodes during the prodromal period preceding the rash or with the rash.

The public health response to monkeypox depends on timely and comprehensive laboratory testing and reporting of those results. Tests should be performed on persons for whom monkeypox is suspected based on clinical presentation and 

. Positive diagnostic results from testing of skin lesion material for 

DNA in persons without epidemiologic criteria or known risk factors should be verified through repeat testing and/or confirmatory testing.

If there are no identified epidemiologic risk criteria for monkeypox infection, other possible causes of rash in adults should be considered, including secondary syphilis, herpes, and varicella zoster. In children without identified epidemiologic risk criteria for monkeypox, varicella zoster and molluscum contagiosum (MC) should be considered in the differential diagnosis. MC is an infection caused by a poxvirus (molluscum contagiosum virus) that is diagnosed more often in children than in adults. 

 is usually a benign, mild skin disease characterized by lesions that may appear anywhere on the body. CDC’s FDA-cleared non-variola virus test used within the Laboratory Response Network laboratories and most commercial laboratories, does not cross-react with molluscum contagiosum virus. In children and adolescents, as in adults, other potential etiologies of illness should be tested for in parallel with or before 

testing, based on clinical presentation and epidemiologic criteria.

The recommended specimen type is material collected from the surface of a lesion or crust from a healing lesion. CDC recommends that three lesions per patient be swabbed. Swab the surface of the lesion vigorously to collect adequate DNA. It is not necessary to de-roof or lance the lesion before swabbing. For some individuals, the lesions may not be overtly visible (such as within the oral cavity or within the rectum), therefore clinicians should perform a thorough evaluation including a full body skin, oral, genital, and rectal examination to identify appropriate lesions for sampling.

To build upon CDC’s and the Laboratory Response Network’s testing capacity, CDC recently worked to bring testing online at five commercial laboratory companies. All five commercial laboratories are now online and, combined with the CDC’s Laboratory Response Network, have increased national 

testing capacity from 6,000 to up to 80,000 specimens per week.† It is not necessary to first consult with state or federal health officials prior to initiating diagnostic testing at commercial laboratories.

Non-variola orthopoxvirus testing continues to be available through the State Public Health Laboratory (SPHL). Providers requesting testing through the SPHL should call the Infectious Disease Epidemiology (IDEpi) 24/7 clinician hotline (800-256-2748) for specimen collection instructions and courier transport.

Once results are received from the laboratory, a positive 

 test is considered to meet the case definition for probable 

infection since there are no other circulating 

within the United States that cause systemic disease. Clinical care and prevention precautions should begin based on the 

 test result and should not wait for any additional viral characterization testing that may be performed.

Information for Healthcare Providers on Tecovirimat Treatment

Tecovirimat (also known as TPOXX or ST-246) is approved by the Food and Drug Administration (FDA) for treating human smallpox disease caused by 

 in adults and children. Its use for other 

infections, including monkeypox, is not approved by the FDA. However, CDC has an 

expanded access Investigational New Drug application

 (EA-IND) to allow access to and use of TPOXX to treat monkeypox in adults and children of all ages.

The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs. The EA-IND also provides liability protection under the 

 for healthcare providers prescribing, administering, or dispending the drug, and ability for patients to seek compensation if they are seriously injured by the medication through the Countermeasures Injury Compensation Program ( 

). In the largest safety study of 359 healthy adult volunteers, other than local site reactions the most common adverse reactions among those receiving tecovirimat were headache (12%) and nausea (5%) [ 

 . The safety of tecovirimat has not yet been studied in people with 

Tecovirimat may be considered for treatment in people infected with 

TPOXX is available through the Strategic National Stockpile, and LDH has pre-positioned supplies of TPOXX within their Louisiana. All clinicians and care facility pharmacists requesting TPOXX should contact the 

IDEpi clinician 24/7 hotline: 800-256-2748.

TPOXX Expanded Access Investigational New Drug Protocol (

CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the EA-IND protocol. The streamlined process reduces the number of required patient treatment forms from six (21 pages) to two (7 pages); decreases patient visits to three visits that can all be conducted via telemedicine; and makes collecting blood, lesion samples, and lesion photos optional. Additional information about the EA-IND protocol for TPOXX can be found 

It is important to note that clinicians can start the patient’s treatment upon obtaining informed consent. All forms can be completed and submitted after treatment initiation to facilitate timely care of the patient. Timely return of patient intake and clinical outcome forms by providers and healthcare facilities enables CDC to monitor clinically appropriate and safe use of TPOXX.

Information for Providers on Jynneos Vaccine

The FDA has licensed JYNNEOSTM (also known by the brand names Imvamune and Imvanex), a replication-deficient smallpox vaccine, for the prevention of smallpox and monkeypox. JYNNEOSTM is an attenuated live virus vaccine. As a replication-deficient vaccine, it can be used for vaccination of people 18 years and older with certain immune deficiencies or conditions, such as HIV or atopic dermatitis. JYNNEOSTM has been studied in people with HIV and atopic dermatitis and no severe adverse events were identified.

LDH has ordered all available JYNNEOSTM doses that have been allocated to Louisiana by CDC. These vaccines are being distributed to regional offices of public health and a limited number of partner providers. Because doses remain in limited supply, LDH is prioritizing JYNNEOSTM vaccine for 2 purposes:

Individuals who are eligible for PEP are identified by LDH epidemiologists during case investigation. These individuals will be contacted by public health staff and referred to parish health units for PEP vaccination.

The supply of vaccine allocated to LDH is not abundant enough to immediately vaccinate all those who may benefit from vaccination with JYNNEOSTM. As a result, PEP++ vaccine doses will be prioritized according to the greatest risk for exposure. Eligibility groups will expand as the vaccine increases. At this time, the following groups are eligible for PEP++ vaccine in Louisiana:

Locations that are administering PEP++ vaccines (based on availability) can be found 

Update for Clinicians on Monkeypox in People with HIV, Children and Adolescents, and People who are Pregnant or Breastfeeding

CDC recently issued clinical considerations for monkeypox infection in multiple populations including: 

. These newly released clinical considerations complement existing clinical guidance for managing monkeypox and provide information on signs and symptoms of 

 infection; pre- and post-exposure prophylaxis; treatment; and infection control in these populations. The update CDC released through the health alert network can be found 

†Testing at public health laboratories remains free. Commercial laboratory companies will bill private insurance, Medicaid or Medicare for all testing performed. Those who are underinsured or uninsured will receive a bill for that testing. The Administration continues to work to identify funding that would cover the cost of monkeypox testing regardless of the individual’s coverage. Clinicians may find the relevant CPT code for Monkeypox virus testing on each commercial laboratory’s website.

Update for Clinicians on Testing and Treatment for Monkeypox

The Louisiana Department of Health (LDH) is issuing this heath update in order to provide healthcare providers in Louisiana with the most recent information regarding clinical presentations of U.S. monkeypox cases to date.

 The Louisiana Department of Health (LDH) is reporting the first detected case of monkeypox infection in a Louisiana resident, from LDH Region One, identified by testing at the Louisiana State Public Health Laboratory (LSPHL). In addition, an out-of-state resident visiting Louisiana also tested positive for monkeypox/orthopoxvirus at the LSPHL. No further information will be shared about these cases to protect the patients’ privacy. Monkeypox is a potentially serious viral illness that typically involves flu-like symptoms, swelling of the lymph nodes and a rash that includes bumps that are initially filled with fluid before scabbing over. Illness could be confused with a sexually transmitted infection like syphilis or herpes, or with varicella zoster virus (chickenpox). Most infections last two to four weeks.

LDH is working closely with the U.S. Centers for Disease Control and Prevention (CDC) and the patients’ healthcare providers to identify and notify individuals in Louisiana who may have been in contact with the patients while they were infectious. Monkeypox virus is most often spread through direct contact with a rash or sores of someone who has the virus. It can also spread through contact with clothing, bedding and other items used by a person with monkeypox, or from respiratory droplets that can be passed through prolonged face-to-face contact.

Since May 2022, 605 monkeypox cases have been identified in 36 states. Globally, more than 7,200 cases have been reported from 54 countries; the case count continues to rise daily. The actual number of cases is likely to be underestimated, in part due to the lack of early clinical recognition of an infection previously seen in only a handful of countries. Information about international cases is available from the 

 and information about U.S. cases is available from the 

It is a reasonable presumption that more undiagnosed human cases of monkeypox exist in Louisiana than have been formally tested and identified to-date.

Clinical presentations of monkeypox cases to date

Descriptions of classic monkeypox disease describe a prodrome including fever, lymphadenopathy, headache, and muscle aches followed by development of a characteristic rash culminating in firm, deep-seated, well-circumscribed and sometimes umbilicated lesions. The rash usually starts on the face or in the oral cavity and progresses through several synchronized stages on each affected area and concentrates on the face and extremities, including lesions on the palms and soles.

Thus far in the U.S. outbreak, all patients diagnosed with monkeypox in the United States have experienced a rash or enanthem. Although the characteristic firm, deep-seated, well-circumscribed and sometimes umbilicated rash has been observed, the rash has often begun in mucosal areas (e.g., genital, perianal, oral mucosa) and in some patients, the lesions have been scattered or localized to a specific body site rather than diffuse and have not involved the face or extremities. In some instances, patients have presented with symptoms such as anorectal pain, tenesmus, and rectal bleeding which upon physical examination, have been found to be associated with visible perianal vesicular, pustular, or ulcerative skin lesions and proctitis.

The clinical presentation of monkeypox may be similar to some STIs, such as syphilis, herpes, lymphogranuloma venereum (LGV), or other etiologies of proctitis. Clinicians should perform a thorough skin and mucosal examination for the characteristic vesiculo-pustular rash of monkeypox; this allows for detection of lesions the patient may not have been previously aware of. The search for lesions consistent with monkeypox should be performed even if lesions consistent with those from more common infections are observed; this is particularly important when evaluating patients who have epidemiologic risk factors for monkeypox. Early data suggest that gay, bisexual, and other men who have sex with men make up a high number of cases. However, anyone who has been in close contact with someone who has monkeypox is at risk.

Orthopoxvirus Testing Now Available Commercially

On Wednesday, July 6, Labcorp announced that it will begin testing with the CDC non-variola orthopoxvirus 510K cleared assay, an orthopoxvirus test that can detect monkeypox virus. Labcorp will offer this testing at its largest facility in the U.S. and will be able to accept specimens from anywhere in the United States and Puerto Rico. Labcorp will be able to perform up to 10,000 tests per week. Along with the additional 10,000 tests per week available through CDC’s 

, this will double national testing capacity. Labcorp will use electronic laboratory reporting (ELR) to report results to jurisdictions as outlined in 

. Labcorp will expand this testing capability to its other facilities as needed. Four additional commercial laboratory companies will begin testing for monkeypox in the coming weeks. CDC’s agreement with these commercial laboratories will last through at least November 2022. 

In addition to commercial laboratory testing availability, testing continues to be available through the LSPHL. If testing is requested through the LSPHL, providers should call the IDEpi hotline (800-256-2748) to receive detailed guidance regarding specimen submission and transport to the LSPHL.

Update on the Monkeypox Virus

Request for Exception to Limitations on Dispensing for Opioid Use Disorder (OUD)

If you are a provider for patients seeking treatment for OUD, you can still apply for an exception to 

, a DEA-registered practitioner working in a hospital, clinic, or emergency room, or any DEA-registered hospital/clinic that allows practitioners to operate under their registration number as per 

, may request an exception to the one-day supply limitation currently imposed pursuant to 21 CFR 1306.07(b).  Consistent with Pub. L. 116-215, DEA will grant such requests to allow a practitioner to dispense (but not prescribe) up to a three-day supply of the medication under the circumstances described in subsection 1306.07(b).

Requests for exception must be emailed to: 

Request for Exception to Limitations on Dispensing for Opioid Use Disorder 

This message is being sent via the Louisiana Department of Health Emergency Operations Center’s (LDH EOC) Louisiana Health Alert Network (LA HAN) for all LA HAN recipients. This message is from LDH regarding an 

 Update on the Monkeypox Virus Outbreak in the United States.  

Since May 2022, monkeypox cases, which have historically been rare in the United States, have been identified in 18 states and territories among both persons returning from international travel and their close contacts domestically. Globally, more than 1,600 cases have been reported from more than 30 countries; the case count continues to rise daily. In the United States, evidence of person-to-person disease transmission in multiple states and reports of clinical cases with some uncharacteristic features have raised concern that some cases are not being recognized and tested.

The current identification of West African monkeypox cases in many countries that do not have endemic disease and involving patients with no direct travel history to an area with endemic monkeypox, suggests person-to-person community spread. The first case of monkeypox in the United States was diagnosed in a traveler who returned to Massachusetts from Canada on May 17, 2022. Since then, 65 cases have been identified in 18 states and territories and more than 1,600 have been identified in 35 countries and territories that do not have endemic disease. As of June 15, no cases have been identified in Louisiana.

The case fatality rate of monkeypox associated with the West African clade of monkeypox virus is 1%, and possibly is higher in immunocompromised individuals; no deaths have been reported globally from the current outbreak. Any person, irrespective of gender identity or sexual orientation, can acquire and spread monkeypox. In this outbreak, however, many of the reported cases in the United States are among gay, bisexual, or other men who have sex with men (MSM). Close contact, sustained skin-to-skin contact including sexual contact, with a person with monkeypox or contact with contaminated fomites (e.g., shared linens) are the most significant risk factors associated with human-to-human transmission of 

Clinical presentations of confirmed cases to date

Descriptions of classic monkeypox disease have traditionally described a prodrome including fever, lymphadenopathy, headache, and muscle aches followed by development of a characteristic rash culminating in firm, deep-seated, well-circumscribed and sometimes umbilicated lesions. The rash traditionally has started on the face or in the oral cavity and progresses through several synchronized stages on each affected area and concentrates on the face and extremities, including lesions on the palms and soles.

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