The MSD office will be closing at 2 p.m. on Friday, September 1st for the Labor Day holiday. We will resume business on Tuesday, September 5th at 8:00 a.m. MSD staff wish all our members a safe and enjoyable Labor Day holiday.

This Action is in Addition to Reducing the Cost of Insulin to $35/Month

The Inflation Reduction Act of 2022 makes improvements to Medicare that in turn provides financial relief for those with Medicare. For the first time, the law provides Medicare the ability to directly negotiate the prices of certain high expenditure, single source drugs without generic or biosimilar competition. Medicare has selected 10 drugs under Medicare Part D for negotiation for initial price applicability year 2026 (Eliquis; Jardiance; Xarelto; Januvia; Farxiga; Entresto; Enbrel; Imbruvica; Stelara; and Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill). The Centers for Medicare and Medicaid Services (CMS) selected the drugs through a process that prioritized ones that account for the highest Medicare spending, and have been on the market for years and do not yet face competition from rivals. Seniors paid $3.4 billion in out-of-pocket costs for these drugs in 2022. Astra Zeneca filed a legal challenge to the drug price negotiation provisions of the Inflation Reduction Act. While a press release indicated the challenge was based on orphan drugs for patients with rare diseases, a pharmaceutical executive reported the suit claims the negotiations with Medicare are unconstitutional. Over the next four years, Medicare will negotiate prices for up to 60 drugs covered under Medicare Part D and Part B, and up to an additional 20 drugs every year after that.

Increased Competition, More Options for Delawareans and Employers

For the second consecutive year, Delawareans will have access to increased options on the Health Insurance Marketplace, Insurance Commissioner Trinidad Navarro announced today, with 57 total plans offered by four insurers, along with 12 dental plans for the 2024 plan year. Consumers will have the opportunity to purchase plans from Celtic Insurance Company Ambetter Health of Delaware, a carrier new to the state’s marketplace, in addition to plans from Aetna Health, AmeriHealth Caritas, and Highmark Blue Cross Blue Shield of Delaware. As recently as the 2022 plan year, consumers had only one carrier and 12 plan options to choose from. Insurance Commissioner Trinidad Navarro stated, “Our Office of Value-Based Health Care Delivery has confirmed carrier’s filings reflect compliance with our affordability standards, including increasing spending on primary care to lower overall cost of care. We look forward continuing to make progress in this work.” Enrollment numbers are expected to rise as Medicaid redeterminations continue following the end of the COVID-19 Public Health Emergency. A Special Enrollment Period for Marketplace plans is available for persons no longer eligible for Medicaid. Open Enrollment takes place November 1 through January 15. Be aware of non-compliant alternative health plans. Following in-depth reviews by independent actuaries and the Office of Value-Based Health Care Delivery, rates for regulated 2024 health, dental, and small group insurance plans were also announced today. 

CMS Asks States to Assess, Fix Systems

Following the end of pandemic-era conditions for Medicaid coverages, states have resumed their regular process for renewing Medicaid and Children's Health Insurance Program (CHIP) enrollment. States are required by federal regulation to use information already available through existing reliable data sources (e.g., state wage data) to determine whether people are still eligible for Medicaid or CHIP. The Centers for Medicare and Medicaid Services (CMS) believes that eligibility systems in a number of states are programmed incorrectly and are conducting automatic renewals at the family level and not the individual level. CMS has sent a letter to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands requiring them to determine whether they have an eligibility systems issue that could cause people, especially children, to be disenrolled from Medicaid or CHIP even if they are still eligible for coverage, and requiring them to immediately act to correct the problem and reinstate coverage.

CDC Issues Health Alert Network Health Update

The Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Update to share new information with clinicians, public health authorities, and the public about locally acquired malaria cases identified in the United States. On August 18, 2023, a single case of locally acquired malaria was reported in Maryland in the National Capital Region. This case was caused by the Plasmodium falciparum (P. falciparum) species and is unrelated to the cases involving local transmission of Plasmodium vivax (P. vivax) malaria in Florida and Texas described in the HAN Health Advisory 494 issued on June 26, 2023. As an update to that report, to date, Florida has identified seven cases and Texas has identified one case of locally acquired P. vivax malaria, however, there have been no reports of local transmission of malaria in Florida or Texas since mid-July 2023.

Antibodies Against COVID Diminish Over Time, Americans Due for Update

The COVID-19 vaccines for current variants are expected to be available in pharmacies and clinics in mid- to late-September, according to Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) officials. The first step is the approval by the FDA, which should take place in the next few weeks. Then the Advisory Committee on Immunization Practices (ACIP) will make recommendations to the CDC. The ACIP is scheduled to meet September 12 to discuss COVID-19 vaccines. After the CDC Director signs off, vaccines can be administered. Three vaccines are expected to be available. Two are mRNA vaccines (Pfizer and Moderna), the third vaccine from Novavax uses and older type of technology that contains the spike protein of the virus. The FDA plans to grant full licensure for the Pfizer and Moderna vaccines for those 12 and older. For children 11 and under, vaccines, including the Novavax vaccine, will be available under an emergency use authorization. These vaccines will be the first COVID-19 vaccines to be available directly from the manufacturers as part of the commercial market, rather than provided free by the government. Under the Affordable Care Act, most insurance plans are required to cover the full cost of vaccines without a co-pay. Those who don't have insurance or have enough insurance can still obtain the vaccine for free through the government's Bridge Access Program at a federally qualified health center, public health department, or pharmacy, such as CVS, Walgreens, Walmart and others.

CDC Launches New Initiative for Hospital Sepsis Teams

The Centers for Disease Control and Prevention (CDC) announced the launch of a new initiative aimed at supporting sepsis teams at U.S. hospitals in light of new data that found a third of patients who die in hospitals had sepsis while hospitalized. The CDC’s "Hospital Sepsis Program Core Elements" are essential to optimize patient care and help clinicians, hospitals, and health systems in efforts to improve the hospital management and outcomes of sepsis. Hospital Sepsis Program Core Elements will act as a manager’s guide on how to organize staff and identify resources needed to support the care of patients with sepsis for bringing sepsis rates down.

Most Often Used in Treatment of ADHA, Binge Eating Disorder, Narcolepsy

On August 1, 2023, the Drug Enforcement Administration (DEA) and U.S. Food and Drug Administration (FDA) issued a joint letter updating the public on the ongoing prescription stimulant shortages, most often used in the treatment of ADHD, binge eating disorder, and narcolepsy, impacting patients across the United States. The DEA and FDA advised that they are committed to working together on this issue and providing up-to-date information. The DEA and FDA have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount. The FDA is asking professional groups and health care professionals to accelerate efforts to support appropriate diagnosis and treatment of ADHD, such as further development of additional clinical guidelines for ADHD in adults. Read DEA/FDA joint letter.

Tyruko, First Biosimilar to Tysabri Injection

The U.S. Food and Drug Administration (FDA) approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).

CDC Issues Communication

Ringworm, also called tinea or dermatophytosis, is a common fungal infection of the hair, skin, or nails caused by dermatophyte fungi. Usually, ringworm skin infections are minor ailments that can be treated successfully with topical antifungal medications or oral terbinafine, a first-line oral antifungal drug for ringworm, in cases of widespread infection. However, ringworm caused by Trichophyton indotineae, a frequently antifungal-resistant fungus, can cause widespread, highly inflamed lesions on the face, trunks, arms, legs, or groin. Trichophyton indotineae infections generally do not improve when treated with most topical antifungals or terbinafine. Outbreaks of antifungal-resistant ringworm are occurring in the Indian Subcontinent, and cases have been detected throughout Asia and Europe. Read the recommendations for clinicians.

Public Comments Sought on Draft Recommendations from USPSTF

The U.S. Preventive Services Task Force (USPSTF) seeks comments on a draft recommendation statement and draft evidence review on primary care interventions to prevent child maltreatment. The Task Force is calling for more research on how to prevent child maltreatment before it occurs in children and adolescents who do not show signs or symptoms of abuse and neglect. The draft recommendation statement and draft evidence review are available for review and public comment from August 29, 2023 to September 25, 2023 here. Any visitor to the Task Force website can comment on any of the listed USPSTF draft documents. The USPSTF writes these documents for researchers, primary care doctors, and other health care providers, using medical and scientific language as appropriate for these audiences. Learn more about the process.

By Order of Governor Carney

Governor John Carney ordered the Delaware flag to be lowered to half-staff at all state facilities today, Thursday, August 31, 2023, from sunrise to sunset, in recognition of International Overdose Awareness Day, as declared by Senate Joint Resolution 2. Local governments, businesses, and Delawareans were encouraged to do the same to promote awareness of overdose prevention strategies and to acknowledge all who have suffered the loss of a loved one to overdose.

Applications Now Open

The Physicians Foundation recently launched a call for applicants for the Fellowship Program! New or early-career physicians are encouraged to apply by September 19. With a focus on drivers of health (DOH), the Fellowship Program enhances physicians’ leadership skills so they can strengthen the physician-patient relationship, support medical practices’ sustainability, and navigate the changing health care system. The fellow will develop and implement a project that supports physicians in their understanding of DOH and integration into medical practices. 

Requirements include:

• Open to physicians who are new or early-career in their practice.
• Applicants must demonstrate experience with and/or interest in DOH, physician leadership, health policy, health equity and clinical/care delivery innovation.
• Submit a program application with a current resume/CV and statement of intent that briefly describes how participation will be a transformative experience for you to learn how to make positive, constructive contributions to the medical profession in the future.
• Receive two (2) letters of recommendation, one of which is recommended to be from the fellow's state or county medical society.

APPLY FOR THE FELLOWSHIP

Eligible Families Will Receive Emergency Food Assistance Benefits for Kids

The Delaware Division of Social Services is issuing retroactive emergency food assistance benefits under the Pandemic Electronic Benefit Transfer (P-EBT) program for School Year 2022-2023 and Summer 2023 to Delaware households with eligible children. Eligible households began receiving P-EBT benefits beginning in August. Delaware's P-EBT Program provides food assistance to families with children who lost access to free or reduced-price school meals due to school closures or reduced in-person attendance as a result of the COVID-19 pandemic. The P-EBT Program was implemented as a result of the federal public health emergency declaration for COVID-19 and will end after the Summer 2023 retroactive benefits are issued. Eligible households will receive written notification in the mail regarding P-EBT benefits for the 2022-2023 school year and Summer 2023. 

Data Breach Dates Back to End of May, Involves MOVEit Software

Town Square Live has reported that the year's biggest security breach involves the MOVEit software and so far has affected 60 million people, including customers of M&T Bank, Delaware's largest bank. Cl0p, a ransomware group linked to Russia has claimed responsibility. The data breach dates back to the end of May, noting that hackers most likely knew about the vulnerability in the MOVEit software as early as 2021. The largest leak involves 11 million people serviced by Maximus, a company that manages federal data. The Centers for Medicare & Medicaid Services (CMS) has indicated the data breached may have included everything about the health and personal identity of 612,000 current Medicare beneficiaries. In a letter from Global Atlantic, the company states it believes the hack has included names, social security number, and dates of birth of customers from its brands that include Accordia Life, Commonwealth Annuity, First Allmerica Finance, and Forethought Life.

Scoreless Prerequisites to Attest to Completing to Obtain PI Points

MIPS Promoting Interoperability (PI) has its core objectives and measures but did you know there are a few scoreless prerequisites you must attest to completing in order to obtain any PI points? The Chirpy Bird blog explores the most common pitfall practice overlook and how to avoid it. The Promoting Interoperability Security Risk Assessment!

A few key takeaways:

1. The Mighty SRA: Security Risk Analysis (SRA) might seem like another checkbox, but it's a vital MIPS component. Forgetting this step? It could cost you ALL your Promoting Interoperability points, irrespective of your performance elsewhere. 🚫❌
2. Beyond Your EHR: Remember, the SRA isn't confined to your EHR. It extensively scrutinizes ePHI throughout all office systems, policies, and procedures. 🖥️🔒
3. Regular Reviews: An SRA isn't a "set it and forget it" task. For every system update or new installment, an analysis is essential. Plus, you need a yearly review for each MIPS performance cycle. 🔄📅

AMA Helps Debunk Myths

Physicians often believe that the Health Insurance Portability and Accountability Act (HIPAA) and other privacy laws prohibit them from responding to a review a patient or their caregiver posts on online—even if the review is negative or contains untrue or inflammatory information that can be harmful to them or their practice. There are no federal laws or regulations that expressly prohibit physicians or their practices from responding to online patient reviews. That having been said, unlike other businesses that can respond to online reviews however they see fit, HIPAA patient-privacy protections and state laws limit what physicians can say in response to a patient review in a public forum, according to research from the AMA through its "Debunking Regulatory Myths" series. Read more.

Software Issues May Cause Ventilators to Stop Without Notice

Hamilton Medical Inc. is recalling the HAMILTON-C1, C2, C3, T1 ventilators after receiving reports of software issues that may cause the ventilators to stop without notice. The ventilator will switch to 'Ambient State,’ if the device is used for more than 91 days without a restart. There have been 80 reported complaints, no injuries and no deaths related to this recall. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Six of the Latest Recalls are Class I Recalls

Today, the U.S. Food and Drug Administration (FDA) provided an update for Getinge/ Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA issued the letter to help ensure health care professionals are aware of the latest recalls and recommendations to users.Since June 2023, Getinge/Maquet/Datascope initiated additional voluntary recalls related to the potential for device failure with Cardiosave IABP devices and provided mitigation strategies. Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops). The FDA continues to closely monitor issues with Cardiosave IABP devices. The FDA has identified six of these latest recalls as Class I recalls, the most serious type of recall. Please be aware, these recalls are voluntary corrections, not product removals.

Due to Label Mix-Up

Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labeled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg. Digoxin Tablets USP, 0.125mg are yellow, circular, beveled, uncoated tablets scored between "N" and "201" on one side and plain on the other side. Digoxin Tablets USP, 0.25mg are white to off-white, circular. beveled, uncoated tablets scored between "N" and "202" on one side and plain on the other side. Risk Statement: The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Patients who intend to take Digoxin Tablets USP, 0.125mg, but unknowingly Digoxin 0.25mg would receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose.

Practice Management: Telemedicine

Building a successful team-based telehealth program means relying on the skills of IT partners, nurse practitioners, medical assistants, and other members of the clinical and administrative teams. Use a LISTEN-SORT-EMPOWER model to engage care teams with daily improvements and problem-solving, demonstrating that leaders have confidence in the team’s abilities.

LEARN MORE:

Toolkits:

• Telehealth and Team-Based Care
• LISTEN-SORT-EMPOWER

Podcast: Telemedicine Is a Team Effort

Webinar: How to Engage Support Staff to Implement Team-Based Care in Telemedicine 

Beebe Healthcare

ChristianaCare

Yehuda E. Kerbel, MD - Orthopaedic Surgery, First State Orthopaedics

Hamdan K. Mallick, MD - General Surgery Resident, Bayhealth

Jessica McKeown - Medical Student, PCOM/ChristianaCare

Kelly E. Moyer - Medical Student, SKMC/ChristianaCare

Please join MSD in welcoming the newest members of the Medical Society of Delaware. As the third oldest medical society in the country, MSD has an amazing history. Thank you for taking part in our continued success!

Yeswanth Attoti, MD - Internal Medicine, Seaford Internal Medicine, LLC

Ronald A. Luna, MD - Internal Medicine, Seaford Internal Medicine, LLC

MSD members are afforded a seven-day review period from the date of this publication to comment regarding applicants for membership. Please contact Michelle Seymour at (302) 224-4905 or Michelle.Seymour@medsocdel.org with any comments on the current pending members listed above or if you know of someone interested in joining MSD. You could be eligible for a membership referral dues discount!

The Latin phrase Rerum Cognoscere translates to learn, examine, or become aware of facts or things. In this section, we highlight measurable items of interest in health care from MSD, Delaware, the US, and the world.

CDC Director Rochelle P. Walensky, M.D., M.P.H. adopted the 2023-2024 Advisory Committee on Immunization Practices’ (ACIP) recommendations on annual influenza (flu) vaccination for everyone 6 months and older in the United States on June 27, 2023. There were small changes to the annual recommendations around flu vaccination, including an acknowledgement of the updated flu vaccine composition for the 2023-2024 flu season and a change in the recommendations for vaccination of people with egg allergies. Dr. Walensky’s adoption of the ACIP recommendations makes them official CDC policy, which have been published in the Morbidity and Mortality Weekly Recommendation Report August 23, 2023. Health care professionals should begin vaccinating patients according to CDC’s recommended timing, which remains the same as last season. Read the CDC Vaccine Recommendations for the 2023-2024 flu season.

The national emergency and public health emergency (PHE) declarations related to the COVID-19 pandemic ended on May 11, 2023. The Centers for Medicare & Medicaid Services (CMS) has resources available, some of which have been updated based on recent action by Congress.

• Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (Updated 5/12/2023).
• Provider-specific fact sheets for information about COVID-19 Public Health Emergency (PHE) waivers and flexibilities: https://www.cms.gov/coronavirus-waivers
• Acute Hospital Care At Home
• Loss of Medicaid or CHIP coverage
• FAQs on CMS Waivers, Flexibilities, end of COVID-19 PHE (May 4, 2023)

Updates will continue to be provided as we approach the end of the PHE. You are encouraged to regularly visit the CMS Emergencies Page for the most up to date information.

• Find COVID-19 Vaccines: https://www.vaccines.gov/
• No Cost COVID-19 Testing Locator can help people find current community and pharmacy partners participating in the Increasing Community Access to Testing (ICATT) program.
• FDA At-Home OTC COVID-19 Diagnostic Tests provides a list of all FDA-authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests
• Federal website for information on navigating COVID: COVID.gov
• CDC Isolation and Precautions for People with COVID-19
• COVID-19 Therapeutics Locator
• CDC COVID Data Tracker
• CDC will report regional-level test positivity data from the National Respiratory and Enteric Virus Surveillance System (NREVSS)
• COVID-19 by County Community Level Check (# hospital admissions and beds used and total number of new cases)
• 2nd bivalent COVID-19 Vaccine Booster: Who Should Receive It?
• (Delaware) General Questions: call 211 or email DPHCall@delaware.gov or Vaccine@delaware.gov for vaccine-specific questions.
• Latest information on Delaware's response (testing, treatment, vaccination): de.gov/coronavirus (Updated 2/2023)