Physicians Must Advocate for Themselves to Preserve Patients' Access to High-Quality Physician Care

With the House returning on Tuesday this week for likely the last legislative work period of 2023, the American Medical Association (AMA) flagged a letter to Congressional leadership urging legislative action to stop the impending 3.37 percent cut to Medicare physician payments. The AMA strongly supports this letter and urges physicians to push their Members of Congress to cosign it. (Note: Physicians and medical societies themselves cannot sign on.) Absent Congressional intervention, physicians will be forced to endure, effective January 1, 2024, another round of damaging cuts stemming from budget neutrality requirements within the CY2024 Medicare Physician Fee Schedule (MPFS) Final Rule. Please note that physicians are still facing this cut despite the fact that Congress provided a 1.25 percent increase to the MPFS conversion factor via the Consolidated Appropriations Act, 2023 (CAA 2023). AMA President, Jesse Ehrenfeld, MD, spoke at MSD's recent Annual Meeting and his message was clear that there is a need for physicians to advocate for themselves to achieve a more sustainable system that preserves patients' access to high-quality physician care.

The Dear Colleague letter comes on the heels of an AMA led letter to House and Senate leadership also urging expeditious legislative action to stop these payment reductions. This November 16 letter was signed by more than 100 national medical specialty and state medical associations, including the Medical Society of Delaware. 

December 12^th is the tentative deadline for Members of Congress to cosign this letter. There is no accompanying Senate letter at this time. Thanks for your ongoing assistance in stopping this latest round of cuts. House of Representatives look up: https://www.house.gov/representatives. Senate look up: https://www.senate.gov/senators/senators-contact.htm

Hanukkah Begins at Sundown on December 7th

Hanukkah is the eight-day celebration commemorating the rededication of the Holy Temple in Jerusalem after it was retaken by the Maccabees, a group of Jewish warriors, from the Greeks in the 2nd century BCE. The holiday is widely known as the Festival of Lights. Hanukkah celebrates freedom from oppression and supports and celebrates freedom of religious expression. Given the current world events, let us all take time to reflect not only on December 7th, but throughout the year. In light of our newsletter being sent on Thursdays each week, MSD is wishing you in advance, a Hanukkah full of beauty and light. Chag Urim Sameach!

COVID Cases Caused by BA.2.86 Variant Has Tripled in Past Two Weeks

As reported by HealthDay, the prevalence of a highly mutated COVID variant has tripled in the past two weeks, new Centers for Disease Control and Prevention (CDC) data show. CDC reported this week that nearly 10% of new COVID cases are a result of the BA.2.86 variant. Officials first warned of the highly mutated variant back in August, and it has since spread in several regions of the United States. The World Health Organization indicated that preliminary data on the variant suggests it does not trigger more severe illness than previous variants, but noted the recent and substantial rise in BA.2.86 cases. 

Ordering Refresh for Every US Household

The Administration for Strategic Preparedness and Response (ASPR) is committed to ensuring equitable access to COVID-19 tests, especially ahead of the holidays. ASPR is refreshing the ability to order on COVIDTests.gov for every U.S. household to order additional tests at no charge. Households that ordered this fall can order four more tests, and those that have not ordered this fall can submit two orders for a total of eight tests. Additionally, ASPR will continue to provide over four million free COVID-19 tests per week directly to long-term care facilities, schools, community health centers, and food banks. 

Warning to Health Care Industry About Threat of Emotet Malware

The HHS Health Sector Cybersecurity Coordination Center (HC3) issued a brief about Emotet, a malware strain that has impacted the health care sector since at least 2014. The malware has been described as the world’s most dangerous malware by Europol. HC3 stressed that the information in the brief is accurate as of the date of publication, but Emotet will likely evolve and update its capabilities in the future. Health care is one of the primary sectors targeted by Emotet. In the first quarter of 2023, the health care sector faced approximately 59 new cyberattacks per day, with increasing targeting. Emotet attacks are often delivered via phishing, but also via known vulnerabilities and brute force. The cybercriminal ecosystem is resilient, fluid and dynamic – gangs form and disband, but the talent and intellectual capital continues to grow over time. This is not expected to change. See slides 63 and 64 of the brief for mitigation and defense options.

FDA Issues Drug Safety Communication

The U.S. Food and Drug Administration (FDA) is warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the FDA is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.

FDA Issues Safety Communication

The U.S. Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources. FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action. Click for more information about this alert.

FDA Approves Ogsiveo Tablets for Adult Patients with Desmoid Tumors

On Monday this week, the U.S. Food and Drug Administration (FDA) approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials. 

Request Your Patients to Sign Up for V-Safe

The Centers for Disease Control and Prevention's (CDC’s) V-safe is expanding to include the maternal respiratory syncytial virus (RSV) vaccine. Earlier this fall, V-safe added functionality to allow people aged 60 and older who received an RSV vaccine to register for V-safe using their smartphone, tablet, or computer to tell CDC vaccine safety experts how they feel following vaccination. Now, people between 32-36 weeks pregnant who receive an RSV vaccine can register for a V-safe account to begin receiving and completing health check-ins. Pfizer’s bivalent RSVpreF vaccine (Abrysvo) is recommended for use during pregnancy. Vaccine safety monitoring is a top priority at CDC. V-safe is one of several systems CDC uses to closely monitor the safety of vaccines in the United States. The information gathered through V-safe helps CDC communicate timely and transparent information about the safety of vaccines to public health officials, healthcare providers, and the public.

Help promote V-safe:

• Ask your patients to sign up for V-safe at vsafe.cdc.gov.
• Share V-safe factsheets with instructions on how to register and complete health check-ins.
• Hang a V-safe poster near vaccination areas. 

2022-23 Flu Vaccination Cut ED Visits and Hospitalizations in Kids by Half

Flu activity continues to increase in most parts of the country, most notably in the South Central, Southeast, Mountain, and West Coast regions. The Centers for Disease Control and Prevention (CDC) also is reporting two flu-related deaths in children this week for a total of three this season.

A new study estimates that during the 2022-2023 flu season, vaccination reduced the risk of flu-related emergency department visits, urgent care visits, and hospitalizations by almost half among children and adolescents. Data for this study were collected in the VISION (VE) Network. CDC estimates that the burden of flu during the 2022–2023 season was similar to some seasons before the COVID-19 pandemic. An estimated 31 million people got sick, 14 million visited a health care provider, 360,000 were hospitalized, and 21,000 people died due to flu illness or related complications. CDC also updated its past flu burden estimates for the 2019-2020 and 2021-2022 seasons.  

Learn about Inflation Reduction Act Tax Credits and Grant Programs

The HHS Office of Climate Change and Health Equity (OCCHE) announced the launch of their 2024 Catalytic Program on Utilizing the Inflation Reduction Act (IRA). The three-month program will feature national webinars as well as breakout sessions for hospitals, health centers, and other health care professionals to help organizations assess their needs and assets, learn about Inflation Reduction Act tax credits and grant programs, and successfully utilize these opportunities. Please contact OCCHE@HHS.gov with any additional questions.

Settlement with Ohio Triggers Contingency in Delaware's Settlement

On Wednesday this week, DuPont, Chemours and Corteva announced a settlement of PFAS liabilities with the State of Ohio. This settlement triggers a contingency in Delaware's 2021 settlement with the same companies that will result in the payment of an additional $25 million to Delaware. Attorney General Kathy Jennings issued the following statement in connection with this news: "We are thrilled that our forward-thinking settlement with Dupont and others is now $25 million more valuable to the State of Delaware. That’s 50% more to restore our natural resources, to support public health initiatives in impacted communities, and to keep our neighbors healthy." The original press release announcing Delaware's settlement is available here.

Adopts Advanced Clean Cars II Rule

The Department of Natural Resources and Environmental Control has finalized regulations to adopt the Advanced Clean Car II (ACC II) program, which aims to reduce pollution from light- and medium-duty vehicles, but will cap the zero emission vehicle requirement at 82%. In doing so, Delaware is taking a significant step to improve air quality and address climate change. The regulations require automakers to deliver an increasing amount of zero-emission vehicles (ZEVs) for sale in Delaware. Zero-emission options, including battery-electric, plug-in hybrid electric, and fuel cell electric vehicles, will be more accessible across the state. Under the finalized regulation, starting with model year 2027, 43% of new cars and trucks sent to Delaware for sale will be ZEVs. The percentage will increase to 82% in 2032. The regulations will expire in model year 2033. This is similar to regulations in some other states. The changes will be phased in over the five-year period and the regulations do not prohibit the sale or use of internal combustion engine vehicles. The decision was announced by a DNREC Secretary’s Order and is set for publication in the Delaware Register of Regulations on Dec. 1, 2023. It was informed by state law, the federal Clean Air Act, information included in the technical response memo and comments received from the public during the rule-making process.

Is a New iPhone Feature a Possible Security Risk?

If you have an iPhone and have done the recent iOS 17 update, a new feature has been added called "NameDrop." The feature has been added in Apple's iOS 17 and WatchOS 10.1 updates that allows users to share contact details and more by having devices next to each other. This feature is defaulted to the ON position and allows the sharing of your contact information. According to Tom's Guide, several conditions need to be met for this feature to work. First, the feature will only run on phones and watches with the correct update. Assuming both devices have the NameDrop feature available, the information can then only be transferred after confirmation by both parties. If the NameDrop feature still makes you uncomfortable, it is easily turned off. Just follow these step to shut this feature off: Go to Settings, General, AirDrop, Bringing Devices Together, and change to OFF.

Addresses Serious "Zero-Day Flaw" Exploited by Hackers

According to Tom's Guide, Google has released a new emergency security update for Chrome to address a high severity zero-day vulnerability that’s currently being exploited by hackers.

The zero-day in question has now been patched in Chrome version 119.0.6045.199/.200 for Windows and version 119.0.6045.199 for Mac and Linux. In an advisory sent out alongside the emergency security update, the Chrome team explained that it also contains fixes for 6 other security flaws, all of which are high-severity vulnerabilities. If you haven’t updated Chrome lately, you may want to install this emergency security update as there is a chance — though relatively small — that the zero-day flaw could be used by hackers in their attacks. Even then, you always want to keep your browser up to date as cybercriminals often target users that are running outdated software.

MSD Relaunches it's Mentorship Program - Join the Fun!

The Committee on Membership’s ad hoc work group has relaunched MSD’s mentorship program. All are welcome. You will be paired with a physician who you will meet and connect with based on your desired timelines and desired level of engagement. This program is built for you! Opportunities for individual and group meet-and-greets, check-ins, and virtual and/or in person events are being planned for everyone. You will make a difference! Current members of this workgroup include: Raghda Bchech, MD; Jay Dave, DO; Nicole Kushner, DO & Cydney Teal, MD. For questions contact Michelle.Seymour@medscodel.org

Sign up to participate today! Click the survey link below or scan the QR code with your phone: https://www.surveymonkey.com/r/MSDMentorProgram

"Kind to Kids" - Children, Teens in Foster Care Affected by Trauma

The Medical Society of Delaware (MSD) has selected Kind to Kids as our winter season charity fundraising beneficiary. Our goal is to raise $1,200 to help children and teens in foster care who are victims of child abuse and neglect. Your donation will provide direct support for a child in foster care. Kind to Kids is a foundation that helps meet the needs of children and teens in foster care who are deeply affected by the trauma in their lives. 100% of every dollar donated online will go directly to help a foster child during these difficult times. Please donate now and help us make a difference in the lives of these deserving kids. You can donate online at https://www.classy.org/fundraiser/5051939. Thank you for your support! 

Prevent Diabetes in At-Risk Patients

More than one in three U.S. adults have prediabetes, and about 80% of people with the condition are unaware of it. With the right interventions, physicians and care teams can help prevent type 2 diabetes in at-risk adult patients. Consider a prediabetes screening program for your patients, offer additional education, or refer at-risk patients to a lifestyle change program from the National Diabetes Prevention Program.

LEARN MORE:

Toolkit:

• Team-Based Care of Type 2 Diabetes and Prediabetes

Resource:

• AMA Prevent Diabetes

Podcast:

• A Busy Physician’s Guide to Prediabetes & Diabetes

Webinars:

• AMA Prediabetes Quality Measures
• A Team-Based Approach to Treating Prediabetes

AMA STEPS Forward^® offers a collection of engaging and interactive educational content designed to help put the joy back into medicine.

Don't Miss These Deadlines!

As the end of the year approaches, we want to remind you of some important upcoming MIPS deadlines.

2024 MVP Registration Deadline: November 30, 2023

If you plan to report a MIPS Value Pathway in the 2024 performance year, you must register on or before November 30, 2023.

2024 Virtual Group Election Deadline: December 31, 2023

If you are planning to participate in MIPS as part of a virtual group, you must elect your group for the 2024 performance year by December 31, 2023.

End of 2023 Performance Year: December 31, 2023

The 2023 performance year ends on December 31, 2023. This is the last day to submit your MIPS data for the 2023 performance year.

EUC Deadline: January 2, 2024

The Exception and Unforeseen Circumstances (EUC) deadline is January 2, 2024. This is the last day to submit an EUC application for the 2023 performance year.

2023 Submission period: January 1, 2024

The submission period for submitting 2023 performance year starts January 1, 2024.

Due to Crystallization

Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted. Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Potential Device Failures

On Thursday this week, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform consumers, health care professionals, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, particles in the syringes, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes. The FDA received information about quality issues associated with several Chinese manufacturers of syringes. They are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance. At this time, while the FDA continues its evaluation, consider using plastic syringes not manufactured in China, if possible.

FDA Cautions Public, Physicians of Emerging Safety Issue

On Tuesday, the U.S. Food and Drug Administration (FDA) alerted patients and health care professionals of an emerging safety issue involving Philips Respironics’ DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treatment of obstructive sleep apnea. The FDA issued a safety communication to inform the public of reports involving thermal issues with the machine, some of which cited patient injuries, and to provide safety recommendations for patient use, including carefully monitoring machines for signs of overheating. The agency recently received medical device reports (MDRs) associated with issues, such as fire, smoke, burns and other signs of overheating while using the machine. The FDA is in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly. While the FDA continues to analyze and address this issue, the agency is recommending those who use the machine to follow the manufacturer’s instructions in the user manual and to inspect and examine the machine for unusual smells or changes in appearances before and after each use. More information on the agency’s safety recommendations can be found in the FDA’s safety communication on this issue. 

This new safety issue comes as the FDA continues to closely monitor Philips’ handling of the June 2021 recall impacting millions of sleep therapy and respirator machines, including CPAP machines. The polyester-based polyurethane (PE-PUR) foam used in the recalled machines to reduce sound and vibration can break down and could potentially be breathed in or swallowed, posing possible risks to the person using the device. Of note, the DreamStation 2 machines are manufactured with a silicone-based foam, not PE-PUR foam, and were not included in the June 2021 recall.  

Bayhealth

Charles G. Case, MD - Family Medicine, Henrietta Johnson Medical Center

Dean E. Johnson, MD - EM, Bayhealth, EM Residency Program Director

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!

David D. Chen, MD - IM/Peds at ChristianaCare

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(s) 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.

• Ellume tests available for those who are blind or have low vision (free at-home COVID-19 tests) https://acl.gov/accessibletests
• 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)
• (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)