How to Get Involved - Register Now for the AMA Webinar

Physicians face a 3.37% reduction in Medicare payments at the start of 2024, absent congressional intervention. Lawmakers have until Jan. 19 to act and avoid this potentially devastating cut to physician practices—practices that have already weathered the pandemic, a 2% pay cut in 2023, and no adjustment for inflation. Without a sustainable Medicare payment system that physician practices can rely on, patient access to care will be in jeopardy. Register now for a webinar on Tuesday, January 9 at 12:00 Noon ET to hear about what’s happening with Medicare payment on Capitol Hill as the new year begins, what the AMA is doing to fight for legislative solutions, and how you can get involved in the AMA’s Physicians Grassroots Network campaign.

Final Donor List for 2023 - Give Now for 2024!

The 1789 Club recognizes the philanthropic investment by physicians in the future of medicine in the state of Delaware, and the part the Medical Society of Delaware will play in shaping that future. Donors providing a gift of at least $1,789 are part of an exclusive cohort on the 1789 Club and receive a special 1789 Club lapel pin that is a reproduction of

our Society’s original Seal. Join today by giving to the MSD Mission Appeal and help lead the way to a healthy Delaware!

Thank you to all who donated to the 2023 Mission Appeal. Just over $40,000 was received from our 2023 donors, making 2023 our second highest yearly total. Approximately $200,000 has been received since the start of the campaign. Your support allows us to grow and sustain the Delaware Foundation for Medical Services (DFMS) and Delaware Medical Education Foundation (DMEF). It is never too late to give. Please consider the MSD charitable foundations in your 2024 charitable giving.

The Importance of Accuracy of Death Certificates

Join MSD on Wednesday, January 17, 2024, at 6:00 p.m. at the MSD office in Middletown for an important “Hot Topics” education session. Robert N. Anderson, PhD from the Center for Disease Control and Prevention will address the importance of accuracy of death certificates, including for patients diagnosed with cancer. This is an opportunity for health care professionals to enhance their skills in accurately documenting and certifying the cause of death, to include the context of cancer diagnoses. This activity has been approved for a maximum of 1 AMA PRA Category 1 Credit™.

Health Care Professionals Invited to Office Hours

The Division of Public Health's Office of Infectious Disease Epidemiology (OIDE) now has office hours for Delaware health care professionals. Beginning in January, OIDE will host an accessible and informative platform for health care professionals to engage with epidemiologists and other experts to stay informed about key public health topics. The monthly "Epichat" forum is an opportunity to learn about Delaware's reportable diseases, ask questions, and share insights. Resources will be shared. OIDE will provide information and guidance on various public health topics. The Epichat series will feature online discussions with epidemiologists and subject matter experts via DPH's One Health partnership.

• Thursday, January 25 at Noon - Delaware Reportable Diseases and reporting requirements and procedures, and case studies and examples.

• Thursday, February 22 at Noon - West Nile Virus transmission, surveillance, reporting, and mosquito control and prevention.

• Thursday, March 21 at Noon - Lyme disease's epidemiology, geographic distribution, clinical presentation, diagnosis, treatment, and tick prevention and control.

To receive Epichat notifications, contact Reportdisease@delaware.gov. Click to register for the January session: January EpiChat - Reportable Diseases. For more information, contact OIDE at 302-622-4149.

FDA Evaluating Need for Regulatory Action

CNN is reporting that the US Food and Drug Administration (FDA) is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications like Ozempic, Mounjaro, and Wegovy. These drugs, known as GLP-1 receptor agonists, are approved to treat diabetes or weight loss. They mimic GLP-1, a hormone made naturally in the body whose roles include slowing the passage of food through the stomach. The FDA is evaluating the need for regulatory action after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, aspiration, and suicidal ideation in people using these medications. Some research has linked GLP-1 agonists to serious digestive problems such as stomach paralysis, pancreatitis and bowel obstructions, although the risks of these events appear to be rare. Many of these side effects are mentioned in the drugs’ prescribing information or on their labels. The American Society of Anesthesiologists recommended in June that people who use GLP-1 agonists stop taking them for a week before surgical procedures because of the potential for gastrointestinal problems that may increase the risk of regurgitation and pulmonary aspiration of gastric contents during general anesthesia and deep sedation. 

Found in U.S. Drug Supply Chain

The U.S. Food and Drug Administration (FDA) continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. FDA and Novo Nordisk (manufacturer of Ozempic [semaglutide]) are testing the seized products and do not yet have information about the drugs’ identity, quality or safety. Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton. 

USPSTF Draft Research Plan open to Public Comment

The U.S. Preventive Services Task Force (USPSTF) posted a draft research plan on medication to reduce the risk of breast cancer. The draft research plan is available for review and public comment from December 28, 2023, through January 31, 2024. Note the public comment period has been expanded from the standard four weeks to five weeks to account for the holidays. To review the draft research plan and submit comments, go here.

FDA Issues Letter to Clinical Laboratory Staff and Health Care Professionals

The U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Professionals as a reminder about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serological tests for genital herpes. According to the Centers for Disease Control and Prevention (CDC), clinical diagnosis of genital herpes can be challenging. When using current HSV tests, the chance of a false result increases if a person:

• gets a blood test too soon after infection

• has a low risk of infection

• receives test results that are near the cutoff (low positive)

The Letter to Health Care Professionals includes important information about HSV-2 false reactive results including:

• Reminders and recommendations

• Instructions for reporting problems with these tests

CMS Releases Report

The Centers for Medicare and Medicaid Services (CMS) released the final report on the evaluation of the Comprehensive Primary Care Plus (CPC+) Model. CPC+ was a primary care practice transformation model, supporting practices at varying levels of readiness in two tracks. The report found that during the five performance years of the model, participating practices transformed the way they provided many aspects of care. This transformation led to reduced outpatient emergency department visits, acute inpatient hospitalizations, and acute inpatient expenditures. However, these reductions were insufficient in either track to reduce total Medicare expenditures or achieve net savings, after accounting for increased expenditures in other areas and enhanced CPC+ payments. In both tracks, CPC+ practices that also participated in the Medicare Shared Savings Program at baseline successfully reduced acute inpatient expenditures and total expenditures.

Key Takeaways

The Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model tested whether commitments to CVD preventive care and targeted incentives could lower the incidence of first-time heart attacks and strokes among Medicare beneficiaries ages 40 to 79 who had not had a previous heart attack or stroke. As part of the five-year randomized trial, participating health care professionals used a standardized risk assessment tool to calculate their Medicare patients’ risk of having a heart attack or stroke within 10 years. Participants then received supports and incentives to reduce the CVD risk of high-risk beneficiaries, defined as those with a 30 percent or higher risk of a CVD event at baseline. Over five years, the model reduced the incidence of first-time heart attacks and strokes by 3 to 4 percent, preventing one or more events per 400 high- and medium-risk beneficiaries enrolled, and reduced the all-cause death rate. The observed effects on long-term health outcomes followed improvements in CVD preventive care, as evidenced by health care professionals' increased use of CVD risk assessment and beneficiaries’ increased used of statins and antihypertensive medications. The model improved CVD risk factors, such as blood pressure and cholesterol levels, and decreased CVD risk scores for high-risk beneficiaries within one year of enrollment. There were unintended effects on service use, including increased hospitalizations for all causes. The model had no measurable impact on Medicare spending.

$1.075 Million Awarded to Delaware Organizations

The Delaware State Housing Authority (DSHA) and the Federal Home Loan Bank of Pittsburgh (FHLBank) announced a combined total of $1.075 million has been awarded to selected nonprofit organizations to support initiatives in Delaware that lead to stable housing for individuals and families who are homeless or determined to be at-risk of homelessness. Home4Good grants are supported by FHLBank member financial institutions. Home4Good was established by FHLBank and has been combined with DSHA funds to combat homelessness with the support of FHLBank member financial institutions. The funding is distributed as grants to organizations that help individuals retain or find housing, provide supportive services, or address other unmet needs within the existing homeless provider network. The funding will be used to address four key areas: homelessness prevention, homelessness diversion, rapid re-housing, and innovation. 14 programs from 10 organizations in the state will receive funding. These organizations include Brandywine Counseling and Community Services; Catholic Charities, Inc.; Family Promise of Northern NCC; Lutheran Community Services, Inc.; Ministry of Caring, Inc.; People’s Place II; Salvation Army; The Way Home; West End Neighborhood House, Inc.; and YWCA Delaware, Inc.

Delaware Has No Reports of Kids with High BLLs (As of the End of December)

The Food and Drug Administration (FDA) has received reports from multiple states that suggest children may have higher blood lead levels (BLLs) after consuming recalled cinnamon-containing applesauce products. The Delaware Division of Public Health (DPH) has received no reports of children with high BLLs in response to the recall of cinnamon-containing applesauce products. The Centers for Disease Control (CDC) has received reports of 67 confirmed cases, 122 probable cases and 16 suspected cases from 33 different states as of December 15. The CDC has advised clinicians and health departments to consider the possibility of illness due to lead exposure and report cases to their local health authorities. Per the FDA, the recalled WanaBana, Schnucks, or Weis-brand apple cinnamon pouches should not be eaten, sold, or served. Due to the long shelf life of these products, consumers should check their homes and dispose of them. To prevent others from salvaging recalled products from the garbage, consumers and retailers should carefully open the pouch and empty the contents into a trash can before discarding the packaging. After discarding the product, clean up any spills and wash your hands. DPH remains vigilant as it monitors statewide conditions. Cases can be reported to the DPH Office of Lead Poisoning Prevention by emailing HSPContact@Delaware.gov.

For more information about specific recalled products, visit https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023. 

FDA Issues Safety Communication

On Wednesday this week, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform health care professionals not to use the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and to inform patients who may have received certain implants used in the Synovo Total Hip System after 2019 that the safety and effectiveness of these devices have not been established.

FDA Issues Letter to Health Care Professionals

The U.S. Food and Drug Administration (FDA) has provided an update from ongoing evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators. This update is based on new data and information from Drager for its newly manufactured neonatal incubators. FDA has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run for a week before clinical use. Testing on Drager’s newly manufactured neonatal incubators did not demonstrate concerning levels of airborne chemicals. In addition to the Drager neonatal incubators, certain GE Healthcare neonatal incubators do not need to run prior to use, as noted in our October 2023 update.

Evaluate Your Existing Corporate Compliance Program

On November 6, 2023, the Office of Inspector General (OIG) released its New General Compliance Program Guidance (GCPG). The GCPG is intended to serve as a voluntary reference guide for the health care compliance community and other health care stakeholders discussing general compliance risks and compliance programs. The GCPG addresses applicable federal health care laws, the "seven elements" of a compliance program, adaptations for small and large entities, and other compliance considerations. The GCPG is not binding on any individual or entity OIG uses the word "should" in the GCPG to present voluntary, nonbinding guidance).

This is off the heels of the Department of Justice's (DOJ's) updated guidance issued in March 2023 regarding the DOJ's Evaluation of Corporate Compliance Programs. Further, the OIG announced its intent to publish industry-specific Compliance Program Guidance. All providers of health care are required to have a corporate compliance program that is adequate and effective based on the size and scope of the organization. They should evaluate their existing corporate compliance programs as it is clear that these are coming under increased scrutiny by the OIG and DOJ - especially where there is a compliance issue under investigation by an auditing agency.

Period 6

The Provider Relief Fund (PRF) Reporting Portal opened January 1 and will remain open through March 31 at 11:59 p.m. ET. Those who received one or more PRF (General or Targeted) and/or American Rescue Plan Rural payments exceeding $10,000, in the aggregate, from July 1, 2022, to December 31, 2022, must report on their use of funds during Reporting Period 6 to comply with PRF Reporting Requirements. More information and resources can be found on the PRF Reporting webpage.

Tackle QI Projects in 2024

Focus your organization’s culture on improvement in the year ahead with the Plan-Do-Study-Act framework. This iterative quality improvement method helps you identify an appropriate project, implement your initiative, study the results and make adjustments for even more improvements. Practices, health systems and individual teams use the system to improve their culture and save time for team members.

LEARN MORE:

Toolkit:

• Plan-Do-Study-Act

Playbook:

• Saving Time

Performance Improvement-Continuing Medical Education Activities:

• Increasing Annual Prescription Renewal for Patients on Chronic Medications
• Removing Unnecessary EHR Inbox Messages

Podcast:

• Small Interventions Matter

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

How Medical Students Can Hone Situational Awareness

The knowledge piece of clinical clerkship is often what medical students focus on as they prepare for those key rotations. Understanding the environments a student will be entering and how they work is an often overlooked, yet important, part of preparing for rotations such as surgery or obstetrics and gynecology. Here’s how to prepare. 

Delaware Medicaid to Receive $7.6 Million Under FCA, DFCRA Allegations

Attorney General Kathy Jennings announced in late December that Delaware’s Medicaid program would receive $7,666,379 following a settlement that would resolve federal False Claims Act (FCA) and Delaware False Claims and Reporting Act (DFCRA) allegations against Christiana Care Health System (CCHS). The case, which was initiated by a whistleblower, alleges that CHSS provided free or below-market value support services to non-employee doctors, who then referred patients to CHSS. These referrals in turn led to CHSS billing Medicaid. State and federal authorities maintain that the providing of these free or below-market value support services induced referrals in violation of Delaware’s Patient Brokering and Anti-Kickback laws. Because the inducements were unlawful, any resulting billing to Medicaid was a false (fraudulent) claim, and thus illegal under the FCA and DFCRA. The settlement resolves allegations that CHSS submitted, or caused the submission of, false claims to Medicaid by providing support services (including CHSS nurse practitioners, hospitalists, and physician assistants) to non-CHSS physicians at no cost or below fair market value. The alleged false claims occurred between April 1, 2011, and September 30, 2013, with respect to the CHSS neonatology department, and between April 1, 2011, and April 14, 2017, with respect to CHSS’s cardiovascular surgery, urology, neurosurgery, and ear nose and throat departments.

Information on Recent Product Recalls

Hospira, Inc

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection. Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the health care professional to visually inspect the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Hospira, Inc

Hospira, Inc. is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial. Should a patient receive injectable product containing glass particulate matter as a result of this issue, the patient may experience adverse events including injection site reaction, localized vein inflammation or phlebitis, thrombus, embolus and/or end-organ granuloma or life-threatening blood clot events. The risk is reduced by the possibility of detection, as the label contains a statement directing the health care professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Pfizer has not received reports of any adverse events related to this recall.

Insight Pharmaceuticals - Americaine Benzocaine Topical Anesthetic Spray

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by the manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended. Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Americaine® 20% Benzocaine Topical Anesthetic Spray is packaged in white aerosol cans with Teal caps with Lot codes located on the bottom of the can.

Reckitt/Mead Johnson Nutritial - Nutramigen Hypoallergenic Infant Formula

Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced on Tuesday this week that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria. Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body. Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023 through retail stores nationwide. No illnesses have been reported to date in connection with this recall, and it is likely most of the product that was distributed in the U.S. has already been consumed. Consumers who have Nutramigen Hypoallergenic Infant Formula Powder with certain batch codes should stop using it and throw it away or contact Reckitt/Mead Johnson Nutrition for a refund.

Kendal G. Schaetzle, DO - Family Medicine Resident, 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 who is interested in joining MSD. You could be eligible for a membership referral dues discount!

Bayhealth

TidalHealth

January 17 - Evidence-Based Opportunities to Improve Hypertension Control and Prevention, 12:00-1:00 p.m., virtual. This activity has been approved for a maximum of 1 AMA PRA Category 1 credit.

January 17 - MSD Hot Topic CME Death Certificate Diagnosis, 6:00-7:00 p.m., MSD Office, 651 N. Broad St., Middletown. This activity has been approved for a maximum of 1 AMA PRA Category 1 credit.

January 26 - Delaware Academy of Dermatology Winter Meeting, Dermatology Tips for the General Dermatologist, 6:00-8:00 p.m., Harry's Savoy Grill, Wilmington. DAD member and non-member pricing applied. This activity has been approved for a maximum of 1 AMA PRA Category 1 credit.

February 2-4 - American Diabetes Association 2024 Clinical Update Conference, virtual and in-person at the Omni Orlando Resort at Champions Gate, Orlando, FL

February 11-13 - Medical Society Consortium on Climate and Health 7th Annual Meeting, presented virtually and in person in Arlington, VA on February 11-12, with in-person Congressional visits on February 13.

April 13 - SAVE THE DATE! Delaware Academy of Family Physicians Annual Meeting, Bayhealth SIM Center, Dover.

April 17 - SAVE THE DATE! 18th Annual Delaware Healthy Mother & Infant Consortium Summit, 9:00 a.m.-4:00 p.m., Chase Center on the Riverfront. Check DEThrives.com for updates.

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.

• Updates to Clinical Testing Guidance Algorithms - CDC has updated several testing guidance pages for patients with acute respiratory illness (1) not being hospitalized, (2) being hospitalized, and (3) hospitalized and non-hospitalized patients when SARS-CoV-2 and influenza viruses are co-circulating. Clinicians can use these updated resources to inform clinical decision making. (12/8/2023)
• 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)