Challenges Lisa Blunt Rochester for Tom Carper's Seat

After Congresswoman Lisa Blunt Rochester announced her intentions to run for US Senator seat being vacated by Tom Carper, the Independent Party of Delaware has announced its candidate for the 2024 US Senate race, selecting former Democratic State Senator Michael S. Katz, MD, MBA. Dr. Katz has been described as a non-career politician committed to representing the interests of all Delawareans. Dr. Katz received his medical degree from Georgetown University School of Medicine, and an MBA from Georgetown University School of Business. He was elected to the Delaware State Senate District 4 as a Democrat in 2008, serving one term. Photo credit of the Independent Party of Delaware website.

Approval Could Significantly Expand Access and Reduce Barriers

Today, the U.S. Food and Drug Administration (FDA) approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online. The timeline for availability and price of this nonprescription product is determined by the manufacturer. Other approved formulations and dosages of other oral contraceptives will remain available by prescription only. 

US Representatives Circulate Sign-On Letter to House Leadership

On June 15, US Representatives Ami Bera, MD (D-CA-6) and Larry Bucshon, MD (R-IN-8)—along with original cosigners Reps. Kim Schrier, MD (D-WA-8), Earl Blumenauer (D-OR-3), Mariannette Miller-Meeks, MD (R-IA-1), and Brad Schneider (D-IL-10)—circulated a Dear Colleague and sign-on letter to House leadership in support of Medicare physician payment reform. This letter builds off the congressional request for information these bipartisan lawmakers issued last September, soliciting feedback from stakeholders on a comprehensive solution to bring the physician Medicare payment program into the 21st Century. It also comes on the heels of the first MACRA oversight hearing held in years by the House Energy and Commerce Subcommittee on Oversight and Investigations on June 22. (The AMA sent a letter to the committee in advance of the hearing, which can be viewed here.) The letter recognizes that MACRA is on a downward trajectory.

Rep. Lisa Blunt Rochester is a House co-signer on the letter. Please contact Delaware's Federal Congressional Delegation and thank them for signing on to this letter in support of Delaware's physicians to make MACRA reform a priority. The sign-on deadline has been extended until COB July 27.

Remedy for 340B-Acquired Drug Payment Policy, CY 2018-22 Proposed Rule

On July 7, 2023, in light of the Supreme Court’s decision in American Hospital Association v. Becerra (142 S. Ct. 1896 (2022)) and the district court’s remand to the agency, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule outlining the proposed remedy for the 340B-acquired drug payment policy for Calendar Years 2018-2022. CMS is publishing this proposed rule to remedy the payment rates the Court held were invalid. Aspects of this proposed policy will affect nearly all hospitals paid under the OPPS. This proposed rule will have a 60-day comment period, which will end on September 5, 2023. This fact sheet discusses the provisions of the proposed rule (CMS- 1793-P), which can be downloaded at https://www.federalregister.gov/documents/current. CMS anticipates issuing the final rule before the Calendar Year (CY) 2024 Outpatient Prospective Payment System/Ambulatory Surgery Center (OPPS/ASC) final rule is published in fall 2023. Read more.

Closing Loopholes Offering Misleading Short-Term Insurance Products

The Biden Administration last week announced new steps to restrict short-term health insurance plans and surprise medical bills, stepping up the war against so-called junk fees to lower” health care costs. These steps will include a proposed rule that closes loopholes companies use to offer misleading short-term insurance products, discriminate based on pre-existing conditions, offer little to no coverage, and burden patients with thousands of dollars worth of medical expenses. This proposal essentially restores the regulations in place before 2018 when the previous administration enabled consumers to keep short-term plans for up to 364 days and to renew them for up to three years. Short-term plans would be short-term, meaning four months or less, functioning as gap coverage for consumers in between other forms of insurance, such as job-based health benefits. The proposed rule would disallow reenrollment in the same plans, although consumers would be permitted to purchase different short-term policies consecutively for up to 36 months. Insurance companies would also be required to provide a clear disclaimer upfront about what is covered and not covered instead of burying it in fine print.

FDA Offices, HHS Working in Partnership as Part of Government Response

On Tuesday, the FDA’s Center for Veterinary Medicine (CVM) detailed how it is working to stop illicit xylazine from entering the United States. The Center is working in partnership with other offices across the FDA and Department of Health and Human Services as part of a whole-of-government response to this critical and growing issue. In February, in coordination with FDA’s Office of Regulatory Affairs, CVM took action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country.

To Comply with 21st Century Cures Act

Managed Care Organization-Only Providers (MCOPs) contracted with the Delaware, Division of Medicaid and Medical Assistance (DMMA) Managed Care Organizations (MCOs) must comply with the 21st Century Cures Act, by registering with the Delaware Medical Assistance Program (DMAP). All providers are required to verify and enroll their correct Medicaid ID number and address in order to continue to receive Medicaid reimbursement for services. Failure to comply will result in the termination of their Medicaid contracts. A large number of clinicians have not registered and could be in jeopardy of having their Medicaid contract terminated. The state of Delaware continues to conduct outreach and mitigation efforts to discourage termination of contracts to ensure that Delaware maintains an optimum network to provide needed services to members. Note… Clinicians who are currently engaged (actively working) with the DMAP screening and enrollment process are not at risk of suspended payment(s) and/or termination from Delaware MCO network participation. For assistance with enrollment or questions, please email the Provider Enrollment Team at delawarePRET@gainwelltechnologies.com.

NOTE: This content information as given by DMMA includes the use of the word "provider" and has not been altered by MSD.

Compares Health Care Costs, Quality Based on Delaware Medical Claims

The Delaware Department of Health and Social Services (DHSS) announced on Wednesday enhancements to the CostAware website, designed to help Delawareans understand how their health care dollars are spent by comparing the variation of average costs for different episodes of care and medical services based on actual medical claims in Delaware.

$10 Million in Grant Awards

The Delaware Prescription Opioid Settlement Distribution Commission approved recommended grant awards of approximately $10 million distributed among 38 organizations for the state’s second round of funding on Monday this week. The recommendations must now receive approval from the Behavioral Health Consortium when it meets on July 18th. A final decision will dictate which organizations and agencies will receive funding for seven categories, including harm reduction, prevention, and workforce development initiatives. Commission co-Chairs Lt. Gov. Bethany Hall-Long and Attorney General Kathy Jennings both noted there were 17 overdose deaths in the state last week and that funding would aid several areas to prevent opioid-related deaths. Delaware continues to be among the top three states with the highest drug overdose rates in the country.

Optimize Your Health Care Outcomes

The latest blog post by "Chirpy Bird," a health care quality and regulatory consulting firm, simplifies MIPS Improvement Activities, offering you the roadmap to optimize health care outcomes. Three key takeaways from the article:

1. Selecting MIPS Improvement Activities - Don't get caught in doing the same thing year after year, these measures can and have changed!
2. Solid record-keeping - the key to MIPS compliance.
3. Max 40 points in this category - focus on quality over quantity.

Effective July 1, 2023

The American Board of Surgeons (ABS) requires reporting of Continuing Medical Education (CME) credits directly from the accreditor to the ABS. ABS Diplomates can no longer manually report CME credits to the ABS. MSD is prepared for this new requirement. Effective July 1, 2023, CME program registration (qualifying for ABS reporting) through MSD, offers the option of ABS reporting via a check box. The required information to be reported will be collected at time of registration. For more information, please visit https://www.absurgery.org/default.jsp?news_abscme0223. Should you have any questions, please contact Lynn Robinson, Director of Professional Education at Lynn.Robinson@medsocdel.org or (302) 224-5198.

Detects the Virus in as Little as 5 Minutes

An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 virus in a room with an infected person within 5 minutes. A technology called wet cyclone was used to sample the equivalent of 176 cubic feet of air in 5 minutes. A light on the device turns from green to red when the virus is detected, which the researchers said indicates that increased air circulation is needed. The device stands just 10 inches tall and 1 foot wide and is considered a proof of concept. The next step would be to implement the technology into a prototype to see how a commercial or household design could be achieved. The researchers foresee potential for the device to be used in hospitals and schools, as well as to be able to detect other respiratory viruses such as influenza and respiratory syncytial virus. The project was a collaboration among researchers from Washington University's engineering and medical schools. Nature Communications published the results.

Latest Drug Shortage Information

Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide the U.S. Food & Drug Administration (FDA) with most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. For the latest drug shortage information, visit https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.

Wilmington Senior Center Helping to Create Obesity Patients' Bill of Rights

To create a Patients' Bill of Rights for People with overweight and obesity, the National Consumers League and the National Council on Aging are conducting a four sessions of town halls in different parts of the country in 2023 to help determine what "rights" are necessary for older adults to be in charge of their own health when seeking and obtaining obesity care. The Wilmington Senior Center hosted a town hall on Tuesday this week that included medical specialists and guest speakers who discussed their own battles with weight control. MSD member Kimberly Rogers, MD served as one of the panelists.

Six Batches Recalled Due to Container Defect

Cipla announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level. The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, six batches manufactured using the same lot of valves are being recalled. There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.

Risk of Serious Burn Injuries to Patients

Megadyne is recalling MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of patients receiving burn injuries from use. These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Risk of Unexpected Depleted Battery and Ventilator Stop

Draeger Medical is recalling the Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of a depleted battery, even after being re-connected to AC power. The ventilator may not automatically switch back to using AC power when it is plugged in and may continue using the battery until it is depleted, then stop providing ventilation. A battery alarm: “Charge int. battery” and “Int. battery discharged” does occur with this issue. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Manifold Failure that May Cause Gas Leaks, Interrupt Therapy to Neonates

NOxBOX Ltd. is recalling NOxBOXi Nitric Oxide Delivery Systems due to a misalignment of the check valve in the device’s manifold, which may cause the manifold to fail. If it fails, nitric oxide or oxygen may leak out. The device may also change gas cylinders earlier than expected or not at all. This issue may lead to interrupted nitric oxide therapy, causing a drop in blood oxygen levels (desaturation) or increased pressure on the artery that carries oxygen from the heart to the lungs (pulmonary artery), which may pose even greater risks to neonates with congenital heart disease. Use of affected devices could lead to serious injury or death in an already fragile patient population. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Lisa Gruss - External Affairs & Development Officer

Lisa Gruss has joined the Medical Society of Delaware and serves as the External Affairs and Development Officer. Her responsibilities will include developing and executing the Society's fundraising initiatives and supporting the Government Affairs Committee in conjunction with MSD's lobbyists. She has over 20 years of experience in physician engagement with diverse experience in science, clinical knowledge, population health management, clinical transformation, and sales execution. In over 10 years of leadership experience, she has developed and strengthened policies, programs and systems that transform organizations. Lisa comes to MSD with a diverse career background in pharmaceutical research and development and sales, population health, managed care, and health care quality improvement.  She holds a BS in Biology, a MS in Genetics, and an MBA. Lisa can be reached at Lisa.Gruss@medsocdel.org or at (302) 893-3907. Welcome to the team, Lisa!

Submit Your Idea as a Resolution and Make a Difference

Turn your idea into a resolution. MSD is accepting resolutions for health care-related issues to be considered by the Council at the MSD Annual Meeting scheduled for Saturday, November 18th. Resolutions must be submitted in writing by Tuesday, October 31st (absolute deadline). This is an excellent opportunity to share your concerns with your peers and make a difference. Not sure where to start? MSD has created a Resolution Writing Guide to help! Please contact Mary LaJudice, Senior Director of Corporate Services, with any questions or to submit your resolution (Mary.LaJudice@medsocdel.org or 302/593-8589).

Opportunity for Those Nearing Retirement or Transitioning to Part-Time

The Saint Francis Family Medicine Residency Program is looking for part-time preceptors to work with their residents. If you are interested in sharing your knowledge 1-3 half days per week in their office, they would love to have you join them! This opportunity is perfect for a board-certified family medicine physician who is moving toward a part-time practice or retirement, or is just interested in teaching the next generation and can spare a half day or two or three. The office suite just went through a complete renovation, so you will be working in a beautiful new facility! Excellent compensation, flexible days. If interested, please email Louise at louise.digenova@che-east.org.

Bayhealth

ChristianaCare

Tidalhealth Nanticoke

Amanpreet K. Aujla, MD - Family Medicine Residency, Saint Francis

Mackenzie Bredbenner, MD - Family Medicine Residency, Bayhealth

Ragini Ganjoo, MD - Family Medicine Residency, Saint Francis

Merna Haridi, MD - Family Medicine Residency, Saint Francis

Maria D. Henriquez, MD - Family Medicine Residency, Saint Francis

Austin C. Lonski, DO - Family Medicine Residency, Bayhealth

Georgy V. Mathew, MD - Internal Medicine Residency, Bayhealth

Rondo Kabra Mbaidjol, MD - Emergency Medicine Residency, Bayhealth

Henry P.H. Miller, DO - Family Medicine Residency, Bayhealth

Michael R. Persch, MD - Family Medicine Residency, Saint Francis

Jacob H. Scott, MD - Family Medicine Residency, Saint Francis

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 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)

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.