Opportunity to Advocate on Crucial Health Care Issues

The American Medical Association (AMA) National Advocacy Conference (NAC) took place February 13-15, 2023, in Washington, DC. The NAC provides opportunity to meet face-to-face with members of Congress and gain important insights from industry experts, political insiders, and members of Congress about current efforts being made to improve the health care system. Key facts discussed with legislators included Medicare physician payment reform, scope of practice, and graduate medical education.

Advocating for the physicians in Delaware were Janice E. Tildon-Burton, MD, MSD AMA Delegate; Robert J. Varipapa, MD, MSD President; and Mark B. Thompson, MSD Executive Director.

CMS Leverages Data by Medicare Part D Prescribers

The Centers for Medicare and Medicaid Services (CMS) is committed to combating the opioid crisis and routinely gives Medicare physicians and other non-physician health care professionals information and reliable resources to prescribe opioids safely and appropriately. As part of that data-driven effort to ensure patients receive the best possible care, CMS sent letters to 247 Medicare Part D prescribers who are in the highest 10th percentile of prescribers in their specialty and state. The letters included personalized information about their prescribing practices and highlighted trusted opioid prescribing resources available to them.

Drug Companies to Pay Rebates for Drug Prices Rising Faster Than Inflation

Effective January 1, 2023, the Inflation Reduction Act of 2022 requires drug companies that raise their prices for certain Medicare Part B drugs faster than the rate of inflation to pay Medicare back for the difference. On February 9, CMS sent educational material to prescribers and Medigap plans advising that, beginning April 1, 2023, beneficiary coinsurance for certain Part B drugs (including biological products) with prices that increase at a rate faster than inflation will be adjusted so that coinsurance for people with Medicare reflects the lower inflation-adjusted payment amount. This new inflation rebate applies to certain Medicare Part B single source drugs and biological products. CMS will post the April drug pricing files in March.

Announces New Models and Supports Access to $2 Generic Drugs

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) announced that the Secretary of the Department of Health and Human Services (HHS) has selected three new models for testing by the CMS Innovation Center to help lower the high cost of drugs, promote accessibility to life-changing drug therapies, and improve quality of care. The Secretary released a report describing these three models to respond to President Biden’s Executive Order 14087, “Lowering Prescription Drug Costs for Americans,” which complements the historic provisions in the Inflation Reduction Act of 2022 that will lower prescription drug costs. The three selected models are:

• The Medicare $2 Drug List: Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that participate in the model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.
• The Cell and Gene Therapy Access Model: Under this model, state Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies. As new therapies come to market, this will help Medicaid beneficiaries gain access to life-changing, high-cost specialty drugs for illnesses like sickle cell disease and cancer.
• The Accelerating Clinical Evidence Model: CMS would develop payment methods for drugs approved under accelerated approval, in consultation with the Food and Drug Administration, to encourage timely confirmatory trial completion and improve access to post market safety and efficacy data. This would reduce Medicare spending on drugs that have no confirmed clinical benefit.

Be Aware of Changes So Cost is Not a Barrier to Vaccination

The start of 2023 marked the elimination of out-of-pocket vaccination costs for millions of people age 65 and older who have Medicare. This includes the hepatitis A and hepatitis B vaccines. In addition to coverage for specific vaccinations under Medicare Part B, thanks to the Inflation Reduction Act, patients with Medicare’s prescription drug coverage (Part D) will now pay no deductible and will not be responsible for any cost-sharing for vaccines recommended by CDC’s Advisory Committee on Immunization Practices (ACIP). Please be aware of this change so that cost is not a barrier to vaccination. 

Hepatitis A and Hepatitis B Vaccine Recommendations

• CDC recommends vaccinating older adults against hepatitis A if they are at risk for hepatitis A infection or severe disease from hepatitis A infection. 
• CDC recommends vaccinating patients age 60 and older who have risk factors for hepatitis B. Adults age 60 and older without risk factors may request vaccination.

Physicians can find more information at these sites:

• Inflation Reduction Act CMS Implementation Timeline (CMS)
• Medicare Part D Vaccines Fact Sheet (CMS)
• Issue Brief: Inflation Reduction Act Prescription Drug Provisions (Kaiser Family Foundation) 

Unapproved Potassium Phosphates Drug Product by Hospira

The U.S. Food and Drug Administration (FDA) is warning health care professionals and pharmacies to avoid using Hospira's unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population. The potassium phosphates injections are phosphorus replacement products intended for use as a source of phosphorus in IV fluids to correct hypophosphatemia and for parenteral nutrition in adults and pediatric patients. This product alone may produce daily aluminum exposures of up to twice the FDA-recommended limit for parenteral nutrition, with additional aluminum exposure expected from the other components of parenteral nutrition. Patients on prolonged courses of parenteral nutrition support are at greatest risk of exposure to toxic levels of aluminum. Exposure to toxic levels of aluminum can lead to softening of the bones (osteomalacia), reduced bone mineralization, neurological dysfunction, microcytic hypochromic anemia, and reduction or stoppage of bile flow (cholestasis). The FDA recommends health care providers use an FDA-approved potassium phosphates injection product with the aluminum content level considered acceptable for each patient based on age, weight, and recommended dose of phosphorus.  

• FDA considers Fresenius Kabi’s product appropriate for patients of all ages. 
• FDA considers CMP Development’s product appropriate for pediatric patients 12 years of age and older who weigh at least 40 kg and adults weighing at least 45 kg. 

These FDA-approved products provide detailed dosing instructions for preparation and administration to minimize the risk of aluminum toxicity. 

Based on New Evidence of Ways Pathogens Spread in Health Care Settings

Previously published guidelines provided comprehensive recommendations for detecting and preventing healthcare-associated infections (HAIs). The intent of the new guidance is to highlight practical recommendations in a concise format designed to assist acute-care hospitals in implementing and prioritizing efforts to prevent HAIs through hand hygiene. The advisories are based on new evidence showing ways that various pathogens can spread in health care settings. They are most appropriate for hospitals, but are applicable to long-term and ambulatory care settings. One of the most important recommendations has to do with new recognition of how pathogens can spread through "premise plumbing," i.e., the hospital's sinks. Among the recommendations, published in Infection Control & Hospital Epidemiology, from the Society for Healthcare Epidemiology, the Infectious Diseases Society of America, the Association for Professionals in Infection Control and Epidemiology, the American Hospital Association, and the Joint Commission are:

• Healthcare workers should cut their fingernails so they don't extend beyond the fingertips, and should keep them natural.
• Patient-facing health care workers should avoid washing their hands so much that they become dry and cracked, which can lead to cuts or bruising and infection, putting the patient and the provider at risk. Instead, alcohol-based hand sanitizers should be used.
• Hospitals should install hand sanitizer dispensers not just on the inside or outside of each patient room, but in both places.
• Certain basins should be dedicated to hand-washing alone, with no other fluids being dumped into them, to avoid infectious organisms splashing onto the counter or becoming aerosolized. Instead, use a toilet or a dedicated receptacle for other fluid disposal purposes.
• Instead of cleaning sink drains with a splash of bleach -- now common practice -- use products newly approved by the U.S. Environmental Protection Agency specifically capable of removing biofilm.

The new report is not intended to replace recommendations from the CDC's Healthcare Infection Control Practices Advisory Committee.

Clarifies Donations from Retail Food Establishments Acceptable with Proper Food Safety Practices

One-third of all food in the U.S. goes uneaten. Wasted food is the single largest category of material placed in municipal landfills and represents nourishment that could have helped feed families in need. The U.S. Food and Drug Administration’s (FDA) recently released 2022 Food Code helps reduce barriers to food donations by clarifying for the first time that food donations from retail food establishments are acceptable as long as proper food safety practices are followed. This addition in the Food Code is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. The National Strategy provides a roadmap of actions the federal government will take to end hunger and reduce diet-related diseases by 2030 – all while reducing disparities. The FDA encourages donation of food that is stored, prepared, packaged, displayed, and labeled according to applicable provisions contained in the Food Code or local, state and federal statutes, regulations, and ordinances. While the Food Code never prohibited such donation practices, this update will make it more explicitly clear that such practices are acceptable.

Governor Proclaims February as Black History Month in Delaware

Governor John Carney signed a proclamation declaring February as Black History Month in Delaware. The event took place at the Claymont Community Center, a historic site of the former Claymont High School, and the desegregation lawsuit that eventually became part of the landmark case, Brown vs. Board of Education. There are events taking place in the state for Black History Month, many hosted by the Delaware Division of Historical and Cultural Affairs and the Delaware Libraries. View photos from the proclamation signing event.

A Quarterly Journey of Self-Discovery

The Delaware Racial Justice Collaborative 2023 Racial Equity Challenge series, powered by United Way of Delaware (UWDE), is a quarterly journey of self-discovery designed to help Delawareans build more effective social justice habits, particularly those dealing with issues of race, power, privilege, and leadership. For five consecutive days each quarter during 2023, participants are prompted with a daily e-mail challenge — such as reading an article, listening to a podcast, or watching a video – and are then encouraged to reflect on that content and to relate the situation to their own lives. Participants discover how racial inequity and social injustice impact our community. The goal is to build new understandings and new connections and in so doing, to begin dismantling systemic racism in Delaware. This year’s Challenge topics are:

• February 20-24--- Implicit Bias in the Workplace
• May 22-26 --- Implicit Bias in HealthCare
• August 21-25 --- Implicit Bias in Schools/Parenting
• November 27-December 1--- Implicit Bias in Voting

Registration Open for Free Summit for Delaware Youth

The Kick Butts Generation of Delaware (KBG) forces across the state will be attending the 2023 KBG Youth Summit at the University of Delaware to gain knowledge and skills to help keep their peers tobacco-free. The summit will educate the state’s youth about the dangerous marketing tactics used by Big Tobacco and equip them with tools to tackle tobacco-related issues in their schools and communities. Registration is open to Delaware youth who are passionate about tobacco prevention. The free, KBG Youth Summit is on Saturday, February 25, 2023. The summit is free, but registration is required. Youth in grades 4th to 12th should register at kbgde.org/youthsummit2023. Registration closes Monday, February 20th. Other summit programming includes a session on the environmental impacts of vaping, as well as a session on the deadly history of the tobacco industry. The event offers networking opportunities with peers across the state, creating a public service announcement and other fun activities including a dance break and tobacco-related activity sheet.

Due to Recent Changes Passed in the 2023 Consolidated Appropriations Act

The Delaware Department of Health and Social Services (DHSS) wants to ensure that all community partners are aware of the Supplemental Nutrition Assistance Program (SNAP) benefits changing March 1 due to a recent change in federal law passed in the Consolidated Appropriations Act of 2023. More details are included in the DHSS Policy Brief.

Wismettac Asian Foods - Shirakiku Brand Spice Seasoning Distributed in DE

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 10.58 oz packages of Shirakiku brand Spice Seasoning products (Spice Ichimi Togarashi 300g and Spice Shichimi Togarashi 300g). The product package of Ichimi spice seasoning contains Shichimi spice seasoning contents (incorrect package) causing the undeclared allergen of sesame seeds. The outer carton of “Ichimi” and “Shichimi” may possibly contains inner packages of “Ichimi”, and the inner packages contain “Shichimi” contents. People who have an allergy or severe sensitivity to sesame run the risk of serious or life-threatening allergic reaction if they consume these products. The product was distributed in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, Il, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV mainly through restaurants and some through retail stores.

You Can Make a Difference

The MSD Environmental & Public Health Subcommittee is looking for interested members to participate to address topics ranging from pandemics to gun safety to the opioid crisis to deadly air pollution. If you are interested in making an impact with other members having common objectives to help improve the health of patients, the environment, and the planet, this committee is for you. Membership on the Environmental & Public Health Subcommittee is on an annual appointed basis. Quarterly meetings are held via zoom during the evenings. If you have an interest in participating on this Subcommittee, please complete the Committee Interest form and return.

Diamond State Financial Group

MSD is pleased to highlight a 2023 Premier Educational Program Partner. Diamond State Financial Group (DSFG) is a part of the growing effort to keep our medical professionals educated through its partnership with MSD as a Premier Educational Program (PEP) Partner.

Premier Educational Partners have joined with the Medical Society of Delaware in supporting high quality professional medical education for Delaware physicians and other health care professionals to advance the health and well-being of Delaware's citizens. DSFG provides customized solutions to assist you in reaching your financial goals. DSFG offers a comprehensive line of products and services, and can assist with such needs as college funding, and retirement or estate planning, as well as enrollment in MSD’s group 401(k) plan. DSFG is committed to helping you accomplish your long-term financial objectives. For more information on Diamond State Financial Group please visit: http://www.dsfg.com/

If you would like to become a PEP Partner, please contact Lynn Robinson, Director of

Professional Education.

Improve Human Papillomavirus (HPV) vaccination rates through evidence-based education at NO COST to your practice. The Quality Insights Program provides one-on-one education for health care professionals by trained clinical educators; presents evidence-based, non-commercial aims of academic groups, research centers, and clinicians; provides an effective and convenient way to stay up-to-date on latest research findings; improves clinical care based on best available safety, efficacy, and cost-effective data; and offers customizable modules based on your practices’ interests and needs. If you are interested in participating in this program or would like more information, please contact Danielle Collins at dcollins@qualityinsights.org or call 484-798-1829.

ChrisitianaCare

ChristianaCare announced the launch of a new clinically integrated network, the ChristianaCare Clinical Alliance. ChristianaCare Clinical Alliance is a formal partnership among clinicians who work collaboratively to deliver well-coordinated, evidence-based care to improve quality, efficiency and health outcomes. Unlike other clinically integrated networks in the region that are limited to primary care, the ChristianaCare Clinical Alliance will include clinicians from across the care continuum. Participants in the ChristianaCare Clinical Alliance will have access to new value-based care arrangements with payors that provide financial rewards for improving quality and reducing unnecessary utilization. The Clinical Alliance will give its members the tools to be successful in these arrangements, including ChristianaCare’s CareVio®, which has been recognized as one of the nation’s most innovative care management programs. The network also will provide expert support for quality, reporting and practice optimization. For more information including how to join, visit the ChristianaCare Clinical Alliance website.

On January 30, 2023, the Biden-Harris Administration announced its intent to end the national emergency and public health emergency (PHE) declarations related to the COVID-19 pandemic on May 11, 2023. The Centers for Medicare & Medicaid Services (CMS) has resources available to help you prepare for the end of the PHE, some of which have been updated based on recent action by Congress. The following materials reflect recent changes and are currently available on the CMS Emergencies Page:

• Provider-specific fact sheets for information about COVID-19 Public Health Emergency (PHE) waivers and flexibilities: https://www.cms.gov/coronavirus-waivers
• CMS 1135 Waiver / Flexibility Request and Inquiry Form: https://cmsqualitysupport.servicenowservices.com/cms_1135
• Acute Hospital At Home: https://qualitynet.cms.gov/acute-hospital-care-at-home

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.

• DPH Flu Dashboard
• DPH Delaware Weekly Influenza Surveillance Reports by week.
• CDC https://www.cdc.gov/flu/weekly/index.htm

• (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)
• Delaware "My Healthy Community" COVID-19 Dashboard (updated weekly on Wednesdays)
• COVID-19 by County Community Level Check (# hospital admissions and beds used and total number of new cases)
• COVID-19 Community Transmission (based on cases per 100,000 people and positivity rate, both measured over the last 7 days)
• DPH Public Health Alerts: de.gov/publichealthalerts
• Federal website for information on navigating COVID: COVID.gov
• CDC COVID-19 Quarantine and Isolation Calculator
• COVID-19 Therapeutics Locator
• CDC COVID Data Tracker Weekly Review.
• 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
• Subscribe to the COVID-19 Update podcast - on Apple Podcasts or Simplecast.