"Dear Colleague" Letter Urges CMS to Finalize Proposed Rule

Last year the US House of Representatives passed the Improving Seniors' Access to Timely Care Act, bipartisan legislation with over 300 cosponsors requiring Medicare Advantage plans to identify and issue real-time decisions for routinely approved services, adopt federally developed standardized electronic prior authorization processes, provide greater transparency surrounding the development and use of utilization management guidelines, and force them to provide rationales for denials. Unfortunately, the bill failed to receive a floor vote in the Senate. However, late last year the Centers for Medicare & Medicaid Services (CMS) offered new proposed rules that, once finalized, would align with many of the key provisions of the Improving Seniors' Access to Timely Care Act. Champions in both the House and Senate began circulating a "Dear Colleague" letter urging CMS to promptly finalize the proposed rule. In particular, the letter urges CMS to include a mechanism for Medicare Advantage (MA) plans to issue real-time prior authorization decisions for routinely approved services, establish a 24-hour deadline for MA plans to respond to emergent prior authorization decisions, and provide detailed transparency metrics. Please contact the Delaware Representative and Senators and urge them to sign on to this important "Dear Colleague" letter today.

Series of Bills Introduced to Build on House Bill 99

House Bill 99 (HB 99) was introduced and assigned to the House Natural Resources & Energy Committee last week and has now been reported out of Committee. This legislation establishes a statutory target of greenhouse gas emissions reductions over the medium and long term to mitigate the adverse effects of climate change due to human generated greenhouse gas emissions in the state (50% by 2030 and 100% by 2050 using the 2005 baseline).

This week, Governor Carney joined members of the General Assembly and advocates to unveil a series of measures aimed at reducing greenhouse gas emissions in an effort to address the growing crisis of climate change. The pieces of legislation will build on HB 99. The bills include working to zero emission by 2040 for state-owned passenger vehicles; implementing "clean construction preferences"; requiring certain new commercial building roofs to support solar infrastructure; increasing the percentage of electric school buses in use; codifying the Clean Vehicle Rebate program; assessing availability of residential charging stations for electric vehicles; and requiring new single and multifamily homes to include electric vehicle charging infrastructure.

Governor to Terminate Order on May 11, 2023

Governor John Carney last Friday announced the final short-term extension and anticipated end date for the State of Delaware’s Public Health Emergency order. Barring any unforeseen circumstances, Governor Carney plans to terminate the order on May 11, 2023 — the same date the federal Public Health Emergency is set to expire. The Governor previously announced his plan to terminate the order on May 11, 2023, in concurrence with the expiration of the federal Public Health Emergency.

To Advise Whether to Continue International Public Health Emergency

Reuters reports that a panel of global health experts will meet on Thursday, May 4th to decide if COVID-19 is still an emergency under the World Health Organization's rules, a status that helps to maintain international focus on the pandemic. There is no consensus on which way the panel may rule and a final decision is expected in the coming days.

CDC to Stop Tracking COVID Community Spread; Most Federal Vaccine Requirements to be Lifted

The COVID-19 Public Health Emergency is to end on May 11, 2023. The ending of the Public Health Emergency (PHE) may impact an individual’s coverage of COVID-19 tests. We encourage you to know these changes and share the New Consumer Fact Sheet on COVID-19 tests:

• English - https://www.cms.gov/files/document/covid-over-counter-test-coverage.pdf
• Spanish - https://www.cms.gov/files/document/covid-over-counter-test-coverage-spanish.pdf

The Centers for Disease Control and Prevention (CDC) will stop tracking the spread of COVID in communities and, instead, rely more on COVID-related hospitalizations, much like the spread of the flu is currently tracked. This is tied to the May 11th expiration of the national public health emergency.

The Biden Administration will end most of the last remaining federal COVID-19 vaccine requirements next week when the national PHE ends. Vaccine requirements for federal workers and contractors, as well as international air travelers will end. The government is also beginning the process of lifting vaccine requirements for Head Start educators, CMS-certified health care facilities, and noncitizens at US borders.

Continues Efforts to Ensure Delaware is a Trauma-Informed State

Governor Carney and First Lady Tracey Quillen Carney joined Lt. Governor Bethany Hall-Long, Trauma Matters Delaware, advocates, and members of the community on Thursday, May 4th at Legislative Hall to sign a proclamation for Trauma Awareness Month. This is the 5th year of Trauma Awareness Month in Delaware. In October 2018, Governor Carney signed Executive Order 24, prioritizing efforts for Delaware to become a trauma-informed state and incorporating Trauma Awareness Month as a key initiative.

Dr. Varipapa Attends Medical Society of New Jersey Meeting

MSD President Robert J. Varipapa, MD ended his week last week by attending the Medical Society of New Jersey Annual House of Delegates Meeting on Saturday, April 29th in New Brunswick, New Jersey. A kickoff reception was held Friday evening. American Medical Association (AMA) President-Elect Jesse M. Ehrenfeld, MD, MPH also attended the meeting providing opportunity for Dr. Varipapa and Dr. Ehrenfeld to meet in person.

Pictured left to right are Jesse M. Ehrenfeld, MD, MPH, President-Elect of the American Medical Association; and Robert J. Varipapa, MD, MSD President.

Wills, Revocable Trusts, Things to Know About Elder Law

Members of the Physician Emeritus Section gathered for their first ever Sussex county luncheon meeting on Thursday April 27 at the 1776 Steakhouse Restaurant in Rehoboth Beach. Karla B. Levinson, Attorney at Law with the Levinson Firm, LLC presented on “Wills v. Revocable Trusts plus 10 Things Every Senior Needs to Know about Elder Law.” Ms. Levinson led an informative discussion with an overview of the estate planning process, why a Will is important, and shared tips that are important to know in order to protect yourself and your family. The group will meet again in in June and October in Wilmington and plans will be made for future luncheons at this location for next year. For more information, contact Michelle Seymour at 302-224-4905 or michelle.seymour@medsocdel.org.

All Members Asked to Provide Input to Direct MSD's Goals

MSD has embarked on the development of a three-year strategic plan for the organization. MSD has engaged Aloysius, Butler, and Clark (AB&C), a marketing communications and research agency to help facilitate this initiative. We're looking for all our members' input and perspectives as we develop our strategic plan for MSD. To achieve this, we ask that you complete a very brief survey, less than 5 minutes to take, to capture your opinions. AB&C is administering the confidential survey. The first 100 participants completing the survey and including an email address at the end of the survey will be eligible for a drawing for one of two $100 Amazon gift cards. Your opinions and insights are important and we encourage you to complete the survey as soon as possible. Please know that we respect your privacy. Your answers will only be viewed by AB&C. Your email address will not be used for any third-party solicitation purposes. Access the survey.

Confidential, Voluntary Questionnaire Developed to Capture Information

The MSD Committee on Diversity, Equity, and Inclusion is working to support a diverse physician workforce and inclusive culture. Prior to 2021, MSD did not collect information on racial, ethnic, and gender identification of our members. As a starting point toward understanding and improving our membership diversity, your help is greatly appreciated in submitting this information. A brief, four-question questionnaire has been developed and will take less than a minute to complete. Your information will not be made public but will be used in aggregate to assess the diversity of our membership with the goal of understanding the diversity of the physician workforce in Delaware. Access the questionnaire.

Fast, Efficient, Free Publishing at Your Fingertips!

The MSD Academic Channel is a section of the Cureus Journal of Medical Science devoted solely to the Medical Society of Delaware and the articles and other content produced by physicians. Take advantage of the benefits provided by the MSD Academic Channel and submit your next article. Publish and post all of your articles, posters, and abstracts in one place to build your personal brand!

• ZERO PUBLICATION FEES thanks to MSD's Academic Channel subscription
• EASY ONLINE SUBMISSION
• EXPERT REVIEW by Channel editors, peer reviewers, and Cureus editors to ensure your article is fine-tuned and polished prior to publication
• PRIORITY SUPPORT for help during the submission and publication of your article
• UNMATCHED TRANSPARENCY with the ability to track your article through editorial and peer review all the way to publishing
• RETAIN COPYRIGHT of your own work
• OPEN ACCESS - published articles are immediately available to all readers with no required registration or subscription
• INDEXED in PubMed, PMC, Web of Science and Google Scholar
• AVERAGE PUBLICATION TIME is 37 days
• 3.3 MILLION monthly reads

Arexvy Approved for Individuals 60 Years of Age and Older

The U.S. Food and Drug Administration (FDA) approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

Deadline for Completion: June 30th

The Controlled Substance Registration (CSR) biennial renewal deadline is June 30, 2023. All active CSR renewals must be completed through the DELPROS system (https://delpros.delaware.gov/OH_CommunitiesLogin).

RENEWING

As a condition of CSR renewal, registrants will be asked to attest to completion of two hours of continuing education in the areas of controlled substance prescribing practices, treatment of chronic pain, or other topics related to the prescribing of controlled substances.

APPLYING

Those who are applying for a Delaware CSR must complete a mandatory one-time, one-hour, two-part course pertaining to safe prescribing and distribution of controlled substances, treatment of pain, and recognition and treatment of opioid use disorder. Completion of this course is beneficial prior to applying for a CSR as the initial application will ask for attestation of completion of the mandatory education. To fulfill the mandatory course requirement, the Division of Professional Regulation (Office of Controlled Substances) offers the only approved course. CSR Webinar Part 1 and Part 2 can be found at: https://dpr.delaware.gov/boards/controlledsubstances/mandatory_course/. The course has received approval for continuing medical education credit and may qualify as acceptable continuing education required for maintaining other professional licenses.

All physicians and non-physicians who hold an active Delaware Controlled Substance Registration are required to register for access to the Delaware Prescription Monitoring Program.

For questions, please contact the Division of Professional Regulation at (302) 744-4500 or customerservice.dpr@delaware.gov.

Rule to Become Public After Full Publication in Federal Register

The Drug Enforcement Administration (DEA) received a record 38,000 comments on its proposed telemedicine rules and recognizes the importance of telemedicine in providing Americans with access to needed medications. In a statement made on Wednesday this week, DEA Administrator Anne Milgram indicated the DEA is extending the current flexibilities to buy some time to consider whether the agency should require patients to see physicians face-to-face to get prescriptions for controlled drugs or continue to allow telehealth prescriptions. For this reason, last week, DEA, in concert with the Department of Health and Human Services, submitted a draft Temporary Rule to the Office of Management and Budget entitled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” Further details about the rule will become public after its full publication in the Federal Register.

To Advance Medical Product Research and Development

The U.S. Food and Drug Administration (FDA) is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices where some or all the trial-related activities occur at locations other than traditional clinical trial sites. The agency released a new draft guidance that provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, instead of having them visit research sites.

"Providing Urgent Maternal Protections for Nursing Mothers Act"

Providing Urgent Maternal Protections for Nursing Mothers Act or the PUMP for Nursing Mothers Act expands workplace protections for employees with the right to break time and a private space to pump breast milk. Specifically, it expands the requirement that employers provide certain accommodations for such an employee to cover salaried employees and other types of workers not covered under existing law. Further, time spent to express breast milk must be considered hours worked if the employee is also working. The bill also extends from one year to two years the available time period for such accommodations. The law was passed in December and was rolled out in phases to give employers tie to adjust to the new requirements. Last week, this law went into full effect.

New Certification Program Will Be Available July 1st

To help organizations pursuing the new Health Care Equity Certification, The Joint Commission has launched the Health Care Equity Certification Resource Center to provide practical strategies for meeting the program’s standards and elements of performance. Read more.

American Academy of Ophthalmology Mid-Year Form

(As submitted by Sean P. Considine, MD) On April 20, 2023, I had the opportunity to attend the American Academy of Ophthalmology’s (AAO) Mid-Year Forum in Washington D.C. I was honored to represent the state of Delaware as a resident alongside Drs. Paula Ko and Dorothy Moore. There, we met with the legislative aids of Congresswoman Lisa Blunt Rochester, and Senators Chris Coons and Tom Carper to advocate on behalf of issues vital to our practice and careers such as Veterans Affairs (VA) optometric scope of practice, Medicare reimbursement, as well as research funding for the National Eye Institute. As a resident who receives incredible training at the Wilmington VA, the VA scope of practice was an extremely important topic to me and my fellow residents at the Mid-Year Forum. I would like to thank the Delaware Academy of Ophthalmology (DAO) for sponsoring me for such an incredible experience. As an added surprise, Senator Tom Carper asked the three of us to join him on the steps of the Capitol for a photo. Pictured left to right, Sean P. Considine, MD, PGY-3 Temple Resident; Dorothy Moore, MD, Councilor to the AAO; Paula Ko, MD, President of the DAO; and US Senator Tom Carper.

In the Areas of Physician Care, Grassroots, or Education/Research

To celebrate their 50 years of using quality improvement science, education, and collaboration in health care and communities, Quality Insights is pleased to offer grant opportunities totaling $100,000 to spark innovation or give a boost to promising projects. Please review for consideration of applying for a grant in the area of physician care, grassroots, or education/research. This grant program is available to non-profit organizations and educational institutions in Delaware and certain other states and territories. Quality Insights estimates eight to fifteen awards in amounts up to $20,000. An FAQ document, submission guidelines, and application are available at their website. Grant submission opens on 4/11/2023 and ends on 6/30/2023.

Improving the Diagnostic Process, A Free 18-Month Program

Is your practice interested in improving the cancer diagnostic process for your patients who 

receive some or all of their care via telemedicine? The Agency for Healthcare Research and Quality (AHRQ) is recruiting practices for a free 18-month program to improve diagnostic verification, timeliness, and communication with patients. Practices will receive training and one-on-one expert coaching to implement sustainable improvements to effectively close the loop at critical points in the cancer diagnostic process. Learn more and sign up for an informational webinar on the program website: safetyprogram4telemedicine.org. Access the

flyer for more detailed information.

Due to Labeling Error

Teva Pharmaceuticals USA is recalling specific lots of various strengths of Fentanyl Buccal Tablets CII to the consumer level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide that are provided with these recalled lots.

Due Potential Presence of Salmonella Infantis

General Mills announced a voluntary national recall of two-, five- and 10-pound bags of its Gold Medal Unbleached and Bleached All Purpose Flour with a “better if used by” date of March 27, 2024, and March 28, 2024. The recall is being issued for the potential presence of Salmonella Infantis, which was discovered during sampling of the five-pound bag product. Consumers are asked to dispose of affected products by this recall.

ChristianaCare

More than 70 million Americans suffer from sleep-related problems. To address this growing need, ChristianaCare has opened a new comprehensive sleep wellness center in the Medical Arts Pavilion II on the ChristianaCare Newark Campus.

Saint Francis Healthcare

Delaware Hospice and Saint Francis Hospital of Trinity Health Mid-Atlantic held a ribbon cutting ceremony on Wednesday, May 3rd for Delaware Hospice's new 8-bed inpatient hospice unit at Saint Francis Hospital. Opened in October 2022, the new, inpatient hospice unit allows Delaware Hospice to provide end-of-life care to Saint Francis patients, Delaware Hospice patients, and those eligible for this service in the community.

Join the second National Health Equity Grand Rounds event, Follow the Money! Understanding the Structural Incentives for Inequity in Health Care and Beyond, on Tuesday, May 9 from 2:00-3:30 pm ET. Expert speakers will challenge our audience to participate in reimagining a health care system that centers community and healing over profiteering. Health care professionals may receive no-cost continuing medical education (CME) credit by attending.

The Delaware Academy of Family Physicians (DAFP) Research & Education Foundation (REF) is a 501(c)(3) corporation and the philanthropic arm of the Delaware Academy of Family Physicians. The DAFP REF offers important programs to encourage medical students and residents to come to Delaware to explore the world of primary care and consider becoming a family physician in our state to improve access to care and provide patient education for our Delaware communities. To support these programs the DAFP Research & Education Foundation invites you to join us as a golfer and/or sponsor to our 2023 DAFP Healthcare Heroes Golf Outing being held on Friday, May 12, 2023, at the White Clay Creek Country Club in Wilmington, DE. A Shotgun start will be at 10:00am. Learn more and register. Sponsorship information.

The Christina Secretaries’ Association is hosting a Health & Wellness event on Tuesday, May 16th from 4:45 p.m. - 6:15 p.m. at the Delaware State Education Association located at 4135 Ogletown-Stanton Rd, Ste. 101, Newark. They are looking for health care professionals to attend the event to conduct a diabetes screening, blood pressure, or to check body alignment. Tables will be available and electric outlets will be available. They estimate 25 members attending, ranging in age between between 30-65. If you are interested in helping, please contact Karen Ewing, President at KAREN.EWING@CHRISTINA.K12.DE.US.

Protecting patients from inappropriate scope of practice expansions - Patients deserve care led by physicians. Through research, advocacy and education, the AMA vigorously defends the practice of medicine against scope of practice expansions that threaten patient safety. Register now for this webinar on Wednesday, May 17 at Noon ET. Join us to hear more about the importance of these issues to organized medicine from the AMA, the Medical Association of Georgia and Washington State Medical Association. We’ll discuss the unique challenges states encounter when facing multiple scope bills, how to overcome these issues and ways physician advocates can get involved.

eNews & Views April 27, 2023 Issue

Last week's newsletter incorrectly listed the Member Spotlight physician as Bryce S. Sachais, MD, Medical Director of the Blood Bank of Delmarva. Dr. Sachais' first name is Bruce. MSD apologies for this error.

Emily Webster Gripp - PCOM Class of 2025, ChristianaCare Branch Campus

Karlee E. Grudi- PCOM Class of 2023 (IM Residency at ChristianaCare)

Makala Lulu Wang - PCOM Class of 2025      

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!

Anne M. Caswell - Internal Medicine Residency at Bayhealth

Sarah M. Gillespie - Emerg Med/Internal Med Residency at ChristianaCare

Isabella C. Hamilton - Diagnostic Radiology Residency 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 member(s) listed above or if you know of someone interested in joining MSD. You could be eligible for a membership dues referral discount!

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
• Acute Hospital At Home: https://qualitynet.cms.gov/acute-hospital-care-at-home
• Loss of Medicaid or CHIP coverage
• FAQs on COVID-19 (released March 29, 2023)
• 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.

• (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)
• CDC COVID-19 Testing Locator Website (no-cost COVID-19 Testing. launched 1/2023)
• 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.  

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.