Update on Disruption in Production of Intravenous (IV) Fluid Due to Impacts from Hurricane Helene

via VDH


Dear Colleague:

Last week, the Baxter International Inc. North Cove Facility in Marion, NC was impacted by Hurricane Helene. Baxter is a major U.S. manufacturer of IV solutions, accounting for approximately 60% of domestic production. Baxter has announced reduced supply of intravenous and peritoneal dialysis (PD) solutions due to the damage of its manufacturing plants from hurricane Helene.

In letters to its clients, Baxter indicates it has implemented reduced supply allocations on a number of products. We understand that allocation amounts range from 40-50 percent from some of the more common IV solution products. Therefore, healthcare providers are expected to receive fewer IV products from Baxter than they are traditionally accustomed to receiving in orders placed based on consumption of these resources. For the most current updates on the product availability, please contact the manufacturer directly.

As of today, FDA has not declared any new shortages related to items produced at the North Cove facility. Baxter reports that they are taking additional steps to manage inventory of their North Cove production to assure equitable access. We understand that the FDA is also working with Baxter’s additional facilities to increase supply and reduce the risk of new shortages until Baxter can resume manufacturing the impacted products.

IV Solution Temporary Conservation Measures

Virginia Department of Health (VDH) is requesting all health care providers to immediately implement temporary conservation measures to mitigate the potential impacts of this manufacturing disruption. This is a rapidly evolving situation, and this information is subject to change. Virginia Department of Health is working closely with the Virginia Hospital & Healthcare Association (VHHA), and coordinating with Administration for Strategic Preparedness and Response (ASPR), Quality Insights Renal Network, Virginia’s EMS Councils, and other health care organizations to closely monitor this situation and we will continue to provide updates as soon as available.

Resources

Dialysis Management and Conservation

List of Impacted Products

Small- and Large-Volume Fluid Shortages – Suggestions for Management and Conservation

Patient safety nonprofit releases guidance for navigating medical supply chain disruptions caused by Hurricane Helene

Sincerely,

Karen Shelton, MD
State Health Commissioner

Healthcare Provider and Health Systems Audits: Responding to an Auditor’s Request for Records


The Reimbursement Team at Hancock, Daniel & Johnson, P.C. provides legal representation to providers and health systems embroiled in disputes with government and private payors.

In the event of audits, our clients often come to us immediately to assist in responding to record requests, but it is sometimes appropriate for a provider to handle the initial production internally.

In those cases, we provide the following tips to avoid common mistakes in responding to an auditor’s request for records and to maximize the opportunity for good audit results:

  1. Start early to respond to a request for medical records. As soon as a notice of an audit and request for documents is received, develop a plan for responding. The process is time-consuming and could require multiple reviews of medical records.
  2. Identify who is conducting the audit and note when the audit is being conducted by a governmental regulatory body that typically reviews for fraud, waste, and abuse. In those situations, it may be best for Hancock Daniel’s Reimbursement Team to help navigate the document production.
  3. Determine, if possible, what issue is under audit. Is it medical necessity, E&M code leveling, or something else? This will help determine whether to produce more records than those requested. For example, if the audit involves a medical necessity review, a clinician should be involved in identifying which records to submit because proving medical necessity may require a review of records before the date of service at issue and not just the office note from that date.
  4. Make note of the deadline for submitting the records. If necessary, request an extension and be sure to get the extension in writing. Do not miss the deadline for submitting the records. Missing deadlines can result in procedural defaults and force the provider to defend an overpayment and recoupment request. It can also unnecessarily force the provider into the appeals process, which can be expensive and time consuming.
  5. Collect the records and do not send the request to a medical record vendor. Responding to an auditor’s medical records request is different than responding to a request made for other purposes and it should not be put in the hands of a record vendor.
  6. Once the records are collected, ensure they are complete. One of the most common errors providers make is sending incomplete records. This can have devastating consequences because the auditor may conclude that the records do not exist and/or the care was not provided and refer the matter to regulatory bodies to consider whether there is fraud, waste, and abuse.
  7. Do not include extraneous or irrelevant records. Do not send the entire electronic medical record unless it is requested. Sending unnecessary records such as nursing flowsheets and administrative forms can complicate the review process and potentially raise questions about compliance practices.
  8. Be sure the records are legible. The goal is to make it easy for the auditor to find the information in the records that justifies the claim paid for that service. Do not submit a printed and scanned copy of the records because they are often illegible, and the auditor will have a more difficult time finding the necessary information.
  9. Organize the records. Do not send a pile of unorganized records without any context or explanation. This can make the audit process needlessly challenging. Organize and label records in a logical manner that demonstrates the office is managed well, has a commitment to regulatory compliance, and can be trusted to provide accurate claims for payment.
  10. Review the records for any potential issues that the auditor may find. Identify any errors (incorrect patient or date of service) or omissions (missing signatures). Never modify or alter records in response to audit requests. It is imperative to maintain the integrity of the medical records and produce them in the original, unaltered state. Any attempts to manipulate, falsify, or add documentation can create exposure to severe legal consequences. While records cannot be altered, any issues can be identified and explained to the auditor in the cover letter to mitigate potential concerns. This review can also reveal risk exposure and provide information about whether to engage legal counsel before submitting the records.
  11. Draft a cover letter to send with the record production. Include sufficient information that identifies the date of the records request, the date the records are submitted, and a description of what records are being submitted. In the cover letter, send a message of transparency to the auditor. Avoid any defensiveness or indication that you do not want the auditor to see the medical records. They have a right to see the records that support your claims, either through regulations or by contract.
  12. IMPORTANT. Keep a copy of the cover letter and a complete copy of the exact records produced in case an appeal is necessary in the future.
  13. When the audit results are received, review them and if an overpayment is noted, immediately contact a member of Hancock Daniel’s Reimbursement Team to help determine whether an appeal would be appropriate.

Click here for a full PDF version of this advisory.


The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.

NPSA Day 2024 with Melina Davis and J. Corey Feist

Join Melina and Corey for a conversation about the importance of recognizing National Physician Suicide Awareness Day and the work being done to support our healthcare heroes.


The Dr. Lorna Breen Heroes’ Foundation: https://drlornabreen.org

SafeHaven: https://safehavenhealth.org

National Physician Suicide Awareness Day is September 17

Every day in the U.S., a physician dies by suicide. 

Physicians have one of the highest suicide rates of all professions. With between 300 and 400 physician suicides each year, that means, on average, one takes their life every day. 

Physician suicide is an epidemic that crosses specialties, genders, and ages. Unfortunately, suicide is not limited to physicians. Medical students and residents are also at risk — in fact, statistics show their risk is even higher. 

September 17 is National Physician Suicide Awareness Day, a day created to bring attention to this crisis — to hopefully lead to increased prevention by changing paradigms and breaking down what has long been a culture of silence around physician mental health and suicide. 

Statistics 

The statistics on physician suicide are sobering. 

More than half of physicians feel inappropriate feelings of anger, tearfulness, or anxiety. That figure is three-quarters for medical students and 68% for residents.  

One-third of physicians feel hopeless or that they have no purpose. That compares to more than half of medical students and 43% of residents. 

More than half of physicians know a physician who has either considered, attempted, or died by suicide in their career.  

One-fifth of physicians know a colleague or peer who has considered suicide in the past year. That rate is one-quarter for medical students, and the same one-fifth for residents. 

It is estimated that one million Americans lose their physician to suicide each year.  

Eight in 10 physicians and residents, and three-quarters of medical students, agree there is stigma surrounding mental health and seeking mental health care among physicians.  

Burnout Root Causes

Burnout is one contributing factor of physician suicide. The burnout rate among physicians and residents has increased from 40% to 60% since 2018, with medical students reporting burnout at a 70% rate. Left untreated, burnout can cause depression, anxiety, and post-traumatic stress disorder, all of which can lead to the development of suicidal thoughts.  

Today there is greater awareness about the need to recognize and address burnout among physicians, but there is still a long way to go — including finding solutions for the root causes of burnout which, the American Medical Association (AMA) contends, requires fixing “what’s broken in healthcare today — and it’s not the doctor.”  

According to the AMA: “The answer lies not in offering us more yoga classes, coffee gift certificates, or dinners with hospital leadership. While wellness has its place, to focus solely on physician resilience is to blame the victim. Curbing burnout for physicians will require actions at the system level, as well as a greater degree of collaboration among clinicians, health systems, insurers, government, medical societies, EHR (Electronic Health Record) vendors and other health system stakeholders.” 

Warning Signs and Prevention Strategies

Recognizing warning signs of suicide risk among colleagues is one key to physician suicide prevention. The AMA offers a CME module “Identifying and Responding to Suicide Risk” that covers identifying both at-risk patients and colleagues. 

One strategy to recognize suicide risk among physicians is physicians being alert to stressors their colleagues may be facing. This could include recent loss of a patient, license restriction, malpractice, financial problems, and a high-capacity workload. 

Another important strategy is creating a culture for physicians that is more open to discussions about mental health. Physicians are encouraged to lead by example and talk about their own stories and struggles, which will indicate to colleagues that it is OK for them to do the same.  

Providing resources for physicians to seek confidential support when they need it is also critical. MSV’s SafeHaven program does just that, offering clinicians in-person and virtual counseling assistance 24 hours a day, 7 days a week — so they can get the support they need with the confidence their medical licensing will not be at risk.  

In fact, that is the final piece of the puzzle for improving the culture around physician mental health: removing barriers to seeking help, when doing so can potentially jeopardize a career. Culture change will require significant policy changes, like changing questions on licensing that discourage physicians from being honest about seeking help. 

To learn more about National Physician Suicide Awareness Day, visit https://npsaday.org

2024 Nominating Committee Report

The Nominating Committee considered all eligible candidates for the upcoming term of office. The committee recommends the following slate for consideration by the society membership.

MSV Board of Directors
Term 2024-2025/2026


Officers (Elected for 1-year term)

President-Elect | Mark Townsend, MD
Speaker | Michele Nedelka, MD
Vice Speaker | Atul Marathe, MD

 

Officer (Elected for 3-year term)

Secretary-Treasurer | Art Saavedra, MD

 

Directors (Elected for 2-year term)

District 2 | Lee Ouyang, MD
District 2 | Sharon Sheffield, MD
District 6 | Mark Kleiner, MD
District 8 | Marc Alembik, MD
District 10 | William Hutchens, MD
District 10 | William Prominski, MD

 

Directors (Elected for 1-year term)

District 7 | John Mason, MD
MSV Foundation | José Morey, MD
Resident | Matthew Adsit, MD (VCU Orthopedics)
Medical Student | Elizabeth Ransone (VCU)

 

Associate Directors (Elected for 2-year term)

District 2 | John Sweeney, MD
District 6 | Joe Hutchison, MD
District 8 | Zerline Chambers-Kersey, MD
District 10 | Kevin Donohue, DO

 

Associate Directors (Elected for 1-year term)

District 7 | Mohit Nanda, MD
Resident | Terry Henry, MD (VCU-Ophthalmology)
Medical Student | Shawn Dziepak (VCOM)

Virginia Delegation to the American Medical Association Term 2025-2026

Elected for a 2-year term

Delegates

Thomas Eppes, Jr., MD
Michele Nedelka, MD
Lee Ouyang, MD

 

Alternate Delegates

Joshua Lesko, MD
Mohit Nanda, MD
Josephine Nguyen, MD

2024-2025 Nominating Committee

Elected for a 1-year term

 

District 1 | Sterling Ransone, MD
District 2 | Randolph Gould, MD
District 3 | Clifford Deal, MD
District 5 | Bhushan Pandya, MD
District 6 | Cynda Johnson, MD
District 7 | Claudette Dalton, MD
District 8 | Carol Shapiro, MD
District 9 | Abraham Hardee, DO
District 10 | Andrea Giacometti, MD (ACMS)
Academic | Cynthia Romero, MD (Macon & Joan Brock Virginia Health Sciences at ODU) (Chair)
AMA Advisor | Tom Eppes, MD
2022-2023 Former President Advisor | Harry Gewanter, MD
2023-2024 Former President Advisor | Alice Coombs, MD

CEO Melina Davis Recognized on Virginia 500 Power List

The Virginia 500 Power List names the most powerful Virginia executives and officials in business, nonprofits, higher education, government, and politics.

We congratulate our CEO and EVP, Melina Davis, for receiving recognition for her contribution to healthcare on the 2024 Virginia 500 Power List.

Read the full 2024 – 2025 Virginia 500 Power List here.

Communicable Disease Updates

via VDH


Dear Colleague:

I am writing to provide you with brief updates on pertussis, H5N1, Mpox, and invasive group A Streptococcus (group A strep) disease.

Pertussis

The Virginia Department of Health (VDH) is reporting an increase in pertussis (whooping cough) cases. As of August 1, 2024, more than five times as many cases have been reported compared to the same time last year and exceed pre-pandemic levels. This trend is linked to a rise in pertussis outbreaks across the Commonwealth occurring in group settings, including universities, schools, religious communities, and childcare settings. Outbreaks of pertussis can be large and last for several weeks or longer, impacting both vaccinated and unvaccinated persons.

VDH recommends that healthcare providers:

Avian Influenza A(H5N1)

VDH continues to monitor the outbreak of highly pathogenic avian influenza (HPAI) A(H5N1) in poultry and dairy cattle that has resulted in human infections in parts of the United States. At this time, there are no reports of cases in cattle or people in Virginia and the risk of H5N1 infection for the general public remains low. For more information on H5N1, please see VDH’s Avian Influenza webpage.

VDH recommends that healthcare providers:

  • Ensure people who have job-related exposure to infected or potentially infected cattle, birds, or other animals get vaccinated for seasonal influenza. While the seasonal influenza vaccine will not protect against H5N1, it can help prevent a person becoming ill with seasonal flu or becoming coinfected with a seasonal flu virus and H5N1.
  • Maintain a low threshold for testing people for H5N1 if they have compatible signs and symptoms and a relevant exposure history.

Streptococcal Disease, Group A, Invasive

There has been a noted increase in reported invasive Group A Streptococcus (iGAS) cases and outbreaks in Virginia for the past few years. This increase follows national trends of increasing invasive and noninvasive group A strep cases. In Virginia, an increase in iGAS cases have continued for the first half of 2024, surpassing the number of cases reported in 2023 during the same timeframe.

Healthcare providers should:

  • Consider antibiotic resistance testing for iGAS infections. CDC reports about 1 in 3 iGAS infections are now caused by bacteria that are resistant to erythromycin and clindamycin.
  • Consider iGAS in groups that are at increased risk for getting a serious group A strep infection such as: people with preceding viral infections like flu or chickenpox, people aged 65 years or older, residents of long-term care facilities, people who inject drugs or who are experiencing homelessness, and people with immunocompromising conditions.
  • Stay up to date on infection prevention strategies in long term care facilities for GAS and wound care.

Mpox

CDC recently issued a Health Alert Network health update about the large, ongoing clade I mpox outbreak in the Democratic Republic of the Congo (DRC). It continues to grow and has spread to neighboring countries​. The World Health Organization (WHO) declared mpox to be a public health emergency of international concern on August 14. The risk for Clade I mpox in the general U.S. population is very low. Clade I cases in the U.S. have not been reported.​

VDH asks providers to maintain a high index of suspicion of mpox in recent travelers to affected areas and their close contacts. Providers should report suspected cases to the local health department and discuss clade testing at the Division of Consolidated Laboratory Services. Mpox cases associated with the ongoing 2022 global outbreak and milder virus strain (Clade II) continue to occur in VirginiaPeople at risk for mpox can maximize their protection by getting both doses of the JYNNEOS vaccine.

Thank you for your continued partnership and attention to these timely updates.

Sincerely,

Karen Shelton, MD
State Health Commissioner

2nd Annual Virginia’s Top Doctors Survey

Virginia Business magazine is conducting its second annual statewide, peer-selected Virginia’s Top Doctors survey. The MSV, in partnership with Virginia Business, is requesting your help in naming the peers you regard as most effective by medical specialty.

The winners will be published in the January 2025 issue of Virginia Business. Click hereto access your secure electronic voting ballot form for Top Doctors, and show your appreciation for your peers and colleagues.

Thank you for participating and recognizing Virginia’s Top Doctors.

Vote Now!

Want to share this survey? Please refer your colleagues who are licensed, active doctors to vote at docs.virginiabusinessvoting.com.

ODU-EVMS-Sentara partnership will expand the health care workforce

Op-ed by Dr. Alfred Abuhamad (Dean, EVMS) and Brian O. Hemphill, Ph.D. (President, ODU)


via The Virginian-Pilot

Hampton Roads, like many communities across the country, faces a shortage of health care workers. The Association of American Medical Colleges projected that by 2036 the U.S. will face a shortage of as many as 86,000 physicians. Additionally, the global professional services firm Mercer estimates that the United States will be short 3.2 million health care professionals by 2026, and the Health Resources and Services Administration reports that 100 million Americans already live in areas exhibiting primary medical health professions shortages.

Now for the good news…

Continue Reading

Ripple of Change Podcast: SafeHaven With Melina Davis and Ally Jaffee

Melina Davis, CEO of the Medical Society of Virginia, and Ally Jaffee, NHS Psychiatrist, join Dr. Otten to discuss a nationally and internationally growing movement and program: SafeHaven.

Listen now to learn more about the need for confidential support and psychological safety for our healthcare professionals