CareManagement June/July 2022

JOURNAL OF THE COMMISSION FOR CASE MANAGER CERTIFICATION | THE CASE MANAGEMENT SOCIETY OF AMERICA | THE ACADEMY OF CERTIFIED CASE MANAGERS

Vol. 28, No. 3 June/July 2022 INSIDE THIS ISSUE

SPECIAL SECTIONS:

CONTINUING EDUCATION ARTICLES:

11 Case Management: A Look Back, A Plan Forward

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Approvals, warnings and the latest information on clinical trials—timely drug information case managers can use.

Laura Ostrowsky, RN, CCM, MUP Health care has changed in many ways over the past 50 years.

Costs have risen, length of hospital stay has dropped, and levels of care have multiplied. In 1985 Medicare changed the payment methodology from per diem to diagnosis-related groups, a period which could be considered the “dawn” of case management. A major milestone was reached in 1990 when the Case Management Society of America (CMSA) was founded. Case management started out as a review of medical necessity but has blossomed into an essential part of health care delivery and planning.

16 HIPAA (Part 1): What Is It and Why Should I Care?

HIPAA was signed into law in 1996 by President Bill Clinton. It was first proposed with the simple objective to ensure health insurance coverage after changing or leaving a job. The privacy rule protects the privacy of a person’s health information and keeps it from being misused. HIPAA gives people the right to receive and review their health records and to choose with whom their health care providers and health insurance companies share their information (including friends, family members, and caregivers). The law also includes standards for setting up and maintaining secure electronic health records.

22 The Post-COVID Pathway to Resilience in Case Managers CE3 Rajitha Bommakanti, RN, CCM During the pandemic, the inadequate resources, overloaded caseloads, and the intensive care units at maximum capacity put an extra burden on healthcare workers. As case complexity increased, the experiences of moral distress heightened among healthcare workers. In order to lower inflammation in the body and for the body to heal and rejuvenate at the cellular level, evidence-based polyvagal theory tools can be incorporated. Seven simple techniques can be used to increase the tone of the vagus nerve to calm the nervous system and lower stress. These include mindful breathing; singing, humming, and gargling; meditation; exercise; social engagement; and compassion; and laughing.

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Members: Take exam online or print and mail.

Nonmembers: Join ACCM to earn CE credits.

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LitScan for Case Managers The latest in medical literature and report abstracts for case managers.

DEPARTMENTS: 2 From the Editor-in-Chief Becoming Patient Centric

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Kathleen Fraser, RN-BC, MSN, MHA, CCM, CRRN, FAAN

CE Exam

PharmaFacts for Case Managers

join/renew ACCM online at academyCCM.org

or use the application on page 41

3 From the Executive Editor Celebrations and Reflections

4 Legal Update I

Why Every Provider Must Establish and Maintain a Fraud and Abuse Compliance

5 Legal Update II Nurses!

6 News from CMSA

Greetings from the New President of CMSA

7 News from CARF

Greetings from the New President of CMSA

8 News from CDMS/CCMC

“You’ve Got This”: The Message to CCM & CDMS Exam Candidates —and All of Us

9 News from the VA

Journey of Care Coordination and Integrated Case Management in the Veterans Health Administration

10 CM Insights

Meeting Clients Where They Are, Even When They are Far Away

40 How to Contact Us 40 FAQs 41 Membership Application

FR O M TH E E D I TOR -I N -CH I EF

Becoming Patient Centric

Editor-in-Chief/Executive Vice President Gary S. Wolfe

Gary S. Wolfe, rn, ccm, fcm Editorial Board

Being patient centric means putting the patient in the center and in control of all their healthcare decisions and activities. It means putting the patient first in an open and sustained manner to respectfully and compassionately achieve the best outcome for the patient and the patient’s family.

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ur healthcare delivery system has many problems. Case managers hear about these problems every day. Some of the things we hear include: • I can’t get in to see my provider • My doctor never listens to me • I would like my provider to explain all my options • I don’t understand what is going on This is a very abbreviated list. The list goes on and on. What it really points out is how broken the healthcare delivery system really is. So how do we make it better? What role do case managers play in making it better?

The biggest impact on the healthcare delivery system could be made if we adopted a patient-centric approach. We talk about it all the time, but in reality we are a long way away from being patient centric. What do we mean by being patient centric? Being patient centric means putting the patient in the center and in control of all their healthcare decisions and activities. It means putting the patient first in an open and sustained manner to respectfully and compassionately achieve the best outcome for the patient and the patient’s family. We could adopt the United Kingdom’s National Health Service phrase, “no decision about me, without me.” Patient centricity means that the patient is an active participant and not passive in all aspects of their care.

There are many advantages of a patient-centric health care delivery system including: 2 CareManagement June/July 2022

• Increased engagement between patients, healthcare providers, and other stakeholders makes patients better informed about their health conditions and treatment options, which leads to better care • Participation, communication, and collaboration of healthcare experts with patients make the process of healthcare decisions timelier and more successful • Improved health outcomes and increased patient satisfaction with the provided healthcare services • Improved resource allocation and multilevel care planning • Improved patient and provider satisfaction • Cost effectiveness • Improved quality • Increased trust in providers and the healthcare system Principles of patient-centered care include: • Respect everyone with dignity, compassion, and courage • Establish efficient care and treatment plans with patient and family involvement • Individualize care, support, and treatment for every patient.

We support these principles by respecting patients and families and by respecting patient perspectives and choices. We share information recognizing everyone is a participant. We actively collaborate with the patient, family, and all members of the delivery team. We are sincere continues on page 38

Barbara Aubry, rn, cpc, chcqm, faihcq Jennifer E. Voorlas, msg, cmc Adele Webb, rn, phd, aacrn, cpnap, faan Executive Editor

Catherine M. Mullahy, rn, bs, ccrn, ccm, fcm Contributing Editor

Elizabeth Hogue, Esq. Copy Editor

Esther Tazartes, MS Art Director and Webmaster

Laura D. Campbell Circulation Manager

Robin Lane Ventura Member Services Coordinator

Kathy Lynch Senior VP Finance & Administration

Jacqueline Abel Publisher, President

Howard Mason, rph, ms Vol. 28, No. 3, June/July 2022. CareManagement (ISSN #1531-037X) is published electronically six times a year, February, April, June, August, October, and December, and its contents are copyrighted by Academy of Certified Case Managers, 2740 SW Martin Downs Blvd. #330, Palm City, FL 34990; Tel: 203-454-1333; Fax: 203-547-7273.

Subscription rates: $120 per year for ACCM members; $150 for institutions.

Opinions expressed in articles are those of the authors and do not necessarily reflect the opinions of the editors or the publisher or the Academy of Certified Case Managers. One or two copies of articles for personal or internal use may be made at no charge. For copying beyond that number, contact Copyright Clearance Center, Inc. 222 Rosewood Dr., Danvers, MA 01923, Tel: 978-750-8400.

CareManagement is indexed in the CINAHL® Database and Cumulative Index to Nursing & Allied Health Literature™ Print Index and in RNdex.™

© Academy of Certified Case Managers, Inc. 2022

FR O M TH E E XECUT I V E ED I T O R

Celebrations and Reflections

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e’ve reached midyear of 2022, and June is typically a time to celebrate.

We look forward to beautiful weather and time to enjoy and celebrate the special times in our lives—graduations, weddings, family reunions, and birthdays for the newest arrivals.

We are professionals, but we are also individuals who hopefully have rich and deeply satisfying personal lives.

As we were putting together this issue of CareManagement, it occurred to me that there were numerous significant occasions in the month of May. There was Mother’s Day, Nurses Week, Mental Health Awareness Month, ALS Awareness Month, Armed Forces Day, International Red Cross Day, and Memorial Day. It seems that every day in May, and in fact most months, we need reminders to take note of special occasions, even if only for a few moments in a very busy day. It’s somewhat of a sad commentary that our lives have become so scheduled and yes, overcommitted, that we do need these “push-pause” moments (thanks, again, CCMC for those!) to stop, reflect, and be in the moment.

Country music legend George Strait has a song titled, “The Breath You Take,” in which there is a repeated lyric that says, “Life’s not the breaths you take, but the moments that take your breath away.”

Even though I haven’t called the phone numbers of my friends, some of them dating back to grammar school, and the phone number associated with my childhood home in years, I still remember them. In contrast, I now have difficulty recalling many of the phone numbers of individuals,

including my children and grandchildren (don’t tell them!), that I call very frequently…and why? Because I no longer have to remember them—I have access immediately on phone, a click away. The same is true for the day/date.

When someone asks me what the date is, I often have to acknowledge that I don’t know or can’t recall. Thankfully, it’s comforting to know that I’m not

We need to take time periodically to assess not only our patients’ needs but also our own needs and the needs of our colleagues, family, and friends. alone as more and more individuals rely on their phones.

We are so inundated with bits and bytes of information that it’s extremely difficult and continuously challenging to take it all in and to process information and use it in meaningful ways.

How should we determine what is truly significant, and, equally important, what is the best way to discern its relevance to the work we do each day, especially as it relates to the patients entrusted to our care? We need to take time periodically to assess not only our patients’ needs but also our own needs and the needs of our colleagues, family, and friends.

There are numerous articles, webinars, blogs, courses, and books that provide us with information and education. Each of these attempts to persuade us that their content should be considered more important and actionable than all the others. As each of the issues of CareManagement journal is created, we recognize that

Catherine M. Mullahy

professionals need information that will enhance their practice, improve outcomes for their patients, and underscore their commitment to be part of the lifelong learning experience that case managers embrace.

We recognize that our patients and their families have needs, including clinical, behavioral, financial, legal, and ethical, that are increasingly challenging and complex. We also need to examine our patients’ social determinants of health. All of these needs must be assessed and incorporated within the intervention we are providing.

How can we continue to meet the needs of case managers who are trying to balance multiple demands and responsibilities while facing increased stresses within their practice settings?

We cannot create change from outside these settings, but we can provide the education, tools, resources, and encouragement that can influence change. In fact, we encourage our readers to become change agents within their practice settings.

We invite you to share what you would like to see in this publication.

Take a few minutes and look at the “Inside This Issue” (cover of this publication) and the overview of the CE articles, special sections, columns, and features. I would truly appreciate it if you would contact me directly and share your “most valued” content and recommendations for topics. Consider this a personal invitation to become a part of this publication. Take a look at ACCM | CareManagement for more information about each of these features and for our Author Guidelines. I welcome the opportunity to work with you and look forward to hearing from you! continues on page 36 June/July 2022 CareManagement 3

LEGAL UPD A TE I

Why Every Provider Must Establish and Maintain a Fraud and Abuse Compliance Program Elizabeth Hogue, Esq.

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roviders may have heard or read about the importance of Fraud and Abuse Compliance Programs in their organizations. Despite the wealth of available information about Compliance Programs, many providers continue to express uncertainty about their value.

Here are some of the questions providers commonly ask about Compliance Programs:

Why should we have a Fraud and Abuse Compliance Program?

First, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has clearly stated that all providers are now required to have current Compliance Programs that are fully implemented.

As a practical matter, when providers establish and maintain Compliance Programs, it clearly discourages regulators from pursuing allegations of fraud and abuse violations.

Technically speaking, the Federal Sentencing Guidelines make it clear that establishment and implementation of Compliance Programs is considered to be a mitigating factor. That is, if accusations of criminal conduct are made, the consequences may be substantially less severe as a result of a fully implemented Compliance Program.

In addition, providers with Compliance Programs are more likely to avoid fraud and abuse. This is Elizabeth Hogue, Esquire, is an attorney who represents health care providers. She has published 11 books, hundreds of articles, and has spoken at conferences all over the country.

4 CareManagement June/July 2022

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has clearly stated that all providers are now required to have current Compliance Programs that are fully implemented. because Programs routinely establish an obligation on the part of every employee to report possible instances of fraud and abuse and include training for all employees.

Compliance Programs may help to prevent qui tam or so-called “whistleblower” lawsuits by private individuals, rather than by government enforcers, who believe that they have identified instances of fraud and abuse. There are significant incentives to bring these legal actions since “whistleblowers” receive a share of monies recovered as a result of their efforts. Some “whistleblowers” have received millions of dollars. Compliance Programs make it clear that employees have an obligation to bring any potential fraud and abuse issues to the attention of their employers first.

In addition, the federal Affordable Care Act (ACA) requires providers to have Compliance Programs. In short, it’s the law!

Finally, the Deficit Reduction Act (DRA) requires providers who receive more than $5 million in monies from state Medicaid Programs per year to implement policies and procedures,

provide education to employees, and put information in their employee handbooks about fraud and abuse compliance. These requirements can be met through implementation of Fraud and Abuse Compliance Programs.

We don’t receive reimbursement from the Medicare or Medicaid Programs. Do we still need a Compliance Program?

Statutes and regulations governing fraud and abuse also apply to providers who receive payments from any federal and state healthcare programs, including Medicaid, Medicaid waiver, and other federal and state health care programs such as Tricare. Many private insurers have followed the federal government’s “lead” in terms of fraud and abuse enforcement. So private duty providers must have compliance programs, too.

We hear that the OIG has provided guidance for various segments of the healthcare industry regarding Compliance Programs. Specifically, the OIG has already published guidance for clinical laboratories, hospitals, home health agencies, hospices, physicians’ practices, third-party billing companies, and home medical equipment companies. Should we just use the model guidance that is applicable to us?

The answer is “No!” Guidance from the OIG is not a model Compliance Program. Guidance from the OIG consists of general guidelines and does not constitute a valid Compliance Program. In addition, the OIG has made it clear that Programs must be customized for each organization. continues on page 39

LEGAL UPD A TE I I

Nurses!

Elizabeth Hogue, Esq.

LEAD THE DELIVERY OF WORLD-CLASS CARE

It’s National Nurses Week! This article relates what several nurses have to say about the profession.

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lorence Nightingale said, in a widely-read article published in 1876, that the goal of nursing is to “get people going again” with a “sound body and mind.”

John Darnielle, frontman for The Mountain Goats, who trained as a nurse, said in an interview published in The New Yorker on April 24, 2022: “You become a nurse because you’re already the kind of person who wants to do something for people. You feel like you have something to bring. They’re called the caring professions: providing care is the thing, and you don’t go into the profession unless that’s something you want to do. It becomes a big part of who you are. You see some amazing things happen. Spiritually, I think, to be able to help anybody, your existence now has some kind of meaning. I don’t think of my audience as patients, you know, but I do think that, in my nursing years, I learned to identify myself, or to be happy with myself, based on how much good I had done for somebody.”

In Becker’s Hospital Review on July 20, 2017, nurses described why they do what they do: • One nurse emphasized the importance of educating patients with chronic diseases about how to take care of themselves to prevent visits to emergency rooms and hospitalizations. She said that chronically ill patients really need someone to care about them and to point out to them what they should do differently because sometimes they just don’t know any better.

• Another nurse pointed out that sometimes clinicians’ jobs are harder than those of office workers. This especially true because clinicians may have worked hard to save a patient’s life without success. The failure sticks with practitioners and may manifest itself in a determination to work as hard as possible to help patients in the future.

• A third nurse pointed out that nursing seems to have continued on page 39

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Join us and provide the clinical expertise and strong leadership that will define our patient care. You will: • Assess and coordinate care for a diverse group of patients • Collaborate and consult with a multi-disciplinary healthcare team • Develop and implement individualized care plans • Utilize evidence-based tools for risk stratification • Perform utilization review • Assure exceptional care throughout the entire continuum At UCLA Health, you’ll enjoy: • Excellent compensation and comprehensive benefits • Empowering culture with commitment to consistent excellence • Strong resources and opportunities only UCLA Health can offer • Lifestyle advantages of our Southern California locations

VIEW CURRENT OPENINGS

NEWS FR OM

CASE MANAGEMENT SOCIETY OF AMERICA

Greetings from the New President of CMSA Colleen Morley, DNP, RN, CCM, CMAC, CMCN, ACM-RN

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t the time of this writing (April 2022), I am anticipating being sworn in as the new CMSA National President at this year’s annual conference in Orlando, Florida, in June.

I am so grateful and excited to be taking on this role with the oldest and largest professional organization for the case management community.

The CMSA community holds a special place in my heart and my life and the opportunity to give back on a national level is indeed an honor.

2022 has been a very busy and great year for CMSA. CMSA is blessed with a richness of talent within our membership and those who are willing to share their gifts and volunteer their time to serve in any capacity. At the CMSA National Conference, we are happy to update the attendees on the great work this incredible group of volunteers has been doing.

One of the major projects that the CMSA volunteers have undertaken is Dr. Colleen Morley, DNP, RN, CCM, CMAC, CMCN, ACM-RN, is the Regional Director of Case Management for Pipeline Health Systems/Chicago Market. She has held positions in acute care as Director of Case Management at several acute care facilities and managed care entities in Illinois, overseeing utilization review, case management, and social services. Her current passion is in the area of improving health literacy. She has recently authored her 1st book, “A Practical Guide to Acute Care Case Management”, published by Blue Bayou Press.

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One of the major projects that the CMSA volunteers have undertaken is a review of the CMSA Standards of Practice. These Standards of Practice set the bar for the practice of our profession and form the foundation for the development of evidence-based practice for case management. a review of the CMSA Standards of Practice. These Standards of Practice set the bar for the practice of our profession and form the foundation for the development of evidence-based practice for case management. The CMSA Standards of Practice Task Force completed their thorough review of the Standards of Practice, last updated in 2016 and introduced the 4th edition at the CMSA National Conference. Did you know that CMSA was the first case management professional organization to create Standards of Practice in 1995? The 2022 updates were released this Spring and are now available at www.cmsa.org.

Public Policy

The Public Policy Committee has identified legislative priorities related to case management and held a very successful 3-part webinar series on the topics of telehealth, mental health, and workforce development earlier in the year. These webinars led up to the 2022 CMSA Virtual Hill Visits program, where over 45 CMSA members met with the offices of various members of Congress during the week of February 21, 2022. Over 45 registrants attended a preparatory session before the event and during 28 scheduled meetings, progress was made in increasing the recognition and awareness of case management as well as advancing the

efforts to continue telehealth and mental health services and funding going forward. Progress being made towards case management no longer being the best kept secret in healthcare!

Collaborations

CMSA is excited to continue partnering with the Aging Life Care Association and the American College of Physician Advisors in 2022 to develop joint educational programs and informative articles. CMSA was proud to attend both organizations’ annual conferences in April and continues to collaborate on working together for support and added member value.

Salary & Trends Survey

CMSA partnered with Case Management Institute to launch a joint Salary and Trends Survey, exceeding the goal of 2,000 total respondents.

Data were collected in the areas of demographics, experience, professional development and certification, current job salary and benefits, and challenges faced today. The results of the survey were shared during the CMSA annual conference in June. Thank you to Deanna Cooper and Case Management Institute for their partnership to obtain this important data from across the case management community. continues on page 39

NEWS FROM

CARF…THE REHABILITATION ACCREDITATION COMMISSION

Applying Standards to Persons Served with Limb Loss, Brain Injury, and Spinal Cord Injury Terrence Carolan, MSPT

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edical rehabilitation programs often serve a patient population with many different types of diagnoses. In many cases, programs work with a large percentage of patients from certain populations (ie, stroke). Ensuring that the program meets the needs of these frequently served populations is somewhat easier because of the volumes of patients served. When programs serve patient populations that make up a relatively small percentage of their total volume, it can be more challenging to ensure both the competency of staff and the needed depth of the program itself.

CARF has identified 3 populations that programs must focus on even if they serve only 1 person with these diagnoses: persons with limb loss, brain injury, and/or spinal cord injury.

These standards in CARF section 2.D help to ensure that the program is able to meet the unique needs of these populations when these diagnoses may not be focal points of the program’s service delivery.

For limb loss any medical rehabilitation program should be sure to focus on several aspects of the care of these Terrence Carolan, MSPT, is the Managing Director of Medical Rehabilitation in Tucson, Arizona. He is part of the medical rehabilitation team responsible for the training of CARF surveyors and for the development and revision of CARF standards.

Medical rehabilitation programs often serve a patient population with many different types of diagnoses. CARF has identified 3 populations that programs must focus on even if they serve only 1 person with these diagnoses: persons with limb loss, brain injury, and/or spinal cord injury. individuals. Using limb loss–specific competencies will ensure that staff maintain the appropriate skill sets required to work with these individuals. Have you ever found yourself in a situation where you’ve been taught a skill, several months have passed, and then you’re asked to demonstrate that skill? Your confidence in performing that skill may have faded as time passed, and you may need a refresher on how to best demonstrate that skill.

This is the intent behind developing competencies for specific populations.

Education is also crucial to the successful improvement and discharge of any patient. For persons with limb loss, this education should include a broad swath of content including use of the prosthesis and environmental modification (eg, when the patient’s residence needs to modified). Providing peer support is also key to patients’ successful movement through the program, and other support that should be considered includes psychological services, sexual counseling, specialty consultants, substance use counseling and treatment, and smoking cessation.

When working with patients with brain injury, the program will need to address the impact of behavior,

cognition, communication, and medical and sensory deficits on physical, psychological, social, and vocational function as well as education and family dynamics and participation. The program also should assess future risks to the patient and also be aware that the patient’s family and support system may have been profoundly impacted by the brain injury and the family may also need support.

Finally, when the program includes any patients with spinal cord injury (SCI), it is important for the program to clearly define its scope of service for persons with SCI including information on the etiology, completeness, and levels of SCI as well as what comorbidities are included in that scope. Does the program accept patients using ventilators? Is the program prepared to work with patients with any level or completeness of SCI? Once this is all defined, it is important that the program shares this information with the public. This will allow prospective patients, payers, and others to understand if the program is the right setting for the patient. Because of the unique needs of persons with SCI, the program will need to either provide or continues on page 38 June/July 2022 CareManagement 7

NEWS FROM THE COMMISSION FOR CASE MANAGER CERTIFICATION

CERTIFICATION OF DISABILITY MANAGEMENT SPECIALISTS COMMISSION

“You’ve Got This:” The Message to CCM and CDMS Exam Candidates—and All of Us MaryBeth Kurland, MPA, CAE, ICE-CCP

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n March and April 2022, the latest group of candidates were eligible to take the Certified Case Manager (CCM) and Certified Disability Management Specialist (CDMS) examinations to pursue board certification. Just as in prior years, these candidates prepared themselves with study guides and other resources.

For the first time, however, these candidates also received something else: an inspiring message that was relevant

Commission): “As you get ready to take the exam, the Commission would like to invite you to pause, focus and be present.”

What followed was a one minute and thirty-second video featuring April Lewis, a mental fitness coach.

Her opening words were directed to the candidates, addressing their mental and emotional state in the moment: “You may be experiencing a lot of emotions right now. Some may

the final moment before taking their examinations, April reminded the candidates that their priority was on staying focused on their goal: “…Take deep breaths, take your time, and give this exam all that you have.”

This particular Push Pause message, part of an ongoing series from the Commission to support all case managers and disability management specialists, was meant to speak especially to those pursuing certification,

There will always be distractions and competing priorities that steer our attention in various directions. At times, the burden becomes overwhelming, and we don’t know how we’ll do it all.

That’s when we come back to our center. We are prepared. All we can expect of ourselves is to do our best. Knowing that we’ve done our best is more important that any outcome. to pursuing a professional certification in these challenging times.

A special “Push Pause” video reflection was sent out only to candidates with a message from the Commission for Case Manager Certification (the MaryBeth Kurland, MPA, CAE, ICECCP, is the CEO of the Commission for Case Manager Certification, the first and largest nationally accredited organization that certifies more than 50,000 professional case managers and disability management specialists. The Commission oversees the process of case manager certification with its CCM® credential and the process of disability management specialist certification with its CDMS® credential.

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be good, some not so good, both of which are okay because you’re human.

But I am here to remind you to be present, to be focused and to be confident in your capabilities.”

In helping candidates focus, April reminded them that this examination is their priority—no matter what else is on their minds or where their attention wanted to wander. As encouragement, she shared with them her favorite quote: “Be where your feet are.

Be very present this moment.”

Expanding on that theme, April reminded candidates that, in any situation in life, all they can expect of themselves is to do their personal best. “Regardless of how the outcome comes, regardless of what the result is, knowing that you’ve done your best, you can be pleased with you.” In

which is widely recognized as a proxy for workforce readiness. Yet, at the same time, April’s wise words are a reminder for all of us, no matter what we are facing in our professional and personal lives. There will always be distractions and competing priorities that steer our attention in various directions. At times, the burden becomes overwhelming, and we don’t know how we’ll do it all. That’s when we come back to our center. We are prepared. All we can expect of ourselves is to do our best. Knowing that we’ve done our best is more important that any outcome.

Such messages bolster our resilience. The practice of Positive Psychology teaches us of the importance of resilience, describing it as continues on page 36

NEWS FR OM

Journey of Care Coordination and Integrated Case Management in the Veterans Health Administration Stacey Castel, MSW, LCSW, Andrea Macomber, MSN, RN, ACM-RN, Anita Mingo, LICSW, and Veterans Health Administration Deborah Ramirez, RN, MS, CPUM

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he Veterans Health Administration’s Care Coordination and Integrated Case Management (CC&ICM) model stems from evidence-based practice that increases care coordination, communication, and collaboration to improve the health outcomes of the veteran population. CC&ICM builds upon existing care and case management efforts across the Veterans Health Administration (VHA) toward an integrated care model that will standardize, communicate, and elevate the approach to care coordination for veterans accessing care and services across the care continuum within and external to VHA. The VHA is the largest integrated health care system in the United States, serving more than 9,000,000 veterans. The CC&ICM model will provide VHA’s nurses and social workers with the tools to help veterans navigate the VHA health care systems, community care, and telehealth care delivered in their homes.

Andrea Macomber is the Acting VISN 1 Consortium Lead For VANEC. She is ACMA case management certified.

Andrea has diverse clinical practice expertise in the areas of cardiology, critical care, case management, VHA care in the community, and utilization review. She is Green Belt Certified in Lean Six Sigma and has worked on numerous process improvement projects that included LOS, decreasing readmissions, utilization review, and transfer flow.

The Veterans Health Administration (VHA) is the largest integrated health care system in the United States, serving more than 9,000,000 veterans. The Care Coordination and Integrated Case Management (CC&ICM) model will provide VHA’s nurses and social workers with the tools to help veterans navigate the VHA health care systems, community care, and telehealth care delivered in their homes.

Today, patients need wound vacuums, intravenous antibiotic therapy, and heart failure monitoring in their homes upon discharge from the acute care setting. Twenty years ago, these therapies and treatments would have been considered acute hospital level of care; however, this is no longer the case. The CC&ICM model expands the transformation of culture and practice through systems and clinical integration of services to provide veterans with quality, safe, efficient, and effective care in across settings and levels of care.

The model deployment will spread across the VHA enterprise in phases.

Phase 1 began in in October 2021 with more than 30 Veterans Affairs (VA) medical facilities. The second phase began in April 2022 with 50 additional VA facilities, and the remaining VA sites are scheduled to begin their CC&ICM journey in January 2023.

There are five milestones associated with the full implementation of the CC&ICM framework. The five milestones include 1) leadership awareness, 2) facility readiness, 3) implementation

preparedness, 4) systems and clinical integration, and 5) CC&ICM governance structure at the facility and Veterans Integrated Services Network level. In this article, the first two of the five milestones will be reviewed. The first milestone is to achieve leadership awareness, buy-in, and endorsement.

Multiple modalities and engagement tactics are used to reach this milestone, including both virtual town halls and smaller site consultation sessions.

The second milestone focuses on VA medical facility readiness. Readiness includes the appointment of CC&ICM executive sponsors, nursing and social work dyad co-champions, and comprehensive stakeholder identification.

Stakeholders may consist of various care coordination roles from different areas. Examples of stakeholders include primary care, specialty care, mental health, rehabilitative services, pharmacy, nutrition and food services, acute care, emergent care, community care, telehealth, quality safety and value, whole health, and systems redesign. Stakeholders play a pivotal role continues on page 36 June/July 2022 CareManagement 9

C ASE MANA G E R I N S I GH T S

Meeting Clients Where They Are, Even When They are Far Away Jennifer Axelson, LCSW, CCM, CLP

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ou may have heard the saying “meet the client where they are.” This implies that as case managers, we are to consider each client’s individual situation, perspectives, goals, preferences, supports, fears, and anything else that could be an impactful factor on their stability, needs, and/or progress. It is also important to note that meeting a client where they are is not an approach only taken during initial interactions but rather should be at the forefront of each and every interaction with your clients. It is only after you have truly assessed where the client is that you can develop a care management plan that can meet your client’s acute and long-term needs while respecting their autonomy.

This can, however, be difficult when we are brought into a situation that has already devolved into crisis, we cannot evaluate the situation in person, and there are multiple factors at play that are impacting your client’s stability and needs. As case managers, we are called upon to understand the situation, prioritize our interventions, collaborate with and coordinate services from multiple vendors, and calm Jennifer Axelson, LCSW, CCM, CLP, is the Director of Care Management for Arosa, the largest provider of integrated care management in the country. Jennifer is a licensed clinical social worker, certified case manager, and certified life care planner.

10 CareManagement June/July 2022

Meeting a client where they are is not an approach only taken during initial interactions but rather should be at the forefront of each and every interaction with your clients. It is only after you have truly assessed where the client is that you can develop a care management plan that can meet your client’s acute and long-term needs while respecting their autonomy. a chaotic situation. This is when care managers are at their best and can truly shine. To illustrate such a situation, I will share with you the story of two of our clients, Bob and Carol.

Bob and Carol had been our clients for over 10 years. They both had multiple medical problems and they used Arosa, formerly Lifecare Innovations, Inc., to assist in obtaining second opinions, reviewing medical bills, and finding rehabilitation options.

They had always partnered with us to ensure their stability, sought advice when issues arose, and then followed the advice provided. We helped them maintain their independence as they managed two cancer diagnoses, kidney failure, sleep apnea and more.

Bob and Carol loved to travel, and they never let their many medical problems prevent them from living the life they loved. During one of their many cross-country trips, Carol developed a case of pneumonia. Bob was worried and took her to the local hospital, 2,000 miles from home. While in the hospital, Carol fell and broke her hip and a simple three-day stay turned into a nightmare. Bob’s health was extremely fragile and he required specialized equipment at night to manage his sleep apnea. He thought he could

manage the situation and attempted to do so for a week. His daughter called us frantically, filled us in on the situation, and asked us to contact Bob to offer assistance.

The broken hip was quite problematic for Carol and she had appeared to lose her will to live. The hospital suggested a six-week rehabilitation stay in a local facility or a transition to hospice care. Meanwhile, Bob was staying in a hotel, was not using his sleep apnea equipment, and was getting more and more fragile as the saga unfolded. He began yelling at the hospital personnel and threatening them at every interaction. The hospital was at a loss and called in their patient advocate team. Carol refused to talk and was declining every day. Bob asked us to intervene and review the treatment plan with the doctor and the discharge plan with the hospital.

We found ourselves in a situation where both of our clients had acute needs and no family support present with them. The first thing we did was stabilize Bob and got him the needed sleep apnea equipment. Next we focused on the treatment of Carol. We all concluded that she needed to be home. This couple was overwhelmed continues on page 36

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Case Management: A Look Back, A Plan Forward Laura Ostrowsky, RN, CCM, MUP

C

ase management is a relatively young profession.

Many current case managers have been with it since its beginning and its prehistory. For those of you who began your case management journey in the 21st century, I want to put your career into a historic context. For the last 50 years, health care has changed in many ways. Costs have risen, length of hospital stay has dropped, and levels of care have multiplied. Many diseases have been prevented (through vaccine development), cured, or mediated. Technology has advanced, which has raised costs but also improved quality and outcomes. We’ve gone from a patriarchal system where doctors were the primary (or only) decision makers to one in which the patient plays an active part and is an accepted and acknowledged member of the team. Case management is an outgrowth of these changes and becomes a more essential partner with each new development.

In the 1970s, Medicare and Medicaid employed Professional Standards Review Organizations (PSROs) to monitor care, improve quality, and control costs, purposes that haven’t changed. The PSROs were responsible for monitoring the quality and use of medical services and provided peer review by medical professionals. Established in 1972 by Public Law 92-603, the PSROs are administered by the Health Standards and Quality Bureau, formerly the Bureau of Quality Assurance of the Health Care Financing Administration (Social Security Program Operations Manual System). Standards and criteria for level and quality of medical service were established, and care was reviewed Laura Ostrowsky, RN, CCM, MUP, is the current president of the NYC chapter of CMSA and a Director on the National CMSA board. She teaches a CCM preparation course with the Case Management Institute, works with Athena Forum, and writes and consults on all things case management. Laura has 40 years of health care exerience, including time as a staff nurse, QA Coordinator, and Director of UR and QA, followed by directorships in CM at New York Presbyterian and Memorial Sloan Kettering Cancer Center.

against these standards. To control costs, coverage was only provided for medically necessary services, which was known as utilization review. Private insurers soon adopted the same practice. They reviewed care to determine whether it met contractual as well as clinical guidelines. Care or services had to be deemed reasonable and necessary to qualify for coverage. Care could be denied for preexisting conditions and noncovered services (as defined by the contract) or failure to meet acute care guidelines. PSROs also looked at quality of care along with the Joint Commission on Accreditation of Hospitals, which mandated that hospitals have standards and policies and procedures in place to promote and maintain quality and that they be regularly reviewed and updated.

Because ambulatory care was rarely covered, patients were often admitted for procedures that could be done on an outpatient basis (eg, radiology procedures and diagnostic tests like colonoscopies and endoscopies). Utilization review was put in place to avoid these unnecessary admissions. Insurance plans expanded and evolved to accommodate the needs of ambulatory care patients. Most patients now have both hospital and medical coverage.

Utilization management took utilization review a step further by examining what was being denied and using that information to minimize or prevent denials as well as to justify hospital stays as medically necessary. We learned to appeal denials and have them reversed so that our employers/ institutions would be paid for the care rendered. A study of denials—both those upheld and those reversed—gave insight into what was needed to prevent denials. We used that information working with physicians and other clinical personnel to improve documentation to justify hospital stays. Some denials were simply a lack of adequate clinical documentation. Utilization management also meant looking not only at medical necessity but at avoiding duplication of services and logically sequencing care to expedite services, eliminate waste, and enhance quality outcomes. It was the first step in the direction of being proactive rather than reactive.

Health care costs continued to rise. In 1960, health care expenditures as a percent of the gross domestic product (GDP) were 5%, and in 1980 they were 8.9%. Costs remain June/July 2022 CareManagement 11

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Case managers became integral not only to the financial bottom line but to efficient patient flow, patient education, patient engagement and satisfaction, and keeping the team on task. Case managers assessed and reassessed patients as needed, tailoring plans to patients’ clinical, financial, and social situations. They collaborated, coordinated, and communicated information, breaking down silos and creating functional teams.

a concern: in 2020, they were nearly one fifth or 19.7% of the GDP (Statistica, U.S. Health Spending as Share of GDP 1960-2020, 2022). In the 1980s, regulators and payers were studying length of stay in hospital as a factor in these costs.

Billing was done per diem, so insurers and PSROs sought to carve out or deny payment for excessive days.

In 1985 Medicare changed the payment methodology from per diem to diagnosis-related groups (DRGs). DRGs did not start as a payment methodology. They were created in the 1960s at Yale as a framework for monitoring the quality of care and the utilization of services in the hospital setting (CMS, 2019). From the payment perspective, a DRG assignment correlates with the diagnosis identified as the reason for admission and care received in the hospital. Based on the DRG, the hospital receives a fixed amount regardless of how much money it actually spends on treatment. If the hospital can provide the care within or even less than the DRG amount, they will cover their costs or make a profit. If not, a loss will be incurred. The payment was based on an average length of stay per case. It was the first step away from paying for volume. Excessive length of stay was penalized not by outright denial but by limiting payment to an expected length of stay. Cost overruns would now be the responsibility of the provider, not the payer. Private insurers soon piggybacked on government payers and also adopted DRGs as their payment methodology. By 1988, New York was an all-payer DRG state.

I think of that period of time as the “dawn” of case management. We moved from passive review to active management of the patient stay in the hospital. Review information was used for performance improvement, leading to better quality of care and more efficient delivery of care. And it worked: length of stay began to drop. The way care was delivered changed. Same day admissions and ambulatory surgery increased dramatically. Patients were no longer admitted the day before surgery for what was essentially a sleepover. Case managers were able to help streamline processes, scrutinize medical necessity, improve documentation, decrease length of stay, and minimize excessive or redundant testing. The healthcare industry needed case management.

A major milestone was reached in 1990 when the Case 12 CareManagement June/July 2022

Management Society of America (CMSA) was founded.

CMSA was dedicated to the support and development of the profession of case management, which became a recognized specialty with a clearly defined mission and standards of practice. Case management was poised for the challenges of yet another major change in the delivery of health care.

DRGs contributed to an increase in efficiency and decrease in length of stay, but hospitals still struggled to contain costs. Technology, primarily minimally invasive and noninvasive procedures, also made it easier to shorten time in hospital or eliminate admission by expanding the number and type of ambulatory procedures and surgery. New pharmaceuticals changed how care was delivered, with some stronger oral medications making it possible to move from intravenous to oral medications sooner, thus eliminating more hospital days. Although pharmaceuticals and advanced technology shortened length of stay and eliminated some admissions, they came with their own costs that have been steadily rising. We now have advanced diagnostics, computed tomography (CT) scans, magnetic resonance imaging (MRI), and positive emission tomography (PET) scans as well as robots and lasers in surgery; cardiac catheterizations with shunt insertions have eliminated the need for open heart surgery for some patients. The increasing cost of medications is constantly in the news. Prescription drug prices have skyrocketed, but lives are being saved. In 2016, with 17.9% of the GDP spent on health care, pharmaceuticals accounted for nearly 10% of that expenditure (Prescription Drug Spending in the U.S. Health Care System, 2018).

Advances in home care capabilities meant that some patients could have infusion therapy at home. Home care expanded not only to infusion care but also to more complex wound care, home ventilators, and a variety of forms of in-home monitoring. We now have telehealth, which is not as new as many people think, but more ubiquitous because of the COVID-19 pandemic, and we also have changes in regulations that allow for billing and reimbursement for telehealth visits.

With the decrease in length of stay because of DRGs and changes in medical practice, patients were leaving “quicker and sicker.” Complex care required care coordination and a team-based approach. To prevent readmissions, we needed

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Although well care, prevention, and screening are initially a cost outlay, they are truly a longterm investment in keeping costs down by promoting health, preventing disease, controlling disease progression, and maintaining stability for those with chronic conditions.

safe discharge plans that included patient and caregiver education. It was essential that these plans provided the right care, in the right place, at the right time. It was also essential that our patients/partners understood their care and had the ability to self-manage working with their providers. Many patients no longer required acute care but were not ready to go home. In the 1960s and 1970s, patients went to nursing homes for limited rehabilitation and respite before returning home. Some stayed for long-term custodial care. Levels of posthospital care then became more clearly delineated and the designations changed. What were once referred to as nursing homes started being called skilled nursing facilities; these facilities provided postacute care including subacute rehabilitation, respiratory care, cardiac rehabilitation, and wound care. A higher level of rehabilitation was provided in acute care rehabilitation hospitals or designated units. Longterm acute care hospitals were created to provide extended care for patients who required an acute level of care but not the infrastructure of an acute care facility with, for example, advanced diagnostics and operating rooms. To identify and implement a safe and appropriate discharge plan, you needed a professional who understood clinical issues, insurance reimbursement, and levels of care.

Case managers became integral not only to the financial bottom line but to efficient patient flow, patient education, patient engagement and satisfaction, and keeping the team on task. Case managers assessed and reassessed patients as needed, tailoring plans to patient clinical, financial, and social situations. They collaborated, coordinated, and communicated information, breaking down silos and creating functional teams.

The passage of The Affordable Care Act (ACA) increased access to health care for millions of Americans, ending lifetime limits and denials for preexisting conditions. It also brought patients into the system who were unfamiliar with insurance coverage. Many had used the emergency department as their primary care provider. They didn’t understand how to leverage their coverage to improve and maintain their health using well care, checkups, screening, vaccinations, and more. They needed navigators and educators—they needed case managers. Case managers empower patients to care for

themselves to make decisions about their care. They ensure patients are provided with the education and information they need to be their own advocates.

The 21st century brought changes in the focus of health care. This includes transition planning (not just discharge planning, a limiting concept that ignores the complete continuum of care) along with a major shift to outpatient care, changes in regulations, and a focus on wellness, not just illness. From the reimbursement perspective, we had gone from per diem to case payment. Now outcomes determine value as defined by value-based care. The need to anticipate change rather than react to it became the road to success.

Words like agility, flexibility, and complexity entered the vocabulary. The current approach to improving care is through a big picture view that identifies ways to improve population health and understands that social determinants of health make a difference for both the individual and community. This is currently affecting the way we identify demographics and care rendered via coding. International Classification of Diseases, 11th Revision (ICD-11) now includes codes identifying social determinants of health because they affect costs and may intensify treatment complexity as well as increase length of stay (Centers for Medicare & Medicaid Services, 2021). Think about setting up a discharge plan for a homeless patient or one who lives in a walk-up apartment versus someone in an elevator building with excellent electric circuitry that can support medical equipment. Who addresses these types of issues? Case managers of course.

Population health is an outgrowth of the ACA and societal changes in attitudes to caring for our citizens. It recognizes the effects that social determinants of health have on specific populations. How do people access care?

Who can access care? How easy is it to access care? Is health care a right or a privilege? We were all made aware of how the pandemic highlighted disparities in health care and the toll it took on inner cities, people of color, and the economically disadvantaged. Although well care, prevention, and screening are initially a cost outlay, they are truly a long-term investment in keeping costs down by promoting health, preventing disease, controlling disease progression, and maintaining stability for those with chronic conditions.

June/July 2022 CareManagement 13

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Payment methodology and reimbursement changes are another area where case management interventions are essential. Consumers now have to make choices about their health care coverage whether they are, for example, purchasing coverage from a health care exchange, choosing from several options provided by their employers, or signing up for initial or annual Medicare enrollment.

Failure to take these steps increases costs in healthcare as well as for industry, employers, and society as a whole. For instance, when we look at lost work time and loss of trained employees due to disability, the societal costs are huge.

Multicultural issues and diversity also affect care. Case managers know that adherence and compliance are achieved by working with the patient within their beliefs, routines, and habits (eg, think diet) to achieve the best outcomes.

Diversity affects not just patients but providers and is more than culture, ethnicity, or race. It is the diversity of specialties, professions, and levels of care and coordinating care among these at times disparate groups. I think you can see where this is going. Case management to the rescue.

Patient flow is a concept that often uses the business efficiency process known as time and motion studies. You observe and map out the steps in a process and then identify what can be changed, eliminated, or speeded up to save time. Health care organizations looked at individual tasks and sections of patient flow. They looked at the admission and discharge processes, bed assignment and availability, clogs in the process, and wait times. Operating room turnaround was another candidate for patient flow initiatives. Committees were set up with physicians, nurses, and admitting and emergency department personnel as well as facilities and housekeeping. Case management was overlooked for the first few years.

The committees were proud of the minutes and even hours they trimmed off of processes. Operating room turnaround was tightened, discharges were taking place earlier in the day, and wait times had improved, but these measures had minimal effect on overall length of stay. When case managers were included, they pointed out that saving time was important, but noted that, for example, if a patient no longer needed to be in the hospital and could have been discharged a day earlier, the committee was missing out on significant time savings. These committees began to look at the bigger picture rather than focusing on piecemeal projects. Recognition of case management’s contribution has been incremental with each new initiative that is proposed, whether imposed by regulation or simply identified through process improvement.

Payment methodology and reimbursement changes are another area where case management interventions are 14 CareManagement June/July 2022

essential. Consumers now have to make choices about their health care coverage whether they are, for example, purchasing coverage from a health care exchange, choosing from several options provided by their employers, or signing up for initial or annual Medicare enrollment. Patients undergoing treatment who need to change or choose insurance must consider, to name a few, cost, cost benefit, continuity of care, network options, pharmaceutical coverage, and high or low deductibles. These are not easy decisions, and expert consultation is often needed to make an informed choice.

Care is highly consumer driven since there are choices to be made, but much of the information needed to make those decisions often feels beyond the knowledge base of the ordinary consumer. Case managers and insurance navigators can guide patients through these stressful and confusing situations, helping them make good choices in complex situations, whether the issues are financial, clinical, or a combination.

As health care consumers grow more savvy, their choices could begin to have an impact on the success of health care providers, both individuals, groups, and institutions. The Hospital Consumer Assessment of Healthcare Providers and Systems was developed by the Centers for Medicare & Medicaid Services to give patients a voice. It is a national survey designed to collect information on patients’ perceptions of hospital care (CMS.gov). The information is publicly reported, thus allowing consumers to compare hospitals. It is also factored into reimbursement (Detwiler and Vaughn, 2020).

Payment is no longer based solely on volume. In addition to DRGs and case-based payments, the Centers for Medicare & Medicaid Services is making value or quality a payment strategy. Payment for quality care is higher based on a number of criteria. The goal is to provide better care and lower costs. Readmission reduction is one aspect of these programs. Admissions are reduced by coordinating care and creating safe and effective discharge plans as well as encouraging adherence and communication among providers, which is another focus of case management (CMS.gov).

Another payment program in development is the assumption or sharing of financial risk. In these programs the payer (government or private) and the provider agree to assume or share the financial risk or provide care for a

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set population. The contract payment amount is based on the total number of “covered lives” or enrollees. Providers who exceed the contracted amount suffer a loss, complete or partial depending on whether it is a full or shared risk. On the other hand, they stand to make a profit if they can deliver quality outcomes within or below the contracted amount (NYS Department of Health).

Whatever the current payment methodology, the goal is improved quality and lower or contained costs. To achieve these goals requires a coordinated program of patient care with aggressive case management.

This evolution in care delivery, payment methodologies, policies, and practices has opened up all kinds of professional and leadership opportunities for case managers. Case managers are focusing efforts on data analytics and information technology to leverage information about population health and social determinants of health and to establish programmatic priorities. Analytics provide us with the ability to validate our work and our value. Choices of advanced degrees for case managers have expanded beyond nursing or social work to master of business administration (MBA), epidemiology, advanced statistical analysis, and public health as well as policy analysis and law. We are seeing more case managers pursing doctoral degrees.

Case management leaders have become department heads and administrators in many areas, including case management, quality, patient representatives, compliance, and patient education. The case management department may reside in a number of areas of the table of organization and report to medical directors, financial services, or nursing. There are growing opportunities for case management professionals in the C-suite as population health, the patient experience, and social determinants of health begin to take on greater importance. With regard to finance, case managers can bring specialized knowledge to managed care contracting and risk analysis. Through data analysis of current trends and future projections, they can contribute to strategic planning at the institutional level or in government. There really is no limit to where case management can take you.

Case management started out as a review of medical necessity but has blossomed into an essential part of health

Keep up to date with case management trends Gain insight into best case management practices

care delivery and planning. Case management is a force for the kind of health care we want and need. There is no movement forward without us. CE1

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References American Academy of Actuaries (March, 2018). Prescription Drug Spending in the U.S. Health Care System https://www. actuary.org/content/prescription-drug-spending-us-health-caresystem#:~:text=Health%20care%20spending%20in%20the,was%20 spent%20on%20prescription%20drugs.

CMS.gov. Design and Development of the Diagnosis Related Group (PDF). https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_ cms/Design_and_development_of_the_Diagnosis_Related_Group_ (DRGs).pdf CMS.gov. Value-Based Programs. https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-Assessment-Instruments/Value-BasedPrograms/Value-Based-Programs CMS.gov. HCAHPS: Patients’ Perspectives of Care Survey. https://www. cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ HospitalQualityInits/HospitalHCAHPS#:~:text=HCAHPS%20 (pronounced%20%22H%2Dcaps,perceptions%20of%20their%20 hospital%20experience.

Detwiler and Vaughn (September 2020). Patient Satisfaction and HCAHPS Reimbursement, RELIAS. https://www.relias.com/blog/howdo-patient-satisfaction-scores-affect-reimbursement NYS Department of Health. Provider Risk Sharing: Options and Considerations. https://www.health.ny.gov/health_care/medicaid/ redesign/dsrip/provider_risk_sharing.htm Social Security Program Operations Manual System. https://secure.ssa. gov/apps10/ Statistica. https://www.statista.com/statistics/184968/us-healthexpenditure-as-percent-of-gdp-since-1960/#:~:text=U.S.%20 national%20health%20expenditure%20as%20percent%20of%20

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HIPAA (Part 1): What Is It and Why Should I Care?

Kathleen Fraser, RN-BC, MSN, MHA, CCM, CRRN, FAAN

D

o you hate, fear, or try to avoid the Health Insurance Portability and Accountability Act (HIPAA) altogether? HIPAA is also known as the Kennedy-Kassebaum Act and was signed into law in 1996 by President Bill Clinton. It was first proposed with the simple objective to ensure health insurance coverage after changing or leaving a job. The privacy rule of the Kennedy-Kassebaum Act protects the privacy of a person’s health information and keeps it from being misused.

Congress added an administrative simplification section to the bill and named it after Senators Ted Kennedy and Nancy Kassebaum, the Act’s two leading sponsors. It gives people the right to receive and review their health records and to choose with whom their health care providers and health insurance companies share their information (including friends, family members, and caregivers). The FIGURE 1

law also includes standards for setting up and maintaining secure electronic health records.

Title I is the protection of health insurance coverage for employees and their families, and the Portability Provision of the Act is designed to improve portability of health coverage.

Title II covers the width and the breadth of case management starting with the five elements under the Administrative Simplification Rule with the National Provider Identifier Standard, Transactions and Code Set Privacy Standard, HIPAA Privacy Rule, HIPAA Security Rule, and HIPAA Enforcement Rule (Figure 1). The four rules for protecting patient health information within HIPAA are The Privacy Rule, The Security Rule, The Breach Notification Rule, and The Enforcement Rule. The sections predominately relevant to case management and part 1 in this series are the Privacy Rule and the Security Rule within Title I and Title II.

HIPAA FLOWCHART

HIPAA Health Insurance Portability and Accountability Act of 1996 TITLE I

Health Care Access, Portability and Renewability

TITLE II Preventing Health Care Fraud and Abuse

Medical Liability Reform

Administrative Simplification

Electronic Data Interchange

Privacy

TITLE III

TITLE IV

TITLE V

Tax-related Health Provision

Group Health Plan Requirements

Health Care Revenue Offset

Security • Security Standards: General Rules • Administrative Safeguards • Technical Safeguards • Physical Safeguards

Transactions

Identifiers

Code Sets

• Organizational Requirements • Policies and Procedures • Documentation Requirements

16 CareManagement June/July 2022

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HIPAA is also known as the Kennedy-Kassebaum Act and was signed into law in 1996 by President Bill Clinton. It was first proposed with the simple objective to ensure health insurance coverage after changing or leaving a job. The privacy rule of the Kennedy-Kassebaum Act protects the privacy of a person’s health information and keeps it from being misused.

As case managers and patient advocates, the goal of this series on HIPAA is to educate case managers not only on the purpose of HIPAA but to demonstrate that HIPAA also serves as a patient advocate, so to speak, just as we do.

HIPAA should be thought of as an extension to what we do, instead of a burden.

A parenthetical statement in HIPAA “throws case managers in” with the list of health care providers who do not need the authorization by falling under the criteria of a provider.

However, according to Cathy Kauffman-Nearhoof, RN, BSN, CCM, CMCN, CLNC, the “health care world simply does not always see independent case managers in that bucket.”

There is a lack of agreement within the HIPAA consultation community. HIPAA has the following recommendation for case managers who are not acting on behalf of a hospital or other health care facility: “just proceed with the appropriate authorization.” It is the most conservative and safest approach, rather than attempting to garner consensus for the case manager in a care coordinator role Care Coordination-45 CFR § 164.506(c). As health care professionals, we will see how these duties ultimately protect individual rights.

A recurring theme, however, is that HIPAA provides components for fundamental privacy rights and advocacy that must remain protected and unscathed while still balancing the need to deliver palpable health care to society at large. Simply put, portability of insurance, patient access, protection, and accountability! Admittedly, HIPAA can be a misunderstood body of law; to understand it, it is important to discover the basic tenets of HIPAA so that you can then help others to understand and appreciate its intent. It is also Kathleen Fraser, RN-BC, MSN, MHA, CCM, CRRN, FAAN, is the Owner/CEO/President of Fraser Imagineers and is a former Executive Director of CMSA. When the pandemic struck, Kathleen enrolled in law school and developed a passion for HIPAA. Although she knew that providers fear and resent the regulations and realized that the interplay of HIPAA with COVID-19 would make it worse, she wanted to demonstrate the true beauty of the laws for the patients and staff of the nation’s healthcare organizations. Kathleen has a jurisprudence degree in Health care Law, Policy and Management.

a daunting body of law encompassing both privacy and security requirements for health care plans, clearing houses, and providers. For the expansion of health care, we must protect, safeguard, and keep confidential the same information that we need to use and disclose. This is no small feat and requires those tasked with the responsibility to know what they know, know what they don’t know, and seek help to successfully manage HIPAA-related obligations. It is imperative to understand the terminology and identify who is responsible for complying with the laws to safeguard personal health care information (PHI).

Covered entities (CEs), also known as “entrusted guardians”, strive to improve on health care standards, practices, and outcomes. Privacy and security are the foundation of the Administrative Simplification Rules that demand the confidentiality, defense, and safety of protected health information (Figure 2). The fundamental goal of the administrative simplification section of the bill was to save money.

It was requested and supported by the health care industry because it standardized electronic transactions and required standard record formats, code sets, and identifiers. The impact of electronic standardization, however, was that it increased risk to the security and privacy of individually identifiable health information. After Congress did not provide legislation defining the privacy and security requirements of HIPAA, the Department of Health and Human Services (DHHS) was required to provide them. The Code of Federal Regulations (CFR) is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. It is divided into 50 titles that represent broad areas subject to federal regulation and will be listed when appropriate in this article.

HIPAA establishes rules that protect and secure patient health information, but what exactly is it and why should we care? It is the analysis, acquirement, and protection of medical information. However, to properly analyze, acquire, and protect valuable individually identifiable health information, it must be followed by health care providers. Covered health information includes electronic records, paper records, fax documents, and oral communication. Information that is not “individually identifiable” or cannot be linked to a specific June/July 2022 CareManagement 17

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HIPAA gives people the right to receive and review their health records and to choose with whom their health care providers and health insurance companies share their information (including friends, family members, and caregivers). The law also includes standards for setting up and maintaining secure electronic health records.

person is not covered 45 CFR §160.103. A major goal of the Privacy Rule is, of course, to guarantee the protection of individuals’ health information and allow health information to flow as needed while still promoting high-quality health care and protecting the public’s health and well-being. CEs and BAs (business associates) mut ensure the confidentiality, integrity, and availability of all electronic protected health information. BAs are actuaries, accountants, practice management services, lawyers, and cloud service providers. The Privacy Rule requires the CE to obtain a written agreement/ contract from the BA assuring the PHI it receives or creates on behalf of the CE is protected 45 CFR § 164.502(e), 164.504(e), 164.532(d) and (e).

The National Provider Identifier (NPI) Standard is a HIPAA Administrative Simplification Standard. The NPI is a unique single identification number for covered health care providers issued by the federal government to health care providers. Covered health care providers and all health plans and health care clearinghouses must use the NPIs in the administrative and financial transactions adopted under HIPAA. The NPI is a 10-position, intelligence-free numeric identifier (10-digit number). This means that the numbers do not carry other information about health care providers, such as the state in which they live or their medical specialty.

The NPI must be used in lieu of legacy provider identifiers in the HIPAA standards transactions. As outlined in the Federal Regulations, HIPAA-covered providers must also share their NPI with other providers, health plans, clearinghouses, and any entity that may need it for billing purposes. The purpose of a an NPI is to improve the efficiency of the health care system and to help reduce fraud and abuse.

HIPAA transactions and code set standards are rules to standardize the electronic exchange of patient-identifiable health-related information. They are based on electronic data interchange standards, which allow the electronic exchange of information from computer to computer without human involvement. Before the passage of HIPAA in 1996, Congress determined that to improve the efficiency and effectiveness of the health care system and decrease administrative burdens on providers (i.e., medical practices, hospitals, and health care plans), it was necessary to have national standards for the electronic exchange of health 18 CareManagement June/July 2022

care transactions. These standards apply to nine types of administrative and financial health care transactions used by payers, physicians, and other providers, including claims submission, claims status reporting, referral certification and authorization, and coordination of benefits.

CEs may not use or disclose PHI except as permitted under the privacy rule, as authorized in writing by the individual who is the owner of the individually identifiable health information or the individual’s personal representative 45 C.F.R. § 164.502(a). CEs are permitted to use PHI without authorization for treatment, payment, and health care operations, for public interest and benefit activities, and for a limited data set for research, public health, or health care operations 45 C.F.R. § 164.506(c). CEs need written authorization to use or disclose psychotherapy notes except if the CE who originally created the notes uses them for treatment, their own training, or for legal proceedings by the individual who is the subject matter of the notes, or if the public safety or health is in question, or by a health oversight FIGURE 2

PROTECTED HEALTH INFORMATION

• Name • Address • Phone number(s) • Email address(es) • Social Security number • Birthdate • Medical record number • Health plan ID • Account number • Certificate/license number(s) • Device number • Vehicle number • URL • Driver’s license number • IP address • Biometric identifier including fingerprints and full face photo

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HIPAA Health Insurance Portability and Accountability Act of 1996

TITLE I

TITLE II

TITLE III

TITLE I

agency and as required by law 45 C.F.R. § 164.508(a)(2). or loss. Have administrative policies and procedures Health Care “Minimum Necessary” is critical with following HIPAA Preventing designed toMedical clearly show how the entity will comply with Group Tax-related Access, Health Care Administrative guidelines. Take reasonable efforts to use, disclose, and/or the act.

Physical safeguards need controls of physical access Liability P Health Health Portability and Fraud and Simplification Reforminappropriate access to protected Requirem Provision request only the amount of PHI needed (minimum necessary) Abuseto protect against data.

Renewability to accomplish the task at hand. Create minimum necessary Technical safeguards need controls of access to computer policies and procedures noting exceptions for treatment, an systems enabling CEs to protect communications containing individual or their representative, and authorization and comPHI transmitted electronically over open networks from pliance required by HIPAA. CEs must create policies and probeing intercepted by anyone other than the intended recipiElectronic Data Information Technology for Economic and cedures that restrict access and use of PHI based on the roles ent.

The Health Secu Privacy Interchange of the workforce in question. Policies and procedures must be Clinical Health Act includes enforcement, notification •ofSecurity a Standar set up to identify who in each workforce group needs access to breach, electronic health record access, BAs, and business • Administrative Sa PHI to carry out their duties and to define categories of PHI associate agreements and other requirements for marketing • Technical Safegu that each workforce group needs to carry out their duties. communications, restrictions, and accounting.

• Physical Safegua Patients have the right to receive Notice ofTransactions Privacy Entrusted guardian organizations must have written Identifiers Code Sets • Organizational R Practices, which is a document defining how health care propolicies and procedures that are consistent with HIPAA • Policies and Proc viders protect patient privacy. Providers and plans must also regulations. They must also have a specific person assigned Documentation be responsive to patients when they ask for access to their to ensuring that protected information is kept private •and health records, changes to their protected health informasecure. This person is responsible for training other employtion, provider-patient communications, and records of disees regarding the guidelines set forth by HIPAA, ensuring closure. A CE must disclose PHI when the individual or their that all regulations are followed, and disciplining employrepresentative makes a request and there is a compliance ees who do not comply. Specifically, CEs must ensure the procedure 45C.F.R. § 164.502(a) (2) (Figure 3). confidentiality, integrity, and availability of ePHI that they Reasonable Reliance comes into play if a CE makes a create, receive, maintain, or transmit; identify and protect request, and then the entity responding to the request may against reasonably anticipated threats to the security or rely on the request for PHI as being the minimum necessary to accomplish the intended purpose of the disclosure. What a FIGURE 3 DETERMINING IF YOU ARE A COVERED ENTITY prudent person would believe and act upon if told something by another. This is also true if the request comes from a pubDoes the person, lic official, a professional, or a researcher. Complex organizabusiness, or agency NO, not a tions can be a CE and have multiple covered functions. Each furnish, bill, or receive NO covered different covered function must operate under the applicable payment for health provider care in the normal privacy rules related to that function, although the CE must course of buiness? still safeguard PHI if an individual receives services from one covered function but does not receive services from another.

The Security Rule requires CEs to maintain reasonable and YES appropriate administrative, technical, and physical safeguards for protecting electronic PHI (ePHI). Keep data under lock and key! Ensure the confidentiality, integrity, and availability of all Does the person, ePHI they create, receive, maintain, or transmit. Identify and business, or agency NO, not a transmit (send) any protect against reasonably anticipated threats to the security or NO covered covered transactions provider integrity of the information. Protect against impermissible uses electronically? or disclosures, ensure compliance by their workforce including the confidentiality and availability of all ePHI they create, receive, maintain, or transmit 45 CFR § 164.306 and 164.308.

YES Protective measures are created to protect ePHI in accordance with the HIPAA Security Rules and comply with the National Institute of Standards and Technology.

YES, is a Store encryption data tools separately/away from covered encrypted data, and always destroy media properly while provider controlling access and safeguarding information from inappropriate disclosure or accidental or intentional destruction June/July 2022 CareManagement 19

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A major goal of the Privacy Rule is to guarantee the protection of individuals’ health information and allow health information to flow as needed while still promoting high-quality health care and protecting the public’s health and well-being.

integrity of the information; protect against reasonably anticipated, impermissible uses or disclosures; and ensure compliance by their workforce.

Compliance with the Privacy Rule outlines a CE may disclose PHI to facilitate treatment, payment, or health care operations without a patient’s express written authorization.

Any other disclosures of PHI require the CE to obtain written authorization from the individual for the disclosure.

When a CE discloses any PHI, it must make a reasonable effort to disclose only the minimum necessary information required to achieve its purpose. Most important is the right of the client under HIPAA listing their right of access, amendment of information, written notice of privacy practices, accounting of PHI disclosures, the ability to file a complaint, personal representatives and PHI and authorized disclosures of PHI. CEs, however, are prohibited from the four actions of reidentifying or attempting to reidentify an individual, using PHI for marketing communications, selling PHI, or electronically disclosing PHI without notice.

CEs violating these rules are vulnerable to injunctive relief restraints. Injunctive relief, also known as an injunction, is a remedy that restrains a party from doing certain acts or requires a party to act in a certain way. It is generally only available when there is no other remedy of law and irreparable harm will result if the relief is not granted. Disciplinary action can include civil penalties, revoking an agency’s license, and/or probational suspension.

The expanded definition of CEs includes health care providers who transmit electronic PHI, health care

FIGURE 4

clearinghouses, and health care plans (Figure 4). The Privacy Rule standards apply to only the health plans, health care clearinghouses, and health care providers who transmit any health information electronically in connection with certain transactions. These “covered entities” under HIPAA include any person who engages in, for example, the practice of assembling, collecting, analyzing, using, evaluating, storing, or transmitting PHI. There are HIPAA noncovered entities, on the other hand, in which many organizations that have health information about an individual do not have to follow the Privacy Rule. Examples include life insurers, employers, workers’ compensation carriers, many schools and school districts, lawyers with client medical records, many state agencies, child protective service agencies, many law enforcement agencies, and many municipal offices.

The Privacy Rule requires that a CE obtain written assurances from its BA and that the BA will safeguard the PHI it receives or creates on behalf of the CE. The writing is to be a contract or other agreement between the CE and the BA. When disclosures require authorization by a provider, authorization must be obtained to give an individual’s information to their employer, use or share information for marketing or advertising purposes, and share private notes about an individual’s mental health counseling sessions. Nondisclosures of PHI protect any information that could confirm the identity of a patient unless the patient gives express consent to share information, and the nondisclosure rule restricts the transmission of patient information. This includes medical conditions, provision of health care, and payments of health care

COVERED ENTITIES INCLUDE HEALTH CARE PROVIDERS, HEALTH PLANS, AND HEALTH CARE CLEARINGHOUSES

A Health Care Provider

A Health Plan

A Health Care Clearinghouse

This includes providers such as:

This includes:

This includes entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content) or vice versa.

• Doctors

• Health insurance companies

• Clinics

• HMOs

• Psychologists

• Company health plans

• Dentists

• G overnment programs that pay for health care, such as Medicare, Medicaid, and the military and veterans health care programs

• Chiropractors • Nursing Homes • Pharmacies

20 CareManagement June/July 2022

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FIGURE 5

WHEN IS STATE LAW “MORE STRINGENT” THAN HIPAA?

A state law is “more stringent” than HIPAA when the state law: • gives a person greater rights to see, copy, or amend his or her own health information • prohibits or restricts a disclosure that would be allowed under HIPAA • narrows the scope or duration of an authorization, reduces the coercive effect of the circumstances surrounding an authorization, or increases the privacy protections afforded by authorization • requires more detailed record keeping for a longer duration • provides greater privacy protection for the person who is the subject of the individually identifiable health information

but does not apply to releases for organ donation, medical research, judicial proceedings, or requirements by law.

Who enforces the health information privacy and security standards established under the HIPAA? The HIPAA Privacy and Security Rules are enforced by the Office for Civil Rights.

HIPAA sets the federal standards for privacy protections of individually identifiable health information, which is a subset of health information; as the name suggests, it is health information that can be linked to a specific person or if it would be reasonable to believe that an individual could be identified from the information. So, when does HIPAA preempt state law and when does it not (Figure 5)? HIPPA preempts state law... until it doesn’t! HIPAA enforcement takes place in both the federal government and state government Office for Civil Rights, which receives and investigates HIPAA complaints and issues penalties and fines. Enforcement action can be taken with respect to any of the HIPAA rules.

Preemption under HIPAA is the interaction between state law and HIPAA and is complicated. In general, HIPAA preempts state law that is “contrary” to the federal rule. A provision of state law is contrary to HIPAA if a CE would find it impossible to comply with both the state and federal law provisions and the provision of state law would be an obstacle to the accomplishment and execution of the goals of HIPAA. Of course, there are several exceptions to this general rule.

First, HIPAA does not preempt most state laws that relate to public health. HIPAA also preserves certain state laws related to the oversight of health plans.

A contrary state law provision is not preempted if it relates to the privacy of individually identifiable health information and is “more stringent” than HIPAA. The simple rule of thumb is that any HIPAA provision—in state or federal laws—that gives greater protection to patients’ privacy or

right to access their own health information takes precedence. The CE must determine what law (i.e., federal or state) governs when and apply them appropriately.

Congratulations, you have made it through the tedious areas of the rules of HIPAA. Part 2 of this article, which will be published in the next issue of CareManagement, will discuss “How to Create a Compliance Committee” and provide the 7 elements of implementing a successful program. The Breach Notification Rule and The Enforcement Rule with all of the compliance and penalty aspects will be addressed.

Also, the latest updates/decisions of DHHS and Office for Civil Rights and their waive of penalties in cases of good faith while using telehealth during the nationwide COVID-19 public health emergency will be discussed. Stay tuned for “HIPAA Part 2: “Is it a Breach or Disclosure?” in the next issue of CareManagement! CE II

CE exams may be taken online!

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Members only benefit! This exam expires December 15, 2022.

Take this exam online > Members who prefer to print and mail exams, click here. You must be an ACCM member to take the exam, click here to join ACCM.

References Administrative Simplification Overview (3/26/2021), https://www.cms.gov/ Regulations-and-Guidance/Administrative-Simplification/hipaa-aca Breach Notification, HIPAA Enforcement, and Other Laws and Requirements (4/9/2019), https://www.healthit.gov/sites/default/files/pdf/ privacy/privacy-and-security-guide.pdf Breach Notification Rule (10/1/2011-2021), https://www.hhs.gov/hipaa/ for-professionals/breach-notification/index.html Federal Register (11/21/2008-2021), https://www.govinfo.gov/content/ pkg/FR-2008-11-21/pdf/E8-27475.pdf HIPAA Privacy and Security in the Workplace During the COVID-19 Pandemic 3/17/2020), https://www.hhs.gov/sites/default/files/ocr/privacy/ hipaa/administrative/combined/hipaa-simplification-201303.pdf Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524 (1/23/2020), https://www.hhs.gov/hipaa/for-individuals/ guidance-materials-for-consumers/index.html National Provider Identifier (NPI) (12/21/2021), https://nppes.cms.hhs.gov/ Relias Media. Discharge Planning Advisor: Independent CMs face greater HIPAA challenge. https://www.reliasmedia.com/articles/26811-discharge-planning-advisor-independent-cms-face-greater-hipaa-challenge What the HIPAA Transactions and Code Set Standard Mean for Your Practice (12/08/2001-2021), https://www.aafp.org/fpm/2001/1100/p28.html June/July 2022 CareManagement 21

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The Post-COVID Pathway to Resilience in Case Managers Rajitha Bommakanti, RN, CCM

L

iving through a global pandemic has transformed many of our lives. The pandemic has given us more time to think, and we have learned different ways of living, thinking, working, and appreciating things. It gave us time to step back and take a different view about what is unfolding to spur us on towards a better and a brighter future.

We live in an era where we have become accustomed to a life of convenience. We have endless industries that support our luxurious lifestyles. We never stopped to think if this is sustainable. Our planet is our home, but it is a finite resource that we conveniently forgot. Nature has the capability to balance by self-regulation, self-sustainment, and by consolidating resources. But when humans interfere with nature, the systems get disrupted and this creates conditions for the emergence of new pathogens. As humans are invading tropical forests and other wild landscapes that harbor many animals and plants, the outbreaks of animal-borne and other infectious diseases are occurring. This pandemic has been a knock on the door, warning that we will experience even more such events in the future as the world heats up.

On the other hand, we need to consider if this is one of Mother Nature’s ways of resisting humanity’s assault on her essential life systems. Disrespecting nature has brought the whole world to its knees. This pandemic has been a world-shattering occurrence. Millions of people across the planet were infected, more than 6,000,000 people were killed, and the virus reduced global economic growth.1 What lessons have we learned from the disruption that COVID-19 has caused in our lives? Is coronavirus nature’s warning? Is it nature’s way of telling us that we’ve gone too far and must alter our behavior in case we risk further contamination? What then?

The modified lifestyle of self-isolation and quarantine in the last 2 years have been a shock to many. As the cities around the world were under lockdown and the global economy plummeted, global air pollution decreased. As nature continues to evolve, we must learn from its adaptation and apply that same mentality to our own lives. This pandemic has given us time to reflect, restructure, and rebuild towards a future that asks us to be more conscious than ever. The 22 CareManagement June/July 2022

only way to avert such a catastrophe and assure ourselves that Earth will not become an avenger planet is to be mindful of Mother Nature’s warning and cease the further desecration of essential ecosystems.

The COVID-19 pandemic has helped us to assess which aspects of our current lifestyle are necessary and to determine the positive aspects of changing our habits. We also need to determine why some people get sick while others stay healthy when exposed to COVID-19. In some people the immune system is on overdrive and creates a storm of widespread inflammation of the lungs that damages the tissues in the lungs.

People at highest risk for getting very sick from COVID-19 include those with chronic diseases (eg, diabetes, heart disease, chronic kidney disease, liver disease, and obesity), children, and adults who are older than 65 years old.1 The number one reason that determines the likelihood of having these chronic illnesses is what we eat and what we do not eat; what we eat is more important than our genetic makeup. For most people a healthy lifestyle trumps their genetic makeup.

Research has shown that our food choices can shape our destiny.2 Simple changes in diet and lifestyle may help prevent more than 90% of cases of type 2 diabetes, 80% of cases of coronary heart disease, and 70% of cases of colon cancer.2 Research shows that we have the power to sway the gene expression towards a healthy body. So, what steps can we take right now to decrease our risks of COVID-19 infection?

The type of food we eat plays a substantial role in how we feel physically and mentally and in keeping our immune system in top condition. Removing animal products including meat and dairy from our diet can be helpful in improving our mood, lowering stress, and reducing depression and Rajitha Bommakanti, RN, CCM, has been a nurse for over 30 years in various medical specialties and currently works as an ER case manager. She is a health partner in educating, inspiring, and empowering people to make small changes to their lives to improve their health. She is the founder of the Healthy You Lifestyle Center (www.healthyoucenter.com). You can contact her at healthyoucenter@gmail.com.

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The type of food we eat plays a substantial role in how we feel physically and mentally and in keeping our immune system in top condition. Removing animal products including meat and dairy from our diet can be helpful in improving our mood, lowering stress, and reducing depression and anxiety.

anxiety. Consumption of processed meat increases the risk of colorectal cancer and cardiovascular disease and can even shorten our lifespan.2 By making simple lifestyle changes we can resist pathogens, live a robust life, and have a healthier society. The typical American diet consists of meat, dairy, refined grains, ultraprocessed foods, and alcohol, with relatively limited quantities of fruits, vegetables, whole grains, and beans (Figure 1). This type of dietary pattern alters our gut microbiome, putting us at high risk for inflammation and increased oxidative stress. Alternatively, adhering to dietary patterns that are rich in fruits, vegetables, whole grains, nuts, and legumes can be critical for survival during times of physical injury.

FIGURE 1

THE HEALTHY YOU LIFESTYLE CENTER

Processed, refined, high fat, and sugary foods promote inflammation.

Inflammation leads to anxiety and depression.

Fruits, vegetables, legumes, beans, nuts, and seeds lower inflammation, nourish the gut bacteria, and boost mood.

We can become better prepared for the coming years to protect and improve our health. The backdrop of a global pandemic has given most of us a deep respect for how forces outside of our control can alter our lives. Adopting this mindset will set us up for a successful future. As we are in the process of building healthy societies, we are laying the groundwork for the future generations, showing them the importance of compassion and community during this public health crisis.

The pandemic has touched everyone’s life in some form, directly or indirectly. The frontline workers took a harder hit than the rest of the population. The impact of the pandemic took a toll on healthcare workers and first responders, and their mental and physical health is still being affected. Several studies have shown that the pandemic had a negative impact on the mental health of healthcare workers. The pandemic has proven that even though first responders and other healthcare workers are resilient, they are not immune to the damaging effects of trauma. Thirty-two scientific studies have concluded that the most common mental health disorders in severe epidemics are posttraumatic stress syndrome (PTSS), depression, and anxiety. Female nurses who were in close contact with COVID-19 patients had higher levels of stress, depression, and anxiety compared with their male coworkers.3 A study showed that over 70% of female nurses had depression, anxiety, and insomnia. The results of the study survey showed that female nurses who were caring for COVID-19 patients were concerned about their families, about infection, and about the lack of personal protective equipment.3 During the pandemic, the inadequate resources, overloaded caseloads, and the intensive care units at maximum capacity put an extra burden on healthcare workers. As case complexity increased, the experiences of moral distress heightened among healthcare workers. Moral injury is characterized by experiences of shame, guilt, and disgust along with negative thoughts about oneself, others, or the world.4 Unresolved moral distress ramps up over time, and the symptoms escalate and intensify, compromising clarity and focus and resulting in burnout.5 Healthcare workers had to make difficult decisions while working under pressure and balancing their own physical and mental health, which contributed to the compounding effects of moral injury in healthcare workers during the pandemic.

Moral distress can have physical effects on the health of the healthcare worker; these effects include rapid heart rate, elevated blood pressure, inadequate sleep, indigestion, anger, and frustration, which can lead to disengagement from work and withdrawal from patient care.3 The ongoing stressors can negatively impact the immune response by weakening the defenses, which can allow pathogens to invade. Sustained elevation of the proinflammatory cytokines can give rise to chronic mental and physical diseases.6 Any threat, real or June/July 2022 CareManagement 23

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The pandemic has proven that even though first responders and other healthcare workers are resilient, they are not immune to the damaging effects of trauma. Thirty-two scientific studies have concluded that the most common mental health disorders in severe epidemics are posttraumatic stress syndrome, depression, and anxiety. perceived, can promote inflammation in the body, as our mind cannot differentiate between real or perceived events.

Stress hormones such as cortisol and adrenalin shut down the body’s ability to fight off foreign invaders, which makes the body more susceptible to infections and can suppress the immune system.8 Stress can also indirectly affect the immune system because individuals may use unhealthy behavioral coping strategies (eg, drinking alcohol, poor diet, lack of exercise, and smoking) to reduce stress. Recognizing the signs and symptoms of stressors and learning how to handle stressors can help lower inflammation and burnout. One approach is by regulating the cytokine storm to calm an overactive immune response induced by external environmental stimuli.

Cytokines have both pro- and anti-inflammatory properties. Proinflammatory cytokines are needed for survival and defend against threats from intracellular pathogens; anti-inflammatory cytokines are for growth and regeneration of cells in the body.6 When events happen in life, unconscious memories hide in the subconscious mind and are recorded.7 They can dramatically affect everyday life behavior and emotions. Those hidden memories create a certain level of shock in the mind, which sends distress signals down the nervous system, which in turn tells the endocrine system to increase adrenaline and cortisol; as those levels are increased, our immune system weakens.7 The initial stress isn’t bad, but the low-grade continual brewing of stress is what records in the subconscious mind and becomes hardwired within the brain. Repeated recordings over time will cause destruction, and an overstressed nervous system will in turn cause an overproduction of stress hormones and suppression of immune function. Any type of traumatic memories automatically gets downloaded into subconscious memory through a protein called glutamate that sears synapses together with bonds are hard to dissolve.8 Neuroscience researchers suggest that our visual perception is the ability to perceive our surroundings, which is influenced by dopamine and serotonin production.9 If we perceive love, then the brain releases chemicals that allow us to feel love, happiness, and joy (Figure 2). Chemicals such as dopamine, serotonin, and oxytocin, the “feel-good” reward hormones, are released; these chemicals make one feel giddy and euphoric. But if we are in fear, the brain releases fear hormones like cortisol and adrenaline and puts the sympathetic 24 CareManagement June/July 2022

FIGURE 2

CYCLE OF HAPPINESS

nervous system in overdrive, which interferes with immune system, growth, and maintenance of the body as we prepare to run away from the threat. Our brain is always scanning our environment to protect us from potential threats. The perception in our mind controls the fate of genetics and biology.

When we change the perception in our minds, then we can change the biology. This shows that genes don’t control us, but we control the genes of biology.

According to the Centers for Disease Control and Prevention, case managers and other healthcare workers who experience stress at work might experience job dissatisfaction, depression, sleep problems, headaches, upset stomachs, and other health issues.10 Burnout and moral distress can affect job performance, and case managers might be confronted with ethical dilemmas daily. Lack of resources and staffing shortages since the pandemic has put an extra burden on the physical and emotional health of case managers.

How can we address the root cause of stress and lower inflammation in the body? The human body has an innate ability to heal itself. Our mind, body, and spirit play important roles in the healing process. How can we heal them?

There is no magic pill to lower inflammation and reduce stress, but if we practice the evidence-based tools based on the

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The polyvagal theory is the description of the autonomic nervous system specific to the vagal pathways that are influenced by the central nervous system, regulating the face-heart connection.

The vagus nerve is the longest of the 12 cranial nerves and is the modulator of the gut-brain axis that serves as the highway of information for the parasympathetic nervous system, which calms the nervous system and balances the sympathetic system.

polyvagal theory developed by Stephen Porges on a regular basis, we may be able to regulate the stress experienced by the nervous system and have calming responses throughout the course of the day.

Habits are fueled by the subconscious mind and are beyond our control. The conscious mind is the creative mind that powers the awareness of the environment, emotions, and current thoughts as well as the physical sensations in the body. The subconscious mind cannot reason or think independently; it merely records, pushes a button, and plays back the recording. The subconscious mind does not have a memory bank for storage but can also retrieve data by reprogramming. The subconscious mind can be reprogrammed by using the right techniques and by practicing, repeating, and practicing. If we repeat a behavior over and over and behave that way, then the subconscious mind will learn and program a new behavior.

The polyvagal theory is the description of the autonomic nervous system specific to the vagal pathways that are influenced by the central nervous system, regulating the face-heart connection.12 The vagus nerve is the longest of the 12 cranial nerves and is the modulator of the gut-brain axis that serves as the highway of information for the parasympathetic nervous system, which calms the nervous system and balances the sympathetic system. The vagus nerve, which is the main component of the parasympathetic nervous system, transmits neurotransmitters between the emotional center of the brain and a vast array of bodily functions including mood, immune response, digestion, and heart rate. The brain reads and regulates the body through the vagus nerve, which sends information about the state of the inner organs. The vagus nerve is responsible for internal organ functioning such as digestion, heart rate, breathing, cardiovascular activity, and reflex actions.12 The vagal tone is correlated with the capacity to regulate stress responses and can play a role in the autonomic nervous system, which influences peoples’ unconscious activities such as breathing and digestion, contributing to resilience and the mitigation of mood and anxiety symptoms.

In order to lower inflammation in the body and for the body to heal and rejuvenate at the cellular level, evidence-based polyvagal theory tools can be incorporated.

In polyvagal theory, Dr. Porges discusses three ways of

responding to the environmental stimuli via the autonomic nervous system: social engagement, fight or flight, and freeze.

Vagal nerve toning can be used to lower inflammation, get into a state of safety, improve mental well-being, and heal the trauma-affected nervous system. Our bodies are wired with a built-in stress reliever, the vagus nerve. According to Porges, if a person has a weak vagus nerve, it is hard for them to regulate their emotions. On the contrary, a high vagal tone is associated with emotional stability and resilience. Seven simple techniques can be used to increase the tone of the vagus nerve to calm the nervous system and lower stress.

• Mindful breathing: Extending exhalation longer than inhalation for a period of time activates the parasympathetic nervous system.13 This helps people who are stuck in forms of fight or flight response to move into a state of safety. Slow nasal breathing slows the heart rate, which is recognized as cues of safety, and the vagus nerve sends that information to parts of the body so they can turn off their defenses that arise from threats. Breath moderates the communication between the sympathetic and parasympathetic nervous system and raises the heart rate variability.13 There are several types of breathing; the main points to remember are to breathe through the nose, breathe into the abdomen, short inhalation, hold breath, followed by long exhalation and slow breathing down to 4–12 breaths a minute. Breathing techniques are an efficient and quick way to move away from stress into a calm state. Practicing mindful breathing helps connect a basic physiological process with the prefrontal cortex, which helps integrate and shift the neurological state. Breathing helps calm the brain and regulate the nervous system.

• Singing, humming, gargling: The vagus nerve goes through the vocal cords and the muscles at the back of the throat.13 By singing, humming, and gargling, the vagus nerve gets stimulated. Singing and humming stimulate diaphragmatic breathing, which enhances vagal stimulation. Something as simple as gargling for 10–20 seconds can also stimulate the vagus nerve.

• Meditation: Reduces sympathetic activity and increases the vagal tone through relaxation, enhances positive emotions, and promotes self-love and compassion.13 June/July 2022 CareManagement 25

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Meditation addresses the root cause by trying to fix what is at the depth of oneself; it’s like pulling out the weeds in the garden so that they don’t grow back. The practice of meditation helps one to accept the things that come in life without any judgement. Meditation is like maintenance of the nervous system, which builds resilience to be able handle stressful situations.

• Exercise: Activates the vagus nerve in numerous ways and is beneficial for physical health.13 Exercise not only strengthens our muscles and bones but also helps pump up the production of feel-good hormones and in turn reduces stress. The practice of yoga asanas stimulates the internal organs in turn toning the vagus nerve.

• Social engagement: It is the way we interact with others, how others interact with us, eye contact, posture, tone of voice, how we respond to others, and how others respond to us.13 Is the interaction and response with love and caring or is it with fear and anxiety? Depending on the situation, the vagus nerve will send messages whether to activate or deactivate. When a person gets rid of a threat, they become calm and are more present, allowing the body to regulate and heal and to optimize the functioning of the body.

• Compassion: Being compassionate to oneself and others is a physiological state where a person is not sending cues of anger, threat, or hurt but is a peaceful and supportive observer.13 Porges calls this coregulation, which helps the nervous system of the person who has been hurt to feel calm and safe without being defensive. It is a beautiful feeling to fall in love and stay there, but when one feels disgust, an individual cannot stay in the space of love.

To stay in the experience of love, one needs to practice self-compassion. To be compassionate towards others, one needs to grow in compassion for self. Self-compassion is treating oneself with the same kindness and understanding as one would treat a dear friend who is suffering. When case managers are confronted with really difficult situations such as emotional overflow, they need to actively practice compassion and self-compassion.

• Laugh: A good laugh stimulates diaphragmatic breathing, which activates the vagal nerve.13 It is a playful spirit that connects to the social engagement system.

Case managers can discharge the traumatic stress and transition back into the window of the regulated nervous system by practicing 1-2 of the above techniques 3-5 times a day. Most only take a few minutes, and the investment of time will pay off in greater concentration, better resilience, and an improved sense of well-being. Build the habit slowly and be consistent with the practice. When individuals are relaxed, their vagal tone will naturally be high; when they are under pressure, the effectiveness shuts down. While the tone of the vagus nerve directly affects one’s well-being and the capacity 26 CareManagement June/July 2022

Exclusively for ACCM Members

to self-regulate and to connect with others, it is important to remember that one’s ability to handle stress is tied to the brain and the reactions to the pressures of everyday life. It’s all about how one perceives the world around them and the way they react or respond. When individuals experience their environment as safe and being with someone who is safe, this will help the nervous system settle down and create a space to connect and share experiences. These individuals operate from the social engagement system.

Building resilience is a journey that case managers must take one step at a time; with the right tools, the journey becomes easier, and they will learn to stay safe. Recognizing when one is outside their own window of tolerance and building personal strategies to soothe or stimulate the system is key to regulating in an ongoing way. By taking proper care of themselves, case managers will be able to ensure that their clients get their very best. CE III

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References 1. Cuschieri S, Grech S (2020). Obesity population at risk of COVID19 complications. Global Health, Epidemiology and Genomics 5, e6, 1–6. https://doi.org/ 10.1017/gheg.2020.6 2. Kahleova, H., Barnard, N.D. (2022). Can a plant-based diet help mitigate Covid-19? European Journal of Clinical Nutrition. https://doi. org/10.1038/s41430-022-01082-w 3. De Kock, J.H., Latham, H.A., Leslie, S.J. et al. (2021). A rapid review of the impact of COVID-19 on the mental health of healthcare workers: implications for supporting psychological well-being. BMC Public Health, 21, 104. https://doi.org/10.1186/s12889020-10070-3 4. Greenberg, N., Docherty, M., Gnanapragasam, S., & Wessely, S. (2020). Managing mental health challenges faced by healthcare workers during covid-19 pandemic. British Medical Journal, 368, Article m1211. https://doi.org/10.1136/bmj.m1211 5. Litam, S. D. A., & Balkin, R. S. (2020). Moral injury in health-care workers during COVID-19 pandemic. Traumatology. Advance online publication. http://dx.doi.org/10.1037/trm0000290 6. Rumende CM, Susanto EC, Sitorus TP. (2020). The management of cytokine storm in COVID-19. Acta Medica Indonesiana. 52(3):306-313.

References continued on page 37

PharmaFacts for Case Managers Alymsys® (bevacizumab-maly) INDICATIONS AND USAGE Metastatic Colorectal Cancer Alymsys, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC).

Alymsys, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.

Limitations of Use: Alymsys is not indicated for adjuvant treatment of colon cancer.

First-Line Non-Squamous Non–Small Cell Lung Cancer Alymsys, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).

administer Alymsys until at least 28 days following major surgery and until adequate wound healing.

Metastatic Colorectal Cancer The recommended dosage when Alymsys is administered in combination with intravenous fluorouracil-based chemotherapy is: • 5 mg/kg intravenously every 2 weeks in combination with bolus-IFL. • 10 mg/kg intravenously every 2 weeks in combination with FOLFOX4.

• 5 mg/kg intravenously every 2 weeks or 7.5 mg/ kg intravenously every 3 weeks in combination with fluoropyrimidine-irinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy in patients who have progressed on a first-line bevacizumab product-containing regimen.

First-Line Non-Squamous Non-Small Cell Lung Cancer The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel.

Recurrent Glioblastoma Alymsys is indicated for the treatment of recurrent glioblastoma (GBM) in adults.

Recurrent Glioblastoma The recommended dosage is 10 mg/kg intravenously every 2 weeks.

Metastatic Renal Cell Carcinoma Alymsys, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).

Metastatic Renal Cell Carcinoma The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with interferon alfa.

Persistent, Recurrent, or Metastatic Cervical Cancer Alymsys, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.

Persistent, Recurrent, or Metastatic Cervical Cancer The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Alymsys, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Recurrent Disease Platinum Resistant The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week).

The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with topotecan (every 3 weeks).

DOSING INFORMATION Important Administration Information Withhold for at least 28 days prior to elective surgery. Do not

DOSAGE FORMS AND STRENGTHS Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL June/July 2022 CareManagement 27

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(25 mg/mL) clear to slightly opalescent, colorless to pale brown solution in a single-dose vial.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Gastrointestinal Perforations and Fistulae Serious, and sometimes fatal, gastrointestinal perforation occurred at a higher incidence in patients receiving bevacizumab products compared to patients receiving chemotherapy.

The incidence ranged from 0.3% to 3% across clinical studies, with the highest incidence in patients with a history of prior pelvic radiation. Perforation can be complicated by intra-abdominal abscess, fistula formation, and the need for diverting ostomies. The majority of perforations occurred within 50 days of the first dose.

Serious fistulae (including tracheoesophageal, bronchopleural, biliary, vaginal, renal and bladder sites) occurred at a higher incidence in patients receiving bevacizumab products compared to patients receiving chemotherapy. The incidence ranged from < 1% to 1.8% across clinical studies, with the highest incidence in patients with cervical cancer. The majority of fistulae occurred within 6 months of the first dose. Patients who develop a gastrointestinal vaginal fistula may also have a bowel obstruction and require surgical intervention, as well as a diverting ostomy.

Avoid Alymsys in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. Discontinue in patients who develop gastrointestinal perforation, tracheoesophageal fistula or any Grade 4 fistula. Discontinue in patients with fistula formation involving any internal organ.

Surgery and Wound Healing Complications In a controlled clinical study in which bevacizumab was not administered within 28 days of major surgical procedures, the incidence of wound healing complications, including serious and fatal complications, was 15% in patients with mCRC who underwent surgery while receiving bevacizumab and 4% in patients who did not receive bevacizumab. In a controlled clinical study in patients with relapsed or recurrent GBM, the incidence of wound healing events was 5% in patients who received bevacizumab and 0.7% in patients who did not receive bevacizumab.

In patients who experience wound healing complications during Alymsys treatment, withhold Alymsys until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days following major surgery and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established.

Necrotizing fasciitis, including fatal cases, has been 28 CareManagement June/July 2022

reported in patients receiving bevacizumab, usually secondary to wound healing complications, gastrointestinal perforation, or fistula formation. Discontinue Alymsys in patients who develop necrotizing fasciitis.

Hemorrhage Bevacizumab products can result in two distinct patterns of bleeding: minor hemorrhage, which is most commonly Grade 1 epistaxis, and serious hemorrhage, which in some cases has been fatal. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving bevacizumab compared to patients receiving chemotherapy alone. Across clinical studies, the incidence of Grades 3 to 5 hemorrhagic events ranged from 0.4% to 7% in patients receiving bevacizumab.

Serious or fatal pulmonary hemorrhage occurred in 31% of patients with squamous NSCLC and 4% of patients with non-squamous NSCLC receiving bevacizumab with chemotherapy compared to none of the patients receiving chemotherapy alone.

Do not administer Alymsys to patients with recent history of hemoptysis of 1/2 teaspoon or more of red blood. Discontinue in patients who develop a Grades 3 to 4 hemorrhage.

Arterial Thromboembolic Events Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, and angina, occurred at a higher incidence in patients receiving bevacizumab compared to patients receiving chemotherapy. Across clinical studies, the incidence of Grades 3–5 ATE was 5% in patients receiving bevacizumab with chemotherapy compared to ≤2% in patients receiving chemotherapy alone; the highest incidence occurred in patients with GBM. The risk of developing ATE was increased in patients with a history of arterial thromboembolism, diabetes, or >65 years.

Discontinue in patients who develop a severe ATE. The safety of reinitiating bevacizumab products after an ATE is resolved is not known.

Venous Thromboembolic Events An increased risk of venous thromboembolic events (VTE) was observed across clinical studies. In Study GOG-0240, Grades 3 to 4 VTE occurred in 11% of patients receiving bevacizumab with chemotherapy compared with 5% of patients receiving chemotherapy alone. In EORTC 26101, the incidence of Grades 3 to 4 VTE was 5% in patients receiving bevacizumab with chemotherapy compared to 2% in patients receiving chemotherapy alone.

Discontinue Alymsys in patients with a Grade 4 VTE, including pulmonary embolism.

PharmaFacts for Case Managers Hypertension Severe hypertension occurred at a higher incidence in patients receiving bevacizumab products as compared to patients receiving chemotherapy alone. Across clinical studies, the incidence of Grades 3 - 4 hypertension ranged from 5% to 18%.

Monitor blood pressure every two to three weeks during treatment with Alymsys. Treat with appropriate anti-hypertensive therapy and monitor blood pressure regularly.

Continue to monitor blood pressure at regular intervals in patients with Alymsys-induced or -exacerbated hypertension after discontinuing Alymsys. Withhold Alymsys in patients with severe hypertension that is not controlled with medical management; resume once controlled with medical management. Discontinue in patients who develop hypertensive crisis or hypertensive encephalopathy.

Posterior Reversible Encephalopathy Syndrome Posterior reversible encephalopathy syndrome (PRES) was reported in <0.5% of patients across clinical studies. The onset of symptoms occurred from 16 hours to 1 year after the first dose. PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present. Magnetic resonance imaging is necessary to confirm the diagnosis of PRES. Discontinue Alymsys in patients who develop PRES. Symptoms usually resolve or improve within days after discontinuing bevacizumab products, although some patients have experienced ongoing neurologic sequelae. The safety of reinitiating bevacizumab products in patients who developed PRES is not known.

Renal Injury and Proteinuria The incidence and severity of proteinuria was higher in patients receiving bevacizumab as compared to patients receiving chemotherapy. Grade 3 (defined as urine dipstick 4+ or > 3.5 grams of protein per 24 hours) to Grade 4 (defined as nephrotic syndrome) ranged from 0.7% to 7% in clinical studies. The overall incidence of proteinuria (all grades) was only adequately assessed in Study BO17705, in which the incidence was 20%. Median onset of proteinuria was 5.6 months (15 days to 37 months) after initiating bevacizumab. Median time to resolution was 6.1 months (95% CI: 2.8, 11.3). Proteinuria did not resolve in 40% of patients after median follow-up of 11.2 months and required discontinuation of bevacizumab in 30% of the patients who developed proteinuria.

In an exploratory, pooled analysis of patients from seven randomized clinical studies, 5% of patients receiving bevacizumab with chemotherapy experienced Grades 2 - 4 (defined as urine dipstick 2+ or greater or > 1 gram of protein per 24 hours or nephrotic syndrome) proteinuria. Grades 2 to 4 proteinuria resolved in 74% of patients.

Bevacizumab was reinitiated in 42% of patients. Of the 113 patients who reinitiated bevacizumab, 48% experienced a second episode of Grades 2 to 4 proteinuria.

Nephrotic syndrome occurred in <1% of patients receiving bevacizumab across clinical studies, in some instances with fatal outcome. In a published case series, kidney biopsy of 6 patients with proteinuria showed findings consistent with thrombotic microangiopathy. Results of a retrospective analysis of 5,805 patients who received bevacizumab with chemotherapy and 3,713 patients who received chemotherapy alone, showed higher rates of elevated serum creatinine levels (between 1.5 to 1.9 times baseline levels) in patients who received bevacizumab. Serum creatinine levels did not return to baseline in approximately one-third of patients who received bevacizumab.

Monitor proteinuria by dipstick urine analysis for the development or worsening of proteinuria with serial urinalyses during Alymsys therapy. Patients with a 2+ or greater urine dipstick reading should undergo further assessment with a 24-hour urine collection. Withhold for proteinuria greater than or equal to 2 grams per 24 hours and resume when less than 2 grams per 24 hours. Discontinue in patients who develop nephrotic syndrome.

Data from a postmarketing safety study showed poor correlation between UPCR (Urine Protein/Creatinine Ratio) and 24-hour urine protein [Pearson Correlation 0.39 (95% CI: 0.17, 0.57)].

Infusion-Related Reactions Infusion-related reactions reported across clinical studies and postmarketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis. In clinical studies, infusion-related reactions with the first dose occurred in <3% of patients and severe reactions occurred in 0.4% of patients.

Decrease the rate of infusion for mild, clinically insignificant infusion-related reactions. Interrupt the infusion in patients with clinically significant infusion-related reactions and consider resuming at a slower rate following resolution.

Discontinue in patients who develop a severe infusion-related reaction and administer appropriate medical therapy (e.g., epinephrine, corticosteroids, intravenous antihistamines, bronchodilators and/or oxygen).

Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal studies, bevacizumab products may cause fetal harm when administered to pregnant women. Congenital malformations were observed with the administration of bevacizumab to pregnant rabbits during organogenesis every 3 days at a dose as low as a clinical dose of 10 mg/kg. Furthermore, animal models June/July 2022 CareManagement 29

PharmaFacts for Case Managers link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Alymsys and for 6 months after the last dose.

Ovarian Failure The incidence of ovarian failure was 34% vs. 2% in premenopausal women receiving bevacizumab with chemotherapy as compared to those receiving chemotherapy alone for adjuvant treatment of a solid tumor. After discontinuing bevacizumab, recovery of ovarian function at all time points during the post-treatment period was demonstrated in 22% of women receiving bevacizumab. Recovery of ovarian function is defined as resumption of menses, a positive serum β-HCG pregnancy test, or an FSH level < 30 mIU/mL during the post-treatment period. Long-term effects of bevacizumab products on fertility are unknown. Inform females of reproductive potential of the risk of ovarian failure prior to initiating Alymsys.

Congestive Heart Failure (CHF) Alymsys is not indicated for use with anthracycline-based chemotherapy. The incidence of Grade ≥ 3 left ventricular dysfunction was 1% in patients receiving bevacizumab compared to 0.6% of patients receiving chemotherapy alone. Among patients who received prior anthracycline treatment, the rate of CHF was 4% for patients receiving bevacizumab with chemotherapy as compared to 0.6% for patients receiving chemotherapy alone.

In previously untreated patients with a hematological malignancy, the incidence of CHF and decline in left ventricular ejection fraction (LVEF) were increased in patients receiving bevacizumab with anthracycline-based chemotherapy compared to patients receiving placebo with the same chemotherapy regimen. The proportion of patients with a decline in LVEF from baseline of ≥ 20% or a decline from baseline of 10% to < 50% was 10% in patients receiving bevacizumab with chemotherapy compared to 5% in patients receiving chemotherapy alone. Time to onset of left-ventricular dysfunction or CHF was 1 to 6 months after the first dose in at least 85% of the patients and was resolved in 62% of the patients who developed CHF in the bevacizumab arm compared to 82% in the placebo arm. Discontinue Alymsys in patients who develop CHF. ADVERSE REACTIONS The clinically significant adverse reactions are described in Warnings and Precautions (see Product Information).

USE IN SPECIFIC POPULATIONS Pregnancy Based on findings from animal studies and their mechanism of action, bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases 30 CareManagement June/July 2022

of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks. In animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects. Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryofetal development, and postnatal development.

Advise pregnant women of the potential risk to a fetus.

Lactation No data are available regarding the presence of bevacizumab products in human milk, the effects on the breast fed infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential for serious adverse reactions in breastfed infants from bevacizumab products, advise women not to breastfeed during treatment with Alymsys and for 6 months after the last dose.

Females and Males of Reproductive Potential Contraception Females Bevacizumab products may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Alymsys and for 6 months after the last dose.

Infertility Females Bevacizumab products increase the risk of ovarian failure and may impair fertility. Inform females of reproductive potential of the risk of ovarian failure prior to the first-dose of Alymsys.

Long-term effects of bevacizumab products on fertility are not known.

In a clinical study of 179 premenopausal women randomized to receive chemotherapy with or without bevacizumab, the incidence of ovarian failure was higher in patients who received bevacizumab with chemotherapy (34%) compared to patients who received chemotherapy alone (2%). After discontinuing bevacizumab with chemotherapy, recovery of ovarian function occurred in 22% of these patients

Pediatric Use The safety and effectiveness of bevacizumab products in pediatric patients have not been established.

In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age continues on page 37

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LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to case managers in an easy-to-read format. Each abstract includes information to locate the full-text article if there is an interest. This member benefit is designed to assist case managers in keeping current with clinical breakthroughs in a time-effective manner.

AIDS. 2022 Apr 20. doi: 10.1097/QAD.0000000000003229.

AIDS Res Hum Retroviruses. 2022 Apr 22. doi: 10.1089/ AID.2021.0178. Online ahead of print.

Coordination of inflammatory responses in children with perinatally-acquired HIV infection

A heavy burden: preexisting physical and psychiatric comorbidities, and differential increases among male and female participants after initiating antiretroviral therapy in the HIV Outpatient Study, 2008-2018

Online ahead of print.

Weinberg A, Giganti MJ, Sirois PA, et al.

OBJECTIVE: We investigated dynamics of inflammatory biomarkers in children with perinatally-acquired HIV (PHIV) who started antiretrovirals at age <3 years and achieved sustained virologic control (HIV plasma RNA<400 copies/mL).

DESIGN: This was a retrospective analysis of inflammatory biomarkers in children enrolled in a randomized trial of early (<3 years of age) PI-based versus NNRTI-based regimens (P1060), who achieved sustained virologic control and participated in a neurodevelopmental follow-up study (P1104 s) between ages 5-11 years.

METHODS: We measured 20 inflammatory biomarkers using ELISA or chemiluminescence at onset of sustained virologic control (Tc) and at P1104 s entry (Te).

RESULTS: The 213 participants had median ages of 1.2, 1.9, and 7.0 years at antiretroviral initiation, Tc, and Te, respectively, with 138 on PI-based and 74 on NNRTI-based regimens at Tc. Eighteen markers decreased and two increased from Tc to Te (TeTc). Biomarker subsets, particularly cytokines, the chemokine IP-10, and adhesion molecules sICAM-1 and sVCAM-1, correlated at Tc, Te, and Te-Tc. At Tc, higher biomarker levels were associated with younger age, female sex, HIV plasma RNA ≥750,000 copies/mL, lower nadir CD4+%, lower nadir weight z-scores, and NNRTIbased treatment. Greater Te-Tc biomarker declines were associated with younger age, male sex, higher Tc biomarker levels, lower nadir CD4+%, and NNRTI-based treatment. Duration of controlled viremia and nadir height Z-scores showed mixed associations.

CONCLUSIONS: Biomarker expression showed substantial coordination. Most markers decreased after virologic control.

Demographic and clinical variables associated with biomarker patterns were identified. Mechanistic studies of these biomarker patterns are needed to inform interventions to control inflammation.

Tedaldi EM, Armon C, Li J, et al.

Attention to non-AIDS comorbidities is increasingly important in the HIV care and management in the United States. We sought to assess comorbidities before and after antiretroviral therapy (ART) initiation among persons with HIV (PWH). Using the 20082018 HIV Outpatient Study (HOPS) data, we assessed changes in prevalence of physical and psychiatric comorbidities, by sex, among participants initiating ART. Cox proportional hazards models were fit to investigate factors associated with the first documented occurrence of key comorbidities, adjusting for demographics and other covariates including insurance type, CD4+ cell count, ART regimen and smoking status. Among 1,236 participants who initiated ART (median age 36 years, CD4 cell count 375 cells/ mm3), 79% were male, 66% non-white, 44% publicly-insured, 53% ever smoked, 33% had substance use history, and 22% had body mass index ≥ 30 kg/m2. Among females, the percentages with at least one condition were: at ART start, 72% had a physical and 42% a psychiatric comorbidity, and after a median of 6.1 years of follow-up, these were 87% and 63%, respectively. Among males, the percentages with at least one condition were: at ART start, 61% had a physical and 32% a psychiatric comorbidity, and after a median of 4.6 years of follow-up, these were 82% and 53%, respectively.

In multivariable Cox proportional hazards analyses, increasing age and higher viral loads were associated with most physical comorbidities, and being a current/former smoker and higher viral loads were associated with all psychiatric comorbidities analyzed.

HOPS participants already had a substantial burden of physical and psychiatric comorbidities at the time of ART initiation. With June/July 2022 CareManagement 31

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advancing age, PWH who initiate ART experience a clinically significant increase in the burden of chronic non-HIV comorbidities that warrants continued surveillance, prevention, and treatment.

J Infect Dis. 2022 Apr 28;jiac156. doi: 10.1093/infdis/ jiac156. Online ahead of print.

Machine learning quantifies accelerated whitematter aging in persons with HIV Petersen KJ, Strain J, Cooley S, et al.

BACKGROUND: Persons with HIV (PWH) undergo white matter changes which can be quantified using the brain age gap (BAG), the difference between chronological age and neuroimaging-based ‘brain-predicted age.’ Accumulation of microstructural damage may be accelerated in PWH, especially with detectable viral load (VL).

METHODS: 290 PWH (85% with undetectable VL) and 165 HIV-negative controls participated in neuroimaging and cognitive testing. BAG was measured using a Gaussian process regression model trained to predict age from diffusion MRI in publicly available normative controls. To test for accelerated aging, BAG was modeled as an age×VL interaction. The relationship between BAG and global neuropsychological performance was examined. Other potential predictors of pathological aging were investigated in an exploratory analysis.

RESULTS: Age and detectable VL had a significant interactive effect: PWH with detectable VL accumulated +1.5 years BAG/ decade vs. HIV-negative controls (p = 0.018). PWH with undetectable VL accumulated +0.86 years BAG/decade, though this did not reach statistical significance (p = 0.052). BAG was associated with poorer global cognition only in PWH with detectable VL (p < 0.001). Exploratory analysis identified Framingham cardiovascular risk as an additional predictor of pathological aging (p = 0.027).

CONCLUSIONS: Aging with detectable HIV and cardiovascular disease may lead to white matter pathology and contribute to cognitive impairment.

Infect Control Hosp Epidemiol. 2022 Apr 19;1-17. doi: 10.1017/

ice.2021.510. Online ahead of print.

Hospital-acquired COVID-19 among patients of two acute-care hospitals: implications for surveillance Trick WE, Santos CAQ, Welbel S, et al.

OBJECTIVES: We quantified hospital-acquired COVID-19 during the early phases of the pandemic, and we evaluated solely temporal determinations of hospital acquisition.

32 CareManagement June/July 2022

DESIGN: Retrospective observational study during early phases of the COVID-19 pandemic, March 1-November 30, 2020. We identified laboratory-detected SARS-CoV-2 from 30 days before admission through discharge. All episodes detected after hospital day 5 were categorized by chart review as community or unlikely hospital-acquired, or possible or probable hospital-acquired.

SETTING: Two acute-care hospitals in Chicago, IL. PATIENTS: All hospitalized patients including an inpatient rehabilitation unit.

INTERVENTIONS: Each hospital implemented infection-control precautions soon after identifying COVID-19 cases, including patient- and staff-cohorting, universal masking, and restricted visitation policies.

RESULTS: Among 2,667 patients with SARS-CoV-2, detection before hospital day six was most common (n=2,612; 98%); days 6-14 uncommon (n=43; 1.6%); and, after day 14, rare (n=16; 0.6%). By chart review, most episodes after day 5 were categorized as community-acquired, usually because SARS-CoV-2 had been detected at a prior healthcare facility (68% of cases on days 6-14; 53% of cases after day 14). Incidence for possible and probable hospital-acquired cases, per 10,000 patient-days, was similar for ICU- and non-ICU patients at Hospitals A (1.2 vs 1.3, difference = 0.1; 95% CI, -2.8 to 3.0) and B (2.8 vs 1.2, difference = 1.6; 95% CI, -0.1 to 4.0).

CONCLUSIONS: Most patients were protected by early and sustained application of infection-control precautions, modified to reduce COVID-19 transmission. Using solely temporal criteria to discriminate hospital- vs community-acquisition would have misclassified many “late-onset” SARS-CoV-2 positive episodes.

PLoS One. 2022 Apr 28;17(4):e0267512. doi: 10.1371/journal. pone.0267512. eCollection 2022.

Transient elastography score is elevated during rheumatoid factor-positive chronic hepatitis C virus infection and rheumatoid factor decline is highly variable over the course of direct-acting antiviral therapy Auma AWN, Kowal C, Shive CL, et al.

BACKGROUND: Elevated rheumatoid factor (RF) levels and systemic immune activation are highly prevalent during chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) therapy has been associated with normalization of various soluble immune activation parameters. Whether the RF levels relate to soluble immune activation markers during chronic HCV infection, and over what time frame RF levels normalize during and after DAA treatment is unknown and was investigated here.

METHODS: In a longitudinal study, plasma and serum was

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obtained from HCV infected RF positive (RF+) and RF negative (RF-) participants. The levels of RF, HCV RNA and soluble markers of inflammation were determined before (week 0), during (weeks 4, 8 and 12) and after (week 24) treatment with HCV DAA therapy. In a subset of RF+ participants, the analysis was extended to over 70 weeks after therapy initiation. Hepatic and other clinical parameters were determined at baseline (week 0) in all participants.

RESULTS: Before therapy, transient elastography (TE) score was greater in RF+ compared to RF- HCV infected participants, while the systemic levels of soluble inflammatory markers were comparable. Following DAA therapy initiation, HCV RNA levels became undetectable within 4 weeks in both the RF+ and RF- groups. RF levels declined in the first 6 months in most RF+ persons but most commonly remained positive. The levels of some soluble inflammatory markers declined, mainly within 4 weeks of DAA therapy start, in both the RF+ and RF- groups. The baseline (week 0) TE score correlated with RF levels before, during and after DAA therapy, while plasma IL-18 levels correlated with RF level after DAA therapy.

CONCLUSION: During chronic HCV infection, TE score is elevated in RF+ HCV infected individuals and factors other than HCV viremia (including liver stiffness or fibrosis and select markers of inflammation) likely contribute to persistence of RF after treatment of HCV with DAA.

Am J Cardiol. 2022 Apr 23;S0002-9149(22)00331-9. doi: 10.1016/j. amjcard.2022.03.026. Online ahead of print.

Patient perceptions of exertion and dyspnea with interleukin-1 blockade in patients with recently decompensated systolic heart failure Mihalick V, Wohlford G, Talasaz AH, et al.

Interleukin-1 (IL-1) blockade is an anti-inflammatory treatment that may affect exercise capacity in heart failure (HF). We evaluated patient-reported perceptions of exertion and dyspnea at submaximal exercise during cardiopulmonary exercise testing (CPET) in a double-blind, placebo-controlled, randomized clinical trial of IL-1 blockade in patients with systolic HF (REDHART [Recently Decompensated Heart Failure Anakinra Response Trial]). Patients underwent maximal CPET at baseline, 2, 4, and 12 weeks and rated their perceived level of exertion (RPE, on a scale from 6 to 20) and dyspnea on exertion (DOE, on a scale from 0 to 10) every 3 minutes throughout exercise. Patients also answered 2 questionnaires to assess HF-related quality of life: the Duke Activity Status Index and the Minnesota Living with Heart Failure Questionnaire. From baseline to the 12-week follow-up, IL-1 blockade significantly reduced RPE and DOE at 3- and 6-minutes

during CPET without changing values for heart rate, oxygen consumption, and cardiac workload at 3- and 6-minutes. Linear regression identified 6-minute RPE to be a strong independent predictor of both physical symptoms (Minnesota Living with Heart Failure Questionnaire; β = 0.474, p = 0.002) and perceived exercise capacity (Duke Activity Status Index; β = -0.443, p = 0.008). In conclusion, patient perceptions of exertion and dyspnea at submaximal exercise may be valuable surrogates for quality of life and markers of response to IL-1 blockade in patients with HF.

Cardiol Clin. 2022 May;40(2):183-189. doi: 10.1016/j. ccl.2021.12.006.

Sleep breathing disorders in heart failure Coniglio AC, Mentz RJ. Sleep-disordered breathing (SDB), including obstructive sleep apnea, central sleep apnea (CSA), and Cheyne-Stokes respiration, is common in patients with heart failure (HF) and associated with lower left ventricular ejection fraction (EF), increased arrhythmia burden, and increased mortality. Continuous positive airway pressure therapy improves short-term and long-term outcomes in HF patients. Adaptive servoventilation (ASV) therapy in patients with low-EF HF with predominant CSA is not recommended.

Ongoing trials are evaluating whether ASV will have a role in SDB treatment. Phrenic nerve stimulation is an emerging treatment option that has shown promising outcomes. All HF patients should be screened for SDB.

Ann Thorac Surg. 2022 Apr 14;S0003-4975(22)00516-1. doi: 10.1016/j.athoracsur.2022.03.065. Online ahead of print.

Improvements in extracorporeal membrane oxygenation for primary graft failure after heart transplant Guo A, Kotkar K, Schilling J, et al.

BACKGROUND: Severe primary graft failure is a life-threatening complication of heart transplant that may require veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support.

Surgical practices and management strategies regarding VA-ECMO vary between and within centers.

METHODS: We performed a single center retrospective cohort study on adult patients who received VA-ECMO for primary graft failure between 2013 and 2020. Clinical data were obtained from chart review and national databases. Patients were stratified by transplant before or after 2017, when our center adopted additional objective criteria for VA-ECMO, partial-flow support, and changed June/July 2022 CareManagement 33

F O R

C A S E

M A N A G E R S

from central cannulation to chimney graft arterial cannulation of brachiocephalic, axillary, or aorta. Primary outcome was survival to device weaning. Secondary outcomes were survival to discharge, survival to one year, complications on support, and time to sedation weaning and extubation.

RESULTS: From 276 heart transplant recipients, 39 severe primary graft failure patients requiring VA-ECMO were identified.

Incidence of graft failure was 13% (18/135) pre-2017 and 15% (21/141) post-2017. Survival at all timepoints improved significantly after 2017 with greatest difference in survival to device weaning (61% pre-2017 vs. 100% post-2017). After controlling for other factors in multivariable Cox regression modeling, transplant after 2017 was a predictor of reduced mortality (HR 0.209 [0.06 - 0.71], p = 0.01). Significant differences were not observed in other secondary outcomes of recovery.

CONCLUSIONS: The new VA-ECMO strategy displayed reasonable survival and a remarkable improvement from the prior system.

J Thorac Cardiovasc Surg. 2022 May;163(5):1873-1885.e7. doi: 10.1016/j.jtcvs.2020.09.044. Epub 2020 Sep 16.

Trends in the use of hepatitis C viremic donor hearts Li SS, Osho A, Moonsamy P, et al.

OBJECTIVE: To examine trends in utilization of hearts from hepatitis C virus (HCV) viremic donors for transplantation, a strategy to expand organ availability.

METHODS: The United Network for Organ Sharing (UNOS) registry was queried for adult patients undergoing heart transplantation between 2015 and 2019. We excluded multiorgan transplants, incomplete data, and loss to follow-up. Nucleic acid testing (NAT) defined HCV status.

RESULTS: Between 2015 and 2019, a total of 11,393 adults underwent heart transplantation: 326 from HCV NAT+ donors and 11,067 from NAT- donors. The use of NAT+ hearts increased from 1 in 2015 to 137 in 2018 against a static number of NAT- organs.

The use of NAT+ hearts varied significantly across regions and individual centers. More than 75% of NAT+ hearts were transplanted in the Northeast region, leading to further travel (mean, 299 miles vs 173 miles for NAT- transplantations; P < .001), with longer ischemic times (mean: 3.52 hours vs 3.10 hours; P < .001). More than one-half of NAT+ transplantations were performed by 5 individual centers, and a single institution accounted for >20% of all transplantations from viremic donors. Survival in the 2 groups did not differ

by Kaplan-Meier analysis (P = .240), and multivariable regression showed no differences in acute rejection (P = .455) or 30-day mortality (P = .490). Of the 326 recipients of NAT+ hearts, 38 serocon34 CareManagement June/July 2022

verted and 14 became viremic within 1 year. Survival was 100% in the viremic patients and 97.4% in seroconverted patients at 1 year.

CONCLUSIONS: Heart transplantation from HCV viremic donors continues to increase but varies significantly across UNOS regions and individual centers. Short-term outcomes are comparable, but effects of seroconversion and long-term outcomes remain unclear.

Diabetes Care. 2022 Apr 27;dc212472. doi: 10.2337/dc212472. Online ahead of print.

The importance of office blood pressure measurement frequency and methodology in evaluating the prevalence of hypertension in children and adolescents with type 1 diabetes: The SWEET International Database Vazeou A, Tittel SR, Birkebaek NH, et al.

OBJECTIVE: The prevalence of hypertension is higher in children and adolescents with type 1 diabetes (T1D) compared with those without. This retrospective analysis of a large cohort of children and adolescents with T1D from the SWEET (Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference) international consortium of pediatric diabetes centers aimed to 1) estimate the prevalence of elevated office blood pressure (BP) and hypertension and 2) investigate the influence of BP measurement methodology on the prevalence of hypertension.

RESEARCH DESIGN AND METHODS: A total of 27,120 individuals with T1D, aged 5-18 years were analyzed. Participants were grouped into those with BP measurements at three or more visits (n = 10,440) and fewer than 3 visits (n = 16,680) per year and stratified by age and sex. A subgroup analysis was performed on 15,742 individuals from centers providing a score indicating BP measurement accuracy.

RESULTS: Among participants with BP measurement at three or more visits, the prevalence of hypertension was lower compared with those with fewer than three visits (10.8% vs. 17.5% P < 0.001), whereas elevated BP and normotension were higher (17.5% and 71.7% vs. 15.3% and 67.1%, respectively; both P < 0.001). The prevalence of hypertension and elevated BP was higher in individuals aged ≥13 years than in younger ones (P < 0.001) and in male than female participants (P < 0.001). In linear regression models, systolic and diastolic BP was independently determined by the BP measurement methodology.

CONCLUSIONS: The estimated prevalence of elevated BP and hypertension in children and adolescents with T1D is ∼30% and depends on the BP measurement methodology. Less frequent BP evaluation may overestimate the prevalence of hypertension.

Case Managers: There’s no better time to advance your career than now!

Whether you're an experienced Certified Case Manager (CCM), a new case manager looking to earn your CCM credential, or a case manager thinking about starting your own case management practice, Catherine M. Mullahy, RN, BS, CRRN, CCM and Jeanne Boling, MSN, CRRN, CDMS, CCM can help. Their award-winning case management education and training resources incorporate their decades of experience, leadership and success in case management. These CMSA Lifetime Achievement Award Winners and veterans who helped develop case management standards and codes of conducts have created ™Best in Class∫ tools to address your career needs and goals.

Here are just some of Mullahy & Associates' career-advancing resources: THE CASE MANAGER’S HANDBOOK, 6TH EDITION nT he definitive resource in case management nA trusted study guide for CCM preparation

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“You’ve Got This:” The Message to CCM and CDMS Exam Candidates —and All of Us continued from page 8 “something that can heal all wounds and right all wrongs.” When we focus on our strengths, we reinforce a positive state of mind. This, in turn, helps us become more resilient.

To become more aware and more resilient, we ground ourselves in the moment. We stay out of past and let the future unfold as it will. The present moment is rich with opportunity and potential. In a state of mindfulness, we remind ourselves of the truth we hold in our core: We’ve got this. We can do our best—and that is the best we can do. CM

Journey of Care Coordination and Integrated Case Management in the Veterans Health Administration continued from page 9 in providing input and information to complete the facility readiness assessment and resource survey.

The facility readiness assessment and resource survey examines ten domains of systems integration of care coordination, care management, and case management services across the organization. Stakeholders prioritize and identify system integrations opportunities by assessing the impact and effort required for each domain.

The readiness assessment will assist in developing the facility implementation plan to deliver CC&ICM practices across the organization.

The following critical action is the completion of the resource survey. The resource survey demonstrates the current state of care coordination staffing and resource perspective to obtain information on where care coordination occurs within the VA health care system. Additionally, the survey may assist the sites in identifying those 36 CareManagement June/July 2022

Celebrations and Reflections continued from page 3

Meeting Clients Where They Are, Even When They are Far Away continued from page 10

We hope you have many special moments to enjoy yourself with family and friends this summer.

We’ll be here when you return, as you continue to strive to “…make a difference…one patient at a time…”!!

Warmest regards,

Catherine M. Mullahy, RN, BS, CRRN, CCM, FCM, Executive Editor cmullahy@academyccm.org

who may fill the lead coordinator role, which is an integral component of the CC&ICM framework.

The lead coordinator is a supporting role that provides a single, readily accessible, and identifiable point of contact for a military service member, veteran, their family members, or caregiver. Lead coordinators offer effective communication and collaboration between veterans and VA health care or community providers, which contributes to improved veteran health outcomes and experience.

Systems changes involving multiple services and programs require a high level of collaboration and, therefore, can be difficult to achieve. The CC&ICM model with systems integration provides stability, structure, and standards across VA health care systems. The overall goal is to provide veterans with consistent, equitable, compassionate, and coordinated care.

CC&ICM believes in a proactive and whole health approach to veteran care to ensure core case management functions and best practices are deployed. CM

with their travel nightmare. The hospital did not know how to deal with the angry, exhausted, sleep deprived husband who was irrational in his expectations. We all believed the best chance for dual stability was to return them home as soon as possible. A return home meant that Carol could rehab near her family and friends, and Bob could get rest and support.

We consulted with a personal injury attorney to determine if a suit should be filed for the broken hip. The family concluded that their goal was to get Carol home and not pursue fault in this case. This is where the family allowed us to negotiate with the hospital to get Bob and Carol home. We insisted that the hospital coordinate and pay for an air ambulance, fully staffed with a physician and nurse, to fly them home. The hospital agreed.

Furthermore, we asked them to pay for transporting the car home so Bob could ride in the air ambulance with his wife. And finally, we asked for the hotel and all co-pays to be waived to which they also agreed.

The couple was transferred to a hospital in their hometown within three days of their call to us. Once she was in her hometown, Carol was able to focus on getting better. She completed her rehabilitation in a center one mile from their home. Bob was supported by family and friends, used his sleep apnea equipment, and visited Carol daily.

This was over two years ago. Carol was able to come home after her rehabilitation stay and the couple is living independently in their home. Carol is going to water exercise classes three days a week and is a social butterfly.

After sufficient rehabilitation, she expressed a desire to drive again, continues on page 37

CE3

Meeting Clients Where They Are, Even When They are Far Away continued from page 36

HIPAA (Part 1): What Is It and Why Should I Care?

which after significant testing and coordination, was granted.

This family needed to be home and together to recover from their ordeal. They are planning more trips this year, but before they go they are providing us the itinerary and will call us at the first sign of trouble, not after the fact. It is delightful to participate in improving the quality of life for these two people. We welcome the opportunity they provide us to help them face the challenges they encounter in the future.

This situation called upon us to calm a chaotic situation, for clients with different needs, all from thousands of miles away. Taking the time to meet Bob and Carol where they were, allowed us to accurately evaluate their needs, understand their perspectives, and develop a care management plan that successfully returned them to stability. This case has proved to us, we can still meet clients where they are… even if that happens to be thousands of miles away! CM

7. Bergland, C. (2015). Unconscious memories hide in the brain but can be retrieved. Psychology Today.

Reprinted by permission from “Case Management: Elevate, Educate, Empower” by Colleen Morley and Eric Bergman, Editors, CMSA Chicago, Westchester, Il 2021.

continued from page 26

8. Gustafson C., Lipton, B. (2017). The jump from cell culture to consciousness. Integrative Medicine (Encinitas, Calif.), 16(6), 44-50.

9. Lipton, B. H. (2005). The Biology of Belief. Second Edition, New York, Hay House, Inc 10. Bourbonnais R, Comeau M, Vézina M (1999). Job strain and evolution of mental health among nurses. Journal of Occupational Health Psychology, 4:95-105.

11. Porges, W. S. (2001). The polyvagal theory: phylogenetic substrates of a social nervous system. International Journal of Psychophysiology, 42, 233-146. https://doi.org/10.1016/S01678760(01)00162-3 12. Porges S. W. (2009). The polyvagal theory: new insights into adaptive reactions of the autonomic nervous system. Cleveland Clinic Journal of Medicine, 76(Suppl2), S86–S90. https://doi.org/10.3949/ ccjm.76.s2.17 13. Gerritsen, R., & Band, G. (2018). Breath of Life: The Respiratory Vagal Stimulation Model of Contemplative Activity. Frontiers in Human Neuroscience, 12, 397. https://doi.org/10.3389/ fnhum.2018.00397

PharmaFacts for Case Managers continued from page 30 of 18 years who received bevacizumab. Bevacizumab products are not approved for use in patients under the age of 18 years.

Antitumor activity was not observed among eight pediatric patients with relapsed GBM who received bevacizumab and irinotecan. Addition of bevacizumab to standard of care did not result in improved event-free survival in pediatric patients enrolled in two randomized clinical studies, one in high grade glioma (n= 121) and one in metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma (n= 154).

Based on the population pharmacokinetics analysis of data from 152 pediatric and young adult patients with cancer (7 months to 21 years of age), bevacizumab clearance normalized by body weight in pediatrics was comparable to that in adults.

Geriatric Use In an exploratory pooled analysis of 1,745 patients from five randomized, controlled studies, 35% of patients were ≥65 years old. The overall incidence of ATE was increased in all patients receiving bevacizumab with chemotherapy as compared to those receiving chemotherapy alone, regardless of age; however, the increase in the incidence of ATE was greater in patients ≥65

years (8% vs. 3%) as compared to patients <65 years (2% vs. 1%) CLINICAL TRIALS Various clinical trials have been conducted in specific cancer sites. Please see Product Insert for information.

How Supplied Alymsys (bevacizumab-maly) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a carton containing single-dose vial in the following strengths and packaging configurations: • 100 mg/4 mL (25 mg/mL): carton of one vial (NDC 701211754-1); carton of 10 vials (NDC 70121-1754-7).

• 400 mg/16 mL (25 mg/mL): carton of one vial (NDC 701211755-1); carton of 10 vials (NDC 70121-1755-7).

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.

Please consult Product Insert for full prescribing information.

Alymsys is manufactured and distributed by Amneal Pharmaceuticals LLC. June/July 2022 CareManagement 37

Becoming Patient Centric continued from page 2 and caring. We make sure family and friends are involved as determined by the patient. We make sure the entire healthcare team is working together.

We support the patient and family emotionally.

The transition to a patient-centric approach can be time consuming and somewhat expensive, but perhaps the biggest challenge is changing the culture. We need buy-in from everyone to ensure that all staff are prepared and adequately trained and that the proper expectations are set across the organization. The patient-centric organization will have new experiences that will have an immediate impact on patient care.

Reimbursement policies will have to be adjusted. New tools and systems will be introduced. Change will be inevitable and, in some cases, difficult.

Case managers are pivotal in creating patient-centric organizations.

As patient advocates, we are patient centric, and thus case managers

Applying Standards to Persons Served with Limb Loss, Brain Injury, and Spinal Cord Injury continued from page 7 arrange for services for these patients.

Mobility is of critical importance to persons with SCI, and it is essential that the program work with patients to learn that same mobility in home and community settings and not just in the environment of the program. This may include trialing different types of wheelchairs (power and manual) and also training and assessing patient mobility on varied surfaces that will be found in the community (eg, uneven grassy surfaces, gravel, and ramps).

For persons with SCI, intimacy and sexual health may be areas of concern after the injury takes place. Having 38 CareManagement June/July 2022

should lead the charge in reforming the healthcare delivery system. It would be easy for your organization to become patient centric. Start by having open discussions with your coworkers about what patient-centric means, and be sure to include patients in the discussion. Listen to each other and be respectful of all ideas. As the discussion grows, involve key decision makers in your organization. There will be a groundswell of enthusiasm, which will speed implementation.

A truly patient-centric organization will improve healthcare delivery for patients, providers, and everyone involved in healthcare delivery. Case managers can play a leading role in this healthcare reorganization.

Gary S. Wolfe, RN, CCM, FCM, Editor-in-Chief gwolfe@academyccm.org ACCM: Improving Case Management Practice through Education

a concrete plan in these areas will give patients a clear understanding of what next steps can be taken and also provide the team with structure to understand what services can either be provided by the program or arranged by an outside provider. Because of the mobility limitations of a person with SCI, it’s not uncommon for individuals to need to hire and manage a personal assistant, and there is guidance from the CARF standards on what specific areas to educate a patient on in this area.

If you are interested in receiving more information about CARF accreditation in your setting or to identify IPR programs in your area, contact Terrence Carolan at tcarolan@carf.org. CM

Nurses! continued from page 5 become a task-oriented profession.

She said that nursing needs to be “re-humanized.” It’s important to stop performing tasks, make eye contact, smile, have a discussion and sit down when clinicians are talking to patients.

• The importance of remaining calm regardless of the circumstances was important to the well-being of patients, according to another practitioner. No matter the situation, don’t let patients see you sweat. Clinicians can’t freak out and provide effective assistance to patients!

• Finally, a nurse reminded clinicians about the importance of what they do: “Every day you wake up and you get out of bed and you know you’re going to help at least ten people today...You could possibly be what stands between life and death for them. If that’s something you want to take on, it’s a calling you have to approach with the utmost respect and compassion.”

This may be the most important point. Nurses work hard every day because it’s a calling, not a job. We cannot lose sight of the fact that nurses are the heart of healthcare. We simply must treasure and cherish those who make it possible to provide care to patients. CM ©2022 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.

Why Every Provider Must Establish and Maintain a Fraud and Abuse Compliance Program continued from page 4 We have read that, before implementing Compliance Programs, providers must conduct expensive internal audits that can take many months to complete. Is this true?

While beginning the compliance process with an extensive internal audit is certainly one way to proceed, it is not the only viable way to work toward compliance. It is equally valid to begin with Compliance Programs that are customized for the organization that includes training for all employees about fraud and abuse and Compliance Programs. Then all staff members can subsequently participate in internal compliance activities, including audits, with a process in place to handle any issues that arise as a result of the audits, We have all sorts of policies and procedures in our organization. Why do we need something else called a Compliance Program?

Greetings from the New President of CMSA continued from page 6 Case Management Fellow

The Case Management Fellow program launched last year with the announcement of the CMSA Founding Fellows. Case Management Fellows (FCM) will represent a diverse community of thought leaders who take an active role in identifying future trends and issues affecting case management and serve the public and the case management profession by advancing the standards of practice through excellence. The 2022 Class of Case Management Fellows were inducted in June during the CMSA annual conference.

Compliance Programs are specific types of documents that routinely address issues that providers do not usually cover in internal policies and procedures. In addition, providers may not gain benefits under the Federal Sentencing Guidelines described in paragraph one (1) above if there is no formal document called a Compliance Program.

We just spent a lot of money to become accredited or reaccredited. Doesn’t certification mean that we are in compliance?

On the contrary, Compliance Programs appropriately address potential fraud and abuse issues. They also include mechanisms for helping to ensure compliance such as processes for identification and correction of potential problems that are not addressed during the certification process. In other words, organizations may be accredited but fail to meet applicable compliance standards for fraud and abuse.

Will the fact that our organization has a Compliance Program make any difference with regard to the outcome of fraud and abuse investigations and the imposition of Corporate Integrity Agreements (CIA’s)?

Case Management Boot Camp

Case management is a growing health care profession, with a presence in every health delivery setting. Professionals moving to case management positions may or may not have access to adequate orientation and training. They often learn on the job and are not exposed to skills that advance the practice of case management. CMSA is excited to fill this gap with a newly developed CMSA CM Boot Camp for case managers looking to build their skills and practice. Ideal for the case manager with less than 5 years of experience and those looking to change their area of practice, the CM Boot Camp program will include interactive exercises, activities, and case studies to

Yes, it may make a considerable difference based on statements from the OIG. If providers have Compliance Programs in place that are current and fully implemented, the OIG may be less aggressive in pursuing potential violations. When the OIG actually discovers problems with fraud and abuse in organizations, providers are usually asked to develop and implement a Corporate Integrity Agreement (CIA). The OIG often requires CIA’s to include a process for stringent monitoring by the OIG on a continuous basis. These monitoring activities can be extremely burdensome to providers in terms of both time and money. Providers with valid Compliance Programs are not necessarily asked to develop and implement CIA’s.

Now is the time for all providers to recognize and act upon the need to establish and maintain Compliance Programs. “Working on it” is no longer good enough. CM ©2022 Elizabeth E. Hogue, Esq. All rights reserved. No portion of this material may be reproduced in any form without the advance written permission of the author.

provide real-life scenarios and practical application. CM Boot Camp officially launched in June, with a preconference session available for in-person attendees, with more to come this year.

What’s Next?

New programs, benefits, and opportunities are planned throughout the year, and we can’t wait to share them all with you in future CMSA updates.

And let’s not forget to celebrate Case Management Week in October! I am looking forward to seeing and hearing all about the celebrations that will be going on. CM

June/July 2022 CareManagement 39

HOW TO CONTACT US

REFER A COLLEAGUE TO ACCM Help your colleagues maintain their certification by referring them to ACCM for their continuing education needs. They can join ACCM at www.academyCCM.org/join or by mailing or faxing the Membership Application on the next page to ACCM. Why join ACCM? Here are the answers to the most commonly asked questions about ACCM Membership: Q: Does membership in ACCM afford me enough CE credits to maintain my CCM certification?

A: If you submit all of the CE home study programs offered in CareManagement, you will accumulate 90 CE credits every 5 years.

Q: D oes membership in ACCM afford me enough ethics CE credits to maintain my CCM certification?

A: If you submit all of the CE home study programs for ethics credits offered in CareManagement, you will accumulate at least 10 ethics CE credits every 5 years.

Q: Are CE exams available online?

A: Yes, ACCM members may mail exams or take them online. When taking the exam online, you must print your certificate after successfully completing the test. This is a members only benefit. If mailing the exam is preferred, print the exam from the PDF of the issue, complete it, and mail to the address on the exam form. : Where can I get my membership certificate?

Q A: Print your membership certificate instantly from the website or click here. Your membership is good for 1 year based on the time you join or renew.

Q: How long does it take to process CE exams?

A: Online exams are processed instantly. Mailed exams are normally processed within 4 to 6 weeks.

Q: Do CE programs expire?

A: Continuing education programs expire in approximately 90 days.

Continuing education programs that offer ethics CE credit expire in 1 year.

Q: Is your Website secure for dues payment?

A: ACCM uses the services of PayPal, the nation’s premier payment processing organization. No financial information is ever transmitted to ACCM. application on next page

join/renew ACCM online at www.academyCCM.org 40 CareManagement June/July 2022

Editor-in-Chief/Executive Vice President: GARY S. WOLFE, RN, CCM, FCM 541-505-6380 email: gwolfe@academyccm.org Executive Editor: Catherine M. Mullahy, RN, BS, CRRN, CCM, FCM, 631-673-0406 email: cmullahy@academyccm.org Publisher/President: Howard Mason, RPH, MS, 203-454-1333, ext. 1; e-mail: hmason@academyccm.org Art Director: Laura D. Campbell e-mail: lcampbell@academyccm.org Copy Editor: Esther Tazartes e-mail: justice@dslextreme.com Subscriptions: 203-454-1333 Website: academyCCM.org

ACCM

Academy of Certified Case Managers

Executive Vice President: Gary S. Wolfe, RN, CCM, FCM 541-505-6380 email: gwolfe@academyccm.org Member Services: 203-454-1333, ext. 3 e-mail: hmason@academyccm.org Phone: 203-454-1333; fax: 203-547-7273 Website: academyCCM.org Vol. 28, No. 3, June/July 2022.

CareManagement (ISSN #1531-037X) is published electronically six times a year, February, April, June, August, October, and December, and its contents are copyrighted

by Academy of Certified Case Managers, Inc., 2740 SW Martin Downs Blvd. #330, Palm City, FL 34990; Tel: 203-454-1333; Fax: 203-547-7273.

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HEALTH CARE CASE MANAGEMENT

GET CERTIFIED.

STAY CERTIFIED.

DEVELOP OTHERS.

Ready to demonstrate your value?

When you become a CCM®, you join the top tier of the nation’s case managers. It’s a commitment to professional excellence, elevating your career and influencing others.

The CCM is the oldest, largest and most widely recognized case manager credential.

Those three letters behind your name signal the best in health care case management.

Employers recognize proven expertise.

Among employers of board-certified case managers: ●●50% require certification ●●62% help pay for the exam ●●45% help pay for recertification Join the ranks of more than 45,000 case managers holding the only cross-setting, cross-discipline case manager credential for health care and related fields that’s accredited by the National Commission for Certifying Agencies.

You’re on your way to great things.

H2R6.26.2018CMBOK

GET CERTIFIED. STAY CERTIFIED. DEVELOP OTHERS. Commission for Case Manager Certification | 1120 Route 73, Suite 200 | Mount Laurel, NJ 08054 ccmchq@ccmcertification.org | www.ccmcertification.org | 856-380-6836